cyrilzakka/clinical-trials huggingface dataset:
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets

The main purpose of the trial is to investigate the effect of locally delivered ciclosporin as an adjunct to non-surgical mechanical debridement in the treatment of chronic periodontitis and to compare it to mechanical debridement alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients in good general health
* 2 pairs of contralateral interproximal periodontal sites with probing depths of ≥7mm in single-rooted teeth not associated with furcations or root furrows.The test sites should have a distance of at least two teeth to the control sites.
* Teeth selected should have a vital pulp as determined by thermal or electric stimulation

Exclusion Criteria:

* Patients already included in other clinical trials involving therapeutic intervention (either medical or dental)
* Periodontal treatment during the last 6 months
* Antibiotic treatment 6 months prior to the start of the trial
* Antibiotic prophylaxis required for dental treatment
* Patients with acute infectious lesions in the areas of intended treatment
* Regular anti-inflammatory medication
* Known history of ciclosporin allergy
* Ongoing medication that may affect the clinical features of periodontitis
* Patients who are smokers
* Patients that are immuno-compromized or on immunosuppressive medication
* Patients who are pregnant or lactating
Stress-reducing Intervention in Urothelial Carcinoma

The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone.

This is a prospective, interventional, clinical study with a target of 50 subjects and an anticipated total duration of 36 months.

The goal of this study is to test the HRV BI in patients with MIBC treated with total of 3 to 4 courses of chemotherapy Gemcitabine 1000 mg/m2 + Cisplatin 70 mg/m2 day 1 (GC, new course day 22) or Methotrexate 30 mg/m2 day 1, Doxorubicin 30 mg/m2 day 2, Vinblastine 3 mg/m2 day 2, Cisplatin 70 mg/m2 day 2 with Pegfilgrastim 6 mg s.c. day 4 (ddMVAC, new course day 15) in neoadjuvant setting followed by radical cystectomy or irradiation concomitantly with cisplatin 70 mg/m2 weekly (SOC) and compare to SOC.

Participants will undergo 4 sessions of HRV BI with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain, and how to perform deep paced breathing with the HRV monitoring. They will perform the training daily (3-times, minimum 7 minutes each) at home with the online control for 3 months.

Researchers will compare the effect of addition of 3-months training of HRV BI to SOC on inflammation, HRV, quality of life (QoL), cognitive functions, salivary cortisol slopes, sleep quality and treatment outcomes.

Eligibility Criteria:
Inclusion criteria:

1. Patients older than 18 years.
2. Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy.
3. No prior chemotherapy.
4. No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.
5. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 ml/min.
6. Absolute granulocytes count 1,500/mm3 or higher, platelets 100,000/mm3 or higher, bilirubin 1.5x the upper limit of normal value and lower.
7. Adequate liver functions.
8. Basic computer skills.
9. Signed informed consent.

Exclusion criteria:

1. Diabetes mellitus with symptomatic neuropathy.
2. Using antiarrhythmic drugs, opiates and/or antidepressants.
3. Implanted permanent pacemaker (PPM).
4. Human Immunodeficiency Virus (HIV) infection.
5. Not fitting inclusion criteria.
Delphi Process to Achieve Global Consensus on Gender Equity in Critical Care

Gender inequalities in healthcare, including among critical care professionals, have been widely recognized over the last decade. Significant gender disparities persist in areas including leadership, academia, research, workplace remuneration, and medical publication among critical care professionals. Furthermore, there remains a notable gap in knowledge and awareness regarding gender equity (all genders) and inclusivity among healthcare professionals.

Given the limited research and evidence on these issues, Investigator propose employing the Delphi methodology to generate consensus among global critical care practitioners on position statements aimed at addressing gender equity (all genders) in critical care.

To generate consensus among a diverse panel of critical care practitioners, scientists, and researchers on the strategic measures to achieve gender equity in critical care within healthcare institutions, professional societies, organizations, and boards in various professional domains.

Eligibility Criteria:
Inclusion Criteria:

* Professionals working in Intensive Care, Critical Care Practitioner, Scientists, or Researcher
* Any one of the following: having publications, engagement in advocacy related to gender equity, and currently or in the past holding an official leadership position in the Critical Care Society, Intensive care unit, or a healthcare institution
* Completed the Harvard Implicit Association Test (IAT)5

Exclusion Criteria:

* unwilling to participate
Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)

This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.

Please refer to detailed description in the following context.

Eligibility Criteria:
Inclusion Criteria:

* The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
* Primary lung adenocarcinoma diagnosed histologically/cytologically.
* Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
* EGFR mutation positive (19Del or L858R, with or without T790M)
* The presence of at least one measurable lesion and suitable for accurate repeated measurements.
* ECOG performance status 0-1.
* For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.

Exclusion Criteria:

* Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
* Patients with EGFR exon 20 insertion mutation.
* Exposure to other antitumor therapies prior to enrolment.
* Major surgery was performed in the four weeks prior to the first dosing of the study drug.
* Pregnant or lactating female patients.
* Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration.
* Have a history of or present complications with other malignancies.
* Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study.
* ECG QT interval prolongation or associated risk.
* A history of interstitial pneumonia or related risk.
* Inadequate bone marrow or organ reserve.
* Other circumstances that are not suitable for participation in this study.
Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients

This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patients with cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists or patients with locally advanced or metastatic basal cell carcinoma who are not amendable or eligible for standard therapy.
* Protocol-defined renal , liver and bone marrow function

Exclusion Criteria:

* CNS (Central Nervous System) tumors as well as history of brain metastases
* Systemic anticancer treatment (including biologic therapy/antibodies) within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies).
* Radiation therapy within 4 weeks before first dose
* Investigational agents within 4 weeks before start of study therapy
* Patients with known allergy/hypersensitivity to warfarin or bupropion and/or related compounds
* Patients with a history of/or active bleeding disorders
* Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed.
* Patients receiving treatment with bupropion.
* Patients who have neuromuscular disorders that are associated with elevated CK (Creatine phosphokinase) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
* Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C (testing is not mandatory for study entry)
* Patients currently receiving systemic corticosteroids

Other protocol-defined inclusion/exclusion criteria may apply
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 65 to 75 years of age
* Stable Body Weight
* Dissatisfaction with the submental area expressed by participants
* Acceptable volume of submental fat graded by clinician
* BMI of ≤40.0 kg/m\^2
* Signed informed consent (ICF)
* SMF rating of 2 or 3 by clinician and patient

Exclusion Criteria:

* No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
* Absence of clinically significant health problems
* Anatomical features for which reduction in SMF may result in aesthetically unacceptable outcome, judged by clinician
* History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
* Body mass index of ≥40.0 kg/m\^2
Validity of Smart Cap and Smart Sweat Patch

The main objectives are to determine the validity of a Smart Cap in measuring fluid intake during running and fitness exercise and the validity of a Smart Sweat Patch in measuring sweat rate and sweat chloride concentration during outdoor cycling, running, and fitness exercise. A secondary objective is to compare regional sweating rate and sweat electrolyte concentrations (sodium, chloride, and potassium) on contralateral arms with vs. without tattoos.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female
* Subject is 16-65 years of age
* Subject is moderately-trained (participates in regular outdoor fitness (\~1 h), cycling (1-2 h), or running (0.5-1 h) sessions ≥2x per week)
* Subject is participating in an instructor-led fitness session, typical training run, or group bicycle ride

Exclusion Criteria:

* Subject is pregnant
* Subject is a smoker
* Subject is taking a medication or oral supplement that could interfere with study results
* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)
* Subject has ≥ 2 cardiovascular risk factors as assessed on the General Health History Questionnaire
* Subject has participated in a clinical trial within past 30 days
* Subject has participated in any PepsiCo trial within past 6 months
* Subject has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
* Subject is employed by, or has a parent, guardian or other immediate family member employed by, a company that manufactures any products that compete with any Gatorade products. If subject is unsure if a company would be considered a competitor to Gatorade they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Have persistent facial erythema on the cheeks of at least moderate severity.
* Women must not be able to bear children

Exclusion Criteria:

* Have more than 12 inflammatory lesions on the face
* Previous treatment of facial skin with lasers or electrocauterisation within 2 months prior to entering the study
* Have facial hair that makes it difficult to evaluate rosacea on the face Other protocol-defined inclusion/exclusion criteria may apply
Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI

The purpose of this study is to assess:

* the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
* ticagrelor and its metabolite levels by LC-MS/MS

Ticagrelor is an anti-platelet agent of the cyclopentyltriazolopyrimidine class. It is administered by the oral route, rapidly absorbed (2-3 hours), and has a bio-availability estimated at around 36%. Contrary to other P2Y12 inhibitors, ticagrelor is not a pro-drug and does not need to be metabolized to exert is pharmacodynamic effect. It had been previously showed that stimulation of platelets by ADP or inhibitors of platelets by ticagrelor modified the organisation of the platelet membrane, with a re-distribution of cholesterol and P2Y12 receptors towards the lipid rafts. This suggests that lipid membranes and cholesterol may play an important role in the anti-platelet activity of ticagrelor.

In this context, the aim of the study is to assess:

* the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
* ticagrelor and its metabolite levels by LC-MS/MS.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years and less than 90 years,
* Patients admitted for myocardial infarction treated with ticagrelor in association with aspirin.
* Patients affiliated to a social security system (or be a beneficiary thereof);
* Sign written informed consent indicating that they have understood the study procedures and objectives, and that they accept to participate and adhere to the study requirements.

Exclusion Criteria:

* Patients with limited legal capacity or patients under legal guardianship
* Patients under judicial protection
* Patients not affiliated to any social security system
* Patients taking any antiplatelet agent other than ticagrelor Patients taking ticagrelor for \<48 hours (treatment not stabilised) Patients with hemoglobin concentration \<10 g/dL on the most recent blood test
Endurant Stent Graft Natural Selection Global Postmarket Registry

The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

The Endurant Stent Graft Natural Selection Global Post-market Registry, ENGAGE is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. This subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. ENGAGE aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. ENGAGE will not impose CIP required study procedures affecting clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or minimum age as required by local regulations
* Indication for elective surgical repair of AAA with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System
* Signed consent form ("Patient informed consent Form" or "Patient Data Release Authorization Form"). The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information
* Intention to electively implant the ENDURANT Stent Graft System
* Ability and willingness to comply with the CIP.

Exclusion Criteria:

* High probability of non-adherence to physician's follow-up requirements
* Current participation in a concurrent trial which may confound study results
Profile Fecal Analysis of Neutropenic Enterocolitis

A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis


Eligibility Criteria:
Inclusion Criteria:

* patient\>= 18 years old;
* cytological diagnosis of de novo Acute Myeloid Leukemia (AML) (\>20% myeloid blasts);
* eligible for intensive chemotherapy (no severe co-morbidity);
* not having received any prior chemotherapy;
* affiliation to the national social security system.

Exclusion Criteria:

* acute promyelocytic leukemia (AML 3);
* inability to understand the nature of investigations or to give informed non-opposition;
* person subject to a legal protection measure.
Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients

This study will investigate the use of High-definition Transcranial Direct Current Stimulation (HD-tDCS) in the functional improvement of hand dexterity while performing music-assisted hand exercises.

Stroke is a serious medical and health problem in the US, and most of the stroke patients suffer from upper-limb motor deficits including weakened hand dexterity. As upper-limb motor functions are crucial for most of the daily living activities, there is a need for effective intervention. The current therapeutic approaches involve intensive physical therapy training involving repetitive tasks which causes fatigue and lack of engagement in the patients. To address this issue, the investigators will investigate the combined use of individually targeted noninvasive brain stimulation (T-NIBS) using High-definition Transcranial Direct Current Stimulation (HD-tDCS) and music-assisted hand exercises using MusicGlove to modulate the neuroplasticity in the desired manner to observe functional changes in hand dexterity.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-75 years
* Clinically diagnosed with hemiparetic stroke (weakness on one side - either left or right side of the body)
* Have had a stroke for more than 6 months
* Have weakness in moving the fingers of the affected hand
* Able to understand and perform the instructions that are part of the tDCS-MusicGlove testing and intervention.
* Willing and able to participate in and travel to Kessler Foundation for the screening session, MRI session, and tDCS-MusicGlove sessions.
* Able to sit and be active for 1.5 hours during the session without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
* Able to provide informed consent.
* Medically stable and not planning for a major change in medications for at least 4 weeks

Exclusion Criteria:

* Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)
* Have lost the sensation of hand movement
* Have a history of alcohol abuse and/or illicit drug use
* Have a history of smoking within the past 5 years
* Have a problem with the eyesight that would make it difficult to notice the changing instructions on a computer screen
* Currently enrolled in another research study that might affect this research study
* A history of epilepsy (including family members who are diagnosed with epilepsy)
* An active history of migraine or chronic headache
* A history of mental illness (e.g. schizophrenia, anxiety, depression, and PTSD)
* Past or current history of treated ringing in the ears known as tinnitus or severe hearing problems
* Have a tattoo with metal-based ink in the head or neck.
* Have severe skin damage on the scalp
* Afraid of confined spaces (claustrophobic)
* Have metallic implants, including intracranial electrodes, surgical clips, shrapnel or a pacemaker.
* Currently taking medications that increase the risk of seizures
* Pregnant
A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer

The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent unresectable gastric or GEJ cancer
* Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
* Patients with normal oral intake
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients who have measurable target lesion
* Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
* Patients with adequate organ function
* Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
* Patients with written informed consent

Exclusion Criteria:

* Patients have double cancer
* Patients have infection required systemic therapy
* Known central vervous system (CNS) metastasis
* Patients with history of pneumonitis or pulmonary fibrosis
* Patients with history of serious anaphylaxis induced by antibody preparation
* Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease
* Female who is pregnant, lactating or suspected pregnancy
* Patients with psychosis or dementia to interfere to obtain informed consent appropriately