Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Rare Diseases

Sarcoma

Recurrence

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Neoplasms, Bone Tissue

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Bone Neoplasms

Osteosarcoma

Disease Attributes

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Connective Tissue Diseases

Bone Diseases

Soft Tissue Sarcoma

Ewing Sarcoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Vaccines

Temozolomide

Immunomodulating Agents

Camptothecin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Participants randomized to Group A received oral temozolomide 100 mg/m2 daily (Days 1-5), total dose 500 mg/m2/cycle) and oral irinotecan 50 mg/m2 daily (Days 1-5, total dose 250 mg/m2/cycle). Vigil immunotherapy was administered at a concentration of 1 X 10e6 cells/dose given via intradermal injection on Day 15 of each cycle. 1 cycle = 21 days

Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.

Participants randomized to Group B received oral temozolomide 100 mg/m2 daily (Days 1-5), total dose 500 mg/m2/cycle) and oral irinotecan 50 mg/m2 daily (Days 1-5, total dose 250 mg/m2/cycle).

1 cycle = 21 days

Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.

Participants randomized to Group B were able to receive Vigil immunotherapy at a concentration of 1 X 10e6 cells/dose given via intradermal injection on Day 15 of each cycle. Confirmation of progression by central radiologist and pre-approval from sponsor was required. 1 cycle = 21 days

Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms.

Vigil

Injectable formulation of irinotecan was distributed from central supplier. 1 Cycle (5 doses of 50 mg/m2 per syringe) was drawn into provided oral syringes and dispenses to the subject with instructions to refrigerate until administration.

Dose: 100 mg/m2 daily, oral Schedule: Days 1-5, every 21 days Administered at least 1 hour before Irinotecan.

John Nemunaitis, MD

The goal of this clinical trial was to compare participants with first relapse or refractory Ewing's sarcoma when treated with investigational product (Vigil) in addition to the standard treatment of irinotecan and temozolomide compared to the standard treatment of irinotecan and temozolomide alone. The main question it aimed to answer is "Will participants who receive Vigil in addition to irinotecan and temozolomide have a prolonged time to progression and improved quality of life compared to the participants who receive irinotecan and temozolomide alone?".

This was a multicenter, Phase III study in participants with metastatic Ewing's sarcoma Family of Tumors (ESFT) refractory/intolerant or recurrent to 1 prior line of chemotherapy. Participants who agreed to participation had tumor tissue harvested from a scheduled standard surgical procedure (e.g., tumor biopsy or palliative resection). The tumor tissue removed was shipped to Gradalis, Inc. to attempt to manufacture the investigational product, Vigil.

Subjects who met eligibility criteria including manufacture of a minimum of 4 doses of Vigil were randomized 1:1 to either Group A (Vigil + Irinotecan + Temozolomide (Tem/Iri)) or Group B (Irinotecan + Temozolomide). Screening for the main portion of the study occurred as early as one week but no later than 8 weeks following tumor procurement.

Subjects received repeat cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or other criterion was met for discontinuation from study. Subjects randomized to Group A (Vigil + Tem/Iri) received up to 12 doses depending upon the quantity of Vigil manufactured from the surgical specimen. 1 cycle = 21 days. If irinotecan + temozolomide was administered beyond 12 cycles, it was administered off study. Subjects randomized to Group B (Tem/Iri) may have crossed over to receive single agent Vigil every 21 days following End of Treatment assessment and documented disease progression confirmed by central radiology vendor, for up to 12 doses of Vigil depending upon the quantity of Vigil manufactured.

Participants were managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses including IFNγ-ELISPOT analysis of cytotoxic T cell activation in response to autologous tumor antigens will be collected at tissue procurement, post-procurement screening and Day 1 (prior to chemotherapy administration) at Cycles 2, 4, and 6, end of treatment (EOT), 3 months after EOT, and every 6 months thereafter. Blood for ctDNA analysis was collected at tissue procurement, prior to chemotherapy administration at baseline and on Day 1 prior to chemotherapy administration at Cycles 2, 3, 4, and 6, and EOT. After progression, participants were contacted quarterly for documentation of post study therapies and survival status information.

Participants were randomized 1:1 to either Group A (Vigil + irinotecan and temozolomide) or Group B (irinotecan and temozolomide alone). Participants randomized to Group B were able to receive Vigil (Cross-Over) after confirmation of progression by central radiologist and sponsor approval.

A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide

A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma

Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) for target lesions and assessed CT/MRI by local investigator.

OS is defined as time from randomization to death or to the date of last follow-up. The date of last follow-up confirming survival will be used as the censoring date for subjects who are alive and/or do not have a known date of death.

ORR is defined as the proportion of participants who have prolonged stable disease or a partial or complete response or complete response to therapy according to RECIST 1.1.

Participants were considered eligible for treatment, if the tissue submitted to Gradalis met all criteria, including manufacturing product release criteria.

Gradalis, Inc.

Participants randomized to Group A received oral temozolomide 100 mg/m2 daily (Days 1-5), total dose 500 mg/m2/cycle) and oral irinotecan 50 mg/m2 daily (Days 1-5, total dose 250 mg/m2/cycle). Vigil immunotherapy was administered at a concentration of 1 X 10e6 cells/dose given via intradermal injection on Day 15 of each cycle. 1 cycle = 21 days

Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion was met for discontinuation from study.

Group A: Vigil in Combination With Irinotecan and Temozolomide

Participants randomized to Group B received oral temozolomide 100 mg/m2 daily (Days 1-5), total dose 500 mg/m2/cycle) and oral irinotecan 50 mg/m2 daily (Days 1-5, total dose 250 mg/m2/cycle).

1 cycle = 21 days

Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion was met for discontinuation from study.

Group B: Irinotecan and Temozolomide

Participants assigned to Group B crossed-over to received Vigil monotherapy at a concentration of 1 X 10e6 cells//dose via intradermal injection every 21 days following End of Treatment assessment.

Participants received up to 12 doses of Vigil depending upon the quantity of Vigil manufactured.

Cross-over to Vigil Alone

Participants randomized to Group A received oral temozolomide 100 mg/m\^2 daily (Days 1-5), total dose 500 mg/m\^2/cycle) and oral irinotecan 50 mg/m\^2 daily (Days 1-5, total dose 250 mg/m\^2/cycle). Vigil immunotherapy was administered at a concentration of 1 X 10e6 cells/dose given via intradermal injection on Day 15 of each cycle. 1 cycle = 21 days

Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.

Participants randomized to Group B received oral temozolomide 100 mg/m\^2 daily (Days 1-5), total dose 500 mg/m\^2/cycle) and oral irinotecan 50 mg/m\^2 daily (Days 1-5, total dose 250 mg/m\^2/cycle).

1 cycle = 21 days

Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

An assessment of Performance Status (PS) on the Karnofsky or Lansky scale is standard way of measuring the ability of cancer patients to perform ordinary tasks. The PS scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. The assessment is made by an investigator during the physical exam of the subject.

Baseline Performance Status

Only 1 subject randomized to Group B was eligible to Cross-over to receive Vigil.

Early termination of trial leading to small numbers of subjects analyzed. Technical problems with measurement leading to unreliable or uninterpretable data.

Clinical and Regulatory Operations

Participants randomized to Group B received oral temozolomide 100 mg/m2 daily (Days 1-5), total dose 500 mg/m2/cycle) and oral irinotecan 50 mg/m2 daily (Days 1-5, total dose 250 mg/m2/cycle). 1 cycle = 21 days

Participants continued treatment for a maximum of 12 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.

PFS is not adequately assessable for difference between cohorts given only 5 participants were enrolled and received treatment.

Progression Free Survival (PFS)

OS is not adequately assessable for difference between cohorts given only 5 participants were enrolled and received treatment.

Overall Survival (OS)

No subjects on trial achieved a partial or complete response, therefore the ORR was not determined.

Overall Response Rate (ORR)

Participants who underwent tissue procurement and the processed tissue samples were successfully shipped to Gradalis whereby Vigil production was attempted.

Total Number of Tissue Procurements

All enrolled subjects who completed tissue procurement and the tissue was received by Gradalis for Vigil Manufacture. Any subjects whose tissue was not submitted to Gradalis was excluded in the analysis.

Vigil Manufacture Success Rate: Number of Participants Eligible for Treatment on the Main Study.

Main Study

Group B Crossover to Vigil Alone

Digestive System Diseases

Gastrointestinal Stromal Tumors

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Amino Acids

Sunitinib

Tyrosine Kinase Inhibitors

Imatinib Mesylate

Tyrosine

Participants with unresectable or metastatic GIST who will receive orally administered THE-630.

Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 at the recommended Phase 2 dose based on the dose escalation phase.

Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 at the recommended Phase 2 dose based on the dose escalation phase.

Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 at the recommended Phase 2 dose based on the dose escalation phase.

Oral THE-630 administered once daily in a continuous regimen

THE-630

Stew Kroll

This study will assess the safety, efficacy, and pharmacokinetics of THE-630 in participants with advanced gastrointestinal stromal tumors (GIST).

The drug being tested in this study is called THE-630, an orally administered KIT tyrosine kinase inhibitor. The study will be conducted in two parts: a dose escalation phase, followed by an expansion phase. The patient population of the initial dose escalation phase (Phase 1) of the trial will include patients with unresectable or metastatic GIST. Patients must have disease progression on or be intolerant to imatinib therapy and have also received at least 1 of the following: sunitinib, regorafenib, ripretinib, or avapritinib. The primary objective of the dose escalation phase is to determine the safety profile of oral THE-630, including the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D).

Once a recommended dose has been determined in the escalation phase, the expansion phase (Phase 2) will enroll 3 cohorts of patients with unresectable or metastatic GIST defined by prior therapy:

* Cohort 1: Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib (≥5th Line).
* Cohort 2: Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting (3rd-4th Line).
* Cohort 3: Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST (2nd Line).

The safety and tolerability of orally administered THE-630 will continue to be assessed in the expansion cohorts. However, the primary objective of the expansion component of the trial is to evaluate the anti-tumor activity of THE-630 in these GIST patient populations.

A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

A Phase 1/2 Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of the Oral KIT Inhibitor THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Cmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Tmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

AUC 0-24 of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

AUC 0-t of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses

Theseus Pharmaceuticals

Nervous System Diseases

Joint Diseases

Contracture

Fibroma

Dupuytren Contracture

Neoplasms, Fibrous Tissue

Muscular Diseases

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Percutaneous needle fasciotomy with corticosteroid injection

Percutaneous needle fasciotomy with saline injection

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Percutaneous needle fasciotomy

Corticosteroid injection

Saline injection

Laura H Matthiesen, MS, PhD-student

Jeppe Lange, MD, PhD

Laura H Matthiesen, PhD Student

Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.

Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial

Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Regionshospitalet Silkeborg

Medical Student, PhD Student

Micronutrients

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Hematinics

Vitamins

Doxorubicin

Liposomal doxorubicin

Leucovorin

Methotrexate

Cisplatin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

Doxorubicin 25 mg / m2 IV on days 1-3, Cisplatin 120 mg / m2 IV on day 1 against the background of hyperhydration. G-CSF support from 4 to 13 days. Methotrexate 12 g / m2 at 28 and 35 days IV with leucovorin 60 mg / m2 in the first 5 days after each administration of methotrexate. The interval between cycles is 42 days

Doxorubicin 25 mg / m2 IV on days 1-3, Cisplatin 120 mg / m2 IV on day 1 against the background of hyperhydration. G-CSF support from 4 to 13 days. The interval between cycles is 28 days

Doxorubicin, Cisplatin, Methotrexate

Doxorubicin, Cisplatin

Anastasia Tararykova

Andrei Konev

Beniamin Bokhyan, PhD

Aslan Valiev, PhD

Two cycles of neoadjuvant three-component chemotherapy according to the MAP prototoc: Doxorubicin 25 mg / m2 IV on days 1-3, Cisplatin 120 mg / m2 IV on day 1 against the background of hyperhydration. G-CSF support from 4 to 13 days. Methotrexate 12 g / m2 at 28 and 35 days IV with leucovorin 60 mg / m2 in the first 5 days after each administration of methotrexate. The interval between cycles is 42 days.

The advantage of this regimen is to use the three-component chemotherapy regimen, which should increase the degree of tumor necrosis and increase the rate of tumor response to treatment, which will further improve the disease prognosis. Currently, the use of such treatment for adult patients (over 24 years old) is controversial. Since it is believed that the elimination of methotrexate in adult patients is more delayed than in patients under 24 years old, and can lead to serious adverse events (SAE). However, the use of modern standard methods of hemodialysis makes it possible to avoid SAE.

The role of methotrexate in neoadjuvant chemotherapy for bone tumors is a topic for debate. However, the benefits of methotrexate have been confirmed in at least one phase II study showing better results with high doses of methotrexate in the context of triple chemotherapy. Moreover, many studies have shown a correlation between peak serum methotrexate levels, tumor response to chemotherapy, and treatment outcome. Thus, it is possible that the negative results of the effectiveness of methotrexate have been compromised due to the administration of insufficient doses or incorrect administration of the drug. The optimal regimen of methotrexate administration has not been established. However, the control group in the EURAMOS-1 study of the American Osteosarcoma Research Group (AOST) is considered as the standard. The main practical problem with the use of triple chemotherapy in a group of patients aged 24 and older is that the slow clearance of methotrexate can delay the administration of the next cycle of doxorubicin-cisplatin, thereby reducing the dose intensity and adversely affecting the outcome. Currently, there are both isolated clinical cases and observations of a small number of included patients. The use of three-component neoadjuvant chemotherapy for primary bone tumors will improve the rate of response to treatment, reduce the frequency of recurenses and disease progression.

Neoadjuvant Combination of Doxorubicin, Cisplatin and Methotrexate in Patients Aged 24-40 Years With Primary Bone Tumors

Neoadjuvant Three-component Chemotherapy Based on a Combination of Doxorubicin, Cisplatin and Methotrexate in Patients Aged 24-40 Years With Primary Bone Tumors to Increase the Response Rate Compared With Two-component Chemotherapy

Proportion of patients who have a partial or complete response to therapy

Proportion of tumor necrosis after chemotherapy

Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0

Blokhin's Russian Cancer Research Center

Leiomyoma

Myofibroma

Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure are treated with the Philips MR-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.

Philips MR-guided HIFU system

Erik Fosse, Professor

This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary 3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.

Fibroids occur in 20-50% of women over 30 years of age, and with increasing size produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infertility. Uterine leiomyomas are benign tumors originating from smooth muscle cells of the uterus and occasionally the smooth muscle of uterine blood vessels. Fibroids are estrogen dependent tumors ranging in size and number and can be found within the myometrium(intramural), at the uterine periphery extending to the serosa (subserosal), or pushing into the uterine cavity (submucosal). Symptomatic fibroids impact health and well-being of the female including lost work hours and reduced quality of life.

Current medical treatments include invasive removal of the fibroid (hysterectomy, myomectomy), drug therapy (GnRH analogues or progestin compounds) or treatments causing necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. For the relief of symptoms, women wishing to preserve the uterus may choose between invasive procedures of myomectomy, Uterine Artery Embolization (UAE), ablation or cryotherapy. The surgically invasive procedures require anesthesia, hospital stays, and long recovery periods. HIFU may offer an alternative to the above mentioned surgically invasive procedures.

In MRI-guided High Intensity Focused Ultrasound (HIFU), the ultrasound generated by the transducer is focused into a small focal tissue volume at specific target locations. During treatment, the beam of focused ultrasound energy penetrates through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis. The MRI system allows 3D planning, means of measuring the temperature increase generated by HIFU, and the capability to quantifying the energy/dose delivered to the treatment zone.

This study is a single-center, single arm, non-randomized trial evaluating the safety, technical effectiveness and volume treatment capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine fibroid patients. Patients who have symptomatic uterine fibroids, who are eligible according to the inclusion and exclusion criteria and provide informed consent will be enrolled in this study. It is anticipated that women will participate in the study for a 2month period to include the screening, HIFU treatment and post treatment follow-up.

This clinical study is designed to confirm safety and demonstrate technical effectiveness of the Philips HIFU system for Uterine Fibroid treatment. Safety will be primarily assessed by evaluating minor complications and adverse events, and technical effectiveness will primarily be assessed with MRI measurements. Specific primary and secondary endpoints are detailed below.

The study will use a combination of three primary endpoints: MR imaging of ablated volumes and minor complications/adverse events analysis to establish the safety and technical effectiveness of the Philips MR-HIFU system. These endpoints will determine the trial success.

The treatment capabilities and technical effectiveness of the Philips MR-guided HIFU system will be assessed by (measurement type is noted in parentheses)

1. Comparing the actual MR-measured ablated volumes to MR thermal dose predicted volumes Safety of the Philips MR-guided HIFU system will be demonstrated by
2. Evaluating any minor complications or adverse events that result from the MR-guided HIFU treatment
3. Verifying with MR imaging that no unintended lesions are formed as a result of the Treatment

   In addition, the following endpoints will be collected to supplement the primary outcomes:
4. Pain and discomfort scores before, during and after treatment: These endpoints will be recorded using a 10-point visual analog scale for pain 4-point scale for discomfort.
5. Return to Activity: This duration in days will be determined by the time after which the patients return to work (i.e. days after leaving the hospital) or to the usual activities for those not employed.
6. Length of Hospital Stay (LOS): This duration in hours will be measured from the time the patient will arrive to the hospital until she will leave the hospital.
7. Quality of Life questionnaires: the SF-36(http://www.sf36.org/tools/SF36.shtml) and UFS-QoL (which includes SSS)

Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner

Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner

Number of adverse events reported in the study divided by the total number of treated subjects.

Mean absolute change in the Symptom Severity Score (SSS) of the uterine Fibroid Symptoms Quality of Life questionnaire from baseline to 30 days after treatment.

Mean absolute score change in the Quality of Life questionnaire from baseline to 30 days after treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide	NCT03495921	Ewing Sarcoma Ewing Family of... Ewing's Tumor M... Ewing's Sarcoma... Ewing's Tumor R... Rare Diseases Sarcoma Neoplasms, Conn... Neoplasms by Hi... Neoplasms, Bone... Neoplasms, Conn... Sarcoma, Ewing Neoplasms	Vigil Irinotecan Temozolomide	2 Years -	Gradalis, Inc.
A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)	NCT05160168	Gastrointestina... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Gastrointestina... Digestive Syste... Digestive Syste... Gastrointestina...	THE-630	18 Years -	Theseus Pharmaceuticals
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Neoadjuvant Combination of Doxorubicin, Cisplatin and Methotrexate in Patients Aged 24-40 Years With Primary Bone Tumors	NCT05057130	Osteosarcoma Neoplasms, Conn... Neoplasms, Conn... Sarcoma Sarcoma of Bone	Doxorubicin, Ci... Doxorubicin, Ci...	24 Years - 40 Years	Blokhin's Russian Cancer Research Center
Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner	NCT01064960	Uterine Leiomyo...	Philips MR-guid...	18 Years - 59 Years	Philips Healthcare

Spots Global Cancer Trial Database for neoplasms, connective tissue