louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01648283: CYP2B6 Polymorphisms in Methadone Disposition
Official title: Role of CYP2B6 Polymorphisms in Methadone Metabolism and Clearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: methadone polymorphisms
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes methadone.

Detailed description: This investigation determined the influence of CYP2B6 genetic variation, specifically CYP2B6\*6 polymorphism, on clinical methadone plasma concentrations, clearance, and metabolism. The hypothesis was that CYP2B6\*6 heterozygotes or homozygotes would have reduced metabolism and clearance. A secondary objective was to evaluate other less common genotypic variants, when encountered. Healthy volunteers in genotype cohorts CYP2B6\*1/\*1, CYP2B6\*1/\*6 , and CYP2B6\*6/\*6, and also CYP2B6\*4 and CYP2B6\*5 carriers, received single doses of IV and oral methadone. Plasma and urine methadone and metabolite concentrations were determined by tandem mass spectrometry. The primary outcome measure was methadone metabolism, measured as plasma metabolite/patent area under the concentration-time curve ratio and metabolite formation clearance.

Eligibility criteria: Inclusion Criteria:

Each subject must meet all of the following criteria:

* 18-50 yr old
* CYP2B6\*1/\*1, CYP2B6\*1/\*6 or CYP2B6\*6/\*6 genotype
* Good general health with no remarkable medical conditions
* BMI \< 33
* Provided informed consent

Exclusion Criteria:

Subjects will not be enrolled if any of the following criteria exist:

* Known history of liver or kidney disease
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP2B6
* Females who are pregnant or nursing
* Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
* Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)

Primary outcomes:
measure: Methadone Metabolism
timeFrame: up to 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Schoool of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan Kharasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kharasch ED, Regina KJ, Blood J, Friedel C. Methadone Pharmacogenetics: CYP2B6 Polymorphisms Determine Plasma Concentrations, Clearance, and Metabolism. Anesthesiology. 2015 Nov;123(5):1142-53. doi: 10.1097/ALN.0000000000000867.
Clinical trial NCT03750383: Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects
Official title: A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: RSV Infection
Keywords: drug drug interaction study
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
First posted: 2018-11-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 2-Part Single Group study
Primary purpose: BASIC_SCIENCE

Brief summary: A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects


Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.

Primary outcomes:
measure: Cmax of EDP-938 with and without coadministration with cyclosporine
timeFrame: Up to 12 days
measure: AUC of EDP-938 with and without coadministration with cyclosporine
timeFrame: Up to 12 days
measure: Cmax of EDP-938 with and without coadministration with prednisone
timeFrame: Up to 21 days
measure: AUC of EDP-938 with and without coadministration with prednisone
timeFrame: Up to 21 days
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Associates, Inc.,
state: Kansas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00497783: Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)
Official title: Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.


Eligibility criteria: Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of Anti-inflammatory or immune-suppression drugs
* Topical medication use at the tested region
* Active cutaneous gynaecological disease which may interfere in study results
* Personal history of allergic disease at the area to be treated
* Allergic or atopic history

The above information is not intended to contain considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Clinical and local tolerability
timeFrame: 21 days
measure: Adverse events and their association with the treatment.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05761483: Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.
Official title: Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. Registry of the Italian Society of Digestive Endoscopy.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplant Disorder
Ischemic Cholangiopathy
Non-anastomotic Biliary Stricture
Biliary Stricture
Biliary Stents (Plastic)
Keywords: ERCP
Biliary stents
Liver transplantation
Ischemic cholangiopathy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 40
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 that underwent liver transplantation and has a diagnosis of biliary strictures secondary to ischemic cholangiopaty (biliary stenoses involving bile ducts of the donor and extending to the hilum)

Brief summary: The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Non anastomotic biliary strictures diagnosed by direct cholangiogram (T-tube) or MRCP
* Stricture involving the hepatic hilum until secondary branches
* Increase of liver function tests
* Signature of the informed consent

Exclusion Criteria:

* Previopus endoscopic or percutaneous treatments
* Patient candidate to metal stents placement
* Previous surgery resulting in altered anatomy

Primary outcomes:
measure: Evaluation of endoscopic treatment of non-anastomosis biliary strictures
timeFrame: 2 Years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Gemelli IRCCS, Rome, Italy
name: Andrea Tringali, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04974983: Impact of Bevacizumab on Symptom Burden and Neurological Deficits in Patients With Recurrent Glioblastoma
Official title: Impact of Bevacizumab on Symptom Burden and Neurological Deficits in Patients With Recurrent GBM: A Retrospective Patient Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Angiogenesis
Keywords: Glioblastoma
Angiogenesis
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 203
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent glioblastoma either treated with or without bevacizumab

Brief summary: This retrospective non - interventional patient chart review will be utilizing real world clinical data from patients treated for rGBM at the University Regensburg Medical center either with or without bevacizumab. Only patients will be analyzed who were potentially eligible for bevacizumab treatment. The study is designed to investigate the potential effects of bevacizumab treatment on the functional status, symptom burden, neurological deficits, time to tumor progression and overall survival between cohorts potentially eligible for bevacizumab.


Eligibility criteria: Inclusion Criteria:

Diagnosis of recurrent glioblastoma

Exclusion Criteria:

Severe neurocognitive deficits

Primary outcomes:
measure: Functional outcome
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
References:
Clinical trial NCT02595983: The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant
Official title: An Open-label Study to Evaluate the Efficacy and Safety of Revusiran in Patients With Transthyretin-mediated Familial Amyloidotic Polyneuropathy With Disease Progression Post-Orthotopic Liver Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transthyretin (TTR)-Mediated Amyloidosis
Familial Amyloidotic Polyneuropathy (FAP)
ATTR Amyloidosis
Familial Amyloid Neuropathies
Keywords: FAP
Familial Amyloidotic Polyneuropathy
ATTR Amyloidosis
Orthotopic Liver Transplant
RNAi therapeutic
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 12
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: The purpose of this study was to evaluate the safety and effectiveness of revusiran (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has continued to worsen after liver transplantation. Dosing has been discontinued; patients are being followed-up for safety.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of FAP (familial amyloidotic polyneuropathy) with documented TTR mutation
* Received an orthotopic liver transplant ≥12 months before the date of informed consent
* An increase in polyneuropathy disability (PND) score post-transplant
* Polyneuropathy Disability score of ≤3b

Exclusion Criteria:

* New York Heart Association (NYHA) classification of \>2
* Other known causes of sensorimotor or autonomic neuropathy (eg, autoimmune disease)

Primary outcomes:
measure: Percentage Change From Baseline in Serum TTR at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage Change From Baseline in Serum TTR Over 18 Months
timeFrame: Weeks 3, 7, 12, 18, 24, 26 (Month 6), 39 (Month 9), 52 (Month 12), 57, 78 (Month 18)
measure: Change From Baseline in Modified Neurological Impairment Score (mNIS +7) Composite Score Over 18 Months
timeFrame: Baseline, Months 6, 12, 18
measure: Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) Questionnaire Score
timeFrame: Baseline, Months 6, 12, 18
measure: Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score
timeFrame: Baseline, Months 6, 12, 18
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Trial SIte
city: Münster
country: Germany
facility: Clinical Trial SIte
city: Porto
country: Portugal
facility: Clinical Trial SIte
city: Majorca
country: Spain
facility: Clinical Trial SIte
city: Umea
country: Sweden
facility: Clinical Trial Site
city: London
country: United Kingdom
facility: Clinical Trial SIte
Study officials:
affiliation: Alnylam Pharmaceuticals
name: John Vest, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01589783: Vitamin D During Pregnancy
Official title: Evaluation of the Influence of Education, Knowledge and Existing Guidelines on the Consumption of Vitamin D During Pregnancy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: Pregnancy
Vitamin D
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are recruiting either pregnant women or those who just gave birth (and still hospitalized) and a group of both family practice physicians and obstertricians.

Brief summary: Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of this vitamin for the proper development of the fetus, are a significant risk group. The purpose of this study is to examine which factors - education, knowledge from non-professional sources, recommendations from medical staff - influence the use of vitamin D among pregnant women in light of the lack of a clear health policy, and to help formulating guidelines for a new health policy with specific recommendations for vitamin D dosage in pregnancy.


Eligibility criteria: Inclusion Criteria for the pregnant of newly post-partum women:

* women between 18-50
* pregnant or just given birth and still hospitalized
* understand and can read Hebrew

Exclusion Criteria:

* those who do not understand or read Hebrew

Primary outcomes:
measure: Use of Vitamin D in Pregnant Women
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Drorith Hochner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02757183: Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.
Official title: Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: AnalyticsPlus, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2016-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from the list of diabetes patients coming to Cedars-Sinai Medical Center for their regular treatment. Several physicians will be involved in making this program available to their patients. Eligible and consenting patients will be recruited.

Brief summary: The "INTELLIH" (brand name of the mobile health application) Diabetes Study is to understand the usage of a mobile health application, IntelliH, and connected wireless devices such as glucometer by the diabetic patients and ascertain if there are any improvements in short-term health outcomes.

Detailed description: The proposed pilot program is the first of its kind in the nation to use a product, "IntelliH" - Intelligent Health for All, that combines four key technologies in one platform: 1) Mobile health application (mHealth) App and web portal, 2) wireless sensors and wearable devices, 3) Secure text messaging when both sender and receiver are logged in to the system and video-based patient interaction, and 4) remote health monitoring. The purpose of this pilot program is to understand a) usage and adoption of these technologies by providers and patients, and b) document the short-term improvements in health outcomes in a diabetic population. This pilot study will follow 20 diabetic patients (Type 1 or Type 2) as they beta-test this system, and will acquire data on consented subjects over a period of six months.

Eligibility criteria: Inclusion Criteria:

* A1c greater than or equal to 6.5%.
* Age greater than or equal to 18 years.
* Ability to comply with study protocol.
* Available and usable internet facilities at home.
* Availability and usable smart phone.

Exclusion Criteria:

-Inability to comply with instructions and directions.

Primary outcomes:
measure: Usage and Adoption of the smart phone based mobile health application
timeFrame: Six Months
Secondary outcomes:
measure: Blood glucose range maintenance and variation
timeFrame: Six months
measure: Adherence to Prescribed Medication
timeFrame: Six months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ruchi Mathur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642783: Sensory Properties of Bowel Cleansing Solutions
Official title: Sensory Evaluation of Laxative Bowel Solutions Used Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laxative Bowel Cleansing Solutions
Keywords: laxatives
sensory evaluation
acceptability
colonoscopy
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte + ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen, France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the manufacturer's instructions. Descriptive analysis was conducted with trained panelists (N= 14) to create a sensory profile for the solutions and generated attributes were rated on an unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory evaluation software. Acceptability testing was carried out with untrained participants (N=80) and samples were rated on the 9-point hedonic scale. Moreover, a Just-About-Right (JAR) scale was included for the four basic tastes to determine their compatibility with optimum taste/acceptability levels in the products.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 50 years

Exclusion Criteria:

* allergies to polyethelene glycol (PEG), artificial sweeteners

Primary outcomes:
measure: rating of sensory attributes
timeFrame: 3 weeks
Secondary outcomes:
measure: Acceptability Score
timeFrame: 1 week
measure: Just about right score
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05197283: Determining the Glycemic Effects of Three Types of Spaghetti
Official title: Determining the Effect of Three Types of Spaghetti (Regular, Whole Wheat and High Fiber-low Carbohydrates) on Glycemic Responses in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Keywords: blood glucose
spaghetti
glycemic index
glycemic load
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment
Primary purpose: OTHER

Brief summary: This study investigated the effects of thee types of spaghetti No7 on the glycemic response

Detailed description: This study aimed to 1. determine the glycemic index and glycemic load of thee spaghetti No7 types (regular, whole wheat and high fiber-low carbohydrates) and 2. investigate the effects of these spaghetti types on postprandial glycemic response in healthy subjects

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic men and women
* body mass index between 18 and 25 kg/m2

Exclusion Criteria:

* severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol abuse
* drug dependency

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Salivary insulin responses
timeFrame: 2 hours
measure: Subjective appetite ratings
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou
role: PRINCIPAL_INVESTIGATOR
References: