cyrilzakka/clinical-trials huggingface dataset:
The Impact of Obesity on Nonsurgical Periodontal Therapy

The purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).

Normal weight (BMI 18.5-24.9 kg/m2) and obese (BMI \>30 kg/m2) women will be randomly assigned to two nonsurgical periodontal treatments:

1. scaling and root planing + placebo
2. scaling and root planing + metronidazole

Eligibility Criteria:
Inclusion Criteria:

* Normal weight or obese (according to BMI)
* nonsmokers or former smokers (3 or more years)
* no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use)
* have 10 teeth present
* have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm

Exclusion Criteria:

* Pregnancy
* Development of diabetes or other conditions that may impair periodontal healing
The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans

The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

1. African American race/ethnicity
2. 18 years or older
3. Own a smart phone
4. Have basic Internet navigation skills
5. Have at least weekly Internet access (i.e. at home, church, or other public access)
6. Have an active email address
7. Intake of fruits/vegetables less than 5 servings a day
8. No engagement in regular physical activity
9. Able to engage in moderate physical activity

Exclusion criteria:

1. Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping
2. Pregnant (due to associated hormonal and weight changes)
3. Visual/hearing impairment or mental disability that would preclude independent app use
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare hematologic malignancy. In 2008, it was recognized by the WHO as a distinct entity and separately listed in the group of acute myeloid leukemias and related precursor neoplasms.

The final diagnosis of BPDCN relies on a compatible immunophenotype. The triple positive CD4+CD56+CD123+ phenotype associated with negativity for lineage-specific markers is a minimum requirement for defining BPDCN. The highly specific marker BDCA2/CD303, as well as other plasmacytoid dendritic cell-associated antigens (e.g. TCL1 and CD2AP), might be of great support to exclude potential mimickers of BPDCN (acute myeloid and monocytic leukemias, precursor lymphoblastic T-cell leukemia/lymphomas and T- and NK/T cell lymphomas.

At present, there is no consensus on the optimal treatment of BPDCN. The majority of patients receive multi-agent chemotherapy with AML or ALL treatment regimens, while a few patients undergo allogeneic haematopoietic stem cell transplantation (HSCT). In recent years, different novel and innovative therapies are in development to target surface molecules in BPDCN. The patients are still in need of better treatments and the optimal therapy of disease remains to be determined.

This is a multicenter, international prospective and retrospective registry with the aim of collecting data of patients with a diagnosis of BPDCN globally.

Patients will be recruited directly by the national study groups / participating centers.

Participating centers will collect and verify informed consent of all prospective patients enrolled at their center.

The following data will be collected through questionnaires:

1. Patient characteristics
2. BPDCN characteristics
3. Treatment details
4. Outcomes
5. Cause of death
6. End of data collection

Quality control and data management will be conducted by the Immune Oncology Research Institute.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPDCN
* Signed informed consent form for prospective patients

Exclusion Criteria:

-
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to \< 12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or Female, 2 to \< 12 years of age
* Weight ≥ 10 kg
* Chronic HBV infection ≥ 6 months
* Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
* HBV Viral Load ≥ 100,000 copies/mL
* Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening
* Creatinine Clearance ≥ 80 mL/min/1.73m\^2
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3, hemoglobin ≥ 10 g/dL
* Negative pregnancy test at screening
* No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)

Key Exclusion Criteria:

* Pregnant or lactating
* Decompensated liver disease
* Received interferon therapy within 6 months of screening
* Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of screening
* Alpha-fetoprotein levels \> 50 ng/mL
* Evidence of hepatocellular carcinoma (HCC)
* Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
* Chronic liver disease not due to HBV
* History of significant renal, cardiovascular, pulmonary, neurological or bone disease
* Long term non-steroidal, anti-inflammatory drug therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Pilates Method and Therapeutic Exercise in Children That Play String Instruments

Introduction: An inappropriate posture in children for a while kept playing some instrument of the group of the rubbed string, can cause pain and alterations of the spine, as it continues to consolidate.

Objective: To study the benefits acquired during the application of the Pilates Method combined with therapeutic exercise against the Therapeutic Exercise to reduce alterations of the vertebral rachis in children from 10 to 14 years old who play instruments of rubbed strings.

Material and methods: A pilot study designed by a randomized controlled trial in two parallel intervention groups was carried out; 9 children performed the combination of the Pilates Method and Therapeutic Exercise (experimental) and 7 children performed the Therapeutic Exercise (control). At the beginning and at the end of the study, pain measurements have been made through the Visual Analogue Scale (EVA), and the Kinovea programme for the alignment of shoulder, scapula and hip postures.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with typical development and ages between 10 and 14 years old.
* Subjects who play the violin, viola, cello or double bass. Subjects who have learned to play the violin, viola, cello or double bass in this school year or up to a maximum of four previous years, eligible to receive Pilates classes.
* Subjects with cognitive ability to understand simple orders.
* Subjects who are enrolled this year in Orchestrated Neighborhoods.

Exclusion Criteria:

* Subjects whose ages are not between 10 and 14 years of age.
* Subjects who do not play the violin, viola, cello, or double bass.Subjects who have more than four school years playing the violin, viola, cello or double bass.
* Subjects who do not have cognitive capacity to understand simple orders.
* Subjects who are not registered this year in Orchestrated Neighborhoods.
* Subjects who do not complete the four sessions of Therapeutic Exercise + Pilates or Therapeutic Exercise.
Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy

This project is aimed at the discovery of neuro-modulation techniques that may alleviate chemotherapy induced cognitive deficits (CICD), especially in executive (higher-order) cognitive function (EF).

The specific aim for this study is to use magnetic resonance spectroscopy (MRS), self-report, and neuropsychological testing to identify changes in brain metabolite concentrations/ratios and changes in EF deficits associated with chemotherapy, before and after accelerated theta-burst transcranial stimulation (iTBS). The secondary aim is to assess for any association of changes in executive function with brain metabolite concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Women or men with a history of non-metastatic cancer who have completed definitive curative cancer therapy
* Received cytotoxic chemotherapy as a part of their therapy for cancer and at least one month has passed since the final cytotoxic chemotherapy treatment
* ≥ 18 years of age at time of cancer diagnosis and receipt of chemotherapy
* Patients must report subjective symptoms of "chemo-brain" (memory loss, difficulty with concentration, word-finding difficulties) with a FACT-Cog perceived cognitive impairment score \< 60
* Ability to sign informed consent and comply with study procedures

Exclusion Criteria:

* Patients with a recurrence of cancer or those with current metastatic disease
* Patients with a history or current diagnosis of brain metastasis
* Patients with a history or current diagnosis of a primary brain tumor
* Patients with a history of brain surgery or brain radiation
* Patients receiving maintenance systemic therapy for cancer, other than endocrine therapy
* Patients who cannot produce or request adequate medical record documentation to ensure they meet inclusion and exclusion criteria
* Women who are currently pregnant
* History of childhood cancer or receipt of chemotherapy in childhood (\<age 18). Developmental insult to the PFC, can be associated with long-term, durable and sometime debilitating cognitive deficits. Hence, we avoid any cognitive confounds that maybe related to this issue.
* Patients with a weight over 250 lbs., as these patients would not fit in the MRI scanner used in the protocol
* Patients who require benzodiazepines for MRI due to claustrophobic anxiety
* Patients with chest wall tissue expanders or other retained 7 Tesla MRI-incompatible metal. Any other specific contraindication to TMS or MRI not already listed above, including:
* (a) any implanted device in the head, neck or upper body (e.g. cochlear implant, cranial or other electrodes, pacemaker or defibrillator, medication pump, stent, aneurysm clip, etc.)
* (b) personal history of seizures or epilepsy, personal history of multiple concussions or unexplained loss of consciousness. This will be determined by physician judgement
* History of adverse reaction to previous TMS or MRI exposure
* Active substance use disorder in the past 6 months, excluding tobacco use disorder, as diagnosed by study physicians
Support Groups in the Metaverse for Ukrainian Refugees

The goal of this clinical trial is to test the efficacy of support groups held in the Metaverse, designed to promote mental health and well-being in Ukrainian refugees.

Participants:

* will be allocated to one of three conditions: (1) Metaverse support group (intervention); (2) In-Person support group (intervention); or (3) Waitlist.
* will be asked to participate in 5 support group sessions, once per week, for each intervention condition.

The Metaverse support groups will be compared with the In-Person support groups and with the Waitlist, to test:

* the efficacy of the Metaverse condition compared to the In-Person condition.
* the efficacy of the intervention conditions compared to the waitlist.

This protocol outlines a randomized clinical trial to assess the efficacy of virtual support groups (i.e., groups meeting in the Metaverse) for Ukrainian refugees. The study will provide essential insights into the potential benefits of using the Metaverse in delivering support group sessions. The results will contribute to the development of targeted and scalable interventions and policies to promote the well-being of Ukrainian refugees.

Participants will be recruited from Ukrainian refugee communities. The participants will be randomly assigned to one of three conditions: (1) Metaverse intervention group; (2) In-person intervention group; and (3) Waitlist. Stratification will consider factors such as age, gender, trauma history, and language proficiency to achieve balanced group distributions.

The In-Person and Metaverse groups will participate in five weekly support group sessions led by licensed psychologists.

All three groups will be evaluated at (1) pre-intervention (baseline), (2) after session no. 2, (3) post-intervention, and (4) 3-month follow-up.

G\*Power analysis yields a total of N=45 (f = 0.25, power = 0.95) for the three conditions.

Statistical analysis plan: includes the analysis of primary and secondary outcomes, which will be assessed using predefined measures described at the measures section. Additionally, we will assess various predictors to gain insights into the factors influencing intervention outcomes. These predictors will be measured using specific instruments, including a screener (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-adult version) and Working Alliance Inventory-Short Form (WAI-S).

Eligibility Criteria:
Inclusion Criteria:

- Part of Ukrainian refugee communities

Exclusion Criteria:

* Younger than 18.
* Not part of the Ukrainian refugee community.
* Formally diagnosed with a mental disorder.
* PTSD
* Currently participating in any ongoing therapeutic intervention or treatment for mental health.
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer

This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as copper Cu 64 DOTA-trastuzumab PET, may help predict a patient's response to trastuzumab and pertuzumab before surgery in patients with locally advanced HER2 positive breast cancer.

PRIMARY OBJECTIVES:

I. To evaluate the standardized uptake value maximum (SUVmax) in patients with previously untreated HER2+ breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate if the uptake of copper 64 Cu-64-DOTA-trastuzumab, a proposed indicator of responsiveness to HER2-directed therapy, correlates with serpin peptidase inhibitor alpha-1 antiproteinase, antitrypsin, member 1 gene (SERPINA1) expression, which has been shown to be associated with estrogen receptor positive (ER+)/ HER2+ patient survival, both in the HER2+/ER+ patients and in all patients.

II. To compare uptake of copper Cu 64-DOTA-trastuzumab in the patients with complete pathologic response (pCR) versus (vs) non-pCR patients.

OUTLINE:

Patients receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and 2. Within 4 days after completion of PET scans, patients then receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.

After completion of study treatment, patients are followed up for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be women who have histological confirmation of HER2 positive breast cancer
* The primary tumor must be \>= 2.0cm in size and/or have biopsy proven axillary nodes that are \>= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging (MRI)
* The current cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
* Patients may not have received prior HER2 directed therapies
* Participants must have normal cardiac ejection fraction (per label, as defined as institutional normal)
* Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy
* Ability to provide informed consent
* Negative Serum Pregnancy test

Exclusion Criteria:

* Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy
* Concurrent malignancy other than non-melanoma skin cancer
* Patients must not have known metastatic disease
* Patients must not have received prior treatment for the current breast cancer
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease

There are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.

This is a cross-sectional study design. Subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. Data related to the diagnosis and interval assessment of enrolled subjects will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* IBD
* Methotrexate Therapy

Exclusion Criteria:

* Inability to provide relevant samples
Prevalence of Non-alcoholic Fatty Liver Disease Among Non-obese Obstructive Sleep Apnea by Using Transient Elastography

Obstructive sleep apnea (OSA) and non-alcoholic fatty liver disease (NAFLD) are both common diseases related to metabolic diseases with potential cardiovascular consequences and liver complications respectively. Though studies show OSA may take part in the progression of hepatic steatosis, the independent contribution of OSA on liver fat accumulation is unknown. It is hypothesized that nocturnal intermittent hypoxia from OSA is the main driver of NAFLD in non-obese OSA patients. This study is to assess the effect of OSA on NAFLD in non-obese patients.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or more

Exclusion Criteria:

* underlying cause of liver disease
* history of excessive alcoholic consumption (more than 30 g/day for men and 20 g/day for women)
* secondary causes of hepatic steatosis (such as chronic use of systemic corticosteroids)
* positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or histological evidence of other concomitant chronic liver diseases.
Safety and Performance Evaluation of the AutoLap System

The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated Informed Consent Form.
2. Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.

Exclusion Criteria:

1. Previous upper abdominal surgery and contraindications to Pneumoperitoneum.
2. Pregnancy.
3. Obesity (BMI \>35 Kg/m2).
4. Generalized peritonitis.
5. Septic shock from cholangitis.
6. Severe acute pancreatitis.
7. Uncorrected coagulopathy.
8. Previous abdominal operations which prevent safe abdominal access or progression of the procedure.
9. Advanced cirrhosis with failure of hepatic function.
10. Suspected gallbladder cancer.
11. Acute cholecystitis
12. Presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
13. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.

Potential participants will be consented and screened for study eligibility. Eligible participants will be randomized in a 1:1:1 ratio to one of the three study intervention arms. Study intervention will be administered in 28-day treatment cycles and continued until disease progression, intolerable toxicity, Investigator decision or withdrawal of consent by the participant, or termination of the study by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection
* ECOG Performance Status of 0-1
* No prior systemic treatment for advanced local or mCRC
* Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory

Exclusion Criteria:

* Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor
* Participants with BRAF V600E mutation
* Unable to swallow tablets.
* Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis
* Participants with an active, known or suspected autoimmune disease.
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.

Other protocol-defined inclusion/exclusion criteria apply