louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06231004: Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP
Official title: A Study on the Correlation Between the Microbiome and Type 2 Inflammatory Diseases of Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients in the First Affiliated Hospital, Nanjing Medical University and volunteering for this study

Brief summary: Nasal microorganisms, exfoliated cells, nasal secretions, fetal microorganisms and blood were collected from patients with chronic sinusitis with nasal polyps before medication. Nasal polyp tissues of the patients were clamped for pathologic biopsy in the outpatient clinic. Methylprednisolone was then administered to the patients for 17 days, and the nasal microbial changes were observed after the administration of the drug. Patients underwent surgical treatment after the administration of the drug, and postoperative patients were followed up for a long period of time until polyp recurrence. During the follow-up, the microorganisms in the patients' postoperative nasal cavities were collected and the postoperative microbial changes were recorded

Detailed description: In this study, we retrospectively collected pathologic paraffin specimens and patient information from previous cases of sinusitis with nasal polyps, and prospectively collected specimens from newly enrolled patients with nasal polyps.

Eligibility criteria: Inclusion Criteria:

- The diagnosis of CRSwNP was based on EPOS20201 ECRSwNP was defined as EO accounting for more than 27% of the total infiltration Subjects undergoing septoplasty due to anatomical variations served as controls Discontinuation of steroid (oral or aerosol) and antileukotriene therapy for at least 4 weeks prior to biopsy or surgery

Exclusion Criteria:

- Exclude patients with a diagnosis of posterior maxillary sinus polyps, cystic fibrosis, allergic fungal sinusitis, primary ciliary dyskinesia, allergic rhinitis, immune deficiency, or coagulopathy Exclusion of patients with aspirin intolerance (AERD) Exclude smokers Exclude pregnant women

Healthy Volunteers:

Only patients with deviated septum without any other nasal diseases served as a control group, and the participants in this group were not treated with corticosteroids and went in for septal correction. The rest of the criteria were the same

Primary outcomes:
measure: Nasal polyp size after glucocorticosteroid
timeFrame: 17days
measure: endoscopic evidence of returned polyposis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital, Nanjing Medical University
name: Lei Cheng
role: STUDY_DIRECTOR
References:
Clinical trial NCT01859104: Feasibility of Use of BariCare App in Pre-transplant Population
Official title: Feasibility and Efficacy of Engagement Modules for Renal and Liver Transplant Candidates
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Pre-Renal Transplant Candidate
Pre-liver Transplant Candidate
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 0
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: This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.


Eligibility criteria: Inclusion Criteria:

1. Individuals who are candidates for liver or renal transplant.
2. Individuals who own a smartphone.
3. Individuals who are obese.

Exclusion Criteria:

1. Patients with prior history of bariatric surgery.
2. Patients with active psychiatric disorder.
3. Patients with active tobacco use.
4. Patients with active substance use (alcohol, illicit drugs, etc.)

Primary outcomes:
measure: Smart Phone App Feasibility
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manpreet Mundi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756804: Perioperative Patient Skin Antiseptic Preparation Evaluation
Official title: A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infection
Lead sponsor: Zurex Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.


Eligibility criteria: Inclusion Criteria:

1. Be male or female and at least 18 years of age.
2. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English.
3. Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.
4. Expect to be available for up to 30-days after the surgery.

Exclusion Criteria:

1. Active infection or fever including evidence of infection at or adjacent to the operative site.
2. Immunosuppressed.
3. Kidney/liver failure.
4. Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.
5. Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD\&C Yellow #6.

Primary outcomes:
measure: Surgical Site Infection Occurrence
timeFrame: Within 30 days after surgery
measure: Allergic Reaction and Skin Irritation
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Subgroup Analysis of Rates of Surgical Site Infections
timeFrame: Within 30 days after surgery
measure: Subgroup Analysis of Rates of Surgical Site Infections
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: MCW/FH
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Joseph P Hart, MD, FACS, DFSVS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04407104: Allergy to Almond in Children
Official title: Allergy to Almond in Children: Diagnostic Values and Severity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Food Allergy in Children
Keywords: almond
tree nuts
atopy
allergy
children
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children sensitized to almond and challenged in our unit

Brief summary: Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.

Detailed description: Secondary objectives are

* description of allergic reactions to almond (symptoms, severity)
* modelisation of eliciting dose to almond in our population
* evaluation of the association between atopic comorbidities and allergy to almond in children sensitized to almond
* evaluation of the association between allergy to almond and the importance of skin and sIgE sensitization

Eligibility criteria: Inclusion Criteria:

* oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020

Exclusion Criteria:

* doubtful or incomplete oral food challenge to almond

Primary outcomes:
measure: diagnostic values of skin prick-test and sIgE to almond
timeFrame: BASELINE
Secondary outcomes:
measure: allergic reactions during oral food challenge
timeFrame: BASELINE
measure: eliciting doses to almond
timeFrame: BASELINE
measure: atopic comorbidities
timeFrame: BASELINE
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00332904: Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis
Official title: Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Cirrhosis
Portal Hypertension
Keywords: betablocker
aldosterone antagonist
peripheral haemodynamics
cardiac haemodynamics
oxygenation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2006-06-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients with liver cirrhosis.

Detailed description: Cardio-pulmonal complications to patients with liver cirrhosis and portal hypertension determine the patients' prognosis. Most patients have hemodynamical changes in circulation with increased cardiac output and decreased systolic function in stress. Endothelial dysfunction is a parameter for bad prognosis in cardiovascular disease. The Renin-angiotensin-aldosterone-system plays an important role in natrium and volume regulation. Descriptions of changes in the peripheral circulation and oxygenation have been deficient up to now.

Patients with liver cirrhosis and portal hypertension are betablockers and/or aldosterone antagonists routine treatment - effects on peripheral hemodynamics and oxygenation in relation to central hemodynamic changes are deficient.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* Clinical indication for treatment with betablocker or aldosterone antagonist
* Must not have been treated earlier with betablocker or aldosterone antagonist
* Must have been alcohol abstinent for more than 4 weeks

Exclusion Criteria:

* Gastrointestinal bleeding in the last 2 weeks
* Encephalopathy \> grade 1
* Acute medical conditions
* Malignant disease
* Pregnancy

Primary outcomes:
measure: effect of treatment on hemodynamic and cardiac parameters
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Soeren Moeller, MD, DMSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01998204: Requirement of Propofol for Induction of Unconsciousness in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
propofol
deep brain stimulator
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study recruits patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia and non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia

Brief summary: Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The investigators clinical experience showed a trend of delayed emergence among patients undergoing deep brain stimulator (DBS) implantation and pulse generator placement under general anesthesia. Abnormal pharmacodynamics might be present among these patients, which had never been investigated.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia
* non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia

Exclusion Criteria:

* ASA score higher than Class III
* predicted difficult airway
* hearing impairment
* inability to corporate with instruction
* alcohol or drug abuser
* patients refusing to provide informed consent

Primary outcomes:
measure: Consciousness status
timeFrame: Participants will be monitored during the period of propofol infusion, an expected average of less than 10 min
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, Changhai Hospital, Second Military Medical University
name: Jia-feng Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu XP, Yu XY, Wu X, Hu XW, Chen JC, Li JB, Wang JF, Deng XM. Propofol requirement for induction of unconsciousness is reduced in patients with Parkinson's disease: a case control study. Biomed Res Int. 2015;2015:953729. doi: 10.1155/2015/953729. Epub 2015 Oct 1.
Clinical trial NCT01722604: Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Open Angle or Ocular Hypertension
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-11-07
Enrollment: 258
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 main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.


Eligibility criteria: Inclusion Criteria:

* Male and females 18 years of age or older,
* diagnosed with primary open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

* Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
* ocular hypertension.

Primary outcomes:
measure: Intraocular Pressure (IOP) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in Intraocular Pressure (IOP) From Baseline to Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Louisville
country: United States
facility: US01
state: Kentucky
Study officials:
References:
Clinical trial NCT01820104: Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males: a Randomised Crossover Study
Official title: Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole, DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).

Detailed description: Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. We sought to examine the effect of PPI (lansoprazole), DPP4 (sitagliptin), and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).

Eligibility criteria: Inclusion Criteria:

* General good health condition
* Male subject, between 18 and 50 years

Exclusion Criteria

* Overweight (Body Mass Index ≥30)
* Metabolic disorders
* History of gastrointestinal disorders
* Regular (daily) intake of medication
* Smoking more than 10 cigarettes/day
* History of drug abuse
* Exhaustive (\> 3 units/day) alcohol consumption
* Exhaustive (\> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
* Recent (in the last 14 days) donation of blood
* Recent (in the last 2 days) donation of blood plasma
* Participation in another trial within 4 weeks before the start of the study

Primary outcomes:
measure: Glucose Tolerance
timeFrame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration
Secondary outcomes:
measure: Plasma insulin and C-peptide concentrations during oral glucose tolerance test
timeFrame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of pharmacy, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT06377904: Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics))
Official title: Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Patients Hospitalized in Geriatrics for Heart Failure
Patients Aged 75 and Over
Keywords: Heart failure
Geriatrics
AGE
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 810
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 75 and over hospitalized in geriatrics for heart failure

Brief summary: This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure.

Detailed description: Multicenter study, including patients aged 75 and over, hospitalized in geriatrics and having suffered heart failure in the geriatric wards of 3 centers. The following elements will be collected:

* Demographic data
* History (comorbidities)
* Type of heart disease
* Frailty criteria
* Clinical signs of heart failure
* Geriatric syndromes (falls, cognitive disorders, (MMSE) confusion, malnutrition, loss of autonomy (ADL, IADL), bedsores)
* Biology available (CBC, ionogram, creatinine, NT pro BNP, BHC, troponin, TSH, HBA1C)
* ECG and echocardiography data
* Treatment on admission, during stay and on discharge
* Mode of discharge and length of stay
* Follow-up at 3, 6, 9 months and one year, through telephone calls with the patient, caregiver or attending physician. Questions will cover various aspects of health and quality of life, physical activity limitations, autonomy, symptoms, anxiety, depression, as well as neurocognitive status (using adapted questions).

Eligibility criteria: Inclusion Criteria:

* Patients aged 75 and over Hospitalized in a geriatric ward with heart failure No oral opposition from patient

Exclusion Criteria:

* Patient under 75 years of age Patient not wishing to participate in the study Subject under guardianship/curatorship/supervision of justice

Primary outcomes:
measure: Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure
timeFrame: 36 months
Secondary outcomes:
measure: Factors associated with patients hospitalization or rehospitalization
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03940404: Anlotinib Therapy in Patients With Advanced Lung Cancer.
Official title: Anlotinib Hydrochloride Therapy in Patients With Advanced Lung Cancer: A Real World Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Cttq
First posted: 2019-05-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: advanced lung caner

Brief summary: Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world.

Subjects of the study: advanced Lung cancer.

Methods of the study:

This is a real world, prospective, Non-Interventional, Follow-up registration study.

Patients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle.

End point:

Primary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).


Eligibility criteria: Inclusion Criteria:

1. Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.
2. Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment.
3. Eastern Cooperative Oncology Group performance status of 0-2.

Exclusion Criteria:

1. Contraindication of anlotinib.
2. Pregnant or lactating women.
3. Other patients who can't enroll after investigator's assessment.

Primary outcomes:
measure: PFS
timeFrame: 1 year
Secondary outcomes:
measure: OS
timeFrame: 1 year
measure: ORR
timeFrame: 1 year
measure: DCR
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First People's Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Shenglin Ma
role: PRINCIPAL_INVESTIGATOR
References: