louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06914024: Clinical Association Between Celiac Disease and Intussusception in Children
Official title: Clinical Association Between Celiac Disease and Intussusception in Children Attending Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Celiac Disease in Children
Intussusception
Keywords: pediatric gastrointestinal disease
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2025-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. To explore the potential association between celiac disease and intussusception in pediatric patients, identifying any common clinical features or patterns that may suggest a link between the two conditions.
2. To determine the prevalence of Celiac Disease among children diagnosed with intussusception attending assiut university children hospital.

Brief summary: Clinical association Between Celiac Disease and Intussusception in children


Eligibility criteria: Inclusion Criteria:

Children aged 6 months to 18 years Diagnosed with celiac disease based on serology and biopsy Diagnosed with intussusception confirmed by imaging Parent or legal guardian provides informed consent

Exclusion Criteria:

Children with known gastrointestinal abnormalities other than celiac disease History of abdominal surgery Incomplete or unavailable medical records Patients on immunosuppressive therapy

Primary outcomes:
measure: Celiac Disease and Intussusception
timeFrame: 1year
Secondary outcomes:
measure: Analysis of clinical characteristics associated with intussusception
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04887324: Real-life Data of Constitutional Von Willebrand Disease in Western France
Official title: Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Von Willebrand Diseases
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 922
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Constitutional Von Willebrand Disease patients

Brief summary: The objective of this observational study HOPSCOTcH-WILL II is to provide an accurate and detailed account of current Von Willebrand Disease (VWD) therapeutic management by collecting real-life data on hemorrhagic treated events in the 5 Western French Hemophilia Treatment Center.

The HOPSCOTCH-WILL II study aims to describe therapeutic management of patients with VWD, following the provision of a recombinant drug in France; It will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.


Eligibility criteria: Inclusion Criteria:

* Constitutional Von Willebrand Disease patient, of any severity, with or without Von Willebrand Factors inhibitors
* Patient included in the research database BERHLINGO
* Patient treated or not by desmopressin or Von Willebrand Factor/FVIII/by-passing agents available on the French market (at baseline)
* Patient who agrees to participate in the HOPSCOTcH-Will II and followed in one of the 5 investigator centers

Exclusion Criteria:

- Patients under guardianship

Primary outcomes:
measure: Observational study, description of the global therapeutic modalities required for severe treated hemorrhagic events in constitutional Von Willebrand Disease patients of any severity
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHR de Brest
city: Le Mans
country: France
facility: CH Le Mans
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Nantes University Hospital
name: Marc Trossaert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06253624: Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery
Official title: Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Lateral Ligament
Gait Analysis
Keywords: ATFL repair
Arthroscopy
Pedobarography
Plantar pressure distribution
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study will investigate alterations in post-surgical gait patterns among patients who have undergone all arthroscopic repair surgery for the anterior talofibular ligament (ATFL) due to ankle instability. The gait biomechanics of patients scheduled for surgery will be assessed preoperatively using pedobarographic analysis. Subsequent changes in walking biomechanics will be evaluated and interpreted at the 3rd and 6th postoperative months. Consequently, the impact of the all arthroscopic anatomical ATFL repair method on walking will be documented.


Eligibility criteria: Inclusion Criteria:

* Presence of unilateral ankle instability.
* Planning for all arthroscopic anterior talofibular ligament (ATFL) repair surgery.

Exclusion Criteria:

* Presence of foot and ankle deformities.
* Presence of orthopedic or neurological pathologies that may affect walking biomechanics.
* History of prior foot and ankle surgery.
* Assessment of surgical stability deemed unsuccessful at the 3rd or 6th month postoperative control.

Primary outcomes:
measure: Pedobarography
timeFrame: one day before surgery
measure: Pedobarography
timeFrame: 3 months after the surgery
measure: Pedobarography
timeFrame: 6 months after the surgery
Secondary outcomes:
measure: American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
timeFrame: one day before surgery
measure: American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
timeFrame: 3 months after the surgery
measure: American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital
Study officials:
affiliation: Gazi University
name: Ulunay Kanatlı
role: STUDY_CHAIR
affiliation: Gazi University
name: Mehmet A Tokgöz
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Zeynep Hazar
role: STUDY_DIRECTOR
References:
Clinical trial NCT01291524: Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Official title: An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
timeFrame: 3 days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
Clinical trial NCT06756724: Vessel Angles and Diameters in Stroke Disease
Official title: Morphometric Insights Into Stroke Development: Analyzing Bifurcation Angles and Diameters of Common and Internal Carotid Arteries Using Frankfurt Plane Reoriented Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Not Otherwise Specified
Control Condition
Keywords: Ischemic stroke risk
Carotid artery bifurcation
Computed tomography angiography
Bifurcation angles
Vessel diameters
Carotid artery morphology
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals applying to the Emergency Department of Tokat Gaziosmanpasa University Medical Faculty Hospital

Brief summary: Retrospective analysis of internal carotid artery morphology on CT angiography images of patients with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Our study included 66 healthy individuals for control group. The control group consisted of individuals without any pathology or ischemia, selected from patients who underwent brain CTA for headache but showed no structural lesions. Additionally, none of the control group had a history of stroke or evidence of prior ischemic stroke on MRI.

Exclusion Criteria:

* After excluding patients with plaques in the carotid arteries (CCA and ICA), systemic vascular disease, risk factors for cardiogenic stroke, cardioembolism, ischemic stroke due to vasculitis or drug use, and other uncommon causes of stroke, 62 ischemic stroke patients were included in the study.

Primary outcomes:
measure: Internal carotid artery angle (degree measure)
timeFrame: 1 week
measure: Internal carotid artery diameter (cm)
timeFrame: 1 Week
Secondary outcomes:
measure: Internal carotid artery angle and diameter
timeFrame: 1 Week
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
state: Merkez
Study officials:
References:
citation: Liu Y, Ni L, Wang C, Shi P, Yin L, Fu XY, Zhou HD. Association between internal carotid artery kinking and ischemic stroke: A population-based cross-sectional study. J Stroke Cerebrovasc Dis. 2023 Dec;32(12):107417. doi: 10.1016/j.jstrokecerebrovasdis.2023.107417. Epub 2023 Nov 2.
citation: Apaydin M, Cetinoglu K. Carotid angle in young stroke. Clin Imaging. 2021 Feb;70:10-17. doi: 10.1016/j.clinimag.2020.10.020. Epub 2020 Oct 13.
citation: Arora S, Chien JD, Cheng SC, Chun KA, Wintermark M. Optimal carotid artery coverage for carotid plaque CT-imaging in predicting ischemic stroke. J Neuroradiol. 2010 May;37(2):98-103. doi: 10.1016/j.neurad.2009.04.002. Epub 2009 Jul 1.
citation: Cui Y, Lv X, Wang F, Kong J, Zhao H, Ye Z, Si C, Pan L, Liu P, Wen J. Geometry of the Carotid Artery and Its Association With Pathologic Changes in a Chinese Population. Front Physiol. 2020 Jan 21;10:1628. doi: 10.3389/fphys.2019.01628. eCollection 2019.
Clinical trial NCT05957224: Differences in Postprandial Glucose Changes
Official title: An Intervention Comparing Changes in the Plasma Glucose Profile Over a Three-hour Timespan in Persons With T2DM Following Caribbean Shake vs Glucerna Intake: A Double Blinded, Cross-over Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type II
Overweight or Obesity
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There is a one-week washout period between intake of the two shakes.
Primary purpose: OTHER

Brief summary: Following a meal, in nondiabetic individuals, blood glucose rises to peak at 1hr and returns to baseline in 2 - 3 hours. In T2DM, this peak is higher and prolonged. Meal plans for persons with T2DM should comprise evenly spaced, complex carbohydrate portions in order to avoid post-prandial glucose spikes. Researchers have developed an expanded line of Caribbean-flavoured, low-calorie meal-replacement shakes which have been formulated to match the macronutrient and caloric content of a commercially available brand. In this trial investigators aim to (1) examine the change in glucose levels post intake of Caribbean vs the commercially available brand and (2) to conduct a comparative sensory analysis of the two shakes.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of T2DM for any length of time,
2. last HbA1C (within the last 6 months) of \< / = 8%

Exclusion Criteria:

1. On insulin for any length of time

Primary outcomes:
measure: Change in plasma glucose concentration post oral intake of shake
timeFrame: 30 minutes, 60 minutes and 120 minutes post oral intake of shake
Secondary outcomes:
measure: Sensory analysis of taste, texture, smell and appearance of shakes
timeFrame: within 1hour post oral intake of shake
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00707824: Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus
Official title: Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Keywords: pruritus
epidural morphine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-07-01
Enrollment: 165
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?

Detailed description: 182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to achieve a T4 sensory level bilaterally.

After the umbilical cord was clamped,patients were assigned randomly to three groups.The placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4 mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain control.

Outcome measures :

Incidence and severity of postoperative pruritus Quality of pain control Side effects of epidural morphine and nalbuphine such as respiratory depression,sedation

Eligibility criteria: Inclusion Criteria:

* full term parturient undergoing elective cesarean section
* ASA 1-2

Exclusion Criteria:

* drug or alcohol abuses
* contraindication for regional anesthesia
* received opioids within 12 hours

Primary outcomes:
measure: incidence and severity of pruritus
timeFrame: 24 hr
Secondary outcomes:
measure: visual analogue pain score
timeFrame: 24 hr
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Orawan Pongraweewan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06373224: Cold Saline Irrigation Before Endobronchial Biopsy
Official title: Evaluating the Use of Preventive Cold Saline to Decrease Bleeding Associated With Endobronchial Biopsy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lung Diseases
Keywords: Biopsy
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.


Eligibility criteria: Inclusion Criteria:

* Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital

Exclusion Criteria:

* Under 18 years old
* Does not speak English
* Unable to consent to involvement in the research study
* Is pregnant
* Has a bleeding disorder/diagnosis
* Currently taking anticoagulant medications and not stopped for procedure
* Documented low platelets (\<100,000)
* Had a biopsy taken immediately prior to the endobronchial ultrasound

Primary outcomes:
measure: Incidence of unreadable biopsy slides
timeFrame: from enrollment until discharge from biopsy appointment, up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Austin Pittman, BSN, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04380324: A Study of NKTR-358 (LY3471851) in Healthy Participants
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Dose of NKTR-358 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2020-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of a study drug known as LY3471851 in healthy participants. The study will last about 50 days for each participant.

Detailed description: LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Eligibility criteria: Inclusion Criteria:

* Overtly healthy males and females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Previous or current autoimmune disease/disorder
* Current active bacterial, viral, or fungal infection
* Administration of an inactivated vaccine within two weeks of study drug administration or live attenuated vaccine within 90 days of dosing .

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Day 50
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
timeFrame: Predose on Day 1 through Day 50
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3471851
timeFrame: Predose on Day 1 through Day 50
measure: Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs)
timeFrame: Predose on Day 1 through Day 50
measure: PD: Change from Baseline in Treg Activation Markers
timeFrame: Predose on Day 1 through Day 50
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences
state: Kansas
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: