linjc16/ctgov huggingface dataset:
Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: exemestane


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 exemestane or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: exemestane|25 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 21 days |
Safety and Efficacy of BMMNCin Patients With Mental Retardation

Study Overview
=================
Brief Summary
-----------------
Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .

Official Title
-----------------
An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Patients With Mental Retardation. It is Self Funded (Patients' Own Funding) Clinical Trial

Conditions
-----------------
Mental Retardation

Intervention / Treatment
-----------------
* Biological: Intravenous transfer of BMMNC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age limit: 5 -50 Primary diagnosis of mental retardation (IQ < 70) willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation. To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study. willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol. Exclusion Criteria: Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis Advanced age that may produce deteriorating cognitive or motor functioning Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer Poor general health

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 50 Years

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

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

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 |
| --- | --- |
| Other: BMMNCs<br>Intravenous transfer of (BMMNCs) | Biological: Intravenous transfer of BMMNC<br>* Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binet-Kamat Test | CHANGE in IQ as measured by Binet-Kamat Test | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vineland Social Maturity Scale | CHANGE in Social Quotient as measured by Vineland Social Maturity Scale | baseline and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mental retardation , stem cell,BMMNC
Effect of Tiotropium on Inflammation and Exacerbations in COPD

Study Overview
=================
Brief Summary
-----------------
Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.

Detailed Description
-----------------
Patients with COPD will be randomised to tiotropium or placebo in addition to their usual medication. They will be followed prospectively over 1 year and provide sputum for quantification of IL-6 and IL-8 at baseline and at 3 monthly intervals.Serum IL-6 will also be quantified at baseline and over the year. Changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. Exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.

Official Title
-----------------
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Changes in Inflammatory Markers in Induced Sputum Following Treatment With Tiotropium Inhalation Capsules 18mcg Once Daily in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: tiotropium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of COPD, FEV1 < 80% predicted, minimum 10 pack year smoking history Exclusion Criteria: asthma, atopic disease, eosinophilia, history of malignancy, history of clinically significant pulmonary disease
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum IL-6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum IL-8 |  |  | 
| sputum MPO |  |  | 
| serum IL-6 |  |  | 
| serum CRP |  |  | 
| exacerbation frequency |  |  | 
| FEV1 |  |  | 
| FVC |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammation, exacerbations
Suturing vs Biological Adhesive in Simple Lacerations of Hand

Study Overview
=================
Brief Summary
-----------------
To assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive.

Official Title
-----------------
Suturing Vs Adhesion for Hand Lacerations in the ER A Randomized Prospective Study

Conditions
-----------------
Lacerations

Intervention / Treatment
-----------------
* Procedure: suturing laceration
* Procedure: bioadhesive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any age Hand laceration distal to the volar wrist crease. Exclusion Criteria: Fracture , tendon, artery involvement, more than 8 hours from laceration to trx, Immunosuppression Anticoagulation therapy Diabetes Unable to achieve homeostasis in more than 15 minutes Unwilling to participate in the study Unable to participate in the follow up or bite of any kind.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>suturing lacerations of the hand | Procedure: suturing laceration<br>* suturing simple lacerations of the hand<br>|
| Active Comparator: 2<br>using bioadhesive on lacerations of hand | Procedure: bioadhesive<br>* using bioadhesive on simple lacerations of the hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound appearance |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain of treatment and time length of treatment |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand, Laceration, bioadhesive, ER, Hand laceration distal to the volar wrist crease
Florida Cerebrovascular Disease Biorepository and Genomics Center

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by cerebrovascular disease. The information and blood samples collected may be used in future research for the study of cerebrovascular disease and to learn about, prevent or treat other health problems.

Official Title
-----------------
Creating a Florida Cerebrovascular Disease Biorepository and Genomics Center

Conditions
-----------------
CADASIL, Cerebral Venous Thrombosis, Cerebrovascular Disease, Ischemic Stroke, Transient Ischemic Attack, Intracerebral Hemorrhage, Aneurysmal Subarachnoid Hemorrhage, Vascular Dementia, Anoxic Brain Injury, Unruptured Intracranial Aneurysm, Carotid Artery Stenosis Symptomatic, Asymptomatic Carotid Artery Stenosis, Non-Aneurysmal Perimesencephalic Subarachnoid Haemorrhage, Moyamoya Disease, Fibromuscular Dysplasia, Subarachnoid Hemorrhage, Leukoaraiosis, Arteriovenous Fistula, Reversible Cerebral Vasoconstriction Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid hemorrhage, leukoaraiosis, arteriovenous fistula, reversible cerebral vasoconstriction syndrome (RCVS), and CADASIL. Exclusion Criteria: • All patients with the following known or suspected virulent microorganisms causing an active or latent infection will be excluded from the study: Human immunodeficiency virus (HIV); Any viral hepatitis; West Nile virus (WNV); Influenza virus; Tuberculosis (TB); Any bacteremia; Any fungemia; Any prionopathy.

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 |
| --- | --- | --- |
| Stroke or TIA at 12 months | Number of participants to experience new diagnosis of TIA or stroke. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale | Measure of overall functional status | 1 year |
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.

Official Title
-----------------
A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

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

Intervention / Treatment
-----------------
* Drug: Mesalamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men or women, 18 to 55 years of age weight within +/- 25% for height and weight for body frame willing to participate and sign a copy of the informed consent form Exclusion Criteria: recent history of drug or alcohol addiction or abuse pregnant or lactating women history of allergic response to mesalamine evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant receipt of any drugs as part of a research study within 28 days prior to study dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Drug<br> | Drug: Mesalamine<br> <br> |
| Active Comparator: Reference Drug<br> | Drug: Mesalamine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability, Mesalamine
Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid Arthritis (RA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study (20000201 or 20000198). In addition, this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis.

Official Title
-----------------
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI) in Subjects With Rheumatoid Arthritis (RA)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Pegsunercept (PEG sTNF-RI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects who have completed 24 weeks of double-blind treatment in a previous protocol (20000201 or 20000198) - Females of childbearing potential and males must practice adequate contraception, in the judgement of the investigator, during the course of the study - The subject or legally acceptable representative must give informed consent for participation in the study before any study specific procedures are performed Exclusion Criteria: - Greater than a 7-day duration from the week 24 visit in the previous study to the first dose in this study - Any medical disability or condition (e.g., evidence of clinically significant liver dysfunction, active infection requiring treatment with systemic anti-infective agents) that would interfere with the assessment of safety of the study material or would compromise the ability of the subject to provide adequate informed consent - Concurrent treatment with an investigational agent

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegsunercept (PEG sTNF-RI)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of RA assessment outcomes |  |  | 
| Assessment of Compliance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Inflammation, Pegsunercept, PEG sTNF-RI, Autoimmune, Amgen, Clinical Trials
Catastrophism Among Chronic Pain Patients in Rheumatology

Study Overview
=================
Brief Summary
-----------------
Pain catastrophizing is conceptualized as a negative cognitive-affective response to anticipated or actual pain and has been associated with a number of important pain-related outcomes. The aims of this study are To describe the characteristics of the patients and determinants of catastrophizing in chronic painful patients hospitalized in rheumatology in the Nîmes University Hospital To describe the impact of the catastrophizing on the level of insomnia and the drugs consumption in chronic painful patients hospitalized in rheumatology in the Nîmes University Hospital

Conditions
-----------------
Catastrophizing Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults hospitalized in the department of rheumatology of the Nîmes University Hospital with chronic pain (≥ 6 months) Exclusion Criteria: benzodiazepine or neuroleptic use for epilepsia, alcool, psychiatric disorders Restless Legs syndrom Obstructive Sleep Apnea narcolepsy

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 |
| --- | --- | --- |
| Pain Catastrophizing Scale |  | Day 0 |
A Study in Subjects With Perennial Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.

Official Title
-----------------
A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis

Conditions
-----------------
Perennial Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: INS37217 Nasal Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing. Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies. Have not started or had a change in immunotherapy regimen. Exclusion Criteria: Have a physical obstruction in the nose. Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial. Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy. Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms. Have asthma of sufficient severity to require use of excluded medications. Have taken any medications excluded as listed in the protocol. Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality. Are a current smoker, recent smoker or past smoker as defined in the protocol.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INS37217 Nasal Spray|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total nasal symptom score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average total nasal symptom scores over various timepoints average individual symptom scores |  |  | 
| global assessment of perennial allergic rhinitis symptoms |  |  | 
| instantaneous assessment of symptoms |  |  | 
| change from baseline in quality of life assessments |  |  | 
| physical and anterior nasal exams |  |  | 
| laboratory tests |  |  | 
| ECG |  |  | 
| vital signs |  |  | 
| adverse events |  |  |