louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00086086: Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Effects of Treatment With 2 Regimens of Subcutaneous Darbepoetin Alfa (Weight-based Dosing and Fixed Dosing) on Hemoglobin Concentration Response in Subjects With Symptomatic CHF and Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Anemia
Keywords: Symptomatic Congestive Heart Failure
CHF
Anaemia
Anemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-06-24
Enrollment: 150
Sex: ALL
Minimum age (years): 21
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 evaluate whether weight-based or fixed starting doses result in comparable hemoglobin increases and treatment effects in patients with heart failure and anemia.


Eligibility criteria: Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion

Primary outcomes:
measure: Rate of rise of hemoglobin concentration
Secondary outcomes:
measure: Change in left ventricular ejection fraction
measure: Change in 6-minute walk distance
measure: NYHA classification
measure: Patient-reported outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: van Veldhuisen DJ, Dickstein K, Cohen-Solal A, Lok DJ, Wasserman SM, Baker N, Rosser D, Cleland JG, Ponikowski P. Randomized, double-blind, placebo-controlled study to evaluate the effect of two dosing regimens of darbepoetin alfa in patients with heart failure and anaemia. Eur Heart J. 2007 Sep;28(18):2208-16. doi: 10.1093/eurheartj/ehm328. Epub 2007 Aug 6.
Clinical trial NCT04967586: Medical Students and Risk of COVID-19 Infection
Official title: Medical Students and Risk of COVID-19 Infection: a Descriptive Study From the University of Jordan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 1830
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical Students at The university of Jordan from second till sixth year

Brief summary: This study aims to estimate the prevalence of infected medical students with COVID-19 in the University of Jordan and to compare number of cases between students in clinical and basic years. In addition, this can provide insight into the awareness of infection control practices among students. Furthermore, to examine if hospital rotations increased risk of infection between clinical year medical students.


Eligibility criteria: Inclusion Criteria:

All medical Students

-

Exclusion Criteria:

* none

Primary outcomes:
measure: COVID 19 infection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
affiliation: The University of Jordan
name: Amjad bani Hani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05507086: Infectious Pseudochromdrosis Caused by Bacillus Cereus
Official title: Blue Sweat - Infectious Pseudochromdrosis Caused by Bacillus Cereus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infectious Disease
Bacterial Overgrowth
Pigment Deposition
Keywords: Infectious pseudochromhidrosis
Chromhidrosis
Sweat
Bacillus cereus
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus

Brief summary: Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus.

Detailed description: Case series/observational study. Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus. Demography, clinical presentation, diagnosis, treatments, microbiology and causality.

Eligibility criteria: Inclusion Criteria:

* Infectious pseudochromhidrosis caused by Bacillus cereus

Exclusion Criteria:

* Other types of blue chromhidrosis

Primary outcomes:
measure: Remission
timeFrame: 1 year
measure: Repeated bacteriological swab
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Department of Microbiology
state: Viken
Study officials:
References:
Clinical trial NCT01854086: Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday
Official title: Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday: Data From a Single Outpatient Endocrine Clinic.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: osteoporosis
postmenopausal
patient compliance
compliance
diphosphonates
bisphosphonates
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with osteoporosis,who been treated in Endocrinology Clinic of Medical Center

Brief summary: The purpose of the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during "drug holiday".


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Diagnosis of osteoporosis in the medical record
* At least one prescription drug to treat osteoporosis in the last 5 years
* Insured by "Clalit" Health Services
* Hebrew-speaking capability and readiness to answer a questionnaire

Exclusion Criteria:

* Premenopausal women
* No diagnosis of osteoporosis in the medical record
* No treatment for osteoporosis in the last 5 years
* Women who do not speak Hebrew or are unable to answer a questionnaire

Primary outcomes:
measure: Compliance and persistence to osteoporosis drug therapy
timeFrame: Participants will be followed for the duration of their clinic visit, an average of 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center the clalit health care services group
Study officials:
References:
citation: Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005 Sep;21(9):1453-60. doi: 10.1185/030079905X61875.
Clinical trial NCT05375786: Epidemiological Study on Asymptomatic Infections and Mild Illness With Covid-19 in Shanghai
Official title: Epidemiological Study on Asymptomatic Infections and Mild Illness With Covid-19 in Shanghai
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic infections or mild Illness with covid-19 in fangcang shelter hospitals in Shanghai

Brief summary: this study is to clarify the epidemiological characteristics of Omicron variant infected persons in Shanghai, such as distribution characteristics, host and clinical characteristics, disease outcome and risk factors. especially asymptomatic infections.


Eligibility criteria: Inclusion Criteria:

* SARS-Cov-2 RNA positive.
* asymptomatic or mild clinical manifestation.
* informed consent signed.

Exclusion Criteria:

* informed consent rejected.

Primary outcomes:
measure: Viral clearance time
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Erzhen CHEN, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05422586: Way To Drive Validation Study
Official title: Validation Study of Penn's Way to Drive Telematics Research Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validity
Distracted Driving
Driving Behaviors
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who completed in the study team's recent clinical trial with User Based Insurance customers and stated interest in being contacted about further research opportunities. The adults participated in a driving monitoring study (May 2021) and met the eligibility criteria, including 4 trips per week.

Brief summary: Way to Drive is a smart phone-based driving telematics application. Research participants are invited to download the app, which uses phone sensors to track driving behaviors including mileage, hard breaking events, and handheld phone use while driving, measured as the phone screen being unlocked while the phone is in the hand and the vehicle is in motion. Before the study team launches a clinical trial using the app, the researchers will test its capabilities and reliability.


Eligibility criteria: Inclusion Criteria:

* 18 or older (only adult drivers will be invited)
* Willing to download Way to Drive and allow it to track the user's location while the user is in motion (i.e. over 5mph)
* Will make at least 4 driving trips per week for the duration of the study.
* Able to provide informed consent

Exclusion Criteria:

* Under 18 Cannot complete online surveys
* Does not have smart phone
* Not willing to download Way to Drive app and allow location tracking while in motion
* Will not be driving at least 4 times per week during the study.

Primary outcomes:
measure: Number of driving trips classified correctly (driver/passenger) by the Way to Drive Telematics App
timeFrame: 28 days
Secondary outcomes:
measure: Number of driving events accurately captured (trip captured or missing) by Way to Drive Telematics App
timeFrame: 28 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mucio Delgado
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03286686: Sensori-motor and Perceptual Functions of the PPC.
Official title: Sensori-motor and Perceptual Functions of the Posterior Parietal Cortex (PPC) in Patients With Optic Ataxia (AO) and Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Optic Ataxia
Keywords: optic ataxia
posterior parietal cortex functions
multisensory integration
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To produce hand's movement directed towards a target, the investigator must combine several sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.

The aim of the study is to understand the different functions of the PPC and especially how the processes of spatial coding of the sensory information influences perception and motor planning.

In this study, the investigator want to explore the sensory motor and the perceptual performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral tests.

Objectify the consequences of PPC impairment (visual-motor and perceptual consequences) on patients' quality of life and autonomy.


Eligibility criteria: Inclusion Criteria:

All patients and healthy subjects:

* male and female, age from 18 to 75 years included
* normal vision or corrected vision
* covered by social security
* signed written informed consent

Patients:

* neurological injury in posterior parietal cortex supported by a cerebral MRI
* present optic ataxia symptoms Healthy subjects
* no known neurological injury

Exclusion Criteria:

- unable to comply with the tasks (neurological, psychiatric, sensory or motor troubles)

Primary outcomes:
measure: response error - number of pointing error
timeFrame: Day 0 after each stimulation
measure: response error -measure of reaction times
timeFrame: Day 0 after each stimulation
measure: response error - percentage of right responses
timeFrame: Day 0 after each stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: U1028 INSERM - CNRS UMR 5292 Equipe ImpAct
Study officials:
affiliation: INSERM U1028 - Impact - CRNL
name: Laure PISELLA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00175786: Magnetic Resonance Imaging of Patients With Normal Tension Glaucoma
Official title: Neuroradiologic Screening of Patients With Normal Tension Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Tension Glaucoma
Keywords: Glaucoma
Normal Tensions Glaucoma
Neuroradiology
Tumor
MRI
Magnetic Resonance Imaging
Compressive Lesion
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to study the occurrence rate of masses such as brain tumors in patients with newly diagnosed Normal Tension Glaucoma.


Eligibility criteria: Inclusion Criteria:

* Lack of understanding of the study
* Unable or unwilling to undergo MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Hospital and Health Sciences Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Frederick Mikelberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01700686: The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.
Official title: The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bone Loss
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2012-10-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from The Bariatric Clinic, The Hospital of Roskilde-Koege, The University of Copenhagen.

Brief summary: The overall purpose is to explore the link between the gut and the bones by investigating meal stimulated changes in the blood level of a number of hormones and markers related to intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric bypass). The hormones will be measured in blood samples taken before and after surgery. The results are compared with changes in body weight and body composition as measured by DEXA scanning.


Eligibility criteria: Inclusion Criteria:

* Caucasians fulfilling the criteria for laparoscopic gastric bypass.
* BMI\>40kg/m2.

Exclusion Criteria:

* Pregnancy
* Chronic obstructive pulmonary disease
* Diabetes mellitus
* Chronic inflammatory bowel disease
* Major psychiatric disorder
* Drug abuse

Primary outcomes:
measure: Meal stimulated changes in gut hormones and bone markers.
timeFrame: Before surgery and 4 weeks and 6 months after surgery.
Secondary outcomes:
measure: Changes in bone mass and body composition.
timeFrame: Before surgery and 6 months after surgery.
Other outcomes:
Locations:
city: Koege
country: Denmark
facility: Hospital of Roskilde-Koege, The University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Bolette Hartmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01985386: Iron Absorption From GDS Capsules II
Official title: Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System (Ferrous Sulfate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: Iron absorption
Slow release iron
Gastric delivery system
Iron deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.


Eligibility criteria: Inclusion Criteria:

* female,
* age 18-50 years,
* max. body weight 65 kg,
* serum ferritin \< 30 µg/l

Exclusion Criteria:

* pregnancy,
* lactation,
* regular intake of medication,
* blood donation or significant blood losses over the past 4 months

Primary outcomes:
measure: Fractional iron absorption
timeFrame: 2 weeks after test meal consumption
Secondary outcomes:
measure: Serum isotope appearance
timeFrame: 1, 2, 4 and 8 hours on days 1 and 8
Other outcomes:
measure: Serum non transferrin bound iron
timeFrame: 1, 2, 4 and 8 hours on days 1 and 8
Locations:
city: Zurich
country: Switzerland
facility: Human Nutrition Laboratory, ETH Zurich
Study officials:
affiliation: ETH Zurich (Switzerland)
name: Isabelle Aeberli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04714086: Expanded Access Program for Avapritinib
Official title: Expanded Access Program (EAP) for Avapritinib
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Tumors
Keywords: Avapritinib
BLU-285
Solid tumors
Gastrointestinal stromal tumors (GIST)
Gliomas
Lead sponsor: Blueprint Medicines Corporation
Sponsor class: INDUSTRY
First posted: 2021-01-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This record comprises the currently available Expanded Access Programs (EAP) for avapritinib (BLU-285):

1) A Post Trial Access (PTA) program to provide continued access to treatment with avapritinib to BLU-285-1107 participants with solid tumors who are unable to access commercially available avapritinib after trial BLU-285-1107 (NCT04908176) has ended.


Eligibility criteria: Inclusion Criteria:

-Participant has received treatment with avapritinib in BLU-285-1107 clinical trial and continues to receive clinical benefit from avapritinib treatment, as assessed by the Investigator.

Exclusion Criteria:

* Participant requires ongoing treatment or has received treatment within 28 days before the start of avapritinib administration with drugs or foods that are strong CYP3A inhibitors or inducers.
* Female participants of childbearing potential who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment.
* Male participants who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment.
* Participant is pregnant, as documented by a serum β-hCG pregnancy test. Participants with β- hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor after pregnancy has been ruled out.
* Female participants of nonchildbearing potential (premenarchal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) do not require a serum β-hCG test.
* Participant is breastfeeding.
* Participants who require anticoagulants, with the exception of stable doses of prophylactic reversible anticoagulants.
* Participants who are unable to swallow tablets.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03957486: Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring
Official title: Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effect of arterial cannulation on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy


Eligibility criteria: Inclusion Criteria:

* Laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

* atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Primary outcomes:
measure: difference between SpHb value and SaHb value (SpHb - SaHb) in g/dL
timeFrame: 3 time points from the start of anesthesia to the end of anesthesia, an average 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study officials:
References: