louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01360515: A Study of Disposable Transnasal Esophagoscope
Official title: A Novel Disposable Transnasal Esophagoscope: a Prospective Pilot Trial of Feasibility, Safety and Tolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Esophageal Varices
Esophageal Disease
Keywords: esophagoscope
esophageal disease
gastroesophageal reflux
esophageal varices
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50

Brief summary: This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.

Detailed description: A disposable, transnasal esophagoscope, E.G. ScanTM was developed by IntroMedic Co. Ltd. (Seoul, Korea). This device was designed to allow patient to undergo endoscopy with minimum pain without sedation. This endoscopy system consists of thin probe with a CMOS camera, controller and simple display system. This system is light enough to carry and does occupy much space, and thus, it can be used at patient bed sides in intensive care units, in emergency rooms, and even in doctor's offices.

Eligibility criteria: Inclusion Criteria:

1. aged 20 years or older
2. endoscopy indicated for reflux symptoms (heartburn, epigastric soreness and/or regurgitation), dyspepsia (epigastric discomfort, bloating, early satiety), or non-cardiogenic chest pain, or known or suspected to have esophageal varices, infectious esophagitis, or other esophageal disease based on their medical history
3. a written informed consent form

Exclusion Criteria:

1. history or symptoms of severe rhinitis and sinusitis
2. symptoms of acute respiratory inflammation at the time of examination
3. abnormal anatomy of the nasal cavity or nasopharynx due to nasal tumors or previous nasopharyngeal surgery
4. taking anticoagulants such as coumadin
5. patients for whom a EGD could not be performed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Yonsei University
name: Si Young Song, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00754715: Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers
Official title: A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Multiple dosing study,
safety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.


Eligibility criteria: Inclusion Criteria:

* Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
* Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion Criteria:

* History of previous or ongoing psychiatric disease.
* Abnormalities in ECG that may interfere with interpretation of data.

Primary outcomes:
measure: Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
timeFrame: From first to last visit
Secondary outcomes:
measure: Safety and tolerability of AZD2516 by assessment of non-serious adverse events
timeFrame: Collected from start of residential period until last visit.
measure: Determine the single ascending dose pharmacokinetics of AZD2516
timeFrame: PK sampling taken at defined timepoints during residential period
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Bo Fransson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Lars Ståhle, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01030315: A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics and Pharmacokinetics of Single Intravenous Doses of HM10760A in Healthy Adult Caucasian and Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Erythropoietin
Long-acting
EPO
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study design:

* Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort, subjects will be randomized to receive a single dose of HM10760A or placebo.

Primary Objective:

* To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.

Detailed description: Secondary Objectives:

* To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters
* To assess the immunogenicity of a single IV dose of HM10760A.

Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian and Japanese male and/or female volunteers
* Age 18 to 55 years
* Hemoglobin of \>12 g/dL and \<16 g/dL for male subjects, \>10 g/dL and \<14 g/dL for female Caucasian subjects

Exclusion Criteria:

* Prior exposure to EPO, darbepoetin, other EPO support proteins
* hypersensitivity to EPO, darbepoetin, E.coli derived proteins
* Hemoglobinopathy
* SBP \> 140 mmHg or \< 90 mmHg or DBP \> 95 mmHg
* Chronic, uncontrolled, or symptomatic inflammatory disease
* Malignancy(except non-melanoma skin cancer)

Primary outcomes:
measure: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level.
timeFrame: 84 days after the investigational drug administration.
Secondary outcomes:
Other outcomes:
Locations:
city: US
country: United States
facility: Hanmi Clinical
state: California
Study officials:
References:
Clinical trial NCT02375815: Statin Choice Decision Aid Implementation First Phase
Official title: The Statin Choice Implementation Project: Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Factor Risk
Keywords: statin
decision aid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to answer a key question in the field of implementation science. Specifically, it seeks to determine if a proposed model for the implementation and scale-up of healthcare innovations (the AIDED model) is effective and useful. To fully evaluate the potential of this model, the investigators will conduct a multi-year study comprising 3 phases. This proposal represents the first of these phases.


Eligibility criteria: Subjects of the Mayo Clinic Care Network

Primary outcomes:
measure: Effective Implementation of Statin Choice Decision Aid (SCDA), as indicated by the cumulative reach (% usage in appropriate primary care consultations) across all 3 health systems (as measured by EMR-based calculations).
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Coeur d'Alene
country: United States
facility: Kootenai Health
state: Idaho
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: St. Joseph
country: United States
facility: Mosaic Life Care
state: Missouri
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
Study officials:
affiliation: Mayo Clinic
name: Victor Montori, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leppin AL, Boehmer KR, Branda ME, Shah ND, Hargraves I, Dick S, Elwyn G, Ting HH, Ye S, Gilles R, Abbas M, Alexander A, Montori VM. Developing a toolkit to implement the Statin Choice Conversation Aid at scale: application of a work reduction model. BMC Health Serv Res. 2019 Apr 24;19(1):249. doi: 10.1186/s12913-019-4055-8.
Clinical trial NCT01103115: Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
Official title: Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
AIS
low bone mass
osteopenia
bone health
bone density
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 330
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Calcium and Vit D supplementation is effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).

Detailed description: Adolescent Idiopathic Scoliosis (AIS) is a prevalent condition mainly affecting females with disease onset at early puberty. It can lead to serious health problems and is associated with low bone mass which can persist with growth. Osteopenia is found to be an important prognostic factor for curve progression in AIS. Nutritional studies indicated AIS subjects had low dietary calcium intake. Evidences suggested that Vit D insufficiency could be present in AIS. Calcium and vitamin D supplementation can therefore be a viable treatment option for low bone mass in AIS subjects. The primary objective of this prospective randomized double-blinded placebo-controlled trial is to find out whether calcium and vitamin D supplementation can improve bone mineral density (BMD) in osteopenic AIS subjects. The secondary objective of this study is to evaluate whether the supplementation is effective in controlling curve progression in AIS.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 11-14 (Tanner stage \< IV)
* Low BMD (z-score \< 0 from age-matched population mean)
* Cobb's Angle greater or equal to 15°
* Presentation at the Scoliosis Clinic without prior treatment for low bone mass.

Exclusion Criteria:

* Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
* Patient with known endocrine and connective tissue abnormalities, or
* Patient with eating disorders or GI malabsorption disorders or
* Prior treatment for low bone mass before being recruited into the study.
* Patient currently taking medication that affects bone metabolism eg corticosterone or estrogen.

Primary outcomes:
measure: Bone mineral density
timeFrame: 2-year time point
Secondary outcomes:
measure: Curve severity
timeFrame: 2-year time point
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Tsz-ping Lam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04142515: Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated for Giant Cells ARTEitis (Horton's Disease)
Official title: Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated at Nîmes Carémeau University Hospital, for Giant Cells ARTEitis (Horton's Disease), for Diagnosis and During Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Horton Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 83
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 45 years or older with giant cell arteritis according to ACR criteria or revised criteria incorporating imaging parameters, managed at the University Hospital of Carémeau in Internal Medicine from 01/01/2011 to 01/01/2020.

Brief summary: Giant cell arteritis (GCA) or Horton's disease: frequent large vessel vasculitis (cephalic) (incidence estimated at 9 per 100,000 in France), potentially responsible for blindness.

Treatment: corticosteroid therapy, which is effective in the vast majority of cases.

Clinical problem: relapse; 36% to 44% of patients have a relapse that occurs in the first year for many patients, requiring a re-escalation of corticosteroid therapy, with its consequences:

* Cumulative dose of corticosteroid therapy that causes cardiovascular and infectious morbidity.
* Requires additional immunosuppressive treatment.


Eligibility criteria: Inclusion Criteria:

* Patients aged 45 years or older
* Patients with giant cell arteritis according to ACR criteria or revised criteria incorporating imaging parameters,
* Patients managed at the University Hospital of Carémeau in Internal Medicine from 01/01/2011 to 01/01/2020.

Exclusion Criteria:

None

Primary outcomes:
measure: Clinical and paraclinical characteristics of patients diagnosed with ACG
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHUNimes
Study officials:
References:
Clinical trial NCT00592215: Second Trimester Labor Induction
Official title: A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Second Trimester Labor Induction
Keywords: Second trimester labor induction
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Maryland
First posted: 2008-01-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.

The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.


Eligibility criteria: Inclusion Criteria:

* English-speaking women
* 18 years of age and above
* Voluntarily choose to undergo pregnancy termination via labor induction
* An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
* Able to provide written consent

Exclusion Criteria:

* Premature rupture of membranes
* Preterm labor
* Intrauterine fetal demise
* Chronic systemic corticosteroid use or adrenal disease
* Hypersensitivity to prostaglandins
* Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
* Known coagulopathy or treatment with anticoagulants
* Prior caesarean delivery or myomectomy
* Placenta previa

Primary outcomes:
measure: Abortion rate
timeFrame: 8 hours after misoprostol administration
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Rameet Singh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01663415: A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Official title: A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: MDV3100
prostate
cancer
enzalutamide
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2012-08-13
Enrollment: 0
Sex: MALE
Standard ages: CHILD
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 investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.


Eligibility criteria: Inclusion Criteria:

* Progressive prostate cancer while on androgen deprivation therapy
* Castrate testosterone level
* Maintenance of surgical or medical castration for duration of study
* Radiographically visible metastatic disease
* Symptomatic from prostate cancer
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Life expectancy \>=6 months

Exclusion Criteria:

* Brain metastases or leptomeningeal disease
* Prior cytotoxic chemotherapy for prostate cancer
* Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
* History of seizure or condition that may predispose to seizure
* History of loss of consciousness or transient ischemic attack within 12 months
* Clinically significant cardiovascular disease

Primary outcomes:
measure: Radiographic progression free survival (PFS)
timeFrame: 26 months
Secondary outcomes:
measure: Overall survival
timeFrame: 26 months
measure: Time to PSA progression
timeFrame: 26 months
measure: Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: Baseline and 26 months
measure: Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)
timeFrame: Baseline and 26 months
measure: Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)
timeFrame: Baseline and 26 months
measure: Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)
timeFrame: 26 months
Other outcomes:
Locations:
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00304785: Latanoprost Versus Fotil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Pharmaceutical Research Network
Sponsor class: OTHER
First posted: 2006-03-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the intraocular pressure effect and safety of latanoprost 0.005% given every evening versus PTFC given twice daily.


Eligibility criteria: Inclusion Criteria:

* adults with primary open-angle or pigment dispersion glaucoma, or ocular hypertension
* untreated intraocular pressure should be between 24-36 mm Hg inclusive
* visual acuity should be 5/50 or better in both eyes

Exclusion Criteria:

* presence of exfoliation syndrome or exfoliation glaucoma
* contraindications to study medications
* any anticipated change in systemic hypotensive therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Gabinety Okulistyczne
city: Poznan'
country: Poland
facility: Kierownik Kliniki Okulistycznej Akademii Medycznej
city: Warsaw
country: Poland
facility: Instytut Jaskry
city: Warsaw
country: Poland
facility: Katdra Klinika Okulityki Akademii Medycznej w Warszawie
city: Warszawa
country: Poland
facility: Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny
Study officials:
affiliation: Pharmaceutical Research Network, LLC
name: William C. Stewart, MD
role: STUDY_DIRECTOR
affiliation: Gabinety Okulistyczne
name: Józef Kałużny, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kierownik Kliniki Okulistycznej Akademii Medycznej
name: Krystyna Pecold, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny
name: Roman Sobecki, Dr. n.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Instytut Jaskry
name: Krystyna Czechowisz-Janicka, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Katdra Klinika Okulityki Akademii Medycznej w Warszawie
name: Dariusz Kecik, Professor
role: PRINCIPAL_INVESTIGATOR
References: