louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03568201: Systolic Ankle arteriaL Pressure and Transcutaneous oximetrY During a TURTLE Test in Athletes
Official title: Application de l'oxymétrie Dynamique et Des Index de Pression Pour le Diagnostic Des Plicatures Iliaques du Sportif
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iliac Kinking
Keywords: Diagnosis
Peripheral artery disease
Sports
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: transcutaneous oximetry
Primary purpose: DIAGNOSTIC

Brief summary: Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects

Detailed description: Patients suspected of PES and healthy controls after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of thigh flexion in the standing position.

Eligibility criteria: Inclusion Criteria:

- Age over 18 years Insurance company affiliation Symptoms consistent with iliac kinking (patients) or absence of symptoms (controls)

Exclusion Criteria:

* Refuse to participate Exclusion period from another protocole Non affiliation to the French healthcare system

Primary outcomes:
measure: Presence of a significant DROP decrease
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: University hospital in Angers
name: Pierre Abraham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002001: Sleep Disorders Pre and Post Liver Transplantation
Official title: Prospective Study to Evaluate Sleep Disturbance in Patients With Liver Disease Pre and Post Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the pre and post-transplantation liver clinics

Brief summary: Sleep disturbance and sexual dysfunction are common complaints of patients with cirrhosis . The term sleep disturbance describes insomnia, poor quality sleep, circadian rhythm disorders and obstructive sleep apnea and is associated with reduced health-related quality of life (HRQoL) score indices. Sleep and sexual disorders have only been formally evaluated in small studies in these patients and to date, no studies have objectively assessed these patients. In addition, no studies have been performed in these patients after liver transplantation. The investigators' hypothesis is that sleep and sexual disturbance is commonly seen in patients with advanced cirrhosis and improves after liver transplantation. However, despite this, HRQoL remain impaired because of residual sleep disturbance.This study will be unique in providing cross-sectional follow-up of patients with cirrhosis at baseline and after liver transplantation (\> 6 months).


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* Comprehend and read English
* On liver transplantation list or post-liver transplantation

Exclusion Criteria:

* Non-English speaking
* \< 18 years and \> 85 yrs

Primary outcomes:
measure: Sleep disturbances in patients with advanced cirrhosis
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: George Therapondos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269501: Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain
Official title: The Effect of a Specific Exercise Program on Patients Suffering From Migraine and Co-existing Tension-type Headache and Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Tension-type Headache
Neck Pain
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of a physical exercise program on patients suffering from migraine and co-existing tension-type headache and neck pain. The investigators hypothesized that migraine patients are ofte physically inactive because of their headache and that they will benefit from a specific exercise program.

Detailed description: Migraine and tension-type headache are among the most common neurological diseases and are causing reduced quality of life, private and socio-economic consequences in terms of medical consumption and work-related absenteeism. The clinical experience shows that physical activity, like cycling and brisk walking, can prevent migraine attacks, but the evidence of the efficacy is sparse.

The primary aim of the study is to investigate the acute and the long term effect of exercise on patients suffering from migraine and co-existing tension-type headache and neck pain.

The project will be the first of its kind that explores the effect of an exercise program on patients who both suffer from migraine, tension-type headache and neck pain. We expect that the participants from the exercise program will achieve a reduced pain impact on everyday life, an improved fitness and quality of life, and a decrease of absence days and medication use.

Eligibility criteria: Inclusion Criteria:

* Migraine
* Tension-type headache
* Neck pain

Exclusion Criteria:

* Whiplash injury or other significant neck trauma
* Nerve root compression
* Post traumatic headache
* Medication overuse headache
* Cluster headache
* Trigeminal neuralgia
* Pregnancy and breast feeding
* Severe physical and psychological illnesses
* Alcohol and or drug abuse
* Current insurance claim owing to headache
* Persons not able to speak or understand Danish
* Persons deemed not to implement the program because of musculoskeletal pain or physical limitations

Primary outcomes:
measure: Changes in pain
timeFrame: At baseline and after three, six and 12 months follow-up
Secondary outcomes:
measure: Changes in headache and neck pain impact
timeFrame: At baseline and after three, six and 12 months follow-up
measure: Changes in quatitative sensory testing
timeFrame: At baseline and after three and six months follow-up
measure: Changes in aerobic fitness
timeFrame: At baseline and after three and six months follow-up
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center, Department of Neurology
Study officials:
References:
Clinical trial NCT01901601: LALAK for Opacities
Official title: Randomized Clinical Trial of OCT-Guided Laser-Assisted Lamellar Anterior Keratoplasty in Adults for Stromal Opacities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: STROMAL OPACITIES
Keywords: KERATOPLASTY
STROMAL OPACITIES
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
First posted: 2013-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to compare and develop new surgical technique of partial-thickness corneal transplantation for treating corneal opacity. A newly developed technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested and compared with standard full-thickness corneal transplantation, Intralase-enabled keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea and does not have the risks associated with conventional IEK. Additionally, optical coherence tomography (OCT) will be used to guide the depth of the graft and donor dissections.

The data will be analyzed to understand whether the new technique (LALAK) can repeatedly achieve good visual outcomes with lower risk from the operation compared to the visual outcomes and risk associated with the current standard of care, IEK.


Eligibility criteria: Inclusion Criteria:

* Eyes with corneal opacities that cannot be adequately or safely corrected with spectacles, contact lens or excimer laser surface ablation. The cornea must have healthy endothelium (endothelial cell density \> 1,500/mm2).

Exclusion Criteria:

1. Preoperative corneal thickness less than 400 microns.
2. Inability to give informed consent.
3. Corneal edema
4. Central guttata
5. Inability to maintain stable fixation for OCT imaging.
6. Inability to commit to required visits to complete the study.
7. Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
8. Patients with severe collagen vascular diseases or ocular surface disorders

Primary outcomes:
measure: BSCVA (Snellen chart)
timeFrame: 24 months
measure: intraoperative perforation rate
timeFrame: 24 months
Secondary outcomes:
measure: postoperative refractive error
timeFrame: 24 months
measure: topographic astigmatism
timeFrame: 24 months
measure: interface clarity
timeFrame: 24 months
measure: endothelial cell count
timeFrame: 24 months
measure: complications
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Casey Eye Institute, Oregon Health & Science University
name: Winston Chamberlain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02987101: Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
Official title: Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Ulcer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 30
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: Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction as an adjunct to standard wound care.

Detailed description: Chronic leg ulcers are associated with decreased quality of life and an increased mortality. In many cases these ulcers are treated conservatively and the healing time can be several months. In this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction (SVF) as an adjunct to standard wound care.

The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and these are randomized in two groups of which one receives standard wound care only and the other group receives autologous stromal vascular fraction treatment in addition to standard wound care.

Eligibility criteria: Inclusion Criteria:

* Arteriovenous chronic leg ulcer
* Present beyond 4 months
* Conservative treatment not leading to progress
* Wound size between 2-30cm2
* ankle-brachial index (ABI) ( 50-90% and/or toe pressure 50-70% and where ankle pressure \> 60 mmHg or toe pressure \> 40 mmHg
* Written informed consent

Exclusion Criteria:

* Uncontrolled wound infection
* Osteomyelitis
* Hemoglobin \<6.0mmol/L
* HbA1c \>80mmol/mol
* Underlying malignancy
* Pregnancy or lactating
* Renal insufficiency requiring dialysis
* Charcot foot
* Underlying malignancy

Primary outcomes:
measure: Change in wound size
timeFrame: 6 months
Secondary outcomes:
measure: Distal blood pressure measurement
timeFrame: 6 months
measure: Transcutaneous oxygen tension
timeFrame: 6 months
measure: Treatment-related adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Dept. Plastic Surgery, OUH, Consultant, Professor
name: Jens A Sørensen, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01795001: The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy
Official title: The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fuchs' Endothelial Dystrophy
Keywords: pathophysiology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: Funds for Research in Ophthalmology, Belgium
name: Mieke Perdaens fund for Eye Research
First posted: 2013-02-20
Enrollment: 460
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Fuchs' Endothelial Corneal Dystrophy (FECD), normal control patients, and patients with non-Fuchs edematous corneas; in university hospital setting.

Brief summary: The purpose of this study is to gain further insights into the molecular pathogenesis of Fuchs' endothelial corneal dystrophy (FECD), to identify targets for potential specific drug therapy.


Eligibility criteria: Inclusion Criteria:

* FECD
* normal corneas (including enucleations for uveal melanoma)
* non-FECD oedematous corneas

Exclusion Criteria:

* prior irradiation therapy for uveal melanoma
* corneal extension of uveal melanoma

Primary outcomes:
measure: cytokine levels
timeFrame: at time of prelevation (once, no intervention)
measure: gene expression levels
timeFrame: at time of prelevation (once, no intervention)
measure: protein content
timeFrame: at time of prelevation (once, no intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Translational Cell and Tissue Research - campus Sint-Raf - UZ Leuven
Study officials:
affiliation: KU Leuven
name: Joost J van den Oord, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390701: Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation
Official title: Blood Pressure Lowering Effect of Low-frequency Transcutaneous Electrical Nerve Stimulation and Felodipin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: randomized
cross-over
transcutaneous electrical nerve stimulation
felodipin
hypertension
blood pressure
treatment
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the blood pressure reducing property of transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.

Detailed description: Hypertension is a major risk factor for development of several vascular complications and is common world wide. Drug treatment is often necessary to achieve adequate blood pressure reduction but blood pressure control in studied countries is unsatisfactory low. Reasons for failure in treatment are several. Among others reasons intolerable side-effects may prevent successful treatment irrespective of the number of drugs.

Transcutaneous electrical nerve stimulation (TENS) constitutes no risk of interaction with pharmacological agents and previous studies have reported blood pressure reduction.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of hypertension, untreated or currently treated with a maximum of one blood pressure (BP) lowering agent

Exclusion Criteria:

* systolic blood pressure \>170 mmHg and/or diastolic blood pressure of \>105 mmHg
* second- or third-degree atrioventricular block
* current use of opiates or other intoxicants
* neurological disorders (such as Parkinson's disease, multiple sclerosis or peripheral neuropathy)
* need of treatment with TENS, regardless the reason

Primary outcomes:
measure: Blood pressure reduction
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
Study officials:
affiliation: Department of Medicine, Geriatrics and Emergency Medicine, Sahlgrenska University Hospital/Östra
name: Jonas Silverdal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Medicine, Department of Emergency and Cardiovascular Medicine, Sahlgrenska University Hospital/Sahlgrenska
name: Karin Manhem, ass.prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Multidisciplinary Pain Center, Sahlgrenska University Hospital/Östra
name: Clas Mannheimer, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, Sahlgrenska University Hospital/Mölndal
name: Georgios Mourtzinis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Neuroscience and Physiology, Department of Physiology, University of Gothenburg
name: Elisabet Stener-Victorin, ass.prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05071001: Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
Official title: Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adults Treated During Childhood or Adolescence for a Malignant Bone Tumor (Osteosarcoma and Ewing Sarcoma)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints


Eligibility criteria: Inclusion Criteria:

For study OSE A and B

* Patients treated for a bone sarcoma: Ewing or osteosarcoma
* Age under 19 years at initial diagnosis
* Treated in the Pediatric Oncology Department of Gustave

For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis

* Treated with at least one course of HDMTX for osteosarcoma
* Treated without HDMTX for Ewing sarcoma
* Time interval between the end of treatment and inclusion \>10 y
* Age \> 21 y at inclusion
* Patients with informed consent signed
* Patient under guardianship
* Affiliated to French health insurance or beneficiary of the same or equivalent

For study OSE- B only:

* Treated with at least 8 courses of HDMTX for osteosarcoma
* Treated without HDMTX for Ewing sarcoma
* Patients with Ewing sarcoma will have to be matched with osteosarcoma patients according to age at the time of treatment, sex, and duration of follow-up
* School level equivalent of at least the end of primary school

Exclusion Criteria:

For study OSE A and B

* Brain radiotherapy
* Previous relapse except those treated by local treatment without any chemotherapy
* Second malignancy treated with chemotherapy
* High dose chemotherapy with stem cell support
* Non-French speaking patients
* Pregnant and breastfeeding women

For study OSE- B only:

- Patient deprived of his liberty by a judicial or administrative decision

Primary outcomes:
measure: scores obtained in FactCOG as a whole and in each subscale
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References:
Clinical trial NCT04353401: WGS Analysis of COVID-19 Positive Patients
Official title: Whole Genome Sequencing Analysis of of SARS-CoV-2 Positive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
COVID-19
Keywords: Covid-19
WGS
viral load
viral genome
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 positive patients

Brief summary: We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.


Eligibility criteria: Inclusion Criteria:

* Ability and acceptance to provide written informed consent and fluent in English.
* Men or women between 18-100+ years, inclusive.
* Willing to comply with study procedures.
* SARS-CoV-2 positive test result as confirmed by a RT-PCR assay with a sputum or nasopharyngeal sample (either done prior to or at the screening visit).

Primary outcomes:
measure: Associations with severity and outcomes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Vanda Investigational Site
state: Ohio
Study officials:
References: