linjc16/ctgov huggingface dataset:
Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical

Study Overview
=================
Brief Summary
-----------------
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition. During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

Detailed Description
-----------------
Purpose : To create and validate a score predicting the diagnosis of HIT

Official Title
-----------------
Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)

Conditions
-----------------
Heparin-induced Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients presenting, either during or immediately after treatment: thrombocytopenia and/or venous or arterial thrombosis for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study Exclusion Criteria: do not possess sufficient clinical data prior to performance of the biological test cannot assure follow-up of the patient until normalization of the platelet count

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 |
| --- | --- | --- |
| the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests |  | inclusion and 40 days after the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathogenic nature of anti HPF4 antibodies of IgM and IgA type |  | inclusion | 
| new biological test detecting HIT |  | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIT, Heparin-induced thrombocytopenia, heparin treatment, venous thrombosis, arterial thrombosis, predictive clinical score, biological test, anti-H-PF4 antibodies
Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Collection of thermal images of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device (RI4.0), capabilities which will assist in early detection of breast cancer.

Official Title
-----------------
Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: female Age: 18 years and older Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination. Subject who have signed an informed consent form. Exclusion Criteria: Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, prior to being imaged by RI4.0. Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study. Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study. Subjects who have undergone a mastectomy. Subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident). Subjects with prior breast reduction surgery or breast augmentation surgery. Subjects who have a fever on the day of their biopsy. Subjects who are pregnant. Subjects who are breast-feeding.

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 |
| --- | --- | --- |
Assessement of the C-ARM ARCO FP-Rk521 S in Surgical Conventional Practice

Study Overview
=================
Brief Summary
-----------------
THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and its ability to be used during surgery.

Detailed Description
-----------------
Expected performance of TED developped technology compared to current equipment (intensifier tube) represent a significant improvement; especially in term of image rendering, irradiation dose reduction and ergonomy. THALES-EVAQUAL is a prospective,monocentric, unrandomized, and uncontrolled study which objective is to assess C-ARM ARCO FP-Rk521S in term of quality of image. It also evaluates its ability to be used during Orthopedic, neurological and neurological surgeries. Patient included in the study will have a surgery during which C-ARM is used. This study doesn't modify the medical care of the patient. After each surgery, a digital scale of image quality will be filled by the surgeon for each aquisition. Other feedback questionnaires regarding the suitability of the device and the satisfaction of the surgeon will also be completed.

Official Title
-----------------
Prospective Assessment of the Quality of the Image and the Usability of the C-ARM ARCO FP-Rk521S Used in Surgical Conventional Practice

Conditions
-----------------
C.Surgical Procedure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject having signed the non-objection form; Requiring one of the following surgical procedures: Urology: soft ureteroscopy, uteroscopy, sacral neuromodulation, JJ sent placement. Orthopedics: vertebroplasty, gamma nail placement, sacro-iliac screw fixation. Neurology: spinal surgery Exclusion Criteria: Subject who refuse to participate in the study; Who are under legal protection measure or unable to express their consent (guardianship, curatorship); Deprived of liberty by judicial or administrative decision.

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 |
| --- | --- |
| Use of C-ARM ARCO FP-Rk521S<br>C-ARM ARCO FP-Rk521S is mobile X-ray device that combines a X-Ray sensor and a sensor management software used during surgeries for real-time imaging. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital scale of image quality | Digital scale of image quality completed for each acquisition by the surgeon | up to 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C-arm, Medical Imaging Device, Radiological
Stenting of Haemodialysis Acces Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.

Official Title
-----------------
Stenting of Haemodialysis Acces Re-stenosis Trial (SHARE Trial)

Conditions
-----------------
Outflow Stenosis

Intervention / Treatment
-----------------
* Device: Viabahn stent-graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of 18 years of age Patients have a life expectancy of at least 2 years Signed informed consent Recurrent stenosis at the venous anastomosis or in the draining vein of a loop arterio venous fistula, within 2 cm from the anastomosis. Exclusion Criteria: Patient unsuitable for administration of contrast agent Pregnancy Dementia or altered mental status that would prohibit giving conscious informed consent Need for adjunctive major surgical or vascular procedures within one month

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
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>viabahn stent-graft | Device: Viabahn stent-graft<br>* The viabahn stent-graft is a combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based delivery system. It was originally designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. This device is also increasingly used for the exclusion of popliteal aneurysms. Its flexibility might make the device ideal for the treatment of recurrent outflow stenosis in AV loop-fistula.<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
-----------------
outflow stenosis, stentgraft
Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay

Study Overview
=================
Brief Summary
-----------------
A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.

Detailed Description
-----------------
Medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. Data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.

Official Title
-----------------
Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment

Conditions
-----------------
Developmental Disabilities, Feeding Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13 months to < 18 years of age on admission to facility Required enteral nutrition to meet 90% or more of their energy needs prior to switch to a Peptide based formula Received enteral nutrition with an intact protein formula for a minimum of two weeks prior to a switch to a Peptide based formula Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a Peptide based formula Have documentation of an assessment of feeding tolerance following the switch to a Peptide based formula Formulas received must be indicated for use in children or adults (not infant formulas). Exclusion Criteria: Recent abdominal surgery, change in tube position/placement (within past 30 days) Cow's milk protein allergy Any current infections including upper respiratory, viral, gastroenteritis, wound infection.

Ages Eligible for Study
-----------------
Minimum Age: 13 Months
Maximum Age: 17 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 |
| --- | --- | --- |
| Feeding tolerance after switching to Peptide based formula | Categorized as no change, tolerance improved, tolerance worsened. | up to 30 days post formula switch | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake of target feeding volume | Documentation of feeding volume after switch as less than, about the same as, or more than feeding volume achieved before switch. | up to 30 days post formula switch | 
| Feeding intolerance parameter(s) identified before switch to Peptide based formula and feeding tolerance parameter(s) improved by switch. | Intolerance Parameter's: Gagging/retching, vomiting, high residuals, abdominal distention/ gas, stool consistency issues (too hard, too loose). | up to 30 days post formula switch |
Endoplasmic Reticulum Stress in Chronic Respiratory Diseases

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate whether ER stress is implicated in the pathogenesis of various pulmonary disorders Measurement: Unfolded protein responses (UPRs) in blood (PBMCs)of patients CHOP GRP 78 and so on Unfolded protein responses (UPRs) in blood (PBMCs)of healthy controls CHOP GRP 78 and so on

Official Title
-----------------
Endoplasmic Reticulum (ER) Stress in Patients With Various Chronic Pulmonary Diseases

Conditions
-----------------
ER Stress,, Chronic Airway Disorders,, Lung Cancer,, Interstitial Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 yrs Definitive diagnosis as chronic pulmonary diseases by physician Exclusion Criteria: Any other chronic medical illness such as DM, HTN, and other malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Control group<br>healthy control group | |
| Disease group<br>asthma, COPD, ILD, lung malignancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Baby Bump Lifestyle Intervention Supplement Study

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.

Official Title
-----------------
Baby Bump Lifestyle Intervention Supplement Study

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

Intervention / Treatment
-----------------
* Dietary Supplement: Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman presenting to her first obstetrical visit for this pregnancy Must be in the first trimester (<13 weeks) 18 years or older High-stress levels as measured by the Perceived Stress Level Questionnaire Must be a single pregnancy (e.g. not twins, triplets, etc.) Exclusion Criteria: Diabetes (types 1 and 2) Diagnosis of gestational diabetes in prior pregnancy Hyperemesis gravidarum or severe morning sickness that interferes with supplement intake Major medical illnesses including but not limited to: malabsorption syndromes (Celiac's disease, Crohn's, Ulcerative Colitis), Systemic Lupus Erythematosus and other major autoimmune conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo supplement | Dietary Supplement: Supplement<br>* Supplement will be given to this group to take daily for 8 weeks<br>|
| Experimental: Supplement<br>actual supplement | Dietary Supplement: Supplement<br>* Supplement will be given to this group to take daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower blood stress markers via venous draw | We hypothesize that the addition of nutrients during gestation will decrease the levels of stress hormones/reactants in pregnant women who are at high risk for stressful pregnancies. | 9 months |
Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.

Official Title
-----------------
Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial

Conditions
-----------------
Hip Dislocation, Congenital, Congenital Deformity of Hip Joint

Intervention / Treatment
-----------------
* Other: Pavlik Brace
* Other: Plastizote Brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0-2 months of age Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound Exclusion Criteria: Ages greater than 2 months Neurological condition Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound Chromosomal abnormality

Ages Eligible for Study
-----------------
Maximum Age: 2 Months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plastizote Brace<br> | Other: Plastizote Brace<br>* Plastizote Brace<br>|
| Active Comparator: Pavlik Brace<br> | Other: Pavlik Brace<br>* Pavlik Brace<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of instability | Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage | 3-4 week interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of instability | Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage | 6 month interval |
Quetiapine Efficacy in Bipolar Depression Study

Study Overview
=================
Brief Summary
-----------------
To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are diagnosed as bipolar depression

Official Title
-----------------
A 8-Week, Multicenter, Open-Label, Observational Study of the Efficacy of Quetiapine Fumarate (SEROQUEL) Immediate-Release Tablets in Adult Patients With Bipolar Depression

Conditions
-----------------
Bipolar Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent Meet DSM-IV-TR criteria for bipolar depression at the time of baseline Exclusion Criteria: Since this programme intends to describe quetiapine use in routine clinical practice when prescribed as treatment of bipolar depression, there are no programme specific exclusion criteria, other than: Or, any of the following is regarded as a criterion for exclusion from the programme: Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history Known intolerance for or lack of response to quetiapine, as judged by the investigator

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?
-----------------
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
-----------------
Bipolar depression, quetiapine, observational, Naturalistic