linjc16/ctgov huggingface dataset:
Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.

Official Title
-----------------
Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Risedronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic spinal cord injury of greater than 18 months Osteopenia or osteoporosis of the hip Must be able to swallow tablets and sit upright Exclusion Criteria: Bilateral heterotopic ossification Bilateral lower extremity metal implants Pregnant or lactating females Paget's disease Osteomalacia Steroid induced bone loss Untreated parathyroid or thyroid disease Symptomatic hypocalcemia or hypophosphatemia Treatment in the last year with calcitonin, fluoride or anabolic steroids Current treatment with prednisone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Risedronate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density of the distal femur between baseline and 18-months |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density of the hips and proximal tibia between baseline and 18-months |  | 18 months | 
| The change in biochemical bone markers of bone turnover between baseline and 18-months |  | 18 months | 
| The frequency and severity of adverse events |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injury
AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).

Official Title
-----------------
Crossover Trial of VPAP (Variable Positive Airway Pressure) Ventilation Versus AutoVPAP in Neuromuscular and Chest Wall Disease: Effects on Nocturnal Hypoventilation, Sleep Quality and Tolerance

Conditions
-----------------
Chest Wall Disorder, Neuromuscular Disease

Intervention / Treatment
-----------------
* Device: VPAP non-invasive ventilator
* Device: AutoVPAP non-invasive ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-80 years Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 > 6.5 kPa when breathing spontaneously) with Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty) Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic. All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV403. Able to understand treatment and protocol Exclusion Criteria: Unstable respiratory failure (PaO2 < 7.5 kPa, PaCO2 > 8.0 kPa, Uncontrolled heart failure or arrhythmia Moderate or severe bulbar weakness. Unable to understand treatment or protocol

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VPAP non-invasive ventilator|nan|
|Device: AutoVPAP non-invasive ventilator|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare tolerance of AutoVPAP versus standard VPAP |  |  | 
| Compare effects on overnight heart rate variation (as a measure of autonomic stress) |  |  | 
| Measure of hours of use of device |  |  | 
| Measure of effect on daytime sleepiness |  |  |
Characterization and Progression of Minor Phenomena in Parkinson's Disease (PD)

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease psychosis encompasses a range of symptoms, including minor phenomena, frank hallucinations, and delusions. Minor phenomena include passage hallucinations (fleeting sense of a person, animal or object passing in the periphery), presence hallucinations (feeling of nearby presence), and illusions (misrepresentation of external stimuli). Some forms of PD psychosis may be progressive. The primary objective of this study is to: 1) To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.

Official Title
-----------------
Characterization and Progression of Minor Phenomena in Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Parkinson Disease Psychosis, Hallucinations, Delusion

Intervention / Treatment
-----------------
* Other: Observation of minor phenomena


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease (as determined by Movement Disorders Society diagnostic criteria for clinically probable Parkinson's disease) Parkinson's disease minor phenomena ≥30 years of age Proficient in English Willing and able to provide informed consent Exclusion Criteria: Any current or prior history of formed hallucinations or delusions Current or prior treatment with an antipsychotic medication (regardless of indication) Diagnosis of mania with psychotic features, bipolar or related disorder, depression with psychotic features, or a psychotic disorder Unable or unwilling to complete study activities Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| PD participants with minor phenomena<br> | Other: Observation of minor phenomena<br>* observation twice a year over 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative probability of developing hallucinations or delusions over time | Kaplan-Meier curves will be used to describe the cumulative probability of hallucinations and/or delusions over time. Participants will be determined to have met the primary endpoint if they have hallucinations and/or delusions on the basis of interview or initiate treatment with an antipsychotic medication. | baseline to 36 months |
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Official Title
-----------------
A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: ReFacto


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 6 years Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis) Ability to adhere to the protocol requirements Exclusion Criteria: Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as > 0.6 BU Prior participation in this study Any concomitant bleeding disorder other than hemophilia A

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia A
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

Study Overview
=================
Brief Summary
-----------------
To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain

Official Title
-----------------
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Buprenorphine
* Drug: Sterile saline
* Drug: lidocaine, epinephrine (Local anesthetic)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered Exclusion Criteria: pregnancy, allergy to buprenorphine, allergy to local anesthetic

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: buprenorphine and local anesthetic<br>buprenorphine added to local anesthetic | Drug: Buprenorphine<br>* Buprenorphine plus local anesthetic<br>Drug: lidocaine, epinephrine (Local anesthetic)<br>* 2% lidocaine 1:100,000 epinephrine<br>|
| Placebo Comparator: sterile saline and local anesthetic<br>sterile saline (placebo) added to local anesthetic | Drug: Sterile saline<br>* Placebo 1,8 ml<br>Drug: lidocaine, epinephrine (Local anesthetic)<br>* 2% lidocaine 1:100,000 epinephrine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia | The number of patients with extended postoperative analgesia when compared to the baseline in pain scores on a visual analog scale during a three-day period will be analyzed. A questionnaire containing a visual analog scale and a log for recording the use of rescue analgesics will be used to gather the data. | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, endodontic, postoperative
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy

Study Overview
=================
Brief Summary
-----------------
To evaluate how safe and effective AIV001 treatment is on scar formation and/or keloid recurrence following keloidectomy.

Official Title
-----------------
An Exploratory Study to Evaluate the Safety and Efficacy of Intradermal Administration of AIV001 Aqueous Suspension on Scar Formation and Keloid Recurrence Following Keloidectomy

Conditions
-----------------
Keloid

Intervention / Treatment
-----------------
* Drug: AIV001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of female, aged 18 to 60, inclusive No clinically relevant abnormalities identified by a detailed medical history and vital signs Presence of one keloid scar, up to 2.2 cm length and up to 1.2 cm width, at least 1 year from formation, and located on trunk or arms Willing to undergo surgical excision of keloid No concurrent treatment of the study keloid or prior treatment within last 2 months Exclusion Criteria: Prior keloidectomy of study keloid History of genetic disorder that predisposes to keloids (e.g., Ehlers-Danlos syndrome, Ullrich congenital muscular dystrophy, etc.) Corticosteroids (topical, injectable, inhalable, intranasal, or oral) within last two months (except as prescribed by physician for seasonal allergies) Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula Subject has active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura

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: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIV001 Treatment Dose 1<br>Intradermal, Dose 1 | Drug: AIV001<br>* Intradermal<br>|
| Experimental: AIV001 Treatment Dose 2<br>Intradermal, Dose 2 | Drug: AIV001<br>* Intradermal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence of adverse events | Approximately 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keloid recurrence | Number of subjects experiencing keloid recurrence within study duration | 365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scar formation, Keloidectomy
Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.

Study Overview
=================
Brief Summary
-----------------
Evaluation of the clinical results after total knee prosthesis, and correlation with the alignment of the lower limb. Radiological measurements by means of 3D technology will be performed. The clinical result will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee score-questionnaire).

Official Title
-----------------
Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.

Conditions
-----------------
Osteoarthritis of the Knee Joint

Intervention / Treatment
-----------------
* Procedure: patients that undergo a total knee prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with osteoarthritis of the knee joint, without severe bone deformation Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| total knee prosthesis<br>Patients that undergo a total knee prosthesis. | Procedure: patients that undergo a total knee prosthesis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical results after total knee prosthesis with standardized questionnaires after 6 months | Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire). | 6 months after total knee prosthesis | 
| Clinical results after total knee prosthesis with standardized questionnaires after 12 months. | Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire). | 12 months after total knee prosthesis | 
| Clinical results after total knee prosthesis with standardized questionnaires after 24 months. | Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire). | 24 months after total knee prosthesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope. | imaging with 3D software (MIMICS) | 6 months after total knee prosthesis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis
Functional Implications of Arthroscopic Iliopsoas Release

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas release. To complete this aim, we will recruit patients who have undergone arthroscopic iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as their own control. To delineate the effects of arthroscopic surgery alone from those resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a second control group consisting of patients who have undergone arthroscopic surgery by Dr. Aoki without iliopsoas release. For both hips of each subject, we will: Quantify the muscle volume of the iliopsoas muscle with MRI. Quantify hip flexion strength with isokinetic dynamometry. Quantify patient function and satisfaction with functional outcome surveys. This data will allow us to test the following hypotheses: Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength. Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength. Patient function and satisfaction positively correlates to muscle bulk and strength.

Official Title
-----------------
Functional Implications of Arthroscopic Iliopsoas Release

Conditions
-----------------
Arthroscopic Iliopsoas Release

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects will be greater than 18 years of age. We will recruit 18 subjects who have undergone arthroscopic iliopsoas release by Dr. Aoki. We will recruit 18 additional subjects that had hip arthroscopy with Dr. Aoki without iliopsoas release to serve as a control group. Exclusion Criteria: As the nonoperative contralateral hip will serve as a control to the operative hip, we will exclude patients for this study who have undergone bilateral procedures. We will exclude any patients who are not comfortable with the MRI scan, stationary bike or strength testing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Volume |  | 1 yr post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Flexion Strength |  | 1 yr post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroscopic, Iliopsoas, MRI