linjc16/ctgov huggingface dataset:
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2 diabetes in overweight girls.

Official Title
-----------------
Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes

Conditions
-----------------
Abdominal Obesity, Physical Activity

Intervention / Treatment
-----------------
* Other: Control
* Other: Resistance Exercise
* Other: Aerobic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy overweight (BMI >-95th) youth between 12 and 18 years of age Waist circumference >-75th percentile Sedentary (no structured exercise >2 times/week for past 6 months) Non-smokers, non-diabetic, no medical conditions Weight stable for past 3 months Exclusion Criteria: Smokers Diabetes Psychiatric disorders Syndromic obesity Pregnancy Taking medications known to affect study outcomes

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Standard care control (no-exercise) | Other: Control<br>* Standard care control (no exercise)<br>|
| Active Comparator: Aerobic Exercise<br> | Other: Aerobic exercise<br>* Supervised aerobic exercise using treadmills, bikes, and ellipticals<br>|
| Active Comparator: Resistance Exercise<br> | Other: Resistance Exercise<br>* Supervised resistance exercise using stack weight equipments.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal obesity, visceral fat |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity by a 3-hour hyperinsulinemic-euglycemic clamp, oral glucose tolerance test, liver fat and intramyocellular lipid by 1H-magnetic resonance spectroscopy. |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Regular exercise
Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up …) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.

Official Title
-----------------
Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

Conditions
-----------------
Ovarian Reserve

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female 18-39 years suffering from breast cancer treated with adjuvant or neoadjuvant chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| young women with breast cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients | Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Ovarian reserve, Anti-Mullerian Hormone (AMH), Chemotherapy
Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia

Study Overview
=================
Brief Summary
-----------------
Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear but may be attributed to an autonomic nervous reflex induced by catheterization of the ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia and catheter stimulation might be a support cause of these SCRE. Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma are prospectively included in this observational study. Endovascular procedures are performed under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium. SCRE are strictly pre-defined and included arterial hypotension, bradycardia and bronchospasm. SCRE are recorded and the factors influencing their occurrence are investigated.

Official Title
-----------------
Prospective Analysis of Serious Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep and Standardized Anesthesia

Conditions
-----------------
Retinoblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: superselective ophthalmic artery chemotherapy for retinoblastoma required Exclusion Criteria: no

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 15 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 |
| --- | --- | --- |
| Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma. |  | from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes. |
Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Study Overview
=================
Brief Summary
-----------------
A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.

Official Title
-----------------
An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.

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

Intervention / Treatment
-----------------
* Drug: Budesonide inhalation suspension
* Drug: Montelukast Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 2 to 8 at study entry At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in Exclusion Criteria: Severe or unstable asthma any significant finding at a physical exam an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Budesonide inhalation suspension | Drug: Budesonide inhalation suspension<br>* 0.5mg<br>* Other names: Pulmicort Respules;|
| Active Comparator: 2<br>Montelukast sodium | Drug: Montelukast Sodium<br>* 4mg or 5mg<br>* Other names: SINGULAR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids |  | Each clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Severity of Adverse Events |  | Each clinic visit | 
| Time to 1st additional asthma medication measured at 12 weeks and 26 weeks |  | Each clinic visit | 
| Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks |  | Each clinic visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Pulmicort, Children, paediatrics, budesonide
EARLY-MYO-CMR-II Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to depict the myocardial tissue characteristics in NSTEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 2000 NSTEMI patients in 10 sites. Subjects will be followed for up to 5 years.

Detailed Description
-----------------
This is a prospective, multi-center, non-randomized, observational registry study of NSTEMI patients that undergo CMR examination. Information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 2000 NSTEMI patients in 10 sites with follow-ups of up to 5 years. The aim of the project will be as following: To investigate myocardial pathological features and functional changes in NSTEMI patients. To identify CMR-derived indices that are associated with adverse clinical outcomes. To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in NSTEMI patients. To compare myocardial tissue characteristics and functional changes in STEMI (data derived from EARLY-MYO-CMR) and NSTEMI patients. To verify GRACE Score classification in NSTEMI from CMR imaging view.

Official Title
-----------------
EARLY-MYO-CMR-II (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in NSTEMI) Registry

Conditions
-----------------
Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSTEMI patients who have had CMR imaging performed and have provided written consent. Patient older than 18 years old with non-ST-segment elevation myocardial infarction (NSTEMI): Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, One of the two following criteria: New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram, Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal, Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements. Exclusion Criteria: Patient who is unable to comply with the follow-up schedule. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study. Patient has a life expectancy of less than 6 months due to any condition.

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 |
| --- | --- | --- |
| Major adverse cardiac events(MACE) |  | 1 year |
Bexarotene Treatment in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on severity of psychopathology, cognitive impairment, and quality of life in schizophrenia patients in an open label trial. The rationale behind add-on oral bexarotene to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis (Goodman, 1995) and the growth factors deficiency and synaptic destabilization hypothesis (Moises et al, 2002) of schizophrenia. In this clinical trial, a novel regimen of low dose bexarotene (Targretin, 75 mg/day) will be added for 6 weeks to the standard treatment of 15 schizophrenia patients on stable antipsychotic treatment. Participants will be assessed at baseline and after 2, 4 and 6 weeks of treatment. A battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.

Official Title
-----------------
Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: bexarotene (Targretin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 schizophrenia stable blood parameters normal baseline fasting triglyceride ability to sign informed consent Exclusion Criteria: lipid abnormalities leukopenia or neutropenia organic brain damage (mental retardation) alcohol or drug abuse renal disease hepatic dysfunction history of pancreatitis thyroid axis alterations suicide attempt in past year cataracts systemic treatment with more than 15,000IU vitamin A daily patients with known hypersensitivity to bexarotene or other components of the product pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: bexarotene (Targretin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schedule for Assessment of Mental Disorder |  |  | 
| The Positive and Negative Syndrome Scale |  |  | 
| Montgomery and Äsberg Depression Rating Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bexarotene, schizophrenia, psychopathology, cognitive impairment, quality of life, open lable trial
Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

Detailed Description
-----------------
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.

Official Title
-----------------
Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts

Conditions
-----------------
Thoracoabdominal Aneurysm, Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Endovascular Aneurysm Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age. Not pregnant Willing and able to comply with two-year follow-up period. Willing and able to give informed consent prior to enrollment No known allergy to stainless steel or polyester No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately. Life expectancy greater than two years High risk candidate for open surgical repair Exclusion Criteria: see above

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular Aneurysm Repair<br>Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts | Device: Endovascular Aneurysm Repair<br>* Endovascular exclusion of aneurysm<br>* Other names: Cook Zenith;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Aneurysm Rupture | Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan | 2 years |
A Reversal in the Vascularity of Metastatic Liver Tumors From Colorectal Cancer After the Cessation of Anti-VEGF Therapy

Study Overview
=================
Brief Summary
-----------------
Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer. Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking. Methods: The study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently underwent liver resection. CEUS was performed before and immediately after 4 courses of chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34 antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined.

Official Title
-----------------
A Reversal in the Vascularity of Metastatic Liver Tumors in Patients With Colorectal Cancer After the Cessation of Anti-VEGF Therapy: A Study Using Contrast-enhanced Ultrasonography and Histological Techniques.

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who received chemotherapy (FOLFOX) including bevacizumab. The patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bevacizumab including chemotherapy<br>Patients treated with bevacizumab including chemotherapy for metastatic liver tumor derived from colorectal cancer before metastasectomy. | |
| no adjuvant chemotherapy<br>Patients with no adjuvant chemotherapy including bevacizumab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery.

Official Title
-----------------
Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Device: PainShield
* Device: Sham PainShield


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject's Age ≥ 18 Subject is able, agrees and signs the Informed Consent Form Subject requires laparoscopic-assisted abdominal surgery Incision size following the laparoscopy between 4-7 cm Exclusion Criteria: Epidural analgesia IV PCA Subject has any condition, which precludes compliance with study and/or device instructions Subject is currently participating in another clinical 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Device: PainShield<br> <br> |
| Sham Comparator: 2<br> | Device: Sham PainShield<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort will be measured using appropriate validated questionnaires. |  | Pain assessment will be performed daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections will be assessed by concomitant antibiotic intake |  | Concomitant medications will be assessed daily | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic-assisted surgery, abdominal, pain relief, wound healing, low intensity ultrasound