louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01504048: Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis
Official title: Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Diarrhoea
Lymphocytic Colitis
Collagenous Colitis
Keywords: Microscopic colitis
Intestinal Diseases
Inflammatory Bowel Diseases
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.

Detailed description: Microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. Obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. Chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (Suzuki 2011).

The aim of this study is to investigate if chromoendoscopy using Indigo-Carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic non-bloody diarrhea for at least one month

Exclusion Criteria:

* Patients who decline to participate
* Unable to give informed consent

Primary outcomes:
measure: Detection of microscopic colitis using chromoendoscopy
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karoliniska University Hospital, Dept. of Gastroenterology
Study officials:
affiliation: Karolinska University Hospital
name: Peter T Schmidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suzuki G, Mellander MR, Suzuki A, Rubio CA, Lambert R, Bjork J, Schmidt PT. Usefulness of colonoscopic examination with indigo carmine in diagnosing microscopic colitis. Endoscopy. 2011 Dec;43(12):1100-4. doi: 10.1055/s-0031-1291423. Epub 2011 Nov 4.
Clinical trial NCT04000048: Molecular Heterogeneity in Multilobar Low-grade Gliomas
Official title: Phylogenetic Analysis of Intra-tumor Molecular Heterogeneity on a Pilot Series of Diffuse Low-grade Multilobar Gliomas: Tumor Ontogenesis and Therapeutic Implications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low-grade Diffuse Glioma
Keywords: Low-grade diffuse glioma
DNA extraction
sequencing
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: resected tumor fragments, of the diagnosis of grade II glioma according to the 2016 WHO classification of brain tumors.

Brief summary: Low-grade diffuse glioma (GDBG) are rare tumors of young adults, whose ontogenesis is poorly understood. Patient management is based on the molecular profile defined by two molecular markers : mutations of the IDH genes and chromosomal 1p19q co-deletion. To date, the IDH and 1p19q statuses are determined on a single fragment collected from the tumor. In the case of GDBGs infiltrating several brain lobes, the sampling is done randomly on only one of the infiltrated lobes. An intra-tumoral heterogeneity of genetic alterations has been suggested and would impact management.

Phylogenetic analysis of genetic alterations found, by high throughput sequencing, in each lobe invaded by the same GDBG will make it possible to assess intra-tumoral heterogeneity and to discuss, at a fundamental level, the hypothesis of a single tumor site with secondary diffusion or that of the convergent progression of two or three distinct tumor sites. Clinically, understanding the ontogenesis of GDBGs will improve their management because of the known link between brain location, dominant molecular profile, and prognosis.


Eligibility criteria: Inclusion Criteria:

* Be over 18 years old.
* Subject not opposed to participating in the study
* Be scheduled in the operating room for the first surgery of a low-grade diffuse glioma presupposition on the basis of clinical and imaging criteria.
* Confirmation, after histopathological analysis of the resected tumor fragments, of the diagnosis of grade II glioma according to the 2016 WHO classification of brain tumors.

Exclusion Criteria:

* Patient minor, or major under legal protection, or unable to give consent.
* Refusal to participate in the study.
* Pathology diagnosis of grade III glioma according to WHO 2016 classification
* Have received oncology treatment (chemotherapy and or chemotherapy) before the first surgery.

Primary outcomes:
measure: Genetic profile
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Gui de Chauliac
Study officials:
References:
Clinical trial NCT05029648: Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty
Official title: Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoas Tendinitis
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 1199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had a total hip replacement for at least six months.

Brief summary: Evaluation of predictive factors for psoas tendinitis after first-line total hip arthroplasty.

A single-centre retrospective study of medical data from the medical records of patients undergoing total hip arthroplasty.

Detailed description: From the medical records of a series of patients operated on for total hip arthroplasty:

Main objective: To assess individual and surgical factors associated with the development of psoas tendinitis.

Secondary objectives:

* To describe the frequency of occurrence of psoas tendinitis
* To describe the outcome of patients who underwent tenotomy.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older, having been informed of the research
* Patient who has had a total hip replacement implanted for at least six months as a first-line treatment
* Patient who has been regularly monitored since the operation and for whom all clinical and radiological data are available during follow-up visits

Exclusion Criteria:

* Patient undergoing revision surgery
* Patient who has indicated his opposition to the use of his medical data
* Patient under legal protection, guardianship or curators

Primary outcomes:
measure: Psoas tendinitis development
timeFrame: 6 months
Secondary outcomes:
measure: Psoas tendinitis occurrence frequency
timeFrame: 6 months
measure: To describe the outcome of patients who have undergone tenotomy
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
affiliation: Clinique de la Sauvegarde
name: Nicolas BONIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03824639: Exercise Training to Improve Cognitive Function
Official title: Exercise Training to Improve Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
exercise therapy
patient adherence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment.

Detailed description: Background/Rationale:

Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in coming decades. AD is known to have a long preclinical phase in which pathophysiologic processes develop many years, even decades, before the onset of clinical symptoms. During this preclinical phase there is evidence of unremitting decline in cognitive function, particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological interventions to slow this decline in cognitive function has been limited, leading to increasing interest in the utility of nonpharmacological interventions including exercise.

Objective:

The investigators propose to assess the feasibility of a novel home-based exercise intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI).

Methods:

The investigators will estimate the difference between the intervention (n=30) and the control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis for sample size calculation for a proposed larger study. Participants will be male and female Veterans 50 years of age or older with amnestic MCI.

Eligibility criteria: Inclusion Criteria:

* Amnestic MCI
* Ability to use a telephone without assistance

Exclusion Criteria:

* Angina Pectoris
* History of myocardial infarction within 6 months
* History of ventricular dysrhythmia requiring current therapy

Primary outcomes:
measure: Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: David Sparrow, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02117739: Photoallergy Potential of Dapsone Gel in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2014-04-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the potential of dapsone gel and its vehicle to cause a photoallergic reaction after repeated application and irradiation to the skin of healthy volunteers under controlled conditions.


Eligibility criteria: Inclusion Criteria:

-Healthy adults.

Exclusion Criteria:

* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
* Sensitivity to adhesive bandages or tape.

Primary outcomes:
measure: Photoallergic (Sensitizing) Potential Using a Visual Scale
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
state: New Jersey
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03471039: PACAP27 Headache Properties in Migraine Without Aura Patients
Official title: Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.


Eligibility criteria: Inclusion Criteria:

* Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.

  * Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.

Exclusion Criteria:

* Tension Type headache for more than 5 days the month on average in the last year.

  * All other primary headaches .
  * Headache later than 48 hours before trial start.
  * Daily intake of any medicine other than oral contraception.
  * Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
  * Pregnant or breastfeeding women.
  * Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
  * Migraine within 5 days before the trial date.
  * Ancestral information or clinical signs of (on the day of inclusion):
* Hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 100 mmHg)
* Hypotension (systolic blood pressure \<90 mm Hg and / or diastolic blood pressure \<50 mmHg)

  * Cardiovascular disease of all kinds, including cerebrovascular disease.
  * Anamnestic or clinical signs of mental illness or abuse.
  * Patients with glaucoma or prostatic hyperplasia
  * Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.

Primary outcomes:
measure: Headache Scores
timeFrame: 0-12 hours
Secondary outcomes:
measure: Facial blood flow (flushing)
timeFrame: 0-120 mins
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References:
Clinical trial NCT01677039: Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
Official title: An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
oxycodone
ethanol interaction
healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* history of moderate alcohol consumption
* total body weight exceeding 64 kg

Exclusion Criteria:

* history of clinically significant disease
* history of sleep apnea
* any condition affecting drug absorption
* pregnant or nursing female subjects
* history of allergy or hypersensitivity to either oxycodone or naltrexone

Primary outcomes:
measure: Maximum observed oxycodone concentration in plasma (Cmax)
timeFrame: hours after dosing
measure: Area under the oxycodone concentration versus time curve (AUC)
timeFrame: hours after dosing
Secondary outcomes:
measure: Time-to-peak concentration (Tmax)
timeFrame: hours after dosing
measure: half-life of drug
timeFrame: hours after dosing
measure: Vital signs and adverse events
timeFrame: hours after dosing
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Malhotra BK, Matschke K, Wang Q, Bramson C, Salageanu J. Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02). Clin Drug Investig. 2015 Apr;35(4):267-74. doi: 10.1007/s40261-015-0278-6.
Clinical trial NCT02861339: Prevalence of Keratoconus in Inflammatory Bowel Diseases
Official title: Prevalence of Keratoconus in Inflammatory Bowel Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keratoconus
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A retrospective study has shown the association between the inflammatory bowel diseases (IBD) and the presence of a keratoconus. This new study will measure the prevalence of keratoconus and follow its activity in patients affected by IBD and followed up in hepatology-gastroenterology department at Nancy Hospital. The prevalence of keratoconus will be compared to known data of literature about general population.

The secondary purpose is to search for a relationship between the presence of a keratoconus and activity criteria of IBD.

Perspectives are a systematic screening for keratoconus in patients affected by IBD with the amelioration of the ophthalmologic care of IBD patients and confirmation of the recent hypothesis of inflammatory origin of keratoconus.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Affiliation to social security plan
* Diagnosis of IBD since more than 3 years, under treatment or not

Exclusion Criteria:

* Protected person
* Pregnant or breastfeeding women
* Person in life-and-death emergency
* Person deprived of liberty
* Refusal to remove contact lenses, where necessary

Primary outcomes:
measure: Absence or presence of keratoconus in IBD patients
timeFrame: day 0
Secondary outcomes:
measure: IBD clinical features using the Montreal classification for IBD
timeFrame: day 0
Other outcomes:
Locations:
Study officials:
affiliation: Service d'ophtalmologie- Hôpitaux de Brabois - CHU de NANCY
name: Karine ANGIOI-DUPREZ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00559039: Effects of Fetal, Infant, and Early Childhood Exposures on Adult Cancer Risk in Women
Official title: Fetal, Infant and Early Childhood Antecedents of Cancer in Women: Maternal Cohort Study of the Nurses' Health Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: breast cancer
unspecified adult solid tumor, protocol specific
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-11-16
Enrollment: 128700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: RATIONALE: Gathering information about pregnancy, infancy, and early childhood exposures may help doctors identify cancer risk factors, and may help the study of cancer.

PURPOSE: This natural history study is looking at the effects of fetal, infant, and early childhood exposures on adult cancer risk in women.

Detailed description: OBJECTIVES:

* Determine if fetal, infant, and early childhood exposures are associated with adult cancer risk in women.

OUTLINE: Mothers of nurses complete questionnaires to collect maternal data, such as pregnancy weight gain, diet during pregnancy, maternal pre-eclampsia, gestational diabetes, gestational age at birth, birth weight, and infant feeding practices. Maternal data is linked to other data collected from critical time periods in the nurses's life cycle, such as menarche, first pregnancy, or adult dietary intake.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Mother of a nurse who is a participant in the Nurses' Health Studies I and II

  * Nurse free of cancer in the year 2000

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Diagnosis of incident cancers and other chronic diseases
measure: Mortality
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michele R. Forman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02203539: The Influence of Light Exposure on Exercise Performance Dependent on Chronotype.
Official title: The Influence of Different Light Exposures on Endurance Performance, Handgrip Strength and Reaction Time in Consideration of the Chronotype.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endurance Performance
Reaction Time
Muscle Strength
Keywords: circadian rhythm
light exposure
exercise capacity
endurance
strength
reaction
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if an exposure to light in the evening has a positive influence on physical performance regarding endurance, strength and reaction time.


Eligibility criteria: Inclusion criteria:

* BMI 18 to 30 kg/m2
* endurance performance \>= 55 ml/min/kg peak oxygen uptake

Exclusion criteria:

* cardiovascular disease
* renal dysfunction
* shiftworking
* travels over time zones in the last 4 weeks
* high blood pressure (systolic blood pressure \>170mmHg, diastolic blood pressure \>100mmHg)
* depression

Primary outcomes:
measure: Work performed in kilo Joule (kJ) during the time trial ergometer test adjusted for the VO2peak.
timeFrame: The outcome measure will be assesed at the end of the 12minute time trial ergometer test.
Secondary outcomes:
measure: Reaction time in milliseconds (ms)
timeFrame: Reaction time task will be performed at baseline (20 to 15 minutes before the light exposure) and 0 to minutes after the light exposure which will be the secondary outcome measure.
measure: Maximum handgrip strength in kilo gramm (kg)
timeFrame: Maximum handgrip strength will be tested at baseline (15 to 10 minutes before the light exposure) and 5 to 10 minutes after the 60 minutes lasting light exposure.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel
Study officials:
affiliation: Departement of Sports, Exercise and Health, University of Basel
name: Arno Schmidt-Trucksäss, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: