linjc16/ctgov huggingface dataset:
Donor After Circulatory Death Heart CAP Trial

Study Overview
=================
Brief Summary
-----------------
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

Detailed Description
-----------------
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Official Title
-----------------
The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

Conditions
-----------------
Heart Transplant

Intervention / Treatment
-----------------
* Device: Transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Recipient Inclusion Criteria: • Primary heart transplant candidates Age ≥ 18 years old Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data. Recipient Exclusion Criteria: Prior solid organ or bone marrow transplant Chronic use of hemodialysis or diagnosis of chronic renal insufficiency Multi-organ transplant.

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: OCS Preservation<br> | Device: Transplant<br>* To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | Patient survival at 6 months post-transplant. | 6 months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization Rate | Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System. | 24 hours post transplant |
Urodynamic Study and Stress Incontinence

Study Overview
=================
Brief Summary
-----------------
A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

Detailed Description
-----------------
group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

Official Title
-----------------
Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: sling surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stress urinary incontinence Exclusion Criteria: mixed incontinence recurrent cases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: urodynamics study group<br>65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery | Procedure: sling surgery<br>* transoburator vaginal tape ,inside out procedure under spinal anathesia<br>|
| Active Comparator: surgery only group<br>60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study | Procedure: sling surgery<br>* transoburator vaginal tape ,inside out procedure under spinal anathesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure of stress incontinence | by clinical assessment | 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure of stress incontinence | by clinical assessment | one month after surgery | 
| cure of stress incontinence | by clinical assessment | 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urodynamic study, stress urinary incontinence
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.

Official Title
-----------------
Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: EX1000
* Drug: biphasic human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs Body Mass Index (BMI) less than or equal to 40.0 kg/m2 HbA1c less than or equal to 9.5% FPG (SMPG) less than or equal to 12 mmol/L Exclusion Criteria: Treatment with more than 1IU/kg insulin daily Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator Known or suspected allergy to trial products or related products Receipt of any investigational drug within one month prior to this trial Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers

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 |
| --- | --- |
| Experimental: A<br> | Drug: EX1000<br>* Treat-to-target titration scheme, s.c. injection<br>|
| Active Comparator: B<br> | Drug: biphasic human insulin<br>* Treat-to-target titration scheme, s.c. injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | For the duration of the trial | 
| Fructosamine |  | For the duration of the trial | 
| FPG |  | For the duration of the trial | 
| 4-point SMPG profiles |  | For the duration of the trial | 
| Incidence of hypoglycaemic episodes |  | For the duration of the trial | 
| Frequency and severity of adverse events (including injection site reactions) |  | For the duration of the trial | 
| Laboratory safety parameters (haematology, biochemistry and lipids) |  | For the duration of the trial | 
| Physical examination and vital signs |  | For the duration of the trial | 
| Total daily insulin dosages |  | For the duration of the trial |
Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.

Official Title
-----------------
A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With Usual Care Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension

Conditions
-----------------
Ocular Hypertension, Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Drug: latanoprost 0.005% (Xalatan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension IOP of > 21 mm Hg on current treatment Exclusion Criteria: Any previous or current treatment with latanoprost or other prostaglandin analogues

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

| Intervention/Treatment |
| --- |
|Drug: latanoprost 0.005% (Xalatan)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and the health care utilization in the two treatment groups over 36 months. |  |  |
Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.

Official Title
-----------------
An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD)

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: pegaptanib sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity in the study eye between 20/40 and 20/320. Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy & neovascularization] of < 12 total disc areas, of which at least 50% must be active CNV. Any subretinal hemorrhage must comprise no more than 50% of total lesion size. General Criteria: Patients of either gender, aged greater than 50 years. Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. Written informed consent. Exclusion Criteria: Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. Patients who are eligible for PDT with Visudyne Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pegaptanib sodium|nan|

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
-----------------
AMD, Age-Related Macular Degeneration, Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization
Do Bonding Disruptions Occur More Often in Children With Asthma Than in Non-asthmatic Populations?

Study Overview
=================
Brief Summary
-----------------
Six studies have preceded this project. Three studies suggested that there is a significant connection between pediatric asthma and disruptions in maternal-infant bonding (Feinberg, 1988; Schwartz, 1988; Pennington, 1991). Three studies suggested that children with asthma benefit from a type of therapy that improves bonding with their mothers (Madrid, Ames, Skolek, & Brown, 2000; Madrid, Ames, Horner, Brown, & Navarrette, 2004; Madrid, Pennington, Brown & Wolfe, 2011). This study proposes to study in a more thorough fashion the question of the incidence of bonding disruptions with between mothers and their children with asthma. This time there will be a larger sample, and more stringent criteria will used in assigning children to the asthma cohort. Through questions answered by mothers whose children have been said to have asthma, we will be able to decide if the children's respiratory conditions are likely to be attributable to asthma or more likely reflective of another respiratory condition such as vocal cord dysfunction or anxiety related hyperventilation (Anbar, 2014).

Official Title
-----------------
Do Bonding Disruptions Occur More Often in Children With Asthma Than in Non-asthmatic Populations?

Conditions
-----------------
Asthma in Children, Anxiety

Intervention / Treatment
-----------------
* Other: Asthma
* Other: Non-asthma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biological mothers of male and female children between 2 and 12 years of age who live with or have contact with their children English is the primary language of the biological mother Exclusion Criteria: Mothers of children only below 2 or above 12 years of age Mothers of children thought to have a chronic health condition other than asthma Mothers who have already completed a questionnaire with another child
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma<br>Mothers of children thought to have asthma | Other: Asthma<br>* mothers who have children that have been diagnosed with respiratory issues<br>|
| Non-asthma<br>Mothers of children without diagnosed respiratory problems | Other: Non-asthma<br>* mothers who have children that do not have a diagnosis of respiratory problems<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with asthma and/or maternal infant bonding issues | A questionnaire will be scored by a pediatric pulmonologist and a psychologist | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, maternal bonding, maternal bonding disruptions, mother-infant interaction
Combined Nutrient Intake and Muscle Protein Synthesis

Study Overview
=================
Brief Summary
-----------------
Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether combined nutrient intake plays an important role in stimulation of the muscle protein growth in elderly people; and whether it represent effective strategies to overcome the impaired muscle protein synthesis in elderly when compared with young subjects.

Official Title
-----------------
Combined Nutrient Intake and Muscle Protein Synthesis

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Other: protein
* Other: protein and carbohydrate
* Other: protein and leucine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males 70-85 years or 18-30 years BMI < 30 Exclusion Criteria: Type II diabetes All co morbidities interacting with mobility and muscle metabolism of the lower limbs Use of anticoagulants Patients suffering from Phenylketonuria Participation in any regular exercise programme

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protein (elderly)<br> | Other: protein<br>* 20g protein<br>|
| Experimental: protein and carbohydrate (elderly)<br> | Other: protein and carbohydrate<br>* 20g protein and 20g carbohydrate<br>|
| Experimental: protein and carbohydrate (young)<br> | Other: protein and carbohydrate<br>* 20g protein and 20g carbohydrate<br>|
| Experimental: protein and leucine (elderly)<br> | Other: protein and leucine<br>* 20g protein, 2.5g leucine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle protein synthesis | Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound C13phe, by the enrichment of the precursor (=plasma availability). | 6 h postprandial period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle, FSR, protein, carbohydrate, leucine
Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called statins). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.

Official Title
-----------------
Safety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled Study

Conditions
-----------------
Relapsing-remitting Multiple Sclerosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing remitting MS with diagnosis defined by the McDonald criteria (McDonald et al., 2001) with no current disease modifying therapy (interferon, copaxone or immunosuppressant drugs) since at least 3 months and an EDSS score < 5. At least one gadolinium positive lesion on the MRI of the selection phase is needed. No current statin therapy. Normal renal and hepatic biological tests. No current pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Intervention/Treatment |
| --- |
|Drug: Pravastatin|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of gadolinium positive lesions at month 6 in each group. |  | at month 6 in each group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up |  | after 6 months of follow-up | 
| Number of new T2 lesions |  |  |