linjc16/ctgov huggingface dataset:
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Study Overview
=================
Brief Summary
-----------------
Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures

Detailed Description
-----------------
Randomised study to determine the effect of HA coating on the stability of lag screws used to reduce femoral neck fractures. Stability of the screw will be determined by RSA measurements. The effect of the HA coating on bone remodeling will be determined by DEXA measurements

Official Title
-----------------
Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Hip Fracture reduction Screw without HA Coating (Hiploc)
* Device: Hip Fracture reduction Screw with HA Coating (Hiploc)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with trochanteric femoral fractures Exclusion Criteria:
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 |
| --- | --- |
| Active Comparator: Screw without HA Coating (Hiploc)<br> | Device: Hip Fracture reduction Screw without HA Coating (Hiploc)<br>* Hip Fracture reduction Screw without HA Coating (Hiploc)<br>* Other names: Hiploc;|
| Experimental: Screw with HA Coating (Hiploc)<br> | Device: Hip Fracture reduction Screw with HA Coating (Hiploc)<br>* Hip Fracture reduction Screw with HA Coating (Hiploc)<br>* Other names: Hiploc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | 3months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEXA |  | 3months, 6 months | 
| RSA |  | 3months,6 months | 
| Complications |  | Anytime |
Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
We want to investigate if early follicular phase downregulation and androgen priming, by use of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs of improvement compared to standard short antagonist protocol

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication and wish for IVF/ICSI treatment Womens age 20-39 years (both inclusive) Regular menstrual cycle within normal range Body Mass Index: 18-30 kg/m2 (both inclusive) Negative pregnancy test before treatment A maximum of 3 earlier IVF/ICSI treatments that did not result in pregnancy Exclusion Criteria: serious systemic disease Presence of polycystic ovarian syndrome (PCOS) Earlier poor response with less than 4 mature follicles Earlier participation in the investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ticagrelor CytoSorb Hemoadsorption

Study Overview
=================
Brief Summary
-----------------
TISORB is a study to show that the CytoSorb device removes ticagrelor from blood during surgery in patients who need emergency surgery on their heart. The hypothesis of TISORB is that removal of ticagrelor by the CytoSorb device during surgery will decrease the risk for surgical bleeding from ticagrelor.

Official Title
-----------------
Ticagrelor CytoSorb Hemoadsorption (TISORB): Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb® 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent or Urgent Cardiothoracic Surgery

Conditions
-----------------
Emergent Cardiothoracic Surgery, Bleeding, Drug Removal

Intervention / Treatment
-----------------
* Device: CytoSorb 300 mL device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor. Exclusion Criteria: Any cardiothoracic surgery > 48 hours after last dose of ticagrelor.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Prospective, open, multi-center, single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacodynamic population<br>Single arm | Device: CytoSorb 300 mL device<br>* Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Pharmacodynamic Endpoint | Change in platelet reactivity as measured by ADPtest on the Multiplate Analyzer immediately before and after cardiopulmonary bypass. The unit of measure is Aggregation Units (AU). | Immediately before and after cardiopulmonary bypass | 
| Primary Pharmacokinetic Endpoint | Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass. | Immediately before and after cardiopulmonary bypass |
Tongji-Ezhou Study

Study Overview
=================
Brief Summary
-----------------
Tongji-Ezhou study (TJEZ) is a prospective cohort study launched at 2013 in EZhou city, Hubei province, with the goal of recruiting and assessing 10,000 individuals and then following them for at least 2 decades. In addition, blood samples would be collected every 3-5 years among 6000 of them to investigate the nutritional biomarkers and potential determinants of chronic diseases such as obesity, type 2 diabetes, metabolic syndrome, and cardiovascular disease.

Official Title
-----------------
Tongji-Ezhou Prospectively Cohort Study

Conditions
-----------------
Diabetes, Cardiovascular Diseases, Obesity, Metabolic Syndrome, Nutritional and Metabolic Diseases, Environmental Exposure, Risk Factor, Cardiovascular

Intervention / Treatment
-----------------
* Other: Dietary and environmental exposure (Observational study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (i) permanent residence in Ezhou district (minimum of 9 months); (ii) written informed consent; (iii) age ≥ 20 years old at the time of enrolling in the study. Exclusion Criteria: (i) with chemotherapy or radiotherapy for cancer and other severe diseases.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Egang hospital physical examination center<br> | Other: Dietary and environmental exposure (Observational study)<br> <br> |
| Ezhou CDC physical examination center<br> | Other: Dietary and environmental exposure (Observational study)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diabetes | Type 2 diabetes was diagnosed when FPG ≥ 7.0 mmol/L and/or OGTT2h ≥ 11.1 mmol/L, or using diabetic medication (self-report). | 5 years | 
| Incidence of metabolic syndrome | Metabolic syndrome is defined as using the updated National Cholesterol Education Program/Adult Treatment Panel III criteria for Asian Americans. These criteria require three or more of the following components: (1) central obesity (waist circumference of ≥90 cm for men or ≥80 cm for women), (2) triglycerides of ≥1.7 mmol/L, (3) HDL-C of <1.03 mmol/L for men or <1.30 mmol/L for women, (4) blood pressure of ≥130/85 mmHg or on medication for hypertension, and (5) fasting glucose of ≥5.6 mmol/L. | 5 years | 
| Diabetic complications | Development of diabetic complications | mean follow up of 10 years | 
| Incidence of cardiovascular diseases | Cardiovascular death, stroke, myocardial infarction, heart failure | mean follow up of 10 years |
Tiemann Mounted Urodynamic Catheter Technique for Difficult Bladder Catheterization

Study Overview
=================
Brief Summary
-----------------
A report of a technique for insertion a soft urodynamic catheter into the bladder, when urethral obstruction causes the catheter to bend and fold over itself at the resistance site.

Detailed Description
-----------------
The urodynamic catheter is mounted on a 12F Coudé tip Tiemann catheter, which then carries the tip of the urodynamic catheter beyond the obstruction site into the bladder. The Tiemann catheter-mounted urodynamic catheter technique can serve as a suitable option to insert a urodynamic catheter into the bladder in all male patients in whom it fails due to kinking.

Official Title
-----------------
RETROSPECTIVE STUDY ABOUT A TECHNIQUE OF INSERTION OF TIEMANN MOUNTED URODYNAMIC CATHETER FOR DIFFICULT BLADDER CATHETERIZATION IN MALES

Conditions
-----------------
URINATION DISORDERS

Intervention / Treatment
-----------------
* Device: INSERTION OF URETEHRL CATHETER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - MEN THAT UNDERWENT URODYNAMIC STUDY EVALUATION BETWEEN 6/2011 TO 9/2013 Exclusion Criteria: NONE -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MALE PATIENTS BEFORE UDS<br>MALE PATIENTS BEFORE UDS WITH DIFFICULT CATHETERIZATION | Device: INSERTION OF URETEHRL CATHETER<br>* USE OF A TIEMANN CATHETER TO INSERT THE URODYNAMIC STUDY CATHETER INTO THE BLADDER<br>* Other names: TIEMANN CATHETER;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Catheterization |  | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
URINARY INCONTINENCE, URODYNAMICS, URINARY RETENTION, URINARY CATHETERIZATION
Prevention of Corticosteroid-induced Glucose Intolerance

Study Overview
=================
Brief Summary
-----------------
Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Detailed Description
-----------------
Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Official Title
-----------------
Treatment With Rosiglitazone for the Prevention of Glucose Intolerance in Patients Treated With Corticosteroids

Conditions
-----------------
Glucose Intolerance

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: corticosteroid treatment Exclusion Criteria: congestive heart failure pedal edema

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosiglitazone|4 mg rosiglitazone per day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose concentration |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corticosteroid treatment, inflammatory diseases
Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study was designed to gather data regarding the efficacy and safety of Rituxan in clinical practice whereby patients may present with concomitant medical conditions, medications as well as varying presentations of rheumatoid arthritis not always captured within the purer population seen in an industry sponsored clinical trial.

Official Title
-----------------
A Phase IV, Post-marketing, Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with active rheumatoid arthritis as defined by ACR criteria > 18 years of age at time of consent Able to start RITUXAN therapy per the approved product monograph within approximately 30 days of confirmed enrollment Exclusion Criteria: Known Type 1 hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary cell proteins or to any component of RITXAN as per approved Product monograph Presence of any significant and or uncontrolled medical condition, which in the Investigator's opinion, precludes the use of RITUXAN as outlined in the Product Monograph

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Study Overview
=================
Brief Summary
-----------------
Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

Detailed Description
-----------------
Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse. Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.

Official Title
-----------------
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Conditions
-----------------
Testicular Germ Cell Tumor

Intervention / Treatment
-----------------
* Procedure: sentinel node procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers Patients 18 years and older No evidence of metastases on first staging (thoraco-abdominopelvic CT) Written and signed informed consent Exclusion Criteria: Patients with evidence of metastases at first staging Patients with a second primary tumour Patients with recent (< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions Patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sentinel node procedure<br>a robot-assisted laparoscopic sentinel node procedure. | Procedure: sentinel node procedure<br>* a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identify patients witha low risk of cancer recurrenceincluded in current active surveillance protocols. | identify patients who have such a low risk of cancer recurrence that it is not necessary anymore to be included in current active surveillance protocols by removing the sentinal lymph node to check for occult metastasis | surgery 1 day, follow up 5 years |
Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)

Detailed Description
-----------------
The present study was designed to critically analyze the role of pralidoxime in patients with moderate to severe poisoning by dividing them into two comparable groups in all aspects and using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by 8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.

Official Title
-----------------
Study Effect of WHO Recommended Dose of Pralidoxime in the Treatment of Organophosphorus Poisoning

Conditions
-----------------
Deaths

Intervention / Treatment
-----------------
* Drug: Pralidoxime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of alleged organophosphorus intake age > 14 years < 60 years clinical signs and symptoms of organophosphorus poisoning. Exclusion Criteria: < 14 years or > 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses ≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 60 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo was given to compare the effects | Drug: Pralidoxime<br>* Pralidoxime was compared to placebo to study the effects of the drug on mortatlity<br>* Other names: Oximes;|
| Active Comparator: Pralidoxime<br>Pralidoxime for treating organophosphorous poisoning patients | Drug: Pralidoxime<br>* Pralidoxime was compared to placebo to study the effects of the drug on mortatlity<br>* Other names: Oximes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate |  | upto one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of ventilation |  | upto one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pralidoxime, atropine, organophosphorous poisoning.
Retrospective, Non-interventional Study of Depo-Eligard®.

Study Overview
=================
Brief Summary
-----------------
Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment

Detailed Description
-----------------
The study will provide data on the tolerance, safety and acceptance of Depo-Eligard® (leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters such as testosterone, PSA levels, symptoms and treatment failure, if available will be collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the treatment for Prostate Cancer. Patient data will be collected after a treatment period of six months.

Official Title
-----------------
Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial

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

Intervention / Treatment
-----------------
* Other: Data Collection on Depo-Eligard exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization Patients on treatment with Depo-Eligard® for at least six months Written consent has been obtained

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data Collection on Depo-Eligard exposure|Retrospective, Non-interventional|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard® |  | After at least 6 months treatment with Depo-Eligard | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of PSA and testosterone levels if available |  | After at least 6 months treatment with Depo-Eligard | 
| Overall evaluation of efficacy |  | After a least 6 months treatment with Depo-Eligard | 
| Overall patient assessment of treatment benefit |  | After at least 6 months treatment with Depo-Eligard | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer