louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01110096: Family Based Intervention in Childhood obesitY
Official title: Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Child
Parent
Family
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Røros Rehabiliteringssenter
name: Oslo University Hospital
name: Evjeklinikken
name: Gjensidigestiftelsen
name: Stiftelsen Helse og Rehabilitering
name: Organisasjonen Voksne for Barn
First posted: 2010-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the effect on BMI of two different treatment options for obesity in childhood. Families with at least one obese child and parent are invited to join the project. The hypothesis is that family camp gives an additional reduction in BMI compared to a less intensive family lifestyle school.

Detailed description: Participants are randomised to two intervention groups:

A): Two weeks family camp and two years follow-up as a cooperation with primary health care, private rehabilitation center and specialist health care.

B): Four days lifestyle school with two years follow-up as a cooperation with primary health care and specialist health care

Eligibility criteria: Inclusion Criteria:

* age 7 to 12 years
* BMI \> iso-BMI 30 (Coles index)

Exclusion Criteria:

* syndromatic obesity
* obesity related to diseases
* local community not involved
* child has present follow-up because of obesity in secondary health care
* parent has present/planned follow-up because of obesity in secondary health care

Primary outcomes:
measure: BMI-SDS
timeFrame: After 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: After 2 years
measure: Physical fitness
timeFrame: After 2 years
measure: Behaviour
timeFrame: After 2 years
measure: Blood samples
timeFrame: After 2 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Tønsberg
country: Norway
facility: Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Study officials:
affiliation: The Hospital of Vestfold
name: Samira Lekhal, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital of Vestfold
name: Jøran Hjelmesæth, PhD, MD
role: STUDY_CHAIR
References:
citation: Benestad B, Karlsen TI, Smastuen MC, Lekhal S, Hertel JK, Steinsbekk S, Kolotkin RL, Odegard RA, Hjelmesaeth J. Health-related quality of life after camp-based family obesity treatment: an RCT. BMJ Paediatr Open. 2019 Apr 3;3(1):e000413. doi: 10.1136/bmjpo-2018-000413. eCollection 2019.
citation: Benestad B, Lekhal S, Smastuen MC, Hertel JK, Halsteinli V, Odegard RA, Hjelmesaeth J. Camp-based family treatment of childhood obesity: randomised controlled trial. Arch Dis Child. 2017 Apr;102(4):303-310. doi: 10.1136/archdischild-2015-309813. Epub 2016 Nov 2.
Clinical trial NCT04566796: Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
Official title: Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sugammadex
Keywords: Sugammadex
preterm neonates
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 60
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the work is to compare the efficacy of Sugammadex and neostigmine in reversing rocuronium-induced muscle relaxation to reach complete recovery of neuromuscular block (TOF ratio≥ 0.9) in preterm neonates.

The secondary aim is to evaluate the safety of using Sugammadex in preterm neonates and to detect any complications that may occur in this age group.


Eligibility criteria: Inclusion Criteria:

* preterm neonates
* scheduled for elective inguinal hernia repair

Exclusion Criteria:

* drug hypersensitivity
* patient is with any diseases affecting the neuromuscular junction
* Patients with family history of malignant hyperthermia

Primary outcomes:
measure: Assessment of reversal
timeFrame: immediately after the surgery
measure: Evaluation of recovery
timeFrame: immediately after the surgery
Secondary outcomes:
measure: number of patients with Complications
timeFrame: immediately after the surgery
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
affiliation: Alexandria University
name: Ahmed M Elshafie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06307496: VIDeOS for Smoking Cessation
Official title: Video Interventions for Dependence On Smoking (VIDeOS) for Cancer Patients: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Smoking Cessation
Keywords: Videos
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the current study is to pilot the efficacy, feasibility, and acceptability of an evidence-based smoking cessation intervention adapted for cancer patients and delivered via video. Investigators aim to assess if this intervention is considered acceptable by participants, feasible to implement, and effective at increasing knowledge about smoking cessation before conducting a fully powered clinical trial.

Detailed description: A randomized controlled pilot study is being conducted to test the acceptability and feasibility of a smoking cessation intervention tailored for cancer patients that is delivered via video. Participants will be in a video intervention or control group that receives information about quitting smoking. Participants will complete surveys prior to randomization, and will complete additional surveys one week, one month, and three months post-randomization to provide their thoughts about the videos, information about changes to smoking behaviors, and knowledge about quitting smoking.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosed with cancer (any type)
* Receiving care at Medical University of South Carolina
* Reads and understands English language
* Currently smoking cigarettes (any amount)

Exclusion Criteria:

- Unstable or poorly managed medical or psychiatric conditions that impair cognition and ability to provide informed consent (e.g., dementia, active psychosis).

Primary outcomes:
measure: Acceptability
timeFrame: 1 week post-randomization
measure: Feasibility
timeFrame: 1 week post-randomization
measure: Retention Rates
timeFrame: 1 week, 1 month, and 3 months post-randomization
Secondary outcomes:
measure: Changes in knowledge about quitting smoking
timeFrame: Baseline, 1 week, 1 month, and 3 months post-randomization
measure: Changes in smoking behaviors
timeFrame: 1 week, 1 month, and 3 months post-randomization
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT00872196: A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies
Official title: A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-072 After Discontinuation of ABT-072 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-072 Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-03-31
Enrollment: 5
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

Brief summary: This is a follow-up study with no treatment and only samples being collected.

Detailed description: The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-072.

Eligibility criteria: Inclusion Criteria:

- Main Selection Criteria: A subject that has received either ABT-072 or placebo in a prior study involving ABT-072.

Exclusion Criteria:

- The investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in a prior ABT-072 clinical study.

Primary outcomes:
measure: Analysis of the prevalence of resistance of specific mutations over time will be summarized.
timeFrame: Approximately 48 weeks.
measure: Analysis of the degree of phenotypic resistance (fold change in susceptibility of ABT-072 compared to wild-type virus) will also be summarized.
timeFrame: Approximately 48 weeks.
Secondary outcomes:
measure: Summary of serious adverse events related to study procedures only.
timeFrame: Approximately 48 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 18222
state: California
Study officials:
affiliation: AbbVie
name: Daniel Cohen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04020796: Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients
Official title: Acute Effects of Beet Juice Intake on Vascular Function in Treated Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-07-16
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, crossover, placebo-controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the acute effects of only one dose of beet juice on hypertensive subjects treated with vascular endothelial function parameters, using the microvascular reactivity method.

Detailed description: Systemic arterial hypertension is an established risk factor for cardiovascular disease (CVD). Among the main modifiable environmental factors of hypertension, the investigators highlight inadequate eating habits, such as low vegetable consumption. Clinical studies have shown that inorganic nitrate from beet juice intake has a protective effect against CVD due to reduced blood pressure, inhibition of platelet aggregation and prevention of endothelial dysfunction. However, there is still no consensus on its benefits of inorganic nitrate in vascular health. Associated with this, there are no previous studies in the literature that correlate the acute effects of inorganic nitrate intake on endothelial function assessed by microvascular reactivity through laser. The objective of the present study is to evaluate the acute effects (single dose) of inorganic nitrate, through the ingestion of beet juice, in the vascular parameters and endothelial function of treated hypertensive patients of both sexes.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* Age between 40 and 70 years
* Previous diagnosis of primary systemic arterial hypertension
* Signed the Informed Consent Term.

Exclusion Criteria:

* Secondary hypertension
* Systolic blood pressure greater than or equal to 180 mmHg or diastolic BP greater than or equal to 110 mmHg
* In use of beta-blockers
* Diabetes mellitus
* History of cancer
* Use of any dietary supplement
* Any serious life-threatening illness
* Cardiovascular diseases

Primary outcomes:
measure: Microvascular reactivity
timeFrame: 150 minutes
Secondary outcomes:
measure: Central blood pressure
timeFrame: 150 minutes
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Samanta de Souza Mattos
state: RJ
Study officials:
affiliation: State University of Rio de Janeiro
name: Samanta S Mattos
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Rio de Janeiro
name: Mario F Neves, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04235296: Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound
Official title: Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of extensive deep burn residual wounds is a common problem in burn plastic surgery. Due to bacterial invasion, excessive maturation of granulation tissue, poor abrasion resistance of new epithelium, and coexistence of wound healing and dissolution can lead to delayed wound healing. Residual wounds rarely heal spontaneously and are prone to recurrence. Mesenchymal stem cells (MSC) boost tissue repair through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1 have been found in MSC conditioned media (MSC-CM), and play a role in promoting tissue repair and regeneration.Our previous animal experiments have confirmed the role of MSC-CM in regulating wound inflammation, repairing damaged repair cells and promoting wound regeneration. In here, we will evaluate the safety and effectiveness of mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound.


Eligibility criteria: Inclusion Criteria:

Patients with thermal burns are all residual wounds that have not healed after 1 month; The distance between adjacent residual wounds of the same patient is greater than 10cm; Patients signing informed consent -

Exclusion Criteria:

Patients with severe heart, lung, liver, kidney, blood and mental system diseases; Combined with diabetes, hypertension and malnutrition; Patients with shock, severe systemic infections, and pregnant or lactating women. -

Primary outcomes:
measure: wound healing rate
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Datong
country: China
facility: PLA Central Theater Air Force Hospital
state: Shanxi
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiaobing Fu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097196: Effects of Home Based Step Aerobic Exercises
Official title: Effects of Home Based Step Aerobic Exercises on the Functional Capacity and Physical Performance of Sedentary Young Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerobic Exercise
Keywords: home-based exercise
step-aerobic exercise
wearable technology
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effects of commercially produced new generation smart step board and step-aerobic exercises for 6 weeks on the functional capacity and physical performance of young sedentary individuals.

Detailed description: The aim of this study is to determine the effects of commercially produced new generation smart step board and step-aerobic exercises for 6 weeks on the functional capacity and physical performance of young sedentary individuals. The primary outcomes to be evaluated are the functional improvements in individuals' balance, functional capacity, muscle strength, and resting heart rate after 6 weeks of step-aerobic exercises. Secondary results are the evaluation of the effects of individuals on jumping performance and exercise motivation. It is thought that the results obtained in the study will reveal new information for studies investigating home-based exercise and rehabilitation practices and may provide evidence for larger studies involving a diagnosis of a disease in the future.

Eligibility criteria: Inclusion Criteria:

* Not participating in an exercise program that is followed regularly for at least 6 months
* Able to use a wearable device and willing to regularly step aerobic exercise
* In possession of a smart phone, tablet or computer
* BMI 25 to 40 kg/m2

Exclusion Criteria:

* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer, and cardiovascular, orthopedic, neurological psychological other diseases
* Not continuing the exercise program for more than three
* Loss of balance due to loss of consciousness or dizziness in the last 6 months

Primary outcomes:
measure: Functional capacity
timeFrame: 10 weeks
measure: Resting heart rate
timeFrame: 10 weeks
Secondary outcomes:
measure: Flamingo Balance Test
timeFrame: 10 weeks
measure: Quadriceps Strength
timeFrame: 10 weeks
measure: Counter movement jump
timeFrame: 10 weeks
measure: Exercise motivation
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Science University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Yunus Emre Kundakci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06852196: Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia
Official title: Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maxillary Hypoplasia
Cleft Lip Palate
Orthognathic Surgery
Keywords: cleft maxillary hypoplasia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, Midfacial hypoplasia is commonly treated by performing conventional Le Fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. .

Midface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. Intraoral findings are anterior and posterior crossbite, CLP, accentuated curve of Spee, Class III dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. Speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.


Eligibility criteria: Inclusion Criteria:

* Cleft patients either cleft alveolus or cleft alveolus and palate.
* Surgically fit patients.
* Patients ready for orthognathic assessment undergoing either surgical or orthodontics correction.

Exclusion Criteria:

* Non- cleft cases .
* Previous correction.
* History of active infection or underlying disease such as hematologic disorders neoplasm, and immune deficiency.
* Patient refused to sign an informed consent.

Primary outcomes:
measure: CEPHALOMETRIC
timeFrame: 1 year
Secondary outcomes:
measure: facial canons
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00710996: Blue Light Intraocular Lenses (IOLs) and Photostress
Official title: Blue Light Intraocular Lenses (IOLs) and Photostress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: AcrySof IQ IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with existing bilateral Intraocular Lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.

Brief summary: To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.


Eligibility criteria: Inclusion Criteria:

* Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery.

Exclusion Criteria:

* Age related

Primary outcomes:
measure: Photostress Recovery Time in Seconds.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Call Alcon Call Center for Study Locations
state: Texas
Study officials:
References:
citation: Hammond BR, Bernstein B, Dong J. The Effect of the AcrySof natural lens on glare disability and photostress. Am J Ophthalmol. 2009 Aug;148(2):272-276.e2. doi: 10.1016/j.ajo.2009.03.014. Epub 2009 May 7.
Clinical trial NCT01708096: Mechanisms Behind Antidiabetic Effects by Gastric By-pass
Official title: Mechanisms Behind Antidiabetic Effects by Gastric By-pass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Typ 2 and Obesity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2012-10-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.


Eligibility criteria: Inclusion Criteria:

* Diabetes typ 2
* 18-70 years
* BMI \> 35 kg/m2
* Treated with oral antidiabetic agents and/or insulin
* laparoscopic surgery

Exclusion Criteria:

* Pharmacological treatment (other then above) witch could affect glucose metabolism
* open surgery

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 12-18 month after gastric bypass
Secondary outcomes:
measure: Weight reduction
timeFrame: 12-18 month after gastric bypass
Other outcomes:
measure: Insulin signaling and glucose transport in skeletal muscle
timeFrame: 12-18 month after gastric by-pass
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Stockholm County Council
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: