louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02007278: Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
Official title: Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Hypoglycemia
Keywords: diabetes
hypoglycemia
glycemic variability
vildagliptin
glimepiride
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.


Eligibility criteria: Key Inclusion Criteria:

* HbA1c between 8%-10.5% in stable metformin dose (\>1500 mg/day), four weeks prior visit 1

Key Exclusion Criteria:

* Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin

Primary outcomes:
measure: Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)
timeFrame: Week 12
Secondary outcomes:
measure: Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)
timeFrame: Week 12
measure: Glycemic Variability Measured by Total Standard Deviation (TSD)
timeFrame: Week 12
measure: Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12
timeFrame: Screening visit , 12 weeks of treatment
measure: Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline
timeFrame: baseline, 12 weeks of treatment
measure: Number of Patients With Incidence of Hypoglycemia
timeFrame: 12 weeks
measure: Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment
timeFrame: 12 weeks
measure: Number of Patients With Any Adverse Events, Serious Adverse Events and Death
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Novartis Investigative Site
state: Antioquia
city: Manizales
country: Colombia
facility: Novartis Investigative Site
state: Caldas
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Chía
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Cali
country: Colombia
facility: Novartis Investigative Site
state: Valle del Cauca
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Cali
country: Colombia
facility: Novartis Investigative Site
city: Monteria
country: Colombia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01328678: A Study of Vitamin D in Subjects With Alopecia Areata
Official title: A Pilot Study of Vitamin D in Subjects With Alopecia Areata
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Vitamin D
Parathyroid
Calcium
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women in and around the Sioux Falls area

Brief summary: The objective of this study is to assess the parathyroid-vitamin D-calcium axis in subjects with alopecia areata. The hypothesis behind this study is that hypovitaminosis D might contribute to the pathogenesis of alopecia areata.

Detailed description: Alopecia Areata (AA) is a T-Cell mediated, non-scarring, polygenic, autoimmune disease of the hair follicle. It has been reported to be associated with other autoimmune diseases, especially autoimmune thyroid disease and vitiligo. It is more common in females. Recently, vitamin D deficiency has been claimed to contribute to the pathogenesis of multiple autoimmune disease. There is a strong inverse correlation between the level of 25-hydroxyvitamin D levels and the autoimmune disease in adolescents.

Eligibility criteria: Inclusion Criteria:

* Men and women who are at least 18 years old
* Subjects with newly diagnosed with alopecia areata

Exclusion Criteria:

* Subjects who take supplemental Vitamin D, by itself or as a part of a multivitamin

Primary outcomes:
measure: Vitamin D levels will be reported in subjects and correlated with the calcium and parathyroid levels.
timeFrame: Initial clinic visit (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Wael Eid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04745078: Carboxytherapy for Periorbital Dark Circles
Official title: Evaluation of the Use of Carboxytherapy in Periorbital Dark Circles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Disorder
Keywords: carboxytherapy
dark circles
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study evaluates carboxytherapy for the treatment of periorbital dark circles

Detailed description: two different concentrations of carboxytherapy administered to patients are compared regarding efficacy

Eligibility criteria: Inclusion Criteria:

* healthy individuals with dark circles

Exclusion Criteria:

* infections, scarring, pregnancy, allergy, on treatment for the condition.

Primary outcomes:
measure: Improvement of Melanin index
timeFrame: 6 weeks
measure: Improvement of erythema index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine,Alexandria University
Study officials:
affiliation: University of Alexandria
name: Ossama H Roushdy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01895478: Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
pediatrics
control
medication adherence
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 77
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control.

This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.


Eligibility criteria: Inclusion Criteria:

* Child presented to study institution emergency department during study period
* Child was 1 - 17 years-old
* Child has physician-diagnosed asthma by parent report
* Attending physician for child believed emergency department visit was due to asthma
* Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study

Exclusion Criteria:

* Child has major pulmonary or cardiac co-morbid illness
* Family of child was non-English speaking
* Child was triaged to the med-trauma bay for severe respiratory distress

Primary outcomes:
measure: Asthma Control
timeFrame: 1 day (Assessment occurs at a single time during emergency department visit)
Secondary outcomes:
measure: Asthma Trajectory
timeFrame: 1 day (Assessment occurs at a single time during emergency department visit)
measure: Medication Adherence
timeFrame: 1 day (Assessment occurs at a single time during emergency department visit)
measure: Asthma burden to family
timeFrame: 1 day (Assessment occurs at a single time during emergency department visit)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital / Hasbro Children's Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT06314178: Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice. Patients Eligible for Inclusion Are Women with a Gestational Age Between 24-42 Weeks Undergoing a Third-trimester Growth Scan. the Image Data from the Scan Are Used to Calculate Fetal Weight.
Official title: Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 185
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of Prenatal Examinations at Rigshospitalet, Copenhagen, Denmark.

Brief summary: The goal of this observational study is to compare a new artificial intelligence (AI) feedback tool with the traditional method for estimating fetal weight during ultrasound scans on pregnant women between 24-42 weeks of gestation. The study aims to investigate the presence of demographic bias in the AI model. The demographic factors examined in the study include Body Mass Index (BMI), the number of births, fetal age, mother\&#39;s age, fetal sex, and the presence of preeclampsia. Moreover, the study will compare the accuracy of the AI model and the Hadlock model, a fetal growth formula, in estimating fetal weight. Participants will have their ultrasound scans pseudonymized and securely stored on password-protected removable drives, ensuring their identity and privacy are maintained. Afterward, the ultrasound data will be sent to the Technical University of Denmark (DTU), where the AI model will analyze the images to estimate fetal weight.


Eligibility criteria: Inclusion Criteria:

* Women with gestational age between 24-42 weeks undergoing a third-trimester growth scan.

Exclusion Criteria:

* Women with multiple pregnancies.

Primary outcomes:
measure: Demographic biases
timeFrame: From enrollment to the birth of the child
Secondary outcomes:
measure: Comparing the accuracy of the Hadlock formula and the AI model
timeFrame: From enrollment to the birth of the child
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
References:
citation: Salomon LJ, Alfirevic Z, Da Silva Costa F, Deter RL, Figueras F, Ghi T, Glanc P, Khalil A, Lee W, Napolitano R, Papageorghiou A, Sotiriadis A, Stirnemann J, Toi A, Yeo G. ISUOG Practice Guidelines: ultrasound assessment of fetal biometry and growth. Ultrasound Obstet Gynecol. 2019 Jun;53(6):715-723. doi: 10.1002/uog.20272.
Clinical trial NCT01881178: The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein
Official title: The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: CRP
Nopalea
Fruit
Juice
Lead sponsor: University of Bridgeport
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 287
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study has been developed to investigate the anti-inflammatory effects of a commercial product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research method employs a double blind, placebo controlled, and time-series (repeat measures) design with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation - testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12 weeks (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is expected that baseline CRP levels in healthy participants will decline.


Eligibility criteria: Live within traveling distance of the research center. Access to a telephone in their residence. Between 35 and 75 years of age Not currently ingesting Nopalea Not pregnant, planning to become pregnant, or nursing a child Not currently taking anti-inflammatory medications Medically stable - i.e. no recent major change in the last 3 weeks of prescription or non- prescription medication Not diagnosed with Type 1 Diabetes Not diagnosed with depression Not diagnosed with an acquired or congenital immune system deficiency

Primary outcomes:
measure: HS-CRP
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Trivita Wellness Center
state: Arizona
Study officials:
affiliation: UBCNM
name: Mark e Mattie
role: STUDY_DIRECTOR
References:
Clinical trial NCT03387878: A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
Official title: A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comfort and Performance of Intermittent Catheter
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the performance of GentleCath Glide™ Intermittent Catheters


Eligibility criteria: Inclusion Criteria:

* Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
* Subjects must be willing and able to provide written informed consent
* Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
* Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
* Patients who self-catheterise at least three times per day
* Able to attend final assessment visit at day 14

Exclusion Criteria

* Subjects who require intermittent catheterisation to administer irrigation or instillation.
* Subjects who are presently participating in another clinical trial.
* Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
* Subjects with known sensitivity to the device components

Primary outcomes:
measure: Performance/Ease of Use
timeFrame: 14 Days
measure: Ease of Removal
timeFrame: 14 Days
measure: Residue Acceptability
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Rzeszow
country: Poland
facility: Specjalistyczny Gabinet Lekarski
Study officials:
References:
Clinical trial NCT03009578: Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia
Official title: Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations.

Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia


Eligibility criteria: Inclusion Criteria:

Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age \>38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study

Exclusion Criteria:

1. Severe anemia \< 7 gm/dl.
2. Women received iron therapy during pregnancy.
3. Intolerance to iron preparations
4. Anemia due to other causes
5. Peripartum blood transfusion.

Primary outcomes:
measure: the percentage of patients achieving Hb rise 3 gm or more
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean rise of Hb from baseline to 6 weeks.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT02854878: Treatment of Head Lice Infestation Using Novel Ultrasonic Comb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediculus Capitis
Lead sponsor: ParaSonic Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs.

23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B


Eligibility criteria: Inclusion Criteria:

* Males and Females
* Age 6 years and older at the time of enrollment
* Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search).
* Hair must be at least 3 cm long.
* Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age).
* For females of childbearing potential, a statement declaring that she is not currently pregnant.

Exclusion Criteria:

* Used any chemical head lice treatment in the 7 days preceding the trial treatment
* Used antibiotics in the week preceding treatment
* Open wounds in the treatment area
* Skin irritation in the treatment area
* Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation
* Known allergies to any of the gel's components
* Participant that is already enrolled in another study
* Participant who can't be combed with fine Comb dense ASSY2000

Primary outcomes:
measure: Adverse events of the device and treatment
timeFrame: up to three days
Secondary outcomes:
measure: Mortality of up to 70% of the mature head lice 3 hours post treatment
timeFrame: 3 hours post treatment
measure: Mortality of up to 50% of the head lice eggs 14 days post treatment.
timeFrame: 14 days post treatment
Other outcomes:
Locations:
city: Herzliya
country: Israel
facility: Herzeliya medical center
Study officials:
References:
Clinical trial NCT00187707: Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Official title: Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. Previously, we have recruited a cohort of healthy volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to identify genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to study the influence of specific polymorphisms in the intestinal transporters, such as the novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailability of gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit, during which they will take a single dose of gabapentin, and provide blood and urine samples over the course of 36 hours (5 terminal elimination gabapentin half-lives) for pharmacokinetic analysis.

Detailed description: Detailed description pending

Eligibility criteria: Inclusion Criteria:

* Subjects must have previously participated in the "SOPHIE" study.
* Subjects will be between the ages of 18 and 40 years old
* Subjects will have been selected as healthy by medical history questionnaire and screening blood work (CBC, Comprehensive Metabolic panel).
* Subjects will be taking no regular medications and will have normal renal function.

Exclusion Criteria:

* Pregnant
* Have a new history indicating they are no longer healthy; Individuals with anemia (hemoglobin \< 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL), will be excluded.
* Taking a medication that could confound study results
* Do not consent to participate in the study.

Primary outcomes:
measure: Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
timeFrame: Gabapentin
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kathleen Giacomini, PhD
role: PRINCIPAL_INVESTIGATOR
References: