linjc16/ctgov huggingface dataset:
Proximal Humerus Fractures: A Retrospective Analysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of open reduction, internal fixation surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Official Title
-----------------
PROXIMAL HUMERAL FRACTURES: A Data Analysis on Patients Undergoing Open Reduction and Internal Fixation for the Surgical Management of Proximal Humeral Fractures

Conditions
-----------------
Proximal Humeral Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking >18 years of age open reduction internal fixation surgical management of a proximal humeral fracture Exclusion Criteria: Non-English speaking <18 years of age Greater Tuberosity Fractures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total operative time | minutes | preoperative to up to 8 years postoperative | 
| amount of blood loss | mls | preoperative to up to 8 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Outcomes | American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score | preoperative to up to 8 years postoperative | 
| Patient Outcomes | Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional. | preoperative to up to 8 years postoperative |
Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

Study Overview
=================
Brief Summary
-----------------
Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death. In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc. The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.

Official Title
-----------------
Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

Conditions
-----------------
Systemic Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with systemic sclerosis, who had an upper intestinal tract manometry 5 years before, with: age over 18 years written informed consent Exclusion Criteria: pregant women patients with psychiatric conditions unwritten informed consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Myocarditis After SARS-CoV2-Vaccination

Study Overview
=================
Brief Summary
-----------------
Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide. SARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far. Aim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease. Study Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.

Official Title
-----------------
Myocarditis After SARS-CoV2-Vaccination: An International Patient Registry on Clinical Manifestations and Outcomes

Conditions
-----------------
Myocarditis and Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-CoV-2 Vaccine-associated Myocarditis (< 30 days after vaccination) confirmed by cardiac MRI without evidence of alternative etiology (infectious, auto-immune myocarditis). Exclusion Criteria: missing individual consent
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 |
| --- | --- | --- |
| Combined Primary Endpoint | Death, Hospitalization, symptomatic Heart Failure | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccination, SARS CoV-19
Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography

Study Overview
=================
Brief Summary
-----------------
This study is a prospective observational chart review. The aim of the study is to evaluate tricuspid regurgitation volume using 3D volumetric assessment as an accurate method for tricuspid regurgitation severity in comparison to VCA.

Official Title
-----------------
Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography

Conditions
-----------------
Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Other: Transesophageal echocardiograpgy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All degrees of tricuspid regurgitation minimal, mild, moderate and severe will be included Exclusion Criteria: Exclusion criteria will be non-sinus rhythm, more than mild pulmonary regurgitation, more than trace aortic regurgitation.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Transesophageal echocardiograpgy|3D acquisition of the right ventricle regurgitation volume|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tricuspid regurgitation volume | We will evaluate patients with different grades TR by both 3DVCA and the 3D volumetric approach | 12 months |
Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with Werner's syndrome and osteoporosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: The patient receives subcutaneous recombinant human insulin-like growth factor 1 daily for 7 months. The dose is adjusted according to the serum hormone level and biological markers of bone turnover. Concurrent therapy includes a metabolic diet, calcium citrate, and estradiol.

Conditions
-----------------
Werner's Syndrome

Intervention / Treatment
-----------------
* Drug: growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Werner's syndrome with osteoporosis and low serum insulin-like growth factor 1 level Patient treated on protocol 04-9215300 Metabolic and Skeletal Effects of Exogenous Recombinant Human Insulin-Like Growth Factor

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: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: growth hormone|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Werner's syndrome, genetic diseases and dysmorphic syndromes, rare disease
Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living

Study Overview
=================
Brief Summary
-----------------
Resident-to-resident elder mistreatment (R-REM) is a significant problem in long-term services and support settings (LTSS), and likely to cause physical and or psychological distress. The proposed project tests an intervention developed for use by LTSS staff. As such, it represents an important step in the process of developing approaches for ameliorating and preventing R-REM in assisted living residences which house residents with dementia and related behavioral disorders, and is thus likely to have significant public health impact.

Official Title
-----------------
Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living

Conditions
-----------------
Assisted Living, Resident to Resident Elder Mistreatment

Intervention / Treatment
-----------------
* Other: R-REM training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all long term residents residing at each facility at baseline, for those unable to consent, proxy consent will be sought Exclusion Criteria: residents receiving hospice care, facilities will have the option to exclude individuals for selected reasons, (e.g., severe psychosis)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-REM training<br>3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment | Other: R-REM training<br>* three training modules for front-line long-term care staff to aid in recognition, management and reporting of R-REM<br>|
| No Intervention: Control condition<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls, accidents, and injuries | Impact on falls, accidents, and injuries as measured by incident reports | Six months before baseline through twelve month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affect | Impact on affect as measured by the Feeling Tone Questionnaire | Baseline, 6- and 12- month follow-up |
Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

Official Title
-----------------
An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Venlafaxine XR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients with diagnosis of generalized anxiety disorder. Exclusion Criteria: Any serious or uncontrolled medical condition. Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pregabalin|nan|
|Drug: Venlafaxine XR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder. |  |  |
Interruptions, Teamwork, Stress and Patient Outcomes in the Operating Room

Study Overview
=================
Brief Summary
-----------------
The operating theatre (OR) in hospitals is a highly complex working environment and can withstand a variety of stresses and strains for the surgical team. So-called Flow Disruption Events (FDs) with a potential risk to patient safety occur very often. The aim of the planned study project is to determine the effects of flow disruption events in the operating theatre on patients, the OR team and the duration of the surgery. The investigators plan an observational study at two university hospital in Southern Germany. The study population includes the entire surgical team during selected surgical procedures as well as the patients treated. The planned sample size is 82 surgical procedures. The investigators intend to collect data in two surgical specialties: Urology and traumatology. Selected surgeries are evaluated by a trained observer and the interruptions and distractions in the course of the surgery are observed with a standardized tool. In addition, non-technical skills of the OR team are recorded: all members of the OR team will complete a short standardized questionnaire that measures mental workload and stress during the procedure. Additionally, post-operative patient outcomes are recorded.

Official Title
-----------------
Surgical Flow Disruptions Inside the Operating Room, Intra-operative Teamwork, Stress and Post-operative Patient-outcomes: An Observational Study

Conditions
-----------------
Intraoperative Flow Disruptions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients: Written consent, completed case OR Team: Written consent, at least 3 months working experience in the clinic, present for the majority of the procedure duration Exclusion Criteria: - OR visitors & students

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 |
| --- | --- |
| RAS Partial Nephrectomy<br> | |
| RAS Radical Prostatectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Teamwork | Teamwork within the medical team including surgeons, nurses and anaesthetists | 4 Hours | 
| Stress, Mental Workload | Intraoperative workload, perceived distraction and stress of medical team | 4 Hours | 
| Patient Outcomes | Intra- and postoperative patient outcomes (Complications, functional outcomes etc.) | 3 Months |
Treatment of Subclinical Hyperthyroidism

Study Overview
=================
Brief Summary
-----------------
Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.

Detailed Description
-----------------
Randomized open-labelled multicentre study comparing radioiodine vs medical supervision without treatment

Official Title
-----------------
Place de l'Iode RadioActif Dans l'HyperThyroïdiE Sub-clinique (PIRHATES)/ Evaluation of the Interest of Subclinical Hyperthyroidism Treatment

Conditions
-----------------
Subclinical Hyperthyroidism, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 50 and greater Isolated decreased thyroid-stimulating hormone (TSH) with normal FT4 and FT3 levels Exclusion Criteria: Iodide overload Non sinusal heart rhythm Severe heart disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperthyroidism, atrial fibrillation, quality of life, radioiodine treatment
Behavioral Economics of Human Drug Self-Administration

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to examine the utility of behavioral economics for understanding reinforcer interactions as they pertain to drug self-administration. In a series of 6 experiments, the researchers will attempt to quantify the effects of qualitatively different reinforcers (money, cigarettes, alcohol, nicotine gum) and their interactions. This work represents a continuation of research by this investigator in the area of addiction and pharmacology.

Conditions
-----------------
Drug Dependence

Intervention / Treatment
-----------------
* Drug: nicotine
* Drug: alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of 20 or more cigarettes per day CO levels >15 ppm More than 12 alcohol drinks per week and beer as preferred alcoholic beverage

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nicotine|nan|
|Drug: alcohol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.

Study Overview
=================
Brief Summary
-----------------
To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.

Detailed Description
-----------------
Efficacy Parameters IOP assessment in each eye

Official Title
-----------------
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.

Conditions
-----------------
Ocular Hypertension Glaucoma

Intervention / Treatment
-----------------
* Combination Product: Bimatoprost Timolol (T4030)
* Combination Product: Bimatoprost Timolol (Ganfort)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent signed and dated* Patient aged ≥18 years old Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a Both eyes with diagnosed ocular hypertension or open angle glaucoma Exclusion Criteria: History of narrow angle and/or angle closure glaucoma Advanced stage of glaucoma

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T4030 Group<br> | Combination Product: Bimatoprost Timolol (T4030)<br>* Eye drop<br>* Other names: Bimatoprost Timolol;|
| Active Comparator: Ganfort Group<br> | Combination Product: Bimatoprost Timolol (Ganfort)<br>* Eye drop<br>* Other names: Bimatoprost Timolol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP assessment | The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Sign | Ocular sign will be assessed through slit lamp examination at each visits | Week 6 Week 12 |