linjc16/ctgov huggingface dataset:
Epidemiological Characteristics and Prognosis Factors of Cancer Patients Admitted at French Emergency Departments

Study Overview
=================
Brief Summary
-----------------
Patients with cancer or hematological malignancy are susceptible to present acute complications linked to their disease or to their specific treatments (dyspnea, sepsis, coma, hemorrhagic syndrome). Emergency physicians are in first line when these complications arise and have to face with some complex situations in which informations about patient malignancy or prognosis may be lacking. Nowadays, there is very few epidemiological data published concerning how cancer patient use Emergency Departments (EDs) and cancer patient care delivery in the EDs. Thus, an observational multicenter prospective cross-sectional study is conducted to study the prevalence of cancer patients admitted to French EDs, and to describe the different reasons for cancer patients to seek care in EDs with their prevalence and underscore those linked to cancer or treatment complication

Official Title
-----------------
Epidemiological Characteristics and Prognosis Factors of Cancer Patients Admitted at French Emergency Departments

Conditions
-----------------
Cancer Patients, Emergencies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (age >=18 years) with active malignancy or a history of cancer in remission within the last 5 years being attended in one of the 400 French emergency centers participating in the study during the 3-day study period Exclusion Criteria: opposition to participate

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 |
| --- | --- | --- |
| Reasons for cancer patients to seek care in EDs |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer location |  | 1 day | 
| hospitalisation rate |  | 1 day | 
| intensive care unit (ICU) admission |  | 7 days | 
| ICU mortality |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, emergency departments (ED)
Effect of Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
Investigator researched that the effect of trunk and lower extremity muscle strength on hamstring flexibility in children with Duchenne Muscular Dystrophy.

Detailed Description
-----------------
Thirty children were asessed by physical therapist. Nineteen children was Level 1 and eleven children was Level 2 according to Brooke Lower Extremity Functional Classification Scale.

Official Title
-----------------
Effect of Trunk and Lower Extremity Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy, Muscle Strength, Lower Extremity, Hamstring Contractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Getting a Duchenne Muscular Dystrophy diagnosis, Being in ambulatuar phases and independently climbing four stairs To be cooperate to physioterapist's directions Exclusion Criteria: Having severe contracture in the lower extremity Having undergone surgery in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| popliteal angle test | The popliteal angle test was performed to assess hamstring flexibility. The popliteal angle was measured in a supine position and the hip flexed 90°, and fixed by first physical therapist. Opposite knee and hip were placed in extension position. Then, the child was asked to rise lower leg straight. The incomplete angle for full extension of the knee was the popliteal angle. | 5 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trunk and lower extremity muscle strength test | Trunk and lower extremity muscle strength was assessed manual muscle strength and myometer. Any test was performed three times and best value was recorded. | 20 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duchenne Muscular Dystrophy, muscle strength, hamstring flexibility, back muscle, lower extremity
CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

Study Overview
=================
Brief Summary
-----------------
Primary objective: Pathological complete response (ypT0N0) rate Secondary objectives: Histopathological R0 resection rate Pathological downstaging (ypT0-T2N0) rate One month surgical complication rate Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes Safety Local and distant recurrence rates Progression-free survival Overall survival

Official Title
-----------------
Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Drug: Oxaliplatin, capecitabine, radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge) No evidence of distant spread No prior therapy for chemotherapy or radiation therapy for rectal cancer Patient considered locally advanced by MRI: Tumour beyond mesorectal fascia, or Tumour ≤ 2mm from mesorectal fascia, or T3 tumour < 5cm from anal verge For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception No peripheral neuropathy > grade1 ECOG PS ≤ 2 ANC > 1,500 x 10^9/L Platelets > 100,000 x 10^9/L Creatinine < 1.5 x IULN Bilirubin < 1.5 IULN SGPT (ALT) < 2.5 IULN No pre-existing condition which would deter chemoradiotherapy No uncontrolled diarrhoea or fecal incontinence No significant small bowel (> 200cc or 6X6X6cm) delineated within the radiation fields No other serious uncontrolled concomitant illness Informed consent signed The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Drug: Oxaliplatin, capecitabine, radiotherapy<br>* Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI staging and TME surgery |  | within 4 - 6 weeks after completion XELOX-RT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure safety - NCI-CTC version 2 |  | from baseline to end of study |
Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study

Study Overview
=================
Brief Summary
-----------------
It is well-established that myocardial infarction (MI) associated with coronary artery bypass graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective therapies to limit myocardial injury after CABG are lacking. Previous studies have shown that curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery and decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion injury in animal models. The investigators aim to evaluate whether curcuminoids prevent MI after CABG, compared to placebo.

Official Title
-----------------
The Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study

Conditions
-----------------
Coronary Artery Bypass Grafting

Intervention / Treatment
-----------------
* Dietary Supplement: Curcuminoids
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing CABG without valve surgery Exclusion Criteria: emergency cardiac surgery any increase in CK-MB above upper limit of normal range (ULN) at the time of randomization patients with cholestatic jaundice (total bilirubin > 2-fold ULN) severe liver disease (AST or ALT > 3-fold ULN)
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: Curcuminoids<br> | Dietary Supplement: Curcuminoids<br>* Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo in capsule form, 4 capsules 4 times/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative myocardial infarction |  | participants will be followed for the duration of hospital stay, an expected average of 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Coronary artery bypass grafting, Anti-oxidant, Curcuminoids
Risk Factors for Delirium in Critically Ill Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Delirium is characterized by changes in mental status, inattension, disorganized thinking, and altered consciousness. Prevalence of delirium in critically ill patients has varied from 20 80% depending on the severity of illness. Despite its high prevalence, delirium is often under-recognized by clinicians due to the difficulties in diagnosis and no interest. Delirium is associated with increased mechanical ventilation days, hospital length of stay, and mortality. The purpose of this study is to analyze the prevalence of delirium and risk factors for delirium in critically ill surgical patients.

Detailed Description
-----------------
The investigators performed a prospective cohort study involving the patients admitted to surgical ICU between april 2013 and august 2013. The included patients were assessed independently by trained ICU nurses using the confusion Assessment Method for the ICU (CAM-ICU). The patients were recorded general characteristics, disease-related factors, and treatment and environment-related factors. Data were analyzed by SPSS 12.0 software, using t-test, Fisher's exact test and logistic regression.

Official Title
-----------------
Risk Factors for Delirium in Critically Ill Surgical Patients

Conditions
-----------------
Delirium, Intensive Care Unit Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above RASS -3 paitent Verbally or nonverbally communication possible patients Exclusion Criteria: Under age 18 Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury Readmitted to ICU History of delirium Transplanted; isolation is required

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 |
| --- | --- |
| Delirium positive<br>delirium patients in critically ill surgical patients | |
| Delirium negative<br>non delirium patients in critically ill surgical patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevelance of delirium | Analyses were performed to delirium prevelance of SICU Patients | with in 6month in SICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors associated with delirium | Analyses were performed to compare patient, disease, treatment and environment-related factors | with in 6month in SICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium, Intensive care unit
The Diagnostic Value of Shear Wave Elastography

Study Overview
=================
Brief Summary
-----------------
Background: The main goal when diagnosing thyroid nodules, is to differentiate the few malignant from the overwhelming background of benign nodules. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic thyroid surgery is necessary. Therefore, there is a need to develope the diagnostic tools for pre-operative diagnostic work-up of thyroid nodules. The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules. Aim: To evaluate the diagnostic value of SWE in the pre-operative diagnosis of thyroid nodules in a tertiary surgical center. Perspectives: An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.

Official Title
-----------------
Shear Wave Elastography in the Diagnosis and Risk-stratification of Thyroid Nodules - a Prospective Study

Conditions
-----------------
Thyroid Nodule

Intervention / Treatment
-----------------
* Procedure: Shear Wave Elastography (SWE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nodules in the thyroid size more than 1 cm and patient undergoing thyroid surgery Exclusion Criteria: Not undergoing thyroid surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Shear Wave Elastography<br>All included patients have SWE performed | Procedure: Shear Wave Elastography (SWE)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity Index | Elasticity Index is obtained by SWE. | same day |
To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate whether urinary catheterization could be avoided for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus multi-site infiltration analgesia.

Conditions
-----------------
Urinary Catheter

Intervention / Treatment
-----------------
* Device: Urinary catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 40 years and older, who were scheduled for a primary TKA for end-stage osteoarthritis and those who were willing and able to return for follow-up over at least a 1-month postoperative period. Exclusion Criteria: Revisions, bilateral procedures, surgical history of urinary system, urinary tract infection and systematical conditions (renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery) needing intraoperative monitoring urine output.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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: Control Group<br>Patients with indwelling urinary catheter | Device: Urinary catheter<br> <br> |
| No Intervention: Study Group<br>Patients without indwelling urinary catheter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative urinary retention |  | 7 days | 
| Postoperative urinary tract infection |  | 7 days | 
| Urine volume |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | 14 days | 
| Intraoperative intravenous fluid |  | 1 day | 
| Duration of the surgery |  | 1 day |
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study

Study Overview
=================
Brief Summary
-----------------
To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use

Detailed Description
-----------------
To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) (hereinafter referred to as CALQUENCE) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use. This investigation will be conducted as the additional pharmacovigilance activity specified in the Japan Risk Management Plan (J-RMP) of CALQUENCE, in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices (PMD Act).

Official Title
-----------------
General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)

Conditions
-----------------
Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma) who are treated with Calquence for the first time will be enrolled in the study after the approval date of the sJNDA for the additional indication. - Exclusion Criteria: None -
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 |
| --- | --- | --- |
| Incidence of ADRs | the incidence of ADRs related to Calquence Safety Specifications : infection, bone marrow depression | 24 weeks |
Novel Treatment for Syndromic Ichthyoses

Study Overview
=================
Brief Summary
-----------------
This is an open label-pilot study to assess the efficacy and safety of a novel cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often times, these children have difficulty in finding easily applied treatments to make their psoriasiform and ichthyotic plaques more manageable. We propose the use of a cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it will lead to regression of involved areas and decreased erythema and warty-like appearance of the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for a 12 month study with a total of 5 visits and 5 phone calls.

Official Title
-----------------
Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses

Conditions
-----------------
Syndromic Ichthyoses, CHILD Syndrome, Smith Lemli Opitz Syndrome, Conradi Syndrome

Intervention / Treatment
-----------------
* Drug: Lovastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent form signed by the subject or subject's legal representative; also, if the subject is under the age of majority but capable of providing assent, signed assent from the subject. Diagnosis of a syndromic ichthyoses (verified by Dr Amy S. Paller). Children and adults 12 months of age and above Exclusion Criteria: Use of any investigational drug within the 30 days before enrollment. Current malignancy. Pregnancy or breastfeeding during the study. (All female subjects of childbearing potential will be assessed for pregnancy at all visits.)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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: Lovastatin solution<br>All patients will receive lovastatin solution | Drug: Lovastatin<br>* Topical lovastatin applied to red, rashy areas two times daily for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician global assessment of severity (PGAS) | Difference in physician global assessment of severity at baseline compared to month 12 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body surface area (TBSA) | Percent change in TBSA affected at baseline compared to at month 12 | 12 months |