cyrilzakka/clinical-trials huggingface dataset:
Impact on UVB Narrow Band and UVA1 Therapy on Serum 25-hydroxyvitamin D Levels

We plan to investigate the serum elevation of 25(OH)D under UVB nb and UVA1 therapy, in order to determine the effect of these nowadays frequently used wavelengths for phototherapy on vitamin D plasma levels. We hope for a better understanding of steady-state and treatment-induced levels of vitamin D changes to better recognize the impact of phototherapy on vitamin D synthesis in the skin, the dimension of vitamin D production to be expected in the course of standard phototherapy and a potential gap in vitamin D production compared to physiological needs which then should be supplemented orally.

This is an open observational study in dermatological patients undergoing phototherapy.

In patients with a skin disease and the routinely given indication for a phototherapy with UVB narrow-band (UVB nb, 311nm) or UVA1 (340-400 nm), the serum 25-hydroxyvitamin D, calcium, parathormone, phosphate and albumin levels will be measured before, during and after completion of the 12-week therapy (30 patients per group). Patients will be recruited in the department of dermatology of the University Hospital Zürich in the outpatient clinic. Following oral and written consent, serum 25-hydroxyvitamin D, calcium, parathormone, phosphate and albumin levels will be measured before the therapy, one week after start as well as after completion of the UVB nb/UVA1 therapy.

In parallel to the study the patients will be asked to fill in a questionnaire evaluating the daily vitamin D consume (milk and milk products, fish, food enhanced in vitamin D, multivitamin supplements), sun exposure per week during previous weeks, degree of tanning, the use of sunscreen, the DLQI and Skindex-29.

A physical examination including clinical score where available will be performed at every "checkpoint". During the first physical examination the Fitzpatrick-skin type of patient will be recorded.

The following participant characteristics will be recorded: age, weight, body mass index (BMI), phototype, skin disease, comorbidities, usual medication, and period of the year where UVB nb/UVA1 therapy is performed (summer vs. winter), cumulative UVB nb/UVA1 doses.

Eligibility Criteria:
Inclusion criteria:

1. Dermatological indication for a phototherapy with UVB nb or UVA1
2. Oral and written informed patient consent

Exclusion criteria:

1. Interruption of the light therapy for more than 14 days
2. Withdrawal of consent to participate
Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)

Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic heart failure (CHF) failure who are prescribed with JARDIANCE® Tablets in Japan
* Patients who have never been treated with Empagliflozin (including treatment for type 2 diabetes mellitus (T2DM)) before enrolment

Exclusion Criteria:

* None
Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding

Endoscopic high-frequency soft coagulation is available for the management of bleeding or nonbleeding visible vessels during endoscopic submucosal dissection. However, its efficacy on peptic ulcer bleeding has not been elucidated so far. The aim of this study was to evaluate the efficacy of hemostasis with soft coagulation using hemostatic forceps by comparing it with argon plasma coagulation (APC) in a prospective, randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* peptic ulcer with stigmata of recent hemorrhage

Exclusion Criteria:

* malignant ulcer
* previous gastric surgery
Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

Primary Objective:

To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus®

Secondary Objective:

To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation

The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days

Eligibility Criteria:
Inclusion criteria:

* Japanese male or female subjects, between 20 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the Japanese Diabetes Society
* Body weight between 50.0 kg and 95.0 kg
* Body Mass Index between 18.0 and 30.0 kg/m2 inclusive
* Stable insulin regimen for at least 2 months prior to study
* Certified as otherwise healthy for type 1 diabetes mellitus patient by assessment of medical history and physical examination
* Women of childbearing potential must have a negative pregnancy test and must use a highly effective method of birth control. During the entire study female subjects of child bearing potential must use two independent methods of contraception. The accepted double contraception methods include use of an intra-uterine device or hormonal contraception in addition to one of the following contraceptive options: 1) condom; 2) diaphragm 3) spermicide.

Exclusion criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
* More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
* Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
* Participation in a trial with any investigational drug during the past 4 months
* Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
* Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days
* Known hypersensitivity to insulin glargine or excipients of the study drug
* Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effect of Ultra-low-dose Naloxone on Remifentanil-induced Postoperative Hyperalgesia - A Randomized Controlled Study

High-dose remifentanil infused intraoperative ironically results in postoperative hyperalgesia. Ultra-low dose nalxone is demonstrated to prevent these opioid-induced hyperalgesia in animal model. In this clinical trial in patients undergoing general anesthesia with remifentanil, we evaluate the effects of ultra-low-dose naloxone on remifentanil-induced hyperalgesia

We enrolled adult patients undergoing thyroidectomy under general anesthesia with desflurane and remifentanil. Remifentanil was administered via target-controlled infusion and anesthetic depth was maintained keeping the BIS between 40 and 60. Patients were randomized into one of three groups depending on intraoperative doses of remifentanil and naloxone: effect-site concentrations of remifentanil 1 ng/ml (control group), 4 ng/ml (remifentanil group), and 4 ng/ml combined with infusion rate 0.8 ng/kg/min of naloxone (remifentanil and naloxone group). Postoperative mechanical pain thresholds, pain intensity, and analgesic consumption were examined during 48 h of postoperative period. The primary outcome was mechanical pain threshold measured on the peri-incisional area 24 h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo elective thyroidectomy

Exclusion Criteria:

* consent refusal, obesity, pregnancy, hx. of thyroid surgery, neurological disorders, psychiatric disorders, hx. of drug abuse or chronic use of opioids or sedative drugs, intake of any analgesic drug within 12h before surgery.
Ticagrelor for PCI Post Thrombolysis

Ticagrelor is a first line therapy along with aspirin for patients undergoing primary PCI for STEMI. However, many patients are still treated with fibrinolytic therapy and the safety and efficacy of Ticagrelor has not been investigated in this patients population. The present study is proposed to study the safety and efficacy of Ticagrelor in patients undergoing PCI post fibrinolytic therapy for STEMI.

The newer antiplatelet agents such as Ticagrelor have demonstrated superiority to Clopidogrel in patients presenting with acute coronary syndrome (ACS). At present Ticagrelor remains a first line therapy as an adjunct to aspirin for patients undergoing primary PCI for STEMI for reducing major adverse events. However, the safety and efficacy of Ticagrelor has not been investigated in patients with STEMI post fibrinolysis. Ticagrelor results in significantly higher platelet inhibition than aspirin or clopidogrel and may expose patients to an increased risk of bleeding if administered post thrombolysis. However, fibrinolytic therapy itself results in a prothrombotic milieu with greater activation of platelets, a condition that can be balanced with addition of stronger antiplatelet agents. Similar concerns were initially reflected for clopidogrel as an adjunct to fibrinolytic therapy but were later proven to be unsubstantiated. In fact, adjunct administration of clopidogrel to fibrinolytic therapy reduces major adverse events as shown by multiple studies and has become the standard of care recommended by guidelines. The present study is proposed to study the safety and efficacy of Ticagrelor in patients undergoing PCI post fibrinolytic therapy for STEMI.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and over.
2. Planned PCI between 4-24 hours after administration of fibrinolytic therapy for STEMI.
3. Treatment with aspirin and clopidogrel as an adjunct to fibrinolytic therapy.
4. Informed written consent.

Exclusion Criteria:

1. Atrial fibrillation or need for systemic anticoagulation therapy.
2. Prior PCI or coronary artery bypass grafting during past 3 months.
3. Active bleeding or high risk of bleeding based upon clinical assessment.
4. Known severe liver or renal disease or patient requiring dialysis.
5. Concomitant oral or IV therapy with strong cytochrome (CYP3A) inhibitors which cannot be stopped.
6. Contraindication to ticagrelor or clopidogrel.
7. Planned surgery during the study period.
8. Any of the following in the absence of a functioning implanted pacemaker: sick sinus syndrome, 2nd or 3rd degree AVB, documented syncope of suspected bradycardic origin.
9. Known clinically important thrombocytopenia or anemia.
10. Known pregnancy or lactation.
11. Condition which may either put the patient at risk or influence the result of the study.
12. Previous randomization in this SETFAST study.
13. Participation in another clinical study with an investigational product or device study over the past 30 days.
Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg

Allogeneic hematopoietic cell transplantation (HSCT) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an HLA-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic minorities and multiethnic families, socio-economic status, among others. This problem has led to an expansion of the donor pool to include alternative donor sources such as HLA-haploidentical (Haplo) relatives, HLA-mismatched unrelated donors, and HLA-matched or mismatched cord blood.

In the Hematology and Internal Medicine Center of Clinica Ruiz, we have seen that 50% reduced doses of post-transplantation cyclophosphamide (25 mg/Kg) on days +3 and +4 have a favorable effect on patient's survival rates compared to the full 50 mg/Kg doses. Haplo-HSCT can be conducted safely on an outpatient basis, using peripheral blood stem cells, this leading into substantial decreases in the costs. Outpatient-based Haplo-HSCT has turned into the solution of the HSCT most frequent problems in low- and middle-income countries (LMIC): Cost and donor availability. The high dose administration of PT-Cy after transplant can lead into hematological and cardiac, toxicities. There is preliminary information about diminished doses of PTCy, might being equally effective in the prevention of GVHD and substantially less toxic.


Eligibility Criteria:
Inclusion Criteria:

* Candidates to receive a Haplo-HSCT (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases).
* Patients able to travel to and remain in Puebla, México during a 4-week period, accompanied by a caregiver.

Exclusion Criteria:

* Patients who refuse to sign the consent form.
* Latent infection.
* Hepatic, cardiac or bronchopulmonary symptomatic diseases
* Abnormalities on previous clinical hematological appointments, considered as contraindication.
* Positive serology for HIV, VHB, VHC
Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes

Children and adolescents with type 1 diabetes need regular insulin injections or continuous insulin delivery with an insulin pump in order to keep blood sugar levels normal. The investigators know that keeping blood sugars in the normal range can prevent long term diabetes complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter the investigators try to control blood glucose levels, the greater the risk for the young person to develop symptoms and signs of low glucose levels (hypoglycaemia). This is a particular problem at night. One solution is to develop a system whereby the amount of insulin injected is very closely matched to the blood sugar levels on a continuous basis. In a closed loop system, for example, a continuous glucose sensor communicates with a computer algorithm which drives an insulin pump. The investigators have been developing such a system in Cambridge over the last year with funding from the Juvenile Diabetes Research Foundation. The investigators have found that this system is very effective at preventing hypoglycaemia in young people with diabetes.

Until now the information from the sensor has been entered manually into the computer and the pump settings have also been changed manually. The investigators now need to move onto the next step which is to fully automate the system. The studies will be done in a clinical research facility. The investigators will study the young people on two nights in order to find out if the closed loop system started early in the evening is as effective as when it is started later before sleep. 12 young people will be recruited from diabetes clinics in the East Anglia region. The studies will provide further important information concerning the safety, efficacy and utility of closed loop systems.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care.
* The subject is between 6 and 18 years of age (inclusive).
* The subject has type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative.
* The subject will have been on insulin pump for at least 3 months

Exclusion Criteria:

* Non-type 1 diabetes mellitus including those secondary to chronic disease
* Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
* Taking medication likely to interfere with interpretation of the results
* Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator).
* Known or suspected allergy against insulin.
* Patients with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator.
Pulmonary Rehabilitation and Smoking

Pulmonary rehabilitation (PR) is known to reduce dyspnea, increase exercise capacity, reduce psychological symptoms and improve quality of life in COPD patients. Some patients continue to smoke despite their illness. Smoking does not create a contraindication to PR. There is insufficient evidence on the effectiveness of PR programs in smoking COPD patients. The purpose of this study, PR completed the program to determine the effectiveness of PR smoker COPD patients.

Pulmonary rehabilitation (PR) is known to reduce dyspnea, increase exercise capacity, reduce psychological symptoms and improve quality of life in COPD patients. Some patients continue to smoke despite their illness. Smoking does not create a contraindication to PR. There is insufficient evidence on the effectiveness of PR programs in smoking COPD patients. The purpose of this study, PR completed the program to determine the effectiveness of PR smoker COPD patients. People who have completed the PR program, smoking and not smoking will be included into the study.

Data of carbon monoxide diffusion test, body plethysmography, 6-min walk test, blood gas analysis, mMRC dyspnea scale, hospital anxiety depression scale, SGRQ and SF-36 quality of life questionnaire performed before and after the program will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients completed 8 PR program

Exclusion Criteria:

* Never smoked patients
* Participated PR program in last year
Doppler Ultrasound Renal Arterial Resistive Indices As Predictor Of Multiorgan Failure In Patients With Acute Hypoxic Respiratory Failure Admitted To Respiratory Intensive Care Unit (Cryptic Shock Index- RICU)

Patients with de novo respiratory failure undergoing non invasive ventilation (NIV) present failure rates of mechanical ventilation ranging from 4 to 50%. Causes for NIV treatment failure are various but the onset of septic shock and subsequent multi-organ failure (MOF) seem play a critical role. Recent data show that the 37% of patients admitted to intensive care unit for de novo respiratory failure without any other organ failure experience multiple organ failure within the first days from admission. Early identification of hypoxic patients at major risk for MOF seems critical. Physiological studies have demonstrated that the underlying mechanisms for organ damage preceding MOF are those involved in the oxygen consumption (VO2)/oxygen delivery (DO2) mismatch. Doppler ultrasound indices of renal arteria resistance are directly correlated tot he VO2/DO2 mismatch. With this study we aim at investigating the correlation between Doppler ultrasound indices of renal arteria resistance in patients with de novo respiratory failure admitted to ICU and the onset of MOF within the first 7 days form admission.


Eligibility Criteria:
Inclusion Criteria:

* patients with de novo respiratory failure admitted to the respiratory intensive care unit of the university hospital of Modena

Exclusion Criteria:

* age lower than 18 or higher than 85
* presence of organ failure apart form lung failure at the time of admission in the respiratory intensive care unit
* pregnancy
* difficult or unreliable ultrasound window for renal arterial resistive index assessment
Microbial Colonization of Dairy Free Oral Probiotics

The aim of this study is to evaluate the colonization efficacy of probiotic lozenges containing dairy and dairy free probiotic Streptococcus salivarius M18, in healthy adults

This is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of two different lozenges containing either dairy or dairy free probiotic bacteria Streptococcus salivarius M18.

Participants will be randomly assigned to one of the 2 groups consuming probiotic lozenge containing dairy free Streptococcus salivarius M18 or dairy based Streptococcus salivarius M18 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility Criteria:
Inclusion criteria:

Male or Female 18y - 80y age

1. In general good health 18 - 80 years of age.
2. Practice good oral hygiene.

Exclusion criteria:

1. Have a history of autoimmune disease or are immunocompromised.
2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
3. History of allergy (e.g. dairy).
Psychological Intervention For Brain Tumor Caregivers

This study is testing a supportive psychosocial intervention for caregivers of people who have malignant brain tumors such as gliomas or other high-grade primary brain tumors. This study was designed because caregivers of patients with malignant brain tumors often experience physical and psychological burdens caring for their loved ones.

The purpose of this study is to find out whether a program offering psychological support can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable.

This study will be a prospective, randomized controlled trial to assess the efficacy of a caregiver-directed intervention designed to improve anxiety in caregivers of patients with malignant brain tumors, in comparison with caregivers who receive usual care.

The aim of this study is to test the efficacy of this intervention in reducing distress in caregivers of patients with malignant brain tumors, in comparison with usual care. The study will be conducted in 120 caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Identified by study staff, a clinician, self, or a patient with a malignant brain tumor as the patient's primary caregiver
* The patient is receiving care at the MGH Cancer Center
* The patient was diagnosed with a malignant brain tumor within the past 6 months
* Able to speak and read in English
* Generalized Anxiety Disorder 7-item (GAD-7) score ≥5
* Participants may or may not be pregnant.

Exclusion Criteria:

* Deemed inappropriate for the study by the patient's clinician or the study PI
* Participated in the pilot study of this caregiver intervention (DF/HCC 18-426)
Telemedicine Follow-up for Post-ACS Patients

The aim is to compare the safety of using telemedicine and office visit follow-up in post-acute coronary syndrome patients

Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at 1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be reasonable choice. Taking into account the absence of studies in this area, providing investigation evaluating parameters of safety for both methodics is relevant.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age ≥ 40 years
3. PCI with coronary artery stenting for ACS
4. Angiographic success PCI

Exclusion Criteria:

1. Patients with cancer
2. Severe CHF (EF LV \<35% or functional class of heart failure III-IV NYHA)
3. Severe valvular heart disease or Prosthetic heart valves.
4. Severe forms of CKD (GFR\<30mL/min)
5. Planned staged revascularization during the next 12 months
6. Planned surgery within the next 12 months