louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00817687: A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation
Official title: A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* in receipt of an initial cadaveric kidney transplant;
* in receipt of graft with biopsy;
* in receipt of a 'marginal' kidney transplant.

Exclusion Criteria:

* in receipt of a second kidney transplant;
* in receipt of a multi-organ transplant or a double kidney transplant;
* malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
* replicating hepatitis B and/or C, or HIV positive serology.

Primary outcomes:
measure: Proportion of patients with >=25% increase in fibrosis score
timeFrame: Day 0 to Week 52
Secondary outcomes:
measure: Renal function (creatinine clearance)
timeFrame: From randomization to Week 52
measure: Incidence and time of occurrence of clinical acute rejection
timeFrame: From randomization to Week 52
measure: Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes
timeFrame: Throughout study
Other outcomes:
Locations:
city: Besancon
country: France
city: Bordeaux
country: France
city: Caen
country: France
city: Clermont-ferrand
country: France
city: Lille
country: France
city: Limoges
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Rouen
country: France
city: Salouel
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Tours
country: France
city: Vandoeuvre-les-nancy
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04770987: Lateral Neck Flexor Endurance and Hyperlaxity
Official title: Lateral Neck Flexor Endurance in Individuals With and Without Systemic Hyperlaxity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Endurance
Hypermobility, Joint
Muscular Weakness
Keywords: neck musculature
endurance
tests and measures
Lead sponsor: University of Hartford
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages of 18-60 with and without systemic hyperlaxity

Brief summary: The lateral neck flexor endurance test has been proposed to assess for unilateral muscular deficits. It is not known if individuals with hyperlaxity have different muscular endurance than individuals without hyperlaxity.

Detailed description: Thirty individuals with systemic hyperlaxity as determined with the Beighton scale will be assessed for lateral neck flexor endurance and compared to age and gender matched controls. Basic demographic information will be collected, and all individuals will report Neck Disability Index (NDI) and Numeric Pain Rating Scales (NPRS) for their neck, as well duration of any neck pain. All participants will then undergo testing of lateral neck flexor muscle endurance, repeated twice on each side. Average hold times will be compared for individuals with hyperlaxity (5 or greater on Beighton scale) and the healthy age and gender matched controls. Analysis will also include covariates of NDI scores, pain scores, and chronicity of symptoms.

Eligibility criteria: Inclusion Criteria:

systemic hyperlaxity of 5 or greater on Beighton Index, healthy age/gender matched controls

Exclusion Criteria:

* neck pain that spreads into the arms;
* whiplash injury within the last 6 weeks;
* diagnosed neuropathy or other nervous system disorders;
* a history of spinal surgery in their neck;
* fibromyalgia;
* insulin dependent diabetes;
* involved in legal activity regarding neck pain

Primary outcomes:
measure: lateral neck flexor endurance
timeFrame: single testing session at enrollment
Secondary outcomes:
measure: Beighton Hyperlaxity Scale
timeFrame: at enrollment
measure: Neck Disability Index
timeFrame: at enrollment
measure: Numeric pain rating scale
timeFrame: at enrollment
Other outcomes:
Locations:
city: West Hartford
country: United States
facility: University of Hartford
state: Connecticut
Study officials:
affiliation: University of Hartford
name: Brian Swanson, PT, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06030687: FoodImage 3 Free-Living
Official title: Multiscale RECIPES (Resilient, Equitable, and Circular Innovations With Partnership and Education Synergies) for Sustainable Food Systems (FoodImage 3; FI3) Free-Living
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Waste Management
Food Supply
Climate
Nutrition Sciences
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Martin, Corby, K., M.D.
First posted: 2023-09-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Participants will be asked to use the app to capture data on food purchases, food waste that occurs during food preparation, food waste that is present after eating, and food waste from cabinet and refrigerator/freezer clean-outs. During collection of much of the food waste data, participants will record in the app if food waste will be disposed of via composting, disposal, fed to pets, or garbage/landfill. They will also indicate if the food was spoiled, past the expiration date, etc. This will occur for 4-8 days. Participants should perform the prep and eat occasions 4-8 days. The shopping and toss occasions should be completed for at least 7 days.


Eligibility criteria: Inclusion Criteria:

* Male or Female, age 18-65 years
* Willing to be recontacted
* Conducts some of the food shopping, food purchasing, and/or food preparation for their household.
* Internet and/or Wi-Fi availability to complete surveys and send images.
* Ownership of an iPhone 9S or later, operable Apple ID, password, and email address that they are willing and able to use to collect data during the study. Subject acknowledges data usage and associated charges are a result of study.
* Willing to complete all study procedures and adhere to study visit timelines -

Exclusion Criteria:

* Refusal or unable to use an iPhone for study related purposes.
* Not willing to adhere to study procedures and study visit timelines.
* PBRC employee
* Any condition or circumstance that in the judgement of the PI could interfere with study participation

Primary outcomes:
measure: Total weight of household food waste
timeFrame: daily during baseline collection
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: John W Apolzan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02564887: Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy
Official title: Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dysphagia
Oral Pharyngeal Cancer
Keywords: dysphagia
oral pharyngeal cancer
Iowa Oral Performance Instrument (IOPI)
IOPI
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with head and neck cancer treated with chemoradiation, often develop a treatment associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer. This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise alone to determine if recovery is enhanced and to determine if rate of recovery is accelerated.


Eligibility criteria: Inclusion Criteria:

* diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in treatment associated dysphagia.

Exclusion Criteria:

* unable to adhere to assigned therapy program due to cognitive deficits
* surgical treatment for head and neck cancer
* unable to give informed consent

Primary outcomes:
measure: Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
timeFrame: 8 weeks
Secondary outcomes:
measure: Airway Protection During Swallowing
timeFrame: 8 week
measure: Change Over Time of Pharyngeal Residue After Swallowing
timeFrame: 8 week
measure: Swallowing Impairment-Self Report
timeFrame: 8 week
measure: Swallowing Impairment
timeFrame: 8 week
measure: Swallowing Impairment-Objective
timeFrame: 8 week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05192187: Why do People With Low Back Pain Fear and Avoid Lifting?
Official title: Why do People With Low Back Pain Fear and Avoid Lifting?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators' main focus of this trial will be to investigate

* why people with low back pain perceive lifting (with a bent back) as harmful.
* whether general measures of pain-related fear are associated with task-specific measures of perceived harmfulness
* why people with low back pain avoid lifting (with a bent back) This will be investigated using self-report (i.e., questionnaires)


Eligibility criteria: Inclusion Criteria:

* low back pain \>3 months

Exclusion Criteria:

* healthy persons
* low back pain \<3 months

Primary outcomes:
measure: cognitions about perceived harmfulness and avoidance of lifting
timeFrame: Day 1 (cross-sectional study)
Secondary outcomes:
measure: Pain-related fear
timeFrame: Day 1 (cross-sectional study)
measure: perceived harmfulness of specific tasks
timeFrame: Day 1 (cross-sectional study)
measure: Disability
timeFrame: Day 1 (cross-sectional study)
measure: Task-specific self-efficacy
timeFrame: Day 1 (cross-sectional study)
measure: Task-specific disability
timeFrame: Day 1 (cross-sectional study)
measure: Pain-related fear
timeFrame: Day 1 (cross-sectional study)
measure: Pain intensity
timeFrame: Day 1 (cross-sectional study)
Other outcomes:
measure: Age
timeFrame: Day 1 (cross-sectional study)
measure: Sex
timeFrame: Day 1 (cross-sectional study)
measure: Physical job requirements
timeFrame: Day 1 (cross-sectional study)
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Thomas Matheve, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02033187: Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients
Official title: Phase 4 Study of the Impact of Daily Bathing With Chlorhexidine-gluconate Impregnated Bathing Cloths on Nosocomial Infections in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthcare Associated Infections
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.

Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the medical, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center

Exclusion Criteria:

1. Being cared for in the burn ICU or patients with TEN/SJS or burns being cared for in one of the non-burn intensive care units.
2. Patients with known allergy to chlorhexidine gluconate
3. Age \< 18 years old
4. Patients where daily bathing would not be safe

Primary outcomes:
measure: A composite of healthcare-associated infections
timeFrame: Daily
Secondary outcomes:
measure: Rates of each individual site infection included in the composite calculation above
timeFrame: Daily
measure: Skin reactions
timeFrame: As needed
measure: Hospital mortality
timeFrame: One year
measure: Hospital length of stay
timeFrame: One year
measure: ICU length of stay
timeFrame: One year
measure: Rate of cultures positive for multi-drug resistant organisms
timeFrame: Daily
measure: Rates of blood culture contamination
timeFrame: Daily
measure: Rates of healthcare-acquired bloodstream infections
timeFrame: Daily
Other outcomes:
measure: Subgroup analysis by the individual intensive care unit
timeFrame: One year
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael J Noto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noto MJ, Domenico HJ, Byrne DW, Talbot T, Rice TW, Bernard GR, Wheeler AP. Chlorhexidine bathing and health care-associated infections: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):369-78. doi: 10.1001/jama.2014.18400.
Clinical trial NCT05341687: Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
Official title: Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (CARDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ards
Mechanical Ventilation Pressure High
Extracorporeal Membrane Oxygenation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 122
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: Patients with ARDS secondary to COVID-19 pneumonia requiring ECMO-VV support

Brief summary: Mortality of patients with COVID-19 associated acute respiratory distress syndrome (CARDS) treated with veno-venous extra-corporal membrane oxygenation (vv-ECMO) is increasing over time since the beginning of the COVID-19 pandemic. The objectives were to retrospectively describe over the first ten days after vv-ECMO implantation, the ventilatory management of CARDS and to assess the impact of static respiratory system compliance (CRS) on the first day of vv-ECMO on 180-day mortality.


Eligibility criteria: Inclusion Criteria:

* Patients with ARDS secondary to COVID-19 pneumonia requiring ECMO-VV support, hospitalized in the intensive care units of the CHRU of Nancy, Marseille or Bordeaux between 01/03/2020 and 31/12/2021.
* Age \> 18 years old

Exclusion Criteria:

* Respiratory parameters not available on ten first day of VV ECMO implantation.
* Patient refusal to participate in the study

Primary outcomes:
measure: Vital status (dead or alive)
timeFrame: Days, 10.
Secondary outcomes:
measure: Evolution of driving pressure
timeFrame: Days, 10
measure: Evolution of tidal volume
timeFrame: Days, 10
measure: Evolution of PEEP
timeFrame: days, 10
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU Nancy
Study officials:
References:
Clinical trial NCT06978387: The Association Between Glycemic Metrics and Cardiovascular Markers in Patients With Type 1 Diabetes.
Official title: The Association Between Glycemic Metrics and Cardiovascular Markers in Patients With Type 1 Diabetes.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children adolescents and young adults (12\> years old) with T1D that are on MiniMed 780G system.

Brief summary: In this cross-sectioanl study, 90 patients aged \>12 years old with T1DM who are on MiniMed 780G system will be included.The investigators aim to assesse the association of patients' adherence to Mediterranean diet (MD) with CGM and insulin metrics, as well as anthropometric measurements, BMI, lipid levels and blood pressure.Moreover, markers of endothelial, cardiovascular and liver function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.

Detailed description: This cross-sectional study will include 90 participants, children adolescents and young adults (12\> years old) with T1D that are on MiniMed 780G system. Participants will be evaluated for adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. HbA1c, CGM and Insulin Metrics, anthropometric measurements, blood pressure and lipid leves will be aso evalutaed. Markers of endothelial cardiovascular and liver function will also be assessed.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
2. HbA1c \< 12.5%
3. Age \>7years at the initiation of the system
4. Patients with Minimed 780G
5. History of 3 clinic visits in the last year

Exclusion Criteria:

Diabetic Ketoacidosis in the 6 months prior to screening visits

Primary outcomes:
measure: Time in Range
timeFrame: Baseline
measure: Time below range
timeFrame: Baseline
measure: Time above range
timeFrame: Baseline
measure: Basal Insulin dose
timeFrame: Baseline
measure: Correction Insulin dose
timeFrame: Baseline
measure: Pulse wave velocity
timeFrame: Baseline
measure: Endothelial glycocalyx
timeFrame: Baseline
measure: Global longitudinal strain
timeFrame: Baseline
measure: E score
timeFrame: Baseline
measure: Assessment of CAP score
timeFrame: Baseline
measure: MED diet
timeFrame: Baseline
measure: Fat mass
timeFrame: Baseline
measure: Lean Mass
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Attikon University General Hospital
Study officials:
affiliation: Attikon General University Hospital
name: Vaia Lambadiari
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05573087: Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults
Official title: Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Performance
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous research has found improvements in performance (VO2max) and clinical (insulin resistance) with cycling REHIIT. In some populations (e.g. obese, arthritic) aquatic exercise is a safer, more enjoyable option. However, to date, no study has yet examined whether aquatic REHIIT confers the same benefits as land-based REHIIT. Therefore, the purpose of this study is to determine whether there are significant differences in clinical and performance outcomes between a land-based and comparable aquatics based Reduced Exertion High Intensity Interval Training (REHIIT) protocol.


Eligibility criteria: Inclusion Criteria:

* English speaking
* sedentary individuals; Sedentary will be defined as less than 150 minutes of exercise/week as defined by the CDC and American College of Sports Medicine
* All subjects will be screened with a resting 12 lead EKG to ensure they are safe to exercise

Exclusion Criteria:

* Any vulnerable populations will be excluded including adults unable to consent/Cognitively Impaired
* individuals who are not yet adults
* pregnant or nursing women
* prisoners or other detained individuals

Primary outcomes:
measure: Changes in Cardiorespiratory Fitness
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Miriam Leary, PhD
role: PRINCIPAL_INVESTIGATOR
References: