linjc16/ctgov huggingface dataset:
Natural Supplements for Unipolar Depression

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.

Detailed Description
-----------------
The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.

Official Title
-----------------
Phase 4 Study: An Open Study of the Efficacy and Tolerability in Unipolar Depression of Augmentation of the One-carbon Cycle With L-methionine, Betaine and Folate

Conditions
-----------------
Unipolar Depression

Intervention / Treatment
-----------------
* Drug: Supplements of L-methionine, betaine and folate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of a MDD or DDNOS; clinical indication for treatment of current depressive symptoms; HDS > 18; women of reproductive potential must use an acceptable method of birth control Exclusion Criteria: Treatment with another psychotropic drug; history of mania or hypomania; history of bipolar illness in first-degree relatives; active homicidality; pregnant; trying to become pregnant, or nursing; unstable medical condition; current substance abuse in the past month; history of sulfa allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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: Supplements of L-methionine, betaine and folate<br> | Drug: Supplements of L-methionine, betaine and folate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms |  |  |
Effect of Touch Screen Tablet on Fine Motor Functions

Study Overview
=================
Brief Summary
-----------------
the objective of this study to asses the effect of touch screen tablet on fine motor functions

Official Title
-----------------
Effect of Touch Screen Tablet on Fine Motor Function un Children With Hemiparetic Cerebral

Conditions
-----------------
Hemiplegic Cerebral Palsy

Intervention / Treatment
-----------------
* Other: touch screen tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemiplegia mid spasticity of upper limb able to follow instructions Exclusion Criteria: fixed deformities visual or respiratory problem

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL GROUP<br>received conventional occupational therapy program | |
| Experimental: STUDY GROUP<br>received conventional occupational therapy program in addition to using tablet | Other: touch screen tablet<br>* traditional occupational therapy in addition to games on tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pinch gauge | used to asses pinch strength | pre and post three month of intervention increase score indicate improvement | 
| peabody scale | to asses the fine motor function | pre and post three month of intervention increase score indicate improvement | 
| nine hole pegboard test | used to asses the fine motor function | pre and post three month of intervention increase score indicate improvement |
OIT Effect on FAQLQ

Study Overview
=================
Brief Summary
-----------------
Patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled also by patients undergoing oral immunotherapy (OIT).

Detailed Description
-----------------
The food allergy quality of life questionnaires (FAQLQ) for children 8-12 y/o, teenagers 13-17 y/o and adults > 18 y/o and parents to children 0-12 y/o and to teenagers will be translated to Hebrew. Questionnaires will be given to patients with food allergy followed at Asaf Harofeh Medical Center. Questionnaires will be examined for internal consistency. The Food Allergy Independent Measure (FAIM) questionnaire for the same age groups will also be translated to Hebrew. The FAQLQ will be validated by correlation with the FAIM. The questionnaires will then be administered to patients and families undergoing food oral immunotherpy, before during and following treatment.

Official Title
-----------------
Quality of Life in Food Allergic Patients Before, During and After Oral Immunotherapy

Conditions
-----------------
Food Allergy

Intervention / Treatment
-----------------
* Other: Oral immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected food allergy Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children 8-12- control<br>Children aged 8-12 years with food allergy who are not undergoing oral immunoterapy | |
| Parents 0-12 - control<br>Parents to children aged 0-12 years with food allergy who are not undergoing oral immunoterapy | |
| Children 8-12 - OIT<br>Children aged 8-12 years with food allergy who are undergoing oral immunoterapy | Other: Oral immunotherapy<br> <br> |
| Teenagers 13-17 - OIT<br>Teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy | Other: Oral immunotherapy<br> <br> |
| Adults >18 - OIT<br>Adults> 18 years with food allergy who are undergoing oral immunoterapy | Other: Oral immunotherapy<br> <br> |
| Parents 0-12 - OIT<br>Parents to children aged 0-12 years with food allergy who are undergoing oral immunoterapy | Other: Oral immunotherapy<br> <br> |
| Parents 13-17 - OIT<br>Parents to teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy | Other: Oral immunotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 1 - 2 years |
A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

Study Overview
=================
Brief Summary
-----------------
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Official Title
-----------------
A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Inhaled Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus Type 2 Failing two or more oral anti-diabetic agents Exclusion Criteria: Asthma, COPD Smoking

Ages Eligible for Study
-----------------
Minimum Age: 35 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inhaled Insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients achieving good control of fasting glucose and lipids |  |  | 
| Rate of hypoglycemia |  |  | 
| Changes in body weight |  |  | 
| Patient satisfaction |  |  | 
| Safety based on adverse events reported and laboratory tests |  |  |
Study of Weight Loss Effect of the Sequential Balloons

Study Overview
=================
Brief Summary
-----------------
The effect of the balloon on weight loss is investigated by multiple studies. However, the effect of the sequential balloons is not studied yet.

Detailed Description
-----------------
We are aiming to study the effect of the sequential balloons in the patients who had weight loss with the first balloon and they need subsequent balloons to have more weight loss after their first balloons are removed after 6 months.

Official Title
-----------------
Study of Weight Loss Effect of the Sequential Balloons

Conditions
-----------------
Weight Loss, Balloon

Intervention / Treatment
-----------------
* Device: Heliosphere bag (air filled balloon)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 45 and weight >120 Kg Patients refused to have bariatric surgery. Exclusion Criteria: Esophageal or gastric or duodenal lesions. Bleeding disorders. uncooperative patients.
Sexes Eligible for Study
-----------------
All

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

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: sequential balloons<br>effect of weight loss by applying sequential balloons | Device: Heliosphere bag (air filled balloon)<br>* sequential balloons . Heliosphere bag (air filled balloon)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | study the weight loss in form of KG and BMI before balloon, 6 months after and 12 months after | 12 months |
Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The clinical progress of the patients whose mobilization the investigators follow up with wearable technology products will be observed in the early postoperative period until discharge. In this way, the investigators primarily aim to examine whether the bowel movements of our more mobilized patients return earlier.

Official Title
-----------------
Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery

Conditions
-----------------
Ambulation Difficulty, Physical Examination

Intervention / Treatment
-----------------
* Procedure: Mobilization recommendations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent laparoscopic abdominal surgery Colorectal cancer patients Curative surgeries Stage 0,1,2,3 patients Exclusion Criteria: Patients who cannot walk Patients converted to open procedure Patients with ostomy Patients for whom laparoscopy is contraindicated Palliative surgeries Patients with distant organ metastases

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Standard treatment and mobilization recommendations will be given to this group. | |
| Experimental: Mobilization Group<br>Mobilization of patients will be encouraged. | Procedure: Mobilization recommendations<br>* Standard mobilization recommendations will be given to all patients, and feedback will be given to the intervention group to increase the number of steps 4 times a day according to the daily targeted number of steps.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to start flatus |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complications |  | 1 year | 
| Length of stay |  | 1 year | 
| Rate of Mortality |  | 1 year |
JAK Inhibition in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). There is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. A deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. By analyzing the changes in the composition of immune cells induced by Janus Kinase (JAK) inhibition, we aim to obtain a better insight into the mechanistic effects of JAK inhibition and the downstream effects. These mechanistic insights are needed to identifying potential responders and non-responders in the future.

Official Title
-----------------
Influence of JAK Inhibitors on the Disease-associated Network of Intestinal Immune Cells in Ulcerative Colitis

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Other: JAK inhibitor treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Age Ulcerative colitis active disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Sequential Assignment
Interventional Model Description: Clinical practice protocol is followed. Additional biopsies and blood samples are taken.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment JAK inhibitor<br>Clinical practice is followed for all patients treated with JAK inhibitor. Additional biopsies and blood is taken. | Other: JAK inhibitor treatment<br>* Standard care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-omics analyses of changes observed after JAK inhibition |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Janus Kinase Inhibitors
Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy

Study Overview
=================
Brief Summary
-----------------
Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and Delta Down.

Official Title
-----------------
Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy

Conditions
-----------------
Hemodynamics

Intervention / Treatment
-----------------
* Diagnostic Test: Comparison of Delta Down and Delta Pulse Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for open chest surgery. Exclusion Criteria: Age < 18 years Patients with arrhythmia

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 |
| --- | --- |
| Study Group<br>All patients included in this study. | Diagnostic Test: Comparison of Delta Down and Delta Pulse Pressure<br>* Comparison of Delta Down and Delta Pulse Pressure Before and After Sternotomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Delta Pulse Pressure Value | Change of Delta Pulse Pressure Value before and after sternotomy. | 10 minutes | 
| Change of Delta Down Value | Change of Delta Down before and after sternotomy. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sternotomy
Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

Study Overview
=================
Brief Summary
-----------------
The study is intended to test the image quality of the FICE system to the predicate device, Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.

Detailed Description
-----------------
No additional description required.

Official Title
-----------------
A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

Conditions
-----------------
Routine Endoscopy

Intervention / Treatment
-----------------
* Device: FICE Image Acquisition followed by NBI Image Acquisition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for diagnostic endoscopy or colonoscopy Ability to comply and willingness to partake in study Exclusion Criteria: less than 21 years of age is an inmate

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FICE Imaging System followed by NBI<br>Images Captured with FICE Image Acquisition System (experimental) followed by NBI Image Acquisition System (standard of care); always in that order. Imaging took place in esophagus, gastric, duodenum and/or colon. | Device: FICE Image Acquisition followed by NBI Image Acquisition<br>* Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality Scores Using Likert Scale | Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI. Likert Scores: Not seen; poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; very good; allows an excellent assesssment, anatomical details are clearly defined; details clear | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FICE, NBI
A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS

Study Overview
=================
Brief Summary
-----------------
This is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients.

Official Title
-----------------
A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)

Conditions
-----------------
MDS

Intervention / Treatment
-----------------
* Drug: IBI188
* Drug: Azacitidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Newly diagnosed MDS subjects with higher risk. Age ≥ 18 years old. Eastern Cooperative Oncology Group score of 0-2. Adequate organ function. Subjects should take effective contraceptive measures. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures. Main Exclusion Criteria: Subject who has transformed from MDS to AML. MDS subjects with lower risk. Subjects who have received chemotherapy. History of chronic hemolytic anemia Prior exposure to any anti-CD47 or anti-SIRPα agents. Subjects participating in another interventional clinical study.

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI188 + azacitidine<br>Participants will receive IBI188 in combination with azacitidine | Drug: IBI188<br>* IBI188: 100 mg/mL, intravenous infusion once a week<br>Drug: Azacitidine<br>* Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle<br>* Other names: VIDAZA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events according to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or customized AE severity grading as defined in the protocol | 28 days | 
| Efficacy of IBI188 in combination with AZA | International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDS