linjc16/ctgov huggingface dataset:
A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

Detailed Description
-----------------
GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.

Official Title
-----------------
A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: GL2907
* Drug: Oxycontine CR 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 45 years old, Healthy Adult Male Subject Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20% Exclusion Criteria: ALT or AST > 1.25 times (Upper Normal Range) Total Bilirubin > 1.5 times (Upper Normal Range) CPK > 2 times (Upper Normal Range) BUN or Creatinine > Normal Range Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GL2907<br>Oxycodone HCl 20mg | Drug: GL2907<br>* once a day<br>* Other names: Oxycodone HCl 20mg;|
| Active Comparator: Oxycontine CR 10mg<br>Oxycodone HCl 10mg | Drug: Oxycontine CR 10mg<br>* twice a day<br>* Other names: Oxycodone HCl 10mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss | Pharmacokinetic of Oxycodone | 48h | 
| AUCτ | Pharmacokinetic of Oxycodone | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Pharmacokinetic of Oxycodone | 48h | 
| t1/2 | Pharmacokinetic of Oxycodone | 48h | 
| Vz/f | Pharmacokinetic of Oxycodone | 48h | 
| CL/F | Pharmacokinetic of Oxycodone | 48h | 
| Cmin,ss | Pharmacokinetic of Oxycodone | 48h | 
| Cave,ss | Pharmacokinetic of Oxycodone | 48h | 
| degree og fluctuation | Pharmacokinetic of Oxycodone (Cmax,ss-Cmin,ss)/Cave,ss | 48h | 
| swing | Pharmacokinetic of Oxycodone (Cmax,ss-Cmin,ss)/Cmin,ss | 48h | 
| R | Pharmacokinetic of Oxycodone Accumulation index | 48h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxycodone, controlled release formulation
Effect of Community Mobile Outreach Approach Compared to Facility Based Directly Observed Treatment Short Course on Treatment Outcome Among Tuberculosis Patients in Jeddah: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of the community mobile outreach approach in improving treatment outcomes (success rate) among tuberculosis patients with those being treated with facility based directly observed treatment short course (DOTS) in Jeddah region.

Official Title
-----------------
Community Outreach Mobile Teams Impact on Tuberculosis Treatment Outcome in Jeddah Region: A Randomized Controlled Trial

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Procedure: Mobile Outreach Approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed TB cases Exclusion Criteria: Visitors having TB especially pilgrims

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators conducted a two-arm, parallel design[1:1], single blind randomized control trial in 200 newly diagnosed TB patients
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Intervention arm patients were served by outreach mobile teams for oral anti-TB treatment under DOTS at the place of their convenience by health care professionals | Procedure: Mobile Outreach Approach<br>* TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision<br>|
| Active Comparator: Control arm<br>Control arm patients were given the traditional facility based DOTS treatment. Control arm was not served by the outreach mobile teams. | Procedure: Mobile Outreach Approach<br>* TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success rate |  | 6 to 8 months |
A Retrospective Chart Review Study of the Outcomes of 2nd Line Therapy With LEn/Dex in Greek Patients With R/R Multiple MyEloma and the Treatment PatterNs Following Progressive Disease

Study Overview
=================
Brief Summary
-----------------
This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece.

Official Title
-----------------
A Retrospective Chart Review Study of the Outcomes of Second Line Therapy With LEnalidomide/Dexamethasone in Greek Patients With Relapsed/Refractory Multiple MyEloma and the Treatment PatterNs Following Progressive Disease, The LEGEND Study

Conditions
-----------------
Relapsed/Refractory Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must fulfill ALL of the following criteria: Subjects of both genders, aged 18 years or older Subjects must have a relapsed or refractory MM diagnosis according to IMWG or EBMT criteria Subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' Summary of Product Characteristics (SmPC) between 01 January 2009 and 01 March 2014 Subjects must have available medical files/records and detailed historical data on their disease course and clinical management Provision of signed ICF for collecting and analyzing medical data pertinent to the objectives of this study Exclusion Criteria: For the candidate subjects NONE of the following criteria should apply: Prior malignancy (within the 3 years preceding initial diagnosis of MM) Concurrent administration of anti-cancer regimens for malignancies other than MM between the time of initial MM diagnosis and time of second relapse Subject participation in an interventional 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 |
| --- | --- | --- |
| Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse | PFS rate | 12 months |
Isocyanate Antigens and T Cells That Cause Asthma

Study Overview
=================
Brief Summary
-----------------
To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated, airway inflammation.

Detailed Description
-----------------
BACKGROUND: Isocyanates are a group of highly reactive widely used low-molecular weight chemicals, and are the most commonly reported cause of occupation asthma in developed countries. Yet, the mechanisms by which isocyanates cause asthma are not well defined. DESIGN NARRATIVE: The study investigates isocyanate antigen-driven T-cell responses in vitro-, following in vivo exposure using patient samples acquired through collaboration with ongoing field epidemiological and clinical studies. The study compares isocyanate antigen-reactive T-cells from primary exposure sites (skin/lung) with those from blood, to evaluate potential routes of sensitization and identify diagnostic indicators of isocyanate sensitivity/susceptibility. Specifically, the study : generates and characterizes hexamethylene diisocyanate (HDI) antigens including isocyanate metabolites, and isocyanate conjugated t normal human and foreign proteins; evaluates the T-cell antigenicity of the HDI antigens, based on blood and lung lymphocyte proliferation, cytokine production, and phenotype in order to identify the molecular form of HDI that initiates airway cytokine production in asthma patients; establishes T-cell lines from the skin, lung and peripheral blood of HDI asthma patients and characterizes the phenotype, antigen specificity, cytokine production and TCR expression of isocyanate responsive T-cells in these different compartments; compares isocyanate responsive of T-cells found in the skin, lung and blood and correlates with clinical sensitivity to determine characteristics associated with exposure and sensitization leading to clinical asthma. The study was renewed in FY 2002 to extend follow-up and analysis through March 2007.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme infusions needed to prevent acute attacks of porphyria. II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is an unblinded study. Patients start a preventive heme regimen and are followed for 6 months prior to tin mesoporphyrin. The frequency of attacks is recorded. Patients receive tin mesoporphyrin once a week for 6 months. Patients must avoid sunlight during treatment and for 2 months thereafter. The frequency of heme infusions is reduced by half and the frequency of attacks of porphyria is monitored. Patients are followed for 6 months after last treatment.

Conditions
-----------------
Porphyria

Intervention / Treatment
-----------------
* Drug: heme arginate
* Drug: tin mesoporphyrin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria causing 6 or more attacks per year Fewer than 2 attacks in the preceding 6 months if already on preventive heme therapy --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Urinary porphobilinogen at least 20 mg/24 hours during acute symptoms Other: Not pregnant Fertile female patients must use effective contraception during and for 6 months prior to study No recurrent symptoms due to another illness No continuous (for longer than 1 month) symptoms of porphyria unless it is in addition to acute exacerbations No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to tin mesoporphyrin No known hypersensitivity to any intravenous heme preparation No other condition which may increase risk to patient

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: heme arginate|nan|
|Drug: tin mesoporphyrin|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
-----------------
inborn errors of metabolism, porphyria, rare disease
Use of ECMO in Acute MI

Study Overview
=================
Brief Summary
-----------------
ECMO offers an acceptable cardiopulmonary support in adults with similar hospital survival rates as other mechanical support. It is versatile and salvages some patients, who may otherwise die. Improvement in intermediate term outcome will require multidisciplinary approach to protect organ function and limit organ injury during this support.

Detailed Description
-----------------
Extracorporeal membrane oxygenation (ECMO) is an established treatment option in patients with Cardiogenic Schock. We retrospectively reviewed early and mid-term outcome as well as predictors of survival during using ECMO. This report reviews our experience with this support system in last 3 years.

Official Title
-----------------
Use of Extracorporeal Membrane Oxygenation in Treatment of Acute Myocardial Infarction Following Cardiac Surgery Procedures

Conditions
-----------------
ECMO and Acute MI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute MI Exclusion Criteria: Contraindication against ECMO

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary resuscitation, ECMO, shock, survival, heart failure, transplantation, heart assist device.
Selective Criteria and a Modified Technique of Applying URAGPI Technique for More Proximal Degree of Hypospadias

Study Overview
=================
Brief Summary
-----------------
Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis. Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations [1]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias [2]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty &quot; URAGPI&quot; versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion. B) Normal appearance of the penis. C) Good functional results.

Official Title
-----------------
Applying of Urethral Advancement, Glanuloplasty and Preputioplasty Technique for More Proximal Degrees of Hypospadias. Selective Criteria and a Modified Technique

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Procedure: URAGPI technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al Exclusion Criteria: circumcised patients sever degrees of chordae previous surgical repair meatal stenosis

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

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

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: Hypospadias in children<br>Distal shaft hypospadias at age of 12 years or less | Procedure: URAGPI technique<br>* the Urethral Advancement, Glanuloplasty and Preputioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks | evaluation according to Hypospadias Objective Penile Evaluation Score | 3 weeks |
Detection of Aggressive Breast Tumors Using Tc-99m-NC100692

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.

Official Title
-----------------
Improved Sensitivity for the Detection of Aggressive Breast Tumors Using 99mTc-NC100692 and a Dual-headed Small Field of View CZT Gamma Camera.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a lesion on mammogram, ultrasound or breast MRI that measured < 15 mm in diameter, is considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4b, 4c or 5), and is scheduled for biopsy (needle biopsy and/or surgical biopsy). OR Have a lesion on mammogram, ultrasound or breast MRI that measured > 15 mm in diameter, is known to be malignant and is scheduled for surgery. Patient age > 18 years of age. Have a negative pregnancy test on the first day of the study, or must be postmenopausal or surgically sterilized. Exclusion Criteria: Patients will be excluded if they have a small lesion (< 15 mm) and have undergone prior needle biopsy of the lesion (such biopsy may effectively remove all or part of the lesion and angiogenesis associated with wound healing might confound imaging results with 99mTc-NC100692). Patient's pregnancy is not negative on the first day of the study, or the patient is unable to complete the pregnancy test Patient is unable to sit on a chair for 40 minutes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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 |
| --- | --- | --- |
| Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MBI, Molecular Breast Imaging, Breast, Breast Cancer, Molecular Imaging
There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?

Study Overview
=================
Brief Summary
-----------------
This study, prospective randomized controlled trial, tried to identify a cut off value of luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible gonadotropin-releasing hormone antagonist protocols. 202 norma-ovulatory women < 39 years were randomized to fixed or flexible group in GnRH antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and progesterone in the two study groups was measured. Total number of retrieved oocytes, implantation and pregnancy rate were recorded. .

Official Title
-----------------
There is a Cut Off Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome? A Randomized Controlled Trial in Fixed Versus Flexible Gonadotropin-releasing Hormone Antagonist Protocols.

Conditions
-----------------
Female Infertility

Intervention / Treatment
-----------------
* Other: LH value


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) age <39 years; (2) normal menstrual cycle (range of 26-32 days); (3) baseline follicle stimulating hormone levels < 12 IU/ml; (4) body mass index (BMI) between 18-30 Kg/m2; (5) no oral contraceptive pills taken in the last year Exclusion Criteria: polycystic ovaries, age >39 years

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LH value in fixed group<br>LH value predictive of IVF in 104 patients entered in fixed protocol | Other: LH value<br>* analyzed LH value in the the arms of the study, fixed and flexible protocols<br>|
| Other: LH value in flexible group<br>LH value predictive of IVF in 109 patients entered in flexible protocols | Other: LH value<br>* analyzed LH value in the the arms of the study, fixed and flexible protocols<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of mature oocytes recruited after IVF with antagonist protocol |  | partecipant will be followed for the duration of the cycle of IVF and for the following three months |