louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01542268: Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)
Official title: Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: pentoxifylline
tight junction signalling
intestinal epithelial barrier
irritable bowel syndrome
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.

Detailed description: Disruption of the intestinal epithelial barrier is part of the pathophysiology of IBS favoring immune activation present in the mucosa of these patients and the development of symptoms in IBS. To evaluate the effect of treatment with pentoxifylline (PTX) in patients with IBS related to clinical response and modulation of the components of the epithelial barrier at the level of intestinal mucosa.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years old
* Most of the patient with IBS will be chose between the patients who go to Digestive System ambulatory external medical office from our Center.
* Be studied and with clinical monitoring al least 6 months before be included.
* Fulfill with Roma III Criteria for IBS (Gastroenterology 2006;130:1377-90) with moderate-severe seriousness according to Modification Francis Scale

Exclusion Criteria:

* 2 weeks before colon biopsia, any patient cann´t take salicylates, NSAID, antibiotics,anticholinergics,opiates or any other medication / product for asintomatic treatment of diarrea.
* 3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive
* 6 months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy.
* Pentoxifilina Alergic Reactions
* Pregnants
* Grave kidney failure
* Grave Hepatic failure
* Menthal or legal disability to sign the consent

Primary outcomes:
measure: Severity of abdominal pain
timeFrame: 3 months from the first day of treatment
Secondary outcomes:
measure: Mucosal byopsies
timeFrame: 3 months from the first day of treatment
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Complejo Hospitalario Universitario de Canarias
state: S/c Tenerife
Study officials:
affiliation: COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS
name: LAURA RAMOS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02928068: Telehealth Coaching for Families of Children With Autism
Official title: Telehealth Coaching for Families of Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: telehealth
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the efficacy of a 12 week telehealth intervention for families of children with autism spectrum disorders under the age of 6 years on child participation and parent efficacy.

Detailed description: Autism spectrum disorders (ASD) are increasingly being diagnosed in children, creating a pressing need for effective and cost-efficient models of early intervention (EI) services. Many EI systems are struggling to meet the needs of the increasing number of families of children with ASD. In rural areas, there is a shortage of EI therapists, and the distances to reach families results in an inefficient use of professional time and research shows that rural families of children with ASD receive fewer EI services, which has detrimental effects on children's developmental trajectories. If occupational therapy interventions for young children with ASD utilize innovative methods of service delivery in rural areas, investigators can increase the number of families that receive services thereby positively influencing child and family outcomes. Therefore, investigators propose to test the acceptability, cost-effectiveness, and efficacy of a 12 week telehealth intervention for families of young children with ASD.

Eligibility criteria: Inclusion Criteria:

* Family with a child up to 72 months old with a diagnosis of ASD and primarily spoke English in the home.

Exclusion Criteria:

* Child has significant visual or hearing impairments or has a known genetic condition associated with autism (e.g., Fragile X Syndrome).

Primary outcomes:
measure: Parent Sense of Competence Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Occupational Therapy Education
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Lauren Little, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Little LM, Pope E, Wallisch A, Dunn W. Occupation-Based Coaching by Means of Telehealth for Families of Young Children With Autism Spectrum Disorder. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205020p1-7202205020p7. doi: 10.5014/ajot.2018.024786.
Clinical trial NCT02921568: Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
Official title: Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Disease
Glaucoma
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
Collaborators: name: Optos, Inc.
First posted: 2016-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
2. Subjects who have signed the informed consent;
3. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
4. Subjects who agree to participate in the study;
5. Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
6. Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
3. Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
4. Subjects with history of leukemia, dementia or multiple sclerosis.

Primary outcomes:
measure: retinal thickness
timeFrame: completion of the study, up to 5 years
measure: Retinal Nerve Fibre Layer Thickness
timeFrame: completion of the study, up to 5 years
measure: Optic Nerve Head Topography
timeFrame: completion of the study, up to 5 years
measure: Cup/Disc Ratio
timeFrame: completion of the study, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
References:
Clinical trial NCT06717568: 3D Depth Camera-Based Assessment of Adolescent Idiopathic ScoliosisUsing a Depth Camera
Official title: Assessment of Adolescent Idiopathic Scoliosis Based on 3D Imaging Technology Using a Depth Camera
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study focuses on adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis, defined by a Cobb angle of ≥10°.

Brief summary: Adolescent Idiopathic Scoliosis (AIS) is a common spinal deformity affecting adolescent health, and early diagnosis and accurate assessment are crucial for preventing disease progression. Traditional assessment indicators, such as the trunk rotation angle (ATR) and Cobb angle, rely on clinical examinations and X-ray imaging, which have certain limitations, including radiation exposure and insufficient sensitivity. The Back Height Difference (BHD), as a quantitative measure of the back surface morphology, may reflect the degree of trunk deformity caused by scoliosis.

The use of the Kinect v2 depth camera to capture three-dimensional point cloud data of the back provides a high-precision, radiation-free assessment method.


Eligibility criteria: Inclusion Criteria:

(1) Adolescents aged 10-18 years, diagnosed with adolescent idiopathic scoliosis (AIS) with a Cobb angle ≥10°; (2) No history of spinal surgery or other corrective treatments; (3) Able to undergo short-term inpatient treatment (5 days) and comply with study procedures.

Exclusion Criteria:

(1) Patients with congenital, neuromuscular, or other secondary scoliosis; (2) Presence of major comorbidities affecting spinal structure or muscle tone (e.g., spinal cord injury, muscular dystrophy); (3) Patients unable to complete standardized assessment procedures.

Primary outcomes:
measure: Back height difference
timeFrame: Day 1 of Admission
Secondary outcomes:
measure: Angle of trunk rotation
timeFrame: Day 1 of Admission
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01725568: BioMonitor Master Study
Official title: Master Study of the Implantable Cardiac Monitor "BioMonitor"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ATRIAL FIBRILLATION, Syncope
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with standard ICM indication who are referred to the hospital

Brief summary: The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.


Eligibility criteria: Inclusion Criteria:

* Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin.

Exclusion Criteria:

* Implanted ICD or cardiac pacemaker
* Allergy to patch electrodes

Primary outcomes:
measure: SADE free-rate
timeFrame: at 3 month follow-up
measure: Rate of appropriate QRS detection
timeFrame: at 6 week follow-up
Secondary outcomes:
Other outcomes:
measure: Sensitivity and Positive Predictive of episode detection
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Locations:
city: Rostock
country: Germany
facility: University of Rostock
Study officials:
affiliation: University of Rostock, Germany
name: Dietmar Baensch, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02515968: Comparison of Desflurane and Propofol on Quality of Recovery in Patients Undergoing Robotic or Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 20
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 investigate whether propofol can improve quality of recovery compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* adult patients aged over 20 yrs who are scheduled for laparoscopic or robotic gastrectomy, ASA 1 or 2.

Exclusion Criteria:

* patients with allergy to anesthetic agents
* body mass index more than 35 kg/m2
* pregnancy

Primary outcomes:
measure: Quality of recovery
timeFrame: Within 24 hours after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04261868: Virtual Reality Game Playing in Amblyopia Therapy
Official title: Virtual Reality Game Playing in Amblyopia Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amblyopia
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: "Amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers", therefore, amblyopia is not a "lazy eye" but it is a "lazy brain".

Purpose: The investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children.

Methods: This RCT was performed on 50 children with unilateral amblyopia ,4 to 10 years old. They were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. Controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 LogMAR), moderate (0.3 to 0.6 LogMAR) and severe (BCVA \< 0.6 LogMAR) amblyopia, respectively.


Eligibility criteria: Inclusion Criteria:

- The best corrected visual acuity worse than 0.3 LogMAR

Exclusion Criteria:

* Patients with abnormal fixation
* Patients with neurological problems
* Patients with any types of ocular pathologies

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: baseline and 6 months after training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05113472: Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers
Official title: Adverse Reactions Following COVID-19 Vaccination: an Ecuadorian Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Event
Keywords: adverse reactions
COVID-19
healthcare workers
Latin America
vaccination
Lead sponsor: Respiralab
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 1291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population included Ecuadorian healthcare workers who received the inoculation with the Pfizer-BioNTech COVID-19 vaccine.

Brief summary: Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

Detailed description: The COVID-19 pandemic bears a burden on medical care and economies worldwide, however immunization at the population level provides a way for to reduce future morbidity and mortality. Vaccine hesitancy and reluctance in getting the COVID-19 vaccine and apprehensions about them have been present along the course of vaccination programs and mass immunizations across the world. Factors such as the quick, large-scale production of vaccines, lack of information, and uncertainty about adverse reactions in the public's eye as well about myths spreading through media channels have given rise to suspicion and fear in the Latin American population. Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

Eligibility criteria: Inclusion Criteria:

* Ecuadorian nationality
* Active practice in the medical field
* Received the Pfizer-BioNTech COVID-19 vaccine

Exclusion Criteria:

* Patients who voluntarily refused to participate.

Primary outcomes:
measure: Adverse reactions
timeFrame: 14 days since administration of either dose
Secondary outcomes:
Other outcomes:
Locations:
city: Samborondon
country: Ecuador
facility: Universidad Espiritu Santo
Study officials:
References:
Clinical trial NCT01478672: Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Official title: Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Heart Disease
Quality of Life
Keywords: Promotion health
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
Collaborators: name: County Council of Norrbotten, Sweden
First posted: 2011-11-23
Enrollment: 741
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of arterial hypertension ischemic heart disease,
* atrial fibrillation or other arrhythmia,
* congestive heart failure (study heart disease)
* HbA1C \> 53mmol/mol (study diabetes)
* Age \> 18 years
* Capability of filling in questionnaires in the own language
* Capability to use the devices provided
* Being cognitively able to participate

Primary outcomes:
measure: SF-36
timeFrame: 12 months follow-up
Secondary outcomes:
measure: HbA1c (for patients with type-2D) Blood pressure for patient with heart disease
timeFrame: 12 months follow-up
measure: Bloodpressure
timeFrame: 12 months follow-up
measure: Blood lipids
timeFrame: 12 months follow-up
measure: Bodyweight
timeFrame: 12 months follow-up
measure: Smoking habits
timeFrame: 12 months follow-up
measure: Alcohol consumption
timeFrame: 12 months follow-up
measure: SOC-13
timeFrame: 12 months follow-up
measure: EQ-5D
timeFrame: 12 monts follow-up
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Luleå University of Technology
Study officials:
References:
citation: Lindberg I, Torbjornsen A, Soderberg S, Ribu L. Telemonitoring and Health Counseling for Self-Management Support of Patients With Type 2 Diabetes: A Randomized Controlled Trial. JMIR Diabetes. 2017 Jun 26;2(1):e10. doi: 10.2196/diabetes.6884.
Clinical trial NCT00870272: Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)
Official title: A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Keywords: Medical Abortion
Mifepristone
Misoprostol
Sublingual administration
Buccal administration
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of \<63 days will be offered the option of participating in the study.


Eligibility criteria: Inclusion Criteria:

* Gestational age less than or equal to 63 days
* General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
* Willing to provide an address and/or telephone number for purposes of follow-up.

Exclusion Criteria:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
* IUD in place
* Chronic renal failure
* Concurrent long-term corticosteroid therapy
* History of allergy to mifepristone, misoprostol or other prostaglandin
* Hemorrhagic disorders or concurrent anticoagulant

Primary outcomes:
measure: Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration
timeFrame: July 2007-March 2009
Secondary outcomes:
measure: Side effects experienced
timeFrame: July 2007- March 2009
Other outcomes:
Locations:
city: Chisinau
country: Moldova, Republic of
facility: State University of Medicine and Pharmacy
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Sheila Raghavan, MSc
role: STUDY_DIRECTOR
References: