Kornimate/medical-research-clean huggingface dataset:
monosialoganglioside(gm1) preventing neurotoxicity induced by cisplatin contained chemotherapy in nsclc patients

Conditions: Non-small Cell Lung Cancer

Summary: evaluate the efficacy and safety of monosialoganglioside(gm1) to prevent the neurotoxicity induced by cisplatin

nsclc patients received a cisplatin-based doublet chemotherapy are included in this trial. patients are randomly assigned into the experimental group and control group based on segmented block randomized method. after enrollment, patients should complete four or six chemotherapy and gm1/placebo injection. during the 3w per cycle chemotherapy, cisplatin injection is conducted in d1/d1-3, gm1/placebo (80mg+250ml n.s) is injected from d0 to d3. neurotoxicity evaluation and quality of life (fact-ntx and erotc scale) assessment will be conducted every cycle and 3w/11w/19w after the chemotherapy.

Eligibility criteria:
inclusion criteria: * cytological and histological confirmation of non-small cell lung cancer (nsclc) diagnosis, single sputum cytology diagnosis is not accepted * expected survival period is more than 3 months * enough blood function reservation: absolute neutrophil count (anc) 2 x 10e9/l or higher;platelet count 100 x 109 /l or higher;hemoglobin 9 g/dl or higher. * enough liver function reservation:the total bilirubin less than upper limit of normal;ast and alt acuities were less than 2.5 times the upper limit of normal (uln);alkaline phosphatase 5 times the upper limit of normal (uln) or less. * clinical doctors identify patients suitable for standard doses of ganglioside drug therapy, and expected time of medication is at least six weeks * within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity; 18 weeks before, did not received platinum-based drugs chemical treatment. * no more than 1 degree of the peripheral nervous system diseases exists before enrollment, also no other symptom or disease could affect the adverse reactions of neurotoxicity pathological. * can't accept other adverse reactions may prevent neurotoxicity treatment or care after enrollment. * sign the informed consent form. exclusion criteria: * patients with poor general condition, ps score more than 2 points * women in pregnancy or lactation * patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception * with other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity * known or assignment of any of these products to test drugs allergic agent composition * doctors think inappropriate for patients with ganglioside medication or estimated time of less than 6 weeks * active infection (determined by the researcher) * according to the researcher's judgment, there is serious disease to endanger the safety of patients, or may prevent the patients from completing the study * have a clear history of neurological or psychiatric disorders, including epilepsy or dementia

Keywords: nsclc monosialoganglioside(gm1) neurotoxicity
prevalence of fabry's disease in a population of patients with chronic pains

Conditions: Pain; Fabry's Disease

Summary: fabry disease (fd) is a rare x-linked multisytemic lysosomal disorder caused by alpha-galactosidase deficiency. globotriaosylcéramide (gb3) deposits are observed in almost all tissues examined. signs of the disease appear earlier and are more severe in affected males than in females. myocardiopathy, renal failure and neurological signs including chronic pain and peripheral neuropathies are the most frequent signs. the availability of two enzymatic replacement therapies now provides a specific and effective treatment for patients. the prevalence of fd is estimated between 1/40,000 and 1/117,000. the frequency of fabry disease has previously been estimated in several series of patients presenting one single sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. however, no data are available about the prevalence of fd in populations of patients suffering from chronic pains of unknown origin. the diagnosis of fd will be performed by standard procedures following international recommendations. these require the search for a deficiency of alphagalactosidase a activity on leucocytes in males and genetic analysis of the gla gene in females (lidove et al. 2007). the patients in whom the diagnosis of fd is established during this study, will be call in for an additional visit in the investigating centre in order to confirm the diagnosis and propose suitable assessment and care.


Eligibility criteria:
inclusion criteria: * patients of both sex * aged from 6 to 65 * with chronic pains of unknown aetiology including: * acroparesthesias * and/or pain crises evolving more than 3 months * continued neuropathic evolving more than 3 months * and/or multiple pains evolving more than 3 months * and/or recurrent abdominal crises of pain who come for a clinical visit in the centre douleurs chroniques in the chu of bordeaux. exclusion criteria: * chronic pain of known cause

Keywords: chronic pains unknown aetiology
behavioral treatment for nightmares in rem sleep behavior disorder

Conditions: Nightmare; Nightmare Disorder With Associated Other Sleep Disorder; REM Sleep Behavior Disorder

Summary: the purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with rapid eye movement (rem) sleep behavior disorder (rbd). people with rbd will be enrolled in the study along with their romantic partners. all participants will receive the treatment via videoconference and will complete 2 assessments. participants with rbd will attend 7 sessions, and their partners will attend 2 of those sessions with them.


Eligibility criteria:
inclusion criteria: * diagnosis of isolated rbd or rbd secondary to neurodegenerative disease * age 18 or older * speak, read, and write english * live in the united states * nightmare frequency ≥3 times per week * disturbing dream and nightmare severity index score indicative of nightmare disorder * sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study * live with a romantic partner who is willing to participate in the study exclusion criteria: * possible dementia * narcolepsy * posttraumatic stress disorder * previous behavioral treatment for nightmares * currently engaged in sleep- or trauma-focused psychotherapy * taking a medication that could cause rbd, if the medication was started prior to onset of rbd symptoms inclusion criteria (partners): * live with a romantic partner who meets all of the above criteria * age 18 or older * speak, read, and write english * live in the united states

Keywords: imagery rehearsal therapy cognitive behavioral therapy for nightmares
glucose, activity, diet, & sleep assessment study

Conditions: Metabolism Disorder, Glucose

Summary: glads is a cross-sectional, observational study assessing free-living diet, physical activity, sleep, and glucose profile over a 2-week period in healthy adult men and women.

monitoring free-living lifestyle behaviors can provide important information on behavioral determinants of health. new technologies have improved accessibility of ambulatory assessment of diet, biomarkers, physical activity, and sleep. the study will assess the effects of free-living diet assessed by questionnaire and sleep and physical activity measured by actigraphy on interstitial glucose measured by continuous glucose monitoring in healthy adult men and women over a 2-week period.

Eligibility criteria:
inclusion criteria: * age: 18-75 y old * in possession of a smartphone * english speaking * live in new york city metro area exclusion criteria: * active food intake disorder
early tracheotomy versus prolonged endotracheal intubation in intensive care unit (icu) patients

Conditions: Respiratory Insufficiency

Summary: this is a phase iii trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.


Eligibility criteria:
inclusion criteria: * patients under ventilation support for at least 4 days * patients needing ventilatory support for \> 7 days * age \> 18 years * informed consent signed exclusion criteria: * patients previously tracheotomised * major hemorrhagic risk * patients previously randomised in a trial

Keywords: icu patients needing prolonged ventilatory support
orem's self-care deficit theory based nursing interventions for immunotherapy treated cancer patients

Conditions: Cancer; Nurse's Role; Treatment Side Effects; Quality of Life

Summary: objective: the aim of this study was to determine the effects of nursing interventions based on orem self-care deficiency theory on symptom management, care needs and quality of life in cancer patients who underwent immunotherapy. method: the research was planned as a randomized controlled trial. the research is planned to be carried out in the medical oncology unit of the health sciences university antalya training and research hospital. it is planned to be done with 58 patients, 29 experimental and 29 control groups. based on orem self-care deficit theory; face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned. patient description form, supportive care needs scale-short form, memorial symptom assessment scale, european organization for the research and treatment of cancer quality of life questionnaire scale and self-care strength scale will be used to collect data.


Eligibility criteria:
inclusion criteria: * coming to antalya training and research hospital medical oncology unit for treatment, * first time taking one of the immune checkpoint inhibitors (ipilimumab ctla-4, pembrolizumab pd-1, nivolumab pd-1, atezolizumab pdl-1), * speaking and understanding turkish, * being literate, * 18 years and older * with solid tumor, * no communication barrier * being able to communicate by phone * individuals who agree to participate in the research. exclusion criteria: * patients receiving other cancer treatments in combination with immunotherapy, * patients with eastern cooperative oncology group performance scale 4.

Keywords: cancer immunotherapy treatment side effects symptom management self-care deficiency care needs oncology nursing
a double blind crossover trial of levetiracetam (keppra®) and placebo in the treatment of restless legs syndrome (rls)

Conditions: Restless Legs Syndrome

Summary: to define the effective dose and tolerability of levetiracetam in individuals with restless legs syndrome (rls). it is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of rls.


Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic rls according to the four irlssg diagnostic criteria 1. an urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. 2. the urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as sitting or lying down. 3. the urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues 4. the urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. irls rating scale score greater than 15 at baseline visit plm-index of 5 or greater during the first night of polysomnography written informed consent obtained prior to any study procedures being performed. exclusion criteria: 1. women of childbearing potential, who have a positive urine pregnancy test or are lactating as the screening visit, or do not practice a clinically accepted method of contraception. 2. individuals who are taking medication for restless legs syndrome without a proper washout period 3. individuals who are taking hypnotics, sedatives, antipsychotics, or neuroleptics 4. history of current diagnosis of other clinically relevant diseases that may confound assessments of rls symptoms (e.g., parkinson's disease, dementia, als, etc.) 5. subjects with serum ferritin below 10µg/l 6. subjects with an untreated sleep disorder that may confound assessments (e.g., narcolepsy, sleep apnea syndrome or other breathing-related sleep disorders, or rem sleep behaviour disorder) 7. subjects with an apnea/hypopnea index of 15 or greater at the initial polysomnography visit 8. subjects employed in shift work (e.g., employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts) 9. subjects who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the subject unsuitable for the study (e.g. severe cardiovascular disease, major depression, psychosis, hepatic or renal failure, etc.) 10. subjects with a positive urine drug test for illicit use of amphetamines, barbiturates, benzodiazepines, opiates, synthetic narcotics, and miscellaneous drugs commonly known as recreational drugs (e.g., cannabinoids including thc, heroine, cocaine) 11. participation in any clinical drug or device trial in the 30 days prior to the screening visit.

Keywords: rls
comparing smoking cessation interventions among underserved patients referred for lung cancer screening

Conditions: Smoking Cessation

Summary: to compare the effectiveness of four interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among underserved smokers referred for lung cancer screening at four large u.s. health systems.

we will conduct a 4-arm randomized trial comparing 4 interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among smokers in underserved demographic groups. the 3,200 participants to be enrolled will be current smokers who are black, hispanic, and/or have low socioeconomic status (defined as household income \<200% of the federal poverty line or a high school education or less) or rural residence who are referred for low-dose computed tomography (ldct) screening at 4 large health systems. all adult patients with ldct orders will be further screened for eligibility. eligible patients will enroll with opt-out consent and complete the study using the nih-funded way to health online research portal. the primary outcome will be biochemically confirmed, sustained abstinence from smoking tobacco for 6 months following participants' selected quit dates. relapse rates will be tracked at 12 months.

Eligibility criteria:
inclusion criteria: * current smoker (≥ 1 cigarettes per day, not including e-cigarettes) * has a low-dose computed tomography (ldct) scan ordered by their physician * underserved, defined as one or more of the following: (a) black, (b) hispanic, (c) rural residence, or (d) low socioeconomic status (defined as one or both of: high-school education or less, or household income \<200% of the federal poverty line) * able to receive study invitation and screening, by virtue of showing up to a radiology location affiliated with a participating health system for the ldct, or having a valid email address or telephone number on file with the health system * access to a cell phone with text messaging or the internet * aged 18 years or older exclusion criteria: * no cell phone

Keywords: patients, underserved early detection of cancer lung cancer nicotine replacement products incentives behavioral economics smoking cessation nicotine dependence
endotracheal intubation without muscle relaxants

Conditions: Muscle Relaxation; Intubation Complication

Summary: prospective study conducted between march 2013 and november 2014 at hospital universitario puerta de hierro-majadahonda, in madrid, spain to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.

this is a prospective study conducted between march 2013 and november 2014 at hospital universitario puerta de hierro-majadahonda, in madrid, spain, with the previous approval by the institutional clinical research ethics committee. a total of 91 subjects who underwent general, gastrointestinal, orthopedic, urology and neurological surgery were randomly selected and provided written informed consent before any study-related procedures were performed. the aim of this study was to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.

Eligibility criteria:
inclusion criteria: * male or female patients * age ≥ 18 years * asa ≤ 3 * able to provide informed consent exclusion criteria: * subjects with left ventricle ejection fraction (levf) ≤ 35% * history of ischemic heart disease in the last year * history of malignant hyperthermia * presence of thoracic drain tubes * increased intracranial pressure (icp) or brain tumors, undergoing neurophysiological monitoring * hemodynamic instability or likely to become unstable during induction of anesthesia

Keywords: endotracheal intubation muscle relaxants inhalational anesthesia
diacutaneous fibrolysis and patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: the aim of the study will be to assess the effectiveness of diacutaneous fibrolysis technique on pain, range of motion (patellofemoral joint mobility test and muscle length test), strength and function in patients with patellofemoral pain syndrome and muscle shortening. muscle imbalance is one of most important factor associated with patellofemoral pain syndrome. shortening of lateral muscles of the thigh have a close relationship with patella position and tracking and patellofemoral pain. the scientific evidence for effectiveness of any soft tissue mobilization technique in patellofemoral pain syndrome patients is poor. diacutaneous fibrolysis is a non-invasive physiotherapeutic technique to release adherences and fibrosis between the different musculoskeletal structures. diacutaneous fibrolysis is applied by a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually. the present study evaluates the effectiveness of diacutaneous fibrolysis technique applied in the soft tissues more related with patellofemoral pain.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral patellofemoral pain longer than three months * anterior or retropatellar pain of non-traumatic origin that is provoked by at least two of the following activities: prolonged sitting or kneeling, squatting, running, hopping, jumping, or stair ascending/descending. * the presence of pain on palpation of the patellar facets, on step down from 25 cm step, or during a double leg squat. * pain over the previous week equal to or greater than 3 on a 10-cm visual analogue scale. * the presence of muscle shortening in rectus femoris or tensor fascia lata muscle length test and/or hypo-mobility or stiffness in the compartmental muscle play. exclusion criteria: * previous knee surgery or traumatic lesions * concomitant injury or pathology of other knee structures * history of patella subluxation or dislocation * evidence of knee joint effusion * pain in and/or referred from the hip or lumbar spine * currently undergoing physiotherapy treatment for patellofemoral pain syndrome or use anti-inflammatories or corticosteroid medication at the same time of the study. * subjects unable or unwilling to give informed to written consent or fulfil questionnaires.

Keywords: physiotherapy patellofemoral pain syndrome manual therapy
c1 inhibitor registry in the treatment of hereditary angioedema (hae) attacks

Conditions: Hereditary Angioedema

Summary: this is a non-interventional treatment registry of hereditary angioedema (hae) patients treated with c1 inhibitor, either plasma-derived (pdc1inh) or the recombinant human form (rhc1inh / ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with ruconest.

see below

Eligibility criteria:
inclusion criteria: * decision to treat the hae patient with c1 inhibitor (either ruconest or pdc1inh) * patients must give written informed consent exclusion criteria: * a diagnosis of acquired c1inh deficiency (aae)

Keywords: hereditary angioedema hae angioedema recombinant c1 inhibitor rhc1inh registry
diagnostic accuracy of the "llift", a novel non-invasive biomarker for the diagnosis of non alcoholic fatty liver (nafl) and steatohepatitis (nash) in a population with high risk of metabolic syndrome"

Conditions: Obesity; NASH - Nonalcoholic Steatohepatitis

Summary: the nafld is the first cause of liver disease worldwide. the severe form of nafld, the nash progresses to cirrhosis and is responsible of liver mortality. the diagnosis of nash requires liver biopsy that cannot be used for the screening of the disease. the broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. there is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of nash.


Eligibility criteria:
inclusion criteria: * patients with 1 at least of the following metabolic criteria : * bmi \> 30 kg/m², * type 2 diabetes (glycemia \> 1.26 g/l or under therapy) * hypertension (\> 140 mmhg / 90 mmhg or under therapy) associated with increased hepatic enzymes * indication of nafld evaluation * patients written consent * affiliated to a social insurance exclusion criteria: * contraindications for liver biopsy or mri. * other confounding cause of liver disease (hcv, hbv, hcc, autoimmune liver disease, hemochromatosis, wilson disease. * alcohol consumption higher than 140g/week for women and 210g/week for men * previous history of alcohol abuse (addiction). * eluding stent \< 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks. * hepatocellular carcinoma * being processed cancer (chemotherapy, radiotherapy or hormone therapy) * pregnant or breastfeeding women. * drug abuse within the past year. * mentally unbalanced patients, under supervision or guardianship

Keywords: nafl nash screening metabolic syndrome diagnostic biomarker non-invasive biomarker