louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04349163: Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period : Prospective Cohort.
Official title: Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological
Keywords: caregivers
covid-19
resilience
questionnaire
CD-RISC 25
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-04-16
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All caregivers willing to answer.

Brief summary: The outbreak linked to SARS-CoV-2 infection was declared a Public Health Emergency of International Concern on 30 January 2020. In all of the emergency Departments, a major reorganization was necessary, notably with the creation of a specific channel for COVID-19 suspect patients. Thus, all caregivers involved must adapt day by day to new places of exercise, new protocols,...The major influx of patients, the precautions to be taken, the specifics of the pathology and its management have profoundly changed daily practice. This exogenous hospital tension impacts all caregivers and more particularly their resilience capacities. Resilience is defined as an ability to recover from or adjust easily to misfortune or change. The Resi-CoV study aims to assess the level of resilience of caregivers of different specialties and trades in the context of covid-19.

Detailed description: Caregivers will be invited to complete a self-administered questionnaire online via a personalized electronic message. Caregivers will be free to participate. Signed consent will not be requested, but the return of the questionnaire will be considered consent. The questionnaire will be administered using Google form® software. Caregivers will have 2 weeks to respond. A reminder will be made at 7 days. The questionnaire will be anonymized upon receipt by the investigator.

Eligibility criteria: Inclusion Criteria:

* Caregivers (physicians, nurses)
* working in the Emergency Department, Anaesthesiology, Infectious Department, Intensive care Unit.
* Voluntary to answer the questionnaire

Exclusion Criteria:

- Working in another Department

Primary outcomes:
measure: compare the level of resilience between physicians and caregivers of different specialties and in different workplaces according to the covid-19 epidemic.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
Study officials:
affiliation: UH Angers
name: Delphine Douillet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00135863: MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
Official title: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammation
Nutrition
Peritoneal Dialysis
Lead sponsor: Ribe County Hospital
Sponsor class: OTHER
Collaborators: name: LEO Pharma
name: Coloplast A/S
First posted: 2005-08-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.


Eligibility criteria: Inclusion Criteria:

* End stage renal disease
* Peritoneal dialysis without complication for minimum of three months
* 18 years or above
* Informed consent

Exclusion Criteria:

* Known coagulatory defects including anticoagulation therapy
* Known bleeding tendency
* Peritonitis within two months prior to inclusion
* Pregnancy
* Breast feeding
* Active infection
* Non-informed consent
* Allergy to heparin or prior heparin induced thrombocytopenia

Primary outcomes:
measure: Grade of inflammation, local and systemic
Secondary outcomes:
measure: Vascular compliance
measure: Nutritional state
measure: Efficacy of Peritoneal Dialysis
measure: Change in local cellular distribution
measure: Change in local and systemic generation of thrombi
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Ribe County Hospital
state: Ribe
Study officials:
affiliation: Ribe County Hospital, Department of Nephrology
name: Robert S Petersen, MD
role: STUDY_CHAIR
affiliation: Ribe County Hospital, Department of Nephrology
name: Mikkel B Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03019263: Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia
Official title: Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2017-01-12
Enrollment: 63
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.


Eligibility criteria: Inclusion Criteria:

* LDL cholesterol \>100 mg/dL
* Written informed consent available

Exclusion Criteria:

* Use of any drug affecting blood lipids
* Hormone replacement therapy
* Adherence to a weigh loss diet in the previous 6 months
* Cancer diagnosis
* Known thyroid, liver, renal or muscle diseases
* Any medical or surgical condition which could lead to an inconstant adhesion to the protocol

Primary outcomes:
measure: LDL cholesterol
timeFrame: 3 months
Secondary outcomes:
measure: Insulin resistance
timeFrame: 3 months
measure: Total cholesterol
timeFrame: 3 months
measure: HDL cholesterol
timeFrame: 3 months
measure: Blood glucose
timeFrame: 3 months
measure: Serum Insulin
timeFrame: 3 months
measure: Body weight
timeFrame: 3 months
measure: Fat distribution
timeFrame: 3 months
measure: Fat Mass
timeFrame: 3 months
measure: Menopausal symptoms
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT05472363: TMS-EEG for Cortical Excitability
Official title: Electroencephalogram Coupled Non-invasive Brain Stimulation For Assessment of Cortical Excitability
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acquired Brain Injury
Stroke
Traumatic Brain Injury
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is being done to look at the safety and diagnostic benefit of conducting an TMS(transcranial magnetic stimulation)-EEG measured before and after a brief experimental stimulation session using investigational devices repetitive TMS or transcranial direct current stimulation (tDCS).


Eligibility criteria: Inclusion Criteria - Stroke:

- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury.

Inclusion Criteria - Healthy Controls:

- No known active neurological disorder.

Exclusion Criteria - Stroke:

* Pregnancy
* Contraindication to MRI or TMS including metallic implanted objects.
* Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
* Severe aphasia.
* History of epilepsy.
* History of active depression or treatment resistant depression.
* History of schizophrenia.

Exclusion Criteria - Healthy Controls:

* Pregnancy
* Contraindication to MRI or TMS including metallic implanted objects.
* History of acquired brain injury.

Primary outcomes:
measure: Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)
timeFrame: Baseline, 3 months
measure: Change in Modified Rankin Scale
timeFrame: Baseline, 3 months
measure: Change in neurological outcome (NIHSS)
timeFrame: Baseline, 3 months
measure: EEG and TMS-EEG functional connectivity
timeFrame: Baseline
measure: MRI based structural connectivity.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Zafer Keser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02639663: Dental Support Device During Breastfeeding as a Mean for Pain Control
Official title: Dental Support Device During Breastfeeding as a Mean for Pain Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breastfeeding
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-12-24
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Detailed description: Dental support device is effective in increasing isometric force in different muscle contraction \[1-7\]. In 2009 an avant-garde study \[8\] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.

Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.

This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.

Eligibility criteria: Inclusion Criteria:

Maternal age 18-45 years. Normal vital signs.

Exclusion Criteria:

Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.

Primary outcomes:
measure: Rate of change in of the vas scores before and after using this device
timeFrame: 24 months
Secondary outcomes:
measure: Duration of breastfeeding
timeFrame: 24 months
measure: The rate of cessation of breastfeeding because of pain
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Ariel many, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01196663: Comparison of the Performance of TMS-thermometer With Standard Esophageal or Urine Bladder Thermometer
Official title: Clinical Evaluation of TMS (Temperature Monitoring System) Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: to Evaluate the Performance of the TMS Thermometer and
Improve Its Algorithm
Keywords: TMS
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This Clinical study is preformed in order to estimate the performance of the TMS thermometer and to make a final tuning of the thermometer mathematical algorithm.

Body temperature of men, women and children will be measured using the TMS thermometer.

Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal thermometer as a reference.

Detailed description: Temperature measurement is vital during surgery. Accurate temperature reading can indicate patient's condition and alarm if something is wrong.

Nowadays, during surgeries temperature is measured mostly using an esophageal or a urinal thermometer, both of which are invasive, therefore they complicate the procedure and require time and activity of the medical stuff.

The TMS thermometer combines a noninvasive, biocompatible patch, which is attached to the body, and a receiving unit, which is placed near the body or the vital signs monitors and receives data from the patch. There is no connection between the body and the receiving unit. The measurement is based on a conductive sensor that measures the skin temperature and applies special algorithm in order to calculate the core body temperature.

The purpose of this clinical study is to evaluate the performance of the TMS thermometer and improve its algorithm by comparing its measurement to the esophageal or urinal temperature measurement

Eligibility criteria: Inclusion Criteria:

* Men, women and children that are about to have surgery which requires temperature monitoring.
* An informed consent was signed by the patient or his guardian.

Exclusion Criteria:

* The medical staff decides that the patient can't participate.

Primary outcomes:
measure: Correlation between TMS and the esophageal/urinary temperature measurements
timeFrame: The results of this study will be presented in 6 months from today (an average)
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Dept of anesthesiology -Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Avi Weissman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06361563: Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada
Official title: Patients With Upper Gastrointestinal Cancer Enrolled in a Patient Support Program to Receive Nivolumab in the Adjuvant Setting: Real World Data From Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 250
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: The study population is comprised of individuals diagnosed with Stage II or III esophageal cancer (EC) or gastroesophageal junction cancer (GEJC) that participated in the Bristol-Myers Squibb Patient Support Program (PSP) in Canada, GEORge PSP (GastroEsophageal Opdivo in Resected patients with residual pathological disease).

Brief summary: The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant nivolumab.


Eligibility criteria: Inclusion Criteria:

* Enrolled in Bristol-Myers Squibb GastroEsophageal Opdivo in Resected Patients with Residual Pathological Disease Patient Support Program (GEORge PSP) in Canada
* Patients who have consented to the use of their de-identified data generated from information collected in the course of the GEORge PSP

Exclusion Criteria:

* Aged \<18 years
* Did not receive concurrent chemoradiotherapy prior to surgery
* Positive margins following resection
* No residual disease following complete resection

Primary outcomes:
measure: Participant sociodemographics
timeFrame: Baseline
measure: Participant Eastern Cooperative Oncology Group (ECOG) score
timeFrame: Baseline
measure: Participant histology results
timeFrame: Baseline
measure: Participant comorbidities
timeFrame: Baseline
measure: Participant tumour location
timeFrame: Baseline
measure: Date of tumour resection
timeFrame: Baseline
measure: Participant primary upper gastrointestinal cancer diagnosis
timeFrame: Baseline
Secondary outcomes:
measure: Initial nivolumab dosage prescribed to participants
timeFrame: Index date
measure: Number of nivolumab treatments received
timeFrame: Up to 484 days
measure: Nivolumab dosage modification
timeFrame: Up to 484 days
measure: Nivolumab treatment duration
timeFrame: Up to 484 days
measure: Reason for participant discharge
timeFrame: Up to 484 days
measure: Participant adverse events (AEs)
timeFrame: Up to 484 days
measure: Management of participant adverse events (AEs)
timeFrame: Up to 484 days
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Bayshore Specialty Rx Ltd.
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01122563: A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment
Official title: Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: OABSS
IPSS
PPBC
3-day micturition diary
Solifenacin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Indonesia Inc.
First posted: 2010-05-13
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic OAB patients having urgency episodes

Brief summary: This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.


Eligibility criteria: Inclusion Criteria:

* Symptoms OAB for 3 months or longer
* At least 3 urgency episode in last 3 days
* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  * Number of micturition ≥8 times/day
  * Number of urgency episodes in 3 days ≥3

Exclusion Criteria:

* Significant stress incontinence or mixed stress/urge incontinence
* Subject with indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy
* Subjects who are prohibited from taking solifenacin as contraindications
* Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
* Participation in any clinical trial in 30 days except for Part-1 of RESORT

Primary outcomes:
measure: OABSS
timeFrame: Weeks 0, 4 and 12
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: Weeks 0, 4 and 12
measure: Quality of Life (QOL) Score
timeFrame: Weeks 0, 4 and 12
measure: Patient Perception of Bladder Condition (PPBC)
timeFrame: Weeks 0, 4 and 12
Other outcomes:
Locations:
city: Bandung
country: Indonesia
city: Jakarta
country: Indonesia
city: Surabaya
country: Indonesia
Study officials:
affiliation: Astellas Pharma Indonesia
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02881463: Prehabilitation Physical Activity in Persons With Osteoarthritis
Official title: Prehabilitation Physical Activity: Relationship With Muscle Function, Postural Stability and Postoperative Recovery in Persons With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 45
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks such as rising from a chair. Therefore interventions aimed at improving muscle strength and sit-to-stand task performance are very important for these patients. The effect of exercise programs, including home exercise programs (HEP), on muscle strength, joint pain and function is well known and widely researched, yet not many studies have investigated the effect of an HEP on electromyographic activity (EMG) of muscles when performing everyday tasks, such as rising from and sitting on a chair. The aim of this study was to investigate effect of prehabilitation in women with severe knee joint OA scheduled for knee joint arthroplasty (TKA).


Eligibility criteria: Inclusion Criteria:

* For OA patients: patients with severe knee joint OA undergoing unilateral total knee arthroplasty (TKA)
* for controls: pain of joints more than 20/100 mm by VAS

Exclusion Criteria:

For both groups:

* previous total joint arthroplasty of lower limbs
* other musculoskeletal, neurological and cardiovascular diseases
* any diseases affecting balance and coordination.

Primary outcomes:
measure: Muscle electromyographic (EMG) activity
timeFrame: up to 12 months
Secondary outcomes:
measure: Knee joint pain intensity
timeFrame: up to 12 months
measure: Knee joint function
timeFrame: up to 12 months
measure: Sit to Stand test
timeFrame: up to 12 months
measure: Mobility test
timeFrame: up to 12 months
measure: Leg muscles strength
timeFrame: up to 12 months
measure: Body balance
timeFrame: up to 12 months
measure: Gait pattern
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Tartu, Faculty of Medicine, Estonia
name: Helena Gapeyeva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: