linjc16/ctgov huggingface dataset:
Drug-Drug Interaction Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone

Detailed Description
-----------------
Pharmacokinetics and Safety in Healthy Subjects

Official Title
-----------------
Open-Label, Randomized, Multiple-Dose, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of BMS-790052 and BMS-650032 Co-administered in Healthy Subjects

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: BMS-650032
* Drug: BMS-790052
* Drug: BMS-650032
* Drug: BMS-790052


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects aged 18 to 49 years Females who are not of childbearing potential, pregnant or breastfeeding Subject Body Mass Index (BMI) of 18 to 32 kg/m² Exclusion Criteria: Women of child bearing potential Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing Any significant acute or chronic medical illness Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations Prior exposure to BMS-650032 or BMS-790052 Positive for HIV or HCV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group A<br> | Drug: BMS-650032<br>* Capsules, Oral, 600 mg, Q12h, Days 1-7<br>|
| Experimental: Treatment Group B<br> | Drug: BMS-790052<br>* Capsules, Oral, 60 mg, Q24h, Days 1-7<br>|
| Experimental: Treatment Group C<br>Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg) | Drug: BMS-650032<br>* Capsules, Oral, 200 mg, Q12h, Days 8-21<br>Drug: BMS-790052<br>* Capsules, Oral, 30 mg, Q24h, Days 8-21<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin |  | Day 21 pharmacokinetic assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered |  | Within 24 hours post dose |
Structured Stroke Management Improves Outcome at 6 Months

Study Overview
=================
Brief Summary
-----------------
Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data. Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. The intervention consists of a structured therapeutic chain of 290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. Primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are directly compared with the same endpoints of the Swiss subgroup of the international stroke trial (IST).

Official Title
-----------------
Structured Stroke Management Improves Outcome at 6 Months

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: structured therapeutic chain of stroke treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (ICB)) with the signs and symptoms of an acute stroke according to the World Health Organisation definition of acute stroke14 within the last 12 hours without the need or possibility of a neurosurgical intervention No thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial The informed consent of the patient or, if not possible, of the relatives Living at home before the event Lack of participation in another trial. Exclusion Criteria: Thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial No informed consent of the patient or, if not possible, of the relatives Not living at home before the event Participation in another trial (26 patients were excluded because of TIA with full recovery within 24 hours after the event)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: structured therapeutic chain of stroke treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality, dependence, psychoscial outcome |  |  | 
| Mortality, dependence and psychosocial outcome |  | 6 months endpoint | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke treatment, Rehabilitation, Stroke chain, Stroke unit
Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.

Study Overview
=================
Brief Summary
-----------------
Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.

Official Title
-----------------
Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.

Conditions
-----------------
Post Stroke Spasticity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox Exclusion Criteria: A patient will be excluded if he has been only treated with Xeomin

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- | --- |
| Mean time to next injection per brand |  | From baseline up to end of data collection (January 2012 up to December 2016) | 
| Median time to next injection per brand |  | From baseline up to end of data collection (January 2012 up to December 2016) | 
| Dosing of botulinum toxin-A in daily practice in relation to time to next injection |  | From baseline up to end of data collection (January 2012 up to December 2016) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average cost per year per brand per patient |  | From baseline up to end of data collection (January 2012 up to December 2016) | 
| Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments |  | From baseline up to end of data collection (January 2012 up to December 2016) | 
| Time interval between 2 injections of the same brand |  | From baseline up to end of data collection (January 2012 up to December 2016) |
Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
Advanced liver disease and low ascitic fluid protein concentration have been identified as risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and improves survival in cirrhotic patients with ascites and low protein concentration in ascitic fluid (<15 g/L) and at least one of the following inclusion criteria: functional renal failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130 mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods: Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral norfloxacin (400 mg/d; n=35) with placebo (n=35).

Official Title
-----------------
Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis

Conditions
-----------------
Spontaneous Bacterial Peritonitis, Hepatorenal Syndrome, Cirrhosis

Intervention / Treatment
-----------------
* Drug: Oral norfloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years, protein concentration in ascitic fluid < 15 g/L and at least one of the following: serum creatinine ≥ 1.2 mg/dl or BUN ≥ 25 mg/dl, serum sodium ≤ 130 mEq/L or severe liver failure as defined by a Child-Pugh score ≥ 9 points and a serum bilirubin ≥ 3 mg/dl. Exclusion Criteria: Previous history of spontaneous bacterial peritonitis or of norfloxacin prophylaxis, allergy to quinolones, hepatocellular carcinoma, organic renal failure and HIV infection

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral norfloxacin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term and long-term survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of the first episode of spontaneous bacterial peritonitis |  |  | 
| Prevention of hepatorenal syndrome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Norfloxacin, primary prophylaxis, SBP
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.

