louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02297009: Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points
Official title: Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: DNA Methylation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2014-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students and research staff

Brief summary: A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa. Samples will be taken from the same participant at different timepoints.

DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit and will be quantified by a nano-drop spectrophotometer.

We will determine global and gene-specific methylation and hydroxymethylation alterations by UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter genes, and genes involved in the oxidative stress pathways will be assessed by PCR-pyrosequencing.


Eligibility criteria: Inclusion Criteria:

* Caucasian

Exclusion Criteria:

-

Primary outcomes:
measure: %Methylation (%)
timeFrame: 5 weeks
Secondary outcomes:
measure: %Hydroxymethylation (%)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: BIOMAT
Study officials:
References:
Clinical trial NCT01281709: Primary Care Physician's Wishes and Influencing Factors Toward Provision of Integrated Health Care
Official title: Primary Care Physician's Wishes and Influencing Factors Toward Provision of Integrated Health Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attitude of Health Personnel
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary care physicians who serve in the excecutive centers of their community medical groups

Brief summary: This questionnaire-based study was focused on understanding primary care physician's wish toward provision of integrated health care, associated knowledge and attitude, and analysis of influencing factors affecting their choices.

Detailed description: The population is aging rapidly in Taiwan. It has been estimated that 15 years from now, the elderly population will comprise over 20% of the general population. Within an aging population, the prevalence of chronic illnesses can be expected to increase, and these patients with multiple chronic illnesses will likely need a larger allocation of available resources with the national health care system. In contrast to a highly-specialized medical environment, integrated health care, with its multitude of health and medical services including diagnosis, treatment, convalescence, rehabilitation, and health promotion, can provide a more efficient synergism between the necessary aspects of delivery, supply, management and organization. Literature has shown that multi-disciplinary, well-managed chronic illness management can increase the convenience of patient medical visits and also decrease medical costs. To provide patients with multiple chronic illnesses more suitable, efficient, and higher quality medical care, and to decrease redundant or ill-advised medications or procedures, as well as to encourage medical systems to further incorporate integrated services to advance the ideal of holistic care, the Bureau of National Health Insurance issued the a decree on September 15th, 2009, named "Integrated care model and medical system-based integration plan". This questionnaire-based study was focused on understanding primary care physician's wish toward provision of integrated health care, associated knowledge and attitude, and analysis of influencing factors affecting their choices.

Eligibility criteria: Inclusion Criteria:

* The primary care physicians, who practicing western medicine, with the doctor licenses approved by the Department of Health in Taiwan

Exclusion Criteria:

* The subjects who are unable to complete the survey independently

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital (NTUH)
name: Tai-Yuan Chiu, Master
role: STUDY_CHAIR
References:
Clinical trial NCT02854709: Effects of Sleep Extension on Glucose Metabolism in Chronically Sleep Deprived Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Extension
Glucose Metabolism
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized cross over study of the effect of 2-week sleep extension in chronically sleep deprived non-diabetic individuals on glucose metabolism.


Eligibility criteria: Inclusion Criteria:

* self-reported sleep duration =\<6 hours/night during the week with a desire to sleep at least 7 hours/night

Exclusion Criteria:

* shift workers,
* diabetes history,
* drugs affecting sleep or glucose metabolism,
* insomnia symptoms,
* high risk for sleep apnea,
* smoking or excess alcohol use

Primary outcomes:
measure: Glucose metabolism
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital
Study officials:
References:
Clinical trial NCT00635609: Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Official title: Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 93
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Detailed description: Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Must be 12 years of age or older.
* Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.

Exclusion Criteria:

* Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
* Has a history of pseudomembranous colitis or antibiotic-associated colitis.
* Has a history of hepatitis or liver damage or renal impairment.

Primary outcomes:
measure: Successful Outcome According to Investigator's Global Assessment (IGA)
timeFrame: baseline and 12 weeks
measure: Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Vista
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Rochester
country: United States
facility: Warner Chilcott Investigational Site
state: New York
Study officials:
affiliation: Warner Chilcott
name: Angelo Secci, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00646009: Symbicort Onset of Action 2
Official title: A Randomized, Multicenter, Placebo and Active-controlled, Single-dose, 4-period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
adults
Symbicort
budesonide/formoterol
Advair Diskus
Ventolin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 48
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 early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosis of asthma and baseline lung function test results as determined by the protocol
* Required and received inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma or asthma that is markedly effected by seasonal factors
* Has required and received non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Primary outcomes:
measure: FEV1 3 minutes post dose
timeFrame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Secondary outcomes:
measure: 12 hour serial FEV1
timeFrame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
measure: Patients perception of effect
timeFrame: Patients perception of effect
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_DIRECTOR
References:
Clinical trial NCT00187109: Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy
Official title: A Phase I/II Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide, Carboplatin and Etoposide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Germ Cell Tumors
Hepatic Cancer
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Keywords: Thrombocytopenia
Platelets
Thrombopoietin
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer. The only remedy for thrombocytopenia at present is platelet transfusion, which is effective in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be effective in stimulating platelet production. The initial phase of this trial will evaluate the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and etoposide in children with solid tumors and lymphomas. The second phase of the study will evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of recurrent, refractory, or previously untreated malignant solid tumor or recurrent/refractory lymphoma for which Ifosfamide, Carboplatin, and Etoposide chemotherapy is the most appropriate treatment.
* Adequate liver and kidney function.
* Adequate performance status.

Primary outcomes:
measure: To evaluate the safety of recombinant human thrombopoietin following chemotherapy which includes ifosfamide, carboplatin and etoposide for solid tumors and lymphoma.
measure: To evaluate whether recombinant human thrombopoietin will reduce the time necessary for platelet counts to recover following chemotherapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Najat C. Daw, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484809: Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children
Official title: A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
juvenile rheumatoid arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Inclusion in this study will be as per the approved indications in the package insert.
* Patients with moderately to severely active RA.
* Children with JRA who have had an inadequate response to one or more DMARDs.

Exclusion Criteria:

* Known hypersensitivity to etanercept or any of its components.
* Known significant concurrent medical disease, including:

  * Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
  * Cancer or history of cancer
  * Active infection
  * Sepsis or risk of sepsis
  * Active tuberculosis or a past history of tuberculosis
  * Pancytopenia
* Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
* Patients who are planning to undergo elective surgery during the study period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05987709: Study of Colorectal Cancer Screening Options
Official title: Study of Colorectal Cancer Screening Options
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Colon Cancer Screening
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.

Detailed description: The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.

Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who are non-adherent after receiving stool test outreach, who have an upcoming clinical appointment, and who are offered a commercially available colorectal cancer blood test versus usual care (i.e. reminder to complete stool testing during their clinical appointment).

Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the test (based on available test performance characteristics) and willingness to obtain/offer the test on an on-going basis, based on qualitative interviews; assess preliminary rates of follow-up colonoscopy completion (after an initial abnormal test result) among participants allocated to the blood test vs. usual care condition.

Eligibility criteria: Inclusion Criteria:

* Age 45-75
* Received a FIT test in the last 3-9 months yet did not return their FIT
* Upcoming appointment or willing to reschedule an appointment at KPNW within 2 - 6 weeks
* Able and willing to provide informed consent if in the intervention arm

Exclusion Criteria:

* On KPNW's do not contact list
* Having a legal authorized representative
* Non-English speakers

Primary outcomes:
measure: Assess colorectal cancer screening completion
timeFrame: Within 3 months of patient identification
Secondary outcomes:
measure: Assess the proportion who completed follow-up testing.
timeFrame: Within 6 months of abnormal FIT test
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Gloria Coronado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01498809: Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury
Official title: Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthostatic Intolerance
Keywords: Orthostatic intolerance in people with spinal cord injury
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with spinal cord injury currently in primary care (less than one year post injury)

Brief summary: This project aims to evaluate the physiological effects of Midodrine administration during orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown to improve orthostatic symptoms in those with spinal cord injury but the physiological mechanisms influenced have not been identified. The investigators will examine key physiological components influencing orthostatic tolerance. The investigators will do this, by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one before Midodrine administration, and one after administration of a 10mg dose of Midodrine.


Eligibility criteria: Inclusion Criteria:

* To be included in the study, participants must have sustained a traumatic spinal cord injury within the ages of 18-49 years.
* Also, participants must have an injury level above the 6th thoracic vertebrae and be a non-smoker for a minimum of one year.

Exclusion Criteria:

* Any participants with a history of cardiovascular disease, pulmonary disease or diabetes mellitus will not be eligible.
* Also, participants will not be eligible to take part in study if they experiences acute distress, or are taking medications known to influence cardiovascular function.
* Patient will be not eligible for the study if he/she has known adverse reaction to Midodrine.

Primary outcomes:
measure: Baroreflex sensitivity
timeFrame: Immediately after drug administration (30 mins)
Secondary outcomes:
measure: Cerebral autoregulation
timeFrame: Thirty minutes after administration
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Hospital and Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Darren Warburton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: GF Strong Hospital University of British Columbia
name: Andrei Krassioukov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734209: How Does Eating Behavior and Hunger in Virtual Reality Meals Compare to Real Meals?
Official title: How Does Eating Behavior and Hunger in Virtual Reality Meals Compare to Real Meals? A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hunger
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover study with 2 repeats. Each person participated in two virtual meals and two real meals in random order.
Primary purpose: BASIC_SCIENCE

Brief summary: Objective: To investigate the differences between eating virtual and real-life meals and test the hypothesis that eating a virtual meal can reduce hunger among healthy women.

Methods: Twenty healthy women will be recruited and partake in a randomized crossover study. The subjects will be asked to eat one introduction meal, two real meals, and two virtual meals, all containing real or virtual meatballs and potatoes. The real meals will be eaten on a plate placed on a scale which communicates with analytical software on a computer. The virtual meals will be eaten in a room, where participants are seated on a real chair in front of a real table, and fitted with the virtual-reality equipment. The eating behavior for both the real and virtual meals will be filmed. Hunger will be measured before and after the meals using questionnaires.


Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 kg/m2 to 29 kg/m2
* "normal" physical activity (measured using the short version of the international physical activity questionnaire, IPAQ)

Exclusion Criteria:

* pregnant or breastfeeding
* smoker
* temporomandibular disorder
* recent serious dental surgery (last 6 months)
* undergoing treatments known to affect appetite (e.g., use of some psychotropic drugs)
* previous history of eating disorders
* vegetarian
* aversion to the food served

Primary outcomes:
measure: Difference in hunger before to after meal
timeFrame: Before to after meal (on average around 10 minutes)
Secondary outcomes:
measure: Food intake
timeFrame: During meal (around 10 minutes)
measure: Meal duration
timeFrame: During meal (around 10 minutes)
measure: Forkfuls
timeFrame: During meal (around 10 minutes)
measure: Additions
timeFrame: During meal (around 10 minutes)
measure: Chews
timeFrame: During meal (around 10 minutes)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Billy S Langlet, PhD
role: PRINCIPAL_INVESTIGATOR
References: