louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03092882: Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
Official title: Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Humana Co.Ltd.
First posted: 2017-03-28
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Digital Self-Management Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Self-Management Program on A1c levels for individuals with uncontrolled Type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Humana Medicare Advantage member
* Type 2 diabetes diagnosis
* HbA1c levels ≥ 8.0% verified by lab test

Exclusion Criteria:

* Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease
* Not fluent in English
* Humana membership is part of a Full or Global risk arrangement
* Enrolled in Humana at Home Care Management

Primary outcomes:
measure: Change from Baseline in A1c at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
affiliation: Evidation Health
name: Jessie Juusola, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578382: Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)
Official title: Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU): A Comparison of Martorell HYTILU, Calciphylaxis and Venous Ulcer (Control)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertensive Ischemic Leg Ulcer
Calciphylaxis
Keywords: Martorell hypertensive ischemic leg ulcer
Calciphylaxis (calcific uremic arteriolopathy)
Ischemic subcutaneous arteriolosclerosis
Hypertension
Diabetes
Medial calcinosis
Wound healing
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: n=20: Having Martorell hypertensive ischemic leg ulcer (as defined above) or n=10: Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or n=20: Having a venous ulcer (as defined above) (controls)

Brief summary: Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects.

Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney transplantation.

Detailed description: Comparative study including

* 20 consecutive patients with Martorell HYTILU
* 10 consecutive patients with Calciphylaxis (calcific uremic arteriolopathy)
* 20 patients with venous ulcer

The following parameters are measured in the blood serum:

White blood count; c-reactive protein; creatinine; calcium (total); free (ionized) calcium; phosphate; albumin; 25-hydroxyvitamin-D; 1-25-dihydroxyvitamin-D; homocysteine; cystatin C alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)

The following parameters are measured in samples of diseased (necrobiotic) skin:

alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)

Eligibility criteria: Inclusion Criteria:

* Having Martorell hypertensive ischemic leg ulcer (as defined above) or
* Having Calciphylaxis (calcific uremic arteriolopathy (as defined above) or
* Having a venous ulcer (as defined above)

Exclusion Criteria:

* None

Primary outcomes:
measure: Martorell HYTILU and calciphylaxis show both decreased tissue protection mechanisms against tissue calcification
timeFrame: 36 months
Secondary outcomes:
measure: Martorell hypertensive ischemic leg ulcer and calciphylaxis are both characterized by non-infectious inflammation
timeFrame: 36 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital of Zurich
state: ZH
Study officials:
affiliation: Department of Dermatology, University Hospital of Zurich, Switzerland
name: Jürg Hafner, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02306382: Multicenter Study for Diagnosis and Treatment of Perianal Abscesses
Official title: Randomized Controlled Multicenter Study for Diagnosis and Treatment of Perianal Abscesses.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perianal Abscess
Anal Fistulas
Incontinence
Keywords: endoanal ultrasonography
drainage
perianal abscess
fistulas
incontience
Lead sponsor: University Hospital, Umeå
Sponsor class: OTHER
First posted: 2014-12-03
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: Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence.

Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal.

The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.

Detailed description: The individual patient is informed about the condition and if meets criteria is offered to take part in the study. Written information and informed consent always noted. Questions about the patients general medical condition is noted and if the person has had problems with perianal abscesses before.

Eligibility criteria: Inclusion Criteria:

* perianal abscess that needs surgical treatment, over the age of 18

Exclusion Criteria:

* Under the age of 18 or unable to understand study information because of language difficulties or dementia.

Primary outcomes:
measure: adverse events
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Umea
country: Sweden
facility: Department of Surgery
state: County Of Vasterbotten §
Study officials:
affiliation: University Hospital, Umeå
name: Karin Gustafsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Umeå
name: Karin Strigård Strigård, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Umeå
name: Ulf Gunnarsson, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02102282: Breast Cancer During Pregnancy
Official title: Observational Study of Breast Cancer Diagnosed During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Breast Cancer
Keywords: Pregnancy
Breast Cancer
Chemotherapy
Surgery
Obstetric managment
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer diagnosed during pregnancy

Brief summary: Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.


Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer diagnosed during pregnancy

Exclusion Criteria:

* Patients who refuse informed consent

Primary outcomes:
measure: Perinatal results
timeFrame: Delivery
Secondary outcomes:
measure: Maternal outcome
timeFrame: 5 year and 10 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Octavi Cordoba, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordoba O, Llurba E, Saura C, Rubio I, Ferrer Q, Cortes J, Xercavins J. Multidisciplinary approach to breast cancer diagnosed during pregnancy: maternal and neonatal outcomes. Breast. 2013 Aug;22(4):515-9. doi: 10.1016/j.breast.2012.10.005. Epub 2012 Oct 30.
citation: Cordoba O, Llurba E, Cortes J, Sabadell MD, Lirola JL, Ferrer Q, Xercavins J. Complete pathological remission in a patient with hormone-receptor positive and c-erbB-2 expression-negative breast cancer treated with FAC chemotherapy during pregnancy. Tumori. 2010 Jul-Aug;96(4):629-32. doi: 10.1177/030089161009600420.
Clinical trial NCT06402682: Management of Esophageal Atresia With Right Aortic Arch: Is the Side of Approach Important?
Official title: Management of Esophageal Atresia With Right Aortic Arch: Is the Side of Approach Important?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Aortic Arch
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients born with esophageal atresia and right aortic arch between 1990 et 2022

Brief summary: Esophageal atresia is associated with a right aortic arch in 2 to 13% of cases. Despite previous studies, consensus on the optimal surgical approach remains lacking. This study aims to analyze the management of esophageal atresia with a right aortic arch in France over three decades, to define the most effective surgical strategy and identify associated complications.


Eligibility criteria: Inclusion Criteria:

* Having been operated on for esophageal atresia and right aortic arch

Exclusion Criteria:

* NO

Primary outcomes:
measure: Post-operative complications
timeFrame: During the first 40 post-operative days
Secondary outcomes:
measure: specific complications
timeFrame: During the first 40 post-operative days
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval
Study officials:
References:
Clinical trial NCT03434782: Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth
Official title: Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dentin Sensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may control dental sensitivity.

Detailed description: The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.

Eligibility criteria: Inclusion Criteria:

* Absence of active carious lesions;
* Never undergone bleaching therapy;
* Good oral hygiene;
* Do not present hypersensitivity;
* Do not smoke;
* Not being pregnant;
* Presence of at least 28 teeth in oral cavity.

Exclusion Criteria:

* Presence of periodontal disease;
* Presence of cracks or fractures;
* Presence of restorations and prostheses;
* Presence of gastroesophageal dysfunction;
* Patients with severe internal dental dimming;
* Presence of periodontal disease;
* Presence of dentin exposure in anterior and/or posterior teeth.

Primary outcomes:
measure: Change in Stimulated pain intensity in different assessment times (P15)
timeFrame: 15 days, with assessments in the 1st, 8th and 15th day of the treatment
Secondary outcomes:
measure: Non-stimulated pain intensity measure, (P21)
timeFrame: 21 days
Other outcomes:
Locations:
city: Belem
country: Brazil
facility: Brennda Lucy Freitas de Paula
state: Para
Study officials:
References:
citation: Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
citation: Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
Clinical trial NCT02388282: A New Method for Estimating Dynamic Intrinsic PEEP
Official title: A New Method for Estimating Dynamic Positive End-expiratory Pressure. Description and Validation With PEEPi Dyn Measured With Transdiaphragmatic Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PEEP, Intrinsic
PEEP, Occult
Respiratory Insufficiency
Keywords: dynamic intrinsic PEEP
diaphragm echography
respiratory mechanics
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with both acute or chronic respiratory insufficiency, who required respiratory mechanics measurements for clinical purpose.

Brief summary: Dinamic intrinsic PEEP is

Detailed description: Dynamic intrinsic positive end-expiratory pressure (PEEPi dyn) play an important pathophysiology role in many acute respiratory pathologies.

The most accurate method to quantify PEEPi dyn is to measure the rise in transdiaphragmatic pressure (Pdi) at end expiration at the point of the contraction of the inspiratory muscles until inspiratory flow starts.

Such method, however, is invasive, poor comfortable and require patient active collaboration.

The purpose of this study is describe a new non-invasive method for estimate PEEPi dyn and validate this method with gold-standard-one.

Eligibility criteria: Inclusion Criteria:

* Acute or chronic respiratory failure
* Age \>=18 y

Exclusion Criteria:

* Lack of informed consent
* Controindication to the placement of oesophageal and gastric catheter:

esophageal varices, gastric or oesophageal bleeding in the previous 30 days, gastric or oesophageal surgery in the preceding year.

* Cardiac arrest
* Severe emodinamic instability (\> 1 vasoacttive drug)
* Acute coronary syndrome (AMI/UA)
* Inability to protect airway
* Respiratory arrest
* Pregnancy suspected or confirmed
* Diaphragm palsy
* Curarization in the preceding five hours
* Mechanical ventilation in controlled mode.

Primary outcomes:
measure: Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements.
timeFrame: 20 minutes
Secondary outcomes:
measure: Correlation and agreement between neural inspiratory time and ecographic inspiratory time
timeFrame: 10 minutes
measure: Inter-rater agreement to assest method reliability
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Sant'Orsola Malpighi
Study officials:
References:
citation: Bernardi E, Pisani L, Fasano L, Lauria G, Comellini V, Appendini L, Conti G, Tosello F, Pizzolato E, Nava S. A New Ultrasound Method for Estimating Dynamic Intrinsic Positive Airway Pressure: A Prospective Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):392-396. doi: 10.1164/rccm.201706-1292LE. No abstract available.
Clinical trial NCT04352582: COVID-19 and Vaccination Attitudes
Official title: COVID-19 and Vaccination Attitudes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: University of Lausanne
First posted: 2020-04-20
Enrollment: 1194
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Representative sample of UK population

Brief summary: The investigators want to study how the exposure to the covid-19 pandemic affects attitudes towards science and vaccination, and how other general attitudes and values are affected.

Detailed description: The investigators will carry out a survey in the UK, asking the same 3 questions on vaccination as in a past survey in late 2019 to the same previous respondents, supplementing this with further questions on covid-19 exposure and attitudes towards, among others, individualism-collectivism, health policy as well as trust in science and institutions.

Eligibility criteria: Inclusion Criteria:

* All volunteers who participated in the November 2019 survey on vaccination will be contacted.

Exclusion Criteria:

* People who have not participated in the November 2019 survey
* People unwilling to participate again

Primary outcomes:
measure: How vaccination and other attitudes are affected by COVID
timeFrame: Over last six months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Survey
Study officials:
affiliation: University Hospital, Geneva
name: Geraldine Blanchard-Rohner, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06422182: Erector Spinae Plane Block in Radical Cystectomy
Official title: Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinae Plane Block
Radical Cystectomy
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.

Detailed description: Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.

Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.

One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.

Eligibility criteria: Inclusion Criteria:

* Age of the patient between 21 to 65 years.
* Both sexes.
* Body mass index (BMI): 20 - 40 kg/m2.
* American Society of Anesthesiologists (ASA) physical status II-III.
* Elective radical cystectomy.

Exclusion Criteria:

* Patient refusal.
* Psychiatric and cognitive disorders.
* Local infection at the site of injection.
* Allergy to study medications.
* Anatomic abnormalities.
* Inability to comprehend or participate in pain scoring system.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: The time of first rescue analgesia
timeFrame: 48 hours postoperatively
measure: Degree of pain
timeFrame: 48 hours postoperatively
measure: Incidence of side effects
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References: