linjc16/ctgov huggingface dataset:
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.

Official Title
-----------------
LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Conditions
-----------------
Diabetic Neuropathies, Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: Ruboxistaurin mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have type I or type II Diabetes Mellitus. Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months. Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy. Must be 18 years or older. Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study. Exclusion Criteria: History of significant liver problems. Have poor kidney function. Drink an excess of alcohol or abuse drugs. Have recently participated or currently participating in a Medical study in which you receive an experimental drug. Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ruboxistaurin mesylate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in neuropathic symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change |  |  |
Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Study Overview
=================
Brief Summary
-----------------
Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.

Official Title
-----------------
Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention

Conditions
-----------------
Left Ventricular Dysfunction

Intervention / Treatment
-----------------
* Device: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LVEF <40% PCI at latest 6 hours after infarction BMI >20 kg/m² and <30 kg/m² Exclusion Criteria: PCI elder than 14 days relevant valvular disease left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event scheduled for CABG DM Type 1 & extensive hypercholesterinemia pacemaker systemic disease Pregnancy

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PCI|Stent implantation after acute myocardial infarction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left ventricular dysfunction, myocardial infarction, left ventricular dysfunction (LVDF) after acute myocardial infarction
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers. The effect of food on the pharmacokinetics of XPF-001 will also be studied.

Official Title
-----------------
Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XPF-001 and to Investigate the Effect of Food on the Pharmacokinetics of a Single Dose of XPF-001 in Healthy Subjects

Conditions
-----------------
Healthy Human Volunteers

Intervention / Treatment
-----------------
* Drug: XPF-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects (Females of non-childbearing potential) with normal or clinically insignificant laboratory results, ECGs and physical examinations. Exclusion Criteria: Subjects with a presence or history of any clinically significant disease. Subjects who have participated in and investigational drug trial within 60 days of admission. Subjects who have used tobacco or nictoine products in the 1 month prior to admission Females who are pregnant or breastfeeding

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Single dose of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|
| Experimental: Cohort 2: Single dose of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|
| Experimental: Cohort 3: Single dose of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|
| Experimental: Cohort 4: Single dose of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|
| Experimental: Cohort 5: Single dose of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|
| Experimental: Cohort A: Repeated doses of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|
| Experimental: Cohort B: Repeated doses of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|
| Experimental: Cohort C: Repeated doses of XPF-001<br> | Drug: XPF-001<br>* Single oral dose, or 6 days of repeated oral doses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events. |  | up to 14 days post dose |
Development of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

Study Overview
=================
Brief Summary
-----------------
In the final months of pregnancy, women need to know whether their 'water is broken' necessitating a race to the delivery room, or whether pressure of the foetus on their bladder has caused them merely to pass urine. They may also have faced the same dilemma on many occasions much earlier in the pregnancy. With this development the investigators will provide them with an immediate answer to this critical question.

Conditions
-----------------
Color Reaction With Amniotic Fluid

Intervention / Treatment
-----------------
* Device: A disposable pad containing sensitive chemical indicators


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amniotic fluid that were taken after the 17th week. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant woman<br> | Device: A disposable pad containing sensitive chemical indicators<br>* After a urine/amniotic fluid leaking, liquid meets the diagnostic device and chemical reactions will occur in the test zones and cause a color change.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost/brinzolamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension Exclusion Criteria: Age (Under 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Travoprost/brinzolamide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP |  | Time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open-angle glaucoma, ocular hypertension
Clinical Assessment of Patients With High Bone Mass Due to Mutation in Lrp5

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe patients with a high bone mass phenotype due to a mutation in the low density lipoprotein l receptor 5 gene (LRP5) and compare them with age and sex matched controls. Moreover, bone density and microarchitecture as well as markers of bone metabolism are evaluated

Detailed Description
-----------------
Cases and controls are closely matched on age and sex and evaluated cross-sectionally. Dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT) are used in order to evaluate bone density as well as microarchitecture. Bone turnover markers and body composition are also measured.

Official Title
-----------------
Clinical Assessment of Patients With High Bone Mass Due to Mutation in Low Density Lipoprotein l Receptor 5

Conditions
-----------------
Osteopetrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lrp5 mutation/ADOI Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- |
| Patients with mutation in the Lrp5 gene<br>Patients known to have a mutation in Lrp5 known to be causing a high bone mass phenotype | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone microarchitecture as assessed by high resolution quantitative computed tomography (HR-pQCT) | HR-pQCT is used to evaluate bone microarchitecture, i.e. bone trabeculae, cortical thickness and trabecular number. Aim is to test if the microarchitecture of these patients are different that observed in normal controls | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone turnover markers | Markers of bone resorption and formation are investigated. | 12 weeks | 
| Bone mineral density | DXA is used to evaluate bone mineral density at total hip, spine, whole body and forearm. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low density lipoprotein receptor 5, high bone mass, autosomal dominant osteopetrosis type I, bone turnover markers
Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery

Study Overview
=================
Brief Summary
-----------------
T2DM has become a major health burden for our society. More and more data support the relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI over 27.5 in Asia. The evidence reviewed above strongly points to the need for a large randomized, controlled trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2 diabetes Mellitus. This study is expected to provide very significant findings about the natural course of diabetes in obese diabetic patients.

Detailed Description
-----------------
This study will recruit 200 obese T2DM patients at MSGH, for a total of 1000 in Taiwan. The inclusion criteria are those with T2DM more than 6 months, under medical management in diabetes center, BMI over 25, age between 20 and 67 years. The goals of this study are to evaluate the nature course of the diabetes for 10 years. The primary outcomes for the treatment will be assessed every year after intervention and will be composite of CVD risk factor; specifically, the proportion of patients with HbA1c < 7%, LDL cholesterol < 100 mg/dl and systolic blood pressure < 140 mmHg.

Official Title
-----------------
Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Observation of natural course of Diabetes Mellitus Type 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months BMI over 25 age between 20 and 67 Exclusion Criteria: Diagnosed with cancer within past five years HIV positive Active TB patients CV events in past six months serum cretinine over 2.0 mg/dl C-peptide bellow 1.0 ng/ml in past three months Diabetic retinopathy; vision bellow 0.1 Cushing's syndrome History of organ transplant History of bariatric surgery History of alcohol or drug dependency in past five years Psychological problems likely to interfere with adherence to protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 67 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 |
| --- | --- |
| Obese diabetic patients<br>Diabetic patients with BMI over 25 Age 20 to 67 Diabetes medically controlled at our center for at least six months | Other: Observation of natural course of Diabetes Mellitus Type 2<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the natural course of the diabetes of obese patients over a period of 10 years |  | ten years |
Ultrasound-guided Erector Spinae Plane Blocks

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the Emergency Department (ED) and Intensive Care Unit (ICU).

Official Title
-----------------
Erector Spinae Plane Block for Rib Fractures: A Pilot Study

Conditions
-----------------
Rib Fractures

Intervention / Treatment
-----------------
* Procedure: EPSB for rib fractures
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old or older. Patients with one or more acute traumatic rib fractures. Exclusion Criteria: Inability to position appropriately. Unconscious or heavily sedated. Patients who are critically ill such that care should not be delayed for regional anesthesia. Patients under the age of 18 years old. Vulnerable populations including prison inmates and pregnant patients. Overlying skin infection, wound, or dressing/equipment (i.e., Chest tube). Inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully. Known or documented allergy to ropivacaine or other amide local anesthetic.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EPSB for rib fractures<br>EPSB for rib fractures | Procedure: EPSB for rib fractures<br>* EPSB for rib fractures<br>Drug: Ropivacaine<br>* Standard of care weight-based optimal Ropivacaine dosing for ESPB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate | Measuring the Number of successful ESPB procedures performed in the ED and ICU | 12 months |
Study of Patient Outcomes 5 Years After Partial Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The study seeks to evaluate the condition of patients 5 years after having undergone partial knee replacement for localized osteoarthritis of the knee. Participating patients will voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after surgery. The aims of the study are to describe the survivorship of the prostheses and the clinical results of patients, and to elucidate and describe the natural history disease of the untreated knee joint compartments after a partial replacement. Patients who were operated by the principal investigator 5 years previously will be invited to participate. The study is observational in nature; there is no element of experimentation or test of an intervention.

Official Title
-----------------
Outcomes of Patients With Unicompartmental Arthritis of the Knee Five Years After Treatment With Partial Knee Replacement

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals who have undergone unicondylar knee replacement of a single tibio-femoral compartment using iBalance prosthesis (Arthrex, Inc, Lakeland Florida) under the care of the principal investigator between December, 2006 and December, 2008 will be invited to participate in the study. Exclusion Criteria: There are no restrictions to inclusion in the study based on surgical or medical criteria; however, individuals who are pregnant, incarcerated, less than 18 years of age, or unable to give valid informed consent on their own behalf will be excluded from the study.

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 |
| --- | --- |
| Unicondylar knee replacement<br>This is a non-intervational, retrospective, observational study of a case series cohort of patients who received a particular surgical operation during a specified time period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to revision of the partial total knee prosthesis | Eligible participants are invited to enroll into this observational study after the 5-year anniversary of the index primary knee replacement procedure. The participant will be evaluated once to determine whether the original implant is in situ, or has been revised. Method of determination will include self-report of the participant, medical records review/verification, and radiographic examination of the prosthesis. | 5 to 7 years after original implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unicondylar knee arthroplasty, partial knee replacement