linjc16/ctgov huggingface dataset:
Prevalence of Musculoskeletal Disorders of Upper Limb in Type 1 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
Osteopenia and osteoporosis, particularly related to insulinopenia, are common in type 1 diabetes and increase the risk of fractures. Musculoskeletal disorders of the upper limb are a common complication of type 1 diabetes. However, there is no official recommendation for screening for musculoskeletal disorders in France.

Detailed Description
-----------------
The aim of the study is to describe prevalence of musculoskeletal disorders of upper limb in type 1 diabetes patients.

Official Title
-----------------
Prevalence of Musculoskeletal Disorders of Upper Limb in Type 1 Diabetes Patients

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female aged of 18 and more with type 1 diabetes agreeing to participate in the study Exclusion Criteria: none

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 1 diabetes<br>type 1 diabetes group: patients with type 1 diabetes | Other: Data collection<br>* Description: musculoskeletal disorders of upper limb evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| musculoskeletal disorders of upper limb | musculoskeletal disorders of upper limb evaluated using Quick Dash (Quick Disabilities of Arm, Shoulder and Hand). Quick Dash is a 11 items questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level. The score ranges from 0 (no disability) to 100 (most severe disability), a higher score indicates a greater level of disability and severity, whereas, lower score indicates a lower level of disability. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
musculoskeletal disorders, prevalence
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy

Study Overview
=================
Brief Summary
-----------------
Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen saturation (ScvO2) in the treatment of severe sepsis and septic shock.

Official Title
-----------------
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Severe Sepsis and Septic Shock Therapy

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Procedure: volume resuscitation, vasoactive drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe sepsis and septic shock patients Exclusion Criteria: <18 years old pregnant and breast-feed woman AMI cerebral hemorrhage contraindication for central venous catheter or arterial catheter; brainstem death

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: △PCO2/Ca-vO2<br>△PCO2/Ca-vO2 directed group | Procedure: volume resuscitation, vasoactive drug<br> <br> |
| Experimental: ScvO2<br>ScvO2 directed group | Procedure: volume resuscitation, vasoactive drug<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 30 days |
Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

Study Overview
=================
Brief Summary
-----------------
This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers. The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.

Official Title
-----------------
Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

Conditions
-----------------
Medical Termination of Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult women (≥ 18 years old) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy Patients for whom the physician decides to use a Mifegyne 600 mg and prostaglandin analogue combination for medical abortion Patients agreeing to participate in the study after having been informed orally by the physician and given the information sheet Informed patients accepting the computer processing of their medical data and their right of access and correction Exclusion Criteria: Patients with known hypersensitivity to mifepristone Patients with known hypersensitivity to prostaglandin analogues (misoprostol or gemeprost). Patients with severe and progressive disease Patients with ectopic pregnancy

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

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

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 |
| --- | --- | --- |
| success rate of the protocol Mifegyne and prostaglandin analogue | The success rate will be defined as complete abortion without surgical procedure | At the follow-up at 2-3 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the protocol Mifegyne and misoprostol per os. | The success rate will be defined as complete abortion without surgical procedure | at the follow up at 2-3 weeks after the inclusion | 
| rate of ongoing pregnancy by term. |  | at the follow up at 2-3 weeks after the inclusion | 
| rate of patients requiring any additional procedures by term. |  | at the follow up at 2-3 weeks after the inclusion | 
| Number of medical abortion using misoprostol | The number of medical abortion using misoprostol will be described. | at the follow up at 2-3 weeks after the inclusion | 
| Evaluation by patients of pain using a 5 level verbal rating scale | Physician will ask patients to evaluate the pain by a 5 level verbal rating scale. the using of pain killers will be also described | at the follow up at 2-3 weeks after the inclusion |
Scorpio Non Restricted Geometry (NRG) Study in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship between these parameters and clinical outcomes will be evaluated as well as the importance of rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes and perform the same or better than other total knee implants.

Official Title
-----------------
The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: Scorpio NRG posterior stabilized (PS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who is candidate for primary total knee arthroplasty (TKA). Patient who has diagnosis of osteoarthritis or rheumatoid arthritis. Patient who is age 20 or over. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form. Patient who is willing and able to comply with postoperative scheduled evaluations. Exclusion Criteria: Patient who has a bacterial infectious disease or has a risk high of a bacterial infection. Patient who requires revision surgery. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 40. Patient who is or may be pregnant female. Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy). Patient who is immunologically suppressed or receiving chronic steroids. Patient who is judged ineligible with specific reason by primary doctor.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Scorpio NRG<br> | Device: Scorpio NRG posterior stabilized (PS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Range of motion(ROM) |  | Pre-operation, intraoperative, 6 months and 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Japanese Orthopaedics Association (JOA) score, |  | Pre-operation, intraoperative, 6 months and 1 year after surgery | 
| Change in Knee Society Score (KSS) |  | Pre-operation, intraoperative, 6 months and 1 year after surgery |
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.

Detailed Description
-----------------
The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes

Official Title
-----------------
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer

Conditions
-----------------
Recurrent or Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: SPARC1613
* Drug: Reference1613


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has given written, informed consent and is available for the duration of study Histologically or cytologically confirmed diagnosis of breast cancer Male or female aged ≥ 18 years Females subjects of child-bearing potential must have a negative urine pregnancy test Female subjects must be non-lactating and non-breastfeeding Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing Exclusion Criteria: Known hypersensitivity to either of the study drugs or their excipients Inability to undergo venipuncture and/or tolerate venous access Pre-existing clinically significant peripheral neuropathy Positive laboratory exclusion test (HIV, HBsAg, or HCV) Treatment with investigational agents or participation in clinical trial within 30 days of study entry

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1613<br>Intravenous administration of SPARC1613 | Drug: Reference1613<br>* Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)<br>|
| Active Comparator: Reference 1613<br>Intravenous administration of Reference1613 | Drug: SPARC1613<br>* Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) |  | Pre-dose,post dose upto 3 days |
Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid

Study Overview
=================
Brief Summary
-----------------
The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.

Official Title
-----------------
Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Dietary intervention (without dairy products)
* Other: Dietary intervention (high milk content)
* Other: Dietary intervention (high cheese content)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males BMI 20-28 mg/m2 Exclusion Criteria: Smoking Medicine use Dietary supplements Lactose intolerance, milk allergy Dislike of dairy products Excessive physical activity (> 10h/wk) Known chronic illnesses

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control diet<br>Diet without dairy products | Other: Dietary intervention (without dairy products)<br>* Control diet without dairy products<br>|
| Experimental: Milk diet<br>Diet with a high content of milk | Other: Dietary intervention (high milk content)<br>* Diet with a high content of milk ( 1200 mg Ca/d from milk)<br>|
| Experimental: Cheese diet<br>Diet with a high content of cheese | Other: Dietary intervention (high cheese content)<br>* Diet with a high content of cheese ( 1200 mg Ca/d from cheese)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal fat excretion | Total excretion of fecal fat (grams/day)avaraged over five days | During day 10-14 in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total, HDL and LDL cholesterol |  | Day 1 and 14 in each period | 
| Triglycerides |  | Day 1 and 14 in each period | 
| Appetite sensation |  | Assessed on day 1, 8 and 14 in each period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity prevention, appetite regulation, hyperlipidemia
Oral Morphine Versus Ibuprofen

Study Overview
=================
Brief Summary
-----------------
Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.

Official Title
-----------------
Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study

Conditions
-----------------
Upper Extremity Fractures, Analgesia Post Fracture

Intervention / Treatment
-----------------
* Drug: Oral morphine
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: patients with known hypersensitivity to either ibuprofen or morphine chronic users of NSAIDS or opioids fractures requiring operative management associated injuries requiring analgesia poor English fluency pregnancy Inclusion Criteria: All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 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 |
| --- | --- |
| Active Comparator: Ibuprofen<br> | Drug: Ibuprofen<br>* Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department<br>|
| Experimental: Oral morphine<br> | Drug: Oral morphine<br>* oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faces Pain scale - revised | The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs. | 30 minutes post intervention compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetaminophen doses | The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fracture, pediatric, oral morphine, ibuprofen
Coronary Spasm Presenting Aborted Sudden Cardiac Death, the Multicenter Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the natural course of coronary spasm patients presenting aborted sudden cardiac death and analyze risk factors.

Official Title
-----------------
The Multicenter Registry to Evaluate the Natural Course of Coronary Spasm Patients Presenting Aborted Sudden Cardiac Death

Conditions
-----------------
Coronary Vasospasm, Cardiac Death

Intervention / Treatment
-----------------
* Other: coronary spasm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and more Coronary spasm Exclusion Criteria: Life expectancy less than 2years Coronary stenosis 50% and more Structural abnormalities of the heart leading to ventricular arrhythmia

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 |
| --- | --- |
| coronary spasm<br> | Other: coronary spasm<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death |  | 1 year | 
| myocardial infarction |  | 1 year | 
| ventricular tachycardia |  | 1 year | 
| ventricular Fibrillation |  | 1 year |
Institut Paoli Calmettes Cervical Cancer Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer

Conditions
-----------------
Uterine Cervical Neoplasms

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of cervical cancer Exclusion Criteria: Non applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Patients with cervical cancer diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with cervical cancer | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |