linjc16/ctgov huggingface dataset:
Disease Modifying Genes in Severe Asthma

Study Overview
=================
Brief Summary
-----------------
Gene and protein bank to study disease modifying and susceptibility genes and proteins in urban patients with asthma.

Official Title
-----------------
Disease Modifying Genes in Severe Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 and above Exclusion Criteria: Greater than 10 pack year tobacco history Lung diseases other than asthma

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To recruit and characterize a cohort of subjects with asthma who reside in a high pollution, high asthma risk neighborhood |  | five yeARS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma and normal
A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.

Official Title
-----------------
Health-Related Quality of Life in Patients Undergoing Percutaneous Biliary Drainage For Malignant Biliary Obstruction

Conditions
-----------------
Malignant Biliary Obstruction

Intervention / Treatment
-----------------
* Behavioral: FACT-Hep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known malignancy presenting for treatment of biliary obstruction Undergoing initial Interventional Radiology PBD procedure Fluent in English to enable instrument completion At least18 years of age Must be physically and mentally capable of completing instruments Must be able to comprehend and execute informed consent Exclusion Criteria: Patients will be excluded if: Indication for drainage is acute, symptomatic cholangitis requiring an emergent procedure Previous PBD procedure Presence of an indwelling biliary stent Medical or psychiatric condition that, in the judgment of the consenting professional, prevents appropriate comprehension and execution of either the informed consent or the study instruments

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 |
| --- | --- |
| Patients Undergoing Percutaneous Biliary Drainage<br>Following Percutaneous Biliary Drainage (PBD), participants will complete Patient Reported Outcomes (PRO) assessments at baseline and at three time points post-procedure: 4 weeks (+/- 1 weeks), 12 weeks (+/- 2 weeks), and 6 months (+/- 2 weeks). | Behavioral: FACT-Hep<br>* Patient Reported Outcomes (PRO) assessments at baseline and at three time points post-procedure: 4 weeks (+/- 1 weeks), 12 weeks (+/- 2 weeks), and 6 months (+/- 2 weeks).<br>* Other names: The Functional Assessment of Cancer Therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the FACT-Hep scores | The FACT-Hep minimum score is 0 and the maximum is 180. | baseline to week 4 post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous Biliary Drainage, Quality of life, 18-366
Blastocyst Culture in a Time-lapse Incubator

Study Overview
=================
Brief Summary
-----------------
Culture media used to support development of zygotes to the blastocyst stage is based on two basic philosophies: a single step medium let-the-embryo-choose or a sequential medium back-to-nature. For single step media, there are two types of protocol can be used for the culture of human preimplantation embryos: Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo culture Uninterrupted single embryo culture, in which the same single medium is used throughout the 5-6 days of culture with no replenishment or replacement on Day 3. Investigators aim to compare the blastocyst development and clinical outcome between the two types of protocols of a single medium (with or without renewal on Day 3)

Official Title
-----------------
The Blastocyst Development and Clinical Outcome in Single Step Medium With or Without Renewal on Day 3 in a Time-lapse Incubator

Conditions
-----------------
Sub-optimal Culture Conditions

Intervention / Treatment
-----------------
* Procedure: Culture media renwal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female partners were under the age of 39 years Intracytoplasmic sperm injection (ICSI) was performed using fresh ejaculates Exclusion Criteria: Day 3 embryo transfer cycles

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 39 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Uninterrupted single embryo culture<br>The same single medium is used throughout the 5-6 days of culture with no replenishment on day 3. | |
| Experimental: Interrupted single medium culture<br>The single step medium is renewed on Day 3 of embryo culture. | Procedure: Culture media renwal<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | diagnosed by the presence of a heartbeat in the gestational sac visualized by ultrasound | 4 weeks post embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | the number of intrauterine gestational sacs over the total number of embryos transferred | 4-6 weeks post embryo transfer | 
| Blastocyst formation rate |  | 5-6 days post intracytoplasmic sperm injection |
Bioequivalency Study of Meloxicam Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fed Conditions

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Meloxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Meloxicam or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Meloxicam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Fourteen day washout | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-inflammatory
Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the response in plasma norepinephrine concentration and plasma glycerol to the agonist (clonidine) and the antagonist (yohimbine) of the alpha-2 adrenergic receptor in 6 patients with regional lipoatrophy and in 6 controls. II. Determine the full sequence of the alpha-2 adrenergic receptor structural gene in genomic DNA from peripheral blood leukocytes.

Detailed Description
-----------------
PROTOCOL OUTLINE: Antihypertensives are held, beginning 3 days before the first study day. An oral challenge is administered as follows: clonidine on day 1, yohimbine on day 2. The order of administration is reversed in alternate subjects. Timed measurements of norepinephrine, glycerol, and free fatty acids follow each challenge. Structural gene sequencing is evaluated for each participant.

Conditions
-----------------
Lipodystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical diagnosis of regional lipoatrophy Control subjects: Women aged 18 to 65 Weight 90% to 150% of ideal No significant acute or chronic illness --Patient Characteristics-- Negative pregnancy test required of fertile women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endocrine disorders, rare disease
Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Official Title
-----------------
A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck

Conditions
-----------------
Head and Neck Cancer, Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Drug: Iressa (Gefitinib)
* Procedure: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck At least one measurable tumour lesion Exclusion Criteria: No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

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: Iressa (Gefitinib)|nan|
|Procedure: Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression, Overall survival, Duration of response. Six months after Last Patient In. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous Cell Carcinoma of Head and Neck, Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
China Kidney Patient Trials Network

Study Overview
=================
Brief Summary
-----------------
This is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in China.

Official Title
-----------------
China Kidney Patient Trials Network

Conditions
-----------------
Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of primary kidney disease Regular visits (at least 6 monthly) with a physician at a participating site eGFR > 15 ml/min/1.73 m2 ≥ 2 years of age Willing and able to sign informed consent Willing to be approached about participation in interventional research studies Exclusion Criteria: 1. Life-expectancy of less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Incident and Prevalent Patients<br>Incident and prevalent patients diagnosed with a kidney disease at participating centres | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR (estimated Glomerular Filtration Rate) | Routine results | Collected six monthly, up to 5 years | 
| Albuminuria | Routine results | Collected six monthly, up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Diabetic Nephropathy, Hypertensive Kidney Disease, Glomerulonephritis, GN, Focal Segmental Glomerulosclerosis, FSGS, Membranous Nephropathy, Minimal Change Disease, IgA Nephropathy, Glomerulonephritis not otherwise specified
Antiplatelet Drug Resistances and Ischemic Events

Study Overview
=================
Brief Summary
-----------------
The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

Detailed Description
-----------------
The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients. Main objective: to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of ischemic events during the 3-year follow-up. Secondary objectives: primary outcome in each pre-specified sub-group : patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry, to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of bleeding events during the 3-year follow-up, to investigate potential determinants of platelet reactivity at entry in the study

Official Title
-----------------
Antiplatelet Drug Resistances and Ischemic Events

Conditions
-----------------
Symptomatic Atherothrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented symptomatic ischemic atherothrombotic disease treated by aspirin, clopidogrel or both. Exclusion Criteria: Known platelet disorder Chronic treatment by antiplatelet drugs other than aspirin or clopidogrel. Chronic anticoagulant treatment Chronic non steroid anti inflammatory drug treatment Active cancer Ongoing aspirin or clopidogrel treatment taken for more than 5 years prior to inclusion

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 |
| --- | --- | --- |
| MACE | adjudicating committee | prospective follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE in pre-specified sub-groups | patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry | prospective follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antiplatelet drug, resistance, atherothrombosis
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia

Detailed Description
-----------------
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with benign prostatic hyperplasia

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With Benign Prostatic Hyperplasia

Conditions
-----------------
Benign Prostate Hyperplasia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: HGP0412 capsule
* Drug: HIP1402 capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>=45, male, diagnosed on BPH, Total IPSS>=13 Exclusion Criteria: Hypersensitivity to investigational products or components PSA>=4ng/ml

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Tamsulosin placebo (12 weeks) | Drug: Placebo<br>* Placebo<br>* Other names: Tamsulosin Placebo;|
| Experimental: Treatment 1<br>HGP0412 capsule (12 weeks) | Drug: HGP0412 capsule<br>* Tamsulon high dose<br>* Other names: Tamsulosin HCl 0.2mg;|
| Experimental: Treatment2<br>HIP1402 capsule (12 weeks) | Drug: HIP1402 capsule<br>* Tamsulon high dose<br>* Other names: Tamsulosin HCl 0.4mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total International Prostate Symptom Score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total International Prostate Symptom Score |  | 4, 8 weeks |
The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients

Study Overview
=================
Brief Summary
-----------------
Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more difficult and raise complication rate. Using anterior corneal incisions was reported briefly in literature as a prophylactic means but was not studied prospectively. we believe (according to our clinical experience) that these anterior incisions do help to reduce the incidence and severity of IFIS signs and complications rate during surgeries.

Conditions
-----------------
Intraoperative Floppy Iris Syndrome

Intervention / Treatment
-----------------
* Procedure: anterior (more central) corneal paracentesis incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cataract candidates treated (in the present or in the past) with tamsulosin aged 55 or more candidates for topical anesthesia no allergy to anticholinergic or adrenergic drugs able to understand and sign an informed consent Exclusion Criteria: history of uveitis iris neovascularization s/p iris surgery traumatic/uveitis induced cataract dialysis / abscence of zonules

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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: anterior corneal incision<br> | Procedure: anterior (more central) corneal paracentesis incision<br>* 3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of IFIS cases observed during operation. |  | during the operations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing the clinical grade of observed IFIS cases |  | during the operations | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IFIS