cyrilzakka/clinical-trials huggingface dataset:
Increasing Vaccine Uptake Among Adolescents in the Rural South

The benefits of adolescent vaccines are well known for preventing meningococcal infection and human papillomavirus (HPV)-related pre-cancerous lesions. Yet, many adolescents in the United States (US) remain under-vaccinated, with vaccination rates among rural adolescents significantly lower than among their urban peers. In addition, there are urban-rural disparities in the coverage of HPV vaccine, particularly in Southern states like North and South Carolina, which currently fall below the Healthy People 2020 goal of ≥80% coverage. The goal of the proposed study is to evaluate the feasibility and preliminary efficacy of a school-based intervention for increasing vaccine uptake among adolescents in rural North and South Carolina.


Eligibility Criteria:
Inclusion Criteria:

- Any public middle school in Cherokee County, South Carolina or Rockingham County, North Carolina school districts
A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan

This study investigates the longitudinal course of developmental patterns in movement and participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan. Additionally, the predictors in the initial stage in determining the final developmental patterns in movement and participation in life activities MPLA of these children will be identified.

Most researches investigated the longitudinal study of functions in adolescent or adult with CP, however, few researches investigate these functions in children with CP. Knowledge of these developmental patterns in movement and participation in life activities MPLA may be helpful in understanding, anticipating, and managing the problems of these children. We hypothesize that the course of developmental patterns in MPLA of young children with CP evolves with their age. This study investigates the longitudinal course of developmental patterns in MPLA of young children with CP in Taiwan. This study includes a validity and reliability study and a prospective longitudinal study of young children with CP over one-year. This study will be executed in 4 years and a validity and reliability study in the first year.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CP

Exclusion Criteria:

* presence of a progressive neurological disorder or a severe concurrent illness or disease not typically associated with CP, such as traumatic brain injury or active pneumonia
Early Diagnosis of Leukemic Children Patients Based on Clinical, Age Estimation and Radiographical Evaluation of Oral Affection

Early diagnosis of leukemia which is malignant tumor affecting bone especially in children is import to allow early intervention improving prognosis. It is known that leukemic patients suffer from clinical signs as anemia, thrombocytopenia, and pronounced hepatosplenomegaly or lymphadenopathy. However, sometimes these clinical signs may be not clearly manifested and may look like anemia. The early diagnosis could be achieved through dentist by accessing clinical and radiographical signs such as oral masses, gingival bleeding /or enlargement and oral ulceration with radiographical features including focal or generalized osteolysis of bone with presence of moth eating appearance and even with abnormal teeth chronology regarding teeth morphology, germ formation of permanent teeth and their sequence of eruption. Therefore, accessing of these special clinical and radiographical features by the dentist could help in early diagnosis of leukemic children patients

Ten children patients suffer from leukemia selected after initial diagnosis from hematology unit of faculty of medicine, Tanta university based on their clinical signs such as; bone pain, fatigability, lymph node enlargement...etc., with abnormal CBC revealing anemia or abnormal WBCs. These patients accessed clinically for oral signs and accessed radiographically using panoramic radiographs and cone beam computed tomography (CBCT) to evaluate chronology and bone density.

Eligibility Criteria:
Inclusion Criteria:

1-Children will be aged from 6-10 years 2 Children diagnosed with leukemia but they don't start treatment yet

-

Exclusion Criteria:

1. Children below or above the age
2. Children already diagnosed by leukemia and started treatment
3. Children diagnosed by other bone lesions showing osteolytic bone or anemia as thalassemia or sickle cell anemia or any other bone pathology
Effect of Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients

The purpose of this study is to investigate whether transcranial direct current stimulation (tDCS) of the prefrontal cortex (PFC) influences lexical access and language production. The experimental paradigm will assess the impact of prefrontal stimulation by tDCS versus sham tDCS (S-tDCS) over the PFC of patients with chronic post-stroke aphasia during three language production tasks and a nonverbal executive functions task.

Background:

Language processing is a complex brain function supported by a large network, including domain-specific language areas as well as domain-general cognitive-control networks (Friederici \& Gierhan, 2013). Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), is increasingly being used as a promising therapeutic tool for psychiatric and neurological diseases (Tortella et al., 2015; Flöel, 2014). In the language domain, several studies revealed that tDCS over languagespecific areas induces changes in cortical function that enhances the recovery of language abilities in patients with post-stroke aphasia (Torres, Drebing \& Hamilton, 2013; Monti et al., 2013). Beneficial effects of tDCS have also been found for stimulation over more domain-general cognitive control regions. Although research on non-invasive brain stimulation and aphasia reveals promising results, studies investigating the modulation of cognitive control-networks on lexical access are rare. Given the importance of a successful interplay between prefrontal and domain-specific language areas, possible therapeutic effects of tDCS over the prefrontal cortex (PFC) in aphasia can be of high value for rehabilitation and basic research.

Procedure:

A planned total of 30 patients will be included. In a first visit, the severity of aphasia, the medical history as well as inclusion/exclusion criteria will be evaluated. After this visit, patients will undergo two tDCS sessions (one tDCS and one S-tDCS session) with a one week interval between the sessions. Each session consists of an online (during stimulation) and an offline assessment (within 30 minutes after stimulation). Three language tasks and a nonverbal executive function task will be conducted online as well as offline in each of the two sessions (tDCS and S-tDCS).

Eligibility Criteria:
Inclusion Criteria:

* Chronic aphasia due to ischemic or haemorrhagic stroke (\> 6 months post-stroke)
* French as dominant language
* Right-handedness
* Left hemisphere lesion with intact bilateral PFC

Exclusion Criteria:

* Diagnosed dementia or psychiatric comorbidity
* Epileptic seizure within the last 12 months
* Metallic head implants
* Pacemaker
* Inability to understand procedures or insufficient language production abilities
* pregnancy
* strong headache on the days of the tDCS sessions
* consumption of alcohol and/or unprescribed drugs on the days of the tDCS sessions or on the day before
High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients and non-small cell lung cancer (NSCLC) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and NSCLC patients receiving immunotherapy.


Eligibility Criteria:
Inclusion Criteria for GI Patients:

* 18 years of age or older
* Diagnosed with locally advanced rectal cancer (Stage II-III)
* Will undergo neoadjuvant chemoradiation at Moffitt Cancer Center
* Able to pick up FFs once/weekly at Moffitt
* Able to speak and read English
* Able to consume foods orally
* Able to provide informed consent

Inclusion Criteria for Thoracic Patients:

* 18 years of age or older
* Diagnosed with stage II-IV non-small cell lung cancer (NSCLC)
* Will undergo Immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at Moffitt Cancer Center
* Able to pick up FFs once/weekly at Moffitt
* Able to speak and read English
* Able to consume foods orally
* Able to provide informed consent

Exclusion Criteria:

* Antibiotic use within 1 month prior to baseline
* If currently using probiotics, unwillingness to cease probiotic use
* Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
* Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
* Infectious disease diagnosed \<1 month prior to baseline
* Already consuming ≥2 servings of fermented foods/day
* Previously diagnosed with a mast cell disorder or histamine allergy
Open Trial of Miglitol in Type 1 Diabetic Patients With Insulin Treatment

The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in patients with Type1 Diabetes Mellitus treated with insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type1 Diabetes
* Criteria of postprandial glucose and HbA1c are met

Exclusion Criteria:

* Type2 Diabetes
* Patients with antidiabetic drugs
* The other exclusion criteria are met
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
* Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
* At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
* Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
* Up to 1 prior line of systemic treatment for NSCLC is permitted
* ECOG Performance Status ≤ 2

Exclusion Criteria:

* Symptomatic brain metastases or symptomatic leptomeningeal involvement.
* History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected.
* Known tumor targetable co-mutations or rearrangements
* Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)

Note: Other protocol-defined inclusion/exclusion criteria apply
Cocoa Supplementation, Inflammaging, and Epigenetic Aging

The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement has an anti-aging effect (epigenetic aging and inflammaging) and examining these findings in the context of CVD risk factors and outcomes.


Eligibility Criteria:
Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:

Inclusion Criteria:

* Provided blood samples at baseline, Year 1, and Year 2 of follow-up.
* Opted to use EMSI for longitudinal blood collections, during which seated BPs were additionally measured.

Exclusion Criteria:

• Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.
Alternate-Day Buprenorphine Administration. Phase IV - 5

The purpose of this study is to determine if three times a subject's daily maintenance dose will hold for 72 hours without changes in agonist and antagonist effects.


Eligibility Criteria:
Please contact site for information.
Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.

The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.

Hot flashes are one of the most common symptoms that are experienced in women during perimenopause, menopause, and as a result of treatment of cancer such as breast cancer. Hot flashes, also known as vasomotor symptoms (VMS) may decrease a woman's quality of life due to discomfort, disruption of daily life, interruption of sleep, and worsening of depression. Previously, estrogen-based therapy was the primary treatment choice for VMS. However, in recent years, this has been considered less favorable due to the increased risk of breast cancer associated with estrogen-based therapy.

While medications such as certain antidepressants, gabapentin and clonidine are available as non-hormonal treatment options, they appear to be less effective in comparison to estrogen therapy with reported adverse effects.

Magnesium supplementation has been found to have very promising results in alleviating VMS in patients with a history of breast cancer. The goal of this study is to further investigate the effects of administering magnesium supplementation in reducing the effects of hot flashes in this targeted population. Our aim is to create a controlled trial using different dosages of magnesium glycinate in the management of hot flashes. Participants will be asked to complete surveys for data collection and analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25-85 years.
* Women with a history of invasive breast cancer, DCIS, or LCIS
* Creatine labs drawn within 90 days as part of Standard of Care.
* Bothersome hot flashes (defined by their occurrence of two or more hot flashes a day and/or of sufficient severity to prompt the patient to seek therapeutic intervention).
* Presence of hot flashes for \>30 days prior to study entry.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Ability to provide informed written consent.
* Life expectancy ≥6 months.
* Willing to work with the enrolling institution for follow-up (during the Active Monitoring Phase of the study).
* ECOG Performance Status (PS) = 0, 1.

Exclusion Criteria:

* Pregnancy (Assessed on Intake Questionnaire. Positive Answer exclusionary)
* Any of the following current (≤4 weeks prior) or planned therapies:
* Antineoplastic chemotherapy (anti-HER2 agents allowed)
* Androgens
* Estrogens (any delivery route)
* Progestogens
* Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period
* SSRIs/SNRIs
* Gabapentin
* Clonidine
* Oxybutinin
* Stage IV or V renal disease or GFR\<30 in the last 90 days
Ramadan Flash Glucose Monitoring Study

Many Muslim patients with diabetes observe dawn to sunset fasting during the month of Ramadan. Hyperglycaemia and hypoglycaemia are possible problems amongst these patients. The aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during Ramadan.

A good knowledge of the profiles of blood glucose with different treatments can help in making Ramadan fasting free of unwanted effects for such patients. Previous studies, including the EPIDIAR have shown an increased risk of hypo- and hyperglycaemia in patients with diabetes who fast during the Holy month of Ramadan.Although self-monitoring of blood glucose (SMBG) is useful in fasting diabetes patients when used within a structured testing regimen, it requires a lot of effort and compliance from the patient and doesn't provide continuous blood glucose data. The amount of data provided using SMBG depends on the frequency of finger pricks measurements. Flash Glucose Monitoring (FGM) sensors provide a record of the individual's glucose levels, trends and patterns for up to 14 days. This sensor doesn't require calibration using finger pricks. FGM data show how day-to-day decisions and behaviours impact the control of blood sugar levels. Availability of FGM makes it possible to explore glucose profiles in a continuous fashion during Ramadan period and make comparisons with non-fasting times outside Ramadan. The aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during Ramadan. The study will compare several parameters extracted from the FGM trace such us the incident of hypoglycaemia and hyperglycaemia, standard deviation, coefficient of variance and time in/above/below range. For this purpose the FreeStyle Libre sensor will be used. Patients will be asked to use the FreeStyle Libre sensor for a period of 3 months: 1 month before Ramadan, during Ramadan and one month after Ramadan.

Eligibility Criteria:
Inclusion Criteria:

* diabetes, age\>=18

Exclusion Criteria:

* pregnancy, renal failure
Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).


Eligibility Criteria:
Eligibility Criteria for the Randomized Study

Inclusion Criteria:

* Untreated or previously treated for WM. Previously treated subjects must have either documented disease progression or had no response (stable disease) to the most recent treatment regimen
* Centrally confirmed clinicopathological diagnosis of WM
* Measurable disease defined as serum monoclonal immunoglobulin M (IgM) \>0.5 g/dL
* Symptomatic disease meeting at least 1 of the recommendations from the Second International Workshop on Waldenström Macroglobulinemia for requiring treatment
* Hematology and biochemical values within protocol-defined limits
* Men and women ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

* Known involvement of the central nervous system by WM
* Disease that is refractory to the last prior rituximab-containing therapy defined as either

  * Relapse after the last rituximab-containing therapy \< 12 months since last dose of rituximab, OR
  * Failure to achieve at least a minor response (MR) after the last rituximab-containing therapy If the subject meets this exclusion criterion and therefore is excluded from the main randomized study, participation in the non randomized substudy (Arm C) may be considered
* Rituximab treatment within the last 12 months before the first dose of study drug
* Known anaphylaxis or (immunoglobulin E) IgE-mediated hypersensitivity to murine proteins or to any component of rituximab
* Prior exposure to ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitors
* Known bleeding disorders (eg, von Willebrand's disease) or hemophilia
* History of stroke or intracranial hemorrhage within 12 months prior to enrollment.
* Any uncontrolled active systemic infection.
* Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
* Currently active, clinically significant cardiovascular disease
* Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Eligibility Criteria for Open-label Substudy Treatment Arm C

The inclusion/exclusion criteria for the substudy (Arm C) are identical to those described above for the randomized study but, to be eligible, subjects need to be considered refractory to the last prior rituximab-containing therapy defined as either

* Relapse after the last rituximab-containing therapy \<12 months since last dose of rituximab, OR
* Failure to achieve at least a MR after the last rituximab-containing therapy.
Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)

Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.

Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are due to have a new defibrillator (including cardiac resynchronisation defibrillator) implant or box change

Exclusion Criteria:

* Contraindications to defibrillator testing e.g. severe untreatable coronary disease Intracardiac thrombus Interruption of anticoagulation Participants undergoing box change, device upgrade or revision Inability or unwillingness to provide informed consent.