linjc16/ctgov huggingface dataset:
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant

Official Title
-----------------
A One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male and female patients of any race between 18 to 65 years old (inclusive) Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation Patients who gave written informed consent to participate in the study Exclusion Criteria Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period Graft cold ischemia time greater than 40 hours. Patients with pulse rate < 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: FTY720|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant |  |  | 
| Permanent resumption of dialysis within 12 months post transplant |  |  | 
| Surgical removal of graft within 12 months post transplant |  |  | 
| Death within 12 months post transplant |  |  | 
| Withdrawal of consent, death, or lost to follow up within 12 months post transplant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12 |  |  | 
| Serum creatinine |  |  | 
| Cystatin C at months 3, 6, and 12 |  |  | 
| Proteinuria at day 28, months 6 and 12 |  |  | 
| Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplantation, kidney, and organ transplant.
Validity and Reliability in Measuring the Subacromial Space by Using Ultrasound

Study Overview
=================
Brief Summary
-----------------
To investigate validity and reliability in measuring the subacrominal space by using ultrasound

Official Title
-----------------
Validity and Reliability in Measuring the Subacromial Space by Using Ultrasound

Conditions
-----------------
Shoulder Impingement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects age range 19-35 years Exclusion Criteria: With any pain in the upper extremities and back

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 35 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subacrominal space
Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound

Study Overview
=================
Brief Summary
-----------------
The investigators are interested in performing a detailed examination of the pancreas via EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis is to make a statistical determination of how many pancreatic cysts the investigators discover incidentally.

Detailed Description
-----------------
The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)

Official Title
-----------------
Prevalence of Pancreatic Cysts During Routine EUS

Conditions
-----------------
Pancreatic Cysts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria included: patients >18 years old with decision making capacity referred for EUS for any other indication other than the evaluation of a known pancreatic cyst, solid mass, or suspected mass. Exclusion Criteria: Any known history or evidence of the following from any previous imaging study: pancreatic cyst, solid mass, suspected pancreatic mass, dilated main pancreatic duct Previous surgical resection of any portion of the upper GI tract such as Billroth II that would not permit complete EUS exam of the pancreas Laboratory and/or clinical evidence of ongoing acute pancreatitis Previous pancreatic surgical resection Pregnancy Incarceration High risk for sedation Coagulopathy and/or thrombocytopenia The patients underwent a complete EUS examination of the pancreas.

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 |
| --- | --- |
| Patients undergoing EUS<br>Patients undergoing EUS for non-pancreatic treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Pancreatic Cysts During Routine EUS | The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications . | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic cysts incidentally found during EUS
Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of 3 Days of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus (HCV) Infected Patients

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

Intervention / Treatment
-----------------
* Drug: BZF961
* Drug: Ritonavir
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent must be obtained before any assessment is performed Male & female treatment naive subjects, age 18-60 years of age with Hepatitis C genotype-1. Subjects must weight at least 50kg to participate in the study, and must have a body mass index (BMI) within the range of 18-36 kg/m2 Able to communicate well with the investigator, to understand and comply with the study requirements. Exclusion Criteria: Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer: or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. Subjects that were previously treated for HCV infection.
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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BZF961<br> | Drug: BZF961<br>* There will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses.<br>Drug: Ritonavir<br>* Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV viral load | Viral load samples will be taken at Day 3. | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety |  | 2 weeks | 
| Total BZF961 concentration in plasma |  | Day 4 |
A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools.

Official Title
-----------------
A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Device: cobas s 201 TaqScreen MPX Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 18-65 years of age Fulfil criteria for plasma donation Exclusion Criteria: Do not fulfil criteria for plasma donation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: cobas s 201 TaqScreen MPX Test<br>* Donors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA |  | Study duration |
HOP-2A - Intratesticular Hormone Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

Detailed Description
-----------------
We will collect a very small amount of fluid from each testicle. Participation will last up to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day, fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).

Official Title
-----------------
Intratesticular Hormone Levels in Healthy Young Men

Conditions
-----------------
Healthy, Male Infertility, Prostate Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males between 18 and 50 years of age sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels) body mass index ≥18 and ≤32 kg/m2 must agree not to participate in another research study involving drug exposure for the duration of the study Exclusion Criteria: men in poor general health, with abnormal blood results sperm counts <20 million/ml on two tests chronic, ongoing alcohol or drug abuse participation in a long-term male contraceptive study within the past three months history of testicular or scrotal surgery history of infertility abnormal testicular exam abnormal DRE chronic pain syndrome use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids known bleeding disorder use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intratesticular Hormones in Normal Men | Average between right and left testis for each subject and serum hormone concentration in 10 normal men | 6-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fine Needle Aspiration, Male Health, Male Contraception
Effect of Sepsis Response Team in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour?

Detailed Description
-----------------
Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour? The time from the patients arrive at the emergency department to an adequate antibiotic is given, before and after introduction of a sepsis response team, was registered.

Official Title
-----------------
Prospective Cohort Study Examining the Effect of a Sepsis Rapid Response Team in the Emergency Department

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

Intervention / Treatment
-----------------
* Other: Sepsis rapid response team


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected sepsis Exclusion Criteria: Patients who was consider not to need antibiotics

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 |
| --- | --- |
| Before of sepsis rapid response team<br>Time from arrival at the Emergency Department to antibiotic is administered, before introduction of sepsis response team in the Emergency Department. | |
| Sepsis rapid response team<br>Time from arrival at the Emergency Department to antibiotic is administered, with sepsis response team in the Emergency Department. | Other: Sepsis rapid response team<br>* Patients with suspected sepsis is managed by a sepsis rapid response team in a structured manner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from arrival the emergency department to antibiotic is given. | Time from arrival the emergency department to antibiotic is given. | 6 months |
Evaluation of Woulgan in Diabetic Foot Ulcer

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.

Official Title
-----------------
Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Device: Woulgan Gel
* Device: Intrasite Hydrogel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type I or II diabetes mellitus. Target ulcer area between 0.5 and 5 sqcm, and more than 4 weeks old. Ankle-brachial pressure index above 0.7. Exclusion Criteria: Ulcers due to non-diabetic etiology. Uncontrolled diabetes defined as HbA1c above 70 mmol/mol and insufficient nutritional status. Ulcers older than 1 year. Any of gangrene, osteomyelitis, cellulitis, or Charcot osteoarthropathy.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Woulgan Gel<br>Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG) | Device: Woulgan Gel<br>* Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.<br>|
| Other: Intrasite Hydrogel<br>Primary dressing with Intrasite Hydrogel | Device: Intrasite Hydrogel<br>* Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm. |  | Until 8 weeks from start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Woulgan Gel as primary dressing in diabetic foot ulcer measured in terms of untoward medical events |  | Until 8 weeks from start of treatment | 
| Useability of Woulgan as primary dressing in diabetic foot ulcer measured as degree of pain (100 mm VAS). |  | Until 8 weeks from start of treatment |
Screening for Hypercholesterolemia in Children Using Dried Blood Spot

Study Overview
=================
Brief Summary
-----------------
Purpose: Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia. Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture. The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement Hypothesis to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia

Official Title
-----------------
Screening for Familial Hypercholesterolemia in Children Using the Blotter Method, or Dried Blood Spot

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Biological: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients/kindreds in family with a documented history of hypercholesterolemia healthy subjects for controls Exclusion Criteria: refusal to participate in the study For control patients: to have a known dyslipidemia

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| subjects with familial hypercholesterolemia<br>blood test | Biological: blood test<br>* Blood spot collection for sampling<br>|
| healthy subjects<br>blood test | Biological: blood test<br>* Blood spot collection for sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling | study of the feasibility and accuracy of the blotter method to screen hypercholesterolemia | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia, Familial, Pediatrics