Kornimate/medical-research-clean huggingface dataset:
circulating blood profile to predict recurrence and response to systemic therapy

Conditions: Melanoma

Summary: to study if a targeted gene expression profile of rna, similar to the netest, can be isolated from the peripheral blood of patients with melanoma, to identify active disease, provide an assessment of treatment responses, or predict risk of relapse, in conjunction with standard clinical assessment and imaging.

* evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified stage iii melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to ldh as a biomarker. * evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified stage iv melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to ldh as a biomarker. * define the assay metrics for sensitivity and specificity in diagnosis in stage iii and iv tumors. * monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in stage iii and iv treated patients.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. primary melanoma \> 1 mm in breslow depth 3. stage iii or iv disease as determined either by sentinel node biopsy, biopsy of clinically enlarged lymph nodes, and/or imaging. if stage iv, must have tissue biopsy confirming presence of stage iv melanoma exclusion criteria: 1. pregnant patients 2. contraindication to contrasted imaging (due to allergy or renal insufficiency) 3. serum pcv \<30%
anterior insula regulation and pain empathy

Conditions: Anterior Insula Activity During Regulation; Empathic Responses After Anterior Insula Regulation

Summary: the aim is to test whether rtfmri-based neurofeedback training on anterior insula impacts pain empathy.

in the present study, investigators plan to use the real-time fmri neurofeedback to train healthy subjects to learn volitional control over their own anterior insula (ai) activity. then the effect of ai regulation will assessed by examining subjects' empathic responses and functional connectivity changes. subjects were separated into two groups randomly. while the experimental group received specific neurofeedback from their own ai, the control group received sham nf from an unspecific region.

Eligibility criteria:
inclusion criteria: * healthy subjects without past or current psychiatric or neurological disorders exclusion criteria: * history of head injury; * claustrophobia; * pregnancy; * medical or psychiatric illness.
telemedicine-based model of care for the management of hepatitis c infected patients

Conditions: Hepatitis C; Telemedicine

Summary: to achieve world health organization 2030 goals of hepatitis c elimination it is mandatory to document after treatment sustained virological response (svr). currently, patients after completing treatment do not show up for svr assessment. the main objective of this study is to evaluate the effectiveness of a telemedicine-based model of care associated with dried blood spot testing at home to assess hepatitis c sustained virological response after treatment compared to the traditional model of care.

this is a prospective, randomized study in which hepatitis c (vhc) infected patients will be randomized to two strategies for hcv care. all hcv infected patients will be evaluated in a first face-to-face consultation with the hepatologist for fibrosis evaluation and treatment prescription the same day. patients will be invited to participate if they are: 1) 18 years or older 2) have contact telephone number 3) sing the informed consent 4) have not advanced fibrosis (f3) or cirrhosis (f4) 5) are not under surveillance by another specialist or drug addiction centre. participants will be randomized into two strategies to assess sustained virological response (svr) during follow-up: 1. the traditional model of care: one appointment for venipuncture for rna testing to assess svr (undetectable rna 12 weeks after treatment cessation), and an appointment with the specialist for result communication. 2. telemedicine-based model of care: the patient will be provided with a home kit to perform the dried blood spot (dbs) testing for hcv rna at 12 weeks (svr), and an appointment for teleconsultation and communicate the results. demographic, clinical and laboratory data will be collected to evaluate the characteristics of included patients and to study predictive factors of adherence. a satisfaction questionnaire will be conducted to compare patients´ satisfaction with both health care models. the hypothesis of the study is that the adherence and svr determination record will increase using the telemedicine-based model of care. for the present study, a 20% improvement in the adherence (svr record) was hypothesized in the group of patients randomized to the telemedicine-based model of care compared to the traditional model of care. taking into account power of 80%, alpha error of 5% and losses of 10% will require 68 patients per group.

Eligibility criteria:
inclusion criteria: * 18 years or older * have contact telephone number * sing the informed consent exclusion criteria: * have advanced fibrosis (f3) or cirrhosis (f4) * are under surveillance by another specialist or drug addition center.
prospective evaluation of taste function in multiple myeloma patients undergoing autologous hematopoietic cell transplantation

Conditions: Multiple Myeloma

Summary: the purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan.


Eligibility criteria:
inclusion criteria: * age 21 or above with diagnosis of multiple myeloma (myeloma is almost unheard of in patients less than 21 years of age). * scheduled to receive conditioning chemotherapy with melphalan followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation * english or spanish speaking * calculated creatinine clearance \> 40 ml/min exclusion criteria: * prior head and neck radiation. * severe periodontal infection. poor oral hygiene and dentition as determined by pre hct dental assessment. * pregnancy * patients with pre-existing moderate-severe dysgeusia

Keywords: melphalan stem cell transplantation 17-404 hematopoietic cell transplantation hct
yspsl for prevention of delayed graft function part a

Conditions: Delayed Graft Function

Summary: selectins have been implicated in the pathogenesis of ischemia/reperfusion (i/r)-induced kidney injury and resultant dgf. psgl-1 is a ligand for p-, e-, and l-selectin. it has been reported that that yspsl (rpsgl-ig) blocks p-selectin and, to a lesser degree, e- and l-selectin. both spsgl-1 and yspsl (rpsgl-ig) have been shown in animal models to reduce both cytokines and tissue damage associated with ischemia reperfusion and to improve renal function post-transplant. therefore, the current phase i/ii clinical study is designed to assess the safety and efficacy of yspsl (rpsgl-ig) in preventing dgf in patients undergoing cadaveric kidney transplants and to determine a dose for future pivotal studies.

this will be a multicenter, single-dose, dose-escalation study. the study will be in 2 parts: the first, part a, will be an open label evaluation of single doses of four dose cohorts and the second, part b will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation study of two dose cohorts. patients who are undergoing cadaveric kidney transplantation and are at risk for development of dgf, based upon known risk factors, will be eligible to participate in the study. a maximum of 24 patients will be enrolled in part a of the study. 60 patients will be enrolled in part b.

Eligibility criteria:
inclusion criteria: * primary cadaver renal transplants other inclusion criteria delineated in protocol exclusion criteria: * full criteria delineated in protocol patient has a planned transplant of a donor kidney from a non-heartbeating donor; patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant) or from donors \<6 years of age; patient has a planned transplant of a kidney from a donor who has received investigational therapies designed to reduce the impact of ischemia/reperfusion (i/r) injury, dgf, or other donor-related immune events; patient is planned to receive a living donor kidney; or patient is planned to receive an abo-incompatible donor kidney.
retrospective study of patients with spasticity in the spanish population

Conditions: Muscle Spasticity

Summary: this is a retrospective study of patients with spasticity in the spanish population.


Eligibility criteria:
inclusion criteria: * diagnosis of spasticity exclusion criteria: * current enrollment in a clinical trial
efficacy and safety evaluation of nabilone as adjunctive therapy to gabapentin for the management of neuropathic pain in multiple sclerosis

Conditions: Neuropathic Pain; Multiple Sclerosis

Summary: the purpose of this study is to determine whether nabilone (cesamet) when used as an adjunctive agent with gabapentin (neurontin) provides significantly improved pain relief over gabapentin alone for the management of neuropathic pain in ms.

neuropathic pain syndromes, which occur due to damage to central and/or peripheral nerve axons, are often more difficult to manage and are commonly refractory to the conventional analgesia approach described by the world health organization, including nsaids and narcotic agents. these pain syndromes are often described by symptoms of burning, stabbing, crawling, shock-like, numbness and/or tingling, and can be quite concerning to the patient, especially when there is an inadequate response to treatment. it has been estimated that the prevalence of chronic pain in ms ranges anywhere from 30-90%, placing it as the second worst disease-induced symptom experienced by this patient population. the pathophysiologic causes of this pain syndrome are complex and multifaceted, with no one specific link attributed to the pain response. due to the complexity of neuropathic pain - which is only partially understood at best - it may be necessary in many cases to treat the source of the pain with more than one agent in order to address the many different contributors to this pain process. more thorough review of how the currently available agents for npp work together would provide clinicians with safety and efficacy data which would aid in providing optimal pain management.

Eligibility criteria:
inclusion criteria: * males and females between the ages of 18-65 years old with clinically definite rrms * edss of \< 6.5 * current treatment with gabapentin that is not effective at a stabilized dose of (\>1800mg/day) for at least 1 month. * visual analogue scale score for npp symptoms \> 5; pain present for at least 3 months * negative serum pregnancy test for all females of childbearing age; not currently breastfeeding * no history of alcohol or substance abuse * no history of non-psychotic emotional disorders * no significant hepatic or renal insufficiency * no significant cardiovascular disease or hypertension * no known hypersensitivity and/or allergy to nabilone or its derivatives * no current use of cannabinoid or related products

Keywords: neuropathic pain multiple sclerosis nabilone gabapentin
sleep bruxism and (peri-)implant complications

Conditions: Dental Implant Complications; Sleep Bruxism

Summary: excessive mechanical forces can cause complications of dental implants and their suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft tissues around the implants. sleep bruxism (grinding and clenching of the teeth during sleep) is considered as an important source of mechanical forces in the oral environment. therefore, in this study, the investigators will investigate whether sleep bruxism is associated with implant and peri-implant complications.


Eligibility criteria:
inclusion criteria: * planned for treatment with implant-supported fixed suprastructure(s). * 18 years of age or older. exclusion criteria: * opposing teeth of implant-supported fixed suprastructure(s) are restored with removable artificial teeth. * patients categorized in the classes 3 or higher according to the asa system for classification of physical status. * use of occlusal splint, mandibular repositioning appliance or any other bruxism mitigating device during sleep. * active periodontitis at the time of implant placement. * known allergy to grindcare® electrode material. * patients with a pacemaker. * swollen, infected or inflamed tissues or skin eruptions, e.g. phlebitis, varicose veins etc. in the placement area of the grindcare® electrode. * pregnant women will not be treated with dental implants. pregnancy after placement of implants will not be a reason to stop participation of the subject in the study.
neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (caelyx®) and paclitaxel in breast cancer

Conditions: Breast Cancer

Summary: in this study, pld, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. the study aimed to determine whether the combination of pld-docetaxel would increase tumour response in patients with breast cancer.


Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed breast cancer; 2. age \>18 years; 3. eastern cooperative group (ecog) performance status 0-2; 4. measurable disease (as per radiological imaging); life 5. expectancy \>12 months; 6. adequate haematologic blood profile; 7. normal liver and kidney function; 8. adequate cardiac function; 9. no metastatic disease; 10. negative pregnancy test (premenopausal women); 11. signed informed consent. exclusion criteria: 1. level 2 cardiac toxic effects were deﬁned as asymptomatic systolic dysfunction (nyha class i) or mildly symptomatic heart failure (nyha class ii) ; 2. previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures); 3. active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;
intravenous lidocaine in open lung resection surgery

Conditions: Lidocaine; Pain, Postoperative

Summary: management of postoperative pain in 2020 remains a challenge for anesthesiologists in the perioperative period. lidocaine is an amide local anesthetic, it is one of the oldest adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and anti-inflammatory properties. lidocaine is proven to be as effective as epidural analgesia in colorectal surgery. however, no study has evaluated the effect of a continuous lidocaine infusion for open lung resection in the post-operative period. the present study aims to evaluate the influence of iv lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) scores of i, ii or iii. * left or right posterolateral thoracotomy with postoperative monitoring in the intensive care unit (icu) for at least 24 hours (h). exclusion criteria: * patient's refusal to participate * asa score of iv or higher * severe hepatic or renal insufficiency * allergy to lidocaine, morphine or nsaids * cardiac arrhythmias or * epilepsy, * delayed extubation for more than 2 h postoperatively * urgent surgery
myosense- automated muscle hypertonicity classification system

Conditions: Stroke; Dystonia; Cerebral Palsy

Summary: it is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. this makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. this research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.


Eligibility criteria:
inclusion criteria: * presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone * over the age of five. exclusion criteria: * intolerable pain with manipulation of the knee, ankle, wrist, or elbow * limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction. * cognitive impairment resulting in inability to provide informed consent or complete the protocol. * under the age of five.
effectiveness of local application of warm air in patients with common cold (heli study)

Conditions: Common Cold

Summary: in a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions: 1. the inhalation of warm air for inducing a warming of the throat and 2. the inhalation of ambient air as control. as outcome the effect on symptoms and duration of the common cold will be assessed. the interventions will consist of visits with a duration of 2-3 minutes on three following days in a finnish sauna. patients will be fully dressed.


Eligibility criteria:
inclusion criteria: * symptom duration between 2 and 24 hours * at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever * no usage of medication bought in a pharmacy * informed consent exclusion criteria: * fever \>38.5°c * systolic blood pressure below 100 mmhg or above 160 mmhg * severe chronic disease, which makes study participation impossible * pregnancy

Keywords: common cold finnish sauna rct
specific use-result surveillance of spiriva respimat in asthmatics

Conditions: Asthma

Summary: the safety of spiriva® 2.5 µg respimat® 60 puffs (hereinafter referred to as spiriva® respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.


Eligibility criteria:
inclusion criteria: * patients diagnosed with severe persistent bronchial asthma * patient aged \>= 15 years * patients who are naive to spiriva respimat and receive spiriva respimat for the first time for treatment of bronchial asthma on top of at least ics (inhaled corticosteroids) treatment. exclusion criteria: * patients who have a contraindication to spiriva respimat defined in the package insert for spiriva respimat * patients who have been enrolled this study before.
hearing problems in children of rheumatic diseased mothers

Conditions: Hearing Disorders

Summary: evaluation of the hearing functions of children born to rheumatic diseased mothers who received gestational antimalarial drugs versus those didn't receive gestational antimalarials drugs compared with normal healthy children.

rheumatic diseases are autoimmune illnesses characterized by tissue damage, caused by abnormal immunologic reaction against own cells, tissues or organs.many of these rheumatic diseases preferentially occur in women during the childbearing age. the transplacental passage of maternal antibody may result in a variety of adverse fetal effects including thrombocytopenia, neutropenia, hemolysis and thyroid disease. both fetal hypo and hyper thyroidism may occur and maternal hypothyroidism particularly during the 1st trimester is associated with impaired fetal neurological development and delayed mental and motor development. hydroxychloroquine (cq), the hydroxyl derivative of chloroquine, is an antimalarial agent which is widely used, either alone or in combination with other agents, in the treatment of sle, rheumatoid arthritis (ra) and various other autoimmune diseases. hydroxychloroquine is safe during pregnancy, as it is not associated with an increased rate of congenital malformations. however, isolated cases of ocular (retinal pigment deposits) and auditory abnormalities were reported. an increase in high-frequency hearing threshold is the earliest change in the auditory function for most drug induced hearing losses, including the irreversible damage caused by antimalarials. the investigators therefore will use audiological methods for detection of hearing impairment in children delivered for mothers receiving antimalarials during pregnancy with rheumatic diseases.

Eligibility criteria:
inclusion criteria: * children males \& females * age 4 to 16 years. * whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment. exclusion criteria: * prematurity, history of prenatal, natal or post natal medical problems. * family history +ve. * consanguinity +ve. * gestational intake of other ototoxic drugs. * use of antimalarial due to diseases other than rheumatic diseases. * administration of antimalarial before pregnancy. * children who have middle ear disorders.
testing the effect of mindfulness for prostatectomy outcomes

Conditions: Prostate Cancer

Summary: this research project has 2 parts: the first part of the research is to develop a couples-based group mindfulness intervention for men undergoing prostatectomy, with input from patients and their partners. the second part is the trial registered here, which will pilot the researchers' mindfulness intervention, developed in part 1, and observe any reduction of distress for men undergoing prostatectomy and their partners.

in part 1 of this research, researchers developed a couples-based group mindfulness intervention for men undergoing prostatectomy, with input from patients and their partners. three patients who had previously undergone prostatectomy, and had expressed interest in participating in future research endeavors, and their partners were recruited to inform the design of the intervention. this group of six stakeholders identified the types of distress experienced by newly diagnosed prostate cancer patients and their partners, as well as their favored intervention approaches. these stakeholders do participate in the intervention or control groups in part 2 of this study. researchers used thematic analysis to assess the type of distress identified by stakeholders as well as approaches favored by them. they mapped these themes on the available mindfulness approaches, identified in their review, to develop an intervention that best captures the concerns of prostate cancer survivors and partners. part 2 is the pilot study. researchers will enroll 20 more couples (men who are planning to undergo radical prostatectomy and their partners) to participate in a pilot study of the intervention. the pilot study will have 2 cohorts (groups). half of the couples will be randomly assigned to the mindfulness intervention (intervention group) and the other half will receive the usual care (control group). all participants in the intervention and control groups in part 2 of the study will be analyzed to determine the effects and feasibility of the intervention.

Eligibility criteria:
part 2--pilot study: inclusion criteria * patients aged 35 - 90 who are planning to undergo radical prostatectomy at university of michigan hospital * partners of these men, aged 18 and older exclusion criteria: * participants cannot be less than 18 years of age

Keywords: mindfulness