linjc16/ctgov huggingface dataset:
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

Official Title
-----------------
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Visilizumab (Nuvion®; HuM291)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in a visilizumab study of IVSR-UC. Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy. Exclusion Criteria: Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent. For U.S. sites, unwilling or unable to provide authorization to use protected health information.

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 |
| --- |
|Drug: Visilizumab (Nuvion®; HuM291)|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
-----------------
Ulcerative Colitis, Colitis, Steroid-Refractory, Visilizumab, Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes

Study Overview
=================
Brief Summary
-----------------
It is known from research that long-term exercise exposure in type 2 diabetes had positive effects. However, the effect of acute exercise in a patient group with already reduced cardiac function is not known. In this study, the impact of acute exhaustive high intensity interval training on cardiac function will be investigated in type 2 diabetes patients. One single session of exhaustive high intensity interval exercise training is expected to lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the right ventricle of the heart is expected to be more affected than the left ventricle.

Official Title
-----------------
Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes

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

Intervention / Treatment
-----------------
* Behavioral: high intensity interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetes type 2 patients<br>diabetes type 2 patients whose cardiac function is tested after 4x4 high intensity interval training | Behavioral: high intensity interval training<br> <br> |
| Other: Healthy volunteers<br>healthy volunteers whose cardiac function is tested after 4x4 high intensity interval training | Behavioral: high intensity interval training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| echocardiography | peak longitudinal systolic tricuspid annular velocity in cm/s | 30 minutes each measurement per subject | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise Therapy, Heart Function Tests, Heart/physiology, Echocardiography
Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.

Official Title
-----------------
Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

Conditions
-----------------
Focus of Study

Intervention / Treatment
-----------------
* Device: PICC or subcutaneous venous port


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer treatment with need for central venous access Age >18 yrs Suspected survival > 4 weeks Need of central venous access >4 weeks Exclusion Criteria: Ongoing uncontrolled systemic infection Prescence of significant thrombosis/stenosis in arm or central veins Unability to communicate Probable upcoming need for dialysis fistula

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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
Interventional Model Description: open label pragmatic
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PICC-line<br>PICC line insertion. | Device: PICC or subcutaneous venous port<br> <br> |
| Active Comparator: PORT<br>Subcutaneous venous port insertion | Device: PICC or subcutaneous venous port<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of catheter related venous thrombosis | regular follow-ups at month 1, 3, 6 and 12. | Upon clinical suspiscion during the one the patient i enrolled in the study |
Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital

Study Overview
=================
Brief Summary
-----------------
A prospective, observational study in a university hospital (UZ Leuven). Patients are included when they are treated with a potentional QT-prolonging drug: haloperidol for delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin, erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole, voriconazole), methadone, tacrolimus and oral oncolytics. An ECG is taken before the administration of the drug and 3-5 days after starting the drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation will be documented. Together with ECG2, an additional blood sample will be collected to measure the blood concentration of the drug.

Official Title
-----------------
Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital

Conditions
-----------------
Delirium, QT-prolongation

Intervention / Treatment
-----------------
* Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment with a potentional QT-prolonging drug of our list inpatient of UZ Leuven, admitted on one of the participating wards Exclusion Criteria: < 18 years old DNR-code 3 not possible to take an ECG before the start of haloperidol

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 treated with a potentional QT-prolonging drug<br> | Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib<br> <br> * Other names: sunitinib: Sutent, ATC-code: L01XE04;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in QTc-interval (corrected for heart rate) |  | before and 3-5 days after the start of a potentional QT-prolonging drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QT-prolongation, Torsade de Pointes, QT-prolonging drugs
ARTIST: ARThrose Intervention STandardisée

Study Overview
=================
Brief Summary
-----------------
International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.

Official Title
-----------------
Evaluation of Standardized Management of Knee Arthritis Patients

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Education, weight reduction and physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic and ambulatory patients suffering from knee osteoarthritis (ACR criteria) 25<BMI<35 signed informed consent Exclusion Criteria: need to surgery within 6 next months co-morbidity

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education, weight reduction and physical exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  |  | 
| Physical Exercise in Leisure |  |  |
A Validation Study of the NightOwl Home Sleep Apnea Test

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the apnea hypopnea index (AHI) estimate, defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. This study will be performed in a sleep lab environment.

Official Title
-----------------
A Validation Study of the NightOwl Home Sleep Apnea Test

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Device: NightOwl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with an indication for an in-lab polysomnography Exclusion Criteria: Intellectually disabled people

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSG and NightOwl<br>During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. | Device: NightOwl<br>* The NightOwl is a finger-mounted home sleep apnea testing device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization | The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants. | Through study completion, an average of 1 month. |
Vascular Sensitivity to Adrenergic Agonists in Patients With CHF and in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF.

Official Title
-----------------
Effect of Medications on Vascular Response in Patients With CHF and in Healthy Subjects

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with congestive heart failure NYHA I-II Stable clinical condition Exclusion Criteria: Resting systolic blood pressure < 100 Resting heart rate < 50 Hypersensitivity to dexmedetomidine, phenylephrine, isoproterenol, terbutaline

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular sensitivity (ED50) and response (Emax) to dexmedetomidine, phenylephrine, isoproterenol and terbutaline |  | 3 weeks |
Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults

Study Overview
=================
Brief Summary
-----------------
To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults.

Detailed Description
-----------------
A double-blinded prospective, randomized study undertaken at outpatient clinic of King Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and divided into three groups according to their initial 25OHD concentrations. Patients are randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD concentration are measure again at the end of the study.

Official Title
-----------------
Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study

Conditions
-----------------
Vitamin D2 Supplementation in Vitamin D Insufficiency

Intervention / Treatment
-----------------
* Drug: Ergocalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult age ≥ 15 years BMI 18 - 35 kg/m2 Serum 25(OH)D < 30ng/ml Exclusion Criteria: Hypercalcemia, nephrolithiasis, or fractures Hepatic disease Kidney disease Granulomatous disease Currently supplemented with vitamin D
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D40000<br>Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly | Drug: Ergocalciferol<br>* Ergocalciferol 40000, 60000 and 80000 once weekly<br>|
| Experimental: D60000<br>Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly | Drug: Ergocalciferol<br>* Ergocalciferol 40000, 60000 and 80000 once weekly<br>|
| Experimental: D80000<br>Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly | Drug: Ergocalciferol<br>* Ergocalciferol 40000, 60000 and 80000 once weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25OHD phase 1 | serum 25OHD concentration after initial vitamin D2 supplemetaiton | 12 weeks |
Microarray Analysis of Gene Expression and Identification of Progenitor Cells in Lung Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study will help us understand the gene expression profiles of lung cancer. We will identify genes related to lung cancer development, their growth and metastasis to the lung. In addition, we will examine the role nicotine in the development and progression of lung tumors of smokers, ex-smokers, non-smokers on supplemental nicotine and non smokers with no exposure to nicotine.

Official Title
-----------------
Microarray Analysis of Gene Expression and Identification of Progenitor Cells in Lung Carcinoma

Conditions
-----------------
Carcinoma, Giant Cell, Carcinoma, Non-Small-Cell Lung, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Adults with non small cell lung cancer Exclusion Criteria:NA

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identify genes related to lung cancer development, their growth and metastasis to the lung. |  | day one |
Safety, PK and PD Study in Healthy Male Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sca-136 Administered Orally to Healthy Male Japanese Subjects

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: SCA-136


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men aged 20 to 45 years at the time of obtaining informed consent. Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG). Exclusion Criteria Presence or history of any disorder that may prevent the successful completion of the study. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).

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

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

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: SCA-136|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  |  |
Leptin Signaling in Lean and Obese Humans

Study Overview
=================
Brief Summary
-----------------
Obesity does not respond to high circulating levels of the hormone leptin. This study is aiming at finding out why this happens and open new avenues for treatment of obesity.

Detailed Description
-----------------
Ex vivo and in vitro identification and study of leptin signaling pathways in commercially available cell lines serum/ plasma samples and discarded tissues from humans.

Official Title
-----------------
Leptin Signaling in Humans

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women ages 18 to 65 BMI ranges between 20 and 45 kg/m2 Exclusion Criteria: subjects requiring special diets history of illness other than obesity of diabetes taking medications known to influence glucose metabolism subjects with history of anaphylactic reaction or hypersensitivity to e. coli derived proteins or anesthetic agents women who are breastfeeding, pregnant or wanting to become pregnant subjects with bleeding dyscrasia or poor wound healing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Group 1<br>Lean and obese, diabetic and non diabetics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Westerns / activation of signaling pathways (uo to two hours after treatment) |  | 04/01/2016 |