linjc16/ctgov huggingface dataset:
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites. This Hypo CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo CAT). The first extension is followed by another long-term study (PASCCAL-1).

Official Title
-----------------
SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study

Conditions
-----------------
Ascites, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: satavaptan (SR121463B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical evidence Moderate or tense ascites Patients with hyponatremia, defined as a serum sodium concentration of ≤130 mmol/L The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: satavaptan (SR121463B)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body weight, change in serum sodium |  | within 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal girth and discomfort |  | 14 days | 
| paracentesis |  | 14 days | 
| trail-making test and quality of life |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhotic ascites, hyponatraemia
Growth Hormones and Cells in Human Milk Depending on Gestational Age

Study Overview
=================
Brief Summary
-----------------
Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk. The aim of this study is to give a profile of human milk concerning non-nutritive factors depending on gestational age and lactation phase.

Detailed Description
-----------------
Neurotrophins (epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF)) as well as amount of cells, especially positive for sex-determining transformer protein (TRA)-1-81 and stage-specific embryonic antigen (SSEA)-4, are planned to be quantified in human breast milk of extremely preterm newborns as well as term newborns at different stages of lactation.

Official Title
-----------------
Growth Hormones and Cells in Human Milk Depending on Gestational Age and Lactation Phase

Conditions
-----------------
Lactation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the newborn infant is being fed with own mothers milk Exclusion Criteria: low amount of breast milk

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurotrophins composition | Concentration of Neurotrophins EGF, VEGF, NGF, BDNF in the human milk | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of cells positive for surface markers TRA-1-81 and SSEA-4 | surface markers characteristic for pluripotent stem cells | day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurotrophins, Stem Cells, Prematurity
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort

Official Title
-----------------
Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults moderate to severe atopic dermatitis treated by JAK inhibitors between december 2020 and september 2021 inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy ineligibility to French ongoing clinical trials Exclusion Criteria: Children mild atopic dermatitis eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy eligibility to French ongoing clinical trials patients' opposition for the use of their records follow up <3 months

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in Eczema Area and Severity Index (EASI) |  | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORing Atopic Dermatitis (SCORAD) |  | at baseline and at 3 months | 
| Investigator's Global Assessment (IGA) |  | at baseline and at 3 months | 
| Dermatology Life Quality Index (DLQI) |  | at baseline and at 3 months | 
| patient-reported pruritus score from 0 to 10 |  | at baseline and at 3 months | 
| patient-reported sleep loss from 0 to 10 |  | at baseline and at 3 months | 
| Adverse effects (biological and clinical) |  | at baseline and at 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Effectiveness, Safety, JAK inhibitors, Atopic dermatitis, Adults
Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

Official Title
-----------------
An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: AZD5672


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass index (BMI) 18-30 kg/m2, inclusive. Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology & urinalysis, as judged by the investigator Exclusion Criteria: Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Ages Eligible for Study
-----------------
Minimum 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD5672<br>* single dose 200mg aqueous solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total radioactivity in plasma, whole blood, faeces and urine. |  | Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h | 
| Additional metabolite identification |  | 0.5h, 3h, 6h, 12h, 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs |  | Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, mass balance, radiolabel, AZD5672
Anti-histamines and Methacholine Challenges.

Study Overview
=================
Brief Summary
-----------------
The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.

Official Title
-----------------
The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Diphenhydramine
* Drug: cetirizine
* Drug: desloratadine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Baseline forced expiratory volume in 1s (FEV1) of 70% or more of predicted Methacholine provocative concentration causing a 20% fall in FEV1 16mg/ml or less No respiratory infection or change in allergen exposure for 4 weeks prior to screening and throughout the study No significant medical co-morbidities allergy Exclusion Criteria: pregnant or breastfeeding females unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diphenhydramine<br>50mg dose given as two 25mg capsules | Drug: Diphenhydramine<br> <br> |
| Active Comparator: cetirizine<br>10mg dose given as 1 10mg capsule and 1 placebo capsule | Drug: cetirizine<br> <br> |
| Active Comparator: desloratadine<br>5mg dose given as 1 5mg capsule and 1 placebo capsule | Drug: desloratadine<br> <br> |
| Placebo Comparator: placebo<br>given as 2 placebo capsules | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in methacholine pc20 |  | change from baseline (pre dose) at 2 hours (post dose) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
airway hyperresponsiveness
Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102

Official Title
-----------------
Open-label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics and Safety of Singulair (10 mg) and Xyzal (5 mg) in Free Combination and Fixed-dose Combination as HCP1102 in Healthy Male Volunteers

Conditions
-----------------
Rhinitis

Intervention / Treatment
-----------------
* Drug: HCP1102
* Drug: Singulair and Xyzal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Age between 20 and 55 Signed informed consent Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypotension or hypertension Has a history of acute infection within 14 days of screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR<br>HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal | Drug: HCP1102<br> <br> * Other names: Singulair and Xyzal combination tablet;Drug: Singulair and Xyzal<br> <br> * Other names: coadministration of Singulair and Xyzal;|
| Experimental: RT<br>coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet) | Drug: HCP1102<br> <br> * Other names: Singulair and Xyzal combination tablet;Drug: Singulair and Xyzal<br> <br> * Other names: coadministration of Singulair and Xyzal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0-34hr | 
| Cmax |  | 0-34hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax |  | 0-34hr | 
| AUCinf |  | 0-34hr | 
| t1/2 |  | 0-34hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinitis
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study

Study Overview
=================
Brief Summary
-----------------
Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.

Detailed Description
-----------------
Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.

Official Title
-----------------
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study

Conditions
-----------------
Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician. Participants must be starting a new regimen of bioidentical hormone replacement therapy. Participants must be expected to receive therapy for at least 12 weeks. Participants must be between 30 and 65 years of age. Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf. Exclusion Criteria: Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription. Participants must not be pregnant or breastfeeding women. Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy. Participants must not be using another bioidentical hormone at the time of enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peri or post-menopausal women.<br>Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms. | The reduction of severity of vasomotor symptoms will be evaluated by utilizing the Menopause Rating Scale (MRS) from baseline to the end of study at 12 weeks. | 12 Week Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate health-related quality of life (HrQol) | The quality of life (HrQol) will be evaluated by utilizing the Women's Health Questionnaire (WHQ)at baseline and at end of study at 12 weeks. | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioidentical Hormone Replacement Therapy
Perception and Knowledge About Menopause Among Pakistani Woman

Study Overview
=================
Brief Summary
-----------------
This study is conducted to find out perception and knowledge about Menopause among Pakistani Woman.

Detailed Description
-----------------
The survey for was conducted in various location and clinics all over Pakistan. 1200 numbers of questionnaires were distributed of which 910 numbers responded from 1st January 2018 to 28th February 2018. Those who agreed to be part of study where ask a self-structured questionnaire related to awareness and symptoms of menopause. Data was analyzed using SPSS Version 23.0. Frequencies were calculated for categorical data.

Official Title
-----------------
Perception and Knowledge About Menopause Among Pakistani Woman

Conditions
-----------------
Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged 35 to 55 Oral Informed consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Find Perception and Knowledge of Menopause in Pakistani Woman | To find perception and knowledge of Menopause in Pakistani woman based on self-structured questionnaire | 0-28 days |
Expressive Arts as a Social and Community Integration Tool for Youth Recovering From Brain Injury

Study Overview
=================
Brief Summary
-----------------
This study utilizes a novel technique-expressive arts therapy-to facilitate social integration for youth recovering from acquired brain injury (ABI). Expressive arts therapy is defined as the use of the arts and artistic media to explore psychological aspects of life. An expressive art (also referred to as 'creative arts' or even just 'arts') encompasses drama, music, art (visual arts such as painting, sculpture etc) and dance/movement. It has great potential to improve community integration for youth recovering from ABI, through facilitating skills required for successful social communication and social cognition. It is hypothesized to improve social and emotional functioning compared to a less structured creative arts program. It is expected that a combination of directed group activities and self-reflection within a creative learning context will improve emotional awareness and social and community integration to a greater degree than a non-expressive creative arts therapy group, in youth who have suffered an ABIAs community integration enables meaningful and productive occupational engagement, enabling opportunities for occupational engagement through increased community integration would greatly enhance the quality of life of adolescents with ABI.

Official Title
-----------------
Expressive Arts as a Social and Community Integration Tool for Adolescents With Acquired Brain Injury: I Want to Thrive, Not Just Survive!

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Behavioral: Expressive Arts--Theatre Skills Training Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6 months post injury Difficulties in social and emotional functioning Entering Grades 10 and 11 in 2007 English fluency Exclusion Criteria: Extreme behaviour, mood and cognitive disturbance

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Expressive Arts--Theatre Skills Training Program|The experimental intervention was an intensive theatre skills training program. The group of adolescent participants recovering from ABI met daily for four hours over a period of 4 weeks. During this 4 hour period, regular breaks were scheduled to provide the participants with a mental and physical break from therapy. Theatre training included voice work, breathing, movement, physical warm-up, character development, script analysis, writing skills, three-dimensional awareness, group dynamics, story development, mask work and clowning among others.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |