cyrilzakka/clinical-trials huggingface dataset:
Tobacco Cessation Via Public Health Dental Clinics

The study will examine the effectiveness of public health dental practitioners using a brief office based intervention designed to help patients quit smoking or smokeless tobacco use, as compared to usual care.

The prevalence of tobacco use is especially high in lower socioeconomic status (SES) populations in the U.S. Community Health Centers provide comprehensive primary care services, and usually dental services, to large numbers of low-income smokers and smokeless tobacco users. The typical patient has multiple dental visits, which can be used for tobacco cessation advice and counseling by the dental office team. This study builds on a successful pilot study conducted in two public health dental clinics.

This study is a randomized clinical trial in which 14 public health dental clinics in Oregon, Mississippi, and New York City were stratified by state, matched within state by racial/ethnic composition, and then randomly assigned to either the Intervention or Usual Care Control condition. In the Intervention Condition, the dental team provided a brief intervention modeled on the "5A's" advocated by the Clinical Practice Guideline.

Eligibility Criteria:
Inclusion Criteria:

* Patients of participating public health dental clinics
* Tobacco users

Exclusion Criteria:

* Emergency patients
Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)

This is a Multinational, Multicenter, retrospective study for the evaluation of the standalone efficacy and safety of an Artificial Intelligence/Machine Learning (AI/ML) technology-based end-to-end Computer assisted Detection/Computer Assisted Diagnosis (CADe/CADx) Software as a Medical Device (SaMD) developed to detect, localize and characterize malignant, and suspicious for lung cancer nodules on Low Dose Computed Tomography (LDCT) scans taken as part of a Lung Cancer Screening (LCS) program.

LDCT Digital Imaging and Communications in Medicine (DICOM) images of patients who underwent lung cancer screening were selected and included into the study. Selected scans will then be analyzed by the CADe/CADx SaMD and compared to radiologist generated reference standards including lesions localization and lesion cancer diagnosis.

Figures of merit at patient level and lesion level detection and diagnostic efficacy will be calculated as well as sub-class analysis to ensure algorithm performance generalizability.


Eligibility Criteria:
Inclusion Criteria:

* ≥50-80 Years of age;
* Current or ex-smoker (\>=20 pack years);
* Patient screened and surveilled for lung cancer screening following lung cancer screening guidelines (equivalent to United States Preventive Services Task Force (USPSTF) 2021 Criteria);
* Received LDCT due to inclusion in high-risk category for lung cancer.

Exclusion Criteria:

* Prior lung resection;
* Pacemaker or other indwelling metallic medical devices in the thorax that interfere with CT acquisition;
* Patients/images used during AI model development;
* Patients with only hilar and/or mediastinal cancer(s);
* Patients with only ground glass cancer(s);
* Patients with nodules, solid or part-solid \>30mm (masses);
* Patients that are not accompanied with the required clinical information;
* Patients with imaging with any of the following: missing slices, slice thickness \>3mm;
* Partial cover of the lung.
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years


Eligibility Criteria:
Inclusion Criteria:

* A male or female aged 18-59 years at the time of the first vaccination.
* Free of obvious health problems

Exclusion Criteria:

* Use of non-registered products
* Administration of immune-modifying drugs.
* Administration of vaccine 30 days before enrolment in study.
* Immunosuppressive or immunodeficient condition.
* Hypersensitivity to a previous dose of influenza vaccine
* Previous vaccination against influenza in 2006
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* History of confirmed influenza infection within the last 12 Months.
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine
Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer

Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer.

Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response.

If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women age ≥ 70 years;
* New histological diagnosis of invasive carcinoma of the breast, grade I or II, estrogen and progesterone receptor (ER and PR) positive, HER2 negative on needle biopsy and limited to Stage I (T1 N0 M0) on clinical and radiological assessment with MRI of the breasts and axillary ultrasound;
* Candidate for breast conserving surgery;
* Signed study consent form completed prior to study entry.

Exclusion Criteria:

* Breast cancer with disease within 5 mm from skin or chest wall;
* Previous or concomitant invasive malignancies treated within 5 years of study entry;
* Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or scleroderma), which would preclude to definitive radiation therapy;
* Psychiatric disorders, which would preclude from obtaining informed consent
* Geographic inaccessibility for follow-up
Evaluation of Metabolism-Boosting Beverages

The purpose of this study is to assess the effect of Metabolism-boosting Beverages (MBB) containing green tea extract with a standardized amount of epigallocatechin gallate (EGCG) and caffeine.

The study will assess the effect of MBB's on 24 hour energy expenditure by performing indirect calorimetry, and on appetite using visual analogue scales (VAS). The planned sample size is 54 healthy male and female adults, both lean and overweight. We plan to test 6 metabolism-boosting beverages in the following order: 1) Raspberry Tea 2) Banana Shake 3) Chai Latte 4) Strawberry Shake 5) Cappuccino 6) Hot Cocoa. In the order that they are screened, each subject will be assigned to receive 1 of 6 Metabolism-boosting beverages. Each MBB will contain 90 mg EGCG and 100 mg caffeine.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females (age between 18 and 65)
* BMI ≥18.5 - ≤ 40.0 kg/m2
* Non-smokers
* No known food allergies to wheat, gluten, soy or nuts
* ≤ 14 alcoholic beverages per week
* No sensitivity to caffeine or green tea
* No alcohol or caffeine on days when metabolism is tested
* Willing and able to give informed consent
* Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin)
* Not pregnant or lactating

Exclusion Criteria:

* Actively dieting
* Chronic uncontrolled health problems (not including obesity or controlled: type-2 diabetes, hyperlipidemia, hypertension)
* History of arrhythmia, or taking anti-arrhythmic medications (e.g. propafenone)
* Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
* Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines)
* Cognitive impairment severe enough to preclude informed consent
* Taking weight loss or appetite-suppressant medications
* Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin)
* Food allergies to wheat, gluten, soy, or nuts
* Sensitivity to caffeine or green tea
SLNB After Neoadjuvant Treatment in Node Positive Patients

From May 2016 till May 2018 all breast cancer patients with operable disease submitted to surgery after neoadjuvant treatment would be divided in four groups considering initially clinical axillary stage, axillary procedure that was done, axillary response to preoperative systemic treatment and pathological axillary stage.

In first postoperative year all patients will be monitored for appearance of locoregional and distant recurrence.

From May 2017 SLNB after neoadjuvant treatment was introduced in clinical practice for breast cancer patients presenting initially with involved axilla but shifted to clinically negative followed neoadjuvant treatment. This retrospective analysis is designed for period of one year before and one year later to compare the clinical outcomes for this patients in the setting where ALND was performed to the setting where SLNB was performed.

The main hypothesis was to establish that SLNB after neoadjuvant treatment, in initially node positive breast cancer patients that achieve complete clinical remission following neoadjuvant treatment, is reliable alternative to ALND in maintenance of locoregional control of disease.

For the purpose of this trial four groups were created and the results would be compared among them. In first postoperative year patients were monitored for the appearance of locoregional and distant recurrence.

Data were collected individually for each patient and recorded in register. All data are available to all members of investigation team, members of Ethic Committee and statistician.

Data collected in this trial would be used for publication.

Eligibility Criteria:
Inclusion Criteria:

* operable breast cancer submitted to neoadjuvant treatment in CHC Rijeka, followed by surgery in period from May 2016 till May 2018

Exclusion Criteria:

* T4 stage
* inflammatory breast cancer
* M1 stage at the time of diagnose
* bilateral disease
* multicentric disease
* unavailable complete required data
The Effect of Flooring on Office Workers' Health and Behaviors

Researchers are trying to better understand how offices and workspaces influence people's performance, behavior and health during the course of weeks and over long periods of time.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Must be adults between the ages of 18 and 60
* Ability to relocate to the Well Living Lab for 9 consecutive weeks
* Full-time Mayo Clinic employees (35+ hours per week)
* Report working a sedentary job (e.g., sit for \>= 50% of their work time).
* Have a working mobile phone that can receive text messages
* Must be present for 80% of the study (minimum of 4 days per week)

Exclusion Criteria:

* Individuals who are shift-workers
* Individuals diagnosed with vascular diseases (i.e., Raynaud's disease, peripheral artery disease, etc.)
* Individuals with diagnosed neurological and psychiatric disorders that may have physical limitations
* Drug (illegal or prescription narcotic), nicotine, or alcohol dependency
* Women who are lactating, pregnant or intend to become pregnant during the duration of the study
* Individuals who are taking medications (either prescribed or over-the-counter) which may affect comfort levels (e.g., opiate based medications)
* Working in occupation requiring standing/stepping \>50% of work time
* Report \< 1 year at current job
* Hospitalization from either a physical or mental disorder in the past six months
* History of cardiovascular, pulmonary, metabolic, neurological, or orthopedic limitations that would prohibit occupational physical activity (e.g., standing, stepping, etc.)
Transgender Health: an Educational RCT

The investigators will conduct a randomized controlled trial (RCT) comparing two different educational approaches on the healthcare of transgender and gender expansive (TGE) youth. Finding best practices to educate healthcare providers and the community at large stand to make an impact on the mental health of TGE youth by helping them feel more welcome and better understood by the communities in which they live.

The study aims are to evaluate two educational interventions: 1) The inclusion of a video clip component of two TGE youth (Video \[V\] vs No video \[N\]) into a one-hour didactic; and 2) The delivery of the same didactic content by a cis- \[C\] vs a trans-gender \[TG\] woman.

This will be a randomized control trial (RCT) of equal allotment to one of four parallel didactic conditions. The investigators will randomly assign participants to one of three teaching conditions: 1) Trans Video \[TV\]; 2) Cis Video \[CV\]; and 3) Cis No video \[CN\]. Participants will complete a baseline assessment (PRE) before the start of the same didactic content, but delivered in the three different ways described above. This design will help the investigators make comparisons across video use (yes/no), about type of presenter (trans/cis), and about the interaction of the two approaches. For the 'no video' condition (CN), the didactic will not include the videos until after completion of the POST assessment.

The study design will ensure that all participants will receive the exact same didactic content during whichever session they attend. All participants will then receive a follow up questionnaire two weeks later (2WK POST) to assess content retention.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Living in the US
* Ages GE 18

Exclusion Criteria:

* None
Development of an Insomnia Treatment for Depressed Adolescents

Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.


Eligibility Criteria:
Inclusion Criteria:

* Between 13-19 years of age
* Are depressed
* Have insomnia

Exclusion Criteria:

* Are not depressed
* Do not have insomnia
* Currently using a sleep aid
* Have bipolar depression
* Have psychotic disorder
* Have a sleep disorder other than insomnia
Comparison of Laparoscopic Adnexal Mass Extraction Via the Transumbilical and Transvaginal Routes

Adnexal masses are a common clinical problem encountered in gynecological practice. Minimally invasive surgery (MIS) for ovarian pathologies has been adopted widely. Its goals are to minimize abdominal incisions and postoperative pain and to prevent incisional complications, such as incisional hernias and adhesions. Compared with open procedures, MIS is associated with faster recovery times, better patient quality of life, and lower postoperative complication rates. The removal of an adnexal mass from the abdominal cavity is performed most commonly using the suprapubic, umbilical, or vaginal route. Apart from these, mini laparoscopy can provide a better cosmetic result without additional operative time or complications. Despite the limited use of mini laparoscopy for gynecological procedures, its use has increased recently.

After excision, an adnexal mass can be removed through a laparoscopic (LS) port using a variety of endoscopic or containment bags. After the mass has been placed in it, the bag is withdrawn, closed, and expelled through the skin incision with simultaneous trocar removal. When a mass is large or cannot be removed through the port, the incision may be enlarged slightly. This situation may yield a cosmetically worse outcome and increases the risk of postoperative complications, such as adhesion, hernia, and increased postoperative pain. Thus, natural orifice surgery (NOS) has emerged for tissue removal in such cases.

This study was performed to compare the transumbilical (TU) and transvaginal (TV) routes for adnexal mass removal from the abdominal cavity


Eligibility Criteria:
Inclusion Criteria:

-Women who underwent laparoscopic surgery for the removal of benign adnexal masses

Exclusion Criteria:

-Patients with missing data about surgery information
The Efficacy of Combination Therapy in Atrophic Scars

There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2).

Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3).

Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5).

Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6)

atrophic scar mangment

Eligibility Criteria:
Inclusion Criteria:

- Patients aged from 12 to 60 years with

* post inflammatory atrophic scar.
* post traumatic atrophic scar.
* post operative atrophic scar

Exclusion Criteria:

* post acne scar.
* active skin infection.
Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis

This is a pilot study (phase 1 clinical trial) to evaluate the safety and tolerability of phenylbutyrate in IBM. In this open label study, 10 patients with sporadic inclusion body myositis will be treated with phenylbutyrate (3 gm twice daily) for 3 months. There will be a run-in period, during which certain biomarkers will be measured at baseline and at the end of the run-in period in addition to final measurement at the end of the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill ENMC 2011 diagnostic criteria for IBM
* Age \> 18 years
* Women must be post-menopausal (no menses in \>12 months) or status post hysterectomy
* Able to give informed consent

Exclusion Criteria:

* Presence of any one of the following medical conditions: chronic infection; chronic renal insufficiency; cancer other than skin cancer less than five years prior; multiple sclerosis or prior episode of central nervous system demyelination; or other chronic serious medical illnesses
* Presence of any of the following on routine blood screening: WBC\<3000; Platelets \< 100,000; hematocrit \< 30%; BUN \> 30 mg %; creatine \> 1.5 mg%; liver disease with serum albumin \< 3 G/DL
* Women who are pregnant or lactating
* History of non-compliance with other therapies
* Coexistence of other muscular disease
* Drug or alcohol abuse within past three months
* Known bleeding disorder
* Known liver disease
* Known congestive heart failure
* Known hypernatremia
* Inability to give informed consent
Dexamethasone for Preterm Labour

The investigators sought to determine whether the incidence of neonatal respiratory distress syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of dexamethasone.

The administration of glucocorticoids to accelerate fetal lung maturity in patients with preterm delivery plays an important role for obstetrics and neonatal care. Many studies have shown that maternal administration of glucocorticoids has a significant beneficial effect in decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* All patient with threatened or established preterm labor between 28 - 34 weeks attended to our emergency unit

Exclusion Criteria:

* emergent obstetric conditions like:

  * Antepartum hemorrhage in severe attack
  * Antepartum eclampsia
A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Lavandula Angustifolia Containing Nasal Spray Medical Device in Preventing Deterioration of COVID-19 in Symptomatic Patients

A Nasal Spray device containing Dead Sea minerals and plant extracts, used to shorten duration and mitigate effects of Covid-19 infection in mild to moderate adult patients

A Nasal Spray device containing Dead Sea minerals and plant extracts, designed to incur a PPAR-alpha agonistic effect, used to shorten duration and mitigate effects of Covid-19 infection in mild to moderate adult patients

Eligibility Criteria:
Inclusion Criteria: Having tested positive to Covid-19 on PCR test -

Exclusion Criteria: Pregnancy Low blood pressure On immune system suppressing medications

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