louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00250003: Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial
Official title: Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial in Nordmaling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prevention
House Calls
Keywords: Elderly
Preventive home visits
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Affairs, Sweden
First posted: 2005-11-07
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To investigate whether preventive home visits for healthy persons 75+, made by professional health workers, can change the pattern of care utilization and if the quality of life can improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality of life improve.

Detailed description: To investigate whether preventive home visits for healthy pensioners aged 75 years and over , can change the pattern of care utilization and if the quality of life can improve. To investigate if the results will last after the intervention has come to an end.

The concept of care utilization can in this trial be clarified as:

* use of primary health care
* use of elderly care including elderly houses
* mortality
* use of hospital care

The concept of quality of life will in this trial be measured with a number of self judgements.

The trial is performed as a randomized controlled trial in a small rural community in the north of Sweden. The staff is professional health workers and the visits is performed in the pensioners own homes.

Eligibility criteria: Inclusion Criteria:

* older than 75 year
* living in their own home
* living in Nordmaling, Sweeden

Exclusion Criteria:

* any need of elderly care, long term care or frequent health care

Primary outcomes:
measure: use of health care facilities during two years 2000-2001
measure: all cause mortality during two years 2000 - 2001
Secondary outcomes:
measure: use of health care facilities 2002-2004
measure: all cause mortality during 2002-2004
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University, Epidemiology and Public Health
state: Västerbotten
Study officials:
affiliation: Epeidemiology and Public Health, Umeå University
name: Lars Dahlgren, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00322803: ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
Official title: International, Multicenter, Randomized, Double-Blind, Placebo Controlled, Two-Period, Cross-Over Study to Demonstrate Safety, Tolerability and Anxiolytic Effects of 600 mg ELB139 Given Orally t.i.d. to Patients With Concurrent Panic Disorder, Challenged by Inhalation of 35% CO2 After a Single Dose and One Week of Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Panic Disorder
Keywords: panic disorder
proof of concept
Lead sponsor: elbion AG
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of concurrent panic disorder
* At least 2 panic attacks within the 4 weeks before the screening visit
* Naïve to the CO2 challenge test
* Age 18-65 years (inclusive)
* Ability to comply with all procedures mandated by the study protocol
* Negative pregnancy test and adequate contraceptive measures

Exclusion Criteria:

* History of poly-pharmacotherapy for panic disorder or treatment resistance
* Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia
* History of abuse of benzodiazepines or tolerance to effects of benzodiazepine
* Any concomitant psychotropic medication
* Evidence of impaired hepatic, renal or cardiac functions
* Participation in any drug trial in the preceding 6 months

Primary outcomes:
measure: degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
measure: difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)
Secondary outcomes:
measure: Total Symptom Score assessed immediately after CO2 challenge (TSS-post)
measure: Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Clinics Berlin
city: Berlin
country: Germany
facility: Emovis, The institute of emotional health
city: Maastricht
country: Netherlands
facility: Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Study officials:
affiliation: Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
name: Eric Griez, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04189003: Molecular Signatures of HPV+ ORL Cancers (OROPAP)
Official title: Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Cancer
Human Papillomavirus-Related Carcinoma
Keywords: ORL Cancers
HPV+ tumor
molecular signature
human papillomavirus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 66
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: Patients with HPV-induced oropharyngeal cancer with survival follow-up greater than 2 years

Brief summary: The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor

Detailed description: OROPAP is a monocentric exploratory study with retrospective inclusion of patients.

The retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.

Frozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.

The HPV molecular signatures will be identified by the capture-HPV technique.

For each patient, clinical-anatomo-pathological data such as tumor size, tumor stage, presence or absence of metastasis, histological stage, different treatment lines and 2-years survival data will be collected through the use of data warehouse available on the HEGP.

Eligibility criteria: Inclusion Criteria:

* Patients with HPV + oropharyngeal cancer

Exclusion Criteria:

* NA

Primary outcomes:
measure: Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix
timeFrame: 18 months
Secondary outcomes:
measure: Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR
timeFrame: 18 months
measure: Correlate identified HPV molecular signature with clinical-anatomo-pathological data.
timeFrame: 18 months
measure: Number of Death of any cause, or eventual relapse
timeFrame: 18 months
measure: Ratio of the number of copies of viral genes to the number of cells
timeFrame: 18 months
measure: Precise description of HPV insertion localisation in human genome when HPV is integrated
timeFrame: 18 months
measure: Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS
timeFrame: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
state: Ile-de-France
Study officials:
affiliation: AP-HP, Hôpital Européen Georges Pompidou
name: Hélène PÉRÉ, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03052803: Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries
Official title: Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Stenosis
Myocardial Ischemia
Keywords: coronary stenosis
fractional flow reserve
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Acist Medical Systems
name: Abbott Medical Devices
name: Boston Scientific Corporation
First posted: 2017-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutifs patients hospitalized for coronary angiography and presenting one or several coronary stenosis needing FFR evaluation

Brief summary: The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.

Detailed description: The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability.

Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing.

The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized at Caen University Hospital for coronary angiography
* Coronary stenosis needing FFR evaluation according to recommendations
* More than 18 years old
* Clinically stable
* De novo coronary stenosis
* Affiliated to social security
* Informed consent signed

Exclusion Criteria:

* Unstable patients defined by acute coronary syndrome \< 7 days
* Contre-indication to adenosine administration (asthma, allergy, high grade atrio-ventricular bloc without pace maker)
* History of coronary artery bypass
* intra-stent restenosis
* Patient not capable of understanding the study
* Informed consent not signed

Primary outcomes:
measure: Simultaneous FFR measure SJM and ACIST
timeFrame: Immediately
measure: Simultaneous FFR measure Boston Scientific and ACIST
timeFrame: Immediately
measure: Simultaneous FFR measure Boston Scientific and SJM
timeFrame: Immediately
Secondary outcomes:
measure: FFR SJM or Boston alone versus simultaneous with ACIST
timeFrame: Immediately
measure: Clinical concordance
timeFrame: Immediately
measure: Drift of the signal
timeFrame: immediately
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
References:
Clinical trial NCT01673503: A Prospective Study of Femtosecond Laser Intracorneal Lensectomi
Official title: A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Astigmatism
Keywords: Myopia
refractive surgery
all femtosecond laser
ReLEx flex
ReLEx smile
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-08-28
Enrollment: 35
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.


Eligibility criteria: Inclusion Criteria:

* 25 to 45 years,
* moderate to high myopia with astigmatism =\< 2 D,
* otherwise eye healthy,
* CDVA of 0.8 or better (Snellen).

Exclusion Criteria:

* systemic or ocular disease or previous eye surgery,
* thin cornea,
* a difference of more than 2 D myopia in the eyes of each subject.

Primary outcomes:
measure: Visual acuity
timeFrame: up to 6 months
Secondary outcomes:
measure: refractive predictability
timeFrame: Pre-surgery, 1 week, 1 month, 3 months, 6 months
Other outcomes:
measure: Corneal biomechanics, corneal nerve changes and dry eye symptoms
timeFrame: pre-surgery and 6 months after
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark
Study officials:
affiliation: Odense University Hospital, University of Southern Denmark
name: Anders H Vestergaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vestergaard AH, Gronbech KT, Grauslund J, Ivarsen AR, Hjortdal JO. Subbasal nerve morphology, corneal sensation, and tear film evaluation after refractive femtosecond laser lenticule extraction. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2591-600. doi: 10.1007/s00417-013-2400-x. Epub 2013 Jun 22.
Clinical trial NCT05278403: Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
Official title: Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Virtual Reality
Physical Therapy
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized groups. A control group and an experimental group.
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial based on the application of virtual reality and video games together with physiotherapy treatment in stroke patients, with the main objective of determining their beneficial effects.

Detailed description: 21 participants who will be divided by randomization between a control group and an experimental group. The results will be quantified with the following scales: Modified Asworth (spasticity). Daniels et al (muscle strength) Tinetti (balance and gait) Berg (balance) Joint range

Eligibility criteria: Inclusion Criteria:

* Patients receiving neurological physiotherapy treatment.
* Patients who have suffered a stroke in the last two years.
* Patients with an age range between 18 and 80 years old.
* Patients with stroke with the ability to have minimal manual pressure with one limb.

Exclusion Criteria:

* Patients with stroke who also have degenerative diseases such as Alzheimer's or Parkinson's.
* Stroke patients who do not understand the instructions.
* Patients who have undergone surgery on the evaluated limbs.
* Patients with scars that limit movement.

Primary outcomes:
measure: Strength
timeFrame: One month
measure: Spasticity
timeFrame: One month
measure: Gait
timeFrame: One month
measure: Balance
timeFrame: One month
measure: Joint range
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
Study officials:
affiliation: Universidad de Murcia
name: Angel Martínez Carrasco, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Murcia
name: Francisco Javier Peláez Vélez, Graduated
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155103: Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma
Official title: Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Carcinoma, Hepatocellular
Polymorphism, Genetic
Keywords: Hepatitis B
Carcinoma, Hepatocellular
Polymorphism, Genetic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-12
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene complex on the development of chronic hepatitis and hepatocellular carcinoma.

Detailed description: We analyzed single-nucleotide polymorphisms in the genes for interleukin-1a, interleukin-1b, interleukin-1-receptor antagonist, interleukin-1-receptor type I, and interleukin-1-receptor type II in 400 normal control and patients (chronic hepatitis and hepatocellular carcinoma). Genotypes were tested for an association with development of chronic hepatitis and hepatocellular carcinoma by multivariable analysis. A second cohort of 1200 normal control and patients (chronic hepatitis and hepatocellular carcinoma) was independently analyzed for the genotype associations identified in the first cohort.

Eligibility criteria: Inclusion Criteria:

* Normal controls
* Cases of chronic hepatitis and hepatocellular carcinoma

Exclusion Criteria:

* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Medical Genetics; National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Hui Tseng, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05344703: Is Y-Balance Test Predictive of Concussion
Official title: Is Y-Balance Test Predictive of Concussion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Brain
Concussion; Eye
Lead sponsor: Arkansas Colleges of Health Education
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group of 6th to 12th graders
Primary purpose: PREVENTION

Brief summary: The Y Balance Test for the lower quarter (YBT-LQ) is a movement screen used to assess an athlete's risk for injury. The YBT-LQ is a dynamic balance test where the participant stands on a single leg and with the opposite lower extremity reaches are far in the anterior direction as they can, and this value is measured. The process is repeated in the posterior medial, and the posterior lateral directions. The final values are controlled for leg length of the participants. The YBT-LQ has been shown to be predictive of lower extremity injury in high school basketball players, but it is typically used as part of a battery of tests to determine the athlete's overall injury risk, but more questions remain to be answered. The research question: Is the YBT-LQ predictive of concussion in high school athletes? What are the norms for YBT-LQ in high school athletes? Does history of concussion effect YBT-LQ? Is the YBT-LQ with visual perturbations predictive of concussions? Is the YBT-LQ with visual perturbations predictive of lower extremity injury? What is the impact of visual perturbations on Y-balance and its injury prevention capability?

The target student participants will be 9th through 12th grade students; however, 6th to 8th grade students will be allowed to participate depending on the school or organization request. Informed consent will be obtained reiterating that participation is voluntary. Testing utilizing the YBT-LQ will occur, and sport of participation, age, height, weight, dorsiflexion, and leg length will be obtained. Follow up will be made via the athletic trainers and school personnel to indicate the effected athletes. Once the post-test follow up is complete athletes will be able to see their pre-test scores, and any questions will be answered at that time. This will be a longitudinal study where testing will take place at least two times per year, preferably three times per year over 4 years.


Eligibility criteria: Inclusion Criteria:

* Participates in sport either school sanctioned or club

Exclusion Criteria:

* History of seizure

Primary outcomes:
measure: Report of concussion in past year
timeFrame: 1 year
measure: Report of lower extremity injury in past year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Fort Smith Public Schools
state: Arkansas
city: Fort Smith
country: United States
facility: Greenwood Public Schools
state: Arkansas
Study officials:
References: