linjc16/ctgov huggingface dataset:
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.

Official Title
-----------------
An Open-label, Single-arm, Multicenter Phase 4 Study to Evaluate Safety and Tolerability of Romosozumab (EVENITY® ) in Postmenopausal Women in India With Osteoporosis and a High Risk of Fracture.

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: Romosozumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants diagnosed with osteoporosis who are postmenopausal and have a high risk of fracture who provided inform consent (in-person or through their legally authorized representative) to participate in the use of romosozumab per local label in India. Exclusion Criteria: Participants who experienced myocardial infarction or stroke within a year prior to entering this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 4: Romosozumab<br>Participants will be dosed with two subcutaneous (SC) injections of romosozumab once a month for 12 months. | Drug: Romosozumab<br>* Single-use prefilled syringe for SC injection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) |  | Up to 12 months | 
| Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAE) |  | Up to 12 months | 
| Number of Participants Experiencing Clinically Significant Changes in Laboratory Assessments |  | Baseline, Month 12 | 
| Number of Participants With Clinically Significant Changes in Vital Signs |  | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Bone Mineral Density (BMD) (Measured by Dual-energy X-ray Absorptiometry [DXA]) of the Lumbar Spine |  | At 6 months and 12 months | 
| Percentage Change From Baseline in BMD (Measured by DXA) of the Total Hip |  | At 6 months and 12 months | 
| Percentage Change From Baseline in BMD (Measured by DXA) of the Femoral Neck |  | At 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EVENITY®, Osteoporosis, Women Health, Romosozumab
VOY-101 in Advanced Non-Neovascular Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The Phase 1 safety study of VOY-101 comprises a two dose Cohort escalation, followed by a Phase 2a.

Detailed Description
-----------------
This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of two dose levels of VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD).

Official Title
-----------------
VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Biological: VOY-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are ≥50 years of age at the time of consent. Are willing and able to understand and provide written informed consent. Are willing and able to return for scheduled treatment and follow-up examinations. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV. Absence of signs of non-exudative MNV. Additional Ocular Inclusion Criteria for study eye. Meet certain genotype criteria for risk of AMD. Exclusion Criteria: Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Phase 1 will enroll in a dose escalation study model (two sequential cohorts), followed by a Phase 2a cohort that will be randomized among two arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Low Dose<br>VOY-101 Low Dose (single dose, IVT) | Biological: VOY-101<br>* VOY-101<br>|
| Experimental: Experimental: High Dose<br>VOY-101 High Dose (single dose, IVT) | Biological: VOY-101<br>* VOY-101<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoints and tolerability | Evaluation of safety and tolerability on ocular and systemic assessments | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in laboratory assessments | Evaluation of laboratory measures from baseline through study termination | 24 months | 
| Change from baseline in markers of inflammation | Evaluation of markers of inflammation from baseline through study termination | 24 months |
Helicobacter Pylori Prevalence in Southern Region of Romania

Study Overview
=================
Brief Summary
-----------------
Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

Detailed Description
-----------------
Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence. The aim of the study is to evaluate the prevalence of H. pylori infection in several areas of the Southern Regions of Romania, considered as vulnerable pertaining to the access of health services. Fecal Helicobacter pylori will be tested, together with antibiotic susceptibility.

Official Title
-----------------
Helicobacter Pylori Prevalence in Southern Region of Romania

Conditions
-----------------
Infections, Helicobacter

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult voluntary participants to Medical services caravan project by Medcorp Association Exclusion Criteria: Age < 18 years old No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori infection rate | rate of fecal antigen test divided by total number of tests (fecal Helicobacter test) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic susceptibility rate | rate of antibiotic (x) susceptibility divided by total number of tests (antibiotic susceptibility test) | 12 months |
The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the effect of synbiotics and placebo in Thai women with polycystic ovary syndrome. The main questions it aims to answer are: Do synbiotics have a positive effect on the gut microbiome? Do synbiotics have a positive effect on reproductive outcomes? Do synbiotics have a positive effect on cardiovascular outcomes? Participants will be randomized, and blinded to receive either synbiotics or placebo. While placebo is a comparison group: Researchers will compare with placebo to see if the effects on reproductive and cardiovascular risk differ.

Detailed Description
-----------------
Analysis of gut microbiome in Thai women with polycystic ovary syndrome and the synbiotics effect on reproductive and cardiovascular risk: A randomized controlled trial

Official Title
-----------------
Analysis of Gut Microbiome in Thai Women With Polycystic Ovary Syndrome and the Synbiotics Effect on Reproductive and Cardiovascular Risk: A Randomized Controlled Trial

Conditions
-----------------
PCOS- Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: synbiotics
* Combination Product: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - PCOS Exclusion Criteria: ATB use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>synbiotics | Dietary Supplement: synbiotics<br>* synbiotics<br>|
| Placebo Comparator: non-intervention<br>placebo | Combination Product: placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome in polycystic ovary syndrome | Gut microbiome will be evaluated by metagenomic analysis of the stool exam of PCOS patient before and after receive synbiotics | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| synbiotics effect on reproductive and cardiovascular risk | evaluation of the reproductive clinical (menstrual regularity, polycystic ovarian morphology on the ultrasound) and serum marker of cardiovascular risk (Lipid profile, HbA1C, fasting blood glucose, hsCRP) will be evaluated compare between synbiotics and placebo groups | 12 months |
Learning Effect of Onsite vs. Online Education in a Medical Context

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to learn about the effects of online medical education in PhD students. The main question it aims to answer is: What is the effect of onsite compared to online research courses on theoretical knowledge of research methodology and motivation for young medical researchers? Participants will join 20 research courses which are computer randomised to be delivered online (intervention) or onsite (control group) with 10-12 PhD students of each course (200-240 participants). Participants will be followed for up to two years after their course. The outcomes are theoretical learning (main) academic achievements motivation self-efficacy Researchers will compare online and onsite research courses to see if there is a difference in theoretical learning, academic achievements, motivation and self-efficacy.

Official Title
-----------------
Learning Effect of Onsite vs. Online Education in a Medical Context

Conditions
-----------------
Online Learning

Intervention / Treatment
-----------------
* Other: Online


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All PhD students on the courses if they are able to give informed consent Exclusion Criteria: Declining to participate Withdrawal of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online setting<br>Research course delivered digitally (Zoom or Teams meeting rooms) at a distance. | Other: Online<br>* Online research course delivered live digitally at a distance.<br>|
| No Intervention: Onsite setting<br>Research course delivered physically in educational facilities. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Theoretical learning | Knows or Knows how according to Miller's Pyramid of Competence measured by MCQ | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Academic achievement | Measured by Google Scholar Profile (number of publications, number of citations, H-index and i10-index | Up to 25 months | 
| Motivation | Intrinsic Motivation Inventory | Up to 3 months | 
| Self-efficacy | Williams and Smith's single item measure of self-efficacy | Up to 3 months |
Safety and Efficacy of Oral NXC-736 in Adult Participants With Severe Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of NXC736 in Patients With Severe Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: NXC736
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women between ≥19 and ≤65 years of age at the time of informed consent Severe alopecia areata as assessed by a SALT score of ≥50 at Screening and Day 1/Baseline Current episode of hair loss for ≥6 months but <8 years Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study Exclusion Criteria: Participants with the following medical history confirmed during screening: ohter Types of alopecia other than alopecia areata (such as cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, androgenic alopecia, telogen effluvium, etc.) Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NXC736<br> | Drug: NXC736<br>* oral administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change(%) in SALT score from baseline at Week 12 |  | 12 weeks |
Clozapine-associated Infection

Study Overview
=================
Brief Summary
-----------------
perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections.

Official Title
-----------------
Clozapine-associated Infection

Conditions
-----------------
Infections

Intervention / Treatment
-----------------
* Drug: search for a clozapine intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case reported in the World Health Organization (WHO) database of individual safety case reports to 11/04/2023 Adverse events reported were including the MedDRA terms: infections (SOC) Exclusion Criteria: Chronology not compatible between the drug and the toxicity
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients presenting a possible drug-induced adverse effects<br> | Drug: search for a clozapine intake<br>* search for a clozapine intake<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase® |  | from the 01/01/1963 to the 11/04/2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigate a potential dose-dependent effect | A logistical regression model will be applied to search for a dose-dependant effect of infection using clozapine quartile doses. | from the 01/01/1963 to the 11/04/2023 | 
| Description of the clinical features of clozapine-related infections | Description of age, sex, time to onset, type of infections using MedDRA | from the 01/01/1963 to the 11/04/2023 |
Patient's Perception of Exercise After Bone Tumor Resection-A Qualitative Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the opinions of patients who have undergone bone tumor resection surgery about post-op exercises.

Detailed Description
-----------------
Semi-structured in-depth individual interviews will be conducted with patients who have undergone bone tumor surgery. In in-depth individual interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. Thematic analysis method will be used in the evaluation of the data.

Official Title
-----------------
Patient's Perception of Exercise After Bone Tumor Resection-A Qualitative Study

Conditions
-----------------
Bone Cancer Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals aged between 18 and 65, Individuals without communication problems, Individuals who have been diagnosed with a bone tumor for the first time and who have undergone resection surgery Patients who have previously received therapeutic exercises Exclusion Criteria: Uncontrollable arrhythmia and/or hypertension Presence of advanced sensory deficit Visual and hearing problems Not having sufficient communication skills (Mini-Mental Test score below 24 points) Patients undergoing head and neck bone resection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-structured in-depth individual interviews about Patient's Perceptions of post-op exercises | Semi-structured in-depth individual interviews will be conducted with patients only once. The same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone cancer tumor, exercise, Patient
HBV Reactivation in Anti CD20 Treatment

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to test and describe the frequency of hepatitis B virus reactivation in patients who received anti-CD20 drugs for a wide variety of autoimmune and hemato-oncological diseases in order to find out whether a group of patients from a certain field was more sensitive to treatment in this respect than patients from other fields.

Detailed Description
-----------------
Hepatitis B virus(HBV) is the most common chronic virus worldwide. it causes an infection of the liver (hepatitis B) and it is transmitted from person to person through contact with virus-contaminated blood, through sexual intercourse, and vertically from mother to fetus. Anti CD20 drug or Rituximab is an anti-CD20 monoclonal antibody on the surface of B lymphocytes, which induces cell death (apoptosis) and thus causes depletion. The main side effects of rituximab are infectious and hypersensitivity reactions. It can also increase the chance of hepatitis B reactivation to the point of acute hepatitis. The information for this retrospective study will be collected from clalit health care's databases. The patients will be sorted according to the indications for which the treatment with anti-CD20 drugs was given in order to see the differences in the response to the drug in different groups of patient

Official Title
-----------------
HBV Reactivation in Anti CD20 Treatment

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects (men and women) of age 18 and above, who received anti-CD20 (Rituximab) drugs as a treatment for a variety of diseases . Exclusion Criteria: healthy subjects. subjects under the age 18. subjects who did not receive anti CD20

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA in the blood. | Reactivation of HBV is defined when one of these three conditions exist: when Participant has An increase of more than log1 in the concentration of HBV DNA in the blood. when Participant has A positive HBV DNA result compared to a negative result before starting treatment with Rituximab (anti CD20). when Participant has HDV (hepatitis D virus) DNA result greater than 20000 IU/mL in the absence of a test before starting treatment The HBV DNA concentration at the beginning of the treatment was defined in the time period between six months before the start of the treatment and 30 days after the start of the treatment. | about 10 minutes per blood test. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti CD20, Rituximab, HBV- hepatitis B virus