linjc16/ctgov huggingface dataset:
Turkish Cross-cultural Adaptation, Validation and the Reliability of UWRI (University of Wisconsin Running Injury and Recovery Index)

Study Overview
=================
Brief Summary
-----------------
The purpose is to perform a scientific study on TURKISH cross-cultural adaptation, validation and the reliability of UWRI

Detailed Description
-----------------
The primary aim of this study is to perform Turkish cross-cultural adaptation, validation and the reliability of UWRI in runners. The secondary aim of this study is investigating injury rate and types among runners.

Official Title
-----------------
Turkish Cross-cultural Adaptation, Validation and the Reliability of UWRI (University of Wisconsin Running Injury and Recovery Index)

Conditions
-----------------
Running Related Injuries

Intervention / Treatment
-----------------
* Other: UWRI-Tr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-45 years old female or male Participating in running as amateur, recreational, competitional or professional runner Being a short, mid, or long distance runner Being native Turkish speaker Agreed to participate in the research Exclusion Criteria: If there is no surgical history related to running injury in the last 12 months If have chronic metabolic disease Paralympic athletes Pregnant and breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: UWRI-Tr|Questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity and reliability | pearson's correlation 2 tailed analysis; >0,60 good, 0,31-0,59 medium, <0,30 bad | 5-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
validity, reliability, PRO, Patient Outcome Report, Turkish, Adaptation, Running, Injury
A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (VR ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. This will serve as a preliminary study for future trials to compare outcomes between VR and standard of care vs standard of care only.

Official Title
-----------------
Use of Virtual Reality as an Adjunct for Anesthesia During Orthopedic Procedures Under Regional or Central Neuraxial Nerve Block. A Pilot and Feasibility Study

Conditions
-----------------
Hip Injuries, Knee Arthropathy

Intervention / Treatment
-----------------
* Other: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old. Patients scheduled for orthopedic procedure under regional or central neuraxial nerve block (anterior primary hip arthroplasty or primary knee arthroplasty). Subject willing to participate and able to provide informed consent. Exclusion Criteria: Age < 18 years old. History of motion sickness or blindness. Unable to consent due to cognitive difficulty. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software. Sensitivity to flashing light or motion. Recent stroke. Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open wound, sores, or skin rash on face).

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 |
| --- | --- |
| Virtual reality<br> | Other: Virtual reality<br>* Use of virtual reality goggles during procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of virtual reality on anxiety level | Evaluate patients' satisfaction with using virutal reality and reduction in anxiety during orthopedic procedures | Up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of virtual reality on pharmacological therapy doses | Elucidate the impact of VR on pharmacological therapy doses required for proper analgesia and anxiolysis and on reduction of drug side effects in patient using VR during surgeries. | Up to 2 hours | 
| Impact of virtual reality on patient's perioperative temperature | Evaluate if utilizing virtual reality has a positive impact in preventing patient hypothermia intra- and post-operatively. | Up to 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, knee arthroplasty, hip arthroplasty
Ultra Sound Guided Fine Needle Aspiration Cytology (FNAC) of Liver and Pancreas Tumours

Study Overview
=================
Brief Summary
-----------------
Patients with tumors in liver or pancreas are randomized to ultrasound (UL)-guided FNAC biopsies with guidance method or UL-guided FNAC biopsies with free-hand method.

Conditions
-----------------
Tumors in Liver, Tumors in Pancreas

Intervention / Treatment
-----------------
* Procedure: FNAC (fine needle aspiration cytology)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult over 18 years tumors in liver and/or pancreas Exclusion Criteria: low coagulation factors mentally ill patients.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: biopsy arm<br>patients with tumors in liver and/or pancreas | Procedure: FNAC (fine needle aspiration cytology)<br>* UL guided biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of obtained biopsy |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients pain and discomfort at procedure |  | immediately | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver, pancreas, cancer, tumor, FNAC
Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.

Detailed Description
-----------------
Renal stones is a common condition affecting up to 1% of the american population. The main symptom is renal colic. Acute treatment is based on the administration of analgesics mainly those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects with more or less the same analgesic potency. In the present study the analgesic effect of intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not pass their stone during their visit to the ED and they are prone to develop another attack of renal colic.In the second phase of the study (Stage II)patients who improved, and are ready to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further pain.

Official Title
-----------------
Efficacy of Tramadol Hcl in the Treatment of Renal Colic

Conditions
-----------------
Renal Calculus

Intervention / Treatment
-----------------
* Drug: Tramadol Hcl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical diagnosis of acute renal colic (Stage I) Patients with diagnosed renal colic who might need prevention of pain and are able to swallow medicines (Stage II) Exclusion Criteria: Patients with known hypersensitivity to the study drugs Pregnancy or lactation Known renal failure or hepatic disease Concommitant drug use which could adversely affect patient's outcome (oral anticoagulant, MAO inhibitors)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tramadol Hcl|Active Comparator|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I) |  | 30, 60, 120 minutes | 
| Need for rescue medication at 30 minutes (Stage I) |  | 30 minutes | 
| Pain improvement according to VAS score at 24 and 48 hrs (Stage II) |  | 24 and 48 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal, Colic, Calculi, Treatment
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy

Study Overview
=================
Brief Summary
-----------------
Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.

Conditions
-----------------
Contrast Induced Nephropathy

Intervention / Treatment
-----------------
* Drug: sodium bicarbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: serum creatinine greater then or equal to 1.5 Exclusion Criteria: EF<30 Overt CHF Alkalemia Hypokalemia GFR<20 cc/min

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: sodium bicarbonate|isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of contrast induced nephropathy |  | 48-72 hours |
The Effect of Oxytocin on the Consolidation of Trauma-Associated Memories

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine whether oxytocin and certain polygenic risk scores affect the development of intrusive memories, a cardinal symptom of PTSD.

Official Title
-----------------
The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder

Conditions
-----------------
Intrusive Memories, PTSD

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy female volunteers German on a native level Exclusion Criteria: former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) any physical illnesses any medication intake (except oral contraceptive) history of traumatic experience, e.g. history of sexual abuse or rape pregnancy or lactation period follicular phase of menstrual cycle for all women not using oral contraceptives

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin and trauma film paradigm<br>Intervention: Drug: Oxytocin nasal spray | Drug: Oxytocin<br>* Drug: Oxytocin nasal spray<br>|
| Placebo Comparator: Placebo and trauma film paradigm<br>Intervention: Drug: Placebos | Drug: Placebo<br>* Drug: Placebo nasal spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Intrusive Memories in the following four days after the intervention | Influence of oxytocin on the development of intrusive memories measured with an intrusion diary | four consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noradrenergic System (measured with salivary alpha-amylase - u/ml) | Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase | Day 1 | 
| Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L) | Influence of oxytocin on the HPA-axis measured with salivary cortisol | Day 1 | 
| Polygenic Risk Score | Influence of polygenic risk score on development of intrusive memories | four consecutive days |
Obalon US Commercial Registry

Study Overview
=================
Brief Summary
-----------------
Retrospective study of the data reported in the Obalon US Commercial Registry

Detailed Description
-----------------
Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.

Official Title
-----------------
Obalon Balloon System: Real-World Evidence Commercial Site Registry

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

Intervention / Treatment
-----------------
* Device: Obalon Balloon System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Started Obalon Balloon Therapy between Jan.-Dec. 2017 Weight loss data through balloon removal BMI >25kg/m2
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Obalon Balloon System|6 month Obalon Intragastric Balloons|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Outcome - Serious Adverse Events | Percentage of Patients with Serious Adverse Events | 6 months | 
| Primary Effectiveness Outcome - Weight Loss Metrics | Mean Weight Loss Metrics | 6 months |
Safety Study of Anti-IgE Immunotherapy in Allergic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate safety and efficacy of three doses and two dosing regimens of RP01 as an anti-IgE immunotherapy in allergic patients.

Detailed Description
-----------------
Immunotherapy is based on the principle of eliciting an immune reaction in order to block the negative effect of a specific disease-causing protein. The potential to treat diseases by means of immunotherapy instead of using conventional drugs represents an attractive opportunity in a number of chronic disease areas, including asthma and allergy. Resistentia's model to treat allergic diseases, and ultimately asthma, is to use the immune system to produce antibodies against the IgE molecules themselves. The resulting anti-IgE antibodies intercept and form complexes with the IgE molecules before they can bind to the mast cells and basophils and are thus able to block any allergen-triggered inflammatory reaction. The approach works in all types of IgE-mediated allergies independently of allergen, and also in patients sensitive to multiple allergens. Comparisons: Three doses and two dosing regimes of RP01 will be compared as regards safety and effect.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Safety and Tolerability Study of Repeated Doses of Anti-IgE Immunotherapy in Allergic Patients

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: RP 01


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergy to at least one aero allergen Increased serum IgE level Exclusion Criteria: Diagnosis of asthma Recent use of systemic corticosteroids or immunosuppressive treatment Allergy vaccination therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: RP 01<br>* Active immunotherapy<br>|
| Experimental: 2<br> | Biological: RP 01<br>* Active immunotherapy<br>|
| Experimental: 3<br> | Biological: RP 01<br>* Active immunotherapy<br>|
| Placebo Comparator: 4<br> | Biological: RP 01<br>* Active immunotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune kinetic parameters |  | 0-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergy, immunotherapy
A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The proposed study aims to objectively assess 2-year clinical and radiographic results for the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This retrospective radiographic review will provide evidence for equivalence or superiority in curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is utilized in conjunction with cement at the glenoid.

Official Title
-----------------
A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

Conditions
-----------------
Total Shoulder Arthroplasty, Glenohumeral Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have completed at least 2 years follow-up following their total shoulder replacement Patients must have had radiographic imaging obtained at that 2 years Exclusion Criteria: Patients less than 21 years of age Patients who have been imprisoned since the time of surgery Patients who are mentally impaired

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Loosening | Radiographic loosening is defined by the presence of radiolucent lines at the bone-cement interface at 2 years. Lines are measured as being either not-present, less than 2mm or greater than/equal to 2mm, in addition to implant seating and the radiodensity between the flanges of the central peg. | 2 years |