linjc16/ctgov huggingface dataset:
Oxygen Consumption Required by Stroke Patients During Completion of the Modified Rivermead Mobility Index (MRMI)

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to measure the oxygen consumption and peak heart rate achieved during Modified Rivermead Mobility Index (MRMI) assessment in age-matched, healthy and stroke patients, and assess the efficacy of the MRMI tasks for aerobic training in patients with stroke.

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of hemisphere stroke aged fifty or above ambulatory with/ without walking aid had ability to provide informed consent and understand the evaluation procedures Exclusion Criteria: brainstem and cerebellar lesion unconscious or drowsy musculoskeletal, respiratory or other disease that may limit activity of daily livings serious cardiovascular disease

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with normal health<br> | |
| Subjects with Stroke<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen consumption |  |  |
Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Study Overview
=================
Brief Summary
-----------------
The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.

Detailed Description
-----------------
20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks. Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy. Follow up for one year after last cycle of alemtuzumab.

Official Title
-----------------
Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome

Conditions
-----------------
Mycosis Fungoides, Sezary Syndrome

Intervention / Treatment
-----------------
* Drug: alemtuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years old Eastern Cooperative Oncology Group (ECOG) 0-2 Liver and renal function test less than twice upper label No active infection Written informed consent One to three regimens of previous chemotherapies Exclusion Criteria: Abnormal renal or hepatic function Mycosis fungoides/Sezary syndrome in transformation HIV + HTLV-1 + Pregnancy Lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: alemtuzumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response |  |  | 
| Time to relapse |  |  | 
| Event free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alemtuzumab, Mycosis fungoides, Sezary
Endobronchial Ultrasound Guided Transbronchial Lung Biopsy With or Without Guide Sheath in Lung Tumors and the Analysis of Echoic Patterns of Lung Tumors and Mediastinal Lymph Nodes, and the Association Between Diagnostic Yield of Transbronchial Lung Biopsy and EBUS Echoic Features.

Study Overview
=================
Brief Summary
-----------------
Endobronchial ultrasonography (EBUS) is useful in localizing peripheral lung lesions. The EBUS, further combined with the guide sheath (GS) technique, has been reported to increase the yield of transbronchial biopsy. However, there are no reports comparing the GS technique and the traditional EBUS technique in diagnosing the peripheral lung tumor. Previous reports have revealed that several characteristic echoic patterns correlate well with the histopathological findings of benign and malignant lesions. Therefore, EBUS may also be useful in the differential diagnosis of malignant lesions of the lung.

Conditions
-----------------
Lung Neoplasms

Intervention / Treatment
-----------------
* Procedure: endobronchial ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with radiologically confirmed peripheral lung mass Exclusion Criteria: Patient clinically not indicated for bronchoscopy exam within the abovementioned cohort

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

| Intervention/Treatment |
| --- |
|Procedure: endobronchial ultrasound|EBUS|

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
-----------------
lung, neoplasm, bronchoscopy, ultrasonography, histology
Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: gaboxadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults who are between the ages of 18 and 64 Exclusion Criteria: Adults who are diagnosed with insomnia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gaboxadol|Duration of Treatment -1 day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time spent awake and time to fall asleep during one night |  | one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of deep sleep during one night. |  | one night | 
| Patient-reported sleep quality and awakenings during 1 night. |  | one night |
Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from Port Wine Stain.

Detailed Description
-----------------
The researcher can detect the defects in nervous system innervation to cutaneous blood vessels contribute to the pathogenesis of Port Wine Stain . Unveiling the pathogenic mechanisms of PWS is crucial to the design of new therapeutic strategies and can use the results to improve current PWS therapeutic outcomes.

Official Title
-----------------
Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples

Conditions
-----------------
Port-Wine Stain

Intervention / Treatment
-----------------
* Other: Biopsy sample from Port Wine Stain Birthmark


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of all ages. Not pregnant. Has diagnosis of port wine stain on the arms, legs, chest, bac. Ability to understand and carry out subject instructions. Subject willing to have skin biopsies on port wine stain and normal skin areas. Exclusion Criteria: Pregnant women. Port Wine Stain on the face. History of skin cancer. Current participation in an investigational drug evaluation Concurrent use of known photosensitizing drugs.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Port Wine Stain Birthmark<br>Biopsy sample from Port Wine Stain Birthmark | Other: Biopsy sample from Port Wine Stain Birthmark<br>* Biopsy sample from Port Wine Stain Birthmark<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of Port Wine Stain Birthmark tissue sample |  | up to 4 weeks |
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315

Study Overview
=================
Brief Summary
-----------------
Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects. Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.

Official Title
-----------------
An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SAM-315


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young healthy subjects: Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day 1. Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg. Elderly Healthy subjects: Men or women aged 65 years and above as of study day 1. BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg. Exclusion Criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. History of any clinically important drug allergy.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Experimental-Placebo Comparator | Drug: SAM-315<br>* Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, tolerability and PK |  | 10 months |
Stress Hormones and Human Cocaine Use - 7

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.

Detailed Description
-----------------
The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. Endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving Questionnaire). We hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.

Official Title
-----------------
Stress Hormones and Human Cocaine Use

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

Intervention / Treatment
-----------------
* Drug: Cocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males between the ages of 20-45. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. Current history of good health and normal EKG. Exclusion Criteria: History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. Use of any psychotropic drugs including MAOIs in the past 6 months.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological measures |  |  | 
| Biochemical |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Effect of Monosodium Glutamate Supplementation on Gastric Emptying and Postprandial Nitrogen Kinetics

Study Overview
=================
Brief Summary
-----------------
There are receptors to free glutamate in the oral cavity and stomach that may mediate effects of this amino acid on gastrointestinal physiology. The investigators hypothesize that a chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the further metabolism of dietary protein in healthy subjects.

Official Title
-----------------
Effect of Monosodium Glutamate on Gastric Emptying and Postprandial Nitrogen in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: MSg supplementation
* Dietary Supplement: NaCl supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 23 to 28 Exclusion Criteria: pregnancy allergy to milk protein gastrointestinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 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: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSG<br>Subjects receive a 6-d supplementation of MSG and are studied on the 7th day in the postprandial period following a standard meal ingestion with 2g MSG | Dietary Supplement: MSg supplementation<br> <br> |
| Placebo Comparator: Control<br> | Dietary Supplement: NaCl supplementation<br> <br> |

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
-----------------
Physiology
Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings

Study Overview
=================
Brief Summary
-----------------
Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening. However, sickle cell disease is most prevalent in low-resource regions of the world, where newborn screening is rare due to the cost and logistical burden of laboratory-based methods. In many such regions, >80% of affected children die, undiagnosed, before the age of five years. A convenient and inexpensive point-of-care test for sickle cell disease is thus crucially needed. In this study we will conduct a blinded, multicenter, prospective diagnostic accuracy study of HemoTypeSC(TM), an inexpensive 15-minute point-of-care immunoassay for detecting sickle cell disease, hemoglobin C disease, and trait phenotypes in newborns, children, and adults.

Official Title
-----------------
Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings: a Multi-Center

Conditions
-----------------
Diagnoses Disease

Intervention / Treatment
-----------------
* Device: HemoTypeSC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agrees to be enrolled (or has parent/guardian approval to be enrolled) Exclusion Criteria: Previous sickle cell screening
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HemoTypeSC|Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive for Hemoblogin A, S, or C |  | Immediate (investigational test) to one week (reference test) | 
| Negative for Hemoglobin A, S, or C |  | Immediate (investigational test) to one week (reference test) | 
| Positive for Hemoglobin AA, AS, AC, SS, SC, or CC |  | Immediate (investigational test) to one week (reference test) | 
| Negative for Hemoglobin AA, AS, AC, SS, SC, or CC |  | Immediate (investigational test) to one week (reference test) |
Prospective Evaluation of Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy (EUS-FNAB) in the Absence of Rapid Onsite Evaluation

Study Overview
=================
Brief Summary
-----------------
<Background/aims> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies across EUS programs in Unites States, Europe and other areas of world. The investigators have a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in which the adequacy of specimens will be assessed by a single endosonographer. <Methods> All EUS-FNAB procedures will be performed by an experienced endosonographer and the adequacy of specimens obtained during EUS-FNAB will be also assessed by a same endosonographer. A specimen will be considered adequate if there is an adequate number of representative cells from the lesion. Samples considered to be adequate will be then interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive change, or negative for malignancy. Performance characteristics of EUS-FNAB including sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up of more than 6 months with repeat imagings.

Official Title
-----------------
Prospective Evaluation of the Yield and Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy in the Absence of Rapid Onsite Evaluation

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: EUS-FNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion Exclusion Criteria: Patients who refuse to undergo EUS-FNA

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 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 |
| --- | --- |
| EUS-FNA<br>Any patients who will undergo EUS-FNA for pancreas lesion during the study period | Procedure: EUS-FNA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity and accuracy of EUS-FNA without ROSE | Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of EUS-FNA without ROSE | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of obtained cytologic specimens |  | 7 days |