louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02849860: Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris
Official title: A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-121 Lotion in Subjects With Acne Vulgaris Under Maximal Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion.

Detailed description: Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion in subjects with moderate to severe acne vulgaris under maximal use conditions.

Eligibility criteria: Key Inclusion Criteria:

* Male or female, between the ages of 9 and \<17 years (16 years 11 months inclusive).
* Written and oral informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.
* Subject must have a score of 3 (moderate) to 4 (severe) on the Evaluator's Global Severity Assessment at the screening and baseline visit in the facial area.
* Subjects with facial acne inflammatory lesions count no less than 20 but no more than 40.
* Subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100.

Key Exclusion Criteria:

* Use of investigational drug or device within 30 days of enrollment or participation in research study or concurrent study with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinical significant rosacea, gram negative folliculitis.
* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
* Subjects with facial beard or mustache that could interfere with any study assessments.

Primary outcomes:
measure: Evaluators Global Severity Score at Day 15
timeFrame: 15 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Valeant Site 02
state: Texas
city: College Station
country: United States
facility: Valeant Site 01
state: Texas
Study officials:
affiliation: Valeant Pharmaceutical
name: Anya Loncaric
role: STUDY_DIRECTOR
References:
Clinical trial NCT01705860: Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation
Official title: A Long Term Follow-Up to Study 017-101-09-001: Effect of Collagenase Santyl® Ointment vs. Placebo on Healing and Scarring Characteristics of 600um Dermatome Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follow up to Acute Wound Scar Study
Keywords: Collagen, collagenase, scar
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult volunteers who were previously treated in study 017-101-09-001 with Collagenase Santyl Ointment and Vehicle (white petrolatum ointment).

Brief summary: The present study will evaluate the long term effects on scar formation for dermatome-induced skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment) alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to evaluate both time to complete wound closure and quality of the resulting scar when Collagenase Santyl® Ointment was used to treat the wound.


Eligibility criteria: Inclusion Criteria:

* Subjects will be considered qualified for enrollment if they participated in the Collagenase Santyl® Ointment Study 017 101-09-001 and provide written informed consent.
* The informed consent document must be read, signed, and dated by the suubject before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject. A photocopy of the signed informed consent document must be provided to the subject and the original signed document placed in the subject's chart.
* Subject participated in the 017-101-09-001 study and received at least one application of a test article, whether Collagenase Santyl® Ointment or White Petrolatum.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Scar Assessment
timeFrame: 1 Day
Secondary outcomes:
measure: Scar Quality
timeFrame: 1 Day
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Healthpoint
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: University of Texas Southwestern Medical Center
name: Shai Rozen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176760: Intact Vagal Innervation for and Glucagon-like Peptide-1 (GLP-1) Effects
Official title: The Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vagotomy, Truncal
Keywords: vagotomy
vagus
GLP-1
Insulin secretion
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2010-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.

The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research individuals with and without intact nervous supply.

Detailed description: GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of glucose and GLP-1 on the insulin secretion

Eligibility criteria: Inclusion Criteria:

* normal fasting plasma glucose
* normal hemoglobin
* informed consent

Exclusion Criteria:

* type 1 diabetes mellitus or type 2 diabetes mellitus
* body mass index \> 30
* inflammatory bowel disease
* intestinal surgery
* serum creatinine \> 250 µM and/or albuminuria
* ALAT \> 2 x normal value
* Severe cardiac insufficiency
* in treatment with medicine which cannot be paused for 12 hours

Primary outcomes:
measure: insulin secretion
timeFrame: four hours
Secondary outcomes:
measure: plasma GLP-1
timeFrame: 12 time points within four hours
measure: plasma GIP
timeFrame: 12 time points within four hours
measure: plasma glucagon
timeFrame: 12 time points within four hours
measure: plasma GLP-2
timeFrame: 12 time points within four hours
measure: plasma PYY
timeFrame: 12 time points within four hours
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of internal medicine F´laboratory, Gentofte Hospital
state: Copenhagen
Study officials:
affiliation: University Hospital, Gentofte, Copenhagen
name: Astrid Plamboeck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Gentofte, Copenhagen
name: Tina Vilsbøll, MD, dr.med
role: STUDY_DIRECTOR
References:
citation: Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Knop FK, Vilsboll T, Holst JJ. Characterisation of oral and i.v. glucose handling in truncally vagotomised subjects with pyloroplasty. Eur J Endocrinol. 2013 Jul 6;169(2):187-201. doi: 10.1530/EJE-13-0264. Print 2013 Aug.
Clinical trial NCT06193460: Evaluation of the Anti-anaesthetic Effects of Low-Level Laser Therapy on Children's Soft Tissue
Official title: Evaluation of the Anti-anaesthetic Effects of Low-Level Laser Therapy on Children's Soft Tissue Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthetic Complication
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Group I (20 teeth): the anaesthesia will be reversed by the photobiomodulation mode of diode laser therapy (low-level laser therapy).

Group II (controlled group) :( 20 teeth) anaesthesia will be withdraw without intervention.
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of the photobiomodulation mode of the diode laser on the anaesthetic area and find the best parameter that would accelerate the withdrawal of anaesthesia.

Detailed description: A randomized clinical trial will be performed at the Pedodontics Out Paediatric Clinic at the Facility of Dental Medical for girls. Al Azhar University has twenty patients with upper or lower first primary molars on the right and left sides that need to be treated. Using the split-mouth technique, the mouth will be split in two halves. The first half represents the first group, and the second half represents the second group.

Group I (20 teeth): the anaesthesia will be reversed by the photobiomodulation mode of diode laser (low-level laser therapy).

Group II (controlled group): 20 teeth of anesthesia will be withdrawn without intervention.

To avoid bias in the 2nd group, the laser will be applied on this side, but in turned-off mode. The type of anaesthesia that will be evaluated is articine hydrochloride 4% with 1:200 epinephrine (vasoconstrictor).

Eligibility criteria: Inclusion Criteria:

Parents have to complete the written consent form. Patient who behaved well. Children aged from 6 to 12 years can evaluate soft tissue anaesthesia. Patients that require treatment with bilateral upper or lower first primary molar infiltration under anaesthesia.

Exclusion Criteria:

Patients who are mentally disordered or hand-capped. uncooperative patients.

Primary outcomes:
measure: Outcomes measuring the duration (in minutes) of anaesthesia withdrawal after laser application
timeFrame: after application of laser immediately and continue each 15 minutes till complete withdrawal of anaesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university
Study officials:
References:
Clinical trial NCT02511860: Burdock and Blood Pressure in African-American Women
Official title: Burdock and Blood Pressure in African-American Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Proactive Health Labs
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study of women aged 18-65, to determine the physiological effects of consuming burdock root in supplement form. Burdock has long been used by herbalists for its diuretic and blood sugar lowering properties.

Detailed description: This study will allow us to determine the effect of burdock consumption on basic laboratory tests such as the complete metabolic panel (CMP) as well as the effect on blood pressure over time. Participants will self-monitor their blood pressures and undergo lab testing. They will also complete symptom inventories to determine subjective factors that change with burdock consumption, such as menstrual water retention. Subjects will undergo electronic body composition testing before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Must be able to swallow tablets
* African-American race
* Able to travel to our clinic in Santa Monica

Exclusion Criteria:

* Severely low blood pressure
* Hypoglycemia
* Baseline creatinine over 1.2

Primary outcomes:
measure: Blood pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 6 Weeks
measure: Extracellular/Total Body Water Ratio
timeFrame: 6 Weeks
measure: Hemoglobin A1c
timeFrame: 6 weeks
measure: Blood urea nitrogen
timeFrame: 6 weeks
measure: Creatinine
timeFrame: 6 weeks
measure: Fasting Blood Glucose
timeFrame: 6 weeks
measure: Liver function tests
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Proactive Health Labs
name: Dr. De
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02260960: The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease
Official title: The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Physician Recommended Nutriceuticals
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity, Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared to administration of placebo.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 and ≤ 90 at the time of informed consent
* Subjects experiencing dry eye based on a global clinical assessment by the attending clinician, subject complaint of dry eye symptoms
* Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312 mOsm/L in at least one eye
* Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye

Exclusion Criteria:

* Allergy to fish oil or safflower oil
* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia
* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring Active ocular or nasal allergy
* LASIK or PRK surgery that was performed within one year of the Screening Visit or at any time during the study
* Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual artificial tear should be continued at the same frequency and no change in drop brand
* Contact lens wear within 12 hours of any study visits
* Pregnancy or lactation during the study
* Abnormal nasolacrimal drainage (by history)
* Punctal cauterization or punctal plug placement within 60 days of screening
* Prohibited Medications - Cyclosporine (Restasis®); any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc...) within 3 weeks (21 days) of Screening and at any time during the study

Primary outcomes:
measure: Tear Osmolarity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Eye Center of Columbus
state: Ohio
Study officials:
affiliation: The Eye Center of Columbus
name: Alice Epitropoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05874960: Helicobacter Pylori Prevalence in Southern Region of Romania
Official title: Helicobacter Pylori Prevalence in Southern Region of Romania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Helicobacter
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population from Southern Regions of Romania, from rural vulnerable areas concerning access to health services.

Brief summary: Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

Detailed description: Observational study, voluntary participation, 12 months, studying Helicobacter pylori prevalence.

The aim of the study is to evaluate the prevalence of H. pylori infection in several areas of the Southern Regions of Romania, considered as vulnerable pertaining to the access of health services.

Fecal Helicobacter pylori will be tested, together with antibiotic susceptibility.

Eligibility criteria: Inclusion Criteria:

* Adult voluntary participants to "Medical services caravan" project by Medcorp Association

Exclusion Criteria:

* Age \< 18 years old
* No informed consent

Primary outcomes:
measure: Helicobacter pylori infection rate
timeFrame: 12 months
Secondary outcomes:
measure: Antibiotic susceptibility rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Medcorp Association
Study officials:
affiliation: Medcorp Association
name: Radu Prodan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04158076: Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Hypertension
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-08
Enrollment: 131
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

Detailed description: This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.

In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

* Patient with known or suspected secondary hypertension
* Other exclusions applied

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, Week 8
measure: Mean sitting systolic blood pressure (MSSBP)
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo Soo Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06505876: Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease
Official title: Effect of Oral Feeding on Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomized controlled clinical trail that involved patients with Chronic Obstructive Pulmonary Disease.The goal of this clinical trial is to compare the clinical effect of Oral Tubes vs Nasogastric Tubes in patients with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Oral esophageal Tube Feeding better improve the nutritional status and pulmonary infection

Detailed description: This is a prospective, randomized controlled clinical trail that involved patients with Chronic Obstructive Pulmonary Disease.The goal of this clinical trial is to compare the clinical effect of Oral Tubes vs Nasogastric Tubes in patients with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Oral esophageal Tube Feeding better improve the nutritional status and pulmonary infection

Participants will be divided into two groups randomly, with different nutritional support respectively.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of COPD confirmed by spirometry
* ≥18 years of age
* Sinus rhythm ≥50/min and \< 120/min at inclusion
* Written informed consent

Exclusion Criteria:

* Known hypersensitivity to metoprolol or related derivatives
* Sinus bradycardia (resting heart rate \< 50/min)
* Sick sinus syndrome unless treated with a pacemaker
* Atrial fibrillation/flutter
* Clinical signs or previous diagnosis of heart failure, angina pectoris, myocardial infarction, cerebrovascular disease, or critical peripheral ischemia

Primary outcomes:
measure: Chronic Obstructive Pulmonary Disease Assessment Test
timeFrame: day 1 and day 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: