Nutritional and Metabolic Diseases

All Conditions

Infections

Symptoms and General Pathology

Digestive System Diseases

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Gland and Hormone Related Diseases

Metabolic Diseases

Communicable Diseases

Gastrointestinal Diseases

Respiration Disorders

Respiratory Tract Diseases

Urologic Diseases

Hematologic Diseases

Endocrine System Diseases

Disease Attributes

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

No intervention

Bo Situ

Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Aggregation-Caused Quenching has limited the application of traditional fluorescent probes to some extent. This project intends to systematically evaluate the detection efficiency of new methods through the detection of biomarkers in clinical samples and the comparison with the detection methods of traditional biomarkers, so as to provide theoretical and experimental basis for the establishment of fast and simple biomarker detection technologies with new biological probes.

Research on the Application and Mechanism of New Biological Probes in Biomedicine

Nanfang Hospital, Southern Medical University

Children's files from this department will be analysed once weekly and medication prescription data will be registered

Norberto Krivoy, MD

One year prospective analysis of drug utilization and prescription point prevalence of medications in a pediatric tertiary care university medical center. Off-label use of medications in the study population will be also registered.

Drug Utilization Prevalence in a Pediatric Care Medical Center

Rambam Health Care Campus

Wounds and Injuries

Hyperthermia

Pain

Fever

Body Temperature Changes

Analgesics

All Drugs and Chemicals

Antipyretics

Acetaminophen

Analgesics, Non-Narcotic

All patients will receive one single dose of 1000mg paracetamol.

All patients will receive one single dose of 1000mg paracetamol. If considered mandatory by the attending physician, similar doses may be administered latter for a maximum period of five days. The maximum allowed daily dose is 3000mg. If the attending physician believes that after the administration of at least of three doses the desired analgesic or antipyretic effect is not achieved, he may administer any other compound in his will.

Paracetamol

Evangelos J Giamarellos-Bourboulis, MD, PhD

Helen Giamarellou, MD, PhD

George Koratzanis, MD, PhD

Konstantinos Atmatzidis, MD, PhD

The present study is aiming to unravel the clinical efficacy of intravenously administered paracetamol as antipyretic and analgesic medication in various medical conditions.

Although modern therapeutics is targeting at prolongation of survival, despite the underlying illness, it also aims at the improvement of the quality of life. Two major symptoms affect considerably quality of life, fever and pain. Both symptoms are common denominators of a vast number of clinical situations some of which have good prognosis and some of which do not have. Among them situations like infectious diseases, hematologic malignancies, solid tumor malignancies, connective tissue disorders and factors connected to surgical operations predominate. Post-operative pain extents too long and imposes severely on the post-operative course of the patient.

A variety of compounds have been developed for the management of fever and pain, the most successful being non-steroidal anti-inflammatory drugs. They exist in a variety of forms for various types of administration. Those administered parenterally are considered more efficacious than those administered orally in terms of the rate of the achieved clinical effect. Furthermore, several conditions necessitate parenteral administration.

Paracetamol is a well-known antipyretic and analgesic compound available for many years for oral administration since intravenous infusion was hampered by water insolubility. Its pro-drug, namely, pro-paracetamol, was applied for intravenous infusion where an amount of 2g was equally potent to 1 g of paracetamol. Pro-paracetamol has been given with success as analgesic medication in women undergoing laparoscopic operation, as antipyretic in patients with hematologic malignancies, as antipyretic in children bearing infectious diseases and as antipyretic in critically ill patients.

Ready-made paracetamol for intravenous infusion has been in the market in some European countries. It has been tested in four clinical trials. In the first trial it was given as post-operative analgesia at a dose of 1g x 4 in 80 patients undergoing laparoscopic cholecystectomy. Clinical efficacy was comparable to parecoxib and valdecoxib. In three other studies, it was given as post-operative analgesia after spinal body ectomy and after resection of the third mole providing conflicting results. However, in all the three latter studies, the number of patients given paracetamol was limited.

In Greece, paracetamol for intravenous infusion at vials of 1g/6.7ml is manufactured by the company Uni-Pharma (ΑPOTEL®). Based on: a) the limited number of patients enrolled in the studies mentioned earlier, and b) the application of that form only after laparoscopic cholecystectomy and spinal body ectomy, the present study is aiming to unravel the clinical efficacy of the above formula of 1g intravenous paracetamol as antipyretic and analgesic medication in various medical conditions.

Paracetamol as Antipyretic and Analgesic Medication

An Open-label Non-randomized Phase IV Trial of the Clinical Efficacy of Intravenously Administered 1000mg Paracetamol as Antipyretic and Analgesic Medication

University of Athens

Evangelos Giamarellos-Bourboulis, Assistant Professor of Medicine

Neoplasms

Hematologic Neoplasms

Each subject receive LMP1 CAR T-cells by intravenous infusion

LMP1 CAR T-cells

He Huang, PhD

Yongxian Hu, PhD

A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies

This is a single arm, open-label, single-center study. This study is indicated for LMP1 positive infectious diseases and hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 144 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies

Clinical Trial for the Safety and Efficacy of Sequential of LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Assessment of ORR (ORR = CR + PR) at Month 1, 3, 6, 12, 18 and 24

From the first remission after LMP1 CAR-T cells to relapse, death or the last visit

From the first infusion of LMP1 CAR-T cells to death or the last visit

From the first remission after LMP1 CAR-T cells to relapse or the last visit

From the first infusion of LMP1 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

Assessment using Activities of Daily Living (ADL) scale (Barthel Index) \[max score: 100, min score: 0, higher scores mean a better outcome\] at Baseline, Month 1, 3, 6, 9 and 12

Assessment of Instrumental Activities of Daily Living (IADL) scale \[max score: 56, min score: 14, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12

Assessment using Hospital Anxiety and Depression Scale (HADS) \[max score: 42, min score: 0, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12

Yake Biotechnology Ltd.

Zhejiang University

Clinical Professor

Acquired Immunodeficiency Syndrome

HIV Infections

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Herbal and Botanical

Turmeric extract

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Enzyme Inhibitors

Turmeric

Participants in this arm will use 2000 mg of intravaginal curcumin once a week for 12 weeks.

Participants in this arm will use 2000 mg of a placebo once a week for 12 weeks.

Curcumin (Curcumin C3 Complex®, prepared by Sabinsa Corporation), a constituent of the spice turmeric, is considered to be a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits.

Study participants will be instructed to insert four 500 mg (2000 mg total) curcumin capsules once a week (excluding days when they are on their menses). Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.

Cervical cytology, colposcopies and biopsies will be performed at the Baseline, Week 4, 8, 12 and 16 visits to collect samples to analyze for the study outcomes.

Study participants randomized to the placebo arm will insert four 500 mg (2000 mg total) of the placebo (gelatin) capsules once a week (excluding days when they are on their menses). Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.

Cervical cytology, colposcopies and biopsies will be performed at the Baseline, Week 4, 8, 12 and 16 visits to collect samples to analyze for the study outcomes.

Placebo

Lisa Flowers, MD

The purpose of this study is to see if curcumin can reverse a cervical precancerous state by looking at people who have the condition and intervening with a study drug or placebo (an inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP) which is a treatment procedure for removing cervical cancer. 40 women with high grade squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000 mg capsule of curcumin or a placebo in their vagina once a week for 12 weeks. After a 4 week long washout period the participants will then undergo removal of the precancerous cells as recommended standard of care. Participants will have regular monthly visits for the duration of the study.

Cervical cancer is the third most common cancer worldwide. The causative agent responsible for cervical cancer is the persistent infection with oncogenic Human Papillomavirus (HPV). Rates of cervical cancer and HPV infection are increased in HIV-infected women due to immunosuppression and cervical cancer is an AIDS-defining diagnosis. Despite the promise of HPV vaccine in the prevention of cervical cancer, the widespread availability of this vaccine is limited due to cost and accessibility. Therefore, prevention strategies to reduce cervical cancer after HPV exposure entail treatment at the most severe premalignant state (high grade squamous intraepithelial lesion or HSIL). As this procedure is expensive and not widely available in resource-limited areas there is a need for an inexpensive, non-invasive alternative method to treat these premalignant cervical lesions.

Curcumin, an extract from turmeric, a popular culinary spice, has been used in traditional Indian medicine for its anti-inflammatory and anti-infectious properties. Recent studies have shown the potential effect of curcumin to reduce tumors and precancerous lesions in animal and human cancer cells. It is postulated that curcumin achieves its effect on cancer cells by modulating different cellular pathways as well as altering HPV effect on tissue cells.

This study will explore the effect of curcumin as a potential medical treatment in HIV-infected women with HSIL lesions of the cervix. 40 women with high grade squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000 mg capsule of curcumin or a placebo in their vagina once a week for 12 weeks. After a 4 week long washout period the participants will then undergo removal of the precancerous cells as recommended standard of care. Participants will have regular monthly visits for the duration of the study.

Topical Curcumin for Precancer Cervical Lesions

Biomolecular Effects of Topical Curcumin in HSIL Cervical Neoplasia

Vaginal samples and cervical biopsies, obtained at each study visit, will be used to determine the association between curcumin and known biomarkers of cervical disease. This exploratory aim seeks to use repeated-measures analyses, utilizing a linear mixed model for the curcumin group to assess the association between nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) and the concentration of curcumin at each time point. NF-κB upregulation is related to the grade of cervical intraepithelial neoplasia (CIN) although the significance of NF-κB activation per se to CIN lesion development and its prognostic value in cervical cancer have not been well defined. The analysis of NF-κB binding activity will provide a direct molecular benchmark for assessing curcumin treatment responses independent from its therapeutic effects.

Vaginal samples and cervical biopsies, obtained at each study visit, will be used to determine the association between curcumin and known biomarkers of cervical disease. This exploratory aim seeks to use repeated-measures analyses, utilizing a linear mixed model for the curcumin group to assess the association between p16INK4a and the concentration of curcumin at each time point. p16INK4a (a tumor suppressor protein) is an indirect marker of cell cycle dysregulation and has been shown to be expressed in cervical dysplasias and carcinomas associated with high risk HPV infections.

Vaginal samples and cervical biopsies, obtained at each study visit, will be used to determine the association between curcumin and known biomarkers of cervical disease. This exploratory aim seeks to use repeated-measures analyses, utilizing a linear mixed model for the curcumin group to assess the association between Rb and the concentration of curcumin at each time point. Rb is an important cell cycle regulator protein in cervical carcinogenesis which is suppressed in most cervical cancer cells. Increased levels of this protein has been linked to regression of cervical cancer lesions.

Vaginal samples and cervical biopsies, obtained at each study visit, will be used to determine the association between curcumin and known biomarkers of cervical disease. This exploratory aim seeks to use repeated-measures analyses, utilizing a linear mixed model for the curcumin group to assess the association between p53 and the concentration of curcumin at each time point. p53 is an important cell cycle regulator protein in cervical carcinogenesis which is suppressed in most cervical cancer cells. Increased levels of this protein have been linked to regression of cervical cancer lesions.

Vaginal samples and cervical biopsies, obtained at each study visit, will be used to determine the association between curcumin and known biomarkers of cervical disease. This exploratory aim seeks to use repeated-measures analyses, utilizing a linear mixed model for the curcumin group to assess the association between vascular endothelial growth factor (VEGF) and the concentration of curcumin at each time point. VEGF expression has been shown to correlate with severity of cervical intraepithelial neoplasia (CIN) lesions and invasive disease.

Vaginal sampling and colposcopy with targeted cervical biopsies will be performed at each study visit. These samples will be used to determine the association between intravaginal curcumin on known HPV-related molecular target HPV E6/E7 mRNA expression within high grade squamous intraepithelial (HSIL) lesions of the cervix in HIV- infected women. The APTIMA® HPV Assay that will be utilized detects full-length HPV E6/E7 mRNA for HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 and correlates very well with integrated HPV, which in turn correlates with full-length HPV E6/E7 protein levels.

Vaginal sampling and colposcopy with targeted cervical biopsies will be performed at each study visit. These samples will be examined to establish the level of curcumin penetration in cervical tissue, as well as the cumulative effect of daily curcumin over time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Research on the Application and Mechanism of New Biological Probes in Biomedicine	NCT04977739	Tumors Cardiovascular ... Respiratory Sys... Digestive Syste... Endocrine Syste... Metabolic Disea... Immune System D... Urinary System ... Nervous System ... Blood Diseases Infectious Dise...	No intervention	18 Years - 70 Years	Nanfang Hospital, Southern Medical University
Research on the Application and Mechanism of New Biological Probes in Biomedicine	NCT04977739	Tumors Cardiovascular ... Respiratory Sys... Digestive Syste... Endocrine Syste... Metabolic Disea... Immune System D... Urinary System ... Nervous System ... Blood Diseases Infectious Dise...	No intervention	18 Years - 70 Years	Nanfang Hospital, Southern Medical University
Drug Utilization Prevalence in a Pediatric Care Medical Center	NCT00550706	Infectious Dise... Metabolic Disea... Cancer		1 Month - 18 Years	Rambam Health Care Campus
Research on the Application and Mechanism of New Biological Probes in Biomedicine	NCT04977739	Tumors Cardiovascular ... Respiratory Sys... Digestive Syste... Endocrine Syste... Metabolic Disea... Immune System D... Urinary System ... Nervous System ... Blood Diseases Infectious Dise...	No intervention	18 Years - 70 Years	Nanfang Hospital, Southern Medical University
Paracetamol as Antipyretic and Analgesic Medication	NCT01070732	Fever Analgesia	Paracetamol	18 Years -	University of Athens
LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies	NCT04657965	Infectious Dise... Hematological M...	LMP1 CAR T-cell...	-	Zhejiang University
Drug Utilization Prevalence in a Pediatric Care Medical Center	NCT00550706	Infectious Dise... Metabolic Disea... Cancer		1 Month - 18 Years	Rambam Health Care Campus
Topical Curcumin for Precancer Cervical Lesions	NCT02944578	Neoplasms	Curcumin Placebo	21 Years -	Emory University

Spots Global Cancer Trial Database for infectious diseases