linjc16/ctgov huggingface dataset:
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.

Official Title
-----------------
A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: BIIB022 With Paclitaxel and Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 18 years old Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer ECOG Performance Status 0 or 1 Exclusion Criteria: History of another primary cancer within 3 years Any prior or concurrent investigational or standard therapy for treatment of NSCLC Prior anti-IGF-1R therapy Unstable diabetes

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB022 in Combination with Paclitaxel and Carboplatin<br>BIIB022 in Combination with Paclitaxel and Carboplatin | Drug: BIIB022 With Paclitaxel and Carboplatin<br>* Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin<br>* Other names: Alkylating agent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIIB022, Stage IV, Taxol, Stage IIIB, Carboplatin, Paclitaxel, Non Small Cell Lung Cancer, Treatment Naive, Anti IGF1R, NSCLC, Open Label, IGF1R, Paraplatin, Cytotoxic, Mitotic Inhibitor, Taxane, Alkylating agent
Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance following a single-dose administration.

Official Title
-----------------
Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Febuxostat Between TMX-67 40mg 2 Tablets and Feburic® 80mg 1 Tablet in Healthy Male Volunteers

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Drug: Feburic®
* Drug: TMX-67


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males aged between 20 and 45 years Subjects whose weight is 50 kg or more and BMI is between 18 and 29 kg/m2 Subjects who were voluntarily decided to participate in the study and provided written informed consent to observe the directions Exclusion Criteria: Medical history which may influence adsorption, distribution, metabolism, excretion of the drug Clinically significant active chronic disease(s) Persons who are deemed ineligible for the study by the investigator according to the clinical laboratory test results or for other reasons

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Experimental: febuxostat (TR)<br> | Drug: Feburic®<br>* 80 mg*1 tablet<br>Drug: TMX-67<br>* 40 mg*2 tablets<br>|
| Experimental: febuxostat (RT)<br> | Drug: Feburic®<br>* 80 mg*1 tablet<br>Drug: TMX-67<br>* 40 mg*2 tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic characteristics (AUClast and Cmax) |  | 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
crossover, pharmacokinetic, hyperuricemia, gout
Optimal Doses for Drug Provocation Tests to Beta-lactams

Study Overview
=================
Brief Summary
-----------------
Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols. investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).

Official Title
-----------------
Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Procedure: simplified drug provocation test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with positive Drug Provocation Test (DPT) to beta-lactams Exclusion Criteria: contra-indications to DPT refusal of participation vulnerable patients according to French regulation

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

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

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: Simplified drug provocation test<br>Assessment of the Hypersensitivity to betalactams by simplified drug provocation test | Procedure: simplified drug provocation test<br>* Assessment of the Hypersensitivity to betalactams by simplified drug provocation test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the new simplified drug provocation test | Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test | up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betalactams, Drug hypersensitivity, Drug provocation test, Reactive dose
Comparing Oral Preparation With Macrogol (Moviprep) and Natriumdihydrogenphosphatdihydrat (Phosphoral)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Moviprep or Phosphoral is the best method of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.

Conditions
-----------------
Colonoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary diagnostic colonoscopy, colonoscopy as a follow-up, intended therapeutic colonoscopy. Exclusion Criteria: patients younger than 18 years pregnancy known bowl obstructions known inflammatory colon disease known kidney disease phenylketonuri glucose-6-phospat deficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| u-65 M<br>Male patients under 65 | |
| u-65 K<br>Female patients under 65 years old | |
| o-65 -K<br>Female patients over 65 years | |
| O-65 M<br>Male patients over 65 years | |

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
-----------------
compliance, Bowel preparations, Moviprep, Phosphoral
Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS. The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.

Conditions
-----------------
Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old AIS secondary to a large vessel occlusion admitted for endovascular therapy. Exclusion Criteria: Pregnant or breast feeding patient patient under legal protection Patient opposition to participate in 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 |
| --- | --- | --- |
| thrombus origin | according to the etiology of the stroke (TOAST classification) | baseline | 
| red cells counts | quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining : | baseline | 
| white cells counts | quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining | baseline | 
| platlet counts | quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining | baseline |
End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
Patients with pulmonary fibrosis and associated usual interstitial pneumonia that require mechanical ventilation for acute respiratory failure experience poor clinical outcomes. This may be influenced by the unfavorable interaction between the fibrotic lung and the stress and strain stimuli generated during controlled ventilation. Although there is no consensus on how to ventilate these patients, much of the recommendations followed in clinical practice are taken from the experience on patients with acute respiratory distress syndrome. Among these, measuring the esophageal pressures and adjusting positive-end expiatory pressure to make trans-pulmonary pressures positive can decrease atelectasis, derecruitment of lung, and cyclical opening and closing of airways and alveoli, thus optimizing lung mechanics and oxygenation. The effect of this strategy on the fibrotic lung has not yet been documented. With this observational study we aim at documenting the effect of PEEP titration maneuver based on end-expiratory trans-pulmonary pressure on lung mechanics of patients with pulmonary fibrosis and UIP pattern,

Official Title
-----------------
End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation

Conditions
-----------------
Idiopathic Pulmonary Fibrosis, Mechanical Ventilation Pressure High

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pulmonary fibrosis with UIP pattern subjected to endotracheal intubation and controlled mechanical ventilation for acute respiratory failure candidate to a trial of PEEP titration according to positive end expiratory pressure. Exclusion Criteria: chest wall deformities chronic obstructive pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| UIP patients<br>Patients with pulmonary fibrosis and UIP pattern undergoing mechanical ventilation for acute respiratory failure | |
| ARDS patients<br>Patients with ARDS undergoing mechanical ventilation for acute respiratory failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung elastance | The effect of PEEP titration according to end-expiratory transpulmonary pressure on lung elastance will be analyzed. | 2 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P/F ratio | The effect of PEEP titration according to end-expiratory transpulmonary pressure on P/F ratio will be analyzed. | 2 hours |
Outcomes After Laparotomy for Penetrating Abdominal Trauma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.

Official Title
-----------------
Outcomes After Laparotomy for Penetrating Abdominal Trauma: A Cohort Study From a Tertiary Trauma Hospital in South Africa

Conditions
-----------------
Penetrating Abdominal Trauma

Intervention / Treatment
-----------------
* Procedure: Laparotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are admitted due to penetrating abdominal injuries, irrespective of injury mechanism, time from injury and prior treatment. Patients that are treated with laparotomy. Exclusion Criteria: Patients that are admitted due to blunt trauma or combinations of blunt and penetrating trauma. Patients who are dead on arrival. Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by TBH before study initiation.

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 |
| --- | --- |
| Time to surgery ≤12 hours<br>Waiting time to surgery ≤12 hours from hospital presentation. | Procedure: Laparotomy<br>* Exploratory laparotomy.<br>|
| Time to surgery >12 hours<br>Waiting time to surgery >12 hours from hospital presentation. | Procedure: Laparotomy<br>* Exploratory laparotomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | In-hospital death. | Through study completion, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications according to the Clavien-Dindo classification. | Through study completion, an average of 2 weeks | 
| Length of stay | Length of hospital stay. | Through study completion, an average of 2 weeks |
Treatment Outcomes of Vaginal Prolapse Repair

Study Overview
=================
Brief Summary
-----------------
Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital.

Detailed Description
-----------------
Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital. Preoperative, intraoperative and post-operative data will be collected from the hospital and physician medical records. A questionnaire will be mailed to patients whose charts have been reviewed to assess urinary and bowel function, satisfaction with treatment and changes in sexual function. Completion of the questionnaire is voluntary.

Official Title
-----------------
Treatment Outcomes of Vaginal Prolapse Repair

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Procedure: Prolift


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women having Prolift repair at William Beaumont Hospital Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients having surgical repair of a vaginal prolapse . | Procedure: Prolift<br>* surgical repair of vaginal prolapse<br>|

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
-----------------
vaginal prolapse
Human Factors Usability Study of Ib2C Conception System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

Detailed Description
-----------------
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

Official Title
-----------------
Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. Conception System

Conditions
-----------------
Cervical Cap Insemination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, any ethnicity 20 - 45 years of age Sexually active Signed Informed Consent Exclusion Criteria: Prior surgery to the cervix or vaginal tract Vaginal prolapse Cervical cancer Hysterectomy History of Toxic Shock Syndrome (TSS)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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
-----------------
Cervical cap insemination, Usability Study
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Buprenorphine HCl (Sublingual) 8 mg Tablets With a Naltrexone Block Under Fasting Conditions

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: buprenorphine hydrochloride


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 buprenorphine hydrochloride 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: buprenorphine hydrochloride|single dose 8 mg sublingual tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 21 days |