cyrilzakka/clinical-trials huggingface dataset:
Analysis of Stannous Fluoride in GCF and Subgingival Plaque

The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.

This is pilot study involving approximately 20 subjects with at least 20 dental pockets between 2- 4mm with bleeding for sampling. Subjects will have up to 10 sites identified as "sampling sites" that will have supragingival plaque, subgingival plaque, and gingival crevicular fluid (GCF) collected at Baseline, 30 minutes, 24 hours, and Week 2.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the study;
* Be 18 years of age or older;
* Agree not to participate in any other oral/dental product studies during the course of this study;
* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
* Agree to use the acclimation products and to refrain from using any other oral care products (including floss and mouth rinse) between the Acclimation and Baseline Visit;
* Agree to use the treatment products and refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss, mouth rinse, or whitening products;
* Agree to return for all scheduled visits and follow study procedures;
* Must have at least 16 natural teeth;
* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study;
* Agree to refrain from all oral hygiene after 11 p.m. the night prior to each visit;
* Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
* Have minimum 20 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.

Exclusion Criteria:

* Having a dental prophylaxis within 2 weeks of Acclimation visit;
* Having rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* A medical condition requiring an antibiotic prophylaxis prior to dental visits;
* A history of hypersensitivity to oral care products containing stannous fluoride; or
* Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer

The primary object of this study is to determine tumor major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy and molecular biomarkers related to the clinical response.


Eligibility Criteria:
Inclusion Criteria:

1.Able to understand the nature of this trial and provide written informed consent.

2.18 years ≤ age ≤ 80 years

3.Histologically documented non-small cell lung cancer

4.NSCLC with resection option for potential cure.This may include clinical stage IB, II and IIIA.

5.Subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy according to disease evaluation.

6.Measurable disease by RECIST v1.1

7.Tumor tissue sample and/or alveolar lavage fluid must be available for biomarker evaluation before operation.

Exclusion Criteria:

1. Subjects are excluded if they are enrolled in any other interventional studies.
2. Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration.
3. Subjects are excluded if they have an active, known or suspected autoimmune disease requiring systemic treatment (e.g.corticosteroids or other immunosuppressive medications) in 2 years before the study drug administration. substitution therapy ( e.g. thyroxine, insulin) are permitted.
4. Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC.
5. History of allergy to study drug components
6. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.
7. Any other conditions that, in the Investigator's opinion, unfit to attend this study.
Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic stable disease with any type of functioning CVC in the upper or lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to remain in the subject for the treatment portion of the study.
* \> 12 to \<18 years of age

Exclusion Criteria:

* Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug
* Active bleeding or high risk of bleeding
Multi-modal Exercise Program in Older Aduls With Knee Osteoarthritis

Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults with knee osteoarthritis.

* Aim: To evaluate the short-term effects of 16 week multi-modal exercise program on physical performance variables in independent community-dwelling older adults with knee osteoarthritis.
* Design: randomized controlled trial.
* Setting: home-based intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Knee pain
* Score in Kellgren-Lawrence Scale ≥1

Exclusion Criteria:

* Unable to ambulate independently
* Mini-mental state examination score \< 24
* Barthel Index score \< 80
* Unstable cardiovascular disease
* Neurological disorder that could compromise exercising
* Upper or lower-extremity fracture in the past year
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors

This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for randomized Dose-Ranging Part. Dose-Ranging Part is designed mainly to further evaluate safety and preliminary efficacy of HM97662 monotherapy in subjects with specific genomic alterations to more precisely determine the potential RP2D that are to be tested in a Dose-Expansion Part. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RP2D to subjects in indication-specific expansion cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically confirmed advanced or metastatic solid tumor who have failed/are intolerant to standard therapy.
* Patients for dose-escalation part must have evaluable or measurable disease at baseline and the patients for randomized dose-ranging and dose-expansion part must have at least one measurable lesion at baseline by CT or MRI per Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥ 3 months before starting HM97662.
* Adequate renal function.
* Adequate hematologic function.
* Adequate liver function.
* Males or females aged ≥ 18 years (or country's legal age of majority if the legal age was \> 18 years) at the time of informed consent.
* For Dose-Ranging Part, documentation of an alteration in at least one of the genes of the SWI/SNF complex in tumor tissue (archival or newly obtained).

Exclusion Criteria:

* Prior exposure to valemetostat or other EZH1/2 dual inhibitor.
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
* Patients currently taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers.
* Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
* Major surgery within 4 weeks before the first dose of study drug treatment in Cycle 1.
* Females who are pregnant or breastfeeding.
* Patients who have undergone an organ transplant.
Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

Primary Objective:

To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after 6 months of treatment in patients with monotherapy until the end of the trial.

Secondary Objective:

To evaluate the effect of glimepiride compared to sitagliptin in:

Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c \< 7% and \< 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of patients with rescue therapy; Safety (adverse events and serious adverse events, hypoglycemia, vital signs and laboratory results).


Eligibility Criteria:
Inclusion criteria:

* Subject naïve to treatment
* HbA1c \> 8.5 up to 11 %
* Lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing

Exclusion criteria:

* Treatment with any oral antidiabetics or insulin
* Known type 1 Diabetes Mellitus
* Pregnant or breast feeding women
* Ketoacidosis history
* History of sensitivity to any of the active substances
* Renal dysfunction : serum creatinine \> or = 1.5 mg/dL in male subjects \> or = 1.4 mg/dL in female subjects
* Liver impairment (ALT, AST \> 3-fold the upper limit of normal range)
* Systemic corticosteroid treatment 3 months prior to study or during the study
* Drug or alcohol abuse history
* Patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months
* Presence of any condition (medical, psychological, social or geographic) current or previously seen that according to Investigators judgment jeopardizes the safety or restricts the participation of the patient during the study
* Neoplasias

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* A male or female aged 18 years or above at the time of vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
* Administration of an influenza vaccine within the six months preceding the study vaccination.
* Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
* Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
* Acute disease and/or fever at the time of enrolment.
* Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic underlying disease, not stabilized or clinically serious.
* History of chronic alcohol consumption and/or drug abuse.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of Guillain-Barré syndrome.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Anaphylaxis following the administration of vaccine(s).
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Off-label Use of Anti-cancer Drugs in Norway -a Prospective Cohort Study

Off-label drug use, where a marketed drug is used outside its approved indication, may allow early access to new and promising treatments. However, its use can be a source of controversy, due to limited evidence for clinical benefit and lack of cost/QALY-estimates, leading to challenging prioritization issues. The number of drugs suitable for off-label use is expected to further increase in the coming years, owing to the rapid progress in the field of oncology, in particular with the current era of precision medicine and targeted therapies. This also challenges the traditional method of running clinical trials, with eligible patient populations commonly being small, underpinning the importance of gaining supplementary real-world evidence from well performed observational studies.

This prospective observational study will therefore assess real-world outcomes of patients treated with off-label anti-cancer drugs, including efficacy in terms of response rates, time to progression/relapse measures and survival; patient-reported outcome measures (PROMS) and self-reported side-effects/toxicity; as well as collecting blood samples for a biobank for further translational research. Further, the study will give a descriptive analysis of the current practice of off-label use of anti-cancer drugs in Norway, including prevalence estimation and health care related cost analyses.


Eligibility Criteria:
Inclusion Criteria:

* Verified cancer diagnosis (based on radiological, histological/cytological or operative evidence).
* Treatment with off-label anti-cancer drug.
* Age ≥ 18 years
* Able to provide written informed consent.

Exclusion Criteria:

* None
Donor-derived Cell-free DNA in Kidney Transplant Recipients

Donor-derived cell-free DNA (dd-cfDNA) is a promising non-invasive biomarker of kidney allograft rejection. In this prospective, single center, observational monitoring study, we aim to evaluate a role of dd-cfDNA in predicting kidney allograft injuries, i.e. rejection and non-rejection injuries within 12 months, and to monitor the effect of anti rejection treatment.

Kidney transplantation represents the best therapeutic option in patients with end-stage kidney disease. Among main causes of graft loss belongs kidney allograft rejection which is diagnosed based on histology/molecular assessment of biopsy sample. This is invasive procedure, but provides more precise result regarding type of rejection. Contrary, donor-derived cell-free DNA (dd-cfDNA) is a novel non-invasive biomarker of allograft rejection with excellent negative predictive power. Moreover it may be useful for predicting allograft injuries and resolution of injuries after treatment.

In the prospective cohort, 100 renal allograft patients will be enrolled and dd-cfDNA levels determined from blood collected at predefined time points (preTX, POD14, M1, 2, 3, 4, 6, 9, 12).

In the second cohort, 40 patients will be enrolled at the time of biopsy with histological and/or molecular diagnosis of rejection and dd-cfDNA levels measured just before initiation of treatment and then at week 1, 2 and 3 after biopsy.

Peripheral blood will be collected in 2x 10 ml cfDNA (Streck) collection tubes for each study visit and dd-cfDNA will be quantified by the Prospera™ test (Natera Inc., Austin, Texas).

All patients will receive standard of care treatment according to centre protocol and no patients or providers will receive the results of dd-cfDNA testing during the study. Study protocol and patient informed consent were approved by Ethical committee.

Eligibility Criteria:
Inclusion Criteria:

* Recipient age ≥ 18 years and \<85 years
* Written Informed Consent cohort 1
* deceased donor kidney transplant recipient cohort 2
* patients with kidney allograft biopsy at center showing any type of rejection which is going to be treated
* patient wishing to repeatedly travel to center

Exclusion Criteria:

cohort 1

* living donor
* multiple transplant
* dual transplant
* haematopoetic stem cell transplant in a history
Long Term Follow up of Small Non-inflammatory Pancreatic Cysts

This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts.

This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts in a multicenter setting.

Inclusion criteria:

Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter referred to the University Hospital Hamburg Eppendorf, Israelitic Hospital Hamburg, Sana Klinikum Lichtenberg, Berlin and Krankenhaus Märkisch-Oderland,Strausberg from 2002 to 2007 identified from EUS database.

Study design:

At least 5 year-long term follow up by inclusion of clinical data, cross sectional imaging if available or actual US findings.

Primary outcome:

To determine the proportion of patients with increase is size and/or changed appearance

Secondary outcomes:

Rate of patients undergo pancreatic surgery (indication, histology of resected specimen). Rate of patients undergo FNA (fluid analysis, cytology).

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter

Exclusion Criteria:

* acute or chronic pancreatitis
* pancreatic cysts \> 3 cm
* Lesion suspicious for malignancy
Effects of Dual Task Prioritization Training on Dual Task Walking in Older People

The purpose of this single-blinded three-armed randomized controlled trial is to investigate the effect of different task prioritization during dual task training on dual task performance.

Introduction: Many activities of daily livings involve performing two tasks simultaneously, i.e. dual tasking. Performing dual task increases the demand on attentional resources, which may further decrease the dual task performance, especially in older adults. According to capacity sharing theory, the two tasks compete and influence with each other due to limited attention and information processing capacity. It has been noted that task prioritization during dual tasking may influence the dual task performance. Previous study indicated that supraposture-focus strategy resulted in better posture and task performance in older people. On the other hand, it is known that dual task training improved dual task performance. However, the effects of applying task prioritization during dual task training have not yet been investigated. Therefore, the purpose of this study is to investigate the effect of different task prioritization during dual task training on dual task performance.

Methods: Participants will be randomized into three groups: posture-focus, supraposture-focus and control group. Participants will receive a total of 12 sessions of cognitive dual task training with different prioritization strategies, i.e. prioritization on posture, cognitive or neither task. Walking and task performance during dual task walking, executive function, and balance performance will be assessed before and after the interventions (pre- and post-test).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years old
* MMSE scores \> 24

Exclusion Criteria:

* Unstable health conditions
* Any neurological, psychological disease or diagnosis of learning disability which interferes the participation in this study
Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort

We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of catheter-related bladder discomfort.

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. The volatile anesthetics such as sevoflurane and desflurane are known to block the muscarinic receptor in different ways.

We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of catheter-related bladder discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for transurethral bladder excision under general anesthesia
* ASA I-III

Exclusion Criteria:

* Bladder outflow obstruction
* Overactive bladder
* End-stage renal disease
* Neurogenic bladder
* Heart failure
* Arrhythmia
* Morbid obesity
* Use of chronic analgesic medication
* Hepatic disease
* Pulmonary disease
* Psychiatric disease
Rotational Stability Analysis of a Toric Monofocal IOL

This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.

This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.

The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.

In total approx. 20 eyes of 20 patients will be recruited for this clinical study.

Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically.

Eligibility Criteria:
Inclusion Criteria:

* Cataracteous Eyes with no comorbidity
* Regular corneal astigmatism \>1 dioptre and \<3D determined by an automatic keratometer (regularity determined by the topography of the keratometry).
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent •\>50 years old

Exclusion Criteria:

* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan's syndrome)
* Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)