louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03728101: Drug Interaction Study of Simvastatin and Dabigatran
Official title: A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults

Detailed description: Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin will be compared with those after multiple administration of simvastatin.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 19 and 50 years
* Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
* Subjects who agree with performing contraception during the study
* Subjects who agreed with written informed consent

Exclusion Criteria

* Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
* Subjects who have clinically significant allergic history or allergy to simvastatin, dabigatran, or other components of drug
* Creatinine clearance is below 60 ml/min
* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) is more than 2-fold of upper limit or normal range
* Subjects who have clinically significant bleeding
* Subjects at risk of bleeding
* Subjects who took drugs which significantly interact with simvastatin or dabigatran prior to dosing
* Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing
* Participated in a previous clinical trial within 90 days prior to dosing
* Subjects with a history of alcohol abuse
* Subjects who are determined by investigator's decision as unsuitable for clinical trial participation

Primary outcomes:
measure: Cmax
timeFrame: 24 hours
measure: AUC
timeFrame: 24 hours, zero to infinite
Secondary outcomes:
measure: aPTT
timeFrame: 24 hours
measure: TT
timeFrame: 24 hours
measure: lag time
timeFrame: 24 hours
measure: peak thrombin
timeFrame: 24 hours
measure: velocity index
timeFrame: 24 hours
measure: area under the curve
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Clinical Instructor
name: Hyewon Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03147001: Protein Ingestion Before Training Low
Official title: Nutritional Strategies for Optimizing Adaptations and Recovery Following Training 'Low'.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Metabolism
Keywords: Endurance exercise
Dietary protein
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Arla Foods
name: Team Denmark
name: Innovation Fund Denmark
First posted: 2017-05-10
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0, 60 and 180 min after the training session biopsies are collected.


Eligibility criteria: Inclusion Criteria:

* Healthy well-trained triathletes or cyclists
* VO2max \> 55 ml O2/kg/min
* Training and has been training more than 7 times a week the last 6 months.

Exclusion Criteria:

* VO2max \< 55 ml O2/kg/min
* Has chronic disease
* has incjected with tracer on a previous occasion.

Primary outcomes:
measure: Muscle protein fractional synthetic rate (FSR)
timeFrame: FSR was measure over at time period of six hours
Secondary outcomes:
measure: Tracer kinetics dilution model
timeFrame: six hours
measure: Muscle signalling
timeFrame: Determined in biopsies sampled before and immediatly after 90min exercise in addition to one and four hours after exercise.
measure: Nitrogen excretion
timeFrame: Urine is collected during two periods. Collection period one: 12 hours prior to morning exercise. Collection period 2: During and four hours following exercise. Blood samples is drawn repeatedly from before to four hours after exercise.
Other outcomes:
Locations:
Study officials:
References:
citation: Larsen MS, Holm L, Svart MV, Hjelholt AJ, Bengtsen MB, Dollerup OL, Dalgaard LB, Vendelbo MH, van Hall G, Moller N, Mikkelsen UR, Hansen M. Effects of protein intake prior to carbohydrate-restricted endurance exercise: a randomized crossover trial. J Int Soc Sports Nutr. 2020 Jan 28;17(1):7. doi: 10.1186/s12970-020-0338-z.
Clinical trial NCT02169401: A Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain
Official title: a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 135
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: Chronic Pain Patients

Brief summary: 08-SMI-2012 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic pain.


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic, intractable pain for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects currently has an active infection
8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
9. Subject has participated in another clinical trial within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years

Primary outcomes:
measure: Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation
timeFrame: Post implantation at; 1, 3, 6, 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: James Cook University Hospital
name: S ElDabe, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06486701: Effect of Singing in Abdominal Surgery Patients
Official title: Effect of Singing on Vital Signs, Pain, Anxiety in Abdominal Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Anxiety
Keywords: Signign
Anxiety
Pain
Vital signs
Abdominal surgery patients
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. Vital signs, pain and anxiety levels are measured before and after singing.

Detailed description: This study is of a randomized controlled type. Patients who have undergone abdominal surgery are divided into experimental and control groups in the early postoperative period. No intervention is made to the control group by the researchers. Vital signs, pain and anxiety levels are measured half an hour apart as pre-test and post-test.

Patients in the experimental group are given a prompt in the postoperative period and asked to sing the song they remember. Pre-test before singing and post-test after singing, vital signs, pain and anxiety levels are measured. It is expected that singing will calm patients, stabilize their vital signs, and reduce anxiety and pain.

Eligibility criteria: Inclusion Criteria:

* Abdominal surgery patiens
* 18 and more than age

Exclusion Criteria:

* No abdominal surgery patients
* under 18 age

Primary outcomes:
measure: Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and anxiety
timeFrame: total of six month
Secondary outcomes:
measure: Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and Anxiety
timeFrame: total of six month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medicana Kadikoy Hospital
Study officials:
References:
Clinical trial NCT00721201: Glucocorticoid Receptor Antagonism in Subclinical Cushings
Official title: A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Subclinical Cushing's
Keywords: subclinical Cushing's
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: HRA Pharma
First posted: 2008-07-23
Enrollment: 6
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: The purpose of this study is to assess the effects of reducing the activity of endogenous glucocorticoid in patients with low-grade cortisol excess


Eligibility criteria: Inclusion Criteria:

* Patients will be eligible for inclusion if: they are males and over 18, lack clinical features classically associated with Cushing's syndrome; have evidence of excess circulating cortisol

Exclusion Criteria:

* Evidence of local or systemic malignancy; overt Cushing's syndrome; severe uncontrolled diabetes mellitus or hypertension; pregnancy; clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure); severe liver disease (liver enzymes ≥ 3 x the institutional upper limit of normal range); significantly impaired renal function (eGFR \<30/min); uncontrolled severe active infection; treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents, within four weeks of admission; In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause; requirement for inhaled or systemic glucocorticoids for existing disease; impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent.

Primary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Glucose homeostasis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Sheffield
name: Dr John Newell Price
role: PRINCIPAL_INVESTIGATOR
References:
citation: Debono M, Chadarevian R, Eastell R, Ross RJ, Newell-Price J. Mifepristone reduces insulin resistance in patient volunteers with adrenal incidentalomas that secrete low levels of cortisol: a pilot study. PLoS One. 2013;8(4):e60984. doi: 10.1371/journal.pone.0060984. Epub 2013 Apr 5.
Clinical trial NCT01849601: Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure
Official title: A Prospective, Multicenter and Single-arm Target Value Clinical Study on the Efficacy and Safety of Peripheral Balloon Dilatation Catheter in PTA Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-05-08
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.


Eligibility criteria: Inclusion Criteria:

* Age: 18 yrs - 80 yrs.
* patients with iliac and / or femoral artery atherosclerotic lesions
* Rutherford grade of 1-5;
* Target lesion stenosis≥70% (visual estimation) (proportion of Trans-Atlantic Inter-Society Consensus(TASC) B, C and D grade lesions not less than 60% )
* Patients being able to understand the purpose of the test, and being volunteered to participate in and sign the informed consent.

Exclusion Criteria:

* Patients not suitable for receiving interventional surgeries of lower limb arteries for treatment;
* Patients require intervention of lesions besides unilateral iliac and femoral artery lesions at the same time;
* Patients have been involved in clinical trials of other drugs or medical devices within the past three months;
* Patient is unable or unwilling to participate in this trial;
* Patients with serious heart and brain, liver and other vital organs failure;
* Patients with life expectancy less than 6 months;
* Pregnant women.

Primary outcomes:
measure: technical success rate of PTA procedure
timeFrame: instant
Secondary outcomes:
measure: safety assessment
timeFrame: day 2 to day 10 after procedure or hospital discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wei Guo
Study officials:
References:
Clinical trial NCT02282501: Leptin and Ghrelin in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critically Ill
Keywords: leptin levels
ghrelin levels
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy.

This prospective, randomised study was designed to compare two enteral feeding methods with respect to changes in levels of leptin and ghrelin in ICU.


Eligibility criteria: Inclusion Criteria:

* who were unable to ingest an oral diet
* given decision on enteral feeding

Exclusion Criteria:

* Carcinomatosis
* irreversible coma
* death or discharge before 14 days of observation
* contraindication to enteral feeding
* intolerance to the prescribed nutrients or infusion regimen
* burn
* multiple trauma
* morbid obesity
* end stage liver or renal or lung disease
* severe sepsis or septic shock
* patients with percutaneous endoscopic gastrostomy
* immunosuppressive drug use
* severe hemodynamic instability
* massive blood transfusion

Primary outcomes:
measure: Change from baseline in serum leptin concentration at three weeks in ICU
timeFrame: first, 7th, 14th and 21th day
measure: Change from baseline in serum ghrelin concentration at three weeks in ICU
timeFrame: first, 7th, 14th and 21th day in ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Altınordu
country: Turkey
facility: Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
state: Ordu
Study officials:
References:
Clinical trial NCT02393001: Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques
Official title: Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: skin cancer
suspicious lesion
skin biopsy
noninvasive
screening
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in the dermatology clinic with suspicious skin lesion to be biopsied will have 4 skin swabs, 2 of the skin lesion and 2 of an area of unafflicted skin

Brief summary: The purpose of this research study is to determine if a very sensitive chemistry lab analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs.

Detailed description: Types of skin cancer, like melanoma, are likely to spread and are becoming increasingly common. At this time, healthcare providers look at patient's skin and remove a sample of suspicious areas of the skin (biopsy) to test for cancer.

This research study will inspect cotton and cloth swabs of normal skin and suspicious areas of the skin that are going to be biopsied just before the biopsy. The swabs will be looked at with a very sensitive chemistry lab analyzer to see if the lab analyzer can confirm conventional lab test findings.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Seen at the dermatology clinic \& determined to need a skin biopsy of a suspicious lesion

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: Compare the off line spectral analyses of saline and alcohol skin swabs of normal control, melanoma negative and melanoma positive skin biopsies.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: The Jerome H. Modell, MD, Professor of Anesthesiology
name: Nikolaus Gravenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02018601: Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block for no Reconstructive Breast Surgery
Official title: Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: no Reconstructive Breast Surgery
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for not reconstructive unilateral breast surgery.
2. Physical status American Society Anesthesiologists (ASA) I-III.
3. Signed informed consent.
4. Aged between 18 and 75 years.
5. Ability to assess pain using a verbal and numerical scales.
6. Assessment of pain at the time of inclusion in the study is lower than 3 verbal simple scale

Exclusion Criteria:

1. Personal history of disorders of hemostasis or previous history of abnormal bleeding evidence.
2. Local infection at the site of the puncture or to puncture prior systemic.
3. Contraindications to study medication.
4. Muscle or neurological disease, peripheral or central.
5. Patients with prior history of opioid.
6. Pregnancy or lactation.
7. Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments)
8. Active Chronic alcoholism or drug addiction.
9. BMI under 20 or mayor 30.
10. Chronic treatment with non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants or opioids.
11. Rejection of the patient

Primary outcomes:
measure: pain score: verbal simple scale
timeFrame: 0,3,6,12,18 and 24h
measure: pain score: visual number scale
timeFrame: 0, 3, 6,12, 18, 24h
measure: opioid requirements
timeFrame: 24 h
measure: sleep quality
timeFrame: 24 h
measure: amount of sleep
timeFrame: 24 h
Secondary outcomes:
measure: percentage of participants with nausea and vomiting
timeFrame: 24 hours
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 24 h
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña
Study officials:
References: