louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02449460: Cardiovascular Epidemiology in Russian Federation
Official title: Multicenter Observational Study of Epidemiology of Cardiovascular Diseases and Risk Factors in Different Regions of Russian Federation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Coronary Artery Disease
Diabetes
Heart Failure
Smoking
Lifestyle
Keywords: hypertension
epidemiology
glucose
body mass index
lipids
smoking
coronary artery disease
arterial stiffness
carotid ultrasound
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
Collaborators: name: National Research Center for Preventive Medicine
name: Russian Cardiology Research and Production Center
First posted: 2015-05-20
Enrollment: 18000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Random sample population

Brief summary: The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included.

Detailed description: Plasma lipids and fasting glucose, heart rate and blood pressure, anthropometry, smoking and alcohol questionaries, nutrition, sleep quality, stress will be assessed. ECG records are obtained form all participants. Subclinical target organ damage (carotid and periferal atherosclerosis, pulse wave velocity) will be measured in selected sites. Brain natriuretic peptide, adipose tissue cytokines, hsCRP and genetic markers are also under evaluation

Eligibility criteria: Inclusion Criteria:

- informed consent

Exclusion Criteria:

No

Primary outcomes:
measure: all cause mortality
timeFrame: 10 years
Secondary outcomes:
measure: Stroke
timeFrame: 10 years
measure: Miocardial infarction
timeFrame: 10 years
measure: Cardiovascular mortality
timeFrame: 10 years
Other outcomes:
Locations:
city: Orenburg
country: Russian Federation
facility: Orenburg Medical Academi
city: Samara
country: Russian Federation
facility: Samara Medical University
Study officials:
affiliation: State Sientific Center of Preventive Medicine
name: Svetlana A Shalnova, Prof
role: STUDY_CHAIR
affiliation: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
name: Alexandra O Konradi, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Research and Production Complex
name: Eugene I Chazov, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06324760: Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome
Official title: Usefulness of Alpha-lipoic Acid Combined With B Vitamins for the Treatment of Restless Legs Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Keywords: RLS
Lead sponsor: Uriach Consumer Healthcare
Sponsor class: INDUSTRY
First posted: 2024-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The data will be collected from patients who meet the selection criteria.

Brief summary: Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.

Detailed description: Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.

Eligibility criteria: Inclusion Criteria:

* Participants must be a minimum of 18 years of age.
* They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment.
* They need to provide explicit consent via an informed consent document.

Exclusion Criteria:

* Patients diagnosed with pathologies other than RLS that affect sleep quality.
* Those with persistent renal diseases or any other chronic, severe medical condition.

Primary outcomes:
measure: Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)
timeFrame: 6 months
Secondary outcomes:
measure: Anthropometric parameters of the patients.
timeFrame: 6 Months
measure: Patients' body measurements
timeFrame: 6 Months
measure: Measurements of patient anatomy
timeFrame: 6 Months
measure: Patients' body characteristics.
timeFrame: 6 Months
measure: Measurements of patient anatomy.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Medical Center Teknon
Study officials:
affiliation: Centro Medico Teknon
name: Javier Albares, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06188260: Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease
Official title: Efficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-01-03
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.

Detailed description: This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.

Eligibility criteria: Inclusion Criteria:

1. Age 20-50 years old
2. Best corrected distance visual acuity ≥ 6/9
3. Mild to moderate OSDI score 13-32
4. Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)

Exclusion Criteria:

1. Any active ocular infections
2. Inflammations or anomalies in the eyelid
3. Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.
4. Pregnancy and breastfeeding
5. Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
6. Subjects who are using artificial tears or other eyedrops will be excluded.
7. Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Change in OSDI score at 2-week visit
Secondary outcomes:
measure: Non invasive tear break-up time (NITBUT)
timeFrame: NITBUT at 2-week and 3-month visits
measure: Meibography
timeFrame: Meibography at 2-week and 3-month visits
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Thomas LAM
Study officials:
affiliation: The Hong Kong Polytechnique University
name: Thomas LAM, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04824560: Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension
Official title: Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
First posted: 2021-04-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate changes in patient knowledge of blood pressure management and perceptions of making lifestyle changes to manage their blood pressure after implementation of an evidence-based one-page teaching protocol with supplemental handouts and optional use of suggested apps and web sites.


Eligibility criteria: Inclusion Criteria:

* Adults from 18 to 75 years old
* Ability to self-consent
* English-speaking
* Able to read/write English
* Currently prescribed at least one medication for treatment of essential primary hypertension

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Pre & Post Survey & Knowledge Test
timeFrame: 8 weeks
Secondary outcomes:
measure: BP Education Helpfulness
timeFrame: 8 weeks
measure: BP Education - Change in Confidence in Managing Disease State (Pre & Post Survey)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Walgreens Store #6587
state: New Mexico
Study officials:
References:
Clinical trial NCT00859560: Retrospective Survey of Bone Fracture in Patients With Arimidex 1mg
Official title: Retrospective Survey of Bone Fracture in Post-Menopausal Breast Cancer Patients With Arimidex 1 mg as Adjuvant Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
post-menopausal women
Arimidex
bone fracture
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 2205
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menoposal breast cancer patients who were previousely registered in clinical experience investigation with Arimidex 1mg as adjuvant therapy.

Brief summary: The retrospective survey is to investigate the incidence of bone fracture in post-menopausal breast cancer patients with Arimidex 1mg, who were previously registered for the clinical experience investigation.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal breast cancer patients treated with Arimidex 1mg at the time of previously conducted clinical experience investigation.

Exclusion Criteria:

-

Primary outcomes:
measure: Bone fracture incidence
timeFrame: Time since starting Arimidex
Secondary outcomes:
measure: Survival
timeFrame: Time since starting Arimidex
measure: Bone density measurement
timeFrame: Time since starting Arimidex
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03499860: Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index
Official title: Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Responsiveness
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
Collaborators: name: Department of Anaesthesiology, Merano Hospital, Italy
First posted: 2018-04-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate whether changes in Perfusion Index (PI) and Pleth Variability Index (PVI) during passive leg raising test can predict fluid responsiveness in spontaneously breathing patients.

Fluid responsive patients are defined as showing an increase in cardiac output \>10% during a passive leg raising test, measured semi-invaseively with FloTrac® (Edwards LifeSciences. Irvine, United States).


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the intensive or intermediate care unit after abdominal surgery (including urological and gynecological surgery performed in laparotomy)
* Spontaneous breathing
* Arterial line already in place
* Oral and written informed consent obtained

Exclusion Criteria:

* Age \<18 years
* Abdominal trauma as the reason for surgery
* Missing informed consent

Primary outcomes:
measure: PI difference
timeFrame: 90 seconds
measure: PVI difference
timeFrame: 90 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Merano
country: Italy
facility: "F. Tappeiner" Hospital Merano
state: Bolzano
Study officials:
References:
Clinical trial NCT06033560: The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
Official title: The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Hypoxemic Respiratory Failure
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 hospital sites across the United States

Brief summary: Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU). Although lifesaving, invasive mechanical ventilation is associated with high mortality, severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients overwhelmed ICU capacity.

Non-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation and in selected cases ICU admission. However, data from different studies are conflicting and studies performed in COVID-19 patients are of limited quality. Furthermore, identification of early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of invasive ventilation, which may be associated with adverse clinical outcome. The development and validation of a prediction model, that incorporates readily available clinically data may prove pivotal to fine-tune non-invasive respiratory support.

The overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to improve outcome in hospitalized hypoxemic COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

* Sars-Cov-2 infection
* hospital admission (emergency department, inpatient or ICU)
* hypoxemic respiratory failure, defined as P/F ratio below or including 200

Exclusion Criteria:

* hypercapnia (PCO2 \> 45 mmHG in combination with acidemia (pH \< 7.35))
* pregnancy
* do not resuscitate order

Primary outcomes:
measure: Proportion of patients requiring invasive mechanical ventilation
timeFrame: 30 days
Secondary outcomes:
measure: Mortality at day 30
timeFrame: 30 days
measure: ICU-free days
timeFrame: 30 days
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References:
Clinical trial NCT00585260: Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN
Official title: Mannitol Bronchoprovocation Challenge Ancillary Study Protocol to Best Adjustment Strategy for Asthma Over Long Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Asthma
Keywords: asthma
bronchoprovocation challenge test
mannitol
methacholine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Syntara
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-01-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an ancillary study conducted as part of the BASALT trial \[NCT00495157\].

The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can safely characterize asthma phenotypes, predict asthma control and exacerbations, predict responses to interventions, and perform more specifically than a direct methacholine challenge and; 2) PX27 pore function in whole blood correlates with measures of airway hyperresponsiveness induced by methacholine and/or mannitol challenges


Eligibility criteria: Inclusion Criteria:

* all subjects randomized to the BASALT protocol

Exclusion Criteria:

* positive urine pregnancy test
* requirement for more than two albuterol treatments for reversal of the methacholine bronchoprovocation challenge procedure at visit 4 in the BASALT parent trial

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: At 6 weeks, 20 weeks, and 32 weeks
Secondary outcomes:
Other outcomes:
measure: Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial
timeFrame: Baseline
Locations:
city: Madison
country: United States
facility: University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Christine A Sorkness, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calhoun WJ, Ameredes BT, King TS, Icitovic N, Bleecker ER, Castro M, Cherniack RM, Chinchilli VM, Craig T, Denlinger L, DiMango EA, Engle LL, Fahy JV, Grant JA, Israel E, Jarjour N, Kazani SD, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF, Lugogo N, Martin RJ, Meyers DA, Moore WC, Pascual R, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Boushey HA; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial. JAMA. 2012 Sep 12;308(10):987-97. doi: 10.1001/2012.jama.10893.
Clinical trial NCT04682860: Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide
Official title: Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gastroenteritis
Abdominal Pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.


Eligibility criteria: Inclusion Criteria:

* Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain

Exclusion Criteria:

* Peritonitis
* Hemodynamic instability
* Pregnancy
* Inability to give consent
* Medication given in the emergency room before being included in the study
* Taking pain medication within 4 hours
* Diabetes Mellitus and other neuropathic diseases

Primary outcomes:
measure: Pain Change
timeFrame: 30 minute and1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Çağdaş Yıldırım, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Remington-Hobbs J, Petts G, Harris T. Emergency department management of undifferentiated abdominal pain with hyoscine butylbromide and paracetamol: a randomised control trial. Emerg Med J. 2012 Dec;29(12):989-94. doi: 10.1136/emermed-2011-200474. Epub 2012 Feb 3.
citation: Arena C, Amoros JP, Vaillant V, Ambert-Balay K, Chikhi-Brachet R, Jourdan-Da Silva N, Varesi L, Arrighi J, Souty C, Blanchon T, Falchi A, Hanslik T. Acute diarrhea in adults consulting a general practitioner in France during winter: incidence, clinical characteristics, management and risk factors. BMC Infect Dis. 2014 Oct 30;14:574. doi: 10.1186/s12879-014-0574-4.
citation: Shane AL, Mody RK, Crump JA, Tarr PI, Steiner TS, Kotloff K, Langley JM, Wanke C, Warren CA, Cheng AC, Cantey J, Pickering LK. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clin Infect Dis. 2017 Nov 29;65(12):1963-1973. doi: 10.1093/cid/cix959.