cyrilzakka/clinical-trials huggingface dataset:
Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries

Cariogram and Cariostat will be used to assess the risk of caries in kindergarten children aged 3 years. Routine preventive measures will be taken for children at low risk of caries, and intensive intervention measures will be taken for children at medium and high risk. Routine measures will be taken for the control group. After one and two year, the prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.

Caries risk-graded intervention for preschool children is needed as different child has different risk to suffer from caries.

Cariogram and Cariostat are two different and common caries risk assessment tools. Cariogram is a complicated but economical computer program which is more sensitive for caries risk assessment. Cariostat is a biological reagents with high specificity but it may be expensive to use for large numbers of children.

The experimental group will be divided into two subgroups, one use Cariogram and the other use Cariostat to assess the risk. Based on the results of the assessment, children with low risk of caries will get routine prevention including twice fluorinated foams each year and hygiene. Children with middle or high risk of caries will receive twice fluorinated varnish each year and professional caries treatment in addition to routine prevention.Routine prevention will be taken for the control group with both Cariogram and Cariostat assessment.

Follow-up will arrange one and two years after baseline recruitment. All participants will receive oral health-related questionnaires at baseline and follow-up.

The prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Junior kindergarten children who enter the kindergarten in September 2021 and can cooperate with the oral health examination.
2. Parents of children fully understand the purpose of the study, cooperate with the questionnaire survey during the study, give informed consent and sign the informed consent form.
3. The child has no serious systemic diseases, has not taken hormones and immunosuppressants within 6 months, and has no history of antibiotic use within 1 month，and is not allergic to fluoride.

Exclusion Criteria:

1. Parents of children refuse to provide information about children's oral health or questionnaires.
2. Children cannot cooperate with oral health examination.
3. The child has a serious systemic disease that may affect the results of the study.
4. Children who are allergic to fluoride.
Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study in adult patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with Retacrit® to correct haemoglobin levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥18 years .
* Patients present with chemotherapy-induced symptomatic anaemia.
* Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.

  * The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
* Patients eligible for epoetin alfa biosimilar treatment.

Exclusion Criteria:

* Patients are not receiving chemotherapy.
* Patients already included in an epoetin zeta study.
* Patients presenting with the contraindications to epoetin zeta.
* Patients presenting with the hypersensitivity to the active substance or any of the excipients.
* The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA).
* Patients with uncontrolled hypertension.
* Patients who cannot receive adequate prophylaxis by antithrombotic agents.
Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix

Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar coagulation could result in the damage of ovarian reserve and decrease the response of the ovaries to hormonal stimulation for assisted reproductive technologies. The possible mechanism may contribute to thermal destruction of ovarian follicles by excessive use of bipolar coagulation for hemostasis purposes.

To avoid additional ovarian tissue damage by conventional bipolar coagulation being potentially important ovarian reproductive function, hemostasis using various topical hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact with blood after application at a bleeding site, the gelatin particles swell and tamponade bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood flow and providing exposure to a high thrombin concentration, thus hastening clot formation. Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where there is superficially pervasive focus of bleeding.

Ovarian reserve is defined as the functional potential of the ovary, which reflects the number and quality of antral follicles left in the ovary, and is correlated with the response to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone (AMH) has been accepted as the most reliable and easily measurable marker for postoperative assessment of ovarian reserve.

The investigators conducted a multicenter, large-scale, randomized controlled trial to investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in preserving ovarian reserve by assessing serial AMH levels in patients undergoing laparoscopic ovarian cystectomy for benign ovarian cysts.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 45 years
* maximum diameter of the cyst between 3 and 10 cm
* regular menstrual bleeding (defined as cycle length less than 21 or more than 45 days)
* appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).

Exclusion Criteria:

* any suspicious finding of malignant ovarian diseases
* postmenopausal status
* baseline serum AMH \< 0.50 ng/mL
* pregnancy
* lactation
* any other endocrine diseases (such as thyroid dysfunction, hyperprolactinemia, or Cushing's syndrome)
* use of hormonal treatments in the 3 months before enrollment
Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection

The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.

Study Plan: Qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. Several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups.

Study Procedure: We will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making.

Subjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential patients. If necessary, patients will also be contacted by a Cardiovascular Research Coordinator and invited to attend a scheduled focus group. After receiving patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. The invitation will be sent via email and followed up with a phone call, if necessary. If a clinician focus group is unable to be scheduled, then individual interviews will be conducted.

Setting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* English or Spanish speaking
* Presence of coronary disease, or a caregiver/relative of one with coronary disease

Exclusion Criteria:

* non-English or non-Spanish speaking
* dementia
Remote Interrogation in Rural Emergency Departments

A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care.

Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in the remote monitoring group comprised of patients with SJM devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with SJM devices that are not compatible with the unpaired transmitter or that have a competitor's device.


Eligibility Criteria:
Inclusion Criteria:

1. Presents to Emergency Department with an implanted pacemaker or defibrillator.
2. Are 18 years of age or older.
3. Are willing and able to provide informed consent for study participation.
4. Are willing and able to complete a 30-60 day follow up phone call.

Exclusion Criteria:

1. Are unwilling to provide written informed consent.
Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, above 18 years of age
* Diagnosis of essential hypertension
* Newly diagnosed,
* Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
* Written informed consent

Exclusion Criteria:

* Known or suspected secondary hypertension
* eGFR lower than 30 mL/min
* Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women
* Other protocol-defined inclusion/exclusion criteria may apply.
Transtheoretical Model of Behavior Change and Anxiety

Examine the utility of the Transtheoretical Model in influencing anxiety among college students. Employ a randomized controlled intervention including a static and dynamic Facebook intervention. The static group accessed a Facebook page featuring 96 statuses. Statuses were intended to engage cognitive processes, followed by behavioral processes of change per the Transtheoretical Model of behavior change. Content posted on the static Facebook page was identical to the dynamic page. However, the static group viewed all 96 statuses on the first day of the study, while the dynamic group received only 1-2 of these status updates per day throughout the intervention. Anxiety was measured using the Overall Anxiety Severity and Impairment Scale (OASIS). Time spent engaging in physical activity was assessed using the International Physical Activity Questionnaire (IPAQ).


Eligibility Criteria:
Inclusion Criteria:

* Having an active Facebook account
* Daily access to a Smart Phone
* Current University of Mississippi email account

Exclusion Criteria:

* Outside the age range of 18-35
Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity

The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones.

The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.

OBJECTIVES: To compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with SAHS as well as in selected control subjects according to weight.

DESIGN: Multicenter, prospective and controlled study. 40 patients with SAHS will be included as well as 40 control subjects.

METHODS: To all subjects included in the study, the following procedures will be performed:

1. Medical History;
2. Anthropometric variables (height, weight, Body Mass Index;
3. Somnolence evaluation using the Epworth scale;
4. Conventional Polysomnography (PSG);
5. Determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, PCR, etc.
6. Conventional biologic evaluation;
7. Patients will be re-evaluated after three months of treatment with CPAP.

Eligibility Criteria:
Inclusion Criteria:

* Apnea-Hypopnea Index \> 15
* Body Mass Index \< 27 or \> 30 Kg/m2

Exclusion Criteria:

* Presence of any chronic disease
* Drug addiction and/or alcoholism
* Refusal to sign informed consent
Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish

The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.

The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.

Study center:

A total of 50 subjects were to be included in 1 site in Iceland.

Methodology:

* Group Loceryl Nail Lacquer+ Cosmetic Varnish:

  * Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails,
  * Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails.
* Group Loceryl Nail Lacquer alone:

  - Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails.
* All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail
* Subjects must have maximum of 50% of nail distal edge involved
* Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening

Exclusion Criteria:

* Subjects with clinically important abnormal physical findings at the Screening/Baseline visit
* Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit
* Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs
Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants

Assesses the efficacy of melatonin in treatment of feeding intolerance in preterm infants, the time needed to reach full enteral intake, the incidence of necrotizing enterocolitis and measures the level of tumor necrosis factor-alpha as a marker of oxidative stress.

This is a prospective study held on ninety preterm infants in Ain Shams University neonatal intensive care units. All enrolled neonates were suffering from feeding intolerance in the form of abdominal distension, gastric residuals or bloody stools. The first group of forty five infants were given melatonin in addition to traditional antibiotic treatment. The second group of forty five infants were given traditional antibiotic treatment only. Both groups were followed up clinically as regards improvement of clinical signs of feeding intolerance and laboratory results till they reached full enteral intake. Both groups were compared as regards incidence of necrotizing enterocolitis and level of tumor necrosis factor-alpha after 72 hours of starting treatment as a marker of oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (\<37 weeks of gestation)
* Evidence of feeding intolerance

Exclusion Criteria:

* Infants with hypoxic ischemic encephalopathy
* Infants on nothing per os
* Infants with high oxygen needs wither on invasive or non-invasive mechanical ventilation
* Major congenital anomalies
* Intracranial hemorrhage
* Respiratory distress syndrome
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer

This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably

PRIMARY OBJECTIVES:

I. To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment.

SECONDARY OBJECTIVES:

I. To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness.

II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency.

OUTLINE:

Patients receive letrozole orally (PO) once daily (QD). Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically confirmed diagnosis of Stage I, II or III breast carcinoma
* Patients must be prescribed letrozole for adjuvant breast cancer treatment
* Prior adjuvant tamoxifen is permitted
* Patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab

Exclusion Criteria:

* Diagnosis of Stage IV breast carcinoma
* Pre-existing myalgias, arthralgias and/or joint stiffness \>= Grade 1, as defined using CTEP CTC identified during baseline physical exam
* Inability to understand or cooperate with study procedures
* Receipt of investigational drug within 30 days before study entry
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* Unwillingness to give informed consent
* Unwillingness to participate or inability to comply with the protocol for the duration of the study
* Patients with serum calcium \>= 14 mg/dL
* Patients with renal dysfunction defined as glomerular filtration rate \<10ml/min calculated using Cockroft-Gault equation
Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults

The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization.

The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the University of Texas Medical Branch (UTMB) ACE unit with an admitting diagnosis of congestive heart failure, respiratory infection, kidney/urinary tract infection, or metabolic disorder; or other condition that will allow a subject to participate in the study after patient review
* Aged 65 years or older
* Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
* Lives within 30 miles of UTMB
* Can stand without assistance at the time of pretesting
* Presents no medical contraindication to wearing a loose fitting velcro strap for the accelerometer on one ankle
* Score ≥26 on the 30-item Mini Mental State Examination or alert and oriented X3 by physician on H\&P
* Is discharged "to home" at ACE unit discharge.

Exclusion Criteria:

* Nursing home resident or hospice patient
* Uncontrolled blood pressure (systolic \>150, or diastolic \> 100)
* History of stroke with motor disability
* Glomerular filtration rate (GFR) \<30 mL/min/1.73m2 or evidence of kidney disease or failure
* Liver disease ( aspartate aminotransferase (AST) /Alanine transaminase (ALT) 2 times above the normal limit, hyperbilirubinemia)
* Recent (within 3 months) treatment with anabolic steroids
* Any other condition or event considered exclusionary by the PI and faculty physician
* Planned or elective hospitalization within 30 days of discharge

Additional Exclusion Criteria for Subjects Randomized to the Testosterone Group

* Breast or prostate cancer
* Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml
* PSA ≥ 3 ng/ml in men at high risk of prostate cancer, such as African Americans or men with first-degree relatives with prostate cancer
* Hematocrit ≥ 50%
* Decompensated heart failure as determined by a physician