louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01091961: Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications
Official title: Pre-Operative Inhibition of the Angiotensin System Study: A Prospective Randomized Single-Blinded Trial of Pre-Operative Management of Medications That Inhibit the Renin-Angiotensin System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: ACE inhibitor
ARB
Non-cardiac surgery
Perioperative
Preoperative
Hypotension
Congestive heart failure
Hypertension
Angiotensin-Converting Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Perioperative Care
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 200
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: Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.


Eligibility criteria: Inclusion Criteria:

* currently taking an ACEi, ARB or both
* no change in these medications during the two weeks prior to study enrollment
* scheduled for non-cardiac surgery requiring regional or general anesthesia
* minimum overnight anticipated length of stay
* age ≥18 years.

Exclusion Criteria:

* explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB
* significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)
* significant hypotension in pre-operative assessment clinic (systolic blood pressure \< 90 mmHg)
* prior enrollment in the study
* participation in another research study of antihypertensive medications

Primary outcomes:
measure: Mean arterial blood pressure
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Clinically significant hypotension
timeFrame: 30 days after surgery
measure: Clinically significant hypertension
timeFrame: 30 days after surgery
measure: All-cause mortality
timeFrame: 30 days after surgery
measure: Cardiovascular morbidity
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Marko Mrkobrada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02176083: Reproductive Health Survivorship Care Plan Pilot
Official title: Intervening on Reproductive Health in Young Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Hot Flashes
Vaginal Dryness
Estrogen Deprivation Symptoms
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.


Eligibility criteria: Inclusion Criteria:

* Breast cancer
* Female
* Completed primary breast cancer treatment
* Age \<=45

Primary outcomes:
measure: Hot Flash Frequency
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
affiliation: UC San Diego
name: Irene Su, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756583: Advance Care Planning Notifications in General Inpatient Medicine
Official title: Advance Care Planning Notifications in General Inpatient Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate the impact of and response by physicians on Hospital Medicine/General Internal Medicine service to a notification identifying seriously ill patients at high risk of death within 30 days as well as within 6 months in a cluster randomized control trial.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Attending Physician on the Hospital Medicine or General Internal Medicine Service at Duke University Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of advance care planning notes as measured by electronic health record data during hospitalization
timeFrame: Up to 30 days
Secondary outcomes:
measure: Proportion of advance care planning codes billed as measured by electronic health record data
timeFrame: Up to 30 days
measure: Proportion of Palliative Care Consults (Inpatient/Outpatient) as measured by electronic health record data
timeFrame: Up to 90 days
measure: Proportion of patients discharged to hospice as measured by electronic health record data
timeFrame: Up to 30 days
measure: Proportion of patients' code status changed to Do-Not-Resuscitate as measured by electronic health record data
timeFrame: Up to 30 days
measure: Proportion of patient deaths as measured by electronic health record data
timeFrame: Up to 14 days
measure: Proportion of patient deaths as measured by electronic health record data
timeFrame: Up to 30 days
measure: Proportion of patient deaths as measured by electronic health record data
timeFrame: Up to 6 months
measure: Proportion of patient re-admitted to the hospital as measured by electronic health record data
timeFrame: Up to 30 days
measure: Proportion of patient re-admitted to the hospital as measured by electronic health record data
timeFrame: Up to 6 months
measure: Proportion of advance care planning paperwork filed as measured by electronic health record data
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: David Casarett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Jessica Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00883883: To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions
Official title: A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SFBC Anapharm
name: Benoit Girard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04136483: Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry
Official title: Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry: a Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm University
name: Child and Adolescent Psychiatry, Stockholm
name: Karolinska University Hospital
First posted: 2019-10-23
Enrollment: 25
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a clinical pilot study that examine the preliminary effect of cognitive-behavioral therapy for insomnia (CBT-I) in adolescents with comorbid psychiatric disorders. Participants (n=25) are recruited from three psychiatric clinics (n=19) and one pediatric pain clinic (n=6). After diagnostic assessment, participants that fulfil inclusion criteria are offered the CBT-I intervention. Pre-post and 3-months follow-up assessments include subjective measures of insomnia symptom severity, sleep parameters (collected through sleep-wake diaries), symptoms of depression and anxiety and daytime functioning.


Eligibility criteria: Inclusion Criteria:

* be between 13-17 years old
* meet criteria for insomnia disorder (primary or secondary insomnia) according to DSM-IV-TR
* have insomnia symptoms at a clinical level, as defined as more than 10 points on the ISI-a
* adequate Swedish language skills

Exclusion Criteria:

* severe psychiatric disorder that is contraindicative of the treatment (i.e., bipolar disorder, psychotic disorder)
* autistic disorder
* severe suicidality (defined as ≥17 points on MINI-kid suicide subscale)
* alcohol or drug dependence
* psychotropic medication
* previous (\> 5 sessions) or ongoing CBT-treatment for insomnia

Primary outcomes:
measure: Change from Baseline Insomnia Severity Index- adolescent version (ISI-a)
timeFrame: 6 weeks and 3 months
Secondary outcomes:
measure: Sleep Onset Latency (SOL)
timeFrame: Baseline, 6 weeks and 3 months
measure: Wake after sleep onset (WASO)
timeFrame: Baseline, 6 weeks and 3 months
measure: Total Sleep Time (TST)
timeFrame: Baseline, 6 weeks and 3 months
measure: Sleep Efficiency (SE)
timeFrame: Baseline, 6 weeks and 3 months
measure: Spences' Children Anxiety Scale (SCAS)
timeFrame: Baseline, 6 weeks and 3 months
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
timeFrame: Baseline, 6 weeks and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Mats Lekander, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03360383: Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures
Official title: Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Fractures
Keywords: Spinal Fractures/surgery
Vertebroplasty
Quality-Adjusted Life Years
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.

Detailed description: This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.

Eligibility criteria: Inclusion Criteria:

* vertebral compression fracture on spine radiograph (minimum 15% height loss)
* level of fracture at Th5 or lower; back pain for 6 weeks or less
* focal tenderness at fracture level on physical examination
* bone oedema of vertebral fracture on MRI
* decreased bone density (T scores ≤-1)

Exclusion Criteria:

* severe cardiopulmonary comorbidity
* suspected underlying malignant disease
* radicular syndrome
* spinal-cord compression syndrome
* contraindication for radiography exam

Primary outcomes:
measure: change of pain relief
timeFrame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Secondary outcomes:
measure: quality of life
timeFrame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Other outcomes:
Locations:
Study officials:
affiliation: PekingUPH department of spinal surgery
name: haiying liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT04440683: Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development
Official title: Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Prevention
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients need to have good compliance

Brief summary: This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Detailed description: Through estrogen receptor antagonists, tamoxifen can reduce the risk of breast high-risk disease progression to cancer, but only reduce the probability of some ER and PR positive tumors, which has no preventive effect on triple negative breast cancer and HER-2 positive breast cancer. In the first hospital of Jilin University, the preparations containing antler ingredients have been clinically proven to be able to treat breast hyperplasia, which has been proved to be able to prevent breast cancer in basic research, and antler ingredients have been proved to be non-toxic and side effects in the treatment dose. This study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 and 80
* Atypical hyperplasia or / and lobular carcinoma in situ confirmed by breast histology
* Women with breast cancer in first degree relatives
* Patients have better compliance with a series of research-related behaviors such as the upcoming comprehensive treatment and follow-up, and can understand and accept the research process of this study, and sign a written informed consent

Exclusion Criteria:

* Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases
* Patients not suitable for this study judged by researchers

Primary outcomes:
measure: Canceration by biopsy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Aiping Shi, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01095783: Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: low back pain
physiotherapy
hemodialysis
end-stage renal disease
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2010-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 determine whether a physiotherapeutic intervention is effective in the treatment of low back pain in hemodialysis patients

Detailed description: Low back pain is a significant morbidity in chronic hemodialysis patients affecting about 1/3 of them. Among the physiotherapeutic interventions, the McKenzie Method (Spine 1983;8:141-4), has shown to be an effective approach to manage patients with low back pain. More specifically, it consists on standardized repetitive flexion and extension exercises of the lumbar spine. Thus far, there has been no randomized intervention testing the effectiveness of physiotherapeutic interventions in chronic renal failure patients on hemodialysis. In this study we selected four of their main proposed exercises (flexion in standing, extension in standing, flexion in lying, and extension in lying position) to apply three times a week for eight weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic low back pain
* Chronic renal failure
* Hemodialysis therapy for more than 3 months

Exclusion Criteria:

* Fractures of the spine
* Psychiatric diseases
* Alcohol of other drugs use
* Planned living donor transplantation
* Clinically unstable patients
* Chronic neurologic diseases

Primary outcomes:
measure: Improvement in functional status of the lumbar spine as measured by the Roland Morris Disability questionnaire, consisting of 24 items wich are reported by the patient. Additionally, the lumbar pain will be assessed by a visual analogue scale.
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
References:
citation: Cristofolini T, Draibe S, Sesso R. Evaluation of factors associated with chronic low back pain in hemodialysis patients. Nephron Clin Pract. 2008;108(4):c249-55. doi: 10.1159/000124328. Epub 2008 Apr 9.
Clinical trial NCT02644083: Tecfidera and MRI for Brain Energy in MS
Official title: Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2015-12-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 21 patients with a diagnosis of relapsing-remitting multiple sclerosis

Brief summary: The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS by 2010 McDonald criteria
* Relapsing clinical course
* Ages 18-55
* Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)

Exclusion Criteria:

* Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease)
* Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan.
* Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant
* Prior treatment of greater than 1 month at any time with DMF
* Inability to tolerate MRI procedures
* Pregnant/breastfeeding

Primary outcomes:
measure: Changes in phosphocreatine (PCr) in cerebral grey matter
timeFrame: baseline and 6 months of treatment with Dimethyl Fumarate (DMF)
Secondary outcomes:
measure: Changes in ATP in normal appearing white matter (NAWM)
timeFrame: baseline and 6 months of treatment with Dimethyl Fumarate
Other outcomes:
measure: Changes in fatigue
timeFrame: baseline and 6 months of treatment with DMF
measure: Changes in fatigue
timeFrame: baseline and 6 months of treatment with DMF
measure: Changes in cognition
timeFrame: baseline and 6 months of treatment with DMF
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Rebecca Spain, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00330083: Safety of ALK Ragweed Tablet
Official title: A RANDOMIZED, MULTIPLE DOSE, DOSE-ESCALATION, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE I TRIAL INVESTIGATING THE OPTIMAL SAFE DOSE OF ALK RAGWEED TABLET AMBROSIA ARTEMISIIFOLIA IN ADULT SUBJECTS WITH SEASONAL RHINOCONJUNCTIVITIS CAUSED BY RAGWEED POLLEN ALLERGY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-05-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults


Eligibility criteria: Inclusion Criteria:

* Ragweed pollen induced rhinoconjunctivitis
* Adults of either sex (18-50 years of age)
* Positive skin prick test to ragweed

Exclusion Criteria:

* Previous treatment with immunotherapy

Primary outcomes:
measure: Assessment of safety by recording of adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Healthcare Discoveries Inc.
state: Texas
Study officials:
affiliation: Healthcare Discoveries Inc.
name: George J. Atiee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.