cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Surgical Access and Repeated Applications of APDT

The aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.

Scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. A method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. However, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. Thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (aPDT) was recently proposed. Therefore, the aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
* Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
* Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;
* Good general health;
* Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;

Exclusion Criteria:

* Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
* Have used antibiotics and anti-inflammatories in the last six months;
* Smoke ≥ 10 cigarettes/day;
* Pregnant or lactating;
* Chronic use of medications that may alter the response of periodontal tissues;
* Indication of antibiotic prophylaxis for dental procedures;
Testing Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial

While older women are disproportionately affected by chronic diseases and conditions associated with aging, including both physical and cognitive impairments, that can be alleviated or delayed by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. This research aims to evaluate, in insufficiently active older women from the national WHISH pragmatic trial, the effects of a technology-driven "citizen science" approach to environmental physical activity barriers called Our Voice plus the ongoing "light-touch" remote physical activity educational program, compared to the "light-touch" remote physical activity educational program plus a control educational intervention that creates awareness around human and planetary health. This study will add important information on the benefits and trade-offs of combining these remotely delivered and practical behavioral health approaches to promote physical and cognitive health for the fast-expanding demographic group of U.S. older women.

Older women are disproportionately impacted by a range of chronic diseases and conditions, such as cognitive impairments, that can be alleviated by regular physical activity (PA), including walking; yet they are the most inactive segment of the US population. This study's primary aim is to enhance the efficacy of a "light-touch", remotely delivered PA educational intervention for older women by testing the added impacts of an innovative, remotely delivered citizen science program to identify and address local environmental barriers to walking and other PA, called Our Voice (OV). The "light-touch" PA educational program (Encore) has been delivered since 2015 to \>23,000 women \>70 years that have been participating in the U.S.-wide Women's Health Initiative Strong and Healthy (WHISH) pragmatic PA trial. The study's hypothesis is that women receiving Encore+OV will show higher 12-month PA levels than women receiving Encore plus the control educational program. Additional questions include changes in cognitive function and sedentary behavior and exploring the relative costs of the two programs for PA change.

Eligibility Criteria:
Inclusion Criteria:

* Is insufficiently physically active based on National Guidelines;
* Can engage in moderate forms of walking in and around their neighborhoods;
* Owns and can use a smartphone;
* Willing to wear the study pedometer;
* No plans to move from the area over the 1 year study period;
* Willing to be randomized and engage in study assessments;

Exclusion Criteria:

* Not currently living in a nursing home or with a dementia diagnosis or other medical condition that would preclude moderate forms of physical activity outside the home or study participation.
Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

A multicenter, randomized, double-blind, active comparator, non-inferiority, multicenter IIb clinical trial to compare the safety and immunogenicity of two dose levels of the MCTI CIMATEC HDT RNA Vaccine against two authorized COVID-19 vaccines in Brazil (Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca) in 300 participants. Each vaccine will be provided as a single booster vaccine in adults aged 18 to 65 years previously immunized with both vaccines (Comirnaty - Pfizer and Covishield - Oxford/Astrazen). The investigational product MCTI C HDT will be administered in one of the two doses evaluated (5µg and 10 µg). The comparator products will be Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca. The primary outcomes will be the number of participants with a 2-fold increase or more on average by titers of neutralizing D64G pseudovirus strain (pNT50) and comparison of titers generated by 5µg and 10µg doses of MCTI-CIMATEC-HDT RNA Vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Complete primary vaccination with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines, and at least one booster dose with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines. The last duration being at least 4 before the study duration.
3. Adult in a healthy condition or with a stable health status if pre-existing medical history.
4. Sign informed consent, be able and willing to make the assessment, be accessible by telephone or in person by the local study team and willing to remain in the study area for the duration of the study
5. For women of childbearing age: a highly negative sensitive urinary pregnancy test during the inclusion visit AND use an effective contraceptive method.

Exclusion Criteria:

1. History of COVID-19 in the 30 days before study enrollment.
2. Participation in other clinical studies in the last 12 (two) months.
3. Receive or plan any immunization during the study, except the seasonal influenza vaccine, within 30 days of enrollment.
4. Receive a blood or immunoglobulin transfusion within 90 days before study enrollment;
5. Blood donation up to 30 days before inclusion in the study;
6. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunomodulatory drugs.
7. History of autoimmune disease or immunosuppression.
8. Rash, tattoos, or any other skin condition that could adversely affect the vaccine injection site.
9. Body mass index (BMI) \> 35.
10. Known or suspected drug or alcohol abuse in the last 6 months;
11. History of previous anaphylaxis or severe allergic reactions to the vaccine, products known to contain polyethene glycol (PEG) or unknown allergens.
12. History of myocarditis or carditis.
Third Year Evaluation on Genistein Efficacy and Safety

BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. However, there is still a knowledge gap regarding the long-term safety of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal women.

OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year therapy with pure, standardized genistein (54 mg/day).

DESIGN: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24 months. After the 24-month visit, a sub-population (138 patients) accepted to continue the intervention until 36 months, thus generating a follow-up study.

SETTING: 3 Italian university medical centers. INTERVENTIONS: Participants received 54 mg of genistein, daily, (n=71) or placebo (n=67). Both intervention and placebo contained calcium and vitamin D3. All patients also received dietary instruction in an isocaloric fat-reduced diet.

MEASUREMENTS: Mammographic breast density at baseline and after 24 and 36 months was assessed by visual classification scale and by digitized quantification. BRCA1 and BRCA2 molecular message, sister chromatid exchanges and endometrial thickness were also evaluated at the same time points. Measurements of lumbar spine and femoral neck BMD and QUS t-score were assayed in our patients. Secondary outcomes were serum levels of B-ALP, IGF-I, sRANKL, osteoprotegerin and urinary excretion of CTX, pyridinoline and deoxypyridinoline. Furthermore insulin resistance (HOMA-IR), glucose levels, homocysteine and hot flushes were also evaluated. In addition for thyroid safety TSH, fT3, fT4, thyroid autoantibodies, and mRNA for thyroid and retinoid receptors were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Have not had a menstrual period in the preceding year
* Had not undergone surgically induced menopause
* Had a follicle-stimulating hormone level \> 50 IU/liter and a serum 17 beta-estradiol level ≤ 100 pmol/liter
* Established osteopenia (-1\<T-score\<-2.5 SD)

Exclusion Criteria:

* Clinical or laboratory evidence of confounding systemic diseases, such as cardiovascular, hepatic, or renal disorders
* Coagulopathy, use of oral or transdermal estrogen, progestin, androgen or other steroids
* Biphosphonates, cholesterol-lowering therapy or cardiovascular medications in the preceding six months
* Smoking habit of more than two cigarettes per day
* Previous treatment with any drug that could affect the skeleton in the preceding year
* A family history of estrogen-dependent cancer
* BMD at femoral neck \> 0.795 g/cm2; this BMD value corresponds to a T score of -1 standard deviation
Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL

This study was performed to determine the prognosis of patients after cardiac arrest using serum markers called NGAL. The initial NGAL values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months.

Serum NGAL is currently being used as a test to determine the likelihood of developing renal failure. However, in a previous study, serum NGAL correlated with neurological prognosis in post cardiac arrest syndrome patients. This prospective study attempts to see the role of serum NGAL as a prognostic factor by including a sufficient number of patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent targeted temperature management after out-of-hospital cardiac arrest.

Exclusion Criteria:

* Patients who did not survived 3 days after cardiac arrest.
* Pre-existing end-stage renal disease or dependence on renal replacement therapy
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury

Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 75 yrs
* 150 mmHg \< PaO2/FIO2 \< 300 mmHg
* mechanical ventilation with PSV or BIPAP
* less than 15 days of mechanical ventilation
* at least 20% of minute ventilation originated from spontaneous breathing

Exclusion Criteria:

* BMI \> 35
* esophageal disease
* neuromuscular disease
* instable thorax
* pneumothorax
* head trauma
* brain injury
* increased intracranial pressure
* agitation
* increased need for vasoactive drugs
* chronic lung disease
* acute coronary disease
* participation in another clinical trial within the last 4 weeks at enrollment

Interruption criteria:

* acute change of mental status
* SaO2 \< 92%
* pHa \< 7.30
* respiratory rate \> 30 or \< 6 /min
* dyspnea
* diaphragm/thorax antagonism
* diaphoresis
* abnormal use of respiratory muscles
* increase of the heart rate above 120% of baseline or absolute value \< 60 or \> 130 /min
* mean arterial pressure above 120% of baseline or absolute value \< 70 or \> 110 mmHg
Lithium Versus Paroxetine in Major Depression

This study is being done to look at how well people respond to two different drug treatments for depression. Clinically, people can respond differently to different treatments for reasons which are not always clear. Some research shows that people with a family history of bipolar disorder or completed suicide may react differently to standard medications used to treat depression than those without a family history. The investigators need to know if these drugs are effective to use in patients with depression who have a family history of bipolar disorder or completed suicide.

Lithium is a mood stabilizing drug that has been used to treat people with both bipolar disorder and depression for the last 50 years. It is available to the public by prescription in Canada and has been used by millions of people world wide. Paroxetine is an antidepressant drug that has been used to treat people with depression for the past 10 years. It is also available to the public by prescription in Canada and has been used by millions world wide.

Subjects who join the study, will be given one of the study drugs, either lithium or paroxetine.

Subjects will be randomized "like the flip of a coin" to receive either lithium or paroxetine.

The study drug will be taken once a day by mouth and the daily dose adjusted to find the right dose for the subject. The study drug will be taken for a 6-week period and subjects will be assessed by the research team on a weekly basis.

Eligibility Criteria:
Inclusion Criteria:

* men or women
* age of 18 years or older
* meet criteria for major depressive episode, and have a family history of bipolar disorder or completed suicide

Exclusion Criteria:

* subjects not able to give informed consent
* pregnant or breast-feeding women
* current panic disorder, post traumatic stress disorder or psychosis
* subjects with a history of mania or hypomania
* subjects with active substance abuse or dependence in the last 6 months
* current depressive episode less than 4 weeks or greater than 12 months in duration
* adequate trial of lithium or paroxetine (lithium level ≥ 0.6mmols/l; paroxetine 20mgs ≥ 5 weeks) for this episode of depression
* concurrent use of other antidepressants or augmenting agents for the treatment of depression
* clinically significant medical illness, in particular renal impairment
Malignant Myoepithelioma of Bone and Soft Tissues: Diagnostic Imaging and Histology in Relation to Prognosis

The purpose of the study is to assess whether there is a correlation between imaging and histology with prognosis in patients with soft tissue and bone MC from the archives of the Rizzoli Orthopaedic Institute all the patients with a histological diagnosis of soft tissue or bone malignant myoepithelioma treated from 1998 to 2021


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients treated at Rizzoli Orthopaedic Institute between 01 Jan 1998 and 31 Dec 2021
* Age ≥ 2 years old
* Diagnosis of soft tissue or bone malignant myoepithelioma (MC-SB)
* Patients with available clinical and imaging data

Exclusion Criteria:

* At least one inclusion criterion not met
Outcomes of an Anticoagulation Clinic in an University Hospital

A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.

A Randomized, Crossover, Clinical Trial performed to compare the results of oral anticoagulation for Chagas and non-Chagas disease patients treated at an anticoagulation clinic and by the usual clinical practice. The primary endpoint was the time that the International Normalized Ratio (INR) was in the therapeutic range and the secondary endpoints were thromboembolic/haemorragic events.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Chagas and non-Chagas disease patients
* Any indication for chronic treatment with warfarin
* Anticoagulation for at least 30 days.

Exclusion Criteria:

* Refusal to participate in the study;
* Use of phenprocoumon;
* Expectation of treatment lower than 1 year;
* Difficulties to attend medical visits;
* Participation in other prospective clinical study involving anticoagulation care during the study period.
Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

The primary objective of this study is to determine the impact of a pragmatic RHD primary prevention program in Uganda.

The secondary Objective are as follow:

1. To improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention.
2. To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.

Our intervention is designed as a service-oriented plan to be implemented through the primary healthcare structure and facilities of both the national health and private system. Additional support will come from the education system, with participation from schools, teachers, patients, patient families, and the public. Our intervention will focus on two of the more easily rectified impediments to primary prevention, namely (1) poor uptake of guideline-based treatments for Group A Streptococcal (GAS) pharyngitis and (2) low levels of public awareness of the importance of sore throat care and treatment.

Eligibility Criteria:
Inclusion Criteria:

• Has agreed to participate in the study via the study's informed consent/assent process.

Exclusion Criteria:

* Known history of ARF or RHD
* Any known co-morbid conditions (HIV, renal deficiencies, severe malnutrition,
* among others) that have resulted in prescription of regular antibiotic prophylaxis
* Structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus).
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.


Eligibility Criteria:
Inclusion Criteria:

* Participant has symptoms of Overactive Bladder (OAB) (frequency and urgency) with Urge Urinary Incontinence (UUI) for a period of at least 6 months prior to screening.
* Participant experiences ≥ 1 episode of UUI per day.
* Participant has not been adequately managed with ≥ 1 oral or transdermal pharmacologic therapies for the treatment of their OAB symptoms.

Exclusion Criteria:

* Participant has symptoms of OAB due to any known neurological reason (e.g., spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
* Participant has a predominance of stress incontinence in the opinion of the investigator, determined by participant history.
* Participant currently uses or plans to use medications or therapies to treat symptoms of OAB, including nocturia.
* Participants who have previously been treated with onabotulinumtoxinA for urological indications within 12 months of starting the Screening Bladder Diary, or any other toxin for urological indications, regardless of when treated (participants treated with onabotulinumtoxinA or other toxins for non-urological indications are eligible, regardless of when treated)
Study of a Postpartum Diabetes Prevention Program for Hispanic Women

The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy.

Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2) biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-α, HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood pressure, CRP, fetuin-A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e., physical activity, diet). Eligible Hispanic women will be recruited after routine GDM screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) intervention (n=150). The intervention will be based on our efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention from randomization (29 wks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American College of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific social, cultural, economic, and physical environmental challenges faced by underserved Hispanic women. Measures of adherence will include the Pregnancy Physical Activity Questionnaire (PPAQ), accelerometers, and dietary recalls. The project is a Renewal Application of R01 DK064902, a study of lifestyle risk factors for GDM in Hispanic women. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of lifestyle interventions among Hispanic pregnant women (R01 DK074876; S3948 ASPH/CDC) and controlled trials of lifestyle interventions among low-income Hispanics with type 2 diabetes and pre-diabetes (R18 DK0658850; R18DK067549) and can readily be translated into clinical practice in underserved and minority populations.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic women with one or more glucose values during the diagnostic test meeting or exceeding the thresholds defined according to the American Diabetes Association

Exclusion Criteria:

* history of type 1 or type 2 diabetes, heart disease, or chronic renal disease
* contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)
* inability to read English or Spanish at a 6th grade level
* \<18 or \>45 yrs of age
* women carrying multiples