cyrilzakka/clinical-trials huggingface dataset:
Micronutrient Status During Pregnancy

An adequate micronutrient status during fetal life and infancy is important for optimal development. Dietary practices during pregnancy, lactation and infancy vary among populations and there is today no clear agreement on what constitutes the best diet, including micronutrient supplementation, during this period. There is consequently no clear agreement on what constitutes an optimal biochemical micronutrient status in mothers and infants. Due to substantial physiological changes in plasma volume, hormones, transport proteins and organ function during these periods, the ordinary reference levels or cut off levels used for biochemical assessment of micronutrient status are unsuited to these groups of patients.

The objective of the study is to establish cut off levels for important vitamins and trace elements during pregnancy, lactation and infancy in order to ensure an optimal infant neurodevelopment and to study how micronutrient status influence the immunosystem.

The investigators have analyzed micronutrients, including all vitamins and trace elements and related aminoacids and markers of cellular immunoactivation in 160 fertile, unpregnant women, 115 pregnant women from pregnancy week 18, throughout pregnancy and the first 6 postpartum months and their infant at 6 months. Infant gross motor development is associated with micronutrient status, so the investigators will relate gross motor development at 6 months to maternal micronutrient status during pregnancy and postpartum, in order to establish relevant cut off levels for micronutrients and related biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* healthy never-pregnant and pregnant women

Exclusion Criteria:

chronic illness-
Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy

The aim of the study was to evaluate the application of water exchange method to upper endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient discomfort. The primary outcome will be the patient discomfort score during upper endoscopy. The secondary outcomes will include cleanliness score, techniques adequacy score, findings of the EGD, and willing to repeat the procedure, as well as the patient and endoscopist satisfaction score with the method.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment

Exclusion Criteria:

* a therapeutic EGD
* sedation with other agents
* American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
* age less than 20 years or more than 65 years
* pregnancy
* refusal to provide written informed consent. All participants signed written informed consents
Brisk Walking Training Compared with Cognitive Behavioral Therapy for the Treatment of Chronic Primary Insomnia in People Aged 60 Years or Above: a Randomized, Partially Blinded, Non-inferiority Trial

This study is a single-blinded (outcome assessor) and parallel-group non-inferiority RCT. Chinese older adults aged ≥60 years with chronic primary insomnia will be randomized evenly (1:1) to either the brisk walking training group or the CBT-I group. Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week). Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). Self-reported and objective sleep outcomes are measured at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥60 years;
2. Ethnic Chinese; able to read, write and speak Cantonese
3. Having a Hong Kong ID;
4. Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T2.
5. Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia)
6. Experiencing any one of the following symptoms for ≥3 days per week

   1. Difficulty initiating sleep; OR
   2. Difficulty maintaining sleep; OR
   3. Early-morning awakening with inability to return to sleep

Exclusion Criteria:

1. Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q);
2. Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes/session);
3. Currently receiving or scheduled to receive CBT-I during the study period;
4. Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE).
5. Working nightshifts and unable/unwilling to discontinue such work pattern;
6. Having a diagnosis of a major depressive disorder, anxiety disorders or other severe mental disorder (bipolar disorders, psychosis). Those with mild depression or anxiety disorders will not be excluded;
7. Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep;
8. Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases).
9. Having a serious somatic condition preventing the participation of brisk walking training/CBT-I.
Diagnostic of Human Immunodeficiency Virus (HIV) and Other Sexual Transmission Diseases (STD) in High Risk Populations: Men Who Have Sex With Men (MSM) Users of Chemsex

The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group of men having sex with men (MSM) users of Chemsex

The main objective is to offer diagnostic tests for HIV, HCV and other STD in the risk group (MSM users of Chemsex) with the purpose of conduct diagnosis, early treatment and monitoring of this infections and reduce the incidence rate of the same ones

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years)
* Men MSM/transgender referred from PEP office
* Men MSM/transgender referred from urgency service attended for acute intoxication or an STD
* Men MSM/transgender referred from STD office
* Men MSM/transgender referred from a local ONG attended for chemsex use
* Specifically drug use for having sexual relations, at least once in a month in the lasts 6 months or more than 10 times the last year
* Reading and understanding ability
* Patients should be given written informed consent
* Negative HIV and HCV men
* HIV positive men but HIC negative referred from HIV daily hospital
* Disposal of sanitary card from CatSalut

Exclusion Criteria:

* Men that not accomplish inclusion criteria
* Drug use for another purposes not sexual
* Drug use for having occasional sexual relations, least than once in the past 6 months
Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan

When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign.

While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer.

This study will assess the clinical effectiveness of utilizing \[11C\]Acetate PET scans in identifying recurrent prostate cancer.

FDG-PET imaging uses a form of radioactive glucose (18-fluoro-deoxyglucose or FDG), which allows the measurement of glucose metabolic rate of any tissue in the body. The most prevalent tumors have a glucose avidity that is typically greater than 2.5 times the avidity of benign tissue. Therefore, FDG-PET is able to discriminate between benign lymph nodes and those containing metastases, and similarly between scar tissue and recurrence of tumor.

Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is much less effective in staging prostate cancer. The current FDA-approved imaging agent for prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab pendetide, labeled with a long-lived radionuclide \[111\]Indium that is used to image the patient over a six day period. However, recent data show that another PET radiopharmaceutical, \[11C\]Acetate (which has been FDA approved for years for cardiac imaging), is avidly taken up by prostate metastasis and is more sensitive than either \[111\]Indium capromab pendetide or FDG-PET.

This study will assess the clinical effectiveness of utilizing \[11C\]Acetate PET scans in identifying recurrent prostate cancer and aim to find at what PSA levels it is most effective.

Eligibility Criteria:
Inclusion Criteria:

* Positive for recurrent prostate cancer by PSA criteria
* Recurrence definition:
* Status post-operative radical prostatectomy, recurrence is defined by a PSA of greater than or equal to 0.2 ng/ml
* Patients who have failed external beam radiation, or status post-brachytherapy, have recurrence as defined as PSA above 2.0 ng/ml the nadir PSA after treatment
* Subject is able to comprehend the study objectives and provide written informed consent before the initiation of any study-related procedures.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) status of ≥ 2
* Any other concurrent malignancy
* Patients without remission of disease (no PSA decrease)
* Patients without recurrence of disease (PSA remains low)
Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.

This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to \<4 years of age to help develop dosing regimens


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 1 to less than 4 years of age at study entry
2. Written informed consent must be signed by the patient's parent or legal guardian.
3. Patients must have the diagnosis of CML or Ph+ ALL
4. Lansky score must be ≥ 50 (Table7-2)
5. Patient must have adequate end organ function as defined by

   * Total bilirubin \< 1.5 x ULN
   * SGPT (ALT) and SGOT (AST) \< 2.5 x UNL
   * Creatinine \< 1.5 x ULN

Exclusion Criteria:

1. Patients who have received drugs a) known to be metabolized by CYP3A4 or 3A5, b) are CYP inhibitors and inducers, within 2 weeks prior to Visit 2 (except for imatinib)
2. Patients who previously received radiotherapy to ≥ 25% of the bone marrow, with the exception of patients who received total body radiation as part of a preparatory regimen for hematopoetic stem cell transplant (HSCT)
3. Patients receiving antibacterial and antipyretic medication to treat active infection
4. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
5. Patients whose parents or legal guardians, in the opinion of the Investigator, were unlikely to comply with the protocol or safety monitoring requirements

Other protocol-defined inclusion/exclusion criteria may apply
Semiquantitative Urine Pregnancy Test Results At ≥9 Weeks of Gestation

Purpose of study is to obtain data on urinary HCG concentrations at \>9 weeks of gestation.


Eligibility Criteria:
Inclusion Criteria:

* pregnant at \>9 weeks of gestation

Exclusion Criteria:

* none
Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

The importance of micronutrients has been extensively reviewed and it was concluded that for prevention and treatment of periodontitis daily nutrition should include sufficient antioxidants, vitamin D and calcium.

Up to now there is limited research available investigating the effect of vitamin C supplementation on the periodontal condition. Supplementation of vitamins and micronutrients has however raised numerous questions on clinical efficacy. Recently, a significant increase of medical literature on the effect of nutraceutical dietary aliments on general health has been noted.

the aim of the present study is twofold. The first objective is to investigate the effect of twice-daily kiwifruit consumption as sole treatment modality in untreated periodontitis, followed after two months by initial periodontal therapy supported by continued kiwifruit consumption. The second objective is to investigate the effect of twice daily kiwifruit consumption on periodontal and systemic parameters of these periodontitis patients 3 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* proximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth,
* PPD≥4 mm and bleeding on probing on at least 25 % of their total sites
* documented radiographic bone loss

Exclusion Criteria:

* younger than 18 years or older than 70 years,
* pregnant or lactating females,
* females using contraceptive pharmacological medications,
* reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases,
* in need of antibiotic treatment during initial periodontal treatment (IPT),
* IPT in the previous 6 months,
* allergic to latex, kiwifruit and fruits in general,
* suffering of eating or digestive disease or food intolerances,
* smoking more than 20 cigarettes per day.
AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors

THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 60 Black adults with hypertension.

Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 60 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services.

The investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 \& 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Self-identify as Black/African American
3. Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (\>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)
4. Live in census tracts identified by Montgomery County Department of Planning52 as HFPA:

   1. Healthy Food Availability Index score is low (0-9.5),
   2. Median household income ≤185% of Federal Poverty Level
   3. \>30% households have no vehicle, Distance to supermarket \>1/4 mile.
5. Participants must have refrigeration, food appliances (microwave, stove),
6. Cell phone to receive messages

Exclusion Criteria:

1. Age \<18 years
2. Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
3. Diagnosis of end-stage renal disease (ESRD)
4. Condition which interferes with outcome measurement (e.g., dialysis)
5. Serious medical condition which either limits life expectancy or requires active management (e.g. cancer)
6. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
7. Patients with cognitive impairment or other condition preventing their participation in the intervention
8. Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
9. Current participation in another clinical trial that could interfere with the study protocol
10. Those planning to move out of the geographic area in 12 months
11. Unwillingness to provide informed consent
12. Other conditions or situations at the discretion of the Investigative team
The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy Subjects

The principal aim of this study is to evaluate the presence of changes in cervical vestibular evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.

Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service of the hospital.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* hearing impairment
* caffeine abuse 24 hours before the test
* medication remains
* hypertension, dyslipidemia, diabetes mellitus or sleep disorders.
Combating Cancer-Related Fatigue: A Personalized Supportive Care Program

This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.

All subjects will be assigned to an exercise and dietary intervention program. Patients will engage in two patient-clinician consultations for exercise and nutrition. The individualized exercise plan designed based on the subject's medical history, current exercise habits, and specific needs, will include a mix of aerobic and resistance training.

Concurrently, participants will receive nutritional consultations from a specialized oncology dietitian. These sessions will focus on creating a diet plan tailored to each participant's nutritional needs, considering their treatment and overall health. Study participants will complete weekly exercise journals to track adherence to the exercise prescription and complete weekly assessments of their adherence to dietary recommendations on an integer scale ranging from 0-10.

Eligibility Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
* Age ≥ 18 years at the time of consent.
* Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.
* Significant symptoms of fatigue, as defined by PROMIS Fatigue score \>50.

Exclusion Criteria:

* Other co-existing malignancies.
* Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.
* Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia/thrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.
* Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention
Biomarkers for the Detection of Lymphatic Insufficiency

Acquired lymphedema is a disease that causes chronic swelling of the limb(s). It is frequently under-recognized or misdiagnosed. This study is designed to lead to the development of an accurate, noninvasive, blood test to allow testing for lymphedema. This approach is particularly useful to investigate relative responses to treatment interventions.

The validation of a sensitive and specific biomarker assay for human acquired lymphatic vascular insufficiency would represent a highly significant development for the patient community. Accurate bioassay for the presence of lymphatic vascular insufficiency should help to pave the road for future human clinical trials of experimental drugs and therapies designed to treat human lymphatic diseases. Molecular profiling will be performed in human tissues (skin) obtained by biopsy. The insights gained from these initial analyses will determine the targets for assay in human body fluids (blood).

Eligibility Criteria:
Inclusion Criteria

For lymphedema participants:

* clinical diagnosis of lymphedema of at least 6 months' duration

Control participants:

* no evidence of lymphedema

Exclusion Criteria

For lymphedema participants:

* active cancer
* infection
* bleeding tendency
* active coronary artery disease
* congestive heart failure
* history of stroke or transient ischemic attack (TIA)
* uncontrolled hypertension
* renal insufficiency (serum creatinine \> 1.1)
* active inflammatory or autoimmune disease (other than lymphedema)

For control participants:

* lymph node dissection
* radiation therapy
* active inflammatory disease