linjc16/ctgov huggingface dataset:
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial

Study Overview
=================
Brief Summary
-----------------
Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48) Main Secondary objectives: Comparison of the two arms for genotypic resistance profile in case of virological failure CD4 changes from baseline Evolution of the lipid profile and morphological changes in fat distribution, and safety Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters

Official Title
-----------------
Randomized Multicenter Open-Label, Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV+3TC+TDF Versus a Dual QD Therapy Containing EFV+TDF

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: EFV+TDF
* Drug: EFV+3TC+TDF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable HAART ≥ 3 months HIV-1 RNA < 50 c/mL ≥ 6 months No HAART failure history Exclusion Criteria: Weight > 45 kg No CD4+ cell count criteria No significant laboratory or clinical abnormalities Creatinine Clearance > 60 mL/min

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>TDF+EFV | Drug: EFV+TDF<br> <br> |
| Experimental: 2<br>TDF+3TC+EFV | Drug: EFV+3TC+TDF<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48) |  | 48 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the two arms for genotypic resistance profile in case of virological failure |  | 48 wks | 
| CD4 changes from baseline |  | 48 wks | 
| Evolution of the lipid profile and morphological changes in fat distribution, and safety |  | 48 wks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV virological control, Lipid profile and morphological fat distribution, Treatment Experienced
Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label, non-randomized controlled trial. Patients with viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be performed postoperatively. All available data will be collected prospectively. Follow-up is 12 months. Informed consent will be obtained from relatives to patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Official Title
-----------------
Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells

Conditions
-----------------
Acute Respiratory Distress Syndrome, Adult

Intervention / Treatment
-----------------
* Biological: Mesenchymal stromal cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Viral-induced acute respiratory distress syndrome Ventilator treatment Extracorporeal membrane oxygenation treatment Relatives provide written informed consent 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stromal cells<br> | Biological: Mesenchymal stromal cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | During hospital stay, an expected average 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary compliance |  | During ventilator treatment, an expected average of 1 month | 
| Pulmonary tidal volume |  | During ventilator treatment, an expected average of 1 month | 
| Adverse events | I.e infection, fever, effect on end-organ function | 6 months | 
| All-cause mortality |  | 12 months | 
| Recovery of organ functions | kidney, liver, heart functions | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal membrane oxygenation
Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Hemodialysis keeps patients with renal failure alive but does not restore normal health. Retention of chemicals that bind to plasma proteins and are therefore poorly removed by dialysis may contribute to ill health in patients receiving conventional treatment. This proposal will test the effect of a new method designed to improve the removal of protein-bound solutes during dialysis. The effects on blood chemical levels of two different dialysis prescriptions will be tested in patients already undergoing nocturnal in-center hemodialysis three times weekly.

Official Title
-----------------
Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis

Conditions
-----------------
End Stage Renal Failure on Dialysis

Intervention / Treatment
-----------------
* Other: low dialysate flow, smaller dialyzer
* Other: high dialysate flow, larger dialyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto Exclusion Criteria: recent use of antibiotics gastrointestinal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dialysate flow, larger dialyzer<br>high dialysate flow, larger dialyzer | Other: high dialysate flow, larger dialyzer<br>* The subject will receive dialysis on the usual schedule and for the usual time but with a higher than usual dialysate flow and large dialyzer.<br>|
| Active Comparator: low dialysate flow, smaller dialyzer<br>low dialysate flow, smaller dialyzer | Other: low dialysate flow, smaller dialyzer<br>* The subject will receive dialysis on the usual schedule and for the usual time but with a lower than usual dialysate flow and small dialyzer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of the chemical p-cresol sulfate |  | Participants will be followed for 2-3 weeks on different dialysis prescriptions and plasma chemical levels will be measured at the end of this period. |
Food-Effect Pharmacokinetic Study of PL2200

Study Overview
=================
Brief Summary
-----------------
This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PL2200 fasted
* Drug: PL2200 fed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy normal male and female volunteers between 21 and 65 years of age. Exclusion Criteria: Abnormal findings on physical examination or clinical laboratories, or significant medical history. Subject with hypersensitivity or contraindications to aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drug (NSAID).

Ages Eligible for Study
-----------------
Minimum Age: 21 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL2200<br> | Drug: PL2200 fasted<br>* Fasted state<br>Drug: PL2200 fed<br>* Fed state<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state. |  | 24 hours | 
| Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-inf of the primary metabolite, salicylic acid, in the fed state versus the fasted state. |  | 24 hours | 
| Effect of food by ratio of least-squares means (LSM) of the PK parameter of Cmax of the primary metabolite, salicylic acid, in the fed state versus the fasted state. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food-effects PK study in healthy subjects.
Diagnostic Rentability of Screening for Associated Conditions in Calcium Pyrophosphate Deposition Disease Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether thorough analytical evaluation is useful to diagnose metabolic conditions associated to calcium pyrophosphate deposition disease.

Detailed Description
-----------------
The diagnostic usefulness of screening for hyperparathyroidism, hemochromatosis, hypothyroidism and hypophosphatasia in patients diagnosed with calcium pyrophosphate dihydrate (CPPD) deposition disease is uncertain. Patients diagnosed with CPPD deposition disease were compared to patients with rheumatoid arthritis and psoriatic arthritis over a 9-year period. All patients were prospectively followed for at least 12 months. Serum calcium, phosphorus, alkaline phosphatase, thyroid-stimulating hormone, ferritin, iron, and total iron binding capacity were determined in all patients.

Official Title
-----------------
Appraisal of the Diagnostic Rentability of Thorough Analytical Screening Searching Associated Conditions in Patients Newly Diagnosed With Calcium Pyrophosphate Dihydrate Deposition Disease

Conditions
-----------------
Chondrocalcinosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as having calcium pyrophosphate dihydrate deposition disease. Exclusion Criteria: Patients mimicking a rheumatoid arthritis disease, with positive rheumatoid factor or with psoriasis.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium Pyrophosphate, associated conditions
Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.

Official Title
-----------------
A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIAsp 30 users<br> | Drug: biphasic insulin aspart 30<br>* The insulin dose and regimen was individualised at the physician's discretion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in post prandial glucose (PPG) |  |  | 
| Change in fasting glucose (FG) |  |  | 
| Difference in prandial glucose increment (PGI) |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Adverse drug reactions (ADR) |  |  |
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in comparison with standard intrauterine insemination (IUI) in natural cycle for couples with unexplained infertility or mild male factor.

Detailed Description
-----------------
A number of randomised controlled trials have been published comparing the efficacy of FSP with standard IUI. A recent meta-analysis has suggested that in couples with unexplained infertility Fallopian tube sperm perfusion together with controlled ovarian hyperstimulation (COH) leads to increased pregnancy rates than IUI and COH. No study has been published comparing the two insemination techniques in natural cycle.

Official Title
-----------------
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study

Conditions
-----------------
Insemination, Artificial

Intervention / Treatment
-----------------
* Procedure: Fallopian tube sperm perfusion
* Procedure: Intrauterine insemination using standard catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertility for at least 2 years age <40 years unexplained infertility or mild male factor Exclusion Criteria: previous assisted reproduction treatment

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: IUI<br>Intrauterine insemination using standard catheter | Procedure: Intrauterine insemination using standard catheter<br>* Patients are treated with standard intrauterine insemination<br>* Other names: Balloon catheter;|
| Experimental: FSP<br>Fallopian tube sperm perfusion using a commercial device for hysterosalpingography and tubal hydropertubation | Procedure: Fallopian tube sperm perfusion<br>* Patients are treated with fallopian tube sperm perfusion<br>* Other names: Cervical cup;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abortion rate |  | 2 years | 
| Ectopic pregnancy rate |  | 2 years |
Randomized Controlled 8-Week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.

Detailed Description
-----------------
The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers. The new bandage is a 2-layer compression system. It will be used over primary dressings to provide the compression that is beneficial to venous leg ulcers.

Official Title
-----------------
Randomized Controlled Eight Week Cross-Over Clinical Evaluation of the 3M Coban 2-Layer Compression System to Evaluate the Product Performance in Patients With Venous Leg Ulcers

Conditions
-----------------
Venous Ulcer

Intervention / Treatment
-----------------
* Device: Coban 2 Layer Compression System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: venous leg ulcer patient can walk Exclusion Criteria: cancerous ulcers diabetic foot ulcer

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coban 2 Layer Compression System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Performance |  |  |
Insulin Variance Throughout the Day

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether a person's sensitivity to their own insulin varies from the morning to the evening.

Detailed Description
-----------------
Study visit 1: about 16 hours - you will come to this visit fasting. You will have an oral glucose tolerance test which takes about 3 ½ hours. An IV line will be placed in your arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before you will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after you consume the drink. You will have a second oral glucose tolerance test which takes about 3 ½ hours. An IV line will be placed in your arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before you will drink a sugar solution. Blood will be drawn at specific times after you consume the drink.

Official Title
-----------------
Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study

Conditions
-----------------
Insulin Sensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are a healthy male or female Have a fasting blood sugar that is between normal and diabetes. Are between 18 and 70 years of age, inclusive. Exclusion Criteria: Are pregnant or breast-feeding a child Take a medication for diabetes Take a medication like cortisone that can change your blood sugar. Take a medication chronically that has not been at a stable dose for at least 1 month Take medication for psychosis that is known to change timing in the day - night cycle

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Enrollment Group<br>Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating change in insulin sensitivity between morning and evening | This study designed to determine whether a person's sensitivity to their own insulin varies from the morning to the evening. The test is useful in the diagnosis of diabetes, and pre diabetes. Oral Glucose Testing provides details about how quickly glucose is absorbed into the bloodstream for use by body cells as energy. The rate of glucose clearance depends on the amount of glucose consumed. Once the participant drink a glucose-rich beverage, Blood will be drawn at different points and tested to see how effective the body breaks down metabolizes blood glucose. | 24 hours |