louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02581592: Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
Official title: The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Hepatic Impairment
Hepatitis
Liver Cirrhosis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2015-10-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of TD-4208.


Eligibility criteria: Inclusion Criteria:

* For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B)
* For normal hepatic function group: Subject is in good health

Exclusion Criteria:

* Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.
* Subject has received an investigational drug (or medical device) within 30 days
* Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose
Secondary outcomes:
measure: Adverse Events (AE)
timeFrame: From the time of study drug administration through the end of the study (Day 5 or early termination)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center (OCRD)
state: Florida
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Borin MT, Lo A, Barnes CN, Pendyala S, Bourdet DL. Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function. Int J Chron Obstruct Pulmon Dis. 2019 Oct 8;14:2305-2318. doi: 10.2147/COPD.S203709. eCollection 2019.
Clinical trial NCT00000292: Acute Withdrawal From Smoked Cocaine - 9
Official title: Acute Withdrawal From Smoked Cocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Substance Withdrawal Syndrome
Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop an experimental paradigm to examine acute withdrawal symptoms from cocaine.

Detailed description: Although there are clearly identifiable withdrawal syndromes following cessation of a number of abused drugs such as alcohol and heroin, it is unclear whether a withdrawal syndrome follows the cessation of crack cocaine. A laboratory model of withdrawal from smoked (crack) cocaine would provide a safe and systematic method of testing the efficacy of behavioral or pharmacological treatments for withdrawal symptoms following cocaine smoking cessation. Therefore, this study investigated acute behavioral, subjective, and physiological withdrawal symptomatology for 6 hrs following 7 deliveries of 2 dose sized (0.07 vs. 0.4 mg/kg) of smoked cocaine. The behavioral measure was performance on a computerized reaction time task, subjective measures included participant and observer ratings of mood and withdrawal symptomatology, and physiological measures comprised heart rate and blood pressure. It was hypothesized that signs and symptoms of withdrawal from smoked cocaine would be greater following the 0.4 mg/kg dose size, compared to the 0.07 mg/kg dose size.

Eligibility criteria: Inclusion Criteria:

M/F ages 21-45 with a history of smoked cocaine use at least twice a week for the past six months, including 0.5 g of cocaine in a 24hr period on at least one occasion. In good health as evidenced by physical exam and complete blood count, chest X-ray and electrolyte and liver function tests, with a normal resting 12-lead electrocardiograph (ECG) and blood pressure of less than 140/90 mmHg. Using an acceptable method of birth control. Having a urine toxicology screen positive for cocaine metabolites.

Exclusion Criteria:

Any DSM-IV Axis I disorder other than cocaine abuse or dependence, or dependence or daily use of psychoactive drugs other than nicotine or caffeine. A history of violence and/or currently on probation, parole or awaiting trial. Pregnant as determined by serum pregnancy screen, lactating or having delivered a child in the past 12 months. Seropositive tests for the human immunodeficiency virus (HIV) or hepatitis B. History of seizure disorder.

Primary outcomes:
measure: Behavioral
measure: Subjective
measure: Physiological measures
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02355392: Prevalence of Hypertension Using Telemedical Home Blood Pressure Measurements
Official title: Prevalence of Hypertension Using Telemedical Home Blood Pressure Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 3159
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population study in the municipality of Holstebro, which has 57.000 inhabitants. Using the Civil Registration System, we invite all citizens aged 55-64 years.

Brief summary: The purpose of this study is to determine the prevalence of hypertension among citizens of Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the insufficiently treated, and to estimate the prevalence of white coat and masked hypertension using home blood pressure measurements with telemedical data transmission.


Eligibility criteria: Inclusion Criteria:

* Age 55 to 64 years
* Registered address in the municipality of Holstebro
* Enrolment at a practice of one of the GPs who had agreed to participate in the study.

Exclusion Criteria:

* Unwillingness to participate
* Incapability to do home blood pressure measurements

Primary outcomes:
measure: Office blood pressure
timeFrame: 10 minuttes
measure: Telemedical home blood pressure
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark
name: Nikolai Hoffmann-Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. High Prevalence of Hypertension in a Danish Population Telemedical Home Measurement of Blood Pressure in Citizens Aged 55-64 Years in Holstebro County. Am J Hypertens. 2016 Apr;29(4):439-47. doi: 10.1093/ajh/hpv116. Epub 2015 Jul 23.
Clinical trial NCT03144492: Microgravity Effects on Co-cultured Vascular Cells Types
Official title: Microgravity Effects on Co-cultured Vascular Cells Types
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microgravity Exposed Endothelial Cells
Keywords: Cell Culture
Microgravity co-culture
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Aeronautics and Space Administration (NASA)
First posted: 2017-05-08
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Study team is interested in sampling a wide variety of health individuals from varying ethnic groups, sex, and age range.

Brief summary: The goal of this study is to assess the affect of ground based microgravity on co-cultured vascular cell types. Our goal is to better understand the cross-talk between vascular cell types grown under conditions such as microgravity as is seen in space. In this pilot study, the investigator proposes to assess changes in cell phenotype and function in microgravity as compared to normal gravity.

Detailed description: This study builds upon previously reported space flight data in GenLab, as well as our own published data whereby the investigator evaluate the effect of microgravity on the differentiation and functional potential of circulating stem cells. The goal of this work is to leverage the powerful genetic analyses done in the SPHINX study and look at the consequences these changes have on cell-cell communications essential for vascular homeostasis, for a possible correlation to cardiovascular deconditioning. The application of this work is targeted at possible "cell based" countermeasures to address the negative effects of microgravity on the vasculature.

Eligibility criteria: Inclusion Criteria:

* Self-reported healthy individuals
* Willingness to have 50mls of whole blood collected

Exclusion Criteria:

* Unwillingness to have blood used in stem cell research

Primary outcomes:
measure: Differentiation (Colony Forming) Kinetics of normal vs microgravity cultured stem cells
timeFrame: Within 4 weeks of collecting cells
Secondary outcomes:
measure: Gene and Protein expression of normal vs microgravity cultured stem cells
timeFrame: through study completion, up to 2 years from the start of the study
measure: Anti-thrombogenic function of normal vs microgravity cultured stem cells
timeFrame: through study completion, up to 2 years from the start of the study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Josephine Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651092: Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy
Official title: to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bilateral Inferior Turbinates Hypertrophy
Keywords: turbinectomy
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt turbinectomy in terms of subjective and objective parameters.

Detailed description: The two methods of nasal inferior turbinectomy are well popularized and in use for long periods of time. Endoscopic submucosal inferior turbinectomy is performed in our hospital and blunt turbinectomy is performed usually in privat clinics outside the hospital where there is no endoscopic equipment. We will examine both subjective (QOL questionaire) and objective parameters(rhinomanometry- a non invasive method to evaluate nasal airflow, saccharine test, nasal endoscopy) in our comparison of the outcome of these two methods.

Eligibility criteria: Inclusion Criteria:

* all patients above 18 years

Exclusion Criteria:

* can not answer a written questionaire

Primary outcomes:
measure: quality of life
timeFrame: 1 year
Secondary outcomes:
measure: rhinomanometry, saccharine test, nasal endoscopy
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: soroka university medical center beer sheva israel
name: nili segal, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fradis M, Golz A, Danino J, Gershinski M, Goldsher M, Gaitini L, Malatskey S, Armush W. Inferior turbinectomy versus submucosal diathermy for inferior turbinate hypertrophy. Ann Otol Rhinol Laryngol. 2000 Nov;109(11):1040-5. doi: 10.1177/000348940010901109.
citation: Williams HO, Fisher EW, Golding-Wood DG. 'Two-stage turbinectomy': sequestration of the inferior turbinate following submucosal diathermy. J Laryngol Otol. 1991 Jan;105(1):14-6. doi: 10.1017/s0022215100114707.
Clinical trial NCT03650192: INVSENSOR00027 Clinical Performance Study
Official title: INVSENSOR00027 Clinical Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old
* Physical status of ASA I or II
* Subjects must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
* Has completed Health Assessment Questionnaire and passed health assessment screening

Exclusion Criteria:

* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Nursing female volunteers
* Excluded at the Principal Investigator's discretion
* Refusal to take the pregnancy test (for female subjects)
* Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
* Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)

Primary outcomes:
measure: Sensitivity of INVSENSOR00027's Posture Change Detection
timeFrame: 1-5 hours
measure: Sensitivity of INVSENSOR00027's Activity Change Detection
timeFrame: 1-5 hours
measure: Sensitivity of INVSENSOR00027's Fall Event Detection
timeFrame: 1-5 hours
Secondary outcomes:
measure: Respiratory Rate Detection
timeFrame: 1-5 hours
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
affiliation: Masimo Corporation
name: Ahmed Alghazi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02195492: Retrospective Follow-up of Synvisc® in Active Patients With Knee Osteoarthritis
Official title: Synvisc® in With Knee Osteoarthritis: Retrospective Follow-up in Active Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 41
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: rheumatological practice

Brief summary: Retrospective collection of data, aimed at a better knowledge of the context of use of Synvisc® among the patients practising a regular activity (professional/leisure), and at evaluating the different practices and their results.


Eligibility criteria: Inclusion Criteria:

* use of Synvisc®
* patients practising a regular activity (professional/leisure)

Exclusion Criteria:

* none

Primary outcomes:
measure: Amount of medication consumed
timeFrame: up to 1 year
Secondary outcomes:
measure: Patient-assessed benefit on a 2-point verbal rating scale
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04219592: IgG-4 Levels in Systemic Sclerosis
Official title: Comparing IgG-4 Levels in Systemic Sclerosis Patients vs. Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Keywords: SSc
IgG4
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical records of SSc patients from Meir Medical Center

Brief summary: This is an observational - non interventional study. The investigators will compare IgG4 levels of 80 healthy donors (from Israel blood bank - MDA) and 80 Systemic Sclerosis patients from Meir Medical Center.

Detailed description: IgG4 levels will be obtained from medical records of 80 SSc patients between the years 2000-2019. These will be compared to IgG4 levels from sera of 80 healthy donors (from Israel blood-bank - MDA). Correlations between IgG4 levels and the following will be made: age, sex, disease type (limited or diffused SSc), disease duration, medications.

Eligibility criteria: Inclusion Criteria:

* SSc patients

Exclusion Criteria:

* other chronic co-morbidities

Primary outcomes:
measure: IgG4 measurement
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT00940992: A Study of DER 45-EV Gel to Treat Rosacea
Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age or older
* Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)
* Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA
* Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study

Exclusion Criteria:

* Subjects who are pregnant, breast feeding, or planning a pregnancy during the study
* Allergy or sensitivity to ingredients in test product
* Any dermatological conditions of the face that may interfere with study evaluations
* Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea

Primary outcomes:
measure: Investigator Global Assessment (IGA) Improvement From Baseline
timeFrame: Baseline to Week 12 / end of treatment
measure: Change in Inflammatory Lesion Counts From Baseline
timeFrame: Baseline to Week 12 / end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: Miami
country: United States
facility: FXM Research Corp
state: Florida
city: Augusta
country: United States
facility: Augusta Centre for Dermatology and Skin
state: Georgia
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Madison
country: United States
facility: Madison Skin and Research, Inc
state: Wisconsin
Study officials:
affiliation: Sponsor GmbH
name: Ofra Levy-Hacham, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02328092: A Double-blind Randomized Clinical Trial on the Efficacy of Magnetic Sacral Roots Stimulation for the Treatment of NE
Official title: Therapeutic Effect of Sacral Root Stimulation on Nocturnal Enuresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Enuresis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 41
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.

Detailed description: The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis. Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.

Eligibility criteria: Inclusion Criteria:

* All subjects diagnosed as patients with primary monosymptomatic nocturnal enuresis according to the Diagnostic and statistical manual of mental disorders, 4th revised edn (DSM-IV)

Exclusion Criteria:

* We exclude any patient with pacemakers or any metallic devices
* Patients with evidence of urinary tract infection.

Primary outcomes:
measure: the number of bedwetting/week
timeFrame: 2.5 months
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 1.5 month
measure: VAS
timeFrame: 1.5 month
Other outcomes:
Locations:
Study officials:
References:
citation: Khedr EM, Elbeh KA, Abdel Baky A, Abo-Elfetoh N, El-Hammady DH, Korashy F. A double-blind randomized clinical trial on the efficacy of magnetic sacral root stimulation for the treatment of Monosymptomatic Nocturnal Enuresis. Restor Neurol Neurosci. 2015;33(4):435-45. doi: 10.3233/RNN-150507.