louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02659449: Assessing the Impact of Different Compression of the Hand Versus Free Hand on the Implementation of the Precision Grip
Official title: Assessing the Impact of Different Compression of the Hand (Made to Measure Gloves / Compression Bandaging) Versus Free Hand on the Implementation of the Precision Grip
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Burned Hands
Keywords: hands
Lead sponsor: Hôpital Léon Bérard
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with burned hands

Brief summary: The purpose of this study is to determine the impact of compressing therapy on the dexterity of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board / Jamar's test)

Detailed description: Patients with burned hands will realise prehension test to explore dexterity of hand when they wear compressive's treatments and with free hands.

Each patient will realise each test with all conditions (free hands/ made to measure gloves/ compressive bandaging).

Running order of test and condition is randomly defined. Each patient realized this tests under the care and devices used at usual care. Realisation of this tests are not influenced by the study. Patient realised this tests during reeducation.

Eligibility criteria: Inclusion Criteria :

* Patient admitted from Leon Bérard Hospital
* Burn hand with 2nd or 3nd degree depp
* Dominant hand if bilateral's burning
* Patients requiring compression of the hand
* Patient receiving final compression gloves since seven days ± two days weekend
* Patient affiliated to a social security

Exclusion Criteria :

* No burning of the hand
* contraindication for the use of compression
* Incompatible articular balance with achievement tests
* Patients already included in a second study
* Minor patient or pregnant woman
* Presence of cognitive disorder, preventing the achievement of tests
* Guardianship or individual under the protection of a conservator
* Patients not receiving social security

Primary outcomes:
measure: Box and Block test
timeFrame: mesure will be realised three time : 48h - 96h -144 hours after inclusion
measure: Purdue Pegboard test
timeFrame: mesure will be realised three time: 48h - 96h -144 hours after inclusion
measure: Jamar's Test
timeFrame: mesure will be realised three time :48h - 96h -144 hours after inclusion
Secondary outcomes:
measure: Quick DASH test
timeFrame: 24 hours after inclusion
Other outcomes:
Locations:
city: Hyeres
country: France
facility: Leon Berard hospital
state: Paca
Study officials:
affiliation: Léon Bérard Hospital
name: Valerie Chavineau-Mortelette, MedD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04199949: Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans
Official title: Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FMD
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types of cancer, and has been proposed to be the 4th leading cause of death worldwide. The investigators aim is to assess the vascular (endothelial) function before and after a 5-day period of reduced activity of upper and lower limbs via an arm sling and daily step counts reduction, respectively, in healthy participants. Twelve young (ages of 18 - 35 years), healthy, males and females, recreationally active with a body mass index between 18 and 27 kg/m2 will be recruited. The participants will then randomly undergo two 5-day interventions: (A) 5 consecutive days of habitual daily levels of physical activity and matched food intake (Control trial). (B) 5 consecutive days of reduced step count by 80% compared to the Control trial combined with their non-dominant arm placed in a sling and a reduction in food (energy) intake (\~20%) to match the reduction in energy expenditure induced by inactivity (Inactivity trial). On days 1 and 6 of each experimental trial, the endothelial function of the brachial and popliteal arteries, and hand grip strength will be measured.


Eligibility criteria: Inclusion Criteria:

* Non-smoking
* Males
* Age (18-35 years old)
* Body mass index (BMI) of 18-27 kg/m2
* Recreationally active
* Ability to give informed consent

Exclusion Criteria:

* Smoking
* Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
* Clinically significant abnormalities on screening including ECG abnormalities
* Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
* Well-trained individuals
* On an energy-restricted diet or seeking to lose weight
* High alcohol consumption (\<3-4 units/day)

Primary outcomes:
measure: Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery
timeFrame: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
measure: Change from baseline of flow-mediated vasodilatation (FMD) of the popliteal artery
timeFrame: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
Secondary outcomes:
measure: Hand grip strength
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: The University of Nottingham
state: Nottinghamshire
Study officials:
References:
Clinical trial NCT01408849: Use of Maytenus Ilicifolia in the Treatment of Dyspepsia
Official title: Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyspepsia
Keywords: Endoscopy
Herbal medicine
Phytotherapy
Lead sponsor: Casa Espirita Terra de Ismael
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2011-08-03
Enrollment: 4
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 study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA score, secondary endpoint is endoscopic classification (Sydney).


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* being literate
* diagnosis of dyspepsia
* initial SODA score \> or = 25

Exclusion Criteria:

* pregnancy
* lactation
* allergy to Maytenus species
* fail to use the drug for 3 uninterrupted weeks
* new onset serious adverse events, attributable to the drug
* patient's request

Primary outcomes:
measure: SODA score
timeFrame: 8 weeks
Secondary outcomes:
measure: Sydney classification
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas FMRP-USP
state: SP
Study officials:
affiliation: University of Ribeirao Preto
name: Ana MS Pereira, PhD
role: STUDY_DIRECTOR
affiliation: HCFMRP-USP
name: Jose S Santos, MD, PhD
role: STUDY_CHAIR
affiliation: HCFMRP-USP
name: Fabio Carmona, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCFMRP-USP
name: Suzeidi B Castanheira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05485649: Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study
Official title: Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Keywords: Pregnancy
Neonatal
Obstetrical
Anti-seizure medication
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant individuals with epilepsy seen at the Toronto Western Hospital Clinic.

Brief summary: The aim of this study is to investigate the pregnancy, delivery, neonatal, and epilepsy outcomes in individuals with epilepsy undergoing pregnancy at the Maternal and Infant Health Programs at the University Health Network - Sinai Health and followed for epilepsy at the Toronto Western Hospital Epilepsy Clinic. In particular, we are interested in the association between following recommended epilepsy management guidelines for pregnant individuals with epilepsy and those aforementioned outcomes.


Eligibility criteria: Inclusion Criteria:

1. WWE seen at the Toronto Western Hospital Epilepsy Clinic since June 1st 2022.
2. Pregnant at any point between June 1st 2022 and June 1st 2024 (period of enrolment).
3. Diagnosed with epilepsy as per the International League Against Epilepsy (ILAE) 2014 definition of epilepsy.

Exclusion Criteria:

* None

Primary outcomes:
measure: Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy
timeFrame: 2 years
Secondary outcomes:
measure: Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT01020149: Evaluation of Nerve Regeneration After Nerve Transsection Using (Diffusion-tensor Magnetic Resonance Imaging) DTI MR Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nerve Degeneration
Keywords: Nerve transsection
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: To prospectively evaluate the nerve regeneration after traumatic nerve transsection using diffusion tensor magnetic resonance imaging (DTI MR imaging).


Eligibility criteria: Inclusion criteria:

* Patients with traumatic nerve transsection and nerve repair.

Exclusion criteria:

* contraindication for MRI;
* pregnancy;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT00179049: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant
Official title: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant (HSCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Graft vs Host Disease
Keywords: T-Lymphocyte Subsets
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
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: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Brief summary: The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease.

Detailed description: The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease (GVHD) by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Their understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.

Eligibility criteria: Inclusion Criteria:

* Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Exclusion Criteria:

* Patients \< 18 or \> 70 years old undergoing either autologous transplant or allogeneic transplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Adetola A Kassim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00589849: T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy
Official title: T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Arrhythmias
Keywords: Myocardial Infarction
Arrhythmia
T-wave alternans
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief summary: T-wave alternans is an electrocardiographic finding that has been shown to predict the occurrence of future cardiac arrhythmias in patients who have had a heart attack. What is unknown about T-wave alternans testing is when is the best time to perform the test. In most studies, T-wave alternans testing is conducted 4 weeks or more after a heart attack. It is unknown if T-wave alternans testing performed prior to hospital discharge in heart attack patients is reliable. The objective of this project is to determine the diagnostic accuracy of T-wave alternans testing performed prior to hospital discharge and again at 30 days after hospital discharge in patients who have suffered a heart attack.


Eligibility criteria: Inclusion Criteria:

* Acute Myocardial Infarction (MI) confirmed by electrocardiographic and or/ enzymatic criteria
* Patients with a left ventricular ejection fraction of 45% or less

Exclusion Criteria:

* Patients with (1) atrial fibrillation, (2) pacemaker rhythm, (3) left bundle branch block, (4) class III-IV heart failure, (5) inability to achieve a target heart rate with exercise or handgrip stress or (6) spontaneous sustained ventricular tachycardia/ventricular fibrillation will be excluded
* Patients with recurrent angina pectoris, MI, coronary revascularization, or any other adverse cardiovascular event in the 30 days following their initial MI will also be excluded

Primary outcomes:
measure: Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI
timeFrame: 30 days
measure: Event Free Survival at 1 Year
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Aryan Mooss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06467149: Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools
Official title: Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty Syndrome
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Education, China
First posted: 2024-06-20
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical assessment and data collection of older adults over 50 years of age with breast cancer diagnosed at a tertiary hospital in China, with no comorbidities of other malignancies.

Brief summary: This study uses the Physical Frailty Phenotype (PFP) as the diagnostic criterion for frailty and aims to explore the frailty screening scale FRAIL (The FRAIL Scale), Tilburg Frailty Index (TFI) and geriatric screening. Screening performance of Tool-8 (Geriatric-8, G-8) in breast cancer patients, to compare the predictive validity of different frailty screening scales for adverse health outcomes in breast cancer patients, and to select appropriate frailty screening methods for breast cancer patients in my country Screening scale.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of breast cancer
* Age ≥50 years old
* the treatment plan discussed by MDT includes surgery and chemotherapy
* can walk on their own (with the assistance of walking aids)

Exclusion Criteria:

* Communication disorders
* Mental disorders that can't cooperate normally
* Combined with other malignant tumours
* Terminal stage of the disease

Primary outcomes:
measure: Falls
timeFrame: From 2023.8~2025.12.
measure: Unplanned hospitalisation
timeFrame: 2023.8~2025.12.
measure: Disability
timeFrame: From 2023.8~2025.12.
measure: Depression
timeFrame: From 2023.8~2025.12.
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Ju Qiu
Study officials:
affiliation: Tutor
name: Ling-Na kong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05236049: Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
Official title: Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Enucleated; Eye
Eye Cancer
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection.

Detailed description: As scleral graft is forbidden in France, it cannot be used for support of enucleation implants. This study investigational product, SclerFIX, was developed to substitute scleral grafts in those cases.

Eligibility criteria: Inclusion Criteria:

* Men or women between 45 and 85 years old, presenting an enucleation caused by malignant tumor resection.
* Oncological treatment compatibility with enucleation and intra-orbital implant.
* Surgery requiring the placement of an enucleation implant.
* Persistence of the oculomotor muscles allowing their insertion into the tissue.
* Patient with social security coverage.
* Consenting and informed patient.

Exclusion Criteria:

* Pregnant or breast-feeding women: women of childbearing age were asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
* Patient presenting an infectious risk (neutropenia, active local infection, immunodeficiency).
* Patient with autoimmune disease.
* Proton-therapy / radiotherapy of the eye before healing.
* Patient with oculomotor muscles invasion or non-attachment of these muscles.
* Allergy to contrast agents used in radiology.
* Patient under legal guardianship.
* Patient not benefiting from the social security cover.

Primary outcomes:
measure: Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
timeFrame: Through study completion (6 months)
Secondary outcomes:
measure: Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility
timeFrame: 7 days, 15 days, 1 month, 3 months, 6 months
measure: Evaluation of surgical wrapping and attachment with muscles
timeFrame: Time of investigational product surgical implantation (Day 0)
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
References:
Clinical trial NCT05373849: Evaluation of the Efficacy of Aromatherapy on the Well-being of Healthcare Professionals
Official title: Evaluation of the Efficacy of Aromatherapy on the Well-being of Hospital Healthcare Professionals: a Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare Professionnals
Keywords: Aromatherapy
stress
anxiety
quality of life
critical care
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The main objective is to evaluate the efficacy of aromatherapy (inhaler sticks) on the well-being of healthcare professionals practicing in medical and surgical intensive care unit, operating room/anesthesia and emergency departments

Detailed description: The secondary objectives of this study are :

1. To evaluate the efficacy of aromatherapy on anxiety of healthcare professionals;
2. To evaluate the efficacy of aromatherapy on stress symptoms of healthcate professionals;
3. To assess compliance with aromatherapy.

Conduct of research:

All participants included in the study will receive the study treatment (essential oils mixtures in inhaler sticks for 2 months) and the control (no intervention for 2 months), in random order. At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.

Eligibility criteria: Inclusion Criteria:

* Healthcare professional ;
* Working in a medical or surgical intensive care unit or in a operating room/anesthesia unit or in the emergency department;
* Agrees not to use any topical, oral or inhaled essential oils during the two study periods, other than those specified in the study protocol;
* Written informed consent;

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* Known allergies to essential oils;
* Asthma;
* Scheduled departure from the unit;
* Antidepressant treatment or anxiolytic treatment;
* Taking topical, oral or inhaled essential oils durink the week prior to inclusion.

Primary outcomes:
measure: World Health Organization index of well-being
timeFrame: Through study completion, 4 months
Secondary outcomes:
measure: Spielberger General Anxiety Questionnaire
timeFrame: Through study completion, 4 months
measure: Perceived Stress Scale
timeFrame: Through study completion, 4 months
measure: Follow-up diary
timeFrame: End of aromatherapy, 2 months
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA
Study officials:
References: