linjc16/ctgov huggingface dataset:
Study of Aripiprazole in the Treatment of Patients With Acute Symptoms of Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if aripiprazole is effective in the treatment of patients with acute symptoms of Bipolar Disorder.

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

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with acute symptoms of Bipolar Disorder

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to apply this smoking cessation program on oral cancer patients, and to analyze the effectiveness of it.

Official Title
-----------------
Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention

Conditions
-----------------
Oral Cancer

Intervention / Treatment
-----------------
* Behavioral: smoking cessation program
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of oral cancer current smoker
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling, smoking cessation drug<br> | Behavioral: smoking cessation program<br>* cross-theoretical model integrating smoking cessation counseling, smoking cessation drug utilization, physician interview and telephone counseling persuasion,<br>|
| Active Comparator: Lifestyle counseling<br> | Behavioral: Lifestyle counseling<br>* ross-theoretical model integrating smoking cessation counseling,physician interview and telephone counseling persuasion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation |  | 6 months |
Different Arm Positions During Single Leg Squat

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effects of different arm positions on muscle activity during single leg squat.

Detailed Description
-----------------
The aim of our study is to examine the effect of different positions of the arms on lower extremity muscle activations during Single Leg Squat (SLS). This prospective cross sectional study included single leg squat test assessments in different arm positions: 1) Arms free, 2) Arms flexed 90 degrees, 3) Hands on hip, 4) Arms across the chest. Inclusion criteria were being a young adult (20-30 years old), physical activity level of at least 4 on the Tegner Activity Scale, and volunteering to participate in the study. Those with a history of lower extremity injury in the last 1 year will be excluded from the study. Our study will contribute to distinguishing SLS variations for clinicians and researchers and choosing the appropriate SLS for evaluation and treatment.

Official Title
-----------------
Vastus Medialis Muscle Activation During Single Leg Squat Performed With Arm Position Variations in Healthy Participants

Conditions
-----------------
Knee Injuries and Disorders

Intervention / Treatment
-----------------
* Other: Single Leg Squat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being between the ages of 20-30 Physical activity level of at least 4 on the Tegner Activity Scale, Exclusion Criteria: History of lower extremity injury in the last 1 year Central or peripheral vestibular disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Single Leg Squat|After initial data collection (Demographic data, Inclusion criteria), surface electromyography EMG assessments will be obtained from 1 muscle ( Vastus Medialis). EMG evaluation will be done in different arm positions during the single leg squat. These records will be taken in 4 different situations: 1) Arms free, 2) Arms flexed to 90 degrees, 3) Hands on hips, 4) Arms across the chest.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface Electromyography | Surface EMG evaluations of Vastus Medialis in 4 conditions in a row (1) Arms free, 2) Arms flexed 90 degrees, 3) Hands on hip, 4) Arms on crossed shoulders. | Procedure (During the intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subject, movement analysis, muscle activity, kneeling
The Effect of Fasudil on Vascular Function in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.

Official Title
-----------------
The Effect of Fasudil on Vascular Function in Humans

Conditions
-----------------
Atherosclerosis, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: fasudil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery disease Hyperlipidemia -OR- Healthy adults Exclusion Criteria: Unstable angina, myocardial infarction or revascularization within 3 months Symptomatic heart failure Creatinine > 3.0 mg/dl Liver enzymes > 3X upper limit of normal Chronic hypoxia Significant anemia Chronic inflammatory disease Pregnancy Willing to withdraw statins for duration of study

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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular reactivity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rho kinase expression |  |  | 
| Rho kinase activity |  |  | 
| eNOS expression |  |  | 
| eNOS activity |  |  | 
| inflammatory markers |  |  |
New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.

Conditions
-----------------
Hip Arthritis, Knee Arthritis

Intervention / Treatment
-----------------
* Procedure: Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight < 100 kg score UCLA > 4 prosthesis of first intention Exclusion Criteria: Pregnant score UCLA < 4 osteotomy near to prosthesis prosthesis requiring an osseous transplant prosthesis already set up infections, contagious diseases (HIV, tuberculosis, hepatitis, venereal diseases) or metastasis neuromuscular diseases able to perturb walking or staying congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional arthroplasty<br>Total hip or knee conventional arthroplasty | Procedure: Arthroplasty<br>* Hip or knee arthroplasty<br>|
| Experimental: Mini-invasive arthroplasty<br>Total hip or knee mini-invasive arthroplasty | Procedure: Arthroplasty<br>* Hip or knee arthroplasty<br>|
| Experimental: Mini-invasive and computer-assisted arthroplasty<br>Mini-invasive and computer-assisted total hip or knee arthroplasty | Procedure: Arthroplasty<br>* Hip or knee arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques |  | 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs |  | 2 years after surgery |
Evaluation of Prognostic Monitoring for Young Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer with completed standard treatment for young ladies will be studied.

Detailed Description
-----------------
200 patients younger than 35 with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease specific protein complexes and pathological state of patients will be analyzed.

Official Title
-----------------
Evaluation of Prognostic Monitoring for Young Breast Cancer Patients Via Analysis of Immunoinflammation-related Protein Complexes in Blood

Conditions
-----------------
Breast Cancer Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump Breast cancer-related chemotherapy and radiotherapy completed Young ladies with ages equal 35 or below Exclusion Criteria: Male Aged above 35 Breast Carcinoma in situ Women in pregnancy or breastfeeding Suffering from other malignant tumors Non-compliant patient

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| young ladies<br>Young ladies≤ 35 years old. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune inflammation-related protein complexes | The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography. | 2 years | 
| blood markers | The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay. | 2 years |
Expanded Access for CC-4047

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-4047.

Official Title
-----------------
Expanded Access for CC-4047

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: CC-4047


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CC-4047|CC-4047 will be administered orally|

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
-----------------
Expanded Access, Compassionate Use
Effect of Montelukast on Basophils, In-vitro

Study Overview
=================
Brief Summary
-----------------
Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.

Official Title
-----------------
The Effect of Montelukast In-vitro on Basophil Histamine and Leukotriene, IL-4 Adn IL-13 Release in Subjects With Allergic Rhinitis or Allergic Asthma

Conditions
-----------------
Allergic Asthma, Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic asthma or allergic rhinitis age 12+ Exclusion Criteria: smokers

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| 1<br>Allergic Asthma | |
| 2<br>Allergic Rhinitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histamine Release |  | during the assay portion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine release. IL-13, IL-4 and leukotriene |  | assay portion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IL13, leukotriene, histamine, IL4, Must be allergic asthma or allergic rhinitis
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (IASD) System in patients with heart failure with preserved ejection fraction.

Detailed Description
-----------------
The study was a multi-center, non-randomized feasibility evaluation of the IASD System at three centers in three countries (Denmark, Australia, and Czech Republic). Relevant ethics committee and competent authority approvals were obtained. The study was conducted in accordance with the Declaration of Helsinki. The protocol required the treatment of a minimum of 5 patients, and allowed up to twenty patients to be enrolled. The primary objective of the trial was to evaluate the safety and potential benefits of the IASD Device System in the treatment of patients with symptomatic heart failure with preserved ejection fraction, despite optimal medical management.

Official Title
-----------------
Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: IASD System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HFpEF Ejection Fraction of at least 45% Imaging and hemodynamic evidence of HFpEF History of exercise intolerance Symptomatic despite optimal medical management Signed study specific informed consent Exclusion Criteria: History of thromboembolic events Significant structural heart disease or coronary artery disease Contraindicated to study required medication Right ventricular dysfunction History of greater than mild restrictive or obstructive lung disease Life expectancy less than one year for non-cardiovascular reasons Known or suspected allergy to implant material Fertile women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Device implantation<br>Subjects are implanted with the study device. | Device: IASD System<br>* Implantation of the DC Devices Inc. IASD System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Device Events |  | One month |
DEFINITIVE AR Two Year Follow-up Extension Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.

Official Title
-----------------
Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study

Conditions
-----------------
Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Was a subject in DEFINITIVE AR I Is able and willing to provide written informated consent prior to study specific data collection. Exclusion Criteria: Withdrew consent in DEFINITIVE AR I. Was reported dead during DEFINITIVE AR I.

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 |
| --- | --- |
| Subjects enrolled in DEFINITIVE AR<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event Rate |  | 2 years |
Comparison of Nutrition Risk Screens

Study Overview
=================
Brief Summary
-----------------
This research study will compare two different screens for nutrition risk in patients who are in the hospital. We will be comparing the ThedaCare Nutrition Risk Screen to see if it is as good and consistent as the standard NRS 2002 Nutrition Risk Screen.

Detailed Description
-----------------
This research study comparing the ThedaCare screen against the NRS 2002 screen will validate the accuracy and reliability of the ThedaCare Screen and the timeliness of nutrition intervention of patients with a diagnosis of malnutrition. Early nutrition intervention will positively affect the patient's clinical complication, LOS, and readmission.

Official Title
-----------------
Comparison of Nutrition Risk Screens in Identification of Hospitalized Patients at Nutrition Risk and/or With Malnutrition.

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 yrs of age Hopitalized Exclusion Criteria: Positve for Pregnancy Inability to give Consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 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 |
| --- | --- |
| NRS2002 Nutrition Risk Screen<br>Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition. | |
| ThedaCare RD/RN Nutrition Risk Screen<br>Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen | Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives) | 24 hr within admission to the hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hospital Nutrition screens