louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04103996: Incidence, Risk Factors and Outcomes of Diaphragm Dysfunction After Lung Transplantation
Official title: Incidence, Risk Factors and Outcomes of Diaphragm Dysfunction After Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Injury
Lung Transplant; Complications, Mechanical
Respiratory Failure
Mechanical Ventilation Complication
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 15
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: We plan to enroll a total of 100 patients who were listed and will benefit from lung transplant

Brief summary: The study is designed to characterize the changes in diaphragm function after lung transplantation.

Detailed description: Diaphragm dysfunction (DD) is a well-known complication after lung transplantation. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation post-transplant - they become too weak to breathe. However, little is known about the pre-transplant predictive factors associated with diaphragm dysfunction . We have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows us to observe changes in diaphragm muscle structure and function.

The goal of the study is to determine whether pre-transplant diaphragm thickness and function are associated with diaphragmatic dysfunction after lung transplantation. This will help us to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.

Eligibility criteria: Inclusion Criteria:

* Adult patients greater than 18 years of age
* Listed for lung transplantation

Exclusion Criteria:

* Known diagnosis of chronic neuromuscular disease
* Relisting for transplantation
* Bridging to lung transplantation with respiratory support

Primary outcomes:
measure: Incidence of diaphragm dysfunction at the first spontaneous breathing trial and at ICU discharge after lung transplantation
timeFrame: First spontaneous breathing trial, an average of 1 to 7 days
Secondary outcomes:
measure: Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction
timeFrame: 1 day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
Study officials:
affiliation: UHN Toronto
name: Ewan Goligher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05229796: Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions
Official title: Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetic Parameters
Lead sponsor: Mutah University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Background: The current study is a randomized, open-label, two-period, two-sequence, two-way crossover pharmacokinetic study in healthy Jordanian subjects to evaluate the pharmacokinetics and bioequivalence profile of two formulations of empagliflozin 10-mg under fasting and fed conditions administered orally.; (2) Methods: The plasma concentrations of empagliflozin were determined using High-performance liquid chromatography- Mass Spectrometry/ Mass Spectrometry (HPLC-MS/MS) method. This study included 26 subjects, 26 in each fasting and fed group.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* healthy
* Jordanian volunteers
* some private hospitals (Amman, Jordan) Phase I Clinical Unit

Exclusion Criteria:

* Smokers
* heavy drinkers
* those who used CYP enzyme inhibitors within the previous 60 days
* those who had taken any medicine within the previous four weeks
* those who had a history of medication allergies
* those who had participated in previous clinical studies within the previous six months
* those with any significant clinical abnormality

Primary outcomes:
measure: The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Wael Abu Dayyih
state: None Selected
Study officials:
References:
Clinical trial NCT06100796: Effect of DM on Outcomes and Response Rate in Patients With Advanced NSCLC on ICI
Official title: Effect of Diabetes Mellitus on Outcomes and Response Rate in Patients With Advanced NSCLC on Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer Metastatic
Diabetes Mellitus
Keywords: NSCLC
DM
ICI
OHA
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All available patients from 2018 till December 2023 will be included.

Brief summary: Retrospectively investigating the effect of DM on response rate and outcomes during immunotherapy treatment in patients with NSCLC in the last 5 years.

Detailed description: Lung cancer continues to be the most common cause of cancer-related death worldwide for both males and females despite the identification of clinically-actionable driver mutations in genomic subgroups of patients. Non-small cell lung cancer (NSCLC) is the most common histological diagnosis for 85% of lung cancer patients. Immune checkpoint inhibitors (ICI) has significantly altered the prognosis for patients with advanced non-small cell lung cancer (mNSCLC) as it has been shown to have distinct and long-lasting impacts on survival in first and second line treatment. As a result, immunotherapy has emerged as the backbone of care for people with NSCLC. Although some patients benefit considerably from ICI, not all patients do. A comprehensive research effort exists to identify and characterize variables that could predict or boost the response to ICI.

At the same time, diabetes mellitus (DM) is becoming more prevalent globally and lung cancer patients frequently suffer from a variety of comorbidities, including (DM). However, its effect on treatment outcomes is still unclear, particularly in the era of immunotherapy.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients with advanced Non Small Cell Lung Cancer who received Immune Check Inhibitors alone or in combination with chemotherapy, either as first line or as a subsequent line

Exclusion Criteria:

* None

Primary outcomes:
measure: Response Rate
timeFrame: 12 weeks after starting immunotherapy regimen.
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assistant Lecturer
name: Doaa Ali Gamal
role: STUDY_CHAIR
References:
Clinical trial NCT05095896: The Serum Lipid Profiles in ITP: a Retrospective Study
Official title: The Serum Lipid Profiles in Immune Thrombocytopenia: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenia
Keywords: immune thrombocytopenia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 457 ITP patients at Department of Hematology of Qilu Hospital were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.

Brief summary: The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.

Detailed description: Background: Immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease characterized by increased platelet destruction and impaired thrombopoiesis. Platelet indices changes depending on the morphology and volume of platelets. Serum lipids have been found to affect platelet formation and activity in certain diseases, thus induce the corresponding variation of platelet indices.

Objectives: To investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.

Methods: The clinical data from 457 ITP patients were retrospectively collected and analyzed, including platelet indices, serum lipids, hemorrhage and therapeutic regimen.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for immune thrombocytopenia.

Exclusion Criteria:

* (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.

Primary outcomes:
measure: Platelet count at 1 month after initial therapy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of Shandong university
state: Shandong
Study officials:
References:
Clinical trial NCT06649786: Comparison of the Clinical Efficacy and Safety of Endoscopic Superior Rectal Mucosal Ligation and Hemorrhoids Ligation
Official title: Comparison of the Efficacy and Safety of Endoscopic Hemorrhoids Ligation: a Single-center Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 96
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: Endoscopic superior rectal mucosal ligation and hemorrhoids ligation are two types of endoscopic ligation, The aim of this study is to compare the clinical efficacy and safety of these two approaches.If you accept this study,you need to provide case information before the operation, complete the endoscopic treatment according to the routine colonoscopy procedure, and follow-up survey after the operation.


Eligibility criteria: Inclusion Criteria:

1. According to the Goligher classification in the Chinese guidelines for the diagnosis and treatment of hemorrhoids (2020) , patients who are diagnosed with grade II-III internal hemorrhoids .
2. Patients who voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. patients who had severe heart, liver, and kidney disease.
2. patients who had severe immune deficiency.
3. patient\&#39;s general condition is too poor to tolerate endoscopic therapy.
4. patients had a history of pelvic chemoradiotherapy.
5. patients had severe infection or inflammatory lesion in the rectum or anal canal,or the rectum or anal canal had undergone surgery.
6. patient is a pregnant woman.
7. patients who disagree with endoscopic treatment and are concerned about the possible risks refused to sign the informed consent form.
8. the follow-up time is insufficient and the clinical data were incomplete.

Primary outcomes:
measure: complication
timeFrame: 7 days after operation
measure: clinical efficacy
timeFrame: 1 month after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00490386: Helicobacter Pylori and Acute Alcohol Induced Pancreatitis
Official title: Alkoholihaimatulehduksen Uusiminen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis, Acute
Helicobacter Infections
Keywords: Retrospective
Length of Stay
Helicobacter pylori
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-06-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This study is performed to measure wether Helicobacter Pylori has an effect on the incidence and course of acute alcohol induced pancreatitis

Detailed description: A recent pilot study unexpectedly discovered, that Helicobacter pylori infection was rare in patients having their first acute alcohol induced pancreatitis (AAIP) when compared to subjects with similar alcohol use but no history of pancreatitis. This subject has not been studied in humans until now. Therefore we seek to study, with a larger material, wether AAIP is associated with lower prevalence of Helicobacter pylori, by measuring the antibodies against Helicobacter pylori from the sera of AAIP patients and from a control group of alcoholics with no history of AAIP.

Eligibility criteria: Inclusion Criteria:

* Acute alcohol pancreatitis (first)

Exclusion Criteria:

* Death during hospitalization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
affiliation: Department of Gastroenterology and Alimentary Tract Surgery, Tampere University
name: Jahangir A Khan, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: 1Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
name: Isto Nordback, MD
role: STUDY_DIRECTOR
References:
citation: Pelli H, Herzig KH, Uotila S, Raty S, Laine S, Sand J, Nordback I. Duodenal diazepam-binding protein expression and plasma cholecystokinin after alcoholic pancreatitis. Scand J Clin Lab Invest. 2006;66(8):677-83. doi: 10.1080/00365510600930918.
Clinical trial NCT03992586: Effect of Rose-colored Glass on Mood
Official title: Effect of Rose-colored Glass on Mood: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Lead sponsor: Florida Center for Dermatology
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 38
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: Decades of psychological research has highlighted the impact of visual perception on mood and happiness. The investigators hypothesized that literally seeing the world through rose colored glasses may have an effect on perception, mood, and happiness. After cataract surgery, which classically increases the vividness of perceived colors, patients report significant satisfaction. The investigators therefore sought to explore whether using pink colored lenses leads to a measurable impact on outcomes.

Detailed description: A randomized controlled clinical trial design will be performed. Subjects will be randomized for either pink lenses (treatment group) or clear lenses (placebo group).

Subjects will be asked to wear the assigned glasses throughout the day during the course of the trial. Glasses will not be work while driving at night.

Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years of age.

Exclusion Criteria:

* Subjects who wear glasses on a regular basis.

Primary outcomes:
measure: Change from baseline in Anxiety Scores on the Visual Analogue Scale at 1 week
timeFrame: 1 week
Secondary outcomes:
measure: Change from baseline in Mood Scores on the Visual Analogue Scale
timeFrame: 1 week
measure: Change from baseline in Happiness Scores on the Visual Analogue Scale
timeFrame: 1 week
measure: Change from baseline in the Center for Epidemiological Studies Depression Scale score
timeFrame: 1 week
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: St Vincent's Medical Center
state: Florida
Study officials:
affiliation: Florida Center for Dermatology
name: Jonathan Kantor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293486: Study of Pomegranate Juice in the Modulation of Oxidative Stress Markers in Endurance-based Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Oxidative Stress
Keywords: Antioxidants
Protein Carbonylation
Malondialdehyde
Punicaceae
Athletic Performance
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Vitalgrana Pomegranate SL
First posted: 2014-11-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate modifications of plasma protein carbonyls and malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice consumption.


Eligibility criteria: Inclusion Criteria:

* Perform specific endurance training sessions
* More than 1 hour per session and more than 3 sessions per week
* Have participated recently in a half marathon or similar event

Exclusion Criteria:

* Intake of antioxidant or anti-inflammatory supplementation
* Present a chronic disorder
* Non-smoker
* No-alcoholic beverage consumption

Primary outcomes:
measure: Protein carbonyls levels changes in plasma
timeFrame: day 0 and 22
measure: Malondialdehyde levels changes in plasma
timeFrame: day 0 and 22
Secondary outcomes:
measure: Blood biochemical parameters changes in plasma
timeFrame: day 0 and 22
measure: C-reactive protein levels changes in plasma
timeFrame: day 0 and 22
measure: Soluble E-selectin levels changes in plasma
timeFrame: day 0 and 22
Other outcomes:
Locations:
Study officials:
affiliation: University Miguel Hernández
name: Enrique Roche, PhD
role: STUDY_DIRECTOR
References:
citation: Aviram M, Dornfeld L, Rosenblat M, Volkova N, Kaplan M, Coleman R, Hayek T, Presser D, Fuhrman B. Pomegranate juice consumption reduces oxidative stress, atherogenic modifications to LDL, and platelet aggregation: studies in humans and in atherosclerotic apolipoprotein E-deficient mice. Am J Clin Nutr. 2000 May;71(5):1062-76. doi: 10.1093/ajcn/71.5.1062.
citation: Trombold JR, Reinfeld AS, Casler JR, Coyle EF. The effect of pomegranate juice supplementation on strength and soreness after eccentric exercise. J Strength Cond Res. 2011 Jul;25(7):1782-8. doi: 10.1519/JSC.0b013e318220d992.
Clinical trial NCT06539286: Dentin Hypersensitivity - Varnish or Laser?
Official title: Dentin Hypersensitivity - Varnish or Laser? A Randomized Clinical Study Comparing Three Wavelengths (2940 nm, 1064 nm and 970 nm) and the Desensitizer Gluma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dentin Hypersensitivity
Lead sponsor: Sigmund Freud PrivatUniversitat
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. This study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (Gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. Patients will be divided randomly into four groups (control group (Gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). Visual Analog Scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. Mixed Anova's and descriptive analysis will be used for statistical evaluation.

Detailed description: A total of 80 patients meeting the inclusion criteria will be included in this randomized clinical study. Participants will be randomly divided into four groups. Pain scores will be measured before treatment, right after treatment, 1 month after treatment and 3 months after treatment using the Visual Analog Scala (VAS). Patients will not know which treatment will be performed before nor will the patients from the laser groups know the wavelengths. Pain scores at check-up meetings will be collected by another doctor other than the one who will perform all laser treatments.

Eligibility criteria: Inclusion Criteria:

* all genders
* 18-70 years
* good general health
* at least two hypersensitive teeth in either jaw
* initial VAS-score \>3

Exclusion Criteria:

* Active carious lesions, insufficient restorations, enamel cracks, reversible pulpitis
* Active periodontal disease, periodontal surgery (in the last 6 months)
* Bleaching procedure in the last 3 months
* Analgetic use in the last 72 hours
* Pregnant/lactating women

Primary outcomes:
measure: Visual Analog Scale changes
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00568386: Acute Comfort and Blur of Systane and Optive
Official title: Acute Comfort and Blurring Profile Evaluation Comparing Systane Lubricant Eye Drops to Optive Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.


Eligibility criteria: Inclusion Criteria:

* Healthy, normal eyes OR documented diagnosis of dry eye

Exclusion Criteria:

* Must not have worn contact lenses for 7 days preceding enrollment

Primary outcomes:
measure: Visual Blur
timeFrame: 3 minutes post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Mike Christensen
role: PRINCIPAL_INVESTIGATOR
References: