linjc16/ctgov huggingface dataset:
Study of Prospective Assessment of Living Kidney Donors: Pre and Post Donation

Study Overview
=================
Brief Summary
-----------------
This is a prospective assessment of 80 living kidney donors.

Official Title
-----------------
Study of Prospective Assessment of Living Kidney Donors:Pre and Post Donation

Conditions
-----------------
Kidney Donation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donors are suitable candidate for living donation Male or female donors minimum 21 years maximum 65 years of age Donors has been fully informed and has given written informed consent Exclusion Criteria: Donors has diabetes mellitus or hypertension. Donors is pregnant or breastfeeding. Donors is known to be HCV,HBV,HIV positive or has significant liver disease. Donors with malignancy or history of malignancy. Donors has systemic or localized major infection. Donors is participating or has participated in another clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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
-----------------
assess the safety of living kidney donation
Caudal Blockade and Electrocardiographic Changes

Study Overview
=================
Brief Summary
-----------------
Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. This study will look at the delayed effects of a caudal epidural block on the electrical activity of the patient's myocardium by trying to characterize the incidence of ECG changes within 60 minutes after the caudal dose is given.

Official Title
-----------------
Caudal Blockade and Electrocardiographic Changes

Conditions
-----------------
Regional Anesthesia Morbidity

Intervention / Treatment
-----------------
* Diagnostic Test: Electrocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA grade 1 or 2 Receiving general anesthesia with a caudal block Exclusion Criteria: Preexisting cardiac comorbidities

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Caudal block<br>Patients that receive regional anesthesia in the form of a caudal block prior to surgery as part of their standard of care. | Diagnostic Test: Electrocardiogram<br>* 12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.<br>* Other names: EKG;|
| Control<br>Patients who do not receive a caudal block. | Diagnostic Test: Electrocardiogram<br>* 12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.<br>* Other names: EKG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in T wave amplitude | Change in T wave amplitude on the ECG tracings | Baseline to 60 mins. post caudal | 
| Change in T wave width | Change in T wave width on the ECG tracings | Baseline to 60 mins. post caudal |
A Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis

Study Overview
=================
Brief Summary
-----------------
The control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative analgesia after shoulder arthroplasty.

Official Title
-----------------
A Randomized Controlled Non-inferiority Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: intra-articular local anesthetic infiltration
* Procedure: inter-scalene block
* Drug: Ropivacaine 2 %


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shoulder arthroplasty Osteoarthritis Consent Exclusion Criteria: Previous surgery in the same shoulder

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IAL<br>intra-articular local anesthetic infiltration with catheter | Procedure: intra-articular local anesthetic infiltration<br>* intra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter<br>Drug: Ropivacaine 2 %<br>* 20 ml of Ropivacaine 2 %<br>|
| Active Comparator: ISB<br>interscalene block with catheter | Procedure: inter-scalene block<br>* inter-scalene block with 20 ml of Ropivacaine 2 % and catheter<br>Drug: Ropivacaine 2 %<br>* 20 ml of Ropivacaine 2 %<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean postoperative pain |  | during the 48 first hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications dues to anesthesia procedure |  | At 12 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder arthroplasty
Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.

Detailed Description
-----------------
The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight. The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.

Official Title
-----------------
Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all infant must be under 1250 gram birth weight Exclusion Criteria: Major congenital anomaly, CardiaC abnormality, without inform consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 2 Days

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clarithromycin<br>Fist group treated with clarithromycin which is include 10 days application. | Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia<br> <br> * Other names: Claprum;|
| Placebo Comparator: placebo<br>Second group treated with salin as same as amount of clarithromycine volume | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonary dysplasia | On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia | 28. day of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | During to hospitalisation the investigator will determine and record some co-morbidities of BPD such as intracranial hemorrhage, necrotizing enterocolitis, patent ductus arteriosus rates.From date of randomization until the end of the hospitalisation up to the 3 months of life. | Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchopulmonary dysplasia, clarithromycin, preterm babies
Study of Transplant Related Anemia Treated With Aranesp® (STRATA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.

Official Title
-----------------
Study of Transplant Related Anemia Treated With Aranesp® (STRATA)

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Aranesp®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria: - Expected to initiate dialysis or transplantation or be scheduled for a kidney transplant within 6 months of study start, or have less than 1 year life expectancy - Systemic hematologic disease, myeloma, hemolytic anemia, or malignancy (excluding basal cell carcinoma) - Active systemic or chronic infection - Uncontrolled hypertension defined as diastolic blood pressure greater than 110 mm Hg on 2 separate occasions during the 2 weeks prior to screening - Known hypersensitivity to Aranesp® or any of the product's excipients - Disorders that compromise the ability of the subject to give written informed consent and/or to comply with study procedures - Use of any erythropoietic protein or androgen therapy within the 12 weeks prior to screening - Females who are pregnant or breast-feeding - Currently enrolled in or received treatment in an investigational drug/device trial within the past 30 days - Have previously been enrolled in this study - Recent history (within 12 weeks prior to screening) of severe cardiovascular events, grand mal seizure, dialysis or major surgery - Have received a red blood cell transfusion(s) within 8 weeks prior to screening, or currently have active bleeding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aranesp®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin values |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 summary and individual domain scores at week 24 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant, Renal transplant, Aranesp®, Darbepoetin alfa, Amgen, Q2W dosing, Q4W dosing
Rubella Susceptibility in Multiparous Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the reasons why multiparous women (women who are pregnant and have been pregnant before) might still be susceptible to rubella.

Detailed Description
-----------------
This study is designed to investigate why multiparous women might still be susceptible to rubella. All pregnant women are checked for rubella immunity, and if they are non-immune, there are standard orders in our hospital to administer the rubella vaccine on the post-partum floor prior to discharge home from the hospital. Despite this, some multiparous women are found to be susceptible (non-immune), and this study will explore the reasons for this.

Official Title
-----------------
Rubella Susceptibility in Multiparous Women

Conditions
-----------------
Rubella, Vaccine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All rubella susceptible women who delivered during the study period.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum, rubella, rubella vaccine, immunity
miRNA (microRNA) and FGF21 (Fibroblast Growth Factor-21) Profile in First Trimester and Gestational Diabetes Prediction

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups. Participants will be retrieved blood sample during first trimester and undergone 100 gm OGTT (oral glucose challenge test) during 24-28 weeks of gestation.

Detailed Description
-----------------
Pregnant women who attended antenatal care at Maharaj Nakorn Chiang Mai hospital during first trimester were recruited. Participants received routine standard prenatal care except, additional blood test during 11-13 week 6 days (Blood was collected for further analysis) performed 75gm OGTT during 24-28 week Baseline data and pregnancy outcome were reviewed.

Official Title
-----------------
miRNA and FGF21 Profile in First Trimester and Efficacy of Gestational Diabetes Prediction and Pregnancy Outcomes

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Other: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnant women who attend at our clinic in first trimester Exclusion Criteria: known underlying disease such as chronic hypertension, pregestational diabetes, SLE normal structural fetal anatomical screening incomplete obstetric data
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 |
| --- | --- |
| Pregnancy with GDM<br>Pregnant women who positive test for 100gm OGTT (abnormal 2 or more blood glucose level according NDDG (National Diabetes Data Group) criteria) | Other: blood draw<br>* Blood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management<br>|
| Pregnancy without GDM<br>Pregnant women who negative test for 100gm OGTT | Other: blood draw<br>* Blood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA profile | miRNA profile in first trimester of pregnancy and efficacy for GDM prediction | within 1 month after blood drawn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FGF21 profile | FGF21 profile in first trimester of pregnancy and efficacy for GDM prediction | 6 months after blood drawn |
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.

Study Overview
=================
Brief Summary
-----------------
The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit. Output data is collected on a PC. By measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. The study will assess changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.

Detailed Description
-----------------
Medical Device Development

Official Title
-----------------
Effect Of Menstrual Cycle On Vaginal Blood Flow (As Determined By The Heat Wash-Out Technique) Before, During And After Visual Sexual Stimulation In Pre-Menopausal Healthy Women.

Conditions
-----------------
Sexual Dysfunction, Physiological

Intervention / Treatment
-----------------
* Device: Vaginal Heat Wash-Out Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles. Subjects must be void of Female Sexual Disorder. Exclusion Criteria: Pregnant or lactating women Postmenopausal subjects Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Heat Wash-Out Device<br> | Device: Vaginal Heat Wash-Out Device<br>* No drug administered. Device tested three times with each subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation. |  | 28d | 
| To assess the safety and toleration of the heat washout device. |  | 28d | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle. |  | 28d |
Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: M518101
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who are able and willing to give signed informed consent Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator. Who have ≥20% of body surface area (BSA) afflicted with plaques Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. Exclusion Criteria: Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity. BMI > 32.0 kg/m2 Who are pregnant or lactating. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study. Whose serum calcium levels exceed the upper limit of reference range Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization. Who have taken any durg with known effects on calcium metabolism within 30days of randomization Who have been treated with any drug with a known risk of QT prolongation within 30days of randomization.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Proper quantity twice a day<br>|
| Active Comparator: M518101<br> | Drug: M518101<br>* Proper quantity twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of M5181 |  | 0, 1, 2, 4, 6, 9 12h after dosing | 
| Peak Plasma concentration (Cmax) of M5181 |  | 0, 1, 2, 4, 6, 9 12h after dosing |