linjc16/ctgov huggingface dataset:
High-tone External Muscle Stimulation for Pain Reduction

Study Overview
=================
Brief Summary
-----------------
Sciatica is a common pain problem that affects not only the patient but also constitutes a socioeconomic burden and thus affects the whole society. So far, current pharmacologic therapies are inadequate for many patients. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to transcutaneous electrical nerve stimulation (TENS) on radicular pain associated with sciatica.

Detailed Description
-----------------
Hospital patients (n=100) with chronic sciatica and stable oral analgesic regimen were included into this randomized controlled cross-over trial. Each intervention was administered for a period of 45 min 5 times within 10 days, with a 3-day wash-out period before cross-over. Health impairments had been assessed using the visual analog scales (VAS) for radicular pain before and after intervention and differences in radicular pain between groups were analysed with the Mann-Whitney test.

Official Title
-----------------
High-tone External Muscle Stimulation for Treatment of Chronic Pain

Conditions
-----------------
Chronic Radicular Back Pain, Lumboischialgia, Cervico Brachialgia

Intervention / Treatment
-----------------
* Device: HTEMS
* Device: TENS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sciatica due to degenerative spine disorders stable oral analgesic regimen Exclusion Criteria: history of drug or alcohol abuse cardiac pacemaker or defibrillator pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HTEMS<br>High-tone external muscle stimulation 5 times within 10 days | Device: HTEMS<br> <br> * Other names: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany);|
| Active Comparator: TENS<br>Transcutaneous electrical nerve stimulation 5 times within 10 days | Device: TENS<br> <br> * Other names: Dumo 2.4 (CEFAR Medical, Lund, Sweden);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain | Back pain measured by an 11-point visual analogue scale (VAS) with 0 = none and 10 = worst pain imaginable | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
back pain, sciatica, electrotherapy, HTEMS, TENS
Platelet Transfusions in Critically Ill Patient

Study Overview
=================
Brief Summary
-----------------
Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU). Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients. International and local guidelines (American Association of Blood Banks-AABB) are mainly based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly studied and unknown and the administration of PLT may be associated with adverse effects including an increased risk of hospital acquired infection. Finally, the short PLT shelve-life may be responsible for inventory issues. Altogether, this makes very important to improve the evidence that support PLT transfusion in ICU patients. This is a multicentre prospective observational study that aims to first determine PLT transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU patients.

Official Title
-----------------
Platelet Transfusion Efficacy in Critically Ill Patients

Conditions
-----------------
Platelet Transfusion, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to intensive care and receiving at least one platelet transfusion in intensive care unit Exclusion Criteria: Age less than 18

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 |
| --- | --- | --- |
| platelet transfusion efficacy | corrected count platelet increment | between 18 hours and 28 days after transfusion |
Fetal Thymus Volume of Dichorionic Diamniotic Twin

Study Overview
=================
Brief Summary
-----------------
In some studies of fetal thymus volume, fetal stress factors; infection, preterm premature premature rupture of membranes, preeclampsia, preterm delivery risk. Generally, there is a direct correlation between fetal growth and thymus volume and it was observed that thymus volume decreased in pregnancies accompanied by fetal stress factors.The aim of this study was to measure fetal thymus volume in second trimester twin pregnancies and to investigate whether there is a statistically significant correlation between preterm birth risk pregnancies.

Official Title
-----------------
Relationships Between Preterm Labor and Fetal Thymus Volume in Twin Pregnancies at Second-trimester

Conditions
-----------------
Twin Pregnancy, Antepartum Condition or Complication, Fetal Thymus Volume, Preterm Birth

Intervention / Treatment
-----------------
* Other: assesment of thymus volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dichorionic di amniotic twin pregnancies between 18 weeks and 23 days 6 days Exclusion Criteria: Single pregnancy, first and third trimester pregnant women, urinary tract infection, immune system diseases fetuses with intrauterine genetic and / or multiple morphological diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dichorionic diamniotic twin pregnancy<br>rutin examination: the assesment of fetal thymus volume at all cases. | Other: assesment of thymus volume<br>* assesment of thymus volume<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal thymus volume | assesment of volume | first 6 months | 
| fetal thymus volume | assesment of volume | last6 months | 
| fetal thymus volume | assesment of volume | last 6 months |
A Study of Indinavir Taken With or Without DMP 266

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).

Detailed Description
-----------------
In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows: Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.

Official Title
-----------------
A Phase III, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: CD4+ cell count of at least 50 cells/mm3. HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening. Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Prior Medication: Excluded: DMP 266. Other nonnucleoside reverse transcriptase inhibitors. Required: One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Efavirenz|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
-----------------
Placebos, Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Reverse Transcriptase Inhibitors, efavirenz
Diagnosis and Treatment of Pheochromocytoma

Study Overview
=================
Brief Summary
-----------------
Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not cancerous) and can be cured by surgical removal. However, pheochromocytomas produce neurohormones called cateholamines (epinephrine and norepinephrine). High levels of catecholamines can result in high blood pressure, headaches, sweating, heart palpitations, nausea, vomiting, and other symptoms. These tumors are considered dangerous because of their unpredictable behavior. Patients with pheochromocytoma may experience blood pressures high enough to cause a stroke or heart attack in patients. This study is designed to take patients suspected of having pheochromocytoma and confirm the diagnosis. This will be done using a variety of laboratory tests including a clonidine suppression test and glucagon stimulation test. These tests use drugs that can stimulate or reduce the activity of the tumor if it is present in the body. Once a diagnosis is confirmed, patients participating in this study will undergo standard procedures to find the exact location of the tumor and receive standard therapy for the condition.

Detailed Description
-----------------
Patients suspected of having a pheochromocytoma will be studied via a series of tests in an attempt to ascertain biochemically whether or not they really have such a tumor. These procedures will include a standard clonidine suppression test and a standard glucagon stimulation test. Once the diagnosis has been made on the basis of biochemistry, then localization and therapy will be done via standard procedures. Measurement of plasma metanephrines on mailed samples is available for physicians who seek further evidence for the diagnosis of pheochromocytoma.

Official Title
-----------------
Diagnosis and Treatment of Pheochromocytoma

Conditions
-----------------
Pheochromocytoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients of any age and either sex who are suspected of having a pheochromocytoma on the basis of one or more of the following: 1. hypertensive episodes in a normotensive subject, 2. abnormal levels of blood and/or urinary catecholamines or their metabolites, or 3. an otherwise unexplained abdominal mass. Patients without any evidence of pheochromocytoma are excluded.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium-Pentagastrin, Clonidine, Glucagon, Pheochromocytoma
A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to validate various biomarkers in patients with RA with varying levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be included as controls. The sudy will measure the baseline levels and the intra- and inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled NO levels will be correlated with intra-articular inflammation (power Doppler ultrasonography) as well as markers of systemic inflammation (CRP, ESR).

Official Title
-----------------
An Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA)

Conditions
-----------------
Rheumatoid Arthritis, Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Power doppler ultrasonography
* Procedure: High frequency ultrasonography
* Procedure: Exhaled nitric oxide assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of rheumatoid or osteo-arthritis. Weight greater than 45kg (females) or 50kg (males) but not overweight. Non-smokers. Taking stable anti-inflammatory medication for Rheumatoid Arthritis (RA) or Osteoarthritis (OA) for at least 8 weeks. Exclusion criteria: Taking regular doses of glucocorticoid medication (greater than 5mg/day). Currently taking biological treatment for RA. Recent participation in another clinical trial.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Power doppler ultrasonography|nan|
|Procedure: High frequency ultrasonography|nan|
|Procedure: Exhaled nitric oxide assessment|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
-----------------
iNOS, Rheumatoid arthritis, Exhaled NO
Band to Bypass - Metabolism Kinetics in Gastric Bypass and Banding

Study Overview
=================
Brief Summary
-----------------
The investigators want to study the changes in secretion of gastrointestinal hormones, absorption and metabolism of food and liquids before and after gastric bypass and in patients who are gastric banded but are getting conversion to a gastric bypass. All patients are with normal glucose tolerance. The investigators hypothesis that food uptake/absorption of food is faster after gastric bypass and the secretion of gastrointestinal hormones change.

Official Title
-----------------
Gastric Banding to Bypass - Metabolism Kinetics in Gastric Bypass and Banding

Conditions
-----------------
Gastric Bypass, Gastric Banding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal glucose tolerance Patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass Exclusion Criteria: Diabetes, Study population must undergo gastric bypass

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Tenelia Triple Combination Study

Study Overview
=================
Brief Summary
-----------------
After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Detailed Description
-----------------
Subjects will visit the centers on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.

Official Title
-----------------
Efficacy and Safety of Teneligliptin Versus Sitagliptin as add-on Therapy to Metformin Plus Glimepiride in T2DM Patinets With Inadequate Glycemic Control

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

Intervention / Treatment
-----------------
* Drug: Teneligliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 Diabetes Mellitus Adults aged ≥ 19 years old Patients with HbA1c 7% 11% at Screening and Run-in visit Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin<br>20mg qd | Drug: Teneligliptin<br>* Subjects will visit the center on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.<br>|
| Active Comparator: Sitagliptin<br>100mg qd | Drug: Teneligliptin<br>* Subjects will visit the center on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbAlc from baseline at Week 24 |  | 24 weeks |
TruGraf® Testing in High-Risk Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

Official Title
-----------------
Molecular Biomarkers in Renal Transplant Recipients at Higher Risk of Acute Rejection

Conditions
-----------------
Kidney Transplant Rejection

Intervention / Treatment
-----------------
* Diagnostic Test: TruGraf® Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody >75%. Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation. Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels). Kidney transplant patients who are at least 30 days post-transplant. Exclusion Criteria: Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant. Recipients who do not meet criteria of high-immune risk. Recipients of previous non-renal solid organ and/or islet cell transplantation. Infection with HIV. Infection with BK. Patients that have nephrotic proteinuria (urine protein >3 gm/day).

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 |
| --- | --- |
| All Subjects Enrolled<br>High immune risk transplant recipients who are undergoing routine management under current standard of care | Diagnostic Test: TruGraf® Testing<br>* 5 mL collection PAXgene blood sample<br>* Other names: Peripheral blood gene expression profiling;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility of TruGraf Results | Percent of total number of TruGraf results that the PI identified as having clinical utility | 1 year | 
| Correlation of TruGraf Results | Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care | 1 year |