linjc16/ctgov huggingface dataset:
Risk Scoring Model for Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension, endometrial thickness and age) scoring model for prediction of endometrial carcinoma

Official Title
-----------------
Assessment of Risk Scoring Model for Prediction of Endometrial Cancer Among Symptomatic Postmenopausal Women(a Prospective Cohort Study).

Conditions
-----------------
Oncology

Intervention / Treatment
-----------------
* Other: Scoring model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm Exclusion Criteria: all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postmenopausal women<br> | Other: Scoring model<br>* Determining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity and sensitivity of RHEA scoring mdel | Positive and negative productive values, specificity and sensitivity of RHEA scoring model | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variables to increase specificity and sensitivity of the score model | Obesity, diabetes mellitus and family history | One year |
Trial of Bilateral tDCS for Depression

Study Overview
=================
Brief Summary
-----------------
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be measured during the trial.

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: Eldith Neuroconn tDCS device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant meets criteria for a DSM-IV Major Depressive episode. MADRS score of 20 or more. Exclusion Criteria: Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine). Inadequate response to ECT in the current episode of depression. Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue. Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk. Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS. Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used). Participants who are not fluent in English will not be included in the trial for safety reasons.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS (1)<br> | Device: Eldith Neuroconn tDCS device<br> <br> |
| Active Comparator: Active tDCS (2)<br> | Device: Eldith Neuroconn tDCS device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) |  | 4 weeks |
Use of Exome Sequence Analysis and Circulating Tumour in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma

Study Overview
=================
Brief Summary
-----------------
Despite recent advances in cancer treatment, little impact has been made on curing as opposed to controlling cancers over the last several decades. Part of the problem is that investigators have an incomplete understanding of how tumours behave as they evolve and in response to treatment. In this trial, the investigators hope to better understand the evolution of BRAF melanoma in response to drugs a patient may have received such as vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours evolve resistance to these drugs and whether this can be predicted through blood tests, in particular of the circulating tumour DNA.

Detailed Description
-----------------
Study population: BRAF mutant melanoma patients Pre-mortem bloods will be taken from the patient on three occasions at one to thirty days apart from each other, with the first blood draw taking place on the patient's first clinic visit. Six 7 ml EDTA and one 6 ml SST vacutainers of blood (a total of approx. 50 ml of blood) will be taken from the patient. When death is expected within the next 48-72 hours, the Medical Oncologist/ Radiation Oncologist/ Hematologist OR delegate will revisit the RAP process with the patient and/or family/substitute decision maker to ensure that they are still in agreement. The patient and the families will also be provided with an additional consent form for participation including blood sampling.

Official Title
-----------------
The Utility and Relevance of Exome Sequence Analysis and Circulating Tumour DNA in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UHN adult patient with BRAF mutant melanoma Exclusion Criteria: Non BRAF mutant melanoma patient Pediatric patient Non-UHN patient

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 |
| --- | --- | --- |
| Percentage correlation between circulating tumour DNA and metastatic sites |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to death |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circulation tumour DNA, tumour heterogeneity, BRAF mutant melanoma, liquid biopsy
Stimulus-response and Parkinson's Disease (SRlearning)

Study Overview
=================
Brief Summary
-----------------
In a computerized experiment, visual stimuli will be presented to the parkinson's disease patients and to the controls. They will respond to each image by acting on the keyboard in a specific manner. Each participant will repeat that task 384 times per session. A break will be inserted every 12 tests so that participants can rest. The experiment consists of three sessions. Each image will be presented three times. For the first two presentations it is assumed that a link will be created between the image and the task, and the image and action. In the third presentation, the same task and the same action will be maintained or will be swapped. In this way, It can be checked whether associations thus generated will affect the performance of the participants when tasks and actions will be incongruent.

Official Title
-----------------
Stimulus-response Associations in Parkinson's Disease Patients

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Behavioral: Stimulus-response


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient : Parkinson's disease Controls: healthy volunteers paired to patients on sex and age group Exclusion Criteria: Other neurological condition Known pregnancy or breastfeeding woman No medical insurance coverage Person under legal protection

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson's disease<br>Parkinson's disease patients | Behavioral: Stimulus-response<br>* See summary<br>|
| Other: Controls<br>Healthy volunteers paired with Parkinson's disease patients on sex and age group, whose data will be extracted from a CNRS existing database | Behavioral: Stimulus-response<br>* See summary<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time (second) |  | immediate |
Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)

Official Title
-----------------
Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)

Conditions
-----------------
Overactive Bladder, Urinary Incontinence, Quality of Life

Intervention / Treatment
-----------------
* Drug: oxybutynin transdermal delivery system (Oxytrol(r))


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency Exclusion Criteria: Patients for whom Oxytrol(r) is contraindicated. Patients treated with Oxytrol(r) prior to participation in this study. Patients residing in long-term care facilities or nursing homes.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxybutynin transdermal delivery system (Oxytrol(r))|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other outcomes such as: |  |  | 
| depression |  |  | 
| work productivity |  |  | 
| participant satisfaction |  |  | 
| effect of enhanced patient education on any of the above outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytrol(r), transdermal oxybutynin, overactive bladder
Bioequivalence Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Primary: To determine the bioequivalence between the new formulation and the current formulation of the investigational drug, MOA-728.

Official Title
-----------------
An Open-label, Single-dose, Randomized, 2-period Crossover, Bioequivalence Study Between the Current Formulation and the New Formulation of MOA-728 Administered Subcutaneously in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MOA-728|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence |  |  |
Next-Gen MS: Feed-forward PRO Data for MS Research

Study Overview
=================
Brief Summary
-----------------
This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).

Official Title
-----------------
Next-Gen MS: A Prospective, Cluster-randomized Study Evaluating the Impact of Feed-forward Patient Reported Outcomes Data to Clinical Teams Managing Adults Living With MS in a Learning Health System for MS Research

Conditions
-----------------
Multiple Sclerosis (MS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants willing and able to provide written informed consent Participants with clinical diagnosis of Multiple Sclerosis (MS) Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Feed-forward PRO<br>Participants in this group will participate in monthly learning collaborative webinars. Feed-forward of patient reported outcomes (PRO) data collected from the main study (NCT04735406) will be used. | |
| Control Group (Usual Care)<br>Participants in the control group will receive usual care practices during the clinical encounters. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14) |  | Baseline up to 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months |  | Baseline up to 18 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Patient Reported Outcomes, Patient Determined Disease Steps, Learning Healthcare System
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone

Conditions
-----------------
Myasthenia Gravis Generalised

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil [CellCept]
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study. Exclusion Criteria: regularly scheduled plasma exchange or intravenous immunoglobulin treatment; medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: mycophenolate mofetil [CellCept]<br>* 1g po bid<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, vital signs. |  | Throughout study |
Evaluation of Exercise Tolerance During Pregnancy

Study Overview
=================
Brief Summary
-----------------
To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Procedure: 6 minutes walking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-50 years old healthy women Exclusion Criteria: BMI (before pregnancy) > 25 complication with their pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 minutes walking test<br> | Procedure: 6 minutes walking test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walking test |  | after 6 minutes |
Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine the safety and tolerability of Dimebon in people with Huntington's disease after short-term exposure (one week) and after longer exposure (three months). Also, the study will assess whether or not there is an effect of Dimebon on the symptoms of Huntington's disease, including cognitive (thinking abilities), motor (movement), behavior, and overall functioning.

Official Title
-----------------
A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

Conditions
-----------------
Huntington's Disease

Intervention / Treatment
-----------------
* Drug: Dimebon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical features of Huntington's disease and a confirmatory family history of HD, or a CAG repeat expansion greater than or equal to 36 Stage I,II,III HD and a total functional capacity greater than or equal to 5 on the Unified Huntington's Disease Rating Scale Exclusion Criteria: Clinical evidence of unstable medical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Dimebon | Drug: Dimebon<br>* Dimebon 10 or 20 mg TID x 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Huntington's Disease Rating Scale |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Huntington's disease, Dimebon, dose-escalation, Phase 1-2a, randomized, controlled, double-blind, Unified Huntington's Disease Rating Scale