linjc16/ctgov huggingface dataset:
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation: A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy controls. A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.

Official Title
-----------------
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.

Conditions
-----------------
Sleep Apnea, Obstructive, Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Continuous positive airway pressure
* Device: Sham continuous positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSA subjects: apnea-hypopnea index >=10 and <100 DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0% Exclusion Criteria: Hematocrit < 32 Pregnancy Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active CPAP<br>Therapeutic continuous positive airway pressure (CPAP). | Device: Continuous positive airway pressure<br>* CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).<br>|
| Placebo Comparator: Sham CPAP<br>Sham (non-therapeutic) continuous positive airway pressure. | Device: Sham continuous positive airway pressure<br>* CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Brachial Artery Flow-mediated Dilation (FMD). | Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline. | 3 months (compared to baseline) |
Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine of creatine will prevent or treat the muscle toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and weakness. This is tested in patients who have had this side effect from 3 different statin drugs.

Detailed Description
-----------------
Muscle toxicity is the most common limiting side effect of statin therapy. Biochemical studies have suggested the presence of intramuscular creatine deficiency in patients with muscle toxicity. This is a test of oral creatine supplementation in statin intolerant subjects as a method of preventing the onset of this side effect as well as resolving these symptoms when present during statin therapy.

Official Title
-----------------
Creatine Supplementation for the Prevention of Statin Myalgia

Conditions
-----------------
Hypercholesterolemia, Aches, Cramps, Weakness

Intervention / Treatment
-----------------
* Dietary Supplement: Creatine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypercholesterolemia in need of aggressive treatment, defined as a high risk of a vascular event, thus subjects with diabetes, pre-diabetes, or known vascular disease intolerance (i.e. muscle toxicity symptoms) of at least 3 statin drugs, each confirmed on rechallenge Exclusion Criteria: history of elevated CPK or rhabdomyolysis while taking a statin, CPK levels elevated above the normal range at baseline, pregnancy. renal insufficiency, defined as a serum creatinine ≥ 2.0 mg/dl. history of congestive heart failure.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Creatine|Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined visual analog pain scales (0-10) for aching, cramping and weakness |  | baseline, after 5 days of creatine loading, after 6 weeks of creatine+statin, after up to 6 weeks on statin without creatine, after 4 days of rechallenge with creatine while still on statin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydroxymethylglutaryl-CoA Reductase Inhibitors, Creatine, Adverse Effects, Muscle Toxicity
Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia

Study Overview
=================
Brief Summary
-----------------
This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.

Detailed Description
-----------------
This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after receiving 8-weekly sessions of the osteopathic manual treatments for truncal flexion dystonia as measured by the distance of the external acoustic meatus from a plumb-line to lateral malleolus, spinal X ray, and heart rate variability.

Official Title
-----------------
Osteopathic Manual Treatment of Postural Abnormality, Pain, and Autonomic Control of Cardiac Function in People With Parkinson's Disease and Truncal Dystonia

Conditions
-----------------
Parkinson Disease, Dystonia, Autonomic Dysreflexia

Intervention / Treatment
-----------------
* Other: osteopathic manual therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease; able to stand for three minutes or more Exclusion Criteria: severe dementia, moderate or severe hallucinations and psychosis; unable to stand for three minutes
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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parkinsons fwd posture manual treatment<br>Subject will receive the intervention, osteopathic manual treatment protocol. | Other: osteopathic manual therapy<br>* Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms<br>|
| No Intervention: Parkinsons forward posture<br>Subjects will receive counseling. | |
| No Intervention: Parkinsons without forward posture<br>Subjects will receive counseling. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in posture | inches of forward head carriage | 8 weeks | 
| change in heart rate variability | heart rate changes | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
manual therapy, heart rate
Prevention of Perioperative Acute Renal Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.

Official Title
-----------------
Prevention of Perioperative Acute Renal Failure in Abdominal Surgery

Conditions
-----------------
Abdominal Surgery

Intervention / Treatment
-----------------
* Drug: Isotonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are undergoing elective abdominal surgery after appropriate information of the study, and its possible risks that may arise therefrom and that at any time to refuse their cooperation, give a written consent to participate in the study. Patients who at the time of the interview have an ASA between 2 and 4. Patients with chronic kidney failure mild moderate (serum creatinine between 1.5 and 3.0 mg / dl) can be included. Exclusion Criteria: Chronic kidney diseases with serum creatinine higher than 3.0 mg /DL Laparoscopic abdominal surgery ASA 1 and ASA 5 patients. Patients with cardiac insufficiency, ascites and respiratory insufficiency Diastolic hypertension > 100 mmHg

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isotonic saline<br>Isotonic saline | Drug: Isotonic saline<br>* Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery<br>|
| No Intervention: No treatment<br>Habitual therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery. |  | 5 years |
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.

Detailed Description
-----------------
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Official Title
-----------------
A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-DFU-201

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Biological: ALLO-ASC-DFU
* Other: Standard therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: 1. Subjects who are considered not suitable for the study by the principal investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| ALLO-ASC-DFU<br>Subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial of ALLO-ASC-DFU-201 | Biological: ALLO-ASC-DFU<br>* Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.<br>* Other names: Allogeneic mesenchymal stem cells;|
| Standard therapy<br>Subjects with Standard therapy in phase 2 clinical trial of ALLO-ASC-DFU-201 | Other: Standard therapy<br>* Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Evaluation of AE | up to 24 months |
Metabolic Syndrome Cohort in Korea

Study Overview
=================
Brief Summary
-----------------
Patients with metabolic syndrome living in Seoul area are included in this prospective registry for more than 10 years. All enrolled patients undergo thorough medical history survey. Enrolled patients will have coronary CT, 2D echocardiogram, treadmill test, pulse wave velocity, augmentation index, carotid intima-media thickness, and abdominal fat mass evaluation. Moreover, lipid profiles and inflammatory markers such as hsCRP, IL-6, TNF-alpha, VCAM-1, ICAM-1, adiponectin, MMP-9 will be measured. All participants will repeat the test and survey every year in Korea University Hospital.

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 out of 5 criteria Central obesity: Men ≥ 90 cm Women ≥ 85 cm Plasma triglycerides ≥ 150 mg/dL HDL cholesterol Men < 40 mg/dL, Women < 50 mg/dL Blood pressure ≥130/85 mm Hg (or treatment for hypertension) Fasting plasma glucose ≥ 100 mg/dL Age between 30 to 64 Consent to our registry protocol Exclusion Criteria: Patients who could not undergo coronary CT, 2D echocardiogram, treadmill test, and pulse wave velocity.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 64 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 |
| --- | --- | --- |
| Cardiovascular events | Cardiovascular events such as fatal and non-fatal myocardial infarction, heart failure, need for coronary and peripheral revascularization, stroke, all-cause death, and cardiac death. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with metabolic syndrome age between 30 to 64: Central obesity (Men ≥ 90 cm Women ≥ 85 cm), Plasma triglycerides ≥ 150 mg/dL, HDL cholesterol Men < 40 mg/dL, Women < 50 mg/dL, Blood pressure ≥130/85 mm Hg (or treatment for hypertension),, Fasting plasma glucose ≥ 100 mg/dL
Multicenter Infection Surveillance Study Following Colorectal Procedures

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.

Detailed Description
-----------------
This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal procedures.

Official Title
-----------------
Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Device: ON-Q Silver soaker System
* Drug: Patient controlled analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, >18 years of age; Scheduled for elective colon procedure; Ability to complete patient survey questionnaires; Provision of informed consent Exclusion Criteria: Patients with a prior allergic reaction to Morphine, Demerol, Dilaudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine); Procedures for hemorrhoids; Inability to perform follow up assessments

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 |
| --- | --- |
| Active<br>Surgical site continuous local anesthetic infusion with ONQ silver Soaker System | Device: ON-Q Silver soaker System<br>* Continuous infusion of local anesthetic to surgical site<br>* Other names: Continuous surgical site local anesthetic infusion;|
| Control<br>Hospital standard of care for pain management (Patient controlled analgesia or epidural) | Drug: Patient controlled analgesia<br>* IV opioids delivered via PCA<br>* Other names: PCA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection |  | 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | Average 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal surgery
APOLLO: Personalized rehAbilitation PrOgram in aLLOgeneic Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
People who undergo allogeneic bone marrow transplant for blood cancers receive the highest chemotherapy doses possible that humans can receive and still survive. As a result, they have devastating side effects during the procedure and for many years afterwards. Damage to organs and muscles cause long-lasting physical weakness and the psychological experience is severe enough to be termed 'post traumatic stress disorder' that also lasts for many years. These effects are worsened by the fact that most Canadians live several hours away from treatment and transplant centers, leaving them entirely on their own to manage these difficult long term effects. The APOLLO team will perform a qualitative study to learn the experiences of people undergoing allogeneic bone marrow transplant while they receive access to a supportive care computer 'app' and telephone support from nursing, exercise and nutrition experts. In this way, the APOLLO team will learn the most helpful type and timing of supportive care from those who know best.

Official Title
-----------------
APOLLO: Personalized rehAbilitation PrOgram in aLLOgeneic Bone Marrow Transplantation

Conditions
-----------------
Allogeneic Disease

Intervention / Treatment
-----------------
* Behavioral: Supportive nursing, nutritional and physical activity with a handheld 'app'


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible for allogeneic transplantation Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Supportive nursing, nutritional and physical activity with a handheld 'app'|Supportive nursing, nutritional and physical activity with a handheld 'app'|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Title: Acceptability of a multimodal supportive care | Description: Questionnaire to assess usefulness of a multimodal supportive care App that includes care navigation (nursing, exercise, nutrition) | 1 year |
Evaluation of Patient Satisfaction and Biting Force of New Design of Extracoronal Attachment (O T Cap Unilateral Attachment) Versus Conventional Partial Denture for Treatment of Unilateral Mandibular Distal Extension Area

Study Overview
=================
Brief Summary
-----------------
Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force.

Conditions
-----------------
Patient Acceptance of Health Care

Intervention / Treatment
-----------------
* Other: O T unilateral attachment
* Other: New design of extracoronal attachment system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with unilateral mandibular distal extension area Normal crown/root ratio of last premolar co-operative patients Exclusion Criteria: completely edentulous patient few remaining teeth patients exposed to radiotherapy and chemotherapy patients with maxillary or mandibular defect

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional partial denture<br>Intervention will be O T unilateral attachment | Other: O T unilateral attachment<br>* O T unilateral attachment system<br>|
| Active Comparator: Conventional removal partial denture<br>Intervention will be new design of extra coronal attachment( O T unilateral attachment) | Other: New design of extracoronal attachment system<br>* O T unilateral attachment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | OHIP-14 questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biting force |  | 12 months |