linjc16/ctgov huggingface dataset:
Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD

Study Overview
=================
Brief Summary
-----------------
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.

Detailed Description
-----------------
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.

Official Title
-----------------
A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Biological: HuCNS-SC sub-retinal transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence. BCVA of 20/320 or better in each eye at screening assessment Exclusion Criteria: Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center. Retinal or macular disease of any other cause in either eye. Diagnosis of glaucoma in either eye. Uncontrolled intraocular pressure in either eye Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection. History of or active autoimmune disease. Previous organ, tissue or bone marrow transplantation. Seropositive for HIV, hepatitis B or C, or CMV IgM

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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: HuCNS-SC<br>HuCNS-SC sub-retinal transplantation | Biological: HuCNS-SC sub-retinal transplantation<br>* HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GA area based on fundus autofluorescence |  | 12 months |
Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy

Study Overview
=================
Brief Summary
-----------------
The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response after more than one year of imatinib therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.

Conditions
-----------------
Leukemia, Myeloid, Philadelphia-Positive

Intervention / Treatment
-----------------
* Drug: Pegylated Interferon and Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy. Exclusion Criteria: Patients in imatinib study Patients with a history of intolerability to interferon. Patients with less than CCR or less than one year of imatinib therapy.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegylated Interferon and Imatinib|nan|

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
-----------------
CML, Imatinib, Pegylated Interferon, Philadelphia Positive CML
Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.

Official Title
-----------------
Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test

Conditions
-----------------
Chronic Pain, Acute Pain

Intervention / Treatment
-----------------
* Other: comprehensive preoperative testing for risk factors of persistent postoperative pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >=18 years American Society of Anesthesiology functional status I-III able to read and understand the information sheet and give informed consent Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: comprehensive preoperative testing for risk factors of persistent postoperative pain|nociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of pain at the site of surgery | clinically important pain defined as either necessitating analgesic treatment or having an intensity of more than 3/10 at rest or 5/10 on movement, at 4 months after surgery | 4 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute pain | maximum pain >3/10 | 24h | 
| subacute pain | average pain, maximum pain >2 | 1 week | 
| prevalence of pain necessitating analgesics at the site of surgery |  | 4 months | 
| prevalence of pain at the site of surgery |  | 8 months | 
| prevalence of pain at the site of surgery |  | 12 months |
Radiologist Diagnostic Performance Versus Artificial Intelligence (AI)

Study Overview
=================
Brief Summary
-----------------
In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation). However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department. Indeed, radiologists may be subject to excessive work, wich cause the risk of inaccurate on X-rays diagnosis. The Artificial intelligence (AI) begins study the detection of fratures on medical imaging. In this retropective study, this technology developed by GLEAMER company is tested to evaluate the detection rate of hip fracture and specifically femoral neck fracture, compared to the radiologist diagnostic, in eldery patients admitted in emergency department. AI could optimize the diagnostic performance of radiologists (increase of confidence level) and improve the efficiency of suspected fractures sorting from emergency department.

Official Title
-----------------
Retrospective Study Comparing Radiologist Diagnostic Performance Versus Artificial Intelligence (AI) for Hip Fracture Suspicion in Elderly Patients

Conditions
-----------------
Painful Hip, Fonctional Impotence After Minor Trauma (Fall)

Intervention / Treatment
-----------------
* Procedure: hip standard radiography/ CT scan/ MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aged 60 and older Minor trauma Admitted in emergency department for painful hip/fonctional impotence after minor trauma Takes at least a hip radiography Exclusion criteria: Painful before the minor trauma Important trauma

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Suspicion of hip fracture<br>Suspicion of hip fracture | Procedure: hip standard radiography/ CT scan/ MRI<br>* hip standard radiography/ CT scan/ MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of femoral neck fracture | Detection rate of femoral neck fracture | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of other hip fracture | Detection rate of other hip fracture | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical imaging diagnosis, Frature detection, Artificial intelligence, Femoral neck fracture, Hip, X-ray, Radiography
The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

Study Overview
=================
Brief Summary
-----------------
Current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. Explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles. This study will elucidate whether there is a relation between clinical variables of the different levels of arterial insufficiency in peripheral arterial disease and mitochondrial respiratory capacity.

Official Title
-----------------
The Relationship Between Peripheral Arterial Disease and Mitochondrial Respiratory Capacity

Conditions
-----------------
Intermittent Claudication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptotic peripheral arterial disease (Ankle-brachial index < 0.9), intermittent claudication (Ankle-brachial index 0.4 - 0.9), or critical limb ischemia (Ankle-brachial index < 0.4) Exclusion Criteria: Diagnosed with intermittent claudication secondary to vascular insufficiency Warfarin or heparin usage Underwent a vascular intervention in the last 6 months Active cancer, renal- or liver disease
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1st level of arterial insufficiency<br>asymptomatic PAD patients | |
| 2nd level of arterial insufficiency<br>Intermittent claudication patients | |
| 3rd level of arterial insufficiency<br>Critical limb ischemia patients | |
| No arterial insufficiency<br>Healthy individuals (control) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mitochondrial respiratory capacity | measured in oxygen glux in pmol.s-1.mg-1, using mitochondrial respirometry on an Oxygraph-2k (Oroboros Instruments, Austria). | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Legs, Muscle, skeletal, Energy metabolism, Blood circulation, Blood vessels, Mitochondria
Hydration Sensor for Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Pilot study of a soft, flexible hydration sensor

Detailed Description
-----------------
Assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in skin hydration between skin affected by atopic dermatitis and areas not affected.

Official Title
-----------------
Validation of Skin Hydration Sensor for Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis, Healthy Children

Intervention / Treatment
-----------------
* Device: Hydration Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children <18 years of age Children with new or prior atopic dermatitis diagnosis English speaking Children who are healthy, aged matched controls Exclusion Criteria: Individuals who are pregnant

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atopic Dermatitis<br>Evaluate sensor performance for hydration sensing. | Device: Hydration Sensor<br>* This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.<br>|
| Healthy aged matched controls<br>Evaluate sensor performance for hydration sensing. | Device: Hydration Sensor<br>* This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Agreement | Percent agreement between experimental sensor and commercially available transepidermal water loss meter. | 1 hour |
Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI

Study Overview
=================
Brief Summary
-----------------
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.

Official Title
-----------------
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels

Conditions
-----------------
Traumatic Cervical Acute Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Neuro-Spinal Scaffold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16-70 years of age, inclusive AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive Recent injury Non-penetrating SCI Exclusion Criteria: Terminally ill subjects not likely to be able to participate in follow-up Incomplete spinal cord injury (AIS B, C, D, and E injuries) No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed Spinal cord injury associated with significant traumatic brain injury or coma that Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuro-Spinal Scaffold<br> | Device: Neuro-Spinal Scaffold<br>* Experimental: Neuro-Spinal Scaffold<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all Adverse Device Effects of any kind/seriousness. |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Injury, SCI, Complete (AIS A) Traumatic Acute Spinal Cord Injury
[S,S]-Reboxetine Add-On Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN

Official Title
-----------------
[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine + Pregabalin
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have pain present for more than 3 months after the healing of shingles skin rash Patients at screening must have a score >/=40 mm on the pain visual analogue scale Exclusion Criteria: Patients with significant renal and hepatic impairment Patients with other severe pain, that may impair the self-assessment of the pain due to shingles Patients with clinically abnormal electrocardiogram

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: [S,S]-Reboxetine + Pregabalin<br> | Drug: [S,S]-Reboxetine + Pregabalin<br>* [S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks<br>|
| Active Comparator: Pregabalin<br> | Drug: Pregabalin<br>* Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated |  | Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean endpoint (week 10) sleep interference score change from baseline |  | Week 10 | 
| Analysis of the Medical Outcomes Study Sleep Scale |  | Week 10 | 
| Analysis of the Patient Global Impression of Change |  | Week 10 | 
| Analysis of the Neuropathic Pain Symptom Inventory |  | Week 10 |
Study for Patients Previously Treated in Avapritinib Clinical Trials

Study Overview
=================
Brief Summary
-----------------
This is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.

Official Title
-----------------
Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: Avapritinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has histologically confirmed metastatic or unresectable GIST as established by entry in a previous avapritinib clinical trial and has been receiving treatment with avapritinib on one of these trials. Patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent. Exclusion Criteria: Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4 Patient has a history of intracranial bleeding either prior to or during avapritinib treatment Patients who have poor organ function, defined as Adverse Events of NCI CTCAE version 5.0 Grade 3 or higher at the time of enrollment must delay start of treatment until symptoms return to Grade 2 or baseline, or the start of treatment has been approved by the Sponsor. Patients who have ongoing cognitive or mood effects Adverse Events of NCI CTCAE version 5.0 higher than Grade 1 must delay start of treatment until symptoms return to Grade 1 or baseline. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of enrollment and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib. Women who are pregnant. Women who are breast feeding.

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: Patients with GIST previously enrolled in avapritinib clinical trials<br> | Drug: Avapritinib<br>* avapritinib tablet<br>* Other names: BLU-285;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by the number of serious adverse events and adverse events of special interest |  | up to 2 years |