linjc16/ctgov huggingface dataset:
Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium, an FDA-approved treatment for bipolar mania, in order to better understand who benefits from treatment and why they respond to medications. Studying this may help improve treatment and outcome in patients with bipolar disorder.

Official Title
-----------------
Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: lithium
* Drug: Lithium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria- bipolar patients (Manic=, depressed=60; 30 patients/year): The patient meets DSM-IV criteria for type I bipolar disorder, manic or mixed, or depressed. The patient has an index Young Mania Rating Scale (YMRS)total score >15 or Montgomery Asberg Rating Scale (MADRS) total score >20. The patient is between 15 and 55 years old. Inclusion Criteria- Healthy subjects (N=40): Healthy subjects will be between the ages of 15 and 55 years. Healthy subjects will have no history of any Axis I psychiatric disorder. Healthy subjects will have no first-degree relatives with affective or psychotic disorders. Exclusion criteria: All subjects will be excluded from participation for the following reasons. Any medical or neurological disorder that could influence fMRI and MRS results. A history of mental retardation or an estimated IQ total score <85. An MRI scan is contraindicated in the subject for any reason, including psychological impediments to being inside the MR scanner. The patient cannot attend follow-up visits.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Manic Patients | Drug: lithium<br>* 600 mg - 1800 mg per day<br>|
| Other: 2<br>Depressed Patients | Drug: Lithium<br>* 600 - 1800 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium. |  | 8 weeks |
Bariatric Surgery and Pharmacokinetics of Quetiapine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on quetiapine are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Quetiapine: BAR-MEDS Quetiapine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine|Patients are tested for their normal prescription quetiapine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quetiapine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Quetiapine fumarate
An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

Study Overview
=================
Brief Summary
-----------------
This is an open-study with a 26 week open label treatment period followed by an optional 26 week open label extension. The total treatment period will be 52 weeks.

Official Title
-----------------
A Multicenter, Open-Label, Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

Conditions
-----------------
Hypogonadism, Testosterone Deficiency

Intervention / Treatment
-----------------
* Drug: ABT-SLV176


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low testosterone Exclusion Criteria: Normal testosterone levels Elevated Prostatic Specific Antigen (PSA) History of breast or prostate cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: ABT-SLV176<br>ABT-SLV176 administered daily | Drug: ABT-SLV176<br>* ABT-SLV176 administered daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with serum total testosterone average concentration, Cavg(0-24) | Cavg (0-24) is the time-averaged Concentration Over the Dosing Interval of 24 Hours. | At Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects falling within the pre-defined ranges of maximum total testosterone concentration (Cmax) | Cmax is the maximum concentration. | At Week 2, Week 4, Week 12 and Week 52 | 
| Average serum total testosterone and Dihydrotestosterone (DHT) concentration (Cavg) | Cavg is the average concentration. | At Week 2, Week 4, Week 12 and Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low testosterone
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.

Detailed Description
-----------------
Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.

Official Title
-----------------
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: AGS-1C4D4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has hormone-refractory metastatic prostate cancer Exclusion Criteria: Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects Patient is currently participating or has participated in an investigational study within the past 30 days Patient has illness or circumstance that could limit compliance with the study requirements Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year Patient has Hepatitis B or C

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.AGS-1C4D4<br> | Drug: AGS-1C4D4<br>* IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC. |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC. |  | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRPC, Advanced hormone refractory prostate cancer
The Treatment and Natural History of Acromegaly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to acromegaly.

Detailed Description
-----------------
The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up.

Official Title
-----------------
Acromegaly Treatment and Natural History

Conditions
-----------------
Acromegaly, Pituitary Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients will be enrolled who are 18 years of age or over who are referred for 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acromegaly<br>Patients with acromegaly | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of IGF-1 Growth Hormone abnormality | resolution of IGF-1 abnormality | every 6 months &amp; at end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly
NPD Measurements in PSC Patients

Study Overview
=================
Brief Summary
-----------------
Primary Sclerosing Cholangitis (PSC) is a chronic disorder of the liver causing jaundice and liver damage. When Cystic Fibrosis affects the liver, the damaged liver looks like the liver in PSC. This study is designed to answer the question whether isolated PSC may be a form of CF only in the liver

Detailed Description
-----------------
Cystic Fibrosis (CF) is a progressive autosomal recessive disorder caused by defects in the cystic fibrosis transmembrane conductance regulator gene (CFTR). CFTR mutations cause loss or impairment of CFTR-mediated ion transport across epithelial cell membranes. CF affects many organs including the respiratory tract, pancreas, intestine, liver and the male reproductive tract. Liver disease occurs less frequently than pulmonary disease. CFTR is expressed in the bile duct epithelial cells and is responsible for the hydration of biliary secretions. CF was until recently, thought to be a multi-organ disease. However, there are now recognized non-classical presentations of CF involving a few organs only and now there is well established data on single -organ involvement including Congenital Absence of the Vas Deferens and recurrent pancreatitis. CF and PSC have several features in common. They both affect intrahepatic bile ducts by inspisated biliary secretions, chronic inflammation and fibrosis. Is PSC the single-organ presentation of CF? Patients with PSC will undergo testing of the CF protein channel by nasal potential testing. This test is performed by insering a thin plastic tube 2 to 3 cms into the nostril and chloride transport can be measured. This test may shows that the patient has an abnormality in the CF protein channel.

Official Title
-----------------
Cystic Fibrosis Transmembrane Conductance Regulator Function as Measured by Nasal Potential Difference Measurements in Patients With Primary Sclerosing Cholangitis

Conditions
-----------------
Primary Sclerosing Cholangitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 10 years Patients diagnosed as Non-IBD PSC Patients diagnosed as IBD PSC Exclusion Criteria: Age < 10 years

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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
-----------------
cystic fibrosis,, nasal potential difference,, primary sclerosing cholangitis
Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control. The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.

Official Title
-----------------
A Randomized, Double-Bind, Placebo-Controlled, Parallel-Group, Fixed-Dose (20 mg/Day), 3-Month, Multicenter Study of the Energy Intake Effects and Safety of SR141716 With or Without Hypocaloric Diet in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: rimonabant (SR141716)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese subjects with Body Mass Index ≥ 30 and < 45 kg/m² The above information is not intended to contain all considerations relevant to a patient's potential 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rimonabant (SR141716)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or free-living days |  |  | 
| Clinical Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypocaloric diet, energy intake
Treatment of Non-falciparum Malaria

Study Overview
=================
Brief Summary
-----------------
Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.

Official Title
-----------------
Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon

Conditions
-----------------
Acute Non-falciparum Malaria

Intervention / Treatment
-----------------
* Drug: artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density > 50-200000/μl of blood Written informed consent Exclusion Criteria: Patients with presence of other clinical conditions requiring hospitalization Presence of other febrile conditions Presence of significant anemia, defined by hemoglobin < 7g/dl Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks Pregnant and breast feeding females

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 60 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: A<br> | Drug: artemether-lumefantrine<br>* Standard artemether-lumefantrine treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasitological cure rate on day 28 |  | D28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of drug related adverse events |  | D28 |
Mechanocardiography in Patients With STEMI

Study Overview
=================
Brief Summary
-----------------
The study aim is to evaluate the capability of mechanocardiography in detecting acute myocardial ischemia in patients suffering evolving ST-segment elevation infarction.

Detailed Description
-----------------
Subsequent patients with ST-segment elevation assigned to the Turku University Hospital Heart Center cathlab for primary percutaneous coronary intervention are enrolled in the study. A 2 to 15 minutes mechanocardiographic recording is acquired before the intervention. A control recording is collected after the coronary intervention, within 24 hours. These recordings are compared and the results analyzed to determine the ability of this novel modality to discriminate between the two circumstances.

Official Title
-----------------
Mechanocardiographic Detection of Acute ST-Segment Elevation Myocardial Infarction - the MECHANO-STEMI Study

Conditions
-----------------
Myocardial Infarction, Acute

Intervention / Treatment
-----------------
* Diagnostic Test: Mechanocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myocardial ischemia with ST-segment elevation in ECG Primary PCI procedure Exclusion Criteria: Age >17 years No informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEMI before PCI<br>ST-segment elevation, recording acquired before coronary intervention | Diagnostic Test: Mechanocardiography<br>* Mechanocardiographic recording<br>|
| STEMI after PCI<br>ST-segment elevation, recording acquired from the same patients after coronary intervention | Diagnostic Test: Mechanocardiography<br>* Mechanocardiographic recording<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed difference in mechanocardiographic signal | In this novel method for recording cardiac mechanics, we anticipate to observe a difference in machanocardiography signal between the two states - before and after an occlusion of a coronary artery. As of yet, the precise nature of the signal change is unclear and will be clarified as the recorded signals are analyzed. | 24 hours |