linjc16/ctgov huggingface dataset:
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, folloiwng a single 600 mg dose administered with food.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazapine 600 mg Tablets Under Fed Conditions

Conditions
-----------------
Epilepsy, Seizures

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding 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 advers response to oxcarbazepine or any other 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: Oxcarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, two period, 7 day washout |
Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19)

Study Overview
=================
Brief Summary
-----------------
Objective: To assess the prognostic value of high-sensitive cardiac troponin T (hs-cTnT) and N-terminal pro brain natriuretic peptide (NT-proBNP) at ICU admission in patients with coronavirus disease 2019 (COVID-19). Design: Multicenter retrospective observational cohort study Setting: Three ICUs at three hospitals in Occitanie, France. Patients: Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission, from March 9, 2020, to May 9, 2020.

Official Title
-----------------
Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19) : COROBIOCHIC

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission Exclusion criteria: - Age < 18, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| hs-cTnT | hs-cTnT | at ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP | NT-proBNP | at ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Troponin, hs-cTnT, NT-proBNP
Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
Purpose: The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma and the beginning of new therapies based on function and activation of NK, justify an improvement of knowledge about the status of the population of NK (number, function, genic expression) in Chronic Lymphocytic Leukemia (CLL).

Detailed Description
-----------------
Method: prospective, monocentric, descriptive study Primary objective: Evaluation of the expression and function of receptors activator of NK cell (KIRs) in patients with CLL at stage A with therapeutic abstention, or stage B or C which require a treatment. Secondary objectives: Measure of the evolution of cytotoxic function of NK cells and theirs biomarkers of activation when the patient receives an immunochemotherapy with Rituximab/ Fludarabine/ Cyclophosphamide (RCF). Verification, by analysis, of functions and biomarkers of the adaptive and innate immunity

Official Title
-----------------
Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Other: Surface expression of functional biomarkers of the NK cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CLL (Score of Matutes >=4) with no history of treatment: Stade A of Binet, Or Stade B or C before the beginning of the treatment with RFC Patients who can undergo blood collection Patient aged 18 years and older Signed consent Non inclusion Criteria: Patient with anemia: haemoglobin < 9 g/dl Pregnancy, breast feeding Patient in an urgent situation, or unable to give a consent

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Surface expression of functional biomarkers of the NK cell|An extra blood sample of 40 ml is required : Stage A patient who does not require a treatment: one sample the day of enrollment. Stage B or C patient who require RFC treatment: sample at D0 of the 1st and 4th cure of RFC, and 3 months after the end of the treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the surface expression of functional biomarkers of the NK cell, functional study, analysis of expression of transcription of values genes. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Lymphocytic Leukemia, NK Cells
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.

Official Title
-----------------
An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)

Conditions
-----------------
Lumbar Vertebra Hernia

Intervention / Treatment
-----------------
* Drug: SI-6603


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root. Patients assessed as positive in the SLR test. Patients with sciatica in either lower leg. Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block. Exclusion Criteria: Patients who have 2 or more lumbar disc herniations as assessed by MRI. Patients with extrusion-type or sequestration-type herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI. Patients who have received nerve block within 3 weeks before screening. Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug I: SI-6603 (Low)<br> | Drug: SI-6603<br>* SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.<br>|
| Experimental: Drug II: SI-6603 (Middle)<br> | Drug: SI-6603<br>* SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.<br>|
| Experimental: Drug III: SI-6603 (High)<br> | Drug: SI-6603<br>* SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The leg pain |  | At each assessment time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemonucleolysis, Lumbar Vertebrae, Hernia
Budesonide 9 mg Capsules in Active UC

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis

Official Title
-----------------
Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Drug: Budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, Men or women aged 18 to 75 years, Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology, Established disease, Exclusion Criteria: Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis, Toxic megacolon or fulminant colitis, Colon resection, Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening), Malabsorption syndromes, Celiac disease, Bleeding hemorrhoids, Active peptic ulcer disease Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured, Any severe infectious disease (e.g., tuberculosis, AIDS), Severe co-morbidity substantially reducing life expectancy, History of colorectal cancer, History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Budesonide<br> | Drug: Budesonide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission at final/withdrawal visit | Clinical remission includes normalisation of stool frequency and absence of blood in stools | 8 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of endoscopic remission/improvement at final/withdrawal visit |  | 8 weeks treatment | 
| Number of stools / bloody stools per week |  | 8 weeks treatment |
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room. Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room

Official Title
-----------------
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

Conditions
-----------------
Neonatal Respiratory Distress

Intervention / Treatment
-----------------
* Procedure: Volume targeted ventilation
* Procedure: Pressure targeted ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants 23-28 weeks' gestation requiring respiratory support at birth will be eligible for the trial. Inclusion criteria are pragmatic to enable the inclusion of ELGAN infants (Extremely Low Gestational Age Newborns). Exclusion Criteria: Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period. Infants will also be excluded if their parents refuse to give consent to this study.

Ages Eligible for Study
-----------------
Minimum Age: 0 Minutes
Maximum Age: 1 Minute

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 |
| --- | --- |
| Experimental: Volume Targeted Ventilation<br>Positive pressure ventilation will be provided using a set tidal volume | Procedure: Volume targeted ventilation<br>* Positive pressure ventilation will be provided using a set tidal volume<br>|
| Active Comparator: Pressure guided Ventilation<br>Positive pressure ventilation will be provided using a set peak inflation pressure | Procedure: Pressure targeted ventilation<br>* Positive pressure ventilation will be provided using a set peak inflation pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of preterm infants receiving the intervention | Number of Participants who have received allocated treatment | Through study completion (total 18 months) |
Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.

Official Title
-----------------
Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients: A Randomized, Multicenter, Unblinded, Clinical Trial

Conditions
-----------------
Acute Respiratory Failure

Intervention / Treatment
-----------------
* Drug: Esketamine hydrochloride
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years old Physician indicated intubation Exclusion Criteria: Pregnancy Intubation during cardiac arrest Known of suspected intracranial hypertension Known allergy to propofol or esketamine Bradycardia (heart rate below 50 beats per minute) or atrioventricular block

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br> | Drug: Propofol<br>* 1.5 mg per kilogram of body weight<br>|
| Experimental: Esketamina<br> | Drug: Esketamine hydrochloride<br>* 2 mg per kilogram of body weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest mean blood pressure | Lowest mean blood pressure | Ten minutes after induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early death | Death within one hour of intubation | One hour | 
| Cardiac arrest | Cardiac arrest requiring resuscitation | One hour | 
| Severe hypotension | Systolic blood pressure below 80 mmHg | One hour | 
| Severe hypoxemia | Peripheral oxygen saturation below 85% | One hour | 
| Number of intubation attempts | Number of attempts | One hour |
Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects

Study Overview
=================
Brief Summary
-----------------
The study purpose is to examine polymorphism of genes associated to post-operative persistent pain and to verify the possible association between genotype phenotype and ADRB2 polymorphism in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2 in VAS>4 patients and to compare it to those with VAS<4.

Official Title
-----------------
LA PREDISPOSIZIONE AL DOLORE PERSISTENTE POST OPERATORIO IN AMBITO ORTOPEDICO: ASPETTI GENETICI

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 ASA I to III Exclusion Criteria: Contraindications to regional anesthesia procedures Not stabilized neurological diseases 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VAS<4<br> | |
| VAS>4<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of SNPs rs12654788 and rs1042713 of ADBR2 gene in patients who complain persistent pain 4 months postoperatively compared to chronic pain free patients. |  | 4 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression frequency of OPRM1, COMT, IL1Ra |  | 6, 12, 24, 48 hours | 
| Serum concentration of TNFα, TGFβ, IFNγ, IL-6 and IL-10 obtained with ELISA system |  | 6, 12, 24 and 48 hours postoperatively |
Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma

Study Overview
=================
Brief Summary
-----------------
Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be non-invasively identified using imaging phenotypes that identify regionally distinct areas of tumor with genetic alterations that drive tumor resistance pathways. The researchers propose a unique approach to assess initial GBM heterogeneity by performing histological and genomic analysis of biopsies targeted by advanced MRI before treatment.

Official Title
-----------------
A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Other: Tumor Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected newly diagnosed or recurrent supratentorial glioblastoma eligible for surgical biopsy and/or resection Patients must be 18 years of age or older Study-specific informed consent approved for this purpose by the IRB of the University of Michigan Exclusion Criteria: Patients unable to undergo MRI

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

| Intervention/Treatment |
| --- |
|Other: Tumor Biopsy|Stereotactic biopsies will be performed prior to resection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify candidate genes with differential expression in therapy-resistant imaging subvolumes |  | At time of surgery |
AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution

Official Title
-----------------
A Phase 1, Single-center, Randomized, Open-label, Two-way Crossover, Formulation and Food Effect Study in Healthy Volunteers, to Assess the Pharmacokinetics of AZD 2066 After Single Doses of a New Oral Solid Formulation and an Oral Solution

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

Intervention / Treatment
-----------------
* Drug: AZD2066


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg Exclusion Criteria: History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator. History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD2066<br>* single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AZ2066 pharmacokinetics |  | several samples within 72 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of food on AZD2066 pharmacokinetics |  | several samples over 72 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
formulation, pharmacokinetic, crossover formulation, food effect, oral solution, healthy volunteers