louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01509664: Encouraging Healthy Food Shopping and Eating Behaviors by Price Reduction: A Community Supermarket Study
Official title: Encouraging Healthy Food Shopping and Eating Behaviors by Price Reduction: A Community Supermarket Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: New York Obesity and Nutrition Research Center
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Columbia University
First posted: 2012-01-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators plan to test the effect of price reduction of fruits and vegetables and non-caloric beverages on food purchasing, food intake, body weight, and body composition of primarily single adult shoppers. One hundred subjects will be randomized to an experimental or control group for a 4 month period. In the experimental group, there will be an automated 50% reduction in fruits vegetables and non-caloric beverages during the middle 2-month period. The investigators expect to observe significant changes in food shopping and eating behavior during this period, which should lead to body weight and fat loss. Some of these new shopping patterns should persist in the last month of the study even though prices revert.


Eligibility criteria: Inclusion Criteria:

* regularly buy 50% of groceries at designated supermarket
* primary food shopper for household, shopping for up to one other person, not counting children ≤ 6 years old

Exclusion Criteria:

* significant medical or psychiatric conditions
* participation in a weight loss program or a related study

Primary outcomes:
measure: Gross Weekly Purchasing of Fruits and Vegetables
timeFrame: week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital center
state: New York
Study officials:
affiliation: New York Obesity and Nutrition Research Center
name: Allan Geliebter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernales-Korins M, Ang IYH, Khan S, Geliebter A. Psychosocial Influences on Fruit and Vegetable Intake Following a NYC Supermarket Discount. Obesity (Silver Spring). 2017 Aug;25(8):1321-1328. doi: 10.1002/oby.21876. Epub 2017 Jun 7.
citation: Geliebter A, Ang IYH, Bernales-Korins M, Hernandez D, Ochner CN, Ungredda T, Miller R, Kolbe L. Supermarket discounts of low-energy density foods: effects on purchasing, food intake, and body weight. Obesity (Silver Spring). 2013 Dec;21(12):E542-8. doi: 10.1002/oby.20484. Epub 2013 Jul 5.
Clinical trial NCT03467984: A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
Official title: A Single-blind, Multi-center, Randomized, Active-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Immunogenicity of Intramuscular Three Injections With LBVE(Multivalent Pneumococcal Conjugate Vaccine) Compared to Prevnar13 in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infection
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 230
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.


Eligibility criteria: Inclusion Criteria:

* Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
* The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures.
* Signed informed consent by subject's parents or LAR(Legally authorized representative)

Exclusion Criteria:

* Previously received any pneumococcal vaccine
* Receipt of immunoglobulin or blood-derived product before the study
* Known or suspected immune disorder, or received immunosuppressive therapy
* Known major congenital malformation or serious chronic disorder
* Participation in another interventional trial

Primary outcomes:
measure: Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
timeFrame: 4 weeks after 3rd(last) vaccination
measure: Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
timeFrame: 4 weeks after 3rd(last) vaccination
Secondary outcomes:
measure: Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
timeFrame: 4 weeks after 3rd(last) vaccination
measure: Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
timeFrame: 4 weeks after 3rd(last) vaccination
measure: Solicited adverse events
timeFrame: Baseline(pre-vaccination) up to 7 days after each vaccination
measure: Unsolicited adverse events
timeFrame: Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: LG chem
state: Gangseo-Gu
Study officials:
References:
Clinical trial NCT05902884: New Biomarkers in Facioscapulohumeral Muscular Dystrophy, Multispectral Optoacoustic Tomography.
Official title: New Biomarkers in Facioscapulohumeral Muscular Dystrophy, Multispectral Optoacoustic Tomography.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: FSHD
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most frequent muscular dystrophies in the adulthood. Multi-spectral optoacoustic tomography (MSOT) is an innovative imaging technique able to non-invasively characterize the molecular composition of the muscle tissue. With this pilot study we will explore the performance of MSOT imaging in FSHD patients and correlate the findings with clinical and MRI data, with the final aim to identify new disease biomarkers.


Eligibility criteria: Inclusion Criteria:

* molecular diagnosis of FSHD
* recent pelvic and lower-limb muscle MRI

Exclusion Criteria:

* presence of conditions that can alter the signal of the muscles under investigation: eg. tattoos, scars or skin abrasions at the site of probe evaluation, recent trauma, decompensated diabetes, symptomatic radiculopathies, acute or chronic inflammatory diseases
* current or presumed pregnancy
* inability to give informed consent

Primary outcomes:
measure: Optoacoustic Absorption Spectrum (peaks at different wavelengths in arbitrary units) in FSHD muscles
timeFrame: 6 months
Secondary outcomes:
measure: Medical Research Council (MRC) Muscle Strength Grades
timeFrame: 6 months
measure: Disease severity (Clinical Severity Scale CSS)
timeFrame: 6 months
measure: Phenotyping (FSHD Comprehensive Clinical Evaluation Form CCEF)
timeFrame: 6 months
measure: Dynamometer test of muscle strength
timeFrame: 6 months
measure: Magnetic resonance imaging
timeFrame: 6 months
measure: Intraclass correlation coefficient
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
References:
Clinical trial NCT04153084: Study of Different Endoscopic Preparations Used in Pediatric Colonoscopy
Official title: Comparative Study of Effectiveness and Safety of Different Endoscopic Preparations Used in Pediatric Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Digestive Illness
Keywords: Pediatric colonoscopy
Endoscopic preparations
PEG
Sodium picosulfate
Bohm solution
Movicol
Picoprep
Colonoscopic examination
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 126
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients who have undergone a colonoscopic exploration during the years 2018-2019, as part of a diagnostic process not related to the study.

Brief summary: The aim of this study is to evaluate the quality, acceptance, tolerability and adverse effects of colonoscopy preparations with the different available preparation guidelines.


Eligibility criteria: Inclusion Criteria:

* From 1 to 16 years old.
* Patients that signed the informed consent form.

Exclusion Criteria:

* Urgent colonoscopy
* History of intestinal resection
* Nephropathy, heart disease or metabolic syndrome.

Primary outcomes:
measure: Evaluate the quality of the colonoscopy preparations in our autonomic community comparing different preparation guidelines : Boston Scale
timeFrame: From November 2018 to December 2019
Secondary outcomes:
measure: Evaluate the acceptance of the different preparations.
timeFrame: From November 2018 to December 2019
measure: Evaluate the tolerance of the different preparations.
timeFrame: From November 2018 to December 2019
measure: Evaluate the security of the different preparations.
timeFrame: From November 2018 to December 2019
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
state: Cádiz
city: Almería
country: Spain
facility: Complejo Hospitalario Torrecárdenas
city: Badajoz
country: Spain
facility: Hospital Materno-Infantil de Badajoz
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatría
Study officials:
affiliation: Hospital Universitario Virgen Rocío
name: Alejandro Rodríguez Martínez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05905484: Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects
Official title: A Phase 1, Double-blind, Single-dose, Randomized, Placebo and Active-Controlled, Four-Way Crossover Study Evaluating the Effects of Bemnifosbuvir on Cardiac Repolarization in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).
timeFrame: 24 hours prior to dosing thru 48 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Atea Study Site
state: Montreal, Quebec
Study officials:
References:
Clinical trial NCT05381584: Balloon Vaginoplasty for Treatment of Vaginal-aplasia
Official title: Balloon Vaginoplasty; Fully Monitored Entry Versus Fractionated Intraumbilical Microports for Treatment of Vaginal-aplasia; A Quasi Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Abnormality
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vaginal aplasia is a congenital anomaly characterized by congenital absence of the vagina with an incidence approximately 1:4,500-6,000. It carries an emotional, sexual, and social embarrassing effect on those women, The primary aim of treatment is creation of a neo vagina for restoration of the ability for vaginal intercourse. There are several techniques for neo vaginal construction with variable satisfaction rates. Most of these procedures are either invasive and technically demanding or require long duration in a very motivated patient

Detailed description: Numerous surgical and nonsurgical procedures with varying degrees of success have been described for correction of the vaginal aplasia, but none have proved to be universally accepted.

Balloon vaginoplasty was first introduced in 2003 by El Saman et al for construction of a naturally lined neo vagina through a laparoscopic.

Technique hosts the triad of a perfect management modality; namely: simplicity, safety and success. The technique acts via mechanical expansion of the vaginal epithelium and underlying tissues at the pre-existing vaginal dimple Being a relatively new modality of management, it went through many refinements to make it much easier and feasible. The cornerstone of refinement always ran around the access to the peritoneal cavity. The latest of which was the fractionated intra umbilical micro ports which have the merits of totally hidden scar at the bottom the umbilicus consequently the best cosmetic outcomes. However, during its insertion process a troublesome partially unmonitored insertion was inevitably observed

Eligibility criteria: Inclusion Criteria:

* Married Females with vaginal aplasia scheduled for balloon vaginoplasty.

Exclusion Criteria:

* Females who refused to consent for participation in the study.
* Unstable marital relationship.

Primary outcomes:
measure: The Operative time
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00771784: Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy
Official title: Effects of Short- and of Long-term Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Diseases, Heart or Respiratory Failure,
Sepsis, Trauma.
Keywords: Endotracheal intubation
tracheostomy
laryngeal mask
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2008-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients.

Brief summary: The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask during percutaneous tracheostomy.

Detailed description: Percutaneous tracheostomy is routinely performed while patients are being ventilated with a laryngeal mask. The efficacy of ventilation during tracheostomy may be affected by length of previous endotracheal intubation.

This is an observational and monocentric study aimed to evaluate the impact of length of endotracheal intubation on efficacy of lung ventilation with a laryngeal mask. Two groups of patients who have to undergo elective percutaneous tracheostomy after either a short or long endotracheal intubation will be enrolled.

Data on the correlational effects of the endotracheal tube on the integrity of laryngeal structures and on ventilation will be collected.

Statistical analyses will use standard tests to compare the two groups of patients.

Eligibility criteria: Inclusion Criteria:

* age 18-80 years
* mechanical ventilation
* need of percutaneous tracheostomy

Exclusion Criteria:

* previous pathologies of upper airways or of oesophagus
* risk of bleeding
* need of FiO2 \>70% and/or of PEEP \>10 cm H2O
* difficult insertion of laryngeal mask
* impossibility of endoscopic visualization of the laryngeal structures

Primary outcomes:
measure: Ventilatory parameters during percutaneous tracheostomy
timeFrame: Thirty minutes.
Secondary outcomes:
measure: Scoring of laryngeal lesions, blood gas exchange, morbidity, mortality.
timeFrame: Thirty minutes.
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Intensive Care Unit, S. Anthony Hospital
state: PD
Study officials:
affiliation: Department of Pharmacology and Anesthesiology, University of Padova
name: Carlo Ori, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05078684: GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)
Official title: Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ventricular Arrythmia
Ventricular Tachycardia
Ventricular Fibrillation
Arrhythmic Storm
Block
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2021-10-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1 for active treatment vs. sham procedure
Primary purpose: TREATMENT

Brief summary: This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.

Detailed description: * The study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (LGSB) before or after catheter ablation.
* Included participants will be dived based on the need for mechanical ventilation and catheter ablation performed \<5 days before the study
* Subsequently, the participants will be randomized to LGSB or to a sham (placebo) procedure.
* The primary endpoint will be a reduction of the burden of clinical arrhythmia \>50% 24 hours after LGSB without escalation of antiarrhythmic therapy.
* The study will include 80 patients over 4 years.

Eligibility criteria: Inclusion Criteria:

1. arrhythmic storm \<24 hours before inclusion:

   * 3 or more episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) terminated by external or internal shock,
   * or incessant VT lasting \>30 minutes,
   * or very frequent nonsustained or sustained VT leading to hemodynamic instability with the need of escalation of the therapy
2. clinical indication for LBGS based on the judgment of the physician, independent of the study

Exclusion Criteria:

1. known allergy to bupivacaine
2. prior LBGS performed \<7 days before the study
3. known reversible provoking trigger of the arrhythmias
4. ventricular arrhythmias triggered by premature ectopic beats during bradycardia
5. hemodynamically tolerated idiopathic VT in patients without structural heart disease

Primary outcomes:
measure: Change in the number of episodes of sustained VT/VF
timeFrame: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
measure: Change in arrhythmia burden quantified by Holter ECG
timeFrame: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
Study officials:
References:
Clinical trial NCT03889184: An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
Official title: An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Rehabilitation
Keywords: meals-on-wheels
home-dwelling older people
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 76
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial

Detailed description: The aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial. The target group is, respectively old people discharged from an hospital stay, old people referred for exercise rehabilitation in the municipality and old people already receiving meals-on-wheels

Eligibility criteria: Inclusion Criteria:

* 65+ year,
* able to speak and understand Danish.
* has accepted to participate
* Is discharged from hospital, or
* is referred to exercise rehabilitation in the municipality or
* is receiving meals-on-wheels

Exclusion Criteria:

* terminal disease,
* living in a nursing home,
* receives a specific diet (e.g. diabetes, dysphagia, vegetarian or vegan)

Primary outcomes:
measure: EuroQoL (EQ-5D-5l)
timeFrame: change after 8 weeks
measure: readmissions
timeFrame: after 30 days
measure: protein intake
timeFrame: change after 8 weeks
Secondary outcomes:
measure: physical function
timeFrame: change after 8 weeks
measure: Satisfaction with food-related quality of life questionnaire (SWFL)
timeFrame: change after 8 weeks
measure: Food related functional ability questionnaire (scale)
timeFrame: change after 8 weeks
measure: Meal quality questionnaire
timeFrame: change after 8 weeks
measure: Compliance
timeFrame: after 8 weeks
measure: adverse events
timeFrame: during the 8 weeks
Other outcomes:
Locations:
city: Albertslund
country: Denmark
facility: Municipality of Albertslund
Study officials:
affiliation: University College Copenhagen
name: Anne Marie Beck, PhD
role: PRINCIPAL_INVESTIGATOR
References: