louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05167305: The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease
Official title: The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease-A Record Based Cross-Sectional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 1316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of liver disease without COVID-19 infection admitted in the time period April- May 2021 and April-May 2019.

Brief summary: Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate.

Monitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.


Eligibility criteria: Inclusion Criteria:

1. Patients of liver disease requiring hospital admission

Exclusion Criteria:

1. Active COVID-19 infection at time of admission or acquiring during hospital stay.

Primary outcomes:
measure: Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019.
timeFrame: Until discharge or death
Secondary outcomes:
measure: Comparison of 30 days readmission rate of patients of liver disease.
timeFrame: Day 30
measure: Comparison of 31 to 90 days readmission rate of patients of liver disease.
timeFrame: Day 31-90
measure: Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019.
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT02844205: Reproducibility of a New Practical Newborn Behavioral Observation Scale
Official title: Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Newborn
Keywords: nursing care
observational scale
neonate
premature infant
developmental care
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infant hospitalized in intensive care unit.

Brief summary: Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care.

However, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development.

A new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient.

The goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.


Eligibility criteria: Inclusion Criteria:

* term of birth between 24 and 33 weeks of amenorrhea
* weight less than 1500g birth;
* postnatal age between 1 and 60 days
* consent form of parent in order to film their baby

Exclusion Criteria:

Primary outcomes:
measure: assessment of the external reproductibility of a new practical newborn behavioral observation scale
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Gilles Cambonie, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310605: Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.
Official title: Cognitive Behaviour Therapy (CBT) for Tinnitus Treatment: Implementation and Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus, Subjective
Keywords: tinnitus
CBT
cognitive behaviour therapy
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: SWOL Limburgs Fonds voor Revalidatie
name: Flemish Government, Belgium
name: The Netherlands Organization for Scientific Research (NWO)
name: Libra Revalidatie en Audiologie
First posted: 2020-03-17
Enrollment: 403
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with tinnitus

Brief summary: This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.


Eligibility criteria: Inclusion Criteria:

* Tinnitus is the primary complaint and reason for seeking help
* Participant is at least 17 years of age,

Exclusion Criteria:

* Unable to read and write in Dutch
* Tinnitus is not the primary complaint
* Person is under 17 years of age
* Participant has a health condition that prevents them from attending treatment centre
* An Ear Nose Throat (ENT) physician assesses the participant as having ontological condition that requires medical treatment

Primary outcomes:
measure: Health Utilities Index-III
timeFrame: 12 months
Secondary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).
timeFrame: 12 months
measure: Tinnitus Catastrophizing Scale (TCS)
timeFrame: 12 months
measure: Fear of Tinnitus Questionnaire (FTQ)
timeFrame: 12 months
measure: Tinnitus Questionnaire (TQ)
timeFrame: 12 months
measure: Tinnitus Disability Index (TDI)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.
Clinical trial NCT00293605: Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
Official title: Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: aseptic loosening
femoral stem design
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2006-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-assessment clinics at Sheffield Hospitals, patients booked for hip replacements.

Brief summary: Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.

Detailed description: 120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.

Eligibility criteria: Inclusion Criteria:

* patients must be aged 60 yrs or more uncomplicated primary or secondary osteoarthritis of the hip undergoing unilateral cemented total hip arthroplasty using a metal on polyethylene bearing couple.

Exclusion Criteria:

* metabolic bone disorders, systemic disorders such as rheumatoid arthritis and patients who have taken pharmacological doses of oral steroids, hormone replacement therapy, tamoxifen, calcium or vitamin D supplements within the last year. Patients with a prior history of bisphosphonates and women of child bearing age.

Primary outcomes:
measure: Proximal femoral BMD change over 2 years measured by DXA
timeFrame: 2 years
Secondary outcomes:
measure: Clinical Evaluation using patient centered questionnaire (Oxford Hip Score)
timeFrame: 2 years
measure: Surgeon centered clinical assessment (Harris Hip Score)
timeFrame: 2 years
measure: Plain radiographic assessment
timeFrame: 2 years
measure: Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.
timeFrame: 2 years
measure: Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.
timeFrame: 2 years
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Orthopaedic Department, Northern General Hospital
state: South Yorkshire
Study officials:
affiliation: STH NHS Foundation Trust
name: Andrew J Hamer, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503005: Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)
Official title: Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Diet
Fasting, Intermittent
Keywords: time restricted eating
intermitted fasting
body composition
metabolism
inflammation
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes.

Recently, dietary regimens such as calorie restriction and intermittent fasting have been promoted as new strategies for reducing obesity and related co-morbidities. These strategies have proven effective in reducing body fat, improving blood pressure, lipid profile and insulin resistance in overweight individuals. However, due to the rigidity of these food protocols, the adherence of subjects to the diet is often limited or maintained only for short periods.

Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the subject's daily calorie intake is consumed only in a certain period of time during the day (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin, HDL, TG).

The literature offers numerous versions of intermittent fasting, and the role of fasting duration is not yet fully clear. Thus. the aim of the present study is to investigate the effect od different duration of fasting in a TRE protocol on body composition and lipid and inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on long term maintenance of diet habits, body composition, lipid and inflammatory profile.


Eligibility criteria: Inclusion Criteria:

* BMI between 18-30 kg/m2
* Stable body weight for at least 3 months

Exclusion Criteria:

* type 2 Diabetes or pre-diabetes for ADA guidelines
* Significant Chronic disease
* recent and acute inflammatory status
* Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen.
* regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day

Primary outcomes:
measure: Body composition
timeFrame: 2 months
Secondary outcomes:
measure: Blood cholesterol (total, HDL, LDL)
timeFrame: 2 months
measure: Blood cytokines (IL-6; IL-1, TNF-a)
timeFrame: 2 months
measure: Morningness-Eveningness Questionnaire (MEQ) on chronotype
timeFrame: 6 month
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
affiliation: University of Padova
name: Tatiana Moro, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05522205: Regulated Cannabis Access in Basel
Official title: WEED CARE - Randomized Controlled Study on Regulated Cannabis Access for Recreational Use in Pharmacies in Basel
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cannabis Use Disorder
Mental Health Disorder
Physical Illness
Keywords: cannabis regulation
health effects
cannabis consumption
Lead sponsor: Health Department of the Canton of Basel-Stadt
Sponsor class: OTHER_GOV
Collaborators: name: University of Basel
name: University Psychiatric Clinics Basel
name: Psychiatric Services Aargau AG
First posted: 2022-08-30
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.

Detailed description: This project consist of two parts: The first part is a randomised controlled study, the second part is an observational study. The randomised controlled study will last six months. Participants will randomly be assigned to one of two groups: Group 1 has immediately access to regulated cannabis in pharmacies; Group 2 has to wait for six months. After six months all participants will have access to regulated cannabis in pharmacies (oberservational study). Every six month participants will be invited to answer online-questionnaires on their cannabis consumption behavior, their mental and physical health. The entire study lasts 2.5 years.

Eligibility criteria: Inclusion Criteria:

* At least 18 years, residence in Basel-Stadt, consuming cannabis at least monthly during the last 6 months (positive urine sample)

Exclusion Criteria:

* pregnant or breastfeeding, currently suicidal, currently psychotic, current inpatient psychiatric treatment

Primary outcomes:
measure: Change in problematic cannabis consumption behaviour
timeFrame: 6 / 12 /18 /24 / 30 months
Secondary outcomes:
measure: Change in depression
timeFrame: 6 / 12 /18 /24 / 30 months
measure: Change in anxiety
timeFrame: 6 / 12 /18 /24 / 30months
measure: Change in psychosis
timeFrame: 6 / 12 /18 /24 / 30 months
measure: Change in physical health
timeFrame: 6 / 12 /18 /24 / 30 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Canton Basel-Stadt
state: Basel-Stadt
Study officials:
References:
Clinical trial NCT00153205: Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
Official title: Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Errors
Keywords: medication errors
medical records systems, computerized
patient safety
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Patient Safety Foundation
name: Boston Children's Hospital
First posted: 2005-09-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine how effective ward-based clinical pharmacists and computerized physician order entry systems are in reducing serious medication errors in pediatric inpatients.

Detailed description: This is a prospective cohort study at Children's Hospital and Brigham and Women's Hospital (BWH), before and after the introduction of two distinct interventions. The first intervention at Children's Hospital was the introduction of clinical pharmacists on inpatient pediatric wards to target errors at the stages of physician ordering and nurse transcription. The second intervention is technological: the introduction of physician computer order entry at the BWH neonatal intensive care unit (NICU). This intervention will most effectively target errors at the stage of physician ordering, and secondarily address errors at the stage of pharmacy dispensing and nurse transcription. Data on serious medication errors will be collected pre and post each intervention.

Eligibility criteria: Inclusion Criteria:

* Patients in the BWH NICU in the study pods during the study period

Exclusion Criteria:

* Patients in other units, non-study pods, or outside of the study period

Primary outcomes:
measure: serious medication errors
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: BWH
name: Rainu Kaushal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926705: Dexmedetomidine Infusion in Hypospadias Surgery
Official title: An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Dexmedetomidine
Fentanyl
Pain
Pediatrics
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 48
Sex: MALE
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.


Eligibility criteria: Inclusion Criteria:

* Children aged 1-12 years undergoing hypospadias repair

Exclusion Criteria:

* Allergy to Dexmedetomidine
* Preoperative use of sedatives or analgesics
* cardiac diseases
* Children with mental retardation

Primary outcomes:
measure: Intraoperative and postoperative fentanyl requirement (in microg/kg)
timeFrame: 6/2008-1/2009
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
affiliation: University of Jordan
name: Khaled R Al-Zaben, MD
role: STUDY_CHAIR
References:
citation: Virtanen R, Savola JM, Saano V, Nyman L. Characterization of the selectivity, specificity and potency of medetomidine as an alpha 2-adrenoceptor agonist. Eur J Pharmacol. 1988 May 20;150(1-2):9-14. doi: 10.1016/0014-2999(88)90744-3.
citation: Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.
citation: Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-158. doi: 10.1213/01.ANE.0000093225.39866.75.
citation: Tobias JD, Berkenbosch JW. Sedation during mechanical ventilation in infants and children: dexmedetomidine versus midazolam. South Med J. 2004 May;97(5):451-5. doi: 10.1097/00007611-200405000-00007.
citation: Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.
Clinical trial NCT02694705: Assessment of Preoxygenation Strategies in the Prehospital Environment
Official title: Assessment of Preoxygenation Strategies in the Prehospital Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Hypoxia
Keywords: Oxygen Inhalation Therapy
Intubation
Emergency Medicine
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Essex and Herts Air Ambulance
First posted: 2016-02-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.

Detailed description: Prospective randomised interventional study.

Healthy volunteers will be positioned supine and undergo preoxygenation by tidal volume breathing for 3 minutes using each technique in turn. The sequence of techniques for each volunteer will be randomised in advance. Investigators will be instructed to ensure a good mask seal throughout the testing period. At the end of a 3 minute preoxygenation period, after a brief breath hold, the volunteer will exhale into reservoir tubing, allowing the fractional expired oxygen concentration (FeO2) to be determined (primary outcome) using a calibrated gas analyser.

The techniques being assessed have been chosen from methods of preoxygenation commonly available to clinicians in the prehospital environment:

1. Continuous Positive Airway Pressure mode with fractional inspired oxygen concentration (FiO2) 100% using a portable ventilator.
2. Bag-valve-mask device (BVM) with 15 l/min oxygen flow.
3. Non-rebreather mask (NRM) device with 15 l/min oxygen flow.

Volunteers will also be asked to indicate the subjective ease of breathing for each technique (secondary outcome) using a visual analogue scale (VAS).

Eligibility criteria: Inclusion Criteria:

* Adult volunteers

Exclusion Criteria:

* Pregnancy
* Respiratory disease
* Bearded
* Facial abnormality
* Edentulous

Primary outcomes:
measure: Fractional Expired Oxygen Concentration
timeFrame: 3 minutes
Secondary outcomes:
measure: Ease of breathing assessment using a visual analogue scale
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Earls Colne
country: United Kingdom
facility: Essex & Herts Air Ambulance Trust
state: Essex
Study officials:
affiliation: Queen Mary University of London
name: Christopher J Groombridge, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.