cyrilzakka/clinical-trials huggingface dataset:
Dose-response Study of Arginine Supplementation in Severe Sepsis

Pilot data in patients and data from pig studies indicate that arginine-NO metabolism is impaired in sepsis with changes in splanchnic metabolism and function, and reduced survival at low nitrate levels. Prolonged intravenous supplementation of L-arginine proved effective in pigs for increasing NO production, restoring gut function, and inhibiting an increase in pulmonary arterial pressure, without any deleterious systemic side effects. Prolonged intravenous L-arginine supplementation could therefore be useful in septic ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from close relative
* Age \> 18 years
* Patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion (see appendix A; in Dutch).
* Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure \<15 mm Hg) during 2 h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration.
* Systemic and pulmonary arterial catheters in place with continuous pressure monitoring.
* Patients in whom the clinician is prepared to provide full life support during the duration of the study, including a life expectance of \> 24 h.

Exclusion Criteria:

* Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.)
* Corticosteroid use (prolonged intake of \> 1mg/kg daily or intake of \> 70 mg/day for 7 consecutive days within 1 month preceding the study)
* Liver cirrhosis
* Chronic pancreatitis
* Diabetes mellitus type I
* Metastases, haematological malignancies or chemotherapy
* Patients on dialysis (CVVH or other)
Massage for Pain Relief During the Active Phase of Labor

The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, Diagram Location of Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction questionnaire.

The pain in labor appears as a subjective experience, individual interaction involving a broad physiological, psychosocial and environmental influences, representing one of the main clinical signs of this phase. Despite presenting an important biological function, is today well established the need for their relief, since its persistence is associated with harmful effects on mother and fetus. Among the available non-pharmacological resources, we highlight the massage therapy that has shown positive effects in relieving pain and promoting the comfort of the mother. The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, Diagram Location of Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction questionnaire. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p \<0.05 to obtain the statistical significance of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* literate
* A single fetus in vertex position
* Low-risk Pregnancy
* From 37 weeks of gestation
* Cervical dilatation from 4 cm with normal uterine dynamics in this phase
* Labor in early spontaneous
* No use of medications during the study period
* Absence of cognitive or psychiatric problems
* Intact membranes
* No risk factors associated
* You want to participate and signing the informed consent

Exclusion Criteria:

* Use of drugs or any procedure that aims to relieve pain
* Intolerance to the application of massage therapy
* Presence of dermatological conditions that indicate against the application of massage therapy
Multicentric and Retrospective Analysis of Adolescent Young Adult (AYA) Hodgkins' Lymphoma Patients

The principal aim of this study is to collect retrospectively all Adolescent Young Adult patients affected by Hodgkin's Lymphoma and treated in pediatric or adult haemato-oncology Centers. The data set collection aims to define the therapy performed and the results obtained in terms of overall survival and acute or late complications.

Hodgkin lymphoma (HL) represents approximately 0.5% of cancer diagnosis each year in developed countries (1, 2). This translates to an annual incidence of 8500 individuals per year in the United States and an incidence rate of 2.49 per 100.000 lymphoid malignancies in Europe (2, 3). A classical bimodal distribution is reported with a first peak occurring in patients between the ages of 15 and 30 years and a second peak in those older than 55 years (4). HL is one of the most common malignancies to occur in the adolescent and young adult (AYA) population. This population is defined by the National Cancer Institute as people diagnosed with cancer between the ages of 15 and 39 years.

The choice of therapy for AYA patients is typically determined by the treatment setting and referral patterns. Patients who are younger than 18 years are usually referred to pediatric Centers, where many patients are treated in the context of clinical trials. For patients treated by adult haematologists many are treated in the community setting.

Considerable variability exists between the treatment of adult and pediatric patients, including the choice of chemotherapeutic agents and the role of radiation. In both the pediatric and adult settings there has been increasing focus on balancing the risk of relapse with the risk of secondary side effects. De-intensification for low-risk patients using PET-adapted strategies is a modern approach that has been applied to all patients with HL independent of age. Variability among age groups still results in uncertainty regarding the optimal treatment approach in the AYA population.

This is a retrospective observational study involving Italian Centers that treat adolescents and young adults Hodgkin lymphoma patients. This type of patients can be treated either in a Pediatric Institution or in Adult Institution with different supportive and therapeutical approaches.

The primary objectives will be overall survival according to different treatment. Secondary end points will be acute or late complications comparing different treatments choice in an homogeneous group of patients, progression free survival according to different treatment.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with diagnosis of Hodgkin Lymphoma with an age at diagnosis ranging between 15 and 24 years enrolled in prospective studies either in AIEOP group and in FIL group or patients treated consecutively in single centers affiliated to AIEOP or FIL and registered in single institutional data base.
* All Hodgkin subtype

Exclusion Criteria:

* None
Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).

Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
2. Documented KIT aberration
3. Adequate organ function as defined by the following criteria:

   * Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
   * Total serum bilirubin ≤ 1.5 x ULN
   * Absolute neutrophil count (ANC) ≥ 1500/µL
   * Platelets ≥ 100,000/µL
   * Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
   * Serum calcium ≤ 12.0 mg/dL
   * Serum creatinine ≤ 1.5 x ULN
4. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
5. May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
6. At least one measurable lesion by RECIST criteria
7. ECOG PS 0-2

Exclusion Criteria:

1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
4. QTc \> 470 msec on baseline EKG.
5. Pregnancy or breastfeeding.
The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method

This study evaluates the effectiveness of virtual reality (VR) therapy in the treatment of depression and anxiety symptoms in patients undergoing the pulmonary rehabilitation. The first study group will receive VR therapy (VR group) as an addition to the traditional pulmonary rehabilitation. The second group (active control group) will receive Schultz Autogenic Training as a standard supplement to the pulmonary treatment. The third group (control group) will undergo only the traditional pulmonary rehabilitation.

Pulmonary rehabilitation leads to the improvement to the physical capacity and overall fitness of the patients with COPD allowing restoration of independence in daily functioning.

Psychological support is required in order to reduce the negative psychological symptoms related to both the pulmonary disease itself and the comorbidities. In this study the investigators want to assess the effectiveness of the virtual reality (VR) therapy compared to standard psychological support (Schultz Autogenic Training).

Thanks to using head mounted display (VR goggles 2018) and the phenomenon of total immersion VR therapy allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the therapy, it can motivate the patient to the rehabilitation process. The additional aim of the VR therapy is to help the patients regain their emotional balance, let them recognize their psychological resources and trigger the natural recovery mechanisms.

The goals of the project:

1. The evaluation of the influence of VR therapy on the depressive symptoms, the anxiety level and the stress level of the patients undergoing the pulmonary rehabilitation.
2. The comparison of the influence of the VR therapy and Schultz Autogenic Training on the pulmonary rehabilitation process.
3. The evaluation of the pulmonary therapy improvements in patients with and without depressive, anxiety or stress symptoms.

Eligibility Criteria:
Inclusion Criteria:

* COPD;
* Pulmonary rehabilitation conducted in ward settings;
* anxiety symptoms scored 8 and more in HADS-A or depressive symptoms scored 8 and more in HADS-D.

Exclusion Criteria:

* inability to self-complete the research questionnaires;
* presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
* initiation of psychiatric treatment during the research project;
* contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
* the patient's refusal at any stage of the research project.
Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

The purpose of this study is to find out if IV lidocaine infusion decreases the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use in burn injury participants undergoing wound debridement in the operating room.

Participants will:

* be randomized to receive either an IV Lidocaine treatment or an IV Saline Placebo during their surgery. The IV treatment continues for 48 hours after surgery.
* be asked about their pain and how they're feeling at 4 timepoints during the 48 hours.
* be asked about their pain 2 weeks after surgery.

The participant and medical care providers will both be blinded to what IV treatment is being received.

Researchers will compare the 2 groups to see if IV Lidocaine helps decrease the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use (this includes opioid tolerance, opioid dependence, and opioid induced hyper-sensitivity to pain).


Eligibility Criteria:
Inclusion Criteria:

* Acute burn patients
* 18 years or older
* \<20% Total Body Surface Area
* Wound debridement surgery scheduled at Harborview Medical Center

Exclusion Criteria:

* History of polysubstance use
* Chronic opioid use (MED\>40mg for more than 6 weeks)
* Cases where the known clinical standard care would be to keep patient intubated postoperatively
* Cases where the known clinical standard care would avoid IV Lidocaine infusion
* Allergy to amide local anesthetics
* Any elevated risk for local anesthetic systemic toxicity as determined by the study team
* Cardiac arrythmias or cardiovascular instability (e.g. shock)
* Severe renal or hepatic impairment
* Pregnancy
* Local anesthesia will be given by another route (e.g. nerve block)
* Prisoners
* Non-English Speaking/reading
Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity

Evaluate effect of DAADs on covid-19 disease.

If Chronic HCV patients who already received DAADs are protected against covid 19 and considered to be immune or not And if DAADS can be used in ttt of covid 19

Eligibility Criteria:
Inclusion Criteria:

1. HCV patient with or without LC.
2. \>18 years old.
3. Received DAADs at 2019.

Exclusion Criteria:

1. Combined HCV and HIV infected patients.
2. Combined HCV and HBV infected patients.
3. \< 18 years old.
4. Pregnant or breast-feeding patients.
5. Patients with autoimmune disease.
6. Patients with multiorgan failure, active cancer, renal insufficiency.
7. Patients received immunosuppressive drugs.
8. Immune compromised patients.
9. Previous confirmed diagnosis of SARS-CoV-2 before starting DAAs.
Comprehensive Geriatric Assessment in an Emergency Department

Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.

Objective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years). Two periods are compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017

Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to observe how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.

Objective

1. Analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED).
2. Analyze the impact on patient flows following the implementation of a Comprehensive Geriatric Assessment in the Emergency Department (ED).

Methods Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years).

First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017 Intervention: In the second period, the AGI was carried out by the emergency medical teams. It basically consists of care adapted to the special needs of geriatric patients, with systematic screening of delirium, delirium prevention, early treatment, pain management with scales adapted to chronicity, conciliation of medication to discharge from the emergency department, among others A comparison will be made of health outcomes and patient flows in ED: direct discharge, admission to emergency observation unit, admission to short stay unit, transfer to intermediate hospital, admission, admission to critical care area, death, time spent in the Emergency Department (ED) and in intermediate hospital, mortality during admission at one and six months, re-entry or reconsultation in the Emergency Department at 30 days and six months will be measured.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 65 years attended in the ED

Exclusion Criteria:

* None
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

Primary Objective:

- To evaluate safety (4 weeks)

Secondary Objectives:

* To evaluate the long-term safety (12 weeks)
* To evaluate the efficacy
* To characterize the pharmacokinetic profile

The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Eligibility Criteria:
Inclusion criteria:

* Aged 6 months through 11 years
* Patients with perennial allergic rhinitis

Exclusion criteria:

* Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy.
* Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4.
* Patients with vasomotor rhinitis or eosinophilic rhinitis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.


Eligibility Criteria:
Age greater than or equal to 21 US resident Can receive packages to their home via UPS/Fedex/USPS Read/write English Insomnia Severity Index Score Greater than 14 Diagnosis of insomnia by a medical physician Subjects with a Generalized Anxiety Diagnosis will be excluded Have not contemplated suicide in the past year Not been institutionalized for mental health issues. Not currently being treated for or suspect a mental health issue Not currently experiencing problems with alcohol or drug abuse Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study Not taking medications affecting the nervous system (e.g. psychiatric medications) Not taking hypnotics or any sleep aid or marijuana (in any form) Can commit to one (1) 20 minute session per day for 8 weeks Has not used a brain stimulation treatment in one year No suspected or known history of heart disease No pacemaker, or any form of medical electronics, including but not limited to a deep brain stimulator, electronic stent, etc.

Not under medical supervision for other serious medical condition Not taking opioids No pain or headaches that interrupt sleep Not participating in any other sleep study Not experiencing restless leg syndrome No Nickel Allergy No Sleep Apena as measured by STOP-Bang Assessment
Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay

This is a randomized control trial of PICU patients admitted for 7 days and expected to remain for at least another 3 days and who have a complex chronic condition. Patients will be randomized to usual care or usual care plus a primary intensivist and group of primary nurses (to facilitate passing of important patient information and informed, expedited decision-making). The primary research question is whether having a primary intensivist and nurses decreases PICU length of stay.

Long-stay intensive care unit (ICU) patients, or children who require prolonged hospitalization in the pediatric ICU (PICU), represent a minority of PICU patients but have a disproportionate impact on hospital resources and unfavorable outcomes, including morbidity, mortality, and repeated critical illness. These patients and their families have multifaceted needs (eg, tailored communication) that pose unique challenges to PICU providers and the parent-provider relationship. These experiences and needs are compounded and complicated by the transitory care that is typically provided by PICU. This transitory care may contribute to 1) patient/family dissatisfaction; 2) ineffective passing of important information day to day and week to week; and 3) delayed decision-making. These latter two potential consequences may, in turn, contribute to prolonged length of stay (LOS).

For these reasons, the investigators propose a randomized control trial to test whether primary intensivists and primary nurses can decrease PICU LOS for long-stay patients. A primary intensivist is one that remains a consistent physician-presence for the patient/family and PICU team throughout the child's PICU stay, despite changes in the intensivist(s) who orchestrates day-to-day management. Primary nurses are a team of PICU nurses who provide the all/most of the bedside care to the child. The investigators hypothesize that the long-stay PICU patients who are randomized to receive primary intensivists and nurses will have a statistically lower LOS than those patients who do not.

Eligibility Criteria:
Inclusion Criteria:

* PICU patients of any age who

  * have a complex chronic condition
  * have been admitted to the PICU for one week and are predicted by the PICU attending to continue to be admitted for at least another 3 days.

Exclusion Criteria:

-