linjc16/ctgov huggingface dataset:
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients

Study Overview
=================
Brief Summary
-----------------
The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients

Detailed Description
-----------------
Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?

Official Title
-----------------
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Other: recombinant erythropoietin injection
* Other: placebo injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 to 65 years old Patient with an ASA 1 or 2 (ASA 1 corresponding to a patient in perfect health and ASA 2 to a patient with moderate involvement and well controlled organ function) patient presenting at least one of the following fractures: Basin and / or femur with surgical indication, associated or not with other fractures. patient with hemoglobin between 9 and 13 g / dl at the time of admission on trauma department Exclusion Criteria: patient with contraindication to synthetic erythropoietin Patient with intravenous iron contraindication pregnant patient or with a risk of pregnancy patient who has not given his consent or does not understand the protocol Patient with hemodynamic instability patient participating in another research protocol for less than 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erythropoietin (EPO) group<br> | Other: recombinant erythropoietin injection<br>* Intravenous injection of 300 international units (IU) per kg (kg) of recombinant erythropoietin with a maximum of 20.000 IU, daily for a maximum of 10 days (D0 to D9).<br>|
| Placebo Comparator: Placebo (PLA) group<br> | Other: placebo injection<br>* Intravenous injection 0,9% saline solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of administered red blood cells |  | Day 30 |
A Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Before prostate puncture, the patient's serum was collected for PHI detection, and multi-parameter MRI was performed to obtain the PI-RADS score. The sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically significant prostate cancer were explored.

Detailed Description
-----------------
This study is a multi-center prospective study. Patients who meet the indications for prostate puncture and whose PSA is in the gray area (4.0 10.0 ng/mL) undergo standard prostate biopsy. The patient's serum was collected for PHI detection before puncture, and multi-parameter MRI was performed before puncture. To explore the sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically meaningful prostate cancer. Assess the benefit of combining PHI and mpMRI before biopsy compared with phi or mpMRI alone. Formulate clinical recommendations for PHI and mpMRI.

Official Title
-----------------
A Prospective, Multicenter Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected prostate cancer Patients can perform standardized prostate biopsy Exclusion Criteria: Have a history of prostate cancer Use of drugs that affect PSA before blood sampling

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Health Index | PHI is a simple, FDA-approved blood test that helps determine the probability of detecting prostate cancer with a biopsy. This test uses an algorithm to assess total PSA, free PSA, and p2PSA, | 1 year | 
| PI-RADS score | In PI-RADS, based on the comprehensive manifestations of prostate T2WI, DWI and DCE, a scoring method is given for the possibility of clinically significant prostate cancer. Specifically: 1 point: very low, extremely unlikely to exist; 2 points: low, impossible to exist; 3 points: moderate, suspicious existence; 4 points: high, may exist; 5 points: very high, extremely likely to exist. | 1 year | 
| Prostate biospy pathology | The pathological results of prostate puncture are used as the gold standard for the diagnosis of prostate cancer, indicating whether the patient is really suffering from prostate cancer | 1 year |
Improved Screening for Osteoporosis

Study Overview
=================
Brief Summary
-----------------
Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and deterioration of bone microarchitecture , leading to increased fracture risk for low trauma, such as spinal fractures or femoral neck . It is estimated that 3 million people are living in France , particularly women , with an incidence that increases with age . This disease is a major public health issue in terms of morbidity and mortality , costs and risk of recurrence (after a first fracture episode) , including risk factors are identified. However, although bone densitometry is a reliable diagnostic tool and preventive treatments are at our disposal, screening for osteoporosis is still insufficient . The objective of our study is to improve the detection of osteoporosis in Hospital Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone densitometry or if risk factors are found. Based on the results , the patient will be sent in rheumatology consultation for implementation of treatment if necessary . Therefore included women hospitalized in medical services , gynecology, surgery and orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women who could answer a simple questionnaire and those previously treated for osteoporosis or have already received a bone density there is less than 3 years old .

Official Title
-----------------
Improved Screening for Osteoporosis in Women Between 50 and 80 Years Hospitalized in Hospital Departmental Vendee

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 50 and 80 years Hospitalized In health services, orthopedics, gynecology, surgery Able to respond to an easy questionnaire Able to give their agreement to participate in the study Exclusion Criteria: Patients with dementia Patients can not express Patients at end of life Patients previously treated for osteoporosis or recent densitometry (BMD) <3 years Patients could not be seen in time by the nurse during their hospitalization Patients receiving a measure of legal protection

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| women between 50 and 80 years hospitalized in CHD Vendée<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients screened at risk for osteoporosis |  | 1 year |
Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

Study Overview
=================
Brief Summary
-----------------
The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE. It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test

Detailed Description
-----------------
To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.

Official Title
-----------------
Canadian Pulmonary Embolism Diagnosis Study

Conditions
-----------------
Suspected Pulmonary Embolism, Deep Venous Thrombosis

Intervention / Treatment
-----------------
* Procedure: Two diagnostic management strategies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically suspected PE Exclusion Criteria: Treatment with anticoagulants for greater than 24 hours of performance of D-d Comorbid condition limiting survival to less than 3 months Absence of acute symptoms within 7 days prior to presentation Current pregnancy Contraindication to contrast (e.g., allergy, renal failure) Geographic inaccessibility which precludes follow-up Physician believes patient is inappropriate for study failure or inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 0 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

| Intervention/Treatment |
| --- |
|Procedure: Two diagnostic management strategies|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DVT or PE during 6 months follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DVT, Pulmonary Embolism, Venous Thrombosis, D dimer, DD, Thrombosis, Diagnosis
Understanding Daily Changes in BDD Risk Using Smartphones

Study Overview
=================
Brief Summary
-----------------
Body dysmorphic disorder (BDD) is associated with high risk for suicide attempts (22-28%) and substance use disorders (49%), underscoring the importance of accurate, real-time risk detection in BDD. This study aims to use smartphone-based digital phenotyping to develop and validate unobtrusive, time-sensitive, and ecologically valid measures of key risk factors for suicide and substance misuse in BDD: negative affect states. As next steps, this research can be extended to detect risk transdiagnostically, with the goal of enabling just-in-time interventions to target suicide and substance misuse across psychiatric illnesses.

Official Title
-----------------
Smartphone-based Digital Phenotyping to Detect High-risk Affect States in Body Dysmorphic Disorder (BDD)

Conditions
-----------------
Body Dysmorphic Disorders

Intervention / Treatment
-----------------
* Other: None, observational study only (no interventions)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age >=18 Current primary diagnosis of BDD BDD severity >= moderate Living in US English proficiency Owns an Android or iOS (Apple) smartphone Has regular Wifi-enabled internet access for data downloads

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 |
| --- | --- |
| body dysmorphic disorder (BDD)<br>Adults with a current primary diagnosis of body dysmorphic disorder (BDD) | Other: None, observational study only (no interventions)<br>* None, observational study only (no interventions)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anxiety intensity, rated from 1 (very slightly or not at all) to 5 (extremely) | Ecological momentary assessment (EMA) of anxiety intensity, where higher scores indicated more severe anxiety. | 3 months | 
| Self-reported shame intensity, based on Positive and negative affect scale (PANAS) shame item, rated from 1 (very slightly or not at all) to 5 (extremely) | Ecological momentary assessment (EMA) of shame intensity, where higher scores indicate more severe shame. | 3 months | 
| Self-reported negative affect intensity, based on Positive and negative affect scale (PANAS) negative affect items (averaged), rated from 1 (very slightly or not at all) to 5 (extremely) | Ecological momentary assessment (EMA)-rated general negative affect intensity, where higher scores indicate more severe negative affect. | 3 months |
A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3

Study Overview
=================
Brief Summary
-----------------
Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream). Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region. At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage. Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.

Conditions
-----------------
Bleeding Hemorrhoids

Intervention / Treatment
-----------------
* Drug: PP110 Gel
* Drug: PP110 Medicated wipes
* Drug: Preparation-H Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 Bleeding hemorrhoids with / without pain Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids Signed Informed Consent Exclusion Criteria: Known rectal sensitivity Rectal infection Grade IV hemorrhoids Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment Known inflammatory bowel disease Anal fissure Military personnel Female patients that are pregnant, or are not using a reliable method of birth control, or are nursing Patients who have been involved in another experimental trial within the past 30 days Patients presently diagnosed with cancer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PP110 Gel<br>PP110 Gel | Drug: PP110 Gel<br> <br> |
| Experimental: PP110 medicated wipes<br>PP110 Medicated wipes | Drug: PP110 Medicated wipes<br> <br> |
| Active Comparator: Preparation-H cream<br>Preparation-H cream | Drug: Preparation-H Cream<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding / Spotting |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 14 days | 
| Discharge |  | 14 days | 
| Itching |  | 14 days | 
| Swelling |  | 14 days | 
| Discomfort |  | 14 days | 
| Painkillers usage |  | 14 days |
Anastomotic Airway Complications After Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of data concerning anastomotic airway complications after lung transplantation.

Official Title
-----------------
Anastomotic Airway Complications After Lung Transplantation : Risk Factors, Treatment Modalities and Outcome : a Single Center Experience.

Conditions
-----------------
Lung Transplantation, Bronchoscopy

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung transplantation Exclusion Criteria: heart and lung transplantation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases of anastomotic airway complication<br>Cases of anastomotic airway complication | Other: no intervention<br>* no intervention<br>|
| Patients with normal anastomotic healing<br>Patients with normal anastomotic healing | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of anastomotic airway complication | Based upon radiological and endoscopic reports the presence and severity of anastomotic airway complications will be assessed. | 18 months |
Physiologic Performance Response to Salbutamol

Study Overview
=================
Brief Summary
-----------------
This project aims to investigate the individual physiological response to beta2-adrenergic stimulation with salbutamol on performance-related outcomes

Official Title
-----------------
Individual beta2-adrenergic Performance Response to Salbutamol

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: salbutamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 45 years of age Trained individuals with maximal oxygen uptake above 55 mL/kg/min for men and 50 mL/kg/min for women Body mass index lower than 26 Exclusion Criteria: Allergy towards study drug Unacceptable side effects of the study drug Chronic disease deemed by the MD to impose a risk or severely confound the study outcomes Current smokers Use of prescription medicine Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: salbutamol<br>salbutamol, 800 microgram from metered dose inhaler | Drug: salbutamol<br>* inhalation of salbutamol<br>|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo<br>* administration of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sprint performance | Power output during maximal cycling | Measured ½ hour after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Quadriceps maximal voluntary contraction | Measured ½ hour after drug administration | 
| Sprint fatigue tolerance | Fatigue index during maximal cycling | Measured ½ hour after drug administration | 
| Cycling endurance performance | 4-min time trial on bike ergometer | Measured ½ hour after drug administration |
An Open-Label Study of the Effect of an Ophthalmic Solution on Asteroid Hyalosis

Study Overview
=================
Brief Summary
-----------------
To determine the safety and initial efficacy of C-KAD ophthalmic solution in patients with asteroid hyalosis

Official Title
-----------------
An Open-Label Study of the Effect of C-KAD Ophthalmic Solution on Asteroid Hyalosis

Conditions
-----------------
Asteroid Hyalosis

Intervention / Treatment
-----------------
* Drug: C-KAD Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of asteroid hyalosis Exclusion Criteria: Active ocular infection Glaucoma Ocular hypertension Ocular inflammatory disorders

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 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: C-KAD Ophthalmic Solution<br> | Drug: C-KAD Ophthalmic Solution<br>* 4 drops applied daily for 180 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the number of asteroid bodies |  | 180 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asteroid hyalosis, Opthalmic Study