louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06806098: Cessation Clinical Trial
Official title: Cessation Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: Digital intervention
Lead sponsor: Truth Initiative
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 2220
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: The Cessation Clinical Trial will investigate the effectiveness of a digital quit tobacco program in promoting abstinence from tobacco product use compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Current tobacco use (past 30-day use of one or more of the following: cigarettes, cigars, little cigars, cigarillos, e-cigarettes, or oral nicotine products)
* US residence
* Active text message plan (phase 2 only)

Exclusion Criteria:

* Age 25 or above (phase 2 only)

Primary outcomes:
measure: 30-day point prevalent abstinence
timeFrame: 7-months post randomization
Secondary outcomes:
measure: Abstinence from all tobacco products
timeFrame: 7 months post randomization
Other outcomes:
Locations:
city: Washington
country: United States
facility: Truth Initiative
state: District of Columbia
Study officials:
References:
Clinical trial NCT01858805: Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer
Official title: Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resectable Esophageal Cancer
Keywords: esophagus carcinoma
surgery
circulating tumor cells
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable.

Brief summary: Despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in patients with EC.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* resectable esophageal cancer

Exclusion Criteria:

* \< 18 years
* esophageal cancer with preoperative distant metastases

Primary outcomes:
measure: overall survival
timeFrame: 2 years
Secondary outcomes:
measure: recurrence-free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT01471405: One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma
Official title: Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-11-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients

Brief summary: This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.


Eligibility criteria: Inclusion Criteria:

* Completed the 2-79-52030-207 study and received 12 injections of lanreotide Autogel 120 mg, regardless of efficacy at the end of this period.
* Subject or in case of subject's death next of kin having given their written informed consent prior to collection of the data by the sponsor (if locally required)

Primary outcomes:
measure: Proportion of patients maintained on medical treatment with lanreotide Autogel
timeFrame: 1 year
measure: Proportion of patients receiving other medical treatments
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients with at least one pituitary surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Praha 2
country: Czechia
facility: III. Interní klinika Karlova Univerzita
city: Bois Guillaume
country: France
facility: CHU de Rouen
city: Bron
country: France
facility: Groupement hôspitalier est Federation d'endocrinologie.
city: Grenoble
country: France
facility: CHU Michallon
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Marseille
country: France
facility: CHU Timone
city: Paris
country: France
facility: Hôpital Bicêtre
city: Pessac
country: France
facility: Hôpital Haut Leveque
city: Reims
country: France
facility: CHU de Reims
city: Toulouse
country: France
facility: Hôpital Larrey
city: Essen
country: Germany
facility: Universität Duisburg-Essen
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang, Goethe-Universität
city: Napoli
country: Italy
facility: Università Federico II di Napoli
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Istanbul
country: Turkey
facility: İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00809705: A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for \>=3 months prior to screening;
* stable weight +/-10% for \>=3 months before screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* acute gastrointestinal symptoms at screening and/or day -1;
* clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.

Primary outcomes:
measure: Tmax, log (AUC), log(Cmax)of paracetamol
timeFrame: Days -1, 1, 5, 29, 33, 78 and 82
Secondary outcomes:
measure: Adverse events, laboratory parameters, vital signs
timeFrame: Throughout study
measure: renal function (creatinine clearance, urine volume and electrolytes)
timeFrame: Throughout study
measure: Multiple dose pharmacokinetics of Taspoglutide
timeFrame: Throughout study
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Neuss
country: Germany
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02958605: Smartphone Apps for Pediatric Resuscitation
Official title: Smartphone Medical Applications to Reduce Treatment Dosage Errors in Pediatric Resuscitation; a Randomized Simulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Status Epilepticus
Anaphylaxis
Keywords: Children
resuscitation
smartphone
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Medical Protective Association
First posted: 2016-11-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Medication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown.

Many smartphone apps have been suggested over the last years with some of them designed to calculate medication dosage for children. The impact of these apps to decrease dosage error has never been evaluated in resuscitation setting.

The aim of the study is to evaluate whether the use of a smartphone application designed to calculate medication doses decreases prescribing errors among residents during pediatric simulated resuscitations.

This will be a crossover-randomized trial using high fidelity simulation among 40 residents rotating in the pediatric emergency department.


Eligibility criteria: Inclusion Criteria:

* Residents (PGY1 to PGY4)
* Completing a rotation in pediatric emergency

Exclusion Criteria:

* Residents who previously participated in this study

Primary outcomes:
measure: Medication error
timeFrame: During resuscitation
Secondary outcomes:
measure: Proportion of tenfold error
timeFrame: During resuscitation
measure: Time for prescribing the first medication
timeFrame: During the simulation (10 minutes)
measure: Error in bolus medication
timeFrame: during simulation
measure: Error in perfusion medication
timeFrame: during simulation
measure: User satisfaction
timeFrame: 2 weeks
measure: User confidence
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT02291705: Ultrasound-guided Rectus Sheath Block In Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Ultrasound, rectus sheath block, children, inguinal hernia
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.

Detailed description: After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated.

Primary end point was pain score using FLACC scale.

Eligibility criteria: Inclusion Criteria:

* The children aged 2-7 years scheduled for inguinal hernia repair

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.

Primary outcomes:
measure: Pain Scores
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: CUKUROVA UNİVERSİTY
name: dilek ozcengiz, MD
role: STUDY_DIRECTOR
References:
citation: Breschan C, Jost R, Stettner H, Feigl G, Semmelrock S, Graf G, Likar R. Ultrasound-guided rectus sheath block for pyloromyotomy in infants: a retrospective analysis of a case series. Paediatr Anaesth. 2013 Dec;23(12):1199-204. doi: 10.1111/pan.12267. Epub 2013 Sep 25.
citation: Flack SH, Martin LD, Walker BJ, Bosenberg AT, Helmers LD, Goldin AB, Haberkern CM. Ultrasound-guided rectus sheath block or wound infiltration in children: a randomized blinded study of analgesia and bupivacaine absorption. Paediatr Anaesth. 2014 Sep;24(9):968-73. doi: 10.1111/pan.12438. Epub 2014 May 22.
citation: Alsaeed AH, Thallaj A, Khalil N, Almutaq N, Aljazaeri A. Ultrasound-guided rectus sheath block in children with umbilical hernia: Case series. Saudi J Anaesth. 2013 Oct;7(4):432-5. doi: 10.4103/1658-354X.121079.
Clinical trial NCT02417805: Cutaneous Microcirculation After Remote Ischemic Preconditioning
Official title: Effects of Remote Ischemic Preconditioning in Cutaneous Microcirculation of Different Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Acute Wound
Chronic Wound
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on second-degree burns, superficial and chronic wounds in a human in-vivo setting for the first time.


Eligibility criteria: Inclusion Criteria:

Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.

Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.

Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.

Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. No soft tissue injury must be evident.

Exclusion Criteria:

General exclusion criteria

* below 18 years of age
* wounds requiring artificial respiration, since consent for the study participation is unobtainable

Exclusion Criteria Groups A, B, D:

* peripheral arterial occlusive disease
* vasculitis
* diabetes mellitus
* chronic kidney or liver disease
* cardiac dysfunction
* arterial hypo- or hypertension

Anamnestic exclusion criteria

* ongoing immunosuppressive or chemotherapy treatment
* drug abuse
* systemic skin diseases
* systemic and local cortisone therapy

Primary outcomes:
measure: Change in microcirculation (composite measure)
timeFrame: Baseline and 1 minute post-dose
Secondary outcomes:
measure: Change in microcirculation (areolar measure)
timeFrame: Baseline, while and 1 minute post-dose
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Tobias Kisch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956605: A Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: A Randomized Trial of Computer-based Attention-training Systems With and Without Neurofeedback in Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: EEG-biofeedback
neurofeedback
computer attention training systems
ADHD
ADD
child
children
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the efficacy of two computer-based training systems to teach children with ADHD to attend more effectively.


Eligibility criteria: Inclusion Criteria:

* child in 6th, 7th or 8th grade
* a diagnosis of ADHD (any subtype) per report of the child's physician
* academic achievement at grade level
* ability to read in English sufficiently to complete assessments and intervention protocols

Exclusion Criteria:

* coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (e.g., bipolar disorder, psychosis)

Primary outcomes:
measure: Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention
timeFrame: Assessments were administered at enrollment in May-June 2006, and then immediately post-intervention after the 3 month intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center / Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center / Tufts University
name: Naomi Steiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03170505: Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
Official title: Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Palate
Keywords: cleft palate
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the Isfahan Cleft palate Clinic with a cleft palate fistula that undergo surgical repair

Brief summary: The fact that still exist is which method for repairing of secondary cleft palatal fistula is the best. This study will have shown whether using of Acellular dermal Matrix decreased the fistula formation versus using Conchal Cartilage during secondary fistula. Among studies that published, they have not consensus for using acellular dermal matrix. Most of the questions are about cost effectiveness, time that surgery and rehabilitation need and patient risk ( risk of transmission disease from other human tissue )

Detailed description: Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group with Conchal Cartilage.

Primary objectives:

The primary objective of this study is to determine whether ADM would lower the incidence of palatal fistula in patients undergoing secondary cleft palate fistula repair.

Secondary objectives:

1. hypo nasality speech after surgery
2. Improvement Speech Score

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.

Exclusion Criteria:

* Selection will be based on the patient's willingness to allow to participate in the study.
* Patients with diagnosed craniofacial syndromes will be excluded from the study.
* Children with known wound healing defects, will be excluded from the study.

Primary outcomes:
measure: Fistula formation
timeFrame: Within 2 year of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00968305: Interleukin (IL)-13 as a Marker in Pediatrics Asthma
Official title: Cytokine Production in Children With Asthma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: African American children with stable asthma
Asthma severity
Interleukin 13 from PHA stimulated PBMC
Lung function (FEV1%)
Total serum IgE
Pediatrics
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2009-08-28
Enrollment: 19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African-American children, ages 8 to 15 years, with clinically diagnosed asthma which had been stable for at least 4 weeks prior to enrollment in the study.

Brief summary: Asthma is a very common childhood chronic illness and is generally more severe in African Americans. The investigators attempted to determine whether a specific immune marker is associated with lung function and asthma severity.

Detailed description: This study examined the relationship between Interleukin (IL)-13 from phytohemagglutinin-activated polymorphonuclear blood cells and asthma severity, lung function (measured as FEV1%), and total serum IgE levels in African American children with clinically diagnosed asthma

Eligibility criteria: Inclusion Criteria:

* African-American race, born in the U.S.
* Age 8-15 years
* Clinical diagnosis of asthma
* Subject is able to understand and follow verbal instructions in English

Exclusion Criteria:

* Asthma exacerbation in the 4 weeks preceding the research visit
* Oral/IV steroid use in the 4 weeks preceding the research visit
* Upper or lower respiratory tract infection in the 4 weeks preceding the research visit
* Antibiotic use in the 4 weeks preceding the research visit
* Use of a short-acting bronchodilator during the 6 hours prior to spirometry (lung function testing)
* Use of a long-acting bronchodilator during the 12 hours prior to spirometry (lung function testing)

Primary outcomes:
measure: Interleukin-13 from phytohemagglutinin activated peripheral blood mononuclear cells
timeFrame: 7 months (from the start to completion of study. The blood was drawn at the one and only visit for each subject)
Secondary outcomes:
measure: Lung function measured by percent predicted forced expiratory volume in the first second (FEV1%)
timeFrame: 7 months (from the start to completion of study, but FEV1% was measured at the one and only visit for each subject)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center; Clinic: University Consultants in Allergy and Immunology
state: Illinois
Study officials:
affiliation: Rush University Medical Center, Department of Immunology and Microbiology
name: Byung H Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: