louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03138525: Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
Official title: Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Healthy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2017-05-03
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center

Brief summary: The purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
* Healthy controls
* Ability to understand and sign informed consent

Exclusion Criteria - All subjects:

* Other concomitant autoimmune or inflammatory diseases
* Ongoing treatment with other immunomodulatory medications
* Previous treatment with rituximab, methotrexate, cyclophosphamide, mitoxantrone, mycophenolate mofetil, or alemtuzumab
* Pregnancy or lactation
* Hypersensitivity to ocrelizumab

Exclusion Criteria - Healthy Controls:

* MS
* First-degree relatives with MS

Primary outcomes:
measure: Monocyte Transcriptome Profiling
timeFrame: 12 months
measure: Antigen microarrays
timeFrame: 12 months
measure: Serum microRNA profiles
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Howard L Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04100525: Intervention for Employed Women With Multiple Sclerosis
Official title: Neuropsychological Feedback Style and Case Management to Improve Intervention Outcome for Employed Women With Multiple Sclerosis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Employment
Vocational Rehabilitation
Lead sponsor: Holy Name Medical Center, Inc.
Sponsor class: OTHER
Collaborators: name: Women United in Philanthropy (WUIP)
First posted: 2019-09-24
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Unemployment is particularly common among women with multiple sclerosis (MS). This study uses a vocational rehabilitation program involving neuropsychological testing as an intervention. The use of in-person feedback and case management following neuropsychological testing is compared to phone feedback only. Adherence to treatment and employment outcomes will be evaluated over three years.

Detailed description: Employed women at a tertiary-care MS center were screened for common issues impacting work productivity (fatigue, cognitive dysfunction, and depression). Women who met screening criteria were randomized to one of two treatment groups: either neuropsychological testing and phone feedback to review findings and tailored recommendations (standard-care treatment); or neuropsychological testing, in-person feedback, and two calls from a care-coordinator (experimental treatment). Adherence to recommendations and employment status at one year are evaluated. Follow-up periods also occur at year two and year three.

Eligibility criteria: Inclusion Criteria:

* Female sex
* Age between 18 and 64
* Employed at least 20 hours per week
* Confirmed diagnosis of MS

Exclusion Criteria:

* Experiencing an MS exacerbation
* Endorsing suicidal ideation or intent
* Pregnant
* Severe psychiatric disorder
* History of traumatic brain injury
* Dementia
* Major neurological illness other than MS

Primary outcomes:
measure: Employment
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Adherence to Recommendations
timeFrame: Approximately 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Holy Name Medical Center, Ferkauf Graduate School of Psychology
name: Frederick W Foley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108925: Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients
Official title: Oxygen Supply and Ventilation During Physical Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Hypoxia
Lead sponsor: LHL Helse
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.


Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease

Exclusion Criteria:

* No exacerbation
* No active heart disease

Primary outcomes:
measure: Pulmonary ventilation
timeFrame: 1 hour
Secondary outcomes:
measure: Dyspnoea
timeFrame: 1 hour
measure: Heart rate
timeFrame: 1 hour
measure: Blood pressure
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: LHL-klinikkene Glittre
state: Akershus
Study officials:
affiliation: LHL Helse
name: Anne Edvardsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080625: Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation
Official title: Effect of Preventive Medicine on the Postreperfusion Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension After Reperfusion in Liver Transplantation
Keywords: postreperfusion syndrome
phenylephrine
epinephrine
liver transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 96
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: PREVENTION

Brief summary: Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver transplantation which is characterized by an acute drop in blood pressure immediately after the prefusion is restored to the transplanted liver. We hypothesized that PRS would be prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion in liver transplantation.


Eligibility criteria: Inclusion Criteria:

- adults scheduled to undergo liver transplantation

Exclusion Criteria:

- pediatric liver transplantation

Primary outcomes:
measure: Occurrence of Postreperfusion Syndrome (PRS)
timeFrame: immediately after reperfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryu HG, Jung CW, Lee HC, Cho YJ. Epinephrine and phenylephrine pretreatments for preventing postreperfusion syndrome during adult liver transplantation. Liver Transpl. 2012 Dec;18(12):1430-9. doi: 10.1002/lt.23511.
Clinical trial NCT04231825: At-home Transcranial Alternating Current Stimulation During Multitasking
Official title: At-home Transcranial Alternating Current Stimulation During Multitasking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multitasking Behavior
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal is to replicate in-lab results from transcranial alternating current stimulation (tACS) with at-home tACS.

Detailed description: Participants will be assessed in-lab on multitasking and sustained attention abilities. Participants will be sent home with a tACS device to be used at-home for five days while engaged in a multitasking paradigm that is different from the multitasking outcome measure used pre/post tACS. After the at-home stimulation is complete, participants return to UCSF for a final in-lab assessment of multitasking and sustained attention ability.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Grade 12 or more education
* Normal or corrected to normal vision and hearing
* Ability to complete cognitive tasks
* Ability to cooperate and comply with all study procedures
* Ability to tolerate tACS

Exclusion Criteria:

* Neurological or psychiatric disorders
* Family history of epilepsy
* History of seizures
* Prior head trauma
* Pregnant
* Implanted electronic devices (e.g., pacemaker)
* IQ \< 80
* Taking psychotropic medication
* Taking anti-depressants or anti-anxiety medication
* Substance abuse
* Color blind
* Glaucoma
* Macular degeneration
* Amblyopia
* Strabismus

Primary outcomes:
measure: Multitasking Performance Cost (Neuroracer Performance Change From Baseline)
timeFrame: Pre-tACS and post-tACS (1 week later)
measure: Single Task Performance Change
timeFrame: Pre-tACS and post-tACS (1 week later)
measure: Multitask Performance Change
timeFrame: Pre-tACS and post-tACS (1 week later)
Secondary outcomes:
measure: Continuous Performance Test RT Change (Test of Visual Attention / Sustained Attention)
timeFrame: Pre-tACS and post-tACS (1 week later)
measure: Continuous Performance Test RTV Change (Test of Visual Attention / Sustained Attention)
timeFrame: Pre-tACS and post-tACS (1 week later)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Sandler Neurosciences Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Theodore Zanto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365325: Handled Echocardiography and Chronic Heart Failure
Official title: Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 118
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations, the other one using also periodical handled echocardiographic examinations.

Detailed description: Randomized, blinded, controlled, monocentric study comparing two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations every three months, the other one using also periodical handheld echocardiographic examinations at the 6th, 12th and 18th month.

The events occurring during the 18 month follow up and the results of the final echocardiography performed in all the patients will be transmitted to and evaluated by an independent observer, unaware of the features of the follow up. At the end of the trial, the randomization code will be opened and the events will be ascribed to the two groups. The primary end point is rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events during the 18 months follow up. Secondary end points include home treated vascular events, cardiovascular death and the composite end point death + rehospitalization.

Eligibility criteria: Inclusion Criteria:

* Chronic Heart Failure in functional class NYHA III
* At least once hospitalization during the last year for worsening of clinical symptoms or for the appearance of acute cardiovascular events
* Patients who cannot easily reach the pertaining Sanitary District for different reasons (i.e. the presence of architectural barriers, the absence of a lift, a too great distance between home and Sanitary District without someone helping)
* age ≥ 70 years
* written informed consent

Exclusion Criteria:

* Patients who were waiting for cardiac surgery or patients who had undergone a cardiac operation within three months

Primary outcomes:
measure: Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
timeFrame: 18 months
Secondary outcomes:
measure: Home treated major vascular events
timeFrame: 18 months
measure: Cardiovascular death
timeFrame: 18 months
measure: Composite end point death + rehospitalization
timeFrame: 18 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
affiliation: Federico II University
name: Ugo Oliviero, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01871025: Early Incentive and Mobilization During COPD Exacerbation
Official title: Early Incentive and Mobilization During COPD Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the effects of early exercise training in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). Interventions are randomized. In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both groups, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.

Detailed description: Prospective randomized study in hospitalized patients for Chronic Obstructive Pulmonary Disease exacerbation (COPD). In one group, early exercise training (aerobic and strength) during hospitalization for COPD exacerbation followed by exercise training at home until 30 days to discharge and in the other the intervention is usual care. In both group, usual respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations have been included. The main variable is the increase in moderate or vigorous daily physical activities at 30 days after discharge.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients for COPD exacerbation

Exclusion Criteria:

* Hospitalization within the previous 14 days,
* current participation in rehabilitation program,
* locomotor or neurological condition or disability limiting the ability to perform exercise,
* lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.

Primary outcomes:
measure: Daily physical activity
timeFrame: 1 month
Secondary outcomes:
measure: Tolerance to exercise
timeFrame: 1 month
measure: COPD Assessment Test (CAT)
timeFrame: 1 month
measure: Physical activity
timeFrame: 1 month
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
Study officials:
affiliation: Parc de Salut Mar
name: Diego Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04357925: Quality of Life in Prostate Cancer Patients
Official title: Quality of Life in Prostate Cancer Patients: Challenges and Prospects for Reducing Disparities in the Caribbean
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate
Public Health
Quality of life
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
First posted: 2020-04-22
Enrollment: 304
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prostate cancer diagnosed in Martinique in differents units care.

Brief summary: Recording cancer data in cancer registries is essential for producing reliable population-based data for service planning, monitoring and evaluation. Prostate cancer (PCa) remains the most frequent type of cancer in terms of incidence and mortality in men in the Caribbean. The quality of life PCa cohort will assess quality of life and patient outcomes in Martinique using a digital platform for patient-reported outcome measures.

Detailed description: The Martinique Cancer Registry database is the largest clinical database among the French population-based cancer registries in the Caribbean, including more than 38 000 cancer cases, with 1650 new cancer cases per year, including 550 new PCa cases per year (2010-2014 latest period). In 2020, follow-up will include vital status, assessment of quality of life with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 and the Prostate cancer module QLQ-PR25. Urinary incontinence and erectile dysfunction recorded prior to treatment will be analysed 1, 3 and 5 years after treatment.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years and residing in Martinique, with prostate cancer diagnosed from 2020
* The patient has provided informed consent
* Patient with social security coverage

Exclusion Criteria:

* Refusal to participate
* Patient with a second cancer, five years after diagnosis
* Patient who could not answer the quality of life questionnaires
* Patient not fluent in French
* Person under legal protection

Primary outcomes:
measure: Evaluation of overall Quality of Life: Questionnaire
timeFrame: At the date of diagnosis of the disease, at 1 year, 3 years and 5 years
measure: Evaluation of overall Quality of Life: Questionnaire
timeFrame: At the date of diagnosis of the disease, at 1 year, 3 years and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort de France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: CHU Martinique
name: Clarisse CONTARET-JOACHIM
role: STUDY_DIRECTOR
References:
Clinical trial NCT01110525: A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives
Official title: A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oral Contraceptives
Keywords: Phase I
Drug-drug interaction
Oral contraceptives
AZD 1981
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.


Eligibility criteria: Inclusion Criteria:

* Females of childbearing potential
* Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.
* Willing to use a highly effective method of birth control, ie, double barrier method contraception.

Exclusion Criteria:

* Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.
* Any clinically significant disease or disorder.
* Any clinically relevant abnormal findings in physical examination.

Primary outcomes:
measure: Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.
timeFrame: PK sampling will be performed regularly during the study period of two months.
Secondary outcomes:
measure: Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2
timeFrame: PD sampling will be done at the end of treatment period 1 and 2.
measure: Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations
timeFrame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
measure: Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured.
timeFrame: PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.
Other outcomes:
Locations:
city: Lulea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D
name: Eva S Pettersson
role: STUDY_DIRECTOR
affiliation: Quintiles AB, Phase I Services
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
affiliation: Quintiles Hermelinen AB
name: Aslak Rautio
role: PRINCIPAL_INVESTIGATOR
References: