louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05553379: Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment
Official title: Clinical Study of the Vivatmo proTM for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Bosch Healthcare Solutions GmbH
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Asthma

Brief summary: This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Detailed description: Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro,

Eligibility criteria: Inclusion Criteria:

1. Subject is 7 to 80 years of age.
2. Has asthma
3. Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
4. Is willing and able to perform Vivatmo pro™ testing

Exclusion Criteria:

1. Subject has used corticosteroids prior to enrollment.
2. Subject has other current serious medical conditions
3. Subject has not been clinically stable for at least 2 weeks prior to the study
4. Subject is unwilling or unable to perform Vivatmo pro testing

Primary outcomes:
measure: Change in FeNO Value [Time Frame: 14 days]
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kralupy Nad Vltavou
country: Czechia
facility: MUDr. Ingeborg Vokálova s.r.o
city: Ostrava
country: Czechia
facility: Alergologie Skopkova, s.r.o
city: Teplice
country: Czechia
facility: Plicní středisko Teplice s.r.o
city: Ústí Nad Labem
country: Czechia
facility: MUDr. Ivan Drnek
city: Mannheim
country: Germany
facility: Kinderpneumologie und Allergologie im Facharztzentrum
Study officials:
References:
Clinical trial NCT01364779: Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients
Official title: Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: aspirin
Chronic kidney disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2011-06-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the nephrology clinic at SIUH and the nephrology clinic at Staten Island rehab and the admitted patients who give consent.

Brief summary: The primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. The secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.

Detailed description: A cross-sectional of "aspirin resistance in hemodialysis patients" previously done in our institution showed that 23/66 (34.7%) hemodialysis patients were aspirin resistant. In a recent systematic review, renal impairment was associated with aspirin resistance . This association was seen in only two out of the twenty studies used in this meta-analysis . Both these studies are from the same center with a predominant Asian population. In this study we will try to evaluate the prevalence of aspirin resistance in CKD patient without being limited to a specific ethnicity.

Eligibility criteria: Inclusion Criteria:

* Patients with known structural kidney disease as evident by history or by urinalysis and CKD stage III or IV determined by MDRD formula and who are taking aspirin.

Exclusion Criteria:

* Younger than 18 years of age.
* Bleeding disorder or myeloproliferative disorders.
* Thrombocytopenia with platelets \< 100.000.
* Malignancy.
* Acute hemorrhagic disease.
* A recent history of receipt of platelet glycoprotein IIb/IIIa blockers.
* Liver disease as evident by abnormal liver function and total bilirubin \> 2mg/dl.
* use of anticoagulation.

Primary outcomes:
measure: prevalence of aspirin resistance in chronic kidney disease patients
timeFrame: 2 years
Secondary outcomes:
measure: risk factors contributing to aspirin resistance in this population.
timeFrame: 2 years
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: staten island University Hospital nephrology clinic
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Suzanne El_Sayegh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861379: The Role of Ghost Ileostomy in Laparoscopic Rectal Resection
Official title: The Role of Ghost Ileostomy in Laparoscopic Rectal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colo-rectal Anastomosis Dehiscence
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 107
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: To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a prospective randomized controlled study comparing 2 groups of patients undergoing anterior resection of the rectum laparoscopically. In the first group of patients at the end of the procedure was always performed a Ghost Ileostomy while in the second group no protective stoma was built at the end of the intervention.


Eligibility criteria: Inclusion Criteria:

* Surgical Indication for Laparoscopic Anterior Rectal Resection
* Medium risk of anastomotic leakage

Exclusion Criteria:

* High risk of anastomotic leakage
* Lower risk of anastomotic leakage
* Advanced neoplasia (T4)
* Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
* Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection

Primary outcomes:
measure: Presence of Clinical Evident Anastomotic Leak
timeFrame: 15 days
Secondary outcomes:
measure: Postoperative complication
timeFrame: 15 days
measure: Ghost Ileostomy complications
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01984879: Vaccination Status, Knowledge and Attitude in Korean Patients With IBD
Official title: Vaccination Status, Knowledge About Vaccination and Attitude to Vaccination in Korean Patients With Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 287
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 inflammatory bowel diseases who are visiting Asan Medical Center and who give consent to the survey

Brief summary: The purpose of this study is to investigate the vaccination status, knowledge about vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel diseases

Detailed description: Using structured questionnaires, the vaccination status, knowledge about vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel diseases will be investigated. The descriptive analyses will be performed and the factors influencing the vaccination status, knowledge, and attitude will be investigated.

Eligibility criteria: Inclusion Criteria:

* Crohn's disease or ulcerative colitis
* Patients who are visiting Asan Medical Center for the first time for the management of inflammatory bowel diseases
* Patients who give consent for participating in the study

Exclusion Criteria:

* Patients who refuse to participate in the study

Primary outcomes:
measure: Vaccination status (MMR, DTaP, BCG, Polio, seasonal influenza, pneumococcus, HAV, HBV, HPV, VZV, and menigococcus )
timeFrame: One year
Secondary outcomes:
measure: Knowledge about vaccination in patients with inflammatory bowel diseases
timeFrame: One year
Other outcomes:
measure: Attitude to vaccination in patients with inflammatory bowel diseases
timeFrame: One year
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Byong Duk Ye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeung JH, Goodman KJ, Fedorak RN. Inadequate knowledge of immunization guidelines: a missed opportunity for preventing infection in immunocompromised IBD patients. Inflamm Bowel Dis. 2012 Jan;18(1):34-40. doi: 10.1002/ibd.21668. Epub 2011 Feb 18.
citation: Ryu HH, Chang K, Kim N, Lee HS, Hwang SW, Park SH, Yang DH, Byeon JS, Myung SJ, Yang SK, Ye BD. Insufficient vaccination and inadequate immunization rates among Korean patients with inflammatory bowel diseases. Medicine (Baltimore). 2021 Nov 12;100(45):e27714. doi: 10.1097/MD.0000000000027714.
Clinical trial NCT04054479: Penehyclidine for PONV Prophylaxis After Strabismus Surgery
Official title: The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PONV
Keywords: Penehyclidine
PONV
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 228
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients scheduled for elective strabismus surgery under general anesthesia in the First Affiliated Hospital of Nanjing Medical University will be included in this study.

Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. Patients 1)had prior PONV, 2)severe motion sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic effects, will be excluded from the study.

The primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting selective anticholinergic agent developed in China) on postoperative nausea and vomiting after strabismus surgery. Secondary outcomes include the effect of PONV risk factors and surgical technique on PONV rank score, occurance of oculocardiac reflex, time to extubation.


Eligibility criteria: Inclusion Criteria:

* ASA I or II
* Aged 3-65 years
* Scheduled for elective strabismus surgery under general anesthesia

Exclusion Criteria:

* Had prior PONV
* Severe motion sickness
* A history of ophthalmic surgery
* Had received drugs known to have antiemetic effects in 24h before surgery

Primary outcomes:
measure: Incidence of PONV
timeFrame: From extubation to 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zhengnian Ding, M.D.
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiaofei Cao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ting Lu, M.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jiacheng Sun, M.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun J, Cao X, Lu T, Li N, Min X, Ding Z. Penehyclidine mitigates postoperative nausea and vomiting and intraoperative oculocardiac reflex in patients undergoing strabismus surgery: a prospective, randomized, double-blind comparison. BMC Anesthesiol. 2021 Feb 13;21(1):49. doi: 10.1186/s12871-021-01266-0.
Clinical trial NCT00518479: Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression
Official title: Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Left Ventricular Hypertrophy
Keywords: Hypertension
Left Ventricular Hypertrophy
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
First posted: 2007-08-20
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the likelihood of complications and death. The high blood pressure explains some but not all of this increase in heart size. This study will investigate the other causes, and will measure the heart muscle 'thickness' very accurately using the latest and most accurate technique called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening remains to be determined. We hope to be able to show that by specifically targeting the cause of heart muscle thickening we can reduce its occurrence more effectively than by other standard means of blood pressure treatment


Eligibility criteria: Inclusion Criteria:

* Recently diagnosed essential hypertension (within 6 months).
* Age 25 to 80 years; Weight \< 100kg.
* Sinus rhythm without significant ventricular or atrial ectopy.

Exclusion Criteria:

* Current angiotensin II receptor antagonist or ACE Inhibitor treatment.
* Contra-indication to any of the protocol anti-hypertensive agents.
* Angina requiring treatment with a Beta blocker or calcium antagonist
* Any disease affecting the autonomic nervous system e.g. congestive cardiac failure, diabetes, neurological disease, malignancy, pregnancy.
* Contraindication to MRI (pacemaker, intra-orbital debris, intra-auricular implants, intra-cranial clips, history of claustrophobia, inability to lie supine for 15 minutes etc).

Primary outcomes:
measure: The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
state: Wesst Yorkshire
Study officials:
affiliation: Leeds University
name: John P Greenwood, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burns J, Sivananthan MU, Ball SG, Mackintosh AF, Mary DA, Greenwood JP. Relationship between central sympathetic drive and magnetic resonance imaging-determined left ventricular mass in essential hypertension. Circulation. 2007 Apr 17;115(15):1999-2005. doi: 10.1161/CIRCULATIONAHA.106.668863. Epub 2007 Mar 26.
Clinical trial NCT00384384: Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients
Official title: Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: Dialysis
Serum potassium
18b glycyrrhetinic acid
insulin sensitivity
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background: 18B Glycyrrhetinic acid (active compound of Licorice) decreases serum potassium via enhanced renal potassium loss in healthy individuals and thereby inducing renal sodium retention and arterial hypertension.In dialysis patients this mechanism is disturbed and compensatory intestinal potassium secretion is enhanced. 18B Glycyrrhetinic acid is an inhibitor of 11B Hydroxysteroid dehydrogenase type 1 (11b HSD1). Inhibition of 11 b HSD1 offers a novel potential therapy to lower intracellular cortisol concentrations and thereby enhance insulin sensitivity.

Hypothesis: Glycyrrhetinic acid decreases serum potassium by enhanced intestinal excretion in dialysis patients and increases insulin sensivity by inhibition of 11b HSD

Methods: double blind, 6 month cross over trial comparing oral 18b Glycyrrhetinic acid with placebo in 24 nondiabetic dialysis patients.

Endpoints: predialytic serum potassium levels, insuline sensitivity assessed by fasting glucose and fasting insulin concentrations


Eligibility criteria: Inclusion Criteria:

* dialysis patients (\>3 months)

Exclusion Criteria:

* diabetics
* hospital stay in the last 4 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Department of nephrology and hypertension, University hospital of berne
Study officials:
affiliation: Department of Nephrology and Hypertension, University hospital of Berne
name: Felix J Frey, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farese S, Kruse A, Pasch A, Dick B, Frey BM, Uehlinger DE, Frey FJ. Glycyrrhetinic acid food supplementation lowers serum potassium concentration in chronic hemodialysis patients. Kidney Int. 2009 Oct;76(8):877-84. doi: 10.1038/ki.2009.269. Epub 2009 Jul 29.
Clinical trial NCT03165084: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes
Official title: iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Type 2
Keywords: Self-management
Primary Health Care
eHealth
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: The Swedish Diabetes Foundation
name: The County Council of Västerbotten
First posted: 2017-05-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to develop and evaluate a person-centred digital intervention in primary healthcare for people with T2D, in addition to their usual diabetes care.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes within the last five years
* 18 years of age or older
* Ability to read and communicate in Swedish
* Own a smart phone

Exclusion Criteria:

* 81 years and over at inclusion
* Life-threatening physical illness (e.g. cancer)
* Documented cognitive impairment
* Those not responsible for their own self care
* Those not residing in their own home environment (e.g. those in nursing homes, in-patient hospital wards)

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline, 6 months, and 12 months
measure: Body Mass Index
timeFrame: Baseline, 6 months, and 12 months
measure: Waist circumference
timeFrame: Baseline, 6 months, and 12 months
measure: Cholesterol, total, LDL and HDL
timeFrame: Baseline, 6 months, and 12 months
measure: Lifestyle habits - physical activity
timeFrame: Baseline, 6 months, and 12 months
measure: Lifestyle habits - diet
timeFrame: Baseline, 6 months, and 12 months
measure: Lifestyle habits - smoking
timeFrame: Baseline, 6 months, and 12 months
measure: Medical treatment
timeFrame: Baseline, 6 months, and 12 months
measure: Diabetes empowerment
timeFrame: Baseline, 6 months, and 12 months
measure: Diabetes-dependent QoL
timeFrame: Baseline, 6 months, and 12 months
measure: Illness perception
timeFrame: Baseline, 6 months, and 12 months
measure: eHealth literacy
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Nursing, Umeå University
Study officials:
affiliation: Umeå University
name: Åsa Hörnsten, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04476784: Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Official title: Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Detailed description: Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current or prior Biofinity contact lens wearer in the past 3 months;
* Monovision contact lens wearer;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Distance Visual Acuity (logMAR) With Study Lenses
timeFrame: Day 1, Day 30 after 6-8 hours of wear, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Pittsburg
country: United States
facility: Alcon Investigative Site
state: Kansas
city: Shawnee Mission
country: United States
facility: Alcon Investigative Site
state: Kansas
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References: