louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00830050: Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
Official title: A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteoarthritis
Keywords: fMRI functional magnetic resonance imaging Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: King's College London
First posted: 2009-01-27
Enrollment: 24
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand can be detected by a form of brain scanning that detects which parts of the brain are activated when pain is felt.


Eligibility criteria: Inclusion Criteria:

* Right-handed, post-menopausal female, any race, 50-80 years
* Clinical diagnosis of osteoarthritis of the hand
* Estimated pain in this joint of at least 5 on a scale of 0 to 10

Exclusion Criteria:

* Any patient who smokes more than 5 cigarettes per day
* Patients receiving some anti-depressant drugs unless the dose is stable
* Patients unable to be admitted or lie still in an MRI scanner

Primary outcomes:
measure: Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest.
timeFrame: 22 days
Secondary outcomes:
measure: Whole brain resting-state distribution of Cerebral Blood Flow
timeFrame: 22 days
measure: Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity
timeFrame: 22 days
measure: Pain induced by a grip task measured with a Visual Analogue Scale (VAS), the Short-Form McGill Pain Questionnaire and patient-rated wrist/hand evaluation (PRWHE)
timeFrame: 22 days
Other outcomes:
Locations:
city: Denmark Hill
country: United Kingdom
facility: Pfizer Investigational Site
state: London
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01916850: Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects
Official title: A Phase 1b, Single-center, Double-blind, Randomized, Placebo-controlled Study on the Safety, Tolerability, and Pharmacokinetic Effects of Multiple Doses of LX4211 400 mg qd and LX4211 800 mg qd in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Adult subjects ≥ 18 to ≤ 55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Willing and able to provide written informed consent

Exclusion Criteria:

* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
* Use of any investigational agent or study treatment within 30 days of dosing
* Use of any protein or antibody-based therapeutic agents within 3 months of Screening
* Prior exposure to LX4211
* Use of cigarettes or any tobacco products within 2 months prior to Screening and while participating in the study
* History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
* History of any major surgery within 6 months of Screening
* History of any hypersensitivity to the inactive components of LX4211
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* History of any active infection within 14 days prior to Day 1
* History of alcohol or substance abuse within 2 years prior to Day 1
* Donation or loss of \>400 mL of blood or blood product within 3 months of dosing
* Positive urine glucose at Screening
* Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
* Inability or difficulty swallowing pills
* Unable or unwilling to communicate or cooperate with the Investigator

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to Day 10
Secondary outcomes:
measure: Area under the curve
timeFrame: Days 1 through 10
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Ikenna (Ike) Ogbaa, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03872050: Deep Phenotyping of Rosacea and Migraine
Official title: Deep Phenotyping of Rosacea and Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Rosacea
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rosacea

* patients invited to participate through 3 different clinics in Copenhagen and Zealand, Denmark

Migraine

* patients attending the outpatient clinic of the Danish Headache Center invited to participate

Brief summary: This study aims to deep phenotype patients with rosacea and migraine

Detailed description: Rosacea and migraine are common disorders that overlap in epidemiology, symptoms, trigger factors, and distribution in the trigeminal area. Recent studies establish a connection between the two disorders, which needs to be investigated.

The purpose of this study is investigate the link between the two disorders by deep phenotyping through semi-structured interviews.

Eligibility criteria: Inclusion Criteria:

* diagnosis with either rosacea and/or migraine

Exclusion Criteria:

* does not want to participate
* cannot co-operate to investigation

Primary outcomes:
measure: Prevalence of migraine in rosacea cohort
timeFrame: 60 minutes
measure: Prevalence of rosacea in migraine cohort Prevalence of rosacea in migraine cohort
timeFrame: 60 minutes
Secondary outcomes:
measure: Prevalence of migraine subtypes in rosacea cohort
timeFrame: 60 minutes
measure: Prevalence of rosacea subtypes in migraine cohort
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Zealand
Study officials:
affiliation: Professor
name: Messoud Ashina, MD, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wienholtz NKF, Christensen CE, Haugaard JH, Zhang DG, Ashina M, Thyssen JP, Egeberg A. Cohort profile: COpenhagen ROsacea COhort (COROCO) and COpenhagen MIgraine COhort (COMICO). BMJ Open. 2020 Aug 20;10(8):e039445. doi: 10.1136/bmjopen-2020-039445.
Clinical trial NCT01847950: Effects of scFOS on Stool Frequency in People With Functionnal Constipation
Official title: Randomized, Placebo-controlled Double-blind Study to Evaluate the Effects of Fructo-oligosachharides on Increase of Stool Frequency in Constipated People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Lead sponsor: Syral
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation


Eligibility criteria: Inclusion Criteria:

* subjects with functional constipation

Exclusion Criteria:

* subjects treated with laxative treatments
* subjects consuming more than 25g/day of dietary fibres
* pregnant women

Primary outcomes:
measure: Frequency of stool emission
timeFrame: 6 weeks
Secondary outcomes:
measure: Stool consistency (Bristol scale)
timeFrame: 6 weeks
Other outcomes:
measure: Transit time
timeFrame: 6 weeks
Locations:
city: Bobigny
country: France
facility: CRNH-CRV Avicenne Hospital
Study officials:
affiliation: CRNH - CRV Avicenne Hospital
name: Robert Benamouzig, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04033250: Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation
Official title: Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 600
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: Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.

The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.


Eligibility criteria: Inclusion Criteria:

* previous IBP
* concurrent medical conditions (e.g. diabetes, constipation)
* medications (e.g. opioids and tricyclic antidepressants)

Exclusion Criteria:

* previous colonic resection
* patients with IBD
* active CRC
* chronic kidney disease at any stage
* congestive heart failure at any stage
* liver cirrhosis

Primary outcomes:
measure: Improved bowel preparation
timeFrame: Index colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam MC
Study officials:
References:
Clinical trial NCT04962750: Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers
Official title: Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2021-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, Low level laser therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser therapy on tinnitus of Scuba divers in Red Sea.


Eligibility criteria: Inclusion Criteria:

- scuba divers

Exclusion Criteria:

* Other ear or neurological diseases

Primary outcomes:
measure: Tinnitus Questionnaire score
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Benha University
name: Osama El-sayyad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541150: Impaired Decision Making in Pedophilic Offenders
Official title: Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pedophilia
Keywords: Pedophilia
Impaired Decision making
Insight
Cognitive Distorsions
Impulsiveness
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 128
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pedophilic behaviors represent a public health problem with serious consequences. The investigators hypothesize a disruption in the decision-making strategies among sex offenders pedophiles. Highlight this type of abnormality would offer a specific treatment of a possible neuropsychological deficit (with cognitive remediation for instance) and perhaps avoid recurrences of this type of behavior.

Detailed description: Cross-sectional study, comparing a group of 64 pedophilic offenders inmates condamned with a group of 64 volunteers non-pedophiles matched by age and level of study.

Eligibility criteria: Inclusion Criteria:

* For the controls, lack of diagnosis of disorders of sexual behavior (paraphilias) current or past (DSM IV)
* For the pedophilic offenders:

  * Placement and conviction for rape or sexual assault of a minor under 15 years
  * Recognition of the facts
  * Existence of a current or past diagnosis of pedophilia (according to the DSM IV).

Exclusion Criteria:

* Presence of a current major depressive episode (DSM IV - MINI)
* History of cerebral neurological disorder or a cranial trauma with loss of consciousness current
* IGT test already done
* Schizophrenia or Other current psychotic disorders(according to the criteria DSM IV of MINI test).
* taking psychoactive drug

Primary outcomes:
measure: Comparison of neuropsychological performances between control group and group of persons suffering from pedophilia
timeFrame: 36 months (at the end of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: CHU de Montpellier
name: Lacambre Mathieu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04706650: Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis
Official title: Exercise Capacity in Axial Spondyloarthritis and Factors Affecting it: a Cross-sectional Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Capacity
Axial Spondyloarthritis
Keywords: axial spondyloarthritis
exercise capacity
cardiovascular risk factors
nonradiographic axial spondyloarthritis
cardiorespiratory fitness
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty eight patients fulfilling the ASAS axial SpA criteria were recruited from the department of Gazi University Physical Medicine and Rehabilitation Rheumatology. 38 control subjects were randomly recruited from local hospital staff with a similar range of sex and age to the patients.

Brief summary: The investigators aimed to study the associations between exercise capacity and cardiovascular (CV) risk factors in axial spondyloarthritis (axSpA) patients and to determine possible relationships with disease-related variables. Thirty eight patients and 38 controls were recruited in our cross-sectional controlled study. Comprehensive systemic and musculoskeletal examinations were carried out in both of the groups. Cardiovascular risk profile data, ASDAS-CRP, 10-year CV event risk, physical activity levels (IPAQ) were recorded. A maximal treadmill exercise test by Bruce protocol was administered to all participants.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of axial SpA
* must be able to walk

Exclusion Criteria:

* established cardiac disease including structural heart diseases,
* uncontrolled hypertension,
* cardiac rhythm disorder,
* unstable angina pectoris,
* chronical renal and/or hepatic disease,
* malignancy,
* neuromuscular disease
* musculoskeletal deformity
* the history of an inflammatory arthritis for control group

Primary outcomes:
measure: Mean difference in exercise capacity of axSpA patients and controls
timeFrame: may- october 2014
Secondary outcomes:
measure: Mean difference in heart rate recovery of axSpA patients and controls
timeFrame: may- october 2014
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05961150: PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry
Official title: PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Valve Diseases
Mitral Valve Disease
Aortic Valve Disease
Tricuspid Valve Disease
Keywords: Minimally-invasive heart valve surgery
Percutaneous cannulation
Endovascular closure device
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Percutaneous peRipheral cannulatiOn for Minimally-InvaSive heart valve surgEry (PROMISE) registry aims to analyse the perioperative outcome of percutaneous peripheral cannulation techniques and their implications during minimally-invasive heart valve surgery.

Brief summary: In addition to conventional heart valve surgery (HVS) via full-sternotomy, which is still the most prevalent therapeutic strategy to address valvular heart disease (VHD), minimally-invasive approaches evolved as safe alternatives, resulting in lower postoperative ventilation times, transfusion rates and shorter in-hospital stay. Femoral artery cannulation is traditionally performed via surgical cutdown to establish cardiopulmonary bypass during minimally-invasive HVS. To avoid groin incision associated infection and lymphocele formation, and further minimize surgical trauma, the use of percutaneous cannulation including novel endovascular closure devices increases as an alternative but remains to be investigated.

The Percutaneous peRipheral cannulatiOn for Minimally-InvaSive heart valve surgEry (PROMISE) registry aims to elucidate the safety, feasibility, and effectiveness of newly developed vascular closure devices during minimally-invasive HVS. Acute intra- and perioperative complications will be evaluated according to modified definitions of the Valve Academic Research Consortium (VARC)-3. In addition, based on the initial results, the comparison of percutaneous cannulation with conventional surgical cut-down techniques is planned.


Eligibility criteria: Inclusion Criteria:

* Retrospective analysis of all patients undergoing minimally-invasive heart valve surgery using novel endovascular closure devices for percutaneous cannulation within 6 high-volume heart valve centres in Germany.

Exclusion Criteria:

* none

Primary outcomes:
measure: Access site related vascular complications.
timeFrame: Date of operation (day 0) until 30 days after operation (day 30).
measure: All-cause mortality.
timeFrame: Date of operation (day 0) until 30 days after operation (day 30).
measure: Cardiovascular mortality.
timeFrame: Date of operation (day 0) until 30 days after operation (day 30).
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg, University Medical Centre Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT06053450: The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.
Official title: The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Nursing Personnel
Keywords: Essential Oil Inhalation Patches
Essential oil and nursing stress
Medical-Surgical unit
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this clinical study is to compare the use of an essential oil inhalation patch in medical surgical nurses on perceived burn-out and stress.

The main question is can essential oil inhalation patches decrease perceived burn-out and stress.

Participants will

* Take part in the study over 30 days, alternating weeks, resulting in each participant using six patches over six shifts.
* Complete anonymous Perceived Stress Survey (PSS) before the study begins and at the conclusion of the study.
* Participants will also complete a (different) survey after two weeks.

Detailed description: Essential Oil inhalation patches are a nonpharmacological option that is worn by the nursing staff on an inpatient medical-surgical unit to determine the efficacy of patch on staff perceived stress \& burn-out levels. Each participant will wear a new patch during six work shifts. Location is on chest or the ID badge area where it can be easily accessed to. The patch provides up to 8 hours of aromatic support. The patches use a unique patented technology that slows the release of the aromatic molecules while maintaining the purity and vitality of the essential oil. The FDA approved medical adhesive patches are roughly 1x1" in size, and are inhalation only- no contact of essential oils on skin. The patch is portable and discreet. No overwhelming aroma for others. The patch has directions for use on package with an expiration date. Used for a non-specific purpose for stress reduction environment for this study.

Eligibility criteria: Inclusion Criteria:

* Full time employee (Nurse, LPN, or LNA) working on L3WD and L4WC
* At least 18 years of age

Exclusion Criteria:

* Pregnant/breastfeeding or planning to become pregnant

Primary outcomes:
measure: Change in baseline perceived stress as measured by the Perceived Stress Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: DHMC
name: Rachel G. Blier, MSN,RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spence Laschinger HK, Leiter MP. The impact of nursing work environments on patient safety outcomes: the mediating role of burnout/engagement. J Nurs Adm. 2006 May;36(5):259-67. doi: 10.1097/00005110-200605000-00019.