linjc16/ctgov huggingface dataset:
Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.

Study Overview
=================
Brief Summary
-----------------
Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.

Official Title
-----------------
Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.

Conditions
-----------------
Proximal Femoral Fracture

Intervention / Treatment
-----------------
* Other: Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 75 years of age Operated on for extracapsular proximal femoral fracture After bodyheight fall Exclusion Criteria: Intra-capsular fractures trochantero-diaphyseal fractures subtrochanteric fractures fractures involving pathological bone

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.|Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cut-out, Gamma nail, Lag-screw, Tip-apex distance, Trochanteric fracture
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This registry study will compile information from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.

Official Title
-----------------
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) for Intra-articular Delivery to Knees With Osteoarthritis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females > 18 years of age Diagnosis of osteoarthritis in one or both knees with Kellgren Lawrence grade ≥ 2 at x-ray evaluation or MRI findings of degenerative changes Pain with or without swelling in the affected area for >4 months Exclusion Criteria: Know spine or disc disease or symptomatic nerve impingement contributing to pain in the affected limb History of documented nerve damage in the affected limb Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to procedure.

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 |
| --- | --- | --- |
| Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS) |  | Days 7, 30, 180 and 365 | 
| Change in knee pain assessed by VAS Assessments |  | Days 7, 30, 90, 180 and 365 | 
| Change in knee function as assessed by the Lysholm Knee Scoring Scale |  | Days 7, 30, 90, 180 and 365 | 
| Change in WORMS scoring (Whole Organ MRI of the knee) |  | Days 180 and 365 | 
| Change in knee function as measured by Tegner Activity Scale |  | Days 7, 30, 90, 180 and 365 | 
| Change in knee function as measured by the Lower Extremity Functional Scale |  | Days 7, 30, 90, 180 and 365 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, knee
Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The objective is to report outcomes,including grade ≥2 overall late rectal and urinary toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)

Official Title
-----------------
Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer

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

Intervention / Treatment
-----------------
* Radiation: Intensity-modulated radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients from June 2000 to December 2010 with untreated histologically confirmed adenocarcinoma of the prostate stage T1c-T4 N0 M0 according to the 1992 American Joint Committee on Cancer staging system Exclusion Criteria: Patients with positive pelvic lymphadenectomy or radiological positives nodes

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Intensity-modulated radiation therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade≥ 2 overall late rectal 5 years after the end of radiotherapy |  | 60 months |
Flow Arrest Safety and Technical Success With Balloon Guide Catheters

Study Overview
=================
Brief Summary
-----------------
The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.

Detailed Description
-----------------
This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.

Official Title
-----------------
Flow Arrest Safety and Technical Success With Balloon Guide Catheters

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Device: Neuro-vascular access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms Adult patient willing to provide Informed Consent Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6 Exclusion Criteria: Posterior circulation stroke Tandem occlusions Cervical carotid stenosis Participating in another clinical trial

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 |
| --- |
|Device: Neuro-vascular access|Adjunctive device providing a conduit for retrieval device during thrombectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation | Incidence of device-related adverse events | Hospital discharge or 7 days | 
| Performance Evaluation | Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment | Completion of procedure |
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease

Official Title
-----------------
A Randomized, Placebo-Controlled, Double Blind, Phase 1 Trial of the Safety, Immunogenicity, and Tolerability of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults

Conditions
-----------------
Meningitis, Meningococcal

Intervention / Treatment
-----------------
* Biological: MnB rLP2086


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy 18-25 year olds Exclusion Criteria: Prior history of vaccination with any meningococcal vaccine Prior history of any invasive meningococcal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MnB rLP2086|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local & systemic safety throughout the trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of an immune response 1 month after dose 2 & 1 month after dose 3 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccines, Healthy Adults, Health, Adult, Meningococcal Vaccines
An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

Official Title
-----------------
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension

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

Intervention / Treatment
-----------------
* Drug: taranabant
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea Stable weight (+/-3 kg) for at least 3 months prior to study start Exclusion Criteria: History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: MK0364 2 mg capsule once daily | Drug: taranabant<br>* taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.<br>|
| Experimental: 2<br>Arm 2: MK0364 1 mg capsule once daily | Drug: taranabant<br>* taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.<br>|
| Experimental: 3<br>Arm 3: MK0364 0.5 mg capsule once daily. | Drug: taranabant<br>* taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.<br>|
| Placebo Comparator: 4<br>Arm 4: Pbo capsule once daily. | Drug: placebo<br>* Placebo capsule once daily. Treatment for 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight after 52 weeks of treatment |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment |  | 52 weeks |
Effects of Dry Needling in Patients With Sleep Bruxism and Temporomandibular Disorders: a Prospective Case Series

Study Overview
=================
Brief Summary
-----------------
The objective of the present study was to assess the effectiveness of deep dry needling in the masseter and temporalis MTrPs on pain, pressure pain threshold (PPT), range of motion and disability in patients with sleep bruxism and myofascial temporomandibular disorders.

Conditions
-----------------
Myofascial Pain

Intervention / Treatment
-----------------
* Device: Deep Dry needling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of myofascial temporomandibular disorders Diagnosis of myofascial trigger point Diagnosis of sleep bruxism Exclusion Criteria: insurmountable fear of needles any systematic joint or muscle disease bleeding disorders or prior physical therapy treatment

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: Dry needling<br>Dry needling in the masseter and temporalis muscles | Device: Deep Dry needling<br>* The muscles were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the myofascial trigger point, eliciting local twitch responses in some insertions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain: visual analog scale, ranging from 0mm (no pain) to 100mm (worst imaginable pain). |  | 1 week | 
| Pressure pain sensitivity: mechanical pressure algometer. |  | 1 week | 
| Range of motion: distance between the upper and lower central dental incisors was measured with a millimeter ruler. |  | 1 week |
Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10% BSA who are receiving etanercept or adalimumab for at least 24 weeks

Detailed Description
-----------------
30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar® once daily for 4 weeks followed by QOD for 12 weeks.

Official Title
-----------------
An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Enstilar 0.005%-0.064% Topical Foam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of chronic plaque-type Patient with 2-10% BSA Physician Global Assessment of 2 or greater Patient has been treated with etanercept or adalimumab for a minimum of 24 weeks Exclusion Criteria: ˂2 or >10% BSA PGA <2 Patient not receiving etanercept or adalimumab, or receiving etanercept or adalimumab <24weeks

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
Intervention Model: Single Group Assignment
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Enstilar<br>once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira | Drug: Enstilar 0.005%-0.064% Topical Foam<br>* Enstilar 0.005%-0.064% Topical Foam applied once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGA x BSA improvement | body surface area multiplied by physician global assessment | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BSA improvement | body surface area improvement | 16 weeks | 
| Dermatology Life Quality Index improvement | patient reported outcome improvements of DLQI (Dermatology Life Quality Index). Calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. | 16 weeks | 
| Itch Numerical Rating Scale | Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch). | 16 weeks |
Evaluation of Effects of Clavicular Hook Plate on Subacromial Space

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators intend to demonstrate that the hook plate may have adverse effects on subacromial structures even with a short period of hardware retention. The investigators also sought to determine if musculoskeletal sonography could be used as a tool to demonstrate shoulder pathology such as subacromial impingement or rotator cuff tear in patients receiving hook plate fixation. The clinical results of patients receiving hook plate fixation, specifically bony union, pain relief, shoulder function and range of motion (ROM), were also evaluated.

Official Title
-----------------
Evaluation of Effects of Clavicular Hook Plate on Subacromial Space

Conditions
-----------------
AC Joint Dislocation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient received surgical treatment for AC joint dislocation of unstable distal clavicle fracture in our hospital from December 2007 to January 2009. Exclusion Criteria: The patient who was expired or the injured limb has preexisting injury or neurological deficit.
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 |
| --- | --- | --- |
Precision Medicine for Preterm Birth

Study Overview
=================
Brief Summary
-----------------
This project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation. However, it is not well known why it works for some women but not for others. There are limited available interventions for the prevention of recurrent PTB. This study will enroll 150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC and 20% will decline use. We will obtain blood samples and samples of cervical cells and cervical vaginal fluid. The objective of the study is to identify genetic, microbial and molecular markers that help to identify which women at risk for recurrent preterm birth will respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized screening test based on these markers.

Detailed Description
-----------------
Women with a prior preterm birth will be recruited between 16 and 22 weeks gestation. At this initial time point, samples of cervical epithelial cells and cervicovaginal fluid will be collected. Approximately 8 weeks later, those samples will be collected a second time, along with a blood sample. Outcome data will be collected after delivery.

Official Title
-----------------
Precision Medicine In Segregating Endotypes in Preterm Birth

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a prior spontaneous preterm birth of a singleton pregnancy (delivered at 16-36 6/7 weeks gestation) Singleton in the current pregnancy Eligible to use 17 hydroxyprogesterone caproate (17OHPC) in this pregnancy for clinical indications 16-22 weeks gestation at the time of visit 1 assessments Exclusion Criteria: Major fetal anomaly Allergy to 17OHPC
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prior preterm birth<br>Pregnant women with a prior preterm birth, eligible to receive 17 hydroxyprogesterone caproate (17OHPC) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth |  | At time of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature birth, Premature delivery, Metabolomics, Microbiota, Genetics, 17 hydroxyprogesterone caproate