louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03959306: Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus
Official title: Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus
Black Seed Oil
Endothelial Dysfunction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 50
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 is to determine the effect of black seed oil on markers of endothelial dysfunction in patients with type 2 diabetes mellitus .Also, to investigate its effect on glycemic control ,lipid profile and quality of life of those patients .


Eligibility criteria: Inclusion Criteria:

1. Age: adult patients with more than or equal 18 years old.
2. Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).
3. Approval to participate and give informed consent.

Exclusion Criteria:

1. Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.
2. Uncontrolled hypertension or recent stroke.
3. Chronic kidney disease or chronic liver disease.
4. Intake of black seed oil during the previous two months or any other antioxidant.

Primary outcomes:
measure: Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)
timeFrame: three months
Secondary outcomes:
measure: Effect on Glycemic Control (Measurement of fasting blood glucose )
timeFrame: three months
measure: Effect on Glycemic Control (Measurement of glycated hemoglobin)
timeFrame: three months
measure: Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)
timeFrame: three months
measure: Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)
timeFrame: three months
measure: Effect on Quality of Life ( Using Diabetes-39 questionnaire )
timeFrame: three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT03464006: Online Support for Outpatient Peripheral Arterial Disease Self-management
Official title: Online Support for Outpatient Peripheral Arterial Disease Self-management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Reliq Health Technologies Inc.
First posted: 2018-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single centre, randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: This study looks to examine whether an online patient tool to monitor factors affecting patients peripheral artery disease can lead to improvements in patients' disease and slow its progression.

Detailed description: The objective of this project is to implement a program involving a new online patient-centred approach to assist in peripheral arterial disease (PAD) self-management in home and work environments, in collaboration with patient circles of care (patients, care-givers, physicians, and allied healthcare professionals). This program involves online modules tailored to the needs of specific patients and diseases, oriented to education, training, monitoring, and continuing support for lifestyle changes (smoking cessation, exercise, healthy diets, weight loss, etc.) and psycho-social needs such as social isolation and loneliness. The investigators have tested an online desk-top version for over 30 out-patients with PAD at St. Michael's Hospital in Toronto. The investigators propose to test its ability for improved outcomes and healthcare quality of life through a multi-centre randomized controlled trial for PAD and a frequently co-occurring chronic illness, high blood pressure.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* diagnosed with peripheral artery disease (ABI\<0.9)

Exclusion Criteria:

* unable to communicate in English
* unwilling to participate
* patients with dementia or other cognitive impairment

Primary outcomes:
measure: Ankle Brachial Index
timeFrame: 1 year
Secondary outcomes:
measure: Blood Pressure
timeFrame: 1 year
measure: Health Related Quality of Life
timeFrame: 1 year
measure: Diabetes Status
timeFrame: 1 year
measure: Vascular Health
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: McMast
name: Michael C Stacey, DS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097106: Synbiotic Dietary Supplement and Gut Microbiota
Official title: Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty two healthy volunteers, aged 18-45 years old, will be recruited for this pilot study, plan to enroll 16 subjects with a BMI 19-25 kg/m2 and 16 subjects with a BMI 30-35 kg/m2.

Brief summary: To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.

Detailed description: This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.

Eligibility criteria: Inclusion Criteria:

* BMI 19-25 (lean) and BMI 30-35 (obese)
* Age 18-45 years old
* subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
* willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)

Exclusion Criteria:

* antibiotic consumption within 28 days of study initiation
* diabetes
* kidney disorders
* history of cardiac disease and medications for cardiac disease
* use of statins and antihypertensive drugs
* inflammatory bowel disease
* irritable bowel syndrome
* history of small intestinal bacterial overgrowth
* history of intestinal surgery, excluding hernia repair and appendectomy
* active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
* immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
* abnormal liver or kidney function as measured by routine serum chemistry testing
* severe anemia or significant white blood cell or platelet abnormalities
* no additional blood or blood product donations during study

Primary outcomes:
measure: Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale
timeFrame: Baseline, Day 28, day 49, day 77
measure: Change in microbiome stool diversity
timeFrame: Baseline, Day 28, day 49, day 77
measure: Change in metabolome stool profile
timeFrame: Baseline, Day 28, day 49, day 77
measure: Change in metabolome urine profile
timeFrame: Baseline, Day 28, day 49, day 77
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Kassandra Spates-Harden
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Gail Cresci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06906406: Health-Related Quality of Life in Children and Adolescents With Clubfoot
Official title: Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clubfoot
Children
HRQOL (Health Related Quality Of Life)
Keywords: HRQoL
PedsQL
Children
Clubfoot
Ponseti
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study investigates the impact of congenital clubfoot and its treatment on the health-related quality of life (HRQoL) in children using a prospective cohort design. The participants will be evaluated using the Pediatric Quality of Life Inventory (PedsQL 4.0) to assess HRQoL and the PBS Clubfoot Score (PBS) for clinical outcomes. Assessments will occur at baseline, 2 years, and 5 years post-treatment initiation. Data collection will include clinical evaluations, standardized HRQoL questionnaires, and Visual Analogue Scale (VAS) assessments for pain and satisfaction. The findings will help optimize treatment protocols for clubfoot by providing comprehensive insights into how different treatment methods impact children's quality of life.

Brief summary: This prospective cohort study aims to evaluate the health-related quality of life (HRQoL) in children aged 2 to 15 years with congenital clubfoot, treated primarily according to the Ponseti method. The study will assess HRQoL using the Pediatric Quality of Life Inventory (PedsQL 4.0) and clinical outcomes using the PBS Clubfoot Score (PBS). Participants will be followed for 2 and 5 years to evaluate changes in HRQoL and clinical function. The primary objective is to understand the long-term impact of clubfoot and its treatment on patients' physical, emotional, and social well-being.


Eligibility criteria: Inclusion Criteria:

* Children aged 2 to 15 years diagnosed with congenital clubfoot.
* Undergoing treatment or follow-up at Drammen Hospital.
* Both unilateral and bilateral cases included.
* Written informed consent from parents or legal guardians.

Exclusion Criteria:

* Concurrent severe medical or psychological conditions affecting outcomes.
* Lack of written informed consent.
* Incomplete or missing data for PedsQL or PBS assessments.

Primary outcomes:
measure: HRQoL Score
timeFrame: Baseline, then at every follow-up over the study period of a total of 5 years.
Secondary outcomes:
measure: PBS Clubfoot Score
timeFrame: Baseline, then at every follow-up over the study period of a total of 5 years.
measure: Pain Assessment
timeFrame: Baseline, then at every follow-up over the study period of a total of 5 years.
measure: Satisfaction Assessment
timeFrame: Baseline, then at every follow-up over the study period of a total of 5 years.
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestreviken
state: Buskerud
Study officials:
References:
Clinical trial NCT04584606: Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients
Official title: Ain Shams University Experience: Clinical Characteristics and Outcome Determinants of Hospitalized Covid-19 Patients at Ain Shams University Obour Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Disease (COVID-19)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).

Brief summary: COVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome

Detailed description: Investigators will convey the Ain Shams University experience as the first university in Egypt to designate one of its hospitals (Ain Shams University Obour Hospital) for management of confirmed COVID19 cases. investigators will try to identify the characteristics of the disease as regards the clinical, laboratory and imaging abnormalities and to assess the outcome determinants. It is a retrospective observational cohort study at Ain Shams University Obour Hospital. All adult patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2)will be included.

Clinical criteria, laboratory data, radiological findings, hospital course and patient outcome will be anonymously collected from records.

Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).
* Standard of care arm of the ongoing clinical trials will be included in our study.

Exclusion Criteria:

* mild cases who don't need hospitalization

Primary outcomes:
measure: Recovery
timeFrame: Until patient is discharged or up to 12 weeks whichever comes first
measure: Mortality
timeFrame: Until patient is discharged or up to 12 weeks whichever comes first
Secondary outcomes:
measure: Conversion of nucleic acid testing for SARS-CoV-2 from positive to negative.
timeFrame: Until patient is discharged or up to 12 weeks whichever comes first
measure: Radiological progression of the COVID 19 disease
timeFrame: Until patient is discharged or up to 12 weeks whichever comes first
measure: Functional progression of the COVID 19 disease
timeFrame: Until patient is discharged or up to 12 weeks whichever comes first
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
affiliation: Ain Shams University, Faculty of Medicine
name: Ashraf Elmaraghy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00627406: Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
Official title: A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: OHSS (Ovarian Hyperstimulation)
Keywords: GnRH antagonist
GnRH agonist
hCG
OHSS
In vitro fertilization
ovulation induction
Clinical pregnancy rate
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 384
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles


Eligibility criteria: Inclusion Criteria:

* Patient complying with the conditions for IVF or ICSI treatment
* Female age over 20 years and under 40 years
* Normal regular cycle and patients with oligomenorrhea
* BMI \> 18 and \< 35
* each patient contributes with one cycle only

Exclusion Criteria:

* Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
* Patients with \> 25 follicles on the day of triggering ovulation

Primary outcomes:
measure: Frequency of Moderate to Severe OHSS.
timeFrame: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test
Secondary outcomes:
measure: Pregnancy Rate
timeFrame: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic, Regional Hospital of Skive
Study officials:
name: Peter S Humaidan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Humaidan P, Polyzos NP, Alsbjerg B, Erb K, Mikkelsen AL, Elbaek HO, Papanikolaou EG, Andersen CY. GnRHa trigger and individualized luteal phase hCG support according to ovarian response to stimulation: two prospective randomized controlled multi-centre studies in IVF patients. Hum Reprod. 2013 Sep;28(9):2511-21. doi: 10.1093/humrep/det249. Epub 2013 Jun 9.
Clinical trial NCT06805006: i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Official title: i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pelvic Organ Prolapse
Genital Prolapse
Keywords: bilateral sacrospinous ligament fixation
suture attachment medical device
Lead sponsor: A.M.I. Agency for Medical Innovations GmbH
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic pelvic organ prolapse indicated for a surgical intervention.

Brief summary: The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.

Detailed description: The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies.

The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.

Eligibility criteria: Inclusion Criteria:

* Surgery for POP
* SSLF with usage of i-Stitch device (\& i-Stitch Loading Units)
* Concomitant procedures are allowed
* Women minimum 18 years old
* Written informed consent for surgery

Exclusion Criteria:

* infection (active or latent)
* allergies to the materials used
* benign or malignant changes
* anticoagulation disorders
* autoimmune connective tissue disorders
* any uterus pathologies

Primary outcomes:
measure: Subjective outcome
timeFrame: 12 months
measure: Subjective outcome
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life (ICIQ-UI SF)
timeFrame: 12 months
measure: Postoperative complications
timeFrame: 12 months
measure: Anatomical outcome (POP-Q)
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Isar Kliniken GmbH
state: Bavaria
Study officials:
affiliation: ISAR Klinikum Munich
name: Ursula Peschers, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04037306: Measurements From Stool to Support Dietary Change
Official title: Measurements From Stool to Support Dietary Change
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diet Habit
Feeding Behavior
Behavior, Health
Keywords: Fiber
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate if daily feedback on food-derived metabolites in stool enhances an individual's ability to make and/or sustain a dietary change.

Detailed description: This is a research study to find out how people respond to information about food-derived compounds measured in their stool.

This study will take place over a three-week period. For these three weeks, participants in a medical weight loss program will be asked to collect samples of their stool daily from Monday to Friday, with optional sampling on weekends. We will measure the amount of butyrate, a breakdown product of fiber, in each sample provided and return this measurement by text message. Participants will be randomized into two groups: one group will have new measurements returned the day after providing each stool sample, and another will have their measurements returned all at once, at the end of the study. Both groups will also receive a daily text message report of their fiber intake, based on the foods they ordered at the weight loss facility cafeteria.

The greatest risks of the study include the possibility of infection while sampling stool, possible gastrointestinal discomfort from changes to the diet, and potential loss of confidentiality.

Eligibility criteria: Inclusion Criteria:

* between the ages of 18 and 80
* must be a client of the DFC (Duke Diet and Fitness Center) weight loss program for at least four continuous weeks.
* must have a smartphone

Exclusion Criteria:

* have diagnosis of Crohn's disease
* have known stricture (narrowing) of the intestine
* have any past history of intestinal obstruction

Primary outcomes:
measure: Change in nutrient intake, as estimated from menu selections
timeFrame: Baseline, Week 2, and Week 3
Secondary outcomes:
measure: Change in butyrate concentration
timeFrame: Baseline, Week 2, and Week 3
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Diet and Fitness Center
state: North Carolina
Study officials:
References: