linjc16/ctgov huggingface dataset:
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

Study Overview
=================
Brief Summary
-----------------
In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.

Official Title
-----------------
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

Conditions
-----------------
Alpha-1 Antitrypsin Deficiency

Intervention / Treatment
-----------------
* Other: collection of sputum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment. For patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes. . Exclusion Criteria: The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| usual COPD<br>Patients meeting the diagnostic criteria for COPD and without AATD | Other: collection of sputum<br> <br> |
| normal smokers<br>subjects with a history of smoking, without symptoms, without AATD and with normal lung function | Other: collection of sputum<br> <br> |
| normal non smokers<br>subjects without a history of smoking, without symptoms, without AATD and with normal lung function | Other: collection of sputum<br> <br> |
| AATD not treated<br>patients with COPD, with AATD and not on augmentation therapy for AATD | Other: collection of sputum<br> <br> |
| AATD treated<br>patients with COPD, with AATD on augmentation therapy for AATD | Other: collection of sputum<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composition of microbioma in sputa |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation with clinical and physiological parameters |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, alpha-1 antitrypsin deficiency, microbioma
Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study is a survey in Japan of Brigatinib tablets used to treat Japanese people with non-small cell lung cancer. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related to lung disease from Brigatinib. During the study, participants with non-small cell lung cancer will take Brigatinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Brigatinib for 1 year.

Official Title
-----------------
General Use-results Survey of Alunbrig Tablets Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
-----------------
* Drug: Brigatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer. Exclusion criteria Participants who has a history of hypersensitivity to any component of birigatinib.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brigatinib Tablets<br>Brigatinib 90 milligrams (mg), tablet, orally, once daily for up to 7 days, followed by 180 mg, tablets, once daily for 51 weeks. Participants received interventions as part of routine medical care. | Drug: Brigatinib<br>* Brigatinib Tablets<br>* Other names: Alunbrig Tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events Related to Interstitial Lung Disease | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 1 year |
Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

Study Overview
=================
Brief Summary
-----------------
The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.

Detailed Description
-----------------
To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo

Official Title
-----------------
Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Drug: 40 mg Triamcinolone acetate 1 cc
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed Exclusion Criteria: Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural steroid injection<br>40 mg triamcinolone acetate 1 cc | Drug: 40 mg Triamcinolone acetate 1 cc<br>* 40 mg Triamcinolone acetate 1 cc<br>|
| Placebo Comparator: placebo injection<br>no injection agent | Drug: Placebos<br>* no injected agent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative morphine consumption |  | Post operative 24 hour of morphine consumption in mg | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score (back and leg) 0-10 |  | 1 day, 2, 6 ,12, 24 weeks | 
| Oswestry disability index (ODI |  | 2, 6 ,12, 24 weeks | 
| MacNab scores |  | 2, 6 ,12, 24 weeks |
Repeating Patterns of Sleep Restriction and Recovery

Study Overview
=================
Brief Summary
-----------------
Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.

Official Title
-----------------
Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?

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

Intervention / Treatment
-----------------
* Behavioral: Repeated sleep restriction and recovery
* Behavioral: Control sleep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) between 18.5 and 30 kg/m2 For female participants: regular menstrual cycles Daily sleep duration in the normal range Blood chemistry in the normal range Exclusion Criteria: Active infection/disease History of psychiatric, neurological, pain-related, immune, or cardiovascular disease; significant allergy Pregnant/nursing Respiratory disturbance index of >5 events/hour on polysomnographic sleep study, leg movements with arousal >10/hour; sleep efficiency <80% Regular medication use other than oral contraceptives Donation of blood or platelets 3 month prior to or in-between study arms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: repeated sleep restriction and recovery<br> | Behavioral: Repeated sleep restriction and recovery<br>* Repeated cycles of sleep restriction and sleep recovery<br>|
| Experimental: control sleep<br> | Behavioral: Control sleep<br>* Regular amounts of sleep across study protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress-related markers | cortisol, ACTH, norepinephrine, IL-6, COX in blood/urine, among others | Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective stress-related markers | Computerized rating scales for the assessment of physical and emotional well-being | Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy individuals
Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Study Overview
=================
Brief Summary
-----------------
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)

Detailed Description
-----------------
This multi-center, retrospective study of cases of serious bacterial infections (including cUTI or AP, HABP, VABP, and/or bacteremia caused by CRE) will consist of a chart review over a 6 month period from September 1, 2013 to March 1, 2014. De-identified data will be collected from the chart review of at least 150 cases of selected infections due to CRE at approximately 20 sites. The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study. Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.

Official Title
-----------------
Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Conditions
-----------------
Bacteremia, Urinary Tract Infection, Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age. Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP, VABP, and/or bacteremia. Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia. 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population |  | 6 month period from September 1, 2013 to March 1, 2014 |
The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs.

Official Title
-----------------
A Prototype Study to Test the Effect of Staggered Dosing on the Pharmacokinetic Interactions Between Paired Combinations of Nelfinavir (NFV), Ritonavir (RTV), and Soft Gelatin Capsule of Saquinavir (SQVsgc)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Ritonavir
* Drug: Nelfinavir mesylate
* Drug: Saquinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Absence of HIV-1 infection as documented by any licensed ELISA test kit within 14 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Any medical condition that, in the opinion of the investigator, would interfere with the patient's ability to participate in this protocol. Patients with the following prior conditions and symptoms are excluded: History of chronic illness such as hypertension, coronary artery disease, arthritis, diabetes, or any chronic gastrointestinal conditions that might interfere with drug absorption.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ritonavir|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Saquinavir|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
-----------------
Drug Interactions, Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Nelfinavir
Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.

Official Title
-----------------
Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study

Conditions
-----------------
Low Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Transanal minimally invasive total mesorectal excision
* Procedure: transanal minimally invasive locoregional resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T2 N0 low rectal cancer Exclusion Criteria: patients unfit for laparoscopic resection Unwilling to share in the study
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAMIS TME<br>T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision. | Procedure: Transanal minimally invasive total mesorectal excision<br> <br> |
| Active Comparator: TAMIS-Local<br>T2 N0 Cases which will undergo transanal minimally invasive locoregional resection. | Procedure: transanal minimally invasive locoregional resection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall percent of postoperative complications. | the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Number of Days starting from the admission till discharge | 30 days | 
| Recurrence. | number of local and distant recurrence | 2 years |
Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.

Official Title
-----------------
Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Paxil-CR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal volunteers (without heart disease) patients with heart disease between ages 18 & 65 Exclusion Criteria: children less than 18 years adults greater than 65 years those who can not keep appointments patients within 2 weeks of a coronary catheterization patients within 6 months of unstable angina or myocardial infarction individuals with allergies to paroxetine or similar medications individuals having adverse events to paroxetine or similar medications individuals with diagnosis of mania individuals with a diagnosis of hypomania individuals with a diagnosis of bipolar disorders individuals with a diagnosis of depression individuals with a diagnosis of panic disorders individuals with a diagnosis of seizure disorders individuals with a history of suicide attempts individuals with a diagnosis of hyponatremia individuals with active bleeding disorders individuals with a diagnosis of narrow angle glaucoma individuals with an estimated creatinine clearance of less that 30 ml/min individuals taking potentially interacting medications

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paxil-CR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease. |  |  |