louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05589662: Clinical, Functional and Musculoskeletal Differences Between Adult Patients With Hemophilia and Their Healthy Peers
Official title: Analysis of Clinical, Functional and Musculoskeletal Variables Between Adult Patients With Hemophilic Arthropathy of the Knee and Ankle and Their Healthy Peers. A Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia Arthropathy
Keywords: Hemophilic arthropathy
Ankle
Knee
Strength
Muscle activation
Pressure pain threshold
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2022-10-21
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilic arthropathy and their healthy pairs

Brief summary: Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy.

Goal. To analyze the clonic, functional and musculoskeletal differences between adult patients with hemophilic arthropathy of the knee and ankle and their healthy peers.

Study design. Cases and controls study patients. 21 patients with hemophilia A and B and 21 subjects without joint damage.

Variables and measuring instruments: pressure pain threshold (pressure algometer); joint status (Hemophilia Joint Health Score scale); and strength (dynamometry) and muscle activation (surface electromyography).

Expected results. Observe the differences between patients with knee and ankle arthropathy and their healthy peers in muscle strength and activation.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A and B.
* Over 18 years
* With medical diagnosis of knee arthropathy
* With clinical evaluation by Hemophilia Joint Health Score
* In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
* Healthy subjects must meet knee joint health criteria; over 18 years; and no previous knee or ankle injuries in the 6 months prior to evaluation.

Exclusion Criteria:

* Patients with neurological or cognitive disorders that prevent the understanding of physical tests
* Not having signed the informed consent document

Primary outcomes:
measure: Assess the muscle strength
timeFrame: Screening visit
Secondary outcomes:
measure: Assess the muscle activation
timeFrame: Screening visit
measure: Assess the pressure pain threshold
timeFrame: Screening visit
measure: Assess the joint status
timeFrame: Screening visit
Other outcomes:
Locations:
Study officials:
affiliation: University of Oviedo
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802762: A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
Official title: A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Optical Imaging
Lead sponsor: NeMoDevices AG
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Graz
name: University of Zurich
First posted: 2013-03-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.


Eligibility criteria: Inclusion Criteria:

1. Adult male or female patient, ≥ 18 and ≤ 75 years
2. Patient with severe SAH (GCS ≤ 12) or severe TBI (GCS ≤ 8)
3. Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days
4. Negative pre-treatment serum pregnancy test for female patients with childbearing potential
5. In patients with severe SAH or severe TBI with need for ICP monitoring an acute emergency situation exists. The inclusion follows

Exclusion Criteria:

1. Known kidney disease, defined as plasma creatinine \> 120 µmol/l
2. Known liver disease, defined as GOT \> 200U/l
3. History of allergic disorders, including allergic reactions against contrast agents containing iodine, against ICG and against plasters, as well as patients with thyroid disease causing hyperthyroidism
4. Pre-existing disability and/or legal representative
5. Participation in another interventional clinical trial within the last 30 days before start of treatment

Primary outcomes:
measure: To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values.
timeFrame: Day 28 after removal of medical device
Secondary outcomes:
measure: To demonstrate the ability of the neuromonitoring system to detect secondary ischemic events in patients with severe subarachnoid haemorrhage (SAH) or severe traumatic brain injury (TBI).
timeFrame: Day 28 after removal of medical device
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Dept. of Neurosurgery, Medical University of Graz
city: Zurich
country: Switzerland
facility: Neurointensive Care Unit, University Hospital Zurich
Study officials:
References:
Clinical trial NCT02819362: Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound
Official title: Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Société d'Imagerie de la Femme
First posted: 2016-06-30
Enrollment: 106
Sex: FEMALE
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: Patients with pathological nipple discharge

Brief summary: Benefit of MRI in pathological nipple discharge.


Eligibility criteria: Inclusion Criteria:

1. Single pore nipple discharge neither green nor milky.
2. Mammography (at least 2 shots, +/- centred on retro-areal) normal.
3. Initial ultrasound: normal.
4. Age over 18 years
5. Female
6. Patient affiliated to the social security scheme.
7. Patient information and informed consent signed and dated

Exclusion Criteria:

Physiological milky or green discharge

Primary outcomes:
measure: The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound.
timeFrame: At baseline
Secondary outcomes:
measure: Diagnostic performances of MRI (sensitivity, specificity, positive predictive value) in pathological nipple discharge with normal mammography / ultrasound.
timeFrame: At baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
Study officials:
References:
citation: Boisserie-Lacroix M, Doutriaux-Dumoulin I, Chopier J, Boyer B, Depetiteville MP, Hoppe S, Brouste V, Chamming's F. Diagnostic accuracy of breast MRI for patients with suspicious nipple discharge and negative mammography and ultrasound: a prospective study. Eur Radiol. 2021 Oct;31(10):7783-7791. doi: 10.1007/s00330-021-07790-4. Epub 2021 Apr 13.
Clinical trial NCT02702362: tDCS on Precuneus in MCS: Repeated Stimulations
Official title: Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients in Minimally Conscious State After a Severe Brain Injury
Keywords: disorders of consciousness
minimally conscious state
traumatic brain injury
stroke
transcranial direct current stimulation
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).

Detailed description: Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the precuneus cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 5 days after the end of the sessions to assess the long term effect of the tDCS.

Researchers expected to see an improvement of the CRS-R total score at the end of the anodal session and that this improvement persists for 5 days.

Eligibility criteria: Inclusion Criteria:

* post comatose patients
* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma or vegetative state
* patients \< 1 months after the acute brain injury
* patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

Primary outcomes:
measure: Change in the CRS-R total score
timeFrame: After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)
Secondary outcomes:
measure: Influence of the time since insult
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06884462: Effect of High-intensity Laser Exercise Versus Moderate-intensity Aerobic Exercise on Diabetic Polyneuropathy Patients
Official title: Effect of High-intensity Laser Exercise Versus Moderate-intensity Aerobic Exercise on Diabetic Polyneuropathy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathies
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic poly neuropathy (DPN) is a length-dependent, symmetrical sensorimotor poly neuropathy and is among the most prevalent and challenging consequences of diabetes4.

The documented prevalence of DPN varies between 13% and 55%, with 25% to 50% of these individuals experiencing neuropathic pain5. This study was conducted to find out the impact of high-intensity laser versus moderate-intensity aerobic exercises on diabetic poly neuropathy patients.


Eligibility criteria: Inclusion Criteria:

* Neuropathic symptoms in the lower limbs, including numbness, tingling, pain, burning, electric shock, and stabbing

Exclusion Criteria:

* sensory polyneuropathy unrelated to diabetes as
* systemic diseases,
* infections,
* inflammatory conditions,
* drug effects,
* metal exposure,
* hereditary factors

Primary outcomes:
measure: Lower extremity functional performance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad
Study officials:
References:
Clinical trial NCT01575262: The Physical Activity Loyalty Card Scheme
Official title: The Physical Activity Loyalty Card Scheme: A Randomised Controlled Trial to Encourage Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Health Behavior
Physical Activity
Keywords: behaviour change
incentives
nudging
physical activity
self-monitoring
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the effectiveness of using incentives to encourage adults to be physically active.

Detailed description: The investigators developed the Physical Activity Loyalty Card (PAL) Scheme which integrates a novel physical activity tracking system with web-based monitoring and nudge initiatives. The tracking system used Near-Field Communication (NFC) technology and a "loyalty card" (PAL Card) which contained a passive Radio Frequency Identification (RFID) tag. Sensors were placed along footpaths in the outdoor environment, in the gym and exercise studio, and participants scanned their PAL card at the sensor when doing physical activity (e.g. walking). A transaction (card ID, sensor ID, and timestamp) was recorded and sent via SMS to a secure data centre. Participants logged onto a personal account on the study website (www.palcard.co.uk) and received real-time feedback on various aspects of their physical activity including minutes, distance and calories expended.

Eligibility criteria: Inclusion Criteria:

* males and females
* aged 18-65 years old
* able to complete 15 minutes of moderate intensity physical activity
* based at least 4 days per week (and 6 hours per day) at worksite

Exclusion Criteria:

* advised by General Practitioner not to participate in exercise

Primary outcomes:
measure: Physical activity
timeFrame: baseline, week 12 and 6 months
Secondary outcomes:
measure: SF-8
timeFrame: baseline, week 12 and 6 months
measure: Euroqol 5D
timeFrame: baseline, week 12 and 6 months
measure: Physical Activity Self-Efficacy Scale
timeFrame: baseline, week 12 and 6 months
measure: Work absenteeism
timeFrame: baseline, week 12 and 6 months
measure: Exit questionnaire
timeFrame: week 12
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Frank Kee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02758262: Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperphagia
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this project is to identify brain mechanisms by which Noninvasive brain stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to new therapeutic avenues to treat this eating disorder.


Eligibility criteria: Inclusion Criteria:

* Hyperphagic

Exclusion Criteria:

* Psychiatric disorders
* Pregnancy

Primary outcomes:
measure: Food craving assessed by the Food Cravings Questionnaire - State
timeFrame: 1 hour
Secondary outcomes:
measure: Brain activity assessed by electroencephalography
timeFrame: 1 hour
measure: Brain activity assessed by blood-oxygen-level dependent contrast imaging
timeFrame: 1 hour
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre interdisciplinaire de recherche en réadaptation et intégration sociale
Study officials:
References:
Clinical trial NCT05185362: Epidemiology of Pecan Nut Allergy
Official title: Retrospective Study on Pecan Nut Allergy Epidemiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Reaction
Keywords: Sensitization to pecan nut (specific IgE and/or skin prick tests)
Challenge proven pecan allergy
Allergic Comorbidities
Oral food challenge
Anaphylaxis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital, sensitized to pecan nut, and having undergone an oral food challenge to this food allergen

Brief summary: IgE-mediated food allergy can manifest with reactions ranging from hives to anaphylactic shock. The diagnosis is based on the confirmation of sensitization to the food allergen by skin tests (prick) and the determination of specific IgE directed against the food source and molecular allergens. The gold standard remains the oral provocation test, which is performed in a hospital environment. Once the diagnosis is made, an elimination diet is still considered as the cornerstone of treatment for most food allergies.

While some allergies, such as cow's milk or egg, tend to resolve spontaneously, others, such as allergy to pecan nuts, show a tendency to be persistent. In addition, pecan allergy is often characterized by potentially serious clinical reactions, compared to other foods, which can even be life threatening. In our clinical practice, the investigators found that patients with allergies to pecan nuts often present with severe hypersensitivity reactions when challenged orally to this food. Beyond this information, there are few studies regarding pecans. The investigators decided to retrospectively evaluate the results of oral food challenge and of the allergy work-up in our patients sensitized and allergic to pecan nuts, to better understand the current epidemiology of such food allergy.


Eligibility criteria: Inclusion criteria:

* Patients assessed for pecan allergy, through oral food challenge, from January 2000 to december 2021, at the University Hospital of Montpellier
* Patients with a positive skin prick test and/or positive specific IgE to pecan nut

Exclusion criteria:

* Patients not affiliated to French Social Security
* Patients not capable of understanding French
* Patients sensitized to pecan nut, who did not perform an oral food challenge to this food allergen

Primary outcomes:
measure: Prevalence of challenge-proven pecan allergy
timeFrame: day 1
Secondary outcomes:
measure: Epidemiological characteristics of pecan allergic patient
timeFrame: day 1
measure: cut-off of specific IgE
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Davide CAIMMI
role: STUDY_DIRECTOR
References:
Clinical trial NCT02170662: Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
Official title: Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Male Pattern Hair Loss
Androgenetic Alopecia
Keywords: male pattern hair loss
androgenetic alopecia
bimatoprost
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of bimatoprost solution on scalp hair growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is not approved for the treatment of scalp hair loss and its use in this study is considered investigational which means it is still being tested in research studies.

Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.


Eligibility criteria: Inclusion Criteria:

1. Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.
2. Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography.
3. Good health with normal blood tests for hematological, renal, and liver function.
4. Able to return to Duke for study visits.

Exclusion Criteria:

1. ECOG \>1.
2. Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12 months or oral dutasteride in the past 24 months.
3. Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month.
4. Taken any chemotherapy in the past 2 years.
5. Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months.
6. Used prostaglandins of any type in the past or currently.
7. Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions.
8. Any skin abnormalities in the target area that would effect hair growth.
9. Any history of glaucoma or elevated intraocular pressure (IOP).
10. Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.

Primary outcomes:
measure: Percent Change in Target Area Total Hair Count
timeFrame: Baseline to week 17; and week 17 to week 34
Secondary outcomes:
measure: Percent Change in the Target Area Terminal Hair Count
timeFrame: Baseline to week 17; and week 17 to week 34
measure: Percent Change in the Target Area Vellus Hair Count
timeFrame: Baseline to week 17; and week 17 to week 34
measure: Percent Change in Hair Diameter
timeFrame: Baseline to week 17; Week 17 to week 34
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Elise Olsen, MD
role: PRINCIPAL_INVESTIGATOR
References: