linjc16/ctgov huggingface dataset:
Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.

Detailed Description
-----------------
PROTOCOL OUTLINE: Sodium and potassium intake resulting in normalization of serum electrolytes and markers of extracellular volume are determined at baseline. A trial diet is then prescribed, with adjustments made to achieve a steady state with normal serum electrolytes. Exercise tolerance and muscle function are evaluated at steady state. Sodium and potassium are sequentially manipulated with diet, enalapril, and polystyrene sulfonate. Exercise tolerance is evaluated during each diet period. A treatment plan to maintain electrolyte balance is developed. The patient is followed monthly for 3 to 6 months, then every 3 months for up to 3 years.

Conditions
-----------------
Pseudohypoaldosteronism

Intervention / Treatment
-----------------
* Drug: enalapril
* Drug: polystyrene sulfonate


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Pseudohypoaldosteronism

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: enalapril|nan|
|Drug: polystyrene sulfonate|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
-----------------
endocrine disorders, pseudohypoaldosteronism, rare disease
Preemptive Analgesia in Cruciate Reconstruction

Study Overview
=================
Brief Summary
-----------------
The aims of this study was to compare analgesic efficacy of preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate ligament injury will randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients will be operated by one orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for rescue pain control and adverse events will be recorded periodically to 48 hours after surgery.

Official Title
-----------------
Comparing Etoricoxib and Celecoxib for Preemptive Analgesia for Acute Postoperative Pain in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Conditions
-----------------
Anterior Cruciate Ligament Injury

Intervention / Treatment
-----------------
* Drug: Celecoxib
* Drug: etoricoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with anterior cruciate ligament injury age 15-50 yr Exclusion Criteria: previous knee surgery

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: placebo<br>identical placebo | Drug: Celecoxib<br>* celecoxib 400 mg 1 cap before surgery<br>Drug: etoricoxib<br>* 120 mg 1 tab before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score |  | 6,12,24,48 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of analgesic used |  | 48 hour postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preemptive analgesia, cruciate ligament
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)

Official Title
-----------------
A 12-month Study to Investigate the Correlations Between Cyclosporine Microemulsion C2 Levels (High, Medium and Low) and AUC0-4 With Regard to Outcome in de Novo Heart and Lung Transplantation - Identification of Target Cyclosporine Microemulsion C2 Levels.

Conditions
-----------------
Heart and Lung Transplant

Intervention / Treatment
-----------------
* Drug: cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving a first heart or bilateral or single lung transplant Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated. Exclusion Criteria: Multi-organ transplants or previously transplanted organs Patients with the need of more than two cyclosporine microemulsion dosages per day Other protocol-defined inclusion/exclusion criteria may applied

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclosporine<br> | Drug: cyclosporine<br>* patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant |  |  | 
| The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treated acute rejections |  |  | 
| Incidence of biopsy-proven acute cellular rejections |  |  | 
| Patient and Graft survival rates |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart transplant, lung transplant, renal function, cyclosporine C2 Levels
Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone

Study Overview
=================
Brief Summary
-----------------
Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT scans of the whole body are performed at baseline, three months later, and six months after that for a total of three combined scans in the first year. Subsequently, these combined scans will be performed at 6-monthly intervals for a total of two combined scans per year.

Conditions
-----------------
Ocular Melanoma, Choroidal Melanoma, Uveal Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of ocular melanoma (a pigmented malignant tumor) involving the choroid and/or ciliary body (the blood vessel layer in the back of the eye and/or the part of the eye behind the iris). Patients 18 years of age or older. Patients able to give informed consent. Exclusion Criteria: Patients who refuse to participate in the study. Patients who are unable to cooperate with or cannot undergo PET/CT scanning. Patients who will be moving out of the area of UCLA during the ten years of this 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Exploratory Study of Volatile Organic Compounds in Alveolar Breath

Study Overview
=================
Brief Summary
-----------------
The purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions.

Detailed Description
-----------------
Individuals with metabolic disorders may sporadically produce malodors despite good hygiene. Analysis of volatile organic compounds (VOCs) helps to gain insights into medical conditions arising due to metabolic dysfunction as different metabolic pathways emit and or consume various VOCs. These VOCs can be detected via the exhaled breath collected and analyzed with a portable breath collection apparatus. VOC profiles will be compared with self-reported symptoms and other observations of participating subjects.

Official Title
-----------------
Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor

Conditions
-----------------
Nutritional and Metabolic Diseases

Intervention / Treatment
-----------------
* Other: Breath test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good general health willing and able to travel to one of the participating sites Exclusion Criteria: medical conditions that, in the opinion of the investigator, would prevent participation elect not to participate in 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 |
| --- | --- |
| Body odor<br>individuals self-reporting idiopathic body odor with or without bad breath | Other: Breath test<br>* Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.<br>* Other names: Exhaled breath metabolomics;|
| Breath odor<br>individuals self-reporting idiopathic bad breath but no body odor | Other: Breath test<br>* Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.<br>* Other names: Exhaled breath metabolomics;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VOCs detected | Expired air sample drawn principally from alveolar breath is analyzed by gas chromatography-mass spectrometry. Chromatograms are searched against the NIST library. The response for each analyte is normalized by using internal standards containing 1-bromo-4-fluoro-benzene. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between breath biomarkers and self-reported observations (questionnaires) | VOC profiles will be compared with self-reported symptoms, observed exposures and other observations of participating subjects. Volatile organic compounds differentiating the disease activity will be identified. | 1 year |
Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images

Study Overview
=================
Brief Summary
-----------------
cHS is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain CT images, and clinical decision support system for diagnosing intracranial haemorrhage by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cHS for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.

Official Title
-----------------
An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images

Conditions
-----------------
Intracranial Hemorrhages

Intervention / Treatment
-----------------
* Device: cHS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 19 years old Brain CT acquired Abnormal cohort: A patient diagnosed with intracranial haemorrhage after a brain CT scan Normal cohort: A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan Exclusion Criteria: Patients with brain tumor or cerebral toxoplasmosis Patients with brain abscess or brain calcification Poor or incomplete brain CT image quality

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Abnormal<br>A patient diagnosed with intracranial haemorrhage after a brain CT scan | Device: cHS<br>* Clinical decision support system for diagnosing intracranial haemorrhage<br>|
| Normal<br>A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan | Device: cHS<br>* Clinical decision support system for diagnosing intracranial haemorrhage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of cHS | Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards | Within 4 weeks after collecting data |
Prognostic Study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease Based on Metabolomics, and Lipidomics

Study Overview
=================
Brief Summary
-----------------
To investigate whether there were differences in metabolomics and lipidomics in patients with coronary artery disease who had major adverse cardiovascular events during follow-up compared with those who did not.

Official Title
-----------------
Prognostic Study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease Based on Metabolomics, and Lipidomics

Conditions
-----------------
Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with the diagnosis of any type of coronary artery disease; Age ≥18 years of age; Patient or guardian provided informed written consent. Exclusion Criteria: Prior surgery, trauma or clinically evident coagulopathic bleeding within the previous 2 weeks; Bipass population with missing follow-up records in Qilu Hospital emergency follow-up cohort.

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 86 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 |
| --- | --- | --- |
| major adverse cardiovascular events | cardiac death, myocardial infarction, heart failure, stroke | 20191101-20220701 |
Expanded Access to Upadacitinib

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Upadacitinib

Conditions
-----------------
Atopic Dermatitis (AD)

Intervention / Treatment
-----------------
* Drug: Upadacitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant must not be eligible for upadacitinib clinical trial.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Upadacitinib|Upadacitinib will be administered as oral tablet.|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo

Study Overview
=================
Brief Summary
-----------------
The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.

Official Title
-----------------
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo and Healthy Control; Comparative Study

Conditions
-----------------
Autophagy

Intervention / Treatment
-----------------
* Other: skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients with non-segmental vitiligo whether active or stable. Age above 12 years. Both sexes. Exclusion Criteria: • Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study. Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease. Pregnancy or breast feeding for female patients.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitiligo patients<br> | Other: skin biopsy<br>* Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.<br>|
| Experimental: healthy controls<br> | Other: skin biopsy<br>* Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients |  | 1 year |
Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction. Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.

Official Title
-----------------
Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Conditions
-----------------
Fentanyl-induced Cough

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective surgeries under general anesthesia. Exclusion Criteria: Patients with contraindications of dexmedetomidine. Patients younger than 18 years old and older than 65 years old.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine 0 μg/kg/min<br> | Drug: Dexmedetomidine<br>* Pretreatment of different doses of dexmedetomidine<br>|
| Experimental: Dexmedetomidine 0.03 μg/kg/min<br> | Drug: Dexmedetomidine<br>* Pretreatment of different doses of dexmedetomidine<br>|
| Experimental: Dexmedetomidine 0.06 μg/kg/min<br> | Drug: Dexmedetomidine<br>* Pretreatment of different doses of dexmedetomidine<br>|
| Experimental: Dexmedetomidine 0.09 μg/kg/min<br> | Drug: Dexmedetomidine<br>* Pretreatment of different doses of dexmedetomidine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of cough | Yes or No | After the infusion of dexmedetomidine up to 10 minutes | 
| The time of cough | After the infusion of dexmedetomidine up to 10 minutes | After the infusion of dexmedetomidine up to 10 minutes | 
| The severity of cough | minor, moderate, severe | After the infusion of dexmedetomidine up to 10 minutes | 
| The occurence of adverse effects of dexmedetomidine | bradycardia, hypotension, hypertension | After the infusion of dexmedetomidine up to 10 minutes |