louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06727591: Evaluation of Horizontal Anterior Mandibular Augmentation With Split Bone Block Technique From the Chin
Official title: Evaluation of Horizontal Anterior Mandibular Augmentation With Split Bone Block Technique From the Chin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Grafting
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare clinically and radiographically bone gain, healing of the surgical site, healing of the grafted bone and stability of the grafted area following horizontal ridge augmentation at anterior mandible using split bone block from the chin area.


Eligibility criteria: Inclusion Criteria:

* Patient with missing anterior mandibular teeth
* horizontal bone width \< 5 mm
* Adequate zone of keratinized tissue

Exclusion Criteria:

* Presence of infection or periapical lesions in adjacent teeth
* Medically compromised patients with a condition that affect the procedure
* Insufficient inter-arch distance
* Bruxism or clenching
* Alcoholism
* Smokers

Primary outcomes:
measure: Postoperative Pain
timeFrame: up to 2 weeks
measure: Implant stability
timeFrame: up to 3 months
measure: Amount of horizontal bone gain
timeFrame: up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT01726491: Epigenetics and the Origin of Muscle Insulin Resistance in Humans
Official title: Epigenetics and the Origin of Muscle Insulin Resistance in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2 in Obese
Obesity
Keywords: Insulin resistance
Exercise
Type 2 diabetes mellitus
Obesity
Epigenetic studies
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups of volunteers will be studied: 1) lean, healthy volunteers, 2)obese volunteers without type 2 diabetes, and 3) volunteers with type 2 diabetes.

Brief summary: The investigators are trying to understand the role of DNA (deoxyribonucleic acid) methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a normal chemical process in the body that modifies DNA. By studying this, the investigators hope to better understand the causes of insulin resistance.

Detailed description: Insulin resistance is defined as the decreased ability of insulin to perform its biological function in the muscle, liver and fat. Genetic and environmental factors are known to influence insulin sensitivity. It is not known how this is mediated. This study looks at the role of epigenetics (modifications of proteins associated with DNA and methylation of DNA) in alterations in insulin resistance. We will study lean healthy people, obese non-diabetic people and people with type 2 diabetes to characterize the DNA methylation patterns in muscle in each group. The second aim of the study is to see how a single bout of exercise affects the DNA methylation in the muscle. The third aim looks at the effect of 8 weeks of supervised exercise on the DNA methylation.

Eligibility criteria: Volunteers must be:

* 21 - 55 years old
* must be non-lactating, non-pregnant
* not taking medications known to affect glucose or if taking them, on stable doses.
* free of significant heart or lung disease

Primary outcomes:
measure: DNA methylation of genes in insulin resistance
timeFrame: Baseline to visit 33 (approx 2 months)
Secondary outcomes:
measure: mRNA expression of genes
timeFrame: Baseline to visit 33 approx 2 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Lori Roust, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Dawn K Coletta, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01635491: Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
Official title: Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Motility
Total Gastrointestinal Transit Time
Segmental Transit Time
Gastric Emptying
Keywords: Gastrointestinal Motility
Transit time
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Motilis,Switzerland
First posted: 2012-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The purpose of this study is to describe gastrointestinal motility and transit times in healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal transit time (GITT) to GITT obtained using radioopaque markers.

The investigators end points are to measure the transit times through different segments of the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.

The study is descriptive and is designed to test and evaluate the usefulness of the Motilis 3D-Transit system. The investigators hypothesize, that with the system transit times through different segments of the gastrointestinal canal can be measured.

The design is made for evaluating the transit times, the inter-subject reproducibility and comparison with gold standard for colonic transit time measurement.

The investigators have chosen to include 20 healthy volunteers.The study is descriptive and therefore power calculation is not needed.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer
* Signed informed consent obtained
* Fasted since midnight

Exclusion Criteria:

* Subject has known GI related symptoms complaints or GI diseases, including swallowing disorders
* Subject has cancer or other life threatening diseases or conditions
* Subject is pregnant
* Subject has undergone abdominal surgery
* Subject has abdominal diameter \>140cm?
* Drug abuse or alcoholism
* Subject's bowel movements are irregular
* Subject has known cardiovascular or pulmonary diseases
* Participation in any clinical study within the last 30 days
* Subject has cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
* Subject takes any medication affecting GI motility
* Subject having MRI within the next four weeks

Primary outcomes:
measure: Total gastrointestinal transit time in healthy subjects.
timeFrame: Three days from baseline visit
Secondary outcomes:
measure: Segmental transit times in healthy subjects
timeFrame: Three days from Baseline visit
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Hepato and Gastroenterolegy
Study officials:
affiliation: Aarhus University Hospital
name: AnneMette Haase, Ph.D Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02167191: HIT in the Healthy Elderly Population
Official title: Determining the Effectiveness of a High Intensity Interval Training Exercise Programme in the Healthy, Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interval Training
Pre Operative Exercise
Prehabilitation
Elderly
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It is widely known that exercise improves general fitness and that fitter patients recover more easily from illness and surgery. Conversely, unfit patients have a significantly higher morbidity and mortality after surgery and a longer inpatient stay. This will become increasingly important in an aging population as baseline fitness generally declines with age.

One method of improving cardiovascular fitness is by using low intensity endurance training programmes, a disadvantage of these it that they can take several months to show improvement. High intensity interval training (HIT) programmes that use short episodes of high intensity exercise have also been shown to improve fitness. These HIT programmes have also shown improvement in functional capacity and quality of life in patients with chronic disease. An advantage of HIT is that improvements in fitness may occur in a shorter time than traditional endurance training. It is also known that HIT can give superior gains over endurance training.

The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by a 2ml/kg/min increase in VO2peak, can be achieved within 31 days via a HIT programme, in a group of healthy elderly volunteers.

As a secondary aim we will assess whether this programme would be acceptable to the group studied, through determination of subject compliance and adherence to the training programme.


Eligibility criteria: Inclusion Criteria:

* Good health
* Male and female
* 60 -75 years old

Exclusion Criteria:

* Uncontrolled hypertension (BP \> 140/100)
* Angina
* Heart failure (NYHA class III/IV)
* Cardiac arrthymias
* Right to left cardiac shunt
* Recent cardiac event
* Previous stroke/TIA
* Aneurysm (large vessel or intracranial)
* Severe respiratory disease including pulmonary hypertension
* COPD/asthma with an FEV1 less than 1.5 l
* Inclusion into any other research study in the last three months which involved: taking a drug; being paid a disturbance allowance; having an invasive procedure or exposure to ionising radiation

Primary outcomes:
measure: VO2 peak
timeFrame: 31 days
Secondary outcomes:
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University of Nottingham
state: Derbyshire
Study officials:
References:
Clinical trial NCT05551091: Glycomacropeptide and Women's Health
Official title: Glycomacropeptide as a Protein Supplement to Curb Hunger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
glucose tolerance
satiety
hunger
microbiome
amino acids
C-reactive protein
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 13
Sex: FEMALE
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants underwent measures of study outcomes at 4 time points: day 1 and day 7 of consuming GMP supplements twice daily (low-dose, 25 g before breakfast and dinner) and day 1 and day 7 of consuming GMP supplements thrice daily (high-dose, 25 g before breakfast, lunch and dinner). For each of the two baseline visits (day 1), participants consumed 300 kcal liquid breakfast meal tolerance test containing soy protein isolate, and then began the low-dose GMP or high-dose GMP for 7 days. On day 7 of each GMP diet, participants returned for a second GMP-based 300 kcal liquid breakfast meal tolerance test. Between the 2 weeks of GMP consumption, participants had a minimum washout period of 5 days.
Primary purpose: TREATMENT

Brief summary: This is a study about how a dietary supplement containing a whey protein affects hormones controlling hunger and satiety (leptin and ghrelin) in postmenopausal women with a body mass index between 28 and 35 kg/m2. Participants can expect to be in study for 4 weeks.

Detailed description: The purpose of this research study is to understand how a dietary supplement containing glycomacropeptide (GMP) affects blood sugar levels and hormones that regulate hunger and satiety. This study is being conducted to find new ways to help women lose weight and reduce their chance of getting diabetes.

Eligibility criteria: Inclusion Criteria:

* no more than 10 years past menopause as defined by the date of last menses, less than 90 years old, BMI of 28 to 35 kg/m2.

Exclusion Criteria:

* BMI\>35 kg/m2, diabetes, and/or an active medical problem or condition that would interfere with study outcomes (malignancy, inflammatory condition, gastric bypass surgery or participation in another study)

Primary outcomes:
measure: Glucose homeostasis
timeFrame: glucose levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial
Secondary outcomes:
measure: Ghrelin, a hormone regulating hunger and satiety
timeFrame: ghrelin levels 0, 15, 30, 45, 60, 90, 120 and 150 minutes postprandial
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Karen E Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02003391: Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure
Official title: Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Open Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 157
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 demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
* Currently on beta-blocker monotherapy (for \>30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
* Have a mean baseline lOP of \>18 mmHg and \<32 mmHg in at least one eye.
* Must be able to understand and sign an Informed Consent form.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Use of medication excluded by the protocol.
* Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
* Ocular surgeries or procedures excluded by the protocol.
* Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
* Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
* Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye
timeFrame: Week 4
Secondary outcomes:
measure: Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
timeFrame: Baseline (Day 0), Week 4
measure: Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
timeFrame: Baseline (Day 0), Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Project Lead GCRA, Pharma
role: STUDY_DIRECTOR
References:
citation: Lerner SF, Park KH, Hubatsch DA, Erichev V, Paczka JA, Roberts TV. Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy. J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23.
Clinical trial NCT06884891: A Phase Ⅲ Comparative Study of QL2108 to Dupixent®
Official title: A Multicenter Randomized, Double-blinded, Parallel, Positive-controlled, Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of QL2108 to Dupixent® in Adult Subjects With Moderate-to-Severe Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase Ⅲ comparative study to evaluate the efficacy and safety of QL2108 to Dupixent® in adult subjects with moderate-to-severe atopic dermatitis. A total of 520 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2108 injection or Dupixent®


Eligibility criteria: Inclusion Criteria:

* Subjects aged from 18 to 75 years (including the boundary value)
* At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history of ≥1 year prior to screening.
* During the screening period and prior to randomization: EASI score ≥16, IGA score ≥3, BSA ≥10%.

Exclusion Criteria:

* People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
* Having participated in drug or device clinical trials within 12 weeks or 5 half-lives of other investigational drugs before the study administration.
* Subjects who have received live vaccines or live-attenuated vaccines within 12 weeks prior to randomization or plan to receive such vaccines during the trial period.

Primary outcomes:
measure: Proportion of patients achieving EASI-75 at week 16.
timeFrame: 16 weeks
Secondary outcomes:
measure: Proportion of patients achieving EASI-75 at week 52
timeFrame: 52 weeks
measure: Proportion of patients achieving IGA-TS (IGA score was 0 or 1 and decreased by ≥2 points from baseline) at week 16 and week 52
timeFrame: 16 weeks and 52 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00564291: Evaluation of Retinal Structure With High Resolution Optical Coherence Tomography (OCT)
Official title: Evaluation of Retinal Structure With High Resolution OCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
CNV
Keywords: OCT
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2007-11-27
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy subjects and patients with macular diseases

Brief summary: Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Detailed description: Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Eligibility criteria: Inclusion Criteria:

* Macular disease
* Healthy subjects

Primary outcomes:
measure: Integrity of retinal layers
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. Ophthalmology, University Hospital Bern
city: Bern
country: Switzerland
facility: Klinik und Poliklinik für Augenheilkunde, University Bern
Study officials:
affiliation: University of Bern
name: Sebastian Wolf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Sebastian Wolf, MD PhD
role: STUDY_DIRECTOR
References:
citation: Lincke JB, Keller S, Amaral J, Zinkernagel MS, Schuerch K. Ciliary body length revisited by anterior segment optical coherence tomography: implications for safe access to the pars plana for intravitreal injections. Graefes Arch Clin Exp Ophthalmol. 2021 Jun;259(6):1435-1441. doi: 10.1007/s00417-020-04967-3. Epub 2020 Oct 19.
citation: Wolf-Schnurrbusch UE, Ghanem R, Rothenbuehler SP, Enzmann V, Framme C, Wolf S. Predictors of short-term visual outcome after anti-VEGF therapy of macular edema due to central retinal vein occlusion. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3334-7. doi: 10.1167/iovs.10-6097.
citation: Rothenbuehler SP, Waeber D, Brinkmann CK, Wolf S, Wolf-Schnurrbusch UE. Effects of ranibizumab in patients with subfoveal choroidal neovascularization attributable to age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):831-7. doi: 10.1016/j.ajo.2008.12.005. Epub 2009 Feb 13.
Clinical trial NCT00634491: Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy
Official title: Effect of Acetazolamide in Prevention of Contrast Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contrast Induced Nephropathy
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Fars Heart Foundation
First posted: 2008-03-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy

Detailed description: Contrast induced nephropathy is one of common causes of acute renal failure many preventive protocol existed . 240 patient that underwent coronary angiography randomly divided in three groups.Group 1,2,3 will receive Bicarbonate ,Acetazolamide+Normal salin and Normal salin respectively.We compare prevalence of contrast nephropathy in each group.

Eligibility criteria: Inclusion Criteria:

* patient that underwent coronary angiography

Exclusion Criteria:

* serum Cr. more than 3 mg/dl
* electrolyte and acid-base imbalance
* pulmonary edema
* allergy to Acetazolamide

Primary outcomes:
measure: Increased base line creatinine at least 25%
timeFrame: 24 hr later
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Fars Heart Foundation , Kowsar hospital
Study officials:
affiliation: Shiraz nephro-urology research center
name: Maryam Pakfetrat, MD
role: STUDY_CHAIR
References:
citation: Assadi F. Acetazolamide for prevention of contrast-induced nephropathy: a new use for an old drug. Pediatr Cardiol. 2006 Mar-Apr;27(2):238-42. doi: 10.1007/s00246-005-1132-z.