linjc16/ctgov huggingface dataset:
Effect of Direct-acting Antiviral Drugs on Erectile Function

Study Overview
=================
Brief Summary
-----------------
Effect of direct-acting antiviral drugs on erectile function

Detailed Description
-----------------
Effect of direct-acting antiviral drugs on erectile function in HCV patients

Official Title
-----------------
Effect of Direct-acting Antiviral Drugs on Erectile Function Among Hepatitis c Patients

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Sofosbuvir and Daklatasuvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV infected patients Male Exclusion Criteria: HCC Age below 18 years

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: Hepatitis C Treatment<br>HCV Treatment (Sofosbuvir and Daklatasuvir) | Drug: Sofosbuvir and Daklatasuvir<br>* HCV Treatment (Sofosbuvir and Daklatasuvir)<br>* Other names: Sofaldy, mpiviropack, daklanork;|
| No Intervention: Supportive treatment<br>supportive liver therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improved erectile functions | Number of patients with improved erectile functions | 6 months |
Intervention for Male STDs in India

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India.

Detailed Description
-----------------
India has the second highest number of HIV infections of any country in the world, and the epidemic continues unabated. This trial is focused on high risk men attending public STI clinics. A proposed 2 and a half year study, this trial will utilize the continuation of a randomized controlled trial of a behavioral intervention compared to HIV C&T and STI treatment alone targeting HIV uninfected male STI patients. The specific aims are to complete the current behavioral intervention trial and to expand the current investigations to include: the evaluation of men who have sex with men as well as women and evaluate the use of alcohol to the entire sample of recruited men. STI patients will be recruited from three sites and if randomized will agree to a 12 month participation commitment. Strategies employed in both arms of the trial are simple and the fundamental components of an HIV prevention strategy. By demonstrating their effectiveness in India the hope is to encourage the public health leadership to adopt them and continue to change drug treatment availability.

Official Title
-----------------
An Intervention for Male STD Patients in India

Conditions
-----------------
Sexually Transmitted Infection

Intervention / Treatment
-----------------
* Behavioral: Behavior


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, over 16 years of age Hindu or Marathi speakers Have no plan to move permanently out of Mumbia in the following 12 months have a symptom of an STI or have had a sexual exposure in the past 6 months. A sexual exposure is defined as having sex with a commercial sex worker (FSW), having unprotected sex with anyone, male or female, or if the patient came to the clinic seeking an HIV test. Patients will be required to provide an address that can be located by a tracer. Exclusion Criteria: 1. HIV positive subjects.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
India, male, sexually transmitted infection, STI, STD
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)

Study Overview
=================
Brief Summary
-----------------
The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer.

Official Title
-----------------
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials

Conditions
-----------------
Cancer Treated With Immune-checkpoint Inhibitors

Intervention / Treatment
-----------------
* Drug: Immune checkpoint inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included in phase III randomized clinical trials (RCT) Metastatic melanoma Exclusion Criteria: N/A

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>chemotherapy | |
| Experimental<br>immune-checkpoint inhibitor | Drug: Immune checkpoint inhibitor<br>* Immune checkpoint inhibitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | time from randomization to death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Time from randomization to progression or death | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, trial, immune-checkpoint inhibitors, meta-analysis
Multiple Gestation Study

Study Overview
=================
Brief Summary
-----------------
The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.

Official Title
-----------------
Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood

Conditions
-----------------
Trisomy 13, Trisomy 18, Trisomy 21, Sex Chromosome Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older at enrollment Clinically confirmed multiple gestation pregnancy Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate Able to provide informed consent Exclusion Criteria: Women carrying singleton pregnancy Surrogate or egg donor used

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple high risk gestation pregnancies<br>women pregnant with twins or triplets at high risk for aneuploidy | |
| Multiple low risk gestation pregnancies<br>women pregnant with twins or triplets at low risk for aneuploidy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be to confirm the diagnostic capability of NATUS risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.' | The chromosomal status will be determined from the CVS or amniocentesis results, if available. A cheek swab or saliva sample will be collected from live-born children if there are no CVS or amniocentesis results. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trisomy 13, Trisomy 18, Trisomy 21, Sex Chromosome Abnormalities, Monosomy X, XXX, XXY, XYY
Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke

Study Overview
=================
Brief Summary
-----------------
Undernutrition is a frequent problem in hospitals (at least 30% of patients, SENECA-NHANES studies). Its impact on morbidity and mortality is well known in gerontology, oncology and intensive care. There are very few neurovascular studies dealing with the consequences of undernutrition present before the stroke. Indeed, most of the medical literature concerns only undernutrition acquired after a stroke. The investigator propose to analyze medical data from a cohort of patients over 70 years of age thrombolysed and/or thrombectomized in the neurovascular department between the years 2014 and 2019.

Official Title
-----------------
Analysis of the Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 70 years of age with cerebral infarction, thrombolysed and/or thrombectomized between 2014 and 2019, managed in the Neurology and Neurovascular Department of the Paris Saint-Joseph Hospital French-speaking patient Exclusion Criteria: Patients with non-thrombolyzed stroke Patient with a TIA (Transient Ischemic Attack) Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patients who object to the use of their data for this research

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| Clinical evolution of the patients: NIHSS | This outcome correspond to the National Institute of Health Stroke Score (NIHSS) at day 5. The score is 0: No stroke symptoms; 1-4: Minor stroke; 5-15: Moderate stroke; 16-20: Moderate to severe stroke; 21-42 : Severe stroke. | Day 5 | 
| Modified Rankin Scale | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Rankin scale: 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | Month 3 |
The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Unlike the general population, a higher body mass index (BMI) is associated with greater survival among patients with chronic kidney disease (CKD). However, obesity is defined as excess body fat that associated with clearly elevated health risks according to the World Health Organization. In addition, muscle wasting is prevalent among CKD subjects. Thus, we hypothesized that different definition of obesity, based on BMI or body fat percentage, might have different impact on clinical outcomes among CKD population.

Official Title
-----------------
The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Diseases, Obesity

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with non-dialysis CKD defined as estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 Exclusion Criteria: subjects with liver cirrhosis subjects with malignancy subjects with an acute cardiovascular event within the 3 months before screening for inclusion amputee pregnancy subjects with pacemaker subjects with metallic implant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | all-cause mortality | medium follow up 4.9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic discordance of obesity, all-cause mortality
Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

Official Title
-----------------
A Double-Masked, Placebo-Controlled, Paired Comparison Study of the Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects 18 years of age or older of either sex of any race diagnosed with ocular hypertension or open angle glaucoma

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Travoprost|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Ocular Hypertension
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Depression

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to depression.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Depression

Conditions
-----------------
Depression, Clinical Depression, Depression, Anxiety, Depression, Postpartum, Depression, Endogenous, Depression in Remission, Depression Chronic, Depression Moderate, Depression Severe

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) Diagnosis of depression based on DSM-V criteria Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Depression<br>Patients who have been diagnosed with depression | Other: No Intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with | Three years |
Depression and Fatigue in MS Patients Treated With Betaferon.

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations. The study is conducted in routine practice setting hence no interference with standard care takes place. Pharmacologic treatments of MS-fatigue and depression will also be recorded.

Official Title
-----------------
The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Biological: Interferon beta-1b (Betaferon, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing-remitting multiple sclerosis Age 18+ Patients initiating Betaferon treatment Exclusion Criteria: Patients previously treated with any immunomodulatory drug

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 |
| --- | --- |
| Group 1<br> | Biological: Interferon beta-1b (Betaferon, BAY86-5046)<br>* Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of fatigue score over time |  | short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of depression score over time |  | short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline | 
| Treatment adherence |  | 12 months | 
| Clinical course of the disease |  | 12 months | 
| Overall treatment tolerability as measured by rate of adverse events |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, Interferon beta-1b, Fatigue, Depression
A Registered Cohort Study on Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
Amyotrophic lateral sclerosis (ALS) is a kind of motor neuron degeneration disorder without effective therapy. This registered cohort study will provide further insights into the clinical course of ALS, and investigate disease-relative risk factors and the genetic background of Chinese ALS patients.

Detailed Description
-----------------
Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease (MND), which is characterized with highly clinical heterogeneity and no effective treatment is available now. The purpose of this registered cohort is to observe the natural history of ALS patients in China, and then identify some factors correlated with disease progression. Besides, ALS-related gene mutations will be screened and explore novel disease causing gene as well.

Official Title
-----------------
A Registered Cohort Study on Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amyotrophic Lateral Sclerosis patients fulfilling the El Escorial criteria (including definite, probable and possible) Progressive muscular atrophy Primary lateral sclerosis Progressive bulbar palsy Exclusion Criteria: History of serious head trauma or neuropsychiatric disease Decline to participate
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 |
| --- | --- | --- |
| Age at death | the time when patient die | 10 years | 
| Age of endotracheal intubation or tracheotomy | the time for the patient accepted endotracheal intubation or tracheotomy | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyotrophic lateral sclerosis, natural history, genetics, prognostic factors