louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04862806: Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL
Official title: Safety, Efficacy and a Simple Model to Predict Response of BNT162b2 mRNA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
BNT162b2 mRNA Covid-19 Vaccine
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Ziv Medical Center
name: Hadassah Medical Organization
name: Ben-Gurion University of the Negev
name: Galilee Medical Center
name: Kaplan Medical Center
name: Meir Medical Center
name: Soroka University Medical Center
name: Rambam Health Care Campus
name: Sheba Medical Center
name: Rabin Medical Center
name: Sourasky Medical Center
First posted: 2021-04-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled CLL patients have received 2 shots of BNT162b2 mRNA vaccine, and the investigators will check the efficacy and safety of this vaccine in the enrolled population- the intervention is the diagnostic test of COVID-19 serology
Primary purpose: DIAGNOSTIC

Brief summary: On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CLL was according to the IWCLL criteria
* All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).

Exclusion Criteria:

* previous covid19 virus infection

Primary outcomes:
measure: Change in the number of participants with BNT162b2 mRNA vaccine-related adverse events as assessed by a questionnaire relating to the development of patients' side effects to the vaccine, which was developed by study investigators.
timeFrame: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
measure: Antibody Persistence after Third Dose of BNT162b2 mRNA COVID-19 Vaccination in Serongative Patients with Chronic Lymphocytic Leukemia
timeFrame: 6 months
Secondary outcomes:
measure: Change in the immune response to BNT162b2 mRNA vaccine assessed on the basis of anti covid-19 IgG levels.
timeFrame: 2-6 weeks after second vaccination, 3 months after second vaccination, 6 months after second vaccination
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Tel Aviv
country: Israel
facility: Hematology Division, Chaim Sheba Medical Center
Study officials:
References:
citation: Herishanu Y, Rahav G, Levi S, Braester A, Itchaki G, Bairey O, Dally N, Shvidel L, Ziv-Baran T, Polliack A, Tadmor T, Benjamini O; Israeli CLL Study Group. Efficacy of a third BNT162b2 mRNA COVID-19 vaccine dose in patients with CLL who failed standard 2-dose vaccination. Blood. 2022 Feb 3;139(5):678-685. doi: 10.1182/blood.2021014085.
Clinical trial NCT01493206: A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Official title: A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Rectal Neoplasm
Recurrent Tumor
Keywords: intraoperative radiotherapy
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Detailed description: Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.

Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

Eligibility criteria: Inclusion Criteria:

* locally advanced or recurrent rectal cancer
* suitable for radical surgery but at high risk of positive resection margins,
* no evidence of metastasis,
* age greater than 18 years,
* histologically confirmed adenocarcinoma,
* ECOG performance status \<2.
* Informed consent

Exclusion Criteria:

* unresectable pelvic disease
* distant metastasis
* significant co-morbidities

Primary outcomes:
measure: clinical outcomes
timeFrame: 3-year
Secondary outcomes:
measure: toxicities
timeFrame: 3-6 monthly up to 30 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Sam Ngan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03434106: Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
Official title: Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Sjögren's Syndrome
Keywords: meibomian gland dysfunction
Sjögren's syndrome
dry eye disease
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.


Eligibility criteria: Inclusion Criteria:

* All the subjects are female and age between 50-60 years
* Patients with primary SS fulfilled the criteria established by the European Study Group
* Patients with SLE and RA met the criteria set by the American College of Rheumatology

Exclusion Criteria:

* The control history of autoimmune disease

Primary outcomes:
measure: Ocular Surface Disease Index
timeFrame: up to 3 months after tear substitutes apply
measure: meibomian gland function
timeFrame: up to 3 months after tear substitutes apply
measure: fluorescein staining of the cornea
timeFrame: up to 3 months after tear substitutes apply
measure: noninvasive tear breakup time
timeFrame: up to 3 months after tear substitutes apply
measure: Schirmer's test with and without anesthesia
timeFrame: up to 3 months after tear substitutes apply
Secondary outcomes:
measure: tear meniscus
timeFrame: up to 3 months after tear substitutes apply
measure: rose bengal staining of the conjunctiva
timeFrame: up to 3 months after tear substitutes apply
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
Study officials:
References:
Clinical trial NCT01627106: A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)
Official title: A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 0
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: This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Symptomatic AF (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
* If female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
* Weigh at least 45 kg
* Receiving adequate anticoagulant therapy

Exclusion Criteria:

* Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
* Severe aortic stenosis
* Systolic blood pressure \<100 mmHg
* New York Heart Association (NYHA) Class III or IV heart failure
* Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
* Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration
* Acute coronary syndrome (including myocardial infarction) within previous 30 days
* History of thyroid dysfunction
* Severe acute respiratory failure or cardiovascular collapse
* Participating in another drug study or has received an investigational drug within 30 days prior to enrollment
* Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up

Primary outcomes:
measure: Number of participants discharged from the emergency room (ER) to home, home-equivalent, or long-term care facility (LTCF) within 12 hours from randomization
timeFrame: Up to 12 hours from randomization
Secondary outcomes:
measure: Number of participants admitted to hospital directly from the ER after randomization
timeFrame: Day 1 (time of ramdomization)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00002106: A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3
Official title: A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Ranitidine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.

Detailed description: Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Asymptomatic HIV-1 infection.
* CD4 count of 400-700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Significant illness.
* Acute illness at randomization.
* Hemodialysis.

Prior Medication:

Excluded:

* Antiretroviral use within 60 days prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: Pacific Oaks Med Group
state: California
city: Coral Gables
country: United States
facility: Community Research Initiative
state: Florida
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
Study officials:
References:
citation: Bartlett JA, Berry PS, Bockmon KW, Stein A, Johnson J, Quinn JB, Weinhold KJ. A placebo controlled trial of ranitidine in HIV infection. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:149
Clinical trial NCT01254006: Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: vingolo enzo maria
name: domanico daniela
name: salvatore serena
First posted: 2010-12-06
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: In this study the investigators are going to study the retinal nerve fibers layers (RNFL) modification of two groups of patients, one taking no drugs, the other taking forskolin, rutin and vitamins B1 and B2.


Eligibility criteria: Inclusion Criteria:

* Age (30-80 years);
* Baseline Intraocular pressure (IOP) (20-32 mmHg): average untreated Intra Ocular Pressure (IOP) for both eyes as determined from 2 to 4 visits within a 6-months period;
* Central Corneal Thickness (CCT) (475-650 µm): average of 3 different measurements from both eyes during the same visit;
* Pattern standard deviation (PSD) (0,50-3,00 dB) average of both eyes as stated on the most recent visual field index report
* Vertical Cup/Disk ratio (0,00-0,80): average of both eyes
* All these data were entered into a calculator specially designed for STAR (Scoring Tool for assessing risk) II parameter. The patients were divided into low-, moderate- and high risk groups according to the result given by the calculator.

Exclusion Criteria:

-other ocular pathologies than glaucoma

Primary outcomes:
measure: retinal nerve fibres layer thickness
Secondary outcomes:
measure: global risk threshold for glaucoma progression
Other outcomes:
Locations:
city: Latina
country: Italy
facility: Univerisity La Sapienza
Study officials:
References:
Clinical trial NCT02916706: Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin).


Eligibility criteria: Inclusion Criteria:

* A signed and dated informed consent form has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place.
* The subject is aged ≥18 years at signature of the informed consent form.
* Hospitalization status: outpatient.
* The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
* The subject is undergoing diet and exercise therapy, and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
* The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14.

Exclusion Criteria:

* The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
* The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration).
* The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 24
timeFrame: at Day 1(baseline) and Week 24
Secondary outcomes:
measure: The Changes in Fasting Plasma Glucose (FPG) at Week 24
timeFrame: at Day 1(baseline) and Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational center
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT02704806: Immunologic Analysis of Peripheral Blood and Aspirated Thromb In AMI Patients
Official title: Immunologic Analysis of Aspired Thromb and Circulatory Immune Cell in AMI Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunol Feature in Circulation and Thromb in AMI Patients
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute myocardial infarction patients

Brief summary: Researchers use FCM to analyze the immunol cell feature and its corresponding activation status, as well as the thromb aspirated through the thromb aspiration device in AMI patients


Eligibility criteria: Inclusion Criteria:

* uncomplicated AMI patients

Exclusion Criteria:

* any self immune disease and recent (within 1 month) or any chronic infection

Primary outcomes:
measure: immunologic feature of AMI patients
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00925106: Pharmacokinetics Of Celecoxib Test Formulations
Official title: A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Bioavailability, pharmacokinetics, celecoxib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers
* Body weight BMI 17.5-30.5

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Positive urine drug screen

Primary outcomes:
measure: AUCinf, AUCt, Cmax
timeFrame: 1.5 month
measure: Visual inspection of median plasma concentration versus time profiles resulting from each formulation
timeFrame: 1.5 month
Secondary outcomes:
measure: Tmax, half-life
timeFrame: 1.5 month
measure: adverse events, laboratory tests, vital signs
timeFrame: 1.5 month
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02411006: Effect of Reminders on Adherence
Official title: Prediction and Pre-commitment Mailings for Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 47088
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence.

Detailed description: The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence. The investigators will send mailings to subjects once per month, and elicit responses via mail, phone, and web surveys.

Eligibility criteria: Inclusion Criteria:

* customers of the investigators' insurance company partner

Exclusion Criteria:

* none

Primary outcomes:
measure: Medication refills
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine Milkman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dai H, Mao D, Volpp KG, Pearce HE, Relish MJ, Lawnicki VF, Milkman KL. The effect of interactive reminders on medication adherence: A randomized trial. Prev Med. 2017 Oct;103:98-102. doi: 10.1016/j.ypmed.2017.07.019. Epub 2017 Jul 24.
Clinical trial NCT00277199: Comparability DE vs CD-CHO1
Official title: Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS188667 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667 in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* Signed consent form
* Healthy subjects as determined by good health as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
* Body weight for all subjects will be \<- 100 kg.
* body Mass Index (BMI) of 18-30 kg/m2 inclusive; BMI = weight (kg)/\[height (m)\]2
* Men and women (not nursing, not prgnant), who are at least 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study for at least 4 weeks before and for up to 10 weeks after the infusion of BMS-188667 in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

* WOCBP and males who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 10 weeks after he infusion of BMS-1886678. WOCBP must also be using an acceptable method of contraception for at least 1 month before dosing.
* Women who are pregnant ore breast-feeding.
* Women with positive pregnanacy tes on enrollment or prior to study drug administration.
* History or current evidence of any signiicant acute or chroinic medical illness

Primary outcomes:
measure: To test pharmacokinetics
Secondary outcomes:
measure: To test Safety and immunogenicity
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Inveresk Clinical Research
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: