linjc16/ctgov huggingface dataset:
Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.

Official Title
-----------------
Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study

Conditions
-----------------
Crohn Disease, Vitamin D Deficiency, Vitamin D Supplement

Intervention / Treatment
-----------------
* Drug: Caltrate Pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate-to-severe CD Treated with Infliximab bio-naïve at the time of diagnosis Exclusion Criteria: had recent supplementation of vitD3 had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment pregnant had cognitive/developmental disorders that affected their ability to complete the study procedures had medical illness or therapies potentially affecting bone, nutrition or growth status

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 |
| --- | --- |
| Vitamain D<br>This group of patients were supplemented with 125IU/d Vitamin D | Drug: Caltrate Pill<br>* VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period.<br>|
| Control<br>The other group did not receive the supplementation of 125IU/d Vitamin D | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25 (OH) D level | Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status. | 54 weeks | 
| disease activity | CDAI evaluation | 54 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the metabolism of calcium and phosphorus | serum levels calcium and phosphorus | 54 weeks | 
| the expression profiles of Th-cell-related cytokines | Serum levels of IL-2, IL-4, IL-6, IL-10, TNF-α and IFN-γ | 54 weeks |
Development and Validation of a NIRS-based Sinusitis Screening

Study Overview
=================
Brief Summary
-----------------
The research at University of California Irvine, Beckman laser institute and Praxis Biosciences Incorporation, develope near-infrared trans-illumination methods. The optical imaging tool that can determine acute sinusitis and the response to treatment therapy.

Detailed Description
-----------------
In the United States, approximately one in seven people develop sinusitis each year, and 20 million cases of acute bacterial sinusitis become chronic to require medical treatment. The optic light from the illumination wand travelled through the pallet into the sinuses and exited the face. The optic device can determine air-filled and fluid/tissue-filled spaces in the sinus cavity during clinical exam.

Official Title
-----------------
Development and Validation of a NIRS-based Sinusitis Screening

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Device: Optic imaging use near-infrared trans-illumination methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age and older Subject with normal sinus Subject who has been diagnosed and confirm by their physician Exclusion Criteria: Younger than 18 years old Pregnant women

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 |
| --- | --- |
| Sinus<br>Optic imaging use near-infrared trans-illumination methods | Device: Optic imaging use near-infrared trans-illumination methods<br>* Optic imaging use near-infrared trans-illumination methods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus Health | Assessment of sinusitis | up to 4 weeks |
Leptin Biology in Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are high in obese subjects indicating resistance to the actions of leptin. High leptin levels have been associated with increased cardiovascular and metabolic risks, but it is not clear if increased leptin or leptin resistance contributes to the increased cardiovascular risk. Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue functions are not completely investigated in humans. Based on preliminary data the investigators hypothesize that resistance to leptin action in obese adipose tissue is responsible for altering the expression of adipose tissue proteins which contribute to the development of cardiovascular and metabolic dysfunction. To test this hypothesis the investigators propose a novel study directed at investigating the leptin dependent changes in adipose tissue protein expression using adipose tissue obtained from lean and obese human subjects

Official Title
-----------------
Leptin Biology in Adipose Tissue

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: obesity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years BMI BMI ≤25 (lean) or >30 kg/m2 (obese) Going to undergo a surgical procedure where omental and subcutaneous adipose tissue may be biopsied. Exclusion Criteria: Inability to provide written informed consent. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal<br>Normal weight subjects | Other: obesity<br> <br> |
| Other: Over weight /obese subjects<br>Overweight and obese subjects | Other: obesity<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in adipose tissue protein expression in response to leptin treatment | The effect of leptin on adipose tissue protein expression will be assessed by Western blot method. The adipose tissue biopsy samples will be treated with leptin for 24 hours in sterile culture conditions. After leptin treatment, the tissue will be lysed, proteins will be separated by denatured SDS-PAGE electrophoresis, transferred on a nitrocellulose membrane and changes in specific proteins will be determined using protein-specific antibodies. | Baseline and after 24 hours of leptin treatment |
PROMUS PREMIER™ China Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.

Detailed Description
-----------------
Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or clinic visit

Official Title
-----------------
Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be at least 18 years of age Subject understands and provides written informed consent Subject who is clinically indicated and will have an attempt of at least one Promus PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least one Promus PREMIERTM Stent Subject is willing to comply with all protocol-required follow-up evaluation Exclusion Criteria: Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an all comers 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System|Promus PREMIERTM Stent System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) | The primary endpoint is the 12-month major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) | 12-month follow up |
Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol

Study Overview
=================
Brief Summary
-----------------
Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features

Detailed Description
-----------------
At the peak of the COVID-19 (SARS-CoV-2) pandemic in New York City, there was a shortage of hospital resources as well as a fear among many New Yorkers of going to the hospital. Emergency Services dead on arrival calls increased by as much as eight-fold.We created the CROWN Program, a pulmonary physician guided home-care protocol to treat ambulatory COVID-19 (SARS-CoV-2) patients with moderate to high risk features. This is a retrospective review of our CROWN program's patient characteristics, results and outcomes.

Official Title
-----------------
Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol

Conditions
-----------------
Covid-19 (SARS-CoV-2)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 (SARS-CoV-2) infection Ambulatory Exclusion Criteria: Need for hospital admission

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 |
| --- | --- |
| COVID-19 (SARS-CoV-2) patients<br>adults 18 or older, ambulatory , with COVID-19 (SARS-CoV-2) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admission | admission to hospital | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 (SARS-CoV-2), Homecare, Ambulatory
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the effect of pneumoperitoneum on remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic gastrectomy.

Official Title
-----------------
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Other: High end-tidal CO2
* Other: Low CO2 group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic gastrectomy under general anesthesia Exclusion Criteria: atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High CO2 group<br>end tidal CO2 : 40-45 mmHg | Other: High end-tidal CO2<br>* maintaining of end-tidal CO2 with the range of 40-45 mmHg<br>|
| Placebo Comparator: Low CO2 group<br>end tidal CO2 : 30-35 mmHg | Other: Low CO2 group<br>* maintaining of end-tidal CO2 with the range of 30-35 mmHg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dose of remifentanil | total dose of remifentanil to maintain for surgical pleth index < 50 | through study completion, an average of 2 hours |
A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: MK0557


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study. Exclusion Criteria: Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0557|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight after 1 year of treatment. |  | After 1 year of treatment | 
| Safety and tolerability. |  | After 1 year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years |  | After 2 years |
Measuring the Spectrum of Tissues During Endoscopy

Study Overview
=================
Brief Summary
-----------------
Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different composition compared to the normal mucose. The investigators plan to gather spectroscopic information from these features. Characterizing their unique spectrums, may help to enhance the detection and identification of these objects during endoscopy.

Official Title
-----------------
Measuring the Spectrum of Tissues During Endoscopy

Conditions
-----------------
Colon Carcinoma, Colonic Polyps, Intestinal Polyps

Intervention / Treatment
-----------------
* Procedure: An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, independent patients who come to Sheba Hospital's gastro-intestinal clinic for endoscopy and are willing to sign an informed consent Exclusion Criteria: None

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 |
| --- | --- |
| People undergoing GI tract endoscopy<br> | Procedure: An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination<br>* An optical fiber, inside the work channel of an endoscope, connected to a spectroscope, enables measuring the spectrum of objects seen by the endoscope<br>* Other names: The brand of the optical fiber is not relevant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Statin for Immunomudulation in Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients

Official Title
-----------------
Use of Statins in Modulation of Inflammatory Answer in Septic Patients

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: amido pill
* Drug: atorvastatina


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of several sepsis or shock septic no more than twenty four hours than diagnosis Exclusion Criteria: use of statins in the last thirty days unequivocal indication for statin treatment active treatment with imunosuppressors drugs High risk of rhabdomyolysis: multiple trauma, crush injuries, baseline creatinine kinase > three times upper limit of normal diagnosis of AIDS unable to receive enteral medications pregnancy expected survival of less than 48 hours

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Placebo Comparator: amido pill<br> | Drug: amido pill<br>* one pill of amido/d by mouth for 10 days<br>|
| Experimental: atorvastatina<br>atrovastatina 80 mg/d by mouth for 10 days | Drug: atorvastatina<br>* atorvastatina 80 mg/day by mouth for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| action in inflammmatory biologic makers |  | 24h; 72h; 10 days | 
| valuation of flow-mediated vasodilation of the brachial artery |  | 24h; 72; 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | at end | 
| time of permanence in intensive care unity |  | at end | 
| time of permanence in mechanical ventilation |  | at end |
Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
In Type 2 Diabetes mellitus patients we will: quantify vasculopathy and blood-retinal barrier (BRB) leakage measure blood-brain barrier (BBB) permeability and neuroanatomical changes correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric sequela

Official Title
-----------------
Blood-retinal Barrier Imaging in Type 2 Diabetes Mellitus: a Window for Blood-brain Barrier Breakdown and Neuropsychiatric Sequela

Conditions
-----------------
Type 2 Diabetes Mellitus, Non-Proliferative Diabetic Retinopathy, Diabetic Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) who are in the clinical database of the ophthalmologic department , above 18 years old at the time of diagnosis and underwent FA examination in the past three years Patients which their medical records are available via a computerized data base Control group: T2DM patients who are in the clinical database of the ophthalmologic department Above 18 years old at the time of diagnosis Underwent FA examination in the past three years and their examination was interpreted as normal, i.e. without suspected diabetic retinopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Diabetic Retinopathy<br>T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) | |

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

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