linjc16/ctgov huggingface dataset:
VR-Based Physical Therapy Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility and acceptability of using the virtual reality-based physical therapy platform in patients with extremity fracture.

Official Title
-----------------
VR-Based Physical Therapy Pilot Study

Conditions
-----------------
Extremity Fracture Lower

Intervention / Treatment
-----------------
* Other: Virtual Reality Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old Diagnosed with an operative fracture of the femur and/or tibia referred to physical therapy as standard of care Exclusion Criteria: Injury Severity Score(ISS) > 18 bilateral lower extremity injuries that preclude crutch ambulation associated spine fractures Glasgow Coma scale (GCS) < 15 at time of discharge major peripheral nerve injury

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Physical Therapy<br>Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session. | Other: Virtual Reality Physical Therapy<br>* Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction with the virtual reality based physical therapy platform. Patient satisfaction will be assessed using a questionnaire created for this study. | Assessed directly after virtual reality physical therapy session | 
| Patient Preference | Patient preference for virtual reality-based physical therapy when compared to standard supervised office based physical therapy. Patient preference will be assessed using a questionnaire created for this study. | Assessed directly after virtual reality physical therapy session |
Efficacy of Physiotherapy on the Health and Quality of Life of the Rheumatic Patient

Study Overview
=================
Brief Summary
-----------------
Despite leading cause of morbidity, treatment strategies for Rheumatic diseases are geared almost exclusively toward medical-pharmacological area away from offering the patient the possibility of an interdisciplinary approach to their disease. Present study test whether treatment of physiotherapy reduces stiffness and pain inherent in rheumatic disease and improve their quality of life related to health.

Official Title
-----------------
Phase II Study of Physiotherapy in Rheumatoid Arthritis: Randomized Single Blind Wait-list Controlled Trial

Conditions
-----------------
Rheumatic Arthritis

Intervention / Treatment
-----------------
* Other: Physiotherapy
* Other: Wait list control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years History of Rheumatoid Arthritis (RA) symptoms for less than 7 years Had RA by American College of Rheumatology (ACR) criteria ACR functional RA class I, II or III Hemoglobin more than 8g/dL without evidence of active bleeding Positive for rheumatoid factor (RF) or anti cyclic citrullinated protein standard conventional medicine were allowed within the approved dosage regimen Exclusion Criteria: connective tissue disease any other alternative or complementary medicine with in last 3 months. corticosteroid, disease modifying medicines Poorly controlled diabetes, hypertension, hepatitis, cardiac disease, liver diseases, carcinoma, drug abuse

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy<br>Physiotherapy included joint protection strategies, performance of therapeutic exercises and patient education. | Other: Physiotherapy<br> <br> |
| Other: Wait list control<br>Wait list control received standard care and were invited to join the physiotherapy once intervention period is finished. | Other: Wait list control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | Change from baseline in Numerical Scale Downie at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | Change from Baseline in Short Form (SF) 36 at 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Functional capacity, Quality of Life
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia

Study Overview
=================
Brief Summary
-----------------
Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.

Official Title
-----------------
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia; having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks; being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone. Exclusion Criteria: any other major psychiatric disorder; significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>risperidone plus placebo | |
| Experimental: aripiprazole 5mg<br>risperidone treatment plus aripiprazole 5mg/day | Drug: Aripiprazole<br> <br> |
| Experimental: aripiprazole 10mg<br>risperidone plus aripiprazole 10mg/day | Drug: Aripiprazole<br> <br> |
| Experimental: aripiprazole 20mg<br>risperidone plus aripiprazole 20mg/day | Drug: Aripiprazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolactin level | Change from baseline in the levels of prolactin | baseline, 2 weeks, 4 weeks, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS (positive and negative syndrome scale) score | Change from baseline in PANSS score | Baseline, 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risperidone;, Aripiprazole;, Hyperprolactinemia;, dose effects
The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients

Study Overview
=================
Brief Summary
-----------------
The investigators aim to study the specific elastance in ALI/ARDS patients during invasive mechanical ventilation.

Detailed Description
-----------------
In sedated and paralyzed ALI/ARDS patients, we studied the specific elastance and also, we compared the specific elastance to healthy subjects during invasive mechanical ventilation.

Official Title
-----------------
The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma

Conditions
-----------------
Acute Lung Injury, ARDS

Intervention / Treatment
-----------------
* Behavioral: mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable ALI/ARDS patients during invasive mechanical ventilation Exclusion Criteria: Hemodynamic failure, pneumothorax

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ALI/ARDS patients and healthy subjects | Behavioral: mechanical ventilation<br>* measurement of specific lung elastance during mechanical ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific elastance |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gas exchange, respiratory mechanics
Different Treatments With the TRV Reposition Chair

Study Overview
=================
Brief Summary
-----------------
To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.

Detailed Description
-----------------
Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.

Official Title
-----------------
Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?

Conditions
-----------------
Benign Paroxysmal Positional Vertigo

Intervention / Treatment
-----------------
* Procedure: Type of repositional maneuvre


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years of age Medical history compatible with BPPV Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test. Exclusion Criteria: Former treatment with a repositional Chair Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Posterior canalolithiasis<br>Type of repositional maneuvre | Procedure: Type of repositional maneuvre<br>* Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV<br>|
| Experimental: Lateral cupulolithiasis<br>Type of repositional maneuvre | Procedure: Type of repositional maneuvre<br>* Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation by VNG Measurements | Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures. | 2 years | 
| Subjective vertigo | A systematic registration of experienced vertigo during each diagnostic procedure will take place. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI) questionnaire | Pre-treatment fulfillment of the questionnaire Dizziness Handicap Inventory (DHI) will quantify the level of experienced vertigo. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epley Maneuvre, TRV Reposition Chair
Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy

Study Overview
=================
Brief Summary
-----------------
Incisional hernia (IH) is a common complication of midline laparotomy. Despite the hope that laparoscopic colon resection would result in fewer incisional hernias, prospective studies demonstrate a similar incidence to open surgery. Observational studies suggest that the rate of incisional hernia after laparoscopic colon resection may be reduced with the use of a transverse compared to a midline extraction incision. However, no randomized trails are available, and a midline extraction incision for hemicolectomy remains the standard current approach. The investigators hypothesize that the use of a lower abdominal transverse muscle splitting incision for specimen extraction in laparoscopic colon surgery will result in fewer incisional hernias compared to a midline periumbilical extraction incision.

Official Title
-----------------
Incisional Hernia After Midline Versus Transverse Extraction Incision in Laparoscopic Colectomy: A Pilot Randomized Trial

Conditions
-----------------
Laparoscopic Colectomy

Intervention / Treatment
-----------------
* Procedure: laparoscopic colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled laparoscopic partial colectomy where an abdominal extraction incision is planned Exclusion Criteria: previous laparotomy rectal resection or anastamosis planned pfannenstiel extraction incision single site surgery planned or performed stoma BMI >35 kg/m2 ASA 4-5

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 |
| --- | --- |
| Active Comparator: midline incision<br> | Procedure: laparoscopic colectomy<br>* Laparoscopic segmental colectomy with planned abdominal extraction site<br>|
| Active Comparator: transverse incision<br> | Procedure: laparoscopic colectomy<br>* Laparoscopic segmental colectomy with planned abdominal extraction site<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection |  | one month | 
| body image |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, colon resection, incisional hernia
Chronic Lymphocytic Leukemia Registry Study - Multicenter Prospective National Study

Study Overview
=================
Brief Summary
-----------------
A prospective, multicenter national observational study for patients diagnosed as chronic lymphocytic leukemia across 25 centers in Turkey

Detailed Description
-----------------
The purpose of this study is to explore the history and real world management of patients diagnosed with CLL, provide insight into the management of CLL, and evaluate the effectiveness of first, second and subsequent therapeutic strategies employed in both the community and academic settings.

Official Title
-----------------
Turkish Chronic Lymphocytic Leukemia Study Group Registry - Multicenter Prospective Study

Conditions
-----------------
Chronic Lymphocytic Leukemia, Del(17P)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as CLL 18 years or older Able and willing to provide the written informed consent Exclusion Criteria: Younger than 18 years

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 |
| --- | --- | --- |
| First line therapy therapy protocol distrubition | The primary objective is to describe percentage of first line therapy protocols in patients initiated on therapy for CLL in the community and academic setting | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, del(17p)
CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest

Study Overview
=================
Brief Summary
-----------------
The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone healing strength of CopiOs to be equivalent to autograft.

Detailed Description
-----------------
Purpose of the study is to evaluate the in-vivo use of CopiOs bone void filler in a single site trial, providing pre and post-operative evaluations of subjects undergoing spinal fusion with autogenous bone graft, in whom the CopiOs has been used as a bone void filler in the post-harvest iliac crest.

Official Title
-----------------
CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest

Conditions
-----------------
Spinal Fusions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years and older Patient must be an appropriate candidate for iliac crest bone harvesting during a spinal fusion. Patient must be skeletally mature. Patient has signed an IRB approved Informed Consent and HIPAA compliant waiver. Exclusion Criteria: Patient is suffering from any co-morbidities that would excessively increase the risk of surgery, including but not limited to pulmonary or cardiac conditions. Patient is pregnant. Patient has a severe degenerative bone disease. Patient has systemic conditions which would affect bone or wound healing. Patient is unwilling or unable to follow postoperative instructions or cooperate in a follow-up program. Patient is suffering from mental illness, alcohol abuse or drug abuse. Patient has known allergies to bovine collagen. Patient has a history of multiple allergies. Patient has infection at the surgical site. Significantly impaired vascularity proximal to surgical site. Sites are in direct contact with articular space. Sites where stresses on void will exceed the load strength of fixation hardware. Patient has hypercalcemia.

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 |
| --- | --- |
| 1<br>Spinal fusion patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data obtained by this study will provide valuable insight on the ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion. |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone Void Filler, Post-Harvest Iliac Crest, Ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
Validity of Information Employed to Generate Standardized Mortality Ratios Using Hospital Administrative Databases (RNMH)

Study Overview
=================
Brief Summary
-----------------
In a retrospective cross-sectional study, investigators aimed to valid the variables employed to generate standardized mortality ratio from hospital administrative databases. For this purpose, investigators have compared those variables collected in administrative databases with the information available in patient medical record.

Official Title
-----------------
Validity of Information Employed to Generate Standardized Mortality Ratios Using Hospital Administrative Databases (RNMH)

Conditions
-----------------
Surgical Condition, Obstetrical Condition, Hospitalization in Acute Care

Intervention / Treatment
-----------------
* Other: Hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All inpatients stays in acute care from high mortality diagnosis related groups (DRGs) registered in administrative databases of participating hospitals from January to December 2010. Exclusion Criteria: Hospital participation refusal
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inpatient stays<br>All patients who were hospitalized in participating hospitals in France during the study period were eligible for inclusion. | Other: Hospitalization<br>* Patients who were hospitalized in acute care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Death collected in hospital administrative databases at the end of in patient stay | within 90 days of admission (D90) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hospital mortality, standardized mortality ratios, patient safety, healthcare quality, hospital performance, administrative data