linjc16/ctgov huggingface dataset:
International Registry and Biorepository for TMA(Thrombotic Microangiopathy)

Study Overview
=================
Brief Summary
-----------------
This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA) annually from pediatric patients with thrombotic mcroangiopathy

Detailed Description
-----------------
Children age, 6 months - 18 years, are eligible if they have one of the following categories of thrombotic microangiopathy (TMA):(1) severe D+HUS; (2) non-familial atypical HUS; (3) familial atypical HUS; or (4) TTP Patients are seen intially and annually thereafter Biosamples are collected for storage annually.

Official Title
-----------------
An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients

Conditions
-----------------
Thrombotic Microangiopathy, Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe HUS, familial or non-familial atypical HUS, TTP Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3<br>Familial atypical HUS | |
| 4<br>Thrombotic thrombocytopenic purpura (TTP) | |
| 1<br>Severe diarrhea-associated hemolytic uremic syndrome (D+HUS) | |
| 2<br>Non-familial atypical HUS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine epidemiology and outcomes of the various forms of TMA |  | Ongoing | 
| Determine genetic causes of TMA |  | Ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiate clinical trials in TMA |  | In the future | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombotic microangiopathy (TMA), Hemolytic uremic syndrome (HUS), Thrombotic thrombocytopenic purpura (TTP)
Pediatric Microbiome Study With Children Now Approximately 8-10 Years Old.

Study Overview
=================
Brief Summary
-----------------
Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology.

Official Title
-----------------
The Evolution of the Skin Microbiome of Children Approximately Ages 8-10 Years of Age

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be the biological mother of a child (approximately age 8-10 years) enrolled in the study All subjects are to have normal healthy skin and no presence of pre-existing or dormant dermatologic skin conditions; Willing to use only the provided cleansing product during the washout time period; Willing to refrain from topical product use on the skin for the duration of the study. Topical products that should not be used include moisturizers, lotions, sunscreens, oils, tanners; Willing to refrain from swimming, using hot tubs, excessive sun exposure or tanning beds during the course of this study; Exclusion Criteria: Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer) a

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>Children 8-10 years of age | |
| Biological Mothers<br>Biological mothers of children now ages 8-10 years of age | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial Community Diversity for Children | Swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial Community Diversity for Adults | swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index | Day 1 | 
| Microbial Community Richness for Children | swabs will be collected from the skin for analysis to determine the total number of different bacterial taxa detected | Day 1 | 
| Microbial Community Richness for Adults | swabs will be collected from the volar forearm, forehead and cheek for analysis to determine the total number of different bacterial taxa detected | Day 1 | 
| Skin Barrier Function | Trans Epidermal Water Loss (TEWL) will be used to assess the skin barrier function | Day 1 | 
| Skin pH | skin pH will be assessed by pH meter | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microflora, microbiome, bacteria taxa
An Investigational Drug Co-Administered With Insulin in Patients With Type 2 Diabetes (0478-065)

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the effectiveness and tolerability of an investigational drug in patients with type 2 diabetes (a specific type of diabetes) who are not currently treated with insulin.

Detailed Description
-----------------
The duration of treatment is 30 weeks.

Official Title
-----------------
A Study to Assess the Efficacy and Tolerability of MK0478 (Muraglitazar, Also, BMS 298585) Coadministered With Insulin in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: MK0478 (muraglitazar)
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People between the ages of 18 and 70 who have a specific type of diabetes called type 2 diabetes which is currently being treated only with oral medication(s). (Patients currently taking insulin would not be allowed to participate.) Exclusion Criteria: People who have specific diseases (such as liver disease, gallbladder disease, pancreatitis, severe blood disorders or history of neoplastic diseases) which will be discussed by the study doctor and for which study participation would not be allowed.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0478 (muraglitazar)|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in daily dose requirements of insulin after 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (a) HbA1C; (b) FPG; (c) Percent of patients with HbA1C <7.0%; (d) TG, HDL-C, non-HDL-C and apolipoprotein B; (e) Free Fatty Acids (FFA); (f) the incidence of hypoglycemic events at 24 weeks |  |  |
The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery

Detailed Description
-----------------
Comparing ventilation with PEEP (positive end expiratory pressure) to ventilation with PEEP and alveolar recruitment, we expect that alveolar recruitment will reduce the incidence of pulmonary complication in patients undergo laparoscopic surgery. Ventilation with only PEEP is generally not enough to reduce postoperative pulmonary complication effectively.

Official Title
-----------------
The Effect of Alveolar Recruitment Maneuver on Postoperative Pulmonary Complications in Laparoscopic Surgery

Conditions
-----------------
Postoperative Pulmonary Complication

Intervention / Treatment
-----------------
* Procedure: Alveolar recruitment maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, ASA I-II, scheduled to elective laparoscopic surgery Exclusion Criteria: Chronic lung disease Cardiovascular disease ASA class ≥ III Receiving ventilation therapy or received within 6 months Refusal of participation in study or failure in informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No alveolar recruitment maneuver<br>Applying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O | |
| Active Comparator: Alveolar recruitment maneuver<br>Applying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O. In addition to this, performing alveolar recruitment maneuver at 2 moments: before surgical incision, end of pneumoperitoneum | Procedure: Alveolar recruitment maneuver<br>* Applying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complication | Performing lung ultrasound to evaluate if pulmonary complication is occurred | Immediately after entering PACU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alveolar recruitment, laparoscopic surgery
Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting

Study Overview
=================
Brief Summary
-----------------
The implementation of lifestyle modifications, home blood pressure (BP) measurement, and optimization of antihypertensive drug therapy have been shown to improve BP control in tightly controlled research settings. The investigators objective is to determine the effect of these interventions in a primary care setting, with the family practitioners and nurses serving as the interventionists. The investigaotrs hypothesis is that a comprehensive intervention performed in a primary care setting would lead to better blood pressure control.

Official Title
-----------------
Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Intensive Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 35-74 years Untreated office blood pressure of ≥ 160/100 mmHg or on active antihypertensive treatment. Exclusion Criteria: Severe psychiatric or neurologic illnesses Heart failure (ejection fraction < 40% or previous hospitalization for heart failure) Hemodynamically significant valvular disease Unstable coronary heart disease Chronic kidney disease (proteinuria > 1 g/l or a serum creatinine concentration > 160 mmol/l)

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 74 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients in this arm received a comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance. | Other: Intensive Care<br>* Comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance<br>|
| No Intervention: Control<br>Patients randomized in this group did not receive any intervention and treatment continued according to conventional practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Office Systolic and Diastolic Blood Pressure |  | Baseline and at 12 Months. |
The Influence of Hearing Discrete Phonemes in Mother's Voice in the Infant's Natural Environment and With Natural Melody on Developing Phonetic Categories Between 4-10 Months Old

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to record voice samples of infant's mothers, process in samples to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and then test the infants in a conditioned head turning test in lab, and to analyze the results.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal newborn infants males and females age 4 months to 10 months old Exclusion Criteria: chronic illness hearing loss history of otitis media serious otitis media

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 10 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lifestyle counseling<br>in the future parents will be advised to expose their infants to phonetic sounds in order to develop their phonetic categories in the future | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response by head-turning test to familiar and unfamiliar phonetic categories |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy normal infants
Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Patients Undergoing General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The investigators evaluate the relation of perioperative anxiety and heart rate variability, also the impact of general anesthesia on the change of heart rate variability.

Official Title
-----------------
Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Psychologically Normal Patients Undergoing General Anesthesia

Conditions
-----------------
STAI, Heart Rate Variability, SDS, General Anesthesia, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatocellular carcinoma patients Exclusion Criteria: uncontrolled hypertension uncontrolled diabetes mellitus known autonomic nerve dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| Heart rate variability |  | change from baseline in HRV at 10 minutes after induction of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI score |  | change from baseline in HRV at 10 minutes after induction of general anesthesia |
Randomized Clinical Trial for Comparison Of Intravenous Carbeitocin Versus Oxytocin In Management Of Placental Delivery In Second Trimester Interruption

Study Overview
=================
Brief Summary
-----------------
Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption.

Conditions
-----------------
CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED

Intervention / Treatment
-----------------
* Drug: Carbetocin
* Drug: oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:16-50 years Pregnancy duration: 14-24weeks Spontaneous abortion or medical induced abortion at 14-24weeks Exclusion Criteria: Age less than 16years and more than 50 years Surgical termination Placenta previa Uterine fibroid

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbetocin and placebo<br>100microgram carbetocin IV and 1cc normal saline(placebo)infusion | Drug: Carbetocin<br> <br> * Other names: pabal;Drug: oxytocin<br> <br> * Other names: syntocinon;|
| Experimental: oxytocin and placebo<br>20Interntional unit oxytocin infusion and 1cc normal saline IV | Drug: Carbetocin<br> <br> * Other names: pabal;Drug: oxytocin<br> <br> * Other names: syntocinon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record duration of spontaneous placental expulsion after delivery of fetus in second trimester interruption |  | at the time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of blood loss in each group by weighing all pads put under the patient after delivery of fetus tell expulsion of placenta( before and after using of pads). |  | at time of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CARBETOCIN AND OXYTOCIN AND SECOND TRIMESTER INTERRUPTION
Evaluation of the Impact of Stress on IVF Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if physiological measures of stress, measured by the non-invasive OTO device, are significantly correlated with IVF outcome.

Detailed Description
-----------------
The OTO device is a wearable device that utilizes multiple methods of electrophysiology to identify the impact of stress on humans. The device consists of the OTO sensor, a belt with two electrode pads worn around the chest, one electrode placed on the thenar of the dominant hand and one electrode placed on the forehead; the sensor pairs with the OTO App via Bluetooth. It tracks 54 physiological properties including temperature, HRV, amplitude frequency analysis (AFA) of ECG and DC potential. This data is analyzed by the proprietary OTO Expert System which creates the overall conclusions on levels of stress, functional reserves, adaptive capacity and level of readiness to additional stressors. Physiological data will be collected from the study participant using the OTO device for the duration of one IVF and frozen embryo transfer (FET) cycle. Study participants will complete questionnaires online related to perceived stress at the beginning and the end of study participation. Study participant's IVF cycle treatment and outcome data will be collected and analyzed in conjunction with the physiological data collected with the OTO device.

Official Title
-----------------
An Evaluation of the Relationship Between Physiological Parameters of Stress and In Vitro Fertilization Outcome

Conditions
-----------------
Stress, Physiological, Infertility, Stress, Psychological

Participation Criteria
=================
Eligibility Criteria
-----------------
Women age 25-40 years old Planning to undergo their first IVF cycle with frozen embryo transfer at one of the participating fertility clinics Have access to the internet and own a smartphone Ability and willingness to wear the OTO device for a few minutes each morning during their IVF and FET cycle Able to read and speak English No medical history of cardiac arrhythmias No cardiac surgery within a year of study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| Physiological Stress | Physiological stress will be measured using the non-invasive OTO device, which tracks 54 physiological properties including temperature, hear rate variability (HRV), amplitude frequency analysis (AFA) of electrocardiogram (ECG) and direct current (DC) potential. | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, Infertility, OTO, In-vitro fertilization, Inception, Stress, Omegawave, FET, Frozen embryo transfer