louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01673139: Effect of 3 Years of Exercise in Patients With Atrial Fibrillation
Official title: Effect of 3 Years of Exercise in Patients With Atrial Fibrillation - A Generation 100 Substudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: SINTEF Health Research
First posted: 2012-08-27
Enrollment: 51
Sex: ALL
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a substudy of "Generation 100". The investigators will follow the persons with atrial fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial fibrillation, symptoms, use of health services or echocardiographic findings.


Eligibility criteria: Inclusion Criteria:

* Included in the "Generation 100 study"
* Atrial fibrillation diagnosis verified by ECG

Exclusion Criteria:

-

Primary outcomes:
measure: Change in burden of atrial fibrillation
timeFrame: At baseline and 3 years
Secondary outcomes:
measure: Size of left ventricle
timeFrame: At baseline and 3 years
measure: Quality of life
timeFrame: At baseline and 3 years
measure: Endothelial function
timeFrame: At baseline and 3 years
measure: Maximal oxygen uptake
timeFrame: At baseline and 3 years
measure: Atrial extrasystoles
timeFrame: At baseline and 3 years
measure: Number of hospitalisations with atrial fibrillation as main diagnosis
timeFrame: Total number during the 3 year intervention period
measure: Total number of electrical cardioversions
timeFrame: During the 3 years of intervention
measure: Change in burden of atrial fibrillation
timeFrame: Baseline and 1 year
measure: Size of left atrium
timeFrame: Baseline and 1 year
measure: Function of left atrium
timeFrame: At baseline and 3 years
measure: Function of left ventricle
timeFrame: At baseline and 3 years
measure: Size of left atrium
timeFrame: At baseline and 3 years
measure: Symptom burden
timeFrame: At baseline and 3 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: St. Olavs Hospital
name: Jan Paal Loennechen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01103739: To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications
Official title: A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Keywords: pharmacokinetics
drug-drug interaction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.

Detailed description: observational- quantify any effects of PF_04531083 on the PK of Simvastatin

Eligibility criteria: Inclusion Criteria:

* young
* healthy
* male and female volunteers

Exclusion Criteria:

* Elderly
* Patients

Primary outcomes:
measure: Pharmacokinetics of simvastatin. AUC, Cmax and half life.
timeFrame: days 1 and 14 of study
measure: Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.
timeFrame: days 1 and 14 of study
measure: Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing
timeFrame: days 2, 4, 7, 11 and 14 of the study
Secondary outcomes:
measure: safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events
timeFrame: days 1 and 15 of the study
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06106139: Ketogenic Diet Improves Thrombocytopenia in Cancer Patients
Official title: The Effectiveness of Ketogenic Diet in Preventing or Improving Thrombocytopenia in Cancer Patients Undergoing Chemotherapy: a Randomized Controlled Single Blind Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ketogenic Diet
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate whether dietary intervention through ketogenic diet can prevent or improve chemotherapy related thrombocytopenia in cancer patients.

Detailed description: In the study, 80 patients with malignant solid tumors undergoing chemotherapy were randomly assigned to the normal diet group, the strict ketogenic diet group, the circulating ketogenic diet group, and the autonomous ketogenic group. During the chemotherapy period, the corresponding dietary intervention was carried out, and the clinical data of patients before and after treatment were collected, including blood routine, blood ketone concentration, weight, blood sugar, blood lipids, adverse events, and changes in platelets before and after chemotherapy, Statistical analysis of data such as the change degree of platelets and the incidence of adverse events in each diet group before and after treatment was carried out to evaluate the impact of ketogenic diet on clinical indicators and adverse reactions of chemotherapy in cancer patients.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 90, regardless of gender
* ECOG score ≤ 2 points
* Received or expected to receive radiotherapy and chemotherapy during tumor activity
* Body mass index 19-29
* Conscious and autonomous eaters

Exclusion Criteria:

* Patients with basic diseases of diabetes
* Complications such as severe liver and kidney dysfunction or digestive tract obstruction, inability to eat
* Those who have a preference for food and have strict requirements for dietary taste
* Disagree to sign informed consent
* Those whose physical conditions are determined by the doctor to be impermissible

Primary outcomes:
measure: thrombocytopenia
timeFrame: During radiotherapy and chemotherapy, approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06459739: Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery
Official title: Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute Post-Operative
Pilonidal Sinus
Hemorrhoids
Anesthesia
Keywords: Sacral ESPB
Postoperative pain
Hemorrhoidectomy
Pilonidal sinus surgery
Analgesia
Lead sponsor: Erzincan Binali Yildirim Universitesi
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 70
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: SUPPORTIVE_CARE

Brief summary: Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Detailed description: Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II patients undergoing hemorrhoid and pilonidal sinus surgery

Exclusion Criteria:

* patients with coagulopathies, pregnant women, patients with significant cardiovascular, hepatic, or renal disease, patients who declined spinal anesthesia or were contraindicated for it, and patients who had previously undergone the same surgery

Primary outcomes:
measure: Postoperative pain
timeFrame: 0.5,2,8,24 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: 0.5,2,8,24 hours
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Binali Yildirim university
Study officials:
References:
Clinical trial NCT03157739: MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
Official title: MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Keywords: Migraine
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to develop, evaluate, and optimize "MigraineManager", the first web-based comprehensive self-management tool for adolescents with migraine, their parents, and clinicians.


Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with migraines using current International Classification of Headache Disorders criteria (ICHD-3 beta) for migraine with or without aura
* Patient has headache frequency of 8+ per month
* Access to the internet whether public (e.g., library) or private (e.g., home, personal)
* English fluency for patient, caregiver, and clinician

Exclusion Criteria:

* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Primary outcomes:
measure: Headache frequency
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Kevin Hommel
state: Ohio
Study officials:
References:
Clinical trial NCT04173039: Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis
Official title: Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Arthritis, Psoriatic
Lead sponsor: Association pour la Recherche Clinique et Immunologique
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.


Eligibility criteria: Inclusion Criteria:

* "Controls" : Patients with a psoriasis confirmed by a dermatologist and with absence of psoriatic arthritis confirmed by a rheumatologist.
* "Cases" : Patients with psoriatic arthritis fulfilling the classification criteria for psoriatic arthritis (CASPAR), with a diagnosis confirmed by a rheumatologist and associated with personal or familial psoriasis.

Exclusion Criteria:

* "Controls": Presence of any chronic rheumatic inflammatory disease such as psoriatic arthritis.

Primary outcomes:
measure: Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population
timeFrame: Anti-CarP antibodies will be assessed in the sera collected at the recruitment visit
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT06017739: Expiratory Flow Accelerator (Efa) vs Efa + High Flow in Chronic COPD and Bronchiectasis
Official title: Hypersecreting Patients (COPD And/or Bronchiectasic) Comparing 2 Technologies: Efa vs Efa + High Flow
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Copd
Bronchiectasis Adult
Keywords: EFA
HIGH FLOW
BRONCHIECTASIS
COPD
HYPERSECRETION
Lead sponsor: Azienda Socio Sanitaria Territoriale della Valle Olona
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: the two arms of the study are:

1. EFA / EFA + High Flow
2. EFA + High Flow / EFA patients are randomly assigned to one of two groups
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the efficacy of using EFA technology versus the combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+ HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized trial.

Eligibility criteria: Inclusion Criteria:

* COPD diagnosed by spirometry
* Bronchiectasis diagnosed by CT
* 2 Exacerbation/year

Exclusion Criteria:

* Cystic Fibrosis
* OSAS
* Non Invasive Ventilation
* Ineffective Cough
* Exacerbation in progress
* Hemodynamic Instability
* severe heart failure

Primary outcomes:
measure: Cough Severity
timeFrame: "Day0", "Week6", Week13"
measure: Expectoration Difficulty
timeFrame: "Day0", "Week6", Week13"
Secondary outcomes:
measure: FEV 1 (Forced Expiratory Volume)
timeFrame: "Day0", "Week6", Week13"
measure: Exacerbations
timeFrame: "Day0", "Week6", Week13"
measure: Inspiratory Capacity
timeFrame: "Day0", "Week6", Week13"
measure: 6 minutes walking test
timeFrame: "Day0", "Week6", Week13"
measure: Saint George Respiratory Questionnaire
timeFrame: "Day0", "Week6", Week13"
measure: Medical Research Council mMRC
timeFrame: "Day0", "Week6", Week13"
measure: SpO2 (Oxygen Saturation by Pulse Oximetry)
timeFrame: "Day0", "Week6", Week13"
Other outcomes:
Locations:
city: Somma Lombardo
country: Italy
facility: Marianna Messina
state: Varese
Study officials:
affiliation: ASST Valle Olona
name: Marianna Messina
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01266239: Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion
Official title: Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Bifurcation lesion, drug-eluting stent, symmetric expansion
Lead sponsor: Shin Yukuhashi Hospital
Sponsor class: NETWORK
Collaborators: name: Abbott Medical Devices
name: Cordis Corporation
First posted: 2010-12-24
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment."

Detailed description: Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues.

1. Impact of asymmetric expansion induced by kissing balloon technique on mid and long term results
2. Difference between SES and EES
3. Impact of abnormal OCT findings on long-term clinical outcome (3yr)

Eligibility criteria: Inclusion Criteria:

1. Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB).
2. The lesion is appropriate for the provisional MV stenting.
3. The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB.

Exclusion Criteria:

1. Left main coronary bifurcation
2. Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus
3. Left ventricular ejection fraction \< 30%
4. Shock state
5. Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 3 years
Secondary outcomes:
measure: abnormal intimal coverage
timeFrame: 9 months
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University
city: Nishinomiya
country: Japan
facility: Hyogo Medical University
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
city: Yokohama
country: Japan
facility: Saiseikai Yokohama Eastern Hospital
city: Yukuhashi
country: Japan
facility: New Yukuhashi hospital
Study officials:
affiliation: New Yukuhashi Hospital
name: Yoshinobu Murasato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toyohashi Heart Center
name: Yoshihisa Kinoshita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00720525: Pulsatile and Steady State Hemodynamics in Diastolic Heart Failure
Official title: Diagnostic Value of Measures of Pulsatile Versus Steady State Hemodynamics in Diastolic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastolic Heart Failure
Keywords: arterial stiffness
arterial wave reflections
diastolic heart failure
Lead sponsor: Klinikum Wels-Grieskirchen
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing invasive assessment for exertional dyspnea

Brief summary: Over the past few years, there has been a growing appreciation that a large number of patients with heart failure have a relatively normal (or preserved) ejection fraction (NFNEF). Epidemiologically, HFNEF is most prevalent among elderly women, most of whom have hypertension, diabetes, or both and often coronary artery disease (CAD). Increased arterial stiffness and/or wave reflections have been described in the same patient groups. Therefore, the investigators speculate that pulsatile hemodynamics, representing arterial stiffness and/or arterial wave reflections, 1) may be altered in HFNEF patients, 2) this may contribute to pathophysiology of HFNEF, and 3) this may be used for the diagnosis of the syndrome.


Eligibility criteria: Inclusion Criteria:

* exertional dyspnea
* undergoing heart catheterization for diagnosis or exclusion of coronary artery disease
* normal EF (\> 50%)

Exclusion Criteria:

* atrial fibrillation
* more than mild valvular heart disease
* pericardial disease
* no informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Cardiology Department, Klinikum Wels-Grieskirchen
Study officials:
affiliation: Cardiology Department, Klinikum Wels-Grieskirchen, Austria
name: Thomas Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber T, Wassertheurer S, O'Rourke MF, Haiden A, Zweiker R, Rammer M, Hametner B, Eber B. Pulsatile hemodynamics in patients with exertional dyspnea: potentially of value in the diagnostic evaluation of suspected heart failure with preserved ejection fraction. J Am Coll Cardiol. 2013 May 7;61(18):1874-83. doi: 10.1016/j.jacc.2013.02.013. Epub 2013 Mar 6.
Clinical trial NCT06773325: Buzzy Application During Heel Blood Collection in the Newborn
Official title: The Effect of Buzzy Application on Pain and Comfort Level During Heel Blood Collection in Newborns: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Buzzy
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 80
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective The aim of this study was to evaluate the effects of Buzzy device application during heel prick blood collection on pain level and comfort in newborns.

Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between September and November 2024 using a randomized controlled experimental design. The study sample consisted of 80 newborn infants born at 37-42 weeks gestational age and within the first 28 days of birth (Buzzy group: n = 40, control group: n = 40). The Buzzy group was treated by placing the Buzzy device approximately 30 seconds before heel prick blood collection. In the control group, routine heel prick was performed without any application. Neonatal introduction form, Neonatal Infant Pain Scale and Neonatal Comfort Behavior Scale were used for data collection.


Eligibility criteria: Inclusion Criteria:

* Those in the neonatal period between 0-28 days,
* voluntary participation of the parent,
* between 37-42 weeks of gestational age
* babies with vital signs within normal limits

Exclusion Criteria:

* The integrity of the skin in the area where the device was to be implanted was compromised,
* Nerve damage or deformity in the extremity to be heel bled,
* Genetic - with a congenital anomaly or congenital metabolic disorder,
* undergoing cardiopulmonary resuscitation,
* No heel prick on the first attempt,
* with osteogenesis imperfecta and infants given analgesics in the last 6 hours

Primary outcomes:
measure: The Neonatal Infant Pain Scale
timeFrame: pre-test post-test (approximately three months)
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yüzüncü Yıl University
state: Tuşba
Study officials:
References: