linjc16/ctgov huggingface dataset:
Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.

Official Title
-----------------
A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients

Conditions
-----------------
Pediatric Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)
* Drug: MMF, cyclosporine, steroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are recipients of primary or secondary renal allograft. Patients who are single-organ recipients (kidney only). Exclusion Criteria: •Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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: Basiliximab<br>Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids | Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)<br> <br> |
| Active Comparator: Basiliximab-free<br>Patients will be on a regimen of MMF, cyclosporine and steroids. | Drug: MMF, cyclosporine, steroids<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first BPAR episode or treatment failure | Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, kidney transplantation, basiliximab
Parkinson's Disease Evaluated by PET and the Effect of Memantine

Study Overview
=================
Brief Summary
-----------------
Purpose of study: To investigate whether the NMDA antagonist Memantine has a substantial effect of brain metabolism in patients with Parkinson's disease (PD), using Positron Emission Tomography (PET). Background: Disturbances in brain metabolism is thought to contribute to degeneration of neurons in brain of PD patients. Production of toxic oxygen radicals and presence of too much excitatory neurotransmitter (glutamate) due to over activity is involved. These factors can theoretically be alleviated by memantine. Hypothesis: Memantine decreases metabolism in areas in PD brain known to be over-active. Decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence and this can be detected by PET.

Official Title
-----------------
Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: memantine (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's Disease (British Brain Bank Criteria) Age 50-70y Exclusion Criteria: Tobacco use Any serious medical conditions (Heart disease, kidney disease, liver disease, endocrinological disorders etc) Metal implants contraindicating MR scan Drug use affecting the central nervous system Psychiatric disorders Head trauma or any disorders of the head, skull or brain Drug addiction or use of any kind of illegal substance affecting the central nervous system Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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: memantine (drug)|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
-----------------
Parkinson's Disease, Positron Emission Tomography, Memantine, NMDA antagonists, Cerebral Blood Flow, Cerebral Metabolic Rate of Oxygen
IW-6463 Safety Study in Healthy Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.

Detailed Description
-----------------
Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.

Official Title
-----------------
Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects

Conditions
-----------------
Other

Intervention / Treatment
-----------------
* Drug: IW-6463
* Drug: Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is an ambulatory adult at least 65 years old at the screening visit Subject is in good health and has no clinically significant findings on physical examination Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state. Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug Other inclusion criteria per protocol Exclusion Criteria: Any active or unstable clinically significant medical condition Other exclusion criteria per protocol

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-6463<br>IW-6463 tablets administered orally | Drug: IW-6463<br>* IW-6463 Tablet<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets administered orally | Drug: Matching Placebo<br>* Matching Placebo Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Cerebral Blood Flow (CBF) at Day 15 | Change from baseline in CBF as measured by magnetic resonance imaging (MRI) and arterial spin labeling (ASL) after administration of IW-6463 vs. placebo | Baseline, 15 days | 
| Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) |  | Up to 42 days |
Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.

Official Title
-----------------
Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine

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

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years of age who are not seeking treatment at the time of the study Must be able to provide written informed consent Must be within 20 percent of ideal body weight and weigh at least 45 kg Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence Must currently be using cocaine as confirmed by a positive BE If female and of child bearing potential, must agree to the use of birth control Exclusion Criteria: - please contact the site directly for more information

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: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Cardiovascular responses |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine craving |  |  | 
| pharmacokinetic assessment |  |  | 
| Psychological Effects of Cocaine |  |  | 
| Abuse Liability |  |  | 
| Mood and personality assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine Dependence
The Hemodynamic Response to Prolonged Dobutamine Infusion

Study Overview
=================
Brief Summary
-----------------
A decrease in the response of beta 1 adrenergic receptors to agonists (desensitization) is thought to play a major role in the pathogenesis of diseases such as congestive heart failure. However, currently, there is no in vivo model that will enable us to measure desensitization of the hemodynamic responses to beta 1 adrenergic receptors in vivo. Our hypothesis is that constant 3 hours intravenous infusion of the selective beta1 adrenergic receptor agonist dobutamine will result in gradual decline in hemodynamic responses to dobutamine over time.

Conditions
-----------------
Healthy, Heart Failure

Intervention / Treatment
-----------------
* Drug: 3 hours intravenous dobutamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: consumption of any medications during the 2 weeks prior to the study history of chest pain or tachycardia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intravenous dobutamine<br>3 hours infusion of dobutamine | Drug: 3 hours intravenous dobutamine<br>* Intravenous dobutamine will be infused during 3 hours. At the first and last 0.5 hors of infusion dose will be increased gradually, while in the middle 2 hours dose will remain constant.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure |  | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Desensitization, beta adrenergic receptors, Healthy subjects
Processing Integration in Neurological Patients Using fMRI

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to explore and map brain areas involved in processing and perception in patients suffering from neurological pathologies and condition. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.

Official Title
-----------------
Processing Integration in Neurological Patients Using fMRI

Conditions
-----------------
Acute Inflammatory Demyelinating Polyradiculoneuropathy, Stroke, Anosognosia, Central and Peripheral Neurodegenerative Pathologies, Neuropsychiatric Conditions

Intervention / Treatment
-----------------
* Device: 3 Tesla Siemens Skyra MRI scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of the investigated neuronal disease Exclusion Criteria: contraindication for MRI scan pregnancy refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Healthy Controls<br>Age matched control for the various clinical groups | Device: 3 Tesla Siemens Skyra MRI scanner<br>* Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging<br>|
| Neurodegenerative patients<br> | Device: 3 Tesla Siemens Skyra MRI scanner<br>* Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging<br>|
| Stroke patients<br> | Device: 3 Tesla Siemens Skyra MRI scanner<br>* Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging<br>|
| Neuropsychiatric patients<br> | Device: 3 Tesla Siemens Skyra MRI scanner<br>* Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD) signal | Distinct maps of sensory and multisensory representations related to certain disorders will be sassed by measurement of the Blood-oxygen-level dependence(BOLD) signal. | 2 years |
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

Study Overview
=================
Brief Summary
-----------------
To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed

Detailed Description
-----------------
Eligible patients will be enrolled into this expanded-access program and treated with an oral dose of 120 μg/kg/day of odevixibat and evaluated on an ongoing basis.

Official Title
-----------------
Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Access Program)

Conditions
-----------------
Progressive Familial Intrahepatic Cholestasis

Intervention / Treatment
-----------------
* Drug: Odevixibat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female patient of any age, with a clinical diagnosis of PFIC, and with a body weight ≥5 kg at Screening visit Patient must have a clinical diagnosis of PFIC Patient must have clinically confirmed pruritus Patient must have elevated serum bile acid levels, specifically measured to be ≥2 × the upper limit of normal (ULN) prior to start of medication Patient and/or legal guardian must sign informed consent (and assent) as appropriate. Patients who turn 18 years of age (or legal age per country) during Exclusion Criteria: Patient is expected to have a liver transplant within 6 months of Screening Decompensated liver disease, coagulopathy, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy International normalized ratio (INR) >1.4 (the patient may be treated with Vitamin K intravenously, and if INR is ≤1.4 at resampling the patient may be started on program medication) Serum ALT >10 × ULN at Screening Serum ALT >15 × ULN at any time point during the last 6 months unless an alternate etiology was confirmed for the elevation Total bilirubin >10 × ULN at Screening Any patient who is pregnant, lactating, or planning to get pregnant Patients who qualify for enrollment in other Phase 2 or Phase 3 trials intended to support marketing approval in PFIC
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Odevixibat|A4250 is a small molecule and selective inhibitor of IBAT|

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
-----------------
pediatric, PFIC, Cholestasis
Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.

Official Title
-----------------
Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients

Conditions
-----------------
Diabetes, Hypertension, Dyslipidemia, Coronary Arteriosclerosis

Intervention / Treatment
-----------------
* Behavioral: Behavioral counseling and peer support
* Behavioral: Interactive Education
* Behavioral: Role modeling
* Procedure: Pharmacologic case management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All diabetic veterans with a Hb-A1c between 7.0- 9.0 % within the last 6 months will be eligible for the study Exclusion Criteria: Patients without an Hb-A1c checked within the last 6 months. Patients who are unable to attend the group sessions, either because of lack of transportation, psychiatric instability (suicidal, psychotic), or organic brain injury that preclude them from diabetes self-care.

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: MEDIC<br>Multidisciplinary education and diabetes intervention for cardiac risk reduction | Behavioral: Behavioral counseling and peer support<br>* Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention<br>Behavioral: Interactive Education<br>* interactive lectures with hands-on learning<br>Behavioral: Role modeling<br>* learning from peers with similar disease and problems<br>Procedure: Pharmacologic case management<br>* provided by clinical pharmacists following pre-established algorithms<br>|
| No Intervention: usual care<br>usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg | The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L). | 4 months |