louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02357069: A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official title: Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: Mochida Pharmaceutical Company, Ltd.
First posted: 2015-02-06
Enrollment: 372
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.


Eligibility criteria: Inclusion Criteria:

* Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
* Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months prior to screening
* Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.

Exclusion Criteria:

* patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
* patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
* patients with any seropositive result for hepatitis B or hepatitis C or HIV
* patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis

Primary outcomes:
measure: Disease activity score based on a 28 joint count (DAS28)
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mochida Investigational site
city: Seoul
country: Korea, Republic of
facility: LGLS Investigational site
Study officials:
References:
citation: Matsuno H, Tomomitsu M, Hagino A, Shin S, Lee J, Song YW. Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate. Ann Rheum Dis. 2018 Apr;77(4):488-494. doi: 10.1136/annrheumdis-2017-212172. Epub 2017 Dec 19.
Clinical trial NCT03595969: Association Between Mitochondrial DNA Content and Risk of Acute Leukemia
Official title: Association Between Mitochondrial DNA Content and Risk of Acute Leukemia in Young Adult
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoblastic Leukemia in Children
Keywords: mitochondrial DNA
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2018-07-23
Enrollment: 300
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 150 eligible chronic lymphocytic leukemia patients were anticipated to include in this study. Moreover, 50 healthy controls without previous cancer history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.

Brief summary: Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of acute lymphoblastic leukemia (ALL).The aim of this study was to explore association between mtDNA content in peripheral blood cells could be used as a risk predictor for ALL.


Eligibility criteria: Inclusion Criteria:

* 1.histological confirmed chronic lymphocytic leukemia; 2.preparing for chemotherapy; 3.no preoperative anticancer treatment.

Exclusion Criteria:

* 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.

Primary outcomes:
measure: Relative copy number of mitochondrial DNA
timeFrame: From date of admission until the date of discharging from hospital, assessed up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Xiao-Fan Zhu
state: Tianjin
Study officials:
References:
Clinical trial NCT02011269: TSO for Plaque Psoriasis
Official title: A Randomized, Blinded, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: TSO
Ova
Psoriasis
plaque psoriasis
plaque-type
Coronado
Moderate to severe plaque psoriasis
Lead sponsor: Coronado Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 0
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: TREATMENT

Brief summary: This is a randomized, blinded, multicenter study to assess the safety and treatment effect of 12 weeks of Trichuris suis ova in subjects diagnosed with moderate to severe chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Males or females, 18 to 75 years old.
* Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
* Baseline moderate to severe psoriasis, defined as both of the following:

  1. Psoriasis covering a body surface area (BSA) ≥ 10%, and;
  2. PGA ≥ 3, and;
  3. PASI ≥ 12

Exclusion Criteria:

* Patients who are currently taking or have taken in the past 30 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, methotrexate, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system. Patients who are on inhaled or ophthalmic steroids are allowed.
* Patients who have demonstrated a primary lack of response to any one of the following biologic agents: etanercept, adalimumab, infliximab or ustekinumab. Patients who initially responded to one of these agents but subsequently lost response (secondary lack of response) are eligible for study entry; however, secondary lack of response to more than one of these agents will exclude the patient from study entry.

Primary outcomes:
measure: Mean percent change in Psoriasis Area and Severity Index (PASI) score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Coronado Biosciences
name: Michael Ryan
role: STUDY_DIRECTOR
References:
Clinical trial NCT03078569: Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF
Official title: Transdermal Testosterone for Poor Responders Undergoing IVF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility, Female
Keywords: Poor responders
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-03-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders.

a randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment.

Detailed description: One of the major challenges of Assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with IVF.

in recent years there is a focus

Eligibility criteria: Inclusion Criteria:

* infertility patients undergoing ART regular menses normal function of thyroid, liver and kidney normal BMI (19.3-28.9) without use of any fertility drugs in the previous two months

Exclusion Criteria:

* patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use

Primary outcomes:
measure: number of retrieved oocytes
timeFrame: 2 year
Secondary outcomes:
measure: number of clinical pregnancies
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson MC
Study officials:
References:
Clinical trial NCT03527069: Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment
Official title: Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypertriglyceridemia
Dyslipidemia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 298
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 evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment


Eligibility criteria: Inclusion Criteria:

* Participants of both sexes, aged 18 years or more;
* Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* Signed consent.

Exclusion Criteria:

* Diagnosis of familial hypercholesterolemia and other genetic diseases;
* Using medications that may interfere with the metabolism or serum levels of triglycerides;
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Presence of concomitant cardiovascular disease, renal failure and hepatic Failure;
* Decompensated diabetes;
* Current smoking;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History of alcohol abuse or illicit drug use;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Reduction of serum triglyceride levels measured between the first visit and last visit.
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
References:
Clinical trial NCT04239469: Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
Official title: Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fibromyalgia
Cannabis
Keywords: cannabis
fibromyalgia
phytocannabinoids
cannabinoid
Lead sponsor: Knop Laboratorios
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso. Patients will be randomized to either placebo or active principle and be followed for 3 months. Assesment of efficacy and safety will be done by measurement of changes in their Fibromyalgia Impact Questionnaire (FIQ) score, Insomnia Severity Index (ISI) score, pain Visual Analogue Scale (VAS) score, plasma cytokine levels and detection of adverse effects.

The active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (THC) and 0.45 milligrams cannabidiol (CBD) per drop.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia based on ACR 2010 criteria
* FIQ \> 39 (refractary symptoms)
* Previous use of at least 2 conventional pharmacotherapies

Exclusion Criteria:

* History of substance use disorder
* History of major psychiatric or cardiovascular diseases
* Pregnancy
* Urine THC (+)

Primary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Baseline to 2 weeks
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Baseline to 4 weeks
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Baseline to 8 weeks
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: Baseline to 2 weeks
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: Baseline to 4 weeks
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: Baseline to 8 weeks
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: Baseline to 12 weeks
measure: Change in pain Visual Analog Scale (VAS) score
timeFrame: Baseline to 2 weeks
measure: Change in pain Visual Analog Scale (VAS) score
timeFrame: Baseline to 4 weeks
measure: Change in pain Visual Analog Scale (VAS) score
timeFrame: Baseline to 8 weeks
measure: Change in pain Visual Analog Scale (VAS) score
timeFrame: Baseline to 12 weeks
measure: Changes in plasma cytokines
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00826969: Ciclesonide for the Treatment of Airway Hyperresponsiveness
Official title: Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.


Eligibility criteria: Inclusion Criteria:

1. Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
2. Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization
3. FEV1 ≥ 70% predicted
4. 18 - 70 years old

Exclusion Criteria:

1. Smoker and ex-smoker with \>10 pack years
2. COPD
3. Upper respiratory tract infection within the past 4 weeks.
4. ICS or oral steroids during the previous month before inclusion
5. b-blockers within the past 4 weeks
6. Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
7. Pregnancy
8. Known malignancy

Primary outcomes:
measure: Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
timeFrame: 4 weeks
Secondary outcomes:
measure: RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)
timeFrame: 4 weeks
measure: Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment
timeFrame: 4 weeks
measure: Level of exhaled nitric oxide after 4 weeks of treatment
timeFrame: 4 weeks
measure: mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)
timeFrame: 4 weeks
measure: Mean change of ACQ after 4 weeks of treatment
timeFrame: 4 weeks
measure: Mean change of AQLQ after 4 weeks of treatment
timeFrame: 4 weeks
measure: Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment
timeFrame: 4 weeks
measure: Exacerbation rates during the 4 weeks of treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT02054169: Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)
Official title: Pilot Study on the Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 340
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The samples consisted of consecutive ED patients.

Brief summary: Delirium is common in older emergency department (ED) patients and often remains unrecognized. Existing instruments to detect delirium are often time consuming and therefore not feasible in the busy ED setting In this study the investigators tested the feasibility of the newly developed modified confusion assessment method (mCAM-ED).


Eligibility criteria: Inclusion Criteria:

* patients aged 65 or older

Exclusion Criteria:

* patients treated in the resuscitation room
* patients transferred or discharged within 2 hours of arrival
* patients with insufficient proficiency in the German language
* patients with an inability to communicate (e.g. aphasic patients)

Primary outcomes:
measure: delirium
timeFrame: two hours after ED admission
Secondary outcomes:
measure: adherence of ED staff to mCAM-ED algorithm
timeFrame: At patient discharge or transfer from ED (average 4 hours after presentation)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christian H Nickel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01467869: Male Fertility Program
Official title: The Miami Project Male Fertility Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injury
Keywords: abnormal semen
assisted conception
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal cord injured men

Brief summary: Following spinal cord injury, most men are infertile and require medical assistance to father children. The conditions that contribute to their infertility are erectile dysfunction, ejaculatory dysfunction, and semen abnormalities. The Miami Project Male Fertility Program is a research study designed to understand and improve impairments to male fertility resulting from spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Any man with spinal cord injury over the age of 18. Control Subjects will be any healthy man over the age of 18 with no recent history of infertility

Exclusion Criteria:

* Women will be excluded.

Primary outcomes:
measure: spinal cord injury (SCI) subjects will learn the best method to obtain their semen and of their possible options for assisted conception.
timeFrame: 2 visits; subjects will provide samples each month up to an average of 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Maimi Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami
name: Emad Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibrahim E, Aballa TC, Lynne CM, Brackett NL. Oral probenecid improves sperm motility in men with spinal cord injury. J Spinal Cord Med. 2018 Sep;41(5):567-570. doi: 10.1080/10790268.2017.1320875. Epub 2017 May 2.