louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03662646: Circadian Rhythms in Patients With IBD or Celiac Disease Upon Diagnosis and Medical Follow-up
Official title: Clock Gene Disruption May be an Initial Manifestation of IBD and Celiac .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Circadian Dysregulation
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients medically treated in our institute.

Brief summary: patients 6-25 years old upon diagnostic evaluation will be recruited . study population will comprise of two groups: newly diagnosed IBD patients/ Celiac disease and healthy controls.

upon enrollment, subjects will fill out sleeping habits questioners, demographic data, medical history.

blood samples will be drawn for CRP and clock gene expression in systemic WBC. intestinal biopsies will be snap frozen for clock gene extraction and amplification only for patients with IBD.


Eligibility criteria: Inclusion Criteria:

* IBD or celiac patients with a confirmed diagnosis, recruited upon diagnosis.
* Both male and female
* Age 6-25 years
* Medically treated for IBD in our institute.

Exclusion Criteria:

* Genetic disorder.
* Known primary or secondary immunodeficiency .
* Pregnancy or lactating

Primary outcomes:
measure: clock gene expression levels in intestinal mucosal samples and WBC peripheral blood.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
citation: Weintraub Y, Cohen S, Chapnik N, Ben-Tov A, Yerushalmy-Feler A, Dotan I, Tauman R, Froy O. Clock Gene Disruption Is an Initial Manifestation of Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2020 Jan;18(1):115-122.e1. doi: 10.1016/j.cgh.2019.04.013. Epub 2019 Apr 10.
Clinical trial NCT01304446: Enteral Nutrition in Cancer Patients
Official title: Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Cancer
Keywords: Nutritional support
Cancer
Malnutrition
Child
Adolescent
pediatric
Lead sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sponsor class: OTHER
First posted: 2011-02-25
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.

DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM.

METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.


Eligibility criteria: Inclusion Criteria:

* Were on chemotherapy;
* Age above one year;
* Malnutrition;
* A z-score of weight for height (zW/H) \< -1.0 to -2.0 in children and ≥ 5th to \< 15th of body mass index (BMI) in adolescents were considered as mild malnutrition;
* A zW/H \< -2.0 in children and \< 5th of BMI in adolescents as severe, respectively;
* In adults, the World Health Organization (WHO) cut-off values were applied: \< 18.5 mild and \< 17 severe malnutrition.

Exclusion Criteria:

* Were on corticosteroid or hormonal therapy;
* Had swallowing abnormalities;
* Had parenteral or tube feeding therapy;
* Had palliative care;
* Presence of non cancer-related diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05914246: VIOLA Post Market Surveillance Clinical Protocol
Official title: VIOLA PMS Clinical Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CABG
Coronary artery bypass grafting
Lead sponsor: Vascular Graft Solutions Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

Detailed description: The goal of this post marketing surveillance clinical trial is to collect post market data on the safety and performance of VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Data will be collected intraoperatively, at discharge, at 6 weeks, and at 9 months post CABG.

Eligibility criteria: Inclusion Criteria:

1. Patient scheduled for isolated CABG on clinical grounds
2. One or more bypass grafts originating from the aorta
3. Ability to give their informed written consent
4. Ability and willingness to comply with study follow up requirements
5. Patient is ≥ 18 years of age

Exclusion Criteria:

1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
2. Prior clinical stroke less than one year before surgery
3. Pre-operative neurological deficits
4. Chronic atrial fibrillation
5. Aortic external diameter less than 25 mm measured intraoperatively
6. No proximal aortic anastomosis eligible for VIOLA use, assessed intraoperatively according to surgeon's discretion (E.G inadequate punch size, thin-walled aorta).
7. Symptomatic carotid disease
8. Acute MI within 24 hours of planned surgery
9. EuroScore II ≥ 4
10. Known allergy to nickel
11. Women of child bearing age
12. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Primary outcomes:
measure: Technical success of the VIOLA device
timeFrame: Acute, intraoperative
Secondary outcomes:
measure: Sealing quality
timeFrame: Acute, intraoperative
measure: Ease of proximal anastomosis suturing
timeFrame: Acute, intraoperative
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Gil Bolotin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00159146: Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
Official title: A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depression
Keywords: Major Depression
Pindolol
Venlafaxine
Augmentation
Major depression (DSM-IVR)
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
name: Tvergaards Foundation
First posted: 2005-09-12
Enrollment: 31
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: This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.

Detailed description: Antidepressant therapy has a delayed onset of action of 4-6 weeks. Pindolol has in some studies shown an accelerating effect. In this study we investigate the effect of 20 mg of pindolol retarded formulation in combination with Venlafaxine compared to placebo Pindolol and Venlafaxine for a duration of 19 days.

Effect is measured by the Hamilton Depression rating Scale and the Preskorn Scale (self-rating).

Eligibility criteria: Inclusion Criteria:

* Major depression

Exclusion Criteria:

* Allergy towards pindolol, venlafaxine or other tablet constituents
* Liver or kidney impairment
* Diabetics
* Age below 18 years
* Severe cardiac disease
* Asthma.

Primary outcomes:
measure: Hamilton Depression Rating Scale scores
timeFrame: 1 week
Secondary outcomes:
measure: Preskorn scores
timeFrame: one day
Other outcomes:
Locations:
city: Hillerod
country: Denmark
facility: Psychiatric Research Unit, Hillerod Hospital
Study officials:
affiliation: Psychiatric Research Unit, Hillerod Hospital
name: Per Bech, Professor
role: STUDY_CHAIR
References:
citation: Martiny K, Lunde M, Bech P, Plenge P. A short-term double-blind randomized controlled pilot trial with active or placebo pindolol in patients treated with venlafaxine for major depression. Nord J Psychiatry. 2012 Jun;66(3):147-54. doi: 10.3109/08039488.2012.674553. Epub 2012 Mar 29.
Clinical trial NCT05967546: Deep Learning for Intelligent Identification of Arrhythmias
Official title: Deep Learning for Intelligent Identification of Arrhythmias (ECG-LEARNING): an Investigator-initiated, National Multicenter, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arrhythmia
Keywords: Arrhythmia
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: 521 Hospital of NORINCO Group
name: Shaanxi Provincial People's Hospital
name: Xiangyang Central Hospital
First posted: 2023-08-01
Enrollment: 4000
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with arrhythmia by twelve-lead electrocardiogram or Holter.

Brief summary: This study aims to design and train a deep learning model for the diagnosis of different arrhythmias.

Detailed description: This study aims to retrospectively and prospectively collect routine clinical data such as electrocardiograms from patients with arrhythmias who meet the inclusion and exclusion criteria. Then we will design and train a deep learning model to analyse the electrocardiographic features of the arrhythmias, and identify the types of arrhythmias and evaluate the value of the model for the diagnosis of different arrhythmias.

Eligibility criteria: Inclusion Criteria:

* For retrospective study: 1.Patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or Holter; 2.The type of arrhythmia is diagnosed by intracardiac electrophysiological examination.
* For prospective study: 1.Patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or Holter; 2.Intracardiac electrophysiological examination is planned.

Exclusion Criteria:

* Lack of routine surface 12-lead electrocardiogram or holter data;
* Lack of intracardiac electrophysiological examination;
* Patients refused to sign informed consent and refused to participate in the study.

Primary outcomes:
measure: A deep learning model designed to intelligently identify the types of arrhythmia.
timeFrame: 1 day after the enrollment.
Secondary outcomes:
measure: The sensitivity, specificity and accuracy of the deep learning model
timeFrame: 1 day after the enrollment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06430346: Exercise Prehabilitation for Locoregional Esophageal Cancer
Official title: Exercise Prehabilitation for Locoregional Esophageal Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 20
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 the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven locoregional esophageal cancer (LEC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Treatment plan including neoadjuvant chemoradiation therapy and surgical resection
* Ability to read and speak English

Exclusion Criteria:

* Regular engagement in resistance training (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on PAR-Q
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely
* Numeric pain rating scale of 7 or more out of 10
* Myopathic or rheumatologic disease that impacts physical function

Primary outcomes:
measure: Retention
timeFrame: Up to 11 weeks
Secondary outcomes:
measure: Exploratory outcomes and changes
timeFrame: Up to 17 weeks
measure: Clinical and treatment outcomes
timeFrame: Up to 17 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Nathan Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406146: Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Uncomplicated Malaria
Lead sponsor: University of Ghana Medical School
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2006-12-04
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.


Eligibility criteria: Inclusion Criteria:

* microscopically confirmed acute uncomplicated falciparum malaria;
* temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
* willingness to comply with follow up schedule;
* written informed consent by accompanying parent or guardian

Exclusion Criteria:

* features of severe malaria or danger signs of malaria
* known intolerance or allergy to any of the study medications
* known treatment with any of the study medications in the month preceding enrollment
* serious underlying disease that may mask outcome assessment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Korle Bu Teaching Hospital
Study officials:
affiliation: Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
name: George O. Adjei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
name: Bamenla Q. Goka, MBchB
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark
name: Jorgen A.L. Kurtzhals, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adjei GO, Kurtzhals JA, Rodrigues OP, Alifrangis M, Hoegberg LC, Kitcher ED, Badoe EV, Lamptey R, Goka BQ. Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malar J. 2008 Jul 11;7:127. doi: 10.1186/1475-2875-7-127.
Clinical trial NCT04181346: Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting
Official title: Phase II Study of Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nausea
Keywords: pregabalin
nausea
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy will be randomized for two arms: pregabalin and placebo.

All patients received will receive IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3.
Primary purpose: TREATMENT

Brief summary: phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)

Detailed description: chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy.

All patients will receive IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3.

Patients will be randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5.

Eligibility criteria: Inclusion Criteria:

* patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy;
* 18 years or older;
* Eastern Cooperative Oncology Group \< 2

Exclusion Criteria:

* Nausea or vomiting 24h before randomization
* aspartate aminotransferase / alanine aminotransferase above 3 times the upper limit
* Severe cognitive compromise;
* regular use of corticosteroids, opioid, benzodiazepines, tricyclic antidepressant, or cannabinoids within 30 days before randomization;
* brain metastasis;
* chronic alcoholism;

Primary outcomes:
measure: Percentage of patients achieving complete control of nausea and vomiting
timeFrame: five days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: IBCC Oncologia
state: SP
Study officials:
References:
Clinical trial NCT02727946: Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients
Official title: Central Venous-arterial Carbon Dioxide Pressure Difference in Correlation to Dynamic Changes of Serum Lactate as an Indicator of Tissue Perfusion in Polytruama Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Early intervention and resuscitation based upon a lot of clinical, laboratory findings make a big difference regarding outcome in poly trauma patients, the study uses the dynamic lactate change and the difference between arterial and venous CO2, oxygen tension or content as indicators for tissue perfusion.

Detailed description: Poly trauma patients have high incidence of mortality and morbidity in spite of improvements and advances in facilities. However, no doubt that early resuscitation and interventions make a big difference upon the overall outcome.

A lot of methods, indices, laboratory and biomarkers have been utilized to evaluate the progress and quality of resuscitation and the early hospital interventions in such group of critically ill patients including central venous pressures, urine output, mixed venous oxygen saturation, and gastric tonometry. Most of recent means focus upon the regional tissue perfusion rather than global, however some researches have tried the difference between arterial and venous CO2,oxygen tension or content ( Pv -a co2\& Pa -v O2 ) in addition to dynamic changes in lactate(3) as predictors for tissue perfusion in sepsis patients after establishment of sepsis campaign (bundle).

Eligibility criteria: Inclusion Criteria:

* multiple trauma patients Adult patients

Exclusion Criteria:

* cardiac renal chronic chest disease diabetic more than 3 years

Primary outcomes:
measure: the difference between partial pressure of oxygen in arterial and venous blood
timeFrame: 6 hours
measure: the difference between partial pressure of carbon dioxide in arterial and venous blood
timeFrame: 6 hours
measure: serum level of lactate and its changes
timeFrame: 6 hours
Secondary outcomes:
measure: Kidney function
timeFrame: 72 hours
measure: hemodynamic stability including pulse rate and mean arterial blood pressure
timeFrame: 72 hours
measure: duration of stay in the critical care unit
timeFrame: 72 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
affiliation: Assiut University
name: Emad Zarief Kamel Said, MD
role: STUDY_DIRECTOR
References: