linjc16/ctgov huggingface dataset:
An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The objective of the present study was to investigate the possibility of using L-lysine, an amino acid that occurs naturally in food and which interferes with nitric oxide (NO) production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks when treatment was terminated. The four-week L-lysine treatment regimen caused a significant increased in blood concentration of the amino acid and was tolerated well. The analysis of outcome measures showed a significant decrease in symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card Sorting Task (WCST) was significantly improved indicating increased problem solving capacity and cognitive flexibility. Subjective reports from three of the patients also indicated decreased symptom severity and enhanced cognitive functioning. In summary, these findings suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive deficits in patients with schizophrenia.

Official Title
-----------------
An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: L-lysine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a stable phase of illness a stable dose of antipsychotic medication no other major medical conditions or other psychiatric diagnosis normal admission laboratory tests and vital signs Exclusion Criteria: substance abuse, apart from smoking

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 56 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-lysine<br> | Drug: L-lysine<br>* 6 g/day for four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic symptoms severity |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment safety assessment |  | Eight weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, L-lysine, PANSS
Pediatric Metabolic Syndrome Study

Study Overview
=================
Brief Summary
-----------------
The Pediatric Metabolic Syndrome Study is an observational study being conducted at the Medical University of South Carolina to investigate cardiometabolic risk parameters in obese subjects ages 4 to 21. A detailed assessment is performed on eligible subjects including fasting labwork, anthropometrics, nutrition analysis, body composition testing, echocardiography, and carotid IMT measurements.

Official Title
-----------------
Pediatric Metabolic Syndrome Study

Conditions
-----------------
Metabolic Syndrome, Overweight and Obesity, Cardiovascular Risk Factor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 4 to 21 years history of obesity (BMI at or over the 95th% for age/gender) Exclusion Criteria: age below 4 or above 21 years no history of obesity current pregnancy current chronic oral steroid use current insulin use

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 21 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 |
| --- | --- |
| obese children and adolescents<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting insulin |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric metabolic syndrome
Yoga Program in Respiratory Function

Study Overview
=================
Brief Summary
-----------------
This study tested the hypothesis that yoga practice can improve respiratory function in the elderly.

Detailed Description
-----------------
Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer. The yoga program comprised 70 min sessions, 3 times/week during 12 weeks.

Official Title
-----------------
Influence of Yoga Program in Respiratory Function of Older Women

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Other: yoga practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary women Exclusion Criteria: Physical impairment

Ages Eligible for Study
-----------------
Minimum Age: 51 Years
Maximum Age: 76 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: yoga group<br>Yoga group | Other: yoga practice<br>* The yoga program comprised 70 min sessions, 3 times/week during 12 weeks<br>|
| No Intervention: 2: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer |  | pre-intervention and post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer |  | pre-intervention and post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedentary elderly women that had medical assignment
Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in saliva.

Detailed Description
-----------------
There is an important need for a rapid, non-invasive, sensitive and specific method for detection of HIV RNA, particularly in clinical settings in which patients at risk for HIV exposure are assessed and screened. A rapid and non-invasive method for quantitative testing of HIV RNA would be also valuable to monitor suppression of HIV RNA as a primary surrogate marker of combination antiretroviral therapy efficacy. An Ottawa-based biotech company (DNA Genotek Inc) has developed and sells to research and clinical labs world-wide a kit (Oragene� DNA Self-collection kit) that permits the collection, stabilization at room temperature, and purification of DNA present in saliva. They have recently developed a kit (Oragene��RNA) that is purported to stabilize RNA in saliva, a non-invasive source of a biological fluid.

Official Title
-----------------
Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Four groups of 10 patients each will be recruited: Controls (HIV and HCV seronegative by previous testing) HIV seropositive with HIV RNA &gt;1000 copies/mL and not on combination antiretroviral therapy. No concurrent HCV infection. HIV seropositive with HIV RNA &lt;50 copies/mL as a consequence of combination antiretroviral therapy use. No concurrent HCV infection. HIV seropositive with HIV RNA &gt;1000 copies/mL and not on combination antiretroviral therapy. HCV RNA positive and not on antiviral therapy. Exclusion Criteria: Not fitting one of the 4 groups

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?
-----------------
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
-----------------
HIV, RNA
Assessment of Potential Interactions Between Cocaine and Tolcapone - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the potential interactions between intravenous (IV) cocaine and tolcapone.

Detailed Description
-----------------
Double-blind, inpatient study by screening responses to cocaine infusions of 20 and 40 mg i.v. subjects into 1 of 2 treatment groups to assess potential interactions between i.v. cocaine infusion and treatment with tolcapone.

Official Title
-----------------
Assessment of Potential Interactions Between Intravenous Cocaine and Tolcapone

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Tolcapone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; DSM-4 criteria for cocaine abuse or dependence Exclusion Criteria: Additional criteria available during screening at the site

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tolcapone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  |
Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children

Study Overview
=================
Brief Summary
-----------------
General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

Detailed Description
-----------------
• Specific objectives: To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in children. To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue perfusion during CPB in pediatric cardiac surgery. To investigate the effects of different anesthetic agents on microvascular reactivity during CPB. To investigate the effects of cardiovascular and vasoactive drugs used during CPB on microvascular reactivity. To evaluate the correlation of microcirculatory alterations observed during CPB with classical markers of tissue perfusion and oxygenation, including plasma lactate levels. To evaluate the correlation of microcirculatory alterations observed during CPB with markers of systemic inflammation, including pro- and anti-inflammatory cytokines. To evaluate the correlation of microcirculatory alterations observed during CPB with the plasma bioavailability of nitric oxide.

Official Title
-----------------
Evaluation of the Systemic Microcirculation in the Course of Cardiopulmonary Bypass Used in the Surgery for Repair of Congenital Heart Defects in Infants and Children

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants and children with congenital heart defects scheduled to corrective cardiac surgery Exclusion Criteria: age inferior to 3 months and superior to 6 years

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 6 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 |
| --- | --- | --- |
| Microcirculatory alterations during cardiopulmonary bypass | Evaluation of the alterations of microcirculatory parameters and tissue perfusion during cardiopulmonary bypass in children submitted to cardiac corrective surgery for congenital heart defects | december 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
congenital heart defects, systemic microcirculation, laser Doppler perfusion imaging, cardiac corrective surgery
Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.

Official Title
-----------------
Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Conditions
-----------------
Refractory Tumors, Malignant Tumors

Intervention / Treatment
-----------------
* Drug: Topotecan, Temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically documented malignant tumor refractory or relapsing after conventional treatments and for which there is no curative treatment available life expectancy > 8 weeks no significant co-morbidity (NCI-CTC < 2) No organ toxicity no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy Exclusion Criteria: Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds Hypersensibility to Dacarbazine (DTIC) Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 21 Years

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

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: Topotecan, Temozolomide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To determine MTD and DLT of each drug |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety profile |  |  | 
| To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated |  |  | 
| To assess the efficacy of the association |  |  |
Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads

Study Overview
=================
Brief Summary
-----------------
This non-intervention qualitative study will use focus groups to assess the feasibility and acceptability of a proposed intervention for a future study. The focus group will discuss a potential biobehavioral family self-management intervention designed to improve sleep in persons with Alzheimer's disease (PAD) and their caregivers (CG).

Detailed Description
-----------------
Approximately 16 caregivers of home-based PAD/CG dyads (person with Alzheimer's disease/caregiver dyads) will be recruited from the community. A series of two audiotaped focus groups will be conducted with these caregiver participants. The first focus group will explore perspectives on what constitutes a feasible and acceptable intervention to improve their sleep and associated symptoms. The second focus group will consist of follow up and confirmation of findings from the first focus group. The intervention will be developed and refined based upon focus group findings.

Official Title
-----------------
Project BEST-Sleep: A Pilot Study to Develop a Biobehavioral Self-Management Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: screen positive on the PROMIS sleep disturbance and associated symptoms measures be a caregiver within a PAD/CG dyad speak/understand English agree to be audiotaped during focus group participation be at least 18 years of age Exclusion: they negative on the PROMIS sleep disturbance and associated symptoms measures, are not a caregiver within a PAD/CG dyad, do not speak/understand English, refuse to take part in audiotaping of the focus groups, are not at least 18 years of age.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Output from Focus Groups | Focus group data will be processed utilizing Atlas.ti software and analyzed using the constant comparative method. | 1 day |
Oral Therapies in Oncology: Cognitive Function and Compliance

Study Overview
=================
Brief Summary
-----------------
The investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. To our knowledge, this study will be among the first conducted on the issue in France and is an innovative approach in the management of cancer patients. The inclusion of cognitive dysfunction is part of a comprehensive approach to improving the quality of life and fully meets the objectives of both plans cancer, including those of the axis Living during and after cancer highlighted in the Cancer Plan

Official Title
-----------------
Oral Therapies in Oncology: Cognitive Function and Compliance

Conditions
-----------------
Oral Therapies, Cancer, Cognitive Function, Compliance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years, Patients treated with a first prescription of exclusive oral therapy (chemotherapy and/or targeted therapy) as part of a cancer, Patients who begin treatment with ZYTIGA ® (abiraterone acetate) are incluables, Patients with asymptomatic brain metastases are incluables, Lack of personality disorders and psychiatric illness scalable, Knowledge of spoken and written French, Having signed the informed consent of study participation. Exclusion Criteria: Pathology psychiatric Refusal to participate, Patient unable to respond to cognitive tests, - Documented use of drugs, Heavy drinking, - Cancer primitive central nervous system, - Participation in a clinical trial.

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 |
| --- | --- | --- |
| Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment. |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral therapies, Cancer, cognitive function, compliance
Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Study Overview
=================
Brief Summary
-----------------
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice

Official Title
-----------------
Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Berodual® Respimat® solution for inhalation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women presenting with symptoms of chronic obstructive pulmonary disease Both previously untreated patients and patients treated previously with Berodual® or with other anti-obstructive respiratory tract agents may be included Exclusion Criteria: Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic obstructive airways disease patients<br> | Drug: Berodual® Respimat® solution for inhalation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall severity rated on 3-point scale |  | up to 4 weeks | 
| Change in reduction in breathlessness rated on a 4-point scale |  | up to 4 weeks | 
| Change in restriction of activity due to breathlessness rated on a 4-point scale |  | up to 4 weeks | 
| Number of awakening due to nocturnal breathlessness rated on 4-point scale |  | up to 4 weeks | 
| Global assessment of efficacy by the patients rated on 5-point scale |  | after 4 weeks | 
| Global assessment of efficacy by the investigator rated on 5-point scale |  | after 4 weeks | 
| Number of patients with adverse drug reactions |  | up to 4 weeks |