louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06349993: Digital Intervention for Depression and Anxiety in Adolescents
Official title: Digital Intervention for Depression and Anxiety in Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Adai Technology (Beijing) Co., Ltd.
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.

Participants will be asked to engage with the digital intervention platform for a period of two months.


Eligibility criteria: Inclusion Criteria:

* The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the DSM-5(the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).
* having a HAMD(Hamilton Depression scale) score upon enrollment
* demonstrate normal cognitive function.
* voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.

Exclusion Criteria:

* with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning
* with concurrent psychiatric disorders (as determined by clinical assessment)
* with concurrent psychiatric disorders (as determined by the assessing clinician)
* at high risk of suicide

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: baseline and immediately after 8-week intervention
measure: Hamilton Anxiety Rating Scale
timeFrame: baseline and immediately after 8-week intervention
Secondary outcomes:
measure: ADHD(attention deficit hyperactivity disorder) Rating Scale-IV
timeFrame: baseline and immediately after 8-week intervention
measure: PHQ-9 (Patient Health Questionnaire-9)
timeFrame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks
measure: GAD-7 (Generalized Anxiety Disorder-7)
timeFrame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuang
Study officials:
References:
Clinical trial NCT02221193: Comparing Site Specific Mouth Disinfection With Commercial Oral Mouth Rinse With Traditional Oral Maouth Disinfection
Official title: Site-Specific Mouth Rinsing to Improve Oral Odor by Altering Bacterial Counts: Blind Crossover Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Oral Odor (Halitosis)
The Study Want to Know if Site Specific Mouth Rinsing With Oral Mouth Disinfectants Can be Better Than Paonoral Mouth Rinsing
Lead sponsor: Al-Baha University
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 20
Sex: MALE
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: To determine whether site-specific mouth rinsing with oral disinfectants can improve oral odor beyond the traditional panoral mouth disinfection with mouth rinses by targeting specifically oral malodor implicate anaerobic bacteria.

Methods: Twenty healthy fasting subjects volunteered for a blinded prospective, descriptive correlational crossover cross-section clinical trial conduct during the month of Ramadan in the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia involving the application of Listerine® Cool Mint® mouth rinse by either the traditional panoral rinsing method or a site-specific disinfection method targeting the subgingival and supragingival plaque and the posterior third of the tongue dorsum while avoiding the remaining locations within the oral cavity. The viable anaerobic and aerobic bacterial counts, volatile sulfur compounds (VSCs) levels, organoleptic assessment of oral odor and the tongue-coating index were compared at baseline, 1, 5 and 9 hours after the treatment.


Eligibility criteria: Inclusion Criteria:

1. Saudi Arabia volunteers to be recruited from Albaha province of Saudi Arabia via an online invitation on the e-learning blog www.alqumber.wordpress.com
2. No antibiotic usage and no antiseptic mouth rinse use for the last 3 months and one week preceding the commencement of the study, respectively.
3. Must be dentate healthy Saudi males aged 17-65 years, who adhere to the ritual of fasting.
4. provided informed consent form.

Exclusion Criteria:

1. Receiving any professional periodontal treatments (prophylactic scaling, root planning, and periodontal surgery) or professional advice during the previous year. 2. Prior to the inception of the study.

Primary outcomes:
measure: viable anaerobic and aerobic bacterial counts
timeFrame: one month
measure: assessment of oral odor
timeFrame: one month
measure: volatile sulfur compounds (VSCs) levels
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05191693: Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study
Official title: Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Papillary Balloon Dilation
Bile Duct Stones
Endoscopic Sphincterotomy
Stone Recurrence
Keywords: endoscopic papillary balloon dilation
Stone recurrence
Lead sponsor: Venizelio General Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 ,who were prospectively followed for at least 12 months

Brief summary: The investigators prospectively evaluated long-term outcomes of ELBPD+EST for CBD stones up to 8-12mm.

EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.

Detailed description: Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm.

Overall, 72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST. The mean CBD diameter was 11.6±1mm, whereas a tapered duct was noted in 7 (9.7%). Post-procedural bleeding occurred in one case, treated successfully a with a fully covered metal stent. Mild cholangitis occurred in two cases. No cases with perforation or PEP were observed. During a mean follow-up of 22.4±6.2 months (range 13-36), CBD stones recurred in 2/72 (2.7%).

EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.

Eligibility criteria: Inclusion Criteria:patients with ELBPD+EST for CBD stones up to 8-12mm from September 2018 to August 2020 -

Exclusion Criteria: Patients with bile duct stones less than 8mm or more than 12mm.

-

Primary outcomes:
measure: Stone recurrence after endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST) in prior ERCP.
timeFrame: 22.4±6.2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: ''Benizelion" General Hospital
Study officials:
affiliation: ''Benizelion" General Hospital, Heraklion, Crete
name: Gregorios Gregorios, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02347293: Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
Official title: Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Metabolic Syndrome
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Normal fasting blood glucose
* BMI 19-25 kg/m2

Exclusion Criteria:

* Gastrointestinal diseases
* Food allergies e.g. lactose-, gluten intolerance
* Metabolic disorder e.g. diabetes
* Tobacco/snuff users
* No antibiotic or probiotic intake 2 weeks prior and during study.
* Vegetarians

Primary outcomes:
measure: Blood Glucose, levels of glucose in blood
timeFrame: Postprandial 0-180 min after breakfast
measure: Insulin, levels of insulin in blood
timeFrame: Postprandial 0-180 min after breakfast
measure: Appetite hormones, levels of Peptide YY (PYY) in blood
timeFrame: Postprandial 0-180 min after breakfast
measure: Markers of colonic fermentation, levels of hydrogen in breath
timeFrame: Postprandial 0-180 min after breakfast
measure: Inflammation markers, levels of Interleukin-6 (IL-6) in blood
timeFrame: Postprandial 0-180 min after breakfast
Secondary outcomes:
measure: Subjective satiety, as measured by VAS
timeFrame: Postprandial 0-180 min after breakfast
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Medicon Village
Study officials:
affiliation: Lund University
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gyll J, Ridell K, Ohlund I, Karlsland Akeson P, Johansson I, Lif Holgerson P. Vitamin D status and dental caries in healthy Swedish children. Nutr J. 2018 Jan 16;17(1):11. doi: 10.1186/s12937-018-0318-1.
citation: Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.
Clinical trial NCT00779493: Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial
Official title: Study Title: Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
constipation
diarrhea
gas
bloating
abdominal pain
disturbance of defecation
irritable colon
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evidence exists to support low-grade inflammation as the inciting factor leading to visceral hypersensitivity and alteration in motility in irritable bowel syndrome.In the medical literature,there is ample in vitro and in vivo evidence supporting turmeric and its derivative curcumin as an antitumor, anti-inflammatory and antioxidant agent. We propose a randomized, placebo-controlled, double blinded, parallel treatment study evaluating the effects of turmeric on the symptoms of irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

Patients from the hospitals and clinics of the Southern California Permanente Medical Group who conform to the Rome III criteria and

* Age 18 years and above,
* Male or female,
* Able to give consent and follow the treatment plan and be able to answer surveys.
* Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study.

Exclusion Criteria:

* Any of the following: diabetes, HIV disease, use of anticoagulants or antiplatelet medication, abnormal coagulation or thrombocytopenia, biliary obstruction, inflammatory bowel, symptomatic gallstones, celiac disease, ongoing use of medications known to cause or exacerbate symptoms of IBS and chronic, daily users of IBS medications.
* Use of scheduled IBS medications for 4 weeks prior to and during the treatment period.

Primary outcomes:
measure: Disease severity will be assessed using the irritable bowel severity score (IBSS) which utilizes a visual analog scale (VAS) (28). The primary outcome will be defined as at least 50% reduction in IBSS.
timeFrame: at 6 months of treatment
Secondary outcomes:
measure: Changes in bowel movement frequency, consistency, frequency of as-needed medication use and bloating as measured by the VAS, and improvement SF-36 Quality of Life survey.
timeFrame: end of observation and the end of treatment periods
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: chris n conteas, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06317493: Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment
Official title: Using Pupillometry to Assess Hearing Thresholds in Young Children With Hearing Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Impaired Children
Keywords: Pupillometry
Hearing threshold
Pediatric cochlear implants
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 180
Sex: ALL
Minimum age (years): 4
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with and without hearing impairment

Brief summary: The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient.


Eligibility criteria: Inclusion Criteria:

* Normal or corrected-to-normal vision
* No history of relevant neurological or psychiatric concomitant disease
* Age: 4-36 months
* At least 1 months of more after initial fitting of the CI or hearing aid (only for aided subjects)

Exclusion Criteria:

* Developmental disorders
* Unwillingness of the subject to participate further

Primary outcomes:
measure: Sensitivity index of pupillometry test
timeFrame: Within 30 minutes from enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: UOC Otorinolaringoiatria
city: Perugia
country: Italy
facility: Università degli Studi di Perugia
city: Torino
country: Italy
facility: Ospedale Martini
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
city: Lubiana
country: Slovenia
facility: Univeristy Medical Center
Study officials:
References:
Clinical trial NCT01092793: Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease
Official title: Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Atherosclerotic Coronary Disease
Keywords: Fish oil
Krill
CAD
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Atherosclerotic coronary heart disease is a condition thought to involve low-grade inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are lacking data in respect to whether differences in composition of various marine oils may influence the inflammatory status differently.

The hypothesis of the current study is that extract from the antarctic krill (Euphausia superba) is better than traditional fish oils when compared head-to-head with balanced composition of omega 3 content on inflammatory status.


Eligibility criteria: Inclusion Criteria:

* Age: 18-80 years
* Sex: Male and female
* Stable atherosclerotic coronary heart disease (heart attack \>3 months ago or objectified angina pectoris).
* No hospitalization for heart disease last 3 months.

Exclusion Criteria:

* Unstable heart disease.
* Heart failure NYHA class III and IV.
* Previous valve and/or aortic surgery
* Significant concomitant disease (i.e. diseases with known inflammatory activation - e.g. various autoimmune diseases, chronic infections, significant acute infections three weeks before or during the study, connective tissue disease, arthritis, chronic pulmonary disease or serious liver- or kidney-disease).
* Simultaneous involvement in other clinical studies involving intervention.
* Planned operation or other invasive procedures (e.g. PCI etc.) during the study period.

Primary outcomes:
measure: Inflammatory blood status
timeFrame: 8 weeks intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Cardiology, Oslo University Hospital / Rikshospitalet
Study officials:
References:
Clinical trial NCT05095493: Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
Official title: Oral Zinc Supplementation to Enhance Effects of Botulinum Neurotoxin Injection: an n of 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystonia, Focal
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single site randomized placebo controlled trial, cross-over
Primary purpose: TREATMENT

Brief summary: Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT injection have suboptimal zinc concentration in their tissues, and will experience improved response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a double blind placebo controlled cross-over study, randomized order placebo and OZS, in patients at a neurology clinic on stable dose of BoNT.


Eligibility criteria: Inclusion Criteria:

* Patients of the PI
* Age 18-80
* Male or female
* With an approved indication for BoNT such as dystonia or hemifacial spasm
* Have received either two or three BoNT injection cycles within the prior 8 months
* Prior two injection cycles length differed by no more than 2 weeks
* Prior two injection cycles used same brand of BoNT and similar dose within 15%

Exclusion Criteria:

* Concommitant use of penicillamine or cisplatin

Primary outcomes:
measure: Patient Global Impression of Change
timeFrame: End of study, week 48
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo
Other outcomes:
Locations:
Study officials:
affiliation: UTSW
name: Padraig E O'Suilleabhain, MD
role: PRINCIPAL_INVESTIGATOR
References: