linjc16/ctgov huggingface dataset:
PleuraSeal Pivotal Study (US)

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.

Official Title
-----------------
A Prospective Multicenter Randomized Clinical Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy

Conditions
-----------------
Open Thoracotomy

Intervention / Treatment
-----------------
* Device: PleuraSeal Sealant System
* Procedure: Standard Tissue Closure Techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy

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: PleuraSeal Sealant Device<br> | Device: PleuraSeal Sealant System<br>* Lung Sealant Device + standard tissue closing techniques (sutures/staples)<br>Procedure: Standard Tissue Closure Techniques<br>* Standard tissue closure techniques (sutures/ staples) alone<br>|
| Other: Control<br> | Procedure: Standard Tissue Closure Techniques<br>* Standard tissue closure techniques (sutures/ staples) alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects remaining air leak free from time of skin closure to hospital discharge. |  | 75 days |
Interactions Between Cocaine and Ethanol and Disulfiram - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.

Detailed Description
-----------------
This is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.

Official Title
-----------------
Interactions Between IV Cocaine and Ethanol and Oral Disulfiram

Conditions
-----------------
Alcohol-Related Disorders, Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Disulfiram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must meet DSM-4 criteria for cocaine abuse or dependence and are not seeking treatment. Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements. Exclusion Criteria: Please contact site for more information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments |  |  | 
| Psychological effects |  |  |
Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With Multiple Sclerosis.

Study Overview
=================
Brief Summary
-----------------
patient with multiple sclerosis will undergo and completed comprehensive survey measuring body mass index and assessment of obesity ,health related quality of life,disability,relapsing and complete data on their dietary habits.

Official Title
-----------------
Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With

Conditions
-----------------
Nutrition Habits in Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 40 years of age males or females all cases of diagnosed multiple sclerosis under treatment or not Exclusion Criteria: disable cases long standing disease more than five years.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| measurement of the body mass index and so assessment of obesity of the patient and multiple sclerosis . also assessment of nutrition habits by dietary habits questionnaire in theses patient . | dietary habits questionnaire include family eating habits personal dietary assessment personal eating habits personal back ground information The questionnaire considers both the type of food consumed and the methods of food preparation. Each item scores from 1 to 5 with a score of 1 indicating very poor dietary behavior and a score of 5 indicating healthy.These items give rise to 10 dietary sub scores: cereals, fruit and vegetables, omega-3 fatty acids, food choices, food preparation, takeaways and snacks, fat, fiber, sodium, Mean scores ranging from 1 to 5 are calculated for each sub score | one and half year | 
| assessment of disability rates of the patient of multiple sclerosis. | the disability rate assessed by expanded disability status scale which is a self-reported surrogate tool used by neurologists to assess gait disability.33,34 Th scored ordinally from 0 (normal) to 8 (bed bound). bound) | one and half year |
Endometrial Advancement After Rec or u-HCG Triggering

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate any potential advantages of replacing human chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for final oocyte maturation with regard to Ovarian hyperstimulation syndrome (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.

Detailed Description
-----------------
Biopsies of endometrium were taken in different groups Pregnancy rates were compared among defferent groups

Official Title
-----------------
Endometrial Advancement After Rec or u-HCG Triggering

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: 10000 IU urinary HCG
* Drug: 250 mcg recombinant HCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 36 years old Male or tubal infertility FSH<12 on day 3 Exclusion Criteria: Endometriosis stage 3 & 4

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 36 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: o Group A=uHCG ovul trig<br>HCG for triggering | Drug: 10000 IU urinary HCG<br>* bolus 10000 units for ovulation triggering<br>* Other names: Pregnyl;|
| Experimental: o Group B=recHCG ovul trig<br>recombinant HCG for triggering | Drug: 250 mcg recombinant HCG<br>* bolus 250 mcg for ovulation triggering in IVF patients<br>* Other names: Ovitrelle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrium histology on the day of OPU |  | day of oocytre pick up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | 14 days after oocyte pick up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrium, histology, pregnancy
Study Evaluating Prevenar in High-Risk Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the local and systemic tolerability of Prevenar in children ages 2 to 5 years old in usual care settings.

Official Title
-----------------
Prospective Post-Marketing Surveillance Study of Prevenar in High-Risk Children Aged 2 to 5 Years

Conditions
-----------------
Pneumococcal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-risk children ages 2 to 5 years old Exclusion criteria: Prior administration of Prevenar Prior and/or concurrent administration of 23 vPs vaccine

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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
-----------------
Children, Vaccine, Prevenar
Comparison of Pupilometer and Ultrasound of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigator-initiated study is to compare the use of pupilometer and ultrasound assessment of optic nerve sheath diameter in predicting the ICP and to see if there is a value that could be used to indicate elevated ICP with either modality as these numbers are inconsistent throughout the literature. Patients that have either an external ventricular drain (EVD) or bolt placed will be enrolled in the study. After the EVD and bolt are placed the patient will undergo pupilometer examination (standard of care) followed by ultrasound assessment of the optic nerve sheath diameter (ONSD). The three values will be recorded. The same patient may have multiple readings performed if there is a change in ICP either spontaneously or due to intervention.

Official Title
-----------------
Comparative Analysis of Pupilometer and Ultrasound Assessment of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)

Conditions
-----------------
Stroke, Intracranial Hemorrhages, Brain Injuries, Subarachnoid Hemorrhage, Ischemic Stroke

Intervention / Treatment
-----------------
* Device: Ultrasound
* Device: Pupilometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years old Intracranial pathology requiring either EVD or bolt placement for ICP measurement Exclusion Criteria: Known disorder of lens or orbit including but not limited to glaucoma, cataract, blindness, lens implants. Patients unable to close eyelids as this would increase risk of corneal abrasion from ultrasound probe.

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

| Intervention/Treatment |
| --- |
|Device: Ultrasound|Type of imaging technology to look at organs and structures inside the body|
|Device: Pupilometer|A device that measures pupil size and how it changes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP). | Analysis of varying ONSD and pupillometer readings to concurrent ICP | 1 day of ONSD examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Pupillometer reading and corresponding intracranial pressure (ICP). | Comparison of Neurological Pupil index (NPi) in both eye and concurrent ICP | 1 day per nursing protocol (standard of care) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
External ventricular drain (EVD), Placement of Bolt
Assessing Early Behavioral Indicators of Formula Tolerance

Study Overview
=================
Brief Summary
-----------------
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

Official Title
-----------------
Assessing Early Behavioral Indicators of Formula Tolerance

Conditions
-----------------
Tolerance

Intervention / Treatment
-----------------
* Other: Control
* Other: Investigational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton at birth Term infant with birth weight of 2500 g or more Crying or fussing for 3 or more hours per day Consuming mostly infant formula Signed Informed Consent and Protected Health Information authorization Exclusion Criteria: Current use of extensively hydrolyzed or amino acid infant formula Planned use of probiotics during the study History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised Enrollment in another interventional clinical research study

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 28 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Marketed partially hydrolyzed cow's milk protein infant formula | Other: Control<br>* Marketed partially hydrolyzed cow's milk protein infant formula<br>|
| Experimental: Investigational<br>Partially hydrolyzed cow's milk infant formula with a probiotic | Other: Investigational<br>* Partially hydrolyzed cow's milk protein infant formula with a probiotic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Behavior Diary |  | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall of Tolerance Questionnaire |  | Baseline and Day 21 | 
| Body Weight |  | Baseline and Day 21 | 
| Infant Behavior Questionnaire - Revised |  | Baseline and Day 21 | 
| Recall of formula intake at each visit |  | Baseline, Day 10, and Day 18 | 
| Fecal microbiome and Fecal calprotectin |  | Baseline and Day 21 | 
| Medically-confirmed Adverse Events |  | 21 Days |
A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.

Official Title
-----------------
A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Biological: NicVAX Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day. Exclusion Criteria: Prior exposure to NicVAX or any other nicotine vaccine. History of clinically significant allergic reactions. Use of systemic steroids. Cancer or cancer treatment within 5 years. HIV infection. History of drug or alcohol abuse or dependence. Required treatment for depression within the past 12 months. Body mass index ≥ 30 [calculated as weight (kg)/height2 (m)]. Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease. Inability to fulfill all visits for approximately 30 weeks.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NicVAX - Phase 3 Lot<br>NicVAX - Phase 3 Lot | Biological: NicVAX Vaccine<br>* NicVAX Vaccine given 6 times over 6 months<br>|
| Active Comparator: NicVAX - Commercial Lot<br>NicVAX - Commercial Lot | Biological: NicVAX Vaccine<br>* NicVAX Vaccine given 6 times over 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | To compare imunogenicity of two lots by serum antibody concentration | At Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Assess safety by adverse events reported | Through Week 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking vaccine, Smoking, NicVAX
Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

Study Overview
=================
Brief Summary
-----------------
To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

Detailed Description
-----------------
Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

Official Title
-----------------
A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation

Conditions
-----------------
Effects of Chemotherapy

Intervention / Treatment
-----------------
* Drug: Bu-CY-E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy; ECOG: 0-2 Tbil < 1.5x ULN and AST/ALT <2.5x ULN With informed consent Exclusion Criteria: Life expectancy < 3 months Women in pregnancy uncontrollable infection disease serum Cr >400mmol/l uncontroled diabetis and heart disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consolidation chemo<br>Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen | Drug: Bu-CY-E<br>* mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT<br>* Other names: mini Bu-Cy-E;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2-year | 
| progression | PET-CT measurement | 2-year | 
| transplantation-related mortality |  | 2-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lymphoma, consolidation chemotherapy, auto-HSCT
Validation of the Utility of Ophthalmology Intelligent Diagnostic System

Study Overview
=================
Brief Summary
-----------------
The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. Application scenarios of the current medical algorithms are too simple to be generally applied to real-world complex clinical settings. Here, the investigators use deep learning and visionome technique, an novel annotation method for artificial intelligence in medical, to create an automatic detection and classification system for four key clinical scenarios: 1) mass screening, 2) comprehensive clinical triage, 3) hyperfine diagnostic assessment, and 4) multi-path treatment planning. The investigator also establish a telemedicine system and conduct clinical trial and website-based study to validate its versatility.

Official Title
-----------------
Validation of the Utility of Ophthalmology Intelligent Diagnostic System: A Clinical Trial

Conditions
-----------------
Ophthalmopathy, Artificial Intelligence

Intervention / Treatment
-----------------
* Device: Ophthalmology diagnostic system.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients and residents who underwent ophthalmic examination of the eye and recorded their ocular information in the outpatient clinic and community.
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 |
| --- | --- |
| Eligible patients for AI test.<br>Device: ophthalmology diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of ocular diseases. | Device: Ophthalmology diagnostic system.<br>* An artificial intelligence to make comprehensive evaluation and treatment decision of ocular diseases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of accurate, mistaken and miss detection of the ophthalmology diagnostic system. |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
conjunctivitis, keratitis, pterygium, cataracts