linjc16/ctgov huggingface dataset:
Motor Deficits and Signal Conduction in Individuals With Williams Syndrome

Study Overview
=================
Brief Summary
-----------------
The current study aims to validate basic research findings of abnormal conductivity and motor abilities from a mouse model in humans. The study will measure nerve conduction properties in WS individuals and characterize motor symptoms in individuals with WS.

Detailed Description
-----------------
50 individuals with WS will take part in the study. All participants will be recruited from the Williams Syndrome Clinic at Edmond and Lili Safra Children's Hospital, Sheba Medical Center directed by Prof. Doron Gothelf, MD, that coordinates treatment and research of WS in Israel. 20 control age-matched subjects will be recruited as well. A Motor Questionnaire, designed especially for this study will be filled by parents. It includes questions about gross motor, fine motor, gait and coordination characteristics of the children (Bellugi, Bihrle et al. 1990, Wilson, Kaplan et al. 2000, Wilson, Crawford et al. 2009) (General references regarding motor abilities and health). In addition, participants will undergo the following assessments at the neuromuscular clinic and at the movement laboratory, Sheba Medical Center in collaboration with Dr. Amir Dori, Dr. Uri Givon and Dr. Meir Plotnik: (1) nerve conduction study (2) nerve ultrasound (3) neurological assessments (4) GAITRite walkway for gait analysis (5) 3-D motion analysis.

Official Title
-----------------
Motor Deficits and Signal Conduction in Individuals With Williams Syndrome

Conditions
-----------------
Williams Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WS patients. Exclusion Criteria: WS patients suffering from additional neurological condition (such as epilepsy). Participants who will have difficulties preforming the tests may ask to be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Williams syndrome<br>Nerve conduction test (NCT) Nerve ultrasound Clinical evaluation GAITRite walkway Motor questionnaire | |
| Control, age matched<br>Nerve conduction test (NCT) Nerve ultrasound Clinical evaluation GAITRite walkway Motor questionnaire | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction test - Amplitude | This test's amplitude outcome present a nerve conduction property that can indicate aberrations in signal conduction. | 30 days | 
| Nerve conduction test - Latency | This test's latency outcome present a nerve conduction property that can indicate aberrations in signal conduction. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Williams syndrome, Nerve conduction, Motor deficits
Comparison of IVF and ICSI in Human IVF

Study Overview
=================
Brief Summary
-----------------
In this prospective randomized clinical trial we plan to compare two fertilization method which are widely used during in vitro fertilization (IVF) treatment. Outcome of conventional IVF and intracytoplasmic sperm injection (ICSI) treatment will be compared in this study.

Official Title
-----------------
Comparison of the Effect of Conventional IVF and ICSI Fertilization Method on Human IVF Treatment Outcome

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: ICSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile patients entering in vitro fertilization treatment At least 1 oocytes collected Semen sample is suitable for IVF and ICSI fertilization as well Number of oocytes collected is lower than 5 AND/OR female age is equal or more than 40 years Exclusion Criteria: Samen sample is not suitable for conventional IVF fertilization Previous conventional IVF treatment resulted in <50% fertilization rate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVF<br>Oocytes fertilized by conventional in vitro fertilization (IVF) method | Procedure: ICSI<br>* Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)<br>|
| Experimental: ICSI<br>Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method | Procedure: ICSI<br>* Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Number of oocytes fertilized | 18 hours after insemination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo quality | Number and quality of blastomeres, amount of fragmentation, embryo grade | 36 and 72 hours after fertilization | 
| Implantation rate | Number of embryos implanted (/number of embryos transferred) | 4 weeks after embryo transfer | 
| Clinical pregnancy rate | Number of clinical pregnancies (/No. of embryo transfers) | 4 weeks after the embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in vitro fertilization, intracytoplasmic sperm injection, fertilization, Assisted reproduction
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.

Official Title
-----------------
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Device: OCS Liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects transplanted in the OCS Liver PROTECT CAP

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

| Intervention/Treatment |
| --- |
|Device: OCS Liver|Transplant with an OCS preserved liver.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Survival | Liver Graft Survival at 24 months post-transplant. | 24 Months |
Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Melanoma antigen (MAGE) gene is known to be expressed in tumor cells, testis and placenta. The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.

Official Title
-----------------
Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer

Conditions
-----------------
Unilatral Pleural Effusion

Intervention / Treatment
-----------------
* Procedure: pleural fluid tapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral pleural effusion on chest radiography Exclusion Criteria: body temperature > 38.3ºC and peripheral blood leukocytosis (>12,000/μl)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pleural fluid tapping|Minimally invasive technique to detect malignant pleural effusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion. |  | 12months interval |
Anal Incontinence After Obstetrical Anal Sphincter Injury

Study Overview
=================
Brief Summary
-----------------
Obstetrical Anal Sphincter Injury is an identified risk factor for anal incontinence. The mechanisms and the risk factors for anal incontinence in Obstetrical Anal Sphincter Injury women are not well known. Anal incontinence in such women is not well documented and probably underestimated. Cohort studies estimated that up to 53% of Obstetrical Anal Sphincter Injury women are incontinent but that most of them does not complain their doctor.

Official Title
-----------------
Incidence and Risk Factors for Anal Incontinence After Obstetrical Anal Sphincter Injury

Conditions
-----------------
Obstetric Trauma, Anal Sphincter Injury, Anal Incontinence

Intervention / Treatment
-----------------
* Other: collection of data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Childbirth between 2005 January 1st and 2019 December 31th Obstetrical Anal Sphincter Injury -≥ 18 y Exclusion Criteria: Patients' refusal lost of view or deceased anal incontinence before the Obstetrical Anal Sphincter Injury

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: collection of data|collection of data for all Obstetrical Anal Sphincter Injury women (score of quality of life, experimenting anal incontinence...)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anal incontinence | loss of stool or gas ≥1/week during ≥1 month | from the childbirth to the day of survey (2 to 16 years after childbirth) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anal incontinence | AI graded by the St Mark Score | Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth) | 
| cinetic of AI occurence | all the resolutive episodes of occurence of anal incontinence are reported | from the childbirth to the date of the survey (2 to 16 years after childbirth) | 
| Quality of life with fecal incontinence quality of life score | fecal incontinence quality of life score | the date of the survey (2 to 16 years after childbirth) | 
| Expectation of the women in term of information | 2 questions on the expectation of the women in term of information towards the Obstetrical Anal Sphincter Injury | the date of the survey (2 to 16 years after childbirth) |
COVID-19 Pandemic and Medical Students

Study Overview
=================
Brief Summary
-----------------
Little is known about changes in levels of academic, financial, psychological, & hygienic impact on medical students during this pandemic.

Detailed Description
-----------------
this is a cross-sectional, questionnaire-based study. It is conducted on a random targeted sample of medical students at medical schools in Universities of Jordan, classified by their academic years (from the 1st to the 6th academic year). A score of 10 points was constructed to reflect the perspective about the items in each group of variables. SPSS version 25.0 was used for the statistical analysis.

Official Title
-----------------
Effects of COVID-19 Pandemic on Medical Students in Jordanian Universities: A Multi-center Cross-sectional Study

Conditions
-----------------
the Effect of COVID-19 Pandemic

Intervention / Treatment
-----------------
* Other: Naser Al-Husban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical students in the basic and clinical years Exclusion Criteria: Inability to complete the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Naser Al-Husban|voluntary completion of an online questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological stress and academic results | e- questionnaire will be completed by students. The questionnaire was built through google forms (without relying on pre-existing ones) and was made available in Arabic. | 2 months |
A Study to Develop a Strategy to Increase Lung Cancer Screening in Women Who May Be at Risk for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a digital strategy to increase awareness about lung cancer screening among women who are eligible to receive it. The digital strategy involves email communications and LungTalk, a web-based (accessed through the Internet) health communication tool that uses text, audio, video, and animation to increase awareness and knowledge about lung cancer screening. This study will focus on women who have recently received a screening mammogram.

Official Title
-----------------
Leveraging Mammography to Identify and Engage Women at Risk for Lung Cancer in Lung Cancer Screening

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: LungTalk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LDCT screening-eligible women who received a BiRADS 1 (negative) or 2 (benign/non-cancerous finding) result from a screening mammogram in the last 7 days Age 50-80 years ≥ 20-pack-year smoking history of combustible cigarettes as per self report Women who currently smoke or quit within past 15 years as per self report Lung screening naïve as per self-report Exclusion Criteria: Lung cancer diagnosis Chest CT within the last 12 months

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women who have had a mammogram<br>Participants will consist of eligible women who have had a mammogram | Behavioral: LungTalk<br>* MSK developed LungTalk, a novel computer-tailored health communication and decision support tool to (1) increase awareness and knowledge about lung screening; (2) decrease perceived barriers to screening based upon misinformation; and (3) increase screening rates.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants accrued through digital outreach to identify breast screening participants eligible for lung screening | Develop a proactive digital outreach and engagement strategy to identify breast screening patients who are eligible for lung screening. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mammogram, LDCT screening, BiRADS 1, BiRADS 2, 21-103, Memorial Sloan Kettering Cancer Center
Fecal Microbiota in Preterm Birth

Study Overview
=================
Brief Summary
-----------------
We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor

Official Title
-----------------
Fecal Microbiota in Preterm Birth

Conditions
-----------------
Gut Microbiome

Intervention / Treatment
-----------------
* Diagnostic Test: Collection of fecal sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman after vaginal delivery of singleton Exclusion Criteria: Fetal abnormalities Gestational diabetes Hypertensive disorder

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm birth<br>Delivery between 24-32 weeks of gestation | Diagnostic Test: Collection of fecal sample<br>* Analysis of fecal microbiome<br>|
| Term delivery<br>Delivery between 37-41 weeks of gastation | Diagnostic Test: Collection of fecal sample<br>* Analysis of fecal microbiome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unique microbial fingerprint | 16S rRNA gene sequencing | 1 year |
Efficacy of Dexpanthenol in Thermic Erythema

Study Overview
=================
Brief Summary
-----------------
The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

Official Title
-----------------
Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.

Conditions
-----------------
Erythema

Intervention / Treatment
-----------------
* Drug: Dexpanthenol foam spray, new formulation
* Drug: Dexpanthenol foam spray, old formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Phototype: I to IV according to Fitzpatrick scale Exclusion Criteria: Pregnant or nursing women Subjects registered as being in exclusion period in the French Health Minister file of subjects Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Dexpanthenol foam spray, new formulation<br>* 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter<br>|
| Active Comparator: Arm 2<br> | Drug: Dexpanthenol foam spray, old formulation<br>* 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application |  | 2 min, 5 min, 10 min, 15 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature |  | 2 min, 5 min, 10 min | 
| Evaluation of the cooling/soothing effect (scores) after first and second application |  | 2 min, 5min, 10 min, 15 min | 
| Evaluation of the foam covering properties after first application |  | 2 min, 5 min, 10 min, 15 min | 
| Incidence of adverse events |  | FPFV - LPLV | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thermal Erythema, Dexpanthenol, Erythema, Efficacy
Administration of BIIB028 to Subjects With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Safety and Tolerability of BIIB028

Official Title
-----------------
A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: BIIB028


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Age greater than or equal to 18 years at the time of informed consent. Subjects with histological or cytological confirmed solid tumors who have failed standard therapies or for which no standard therapy is available. Anticipated survival of at least 3 months in the opinion of the Investigator. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal hepatic and bone marrow function. Must utilize effective contraception. Exclusion Criteria: Pregnant (positive pregnancy test) or nursing women Prior treatment with Hsp90 inhibitors at any time. Prior antitumor therapies including prior experimental agents, approved antitumor small molecules and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer). In addition,prior to enrollment, all asociated toxicities must have been resolved to eligibility levels. Concurrent severe or uncontrolled other medical disease (i.e, diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the Investigator and/ or the Sponsor could compromise assessment of safety. Use of anticoagulants, except low dose warfarin. History of seizure, previous significant head trauma (e.g., associated with loss of consciousness for more than 5 minutes), abrupt discontinuation of benzodiazepines, or use of potentially epileptogenic medication

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BIIB028|IV infusion administered twice weekly until disease progression or unacceptable toxicity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of BIIB028 |  | As specified in Protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK and PD of BIIB028 |  | As specified in protocol | 
| Antitumor activity |  | As specified in protocol |