linjc16/ctgov huggingface dataset:
HbA2 Leuven and Its Impact on HbA1c Results

Study Overview
=================
Brief Summary
-----------------
The study is designed to demonstrate HbA2 Leuven mutation and to asssess its impact on routine HbA1c measurements.

Detailed Description
-----------------
HbA2 Leuven mutation will be investigated using molecular diagnostic techniques. Interference on HbA1c measurements will be assessed in HbA2 Leuven carriers using different methodologies.

Official Title
-----------------
HbA2 Leuven and Its Impact on HbA1c Results

Conditions
-----------------
Family Study HbA2 Leuven Mutation.

Intervention / Treatment
-----------------
* Other: Blood withdrawal
* Genetic: Blood withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family history of HbA2 Leuven mutation. Exclusion Criteria: Any condition inhibiting simple blood withdrawal.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HbA2 Leuven<br>Presence of HbA2 Leuven mutation, demonstrated by molecular diagnosis on blood sample. | Other: Blood withdrawal<br> <br> * Other names: Impact of mutation on routine HbA1c measurements.;Genetic: Blood withdrawal<br> <br> * Other names: Demonstration of HbA2 Leuven mutation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of presence/absence of HbA2 Leuven mutation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of impact of HbA2 Leuven mutation on routine HbA1c measurements |  | 1 year |
Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.

Official Title
-----------------
Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: videolaparocholecystectomy
* Procedure: videolaparocholecystectomy
* Procedure: videolaparocholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old, ASA 1 and 2 Gallbladder adenomatous polyposis and cholelithiasis with no byochemical, clinical and instrumental evidence of acute cholecystitis at the moment of surgery. Exclusion Criteria: Age<18 years old Pregnancy Previous major surgery of the supramesocholic compartment Acute cholecystitis Choledocolitiasis Acute pancreatitis at the moment of surgery Laparotomic conversion during surgery

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder | Procedure: videolaparocholecystectomy<br>* Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder<br>Procedure: videolaparocholecystectomy<br>* Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.<br>|
| Experimental: 2<br>Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure. | Procedure: videolaparocholecystectomy<br>* Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.<br>|
| No Intervention: 3<br>Group3: control group without any local anesthetic use. | Procedure: videolaparocholecystectomy<br>* Group3: control group without any local anesthetic use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain], |  | 6 and 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting. |  | 6 and 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystectomy
Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients

Study Overview
=================
Brief Summary
-----------------
The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.

Official Title
-----------------
Tornier Shoulder Outcomes Clinical Study

Conditions
-----------------
Shoulder Arthroplasty and Fracture Repair

Intervention / Treatment
-----------------
* Procedure: Shoulder Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Willing and able to comply with the requirements of the study protocol Considered for treatment with one or more Tornier shoulder arthroplasty or fracture devices included in this study Exclusion Criteria: Patients who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

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 |
| --- |
|Procedure: Shoulder Arthroplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of device associated and procedure associated adverse events |  | up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of reoperation and revision surgery |  | up to 20 years |
A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).

Official Title
-----------------
A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography

Conditions
-----------------
Cholestasis

Intervention / Treatment
-----------------
* Other: CO2 insufflation
* Other: Room air insufflation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 years referred for ERCP for any indication at UNC Hospitals Exclusion Criteria: age < 18 years COPD requiring oxygen or with known CO2 retention any medical condition with known CO2 retention medical instability making the procedure unsafe absolute requirement for same-day second endoscopy ERCP performed in the OR or under GA inability to read or understand English use of chronic opiates for pain pregnant women

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Other: CO2 insufflation<br>* The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).<br>* Other names: Olympus XUCR manufacured by Olympus Medical.;|
| Placebo Comparator: II<br>Room air will be used for insufflation as the placebo comparator arm. | Other: Room air insufflation<br>* During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain (VAS). |  | pre-procedure and up to 24 hours post-procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of CO2 retention. |  | Intra-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic retrograde cholangiopancreatography, carbon dioxide, randomized controlled clinical trial
The Effect of PXR Activation on Blood Pressure Regulation

Study Overview
=================
Brief Summary
-----------------
We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.

Official Title
-----------------
The Effect of PXR Activation on Blood Pressure Regulation

Conditions
-----------------
Blood Pressure Regulation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers BMI 19-30 kg/m2 Age 18-40 years Systolic blood pressure 95 - 140 mmHg Exclusion Criteria: Any continuous medication Any significant medical condition as judged by the study physician Diastolic blood pressure over 90 mmHg Sensitivity to rifampicin Pregnancy and lactation Difficult venipuncture Abuse of alcohol or medications, or drug use. Participation in other trial with medications in previous 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rifampicin<br>Rifampicin 600 mg daily | Drug: Rifampicin<br> <br> * Other names: Rimapen;|
| Placebo Comparator: Placebo<br>Placebo daily | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic ambulatory blood pressure | Systolic blood pressure measured with ambulatory blood pressure monitor. | On day 8 of each arm | 
| Diastolic ambulatory blood pressure | Diastolic blood pressure measured with ambulatory blood pressure monitor | On day 8 of each arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure |  | On day 9 of each arm | 
| Pulse (ambulatory) |  | On day 8 of each arm | 
| Plasma renin activity |  | On day 9 of each arm | 
| Serum aldosterone |  | On day 9 of each arm | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rifampicin, pregnane X receptor, blood pressure
Detection of Anastomotic Leakage After Esophageal Surgery

Study Overview
=================
Brief Summary
-----------------
Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

Detailed Description
-----------------
This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Official Title
-----------------
Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.

Conditions
-----------------
Esophageal Cancer, Anastomotic Leakage

Intervention / Treatment
-----------------
* Procedure: Contrast swallow radiography, endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary esophageal cancer undergoing transthoracic esophagectomy. Exclusion Criteria: no transthoracic resection no primary anastomosis recurrent disease refusal to participate

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>A prospective, blinded, intraindividual controlled study is conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study is performed prior to endoscopy at the 5th to 7th postoperative day. | Procedure: Contrast swallow radiography, endoscopy<br>* Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of anastomotic leakage |  | 5-7 days after surgical procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
detection of anastomotic leakage, esophageal resection, diagnostic safety
Polycystic Kidney Disease Data Repository

Study Overview
=================
Brief Summary
-----------------
Autosomal dominant polycystic kidney disease (PKD) is the most common inherited kidney disease, affecting more than 400,000 people in the U.S. and 5 million people worldwide. PKD is the 4th most common cause of kidney failure requiring dialysis and/or transplantation. Over half of all PKD patients develop kidney failure by age 60 years, although age of onset of kidney disease varies widely, even among members of the same family. Despite the fact this is a relatively common problem, relatively few patients have been studied for a sufficient period of time to fully understand how patients are affected over the course of their lifetime. The reason for creating this repository is to collect information about PKD so that the investigators may fully understand its complications, including high blood pressure, heart attack, and stroke. This information may also aid in the development of improved treatment strategies.

Detailed Description
-----------------
Visit #1: - An initial detailed history, physical examination, and laboratory evaluation The following imaging procedures will be performed within three months of the first study visit: - Renal and hepatic magnetic resonance imaging Additional assessment and testing: Genetic assessment: An extensive family history of PKD will be obtained from the patient. Genotyping of specific PKD1 and PKD2 mutations Follow-up Study Visits: - Patients will return to the outpatient facility for detailed follow-up examinations every other year after Visit 1.

Official Title
-----------------
Autosomal Dominant Polycystic Kidney Disease Data Repository

Conditions
-----------------
Polycystic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate. Exclusion Criteria: Inability to provide informed consent.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polycystic kidney disdease data repository | Polycystic kidney disease data repository | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PKD
MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial

Study Overview
=================
Brief Summary
-----------------
In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules over six months. We evaluated patients in two groups by modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) to examine their state of disability and recovery

Official Title
-----------------
MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial

Conditions
-----------------
Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: MLC 901
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: an initial cardiac arrest leading to coma, successful return of spontaneous circulation, and persistent coma after the return of spontaneous circulation. Exclusion Criteria: pregnancy, cardiogenic shock (systolic blood pressure less than 90 mm Hg despite epinephrine infusion), possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident), an underlying background of known acute or chronic disease including renal failure, liver or pulmonary disorders, previous stroke, dementia, and brain injury.

Ages Eligible for Study
-----------------
Minimum Age: 14 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mlc-901 group<br> | Drug: MLC 901<br>* MLC901, also known as NeuroAiDII, is a capsule form of drug which should be taken orally and combines nine herbal components<br>* Other names: Nueroaid II;|
| Placebo Comparator: placebo group<br> | Drug: Placebo<br>* placebo capsules filled with stevia sweetened powder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurofunctional outcome using Glasgow Outcome Scale (GOS) |  | 6 months | 
| neurofunctional outcome using modified Rankin Scale (mRS) |  | 6 months |
Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients

Study Overview
=================
Brief Summary
-----------------
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients

Official Title
-----------------
An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers

Conditions
-----------------
Renal Impairment, Diabetes

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: Vildagliptin
* Drug: Vildagliptin
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to <50 ml/min) and severe (CrCl of <30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of >80 ml/min Exclusion Criteria: Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history Other protocol-defined inclusion/exclusion criteria may apply

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin 25 mg qd in Renal Impaired (RI) patients<br> | Drug: Vildagliptin<br>* Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily<br>|
| Experimental: Vildagliptin 50 mg qd in RI Patients<br> | Drug: Vildagliptin<br>* Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily<br>|
| Experimental: Vildagliptin 25 mg qd in matched Healthy Volunteer (HV)<br> | Drug: Vildagliptin<br>* Matching healthy volunteers receiving 25 mg vildagliptin once daily.<br>|
| Experimental: Vildagliptin 50 mg qd in matched HV<br> | Drug: Vildagliptin<br>* Matching healthy volunteers receiving 50 mg vildagliptin once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: pharmacokinetics of vildagliptin and its metabolites |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: safety assessments will include vital signs, electrocardiograms and adverse events |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal impairment, Diabetes, vildagliptin, Galvus, Eucreas