linjc16/ctgov huggingface dataset:
MR in Patients With Collagen VI Related Myopathies

Study Overview
=================
Brief Summary
-----------------
Collagen VI-related diseases include Bethlem myopathy and Ulrich dystrophy. They are both caused by decreased levels or a lack of collagen VI. The first symptoms can be present at birth as joint laxity and hypotonic muscles; often seen with luxation of the hip and scoliosis. During childhood, patients may develop contractures of fingers, wrists, elbows and ankles. Muscle weakness often appears in childhood to early adulthood and is progressive. It often results in walking difficulties. There is no treatment available for Behtlem and Ulrich dystrophies. The primary aim of this study is to investigate the pattern of involved muscles, the function and quality of the muscles and the disease severity using MRI.

Detailed Description
-----------------
See above

Official Title
-----------------
MR in Patients With Neuromuscular Diseases

Conditions
-----------------
Bethlem Myopathy, Ullrich Disease

Intervention / Treatment
-----------------
* Other: Observeational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed Bethlem myopathy or Ulrich disease Exclusion Criteria: All contraindications for undergoing an MRI scan

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Persons with collagen VI defect<br>Observational | Other: Observeational<br>* No intervention, observational<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle fat fraction | The Dixon MRI will be used to quantify the fat fraction in skeletal muscle | One MRI scan pr subject (exam lasts approximately 60 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | MRC in order to test specific muscles in the subjects | Exam lasts approximately 40-60 min |
Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if the combination of gemcitabine and oxaliplatin chemotherapy will be effective in reducing or eliminating the tumor(s) in patients with recurrent or metastatic breast cancer. Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic and lung cancer; oxaliplatin is a chemotherapy drug that is approved by the FDA for the treatment of colon cancer. Neither gemcitabine nor oxaliplatin are approved for the treatment of breast cancer. However, both drugs have been shown to decrease the size of breast cancer tumors.

Official Title
-----------------
Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

Conditions
-----------------
Recurrent Breast Cancer, Metastastic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine and oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven dx of recurrent or metastatic breast cancer Must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. Patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease. Unidimensionally measurable dz (by RECIST) At least 18 yrs of age SWOG PS 0-2 AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 8.0 Total bilirubin less than or equal to 2 x uln; SGOT and/or SGPT and alk phos up to 2.5 x uln Creatinine less than or equal to 2.0 Fully recovered from acute toxicities secondary to prior tx Signed informed consent (including HIPAA authorization) Peripheral neuropathy grade 0-1 Exclusion Criteria Prior tx with gemcitabine or oxaliplatin. Prior tx with cisplatin or carboplatin allowed if completed >12 mos prior to enrollment. Underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx Peripheral neuropathy greater than or equal to Gr 2 Exclusion Criteria: -

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine and oxaliplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Termination of Early Pregnancy in Scarred Uterus With Lletrozole and Misoprostol Compared to Misoprostol Alone

Study Overview
=================
Brief Summary
-----------------
Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone

Official Title
-----------------
Termination of Early Pregnancy in Scarred Uterus With Letrozole and Misoprostol Compared to Misoprostol Alone

Conditions
-----------------
Termination of Early Pregnancy in Scarred Uterus

Intervention / Treatment
-----------------
* Drug: Letrozole 2.5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age of 18 years for mother. Non-viable fetus (missed abortion or blighted ovum) in the 1st trimester of pregnancy evidenced by criteria for diagnosis by TVS . Previous C.S or Myomectomy (1 or more ) lack of any maternal diseases such as: heart disease, asthma, history of thromboembolism, cancer, renal failure, and liver diseases. Exclusion Criteria: * Medical problem in patient Emergency conditions which need intervention . History of allergy to misoprostol or letrozole drugs.
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Missed abortion received letrozole then misoprostol<br> | Drug: Letrozole 2.5mg<br>* Missed abortion received letrozole then misoprostol<br>|
| Missed abortion received misoprostol alone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortion of early pregnancy with letrozole then misoprostol | Letrozole increase cervical ripening | 6 months |
Sleep Apnea and Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that pregnant women with gestational diabetes will have a high incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose control in these women.

Official Title
-----------------
Obstructive Sleep Apnea and Gestational Diabetes : Incidence and Effects of Continuous Positive Airway Pressure Treatment on Glucose Metabolism

Conditions
-----------------
Gestational Diabetes, Sleep Apnea

Intervention / Treatment
-----------------
* Device: Continuous positive airway pressure (S9, ResMed)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational diabetes Exclusion Criteria: pre-gestational diabetes

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP Intervention<br>Continuous positive airway pressure (S9, ResMed) | Device: Continuous positive airway pressure (S9, ResMed)<br> <br> |
| No Intervention: Wait-list<br>Wait list controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose tolerance | Measuring glucose, fructosamine and insulin levels following a mixed meal test at 0 and 2 weeks. Glucose and insulin will be measured at 0 minutes and every 30 minutes thereafter for 2 hours. Fructosamine will be measured at 0 minutes only. | two weeks |
Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores

Study Overview
=================
Brief Summary
-----------------
Aim of the work This study aims at; Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.

Official Title
-----------------
Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores

Conditions
-----------------
Anastomotic Leak

Intervention / Treatment
-----------------
* Diagnostic Test: Predictors of intestinal anastomosis leakage, application of new predictors and new scores


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with intestinal or colonic anastomosis either elective or emergent. Exclusion Criteria: Patients with inflammatory bowel disease will be excluded because this could influence plasma levels of inflammatory biomarkers. patients using corticosteroids Patients unfit for anaesthesia, those having collagen diseases or hematological disorders.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Predictors of intestinal anastomosis leakage, application of new predictors and new scores|Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early detection and management of intestinal anastomotic leak | Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leak(Intestinal fatty acid binding protein, Procalcitonin and CRP) with application of scoring scale(Dekker et al 2011) (Dulk et al ., 2013) to assess presence or absence of leakage. | 6 months |
Deep Learning Model for Diagnosis and Contour of Cervical Lymph Node for Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
The diagnosis of cervical lymph node in nasopharyngeal carcinoma is difficult. Magnetic resonance imaging based deep learning model may be a noninvasive and rapid diagnostic method for cervical lymph node. Thus, the investigators aimed to develop and externally validate a deep learning model to assist in the diagnosis and localization of metastatic lymph nodes in nasopharyngeal carcinoma.

Official Title
-----------------
Magnetic Resonance Imaging Based Deep Learning Model for Diagnosis and Contour of Cervical Lymph Node for Nasopharyngeal Carcinoma: a Multicenter Study

Conditions
-----------------
Deep Learning Model

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathological diagnosis of nasopharyngeal carcinoma; Cervival lymph nodes confirmed by pathology Exclusion Criteria: a history of cancer
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 |
| --- | --- | --- |
| Sensitivity and specificity |  | 2022-12-31 |
Predicting Normal vs. Carrier Status in Euploid Embryos of Translocation Carriers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the accuracy of predicting the normal or carrier status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a balanced translocation.

Detailed Description
-----------------
This study aims to evaluate the validity of using informative SNPs to distinguish balanced from normal embryos. This will involve acquiring material from families to set phase for informative SNPs, evaluation of existing and new embryo SNP array data, and follow up analysis of children born after applying the procedure.

Official Title
-----------------
Evaluation of the Accuracy of Predicting Normal or Carrier Status in Euploid Embryos Produced by Patients With Balanced Translocations

Conditions
-----------------
Balanced Chromosomal Translocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with balanced translocations who have undergone IVF Exclusion Criteria: those who do not wish to know their child(s) karyotype

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- |
| translocation carrier<br>balanced translocation carriers who have undergone IVF | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of correct predictions of normal vs. balanced ploidy status as compared to conventional karyotype |  | up to 12 months once pregnant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
translocation
Polypharmacy and Outcomes After Elective Noncardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study investigates the association of preoperative polypharmacy with outcomes and healthcare resource utilization in a population-based sample of older patients enrolled in a universal pharmacare program

Detailed Description
-----------------
Multilevel multivariable regression analysis will be used to investigate the adjusted association between preoperative polypharmacy and postoperative outcomes and healthcare resource utilization. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Official Title
-----------------
Association of Polypharmacy With Outcomes After Elective Noncardiac Surgery: a Population-based Cohort Study

Conditions
-----------------
Polypharmacy, Surgical Procedure, Operative, Morality, Epidemiology

Intervention / Treatment
-----------------
* Drug: Polypharmacy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intermediate to high risk elective non-cardiac surgery Age >=66 on day of surgery Exclusion Criteria: -

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polypharmacy<br>People taking >=5 unique prescription drugs in the 3 months prior to surgery | Drug: Polypharmacy<br>* Patients who are taking >=5 unique prescription drugs in the 3 months prior to surgery<br>|
| No polypharmacy<br>People taking <5 unique prescription drugs in the 3 months prior to surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | death from any cause | from day of surgery up to 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Patient with a complication based on clusters of ICD-10 Type 2 codes collected in the hospital record | From day of surgery to day of hospital discharge, up to 365 days after surgery | 
| Length of stay | Number of days in hospital after surgery | date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first | 
| Costs of care | Costs related to medical care paid for by the provincial health insurance system | date of surgery up to 90 days after surgery | 
| Institutional discharge | A discharge location at the end of the surgical episode of care that is not back to the patient's original residence (specifically respite or long term care) | date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first | 
| Hospital readmission | Acute hospital readmission after discharge from index hospitalization | From the date of hospital discharge to 30 days after the date of discharge |
Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Official Title
-----------------
A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217) Inhalation Solution
* Drug: Placebo - 0.9% w/v sodium chloride solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have confirmed diagnosis of cystic fibrosis Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height Be able to reproducibly perform spirometry maneuvers Be clinically stable for at least 4 weeks prior to screening Exclusion Criteria: Have abnormal renal or liver function Have chest x-ray at screening suggesting clinically significant active pulmonary disease Be colonized with Burkholderia cepacia Have had a lung transplant

Ages Eligible for Study
-----------------
Minimum Age: 5 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo - 0.9% w/v sodium chloride solution<br>* 4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.<br>|
| Experimental: 2<br> | Drug: denufosol tetrasodium (INS37217) Inhalation Solution<br>* Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary exacerbation |  | 48 weeks | 
| Requirements for concomitant CF medications |  | 48 weeks | 
| Quality of Life |  | 48 weeks |
Use of Virtual Reality in Pain Management in Pediatric Oncology

Study Overview
=================
Brief Summary
-----------------
DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.

Official Title
-----------------
Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial

Conditions
-----------------
Pediatric Tumor

Intervention / Treatment
-----------------
* Other: Virtual reality headset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who tolerates the virtual reality headset patient followed in pediatric oncology patient with a diagnosis of benign tumor or cancer patient who needs to have painful medical procedure during their treatment patient whose parents have signed the informed consent patient affiliated with social security or equivalent Exclusion Criteria: patient with visual or hearing impairement patient with epilepsy or other neurological disease patient with psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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
Interventional Model Description: intervention plus standard care versus standard care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients randomized in this arm will have the virtual reality headset associated to the standard care | Other: Virtual reality headset<br>* Each patient in this treatment group will use a virtual reality headset during 3 procedures. During each procedure, the pain level will be assessed and compared with the assessed group.<br>|
| No Intervention: Standard care<br>patients randomized in this arm will have standard care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self pain evaluation | Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain)) | before blood sampling on catheter with implantable chamber |