cyrilzakka/clinical-trials huggingface dataset:
Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Presence of at least one Class I or II Miller gingival recession ≥ 2.5 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (\< 0.5 mm): A +(Pini-Prato et al. 2010).
* Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
* Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
* Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).

Exclusion Criteria:

* Smoking.
* Pregnancy.
* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
* Previous periodontal surgery in the area.
UW-CTRI Triple Medication Smoking Cessation Study

This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.

Recent research suggests that a new combination therapy may be especially effective in increasing long-term abstinence from smoking. A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge from the simultaneous use of three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge) and the timing of those events, in order to better assess how the use of this combination of tobacco cessation medicines can be most effectively and safely delivered and monitored. Study participants will take the three medications for 12 weeks in a manner consistent with labeling. Adverse events will be assessed at all study visits.

Eligibility Criteria:
Inclusion Criteria:

* Age \>17 years;
* \>=5 cigarettes/day for the previous 6 months;
* alveolar CO \>= 6 ppm; able to read, write and speak English;
* planning to remain in the intervention catchment area for at least 4 months; not currently taking bupropion or varenicline;
* if the participant is currently using NRT, s/he agrees to use only study medication for the duration of the study;
* free of medical contraindications to NRT and varenicline; and,
* if participant is a woman of childbearing potential, using an approved method of birth control during treatment.

Exclusion Criteria:

* Current diagnosis of/treatment for psychosis or bipolar disorder;
* suicidal ideation within the past 12 months; any history of suicide attempts; \* significant hepatic or renal impairment; history of significant allergic reactions to varenicline or any type of NRT in the past;
* use of any investigational drugs in the previous 30 days. -
Dermacyd PH_DESILSTY_FL (Lactic Acid) - Acceptability - Stay on Floral.

Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility Criteria:
Inclusion criteria:

* Integral vaginal mucosa in the product analysis region
* Use the same category cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Application of Decision Analysis Techniques' in Huge Health-checkup Database to Explore the High-risk Group With Metabolic Syndrome

Application of Decision Analysis Techniques' in Huge Health-checkup Database to Explore the High-risk Group With Metabolic Syndrome (MetS)

According to the American Heart Association（AHA）modified Adult Treatment Panel III（ATP-III） and the criteria of Health Promotion Administration, Taiwan. Five indices are used to define metabolic syndrome（MetS): including waist circumference （WC), high blood pressure（H/P）, fasting plasma glucose（FPG）, triglyceride（TG）, and high-density lipoprotein-cholesterol（HDL-C）. The recent researches showed us, there was no research applying the five criteria into their decision model. This study proposal will be the first study which evaluated the importance of the criteria related to apply these indices and decision model into the clinic for risk factors assessment.

This study was divided into 2 stages: (1) to analyze the big database of health examination to find out the major decision-making analysis module of MetS, including the level of importance and decision-making weight of 5 indicators, which can be provided as reference for suggestions on clinical medical treatments or health education focuses of health management of sub-health population; (2) to analyze other demographic variables of the database (educational background, residence, occupation, etc.) and the variables affecting health patterns (including smoking, drinking, long-term sitting work pattern) to find out the important variables affecting high risk group for MetS among populations of all ages, in order to investigate the improvement strategies for early prevention or intervention of important variables. As aging society is coming, it is estimated that the elderly people over the age of 65 in Taiwan will reach 20% by 2025. According to the estimation of Executive Yuan, the growth rate of healthcare service industry will reach at least 17%, and the annual output value will reach USD 18 billion. Therefore, this study intends to develop strategies for preventing chronic illness in the middle-aged and elderly people and find out the characteristic variables of high risk group according to different age groups to further reduce the incidence of MetS or CVD.

Eligibility Criteria:
Inclusion Criteria:

1. In 2006-2016, the MJ Health Research Foundation's member,which continuously tested twice or more of the annual health check database , about 90,000 people.
2. The person who was in charge of the taxi driver health checkup project commissioned by the New North City Transportation Bureau at Far Eastern Memorial Hospital, data period 2012-2016, about 2,000 people.

Exclusion Criteria:

* no
Sub-Sensitivity to Long-Acting Bronchodilators (LABA)

The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects on airway constriction by means of methacholine challenge testing.


Eligibility Criteria:
Inclusion Criteria:

* 20 subjects males or females 18-65 years of age with physician diagnosed asthma Diagnosis of asthma \> 12 months Currently on 2 puffs SABA bid. Baseline percent FEV1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at Screening Visit Positive MTC (≤ 8mg/ml) at the end of 2 week Run-In Currently symptomatic with ACT score less than 19 at the end of run in on ICS ≥ 200 and ≤ 400 ug/day Non-smoker or ex-smoker with \< 10 pk year who stopped \> 1 year ago

Exclusion Criteria:

* Asthma exacerbation, significant airflow obstruction, or respiratory infection between Visits 0 and 2. Patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event).

Pre-existing lung disease other than asthma, including active infections Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study Noncompliance or inability to participate in all assessments. Current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for \>/= 30 days within the 24 months prior to Visit 1.

Any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for \< 30 days in the 24 months Prior to Visit 1, must agree to abstain from all smoking from the time of consent through completion.

History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator.

Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer.

Women with a positive urine pregnancy test.
Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer

* It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients

  1. Primary Purpose: Progression-free survival (PFS)
  2. Secondary Purpose:

     * Objective response rate
     * Time to treatment failure
     * Adverse event (AE), serious adverse event (SAE), and adverse event of special interest (AESI)
     * Severity of (S)AE
     * duration of response (DoR)
     * Overall survival (OS)
     * Intravenous Progressive Survival Period (Intracranial PFS)
     * Relative dose intensity
* Research Design : a Multi-Center Prospective and Restrospective Cohort Study

□ the purpose of the study The study aims to explore the safety, efficacy and resistance of test drugs in patients with local progressive or metastatic epithelial growth factor T790M mutant non-small cell lung cancer who have been treated with epithelial growth factor receptor tyrosine kinase inhibitors.

This study is conducted in Korea. About 600 patients will be monitored until the first occurrence of disease progression, withdrawal of consent, failure of follow-up investigation, and death.

□ Research Procedures and Information Gathering Items There are no additional procedures performed by participating in this study and information on safety and effectiveness during the administration of Rexhraza will be followed up in routine care situations.

The information you will receive when you participate in this study is as follows.

* Subject characteristics, including age, gender, and race
* T790M Positive Mutation Status Results and Types of Tests Performed and Receptors
* a related medical history
* a physical examination
* disease characteristics
* history of chemotherapy
* associated concomitant medications
* administration of a test drug
* Safety and effectiveness
* Resistance mechanism in plasma circulation tumor DNA

Eligibility Criteria:
Inclusion Criteria:

1. Prospective cohort

   * adults over the age of 19
   * Easter Cooperative Oncology Group performance 0-4
   * Patients who are eligible for or are being treated for test medication as per permit: patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI
   * EGFR T790M mutation allows for all results identified in tumor tissue or plasma
   * Patients with brain MR within 3 months of study participation
2. Rectrospective cohort

   * adults over the age of 19
   * Patients who are already using the test drug according to the domestic authorization of the test drug

Exclusion Criteria:

* Patients who have a history of hypersensitivity to test drugs or drugs of similar chemical structure or similar family to those of test drugs
* Pregnant women or lactating women
* Patients participating in other interventional clinical studies
[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint

This protocol will evaluate the sensitivity and specificity of \[124I\]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females age \>18 years
2. Ability to provide informed consent
3. A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment
4. Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint
5. Prosthetic joint implant that has been in site for more than 3 months prior to enrolment
6. Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent
7. Women must be either postmenopausal or surgically sterile
8. Ability to return for all study assessments
9. Clinically euthyroid, or on stable thyroid replacement therapy

Exclusion Criteria:

1. Subjects who are unable to comply with study requirements
2. Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning
3. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis \[NARP\]; myoneurogenic gastrointestinal encephalopathy \[MNGIE\]; myocolonic epilepsy with ragged red fibers \[MERFF\]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome \[MELAS\])
4. Alanine aminotransferase (ALT) \>5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) \>5X ULN
5. Creatinine clearance \<30 mL/min
6. Body mass that exceeds the rating of the CT table
7. Hypersensitivity to iodine
8. Any condition that would put the subject at reasonable risk in the opinion of the investigator
Long-Term Follow-Up (LTFU) of Subjects Dosed With NTLA-2001

This is a follow-up study of subjects who received NTLA-2001 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.


Eligibility Criteria:
Inclusion Criteria:

1. A subject has completed or discontinued from an Intellia-sponsored clinical study in which a complete or partial dose of NTLA-2001 was received.
2. A subject has provided informed consent for the LTFU study.

Exclusion Criteria:

None
The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol

To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance

Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.

Eligibility Criteria:
Inclusion Criteria:

* Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent
* Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA)

Exclusion Criteria:

* Acute myocardial infarction within 2 weeks
* Unstable angina within 2 weeks
* History of using glycoprotein IIb/IIIa inhibitor within 1 month
* Cerebral infarction within 3 months
* Bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count \< 100,000/uL)
* history of gastrointestinal bleeding or genitourinary bleeding within 3 months
* needed oral anticoagulation
* aspirin, clopidogrel or cilostazol hypersensitivity
* congestive heart failure
* serum creatinine level \>2mg/dl
* malignancy
* using cytochrome P450 inhibitor (eg, itraconazole)
Tolerance to Light for Patients Suffering From Keratitis

In order to develop an innovative device to study infectious keratitis, we need to illuminate the cornea of patients suffering from an infectious keratitis with red or near-infrared light. Because of technical reasons the shortest possible wavelength (red) presents advantages.

The aim of this preliminary study is to measure the maximal intensity tolerated during illumination with 6 wavelength corresponding : 2 red, 2 far red and 1 near infrared lights in order to determine the shortest wavelength well tolerated by patients, in comparison with the standard blue light illumination.

Eligibility Criteria:
Inclusion Criteria:

* Social security insurance
* Suspected infectious keratitis (clinically defined. No lab testing required)
* Signed informed consent

Exclusion Criteria:

* Major Blepharospasm
* Aphakia (absence of lens)
* Pregnant woman
* Nursing mother
WASP Classification in Diagnosis of Diminutive Colorectal Polyps

Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Some studies have investigated the value of the narrow-band imaging (NBI) on histological prediction of the polyp. This method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. For instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.

In this study the investigators want to investigate whether the use of NBI would be capable to get accuracy of optical polyp predictions by more than 90% using the WASP (Workgroup serrAted polypS and Polyposis) classification. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial the investigators aim to compare accuracy of the optical diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years old
* Patients with at least one diminutive colorectal polyp

Exclusion Criteria:

* Patients with poor bowel preparation
* Paitents with history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
* Patients with advanced colorectal cancer
* Patients with missed histology information of resected polyps or missed resected specimen
* Patients with emergency operation during colonoscopy
* Patients with unfinished colonoscopy due to any reason
Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks

To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males.

In a randomized, double-blind, cross-over, placebo controlled design, healthy male volunteers receive intranasal oxytocin or placebo prior to functional magnetic resonance imaging.Subjects will then go through a decision making task, a emotion judgement task and an eight-minute resting-state scan in MRI scanner to investigate whether and how intranasal oxytocin alter the topology of functional brain network in resting-state and multiple tasks in healthy males. State anxiety and mood are measured before and after experiment as covariates to be controlled.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* with MRI Contraindications
International Melanoma Algorithm Training Study - IMATS

This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study \[IMATS\]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of any ethnic group
* Lesion located on normal healthy skin
* Maximum number of eight lesions per patient
* etc.

Exclusion Criteria:

* Lesion under finger and toe nails
* Lesion located on eczema, psoriasis areas or similar
* Lesion located on scars
* etc.
Telenutrition Weight Loss Study for Men

This study is a 12-week pilot randomized controlled trial to test the feasibility and effectiveness of a home telenutrition weight loss program in men in West Virginia.

This study is a 12-week pilot randomized controlled trial of a home telenutrition weight loss program for men with obesity and at least one additional risk factor for cardiovascular disease. The primary aims are to:

1. To assess the feasibility and acceptability of the male-targeted telenutrition weight loss program in terms of recruitment, retention and satisfaction and
2. To evaluate the effectiveness of the telenutrition program compared to usual care (informational only) with regard to primary and secondary outcome measures at 12 weeks. We hypothesized that men receiving virtual and telephonic support from a registered dietitian nutritionist would have greater weight loss and greater improvements in diet quality than men who were only provided educational materials.

Eligibility Criteria:
Inclusion Criteria:

* 40-70 year old man
* Body mass index ≥ 30
* Living with spouse or companion
* At least one of the following: hypertension, diabetes, pre-diabetes, hypercholesterolemia or hypertriglyceridemia
* A home computer with high-speed internet access
* A telephone for health coach phone calls

Exclusion Criteria:

* Cancer (except skin or prostate), celiac disease, bacterial or viral infections, renal or liver disease (except non-alcoholic fatty liver disease), or condition that prevents fruits and vegetable consumption
* Major surgery or health event (e.g., stroke, heart attack) in the past six months
* Taking insulin, anti-obesity medications, steroids (e.g., Prednisone), or warfarin (Coumadin)
* Pacemaker or defibrillator
* Currently on a weight loss diet or lost \> 10 pounds in past six months
* Consume more than two alcoholic beverages daily