louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00766025: Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin
Official title: A Phase I, Open Label, Parallel Group, Single and Multiple Dose Study in Taiwanese Subjects Identified as CYP2C19 Poor Metabolizers or Extensive Metabolizers Receiving 20 Milligrams of Rosuvastatin Calcium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CYP2C19 Poor
Extensive Metabolizers
Keywords: Taiwanese Subjects
CYP2C19
Poor Metabolizers
Extensive Metabolizers
Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.


Eligibility criteria: Inclusion Criteria:

* Subject must have blood drawn for genotyping (determination of EM or PM of CYP2C19, determination of OATP-C1B1, BCRP 421C\>A, and CYP2C9.
* Males and females aged 20-65, inclusive
* Women who are surgically sterilized, post-menopausal for at least one year, or not pregnant and/or lactating. Women of childbearing potential must be willing to abstain from sexual activity or use an effective contraception as outlined in protocol.

Exclusion Criteria:

* Subjects with deoxyribonucleic acid (DNA) that codes for OATP-C 1B1 \*5 and \*15, BCRP 421C\>A and/or non wild-type CYP2C9
* History of adverse drug reaction or hypersensitivity to statins or drugs with a similar chemical structure to rosuvastatin
* History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with absorption, distribution, metabolism and excretion (ADME) of drugs
* Any contraindication determined by review of a detailed medical and drug history, complete physical examination, vital signs, blood chemistry, hematology, and electrocardiogram (ECG)

Primary outcomes:
measure: Blood levels of rosuvastatin in Taiwanese subjects identified as CYP2CIP poor and extensive metabolizers
timeFrame: Scheduled times during the 18 days that the study drug is taken
measure: Blood levels for assessment of pharmacodynamic (lipid) parameters
timeFrame: Days -1 and 18
Secondary outcomes:
measure: Safety and tolerability of rosuvastatin in Taiwanese subjects identified as CYP2C19 poor and extensive metabolizers
timeFrame: Screening through completion of the study
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Regeio Mosquea-Garcia, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Robin Meng, MD, PhD
role: STUDY_DIRECTOR
affiliation: Northern Taiwan University Hospital
name: Tzung-Dau Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01162525: Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
Official title: Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence
Fecal Urge Incontinence
Percutaneous tibial nerve stimulation
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal urge continence at the Cantonal Hospital St. Gallen. During this introduction phase efficiency und adverse events will be monitored in this observational study.

Detailed description: Before treatment patients will have a proctological exam, a proctoscopy, endosonography and anorectal manometry. Incontinence scores (Wexner, Vaizey, Hanley) and quality of life scores (FIQL, VAS) will be recorded.

Treatment consists of 4 phases with decreasing frequency of percutaneous tibial nerve stimulations (pTNS).

During phase 1 weekly stimulations of 30 mins are applied for 12 weeks. After 6 and 12 weeks incontinence scores are recorded. Additionally after the end of phase 1 quality of life is measured and an anorectal manometry is preformed.

Phase 2 lasts for 8 weeks, with 2-3 stimulations/month Phase 3 lasts for 8 weeks, with stimulations every 3 weeks Phase 4 consists of one stimulation in one month.

After phase 4 incontinence scores und quality of life are measured.

Eligibility criteria: Inclusion Criteria:

* fecal urge incontinence
* conservative treatment has been performed without success

Exclusion Criteria:

* current anticoagulation treatment
* sphincter defects larger than 120°
* pregnancy
* pace maker
* implanted defibrillators
* severe heart disease
* existing neurological damages
* disposition for strong bleeding

Primary outcomes:
measure: Fecal Incontinence
timeFrame: 6 weeks
measure: Fecal Incontinence
timeFrame: 12 weeks
measure: Fecal Incontinence
timeFrame: 32 weeks
Secondary outcomes:
measure: Fecal Incontinence
timeFrame: before treatment, 6, 12, 32 wks after initial treatment
measure: Anorectal manometric measurements
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: before treatment, 6, 32 wks after initial treatment
measure: Cost
timeFrame: at the end of the treatment
measure: Adverse Events
timeFrame: for each treatment interval
measure: Urinary incontinence
timeFrame: before treatment, 6, 12, 32 wks after initial treatment
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Surgery, Cantonal Hospital St. Gallen
Study officials:
affiliation: Department of Surgery, Cantonal Hospital St. Gallen
name: Lukas T Marti, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00116025: Pharmacokinetics of Ghrelin
Official title: Pharmacokinetics of Ghrelin in Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-06-27
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the half life of the hormone "ghrelin" in the human body. Other purposes are to investigate the effect of ghrelin on appetite and cardiovascular function.

Detailed description: Ghrelin is a recently described acylated peptide hormone produced by the enteroendocrine cells of the mucosal epithelial layer in the ventricle. Ghrelin is the endogenous ligand for the growth hormone (GH) secretagogue receptor (GHS-R).

Ghrelin stimulates pituitary GH release by binding to the GHS-R at both hypothalamic and pituitary levels.

Several studies show that bolus injections of ghrelin have positive effects on cardiac function in healthy humans as well as in humans with cardiac disease. We investigate the changes in cardiac function during ghrelin infusion in healthy subjects.

The pharmacokinetics of ghrelin is described in few studies only, and we aim to elucidate this aspect further.

Comparisons: In a double blind, placebo controlled, cross over study we investigate the effect of 180 minutes ghrelin infusion on 1. cardiac function (tissue Doppler, stroke-velocity index), 2. vascular tone (a. brachialis dilatation), 3. ghrelin-half-life (acylated and des-acylated) and other pharmacokinetic parameters and 4. effect on appetite.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Male
* BMI \< 25 kg/m2
* Non-smoker
* Age \< 40 yrs

Exclusion Criteria:

* Any known disease
* Any medication (except OTCs)
* Former malignant disease
* Alcoholism
* Blood donation (with in 6 months)
* Allergy to test medication

Primary outcomes:
measure: Human ghrelin half life in healthy subjects
Secondary outcomes:
measure: Cardiovascular indices (stroke-velocity index, TEI-index)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Jens Otto L Jorgensen, DrMedSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vestergaard ET, Gormsen LC, Jessen N, Lund S, Hansen TK, Moller N, Jorgensen JO. Ghrelin infusion in humans induces acute insulin resistance and lipolysis independent of growth hormone signaling. Diabetes. 2008 Dec;57(12):3205-10. doi: 10.2337/db08-0025. Epub 2008 Sep 5.
Clinical trial NCT01696825: Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems
Official title: COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metabolism, Drug
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which of three delivery systems of vaginal diazepam have the best systemic absorption, measured by serum diazepam levels. The three delivery systems are: moistened tablet, suppository or cream. Additionally the study will compare the side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic floor dysfunction.


Eligibility criteria: Inclusion Criteria:

* Provide informed consent
* Premenopausal women \> age 18
* Able to provide urine and serum samples during the time period

Exclusion Criteria:

* Current use of benzodiazepines in any form. If history of benzodiazepine use, must not have taken for one week prior to study screening and enrollment
* Pregnancy
* Concomitant use of any narcotic drug, ethanol, or any illicit drug use during the study period that could be deemed unsafe in combination with benzodiazepine medication use as judged by the investigators.
* Any evidence of vaginitis on wet mount slide
* Postmenopausal
* Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
* Any indication/condition/medication that the investigators identify as contraindicated in conjunction with diazepam.

Primary outcomes:
measure: Serum diazepam levels measured over time
timeFrame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration
Secondary outcomes:
measure: Side effects observed with each of three types of vaginal diazepam
timeFrame: Baseline and 2 hours, 4 hours and 8 hours post medication administration
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Women's Urology Center, William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Jason Gilleran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02823925: Bisphosphonate Therapy in MONA Spectrum Disorder
Official title: Bisphosphonates in Multicentric Osteolysis, Nodulosis and Arthropathy (MONA) Spectrum Disorder - an Alternative Therapeutic Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Density
Pain
Fracture
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three siblings were enrolled in the study.

Brief summary: Multicentric osteolysis, nodulosis and arthropathy (MONA) spectrum disorder is a rare inherited progressive skeletal disorder caused by mutations in the matrix metalloproteinase 2 (MMP2) gene. Treatment options are limited. The investigators reviewed the outcome of patients affected with MONA and treated with intravenous bisphosphonates in the clinical Center.

Detailed description: Assessment of the patients:

After informed consent had been obtained from the patients affected from MONA spectrum disorder the investigators assessed the patients regarding the following characteristics: consanguinity, clinical symptoms at diseases on-set, age at on-set of symptoms and age at diagnosis, cognitive development, progression of clinical symptoms related to the diagnosis, molecular investigations, associated disorders as well as therapies besides bisphosphonate therapy. Informed consent from the patients was also obtained to publish the patient's photographs. All investigations are performed according to the relevant ethical guidelines.

Bisphosphonate therapy:

The reported patients received intravenous bisphosphonate therapy either with pamidronate (1 mg/kg/d on two consecutive days every 3 months) or zoledronate (a single dose of 0.05 mg/kg/day every 6 month).

Evaluation of disease progression and therapeutic success:

To assess both progression of MONA spectrum disorder and therapeutic success the patients were regularly evaluated clinically in 3 to 6 month intervals. Clinical evaluation comprised an internal, neurological and orthopaedic status as well as a general assessment of neurocognitive function. Additionally, need for oral analgesic therapy was documented. In irregular intervals, depending also on the clinical symptoms, x-rays of hand and feet were taken and a densitometry of the total body, lumbar spine and hip was performed.

Eligibility criteria: Inclusion Criteria:

* genetically confirmed MONA spectrum disorder
* treatment with bisphosphonates intravenously
* positive informed consent

Exclusion Criteria:

* genetically confirmed MONA spectrum disorder treated otherwise than with bisphosphonates
* oral treatment with bisphosphonates in MONA spectrum disorder
* other inherited osteolysis syndromes than MONA spectrum disorder

Primary outcomes:
measure: bone mineral density
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02190825: Safety and Efficacy Study of the NeuGuide Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Pop Medical Solutions
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP).

Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system.

Ultrasound examinations for all subjects in this study are subjected to the surgeon need and will be performed if required by qualified personnel


Eligibility criteria: Inclusion Criteria:

* Women ages 18-80 years old
* POP-Q stage III prolapse or higher
* Scheduled to undergo a POP Surgery and has agreed to undergo it using the NeuGuideTM device
* Patient is willing to return for follow-up evaluation and fill questionnaires as indicated on study protocol
* No exclusion criteria fulfilled

Exclusion Criteria:

* Diagnosis of reproductive tract anomalies
* Prior pelvic radiation therapy or any malignancy
* Inability to complete written questionnaires.
* Women with significant Pelvic Inflammatory Disease (PID) history
* Women with known allergy to Nickel or Nitinol

Primary outcomes:
measure: Stage of pelvic floor prolapse as defined by POP-Q score
timeFrame: 6 months
measure: Complications (SAE, AE)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bat Yam
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT05145725: Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis
Official title: Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis; Adolescence
Arthrodesis
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
name: Asociación European Spine Study Group
First posted: 2021-12-06
Enrollment: 866
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescents between 12 and 20 years old, suffering from scoliosis. Surgery has been proposed to them. 150 patients are French over the 866 patients.

Brief summary: The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months.

The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.


Eligibility criteria: Inclusion Criteria:

* Patient between 12 and 20 years old
* Scoliosis in adolescents for whom surgery has been proposed based on radiological criteria (Cobb angle\> 25 ° for thoracolumbar and lumbar scoliosis,\> 35 ° for thoracic scoliosis and\> 40 ° for double major scoliosis)
* Patient affiliated or beneficiary of a social security scheme or attached to a beneficiary of a social security scheme
* Patient and legal representative having been informed and not opposing this research

Exclusion Criteria:

* Patient over 20 years old
* Non-surgical scoliosis
* Refusal to participate in the study by the child or parents

Primary outcomes:
measure: Factors associated with an improvement in the SRS-22r score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bruges
country: France
facility: Clinique du dos
Study officials:
References:
Clinical trial NCT01349725: A Safety Study of ARRY-502 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2011-05-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male or female between the ages of 18 and 50 years.
* Females must be of nonchildbearing potential.
* Body mass index (BMI) of 18 to 32 and a total body weight \> 50 kg (110 lbs) and \< 114 kg (250 lbs).
* Additional criteria exist.

Key Exclusion Criteria:

* Evidence or history of clinically significant disease (excepting allergic rhinitis).
* Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
* Gastrointestinal surgery that may interfere with motility or absorption.
* Serious illness requiring hospitalization within the previous 6 months.
* A positive test for drugs or alcohol.
* Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days.
* Use of corticosteroids within the previous 28 days.
* Recent history of blood, plasma or platelet donation.
* Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months.
* Prior exposure to investigational study drug ARRY-502.
* Additional criteria exist.

Primary outcomes:
measure: Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.
timeFrame: 3 weeks
measure: Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
timeFrame: 2 weeks
Secondary outcomes:
measure: Characterize the pharmacodynamics of the study drug as determined by laboratory assays.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00186225: Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors
Official title: Stem Cell Transplantation From Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Cancer
Blood and Marrow Transplant (BMT)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 250
Sex: ALL
Minimum age (years): 4
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Detailed description: Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor.

Eligibility criteria: Inclusion Criteria:- acute leukemia

* chronic leukemia
* lymphoblastic lymphoma
* MDS
* MPS Exclusion Criteria:- organ dysfunction
* HIV positive

Primary outcomes:
measure: oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.
Secondary outcomes:
measure: Overall Survival
measure: Event Free Survival
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Laura Johnston
role: PRINCIPAL_INVESTIGATOR
References: