cyrilzakka/clinical-trials huggingface dataset:
Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Atopic dermatitis diagnosed according to Hanifin and Rajka criteria
* Age 2 - 17 years
* SCORAD 10 - 103

Exclusion Criteria:

* Active skin infection
* History of underlying illness causing immunosuppression within the past 2 years
* Immunosuppressors taken within the past month
* Parathyroid disease
* Sarcoidosis
* Acute or chronic renal disease
* Hyper or hypocalcemia
* Thyroid disease
* Osteomalacia or Paget's disease of bone
* Malabsorption
* Use of VD supplements (\> 400 IU daily) or fish oil supplements in the past month
* Treatment for known VD deficiency in the last 6 months
* Treatment with moderate or high potency topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers, or topical calcineurin inhibitors in the past 7 days
* Phototherapy in the past month
* Autoimmune disease or immunodeficiency
* Planned trip to sunny climate during the 6-week study.
Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .

Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an epidural haematoma formation following the epidural analgesia, "gold standard" in major abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local anesthetics constitute so an alternative.

The study will compare the continuous infiltration of local anesthetics and rachianalgesia in terms of decreased postoperative morphine consumption and incidences of chronic postoperative pain at 3 and 6 months after hepatic surgery compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Surgery of hepatic resection by first under costal.
* Patient classified ASA 1 to 3.
* Information, signed and informed consent

Exclusion Criteria:

* Patients classified ASA 4 or 5.
* Allergy or intolerance to any of the products used in the protocol.
* Emergency surgery, palliative surgery, surgical recovery.
* History of chronic pain requiring the regular use of analgesics, especially opioids.
* History of drug misuse.
* Inability to understand and / or use the patient's self-controlled morphine pump.
* Known history of psychiatric disorders or current psychotropic treatment (excluding benzodiazepine monotherapy)
* Additive behavior with respect to alcohol or non-weaned psychodysleptic substances
* Pregnant Woman or Breastfeeding
CP-690,550 Thorough QTc Study

ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development. The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation.

The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of tobacco- or nicotine-containing products in excess of equivalent of 5 cigarettes per day.
* 12-lead ECG demonstrating QTc \>450 msec or other clinically significant abnormalities at Screening.
* History of risk factors for QT prolongation or torsades de pointes.
* Pregnant or nursing women; women of childbearing potential unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to first dose until completion of follow-up.
* Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.
* Any clinically significant infections within past 3 months or evidence of infection in past 7 days.
Chance to Avoid New Caries by Adding Chlorhexidine to the Preventive Protocol in Adolescent Special Needs

Adolescent Special need individuals are most need of easy forms of antibacterial agents, so in this study, using chemotherapeutic agents like the newly introduced varnish containing chlorhexidine seems to be a quite promising tool for local delivery to patients with special needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against the oral flora while fluorides are well known with their antibacterial ability. This may be an excellent way to reduce the risk assessment in adolescent special needs patients.

Participants will be divided into two groups according to the tested regimen, where (A1) represents participants exposed to risk based conventional protocol, (A2) represents participants exposed to chlorhexidine containing varnish and risk based conventional preventive protocol. The study will be carried over a period of 10 months (one academic year), the study will be divided into three phases Phase I: Information of the Cariogram parameters (caries experience, diet content, diet frequency, plaque amount, mutans streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be collected, which will be used to generate the individual caries profile, based on which the participants will be divided into 2 risks groups. Phase II: Risk based preventive program will be implemented including the restorative part. Phase III: At the end of 10 months, caries profile will be generated again

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of disability like : autism and down syndrome.
* Must be able to open his/her mouth for varnish application

Exclusion Criteria:

* systemically unhealthy patients with fetal diseases
* Age below 13 and above 18
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

At present our current practice is to provide a course of oral iron therapy for those patients with a post-operative haemoglobin which is below normal, but not severe enough to require a blood transfusion. Such a practice is not without side effects from the iron tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the literature to support the current practice of using iron, with only one small randomised trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily) for one month. The haemoglobin will be checked when the patients attends the hip fracture clinic at 6 weeks after discharge.


Eligibility Criteria:
Inclusion Criteria:

* patients with anaemia after surgery for a hip fracture

Exclusion Criteria:

* absence of anaemia, inability to provide consent
Effect of Short-term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3 Insufficient, Prehypertensive Patients

A three-period parallel (baseline, treatment, and post-treatment) design clinical research was conducted. All participants visited a clinical trial center of Korea University Anam Hospital for baseline measurement of clinical variables including ABPM and hematologic biomarkers (ACTH, aldosterone, norepinephrine, cortisol, and 25-hydroxyvitamin D3). After the baseline assessment, participants visited 'Cholipo beach' (Taean, Republic of Korea) for 3 nights and 4 days for the intervention (sunlight exposure program). After a week of wash-out period, post-treatment measurement was processed at Korea University Anam Hospital. Participants were prohibited from vigorous physical activity, alcohol drinking, and smoking during the study period. A normal-sodium diet (2800 mg/day)\[14\], caffeine and smoking restriction was suggested during the whole study period. To control the effect of circadian rhythm on endocrine blood tests and ABPM, we fixed sampling and monitoring start time at 10:00 am. All participants received the same measurements as they did in the baseline measurement during treatment and post-treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* prehypertensive patients
* vitamin D insufficiency
* age 20-45

Exclusion Criteria:

* medical comorbidity other than prehypertension
* participant using medication
* Subjects with a history of cardiovascular, renal, hepatic, gastrointestinal, hematologic, psychological, or gastrointestinal abnormalities, taking any kind of medications
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.

OBJECTIVES:

Primary

* Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma.
* Determine the overall survival of patients treated with this regimen.

Secondary

* Determine the time to progression and types of initial recurrence in patients treated with this regimen.
* Determine tumor response in patients treated with this regimen.
* Determine mortality and morbidity related to treatment in these patients.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed gastric adenocarcinoma

  * Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:

    * T4, N2
    * T4, N3
    * P1, CY1
  * CT scan and laparoscopic staging required

PATIENT CHARACTERISTICS:

Age

* 20 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* WBC ≥ 4,000/mm\^3 AND \< 12,000/mm\^3
* Granulocyte count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL

Hepatic

* AST and ALT ≤ 2.5 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine clearance ≥ 50 mL/min

Pulmonary

* PaO_2 ≥ 70 mm Hg on room air

Other

* Able to swallow oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for gastric cancer

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy for gastric cancer

Surgery

* No prior surgery for gastric cancer

Other

* No other prior therapy for gastric cancer
Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding

The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding. This group intervention will also be compared with a Treatment as usual (TAU) group consisting in a childbirth education class taught by the Health Center midwife. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU.

The aim of this study is to assess a mindfulness and compassion group intervention for pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of stress, negative affect and depression in pregnancy and breastfeeding.

There will be two groups:

1. A face to face mindfulness and compassion intervention for pregnant women in their second trimester of pregnancy and their partners in group format (8 weeks) based in the Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will also receive in their third trimester of pregnancy the childbirth education classes taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the National Health Care System in Spain (TAU).
2. A control group that will receive only the childbirth education class by midwives (TAU) group consisting in a childbirth education class taught by the Health Center midwife at the third trimester of pregnancy.

Each group will be composed of 60 participants with a total sample of 120. The principal hypothesis is that the mindfulness and compassion intervention will be more effective than TAU in the decrease of stress, negative affect and depression and in the increase of positive affect during pregnancy and breastfeeding.

The differences between the intervention and control group will be analyzed. Finally, a qualitative study will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Willingness to participate in the study and signing informed consent
* Ability to understand and write Spanish.
* Women will be in their 6 to 25 weeks of pregnancy.
* All women eligible will be accepted with our without their partner.

Exclusion Criteria:

* Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.),
* Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk
* Currently taking psychopharmacological medication or under psychopharmacological treatment.
LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.

In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>/= 18 years
* Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers

Exclusion Criteria:
ORI2 : ORI for hyperOxia Reduction in ICU

Recently, hyperoxia has been recognized as being potentially deleterious for critically ill patients, with increased duration of mechanical ventilation and even with increased mortality rates. This could be related to pulmonary lesions (including notably atelectasis) but also to increased tissue damage and organ dysfunctions, secondary to increased/induced oxidative stress. At last higher FiO2 led to "over-consumption" of oxygen and therefore to additional costs. Usually, FiO2 and oxygen flows are modified according to the monitoring of SpO2. But, it has also been recognized that modifying FiO2 (and oxygen flows) according to SpO2 monitoring is not routinely (or easily) done. Indeed, nurses (and doctors) are reluctant to reduce oxygen flows when everything appear under control.

The ORI (Oxygen Reserve Index) is an index measured using non-invasive SpO2 sensors (Rainbow sensors- MASIMO) that evaluates non-invasively PaO2 (partial pressure of oxygen). An ORI ≤0 indicates that PaO2 is less than 100 mmHg. When ORI increases (i.e. ORI≥0.01) PaO2 is higher than 100 mmHg. This index increases up to 1. ORI between 0.01 and 1 indicates that PaO2 is probably between 100 and 200 mmHg. Thus, monitoring critically ill patients using the ORI, may help identifying when PaO2 is high and when FiO2 (or oxygen flows in non-intubated patients) may be reduced. This could help reducing the time with hyperoxia (i.e. PaO2 ≥100 mmHg or ≥80 mmHg).

The purpose of this feasibility study is to evaluate if the use of ORI can help to decrease length of moderate hyperoxia (PaO2\>100mmHg) in critically ill patients, in comparison with monitoring the SpO2 only.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in ICU of Angers hospital
* Patient intubated and mechanically ventilated for an expected period of at least 2 days

Inclusion is to achieve within 6 hours after admission (for admitted patients intubated ) or at the time of intubation (for non- intubated patients on admission )

Exclusion Criteria:

* Pregnant Woman
Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt)

Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: From Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques (HeNomics).

The aim of this study is to:

* Analyze and compare the microbiota and the intestinal, salivary and intratumoral microbiome in patients with HCC, patients diagnosed with oncological pathology and in healthy subjects. The analysis of the mycobiota will be carried out by analyzing bacterial culture media, that of the microbiome by genomic analysis. The evaluation will be made by taking into account multiple taxonomic levels: phylum, class, order, family, genus and species.
* Identify tumor antigens (TuAs) with sequence homology with peptides derived from the microbiota/microbiome by bioinformatic analysis. The sequences of tumor antigens known from the literature (https://caped.icp.ucl.ac.be/Peptide/list) will be aligned with sequences derived from bacteria identified in the microbiota/microbiome of patients and healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of primary HCC and other oncological pathology (Pascale Institute) or diagnosis of oncological pathology (without any exclusions) from an accredited medical-clinical facility (Fortore Mountain Community).
* Age ≥18 years
* Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol.
* In the case of paraffin-embedded samples obtained from the UOC of Pathological Anatomy and/or the Institute's Biological Bank, informed consent cannot be acquired, in accordance with the Provision of the Privacy Authority containing the requirements relating to the processing of special categories of data, pursuant to art. 21, paragraph 1 of Legislative Decree 10 August 2018, no. 101, published in the Official Journal - general series - no. 176 of 29/07/2019, point 5 "Provisions relating to the processing of personal data carried out for scientific research purposes (gen. aut. n. 9/2016)" HEALTHY SUBJECTS
* clinical history free from diagnosis of tumor or neoplastic pathology treated during life
* Age ≥80 years
* Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

* Current pathologies requiring antibiotic therapy
* Diagnosis of pre-tumor pathology (in healthy subjects)
MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease

The goal of this research proposal is to identify a miRNA expression profile as a biomarker to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo allogeneic transplantation. This biomarker, once identified, will need validation in larger cohorts.

Human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. If a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. The amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. There will be no pregnant women or children involved in the investigators study.

All patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing fully matched allogeneic PBCSC and bone marrow transplantation who present with clinical signs and symptoms of grade II- IV aGVHD within 100 days after transplantation as defined by skin, GI, and/or liver involvement that are confirmed by biopsy, regardless of age
* Patients undergoing a matched, unrelated donor (8/8) or matched, related donor transplant (6/6)
* Allogeneic transplant is from donor's peripheral blood stem cells or bone marrow transplant
* Patients who develop grade II-IV aGVHD

Exclusion Criteria:

* Patients who receive transplants from incompletely matched donors
* Patients who receive T cell depleted transplants
* Patients who receive haplo-identical transplants
* Pregnant Patients
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.


Eligibility Criteria:
Inclusion Criteria:

* Active primary or recurrent Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
* Best corrected visual acuity of 20/40 to 20/320
* Study eye must:

  * Have active leakage on Fluorescein Angiogram involving the fovea
  * Have edema involving the fovea
  * Be free of foveal scarring
  * Be free of foveal atrophy

Exclusion Criteria:

* Previous use of anti-VEGF or bevacizumab within 6 weeks
* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous haemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) confirmed by indocyanine green angiography (ICGA)
* History of idiopathic or autoimmune-associated uveitis in either eye
* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Current treatment for active systemic infection
* Known allergy to any component of the study drug or history of allergy to fluorescein or indocyanine green, not amenable to treatment