linjc16/ctgov huggingface dataset:
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs

Official Title
-----------------
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Conditions
-----------------
Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Procedure: Bypass
* Procedure: Silverhawk Plaque Excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6) Willing and able, as evaluated by the PI, to provide Informed Consent Willing to undergo up to 5 years of clinical follow up visits as scheduled Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot The patient must be >18 years of age Target lesion(s) is located at or below the level of the superficial femoral artery Target lesion(s) is >50% stenosed by quantitative vascular angiography Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy Exclusion Criteria: Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate Patient has terminal or Stage 4 cancer Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure Previous stent in the target lesion Active infection at planned incision site The patient is a pregnant woman The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bypass|nan|
|Procedure: Silverhawk Plaque Excision|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major amputation-free survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLI, Critical Limb Ischemia, PAD, Peripheral Arterial Disease, Artherosclerosis, Leg Pain, Cardiovascular, Artherectomy, Bypass, Peripheral Bypass, PROOF
A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

Study Overview
=================
Brief Summary
-----------------
This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan

Official Title
-----------------
A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients > 18 years of age or older Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment Exclusion Criteria: Patients enrolled in any clinical trials at any time Overlapping use of nivolumab and ipilimumab

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 |
| --- | --- |
| Adult patients with melanoma<br>Adult patients with melanoma at participating centers in Japan | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ipilimumab treatment after nivolumab treatment |  | Approximately 19 months | 
| Incidence of nivolumab treatment after ipilimumab treatment |  | Approximately 19 months | 
| Duration of nivolumab treatment |  | Approximately 19 months | 
| Duration of ipilimumab treatment |  | Approximately 19 months | 
| Duration of interval between nivolumab treatment and ipilimumab treatment |  | Approximately 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate (ORR) |  | Approximately 19 months | 
| best overall response rate (BORR) |  | Approximately 19 months | 
| overall survival (OS) |  | Approximately 19 months | 
| progression-free survival (PFS) |  | Approximately 19 months | 
| incidence of treatment-related adverse events (AEs) | incidence of treatment-related adverse events (AEs)/adverse reactions (ARs) | Approximately 19 months | 
| severity of treatment-related adverse events (AEs) | severity of treatment-related adverse events (AEs)/adverse reactions (ARs) | Approximately 19 months |
Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness.

Official Title
-----------------
Effects of Post-Stroke Upper Extremity Assistance

Conditions
-----------------
Arm Weakness as a Consequence of Stroke

Intervention / Treatment
-----------------
* Device: compliant support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than 6 months post-stroke passive abduction to 90 degrees at shoulder reduced active (retro)flexion/extension at shoulder when abducted to 90 degrees reduced active flexion/extension at elbow Exclusion Criteria: unable to give informed consent unable to comprehend and follow instructions have a condition (other than stroke) affecting sensorimotor function show evidence of unilateral spatial neglect unable to sit in a chair without armrests for 2 hours

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke survivors<br>Stroke survivors with upper extremity motor impairments | Device: compliant support<br>* Participants will be given compliant arm support and their reachable workspace measured<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Reachable Workspace | Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters). | baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Biceps Activation | Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies. | baseline and while using support device (up to 10 seconds per assessment) |
Relationship Between Macular Thickness Measurement and Signal Strength in Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT stratus, that combines SNR and uniformity of the signal within a scan The scale of signal strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing excellent image quality It has been showed that signal strength has a better image quality discriminating ability than SNR The operation manual recommends a minimum signal strength of 5 for macular thickness measurement There is no consensus on the level of signal strength above which should be considered to be good quality The inclusion Criteria for acceptable signal strength varies widely in the literature the purpose of our study is to examine the relationship between signal strength and macular thickness measured by stratus OCT

Official Title
-----------------
Relationship Between Macular Thickness Measurement and Signal Strength Using Stratus Optical Coherence Tomography

Conditions
-----------------
Optical Tomography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects in this study other than refractive error, all included eyes had no concurrent ocular pathologic features BCVA of at least 20/30, and had spherical refractive error within the range of 4.00 D to 4.00 D Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To examine the relationship between signal strength and macular thickness measured by stratus OCT
Assessing Cosopt Switch Patients

Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Conditions
-----------------
Ocular Hypertension, Open-Angle Glaucoma, Exfoliation Syndrome, Glaucoma, Pigmentary

Intervention / Treatment
-----------------
* Drug: timolol maleate
* Drug: dorzolamide/timolol maleate fixed combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM visual acuity should be 20/200 or better in each eye Exclusion Criteria: contraindications to study drugs anticipated change in systemic hypotensive therapy during the trial use of any corticosteroids by any route in the three months immediately prior to Visit 2

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: timolol maleate|nan|
|Drug: dorzolamide/timolol maleate fixed combination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Retrospective Follow-up of Synvisc® in Active Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Retrospective collection of data, aimed at a better knowledge of the context of use of Synvisc® among the patients practising a regular activity (professional/leisure), and at evaluating the different practices and their results.

Official Title
-----------------
Synvisc® in With Knee Osteoarthritis: Retrospective Follow-up in Active Patients

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

Intervention / Treatment
-----------------
* Drug: Synvisc®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: use of Synvisc® patients practising a regular activity (professional/leisure) 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 |
| --- | --- |
| Synvisc®<br> | Drug: Synvisc®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of medication consumed | antalgics, non-steroid anti-inflammatory drugs (NSAIDs), steroid anti-inflammatory drugs (SAIDs) | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-assessed benefit on a 2-point verbal rating scale |  | up to 1 year |
fMRI Cholinergic Mechanisms in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.

Detailed Description
-----------------
This study will use functional magnetic resonance imaging (fMRI) to study patients treated with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those treated with clozapine to determine which brain areas are involved in clozapine's normalization of sensory gating in schizophrenia.

Official Title
-----------------
fMRI Cholinergic Mechanisms in Schizophrenia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia age 18-60 yrs Exclusion Criteria: claustrophobia weight > 250 lbs metal in body other than dental fillings

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| risperidone<br> | |
| clozapine<br>Patients with schizophrenia treated with clozapine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuronal Response During Sensory Gating | Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli. | Immediate |
Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study

Study Overview
=================
Brief Summary
-----------------
To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC.

Official Title
-----------------
Neoadjuvant Chemotherapy (NACT) Followed by Interval Debulking Surgery vs Upfront Surgery Followed by Chemotherapy (CT) in Advanced Epithelial Ovarian Carcinoma (EOC): A Prospective Randomized Study

Conditions
-----------------
Ovarian Carcinoma

Intervention / Treatment
-----------------
* Other: timing of surgery
* Other: timing of surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:20 to 65 years Epithelial ovarian carcinoma Stage IIIc & IV (pleural effusion only) ECOG PS 0-2 Cytology/biopsy positive patients Good compliance Previously untreated patients Exclusion Criteria: Any medical contraindication of surgery Psychiatric illness Cardiac, liver or renal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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: A<br>Conventional arm: primary surgery followed by chemotherapy | Other: timing of surgery<br>* Surgery is followed by chemotherapy<br>|
| Experimental: B<br>Neoadjuvant chemotherapy followed by interval debulking | Other: timing of surgery<br>* Chemotherapy is followed by surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group |  | post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative morbidity |  | 3 weeks post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epithelial ovarian cancer, neoadjuvant chemotherapy, randomized study
Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures

Study Overview
=================
Brief Summary
-----------------
To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy

Detailed Description
-----------------
The aim of our study will be to elucidate the impact of the use of barbed sutures on robotic myomectomy and laparoscopic myomectomy

Official Title
-----------------
Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures

Conditions
-----------------
Myomectomy

Intervention / Treatment
-----------------
* Device: barbed sutures
* Device: Vicryl@ suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women who underwent robotic myomectomy and conventional laparoscopic myomectomy in the Department of Obstetrics & Gynecology of Far Eastern Memorial Hospital. Exclusion Criteria: Open myomectomy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic or laparoscopic myomectomy<br>Women who received robotic or laparoscopic myomectomy | Device: barbed sutures<br>* Use of the barbed sutures for robotic or laparoscopic myomectomy<br>* Other names: V-Loc;Device: Vicryl@ suture<br>* Use of Vicryl@ suture for robotic or laparoscopic myomectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal drainage amount | Postoperative day 1 abdominal drainage amount | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Blood loss during surgeries | 1 day | 
| Surgical time | Surgical time | 1 day |
Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism

Study Overview
=================
Brief Summary
-----------------
Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy. The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.

Official Title
-----------------
Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience

Conditions
-----------------
Hypoparathyroidism

Intervention / Treatment
-----------------
* Other: Serum calcium concentrations results


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypoparathyroidism Patients treated with teriparatide Patients followed in the reference center for calcium and phosphate metabolism diseases of Lyon. For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their non-opposition Exclusion Criteria: No social security support

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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 |
| --- | --- |
| Teriparatide<br>Patients with hypoparathyroidism treated by teriparatide | Other: Serum calcium concentrations results<br>* To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum calcium concentration |  | 3 months after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum calcium concentration |  | 1 month after treatment initiation | 
| Serum calcium concentration |  | 6 months after treatment initiation | 
| Serum calcium concentration |  | 12 months after treatment initiation | 
| Serum calcium concentration |  | 3 years after treatment initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoparathyroidism, Teriparatide