louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05349916: The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
Official title: The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Type2 Diabetes
Blood Sugar; High
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Grain processing corporation
First posted: 2022-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin \[IMD\], partially digestible maltodextrin) and RS4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice porridge). The primary outcome of the study is the effect of fibers on postprandial blood glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.


Eligibility criteria: Inclusion Criteria:

* Body mass index (18.5 kg/m² ≤ BMI ≤ 29.9 kg/m²)
* No history of abnormal glucose metabolism
* No ongoing use of drugs affecting blood glucose levels
* Fasting blood glucose between 90-110 mg/dL
* Low dietary fiber intake (less than 15 g per day)

Exclusion Criteria:

* Diabetic individuals
* Individuals with history of gastrointestinal disease
* Pregnant or nursing women

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: Acute study: [3 hours of measurement after consumption of test food]
measure: Postprandial glycemic response
timeFrame: Acute study: [3 hours of measurement after consumption of test food]
measure: Postprandial glycemic response
timeFrame: Acute study: [3 hours of measurement after consumption of test food]
Secondary outcomes:
measure: Postprandial insulin response
timeFrame: Acute study: [3 hours of measurement after consumption of test food]
measure: Postprandial insulin response
timeFrame: Acute study: [3 hours of measurement after consumption of test food]
measure: Postprandial insulin response
timeFrame: Acute study: [3 hours of measurement after consumption of test food]
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT06175416: Spontaneous Pneumothorax in Adolescents
Official title: Spontaneous Pneumothorax in Adolescents: Inventory and Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumothorax, Spontaneous
Keywords: Pneumothorax
Spontaneous
Pleural cavity
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 134
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient (aged between 14-20 years old) having pontaneous pneumothorax without apparent cause and operated on at the HUS between 2010 and 2021.

Brief summary: Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "The patient is usually seized with sudden chest pain and difficulty in breathing.

In this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the University Hospitals of Strasbourg


Eligibility criteria: Inclusion criteria:

* Adult patient (18-20 years old)
* Minor patient aged 14-17 years old
* Any gender
* Spontaneous pneumothorax without apparent cause, between 14 and 20 years old
* Patient operated on at the HUS between 2010 and 2021
* Patient not objecting to the reuse of their data for scientific research purposes.
* Holders of parental authority who do not object to the reuse of their child's data for scientific research purposes.

Exclusion criteria:

* Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
* Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes.
* Secondary origin of the pathology: Cystic fibrosis, postoperative pneumothorax, post-traumatic,
* Subject having been treated initially in another structure without further information.

Primary outcomes:
measure: Retrospective description of the management of spontaneous pneumothorax in adolescents in the Strasbourg University Hospital
timeFrame: Files analysed retrospectively from January 1, 2010 and December 31, 2021 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie pédiatrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04013516: Measles Vaccination Cash Incentives Experimental Evidence From Nigeria
Official title: Measles Vaccination Cash Incentives Experimental Evidence From Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Measles
Keywords: Immunization
Incentives
Lead sponsor: IDinsight
Sponsor class: OTHER
Collaborators: name: GiveWell
First posted: 2019-07-09
Enrollment: 1088
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomly assigned to different incentive amounts (treatment arms), a pure control arm, and a placebo arm which consisted of a phone call without an additional incentive.
Primary purpose: OTHER

Brief summary: IDinsight is conducting a randomized controlled trial to assess the impact of various sized cash incentives for caretakers of infants that require a 9-month measles vaccination on the completion rate for the vaccine in Nigeria. The purpose of the experiment is to help New Incentives (NI) determine the optimal size of the incentive as they scale to the North West region of Nigeria.


Eligibility criteria: Inclusion Criteria:

* Caregiver and infant registered with the New Incentives program
* The infant was nine months or older at the start of the study (note there was no upper age limit as New Incentives only began enrolling infants in October 2016)
* Infant had received at least one previous conditional cash transfer for immunization at an All Babies are Equal Initiative clinic,
* Infant had received their Penta-3 vaccine.
* The caregiver had provided a phone number (either a personal number or a number of someone who can reach them) during registration.

Exclusion Criteria:

* Infant had already received a measles vaccine

Primary outcomes:
measure: Measles Vaccination Coverage Rate
timeFrame: We assessed whether eligible infants received measles vaccination at any time during the 4 month study period. Children were a minimum of 9 months at the beginning of the study and a maximum of 7 years at the end of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: All Babies are Equal Initiative (New Incentives)
state: Federal Capital Territory
Study officials:
affiliation: IDinsight
name: Alison Connor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691816: The Experience of the Child With Cancer When Port à Cath Needle : Child's Speech
Official title: The Experience of the Child With Cancer When Port à Cath Needle : Child's Speech
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Oncology
Keywords: Pediatrics; Cancer; Care; Experience; Port-a-cath
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6 to 12 with cancer and who have weekly care, requiring port-a-cath needle placement.

Brief summary: This qualitative research refers to the descriptive phenomenological method of Hurssel which allows an analysis of the experience and an understanding of the phenomenon. Semi-structured interviews are carried out with 10 children followed for cancer in 3 pediatric hemato-oncology departments. The children interviewed are aged 6 to 12 and can be with their parents. A thematic analysis approach is used to analyze the data of this research.


Eligibility criteria: Inclusion Criteria:

* Child followed in pediatric oncology for cancer or hematological disease
* Child wearing a Port-a-cath needle placement and minimum use once a week

Exclusion Criteria:

* Child no speaking the French language

Primary outcomes:
measure: Experience of self management of port-a-cath needle placement
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alexandra Usclade
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01722916: Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase
Official title: Pilot Study of Appropriate Dosing for Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase: A Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Drug Safety
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to find how much hyaluronidase should be used when receiving injections of fillers.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness
* Recent Accutane use in the past 6 months
* Subjects prone to hypertrophic and keloidal scarring
* Subjects with tattoos and/or scars on upper medial arms (the treatment area)
* Subjects with known hypersensitivity to hyaluronic acid

Primary outcomes:
measure: Dose of hyaluronidase injected until the filler is no longer detectable
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alam M, Hughart R, Geisler A, Paghdal K, Maisel A, Weil A, West DP, Veledar E, Poon E. Effectiveness of Low Doses of Hyaluronidase to Remove Hyaluronic Acid Filler Nodules: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):765-772. doi: 10.1001/jamadermatol.2018.0515.
Clinical trial NCT00806416: A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Official title: A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70 mg Alendronate/2800 IU Vitamin D3 Final Market Combination Tablet to a 70 mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.


Eligibility criteria: Inclusion Criteria:

* Male or nonpregnant female age 18 to 65 years
* Female of childbearing potential on appropriate method of contraception and not nursing
* BMI (body mass index) less than or equal to 30 kg/m2
* Subject is in good health
* Willing to limit direct sunlight and apply sunscreen if in the sun more than 1 hour

Exclusion Criteria:

* mental or legal incapacitation
* received bisphosphonate treatment within 3 months of screening
* unable to sit or stand upright for at least 2 hours

Primary outcomes:
measure: Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet
timeFrame: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).
measure: Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
timeFrame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
measure: Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
timeFrame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.
Clinical trial NCT01622816: Comparing Visual Acuity Measurements (How Well You Can See) Using a Standard ETDRS Chart & a Handheld ETDRS Chart
Official title: Prospective Determination of Agreement Between Standard ETDRS (Early Treatment Diabetic Retinopathy Study) Chart and Handheld Illuminated ETDRS Equivalent Chart in Eyes With Retinal Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients enrolled in clinical trials for various retinal diseases at the Wills Eye Institute

Brief summary: Comparing visual acuity measurements (measurements of how well you can see) using a standard ETDRS (Early Treatment Diabetic Retinopathy Study) chart and a handheld ETDRS chart

Detailed description: Prospective determination of agreement between standard ETDRS chart and handheld illuminated ETDRS equivalent chart in eyes with retinal pathology

Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study (one visit per patient).
2. Age greater than 18 years.
3. Clinical diagnosis of retinal disease (including age-related macular degeneration, macular degeneration, retinal vessel occlusion, among others).

Exclusion Criteria:

1. Presence of a significant cataract as determined by your doctor.
2. Presence of a significant posterior capsular opacity (haziness in your eyes) as determined by your doctor.
3. Diagnosis of uveitis (inflammation in part of the eye).

Primary outcomes:
measure: ETDRS Letter Score
timeFrame: 1 Day
Secondary outcomes:
measure: ETDRS Letter Score Consistency
timeFrame: 1 Day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Mid Atlantic Retina- Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute
name: Julia Haller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahimy E, Reddy S, DeCroos FC, Khan MA, Boyer DS, Gupta OP, Regillo CD, Haller JA. PROSPECTIVE EVALUATION OF VISUAL ACUITY AGREEMENT BETWEEN STANDARD EARLY TREATMENT DIABETIC RETINOPATHY STUDY CHART AND A HANDHELD EQUIVALENT IN EYES WITH RETINAL PATHOLOGY. Retina. 2015 Aug;35(8):1680-7. doi: 10.1097/IAE.0000000000000518.
Clinical trial NCT05118516: Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects
Official title: A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASC43F, a Fixed-dose Combination (FDC) Oral Tablet Containing ASC41, a THR β Agonist and ASC42, an FXR Agonist in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: ASC43F
Phase 1
Thyroid hormone receptor beta agonist
FXR agonist
ASC41
ASC42
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-11-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between 18 to 65 years of age.
* Subjects must weigh at least 50 kg (110 pounds \[lbs.\]) for men, and at least 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-32 kilogram per meter square (kg/m2).
* Physical examination and vital signs are within normal range or slightly abnormal.

Exclusion Criteria:

* Any surgical or medical condition which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
* Abnormal clinical or laboratory findings that indicate diseases including but not limited to renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic disease.
* History or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases.
* History of viral hepatitis or HIV
* History of drug or food allergies that caused severe hypersensitivity reactions or anaphylaxis.).

Primary outcomes:
measure: Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).
timeFrame: Baseline to day 7
Secondary outcomes:
measure: To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects
timeFrame: Baseline to day 4
measure: To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects
timeFrame: Baseline to day 4
measure: To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects
timeFrame: Baseline to day 4
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: 8307 Gault Lane
state: Texas
Study officials:
References:
Clinical trial NCT05195216: Psychosocial Factors and Quality of Life in the Effect of Fear of COVID-19 With Cystic Fibrosis
Official title: Psychosocial Factors and Quality of Life in the Effect of Fear of COVID-19 With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 128
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 64 individuals with cystic fibrosis and 70 healthy individuals participated in the study.

Brief summary: The purpose of this study; The COVID-19 pandemic is to investigate the effects of COVID-19 fear levels of patients with cystic fibrosis on the psychosocial and quality of life levels of individuals.

Detailed description: After individuals were informed about the study, it was administered to individuals who gave written informed consent.This study was carried out on individuals with cystic fibrosis and healthy individuals who meet the eligibility requirements, through online forms.

Eligibility criteria: Inclusion Criteria:

* be 16 years of age or older
* Having been diagnosed with Cystic Fibrosis
* Volunteering to participate in the research

Exclusion Criteria:

* Being mentally incapable of successfully applying the scales to be applied for evaluation purposes
* Being treated with sedative and antiepileptic drugs
* Pregnancy

Primary outcomes:
measure: fear of covid-19
timeFrame: November- December/2021
Secondary outcomes:
measure: psychosocial factors
timeFrame: November-December/2021November-December/2021
Other outcomes:
measure: quality of life assessment
timeFrame: November-December/2021November-December/2021
Locations:
city: Istanbul
country: Turkey
facility: Elif Kabasakal
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT00858416: Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis
Official title: Efficacy of Combined Local Mechanical Vibrations, Continuous Passive Motion and Thermotherapy in the Management of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Knee Pain
Lead sponsor: Kineticure
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 71
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee


Eligibility criteria: Inclusion Criteria:

* diagnosis of OA of the knee by ACR criteria
* symptoms consistent with radiographic OA grades 2, 3 or 4 by Kellgren and Lawrence criteria
* moderate to severe knee pain (≥35mm on a 100mm visual analog pain scale (VAS)).

Exclusion Criteria:

* knee or hip surgery

Primary outcomes:
measure: intensity of pain as measured on a 100 mm non-marked VAS and the total Western Ontario McMaster (WOMAC) OA index using a Likert scale,
timeFrame: 10 weeks
Secondary outcomes:
measure: satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale
timeFrame: 10 weeks
measure: range of motion (ROM) of the knee (using goniometer)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville Orthopedic Institute
state: Florida
Study officials:
affiliation: Jacksonville Orthopedic Institute
name: Gary S Kitay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.