linjc16/ctgov huggingface dataset:
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Conditions
-----------------
Post Ocular Surgical Inflammation and Pain

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Punctum Plug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes Exclusion Criteria: Any intraocular inflammation in the study eye present during the screening slit lamp examination Score greater than 0 on the Ocular Pain Assessment in the study eye at Screening Any intraocular inflammation in the study eye present during the screening slit lamp examination

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 |
| --- | --- |
| Active Comparator: OTX-DP (Dexamethasone Punctum Plug)<br>Resorbable hydrogel drug delivery vehicle containing dexamethasone | Drug: Dexamethasone<br> <br> Drug: Punctum Plug<br> <br> |
| Placebo Comparator: PVPP (Placebo Punctum Plug)<br>Resorbable hydrogel drug delivery vehicle containing no drug | Drug: Punctum Plug<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Cells in Anterior Chamber of the Study Eye |  | Day 14 | 
| Absence of Pain in Study Eye |  | Day 8 |
Intra- and Interobserver Agreement in the Assessment of Human Embryos

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the intra- and interobserver agreement.

Official Title
-----------------
Intra-and Inter-observer Agreement in the Morphological Assessment of Human Embryos

Conditions
-----------------
the Focus of This Study is to Measure the Intra- and Interobserver Agreement for the Evaluation of Early Stage Embryos

Intervention / Treatment
-----------------
* Other: embryo development


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fertilized embryos Exclusion Criteria: unfertilized embryos

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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 |
| --- | --- |
| 1<br> | Other: embryo development<br>* intra- and inter-observator analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the intra- and inter-observer variability in the assessement of human embryos | Variation in observer assessment of embryo characteristics on day 1, 2 and 3 of embryo development. Assessment of these characteristics is standard procedure. Safety and tolerability or efficacy issues are not relevant for this outcome. |  |
Chromosome 9 P Minus Syndrome

Study Overview
=================
Brief Summary
-----------------
Patients with deletion of chromosome 9 P are rare ( 200 in the medical literature) and have a diverse set of phenotypic characteristics. We propose using state of the art genome sequencing methods to define the location and size of the deleted portion of chromosome 9 P as well as the genetic background in affected patients (whole genome sequencing) and correlate the genes in the deleted portion of chromosome 9 P with specific phenotypic characteristics of each patient. Enrolled participants will be asked to complete a detailed questionnaire, complete a medical release form, and provide a biospecimen sample.

Official Title
-----------------
Genotype-Phenotype Correlation in Patients With Chromosome 9 P Minus Syndrome

Conditions
-----------------
9P Monosomy, Chromosome 9P Deletion Syndrome, 9p Minus Syndrome, Alfi Syndrome, 9P Partial Monosomy Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having 9P minus syndrome/ deletions on the 9th chromosome Parents and siblings of affected individuals may also be included to determine contribution of genetic background to phenotypic characteristics Exclusion Criteria: No exclusion criteria for either affected individuals or their parents or siblings.
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 |
| --- | --- | --- |
| Genotypic and Phenotypic Correlation | By use of demographic and genetic material we hope to gain a better understanding between the deletion on the short arm of the 9th chromosome and the features presented. | As enrollment increases the team hopes to have preliminary results by 2022 |
Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD

Study Overview
=================
Brief Summary
-----------------
prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain. the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.

Official Title
-----------------
Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD

Conditions
-----------------
Opiate Dependence, Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with a non cancer chronic pain consulting a CETD center Exclusion Criteria: non understanding of french

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSM 5 criteria of SUD | 11 criteria of SUD | Day 0 (at the inclusion) |
Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart

Study Overview
=================
Brief Summary
-----------------
A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of the heart.

Official Title
-----------------
A Randomized, Double-Blind, Placebo- and Moxifloxacin (Open-Label)- Controlled, 4-Period Crossover Study of the Effects of Single Oral Doses of PPM 204 on Cardiac Repolarization in Healthy Subjects

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: PPM-204


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women, aged 18 to 55 years Body mass index in the range of 18 to 30 kg/m2 Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG Exclusion Criteria: History of cardiac, thyroid, muscle, or kidney abnormalities A family history of long QT syndrome and/or sudden cardiac death History of any clinically significant drug allergy, hypersensitivity to sulfonomides or the quinolone class of antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PPM-204|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  |
Study of Breath-holding as a Means to Reduce Tumor Motion From Breathing

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate typical tumor motion caused by breathing using MRI and can help determine whether simple passive breathing and/or breath-holding could be used for the future treatment of similar lung and liver tumors using radiation therapy radiosurgery techniques.

Official Title
-----------------
Feasibility Study for Gated External-Beam Radiotherapy for Patients With Internal, Extra-cranial Tumors

Conditions
-----------------
Neoplasm, Metastatic

Intervention / Treatment
-----------------
* Procedure: MRI with breath-holding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is enrolled on U8700 RSRB # A Phase II Study For Using Radiosurgery On Limited Metastases Of Breast Cancer or U9700 A Pilot Study For Using Radiosurgery On Limited Metastases. ≥ 18 years of age has given Informed consent Exclusion Criteria: -Contraindications for any MRI 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breath-holding<br>MRI with breath-holding | Procedure: MRI with breath-holding<br>* Breath holding for diminished tumor motion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Motion Related to Breathing as Determined From MRI Images | Determine the typical and maximal tumor 3D displacements over the respiratory cycle and how these values vary depending on the tumor location Determine the reproducibility of target position over multiple breath-holds Determine the variability across patients in respiratory-derived lesion motion and target position reproducibility over multiple breath-holds | 20 - 30 seconds |
Tel Aviv Sourasky MC Home Monitoring Clinic Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) patients.

Detailed Description
-----------------
EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes. Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).

Official Title
-----------------
Tel Aviv Sourasky MC Home Monitoring Registry

Conditions
-----------------
Home Monitoring With ICD Patient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved indication for ICD or CRTD. Implanted with or replaced with a Biotronik Lumax device. Patient is willing and able to sign consent form. Willing and able to attend clinic visits and follow up schedule. Transmission of more than 80% at 3-month FU. Patient older than 18 years. Exclusion Criteria: No indication for ICD or CRTD implant. Life expectancy shorter than 12 months. Pregnancy. Participation in other clinical studies.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD implant<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)

Study Overview
=================
Brief Summary
-----------------
This first-in-human exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic microdoses of autologous Thrombosomes® in healthy human subjects.

Official Title
-----------------
Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: Thrombosomes
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum weight 110 pounds (50 kg) Age 18-45 years Able and willing to provide informed consent Has permanent address and phone/e-mail for contact and notification, and able to come to the research site for scheduled study visits for up to 60 days after their last study infusion Understands, speaks and reads standard English language Normal healthy subject able to pass the universal blood donor history questionnaire and screen Exclusion Criteria: Breast-feeding female At any time, previously pregnant female Participation in an experimental drug/device study within the past 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Thrombosomes | Biological: Thrombosomes<br>* Freeze-dried platelets<br>|
| Placebo Comparator: Placebo<br>Buffer/placebo Control | Biological: Placebo<br> <br> * Other names: Buffer/placebo Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety Evaluation |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Hematology, Coagulation and Platelet Immunology Assessment |  | 60 Days |
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.

Official Title
-----------------
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Sections: A Randomized Placebo-Controlled Double-Blind Study

Conditions
-----------------
Caesarean Section, Pain, Acute

Intervention / Treatment
-----------------
* Drug: Bupivacaine Hcl 0.25% Inj
* Drug: saline 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18 and 45 American Society of Anesthesiologists (ASA) physical score I or II Exclusion Criteria: Patients who received general anesthesia hypersensitivity to the agents to be used body mass index (BMI) greater than 35 kg/m2 coagulopathy local infections opioid addiction pregnancy-related hypertension or diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound guided transversalis fascia plane block<br>20 mL of 0.25% bupivacaine | Drug: Bupivacaine Hcl 0.25% Inj<br>* ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine<br>|
| Placebo Comparator: ultrasound guided sham block<br>20 mL of saline | Drug: saline 0.9%<br>* ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | morphine consumption first 24hour | Postoperative first 24hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores | Visual Analogue Scale (0-10) | postoperative 0-24 hours |
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.

Official Title
-----------------
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) Followed by Surgery in Patients With Advanced Primary Epithelial Ovarian Cancer: A Pilot Randomized Study

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Procedure: 1ry cyto-reductive surgery
* Combination Product: Neoadjuvant chemotherapy followed by surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients diagnosed with epithelial ovarian cancer (By histopathology) Age ≥ 18 years old Advanced defined as (stage 2D or more ) by surgical staging. Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2 Chemotherapy naïve Informed consent Exclusion Criteria: Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis. Patients with uncontrolled infection. Patients with active bleeding or conditions associated with high risk of bleeding. contraindications for surgery contraindications To chemotherapy - bevacizumab

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Group 1<br>1ry surgery | Procedure: 1ry cyto-reductive surgery<br>* 1ry surgery then chemotherapy<br>* Other names: 1ry surgery;|
| Active Comparator: Group 2<br>Neoadjuvant Chemotherapy followed by surgery | Combination Product: Neoadjuvant chemotherapy followed by surgery<br>* chemotherapy then surgery<br>* Other names: Neoadjuvant chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient where complete resection of the tumor can be achieved | complete resection of the tumor | 3 month postoperative |
Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

Study Overview
=================
Brief Summary
-----------------
The objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.

Official Title
-----------------
Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Procedure: Surgery with graft
* Procedure: surgery without graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 under guardianship vertebral deformation >20° accept to participate Exclusion Criteria: minor patient surgery not including the pelvis

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 |
| --- | --- |
| surgery with graft<br>The procedure is to place a metal instrumentation (rods and screws) in contact with the spine to correct the deformity. Added to this is a graft between the vertebrae that will allow a bone bridge of ankylosis making the spine completely rigid. | Procedure: Surgery with graft<br>* arthrodesis with autologous bone graft and using pedicular ilio-sacred EUROS ® screw<br>|
| surgery without graft<br>Adult scoliosis surgery is performed with instrumentation without grafting: the teams use variable stiffness rods made of metal or PEEK. | Procedure: surgery without graft<br>* arthrodesis without bone graft using pedicular ilio-sacred EUROS ® screw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Cobb angle | Cobb angle represent the degree of curvature of the scoliosis | change from baseline Cobb angle at 6 months |