louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04308187: Influence of the COvid-19 Epidemic on STRESS
Official title: The COVISTRESS Study: Influence of the COvid-19 Epidemic on STRESS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress, Psychological
Keywords: Stress, Psychological
Coronavirus
Epidemics
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France
name: Wittyfit, Paris, France
First posted: 2020-03-13
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

Detailed description: This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (Facebook, Twitter, institution mailing lists via a referent, flash codes distributed to patients and the public, etc.).

The self-questionnaire will assess stress, perception and knowledge of the epidemic, the feeling of information on the part of businesses / establishments / governments, the means of protection used the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

Eligibility criteria: Inclusion Criteria:

* Anyone volunteer to participate

Exclusion Criteria:

* Anyone non-voluntary to participate

Primary outcomes:
measure: Stress
timeFrame: Day 1
Secondary outcomes:
measure: Perception and knowledge of the epidemic
timeFrame: Day 1
measure: Feeling of information on the part of companies / establishments / governments
timeFrame: Day 1
measure: Means of protection
timeFrame: Day 1
measure: Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients
timeFrame: Day 1
measure: Sociodemographic factors and lifestyle habits
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Fréderic DUTHEIL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02904187: Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
Official title: Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 43
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 primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation


Eligibility criteria: Inclusion criteria for patients:

- profoundly deaf patients with bilateral cochlear implants

Exclusion criteria for patients:

* post-operative complications
* incomplete surgical insertion of one of the cochlear implant
* age under 18 years
* non-compliant patient
* pregnant woman or woman with no efficient contraception method
* informed consent not signed
* no health insurance

Inclusion criteria for control

- normal hearing subjects

Exclusion criteria control

* normal hearing subject
* subject under 18 years old
* unilateral or bilateral hearing loss
* non-compliant subject
* pregnant woman or woman with no efficient contraception method
* informed consent not signed
* no health insurance

Primary outcomes:
measure: Cortical brain activation pattern
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon cedex 03
country: France
facility: Département d'ORL, Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT04829487: The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D
Official title: The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D: A Randomized, Double-blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypovitaminosis D
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of vitamin D supplementation on the pain score of primary dysmenorrhea. Our hypothesis is that by normalizing vitamin D level could help improve pain score of women who have primary dysmenorrhea.

Detailed description: This study is aimed to be conducted in randomised controlled trial, comparing between intervention group and placebo group. We include women with primary dysmenorrhea who also have low vitamin D level in this trial. Our primary outcome is to compare visual analog pain scale between intervention and placebo group after treatment. After randomised and allocated, these women will be given vitamin D 50,000 IU or placebo capsules orally weekly for 8 consecutive weeks. We monitor pain score daily from the cycle before the drugs started until complete 8-week course of the regimen mentioned. Also vitamin D levels will be monitored twice, one before treatment and the other after treatment.

Eligibility criteria: Inclusion Criteria:

* Primary dysmenorrhea
* Hypovitaminosis D

Exclusion Criteria:

* Using calcium, magnesium or phosphorus in the past 3 months
* Using hormonal contraception or IUD in the past 6 months
* No smoking or alcohol drinking
* Chronic underlying diseases
* Allergic to components in study drugs

Primary outcomes:
measure: Visual analog pain scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Reproductive medicine unit, Department of OB-GYN, Faculty of Medicine, Siriraj Hospital
name: Mananya Silpakit, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02610387: The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients
Official title: The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: tDCS
stroke
Spasticity
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 40
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: Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well.

Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on lower limbs spasticity in chronic stroke patients using laboratory and clinical assessments.

Detailed description: In a randomized, sham-controlled, double-blinded clinical study, hemiplegic chronic stroke patients are randomized to receive active tDCS delivered to lesioned leg motor cortex (CZ) or sham combined with balance training with Biodex balance system.

Experimental group receive tDCS stimulation (2mA) for 20 min, 5 sessions in five days paired with 20 min balance training.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years;
* first-ever ischemic stroke;
* chronic phase of recovery (\>6 months);
* ability to walk 6- meter supported or unsupported;
* ability to stand at least unsupported for 40-seconds with eyes closed;
* only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.

Exclusion Criteria:

* Use of any neuro- or psycho-active medications that alters balance;
* any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases;
* ongoing/recent (within 3 months) balance rehabilitation.

Primary outcomes:
measure: Spasticity (Modified Ashworth scale)
timeFrame: After 5 days
Secondary outcomes:
measure: Motoneuron excitability (H-reflex latency)
timeFrame: After 5 days
measure: Motoneuron excitability
timeFrame: After 5 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti Univesity of Medical sciences
state: Velenjak
Study officials:
References:
Clinical trial NCT02404987: An Oral Nutritional Supplement Study in Older Malnourished Spanish Population
Official title: A Prospective, Observational Study, of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished Spanish Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 224
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished.

Brief summary: Post-marketing observational study of a nutritional care plan, including a higher calorie, higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished. The objective is to assess the impact of the ONS on body weight, activities of daily living and quality of life.


Eligibility criteria: Inclusion Criteria:

* Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study.
* Considered malnourished, or is at risk for malnutrition based on NRS 2002 score ≥3.
* ≥65 years of age.
* Conforms to the requirements set forth on the study product label.
* Under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/d of the study ONS, orally, by their health care professional.
* Free living or residing in a nursing home.
* Estimated, or measured, glomerular filtration rate \>60ml/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) Study equation) within 60 days of beginning their nutritional care plan.
* Body mass index (BMI) is \<30 kg/m2.
* Study physician determines the subject is fit to participate.

Primary outcomes:
measure: Body Weight
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Change from baseline to 12 weeks
measure: Katz Activities of Daily Living
timeFrame: Change from baseline to 12 weeks
measure: Quality of Life
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario
Study officials:
affiliation: Abbott Nutrition
name: Rebeca Sanz Barriuso, RD, PharmD
role: STUDY_CHAIR
References:
Clinical trial NCT02480387: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
Official title: A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment of Hepatitis C
Lead sponsor: Peter J. Ruane, M.D., Inc.
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 20
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA \< 6 x106 IU/mL

Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment


Eligibility criteria: Inclusion Criteria:

* Chronic HCV GT1, treatment-naïve, non-cirrhotic adult subjects.
* HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening

Exclusion Criteria:

* Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
* Solid organ transplantation.
* Significant cardiac disease or other significant co-morbidities that could interfere with study treatment.
* Malignancy within the 3 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
* Infection with hepatitis B virus (HBV)

Primary outcomes:
measure: SVR12
timeFrame: Sustained Virologic Response 12 Weeks Post-Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Peter J. Ruane, MD, Inc.
state: California
Study officials:
References:
Clinical trial NCT03469687: Symax International Study
Official title: 5 Year Clinical and Radiographic Follow-up of the Uncemented Symax Hip Stem in an International Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Prosthesis Durability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
name: Stryker Orthopaedics
First posted: 2018-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35.

Exclusion Criteria:

* Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.

Primary outcomes:
measure: Change of Harris Hip Score (HHS) during follow-up
timeFrame: Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years
Secondary outcomes:
measure: Radiographic evaluations
timeFrame: Immediately postoperative radiograhpic evaluation as baseline and changes in radiography at follow-up 6 months, 1 year, 2 years, 3 years and 5 years we evaluated the radiograhip evaluations again
Other outcomes:
Locations:
Study officials:
References:
citation: ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103.
citation: ten Broeke RH, Alves A, Baumann A, Arts JJ, Geesink RG. Bone reaction to a biomimetic third-generation hydroxyapatite coating and new surface treatment for the Symax hip stem. J Bone Joint Surg Br. 2011 Jun;93(6):760-8. doi: 10.1302/0301-620X.93B6.24986.
citation: Kruijntjens DSMG, Kjaersgaard-Andersen P, Revald P, Leonhardt JS, Arts JJC, Ten Broeke RHM. 5-year clinical and radiographic follow-up of the uncemented Symax hip stem in an international study. J Orthop Surg Res. 2018 Jul 31;13(1):191. doi: 10.1186/s13018-018-0888-9.
Clinical trial NCT00764387: Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.
Official title: Contrast-enhanced MRI Examination of Cerebral Neoplastic Enhancing Lesions: Comparison of Diagnostic Efficacy of Gd-DOTA 0.5M and Gadobutrol 1.0 M at 0.1 mmol/kg Body Weight: Intraindividual Comparison Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplastic CNS Lesions
Keywords: Neoplastic CNS lesions
Contrast enhanced MRI
Comparison
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study to compare of two contrast agents in imaging brain lesions.


Eligibility criteria: Inclusion Criteria:

* Known neoplastic CNS lesions

Primary outcomes:
measure: The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.
timeFrame: October 2007 to November 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Andria
country: Italy
state: Bari
city: Catania
country: Italy
city: Chieti
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Novara
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Trieste
country: Italy
city: Verona
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00188487: Magnetic Resonance (MR) in Asthmatic Patients
Official title: MR Perfusion Imaging in Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Asthma is a disease of small airways. Affected areas have reduced lung ventilation causing reflex vasoconstriction. MR perfusion imaging of the lungs is a sensitive method of imaging zonal lung perfusion.

Detailed description: A cohort of 70 Asthmatic Patients and 10 controls, both sets of subjects have HRCT, MRI/A of the Thorax, and Pulmonary Function Tests to correlate the degree of pulmonary dysfunction with findings on imaging tests.

Eligibility criteria: Inclusion Criteria:

* All asthmatic patients are eligible.

Exclusion Criteria:

* Patients in whom MRI is contraindicated

Primary outcomes:
measure: The correlation of MR lung perfusion analysis with computed tomography (CT) findings and pulmonary function tests
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FRCP C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03257787: Evaluation of the Performance of a New Adhesive Strip
Official title: A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the performance of a new adhesive strip when impacted by output.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1 Currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.

3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal or abdominal area (assessed by investigating scientist) 5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Primary outcomes:
measure: Trans epidermal water loss
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of preclinical department
name: Lene F Nielsen
role: PRINCIPAL_INVESTIGATOR
References: