louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01524809: Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
Official title: A Single-Centre, Randomised, Double-Blind, 2- Period Crossover Trial Investigating the Steady State Pharmacokinetics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 26
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: This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Currently on a multiple dose insulin regimen
* HbA1c maximum 12.0%
* BMI (body mass index) below 35 kg/m\^2
* Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria:

* Treatment with insulin aspart within the last 14 days prior to this trial
* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose at least 1.8 U/kg
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
* Cardiac disease
* Severe, uncontrolled hypertension

Primary outcomes:
measure: Area under the serum insulin curve 6-14 hours after dinner at day 15
Secondary outcomes:
measure: Area under the serum insulin curve 6-14 hours after dinner at day 1
measure: Area under the serum insulin curve 0-6 hours after dinner
measure: Area under the curve 0-24 hours
measure: Serum insulin
measure: Apparent t½ (apparent elimination half life)
measure: Cmax, maximum concentration
measure: tmax, time to reach Cmax
measure: Adverse events
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Chen JW, Lauritzen T, Christiansen JJ, Jensen LH, Clausen WH, Christiansen JS. Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Diabet Med. 2005 Mar;22(3):273-7. doi: 10.1111/j.1464-5491.2004.01404.x.
Clinical trial NCT00111709: Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-05-25
Enrollment: 393
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.


Eligibility criteria: Inclusion Criteria:

* Female patient at least 18 years old
* Patient has menses approximately monthly
* Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion Criteria:

* Pregnant and/or nursing
* Cardiovascular disease
* Uncontrolled hypertension

Primary outcomes:
measure: Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Secondary outcomes:
measure: Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.
citation: Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.
Clinical trial NCT00132509: FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
Official title: Comparison of the Classical Rt-PA Procedure (0.9mg/kg Over 60 Minutes) With a Longer Procedure With Lower Dose (0.8mg/kg Over 90 Minutes) in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke, Acute
Keywords: rt-PA
thrombolysis
Acute ischemic stroke
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.

Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low dose-longer infusion".

This is a study of the outcome at 90 days.


Eligibility criteria: Inclusion Criteria:

* Symptoms of ischemic stroke
* Presence of a deficit measurable with National Institutes of Health Stroke Scale (NIHSS)
* Lack of any hemorrhagic lesion on the computed tomography (CT) scan at entry
* Time of therapy less than 7 hours after onset of stroke
* Permanent or aggravating symptoms
* Ages 18-81

Exclusion Criteria:

* Lack of cerebral infarction or of cranial trauma within 3 weeks before therapy
* No surgery within 14 days before therapy
* History of cerebral bleeding
* Blood pressure: systolic \>185 mmHg and/or diastolic \>110 mmHg
* Minor symptoms or symptoms rapidly improving
* Gastro-intestinal or urinary hemorrhage within 21 days
* Arterial puncture within 7 days before therapy
* Epileptic seizure at the beginning of stroke
* Patients under oral anticoagulants or having received heparin within 48 hours, and with elevated activated partial thromboplastin time (aPTT)
* Patients with elevated International Normalized Ratio (INR) or thrombocyte count \< 100 x 10\^9
* Blood glucose value \< 2.7 mmol/l or \> 22.2 mmol/l
* Cardiac, pulmonary, hepatic or renal failure, not allowing a study over 3 months
* History of gastric ulcer within 15 days; gestation and menstruation

Primary outcomes:
measure: Modified Rankin score
timeFrame: day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
Study officials:
affiliation: Hospices Civils de Lyon
name: Paul TROUILLAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05571709: The Effect of Exercise on Myokine Production in Aging Persons
Official title: Does an Acute Exercise Bout Increases Soluble and Muscle Myokine Concentration in Healthy, Older Persons
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Exercise
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aged individuals who perform exercise training are compared to aged individuals who remain sedentary.
Primary purpose: BASIC_SCIENCE

Brief summary: The incidence of age-related diseases, such as cancer and cardiovascular diseases, rapidly rises. These days, age-related diseases cause the majority of all healthcare expenses. During ageing senescent cells secrete a range of harmful inflammatory signals, which leads to chronic inflammation (inflamm-aging) and accelerates aging throughout the rest of the body. Interestingly, people who regularly exercise show less signs of inflamm-aging compared to people with a sedentary lifestyle. Molecules secreted by skeletal muscles, called myokines, may play an important role. However, the underlying molecular mechanisms remain unknown. This pilot study aims to investigate if an acute bout of resistance training is an appropriate tool to induce an increase in the release of muscle derived myokines in aged persons.


Eligibility criteria: Inclusion Criteria:

* Healthy persons

Exclusion Criteria:

* Smoking
* Infection \< 2 weeks ago
* Received a vaccine \< 2 weeks ago
* Allergy to Lidocain
* Immune deficiency
* Presence of a tumour or in treatment
* Usage of anti-coagulant medication
* Presence of following conditions:

  * Haemophilia
  * Auto-immune disease
  * Cardiovascular disease
  * Musculoskeletal diseases which refrains the patient from exercising

Primary outcomes:
measure: Cytokine concentration
timeFrame: Day 2
measure: Myokine production
timeFrame: Day 2
measure: Immune parameters
timeFrame: Day 2
measure: Myokine protein levels
timeFrame: Day 2
measure: Myokine gene expression
timeFrame: Day 2
Secondary outcomes:
measure: Blood pressure
timeFrame: Day 1
measure: Resting Heart Rate
timeFrame: Day 1
measure: International Physical Activity Questionnaire (Short form)
timeFrame: Day 1
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: University of Hasselt
name: Chiel Hex, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00791609: Evaluation the Feasibility of the FOSTI Device
Official title: Evaluation the Feasibility of the FOSTI Device Accurately and in a Real Time Way to Differentiate Malignant From Benign Tissue (Performed ex Vivo) in Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: cancer
Lead sponsor: Optivasive Ltd.
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of subjects who undergo cancer surgery

Brief summary: Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue

Detailed description: Characterization of the optical fiber sensor's interaction with the tissue.

Creating a database of tissue lesions and their 'optical signature' (lesion classifier).

Optimization of the FOSTI device by minimizing the false-positive and false-negative results.

Eligibility criteria: Inclusion Criteria:

* Subjects of all ages.
* Subject is able, agree and sign the Informed Consent Form.

Exclusion Criteria:

* Subject has any conditions, which precludes compliance with study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Optivasive Ltd.
name: Anatoliy Babchenko
role: STUDY_DIRECTOR
References:
Clinical trial NCT03389009: Ultrasound Biomicroscopy Study Of Accommodative State In Smartphone Abusers
Official title: Ultrasound Biomicroscopy Study Of Accommodative State In Smartphone Abusers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasm of Accommodation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2018-01-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Group (A): 40 smart phone abuser subjects (According to the smartphone questionnaire).

Group (B): 40 smart phone non user subjects.

Brief summary: Detection if there is association between spasm of accommodation and smart phone abuse by ultrasound biomicroscopy on anterior segment of the eye


Eligibility criteria: Inclusion Criteria:

1. Age 18 - 35 year.
2. Smart phone excessive use.
3. Emmetrope and myope patients.

Exclusion Criteria:

1. Hypermetrope patients.
2. Any form of tropia.
3. Anterior segment diseases either congenital or acquired.
4. Previous intraocular surgeries.
5. Presbyopic subjects.
6. Drugs induced spasm of accommodation: psychiatric drugs, pilocarpine, physostigmine, echothiophate, prostigmine, isoflurophate, muscarine, digitalis overdose and with sulphonamides
7. CNS diseases : Neurosyphilis, Raeder paratrigeminal neuralgia syndrome, cyclic oculomotor palsy, pineal tumor, Chiari malformation, pituitary tumor, metabolic encephalopathy,

Primary outcomes:
measure: Difference in objective refraction measured before and after cycloplegia
timeFrame: 40-60 minutes after instillation of cycloplegic drop
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00162409: Relationship Between Folic Acid and Warfarin Metabolism and Effect
Official title: The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Folic Acid Deficiency
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Folic acid supplementation has been shown previously to be associated with enhanced formation of p-HPPH from phenytoin, a metabolic pathway which is predominantly mediated through the activity of CYP2C9.

The metabolism of S warfarin, the more active enantiomer of warfarin, is also mediated predominantly through the activity of CYP2C9.

The purpose of the present study was to examine the relationship between folic acid concentration and warfarin pharmacokinetic as well as warfarin dose requirement among patients treated by warfarin. In addition the effect of folic acid supplementation (5 mg/d) for 3 weeks on warfarin pharmacokinetic and warfarin dose requirement will be evaluated in the second part of the study.


Eligibility criteria: Inclusion Criteria:

* Patients on chronic warfarin therapy

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Warfarin pharmacokinetic prior to and following administration of folic acid
measure: Warfarin dose requirement prior to and following the administration of folic acid.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00604409: Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
Official title: Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Liver Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Sirtex Medical
First posted: 2008-01-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.

Detailed description: Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.

Eligibility criteria: Inclusion Criteria:

* Adequate liver function
* Adequate performance status

Exclusion Criteria:

* Significant extrahepatic disease

Primary outcomes:
measure: To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer.
timeFrame: ongoing
Secondary outcomes:
measure: Efficacy
timeFrame: response rate
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Steven J. Cohen, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00046709: Marijuana for Cancer Pain
Official title: Marijuana in Combination With Opioids for Cancer Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Keywords: Cancer pain
All types of cancer except lung cancer
Lead sponsor: Center for Medicinal Cannabis Research
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2002-10-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To find out if it is safe and effective to use smoked marijuana in combination with opioids to treat cancer pain. The study will evaluate whether smoked marijuana, when used with opioids, will have an effect on pain relief, and to see if marijuana reduces the side effects of opioids, which include nausea and/or vomiting.

Detailed description: To take part in this study, you must have ongoing cancer pain which is currently being treated with opioids. If you meet all the eligibility criteria you will be admitted to the General Clinical Research Center at San Francisco General Hospital for 9 days. The treatment consists of smoking one marijuana cigarette 3 times a day.

Eligibility criteria: INCLUSION CRITERIA

* Have ongoing cancer pain
* Be diagnosed with cancer and have at least a six month survival.
* Be on a stable dose of opioid medication for at least 2 weeks before enrollment.
* Have smoked marijuana on at least 6 occasions in their lifetime prior to enrollment.

EXCLUSION CRITERIA

You must not:

* Start chemotherapy, radiation or biphosphonates during the study, or have received any new intervention with any such agents within the past 4 weeks.
* Currently be using smoked tobacco products.
* Currently be in methadone treatment.
* Have smoked marijuana within 30 days of enrollment.
* Be diagnosed with diabetes mellitus.
* Have severe heart disease, uncontrolled hypertension, or lung disease.
* Currently be receiving treatment with corticosteroids.
* Be pregnant or breastfeeding.

Primary outcomes:
measure: Change in level of cancer pain as recorded on a 100mm Visual Analog Scale.
Secondary outcomes:
measure: Change in level of experimentally induced pain on a 100mm Visual Analog Scale.
measure: Change in nausea and emesis in participants exhibiting these symptoms.
measure: Change in disposition kinetics of opioid analgesics.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: UCSF Community Consortium
name: Donald I Abrams, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05189509: EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)
Official title: EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke, Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.


Eligibility criteria: Inclusion Criteria:

* age: 18-80;
* ischemic stroke confirmed by brain CT or MRI
* the time from onset to treatment: 4.5-6 hours
* NIHSS≥4
* prestroke mRS≤1
* signed informed consent

Exclusion Criteria:

* prestroke mRS≥2
* planned endovascular treatment
* planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion
* any contraindiction of intravenous thrombolysis
* other unsuitable conditions judged by investigator

Primary outcomes:
measure: symptomatic intracerebral hemorrhage
timeFrame: 36 hours
Secondary outcomes:
measure: The proportion of excellent prognosis (mRS 0-1)
timeFrame: Day 90
measure: The proportion of favourable prognosis (mRS 0-2)
timeFrame: Day 90
measure: Distribution of modified Rankin Score
timeFrame: Day 90
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 hours, 2 weeks
measure: any intracerebral hemorrhage
timeFrame: 36 hours
measure: any cerebral microbleeding(CMB)
timeFrame: 48 hours
measure: infarct volume
timeFrame: 48 hours
measure: proportion of death
timeFrame: Day 90
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: