linjc16/ctgov huggingface dataset:
Role of Bumetanide in Treatment of Autism

Study Overview
=================
Brief Summary
-----------------
Role of bumetanide in Autism

Detailed Description
-----------------
Role of Bumetanide in Treatment of Autism spectrum disorder in children

Official Title
-----------------
Role of Bumetanide in Treatment of Autism Spectrum Disorder in Children

Conditions
-----------------
Autism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with ASD diagnosed by CARS rating Scale⩾30. Age of patients range between (3-12) years. Exclusion Criteria: Patients with ASD associated with neurological antecedents (including epilepsies and febrile seizures), hepatic, renal dysfunction or electrocardiogram abnormalities and syndromatic children(Rett).

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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: bumetanide group<br>Bumetanide a dose of 0.5 mg twice per day | Drug: Bumetanide<br>* bumetanide 0.5 mg twice daily<br>* Other names: burinex;|
| Placebo Comparator: Placebo<br>Placebo twice daily | Drug: Placebo<br>* placebo tablets twice daily<br>* Other names: Placebo treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improved CARS score | the patients with improved CARS score | 6 months |
Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome. Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion. Patients outcome including liver function recovery, operative time and blood loss are compared.

Official Title
-----------------
Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial

Conditions
-----------------
Hepatectomy

Intervention / Treatment
-----------------
* Procedure: Intermittent Pringle maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Child-Pugh Class A or B Exclusion Criteria: Informed consent not available Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, or transarterial internal radiation When portal vein resection is anticipated Emergency hepatectomy Ruptured hepatocellular carcinoma Rehepatectomy (repeated liver resection) Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver When concomitant bowel or bile duct resection is anticipated

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: 1<br>Intermittent clamp group | Procedure: Intermittent Pringle maneuver<br>* Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.<br>|
| No Intervention: 2<br>No clamp group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative blood loss |  | From skin incision to completion of operation | 
| Operative time |  | From skin incision to completion of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative morbidity and mortality |  | From date of operation to 30-day after operation | 
| Recovery of liver function |  | From date of operation to date of discharge |
Effective Conversion of Individuals at Risk

Study Overview
=================
Brief Summary
-----------------
This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis

Detailed Description
-----------------
The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.

Official Title
-----------------
Effective Conversion of Individuals at Risk

Conditions
-----------------
Obstructive Sleep Apnea, Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Smartphone application use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health 18 years or older, with sufficient English language skills Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11<) Able to download and handle an app on a smartphone Willing and able to give informed consent Exclusion criteria: Diagnosed with OSA and/or AFib Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.) Pregnancy/breast feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Smartphone app use | Other: Smartphone application use<br>* Use of a smartphone application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective conversion | Number of patients that visited the Primary Care Physician | 6 months after consent | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA, AFib
A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin

Official Title
-----------------
A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Cancer (Solid Tumors)

Intervention / Treatment
-----------------
* Drug: BMS-690514


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy Centrally located squamous cell carcinoma of the lung is permitted ECOG performance status of 0-1 Life expectancy of at least 3 months Men and women age 18 and above Exclusion Criteria: Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI Peripheral neuropathy ≥Grade 1 for any reason History of thromboembolic disease or bleeding diatheses within the last 6 months Women of child bearing potential without adequate contraception, breastfeeding, or pregnant Serious, uncontrolled medical disorder or active infection Uncontrolled or significant cardiac disease Uncontrolled hypertension (150/100) Allergy to Cremophor EL®

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: BMS-690514<br>* Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos<br>* Other names: panHER;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation |  | upon occurrence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe anti-tumor activity |  | upon occurence | 
| Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research |  | upon occurence |
Events Preceding Interstitial Cystitis (EPIC)

Study Overview
=================
Brief Summary
-----------------
EPIC is a case/control study that seeks to identify the risk factors for interstitial cystitis by comparing the experiences and medical histories of 400 women who recently developed IC with 400 similar people who do not have the disease.

Detailed Description
-----------------
This project is a systematic, national study of incident IC cases and controls matched by age and gender. By telephone interview and medical record review, we compare exposures of cases and controls seeking significant differences which may be risk factors for IC. This cohort of incident IC cases will initiate a natural history study of the disease. Specific Aim 1. To test the hypothesis that certain features that precede onset of IC symptoms, e.g., bacterial cystitis, distinguish IC cases from controls matched for age and gender, and may be risk factors for the disease. Specific Aim 2. To test the hypotheses that patients with IC have higher prevalences of certain non bladder syndromes, e.g., irritable bowel syndrome, than do controls matched for age and gender. Specific Aim 3. To test the hypothesis that urine APF, HB EGF, and/or EGF are sensitive and specific diagnostic markers for IC in patients with symptoms of ÿ12 months. Specific Aim 4. To test the hypotheses that, in an incident cohort, patients with IC have remissions and that certain clinical features, e.g., bacterial cystitis at disease onset, are prognostic factors for remissions.

Official Title
-----------------
A Case Control Study of Interstitial Cystitis

Conditions
-----------------
Cystitis, Interstitial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Adults(18 and over) who have had symotoms of IC for 12 months or fewer - Exclusion Criteria: Males,children, those who do not have symptoms of IC or those who have had symtoms for greater than 12 months. -

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystitis, Interstitial, Case-Control Studies, Risk Factors
Egg Freezing Pilot Study

Study Overview
=================
Brief Summary
-----------------
University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.

Official Title
-----------------
Oocyte Cryopreservation in Assisted Reproduction

Conditions
-----------------
Infertility, Egg Freezing

Intervention / Treatment
-----------------
* Procedure: Oocyte Vitrification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form. In good general health off of current medications which may confound response to study medications. Desire to seek pregnancy actively during the study period by IVF-ICSI. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study. Ability to use the required medications. Day 3 FSH level < 12 IU/ml Exclusion Criteria: Current pregnancy Patients with significant anemia (Hemoglobin < 10 mg/dL). Patients enrolled simultaneously into other investigative studies that would interfere with this research study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Oocyte Vitrification<br> | Procedure: Oocyte Vitrification<br>* All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Biochemical Pregnancy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of viable oocytes |  | 1 year | 
| incidence of fertilization |  | one year | 
| embryo development (how many fertilized eggs undergo development to a more advanced stage) |  | 1 year | 
| clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, egg freezing, fertility preservation
Safety and Efficacy of Xalkori ROS1

Study Overview
=================
Brief Summary
-----------------
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Official Title
-----------------
XALKORI ROS1+NSCLC DRUG USE INVESTIGATION

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: crizotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive Exclusion Criteria: Patients with past history of hypersensitivity to any of the ingredients of XALKORI

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 |
| --- | --- |
| crizotinib<br> | Drug: crizotinib<br>* XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg Frequency and duration are according to Package Insert as follows.  The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. <br>* Other names: XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions in this surveillance. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | 12, 24, 52 weeks |
Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers

Study Overview
=================
Brief Summary
-----------------
Coronavirus has caused containment of more than half of the world's population and a major and rapid reorganization of clinical and support services. The spread of coronavirus (COVID-19) has posed significant challenges for occupational health services. However, there is currently no data on the influence of this epidemic on the practice and feelings of dental surgeons and associates

Detailed Description
-----------------
This is an observational study by REDCap questionnaire® via an internet link, which will be distributed to occupational health workers by any means The self-survey will assess stress, working conditions and changes in practices related to the coronavirus outbreak. This questionnaire includes 39 questions.

Official Title
-----------------
Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers

Conditions
-----------------
Occupational Health

Intervention / Treatment
-----------------
* Behavioral: Occupational health workers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All volunteers who are screened Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Occupational health workers|Questionnaire online|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress measures | Attitudes and stress related to screening procedure will be measured via questionnaire | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic characteristics | sociodemographic characteristics will be assessed by questionnaires | Day 1 | 
| occupation perception | the perception about occupation will be assessed by questionnaires | Day 1 | 
| work conditions | work conditions will be assessed by questionnaires | Day 1 | 
| Changes in practices | changes in practices related to coronavirus pandemic will be assessed by questionnaires | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Occupational health, Stress
Impact of High-flow Nasal Oxygen During Awake Fiberoptic Bronchoscope Guided Intubation: A Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Retrospective data collection. The aim of this study is to investigate impact of high-flow nasal oxygen on safety(lowest oxygen saturation), efficiency (intubation time, need for multiple attempts) in patients underwent awake fiberoptic bronchoscope guided intubation.

Official Title
-----------------
Impact of High-flow Nasal Oxygen During Awake Fiberoptic Bronchoscope Guided Intubation: A Retrospective Study

Conditions
-----------------
Awake Fiberoptic Bronchoscope Guided Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery Exclusion Criteria: Cases in which other procedures (e.g. arterial line cannulation) were performed prior to endotracheal intubation after entering operation room Patients with Incomplete records of oxygen saturation, attempt number, and time taken for awake intubation
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 |
| --- | --- | --- |
| Intra-procedural lowest saturation | Intra-procedural lowest saturation: lowest oxygen saturation on pulse oximetry during awake intubation | Intra-procedural lowest saturation | 
| need for multiple attempts | need for multiple attempts : more than 2 attempts needed during awake intubation | Intra-procedural (need for multiple attempts : during awake intubation) | 
| time taken for awake intubation | Time taken for awake intubation: time from entering the operating room to completion of awake endotracheal intubation | Intra-procedural (Time taken for awake intubation: time from entering the operating room to completion of awake endotracheal intubation) |