louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04254614: Mobile Application for IBD Patients With Biologics
Official title: A Mobile Application Guiding Patients With Inflammatory Bowel Disease During Biologic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Biologic treatment
Mobile application
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a cohort study with assessments at baseline and after implementation of the mobile application. The study period will cover 6-12 months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Monitoring of biologic treatment in patients with inflammatory bowel disease (IBD) is important given the increased risk of infections. In this study we aim to evaluate the use of a mobile application to guide IBD patients and facilitate the monitoring of biologic treatment.

Detailed description: Biologic treatment can induce and maintain remission in patients with inflammatory bowel disease (IBD). However, biologics are associated with increased risk of infections. Therefore, it is important to regularly monitor patients during the course of therapy. This process can be time consuming for patients as well as clinicians. Mobile applications, have the potential to guide patients and facilitate monitoring of biologic treatment. In this study we aim to evaluate the use of a mobile application to guide IBD patients during biologic treatment. Adult patients with diagnosis of IBD treated with biologics will be included. The mobile application with personalised content will give patients information about their treatment, reminders for example when blood tests and questionnaires to check for adverse events.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of inflammatory bowel disease
* Treatment with infliximab or vedolizumab
* Ability to read and understand Dutch language

Exclusion Criteria:

* Patients recently started with biologic treatment

Primary outcomes:
measure: Patient satisfaction
timeFrame: 6 months
measure: Actual use - frequency
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Satisfaction of care providers
timeFrame: 6 months
measure: Overall satisfaction of care providers
timeFrame: 6 months
measure: Number of outpatient visits
timeFrame: 6 months
measure: Number of telephone contacts
timeFrame: 6 months
measure: Disease and treatment knowledge
timeFrame: 6 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
References:
citation: van Erp LW, Groenen MJM, Heida W, Wisse J, Roosenboom B, Wahab PJ. Mobile application to monitor inflammatory bowel disease patients on intravenous biologic treatment: a feasibility study. Scand J Gastroenterol. 2021 Dec;56(12):1414-1421. doi: 10.1080/00365521.2021.1966832. Epub 2021 Aug 27.
Clinical trial NCT06602414: Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions
Official title: Is Conservative Treatment Still an Option for Distal Biceps Tendon Lesions? Evaluation of Clinical Results of Patients Treated Conservatively for Distal Biceps Tendon Lesions at 1 Year Minimum Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tendon Rupture
Keywords: Distal Biceps tendon rupture
Elbow tendon ruptures
Elbow tendon ruptures conservative treatment
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have suffered an acute distal biceps tendon rupture

Brief summary: A clinical evaluation of the results of conservative treatment after distal biceps tendon rupture with a minimum follow up of 1 year.

The results will be evaluated with clinical scores (MEPS, DASH and SF-12) and strenght and fatigue evaluations with dynamometers for both flexion and supination of elbow and forearm. The results of the affected side will be compared with the controlateral side


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years old at time of injury
* Complete acute distal biceps tendon rupture diagnosed and evaluated at IRCCS Istituto ortopedico Rizzoli between 2000 and 2024 treated conservatively

Exclusion Criteria:

* \&lt; 18 years at time of injury
* Patients who present controindications to the strenght evaluation
* Patients who have developed other non correlated injuries to the affected arm (e.g. fractures or tendon injuries)
* Patients treated surgically for distal biceps tendon rupture

Primary outcomes:
measure: Elbow Function
timeFrame: At baseline (day 0)
Secondary outcomes:
measure: Upper Limb Function
timeFrame: At baseline (day 0)
measure: Short Form Health Survey
timeFrame: At baseline (day 0)
measure: Flexion strenght
timeFrame: At baseline (day 0)
measure: Flexion Fatigue
timeFrame: At baseline (day 0)
measure: Supination Strenght
timeFrame: At baseline (day 0)
measure: Supination Fatigue
timeFrame: At baseline (day 0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Srinivasan RC, Pederson WC, Morrey BF. Distal Biceps Tendon Repair and Reconstruction. J Hand Surg Am. 2020 Jan;45(1):48-56. doi: 10.1016/j.jhsa.2019.09.014.
citation: Athwal GS, Steinmann SP, Rispoli DM. The distal biceps tendon: footprint and relevant clinical anatomy. J Hand Surg Am. 2007 Oct;32(8):1225-9. doi: 10.1016/j.jhsa.2007.05.027.
Clinical trial NCT04005014: Effect of Using Myopia Prediction Algorithm
Official title: Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eye--Refractive Errors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 1680
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.

Detailed description: We propose to enroll Grade 3 children from primary schools in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.

Eligibility criteria: Inclusion Criteria:

* Children at Grade 3 (aged 8-9)
* Has the record of eye refraction examined in the past year
* Written informed consents provided

Exclusion Criteria:

* Definitive diagnosis of other ocular abnormalities except for refractive error
* Previous eye surgery
* Unwilling to participate in this trial

Primary outcomes:
measure: Incidence of SER development of at least -0.5 dioptres (D)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Changes in SER \and AL
timeFrame: Up to 1 year
measure: Changes in proportion of children using atropine
timeFrame: Up to 1 year
measure: Changes in proportion of children using orthokeratology lenses
timeFrame: Up to 1 year
measure: Changes in proportion of children using spectacles
timeFrame: Up to 1 year
measure: Changes in child's average outdoor activity time per day
timeFrame: Up to 1 year
measure: Changes in child's average screen time per day
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04933214: Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease
Official title: Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Keywords: Crohn's disease, Exclusive Enteral Nutrition, Adherence
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 131
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We investigated CD patients who received EEN therapy in tertiary hospital in Hangzhou from December 2020 to May 2021.

Brief summary: The study has not yet been completed


Eligibility criteria: Inclusion Criteria:

* The main inclusion criteria were as follows: had diagnosed CD more than 3 months; had EEN in the past 6 months; were at least 18 years old; agreed to participate in this study.

Exclusion Criteria:

* The exclusion criteria were received treatment from mental health professionals due to any mental or cognitive impairment; suffered from other serious diseases, such as heart, brain, lung, liver and kidney dysfunction; severe infection, anemia, cachexia or other serious complications were found.

Primary outcomes:
measure: Adherence
timeFrame: December 2020 to May 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Study officials:
affiliation: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
name: Yan Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT04164914: Intestinal Microbiota Adaptation to Prebiotic Administration
Official title: Intestinal Microbiota Adaptation to Prebiotic Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: intestinal gas
healthy subjects
microbiota
prebiotics
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Non-absorbable, fermentable residues in the diet increase intestinal gas production and induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however, prebiotics, which are also fermented by colonic bacteria, have been shown to improve this type of symptoms. The aim is to demonstrate whether a prebiotic induces adaptive changes in metabolic activity of gut microbiota and colonic biomass that explain its beneficial effect on gas-related symptoms.

Single-centre, single arm, open label, proof-of-concept study in healthy subjects. The study will consist of a pre-administration phase (2 wk), an administration phase (4 wk) and a post-administration phase (2 wk). A soluble prebiotic fiber (resistant dextrin 14 g/d) will be administered during the 4 wk administration phase. During 4 days immediately before, at the beginning and at the end of the administration phase and at the end of the post-administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal, by means of a barostat; c) microbiota composition by fecal analysis.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* gastrointestinal symptoms
* recent (3 months) antibiotic intake
* change in dietary habits 4 weeks before

Primary outcomes:
measure: Number of daily anal gas evacuations
timeFrame: 28 days
Secondary outcomes:
measure: Volume of anal gas evacuation
timeFrame: 28 days
measure: Microbiota composition by fecal analysis
timeFrame: 28 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institut
Study officials:
References:
Clinical trial NCT06614114: Albumin Bilirubin Index as a Predictor of Outcome of Variceal Bleeding
Official title: Albumin Bilirubin Index as a Predictor of Outcome of Variceal Bleeding
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prediction of Variceal Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients had developed variceal bleed and who had been admitted via emergency

Brief summary: Albumin bilirubin index as a predictor of outcome of variceal bleeding

Detailed description: This study is to clarify the predictive value of albumin bilirubin index for recurrent bleeding within 3 month after endoscopic treatment in patients with cirrhosis and EGVB

Eligibility criteria: Inclusion Criteria:

* age between 18-80 years old

Exclusion Criteria:

* Hcc Hematological disease

Primary outcomes:
measure: prevelence of Variceal bleeding in high alb/bill index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Heba Sayed Zaki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04552314: Bleb Vascularity and the Outcomes After Trabeculectomy
Official title: Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Filtering Bleb
Keywords: filtering bleb
trabeculectomy
glaucoma
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with medically uncontrolled glaucoma who underwent primary trabeculectomy with mitomycin C (MMC) in the Department of Diagnostics and Microsurgery of Glaucoma of Medical University of Lublin, Poland

Brief summary: 1. Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy
2. Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.

Detailed description: Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a \>30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.

Eligibility criteria: Inclusion Criteria:

* primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP)
* pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP)

Exclusion Criteria:

* primary angle closure glaucoma (PACG)
* secondary glaucoma except PEXG
* previous eye surgery
* subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)

Primary outcomes:
measure: Rates of surgical success
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of Bleb vascularity with IOP
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Medical University in Lublin
name: Tomasz Żarnowski, MD, PhD, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02504814: Physiological and Clinical Changes in NHF Therapy
Official title: Physiological and Clinical Changes in NHF Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Hypercapnia
Interstitital Lung Disease
Keywords: nasal high flow
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.


Eligibility criteria: Inclusion Criteria:

* COPD, ILD

Exclusion Criteria:

* Unstable disease

Primary outcomes:
measure: changes in mean airway pressure (mbar)
timeFrame: 1 month
measure: changes in tidal and minute volume (l)
timeFrame: 1 month
measure: changes in breathing frequency (beats/ minute)
timeFrame: 1 month
Secondary outcomes:
measure: changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)
timeFrame: 4 month
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Jens Bräunlich
state: Sachsen
Study officials:
affiliation: University of Leipzig
name: Jens Bräunlich, MD
role: STUDY_DIRECTOR
References:
citation: Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.
Clinical trial NCT05233514: Effect of Aerobic Exercise on Polycystic Ovary Syndrome
Official title: Effect of Aerobic Exercise on Inflammatory Markers in Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants were divided into two groups equal in number: the aerobic exercise group (AEM), and the Metformin group (M). The AEM group performed aerobic exercise three times a week for 12 weeks in addition to Metformin treatment. The M group received Metformin only
Primary purpose: TREATMENT

Brief summary: The development of Polycystic Ovary Syndrome has been linked to chronic low-grade inflammation (PCOS). In this context, the current study looked into the effects of aerobic exercise on IL6, TNF, and C-reactive protein (CRP) in PCOS women. This was a randomized clinical trial including 40 females diagnosed with PCOS who were between the ages of 25 and 35. The participants were divided into two groups, each with an equal number of individuals: aerobic exercise (AEM) and Metformin (M). At baseline and after 12 weeks of intervention, participants' levels of IL6, TNF, and CRP were measured.


Eligibility criteria: Inclusion Criteria:

* Mean age of 26.7 ± 2.3, body mass index (BMI) 23.6±3.5 kg/m2) .
* confirmation by medical history of hyperandrogenic oligo amenorrhea (\<8 menses per year)
* PCO on ultrasonography of more than 10 ovarian follicles 2-9 mm in diameter

Exclusion Criteria:

* Disorders known to cause hyperandrogenisms, such as congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia.
* Renal or hepatic dysfunction

Primary outcomes:
measure: Level of Interleukin 6
timeFrame: 12 weeks
measure: Level of TNF-α
timeFrame: 12 weeks
measure: level of C- reactive protein
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
References:
Clinical trial NCT00670514: Smoking Cessation in a Dentistry Setting
Official title: A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: RCT
tobacco
treatment intensity
dentistry
follow-up
Smoking cessation
Cost effectiveness
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Västmanland County Council, Sweden
First posted: 2008-05-01
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.

Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).

Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).


Eligibility criteria: Inclusion Criteria:

* Adult daily smokers in the county of Västmanland

Exclusion Criteria:

* Reading difficulties
* Not fluent in the Swedish language

Primary outcomes:
measure: Point prevalence abstinence
Secondary outcomes:
measure: Continuous abstinence
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Centre for clinical research, Central Hospital
Study officials:
References:
citation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
citation: Nohlert E, Ohrvik J, Tegelberg A, Tillgren P, Helgason AR. Long-term follow-up of a high- and a low-intensity smoking cessation intervention in a dental setting--a randomized trial. BMC Public Health. 2013 Jun 19;13:592. doi: 10.1186/1471-2458-13-592.
citation: Nohlert E, Tegelberg A, Tillgren P, Johansson P, Rosenblad A, Helgason AR. Comparison of a high and a low intensity smoking cessation intervention in a dentistry setting in Sweden: a randomized trial. BMC Public Health. 2009 Apr 30;9:121. doi: 10.1186/1471-2458-9-121.