linjc16/ctgov huggingface dataset:
A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria

Study Overview
=================
Brief Summary
-----------------
To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal oxalate excretion (but who have had kidney stones), and in subjects who have primary hyperoxaluria.

Official Title
-----------------
Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Drug: Pyridoxamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults > 18 years History of stone formation Good Renal function Normal urinary excretion of stone-promoting chemicals(Ca, uric acid, oxalate, citrate), except for subjects with hyperoxaluria for Study Exclusion Criteria: Pregnancy Hyperparathyroidism Enteric hyperoxaluria. Obstructive uropathy Infection (struvite) stones Severe dietary Ca++ restriction or deficiency Recent significant cardio-vascular events

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pyridoxamine<br>* Two 250 mg capsules, or placebo, given twice a day for four, 4 week periods. Subjects with primary hyperoxaluria will aslo receive escalated doses up to 3500 mg/day for up to 6 1/2 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Excretion of Oxalate at Highest Dose |  | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urinary Supersaturation |  | 4 Weeks |
Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe, Asia and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).

Detailed Description
-----------------
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Official Title
-----------------
Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: inhaled human insulin
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Obstructive Pulmonary Disease Type 1 or type 2 diabetes HbA1c lower or equal to 11.0 % Body Mass Index (BMI) lower or equal to 40.0 kg/m2 Exclusion Criteria: Recurrent severe hypoglycaemia Current smoking or smoking within the last 6 months Other pulmonary disease including asthma Proliferative retinopathy or maculopathy requiring acute treatment

Ages Eligible for Study
-----------------
Minimum Age: 30 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, pre-prandial, inhalation.<br>|
| Active Comparator: B<br> | Drug: insulin aspart<br>* Treat-to-target dose titration scheme, pre-prandial, injection s.c.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections |  | After one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes |  | After one year | 
| Diabetes control measured by change in HbA1c from baseline |  | After one year | 
| Preprandial Insulin Doses |  | After one year |
Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients

Study Overview
=================
Brief Summary
-----------------
Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a cardiac patient, will be found suffering from sleep breathing disorders. The medical literature also shows that there is an advantage of treating the sleep breathing disorders in addition to treating the cardiac disease or evaluating the heart failure condition to provide better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac related breathing disordered.

Official Title
-----------------
Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is hospitalized in the cardiology department or in the sleep lab. Patients who is willing and able to tolerate a full night Polysomnography Patient is not receiving oxygen treatment Patients is 18 years of age or above Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form. Exclusion Criteria: Patients can not tolerate a full night Polysomnography. Patient is receiving oxygen. Participation in a clinical trial within the last 60 days and during the study. Life expectancy < 1 month.

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 |
| --- | --- | --- |
| Detection of Cheyne Stokes respiration |  | over night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep and sleep apnea parameters |  | over night | 
| AH>=15 |  | over night | 
| plethysmography derived respiration signal |  | over night | 
| Total duration of Cheyne Stokes |  | over night |
Cognitive Correlates of Antidepressant Treatment Response in Elders

Study Overview
=================
Brief Summary
-----------------
Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called antidepressants. Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called executive impairment (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.

Official Title
-----------------
Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Zoloft (antidepressant)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above the age of 65, speak English fluently, experience depression, AND not yet on active treatment. Exclusion Criteria: active delirium, substance abuse, mental illness other than major depression, active CNS disease, unstable systematic medical disease, OR current of past psychotic disorder.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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 |
| --- | --- |
| Other: zoloft<br>Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups. | Drug: Zoloft (antidepressant)<br>* Zoloft 50-200 mg po od x 12 weeks<br>* Other names: Sertraline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression |  | June 1, 2007 - June 1, 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antidepressants, depression, zoloft, psychiatry, psychology
Invitro Maturation of Oocytes for Patients With Polycystic Ovaries

Study Overview
=================
Brief Summary
-----------------
In vitro maturation of oocytes after minimal gonadotropin stimulation in patients with polycystic ovaries, to prevent cases of ovarian hyperstimulation.

Official Title
-----------------
In Vitro Maturation of Oocytes for Patients With Polycystic Ovaries

Conditions
-----------------
Infertility, Polycystic Ovaries

Intervention / Treatment
-----------------
* Procedure: in vitro matuartion of oocytes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polycystic ovaries Needing IVF for fertility treatment Exclusion Criteria: Age above 39

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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: Group I<br>patients with PCO undergoing in vitro maturation and subsequently IVF and embryo transfer | Procedure: in vitro matuartion of oocytes<br>* in vitro maturation of (immature) oocytes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maturation rate, |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate, pregnancy rate |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in vitro maturation oocytes
Prediction of Extubation Success by the Patient

Study Overview
=================
Brief Summary
-----------------
The evidence-based approach to wean and consecutively extubate patients is based solely on objective criteria/tests. The introduction of subjective criteria could further improve the actual method.

Conditions
-----------------
Mechanical Ventilation, Respiratory Failure, Extubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all intubated patients ready for a spontaneous breathing trial Exclusion Criteria: not awake not collaborative

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extubation, prediction
Repository Study of Autosomal Dominant Polycystic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The design and establishment of the Polycystic Kidney Disease (PKD) Data Repository does not require, and may be constrained by, a narrowly conceived hypothesis. However, the PKD Repository has been designed to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of the disorder and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including renal failure, cardiovascular disease, and stroke.

Detailed Description
-----------------
The goal of this project is to collect data from a large population of patients with PKD. Based upon the estimated prevalence of PKD (1:500 and 1:1000 live births), it is estimated that there may be 10,000 PKD patients in the New York City area. This sample size far exceeds any database established thus far. As many as 40% of affected PKD patients are reportedly unaware of a family history of this disease, in part because many patients may go undiagnosed until they present with a medical complication (e.g., hypertension, kidney failure). Furthermore, this initiative will provide an opportunity to compare data from racially diverse populations.

Official Title
-----------------
Repository Study of Autosomal Dominant Polycystic Kidney Disease

Conditions
-----------------
Autosomal Dominant Polycystic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Age 18 years and older Previously diagnosed with ADPKD Exclusion Criteria: Inability to provide 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of Autosomal Dominant Polycystic Kidney Disease (ADPKD) progression | The primary interest of this protocol is to characterize the renal and extrarenal manifestations of ADPKD, evaluate the natural history of the disease progression, and explore potential associations between PKD gene variants and ADPKD phenotype. | Up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease, Disease Progression
Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic

Study Overview
=================
Brief Summary
-----------------
Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee arthroplasty in 16 patients undergoing bilateral knee arthroplasty.

Official Title
-----------------
Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic.

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: ropivacaine 0.2%, 50 mL
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: total bilateral knee arthroplasty Exclusion Criteria: immunological diseases treatment with opioids or steroids allergy to any drugs administered

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active<br>subcutaneous wound infiltration with 50 mL ropivacaine 0.2% | Drug: ropivacaine 0.2%, 50 mL<br> <br> |
| Placebo Comparator: placebo<br>subcutaneous wound infiltration with 50 mL saline | Drug: normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  | 1-6 hours postoperative |
DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).

Official Title
-----------------
A Multicenter, Phase IV Study to Evaluate the Ability of Definity® Enhanced Versus Unenhanced Echocardiography to Improve the Accuracy and Reproducibility of Left Ventricular Ejection Fraction When Compared to Cardiac Magnetic Resonance Imaging

Conditions
-----------------
Ventricular Ejection Fraction

Intervention / Treatment
-----------------
* Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects 18 years of age or older Have a documented EF value ranging from 25% to 40% Have been scheduled to undergo or have undergone a cardiac MRI study Exclusion Criteria: Severe valvular dysfunction Inability to remain supine for 30 minutes

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension|The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the ability of Definity® enhanced versus unenhanced echocardiography to improve the accuracy of left ventricular ejection fraction when compared to cardiac magnetic resonance imaging (MRI) in a blinded assessment |  | Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reduced Heart Function
Evaluation of Reliability and Validity of a Smart-phone Postural Control Assessment Application

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability.

Official Title
-----------------
Evaluation of Reliability and Validity of a Smart-phone Application Designed for Chronic Ankle Instability Subjects' Postural Control Assessment

Conditions
-----------------
Other Instability, Ankle and Foot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of ankle functional instability Exclusion Criteria: any other condition would affect postural control performance

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| healthy group<br>recruited for evaluation of system reliability | |
| Chronic Ankle Instability group<br>recruited for evaluation of system validity | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physiological parameter: acceleration data from built-in sensor with unit: m/s^2 | Using the built-in sensor to record the acceleration data during each seconds trial. Both x, y and z axialis will be recorded | 40 seconds | 
| physiological parameter: orientation data from built-in sensor with unit: degree | Using the built-in sensor to record the acceleration data during each seconds trials. Both x, y and z axialis will be recorded | 40 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smart-phone, assessment, chronic ankle instability
The Sun Protection Effect and Efficacy in Treatment of Sunburn Using Topical Corticosteroids.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the sun protection effect and efficacy in treatment of sunburn using topical corticosteroids in a randomised controlled and investigator blinded trial.

Conditions
-----------------
Sunburn

Intervention / Treatment
-----------------
* Drug: corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older, healthy, fair skinned (skin type I-III) Exclusion Criteria: Pregnant or lactating women.In treatment with corticosteroids.

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: corticosteroids|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
-----------------
sunburn, corticosteroids