Study Overview
=================
Brief Summary
-----------------
Our research has shown that pressure sensation from the soles of the feet (plantar mechanoreceptors) plays an important role in controlling several key aspects of balancing reactions, particularly during compensatory stepping . As a result, age-related loss of plantar pressure sensation, which is very common, can lead to impaired control of these reactions. However, we have shown that it is possible to compensate for balance impairments resulting from this loss of sensation by using special footwear insoles to facilitate sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of this approach in laboratory studies, and we have obtained a U.S. patent for the design concept. However, it remains to be determined whether the benefits of the footwear persist over the long term, or whether there is a habituation of the effect. Also, we need to determine whether there are any practical problems associated with wearing such footwear, e.g. due to discomfort or irritation of the skin.

Official Title
-----------------
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.

Conditions
-----------------
Sensation Disorder

Intervention / Treatment
-----------------
* Device: SoleSensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65 to 75 years Exclusion Criteria: Any neurological or musculoskeletal ailments that affect their balance Any drugs that affect balance

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SoleSensor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Short-term Outcome After Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates. Recently, self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning. However, real-life data on the safe use in that specific indication are still lacking. Therefore, this study evaluated short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair.

Official Title
-----------------
Short-term Outcome After Ventral Hernia Repair Using Self-gripping Mesh in Subway Technique - a Retrospective Cohort Analysis

Conditions
-----------------
Short-term Outcome After Ventral Hernia Repair

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ventral hernia repair in sublay technique Exclusion Criteria: ventral hernia repair in other technique

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| self-gripping mesh<br> | |
| non-self-gripping mesh<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | overall complication rate, seroma rate, SSI rate | 1 year |
FRED and FRED JR Devices for Intracranial Aneurysm Treatment

Study Overview
=================
Brief Summary
-----------------
A French, multicenter, prospective, observational, real-world assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms

Detailed Description
-----------------
Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care. Sample Size: 138 patients.

Official Title
-----------------
Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: FRED and FRED JR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FRED and FRED JR|Intracranial aneurysm treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Percentage of patients with neurological death | 1 year | 
| Morbidity Rate | Percentage of patients with major ipsilateral stroke | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Score | worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death) | 1 year | 
| Complete aneurysm occlusion rate | Measured by the Raymond Scale | 1 year | 
| Retreatment Rate | Rate and description of aneurysm retreated or planned for retreatment | 1 year | 
| Patient description | Description of the population of patients treated with FRED and FRED JR in France | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneurysm, endovascular, flow-diverter
Expression of G-protein Coupled Receptor 120 Receptor in Adipose Tissue of German Diabetes Center Cohort Subjects

Study Overview
=================
Brief Summary
-----------------
G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous ligands have been identified as long-chain fatty acids. Recently, it has been shown that GPR120 expression in human adipose tissue is higher in obese than in lean individuals. Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found in type 2 diabetes (T2D). Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified that inhibits GPR120 signaling activity. The investigators now want to investigate if GPR120 expression in adipose tissue may be altered in patients with T2D compared to non-diabetic subjects and might contribute to diabetes-associated metabolic changes. Additionally, the investigators want to assess the frequency of the R270H mutant in T2D.

Official Title
-----------------
Expression of GPR120 Receptor in Adipose Tissue of Type 2 Diabetic Subjects

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus / normoglycemia BMI < 27,5 or > 30 kg/m2 Age 20 - 69 years Exclusion Criteria: severe chronic diseases anemia medication altering fatty acid metabolism

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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 |
| --- | --- |
| Diabetic group<br>Patients with recently diagnosed type 2 diabetes | |
| Controls<br>Age- and BMI-matched normoglycemic subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GPR120 expression in adipose tissue | GPR expression is measured in adipose tissue of recently diagnosed type 2 diabetic patients and age- and BMI-matched normoglycemic controls | Expression measured at baseline (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GPR120, Adipose tissue, Type 2 diabetes
Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.

Detailed Description
-----------------
Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH). This headache may last years, severely affecting quality of life. Laboratory evidence suggests that the persistent headache may be a result of a maladaptive neuroinflammatory response to the hemorrhage injury that is more vigorous than necessary. The goal of this study is to measure key immunomodulators in the blood and the cerebrospinal fluid of these patients in order to determine the magnitude and dynamics of their neuroinflammatory response. In addition, the investigators will collect and analyze observational data about the success of medications to treat headache, with a specific focus on the anti-inflammatory agent dexamethasone, in managing acute headache pain and preventing the development of persistent headaches in patients after SAH.

Official Title
-----------------
Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage (HASH4-CSF) - An Observational Trial

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal, Headache, Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-traumatic subarachnoid hemorrhage Age > 18 years Treated with external ventricular drainage Exclusion Criteria: Pregnancy or lactation Age < 18 years Traumatic SAH

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH. |  | 10 days | 
| Determination of correlation between the neuroinflammatory response and severity/presence of headache pain. |  | 10 days | 
| Determination of correlation between the neuroinflammatory response and development of chronic headache. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH. |  | 10 days | 
| Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, Subarachnoid hemorrhage, Neuroinflammation