linjc16/ctgov huggingface dataset:
Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.

Official Title
-----------------
A Single Dose, Randomized, Two-Period, Two-Treatment, Crossover Bioequivalency Study of Cilostazol 50 mg Tablets Under Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: Cilostazol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Cilostazol or any comparable or similar product.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.

Study Overview
=================
Brief Summary
-----------------
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.

Official Title
-----------------
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients

Conditions
-----------------
Stress Response During Laryngoscopy Intubation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: sterile saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age group 20-60 years ASA grade 1 and 2 control hypertensive patients. Exclusion Criteria: - Consent not given ASA Grade 3 and 4 history of myocardial ischemia or infarction, or had an abnormal ECG on admission to the hospital Patients with cardiovascular, pulmonary, hepatic, and renal disease. Patients on B blockers. patients with difficult airway; laryngoscopy and intubation time more than 20 s, or requiring more than two attempts will be exclude from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine group<br>35 patients will receive dexmedetomidine 0.5 µg/kg was administered intravenously using a syringe pump over 10 min sterile saline pre-induction of anesthesia. | Drug: Dexmedetomidine<br>* Dexmedetomidine preinduction<br>|
| Placebo Comparator: Control group<br>35 patients will receive sterile saline 0.5 µg/kg was administered intravenously using a syringe pump over 10 min pre-induction of anesthesia. | Drug: sterile saline<br>* normal saline preinduction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | through first 15 min post-induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure |  | through first 15 min post-induction of anesthesia | 
| diastolic blood pressure |  | through first 15 min post-induction of anesthesia |
Ocular Surface Microbiome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms.

Detailed Description
-----------------
Dry eye is a very common eye condition, which may or may not be caused by specific microorganisms that live on the surface of the eye. In this study, a combination of tissue culture and molecular biology techniques will be used to identify every microbe (bacteria, fungus, or virus) on the surface of eyes of people with dry eye syndrome, as well as a 'control' group of people who don't have dry eye disease.

Official Title
-----------------
Diversity and Dynamic Stability of the Ocular Surface Microbiome

Conditions
-----------------
Dry Eye Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with ocular surface discomfort with an Ocular Surface Disease Index score of greater than 60 Subjects with and Ocular Surface disease Index score less than 30 Males and females age 18 or older Exclusion Criteria: Contact lens wear Use of oral or topical antibiotics in past 6 months Use of prescription eye medication in past 6 months Penetrating ocular or keratoplasty surgery in last 12 months Children under the age of 18

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dry eye group<br>People with dry eye symptoms | |
| Non-dry eye group<br>People with no dry eye symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To catalog the bacteria and other micro-organisms that are naturally found on the eye surface. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Microbiome
Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)

Study Overview
=================
Brief Summary
-----------------
Study of the intermediate metabolism in children diagnosed with ALL compared to healthy matched controls.

Detailed Description
-----------------
The primary cause of this study is to investigate the changes that ALL may cause to the metabolome of pediatric patients, in order to better understand its mechanism of action and target metabolic pathways for potential therapies.

Official Title
-----------------
Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia

Conditions
-----------------
Acute Lymphoblastic Leukemia, Pediatric, Metabolism Disorder

Intervention / Treatment
-----------------
* Other: Metabolome study


Participation Criteria
=================
Eligibility Criteria
-----------------
Sex: all Minimum age: 1 year Maximum age: 16 years The study accepts healthy volunteers as matched controls for the patinets. Inclusion criteria: 1)Children diagnosed with ALL 2) Diagnosis confirmed with bone marrow biopsy 3) Sampling before the initiation of therapy 4) Informed consent signed Exclusion Criteria: 1) Children with a known chronic illness before ALL diagnosis 2) ALL remission 3) Not signed informed consent Population description: Patients are recruited from the Pediatric Hematology/Oncology Department of Aristotle University of Thessaloniki (AHEPA hospital) and from the Pediatric Hematology/ Oncology Department of Ippokration Hospital, that host all children diagnosed with ALL in nothern Greece. Matched controls are recruited from outpatient clinic of the 2nd and 4th Pediatric Department of Aristotle University of Thessaloniki. Sampling method: Non-probability sample

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 16 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 |
| --- | --- |
| ALL paediatric patients<br>Metabolome study in children diagnosed with ALL after bone marrow biopsy | Other: Metabolome study<br>* Metabolome study in ALL patients compared to healthy controls<br>|
| Healthy matched controls<br>Metabolome study in healthy children matched for gender and age with the patients group | Other: Metabolome study<br>* Metabolome study in ALL patients compared to healthy controls<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls. | The title of aminoacids in blood and urine and of organic acids in urine will be measured through Tandem Mass Spectrometry | Up to six months |
Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort

Study Overview
=================
Brief Summary
-----------------
Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be non-glaucomatous in the Tema Eye Survey. Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed with glaucoma in the Tema Eye Survey.

Official Title
-----------------
Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - glaucomatous and non-glaucomatous patients previously seen in the Tema Eye Survey who are selected and invited to participate Exclusion Criteria: - patients not previously seen in the Tema Eye Survey

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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 |
| --- | --- |
| Subjects identified in the Tema Eye Survey<br>Subjects identified in the Tema Eye Survey | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Glaucoma |  | Day 0 | 
| Progression of Glaucoma |  | Day 0 |
A Study to Compare Two Anti-HIV Drug Combinations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare 2 anti-HIV drug combinations.

Detailed Description
-----------------
Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

Official Title
-----------------
An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Ritonavir
* Drug: Efavirenz
* Drug: Saquinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3. Are at least 18. Are able to complete the study. Exclusion Criteria Patients will not be eligible for this study if they: Have taken any anti-HIV medications for more than 2 weeks. Are pregnant or 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ritonavir|nan|
|Drug: Efavirenz|nan|
|Drug: Saquinavir|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
-----------------
Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz
Psychological Impact of Confinement on the Adult

Study Overview
=================
Brief Summary
-----------------
This clinical interview is made to allow a clinical follow-up of the patients followed in psychiatry of the EPS Ville-Evrard establishment in a simple way and in a secure medical framework during the period of the epidemic and the confinement from March 30 to June 30, 2020.

Official Title
-----------------
Psychological Impact of Confinement on the Adult Population Followed in Outpatient Psychiatry at EPS Ville Evrard: Three-month Longitudinal Clinical Evaluation

Conditions
-----------------
Identify the Psychological Impact of Containment

Intervention / Treatment
-----------------
* Other: clinical interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient followed in outpatient psychiatry at EPS Ville Evrard and agrees to participate - Exclusion Criteria: Adult patient followed in outpatient psychiatry at EPS Ville Evrard and does not wish to participate -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: clinical interview|This interview can be carried out face to face or remotely. In the latter case, it is part of telemedicine, which is recognised by the health authorities in France.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression MINI DIAG and Anxiety questionnaire and the The Global Performance Rating Scale and CGI-truth |  | three month |
A Study of MKC-442 in HIV-Positive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give MKC-442 plus at least two other anti-HIV drugs to patients who have never been treated with nonnucleoside reverse transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase inhibitors and protease inhibitors. This study also determines how long a drug combination including MKC-442 is effective.

Official Title
-----------------
An Open Label Study of MKC-442 in at Least Triple Drug Combination in Patients Previously Treated With Nucleoside Reverse Transcriptase and Protease Inhibitors and Who Are Naive to Non-Nucleoside Reverse Transcriptase Inhibitors

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Emivirine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from plasma, administration of at least 2 available antiviral agents by prescription may be given with MKC-422. Patients must have: - HIV infection with HIV-1 RNA greater than or equal to 2,000 by Roche Amplicor method, within 30 days of entry. Prior Medication: Allowed: Prior nucleoside reverse transcriptase and protease inhibitors. Cytotoxic chemotherapy more than 30 days prior to entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort. Inadequately controlled seizure disorder. Acute and clinically significant medical event within 30 days of screening. Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of the listed laboratory values. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitor therapy. Any unapproved experimental antiretroviral therapy. Prior Treatment: Excluded: Radiation therapy within 30 days of entry, except to a local lesion. Transfusion of blood or blood products within 21 days of screening. Risk Behavior: Excluded: Active substance abuse that may interfere with compliance or protocol evaluations.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Emivirine|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
-----------------
Anti-HIV Agents, Viral Load, MKC 442
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Study Overview
=================
Brief Summary
-----------------
It has already been demonstrated that mental imagining of the complex motor act, such as limb lifting, can evoke the activation of the involved motor centres even if it doesn't result in movement due to paresis. Aim of the study: using the navigated brain stimulation system create a new diagnostic model for the differential diagnostics between the vegetative state and the minimally conscious state. If the investigators could get from patient the efferent motor response after a verbal command, his level of conscious should not be defined less than the minimally conscious state.

Official Title
-----------------
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

Conditions
-----------------
Vegetative State, Stroke, Brain Injury

Intervention / Treatment
-----------------
* Device: Navigated transcranial magnetic brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed vegetative state age 20-85 Exclusion Criteria: oncological history cardiac pacemakers and other metal implants Modified Ashford Scale scores 3 and more predisposing disease with motor neurologic impairment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegetative state<br>Patients with the diagnosis of the vegetative state | Device: Navigated transcranial magnetic brain stimulation<br>* Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEP(motor evoked potential) parameter: latency |  | within the first minute after a verbal command | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEP(motor evoked potential) parameter: amplitude |  | within the first minute after a verbal command | 
| MEP(motor evoked potential) parameter: motor threshold |  | within the first minute after a verbal command | 
| conscious state |  | within the first 6 months after NBS mapping | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosed vegetative state after stroke or traumatic brain injury
A Volunteer Study to Collect Imaging Data for the Development and Validation of ScanNav Anatomy PNB

Study Overview
=================
Brief Summary
-----------------
This is a single-centre, prospective, non-randomised volunteer study to be undertaken in Intelligent Ultrasound's offices at Hodge House, 114-116 St Mary Street, Cardiff, CF10 1DY, UK.

Detailed Description
-----------------
This is a single-centre, non-randomised, prospective study involving up to 100 participants. The data collected in this study will augment the data collected in ML2018_AG_01, ML2018_AG_02, IU2019_AG_03, and IU2020_AG_04. Phase I Collect data from participants for each indicated block area. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images. Phase II Validation will proceed by feeding the videos into the ScanNav AnatomyGuide system and recording the output anatomy highlighting, overlaid on the original ultrasound image. The overlaid video will be examined by experts to identify safety and performance issues.

Official Title
-----------------
A Volunteer Study to Collect Imaging Data for the Development and Validation of Intelligent Ultrasound ScanNav Anatomy PNB

Conditions
-----------------
Ultrasound Imaging of Anatomical Structures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potential participants who meet the following criteria will be considered eligible for the study: Male or female, at least 18 years of age; Able to comprehend and sign the Informed Consent prior to enrolment in the study. Exclusion Criteria: Potential participants who meet the following criteria will NOT be eligible for the study: Aged <18 years of age; Unwilling or unable to provide informed consent; Previous surgery or trauma to the affected area.

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 |
| --- | --- | --- |
| Change in per-class Mean Intersection over Union (IoU) scores of deep-learning segmentation models compared to baseline models | The mean Intersection over Union will be computed for each class for each model trained with the enlarged dataset, using the existing unseen test data set. These scores will be compared with the scores from the existing baseline models to determine the effect of the enlarged training data | 6 months |