louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05116293: Effect of Testosterone Treatment on Drug Metabolism and Transport
Official title: Effect of Gender-Affirming Testosterone Therapy on Drug Metabolism, Transport, and Gut Microbiota
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transgender Persons
Keywords: Testosterone Treatment
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transgender adults planning to take testosterone treatment.

Brief summary: This project will evaluate the effect of gender-affirming testosterone treatment on how other medications are processed by the body.

Detailed description: Gender-affirming hormone therapy may include testosterone, a hormone that the body creates and uses naturally. Testosterone is prepared as a medication that patients may take to increase hormone levels. Changes in testosterone concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how testosterone therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm testosterone treatment does not affect natural bacterial in the gut.

Eligibility criteria: Inclusion Criteria:

* Self-identified trans\* adult at least 18 years of age.
* Not taking testosterone treatment currently.
* Planning to start testosterone treatment through care provider for gender-affirming medical care.

Exclusion Criteria:

* Unwilling/unable to return for project follow-up visits.
* Unwilling/unable to provide written informed consent.

Primary outcomes:
measure: midazolam AUC ratio (treatment/control)
timeFrame: 0-48 hours
Secondary outcomes:
measure: midazolam Cmax ratio (treatment/control)
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Lauren Cirrincione, MPH,Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01071993: Efficacy of Statins In Prevention of CIN
Official title: Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nephropathy
Keywords: prevention
nephropathy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Detailed description: Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Eligibility criteria: 1. Inclusion Criteria:

   * Adults \> 18 years of age
   * undergoing coronary or peripheral angiography with or without intervention
   * Cr \> 1.3 mg/dL or GFR \< 60 mL/min
2. Exclusion Criteria:

   * end-stage renal disease on dialysis
   * acute renal failure
   * previous iodinated contrast media exposure within 7 days of study entry
   * history of hypersensitivity to statins
   * pregnancy or lactation
   * emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock
   * prisoners
   * patients already on maximum dose of statins
   * patient receiving N-acetylcysteine or sodium bicarbonate

Primary outcomes:
measure: Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Veterans Affairs Medical Center
state: Oklahoma
Study officials:
affiliation: Oklahoma Univeristy Health Science Center and VA Medical Center
name: Mazen Abu-Fadel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03163693: The Effects of Dexmedetomidine on cTnI and GP-BB in Patients Undergoing OPCABG
Official title: The Effects of Dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Bypass, Off-Pump
Keywords: Dexmedetomidine
Cardiac Troponin I
Glycogen Phosphorylase Isoenzyme BB
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery bypass Grafting.

Detailed description: Dexmedetomidine is a highly selective α2-adrenoceptor agonist used as a sedative or adjuvant anesthetic drug in clinical settings.From clinical observation, dexmedetomidine has been revealed to reduce the incidence of cardiovascular adverse events in patients with heart diseases during non-cardiac surgeries.Therefore, the aim of this sudy is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients during cardiac surgeries.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing off - pump coronary artery bypass grafting
* ASA physical status III-IV
* Aged 40-70 years
* NYHA physical status II-III

Exclusion Criteria:

* Bradycardia
* Atrioventricular block
* Echocardiography suggested:LVEF \<40%, LVED\>65mm
* Allergic to the drugs

Primary outcomes:
measure: Change of cardiac troponin I at preoperative, postoperative，and 24 hours after surgery.
timeFrame: At preoperative, postoperative，and 24 hours after surgery.
measure: Change of Glycogen Phosphorylase Isoenzyme BB at preoperative, postoperative，and 24 hours after surgery.
timeFrame: At preoperative, postoperative，and 24 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Zhu Di
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811993: A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors
Official title: Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* malignant neoplasms;
* failed prior standard curative therapy;
* ECOG performance Status of 0 or 1;
* adequate bone marrow, hepatic and renal function;
* life expectancy greater than 8 weeks.

Exclusion Criteria:

* chemotherapy within 2 weeks of start of therapy;
* prior irradiation within 4 weeks prior to start of therapy;
* prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;
* major surgery or significant traumatic injury within 2 weeks prior to study start;
* patients receiving concurrent antibody or immunotherapy;
* other exclusion criteria are related to specific treatment regimens.

Primary outcomes:
measure: Adverse events, laboratory parameters, vital signs
timeFrame: Throughout study
Secondary outcomes:
measure: Trough levels of R1507
timeFrame: Throughout study
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Chicago
country: United States
state: Illinois
city: Rochester
country: United States
state: Minnesota
city: Chapel Hill
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00593593: Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
Official title: A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostate hyperplasia
Dutasteride
pharmacovigilance
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 1000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).


Eligibility criteria: Inclusion Criteria:

* Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC
* Subject should be diagnosed with benign prostate hyperplasia
* Subject's prostate volume should be equal or greater than 30 cm3

Exclusion Criteria:

* Known hypersensitivity to any of the AVODART compounds
* Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial
* Receives treatment with enzyme inhibitors CYP3A4 and CYP3A5.
* History of severe liver failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02109393: Rehabilitation in Patients With Progressive Supranuclear Palsy
Official title: Rehabilitation in Patients With Progressive Supranuclear Palsy: Effectiveness of Two Intensive Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Supranuclear Palsy
Keywords: Rehabilitation
Robot-assisted walking training
Treadmill
Lokomat
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary rehabilitation treatment, previously conceived for Parkinson's disease, is effective for patients with progressive supranuclear palsy and whether a driven gait orthosis (Lokomat) can provide further benefits.


Eligibility criteria: Inclusion Criteria:

a) diagnosis of PSP in accordance to the NINDS-SPSP International Criteria (Litvan et al., 1996), b) age between 55 and 85 c) ability to walk unassisted for at least 6 meters, d) stable dopaminergic drugs dosage in the month preceding the admission to the study

Exclusion Criteria:

a) any others significant neurological or orthopedic disorders, b) osteoarthritis, osteoporosis, cutaneous lesions and/or other pressure wounds, c) body weight exceeding 135 kg (the weight limit for the use of Lokomat®), respiratory and cardiovascular diseases.

Primary outcomes:
measure: PSPRS
timeFrame: One month
Secondary outcomes:
measure: BBS
timeFrame: One month
measure: NoF
timeFrame: One month
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Ospedale Generale di Zona "Moriggia-Pelascini"
state: Como
Study officials:
affiliation: Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clerici I, Ferrazzoli D, Maestri R, Bossio F, Zivi I, Canesi M, Pezzoli G, Frazzitta G. Rehabilitation in progressive supranuclear palsy: Effectiveness of two multidisciplinary treatments. PLoS One. 2017 Feb 3;12(2):e0170927. doi: 10.1371/journal.pone.0170927. eCollection 2017.
Clinical trial NCT03124693: Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Surgery
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.


Eligibility criteria: Healthy Volunteers

Inclusion Criteria:

* Has physical status between ASA 1 or 2
* Able to communicate in English

Exclusion Criteria:

* Pregnant or sexually active without birth control.
* Hemoglobin less than 11g/dL
* Known alcohol or drug abuse
* Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
* Nail polish
* Head injury with loss of consciousness within the last year
* Known neurological and psychiatric conditions.
* Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
* Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Reynauds syndrome
* Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg
* Baseline heart rate \<50 beats per minute

Surgical Subjects

Inclusion Criteria:

* Age \> 18 years old
* Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care

Exclusion Criteria:

* Pregnant or lactating women
* Skin abnormalities at the planed application sites that would interfere with transilluminating the finger, or other measurement sites, like burns, scar tissue, nail polish, infections etc.

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
References:
Clinical trial NCT00122993: Worksite Program to Prevent Weight Gain Among Bus Drivers
Official title: Worksite Environmental Interventions for Weight Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Heart Diseases
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-07-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to implement and evaluate a two-year multi-component environmental intervention to prevent weight gain among city bus drivers at four bus garages.

It is hypothesized that transit employees in the intervention garages will gain less weight compared to the transit employees in the control garages.

Detailed description: BACKGROUND:

Environmental influences that support less healthful food choices and sedentary behaviors have contributed to the epidemic increase in overweight and obesity among U.S. adults. Worksite settings are an effective channel through which to reach adults with interventions designed to prevent excess weight gain and obesity.

DESIGN NARRATIVE:

This study will implement and evaluate a multi-component environmental intervention to prevent excess weight gain among 1200 bus drivers working in four garages in a major metropolitan area. Four garages will be randomized to the intervention or control group for a two-year period. The environmental interventions are based on a social ecological framework and target four worksite environmental areas: 1) food availability and incentives; 2) physical activity opportunities and incentives; 3) the social environment; and 4) media/promotion related to health food choices, physical activity, and body weight.

Eligibility criteria: Inclusion Criteria:

* Employed as a bus driver

Exclusion criteria:

* Not employed as a bus operator at one of the four participating garages

Primary outcomes:
measure: Change in body weight
timeFrame: Measured at Year 2
Secondary outcomes:
measure: Changes in energy intake and physical activity
timeFrame: Measured at Year 2
measure: Health claims cost
timeFrame: Measured at Year 2
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Simone French
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01498393: 1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis
Official title: A Randomized, Placebo-Controlled Study of the 1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fungal Nail Infection
Keywords: fungal nail
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-12-23
Enrollment: 10
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 clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.

Detailed description: Toenail fungus (onychomycosis) is a common fungal infection of the nail that affects roughly 10% of Americans. Onychomycosis may be a precursor to many complications like ulcers, or skin infections, which may rarely result in amputation. Current treatment options have relatively limited long-term success and recurrence is common.

The researcher can determine that the laser therapy can heat the nail and destroy and decrease the fungus infecting the nail to improving the appearance of the nail.

Eligibility criteria: Inclusion Criteria:

* Adult Male/ female has been diagnose with fungal nail infection on both great toenails.

Exclusion Criteria:

* Any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator.
* Excessively thick or hypertrophic nails.
* Subjects with diabetes.
* Subjects that are pregnant
* Receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment.
* Subjects with impaired immune systems including, but not limited to HIV, transplant patients on immunosuppression, etc.
* Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
* History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.

Primary outcomes:
measure: Improving the Appearance of fungal nail
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Kristen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortiz AE, Truong S, Serowka K, Kelly KM. A 1,320-nm Nd: YAG laser for improving the appearance of onychomycosis. Dermatol Surg. 2014 Dec;40(12):1356-60. doi: 10.1097/DSS.0000000000000189.