linjc16/ctgov huggingface dataset:
Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to develop a prognostic tool to assess the risk of dead and major complications in patient admitted to hospital for infection. A detailed database of clinical, biochemical and microbiological data is recorded and each item is analyzed and compared with clinical outcomes to develop a prognostic score.

Official Title
-----------------
Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: al least 18 years old admission to hospital for any infection for more than 72 hours Exclusion Criteria: pregnancy

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 |
| --- | --- | --- |
| mortality |  | at 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major complications |  | at 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, score
Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Methods: 51 women were prospectively divided into two groups, according to the symptoms as SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min Pad Test. Subjective [urine stream interruption test (UST), visual survey of perineal contraction and transvaginal digital palpation] and objective (vaginal manometry) evaluations of PFM were performed in all patients.

Official Title
-----------------
Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence. A Prospective Trial

Conditions
-----------------
Urinary Incontinence, Stress, Urge Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of stress urinary or urgency incontinence Exclusion Criteria: neurological diseases previous pelvic surgeries diabetes cognitive difficulties vaginal and urinary infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Group 1<br>Patients with stress urinary incontinence | |
| Group 2<br>Patients with urgency urinary incontinence. | |

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
-----------------
pelvic floor evaluation,, women,, stress urinary incontinence;, urgency urinary incontinence.
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: tocilizumab [RoActemra/Actemra]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients at least 18 years of age with moderate to severe active RA for at least 6 months; inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs; stable DMARD therapy for at least 8 weeks before entering study; patients of reproductive potential must be using reliable methods of contraception. Exclusion Criteria: major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study; patients who have previously failed treatment with an anti-tumor necrosis factor agent; women who are pregnant or breast-feeding.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* 8mg/kg iv every 4 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* iv every 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 20 response |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 50 and ACR 70 responses. |  | Week 24 | 
| Mean changes in parameters of ACR core set |  | Week 24 | 
| AEs, laboratory parameters, vital signs. |  | Throughout study |
Environmental & Genetic Influences on Vitamin D Status

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of environmental and genetic influences on Vitamin D status.

Detailed Description
-----------------
Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is solar exposure, with cutaneous synthesis of vitamin D by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin D can be made by solar exposure. Surprisingly, Vitamin D deficiency has been described in people dwelling in southern Florida and in surfers in Hawaii. We hypothesize that genetic variations in vitamin metabolism accounts for these differences.

Official Title
-----------------
Environmental & Genetic Influences on Vitamin D Status

Conditions
-----------------
Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to consent and come for a study visit. Male or female between ages 18-60. Sun exposure >3 hours daily for at least 5 days weekly for the last 3 months. Exclusion Criteria: Unable to consent or come to a visit Taking Vitamin D supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with Vitamin D metabolism. Related to another participant by blood.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Sun exposed people<br>Sun exposure >3 hours daily for at least 5 days weekly for the last 3 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH)D levels | 25(OH)D levels were measured at the only visit | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic testing of 13 candidate genes | 13 candidate genes were tested and their relationship to 25(OH)D examined. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D deficiency, Sun, Genetics
A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

Study Overview
=================
Brief Summary
-----------------
LIPO-102 is under evaluation for treatment of abdominal adiposity

Official Title
-----------------
A Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

Conditions
-----------------
Weight

Intervention / Treatment
-----------------
* Drug: LIPO-102
* Drug: LIPO-102 Low
* Drug: LIPO-102, Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 50 years old inclusive Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS BMI < 25kg/m sq Stable diet and exercise and body weight Exclusion Criteria: Prior treatment of abdominal subcutaneous adipose tissue Females within 12 months postpardum Known hypersensitivity to the drugs or components

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIPO-102 High<br> | Drug: LIPO-102<br>* LIPO-102 High dose<br>|
| Experimental: LIPO-102, Low<br> | Drug: LIPO-102 Low<br>* LIPO-102 Low dose<br>|
| Placebo Comparator: LIPO-102; Placebo<br> | Drug: LIPO-102, Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events | 8 weeks treatment and 1 week follow up | 
| Change in abdominal circumference | abdominal circumference | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| photographic assessment | abdominal circumference and volume reduction assessment | 8 weeks | 
| Abdominal subcutaneous adiposity questionnaire | Patient reported outcome | 8 weeks | 
| Patient and clinician photo numeric scale | patient and physician reports of change | 8 weeks | 
| Patient global assessment of severity scale | patient reports of change in severity | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of abdominal adiposity
FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible. After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle. In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy. Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy. Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.

Official Title
-----------------
Phase II Study of FOLFOXIRI as Primary Treatment for Stage III Unresectable Locally Advanced Pancreatic Cancer

Conditions
-----------------
Pancreatic Carcinoma Stage III

Intervention / Treatment
-----------------
* Drug: FOLFOXIRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III unresectable pancreatic cancer defined for: extended encasement of superior mesenteric artery or celiac axis/hepatic artery both arterial and venous (portal vein/superior mesenteric vein) encasement unreconstructible vessel encasement ECOG Performance Status 0-1 Age 18-75 Adequate liver, renal and bone marrow function Exclusion Criteria: Evidence of distant metastases Cardiovascular diseases Contraindications to studied drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: FOLFOXIRI<br> | Drug: FOLFOXIRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radical resection rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Within 24 months |
Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

Study Overview
=================
Brief Summary
-----------------
The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.

Official Title
-----------------
Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Biological: Biological sample
* Procedure: Non invasive Arterial investigations
* Procedure: Abdominal tomodensitometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman 18 to 70 years old Renal transplant Dead donor or alive donor Immunosuppression including a calcineurin inhibitor Written consent Exclusion Criteria: MultipleTransplant Morbid Obesity (Body Mass Index (BMI)> 40 kg/m2 sc) Cardiac Arrhythmia Lower limbs occlusive arterial disease Impossibility to understand the information form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Transplant<br> | Biological: Biological sample<br> <br> Procedure: Non invasive Arterial investigations<br> <br> Procedure: Abdominal tomodensitometry<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid-femoral pulse wave velocity |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sectional carotid stiffness |  | 12 months | 
| Carotid intima-media thickness |  | 12 months | 
| Endothelial function |  | 12 months | 
| Arterial calcification |  | 12 months | 
| Pulsed central veinous pressure |  | 12 months | 
| Klotho concentration |  | 1 day | 
| FGF23 concentration |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial stiffness, Klotho-FGF23
Lung Screening Study

Study Overview
=================
Brief Summary
-----------------
RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung cancer in patients who are at high risk for the disease. PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.

Detailed Description
-----------------
OBJECTIVES: I. Compare the efficacy of screening spiral CT scan and screening chest x-ray in detecting lung cancer in current or former smokers at high risk for lung cancer. OUTLINE: This is a randomized, multicenter study of lung cancer screening. Patients are randomized to one of two screening arms. Arm I: Patients undergo one spiral CT scan. Arm II: Patients undergo one chest x-ray. Patients and their primary care physicians are notified of test results within 3 weeks of the exam. PROJECTED ACCRUAL: A total of 3,000 participants (1,500 per screening arm) will be accrued for this study at six screening centers (500 per center) by October 31, 2000.

Official Title
-----------------
Lung Screening Study

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: bronchoscopic and lung imaging studies
* Procedure: comparison of screening methods
* Procedure: computed tomography
* Procedure: radiography
* Procedure: study of high risk factors


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: See General Eligibility Criteria PATIENT CHARACTERISTICS: Age: 55 to 74 Patients with a cigarette smoking history of at least 30 pack-years Current smoker OR Smoker who has quit smoking within the past 10 years No known prior history of lung cancer PRIOR CONCURRENT THERAPY: No concurrent therapy for any cancer except nonmelanomatous skin cancer No prior removal of any portion of the lungs No concurrent participation in other cancer screening trial, including PLCO No concurrent participation in a primary cancer prevention trial other than a smoking cessation trial

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bronchoscopic and lung imaging studies|nan|
|Procedure: comparison of screening methods|nan|
|Procedure: computed tomography|nan|
|Procedure: radiography|nan|
|Procedure: study of high risk factors|nan|

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
-----------------
non-small cell lung cancer, small cell lung cancer
Assessment of the Benefit of Teleconsultations for Children With Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals

Conditions
-----------------
Autism Spectrum Disorder, Child Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents of medico-social structures accepting children and adolescent with autism disorders Exclusion Criteria: Refusal of parents that their child use telemedicine Refusal of parents that their child participate to the research

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group with teleconsultation - before period<br> | |
| Group without teleconsultation - before period<br> | |
| Group with teleconsultation - after period<br> | |
| Group without teleconsultation - after period<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score: CARS, VABS evaluated once a year and ADI-R at least once in the lifetime | Score equals 1 if all three evaluations are performed, 0 otherwise | One year after the start of the before period and one year after the start of the after period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Health economics