louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00132171: Helicobacter Pylori Eradication With a New Sequential Treatment
Official title: High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Non Ulcer Dyspepsia
Duodenal Ulcer
Gastric Ulcer
Chronic Active Gastritis
Gastritis
Keywords: Helicobacter pylori
Eradication
Sequential therapy
Standard therapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2005-08-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. The study aimed to assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection.

Detailed description: One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy \[rabeprazole (20 mg twice daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg, all twice daily for the remaining 5 days\] or standard 7-day therapy \[corrected\] \[rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g), all twice daily\]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment.

Eligibility criteria: Inclusion Criteria:

* Presence of active H. pylori infection
* Age \>18 years

Exclusion Criteria:

* Allergy to drug administered
* Liver or kidney failure
* Pregnancy
* Previous treatment for H. pylori infection

Primary outcomes:
measure: Helicobacter pylori eradication rate
Secondary outcomes:
measure: Compliance to therapy
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Gastroenterology - Nuovo Regina Margherita Hospital
Study officials:
affiliation: Nuovo Regina Margherita Hospital
name: Angelo Zullo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadia C, Fornari F, Pilati S, Mete LS, Merla A, Poti R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003 Mar 1;17(5):719-26. doi: 10.1046/j.1365-2036.2003.01461.x.
Clinical trial NCT05477771: The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position
Official title: The Correlation Between the Cross-sectional Area of the Long Head of the Biceps Tendon and the Tear Position in Patients With Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: long head of the bicep tendon
rotator cuff tear
cross-sectional area
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(LHBT) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the LHBT in the patients suffered from rotator cuff tear with different tear positions. The results may identify the influence of the tear position on the LHBT.


Eligibility criteria: Inclusion Criteria:

* partial or full-thickness but reparable rotator cuff tear;
* small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
* no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.

Exclusion Criteria:

* massive rotator cuff tears being defined by DeOrio and Cofied;
* patients with osteoarthritis of the glenohumeral joint;
* trauma or a history of surgery at the shoulder.

Primary outcomes:
measure: Pre-operative measurement of the cross-sectional area of the long head of bicep tendon
timeFrame: Pre-operative
Secondary outcomes:
measure: Post-operative measurement of the cross-sectional area of the long head of bicep
timeFrame: 2 months after the surgery
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Lin Du
role: STUDY_CHAIR
References:
Clinical trial NCT02355171: Personalize My Treatment (PMT) Registry
Official title: A Large-scale Longitudinal Oncology Registry
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cancer
Lead sponsor: Exactis Innovation
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with all solid tumor types.

Brief summary: The 'Personalize My treatment' (PMT) platform is a novel form of biobanking in which cancer patients willingly consent to provide residual, clinical samples (surplus after diagnostic testing) of their tumors for cancer research, to give access to their medical record for data collection and then followed prospectively throughout the trajectory of their illness. They further willingly consent to be recontacted for being informed of other research projects, including clinical trials.


Eligibility criteria: Age of majority in the province of recruitment.

Primary outcomes:
measure: The primary objective of PMT is to create a collection of cancer patient biospecimens and annotated data that will be used for clinical trial matching and to advance cancer research.
timeFrame: Longitudinal
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Moncton
country: Canada
facility: Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
state: New Brunswick
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: QE II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre - Sunnybrook Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: MUHC McGill University Health Center
state: Quebec
city: Québec
country: Canada
facility: Centre hospitalier universitaire de Québec - Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIUSSS de la Mauricie-et-du-Centre-du-Québec - Centre Hospital Régional
state: Quebec
Study officials:
References:
Clinical trial NCT03971578: Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Official title: Screening Device for Autism Spectrum Disorders Using High Stimulation Rate ABR With Continuous Loop Averaging Deconvolution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Lead sponsor: Intelligent Hearing Systems
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-06-03
Enrollment: 81
Sex: ALL
Minimum age (years): 42
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with autism spectrum disorders and normally developing age- and gender-matched controls

Brief summary: The purpose of this study is to develop an Auditory Brainstem Response (ABR) based neurological screening method to detect increased risk for Autism Spectrum Disorders (ASD) and other neurological conditions in newborns.

Detailed description: In the proposed study, a screening method for neurological deficits, with an emphasis on its application to ASD, will be developed and its feasibility demonstrated. The proposed method will utilize high rate stimulation to acquire Auditory Brainstem Responses in order to determine peak latency and amplitude differences in children with ASD compared to non-ASD. Similarly to newborn hearing screening, the output of the screening method will provide an automated pass or refer outcome that can be used by a physician to determine if the child needs further evaluation.

Eligibility criteria: Inclusion Criteria:

* Children with autism spectrum disorder diagnosis
* Normally developing age- and gender-matched controls

Exclusion Criteria:

* Permanent or temporary hearing loss at the time of testing.
* Craniofacial abnormalities

Primary outcomes:
measure: ABR Peak V Latency
timeFrame: One Week
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami Department of Psychology
state: Florida
Study officials:
References:
citation: Miron O, Beam AL, Kohane IS. Auditory brainstem response in infants and children with autism spectrum disorder: A meta-analysis of wave V. Autism Res. 2018 Feb;11(2):355-363. doi: 10.1002/aur.1886. Epub 2017 Oct 31.
Clinical trial NCT06367478: Evaluation of Nerve Conduction Study
Official title: Evaluation of Acquisition Parameters and Stimulation to Obtain Different Neurophysiological Responses
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nerve Condition
Health, Subjective
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy subjects

Brief summary: the investigators study different modality to obtain nerve evoked reponses. They use different parameters of acquisition and stimulation and they compare amplitude and latency of nerve conduction response


Eligibility criteria: Inclusion Criteria:

* absence of previous nervous pathologies

Exclusion Criteria:

* nerve disease
* diabetes
* polyneuropathy

Primary outcomes:
measure: best amplitude of nerve conduction study
timeFrame: baseline and after 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan
Study officials:
References:
Clinical trial NCT03790878: Emotion Regulation and Emotion Perception
Official title: Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotions
Keywords: Emotion Dysregulation
Empathy
Emotion Perception
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Mind and Life Institute, Hadley, Massachusetts
First posted: 2019-01-02
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact of a brief, emotion regulation intervention on the ability to perceive other people's emotions.

Detailed description: Decision to close enrollment was made on January 2, 2020.

Eligibility criteria: Inclusion Criteria:

1. ages 18-55;
2. have a smartphone and agree to receive text-messages;
3. have difficulty with their relationships or social interactions;
4. high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale (DERS)(Gratz \& Roemer, 2004) with scores over 90.

Exclusion Criteria:

1. Current mania;
2. Meets full criteria for any current psychotic disorder;
3. Currently/chronically homeless;
4. Current suicidal ideation;
5. Psychiatric hospitalization within past 6 months;
6. Unable to read, blind or deaf. Our previous study recruited only participants who were currently in treatment, but this study will include both participants who are currently in treatment, as well as those who are not in treatment.
7. high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung \& Baron-Cohen, 2012).

Primary outcomes:
measure: The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment
timeFrame: During the laboratory experiment (week 1)
measure: Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment
timeFrame: After the one week of phone-based intervention
Secondary outcomes:
measure: Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS)
timeFrame: Beginning of Week one laboratory experiment, End of Week one laboratory experiment
Other outcomes:
measure: Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR)
timeFrame: Laboratory assessment, up to one week
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Mark Z Rosenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02628678: A Study to Evaluate the Effect of Diet on the Tolerability of FOS in Healthy Volunteers
Official title: An Open-label Study to Evaluate the Effect of Diet on the Tolerability of FOS, a Commercially Available Prebiotic, in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Prebiotic
FOS
fructooligosaccharide
polyglycan
microbiome
microbiota
Healthy Volunteers
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2015-12-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to determine the 5-day tolerability of one commercially available prebiotic food ingredient, FOS, in healthy human subjects with and without diet control.


Eligibility criteria: Inclusion Criteria:

1. Be able to give written informed consent;
2. Be male or female of any race, between 18 and 65 years of age;
3. Have a BMI \> 20 \& \< 27 kg/m2;
4. Be willing to follow a controlled low fiber diet for a period of 11 days;

Exclusion Criteria:

1. Are less than 18 and greater than 65 years of age;
2. Are hypersensitive to any of the components of FOS;
3. Are currently taking probiotic or prebiotic supplements, or have taken them in the past 28 days;
4. Unwilling to avoid probiotics/prebiotics supplements for the duration of the study;
5. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgment, entry to the study;
6. Subject is a smoker;
7. Subject has a history of drug and/or alcohol abuse at the time of enrollment;
8. Taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
9. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
10. Subjects may not be receiving treatment involving experimental drugs;
11. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study;

Primary outcomes:
measure: Number of subjects with Adverse Events
timeFrame: 22 days
Secondary outcomes:
measure: The effect of controlling diet on the tolerability of FOS by analyzing the gut microbiome
timeFrame: 22 days
Other outcomes:
measure: The effect of FOS on each subject's gut microbiome
timeFrame: 22 days
Locations:
city: Cambridge
country: United States
facility: Kaleido Biosciences
state: Massachusetts
Study officials:
References:
Clinical trial NCT05308771: To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery
Official title: Use of Visual Pressure Control (VPC) Syringes for Epidural Space Identification in Pediatric Anesthesia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Hernia
Abdominal Wall Defect
Abdominal Neoplasm
Urogenital Disease
Urologic Neoplasms
Thoracic Diseases
Lung Diseases
Lead sponsor: Centre Hospitalier Universitaire de Tivoli
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 15
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pediatric epidural anesthesia has emerged as a safe and effective regional anesthesia technique for providing intraoperative and postoperative analgesia in thoracic and abdominal surgery. The loss of resistance technique is the gold standard for the placement of the epidural.

The VPC (visual pressure control) syringes developed by PAJUNK enable direct visualization of the introduction of the needle into the epidural space.

Detailed description: This trial is a non blinded, pilot study. A minimum of 15 children between the ages of 0 and 16 who require surgery that may benefit from epidural anesthesia will be enrolled.

The number of attempts, the complications (dural and vascular punctures, neurological complications) and the degree of satisfaction of the operator measured by a 7-point likert scale will be studied as secondary objectives.

Eligibility criteria: Inclusion Criteria:

* children aged from 0 to 16y
* surgical procedure that can benefit from a lumbar or low thoracic epidural anesthesia

Exclusion Criteria:

* parental refusal
* allergy to local anesthetics
* coagulation disorders
* spine abnormalities

Primary outcomes:
measure: successful detection of the epidural space
timeFrame: 24 hours
Secondary outcomes:
measure: Number of participants with vascular puncture
timeFrame: 24 hours
measure: Number of participants with dural puncture
timeFrame: 24 hours
measure: Number of participants with nerve damage
timeFrame: Month 3
measure: Operator's satisfaction questionnaire
timeFrame: 24 hours
Other outcomes:
Locations:
city: La Louvière
country: Belgium
facility: Chu Tivoli
state: Hainaut
Study officials:
affiliation: Centre Hospitalier Universitaire de Tivoli
name: Emmanuel Noel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04019171: EXercise Training for Reducing Anxiety in First-Time Inmates
Official title: Interval Exercise Training for Reducing Anxiety in First-Time Inmates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 43
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial with 2 arms ("interval exercise training" or "waiting list") aiming at evaluating the anxiolytic effects of a 6 weeks-long exercise training program in first-time prisoners with elevated anxiety symtpoms


Eligibility criteria: Inclusion Criteria:

* First-time prisoners ; elevated state anxiety (\> 40 on the state anxiety inventory)

Exclusion Criteria:

* Symptoms of and/or known cardiovascular, metabolic, psychiatric, neurological or neurodevelopmental disease

Primary outcomes:
measure: change in state anxiety
timeFrame: before and after the 6 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Legrand FD, Ory E, Herring MP. Evaluation of a brief interval exercise training (IET) intervention for first-time prisoners with elevated anxiety symptoms. Anxiety Stress Coping. 2020 Sep;33(5):581-589. doi: 10.1080/10615806.2020.1768244. Epub 2020 May 21.
Clinical trial NCT01693471: Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine in Asthma Patients
Official title: Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
SF-36
HRQOL
Lead sponsor: Kyorin Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 179
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General Practitioner

Brief summary: The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients whose control levels are partly controlled or uncontrolled.

Detailed description: Period: 2012-2013 Observation Time: 0 week, 4 week

Matters investigated:

1. QOL determination using SF-36 v2
2. Medication compliance (VAS scale)
3. Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma control, concomitant drugs, comorbidities, smoking, alcohol, work

Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 20 years of age
* Outpatients
* Patients with mild or moderate persistent asthma
* Patients with phlegm
* Patients whose levels of asthma control are partly controlled or uncontrolled
* Patients who are planned to treat MUCODYNE
* Patients who voluntarily submitted written consent forms upon participation in this study

Exclusion Criteria:

* Patients with a history of adverse reactions to carbocisteine
* Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease
* Patients with the possibility of pregnancy or suspected pregnancy
* Patients with complication of malignancy
* Current smoker
* Patients with definitive diagnosis for COPD
* Other patients whom investigators or subinvestigators considered inappropriate to participate in this study

Primary outcomes:
measure: Score of SF-36
timeFrame: 4 week
Secondary outcomes:
measure: HR-QOL condition of asthma patients with phlegm
timeFrame: 0 week
measure: Medication compliance: measured by patient response to visual analog scale
timeFrame: 4 week
measure: Relation between a medication compliance measured by patient response to visual analog scale and change of HR-QOL from baseline at 4 weeks
timeFrame: 0 week, 4 week
Other outcomes:
Locations:
city: Ota-ku
country: Japan
facility: Senzoku Respiratory Disease and Allergy Clinic
state: Tokyo
Study officials:
affiliation: Kyorin Pharmaceutical Co.,Ltd
name: Akito Saegusa, Mr.
role: STUDY_CHAIR
References: