linjc16/ctgov huggingface dataset:
Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome

Study Overview
=================
Brief Summary
-----------------
This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease.

Detailed Description
-----------------
The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period. After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain. Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.

Official Title
-----------------
Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism

Conditions
-----------------
Parkinson's Disease, Parkinsonian Syndrome

Intervention / Treatment
-----------------
* Drug: [123I]ß-CIT and SPECT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 21 years of age Normal screening laboratory studies At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment Exclusion Criteria: Pregnancy Significant medical disease including abnormalities found on screening

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [123I]ß-CIT and SPECT imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parkinson, diagnosis
Gonyautoxin in the Treatment of Chronic Tension-Type Headache

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache in accordance with International Headache Society guidelines

Detailed Description
-----------------
Gonyautoxin are phycotoxins, whose molecular mechanism of action is a reversible block of the voltage-gated sodium channels at neuronal level. They are axonal conduction blockers impeding nerve impulse propagation. In order to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache, the patients were locally injected with placebo versus Gonyautoxin following a painful spots injection standarized protocol

Official Title
-----------------
Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins

Conditions
-----------------
Tension-Type Headache

Intervention / Treatment
-----------------
* Drug: Gonyautoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic tensional-type headache patients according to the International Headache Society criteria: patients with headache of a pressing or tightening quality with episodic frequency above 15 days a month Refractory to conventional treatments such as, orally administered analgesics, systemic muscular relaxant, corticoids and antidepressant like Amytriptiline Treated and controlled in the University Hospital Neurology Clinic over 2 years with duration of symptoms over 3 years Exclusion Criteria: Pregnancy Use of headache prophylactic treatment a month prior to infiltration Myasthenic syndromes Muscular dystrophies Inflammatory myopathies Acute and chronic polineuropathies Use of psychotropic substances 24-hour before infiltration Anticoagulant treatment terminal illnesses (AIDS, cancer) drugs or alcohol abuse

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks) |  |  | 
| b) Number of days without headache pain following infiltration |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gonyautoxins, Tension-type Headache, Human Treatment
Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if an intense two-week long cognitive training program helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that scores on clinical cognitive tests will be better after the training.

Detailed Description
-----------------
Twenty of the 30 subjects will be recruited to participate in functional magnetic resonance imaging (fMRI). Scanning will be done while subjects perform a verbal learning task. Ten subjects will be scanned before and after the two week training. Another ten will be scanned twice at a two week interval before beginning the cognitive training.

Official Title
-----------------
Effects of Intense Cognitive Training on Standardized Measures of Cognition in Those With Very Mild Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Behavioral: Cognitive Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of very mild Alzheimer's Disease (CDC of 0.5) and mild Alzheimer's Disease (CDC of 1.0) Exclusion Criteria: Neurologic disorder other than Alzheimer's disease

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive Training | Behavioral: Cognitive Training<br>* Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score of 5 cognitive tests including 1)WAIS digit span, 2) word fluency, 3) trail making test-A 4) Rey Osterrieth complex figure and 5) MMSE |  | 2 weeks with FU at 2 and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity during functional brain imaging |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Cognitive training
Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy system for the medical care of pancreatic and/or biliary disorders.

Official Title
-----------------
Prospective Evaluation of the Clinical Utility of the Thin Scope/Anchoring Balloon Cholangiopancreatoscopy System for Disorders fo the Pancreatobiliary System

Conditions
-----------------
Disorders of the Pancreatobiliary System

Intervention / Treatment
-----------------
* Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years or older Subject has clinical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangioscopy and/or pancreatoscopy Subject must be able to give informed consent. Exclusion Criteria: Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP) The subject is unable to give 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 |
| --- | --- |
| pancreatobiliary disorders/thin scope<br>All patients will be evaluated with cholangioscopy and/or pancreatoscopy using the thin scope. | Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope<br>* Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy using the thin scope system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of a thin endoscope system for the evaluation and/or treatment of pancreatobiliary disorders. |  | approxiamtely 2-4 hours |
Influence of CPB Temperature on CABG Morbidity

Study Overview
=================
Brief Summary
-----------------
To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to define differences in neurologic function in coronary artery bypass graft (CABG) patients.

Detailed Description
-----------------
BACKGROUND: A pilot study of warm versus cold perfusion and preservation was completed in 32 patients prior to the ongoing study. The findings of the pilot study showed 53 percent of patients had evidence of new neurologic disturbance at postoperative day four. Only the neurologic dysfunction could be correlated with warm versus cold perfusion (37.5 percent warm versus 75 percent cold, P less than 0.05). The changes in neurologic function had abated or clearly improved by one month of follow-up, and the distinction in neurologic dysfunction grading was no longer apparent between the two groups. DESIGN NARRATIVE: Patients were randomly assigned to cold, tepid, or warm blood cardioplegia, coinciding with normothermic, tepid, and hypothermic cardiopulmonary bypass. All patients received a standard anesthetic protocol combining narcotic and inhalational anesthesia. Each patient entering the study had extensive clinical data collected prospectively incorporating most aspects of measurable determinants related to myocardial preservation. Additionally, neurologic tests were performed by a blinded neurologist and rated by an objective scoring system, the Mathew scale. The studies were performed preoperatively, on the third or fourth postoperative day, and at one month following surgery. Hematologic data were measured for fibrinolytic potential.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Neurologic Manifestations

Intervention / Treatment
-----------------
* Procedure: cardiopulmonary bypass
* Procedure: heart arrest, induced


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients, referred for elective or urgent coronary revascularization, not having ongoing angina instability, requiring three or more bypass grafts, and under 70 years of age.

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

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cardiopulmonary bypass|nan|
|Procedure: heart arrest, induced|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Posaconazole vs Itraconazole in Preventing IFD Post-HSCT

Study Overview
=================
Brief Summary
-----------------
Invasive Fungal Disease (IFD) after haematopoietic stem cell transplantation (HSCT) remain a clinical challenge.The studay aims to compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.

Official Title
-----------------
Posaconazole Oral Suspension and Itraconazole Oral Solution in Preventing Invasive Fungal Disease (IFD) in Patients With Hematopoietic Stem Cell Transplantation

Conditions
-----------------
IFD Post-HSCT

Intervention / Treatment
-----------------
* Drug: antifungal prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged ≥13 years Patients undergoing hematopoietic stem cell transplantation. Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females Any co-morbidity precluding the administration ofposaconazole or itraconazole

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Arm 1<br>posaconazole oral suspension | Drug: antifungal prophylaxis<br>* posaconazole oral suspension vs itraconazole oral solution<br>|
| Active Comparator: Arm 2<br>itraconazole oral solution | Drug: antifungal prophylaxis<br>* posaconazole oral suspension vs itraconazole oral solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of breakthrough IFD |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| treatment-related mortality |  | 1 year |
Eze/Simva Switch Study in Diabetics (0653A-807)

Study Overview
=================
Brief Summary
-----------------
A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

Official Title
-----------------
A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.

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

Intervention / Treatment
-----------------
* Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
* Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently being treated with Atorvastatin 10 mg for at least 6 weeks Have Type 2 Diabetes Weight must be stable for more than 6 weeks before entering the study Exclusion Criteria: Consume more than 14 alcoholic drinks per week. Pregnant or lactating Have taken another investigation drug within 3 months of starting this study History of congestive heart failure, heart attack, coronary artery bypass surgery Uncontrolled high blood pressure HIV positive History of cancer in the last 5 years

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: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks|nan|
|Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment |  | 6 Weeks |
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

Study Overview
=================
Brief Summary
-----------------
The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.

Official Title
-----------------
Substituting Lantus®(Insulin Glargine[rDNAorigin]Inj) for a Thiazolidinedione vs. a 3rd Oral Agent as add-on Therapy in Patients Failing a Thiazolidinedione & Sulfonylurea or Metformin Combination

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Lantus (insulin glargine [rDNA origin] injection)
* Drug: Metformin
* Drug: Glyburide
* Drug: Thiazolidinedione


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 - 79 years of age With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months Exclusion Criteria: Major cardiovascular events 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
Maximum Age: 79 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: Lantus (insulin glargine [rDNA origin] injection)|nan|
|Drug: Metformin|nan|
|Drug: Glyburide|nan|
|Drug: Thiazolidinedione|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy |  | During the Study Conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hypoglycemia |  | During the study conduct | 
| Change in fasting plasma glucose |  | During the study conduct | 
| Percentage of patients achieving HbA1C less than or equal to 7% |  | During the study conduct | 
| Time to glycemic control |  | During the study conduct | 
| Change in body weight |  | During the study conduct | 
| Change in serum lipid profile |  | During the study conduct |
Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

Study Overview
=================
Brief Summary
-----------------
Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.

Official Title
-----------------
A Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

Conditions
-----------------
Radiculopathy

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation. Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks. Exclusion Criteria: Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy. Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.

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: pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement |  |  |