louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06075199: Intestinal Metaplasia Cohort for Gastric Cancer Prediction
Official title: A Prospective Cohort Study for Gastric Cancer Prediction in Patients With Intestinal Metaplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intestinal Metaplasia of Gastric Mucosa
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient clinic visitors

Brief summary: In this study, we aim to establish a prospective cohort of patients with endoscopically and histologically confirmed intestinal metaplasia, collect gastric mucosal tissue samples from this cohort, and follow the development of gastric cancer over time.

Detailed description: Patients visiting Seoul National University Hospital, who have previously received an incidental diagnosis of intestinal metaplasia during a prior gastroscopy examination, will be considered as potential candidates for this study. Upon obtaining their informed consent to participate, the initial endoscopy procedure will involve the collection of biopsies to ensure an accurate histological diagnosis of intestinal metaplasia. These biopsies will be taken from the antrum and body of the stomach, according to the protocol of the updated Sydney system, to pathologically diagnose the extent and severity of intestinal metaplasia. One to two pieces of tissue remaining from this diagnostic process will be retained for future analysis. Subsequently, patients will be followed up on an outpatient basis to track the development of gastric cancer through routine screening endoscopies. In cases where patients develop gastric cancer, a comparative analysis will be conducted with those who do not develop gastric cancer, to determine the differences in expression of markers in the gastric mucosal tissue that was collected during the initial endoscopy. Our ultimate aim is to identify potential biomarkers that may serve as predictive indicators for the development of gastric cancer in patients with a preexisting diagnosis of intestinal metaplasia.

Eligibility criteria: Inclusion Criteria:

* Patients who visit Seoul National University Hospital
* Patients who have been visually diagnosed with intestinal metaplasia at a prior exam

Exclusion Criteria:

* Patients who have been previously diagnosed with gastric cancer or adenoma
* Patients who have previously received gastrectomy

Primary outcomes:
measure: Gastric Cancer Development
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Soo-Jeong Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01737099: Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: omega-3
DHA
triglycerides
lipids
cardiovascular
hypertriglyceridemia
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.


Eligibility criteria: Inclusion Criteria:

* ages 18-79
* fasting TG levels, 150-499 mg/dL
* baseline DHA intake \<200mg/d
* active and in good health

Exclusion Criteria:

* recent diagnosis of CHD or history of revascularization within 6mos of study
* use of lipid altering medications (other than stable statins)
* use of anticoagulants
* use of omega-3 products within 4 weeks of screening
* serum AST/ALT \>1.5x ULN and/or creatinine \>1.5 mg/dL at screening
* lipid altering foods or supplements
* women who are pregnant or of childbearing potential not using adequate birth control
* current use or history of drug or alcohol abuse
* inability to swallow capsules

Primary outcomes:
measure: Change from baseline in TG levels
timeFrame: week 14
Secondary outcomes:
measure: Change from baseline in lipid panel measures
timeFrame: week 14
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Clinical Research
state: Illinois
Study officials:
affiliation: Biofortis Clinical Research, Inc.
name: Kevin Maki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maki KC, Yurko-Mauro K, Dicklin MR, Schild AL, Geohas JG. A new, microalgal DHA- and EPA-containing oil lowers triacylglycerols in adults with mild-to-moderate hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2014 Oct;91(4):141-8. doi: 10.1016/j.plefa.2014.07.012. Epub 2014 Jul 22.
Clinical trial NCT00195299: Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck
Official title: An Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma
Keywords: Carcinoma
Head
Neck
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This is an open-label, exploratory, biomarker study of intravenous temsirolimus given once weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to beginning their standard therapy for their specific disease. The primary objective of this study is to identify biomarkers of temsirolimus activity.


Eligibility criteria: Inclusion Criteria:

* Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma of the oral cavity, oral pharynx, hypopharynx or larynx.
* Subjects willing to undergo tumor biopsies.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Age \>/= 18 years.

Exclusion Criteria:

* Subjects receiving anticoagulation therapy.
* Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia.
* Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or investigational agent for their head and neck cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
state: Louisiana
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04503499: Effect of Thoracic Manual Therapy in Hemiplegic Patients
Official title: Acute Effect of Thoracic Manual Therapy on Respiratory Capacity in Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: pulmonary function
manual therapy
respiratory function test
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 47
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Neurological problems both lead to many respiratory problems primarily and events secondary to neurological diseases or symptoms can be the cause of respiratory failure. The addition of respiratory failure will adversely affect the course of the neurological picture, making treatment more difficult.

The cardiopulmonary functions of hemiplegia patients decrease due to the decrease in the expansion of the thoracic part on the hemiplegic side and insufficient respiratory muscles. In addition, common symptoms in stroke patients, including limited use of ankylosis and muscle movements, cause oxygen deficiency and increased metabolic demands. After stroke, thoracic expansion is reduced upon paralysis of the diaphragm and respiratory muscles. Continuation of this condition can lead to muscle fibrosis. As a result, the level of thoracic expansion decreases during breathing.

A decrease in thoracic spine mobility correlates with a decrease in forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1). The increase in the rigidity of the chest wall affects the ventilator pumping mechanism, reducing the level of rigidity (increasing the mobility of the chest wall) is recommended as a way to improve lung function.


Eligibility criteria: Inclusion Criteria:

* Being between 45-65 years old
* Stage 4-6 according to Brunnstrom
* According to Modified Ashworth, the upper extremity is at most two values
* Sufficient to answer the level of consciousness survey
* No smoking
* No hearing or vision loss

Exclusion Criteria:

* Not being able to read and write
* Having cognitive impairment
* Hearing difficulties and vision loss
* Having any acute pain
* Acute Bronchitis

Primary outcomes:
measure: Chest circumference measurement
timeFrame: 4 weeks
measure: Forced expiratory volume
timeFrame: 4 weeks
measure: Forced vital capacity
timeFrame: 4 weeks
measure: Forced expiratory volume / Forced vital capacity
timeFrame: 4 weeks
measure: Peak Expiratory Flow
timeFrame: 4 weeks
measure: Maximal Expiratory Pressure
timeFrame: 4 weeks
measure: Maximal Inspiratory Pressure
timeFrame: 4 weeks
measure: Respiratory Muscle Endurance
timeFrame: 4 weeks
measure: Oxygen Saturation
timeFrame: 4 weeks
measure: Heart Rate
timeFrame: 4 weeks
measure: Respiratory Frequency
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
References:
Clinical trial NCT05882799: Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome
Official title: Ultrasound-guided vs. Blinded Dry Needling for Piriformis Syndrome: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Piriformis Syndrome
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Trial
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the effectiveness of ultrasound-guided versus blinded dry needling for the treatment of piriformis syndrome.

Detailed description: This randomized controlled trial aims to compare the efficacy of ultrasound-guided versus blinded dry needling for the treatment of piriformis syndrome. Patients in both groups will receive three weekly sessions of dry needling performed by a single experienced physiatrist. The intervention will involve inserting a sterile acupuncture needle into the trigger points of the piriformis muscle and manipulating the needle to elicit a twitch response. Patients in the ultrasound-guided group will receive dry needling under real-time ultrasound guidance, while patients in the blinded group will receive dry needling without ultrasound guidance. Patients will be assessed before treatment, after treatment, after the third week, and after three months.

Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18-65 years.
* Clinical diagnosis of piriformis syndrome based on the following criteria: buttock pain, radiating pain to the posterior thigh, and tenderness over the piriformis muscle.
* Pain intensity of at least 4 out of 10 on a visual analog scale (VAS).
* Willingness to comply with the study protocol and provide informed consent.

Exclusion Criteria:

* Previous surgery or injection therapy for piriformis syndrome.
* Contraindications to dry needling, such as bleeding disorders or skin infections.
* Pregnancy or breastfeeding.
* History of neurological disorders, such as sciatica, radiculopathy, or neuropathy.
* History of serious psychiatric illness or substance abuse.
* Inability to complete the study questionnaires or follow-up assessments.

Primary outcomes:
measure: Change in Visual Analog Scale for Pain
timeFrame: First day, after three weeks, after three months
measure: Change in Oswestry Disability Index (ODI)
timeFrame: First day, after three weeks, after three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421706: Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects
Official title: Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: clarithromycin
sibutramine
clopidogrel
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

Detailed description: 1. Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6\*1/\*1, \*1/\*6 and \*6/\*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.

Eligibility criteria: Inclusion Criteria:

* must be healthy volunteer

Exclusion Criteria:

* must not be under 18 years old

Primary outcomes:
measure: effects of clopidogrel and clarithromycin on the disposition of sibutramine
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: JaeGook Shin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05258006: Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect
Official title: Clinical and Radiographic Assessment of Autogenous Dentin Nanoparticles in Treatment of Stage III Periodontitis: A Split-Mouth Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis (Stage 3)
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate the effect of demineralized autogenous dentine on treatment of infrabony defects.

Detailed description: In this study, the investigators tested the effect of demineralized autogenous dentine as a bone graft in treatment of stage III periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and bone gain in defect sites.

Eligibility criteria: Inclusion Criteria:

* Patients with good systemic health and no contraindication for periodontal surgery.
* Patients who are able to maintain good oral hygiene.
* Gingival thickness for the site selected should be ≥1mm.
* Probing depth of ≥ 6mm.
* Patient has at least one hopeless teeth

Exclusion Criteria:

* Active infectious diseases (hepatitis, tubercu¬losis, HIV, etc....).
* Medically compromised patients.
* Smokers and alcoholic abusers
* People who suffer from any systemic disease that affect the periodontium.
* Pregnant, postmenopausal women.
* People who take anti-inflammatory drugs, anti¬biotics or vitamins within the previous 3 month.
* People who use mouth washes regularly
* Participants in other clinical trials.

Primary outcomes:
measure: Vertical bone loss
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Probing pocket depth
timeFrame: 6 months
measure: Bone gain
timeFrame: 6 months
Secondary outcomes:
measure: Plaque Index
timeFrame: 6 months
measure: Gingival index
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6 University
Study officials:
References:
Clinical trial NCT04488406: Genetics and Epigenetics of Graves' Orbitopathy
Official title: Genetics and Epigenetics of Graves' Orbitopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Ophthalmopathy
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Graves' orbitopathy undergoing decompressione surgery

Brief summary: Graves' orbitopathy (GO) is an autoimmune disease persisting when immunosuppression is achieved. Orbital fibroblasts from GO patients display peculiar phenotypes even if not exposed to autoimmunity, possibly reflecting genetic or epigenetic mechanisms, to be investigated here.

Primary cultures of orbital fibroblasts from GO and control patients will be established. Cell proliferation, release of hyaluronic acid (HA) and HA synthases (HAS) will be measured. Next Generation Sequencing and gene expression analysis of the whole genome will be performed, as well as global DNA methylation assay.

Detailed description: The investigators will establish primary cultures of orbital fibroblasts from orbital adipose tissue samples taken from six GO patients who underwent orbital decompressive surgery. Normal orbital tissue samples will be collected from six patients undergoing eye surgery for unrelated reasons.

Cell proliferation and HA will be measured using commercial assays DNA and RNA will be extracted. HAS-1, HAS-2 and HAS-3 will be measured were assessed by Real Time-PCR Next Generation Sequencing, Gene expression analysis and DNA methylation assays will be performed

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Graves' Orbitopathy
* Informed consent

Exclusion Criteria:

-Lack of informed consent

Primary outcomes:
measure: Gene expression
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Ospedale Cisanello-Endocrinology I and II
Study officials:
References:
citation: Rotondo Dottore G, Bucci I, Lanzolla G, Dallan I, Sframeli A, Torregrossa L, Casini G, Basolo F, Figus M, Nardi M, Marcocci C, Marino M. Genetic Profiling of Orbital Fibroblasts from Patients with Graves' Orbitopathy. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2176-e2190. doi: 10.1210/clinem/dgab035.
Clinical trial NCT00253006: Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium
Official title: A Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Interstitial Cystitis
Bladder Diseases
Urinary Incontinence
Keywords: NO
mRNA-expression
pathophysiology
painful bladder syndrome
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2005-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life, synthesized by a group of NO-synthase-enzymes in many tissues.

The goal of this study is to illuminate bladder tissue production of NO in individuals with PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different molecular biological methods.


Eligibility criteria: Inclusion Criteria:

* PBS/IC according to International Continence Society (ICS)
* Cystoscopy with bladder distension and deep biopsies within last 5 years
* Cystometry within last 5 years
* Normal urine culture within last month

Inclusion Criteria (for control group):

* Benign non-invasive bladder disease
* No PBS/IC
* Normal urine culture
* No functional bladder disease of known nature (ex. infravesical obstruction)

Exclusion Criteria:

* Age under 18 years
* Inability to understand instructions
* Pregnancy and lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital at Herlev
Study officials:
affiliation: Roskilde County University Hospital at Koege, Dept. of Clinical Biochemistry
name: Pierre Bouchelouche, MD
role: STUDY_DIRECTOR
References:
citation: Birder LA, Wolf-Johnston A, Buffington CA, Roppolo JR, de Groat WC, Kanai AJ. Altered inducible nitric oxide synthase expression and nitric oxide production in the bladder of cats with feline interstitial cystitis. J Urol. 2005 Feb;173(2):625-9. doi: 10.1097/01.ju.0000145900.22849.1d.
citation: Bouchelouche K, Nordling J. Recent developments in the management of interstitial cystitis. Curr Opin Urol. 2003 Jul;13(4):309-13. doi: 10.1097/00042307-200307000-00007.
citation: Logadottir YR, Ehren I, Fall M, Wiklund NP, Peeker R, Hanno PM. Intravesical nitric oxide production discriminates between classic and nonulcer interstitial cystitis. J Urol. 2004 Mar;171(3):1148-50; discussion 50-1. doi: 10.1097/01.ju.0000110501.96416.40.
Clinical trial NCT00918606: An Evaluation of the Pharmacokinetics and Safety of LIPO-102 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Subcutaneous Adipose Tissue Reduction
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.


Eligibility criteria: Inclusion Criteria:

* Male and non pregnant female
* 18-55 years old
* Sufficient abdominal fat for injections
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days before first dose

Primary outcomes:
measure: Safety: Laboratory tests, medical exams
timeFrame: 4 weeks
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 24 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
Study officials:
References: