Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Nervous System Diseases

Leiomyoma

Myofibroma

Pain

Pelvic Pain

Endometriosis

Adenomyosis

Pelvic Inflammatory Disease

Pelvic Infection

Menorrhagia

Metrorrhagia

Communicable Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neurologic Manifestations

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Diseases

Hemorrhage

Uterine Hemorrhage

Menstruation Disturbances

Adnexal Diseases

Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Laparoscopic hysterectomy

Abdominal hysterectomy

Kimberly Kho, MD, MPH

The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.

The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.

Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

1) Patient-centered outcomes composite

1. Quality of life - measured using the Short Form 12 (SF-12v2),
2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ)
3. Body image - measured using the Body Image Scale (BIS)
4. Return to normal activity -measured using the Activities Assessment Scale (AAS)
5. Pain - measured using a 10 point likert scale
6. Productivity - measured using a questionnaire about missed work

Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated

Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy

University of Texas Southwestern Medical Center

Associate Professor, Department of Obstetrics and Gynecology

Digestive System Diseases

Rare Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Quality of Life

Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data.

Questionnaires will be administered to participants

Assessment of patient-reported outcomes (PROs)

Geoffrey Buckle, MD, MPH

Michael Mwachiro, MBChB

Fatma F Some, MBChB, MMed

Gift Mulima, MBBS

Yona Ringo, MD, MMed

Alita Mrema, MD, MMed

Blandina Mmbaga, MD, MMed,PhD

Katherine Van Loon, MD, MPH

This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.

SPECIFIC AIMS:

Aim 1: To describe the types of treatments administered for all patients diagnosed with EC at participating AfrECC sites, including chemotherapeutic regimens, radiation therapy, chemo-radiotherapy, esophageal stenting, esophagectomy, and basic supportive care.

Aim 2: To evaluate the effect of different EC treatment modalities on patient reported outcomes during and after completion of treatment.

Aim 3: To measure the effect of different treatment modalities on overall survival.

Treatment Outcomes of Esophageal Cancer

Descriptive statistics will be used to describe the proportion of EC patients receiving treatment with each modality at participating AfrECC sites. The investigators will assess the associations between demographic and clinicopathologic characteristic and treatment modalities employed (chemotherapy, radiotherapy, chemo-radiation, esophageal stenting, esophagectomy, supportive care alone, or a combination of these treatments)

The 6-item Modified Rosenblatt Index by Rosenblatt, et al. adapted for use within a resource-limited context evaluates EC related parameters scored on a Likert scale assessing presence and severity of symptoms: Odynophagia (0=no pain on swallowing to 3=severe pain); Dysphagia (0=normal, no dysphagia to 4=unable to swallow saliva); Regurgitation (0=never to 3=constant); Chest and/or Back Pain (0=no pain to 2=pain not relieved by non-narcotics or requiring opiate medication); World Health Organization (WHO) performance status/Overall Well-Being (0="A lot better" to 4="A lot worse"). Scores will be assessed at the following time points: Baseline, 1 month and 3 months after initiation of treatment, and every 3 months thereafter.

Survival will be defined as the time elapsed from date of diagnosis (either confirmed or date of diagnostic modality leading to presumptive clinical diagnosis) to date of death. For participants who are not deceased, censorship will be performed on the date when the participant was last known to be alive.

Westat

African Esophageal Cancer Consortium (AfrECC)

National Cancer Institute (NCI)

Celgene Corporation

University of California, San Francisco

Uterine Cervical Neoplasms

Papillomavirus Infections

Virus Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

All Drugs and Chemicals

Vaccines

Automated, system-generated mailed or text message reminders

Parent Reminders

1. Workflow modifications to reduce missed opportunities for vaccination
2. Provider- and clinic-level audit and feedback
3. Provider \& staff training on workflow modifications and communication strategies

Multicomponent clinic-system strategies

Parent reminders and multicomponent clinic-system strategies

Combined Condition

Roshan Bastani, PhD

Beth Glenn, PhD

UCLA and Northeast Valley Health Center (NEVHC), a large, multi-site Federally Qualified Health Center (FQHC), are partnering to address underutilization of the prophylactic HPV vaccine among underserved, ethnic minority adolescents receiving care through FQHCs. We will use a cluster randomized 2x2 stepped-wedge factorial study design, implemented in seven NEVHC clinics, to compare the effectiveness of parent reminders (mailed and text), multi-component clinic system strategies, a combined intervention (parent reminders + clinic system strategies) and usual care on HPV vaccine series completion among NEVHC adolescent patients. FQHCs provide essential health care to underserved groups and have the infrastructure to sustain effective strategies to improve preventive care delivery. Therefore, study findings will be invaluable for informing future efforts to improve HPV vaccination at the population-level.

The primary aims of this study are to: 1) Examine the effects of two types of parent reminders (mailed, text) and multicomponent clinic system strategies on HPV vaccine completion compared to usual care, 2) Examine the comparative effectiveness of the reminders versus the clinic system strategies and 3) Examine whether combining parent reminders with the clinic system strategies produces larger effects compared to either type of intervention implemented alone.

Additional aims include:

* Explore the relationship between child age (12-14 years versus 15-17 years) and intervention effectiveness, due to the difference in dosing schedules for the two age groups.
* Examine parent (e.g., language preference) and provider (e.g., specialty) characteristics that may act as moderators of intervention effectiveness.
* Assess parent perspectives and experiences related to the different interventions.
* Examine the implementation process (including adaptations) for each of the interventions.
* Disseminate study findings widely to a local and national audience of relevant stakeholders.

The multicomponent clinic system strategies include workflow modifications to minimize missed opportunities for vaccination, provider- and clinic-level audit and feedback, establishment of clinic-level policies and protocols, and will also include provider and staff training regarding workflow modifications and patient communication strategies.

The study will be implemented across six study periods of 12 months each. The seven NEVHC clinics will be randomized into three groups (A, B, C). Following a 12-month start-up and observation period (Period 1), as part of a stepped wedge design, Group A will implement the parent reminders beginning in Period 2, Group B will implement the clinic-based intervention beginning in Period 3, and Group C will implement the combined condition beginning in period 4. In Period 5, Group A will crossover to the combined condition. This change from the original protocol was approved by the study funder as of Fall 2021.

Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs

We will assess completion of the HPV vaccine series based on the number and the timing of the HPV vaccine doses received according to data in NEVHC's electronic health record system. We will determine completion status based on guidelines from the CDC Advisory Committee on Immunization Practices. For adolescents who initiated the HPV vaccine series before the age of 15, completion will be defined as receiving 2 doses of the HPV vaccine a minimum of 5 months apart. For adolescents who initiated the HPV vaccine series at age 15 or older, completion will be defined as having received 3 doses with the second dose administered at least one month after the first, the third dose received at least 3 months after the second, and the first and third doses administered at least 5 months apart from each other.

Patient-Centered Outcomes Research Institute

University of California, Los Angeles

Professor, Health Policy and Management, UCLA Fielding School of Public Health

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgical Success After Laparoscopic vs Abdominal Hysterectomy	NCT01793584	Metrorrhagia Menorrhagia Leiomyoma Adenomyosis Pelvic Pain Endometriosis Pelvic Inflamma...	Laparoscopic hy... Abdominal hyste...	18 Years - 80 Years	University of Texas Southwestern Medical Center
Treatment Outcomes of Esophageal Cancer	NCT05177393	Esophageal Canc...	Assessment of p...	18 Years -	University of California, San Francisco
Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs	NCT03726151	Human Papilloma...	Parent Reminder... Multicomponent ... Combined Condit...	11 Years - 17 Years	University of California, Los Angeles

Spots Global Cancer Trial Database for comparative effectiveness