linjc16/ctgov huggingface dataset:
Web Based Orthopaedic Sports Medicine Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with the surgical procedures and nonoperative treatments.

Official Title
-----------------
Orthopaedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based OrthoIllustrated Surgical Outcomes System

Conditions
-----------------
Degenerative and Traumatic Pathology of the Knee, Degenerative and Traumatic Pathology of the Shoulder and Elbow, Degenerative and Traumatic Pathology of the Foot and Ankle, Degenerative and Traumatic Pathology of the Hand and Wrist, Degenerative and Traumatic Pathology of the Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients electing to schedule routine and medically indicated orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment Exclusion Criteria: Non English or Spanish speaking vulnerable populations, excluding minors

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Orthopedic injury, osteoarthritis<br>All eligible patients receiving orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedic surgery, sports medicine
Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.

Official Title
-----------------
Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: Cholecalciferol
* Drug: Cholecalciferol
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SLE by ACR criteria (revised 1997) African American, participating in the SLE in Gullah Health (SLEIGH) Study Outpatient Stable disease with no BILAG A or B in any system for the past 4 weeks Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry Baseline 25(OH)D concentration of < 30 ng/ml Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study Age 18 - 85 years Ability to complete questionnaires in English Ability to give informed consent Exclusion Criteria: Presence of hypercalcemia (>10.4 mg/dL), hypercalcuria (urinary calcium/creatinine ratio ≥ 0.8 mmol/mmol) or known primary hyperparathyroidism Liver disease (serum ALT, AST >2x normal) or total serum bilirubin >1.5x normal History of renal stones Current treatment with any dose of cyclophosphamide Dialysis or creatinine > 2.5 mg/dL Pregnancy Current drug or alcohol abuse Anticipated poor compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>800 IU oral daily dose level | Drug: Cholecalciferol<br>* 800 IU oral daily<br>* Other names: Vitamin D3;|
| Experimental: 2<br>2000 IU oral daily dose level | Drug: Cholecalciferol<br>* 2000 IU oral daily<br>* Other names: Vitamin D3;|
| Experimental: 3<br>4000 IU oral daily dose level | Drug: Cholecalciferol<br>* 4000 IU oral daily<br>* Other names: Vitamin D3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypercalcuria |  | Monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Lupus
Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar

Study Overview
=================
Brief Summary
-----------------
Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.

Official Title
-----------------
A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy

Conditions
-----------------
Depressed Scar

Intervention / Treatment
-----------------
* Drug: Adipocell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 19 years depressed scar less than volume of 5 ml negative for urine beta-HCG for women of childbearing age agreement to participate, with signed informed-consent Exclusion Criteria: failure to meet inclusion criteria any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days allergy to bovine-derived materials Diagnosis of cancer, AIDS, HBV or HCV. Patient has a lot of hairs or a tattoo on depressed site Insufficient adipose tissue for manufacturing of ANTG-adip Patient has depressed scar caused by a malignant tumor Patient whom investigator consider is not suitable in this study

Ages Eligible for Study
-----------------
Minimum Age: 19 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: autologous cultured adipocytes<br> | Drug: Adipocell<br>* autologous cultured adipocytes (ANTG-adip)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: recovery rate(%) |  | week 12 | 
| Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate (%) |  | day 7, 14, 21, 28 days and week 8 | 
| A digital photograph |  | day 1, 3, 7, 14, 21, 28, week 8 and week 12 | 
| Patient satisfaction |  | week 12 |
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Study Overview
=================
Brief Summary
-----------------
The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.

Detailed Description
-----------------
Background: Myoma is the most common gynecoid tumor and produces many vasoactive substances, which may be a cause for secondary hypertension. Early reports suggested the association of myoma and hypertension. We studied the effect of myoma removal on hypertension and erythropoietin level to evaluate this hypothesis. Patients & Methods: In this single centered prospective cohort study, in twenty eight patients who were candidates for myomectomy due to myoma, 24 hour holter monitoring of blood pressure and serum erythropoietin were checked before and 6 weeks after hysterectomy.

Official Title
-----------------
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Conditions
-----------------
Myoma, Hypertension

Intervention / Treatment
-----------------
* Procedure: myoma removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: candidate for myoma removal by hysterectomy operable hysterectomy is indicated Exclusion Criteria: patient refusal inoperable patients other secondary cases of hypertension

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: myoma, with or without hypertension<br>those with myoma with or without hypertension in holter monitoring | Procedure: myoma removal<br>* surgical removal of myoma by hysterectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour holter monitoring of blood pressure |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythropoetin level |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myoma, hypertension, erythropoetin, blood pressure, erythropoetin level
Fluoxetine vs. Brief Psychotherapy for Major Depression

Study Overview
=================
Brief Summary
-----------------
In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main hypothesis is that brief psychotherapy is as effective as fluoxetine.

Detailed Description
-----------------
This study is a randomized comparison of two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. The patients are recruited from occupational health services and suffer from mild to moderate major depressive disorder. The treatments last for 16 weeks. The main outcome measures include HAM-D, BDI, SOFAS, Rand-36. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment using Positron Emission Tomography (PET) . The main hypothesis is that brief psychotherapy is as effective as fluoxetine, but differences between the treatments are seen in PET scanning.

Official Title
-----------------
Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Fluoxetine
* Behavioral: Short-term psychodynamic psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MDD (mild to moderate) HDRS 15 or more, age 20-60 years No treatment for preceding 4 months No DSM-IV axis I or II comorbidity No severe somatic illness No contraindications for fluoxetine treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Fluoxetine | Drug: Fluoxetine<br>* 20-40 mg / day orally<br>|
| Active Comparator: 2<br>Short-term psychodynamic psychotherapy | Behavioral: Short-term psychodynamic psychotherapy<br>* 1 session / week for 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D |  | 0, 16 weeks, one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, Major depressive Disorder, fluoxetine, short-term psychodynamic psychotherapy
Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy

Study Overview
=================
Brief Summary
-----------------
This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.

Official Title
-----------------
Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Device: Actigraphic measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Juvenile idiopathic arthritis evolving for more than a year Exclusion Criteria: intra-articular infiltration performed less than a month ago

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actigraphic measurement<br> | Device: Actigraphic measurement<br>* Physical activity assessed with actigraphic device worn during 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity assessment | Physical activity will be measured with actigraphic device and children will be divided into 3 groups of activity levels: low / moderate / high. Low is < or = 1000 counts per minute Moderate is > 1000 counts per minute High is > 2500 per minute | Day 7 |
A Comparison of McGrath, Pentax and Macintosh Laryngoscopes for Nasotracheal Intubation in Pediatrics

Study Overview
=================
Brief Summary
-----------------
Videolaryngoscope provide better view of the larynx. This better view could improve the navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result in adult, one previous report using Glidescope in children did not show better performance than direct laryngoscope. The aim of this study is to compare the performance of McGrath, Pentax and Macintosh laryngoscope for nasotracheal intubation in children.

Conditions
-----------------
Intubation Time, Intubation Difficulty Scale

Intervention / Treatment
-----------------
* Device: Macintosh laryngoscope
* Device: McGrath videolaryngoscope
* Device: Pentax videolaryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist physical status class I, II Exclusion Criteria: abnormality of airway bleeding tendency

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macintosh laryngoscope<br>Nasotracheal intubation by Macintosh laryngoscope | Device: Macintosh laryngoscope<br> <br> |
| Experimental: McGrath videolaryngoscope<br>Nasotracheal intubation by McGrath videolaryngoscope | Device: McGrath videolaryngoscope<br> <br> |
| Experimental: Pentax videolaryngoscope<br>Nasotracheal intubation by Pentax videolaryngoscope | Device: Pentax videolaryngoscope<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to intubation | Time from nasotracheal tube passing nose until confirmation of tracheal intubation by end-tidal carbon dioxide will be measured | 2 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation difficulty scale | Modified nasal intubation difficulty scale will be assessed : N1(intubation attempts), N2(operators to attempt intubation, N3(alternative intubation techniques or change head position), N4(glottic exposure), N5(lifting force required to expose the vocal cords), N6(optimise glottic exposure with backward, upward and right ward pressure), N7(techniques to aid intubation) | immediately after intubation |
MANTA Registry for Vascular Large-bore Closure

Study Overview
=================
Brief Summary
-----------------
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.

Official Title
-----------------
Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)

Conditions
-----------------
Femoral Arteriotomy Closure

Intervention / Treatment
-----------------
* Device: CE-marked MANTA vascular closure device (VCD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Per MANTA VCD Instructions for Use (IFU)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CE-marked MANTA vascular closure devices per IFU<br>Transcatheter Aortic Valve Replacement (TAVR), Endovascular aneurysm repair (EVAR), TEVAR, etc. | Device: CE-marked MANTA vascular closure device (VCD)<br>* Compile real word data on MANTA VCD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis | The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma). | Immediately after deployment of MANTA VCD | 
| Number of Participants With One or More Major Access Site Related Complications | Major access site related complications adapted from the VARC-2 definitions | within 30 days of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Minor Access Site Related Complications | Minor access site related complications adapted from the VARC-2 definitions | within 30 days of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial Closure Device, Large Bore Closure Device
MR-HIFU for Bone Metastases

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases. Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation. The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases

Official Title
-----------------
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study

Conditions
-----------------
Cancer, Bone Metastases

Intervention / Treatment
-----------------
* Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: radiologic evidence of bone metastases from any solid tumour diagnosis of dominant painful bone metastasis target lesion less than 8cm Exclusion Criteria: primary bone tumours rather than metastases Inability to tolerate stationary position during treatment pregnancy MRI incompatible metal implants

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-HIFU of painful bone metastases<br> | Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response |  | 30 days post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU)