linjc16/ctgov huggingface dataset:
Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor

Study Overview
=================
Brief Summary
-----------------
The purpose of the research study Heart Sounds at Home is for pregnant SSA or SSA/SSB (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

Detailed Description
-----------------
The study will enroll mothers during week 16-19 of gestation and will ask the mothers to use a hand-held Doppler monitor to listen to the baby's heart rate and rhythm twice daily from about week 16 to week 26 of the pregnancy. Pregnant mothers will be asked to keep a log of the heart rates and will undergo a fetal echocardiogram every 2 weeks during their study participation. In addition to these procedures, the study team will collect the mother's medical and obstetrical histories. Should irregular heart rhythms be detected at home, the mother will contact the investigator to be evaluated. After the baby is delivered, the study team will collect information about the baby's birth and heart rhythm evaluation (electrocardiogram).

Official Title
-----------------
Heart Sounds at Home: Prospective Maternal Surveillance of SSA Positive Pregnancies Using a Hand-Held Fetal Heart Rate Monitor

Conditions
-----------------
Sjogren's Syndrome, Neonatal Systemic Lupus Erythematosus, Fetal Heart Block Complete

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with positive SSA or SSA and SSB antibodies Gestational age (GA) between 16 and 19 weeks No signs of antibody-mediated fetal cardiac disease on pre-enrollment echo Exclusion Criteria: Subjects who are more than 19 weeks gestation Subjects who have a fetus with an estimated fetal weight below the 10th percentile will also not be included

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Development of Fetal AV (atrio-ventricular) heart block | Development of fetal AV heart block will be determined by the principal investigator's analysis of the fetal echocardiogram. | Date of randomization until the date of first documented progression, assessed up to 41 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal Systemic lupus erythematosus, Sjogren's syndrome, Fetal Atrioventricular Block, Fetal Heart Block
Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

Study Overview
=================
Brief Summary
-----------------
In patients with hgepatocellular carcinoma (HCC) and portal vein tumoral thrombosis (PVTT), Sorafenib represents the treatment of choice but more recently, trans-arterial radioembolization (TARE) with yttrium-90 has been also proposed. A considerable percentage of such patients are not only able to achieve stability of the disease, but also to obtain a complete radiological response (CR). The possibility of achieving a CR might allow these patients to be listed for liver transplantation (LT), in order to cure not only the cancer but also the underlying cirrhosis that generated it.

Official Title
-----------------
Trans-arterial Radioembolization in Patients With Hepatocellular Carcinoma and Portal Vein Tumoral Thrombosis

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Radiation: yttrium-90 radioembolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of HCC; age ≥ 18 years; performance status according to Eastern Cooperative Oncology Group 0-1; preserved liver function (Child-Pugh score ≤B7); PVTT limited to the first order portal branch. Exclusion Criteria: any contraindication to TARE treatment; macrovascular invasion extended to the main portal trunk and/or to the contralateral portal branch; presence of extra-hepatic disease

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

| Intervention/Treatment |
| --- |
|Radiation: yttrium-90 radioembolization|selective/superselective treatment using resin microspheres labeled with Yttrium-90|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to radioembolization | The primary endpoint of this study was to assess the effect of radioembolization in HCC patients with PVTT | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The secondary endpoint was overall survival (OS) | 5 years | 
| Progression-free survival | The secondary endpoint was progression-free survival (PFS) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, macrovascular invasion, portal vein thrombosis
A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety and efficacy of QTORIN 3.9% rapamycin anhydrous gel in the treatment of adults with Pachyonychia Congenita. This study includes a screening period, baseline period and 6-month treatment period.

Official Title
-----------------
A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita

Conditions
-----------------
Pachyonychia Congenita

Intervention / Treatment
-----------------
* Drug: QTORIN 3.9% rapamycin anhydrous gel
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Adult patients, 18 years or older (16 years or older in the UK) Diagnosed with Pachyonychia Congenita (PC), genetically confirmed Key Exclusion Criteria: Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications. Any significant concurrent condition (including conditions involving or inferior to the ankle) that could adversely affect the patient's participation and/or the assessment of the safety and efficacy in the study. Participation in any other interventional clinical research trial within 30 days prior to the screening visit or during the patient's participation in this study

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br> | Drug: QTORIN 3.9% rapamycin anhydrous gel<br>* QTORIN 3.9% rapamycin anhydrous gel<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Matching vehicle (QTORIN anyhydrous gel)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment of Activities Difficulty Scale |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at its worst as assessed by numerical rating scale |  | 6 months | 
| PROMIS physical function |  | 6 months | 
| Patient global impression of severity (PGI-S) |  | 6 months | 
| Patient global impression of change (PGI-C) |  | 6 months | 
| Clinician global impression of severity (CGI-S) |  | 6 months | 
| Clinician global impression of change (CGI-C) |  | 6 months |
Study on the Appropriateness of Bariatric Surgery in Adolescents

Study Overview
=================
Brief Summary
-----------------
single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.

Detailed Description
-----------------
This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.

Official Title
-----------------
Study on the Appropriateness of Bariatric Surgery in Adolescents

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Other: feasibility


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: failure of weight loss in an organized care> 6 months BMI > à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI > or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life. Patients must have completed their growth (bone age > 13 for girls and >15 for boys). The teenager and his legal representative must have given their informed consent. The subject must be affiliated to a social security scheme Exclusion Criteria: syndromic obesities tumor-induced obesity Patient with severe psychiatric disorders Patient with eating disorders Patients under judicial protection Patient under guardianship or curatorship Patient participating in another study

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
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 |
| --- | --- |
| adolescents<br>adolescents with morbid obesity | Other: feasibility<br>* feasibility<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| potential number of patients eligible for surgery | evaluate prospectively the potential number of patients eligible for surgery, among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, teenagers, co-morbidities, bariatric surgery, epidemiology
The Effect of Different Videolaryngoscopes on Intubation Success in Difficult Airway Patients

Study Overview
=================
Brief Summary
-----------------
Mallampati score > 3 generally indicate difficult airway and difficult intubation. Most anesthesiologist usually use this score system to predict difficult airway management. Different laryngoscopes may be useful in management of difficult airway. This study designed to compare different videolaryngoscopes in intubation success in patient of Mallampati score>3.

Official Title
-----------------
The Effect of Different Videolaryngoscopes on Intubation Success in Difficult Airway Patients

Conditions
-----------------
Mallampati Score, Difficult Intubation, Videolaryngoscope

Intervention / Treatment
-----------------
* Other: intubation time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mallampati score >3 Exclusion Criteria: patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| C-mac D blade used for intubation<br> | Other: intubation time<br>* intubation attempt number and intubation time<br>* Other names: intubation attempt;|
| mcgrath X blade used for intubation<br> | Other: intubation time<br>* intubation attempt number and intubation time<br>* Other names: intubation attempt;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time |  | 60 seconds |
Sleep Apnoea Syndrome Without Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
It is the objective of this study to collect scientific data of sleep apnoea syndrome patients´ cardiac and respiratory function by additional sensors.

Official Title
-----------------
Sleep Apnoea Syndrome Without Chronic Heart Failure

Conditions
-----------------
Sleep Apnoea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with supected sleep apnoea syndrome and scheduled diagnosis at a sleep laboratory male and female patients aged at least 18 years persons who understand and follow the instructions of the study staff singed informed consent Exclusion Criteria: persons being housed in an institution by court or governmental order pregnancy or breastfeeding patients who are not able to consent acute or chronic inflammations of the external and middle auditory canal abnormal anatomic proportionsof the external and middle auditory canal which are pathological or congenital, for example limitation of the auditory canal persons in a dependence or in an employment contract to the investigator participation in another study at the same time

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Data collection |  | 1 night |
Development of Method of Fructose Identification in Urine to Detect the Viral Infection

Study Overview
=================
Brief Summary
-----------------
The goal of this research is the attempt to implement a new research method based on modern electrochemistry successes, in particular the development of the polarographic method of fructose and fructose diphosphate identification and its implementation to detect the viral infection in early stage. There will be 20 samples from the HIV-infected patients and 30 samples from the heath controls. The study will collect 10ml urine and examined fructose and fructose-diphosphate using the polarographic method.

Detailed Description
-----------------
The goal of this research is the attempt to implement a new research method based on modern electrochemistry successes, in particular the development of the polarographic method of fructose and fructose diphosphate identification and its implementation to detect the viral infection in early stage.

Official Title
-----------------
The Development of Fast and Simple Method of Fructose Identification in Urine to Detect the Viral Infection in Early Stage

Conditions
-----------------
Human Immunodeficiency Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection Exclusion Criteria: who are in highly active antiretroviral therapy(HARRT) therapy
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 |
| --- | --- |
| HIV infection patient and health people<br>The study does not have intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform | This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection. 1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units. σ≧10 abnormal positive (+) σ<10 normal negative (-) | Participants provided urine samples once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, fructose
Population-based Estimates of Medical Comorbidities in Women With Lower Urinary Tract Symptoms or Pelvic Organ Prolapse

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the comorbidities of lower urinary tract symptoms or pelvic organ prolapse in a nationwide population-based data in Taiwan during the study period of 2001-2010, a total of 10 years.

Conditions
-----------------
Lower Urinary Tract Symptoms, Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases with lower urinary tract symptoms

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| lower urinary tract symptoms and pelvic organ prolapse<br> | |

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
-----------------
women
Peri-operative Foot CT Perfusion in CLI Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia

Official Title
-----------------
The Clinical Value of Quantitative Analysis of Peri-operative Foot Supply Through CT Perfusion in Patients With Critical Limb Ischemia

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Diagnostic Test: computed tomographic perfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old; CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization; Patients completed both pre- and post-operative CTP workups; Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months. Exclusion Criteria: Patients has participated in other clinical studies; Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate<60 ml/min) Any allergic constitution; Pregnancy and childbirth; Life expectancy<12 months.

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: computed tomographic perfusion|The recruited patients would complete both pre- and post-operative computed tomographic perfusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative computed tomographic perfusion parameters | Pre-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days before revascularization. | 18months | 
| Post-operative computed tomographic perfusion parameters | Post-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days ater revascularization. | 18months | 
| Alteration of computed tomographic perfusion parameters | Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters | 18months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse limb events | Major adverse limb events included major amputation or acute limb ishchemia for vasular causes. | 12months | 
| Major adverse cardiovascular events | Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes. | 12months |