linjc16/ctgov huggingface dataset:
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.

Official Title
-----------------
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: MTRX1011A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SAD Stage RA diagnosed according to the ACR For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period MAD Stage (same as above with the addition of the following) Failure of at least one biologic agent, defined as lack of or loss of response or intolerance Active disease defined by swollen and tender count Exclusion Criteria: Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected History of treatment with any T cell-directed therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: MTRX1011A|Subcutaneous and intravenous single and repeating dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of MTRX1011A in both the SAD and MAD stages |  | Length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the pharmacokinetic response of MTRX1011A |  | Length of study | 
| Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A |  | Length of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RA
Maternal Variables Associated With Adherence in Children With Asthma

Study Overview
=================
Brief Summary
-----------------
A questionnaire will be used in order to find out the reasons for poor adherence for long-term treatment in children with asthma. The hypotheses is maternal factors including the knowledge that asthma is a chronic disease and fear to administer inhaled steroids are major obstacles for appropriate adherence.

Detailed Description
-----------------
Parents to children aged 2 - 12 years with moderate to severe asthma who need long-term treatment with inhaled steroids will be included in the study. Three weeks after their visit in the clinic, they will be requested to answer a questionnaire by telephone.

Official Title
-----------------
Reasons for Poor Adherence for Long-Term Preventing Therapy in Children With Asthma

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents to children aged 2 - 12 years with moderate to severe asthma to whom inhaled steroids was described for a period of at least 4 weeks. Exclusion Criteria: Parents who will not agree to sign the consent form and parents who do not speak and understand the Hebrew language.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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
-----------------
Asthma, Children, Adherence, Maternal factors
PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients

Study Overview
=================
Brief Summary
-----------------
This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.

Official Title
-----------------
A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: DA-1229


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 70 Weights between 50 and 90kg(Female : 40 and 90kg) Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress Stable results of estimated GFR in 4 months recently Exclusion Criteria: Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder) Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction Volunteer who already participated in other trials in 2 months Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1(Severe decrease in GFR)<br>Severe decrease in GFR | Drug: DA-1229<br> <br> * Other names: Evogliptin;|
| Experimental: Group 2(Moderate decrease in GFR)<br>Moderate decrease in GFR | Drug: DA-1229<br> <br> * Other names: Evogliptin;|
| Experimental: Group 3(Mild decrease in GFR)<br>Mild decrease in GFR | Drug: DA-1229<br> <br> * Other names: Evogliptin;|
| Experimental: Group 4(Normal GFR)<br>Normal GFR | Drug: DA-1229<br> <br> * Other names: Evogliptin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve(AUC) last |  | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients
Stressors, Coping Methods and Social Support in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The increasing prevalence of diabetes brought great burden to health status of the investigators population. It is meaningful to investigate the stressor, stress perceived, social support and coping methods in diabetic population in order to provide appropriate assistance to these patients. This study will recruit diabetes patients from out-patient-department and they are invited to complete a questionnaire. The contents of the questionnaire including stress experienced, stress perceived, social support and coping methods. The investigators purpose is to find out the impact of these factors on glycemic controlled and their life quality. The results will be useful to diabetes care team when health education is delivered to patient.

Detailed Description
-----------------
Type 2 diabetes patient aged 30-80 y/o under oral hypoglycemic agents with clear conscious enable to answer questions properly who regularly follow up at our metabolism clinic is eligible. Patients are asked to complete a questions containing basic personal information, diabetes coping method Chinese version (DCM-C)questionnaire, social support and perceived stress scale.

Official Title
-----------------
Stressors, Coping Methods and Social Support in Diabetic Patients

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Aged 30-80 year old under oral hypoglycemic agents clear consciousness Exclusion Criteria: Type 1 diabetes Age below 30 and above 80 Insulin use Conscious not clear

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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
-----------------
stress, coping methods, social support, diabetes mellitus
The Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there is a family history of cardiomyopathy .Our aim is to study the genetics basis for these patients with cardiomyopathy with no clear etiology and who have a first degree family relative with cardiomyopathy as well.

Detailed Description
-----------------
A total of 950 blood samples will be collected from patients with idiopathic cardiomyopathy and their relatives and will be analysed for genetics analysis.

