linjc16/ctgov huggingface dataset:
Polyester Patch in Massive Rotator Cuff Repair Improves Healing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.

Detailed Description
-----------------
To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.

Official Title
-----------------
Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Procedure: arthroscopic rotator cuff repair with a polyester patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al. Exclusion Criteria: We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: arthroscopic rotator cuff repair with a polyester patch|Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function assessed with the Constant-Murley-Score |  | 25 months | 
| Function assessed with the Subjective Shoulder Value |  | 25 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon integrity evaluated radiologically |  | 1-35 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthroscopic rotator cuff repair, patch augmentation
Importance of Forces and Safety Features in Car Crash Multitrauma

Study Overview
=================
Brief Summary
-----------------
The pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. We hypothesise that there is an association between the use and function of safety features and the results for the patient and an association between material damage and the severity of injury.

Detailed Description
-----------------
We plan to study approximately 200 road accidents with multitraumatised patients and accidents with modern cars and severe material damage with little or moderate damage to persons inside the vehicle. A researcher will be alerted by the call centre (Norwegian 911-equivalent), move to the place of accident and take a pure observers role (unless ethically unacceptable due to lack of other health personnel). He will document the accident including use and condition of safety features, conditions inside the coupe, weather conditions, etc. Other available information on the vehicles, crashtests etc will be gathered from the manufacturer. All medical information will be gathered from the ambulance service, hospitals, pathology and forensic departments. Information from police and fire department will also be gathered. Patient, next-of-kin, others invloved will be interviewed as appropriate in follow-up. Four accident groups: Front-to-front or -object > 60 km/hour, same < 60 km/hour, car rolled over on road, car rolled over out-of-road. Factors: Age of vehicle, damage to coupe, cause of accident, on-scene time, initial evaluation by health personnel, injury severity scoring in hospital.

Official Title
-----------------
The Multitraumatized Patient. What is the Importance of Forces Involved and the Use of Safety Equipment for the Amount of Trauma to the Patient Inside the Vehicle.

Conditions
-----------------
Multiple Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with multiple trauma from severe motor vehicle accidents in Eastern Norway patients from motor vehicle accidents in Eastern Norway with severe material damage
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
-----------------
multiple trauma, traffic accident, outcome, safety, injury severity
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

Detailed Description
-----------------
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.

Official Title
-----------------
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Iron Sucrose + Erythropoietin
* Drug: Ferrous Sulfate + Erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Creatine Clearance <40 mL/min Average Baseline Hemoglobin < 10.5g/dL TSAT < 25% and Ferritin <300ng/mL Exclusion Criteria: Blood Transfusion within 30days Uncontrolled Hypertension Suffering form concommitant disease of the liver Serious bacterial infection Pregnancy / lactation Symptomatic HIV Expected to under dialysis or renal transplant during study

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iron Sucrose + Erythropoietin|nan|
|Drug: Ferrous Sulfate + Erythropoietin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hemoglobin and Serum Ferritin at day 43 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success (change in Hgb > 12 & Change in Ferritin 180) |  |  | 
| Maximum change in Hemoglobin during the study |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Chronic Kidney Disease
Prospective Athlete's Heart Study

Study Overview
=================
Brief Summary
-----------------
The Pro@Heart (Prospective Athlete's Heart) study is an international multicentre long-term prospective trial. The primary objective of the Pro@Heart study is to investigate the impact of training load (i.e. accurately evaluated in term of type, frequency, duration and intensity) and genotype on the variability of structural, functional and electrical exercise induced cardiac remodeling (EICR) in young competitive endurance athletes. The second objective is to determine how EICR, training load and genotype are associated with physical performance, health benefits and cardiac pathology (e.g. exercise-related cardiomyopathies and arrhythmias) during follow-up over several decades.

Official Title
-----------------
Prospective Athlete's Heart Study: Long-term Assessment of the Determinants of Cardiac Remodelling and Its Clinical Consequences in Endurance Athletes

Conditions
-----------------
Athlete Heart

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 14-23 years old Athletes competing in endurance sports at national or international level for at least 2 years. Sports include: Triathlon Cycling Distance running (≥ 1500 meters) Rowing Swimming Non athletes engaged in < 3 hours per week of physical activity Exclusion Criteria: Medical history of cardiovascular disease Current smoker of past history of smoking Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 23 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Athletes<br>Males and females aged 14-23 years old Athletes competing in endurance sports at national or international level for at least 2 years. Sports include: Triathlon Cycling Distance running (≥ 1500 meters) Rowing Swimming | Other: No intervention<br>* No intervention<br>|
| Non-athletes<br>Males and females aged 14-23 years old Non athletes engaged in < 3 hours per week of physical activity | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype | Rare and common variants in cardiomyopathy associated genes | Baseline | 
| Training load | Duration and intensity of training | Baseline to 20 years | 
| Atrial fibrillation |  | Baseline to 20 years | 
| Ventricular arrhythmias | Ventricular ectopic beats, non-sustained and sustained ventricular tachycardia | Baseline to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Athlete, Atrial fibrillation, Arrhythmias, Cardiac remodelling, Cardiomyopathy, Genetics
Proctologic Practice and Covid-19

Study Overview
=================
Brief Summary
-----------------
Cross-sectional non-incentivized worldwide web survey. A worldwide survey of 1050 respondents showed that proctologic practice has been seriously affected by the pandemic. Age, gender and level of hospital preparedness predicted the change of status of surgical and outpatient activities. The results of our study may inform the development of strategies to reopen activities while protecting frontline healthcare workers.

Detailed Description
-----------------
A 27-item survey (namely, 'ProctoLock 2020') was designed and developed by the authors using an online platform ('Online surveys' [formerly BOS - Bristol Online Survey], developed by the University of Bristol) in accordance with the American Association for Public Opinion Research (AAPOR) guidelines and the Checklist for Reporting Results of Internet E-Surveys [CHERRIES]

Official Title
-----------------
A Worldwide Survey on Proctologic Practice During Covid-19 Lockdown

Conditions
-----------------
Proctologic Practice During COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of renowned scientific societies with an interest in coloproctology
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 |
| --- | --- | --- |
| Predictive power of respondents' and hospitals' demographics on the change of status of proctologic surgical and outpatient activities |  | April 15th to 26th 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proctology, covid-19
Molecular Characterization of Gliomas Using a Broad Next Generation Sequencing (NGS)Panel

Study Overview
=================
Brief Summary
-----------------
Gliomas are the most common malignant primary brain tumors with poor prognosis. The genotyping of tumors using NGS platforms enables the identification of genetic alterations that constitute diagnostic, prognostic and predictive biomarkers.Here in, we investigated the molecular profile of 32 tumor samples from 32 patients with high grade gliomas by implementing a broad 80-gene targeted NGS panel while reporting their clinicopathological characteristics and outcomes.

Official Title
-----------------
Molecular Characterization of Gliomas Using a Broad NGS Panel

Conditions
-----------------
Malignant Glioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of high grade glioma based on tissue biopsy Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel | The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel | April 2019 - December 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Molecular profile, Mutational status
Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular cardiac patients during dental treatment with the use of a local anesthesia containing epinephrine.

Detailed Description
-----------------
Patients with valvular disease constitute a group in which local anesthesia must be effective to avoid higher release of endogenous catecholamines that could trigger hemodynamic. The study was conducted in the Dental Department of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Brazil). Patients were allocated into two groups through an aleatory numbered table: PL (plain 2% lidocaine, n= 31) and LE (2% lidocaine with 1:100.000 epinephrine, n= 28). The anesthetic amount was registered. DIXTAL monitor (São Paulo- Brazil) captured blood pressure, heart rate, oxygenation and electrocardiogram records.

Official Title
-----------------
Loco Regional Anesthesia for Dental Treatment in Cardiac Patients: Comparative Study Between Plain Lidocaine 2% and Lidocaine 2% With Epinephrine 1:100.000

Conditions
-----------------
Arrhythmias, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acquired valvular disease Exclusion Criteria: Patients having platelets counting lower than 70.000 or INR > 3

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PL<br>Patients who receive local anesthesia with 2% lidocaine without epinephrine | |
| LE<br>Patients who receive local anesthesia with 2% lidocaine with 1:100.000 epinephrine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arrhythmias |  | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pressure |  | during procedure | 
| anxiety |  | during and imediately after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, Local, Lidocaine, Dental care, Arrhythmias, Cardiac, Anxiety
Validation of a Predictive Nomogram of Response or Resistance to Targeted Therapies in Metastatic Clear Cell Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate of a predictive nomogram of response or resistance to targeted therapies in metastatic clear cell renal cell carcinoma

Official Title
-----------------
Validation of a Predictive Nomogram of Response or Resistance to Targeted Therapies in Metastatic Clear Cell Renal Cell Carcinoma

Conditions
-----------------
Metastatic Clear Cell Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Sunitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with metastatic ccRCC Underwent nephrectomy at the University Hospital of Rennes treated by sunitinib first line treatment Exclusion Criteria: translocation renal cell carcinoma other targeted therapies before the sunitinib

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

| Intervention/Treatment |
| --- |
|Drug: Sunitinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary refractory patients (Progression Free Survival (PFS) |  | at 3 months |
A Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, multiple-dose study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of ACHN-975. This study will take place in the US at one clinical site.

Official Title
-----------------
A Phase 1 Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 Administered Intravenously to Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: ACHN-975
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Body weight between 40 and 100 kilograms (between  88 pounds and  220 pounds) Use of contraception Stable health Negative tests for alcohol, tobacco, and drugs of abuse Key Exclusion Criteria: History of clinically significant disease Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACHN-975<br> | Drug: ACHN-975<br>* Intravenous multiple dose<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Intravenous multiple dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of AEs |  | 28 days | 
| Severity of AEs |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of ACHN-975 |  | 16 days |
The Effects of Risperidone and Olanzapine on Thinking

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition. Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.

Official Title
-----------------
The Cognitive Effects of Risperidone and Olanzapine

Conditions
-----------------
Schizophrenia, Psychotic Disorders

Intervention / Treatment
-----------------
* Drug: Risperidone
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with schizophrenia disorder by a DSM IV. Competent to sign informed consent No history of poor response to Risperdal and Zyprexa No organic brain disease Exclusion Criteria: Mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to Risperdal or Zyprexa.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone|nan|
|Drug: Olanzapine|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
-----------------
schizophrenia, cognition, antipsychotic medication, information processing, social cognition, Psychotic