linjc16/ctgov huggingface dataset:
Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
This study evaluates the difference in post prandial tissue glucose levels between two variation of Roux-en-Y Gastric bypass by continuous glucose monitoring.

Official Title
-----------------
Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass: Comparing Tissue Glucose Levels Between Two Surgical Bypass Methods - a Prospective Study

Conditions
-----------------
Continuous Glucose Monitoring, Roux-en-y Gastric Bypass, Hypoglycemia

Intervention / Treatment
-----------------
* Device: Continuous glucose monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent bariatric-metabolic surgery at the Medical University of Vienna in the years 2012-2016 for the long and narrow pouch group Patients who underwent bariatric-metabolic surgery at the Clinic of Hollabrunn in the years 2010- 2012 for the short and wide pouch group Patients on oral medication for diabetes mellitus (for subgroup assessment) Stable weight (not more than + 15kg from lowest weight postoperatively) Stable BMI Exclusion Criteria: Unable to give written informed consent Patients with methods other than RYGB Reoperation within the observed period Any intervention changing pouch size or diameter of the anastomosis after the initial operation Known allergy to oral contrast agent Any regular intake of medication interfering with blood glucose levels

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| long pouch RYGB<br>Patients with the variation of a long and narrow pouch (hypothesis: slower transit of food) | Device: Continuous glucose monitoring<br>* see arm/group descriptions<br>|
| short pouch RYGB<br>Patients with the variation of a short and wide pouch (hypothesis: faster pouch emptying as compared with long and narrow pouch) | Device: Continuous glucose monitoring<br>* see arm/group descriptions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue glucose levels | Difference in tissue glucose levels after the two variations of the Roux-en-y Gastric bypass | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue vs. blood glucose levels | Comparison of tissue and blood glucose levels | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic surgery
Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis

Study Overview
=================
Brief Summary
-----------------
In this research study we want to learn more about the characteristics of neutrophils that are present in the blood and secretions from a breathing tube of patients with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in the lungs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood and secretions from the breathing tube of patients with sepsis so that they can work to develop therapies to prevent these cells from being harmful.

Official Title
-----------------
Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Sepsis


Participation Criteria
=================
Eligibility Criteria
-----------------
Case Inclusion Criteria: sepsis patient in the ICU with a breathing tube Control Inclusion Criteria: scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure Plan to have endotracheal tube for planned procedures. Exclusion Criteria: On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases (oncology patients, patients with transplantation)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 50 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 |
| --- | --- |
| Sepsis Patients<br> | Other: Sepsis<br>* Sepsis patients in the ICU with a breathing tube<br>|
| Control Patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil characteristics | measure and report β2 integrin expression on neutrophils from blood and tracheal aspirate between sepsis patients and non-sepsis patients in pediatric population | One day |
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.

Official Title
-----------------
Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion) The renal cold ischemic time must be < 36 hours. The age of the donor must be between 15 and 65 years. Exclusion Criteria: Patients who are recipients of multiple organ transplants, including more than one kidney Patients who have previously received an organ transplant which failed within one year Patients with current panel reactive T-cell antibody titers of 50% or more Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant Other protocol-defined exclusion criteria may apply.

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) |  |  | 
| Count of CD4 and CD8 positive lymphocytes |  |  | 
| Metabolic control: lipids, glycaemic control, proteinuria, enzymes |  |  | 
| Ultrasound ejection fraction |  |  | 
| Major adverse cardiovascular events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute rejection, renal function, everolimus, cyclosporine microemulsion
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

Study Overview
=================
Brief Summary
-----------------
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)). Planned registration period 3 years Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Official Title
-----------------
Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: Revlimid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Relapsed or Refractory Adult T-cell Leukemia Lymphoma Exclusion Criteria: N/A

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 with T-cell leukemia lymphoma treated with Revlimid<br>Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance | Drug: Revlimid<br>* Revlimid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse events | Up to approximately 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult T-cell Leukemia Lymphoma, Teratogenicity, Myelosuppression, Haemorrhage, Infection, Thromboembolism, Hypersensitivity, Tumor lysis syndrome, Peripheral neuropathy, Ischaemic heart disease, Cardiac failure, Arrhythmia, Renal failure, Interstitial lung disease, Hepatic disorder, Hypothyroidism, Gastrointestinal perforation, Orthostatic hypotension, Convulsion, Somnolence, Confusion, Fatigue, Dizziness, Blurred vision, Second primary cancer, Cataract, Revlimid capsules
DP-R208 Pharmacokinetic Study

Study Overview
=================
Brief Summary
-----------------
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Official Title
-----------------
DP-R208 Pharmacokinetic Study Phase I

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

Intervention / Treatment
-----------------
* Drug: DP-R208
* Drug: Candesartan cilexetil
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18 30 signed the informed consent form prior to the study participation Exclusion Criteria: Clinically significant disease Previously donate whole blood within 60 days or component blood within 14 days Clinically significant allergic disease Taken IP in other trial within 90 days An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT group<br>combination dose of Candesartan and Rosuvastatin and DP-R208 in order | Drug: DP-R208<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Candesartan cilexetil<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Rosuvastatin<br>* Investigational product is prescribed to all of randomized subjects<br>|
| Experimental: TR group<br>DP-R208 and combination dose of Candesartan and Rosuvastatin in order | Drug: DP-R208<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Candesartan cilexetil<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Rosuvastatin<br>* Investigational product is prescribed to all of randomized subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | up to 48 hours post dose | 
| Peak Plasma Concentration (Cmax) |  | up to 48 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DP-R208
Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Studies

Study Overview
=================
Brief Summary
-----------------
An observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested.

Detailed Description
-----------------
Study A5091075, an observational study in subjects who had previously been treated with torcetrapib, was terminated on 20 Dec 2007. The study was terminated following reviews of final safety information from prior torcetrapib studies and the low participation rates observed during the recruitment period for study A5091075 . On the basis of this new information the Sponsor determined that it was unlikely that this study would result in new and scientifically valid information.

Official Title
-----------------
An Observational Safety Follow Up Trial Of The Occurrence Of Major Cardiovascular Events And All Cause Mortality In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Clinical Trials.

Conditions
-----------------
Cardiovascular Disease, Cerebrovascular Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have signed informed consent prior to the initiation of any study-specific activities. Have participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials and were treated with randomized study medication. Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- | --- |
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive smokers focused on improving adherence to using the nicotine skin patch.

Official Title
-----------------
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: Cessation counseling with adherence focus
* Behavioral: Cessation counseling without adherence focus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Latino HIV positive current, daily smoker ready to set quit date in next 30 days willing to try the nicotine patch Exclusion Criteria: suffering from any medical condition which would prevent using the nicotine patch currently using other tobacco products or e-cigarettes currently receiving counseling or medication to quit or reduce smoking

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adherence condition<br>Brief smoking cessation counseling session (based on 5 A's approach) that includes a module focused on improving adherence to using the nicotine patch, plus 8-week supply of nicotine patches. | Behavioral: Cessation counseling with adherence focus<br> <br> |
| Active Comparator: Standard condition<br>Brief smoking cessation counseling session (based on 5 A's approach) that does not include a module focused on improving nicotine patch adherence, plus 8-week supply of nicotine patches. | Behavioral: Cessation counseling without adherence focus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence | No smoking from the target quit date through the 3-month follow-up | 3 months post-quit date | 
| biochemically-verified 7-day point prevalence abstinence | No smoking in the 7 prior days | 3 months post-quit date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine patch adherence |  | 3 months post-quit date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, Latino, Cessation, Nicotine patch, HIV
Stereotactic Volumetric Radiotherapy in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per fraction.

Official Title
-----------------
Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histology of prostate adenocarcinoma Age≥ 18 years Life expectancy≥ 10 years Clinical negative nodes (N0) No metastasis presence (M0) No previous pelvic radiation therapy Total PSA≤10 ng/ml Gleason score ≤ 6 T1-2 ≤ 3 positive biopsy at prostatic mapping Signed informed consent Exclusion Criteria: Positive nodes (N+) or metastatic disease (M+) Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders Anticoagulant treatment in progress Hip or pelvic presence of medical devices that could prevent a correct image acquisition Symptomatic haemorrhoidal disease Adverse reactions to iodinate or paramagnetic contrast media Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years Previous pelvic radiotherapy Psychiatric disorder that preclude to obtain informed consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stereotactic radiotherapy with a total dose of 36.25 Gy in 5 fractions (7.25 Gy per fraction, 2 fractions per week) in low risk prostate cancer patients is delivered to evaluate acute and subacute toxicty | Radiation: Radiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | during treatment and up to 3 month from RT end | up to 3 months | 
| Late toxicity | since 4 month from RT end | up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease | up to 5 year | 
| Disease specific survival | Time from RT end to the date of patient death for cancer | up to 5 years | 
| Overall survival | Time from RT end to the date of patient death for any cause | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypofractionated radiotherapy, SBRT
Acupuncture and Hot Flashes

Study Overview
=================
Brief Summary
-----------------
Methods: 103 participants, after being randomized to medical versus sham acupuncture received bi-weekly treatments for 5 weeks, after a baseline assessment week. They were then followed for an additional 7 weeks. Participants completed daily hot flash questionnaires, which formed the basis for analysis.

Official Title
-----------------
Acupuncture for Hot Flashes: A Randomized Sham Controlled Clinical Study

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Other: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants eligible for this study were females aged 45 to 59 with a reported average of ¡Ý 5 hot flashes a day

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 59 Years

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

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot Flash Score |  |  |