cyrilzakka/clinical-trials huggingface dataset:
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar

The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.

Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This study will look at the retrospective data of patients that have switched from Darbepoetin Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar. Data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the study will be published.

Eligibility Criteria:
Inclusion Criteria

* Patients ≥18 years of age
* Patients with CKD on haemodialysis and fulfilling the following:

  * Received HD for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar
  * Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted)
  * Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment
  * Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment
* Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch
* Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in the 12 weeks prior to switch
* Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements

Exclusion Criteria:

* Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar
* More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar
* Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar
* Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.
Transcranial Magnetic Stimulation (TMS) Study for Adults With Autism Spectrum Disorder (ASD)

This is a randomized interventional study designed to evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in adults with autism spectrum disorder (ASD).

The primary objective of this study is to determine whether rTMS increases the brain response to faces in a population of adults with ASD. This study will assess critical aspects of social cognition using the electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single rTMS session (or Sham) to provide preliminary insight into the potential of rTMS as a tool to modify social brain function in this population.

Participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and a pre and post TMS session with EEG (electroencephalogram) and eye-tracking to measure neural and visual attentional social response. Two study visits will be scheduled for each participant lasting approximately 4-5hrs total.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18 and 40 years old with typical development or with a diagnosis of autism spectrum disorder.
* Individuals able to participate in an EEG and eye-tracking experiment.

Exclusion Criteria:

* Participants reporting significant head trauma or serious brain illness.
* Participants with major psychiatric illness that would preclude completion of study measures.
* Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of seizures.
* Participants taking prescription medications that may affect cognitive processes under study.
* Participants who have taken alcohol or recreational drugs within the preceding 24 hours.
* Females of known/suspected pregnancy or who test positive on a pregnancy test.
* Participants with a history of metalworking or injury by shrapnel or metallic objects are also excluded.
* Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit.
* Participants with an IQ (intelligence quotient) below 80.
Evaluating Silymarin for Chronic Hepatitis C

To investigate the effect of silymarin, derived from the milk thistle plant, Silybum marianum, in preventing and reversing the complications of chronic infection with hepatitis C virus and/or clearing hepatitis C infections.

The objective of this exploratory project is to assess the feasibility of investigating the effect of silymarin, derived from the milk thistle plant, Silybum marianum, in preventing and reversing the complications of chronic infection with HCV and/or clearing HCV infections, thereby generating preliminary results to serve as the basis of a more definitive study. Allopathic therapeutic interventions have not proved promising, particularly with the genotype most commonly encountered in Egypt and they are prohibitively expensive in the developing world. Egypt has the highest prevalence of HCV infection in the world, averaging 15-25% in rural communities. There are limited rigorous assessments of the dietary supplement milk thistle, but there is promise of salutary effect. The specific aims are to evaluate whether silymarin, the extract of milk thistle, can: (1) improves hepatic morbidity in subjects with chronic HCV hepatitis and/or cirrhosis; (2) prevent progression of liver disease in participants who have chronic HCV infections but who have normal liver enzyme levels; (3) help clear HCV infections; and (4) improves these participants' quality of life. Participants will be randomly assigned to receive silymarin or a vitamin supplement (below antioxidant levels). Participants will be recruited from a cohort of HCV-infected individuals currently enrolled in a large observational study in Egypt. Participants will receive the supplements daily for 18 months, with measures obtained every six months. Measures to be assessed will include: retention in the study, compliance with study assignment, self-described symptoms, alanine aminotransferase (ALT) levels, serum collagen markers, abdominal ultrasound, viral load and clearance, and quality of life (SF36 survey). It is hypothesized that silymarin will not lead to clearance of HCV infections but can prevent progression of liver disease in participants with chronic HCV hepatitis and, in some cases, reverse hepatic lesions that are already present, as well as improving the quality of life in individuals who use this dietary supplement. This exploratory project is anticipated to result in successful initiation of larger and more definitive studies of the effect of milk thistle on HCV infection. Evidence of beneficial effect of an inexpensive and benign herbal dietary supplement would have great impact on the large global population suffering from chronic HCV infection.

Eligibility Criteria:
Evaluation of the Efficiency of Z Technique Training

The goal of this clinical trial is to evaluate of the efficiency of training for nurses to use the Z technique in intramuscular injection application.

The main question it aims to answer is:

• Is there an effect of training on the use of Z technique in intramuscular injection practice of nurses?

The sample size was calculated as a minimum of 64 people. It consists of nurses who volunteered to participate in the study.

The research was designed in a semi-experimental single group in the pretest-posttest order and will be carried out in four stages:

In the 1st Stage: The socio-demographic characteristics of the nurses and their knowledge levels about the Z technique will be evaluated before the training.

In the 2nd stage: Training will be given on the Z technique on the planned day, time and place. The education is planned to be given at Tarsus University. The training content will be presented to the participants as a powerpoint presentation (30 min), laboratory practice (15 min) and question-answer (15 min).

In the 3rd Stage: After the training, the knowledge levels and skills of the nurses regarding the Z technique will be evaluated.

In the 4th Stage: 1 month after the training, the use cases of the Z technique will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All nurses who volunteer, work in the hospital and perform injections will take part in the research as participants.

Exclusion Criteria:

* Participants who do not continue the study or who express that they want to leave and who do not apply injections in the clinic they work will be excluded from the study.
Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC).

Therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed non-small cell lung cancer with synchronous brain metastases
2. One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:

   * Well circumscribed tumor(s) with brain edema Grade 0-1
   * Maximum diameter ≤ 3.0 cm
3. No prior surgical treatment or RT for brain metastases
4. No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
5. Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0)
6. Age, 18 and over
7. ECOG performance status 0-1
8. Written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. RTOG neurologic function status of 1\~4
4. Uncontrollable extracranial metastases
Emp-Activity: Empagliflozin Functional Capacity

This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic Heart Failure (HF) in a two-cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for HF, the other cohort will receive HF therapy with drugs with another mechanism of action. Treatment of HF according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to study participation
* Male and female patients ≥ 18 years at Visit 1
* Patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel
* Patients with diagnosis of chronic heart failure NYHA Class 2-4
* Treatment-naïve for SGLT2i at visit 1
* Women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen HF drug(s)

Exclusion Criteria:

* Missing physician's diagnosis of chronic heart failure
* Patients hospitalized at visit 1
* Life expectancy ≤ 12 months according to physician's assessment
* Lack of informed consent
* Pregnant or lactating females
* Participation in a parallel interventional clinical trial
* Chosen treatment with another SGLT2i drug than empagliflozin
* Having been enrolled into the non-empagliflozin-arm of this non-interventional study
* Current or prior treatment with SGLT2i at visit 1
* Patients with contraindications according to current Summary of Product Characteristics (SmPC)
* Patients with dependency or relationship to the treating physician
The Impact of COVID-19 on Pulmonary Procedures

This study investigates the changes in practice by pulmonary procedural programs across the United States as they faced the coronavirus pandemic. Information gathered from this study may help guide pulmonary programs on a wider scale and improve their practice. The study may also help researchers understand where they should focus research efforts to better respond to a pandemic in the future.

PRIMARY OBJECTIVE:

I. To assess how pulmonary medicine programs adapted their procedural practices and techniques, ambulatory operations, and provider staffing in response to the coronavirus-2019 (COVID-19) epidemic.

OUTLINE:

Participants complete survey over 5-10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonologists that are members of the American Association of Bronchology and Interventional Pulmonology (AABIP) and/or the American College of Chest Physicians (ACCP)
* These organizations were chosen because their member databases are composed of pulmonologists in the United States (U.S.) that perform the pulmonary procedures described in this survey. Letters of approval will be obtained from these organizations and provided to the MD Anderson Institutional Review Board (IRB). Once the MD Anderson IRB approves this survey study, the survey will be sent to the relevant subcommittees of these organizations for their electronic dissemination to their membership

Exclusion Criteria:

None
Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures

A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.

After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.

Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.


Eligibility Criteria:
Inclusion Criteria:

* ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
* amniocintesis -single tone,gestional age 16-24 week,
* hysteroscopy-women age 18-60 , diagnostic procedure,

Exclusion Criteria:

* ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
* amniocintesis- Known fetal malformations, amnionitis
* hysteroscopy-pregnancy, PID
A Safety Study of XL019 in Adults With Myelofibrosis

The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2 is activated by cytokine and growth factor receptors and phosphorylates members of the STAT family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation in the majority of patients with myelofibrosis, polycythemia vera and essential thrombocytosis and appears to drive the inappropriate growth of blood cells in these conditions.


Eligibility Criteria:
Inclusion Criteria:

* The subject has primary myelofibrosis (PMF), post-polycythemia vera MF, or post-essential thrombocythemia MF and requires therapy, including subjects who have received prior MF-directed therapy and relapsed or subjects with refractory disease; or if newly diagnosed, then with intermediate or high risk according to the Lille scoring system.
* The subject is unwilling to undergo or is not a candidate for peripheral stem cell/bone marrow transplant.
* The subject is ≥18 years old.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* The subject has adequate organ function.
* The subject has the capability of understanding the informed consent document and has signed the informed consent document.
* Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
* Female subjects of childbearing potential must have a negative pregnancy test at screening.
* The subject has had no diagnosis of malignancy or evidence of other malignancy for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).

Exclusion Criteria:

* The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias.
* The subject is pregnant or breastfeeding.
* The subject is known to be positive for the human immunodeficiency virus (HIV).
* The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Analgesia for Clavicular Fracture and Surgery

Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.

The primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.The hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications.

Eligibility Criteria:
Inclusion Criteria:

* Surgery of the clavicular fractures under combined cervical plexus plus brachial plexus block
* Urgent or planned surgery

Exclusion Criteria:

* Refused to sign informed consent
* Pregnant women
* Allergic to the local anesthetic
Staphylococcus Aureus Carriers Students Nursing Oxacillin Resistant

The Staphylococcus aureus is an important pathogen bacteria actuating as an agent of a wide variety of infections, such as the superficials to the disseminates ones, its commonly find into hospitals ambient, assailing mainly immunosupress patients. Around 30% to 50% of people carries this agent in their nasal bone as part of their normal flora, occuring larger in hospitals workers. The S. aureus is also known for its high capacity of developing resistance to various antibiotic. Facing these considerations, the importance of nursing precaution and the infections control inside hospitals ambient, the purpose of this present study aimed to verify the rates of carriers of S. aureus in nursing students and the connection with the hospitals time involvement during graduation in the Faculty de Medicine de Botucatu - UNESP, embracing the 4 years of graduation college.


Eligibility Criteria:
Inclusion Criteria:

* Students nursing

Exclusion Criteria:

* Students nursing with infection
Characterization and Pathogenesis of ACLF

This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups.

1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis
2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets
3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis

Exclusion Criteria:

* extrahepatic and metastatic malignancy,
* refusal for participation
* decision of attending phycisian
Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.

Atopic eczema is a chronic inflammatory skin disease, mainly affecting children, characterized by itching and flare-ups. It results from genetic and environmental factors, leading to immunological and cutaneous abnormalities.

The aim of this study is to assess the efficacy of a product for atopic skin versus a placebo. Primary objectives include assessing the number, the delay and severity of recurrences of atopic dermatitis (measured by the SCORAD score), and the evolution of symptoms such as dryness and pruritus. Secondary objectives include quality of life and quality of sleep and skin acceptability.

The study protocol is a multicenter, double-blind, randomized clinical trial, in which participants receive either the study product or a placebo, while continuing their topical corticosteroid treatment.


Eligibility Criteria:
Inclusion Criteria:

Specific

* Sex: female and/or male;
* Age: from 3 months up to 12 years old;
* Phototype: I to IV;
* 100% with atopic skin;
* 100% with sensitive skin;
* Subject who had at least 3 eczema flares-up of atopic dermatitis during the last 6 months before start of the study, including the crisis observed on D-X.
* Subject presenting on the visit D-X a flare-up of eczema for which the dermatologist prescribed treatment with topical corticosteroids treatment;
* Subjects with SCORAD between 15 and 40 on D-X;
* Subject who do not require medical treatment anymore after using prescribed topical corticosteroids from D-X up to D0 and clinical signs of atopic dermatitis are resolved, to be defined on D0 visit (in case of insufficient healing of inflammatory lesions, the subject continues medical treatment as recommended by the investigator).

General

* Healthy subject;
* Child whose at least one parent/legal guardian has given freely and expressly her/his informed consent;
* Child whose at least one parent/legal guardian is willing to adhere to the protocol and study procedures;
* Polish citizenship.

Exclusion Criteria:

* Cutaneous pathology on the study zone other than atopic dermatitis;
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study products, including anti-histaminic treatment (except prescribed dermocorticoids on D-X and in case of flare-up during the study course);
* Subject having undergone a surgery under general anesthesia within the previous month;
* Excessive exposure to sunlight or UV-rays within the previous month;
* Subject enrolled in another clinical trial during the study period (concerns the studied zones);
* Subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).