linjc16/ctgov huggingface dataset:
CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.

Detailed Description
-----------------
At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.

Official Title
-----------------
CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation

Conditions
-----------------
Lung Transplant Failure and Rejection, Primary Graft Dysfunction

Intervention / Treatment
-----------------
* Other: blood and exhaled breath specimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all lung transplant recipients > 18 years signed ICF (informed consent form) Exclusion Criteria: none

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 |
| --- | --- |
| LTx (lung transplant) patients<br>identification of possible biomarkers | Other: blood and exhaled breath specimens<br>* identification of possible biomarkers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation. | death | up to 520 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation. | PGD | from transplantation till 72 hours after surgery |
Frequencies of Histo-pathological Findings in Patients With Paraquat Toxicity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine frequencies of histo-pathological findings in dead poisoned patients and evaluate their relationships with age, gender, dosage of poisoning, time of admission and time of death.

Detailed Description
-----------------
Acute poisoning of paraquat which is taken either to commit suicide or by mistake has become a social problem in world. The present study was conducted to determine frequencies of histo-pathological findings in dead poisoned patients and evaluate their relationships with age, gender, dosage of poisoning, time of admission and time of death.

Official Title
-----------------
Study of Frequencies of Histo-pathological Findings in Paraquat Poisoned Patients

Conditions
-----------------
Paraquat Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: every patients who dithionate test were positive Exclusion Criteria: nothing
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 |
| --- | --- |
| poisoned patient<br>after patients died the pathological findings evaluated with autopsy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histo-pathological findings | for evaluate of this outcome we gather autopsy data | 1 day after patient died | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age | we gathered demogeraphic data such as age | 5 min after admission time | 
| gender | we gathered demographic data such as gender | 5 min after admission time | 
| dosage of poisoning | we gathered historical data then estimated dosage of paraquat ingestion | 5 min after admission time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PQ
Smoking: Cytokines in Vitreous and Aqueous Humor

Study Overview
=================
Brief Summary
-----------------
Smoking is a risk factor for ophthalmologic diseases. Inflammation might play a role in their pathogenesis. This study elucidates intraocular cytokine profiles in smokers and non smokers.

Official Title
-----------------
Smoking: Cytokines in Vitreous and Aqueous Humor

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

Intervention / Treatment
-----------------
* Diagnostic Test: cytokine analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled vitrectomy and/or cataract surgery signed informed consent Exclusion Criteria: diabetes uveitis rheumatologic disease anti-inflammatory/immunomodulatory medications st.p. intravitreal injections st.p. glaucoma surgery cataract surgery on the eye to be examined within the past 6 months

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 |
| --- | --- |
| smokers<br>active smokers | Diagnostic Test: cytokine analysis<br>* analysis of intraocular cytokines<br>|
| non-smokers<br>never smokers | Diagnostic Test: cytokine analysis<br>* analysis of intraocular cytokines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cotinine | Concentration of intraocular cotinine | At the time of vitrectomy procedure |
Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

Study Overview
=================
Brief Summary
-----------------
This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.

Official Title
-----------------
Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

Conditions
-----------------
Obesity, Binge Eating

Intervention / Treatment
-----------------
* Drug: Xenical + behavioral intervention
* Behavioral: Behavioral intervention + placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Monolingual Spanish Speaking Obese (BMI >= 30) Exclusion Criteria: Pregnancy Current cardiac disease Serious neurologic illnesses

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Xenical + behavioral intervention | Drug: Xenical + behavioral intervention<br>* 120 mg TID; Behavioral weight loss in Spanish<br>* Other names: Xenical;|
| Active Comparator: 2<br>Placebo + behavioral intervention | Behavioral: Behavioral intervention + placebo<br>* Behavioral weight loss treatment in Spanish Placebo TID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant BMI | Body Mass Index (BMI) | 4 months and 6 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orlistat, Obesity, Binge Eating, Monolingual Hispanic Persons, Behavioral Weight Loss Treatment
Safety and Pharmacokinetics of Probucol and Cilostazol

Study Overview
=================
Brief Summary
-----------------
to investigate the safety and pharmacokinetics, in healthy adult male subjects

Detailed Description
-----------------
Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health Subjects

Official Title
-----------------
Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Cilostazol
* Drug: Probucol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean Gender: Male Age: Over 20 and Under 40years, at time of informed consent body weight: BMI over 19.0 and Under 25.0 Subjects who meet the following criteria at the time of the screening examination Subjects who have given their written informed consent prior to participation in the study Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol Exclusion Criteria: History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse Present or previous significant drug allergy to any prescription or over the counter medication Blood collection exceeding 200ml within 4 weeks, 400ml within 12 weeks, or 1200ml within one year prior to scheduled study drug administration Body weight: under 50Kg

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Other: 1<br>Two compartments with cross-over and parallel | Drug: Cilostazol<br>* cilostazol, then cilostazol/probucol<br>|
| Other: 2<br>Two compartments with cross-over and parallel | Drug: Probucol<br>* Probucol probucol/ cilostazol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters, Number of adverse events |  | during study follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters |  | During study follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety and Pharmacokinetics in healthy subjects
Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)

Study Overview
=================
Brief Summary
-----------------
This study is intended to calculate the core body temperature in patients who are having a Cesarean Section (C/S) and are kept warm with an Upper Body Forced Air Warming device (Bair Hugger) or underbody forced air warmer. These warming devices are approved and are a required item in many if not all surgical procedures. They are used daily throughout the hospital. The research question is: Where is the best place to position the warming blanket in pregnant mothers undergoing Cesarean section delivery. The researchers hope to compare post - operative core body temperatures in patients getting an Upper Body forced air device versus those getting an Underbody Body forced air warming device.

Official Title
-----------------
Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Upper Body Forced Air Warming device
* Procedure: Under Body Forced Air Warming device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age =/> 18 years Elective non-emergent C-section Exclusion Criteria: BMI<18/>40 Bleeding Disorders e.g. hemophilia, coagulation abnormality, clotting disorders, bleeding diathesis Perioperative hemorrhage >1500ml Non-Singleton Pregnancies Complicated Pregnancy (e.g. Eclampsia, Pre-eclampsia) Conversion to Emergency C-section Endocrine Pathology- e.g. Thyroid Disease, Insulin Dependent Diabetes Inmates

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Upper Body<br> | Procedure: Upper Body Forced Air Warming device<br>* Patients will have the Bair Hugger placed over the body<br>* Other names: Bair Hugger;|
| Active Comparator: Under body<br> | Procedure: Under Body Forced Air Warming device<br>* Patients will have the Bair Hugger placed under the body<br>* Other names: Bair Hugger;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core body temperature | Maternal core temperatures will be measured using a temperature sensing Foley catheter | 1 hour post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thermoregulation, Forced air warming, upper or lower body forced air cover, core body temperature
Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder and which of these bothersome symptoms are improved with treatment.

Official Title
-----------------
A Global Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial To Evaluate The Effectiveness Of Detrusitol Sr 4mg On Patient's Perception Of Bladder Condition (PPBC).

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: tolterodine SR, overactive bladder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older patients suffering from OAB symptoms (urinary frequency of at least 8 micturitions per 24h, urinary urgency and at least 3 urge urinary incontinence episodes within 3 days), confirmed by a micturition bladder diary. Exclusion Criteria: Other than urge incontinence History of prostate/uterine or other female organ cancer

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: tolterodine SR, overactive bladder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other safety and efficacy measures at 12 weeks of treatment. |  |  |
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population

Study Overview
=================
Brief Summary
-----------------
One of the first causes of irreversible blindness in mexican population is diabetic retinopathy which is clearly diferent between patients the time of evolution and development of retinopathy and complications. The aim of this study is to explore the inmunogenetic profile and the influence of HLA in this variations of the sickness to predict the severity of diabetic complications.

Official Title
-----------------
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population

Conditions
-----------------
Diabetes Mellitus Type 2, Proliferative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy Diabetes mellitus type 2 with 10 years of diagnosis and proliferative retinopathy Exclusion Criteria: Systemic hipertension Cardic disease Lupus Any kind of artritis Allergies Optic Neuritis VKH Cancer Inmunological diseases

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood sample|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
-----------------
Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy, Diabetes mellitus type 2 with 10 years of diagnosis and proliferative diabetic retinopathy
Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.

Official Title
-----------------
Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Device: Eye-tracking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corrected visual acuity >1/10 Aged over 18 years Patient with the mutation that is to say the presence of an abnormal number of trinuclide: CAG> 38 in the first exon of the huntingtin gene. Total Functional Capacity Scale (CFT) ≥ 3 Exclusion Criteria: Patients or trustworthy person who have not given their written consent, informed and signed. Patients are not affiliated or who are not entitled to Social Security Private patients of liberty by administrative or judicial decision, or patients supervision Associated disease with neurological repercussions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with Huntington's disease<br> | Device: Eye-tracking<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| saccadic measures with the eye tracker | one measure in the evening and one in the afternoon | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
video oculography
Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients

Study Overview
=================
Brief Summary
-----------------
This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.

Detailed Description
-----------------
This prospective, open label, multi-center study evaluates the use of 7.5% icodextrin used in the long-dwell exchange in peritoneal dialysis patients with elevated triglyceride levels. Fasting triglyceride levels will be measured during the study.

Official Title
-----------------
Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients

Conditions
-----------------
Peritoneal Dialysis, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent CAPD/APD on dialysis for at least 3 months Elevated fasting triglyceride levels Exclusion Criteria: enrolled in another study requiring IRB approval allergy to starch-based polymers glycogen storage disease maltose or isomaltose intolerance active alcohol/substance abuse Pregnant or nursing received an investigational drug within 30 days of screening

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting triglyceride levels. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal Dialysis, Hypertriglyceridemia, Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution