linjc16/ctgov huggingface dataset:
Study Where Healthy Volunteers Evaluate LoFric Catheters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day. The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.

Official Title
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A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent

Conditions
-----------------
Catheterization

Intervention / Treatment
-----------------
* Device: LoFric POBE
* Device: LoFric POBE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Healthy volunteers Males age 18 years and over Exclusion Criteria: Known or suspected, current impairment of and/or decreased urethral sensibility History of urethral disease History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection Use of medications that may affect the urethra's dryness (e. g. anti-cholinergic drugs or cortisone) Current drug, alcohol or other substance abuse Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation Allergy to Trimethoprim Suspected poor compliance with the protocol during the complete study period.

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: LoFric POBE<br>* LoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter LoFric POBE, Nelaton 40 cm, CH 12 with current solvent before being catheterized with the test catheters.<br>|
| Experimental: B<br> | Device: LoFric POBE<br>* Unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with new solvent Each subject will use the reference catheter LoFric POBE, Nelaton 40 cm, CH 12 with current solvent before being catheterized with the test catheters.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy volunteers perception of catheterization |  | At each catheterization (three times during one day) |
The Effect of 40gr Okara on Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)

Detailed Description
-----------------
This trail will be a single blinded, cross-over design. The study population will include 10 subjects. The patients will be randomly assigned to receive one of two Muffin cakes, with or without 40 grams Okara on three occasions (three visits). In two visits the subject will receive a Muffin cake with 40 grams Okara (but with similar caloric value), and in one visit a Muffin cake without Okara. Postprandial gastric emptying time will be measured for each subject, by 13C Breath Test. Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.

Conditions
-----------------
Healthy People

Intervention / Treatment
-----------------
* Dietary Supplement: Nutrigal Okara - 100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age 20-65 years old Written Informed Consent Exclusion Criteria: History of gastro-intestinal surgery On medication that may influence gastric emptying, or medication for weight loss Patient on PPI treatment, H2 Blockers or medication for weight loss Known allergies to soy Pregnancy or breast-feeding Smoking Athletes Metabolic syndrome or diabetes mellitus Family history of metabolic syndrome or diabetes mellitus Weight loss > 2 kg during two months before the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Nutrigal Okara - 100|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the influence of 40 gram Okara on gastric emptying |  |  |
Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease)

Study Overview
=================
Brief Summary
-----------------
Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area.

Conditions
-----------------
Autosomal Dominant Polycystic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADPKD patients followed in Nephrology centers in the West of France Age >17 Exclusion Criteria: None

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 |
| --- | --- | --- |
| Clinical description of the patient |  | at the inclusion day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic analysis |  | at the inclusion day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic disease
DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.

Detailed Description
-----------------
To develop a cohort of patients treated with GLP-1 R Agonists who are phenotyped at baseline and at 6 month follow up to determine clinical, imaging and other biomarker predictors of glycaemic response to GLP-1R Agonists. The hypothesis is that one, or a combination, of these biomarkers is associated with glycaemic response to GLP-1R Agonists. The primary outcome is therefore HbA1c reduction after 6 months of GLP-1R A treatment. This is a cohort study of 800 patients being treated with either exenatide or liraglutide for 6 months, and carried out in 4 UK centres.

Official Title
-----------------
DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Exenatide, Liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist Either: On any combination of oral hypoglycaemic agents On Insulin (+/- oral hypoglycaemic agents) HbA1c ≥7.5% (58mmol/mol) and HbA1c < 12% (108mmol/mol) White European Age ≥ 18 and < 80 Exclusion Criteria: Type 1 diabetes HbA1c <7.5% (58 mmol/mol) HbA1c ≥ 12% (108 mmol/mol) Pregnancy or lactation Any other significant medical reason for exclusion as determined by the investigator Inability to consent Participating in a CTIMP during the study period and within 30 days prior to study start.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Exenatide, Liraglutide|Dosage, frequency and duration not specified by protocol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between baseline and 6 months | The primary outcome is the change in HbA1c (absolute difference between the baseline and 6 month measure) in mmol/mol | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLP-1R agonist, biomarker
Adaprev in Digital Flexor Tendon Repair

Study Overview
=================
Brief Summary
-----------------
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.

Official Title
-----------------
A Randomized, Double Blind Clinical Investigation to Evaluate the Safety, Tolerability, and Preliminary Performance of Adaprev™ in Improving Recovery of Tendon Function in Subjects Undergoing Surgical Repair of Flexor Tendons in Zone II of the Hand

Conditions
-----------------
Tendon Injuries

Intervention / Treatment
-----------------
* Device: Adaprev


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II. Exclusion Criteria: Subjects with additional complicated injuries Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred. Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial. Subjects with conditions which may delay healing. Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit. Females who are pregnant

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active - Adaprev<br>Adaprev (Class III medical device) | Device: Adaprev<br>* Class III Medical Device<br>* Other names: Product contains mannose-6-phosphate;|
| No Intervention: Standard Care<br>No different treatment to normal | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing. |  | 26 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint will be an evaluation of the performance of Adaprev™ as measured by the range of motion of the treated finger at twenty six weeks after tendon repair |  | 26 weeks post surgery |
The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(AKI) in patients undergoing valvular heart surgery.

Conditions
-----------------
Acute Kidney Injury

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients over the age of 20 scheduled for valvular heart surgery Exclusion Criteria: Current statin use Left ventricular ejection fraction < 30% Preexisting congestive heart failure Severe coronary artery disease Hemodynamically unstable arrhythmia Cardiogenic shock during perioperative period Ventricular assist device Severe renal dysfunction (eGFR < 15 ml/min per 1.73 m2) History of liver disease or elevated serum transaminases History of rhabdomyolysis or elevated creatinine kinase

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin group<br> | Drug: atrovastatin<br>* Atrovastatin 80mg was administered orally on the evening before surgery. Before anesthesia induction, atrovastatin 40mg was administered orally. And atrovastatin 40mg were administered orally in the evening of postoperative days 0, 1, and 2.<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* Placebo 80mg was administered orally on the evening before surgery. Before anesthesia induction, placebo 40mg was administered orally. And placebo 40mg were administered orally in the evening of postoperative days 0, 1, and 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgery | BUN/Cr cystatin C eGFR urine output incidence of acute kidney injury(based on the AKIN criteria) | renal function change from 24-hour after surgery to 120-hour after surery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AKI, atrovastatin, Valvular heart surgery
ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

Study Overview
=================
Brief Summary
-----------------
This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.

Official Title
-----------------
ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)

Conditions
-----------------
Acute Hepatic Porphyria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of AHP, per physician's determination Exclusion Criteria: Currently enrolled in a clinical trial for any investigational agent

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Patients with AHP<br>Patients with a diagnosis of AHP will be eligible for the study and will be managed and treated per routine clinical practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Selected Events of Interest in AHP Patients | Selected events of interest are defined as hepatic events, renal events, and pancreatitis. | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Rate of Porphyria Attacks | Porphyria attacks are defined as meeting all of the following criteria: an acute episode of neurovisceral pain in the abdomen, back, chest, extremities and/or limbs, no other medically determined cause, and requires treatment with intravenous (IV) dextrose or hemin, carbohydrates, or analgesics, or other medications such as antiemetics at a dose or frequency beyond the participant's usual daily porphyria management. | Up to 6 years | 
| 12-Item Short Form Health Survey Version 2 (SF-12 V2) (Standard Version) | S-12 V2 is a 12-question measure capturing global quality of life and overall health status and evaluates the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. | Up to 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Givosiran, AHP, Acute hepatic porphyria
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.

Official Title
-----------------
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: ESAOTE MyLab60
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: failure to at least one TNF-blocking agent Exclusion Criteria: pregnant or childbearing woman Rituximab contraindication woman unable to use contraceptive means

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rituximab<br>Only one arm; all patients are treated by rituximab (monotherapy or in combination with conventional DMARD) | Device: ESAOTE MyLab60<br>* US evaluation at different time points<br>* Other names: sonography;Drug: Rituximab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global score of power-doppler activity measured by ultrasonography on 12 joints | Each time point will be assessed since the main objective of the study is to detect the time of sonographic relapse prior to clinical relapse | at 6 months after initiation of rituximab and then every 2 month over the follow-up period (18 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rituximab, sonography, clinical response
Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

Study Overview
=================
Brief Summary
-----------------
With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

Detailed Description
-----------------
Background and rationale It is known that a partial meniscectomy of the knee is a risk factor to the development of early osteoarthritis with complaints of pain. Trial objectives and Design 2.1 Trial objectives With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain. 2.2 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain. 2.3 Secondary endpoints A possible correlation between the resected volume and the severity of the pain. Selection and withdrawal of subjects 3.1 Inclusion criteria All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's. Age between 14 and 50 years old Women of child bearing age can be included: the study has no effect on their methods of contraception. 3.2 Exclusion criteria A history of a tibia plateau fracture or severe deformity of the knee Rupture of the ACL/PCL/collateral ligaments of the knee Focal cartilage defects of the knee

Official Title
-----------------
Is Meniscal Volume Critical to Post-meniscectomy Symptoms? A Retrospective Study

Conditions
-----------------
Meniscal Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's. Age between 14 and 60 years old Women of child bearing age can be included: the study has no effect on their methods of contraception. Exclusion Criteria: A history of a tibia plateau fracture or severe deformity of the knee Rupture of the ACL/PCL/collateral ligaments of the knee Focal cartilage defects of the knee

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 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 |
| --- | --- |
| Meniscectomy<br>Patients who underwent a meniscectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How much volume can be resected peroperatively without developing postoperative pain. | A possible correlation between the resected volume and the severity of the pain. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meniscectomy, volume, pain