louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01437839: Food Effect Study For Apixaban Commercial Image Tablets
Official title: An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Food effect study
Pharmacokinetics
Apixaban
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* History or evidence of abnormal bleeding or coagulation disorder (eg, easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery) and/or having a first degree relative under 50 years of age with a history of abnormal bleeding or coagulation disorder

Primary outcomes:
measure: Cmax
timeFrame: dosing to 3 days
measure: AUC(INF)
timeFrame: dosing to 3 days
Secondary outcomes:
measure: AUC(tlqc)
timeFrame: dosing to 3 days
measure: Tmax
timeFrame: dosing to 3 days
measure: t1/2
timeFrame: dosing to 3 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Song Y, Chang M, Suzuki A, Frost RJ, Kelly A, LaCreta F, Frost C. Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults. Clin Ther. 2016 Jul;38(7):1674-1685.e1. doi: 10.1016/j.clinthera.2016.05.004. Epub 2016 Jun 10.
Clinical trial NCT01261039: Production of Vitamin D Metabolites by UV-radiation From Solar Bed
Official title: Production of Vitamin D Metabolites by UV-radiation From Solar Bed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed.
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Background:

Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or supplements.

Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis. Vitamin D may also be important for the immune system-including autoimmune diseases-and the cardiovascular system.

Purpose:

The main purpose of the study is to learn more about the production of vitamin D3 in the skin, by ultraviolet radiation.

Study Course:

Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.

Blood samples are drawn on the first day at following times: Before solar bed, after at 15 minutes, 1, 2, 4 and 6 hours.

Day 1,2,3 and 7 after solar bed exposure:

Blood samples are drawn and adverse events are registered.


Eligibility criteria: Inclusion Criteria:

Healthy adults

Exclusion Criteria:

Abnormal ALT or Creatinine Pregnancy

Primary outcomes:
measure: Vitamin D 25-OHD
timeFrame: 8 days
Secondary outcomes:
measure: Changes in other calcium metabolic factors
timeFrame: 8 days
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Jens-Erik B Jensen, MD, PhD
role: STUDY_CHAIR
affiliation: Dept. of Endocrinology
name: Louise L Schierbeck, MD
role: STUDY_CHAIR
affiliation: Hvidovre University Hospital
name: Ulrich Bang, MD
role: STUDY_CHAIR
affiliation: University of Copenhagen
name: Jakob H Langdahl
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langdahl JH, Schierbeck LL, Bang UC, Jensen JE. Changes in serum 25-hydroxyvitamin D and cholecalciferol after one whole-body exposure in a commercial tanning bed: a randomized study. Endocrine. 2012 Oct;42(2):430-5. doi: 10.1007/s12020-012-9641-z. Epub 2012 Mar 6.
Clinical trial NCT03621839: New CSF Biomarkers for Alzheimer's Disease
Official title: New Diagnosis or Prognosis Biomarkers for Alzheimer's Disease: Biobank of CSF Collected as Part of Differential Diagnosis of Dementia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Dementia
Neurodegenerative Diseases
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consenting patients submitted to a lumbar punction in the context of dementia diagnosis

Brief summary: Today, the Alzheimer's disease (AD) diagnosis is founded not only on clinical criteria but also on complementary examinations to confirm a physiopathological process of AD. In complex cases, lumbar punction could be necessary in order to measure Aβ peptides and Total and phosphorylated Tau but new biomarkers could be useful. The main objective of this project is to conserve these cerebrospinal fluids, collected in usual practice in order to validate new biomarkers for diagnosis, prognosis or therapeutic following of Alzheimer's disease and other dementia.


Eligibility criteria: Inclusion Criteria:

* Lumbar punction collected in usual practice in the context of dementia diagnosis

Exclusion Criteria:

* Absence of consent

Primary outcomes:
measure: CSF collection constitution to have samples available for assessing new Alzheimer's biomarker
timeFrame: 50 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU De Nancy
state: Grand Est
Study officials:
References:
Clinical trial NCT00427739: Data Collection During CT for Axial Flow VADs
Official title: Pilot Study of Data Collection During Computerized Tomography (CT) to Determine Accurate Flow Rates for Axial Flow Ventricular Assist Device (VAD) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Axial Flow Ventricular Assist Device
Cardiac CT
Stage IV heart failure
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2007-01-29
Enrollment: 9
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: Patients with implanted left ventricular assist devices referred for CT scans

Brief summary: At present, there is not accurate way to determine specific flow rates for axial flow ventricular assist devices (VADS). If a right heart cath is needed for these patients for clinical purposes, they will also undergo a cardiac CT scan while the pulmonary artery catheter is in place. It is possible to visualize the flow rates of axial flow VAD's and determine a more accurate rate per specific patient.

Data Analyzed with following results:

Article in Press for Cardiopulmonary Support and Physiology, results state "Pairwise comparison of calculated output from left ventricular assist devices is feasible using first pass dynamic computed tomography test bolus technique versus thermodilution output measurements yielded good agreement (P=.03). The output calculated using dynamic CT underestimated the thermodilution output measurement by 0.54+ 0.37 L/min (95% confidence interval 0.66-0.94).

Detailed description: Description as listed in Summary. The hemodynamic data collected along with pump parameters may help determine more accurate flow rates specific to each patient.

Eligibility criteria: Inclusion Criteria:

* Signed Informed consent

Primary outcomes:
measure: data collection to help determine better clinical evaluation
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University, Division of Cardiothoracic Surgery
name: Benjamin Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367939: Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine
Official title: An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker


Eligibility criteria: Inclusion Criteria:

* Male or female patients (18 years or older)
* Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
* Patients with moderate essential hypertension (WHO II)

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing women
* Treated hypertensive patients with controlled hypertension under current therapy (MSDBP \< 90 mmHg and MSSBP \< 140 mmHg)
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP
Secondary outcomes:
measure: To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate.
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma Ag
role: STUDY_DIRECTOR
References:
citation: Trenkwalder P, Schaetzl R, Borbas E, Handrock R, Klebs S. Combination of amlodipine 10 mg and valsartan 160 mg lowers blood pressure in patients with hypertension not controlled by an ACE inhibitor/CCB combination. Blood Press Suppl. 2008 Dec;2:13-21. doi: 10.1080/08038020802488855.
Clinical trial NCT03571139: Detecting the Influence of Cataract Surgery on the Development of Diabetic Retinopathy in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Using OCT Angiography
Official title: OCT Angiography Changes in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Undergoing Phacoemulsification
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy
Keywords: OCT angiography
Diabetic retinopathy
Cataract surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus type 2 with and without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery.

Brief summary: Detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using OCT angiography.

Detailed description: Patients with diabetes mellitus type 2 with and without without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery, will undergo OCT angiography examination prior to their cataract surgery. Average vessel density (%) in superficial capillary plexus, deep capillary plexus and choriocapillaris, parafoveal vessel density (%) in the superficial and deep plexuses, FAZ area (mm2) in the superficial capillary plexus, FAZ circularity, retinal thickness, microaneurysms and capillary non-perfusion will be taken into analysis.

Patients will be examined on the first day after the cataract surgery with phacoemulsification and in the bag posterior chamber lens implantation.

All patients will undergo OCT angiography examination four weeks after their cataract surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery.
* Patients who need cataract surgery without any intravitreal injections.
* Absence of any ocular disease other than diabetes mellitus.
* Cataract density allowing good visualization of the fundus by OCT angiography.
* Patients with uneventful cataract surgery with phacoemulsification.

Exclusion Criteria:

* Patients who fail to comply with the follow-up schedule.
* Very dense cataract not allowing good visualization of the fundus by OCT angiography.
* Patients with complicated cataract surgery with phacoemulsification.
* Patients who need cataract surgery with any intravitreal injection.

Primary outcomes:
measure: Detecting changes in the retinal vascular plexuses and choriocapillaris after cataract surgery in type 2 diabetes mellitus patients with and without diabetic retinopathy using OCT angiography.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: German Eye Center
Study officials:
affiliation: Cairo University
name: Abeer T Al Hanaineh, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02470039: Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
Official title: An 8-week Randomised, Double-blind, Parallel, Multiple Dose Trial Comparing NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy


Eligibility criteria: Inclusion Criteria:

* Age of 18-70 years (both inclusive) at the time of signing informed consent
* Body mass index of 25.0-40.0 kg/m\^2 (both inclusive)
* Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening
* Insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

Exclusion Criteria:

* Known or suspected hypersensitivity to the trial products or related products
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator

Primary outcomes:
measure: Change in fasting plasma glucose (FPG)
timeFrame: Week 0, Week 8
Secondary outcomes:
measure: Change from baseline in 10-points plasma glucose profile
timeFrame: Week 0, Week 8
measure: Number of treatment emergent hypoglycaemic episodes
timeFrame: From start of treatment until Visit 14 (Day 68)
measure: area under the serum insulin concentration-time curve
timeFrame: During one dosing interval (0 to 24 hours) at steady state (Day 56)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Halberg IB, Lyby K, Wassermann K, Heise T, Zijlstra E, Plum-Morschel L. Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial. Lancet Diabetes Endocrinol. 2019 Mar;7(3):179-188. doi: 10.1016/S2213-8587(18)30372-3. Epub 2019 Jan 21.
Clinical trial NCT01404039: Investigating Motor Cortex Processing for Pain Modulation
Official title: Investigating Motor Cortex Processing for Pain Modulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Motor Activity
Keywords: learning
pain perception
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 115
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 5 experiments: motor learning (3 groups, crossover), sensory learning (4 groups, parallel), observational task (2 groups, parallel), mental imagery (2 groups, parallel), and tDCS over the motor cortex (2 groups, crossover). Please note that the tDCS experiment has never been conducted.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effects of different types of interventions (motor learning, somatosensory learning, observation task, mental imagery and tDCS) on the perception of pain and motor cortex excitability in healthy male subjects. This is an exploratory study of healthy subjects only.

Detailed description: There are 5 experiments:

Exp1: motor learning (3 groups, crossover) - motor leaning with and without visual feedback and a control group.

Exp2: sensory learning (4 groups, parallel) - sensory learning with and without feedback, an simple activation task and a control group.

Exp3: observational task (2 groups, parallel) - an motor observational task and a control group.

Exp4: mental imagery (2 groups, parallel) - a motor mental imagery and a control group.

Exp5: tDCS over the motor cortex (2 groups, crossover) - active and sham tDCS. Note that this study has never been completed.

Eligibility criteria: Inclusion Criteria

1. Provide informed consent to participate in the study
2. 18 to 64 years old
3. No presence of rheumatologic disease as self reported
4. No clinically significant or unstable medical or psychiatric disorder as self reported
5. No history of alcohol or substance abuse within the last 6 months as self reported
6. No neuropsychiatric co-morbidity as self reported
7. No Contraindications to single pulse TMS (TMS will be used to measure cortical excitability)

   * history of seizures
   * unexplained loss of consciousness
   * metal in the head
   * frequent or severe headaches or neck pain
   * implanted brain medical devices
8. No Contraindications to tDCS

   * metal in the head
   * implanted brain medical devices

Primary outcomes:
measure: Change in Motor Cortex Excitability MEP Amplitude
timeFrame: after each intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital (SRH)
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835039: The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy
Official title: The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIE - Perinatal Hypoxic - Ischemic Encephalopathy
Lead sponsor: Albany Medical College
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-02-08
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants with diagnosis of HIE

Brief summary: A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.


Eligibility criteria: Inclusion Criteria:

* Infants with diagnosis at birth of HIE

Exclusion Criteria:

* none

Primary outcomes:
measure: MRI findings of encephalopathy
timeFrame: 6 days
measure: Neurodevelopment at 2 years of age
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Neonatal Intesive Care Unit
state: New York
Study officials:
References: