louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02521376: Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
Official title: A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oncology
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.


Eligibility criteria: Key Inclusion Criteria:

* Calculated body mass index from 18 to 40 kg/m\^2
* Not pregnant
* Normal electrocardiogram
* Participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations.

Key Exclusion Criteria:

* Participation in another clinical study (current or within last 30 days)
* HIV, hepatitis B virus, or active hepatitis C virus infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter: AUCtau of ENTO
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
measure: Pharmacokinetic (PK) Parameter: Cmax of ENTO
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
Secondary outcomes:
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 9 plus 30 days
measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
timeFrame: Baseline up to Day 9 plus 30 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc. (CPMI)
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
city: Munich
country: Germany
facility: APEX GmBH
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00460876: Phase I Trial of Periocular Topotecan in Retinoblastoma
Official title: Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinoblastoma
Keywords: topotecan
periocular
chemotherapy
Lead sponsor: Hospital JP Garrahan
Sponsor class: OTHER_GOV
First posted: 2007-04-17
Enrollment: 5
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.

Detailed description: Patients with bilateral retinoblastoma who have relapsed after attempts of conservative therapy with standard regimens such as carboplatin, etoposide, vincristine and external beam radiotherapy who face immediate enucleation of their single remaining eye are eligible for this protocol. Starting dose of topotecan will be 0.5 mg and dose escalation will be done by the accelerated titration method. Any Grade 3 ocular toxicity or grade 4 non ocular toxicity will be designed as the dose limiting toxicity. Grade 2 scleral toxicity will be considered for DLT. In case of grade 2 ocular toxicity or grade 3 systemic toxicity, the escalation dose will be 0.25 mg. Maximal dose will be 2 mg.

Eligibility criteria: Inclusion Criteria:

* Group Vb (Reese Ellsworth)
* Relapsed or progressed after carboplatin-based regimens and external beam radiotherapy
* Enucleation of the contralateral eye
* Normal renal and liver function

Exclusion Criteria:

* Presence of glaucoma, rubeosis iridis, anterior chamber extension
* Extraocular disease
* Adequate follow up impossible for social reasons

Primary outcomes:
measure: Dose limiting toxicity
Secondary outcomes:
measure: Response rate, description of toxicity, pharmacokinetic profile
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital JP Garrahan
state: CF
Study officials:
affiliation: Hospital JP Garrahan
name: Guillermo L Chantada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chantada GL, Fandino AC, Carcaboso AM, Lagomarsino E, de Davila MT, Guitter MR, Rose AB, Manzitti J, Bramuglia GF, Abramson DH. A phase I study of periocular topotecan in children with intraocular retinoblastoma. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1492-6. doi: 10.1167/iovs.08-2737. Epub 2008 Oct 31.
Clinical trial NCT05100576: Intensified Insulin Therapy With Telemedicine
Official title: Randomized Controlled Clinical Trial of Telemedicine-guided Lifestyle Intervention in Diabetic Patients During Intensive Insulin Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensified Insulin Therapy
Diabetes
Keywords: telemedicine
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.

Detailed description: The primary objective of this study was to evaluate the development of HbA1c levels in patients requiring 3 months of intensified insulin therapy using standard therapy and telemedicine devices currently in use.

The telemedicine system contains a mobile phone-based nutrition diary, bluetooth-related wrist activity meter, weight scale, blood pressure monitor, blood glucose meter, and IT system for transmitting and displaying data from these devices.

Eligibility criteria: Inclusion Criteria:

* Women or men between the ages of 18 and 75
* Patient with Diabetes who needs intensified insulin therapy HbA1c\> = 8%
* IT proficiency is at least basic for cell phones (answering / making a voice call).
* Signing a informed consent
* For women with childbearing potential, by definition, all women who who are physiologically able to conceive are twofold use of contraception
* The subject communicates well with the investigator and is able to perform the test to understand and help comply with the requirements of the protocol

Exclusion Criteria:

* informed refusal any time after the sign of the informed consent
* Planned invasive cardiac intervention (catheter vasodilation or surgical coronary artery bypass grafting, keyboard surgery or replacement)
* Tumor disease
* Pregnant or lactating women
* Any medical condition that does not allow participation

Primary outcomes:
measure: Change of HbA1c level
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 months
measure: change of hypoglycemic episodes
timeFrame: 3 months
measure: Difference in the decisions between the two type of visits
timeFrame: 3 months
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged
Study officials:
References:
Clinical trial NCT01642576: Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men
Official title: Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sexual Dysfunction
Endothelial Dysfunction
Quality of Life
Inflammation
Keywords: obesity
men
sexual function
urinary tract symptoms
endothelial function
inflammation
quality of life
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 90
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effects of 8 months of diet modification, with or without exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and quality of life in obese men.


Eligibility criteria: Inclusion Criteria:

* Male, aged 30-65 years
* Body Mass Index (BMI) \>/= 27.5 kg/m2
* Waist circumference (WC) \>/= 90 cm

Exclusion Criteria:

* pituitary disease or cranial radiotherapy
* previous or current androgen replacement or deprivation therapy
* current treatment for sexual problems or LUTS
* glomerular filtration rate \< 60 ml/min
* liver disease
* alcohol intake exceeding 500 g/week in the previous 12 months
* use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors

Primary outcomes:
measure: erectile function
timeFrame: 8 months
Secondary outcomes:
measure: lower urinary tract symptoms
timeFrame: 8 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Joan Khoo, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486576: Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery
Official title: Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 42
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: The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Detailed description: Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine.

The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Males and females
* Indication for Arthroplasty of hip

Exclusion Criteria:

* Blood donation within the last month
* Lack of wish to participate
* eGFR\< 15ml/min
* pregnancy or breast feeding
* Need of NSAID

Primary outcomes:
measure: u-NGAL
timeFrame: 2-4 hours
Secondary outcomes:
measure: u-Kim1, u-LFABP
timeFrame: 2-4 hours
measure: FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
timeFrame: 2-4 hours
measure: PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot
timeFrame: 2-4 hours
measure: SBP, DBP, heartrate
timeFrame: 2-4 hours
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Medicinsk forskningsafsnit, Regionshospitalet Holstebro
Study officials:
affiliation: Holstebo Regional Hospital
name: Anne Sophie P. Kancir, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592176: The Effect of Bevacizumab (Avastin) on Pterygium
Official title: The Effect of Bevacizumab (Avastin) on Pterygium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pterygium
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 5
Sex: ALL
Minimum age (years): 19
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 is to determine whether local injection of bevacizumab might halt and or cause regression of pterygium growth. This may enable earlier treatment and prevention of pterygium growth into the patient's line of sight thereby limiting the need for surgery and improving quality of life for patients with pterygia.


Eligibility criteria: Inclusion Criteria:

* 19 years of age and older
* Diagnosis of pterygia
* healthy enough to make scheduled follow-up visits

Exclusion Criteria:

* Women of childbearing potential and males who plan to father a child during their participation in the study will be excluded from the study.

Primary outcomes:
measure: The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Number of Patients Having Surgical Removal of Pterygium.
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Callahan Eye Foundation Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Tyler A Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00945776: Weekly Phone Calls Versus Brief Patient Education to Improve Continuous Positive Airway Pressure (CPAP) Compliance
Official title: Weekly Phone Calls vs. Brief Patient Education to Improve CPAP Compliance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: OSA
CPAP
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 128
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: The purpose of this study is to compare the effects of three interventions on CPAP adherence.

Detailed description: To determine whether there is a need for a more intensive one on one interaction with the patient in order to improve CPAP usage. And also to try to identify in general which population of patients may require a more intensive intervention.

Eligibility criteria: Inclusion Criteria:

* All new patients undergoing of the Sleep Center suspected of having sleep apnea and undergoing sleep studies

Exclusion Criteria:

* Refusal to participate, or not suspected of having sleep apnea prior to the study

Primary outcomes:
measure: To determine which intervention will improve CPAP compliance in sleep apnea
timeFrame: 6 weeks
Secondary outcomes:
measure: To try to identify which individual characteristics within a group may require a specific intervention
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: CAMC Sleep Center
state: West Virginia
Study officials:
affiliation: CAMC Health System
name: George L Zaldivar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00304876: Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea
Official title: Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterocolitis
Pseudomembranous Colitis
Antibiotic-Associated Colitis
Keywords: Clostridium difficile associated diarrhea
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: Baylor College of Medicine
First posted: 2006-03-20
Enrollment: 5
Sex: ALL
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 positive for C. difficile

Brief summary: The investigators propose to study intensively the bacteriology of feces in C. difficile associated diarrheal disease, using a variety of conventional and very up-to-date techniques.

Detailed description: Clostridium difficile associated colitis is an increasing problem in hospitals throughout the developed world; the number of cases has increased, and the failure to respond to conventional therapy has become far more common. The investigators have recently documented in the medical literature (Clin Infect Dis, June, 2005; Lancet Infect Dis, August, 2005). Possible reasons for failure of treatment include persistence of C. difficile and/or imbalance of other bacterial flora in the colon. The bacteriology of fecal flora in C. difficile associated diarrhea has not been studied.

Eligibility criteria: Inclusion Criteria:

* Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin
* Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin
* Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy
* Hospitalized patients who have received \>2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Research Institute
state: Maryland
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine, Houston VA Medical Center
name: Daniel M Musher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05926076: COVID-19 Infection
Official title: Comparative Study of COVID-19 Infection in Renal Transplant Recipients and Non Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Renal Transplant Infection
Lead sponsor: Tianjin First Central Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Third People's Hospital
First posted: 2023-07-03
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender.

Brief summary: Post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender.

Detailed description: Data collection：Age, BMI, underlying comorbidities and other basic information were collected retrospectively from the two groups. The medical records were used to collect information about the patients' new coronavirus infection, such as the time of onset of symptoms, time of diagnosis, time of conversion and common symptoms such as fever, cough, nasal congestion and runny nose, muscle aches and pains.To compare the differences of the diagnosis and treatment of KTRs and the general population infected with Omicron

Eligibility criteria: Inclusion Criteria:

Confirmed novel coronavirus infection between December 2022 to February 2023,

Exclusion Criteria:

Age less than 18; failure of the transplanted kidney before the new coronavirus infection; exclusion of oral immunosuppressed and other types of organ transplant recipients from the non-renal transplant population

Primary outcomes:
measure: ICU admission or death
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: yingxin Fu
state: Guangdong
Study officials:
References:
Clinical trial NCT02763176: Measuring hCG Levels in Pregnant Women
Official title: Measuring hCG Levels in Pregnant Women: a Prenatal Study of hCG Using MLPT and Serum Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: hCG
Keywords: hCG testing, multi-level pregnancy test
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2016-05-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women seeking prenatal care.

Brief summary: This study seeks to assess trends in hCG between the 9th and 12th weeks of gestation. Women presenting at prenatal care at the study site who are 70 days gestation or less will be offered participation in the study. 75 consenting women will be asked to provide urine for an MLPT and to have blood drawn for hCG serum testing at 56-63 days, 64-70 days, and 71-77 days' gestation, and 75 consenting women will be asked to provide urine for an MLPT and to have blood drawn for hCG serum testing at 64-70 days, 71-77 days, and 78-84 days' gestation.

Detailed description: Women presenting at the study site for a prenatal visit, and who are ≤ 70 days' gestation, will be offered participation in the study. Efforts will also be made to recruit patients through physician or treating health care professional referral and advertisements. One hundred and fifty consenting women will be enrolled. Up to three additional study visits will be scheduled: At the enrollment, if an ultrasound-confirmed gestational age is not available in the woman's medical record, a transvaginal ultrasound will be performed. If the woman is 56-63 days gestation on the day of enrollment, she will be asked to return weekly until she reaches 71-77 days. If the woman is 64-70 days gestation, she will be asked to return weekly until she reaches 78-84 days. If the woman is less than 56 days gestation, she will be asked to return for the three research visits at the appropriate time to provide the urine samples and blood draws. Women will have one visit during each of their three assigned gestational age weeks. At each visit, women will provide a urine sample for an MLPT and have a blood draw to measure serum hCG.

Eligibility criteria: Inclusion Criteria:

* Intrauterine pregnancy \<= 70 days' gestation
* Be in general good health
* English speaking competency
* Be willing and able to sign consent forms
* Agree to comply with the study procedures, including returning for three study visits that each involve a blood draw and urine pregnancy test for measuring hCG

Exclusion Criteria:

* Women less than 18 years of age.
* Any women not meeting the inclusion criteria listed above will be excluded from participating in the trial.

Primary outcomes:
measure: hCG trends
timeFrame: Between 56-84 days gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: