louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06840249: Pediatric Vascular Trauma
Official title: Outcomes of Pediatric Vascular Trauma in Assiut University Hospital Trauma Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pediatric vascular trauma from age 3 yrs uo to 18 yrs

Brief summary: pediatric vascular trauma

Detailed description: outcomes of treatment and also observation

Eligibility criteria: Inclusion Criteria:

* less than 18 years and more 3yrs

Exclusion Criteria:

* iatrogenic injury in non trauma setting

Primary outcomes:
measure: limb salvage rates
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Morao S, Ferreira RS, Camacho N, Vital VP, Pascoal J, Ferreira ME, Capitao LM, Goncalves FB. Vascular Trauma in Children-Review from a Major Paediatric Center. Ann Vasc Surg. 2018 May;49:229-233. doi: 10.1016/j.avsg.2017.10.036. Epub 2018 Feb 9.
Clinical trial NCT05658549: Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
Official title: Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into four groups. The control group K0 received standard therapy without NAC, while the treatment group, K1, received NAC injections of 1200mg/day, K2 NAC tablets 3x400mg/day, and K3 NAC tablets 3x200mg/day. Different tests using Way ANOVA and LSD or Kruskal-Wallis and Mann-Whitney.
Primary purpose: TREATMENT

Brief summary: This research is a study that compares the administration of N-acetylcysteine at various doses with the outcomes of COVID-19 patients, namely the neutrophil-to-lymphocyte ratio and length of stay.

Detailed description: This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into four groups. The control group K0 received standard therapy without NAC, while the treatment group K1 received NAC injections of 1200mg/day, K2 NAC tablets 3x400mg/day, and K3 NAC tablets 3x200mg/day. Different tests using Way ANOVA and LSD or Kruskal-Wallis and Mann-Whitney.

Eligibility criteria: Inclusion Criteria:

* moderate or severe grade confirmed COVID-19 (patients with symptoms and radiological examination showing pneumonia with or without signs of severe pneumonia: SpO2\<90%, respiratory rate\>30x/min, and severe respiratory distress) who were admitted to UNS Hospital and age 18-60 years old

Exclusion Criteria:

* patients who died during the treatment period

Primary outcomes:
measure: Neutrophil to lymphocyte ratio
timeFrame: Change of Neutrophil to lymphocyte ratio at 7 day
measure: Length of stay
timeFrame: From date of randomization until the date of return from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Sukoharjo
country: Indonesia
facility: Universitas Sebelas Maret Hospital
state: Central Java
Study officials:
References:
Clinical trial NCT03461549: Pressure and Temperature Sensor for Therapeutic Compression Garments
Official title: Open-label Preliminary Assessment of a Thin Flexible Pressure and Temperature Sensor for Therapeutic Compression Garments Using a Cohort of Healthy Adults Phase 2: Point-of-Care Wearable Pressure/Temp Sensor System for Therapeutic Compression Garments in Venous Leg Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Venous Leg Ulcer
Keywords: pressure sensor
temperature sensor
wearables
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Wearifi, Inc.
First posted: 2018-03-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults without a history of medical or surgical problem. There will be no subject compensation.

Brief summary: Pilot study of a soft, flexible pressure and temperature sensor

Detailed description: Assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. The pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.

Eligibility criteria: Inclusion Criteria:

* Healthy adults over the age of 18 years old

Exclusion Criteria:

* Subjects with history of medical or surgical problems

Primary outcomes:
measure: Pressure comparison with PicoPress
timeFrame: 72 hours
measure: Temperature with a comparator device (infrared camera)
timeFrame: 72 hours
Secondary outcomes:
measure: Visual analogue scale of skin irritation
timeFrame: 72 hours
measure: Participant survey
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03036449: Efficacy of a Multifaceted Intervention to Reduce Medication Administration Errors in Neonatal Intensive Care Units
Official title: Efficacy of Tools Associated With a Multifaceted Education Intervention Directed to Health Professionals to Reduce Medication Preparation and Administration Error Rates in Neonatal Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Intensive Care
Keywords: Medication errors
Patient safety
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 5143
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients less than 2 years old, hospitalized in the intensive care during the observation periods and receiving drugs.

Brief summary: The purpose of this study is to determine whether an educational program for caregivers associated with convenient tools is effective to reduce medication preparation and administration errors in the Neonatal Intensive Care Units (NICU).

Detailed description: Medication errors are frequent in neonatal intensive care units and consequences are more severe than in adults. Although errors happen in each step of medication management process, a large proportion of errors occur during medication preparation and administration.

This study will test the hypothesis that rates of medication errors during preparation and administration will be reduced by implementing an education program for NICU caregivers (Nurses) and providing convenient tools.

The trial has a stepped wedge design, in which the NICU's from three hospitals in France will be randomized (Group A, B and C) to the timing of implementation of the educational intervention.

According to the allocation (Group A, B or C), the education intervention will include a complete main program of nine weeks and one to three maintenance educational periods.

Medication administration errors rates will be measured before (baseline measurements) and after each educational interventions (main or maintenance interventions).

Errors will be identified by direct observations of nurse's acts by external observers.

Eligibility criteria: Inclusion Criteria:

* All nurses working in the intensive care units in the day time.

Exclusion Criteria:

* Nurses working as a float or pool nurses.
* Nurses working at night.

Primary outcomes:
measure: Medication administration error rates in the patients
timeFrame: Baseline and up to 49 weeks
Secondary outcomes:
measure: Levels of safety culture among the caregivers (Nurses)
timeFrame: Baseline and up to 49 weeks
measure: Levels of medication errors reported by caregivers.
timeFrame: Baseline and up to 49 weeks
measure: Acceptance of the educational program
timeFrame: Baseline and up to 49 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de pédiatrie - Hôpital Pellegrin
city: Caen
country: France
facility: CHU Côte de Nacre
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References:
Clinical trial NCT05529849: A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects
Official title: A Two-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Subcutaneous Doses of TCMCB07 on Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cachexia
Lead sponsor: Endevica Bio
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.
* Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
* Weight ≥ 50 kg at Screening

Exclusion Criteria:

* Serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol.
* Evidence of current severe acute respiratory syndrome coronavirus 2 infection.
* Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
* Subjects who have received any IP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IP and first dose be less than 30 days.

Primary outcomes:
measure: Number of people with an Adverse Event Assessment
timeFrame: 6 Months
measure: Number of participants with abnormal vital signs
timeFrame: 6 Months
measure: Number of people with abnormal laboratory test results
timeFrame: 6 Months
measure: Number of people with abnormal Electrocardiograms
timeFrame: 6 Months
measure: Number of people with abnormal physical examinations
timeFrame: 6 Months
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 6 Months
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences -- Miami, Inc.
state: Florida
Study officials:
affiliation: Quotient Sciences
name: Maria Bermudez, MD, CPI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02023749: Effects of Nut Consumption on Metabolic Syndrome
Official title: Effects of Nut Consumption on Metabolic Syndrome in Korean Adults - A Randomized Controlled Dietary Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: nuts
metabolic syndrome
lipid profile
inflammation
oxidative stress
endothelial function
Lead sponsor: Ministry of Food and Drug Safety, Korea
Sponsor class: OTHER_GOV
First posted: 2013-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to investigate the effects of nut consumption on metabolic parameters and biomarkers related to inflammation, oxidative stress, and endothelial function in Korean adults with metabolic syndrome.

Detailed description: A randomized, controlled, parallel, dietary intervention study was designed. Subjects with metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the Nut group, which were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks; or allocated to the Control group. Metabolic markers were evaluated at baseline and at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Subjects were enrolled if their body mass index (BMI) was ≥23 kg/m2 and they met the criteria for metabolic syndrome.

Exclusion Criteria:

* Subjects were excluded if they had a nut allergy, peptic disorder, a history of cancer or cardiovascular disease including coronary artery disease, heart valve disease, or stroke, or established chronic diseases such as chronic renal insufficiency or cirrhosis. Subjects were also excluded if they:1) were receiving treatment with hypoglycemic agents for diabetes or had HbA1c \>7%; 2) were receiving corticosteroid treatment; 3) had started antihypertensive or lipid-lowering agents, or changed their doses within the previous month; 4) had a weight change ≥5 % of body weight during the three months prior to the study; 5) were pregnant; or 6) were regular nut consumers (\>15g/day of nuts at least three times a week).

Primary outcomes:
measure: metabolic parameters
timeFrame: 6 weeks
measure: inflammation markers
timeFrame: 6 weeks
measure: Endo-peripheral artery tonometry (EndoPAT) index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan-si
country: Korea, Republic of
facility: Department of Endocrinology and Metabolism, Korea University Ansan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Endocrinology and Metabolism, Korea University Ansan Hospital
name: Nan Hee Kim, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YJ, Nam GE, Seo JA, Yoon T, Seo I, Lee JH, Im D, Bahn KN, Jeong SA, Kang TS, Ahn JH, Kim DH, Kim NH. Nut consumption has favorable effects on lipid profiles of Korean women with metabolic syndrome. Nutr Res. 2014 Sep;34(9):814-20. doi: 10.1016/j.nutres.2014.08.011. Epub 2014 Aug 30.
Clinical trial NCT00974649: Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis
Official title: Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: drop-out
predictors of treatment continuation/discontinuation
IVF/ICSI
infertility
counseling
psychology
Assisted Reproduction
Counselling
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2009-09-10
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study aims to explore and analyse the decision making process of couples in regards to continuing or discontinuing infertility treatment. A longitudinal, prospective cohort design is used which allows the monitoring of patients over a longer period of time. Data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth interviews) to allow for a more specific and in depth experience than can be obtained by using a questionnaire study. Innovative aspects of the study include:

1. exploration of determinants of continuing and discontinuing infertility treatment by using a comprehensive psychological theory (both surface and in-depth)
2. exploration of gender differences in the decision making process in continuing or discontinuing treatment
3. longitudinal and prospective arm of the study will allow to gain insight into the 'process'
4. prediction of continuing/discontinuing treatment based on psychological variables.


Eligibility criteria: Inclusion Criteria:

* first IVF/ICSI treatment
* sufficient knowledge of Dutch to fill out questionnaires
* heterosexual couples

Exclusion Criteria:

* insufficient knowledge of Dutch
* having had previous IVF/ICSI treatment

Primary outcomes:
measure: psychological predictors of continuing or discontinuing infertility treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Gasthuisberg
Study officials:
affiliation: University Hospital Gasthuisberg, Leuven, Belgium
name: Thomas D'Hooghe, M.D., PhD
role: STUDY_DIRECTOR
affiliation: University Hospitals Gasthuisberg, Leuven, Belgium
name: Uschi Van den Broeck, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van den Broeck U, D'Hooghe T, Enzlin P, Demyttenaere K. Predictors of psychological distress in patients starting IVF treatment: infertility-specific versus general psychological characteristics. Hum Reprod. 2010 Jun;25(6):1471-80. doi: 10.1093/humrep/deq030. Epub 2010 Mar 25.
Clinical trial NCT02398149: Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis
Official title: Characterizing Upper Extremity Function in Individuals With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Mount Sinai Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2015-03-25
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with MS who receive care at the Mandell Center for Multiple Sclerosis.

Brief summary: Upper extremity (UE) function is critical to maintaining independence. Better understanding of UE involvement in MS will provide necessary information to prioritize the design and selection of future interventions. The goal of the proposed project is to characterize UE involvement in a population of community-based persons with MS across the International Classification of Functioning, Disability \& Health (ICF) domains and constructs.


Eligibility criteria: Inclusion Criteria:

* Confirmed clinical Clinical diagnosis of MS
* Receive MS care at the Mandell MS Center
* Cognitively able to understand directions and complete protocol
* Signed consent form approved by the Saint Francis Institutional Review Board
* 18 years of age or older

Exclusion Criteria:

* Unwilling or unable to complete assessments

Primary outcomes:
measure: Prevalance of Impairment in the Upper Extremity
timeFrame: 3hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT01181349: Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed)
Official title: Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: neuromuscular blockade; general anesthesia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Portuguese participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents

Brief summary: This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Informed consent signed
* Admission for elective surgery
* Administration of nondepolarizing NMBAs during surgery

Exclusion Criteria:

* Admission for emergency surgery
* Reoperation on the same hospital admission

Primary outcomes:
measure: Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
timeFrame: Upon arrival in the PACU
Secondary outcomes:
measure: Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents
timeFrame: From start of surgery through PACU arrival
measure: Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane
timeFrame: From start of surgery through PACU arrival
measure: Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents
timeFrame: From end of surgery through PACU arrival, an expected average of 10 minutes
measure: Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events
timeFrame: From end of surgery through hospital discharge, an expected average of 6 days
Other outcomes:
Locations:
Study officials:
References:
citation: Esteves S, Martins M, Barros F, Barros F, Canas M, Vitor P, Seabra M, Castro MM, Bastardo I. Incidence of postoperative residual neuromuscular blockade in the postanaesthesia care unit: an observational multicentre study in Portugal. Eur J Anaesthesiol. 2013 May;30(5):243-9. doi: 10.1097/EJA.0b013e32835dccd7.