louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00285688: Antibiotic Resistant Helicobacter Pylori in Rajavithi Hospital
Official title: Antibiotic Resistance Helicobacter Pylori and Clarithromycin Resistance Mutation in Helicobacter Pylori in Rajavithi Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspepsia
Keywords: H. Pylori, Clarithromycin resistant, gene
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2006-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dydpepsia patient with gastroscopic examination

Brief summary: Peptic ulcer disease is the most common gastrointestinal disease. Antibiotic resistant Helicobacter pylori is a major problem worldwide. The gold standard for Helicobacter pylori eradication is composed of Proton-pump inhibitor/Ranitidine bismuth citrate + Amoxycillin + Metronidazole /Clarithromycin. In Thailand, clarithromycin resistant strains increased and led to treatment failure. Data on file at Rajavithi Hospital showed that metronidazole resistant H. pylori was about 50% and Clarithromycin resistant strains accounted for 8%. This molecular genetic study will be performed in patients presenting with dyspepsia, who had an indication for gastroscopic examination, to explore the incidence of antibiotic resistant Helicobacter pylori in Rajavithi Hospital, Thailand.

Detailed description: Genetic and Biomolecular factors determining clarithromycin resistance will be characterized.

Eligibility criteria: Inclusion Criteria:

* male or female with dyspepsia
* age \> 15 years
* fulfil indication for gastroscopic examination
* able to give informed consent

Exclusion Criteria:

* contraindication for gastroscopic examination and biopsy

Primary outcomes:
measure: Incidence of H. pylori Clarithromycin resistance gene
timeFrame: one year
Secondary outcomes:
measure: Characteristic of H. pylori clarithromycin resistant gene mutation
timeFrame: one year
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Rajavithi Hospital
state: Bangkok
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Piyathida Harnsoomboon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansomburana P, Anantapanpong S, Sirinthornpunya S, Chuengyong K, Rojborwonwittaya J. Prevalence of single nucleotide mutation in clarithromycin resistant gene of Helicobacter pylori: a 32-months prospective study by using hybridization real time polymerase chain reaction. J Med Assoc Thai. 2012 Mar;95 Suppl 3:S28-35.
Clinical trial NCT00436488: Frequency of ICAM-1 Polymorphisms in Obese Subjects
Official title: Study of the Association Between ICAM-1 Polymorphisms and Severe Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: ICAM-1
Obesity
Gene variants
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2007-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The genetic contribution to the development of obesity is now well recognized. However obesity is a polygenic disease and thus many genes are likely to be involved. This study aims to investigate the possible association between specific variants of the gene coding for the Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian population

Detailed description: Severely obese subjects referred to our institution will be evaluated. For the aim of the study, a venous blood sample will be obtained from these subjects and from a group of normal weight volunteers. Genomic DNA will be extracted from the blood samples and analysed by standard molecular biology techniques.The allelic and genotype frequencies of the two ICAM-1 variants will be calculated in the obese and control groups. The statistical significance of possible differences will be determined

Eligibility criteria: Inclusion Criteria:

* Obesity

Exclusion Criteria:

* Associated inflammatory diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Auxologico Italiano
name: Anna Maria Di Blasio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03846388: Reproductive Outcome in Assisted Conception Cycles
Official title: Prediction Of Reproductive Outcome in Assisted Conception Cycles in Women With Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 292
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Infertility is the failure to conceive after regular unprotected sexual intercourse for one year. Primary infertility refers woman who has never conceived, and secondary infertility to one who has had a previous pregnancy.The most frequent causes for infertility are ovulatory disorder or anovulation (27-30%) , tubal factor(20-22%), abnormal semen parameters(45-50%). Unexplained infertility refers to infertile couples in whom standard investigations, including tests of ovulation, tubal patency tests and semen analysis are normal. incidence 15-17% of infertile couples. New guidelines on infertility recommend that women with unexplained infertility should be advised for expectant management for 2 years .If pregnancy is not achieved after this period In vitro fertilization Should be considered. The Fast Track and Standard Treatment trial demonstrated A shorter time to pregnancy and higher per cycle pregnancy rates for In vitro fertilization compared with treatment with oral agents or gonadotropins in Patients with unexplained infertility. Successful pregnancy after assisted reproductive technology is influenced by numerous predictors that have been investigated in the previous years. The central predictors of success are the sperm, oocyte quality and endometrial receptivity. Oocyte quality depends mainly on the age of the woman , and her ovarian reserve. Parameters most commonly studied are the woman's age , her antral follicle count , and laboratory tests including serum randomly done during the menstrual cycle levels at day 3 of the cycle.


Eligibility criteria: Inclusion Criteria:

* in vitro fertilization treatment due to many factors including tubal, male, and unexplained factors.
* body mass index (BMI) (18-35)kg/m2

Exclusion Criteria

1. patient age less than 20 and more than 40 years.
2. body mass index less than 18 and more than 35 kg/m2.
3. period of infertility less than 2 years..
4. untreated hyperthyroidism, hypothyroidism, diabetes, hypertension.

Primary outcomes:
measure: live birth rate
timeFrame: 12 months
Secondary outcomes:
measure: Number of fertilized oocytes
timeFrame: 3 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT00653588: Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks
Official title: A 26-Week, Double Blind, Randomised, Multi-Centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin (40 mg) With Atorvastatin (80 mg) in Subjects With Hypercholesterolaemia and Coronary Heart Disease or CHD Risk Equivalents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Coronary Heart Disease
Keywords: Cholesterol
low density lipoproteins
Hypercholesterolemia
Coronary Heart Disease
Rosuvastatin
Crestor
Atorvastatin
Lipitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-07
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..


Eligibility criteria: Inclusion Criteria:

* A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
* Fasting LDL-C concentrations at Visit 1 as defined in the protocol.

Exclusion Criteria:

* History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
* Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
* Severe congestive cardiac failure (as defined by the protocol - Appendix I).
* Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1).

Primary outcomes:
measure: To compare the efficacy of rosuvastatin with atorvastatin by assessing the percentage change from baseline to week 8 in LDL-C concentrations in subjects with hypercholesterolaemia and CHD or CHD risk equivalents.
Secondary outcomes:
measure: To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8
Other outcomes:
Locations:
Study officials:
affiliation: St Michaels hospital, Canada
name: Dr. Lawrence Leiter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04192188: Supportive Periodontal Therapy Under Antiresorptive Therapy
Official title: Supportive Periodontal Therapy Under Antiresorptive Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Antiresorptive Drugs
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing supportive periodontal therapy (SPT) in the Section of Periodontology, Clinic of Conservative Dentistry, University Hospital Heidelberg

Brief summary: This observational study investigates the one-point in time and course of clinical periodontal and dental parameters during supportive periodontal therapy in patients under and without antiresorptive medication.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing supportive periodontal therapy (SPT) after completing anti-infectious therapy (AIT) in the Section of Periodontology, Clinic of Conservative Dentistry, University Hospital Heidelberg
* Regular attendance to SPT (no interruption of interval of more than one year)
* Existing radiographs (orthopantomogram or dental status) of up to six months before AIT
* ART-group: patients on antiresorptive medication (underlying diseases: osteoporosis, cancer diseases)
* Understanding of participation in this study and given informed consent

Exclusion Criteria:

* Patients \< 18 years
* Patients who underwent radiation therapy
* Pregnancy

Primary outcomes:
measure: Is there a difference in the clinical attachment level between patients under antiresorptive therapy and without antiresorptive medication?
timeFrame: 0 months
Secondary outcomes:
measure: Is Intraoral digital photography suitable for DMFT and implants assessment?
timeFrame: 0 months
measure: Is there a difference in the clinical attachmentlevel between baseline and 12 months after the beginning of supportive periodontal therapy in patients under antiresorptive therapy compared to patients without antiresorptive medication?
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Antonio Ciardo, Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108288: Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.


Eligibility criteria: Inclusion Criteria:

* Subjects who are considered medically healthy per investigator's judgment

Exclusion Criteria:

* Subjects with ocular conditions as defined by the protocol
* Subjects with intraocular pressure: \<10 or ≥22 mmHg

Primary outcomes:
measure: Cmax of Carteolol
timeFrame: Day 1 and Day 7
measure: Cmax of Latanoprost Acid
timeFrame: Day 1 and Day 7
Secondary outcomes:
measure: Tmax of Carteolol
timeFrame: Day 1 and Day 7
measure: Tmax of Latanoprost Acid
timeFrame: Day 1 and Day 7
Other outcomes:
Locations:
city: Kansai Region
country: Japan
Study officials:
References:
Clinical trial NCT04229888: Meibomian Gland Dysfunction Treatment
Official title: Meibomian Gland Dysfunction Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Dry Eye
Keywords: dry eye
meibomian gland dysfunction
lipiflow
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.


Eligibility criteria: Inclusion Criteria:

* evidence of meibomian gland obstruction in both eyes
* dry eye symptoms per DEQ-5

Exclusion Criteria:

* active ocular infection
* previous LipiFlow treatment
* beginning new oral or other systemic medications within prior 3 months
* beginning new or changing dosages of ocular medications within prior 3 months
* previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months
* habitual contact lens wear in prior 3 months
* women who are pregnant or nursing

Primary outcomes:
measure: Dry Eye Questionnaire 5 (DEQ-5) Score
timeFrame: 2 weeks
Secondary outcomes:
measure: Meibomian Gland Score
timeFrame: 2 weeks
measure: Tear Break-Up Time (TBUT)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Optometry
state: Indiana
Study officials:
References:
Clinical trial NCT05291988: A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial
Official title: A Multilevel Approach to Improving Colorectal Cancer Screening in Rural Communities of the FH/UW Catchment Area
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This clinical trial determines the feasibility of a multilevel approach to improve colorectal cancer screening within two rural regions of the Fred Hutchinson Cancer Research Center/University of Washington Consortium catchment area. The catchment area is the greater Puget Sound Region (13 counties). These rural counties have the highest overall rates of cancer incidence and mortality in the area; rural/small town residents in the catchment area had the lowest rates of meeting mammogram, Pap, and colorectal screening recommendations. This study involves observational data and questionnaire assessments to determine if an online version of the evidence-informed national colorectal cancer screening program, known as "Screen to Save (S2S)" and a fecal immunochemical test (FIT) kit distribution are acceptable and accessible to patients. FIT kits may help doctors find colorectal cancer sooner, when it may be easier to treat.

Detailed description: OUTLINE:

Participants receive S2S online screening education and FIT kit for sample collection.

After completion of study intervention, patients are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* Age 45 years or older or \< 45 years old with family history of CRC
* Speak and read English or Spanish
* Current resident in Clallam county
* Currently non-adherent to CRC screening recommendations

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: Accessibility
timeFrame: Up to 3 months
measure: Acceptability
timeFrame: Up to 3 months
measure: Participant uptake
timeFrame: Up to 3 months
measure: Demographic information
timeFrame: At pre-intervention only
Secondary outcomes:
measure: Colorectal cancer knowledge
timeFrame: Up to 3 months
measure: Behavioral intention
timeFrame: Up to 3 months
measure: Social engagement
timeFrame: Up to 3 months
measure: Medical and colorectal cancer information
timeFrame: At pre-intervention
measure: COVID-19 impact assessment
timeFrame: At pre-intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Sequim
country: United States
facility: Olympic Medical Cancer Care Center
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Rachel Ceballos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00459888: Cryoplasty CLIMB-registry
Official title: CLIMB Prospective Multicenter Registry Evaluating the Use of the PolarCath Peripheral Dilatation System (Boston Scientific) in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia (Rutherford 4 and 5).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Limb Ischemia
Peripheral Arterial Occlusive Disease
Keywords: CLI
Critical Limb Ischemia
Infrapopliteal
Cryoplasty
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2007-04-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly according the "Instructions For Use" of the CE-approved device (PolarCath Peripheral Dilatation System, Boston Scientific) and only data are collected that have been made available conform the Standard the Standards of Care for these patients.


Eligibility criteria: Inclusion Criteria:

* Symptomatic CLI male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. If patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the PolarCath Peripheral Dilatation System (Boston Scientific) and analysed for registry purposes.

Patients will be considered eligible for inclusion into the registry if satisfying the product DFU specifications.

Primary outcomes:
measure: Clinical patency
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: procedure
measure: angiographic outcomes for the subgroup of patients in which made available.
timeFrame: 12 months
measure: Primary patency rate
timeFrame: 12 months
measure: Limb-salvage rate
timeFrame: 12 months
measure: Serious adverse events
timeFrame: 12 months
measure: Clinical success (improvement of Rutherford classification)
timeFrame: 12 months
measure: Health Economics assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Genk
country: Belgium
facility: ZOL Campus Sint-Jan
city: Ghent
country: Belgium
facility: University Hospital
Study officials:
affiliation: AZ Sint-Blasius, Dendermonde, Belgium
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ghent, Belgium
name: Frank Vermassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosiers M, Deloose K, Vermassen F, Schroe H, Lauwers G, Lansinck W, Peeters P. The use of the cryoplasty technique in the treatment of infrapopliteal lesions for Critical Limb Ischemia patients in a routine hospital setting: one-year outcome of the Cryoplasty CLIMB Registry. J Cardiovasc Surg (Torino). 2010 Apr;51(2):193-202.
Clinical trial NCT05795088: Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Parkinson's Disease
Official title: Role of Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary endpoint of the study is to identify a neurophysiological biomarker (absence of synaptic depotentiation at primary motor cortex , measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of neurophysiological cTBS depotentiation protocol) as predictor of the development of Levodopa-induced dyskinesia in patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
* age between 30 and 80 years;
* ongoing therapy with levodopa;
* fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire.

Exclusion Criteria:

* patients unable to give informed consent;
* cognitive impairment (MMSE ≤ 24);
* history of epilepsy;
* pregnant women.

Primary outcomes:
measure: Alterations of synaptic depotentiation in primary motor cortex
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Flavia Torlizzi
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Paolo Calabresi, MD
role: PRINCIPAL_INVESTIGATOR
References: