cyrilzakka/clinical-trials huggingface dataset:
Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions

The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.

The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Presence of at least one Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);
* Height of keratinized tissue ≥ 2 mm;
* 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.
Comparison of Physical Fitness, Physical Activity Level in Patients With Bipolar Disorder and Schizophrenia

According to the World Health Organization; Bipolar disorder ranks in the top 20 causes of disability among all medical conditions and 6th among mental disorders worldwide. Bipolar disorder is noted as a serious mental illness involving emotional ups and downs.

Schizophrenia is a chronic mental disorder characterized by the appearance of both positive symptoms such as hallucinations and delusions and negative symptoms such as apathy and withdrawal, repetition of cognitive skills, and disorganization. In this study, it was aimed to compare physical fitness, physical activity level, depression and quality of life in bipolar disoder and schizophrenic patients with healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with bipolar disorder and schizophrenia by a physician according to DSM-5 criteria

  * Individuals with bipolar and schizophrenia between the ages of 30-55
  * Patients without any other accompanying psychiatric disorder
  * Patients who can communicate
  * Patients who agreed to participate in this study and gave informed consent

Exclusion Criteria:

* Patients with a psychiatric diagnosis other than bipolar and schizophrenia.
* Pregnancy condition
* Those who did not consent to participate in the study
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.

The study was an open-label design, planned to consist of 2 parts: a safety, pharmacokinetic, and dose-finding portion (Part 1), and a randomized portion (Part 2). Both parts were to include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients were planned to be enrolled in the study.

Part 2, the Phase 2 part of the study, was not conducted due to changes in corporate strategy. There were no safety signals identified in Phase 1/Part 1 that would have precluded the conduct of Part 2. As a result, 30 out of the planned 144 patients were enrolled.

All tumor assessments were conducted by the Investigators or site radiologist. In order to reduce the burden to the patients, data of overall survival (OS) were no longer required (since 29 January 2020). No OS analysis was conducted for Part 1 due to limited data in Part 1.

PK data for Cohorts 4 (150 BID) and 5 (200 BID) were not analyzed as they were deemed unnecessary, as the PK data from Cohorts 1-3 were sufficient to achieve the secondary study objective of assessing the effect of osimertinib on PK parameters of G1T38.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity
* For Part 2, EGFR T790M mutation-positive tumor status
* Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range
* For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1
* For Part 2, measurable disease as defined by RECIST, Version 1.1
* ECOG performance status 0 to 1
* Adequate organ function

Exclusion Criteria:

* Prior treatment with EGFR TKI within 9 days of first study dose
* For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC
* For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI
* For Part 2, prior chemotherapy for advanced NSCLC
* Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose
* Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow
* Prior hematopoietic stem cell or bone marrow transplantation
The Ambient Light Multiple Myeloma Study

The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, Inflammation, Neutropenic Fever and Symptom Burden among Multiple Myeloma Patients undergoing Autologous Stem Cell Transplantation. To achieve this aim, 200 multiple myeloma patients will receive one of two different light-treatments that are designed to promote circadian rhythm alignment. While receiving these light treatments, participants' sleep efficiency, urine melatonin levels, blood inflammatory cytokine levels and symptoms will be assessed over a 2-month period.

Individuals undergoing Autologous Stem Cell Transplant (ASCT) experience major transplant-related complications including elevated symptom burden, high rates of neutropenic fever, and increases in inflammatory cytokines. These transplant-related complications are augmented by circadian rhythms disruption (CRD), which leads to misalignment between melatonin levels and sleep times. Since light is a strong synchronizer of circadian rhythms, the proposed multi-site randomized controlled trial (RCT) will investigate whether lighting designed to deliver circadian effective light that promotes circadian alignment, will: 1) promote higher nighttime melatonin levels and better nighttime sleep, 2) reduce pro-inflammatory cytokines, 3) lower rates of neutropenic fever and 4) improve symptom burden in cancer patients undergoing Autologous Stem Cell Transplant.

Hospital rooms for patients undergoing inpatient Autologous Stem Cell Transplant at the Mount Sinai Medical Center (MSMC) and at the Memorial Sloan Kettering Cancer Center (MSKCC)) will be retrofitted to install 1 of 2 lighting interventions, either circadian-effective (intervention) and circadian-ineffective (comparison) ambient light that may improve sleep.

1-2 weeks and no more than 2 months prior to transplant, participants will be given an Actiwatch, Daysimeter (personal light meter), sleep logs, questionnaires, and a urine collection kit to assess melatonin. One blood sample for cytokine analyses will be collected during one of the hospital visits prior to transplant. Blood draws are always done in the morning and always at a similar time for the same individual. The same outcomes (questionnaires, Actiwatch, Daysimeter, urine samples, blood samples) will be collected during transplant period and once, four weeks after engraftment.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Myeloma diagnosis
* Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
* 21years or older
* Able to provide informed consent.
* English-language proficient

Exclusion Criteria:

* Previous Autologous Stem Cell Transplant procedure
* Pregnancy
* Eye diseases which limit the ability of light to be processed
* Secondary cancer diagnosis within the last 5 years
* Severe sleep disorders
* History of bipolar disorder or manic episodes
* Severe psychological impairment
* Previous use of light therapy
* Active infection including COVID-19 infection
Effect of Prevnar 13 on Ear Infections in Children

Prevnar (7 valent pneumococcal conjugate vaccine \[7vPnC\]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.

Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Subject has received full (3-dose) infant series of Prevnar 13

Exclusion Criteria:

* Prior vaccination with any 7vPnC.
* Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
A Study of a Probiotic in Atopic Dermatitis

The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.

Probiotics were also shown to reduce severity of AEDS when administered to infants with early onset AEDS. In contrast, only a few studies have evaluated the therapeutic effectiveness of probiotics on the groups of older children with established AEDS. In these studies, administration of Lactobacillus strains to unselected children aged 1 year and over was associated with improvement in the clinical severity of eczema. The purpose of this study was to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain, Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against S aureus growth among Lactobacillus species in our preliminary experiment. We administered L sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and evaluated the clinical outcome at the end of the intervention. In addition, we also measured levels of serum chemokines as activity markers for AEDS to provide a more objective evidence for the beneficial role of this probiotic.

Eligibility Criteria:
Inclusion Criteria:

* patients with atopic dermatitis present for at least 6 months before inclusion
* a total SCORAD score above 25
* a change in a total SCORAD score of not more than 10% within 2 weeks

Exclusion Criteria:

* patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or Chinese herbal medicine during the preceding 3 months
Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma

Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.

This is a Phase 2, two-arm, randomized, placebo-controlled, double-blind, multicenter study of relapsed/refractory multiple myeloma patients who have received at least two prior therapies, including a proteasome inhibitor and an IMiD.

Patients who meet all the eligibility criteria will be randomized to one of two blinded treatment arms:

* selinexor + carfilzomib + dexamethasone
* placebo + carfilzomib + dexamethasone

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, histologically confirmed MM, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following:

  * Serum M-protein ≥ 1.0 g/dL by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative IgA; or
  * Urinary M-protein excretion at least 200 mg/24 hours; or
  * Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal.
  * If serum protein electrophoresis is felt to be unreliable for routine M- protein measurement, then quantitative Ig levels by nephelometry or turbidometry are acceptable.
* Must have received ≥ 2 prior anti-MM therapies including a proteasome inhibitor and an IMiD. The most recent proteasome inhibitor must not have been carfilzomib.
* Patients previously treated with carfilzomib are eligible as long as they meet the following criteria:

  * Not received carfilzomib within 6 months (183 days) of Cycle 1 Day 1 (C1D1), and
  * Carfilzomib was not part of their most recent therapy for the treatment of MM, and
  * Did not discontinue carfilzomib treatment because of adverse effects.
* MM that is refractory to the most recent treatment regimen. Refractory is defined as ≤ 25% response to therapy, or progression during therapy, or progression on or within 60 days after completion of therapy.

Exclusion Criteria:

* Smoldering MM.
* Active plasma cell leukemia.
* MM that does not express M-protein or serum FLC (i.e., non-secretory MM is excluded; plasmacytomas without M-protein or serum FLC are excluded).
* Documented active systemic amyloid light chain amyloidosis.
* Active MM involving the central nervous system.
* Active polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.
* Prior autologous stem cell transplantation \< 1 month or allogenic stem cell transplantation \< 3 months prior to C1D1.
* Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.
Effect of Kettlebell Training on Musculoskeletal and Cardiovascular Health

Neck/shoulder and back pain is quite common among employees in sedentary occupations. Furthermore, many have a low level of fitness. Strength training with dumbbells has been shown to alleviate neck/shoulder pain, but many people prefer to also have alternative training options. Empirically, kettlebell training works the neck/shoulder/back while at the same time training the cardiovascular system. This type of training has not previously been tested in a randomized controlled trial. The aim of this study is to test the effect of kettlebell training on musculoskeletal pain, fitness, and muscle strength.


Eligibility Criteria:
Inclusion Criteria:

* employed
* office workers

Exclusion Criteria:

* trauma
* life threatening diseases
* pregnancy
Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups

-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.

Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .

Patient's visits was at baseline, 2 weeks and 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus.
* Male or female patient with age range between 20-75 years old were included.
* medically free individuals

Exclusion Criteria:

* the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study.
* Pregnant females
* patients with history of systemic disorder affecting the immune system
* active liver diseases and cancer
* allergy or intolerance to probiotics.
* any other oral lesions
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy

Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)

Exclusion Criteria:

* Patients with cardiovascular event
* Patients with diabetic complications
* Female subjects who are pregnant or planning to become pregnant
* Subjects with unstable medical conditions (eg, hypertension)
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1j53_NBnEVQik4Ps5a9pZOvuHm1mWHCRZ3DAvI0y8NO8/edit?usp=sharing or Appendix A (https://drive.google.com/file/d/1uC_G8TJ1ujoJbas1p1gFaYFzY7Hw7xMq/view?usp=sharing) for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability).

Inclusion Criteria:

* 1. Aged \>/= 65 years on the index date
* 2. No prior use of Salbutamol and Long-acting Muscarinic Antagonists (LAMA) anytime prior to cohort entry date
* 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 4. At least two claims with COPD diagnosis measured 365 days prior to drug initiation

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Enhancing Health Literacy Through AI-Powered Chatbot: a Randomized Controlled Trial

The goal of this study is to learn if an innovative digital artificial intelligence (AI)-based communication tool works to enhance health literacy among Japanese caregivers regarding Human Papillomavirus (HPV) vaccination.

Participants will:

* Answer a pre-intervention survey, get information regarding HPV vaccination from an AI-based chatbot or leaflet, and answer a post-intervention survey.
* Continue interacting with the chatbot or leaflet for two weeks.
* Answer a follow-up survey.

This study will evaluate the efficacy and feasibility of an AI-driven chatbot in enhancing caregivers' health literacy about HPV vaccination and examines its impact on informed decision-making concerning their daughters' vaccination through a randomized controlled trial (RCT). To achieve this, the study will undertake the following interconnected activities:

1. Randomized Controlled Trial Participants will be randomly assigned to either the control or intervention group. Those in the control group will spend 5-10 minutes reading a publicly accessible HPV vaccination leaflet prepared by the MHLW, serving as the standard of care. Conversely, participants in the intervention group will be invited to interact with the chatbot for 5-10 minutes, posing inquiries (n\>10) about HPV vaccination policies and related topics in Japan. Pre- and post-intervention assessments, as detailed below, will be administered to evaluate the chatbot's effectiveness and feasibility to counter HPV vaccine misinformation and support caregivers' vaccination decision-making processes.
2. Pre- and post-intervention assessments Following informed consent and enrollment, participants will complete a pre-intervention survey to establish baseline data. Post-intervention survey will be introduced at two touchpoints: the first is directly after spending time with either a leaflet (control) or a chatbot (intervention), and the second is two weeks after the first touchpoint.

The surveys are designed to assess the chatbot's effectiveness in enhancing caregivers' digital health literacy about HPV vaccination and facilitating informed vaccine decision-making.

Eligibility Criteria:
Inclusion Criteria:

* A nationally representative sample of female caregivers with daughters aged 12-18 who have not received any HPV vaccine.
* Those who have access to a smartphone or computer with internet connectivity to interact with experiment materials (chatbot or online leaflet).
* Those who provide informed consent and agree to participate in the study.

Exclusion Criteria:

* Those who need help reading through the participant information sheet, providing consent online, accessing experiment materials (chatbot or online leaflet), or answering surveys will be excluded. This may include people who do not have access to an online environment or people with severe cognitive impairments who cannot interact with the experiment materials. Also, those who have participated or are participating in similar studies regarding vaccination or experiments that utilize chatbots will be excluded.