Official Title
-----------------
Open Labeled of the Study the Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic

Conditions
-----------------
Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of cardiomyopathy etiology not known family history of cardiomyopathy ability to understand and sign the informed consent Exclusion Criteria: refusal to participate pregnancy current participation in another active treatment study

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
familial cardiomyopathy, genetics analysis
Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to estimate the accuracy of the pre-operative VRI quantitative results versus the gold standard pre-operative perfusion scan. The secondary objective is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (forced expiratory volume in 1 second [FEV1] and diffusing capacity of the lung for carbon monoxide [DLCO]) in patients who underwent surgical resection.

Detailed Description
-----------------
Pre lung operation candidates for procedures such as lung volume reduction surgery (LVRS), lung resection, bullectomy and lung transplant are frequently evaluated for differential lung function by a semi quantitative lung scintigraphy. VRI may offer the same differential lung function information for the physician without the risks, time and patient discomfort of lung scintigraphy in the treating physician office. Moreover, VRI may provide a safe, quick and simple method to measure split function in lung cancer patients who are candidates for lung surgery. Thus eliminating the safety and complexity issue related with the current ventilation perfusion split function methods. In addition the VRI may aid in achieving the goal of developing strategies to reduce risk and maximize the number of patients that can benefit from surgical therapy.

Official Title
-----------------
Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure

Conditions
-----------------
Emphysema, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to read, understand, and provide written informed consent; Male or female in the age range of 18-80 years; Patients who were referred to perform perfusion scan for pre lung surgery evaluation such as LVRS, thoracotomy, bullectomy and lobectomy. Body mass index (BMI) > 21. Exclusion Criteria: Chest wall deformation; Spine deformation (including scoliosis); Hirsutism; Potentially contagious skin lesion on the back; Skin lesion that would interfere with sensor placement; (Keloids) Cardiac pacemaker or implantable defibrillator;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
Psychological Profile of Women With Infertility in Egypt: A Comparative Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the prevalence of psychological affection in infertile egyptian women

Detailed Description
-----------------
Comparative cross sectional study

Official Title
-----------------
Psychological Profile of Women With Infertility in Egypt: A Comparative Study

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

Intervention / Treatment
-----------------
* Other: hospital anxiety and depression scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Control group: Pregnant women. At least one live birth. Age group 20-40 years. Clinical group: Infertile women either primary or secondary according to (WHO,2013). Age group 20-40ys. Different levels of education. Different methods of treatment of infertility (medical or IVF) Half of them from rural area the other half from urban area. Exclusion Criteria: Male factor of infertility. The women with psychiatric disorders. The women with physical and medical disorders. The women whose current pregnancy has any problems (e.g. growth retardation, macrosomia, placenta previa, threatened abortion, or preterm labour). The women with history of intrauterine fetal death.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: hospital anxiety and depression scale|Detection of infertility effect on emotional status|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of the prevalence of depression among infertile women | questionnaire will be used to collect qualititiative data from women | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychological health, women, anxiety, depression
Understanding Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia.

Detailed Description
-----------------
The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia, for the potential development of more effective therapies for this disease.

Official Title
-----------------
Understanding Chronic Lymphocytic Leukemia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New and existing patients seen for treatment of monoclonal B-cell lymphocytosis Any low grade lymphoproliferative disorder Chronic Lymphocytic Leukemia in the Dana Farber Cancer Institute Hematologic Oncology Clinic or elsewhere Exclusion Criteria: -

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 |
| --- | --- |
| Sample Collection<br>Blood tests required for assessment Specimens and data will also be collected from outside sites Clinical data from patients with Chronic Lymphocytic Leukemia will be gathered into a database at Dana Farber Cancer Institute | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of novel genomic prognostic markers in Chronic Lymphocytic Leukemia | Exploratory science to better understand Chronic Lymphocytic Leukemia | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Lymphocytic Leukemia
Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

Study Overview
=================
Brief Summary
-----------------
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.

Official Title
-----------------
Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients who require treatment with longacting anticholinergic Exclusion Criteria: Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.

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 |
| --- | --- | --- |
| Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks | Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition) | Baseline and after 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the PF-10 Score After 6 Weeks | Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition) | Baseline and after 6 weeks of treatment | 
| Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety | Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications poor (1, 2), satisfactory (3, 4), good (5, 6), and excellent (7, 8)) | Baseline and after 6 weeks of treatment | 
| Patients' Satisfaction After 6 Weeks of Treatment | Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment (very satisfied, satisfied, rather satisfied, neither satisfied nor unsatisfied, rather unsatisfied, unsatisfied, and very unsatisfied) | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease (COPD)