cyrilzakka/clinical-trials huggingface dataset:
Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystatin is more effective than standard amphotericin B in treating patients with fever and neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.

PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin compared with standard amphotericin B to treat fever and neutropenia in patients receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.

OBJECTIVES: I. Compare the efficacy of liposomal nystatin vs standard amphotericin B for the empiric treatment of persistent febrile neutropenic patients. II. Compare the incidence of drug-related toxicity or impairment and infusion-related toxicity in patients treated with liposomal nystatin vs standard amphotericin B. III. Determine the pharmacokinetics of liposomal nystatin.

OUTLINE: Randomized, double-blind study. Arm I: Antifungal Therapy. Liposomal Nystatin. Arm II: Antifungal Therapy. Amphotericin B, NSC-527017.

PROJECTED ACCRUAL: 350 evaluable patients will be studied in this multicenter trial.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Persistent febrile neutropenia associated with 1 of the following within 3 months prior to entry: Cytotoxic chemotherapy Bone marrow transplantation Neutropenia defined as either: ANC no greater than 500/mm3 ANC no greater than 1,000/mm3 and expected to decrease to 500/mm3 or less within 2 days after entry Persistent continuous or spiking fever of at least 38 C No association with administration of pyrogenic substances No response to at least 72 hours of empiric, broad-spectrum antibacterial therapy No microbiologically documented source of infection At least 30 days since documented invasive fungal infection

PATIENT CHARACTERISTICS: Age: 2 and over Performance status: Not specified Life expectancy: At least 28 days Hematopoietic: Not specified Hepatic: No grade 2 or greater hepatic impairment Renal: No grade 2 or greater renal impairment No peritoneal dialysis or hemodialysis Other: No history of severe allergic reaction to polyene antifungal agent No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women during and for 3 months after study

PRIOR CONCURRENT THERAPY: At least 2 weeks since polyene antifungal therapy Concurrent oral prophylactic antifungal therapy with an azole antifungal agent (e.g., fluconazole, itraconazole) allowed if patient remains febrile No concurrent azole therapy At least 30 days since other investigational drug or device except investigational formulation of amphotericin B
Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.

This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.

Eligibility Criteria:
Inclusion Criteria:

* All volunteers will sign the informed consent.
* Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
* The FIGO stage (IIB-IVA) and was not available for surgical treatment.
* There is at least one tumor lesion that is measurable by RECIST.
* During the study, contraception should be ensured.
* Karnofsky performance status \>60.
* WBC \>= 3,000/mm\^3
* Absolute granulocyte count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* INR \< 1.5
* Total bilirubin =\< 1.5 mg/dL
* Serum creatinine =\< 1.5 mg/dL
* AST and ALT =\< 2.5 times upper limit of normal (ULN)
* Serum calcium =\< 1.3 times ULN
* Hemoglobin \>= 9g/dL (transfusion allowed)

Exclusion Criteria:

* Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
* Prior invasive malignancy (except nonmelanomatous skin cancer)
* Contraindication of chemotherapy;
* Rare pathological subtype;
* Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.
The Role of SNP rs2910164 in Patients Treated With Immune Checkpoint Inhibitors

The objective of this study is to investigate whether the SNP rs2910164 in the pre-miR-146a gene is associated with outcome and toxicity of immune checkpoint inhibitor therapy.

The single nucleotide polymorphism (SNP) rs2910164 within the gene for microRNA-146a (miR-146a) reduces miR-146a expression. Previous studies of the investigators demonstrated that this SNP was associated with increased acute GvHD severity in patients undergoing allogeneic hematopoietic stem cell transplantation. In this prospective, observational study the investigators aim to analyze, whether SNP rs2910164 is associated with severity of immune-related adverse events of immune checkpoint inhibitor therapy. Moreover, association of rs2910164 with outcome parameters will be studied.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of cancer
* treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1 or anti-CTLA4)
* age ≥ 18 years
* peripheral blood sample available
* written informed consent
* ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria:

* age \< 18 years
* lack of informed consent
Cardiac Output by Nine Different Pulse Contour Algorithms

The aim of the present study is to compare accuracy and precision of Cardiac Output (CO) by nine different pulse contour algorithms with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB).

After induction of anesthesia, a central venous catheter and a transpulmonary thermodilution catheter (Pulsion Medical Systems, Munich, Germany) are introduced in the right internal jugular vein and in the femoral artery, respectively. The thermodilution catheter is connected to a PiCCO2 monitor (Software version 1.3.0.8). Thereafter, placement of an esophageal doppler probe is performed and the probe is connected to a unique Monitoring System (Deltex Medical, Chichester, UK) with nine different pulse contour algorithms. Cardiac Output by esophageal doppler is used to calibrate the nine different pulse contour algorithms.

After induction of anesthesia and establishment of all monitoring devices, a passive leg raising maneouvre (PLR) is performed and hemodynamic variables including CO by transpulmonary thermodilution (COTPTD) and CO by nine different pulse contour algorithms (COX1-9) are recorded before, during and after PLR. Subsequently, measurements of COTPTD and COX1-9 are carried out every 10 minutes until the beginning of CPB. Fifteen minutes after weaning from cardiopulmonary bypass calibration of nine different pulse contour algorithms by esophageal doppler are performed again and measurements of CITPTD and CIPFX are restarted up to the end of the surgical Intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age with a left ventricular ejection fraction ≥ 0.5.
* Patients undergoing coronary artery bypass grafting.

Exclusion Criteria:

* Patients \<18 years of age and with a left ventricular ejection fraction ≤0.5 are not considered for the study.
* Emergency procedures and patients with hemodynamic instability requiring continuous pharmacologic support, intracardiac shunts, severe aortic-, tricuspid- or mitral stenosis or insufficiency and mechanical circulatory support were also excluded.
Osteopathic Manipulative Treatment Induces Functional Connectivity Changes

Osteopathic Manipulative Treatment (OMT) is a whole-body intervention mainly focused on correcting the somatic dysfunctions present in different regions of the body. Osteopathic research to date has mostly been concerned with various clinical conditions such as musculoskeletal disorders and primary headache. The neurophysiological effects underlying clinical improvements are still under debate. Although models explaining the therapeutic effects of OMT include the potential for higher brain mechanism, OMT effects on functional brain connectivity is not fully understood and still lacking in healthy adults. Magnetic resonance imaging (MRI) research includes several different approaches to estimate cortical functions. Several of these approaches have demonstrated functional brain changes associated with OMT. Using Arterial Spin Labeling MRI, recently was demonstrated that the treatment of somatic dysfunctions induces cerebral perfusion changes in asymptomatic young participant. Thus, the aim of this study is to explore the neural correlates associated with OMT effect in terms of cerebral functional connectivity, as derived by complex network analysis of resting state fMRI data recorded in asymptomatic young volunteers with somatic dysfunctions


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years
* suitability for MRI scanning

Exclusion Criteria:

* cognitive impairment, based on Mini Mental State Examination (MMSE) score ≤ 24 according to norms for the Italian population, and confirmed by a deeper clinical neuropsychological evaluation using the Mental Deterioration Battery and NINCDS-ADRDA criteria for dementia
* subjective complaints of memory difficulties or of any other cognitive deficit, interfering or not, with daily living activities;
* major medical illnesses, e.g., diabetes (not stabilized), obstructive pulmonary disease, or asthma; hematologic and oncologic disorders; pernicious anemia; clinically significant and unstable active gastrointestinal, renal, hepatic, endocrine, or cardiovascular system diseases; newly treated hypothyroidism;
* current or reported psychiatric (assessed by the SCID-II or neurological (assessed by a clinical neurological evaluation) disorders (e.g., schizophrenia, mood disorders, anxiety disorders, stroke, Parkinson's disease, seizure disorder, head injury with loss of consciousness, and any other significant mental or neurological disorder);
* known or suspected history of alcoholism or drug dependence and abuse during lifetime
Course of Face-to-face Interactions in Adults With Autism

This research explores how adults with autism make eye contact during formal and informal interactions; to what extent the nature of a conversation influences how eye contact is made in terms of length, frequency and overall presentation. Also what physiological responses to eye contact are, in order to determine to what extent eye contact leads to an increased, decreased or unchanged stress level. In addition, to gain insight into the similarities and differences in how people with ASD respond to eye contact of others compared to their own eye contact.

This research explores how adults with autism make eye contact during formal and informal interactions; to what extent the nature of a conversation influences how eye contact is made in terms of length, frequency and overall presentation. Also what physiological responses to eye contact are, in order to determine to what extent eye contact leads to an increased, decreased or unchanged stress level. In addition, to gain insight into the similarities and differences in how people with ASD respond to eye contact of others compared to their own eye contact.

The research design chosen is an exploratory mixed methods study, which was developed in co-design with an expert by experience. The design consists of two parts. In the first part, the researcher will have a conversation (with a formal and informal phase, in which the subject will be given the idea that only the formal part is part of the research) with an adult with ASD, during which hidden recordings of the subject's eye behavior will be made, and in addition, skin conductance and duration/frequency of the subject's eye contact will be recorded, without the subject knowing that this is intended for research into eye contact. In the second part, the researcher and subject watch the hidden recording of the subject's eye behavior, during which the subject's skin conductance will be recorded and special features of the subject, as seen by the researcher. Both the arrangement of the subjects and researcher, as well as the physiological measurements, will be tested in advance.

Eligibility Criteria:
Inclusion criteria

* Neurotypical adults and adults with an ASD, determined according to an internationally recognized classification system.
* Able to understand the instructions.
* Motivation to participate in research.

Exclusion criteria

* No good command of the Dutch language.
* Use of alcohol and/or recreational drugs during the research.
* Mentally too unstable to participate in the research.
* Familiarity with treatment in the VGZ.
Test and Usability of Mixed-reality Screening Tool for Early Detection of Cognitive Declines

The aim of this study as part of the SCOBES-AR project is to establish and test a protocol for implementation and usability of mixed reality-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.

Early diagnosis of cognitive impairments is an important step in the adequate management of dementia. The project "Smart Cognition \& Behavior Screening powered by Augmented Reality" (SCOBES-AR) aims to develop a multimodal screening tool (MST) for early detection of cognitive impairments using augmented and virtual reality. In the first project phase validated assessments were selected, combined in MST and tested in 174 healthy elderly adults. In the present project phase, the developed MST will be partly enhanced by mixed reality (MR). This MR-enhanced prototype of screening tool (MR-MST) will be tested and compared to the previously developed MST. In addition, the usability of this enhanced prototype will be examined.

The study aims to establish a protocol for implementation and usability of MR-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.

In this cross-over design study protocol 100 healthy participants (aged 60-75years) will be screened for cognitive declines using: i) specially developed MST (assessment of cognitive functions, olfactory sensitivity, nutritional preferences, gait parameters, reaction times, activities of daily living, and ii) MR-enhanced MST in which the assessments of cognitive functions, reaction time, activities of daily living and gait are performed using tailor made software and augmented reality and virtual reality hardware. The results of the MR-enhanced MST will be compared with those without MR. The usability of the developed MR-enhanced MST will be tested on 10 investigators and 10 test participants using observed summative evaluation and the co-discovery method and on 2 usability experts using the co-discovery method.

This study was funded by the Austrian Research Promotion Agency and received Ethic Vote from the Ethic committee of the Medical University of Graz. The MR-MST prototype and the study protocol for the present study were developed. To date, no results are available for this study protocol.

The development of the MR-MST prototype enables identifying best practise procedure for evaluating cognitive declines in the elderly using multimodal and MR-enhanced model.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 60-75 years
* Interest in participating in the study
* Signed written informed consent form

Exclusion Criteria:

* Clinical diagnosis of mild cognitive impairment or dementia
* Clinical diagnosis of mental illness (e.g. depression, psychosis)
* Reduced mobility (walking aid, wheelchair)
* Aided hearing or visual impairment
* Participation in any other cognitive training study within the last 6 months
* Present guardianship according to the provisions of the Austrian adult protection law
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for venous thromboembolism (VTE). The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge. The study will consist of a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in a 1:1 ratio. The total duration for a patient who completes the study after randomization is expected to be 75 days.

Eligibility Criteria:
Key Inclusion Criteria:

* The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days
* Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score of: greater than or equal 4, or 3 with D-dimer \> 2\* upper limit of normal (ULN), or 2 with D-dimer \> 2\*ULN

Key Exclusion Criteria:

* Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
* Serious trauma (including head trauma) within 4 weeks before randomization
* History of hemorrhagic stroke at any time in the past
* Any medical condition that requires chronic use of any parenteral or oral anticoagulation
Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran's Integrated Service Network (VISN) 21, which serves rural areas in Northern California and (VISN) 12, which serves rural areas surrounding the Hines, IL VA Hospital.

More than 20% of patients in primary care have depressive disorders. While primary care is the principal venue for treatment for depression, fewer than 25% of depressed patients receive adequate treatment for their depression. These outcomes can be worse when there are barriers to treatment such as living in a rural area. Several studies have found that given a choice, about two-thirds of depressed primary care patients prefer psychotherapy or counseling over antidepressant medication.

This is a controlled, randomized trial in which subjects meeting criteria for major depressive disorder (MDD) from primary care settings in VISN 21 including CBOCs will be randomly assigned to one of two conditions: 1) a 16-session manualized telephone administered cognitive behavioral therapy (T-CBT) delivered over 20 weeks or 2) a treatment-as-usual (TAU) condition. Telephone-administered cognitive behavioral therapy (T-CBT) is an intervention aimed at improving coping skills and social functioning. It is divided into two phases: 1) an initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and 2) a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains. T-CBT, administered by doctoral level psychologists, will be compared to a treatment-as-usual (TAU) condition that controls for the natural course of depression during the course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Has a DSM-IV diagnosis of Major Depressive Disorder as assessed using the MINI
* Has a telephone
* Able to speak and read English
* At least 18 years of age
* Able to give informed consent
* Must be registered at a VA community-based, outpatient clinic (CBOC) at VA Eureka or VA Ukiah or VA Santa Rosa, or VA Manteno, or VA Elgin, or VA La Salle

Exclusion Criteria:

* Has a hearing, voice or visual impairment that would prevent participation in T-CBT
* Meets criteria for dementia
* Is diagnosed with Psychotic Disorder, Bipolar Disorder, substance abuse with clinical consensus, or current severe PTSD.
* Is currently receiving psychotherapy or planning to receive psychotherapy during the 20-week treatment phase of the study
* Has a history of suicide attempts or is at high risk for suicide.
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus

this study evaluates the effect of diode laser in treatment of oral lichen planus.

44 patients with erosive oral lichen planus were included in the study and divided into 2 equal groups. Group I received topical steroid therapy three times daily for 4 weeks and antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to 10 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Patient histologically diagnosed with erosive OLP based on WHO modified criteria 2003.
* Presence of painful erosive OLP lesions diagnosed by biopsy

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients currently treated for cancer with Chemotherapy or Radiotherapy
* Patient currently on Corticosteroid therapy or had this treatment on the past 3 months
* Those who had used Anti-inflammatory drugs topical or systemic in the last month
* the use of drugs related to Oral Lichenoid Lesions
* Presence of Amalgam restorations near the OLP lesions
* dysplasia in histopathological examination
* uncontrolled systemic diseases
* physical or mental abnormality which would interfere with or be affected by the study procedure
* Patients with skin lesion