louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01721967: Ranolazine for the Treatment of Chest Pain in HCM Patients
Official title: Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertrophic Cardiomyopathy
Keywords: chest pain
dyspnea
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2012-11-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Left Ventricle wall thickness \>/= 15mm in the absence of other condition causing hypertrophy
* Baseline Angina/Shortness of Breath Frequency of \> 2 episodes per week
* Willing to provide informed consent

Exclusion Criteria:

* Severe stenotic valvular disease
* Severe valvular regurgitation except mitral regurgitation due to systolic anterior motion
* Significant (\>60% stenosis) coronary artery disease
* Acute coronary syndrome within 30 days
* Severe heart failure defined as LV systolic dysfunction with Ejection Fraction \<40% or NYHA class 4 symptoms
* Severe renal impairment (glomerular filtration rate, \<30 mL/min/1.73 m2)
* Moderate-severe hepatic impairment (Child-Pugh classes B and C)
* Hospitalization for cardiac reason within 3 months of enrollment
* Anticipated changes to treatment of HCM within study period, including medications, device implantation, or septal reduction therapies
* Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors
* Active myocarditis, pericarditis, or restrictive cardiomyopathy
* Non-cardiac terminal illness with expected survival less than 6 months
* Women who are of childbearing potential
* Inability to perform or adhere to study protocol

Primary outcomes:
measure: QT Interval
timeFrame: 60 Days
measure: Number of Adverse Events Considered Probably or Possibly Related to Study Drug
timeFrame: 60 Days
measure: Drug Tolerability
timeFrame: 60 days
Secondary outcomes:
measure: Improvement in Number of Episodes of Angina Per Week
timeFrame: Baseline and 60 Days post treatment
measure: Seattle Angina Questionnaire (SAQ)
timeFrame: 60 Days post treatment
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 60 days post treatement
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT00928967: Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients
Official title: Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Quality of life
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 67
Sex: ALL
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: Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria.The choice of treatment must be clearly dissociated from the decision to include the patient in the study.

Brief summary: To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria
* The choice of treatment must be clearly dissociated from the decision to include the patient in the study.

Primary outcomes:
measure: Evolution of the Daily Life score: Analysis of variance for repeated measurements.
timeFrame: After 1, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements
timeFrame: Over 12 months
measure: Correlation coefficient with quality of life scales
timeFrame: Over 12 months
measure: Kinetics of treatment discontinuation: Kaplan Meier
timeFrame: Over 12 months
measure: Rate of treatment continuation
timeFrame: After 12 months
Other outcomes:
Locations:
city: Many Locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01989767: Application of Psychiatric Knowledge in the Rehabilitation Process in Return to Work.
Official title: Application of Psychiatric Knowledge in the Rehabilitation Process in Return to Work.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: sickness absence
rehabilitation
mental disorders
screening
Lead sponsor: Region MidtJylland Denmark
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 317
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis was that education of rehabilitation officers who were responsible for rehabilitation back to work for sick-listed individuals in screening for mental disorders and psychiatric topics would increase the rate of return to work and reduce the number of sicklisted days


Eligibility criteria: Inclusion Criteria:

* sick-listed and belonging to the case-load of rehabilitation officers who participated in the intervention

Exclusion Criteria:

* no

Primary outcomes:
measure: rate of return to work
timeFrame: 1 year
Secondary outcomes:
measure: number of sickness absence days
timeFrame: ½ year
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Psychiatric Research Unit West, Regional Psychiatric Services West
Study officials:
References:
Clinical trial NCT01785667: Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark
Official title: Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Diabetic Retinopathy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Center for Eye Research Australia
name: Moorfields Eye Hospital NHS Foundation Trust
First posted: 2013-02-07
Enrollment: 132
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study includes a cohort of type 1 diabetic patients, who originally were identified in 21 paediatric departments and studied in 1986. This group initially consisted of 1033 children and was estimated to involve around 80 percent of all Danish type 1 diabetic patients below the age of 18. In 1995 further examinations were performed on the cohort; this time 339 chose to participate.

In this study we will invite the participants from 1995 who also participated in the eye examinations, n=324, to participate in yet another follow-up examination.

Brief summary: The objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. These youngsters were originally participating in a nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to establish risk factors for developing diabetic retinopathy. The investigators will have emphasis on retinal vessel geometry and the possibilities for early detection of reversible retinal changes, and prediction of other vascular complications.


Eligibility criteria: Inclusion Criteria:

* Participation in the follow-up study in 1995

Exclusion Criteria:

* No retinal photographs from 1995

Primary outcomes:
measure: Incidence of diabetic retinopathy and proliferative diabetic retinopathy
timeFrame: 16 years
Secondary outcomes:
measure: Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
timeFrame: 16 years
Other outcomes:
measure: Fractal dimensions as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
timeFrame: 16 years
Locations:
city: Odense
country: Denmark
facility: Department of Ophthalmology, Odense University Hospital
state: Fyn
Study officials:
References:
Clinical trial NCT00871767: AZD5672 Bioavailability Study in Healthy Male and Female Subjects
Official title: An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: AZD5672
relative bioavailability
rheumatoid arthritis (RA)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Primary outcomes:
measure: Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
timeFrame: Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Alderley Park, UK
name: Mark Layton
role: STUDY_CHAIR
affiliation: ICON Development Solutions, Manchester, UK
name: Simon Constable
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02356367: French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)
Official title: French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10 CS): Predictive Factors of Poor Compliance
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Central Sleep Apnea
Heart Failure
Keywords: telemonitoring
Adaptive servo-ventilation
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 0
Sex: ALL
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: Heart Failure patient eligible for adaptative servo-ventilation

Brief summary: The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.


Eligibility criteria: Inclusion Criteria:

* Adult Patient with Chronic Heart Failure
* Central Sleep Apnea requiring Adaptative Servo-Ventilation therapy
* Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

* Contra-indications to Adaptative Servo-Ventilation therapy
* Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy

Primary outcomes:
measure: to define the phenotype of compliant or not compliant patients to sleep disordered breathing therapy using microneurography
timeFrame: 12 months
Secondary outcomes:
measure: anxiety and nervous depression
timeFrame: 12 months
measure: sleep disordered breathing symptomatology
timeFrame: 12 months
measure: Nocturia
timeFrame: 24 months
measure: sleep quality
timeFrame: 24 months
measure: Heart Failure status
timeFrame: 24 months
measure: therapy compliance
timeFrame: 24 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Paris
country: France
facility: CHU Bichat
Study officials:
References:
Clinical trial NCT02483767: Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Official title: Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Premenopausal Breast Cancer
Preservation of Ovarian Function
Gonadotropin-Releasing Hormone Agonist
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a prospective randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). All patients are stratified according to age (\<35years vs.36-44years), hormone receptor status (HR+ or ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure, follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure.


Eligibility criteria: Inclusion Criteria:

* The patients signed the written informed consent.
* Histologically proven stage I, II, or III breast cancer
* Must be candidates for adjuvant or neoadjuvant chemotherapy,
* Must be premenopausal.
* Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors.

Exclusion Criteria:

* The patients were previous chemotherapy;
* Evidence of distant metastases;
* Other malignancies in the previous 5 years.
* The patients were using GnRHa, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy.
* Pregnancy or lactation.

Primary outcomes:
measure: ovarian failure
timeFrame: 2 years
Secondary outcomes:
measure: Ovarian dysfunction
timeFrame: 1 year
measure: Time to the resumption of menstrual activity
timeFrame: 2 year
measure: pregnancy
timeFrame: 5 year
measure: DFS OS
timeFrame: 5 year
measure: FSH,E2,AMH
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06785467: eDoula Feasibility and Acceptability
Official title: eDoula: The Feasibility and Acceptability of Mobile Application in Pregnancy, Labor, and Birth Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: Labor
Birth
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Control group will receive routine care and will be recruited postpartum to respond to a survey on their labor and satisfaction outcomes. Once control group recruitment is complete, intervention recruitment will begin. Intervention arm participants will gain access to the eDoula app during pregnancy.
Primary purpose: OTHER

Brief summary: eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum guidance. First, patients without access to the app will be recruited and surveyed on their labor and satisfaction outcomes. Then, recruitment will begin for the intervention arm of the study. Participants will be recruited to use the app and complete a survey during the postpartum period.


Eligibility criteria: Inclusion Criteria:

* Nulliparous
* Singleton pregnancy
* English speaking
* Own a smart phone or other device capable of downloading and running the eDoula app
* Delivered at 36 weeks 0 days gestation or later
* Able to labor

Exclusion Criteria:

* Planned cesarean delivery
* Pregnancy complications including placenta accreta spectrum, vasa previa, intrauterine fetal demise, or known major fetal anomaly
* Delivery planned at a location other than Oregon Health and Science University

Primary outcomes:
measure: Satisfaction with eDoula app
timeFrame: Measured in the 7 days following delivery
measure: eDoula App Use
timeFrame: Recruitment (19-28 weeks gestation) to delivery
Secondary outcomes:
measure: Labor Agentry Scale-10 (LAS-10)
timeFrame: Measured in the 7 days following delivery
measure: Birth Satisfaction Scale-Revised (BSS-R)
timeFrame: Measured in the 7 days following delivery
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Measured in the 7 days following delivery
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Fei Cai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06726967: Vitamin D, Hashimato's Thyroiditis and Thyroid Functions
Official title: The Relationship Between Vitamin D Levels, Thyroid Functions, and Thyroid Autoimmunity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D
Thyroid Autoimmune Disease
Keywords: vitamin D
Thyroid autoimmunity
hashimato's thyroiditis
thyroid functions
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2024-12-10
Enrollment: 81180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital

Brief summary: The goal of this retrospective observational study is to determine whether vitamin D levels differ in patients with Hashimoto's thyroiditis (HT) compared to those without Hashimoto's thyroiditis. The main research questions are:

Are vitamin D levels lower in HT patients compared to non-HT patients? Do vitamin D levels vary between HT and non-HT patients based on thyroid function status?

The study was conducted by retrospectively reviewing the medical records of patients who visited the hospital outpatient clinic.


Eligibility criteria: Inclusion Criteria:

Patients with the following biochemical parameters:

* Vitamin D (25(OH)D) levels
* Thyroid-stimulating hormone (TSH) levels
* Free triiodothyronine (fT3) levels
* Free thyroxine (fT4) levels
* Anti-thyroid peroxidase (anti-TPO) levels
* Anti-thyroglobulin (anti-Tg) levels

Exclusion Criteria:

-

Primary outcomes:
measure: Vitamin D 25 OH D
timeFrame: Baseline
measure: thyroid-stimulating hormone (TSH)
timeFrame: Baseline
measure: free thyroxine (fT4)
timeFrame: Baseline
measure: Anti-thyroid peroxidase (anti-TPO)
timeFrame: Baseline
measure: anti-thyroglobulin (anti-TG)
timeFrame: Baseline
Secondary outcomes:
measure: free triiodothyronine (fT3)
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Rahime E Karakaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: