louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00986362: Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
Official title: The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitrectomy
Keywords: Safety in pediatrics
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2009-09-29
Enrollment: 24
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female infants or children 16 years of age or younger
2. Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy
3. Patient with attached vitreous somewhere in posterior pole
4. Patient's parent or guardian must be willing and able to comply with follow-up requirements
5. Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form

Exclusion Criteria:

1. Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery
2. Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity
3. Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements
4. Medical problems that make consistent follow-up over the treatment period uncertain.
5. Patient must not have participated in an investigational drug or device study in the prior 30 days
6. Female Patients of childbearing potential must not be pregnant or lactating.

Primary outcomes:
measure: Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
timeFrame: Beginning of vitrectomy or after application of suction
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak,
country: United States
facility: Associated Retina Consultants
state: Michigan
Study officials:
References:
Clinical trial NCT06168162: Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics
Official title: Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilation Pressure High
Bariatric Surgery Candidate
Keywords: ventilation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). In obese patients undergoing laparoscopic bariatric surgeries, the risk of postoperative pulmonary complications (PPCs) increases significantly with general anesthesia. Previous studies have shown that protective lung ventilation strategies could improve intraoperative oxygenation and lung mechanics.

In this study would compare the effect of optimum individualized high PEEP versus standard PEEP - on postoperative pulmonary complications


Eligibility criteria: Inclusion Criteria:

* Patients were eligible for participation if the met the following criteria

  * Age between 18 and 60 years old.
  * Body mass index \> 40
  * Laparoscopic bariatric elective surgery under general anesthesia.
  * ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia) score ≥ 45 . ARISCAT score is a clinically practical seven-factor scoring system to assess the risk of a composite PPC.

Exclusion Criteria:

* Previous lung surgery
* ASA status III or IV.
* Moderate to severe obstructive or restrictive lung disease .
* Persistant intraoperative hemodynamic instability .
* Need for postoperative mechanical ventilation

Primary outcomes:
measure: postoperative pulmonary complication
timeFrame: postoperative 10 days after surgery
Secondary outcomes:
measure: Pulmonary functions test
timeFrame: postoperative 1st , 3rd and 5th day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
state: القاهرة
Study officials:
References:
Clinical trial NCT06858462: Evaluation of Dental Caries Using Caries Assessment Spectrum and Treatment Need (CAST) Index, International Caries Detection and Assessment System (ICDAS) Index and World Health Organization (WHO) Index
Official title: Evaluation of Caries Experience Using Three Different Indices CAST, ICDAS, and WHO in a Group of Egyptian Children : a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Caries Experience
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include children aged 4 to 6 years. They will be selected from the outpatient clinic of Pediatric Dentistry Department of the Faculty of Oral and Dental Medicine, Cairo University, according to the Eligibility criteria.

Brief summary: This study goals is to compare the three indices in Egyptian children aged 4 to 6 years in caries detection and time needed for the assessments which will contribute to valuable data for pediatric oral health assessments both locally and globally.

Detailed description: This study will ensure that patients receive precise evaluations and guide early, appropriate preventive measures or treatments. Over time, this will contribute to reducing caries progression and related complications.

Also, Parents become more aware of their children's dental health status, emphasizing the importance of early detection and intervention.Furthermore , Comparing the indices will provide insights into which tool is most efficient and reliable for detecting caries in preschool children.

Eligibility criteria: Inclusion Criteria:

* Children aged 4-6 years.
* Written consent from parents or guardians for participation.
* Children who are cooperative during clinical examinations.

Exclusion Criteria:

* Children with systemic and mental diseases that might affect dental health.
* Teeth with developmental anomalies that interfere with caries assessment.
* Teeth with extensive restorations.

Primary outcomes:
measure: Dental Caries Experience
timeFrame: Baseline ( single visit)
Secondary outcomes:
measure: Time For index Application
timeFrame: Baseline (single visit)
Other outcomes:
Locations:
Study officials:
References:
citation: Pauli LA, Costa VPPD, Azevedo MS, Leal SC, Goettems ML. Discriminant validity of the CAST instrument compared to the dmf index in the deciduous dentition: a cross sectional study. Braz Oral Res. 2021 Jun 16;35:e078. doi: 10.1590/1807-3107bor-2021.vol35.0078. eCollection 2021.
citation: Attia D, ElKashlan MK, Saleh SM. Early childhood caries risk indicators among preschool children in rural Egypt: a case control study. BMC Oral Health. 2024 Jan 3;24(1):10. doi: 10.1186/s12903-023-03771-9.
Clinical trial NCT05217862: Effect Not Imposing COVID-19 Testing Prior to Elective Cataract Surgery
Official title: The Implications of Not Imposing COVID-19 Testing on Patients Prior to Elective Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Surgery
COVID-19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic adult undergoing cataract surgery

Brief summary: The world health organization declared corona virus disease (COVID19) a pandemic since march 2020. Since then the future landscape of medical practices and procedures is being heavily shaped by the emergence of this pandemic. COVID 19 testing has already standardized within the medical field as doctors wearing scrubs or fitness examination before operation. We are now more than 2 years into COVID-19 pandemic with more than 6 effective vaccines available in the market for public to boost and build up their immunity against the virus. Every 3 to 4 months we hear about a new strain and another wave of the virus attacking the world, therefore healthcare institutions face enormous challenges in balancing patients' needs and simultaneous safety to health care workers.

The Indian council of medical research in June 2020 proposed that testing for Covid-19 for asymptomatic patients coming for elective surgeries should be performed for neurosurgery, ear nose, and throat (ENT) surgery, dental procedures, etc. and for non-surgical interventions like bronchoscopy, upper gastrointestinal endoscopy and dialysis. A role of preoperative testing of Covid-19 for every patient is still controversial especially in asymptomatic healthy patients with not known exposure to a COVID positive patient.

Most patients attending eye out patient department (EOPD) are aged 65y and older are considered at a higher risk for worse outcome in case of COVID-19 infection. Therefore a rethink of a cataract surgery pathway should include preoperative perioperative and postoperative care in order to maintain safety conditions for patients and for healthcare staff.

COVID-19 can infect anyone and result in transmission of infection before the patient become symptomatic or even without ever developing symptoms. Therefore preoperative screening of patients undergoing ophthalmic surgery should be considered.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic adult undergoing cataract surgery

Exclusion Criteria:

* Symptomatic patients (fever, cough lethargy malaise , headache, and aches, sore throat and diarrhoea

Primary outcomes:
measure: To identify +ve or -ve COVID patient
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT06510062: Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
Official title: Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Measurement of Circulation on Anatomical Locations of the Body
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer

Exclusion Criteria:

* Is pregnant/nursing
* Has an active infection, open sores, or wounds in the treatment area
* Has any preexisting extremity circulation condition

Primary outcomes:
measure: Blood Flow (Perfusion Unit)
timeFrame: 0 - 1 hour
measure: Ultrasound Diathermy (Degrees Centigrade)
timeFrame: 0 - 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Trumbull
country: United States
facility: ZetrOZ Systems LLC
state: Connecticut
Study officials:
affiliation: ZetrOZ Systems LLC
name: George K Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03972462: NPC-12G Gel 0.2% Sirolimus PK Bridging Study
Official title: Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Sirolimus From Topical Application of NPC-12G Gel to Oral Rapamune® Following Single Administration in Healthy Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability Study
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.


Eligibility criteria: Inclusion Criteria

* Male or female, non-smoker (no use within 3 months prior to screening), ≥ 18 and ≤ 65 years of age, with BMI \> 18.5 and \< 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
* Females of childbearing potential who are sexually active with a male partner must be willing to use one of acceptable contraceptive method throughout the study and for 12 weeks after the last study drug administration

Exclusion Criteria

* Any sign of eczema/dermatitis, skin lesion, wound, or infection at the application site, or any other conditions that would prevent a safe application of the gel formulation.
* Laser or surgery at the gel application site within 2 weeks before the gel application.
* Positive alcohol breath test, urine drug screen or urine cotinine test at screeningation
* History of allergic reactions or hypersensitivity to sirolimus, sirolimus derivatives, or excipient of NPC-12G Gel
* Use of any drugs known to induce or inhibit CYP3A4 metabolism within 30 days prior to the first study drug administration
* Positive pregnancy test at screening
* Breast-feeding subject
* History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening
* Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection
* Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study and up to 3 weeks after the last study drug administration

Primary outcomes:
measure: AUC0-48
timeFrame: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
measure: Cmax
timeFrame: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
measure: Tmax
timeFrame: Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: InVentiv Health Clinical Research Services LLC
state: Florida
Study officials:
References:
Clinical trial NCT06508762: A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993
Official title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-993 in healthy adult participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
* A total body weight of more than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VX-993
timeFrame: From Day 1 up to Day 28
measure: Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993
timeFrame: From Day 1 up to Day 28
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993
timeFrame: From Day 1 up to Day 28
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VX-993 Metabolite
timeFrame: From Day 1 up to Day 28
measure: Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993 Metabolite
timeFrame: From Day 1 up to Day 28
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 Metabolite
timeFrame: From Day 1 up to Day 28
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 28
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References:
Clinical trial NCT00812162: Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men
Official title: Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 48
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. This is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).


Eligibility criteria: Inclusion Criteria:

* Age range: 21 years and older
* Body mass index between 25.0-39.9 kg/m2
* Weight stable (\< 4.5 kg (\~10 lbs) weight gain or loss within last 6 months)
* Body fat \>25% (assessed by skinfold and plethysmography (if needed))
* Non-smoking (within the last 6 months)
* Constant habitual activity patterns (within last 3 months)
* Clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose \<110 mg/dl)
* Not taking medications known to influence appetite or metabolism
* Non-diabetic

Exclusion Criteria:

* Age: \<21 years
* Body mass index: outside of the 25.0-39.9 kg/m2 range
* Gained or lost \> 4.5 kg (10 lbs) within the last 6 months
* Body fat \<25% as assessed by plethysmography
* Smoker (currently or within the last 6 months)
* Intermittently been involved in a diet and/or exercise program within the last 3 months
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
* Clinically diagnosed as diabetic
* Allergies to eggs
* Lactose intolerance
* Clinically diagnosed with diverticulosis
* Clinically diagnosed with diverticulitis

Primary outcomes:
measure: The primary aim is to examine the effects of increased protein intake on appetite, selected appetite hormones (insulin, leptin, ghrelin), whole body energy expenditure, and body composition (fat mass and fat-free mass) changes.
timeFrame: 12 week
Secondary outcomes:
measure: The secondary aim of this study is to evaluate the effects of meal frequency on appetite by asking the men to frequently rate their appetite on days that they purposefully eat 3 vs. 6 times/day.
timeFrame: 12 week
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01502462: Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Regurgitation
Keywords: Clinical course and prognostic factors in patients with severe isolated TR
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 131
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.

Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR

Brief summary: Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.

Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.

Detailed description: Inclusion criteria Severe isolated TR for more than 6 months

Exclusion criteria

1. Severe mitral and aortic valvular heart disease
2. Age equals to or more than 75 years
3. Malignancy or serious comorbidity with life expectancy \< 5years
4. Acute or subacute infective endocarditis requiring antibiotics therapy
5. Untreated hyperthyroidism
6. Constrictive pericarditis
7. Unclosed significant atrial septal defect
8. Previous tricuspid valve surgery
9. Significant coronary artery disease
10. Cardiomyopathy
11. Pregnancy
12. Severe resting pulmonary hypertension(TR Vmax \>4.0 m/s)

Eligibility criteria: Inclusion criteria

* Severe isolated TR for more than 6 months

Exclusion criteria

1. Severe mitral and aortic valvular heart disease
2. Age equals to or more than 75 years
3. Malignancy or serious comorbidity with life expectancy \< 5years
4. Acute or subacute infective endocarditis requiring antibiotics therapy
5. Untreated hyperthyroidism
6. Constrictive pericarditis
7. Unclosed significant atrial septal defect
8. Previous tricuspid valve surgery
9. Significant coronary artery disease
10. Cardiomyopathy
11. Pregnancy
12. Severe resting pulmonary hypertension(TR Vmax \>4.0 m/s)

Primary outcomes:
measure: all cause death
timeFrame: 5 years
Secondary outcomes:
measure: Hospitalization of cardiovascular causes
timeFrame: 5 years
measure: tricuspid valve surgery
timeFrame: 5 years
measure: stroke
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: