linjc16/ctgov huggingface dataset:
Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. This will allow us to evaluate how patients have benefited from the procedure.

Detailed Description
-----------------
This study will include all patients who have laparoscopic surgery for gastroesophageal reflux disorder. Patients who participate will be asked to answer questionnaires regarding symptoms of reflux before and after surgery. In addition medical charts will be reviewed for relevant data.

Official Title
-----------------
Long and Short Term Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disorder

Intervention / Treatment
-----------------
* Other: Symptom questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients must have GERD and must plan to have laparoscopic surgery for GERD. patients must be at least 18 years of age

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I<br>This is a single arm study. All patients will be asked to complete questionnaires and have their medical charts reviewed. | Other: Symptom questionnaire<br>* This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to review pre-operative studies and evaluation reports and compare those with post-operative studies and evaluation reports to evaluate outcome following laparoscopic surgery for GERD. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, laparoscopic surgery
Maternal and Fetal Compatibility in Assisted Reproductive Technology (ART)-Oocyte Donor Influences Live Birth Rate

Study Overview
=================
Brief Summary
-----------------
Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?

Detailed Description
-----------------
The combination of maternal KIR haplotype and parental, donors HLA-C, could predict which couple can benefit for the selection of single embryo transfer (SET)/double embryo transfer (DET), or donor selection by HLA-C in ART, in order to increase the live birth rate (LBR)/cycle since HLA-C1/C1 donors are predicted to be safer and C2/C2 males or oocyte donors may be mor dangerous as identified by epidemiological studies

Official Title
-----------------
Maternal Killer Cell Immunoglobulin-like Receptors (KIR) and Fetal (Human Leukocyte Antigen) HLA-C Compatibility in ART-oocyte Donor Influences Live Birth Rate a Prospective Controlled Cohort Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Genetic: KIR HLAC determinations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 19 - 27 kg/m2 Blastocyst embryo transfer previous. Normal karyotype, thrombophylic and immunological results. Normal clinical history, viral serology, hormonal analysis (TSH, T4, prolactin, estrogen, progesterone), spermiogram, sperm FISH and pelvic ultrasound results. Exclusion Criteria: Pregnancy women. Psychiatric disorders. Uterus alterations. Polycystic ovary syndrome Genetic and autoimmune diseases. Infectious diseases. Corticoid and immunosuppressant treatments previous.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Receiver patients in donor oocyte -ART<br>Maternal and fetal compatibility KIR HLA-C determinations in ART -oocyte donor | Genetic: KIR HLAC determinations<br>* We will take blood samples for KIR HLA-C determinations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compatibility maternal fetal KIR HLA-C | KIR haplotype regions will be defined by the presence of the following KIR genes: Cen-A/2DL3: Tel-A/3DL1 and 2DS4; Cen-B/2DL2 and 2DS2; Tel-B/2DS1 and 3DS1. The HLA-C ligands for KIRs will be divided into 2 groups: HLA-C1 and HLA_C2 | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ART, KIR HLA-C
A Study of Single Dose of ABT-333 in Healthy Male Adults

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Dose of ABT-333

Conditions
-----------------
HCV Infections

Intervention / Treatment
-----------------
* Drug: ABT-333
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided written consent. Subject is in general good health. Exclusion Criteria: See above for main selection criteria.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Single dose of 400 mg | Drug: ABT-333<br>* Tablet, see arms for interventional description<br>|
| Experimental: Group 2<br>Single dose of 800 mg after safety evolution of Group I | Drug: ABT-333<br>* Tablet, see arms for interventional description<br>|
| Experimental: Group 3<br>Single dose of 1200 mg after safety evolution of Group 2 | Drug: ABT-333<br>* Tablet, see arms for interventional description<br>|
| Experimental: Group 4<br>Single dose of 1600 mg after safety evolution of Group 3 | Drug: ABT-333<br>* Tablet, see arms for interventional description<br>|
| Placebo Comparator: Group 5<br>Single dose of placebo | Drug: Placebo<br>* Tablet, see arms for interventional description.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring |  | Daily assessment for 5 days then day 30 or more frequently as needed | 
| To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation |  | Day 1-3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Wound Healing and Pain Management in Partial Thickness Burns

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary ER treatment of superficial partial thickness burns

Official Title
-----------------
Pain Management and Wound Healing in Partial Thickness Burn: Comparative, Post Marketing, Observational Trail Comparing Advanced Foam Dressings to Conventional Treatment.

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with minor superficial partial thickness burns Exclusion Criteria: co-morbidities, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Polymem (R)<br>superficial burns treated with Polymem wound dressing until complete wound healing | |
| Biaten IBU<br>burns treated with Biaten IBU until complete wound healing. | |
| Hartmen dressing<br>burns treated with hartman or saline wet dressing until wound healing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete wound healing | final burn wound closure | up to two to three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound healing, pain, burn
Phase 2 Study of KHK4577

Study Overview
=================
Brief Summary
-----------------
This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.

Official Title
-----------------
Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: KHK4577
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has signed voluntarily the written informed consent form to participate in this study. Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009). Rajka & Langeland criteria of >/= 4.5 at screening visit Investigator's Global Assessment (IGA) score of >/= 3 at screening visit Exclusion Criteria: Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug. Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent. Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent. Subject has complications / history of drug abuse or alcoholism. Subject has drug allergy or history of allergic reaction to a drug medicine. Subject has a significant concurrent medical conditions as defined in the study protocol. Subject is breast-feeding, pregnant or planning to become pregnant in this study period.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: KHK4577<br> | Drug: KHK4577<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement from baseline in Eczema Area and Severity Index (EASI) |  | Pre-dose, Week 1,2,4 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Investigator's Global Assessment score |  | Pre-dose, Week 1,2,4 and 6 | 
| Dermatology Life Quality Index |  | Pre-dose, Week 1,2,4 and 6 | 
| Visual Analog Scale (itching) |  | Pre-dose, Week 1,2,4 and 6 | 
| Incidence of patients with adverse events |  | From Day 1 through Week 6 | 
| Profile of pharmacokinetics of plasma KHK4577 concentration |  | pre-dose, Week 1,2,4 and 6 |
Evaluation of Parturients With Anxiety

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to examine the effects of cognitive bias modification for interpretation (CBM-I) on prenatal anxiety in parturients. Half of the participants will receive CBM-I assignments, while the other half will receive placebo assignments.

Detailed Description
-----------------
Maternal prenatal anxiety has been shown to have implications on neonatal behavior and early childhood behavioral and emotional wellbeing. Recent studies found that adults using computer-assisted feedback-learning paradigms, referred to as Cognitive Bias Modification for Interpretation (CBM-I), experienced significant reductions in levels of social anxiety, trait anxiety, and depression. Our goal is to identify patients with prenatal anxiety and evaluate the effects of CBM-I on symptoms of prenatal anxiety and patient satisfaction with the labor and delivery experience.

Official Title
-----------------
Evaluation of Parturients With Anxiety

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Cognitive Bias Modification for Interpretation (CBM-I)
* Behavioral: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-45 Women before 36-week gestation At least high school level education Exclusion Criteria: They refuse Have impaired decision-making capacity Are blind or extremely visually impaired (excluding use of glasses) Cannot understand or read English Diagnosed with psychiatric disorder other than anxiety

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBM-I assignment<br>Patients will receive CBM-I assignments | Behavioral: Cognitive Bias Modification for Interpretation (CBM-I)<br>* Patients will receive CBM-I training by reading and imaging themselves in a series of emotionally ambiguous scenarios. Each scenario ends with an incomplete final word. Patients need to complete the final word to resolve the scenario in a positive direction.<br>|
| Placebo Comparator: Placebo assignment<br>Patients will receive placebo assignments | Behavioral: Placebo<br>* Patients will receive placebo task which uses neutral rather than emotional material.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety | Change in State-Trait Anxiety Inventory (STAI) scores before and after the CBM-I assignment. | 4 weeks (starting from 36-week gestation) |
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

Study Overview
=================
Brief Summary
-----------------
Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms

Official Title
-----------------
Phase I, Randomized, Open-Label, 2-Way Crossover Study to Evaluate Relative Bioavailability of Single Oral Dose of Celecoxib Administered as Marketed Product, or Overencapsulated Capsule in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg Clinically normal physical exams and laboratory measurements Exclusion Criteria: Subject has received another investigational drug within 4 weeks preceeding this study or planning to participate in another study at any time during the period of this study Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>marketed celecoxib | Drug: celecoxib<br>* dose form<br>* Other names: Celebrex;|
| Experimental: 2<br>overencapsulated celecoxib | Drug: celecoxib<br>* dose form<br>* Other names: Celebrex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | pre-dose, baseline and multiple times post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I,, Healthy, Volunteer, Study
VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

Official Title
-----------------
A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-7145 in Healthy Adult Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: VNRX-7145
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 18-45 years Males or non-pregnant, non-lactating females Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m² Normal blood pressure Normal laboratory tests Exclusion Criteria: Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder History of drug allergy Abnormal ECG or history of clinically significant abnormal rhythm disorder Positive alcohol, drug, or tobacco use/test

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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VNRX-7145<br>Oral dosing | Drug: VNRX-7145<br>* Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)<br>|
| Placebo Comparator: Placebo<br>Oral dosing | Drug: Placebo<br>* Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Number of subjects with adverse events |  | Day 8 | 
| Part 2: Number of subjects with adverse events |  | Day 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: AUC0-tau |  | Days 1-3 | 
| Part 1: Cmax |  | Days 1-3 | 
| Part 1: tmax |  | Days 1-3 | 
| Part 1: CLr |  | Days 1-3 | 
| Part 2: AUC0-tau |  | Days 1-10 | 
| Part 2: Cmax |  | Days 1-10 | 
| Part 2: tmax |  | Days 1-10 | 
| Part 2: CLr |  | Days 1-10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VNRX-7145, Safety, Pharmacokinetics