Kornimate/medical-research-clean huggingface dataset:
experiential and relaxation virtual reality as a tool for easing anxiety in seriously ill children

Conditions: Pediatric Palliative Care; Life Limiting Conditions; Life Threatening Diseases

Summary: the goal of this clinical trial is to assess the use of experiential and relaxation virtual reality (vr) interventions in easing anxiety and other distress symptoms in children with life-limiting and/or life-threatening conditions (llc/ltc). the main questions it aims to answer are: 1. does experiential and relaxation vr help to decrease anxiety in severely ill children? 2. what effect does it have on pain and fear? 3. is there a difference between experiential and relaxation vr in the observed outcome measures? 4. how is the newly developed relaxation vr app breezeterravr perceived by children with llc/ltc? 5. how do caregivers of the patients perceive vr as an intervention tool for psychological distress? researchers will compare baseline levels of outcome measures (e.g. anxiety) to post-intervention levels to determine if there is an effect. participants will: * experience both types of vr interventions-experiential and relaxation vr-for 7 to 15 minutes in two sessions (the number of days between sessions will depend on each child's medical plan), the order of interventions is randomized. * fill out a set of short questionnaires before and after each intervention (approximately 5 minutes per phase).


Eligibility criteria:
inclusion criteria: * age 7-17.9 years * sufficient level of contact with the environment and ability to cooperate * children and parents fluent in czech * diagnosis of a life-threatening or life-limiting disease according to the internationally accepted list of palliatively relevant diagnoses * pediatric patients treated at the university hospital motol exclusion criteria: * age below 7 or above 17.9 years * unstable health status * inability to speak czech * absence of parental consent for participation in the study

Keywords: experiential vr relaxation vr modern technologies in supportive care in medicine pediatric palliative care virtual reality anxiety reduction pediatric
vaporized cannabis and spinal cord injury pain

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Summary: this study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. to further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured.

this study will demonstrate that vaporized cannabis can produce antinociceptive effects compared to placebo in human subjects with spinal cord injury (sci). a within-subject crossover study of the effects of cannabis versus placebo on spontaneous and evoked pain will be performed. a synopsis of antinociception with mood, cognitive impairment, psychomotor performance, and side effects will be obtained to help evaluate the utility of vaporized marijuana in sci neuropathic pain. this study will compare the analgesic and side effect profile of low (3.5%) to high dose (7.0%) delta 9-tetrahydrocannabinol in subjects with spinal cord injury pain. it is hypothesized that a low dose will produce a lesser degree of neuropsychological impairment while maintaining a similar degree of pain relief to the higher dose. the use of two different strengths will help determine tolerable dosing for the treatment of sci neuropathic pain.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 and less than 70 2. pain intensity ≥ 4/10 3. neuropathic pain defined as chronic pain in an area of sensory abnormality corresponding to the spinal cord or nerve root lesion, and the pain should have no primary relation to movement, inflammation or other local tissue damage 4. leeds assessment of neuropathic symptoms and signs score greater than or equal to 12 5. spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability) exclusion criteria: 1. known concomitant cerebral damage/cognitive impairment (tbi, alzheimer's disease vascular dementia, parkinson's disease, dementia with lewy bodies and front temporal dementia 2. clinically significant or unstable medical condition (i.e., cardiac, respiratory, hepatic or renal disease) that, in the opinion of the investigator, would compromise participation in the study 3. neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (hereditary neuropathies; diabetic peripheral neuropathy; traumatic neuropathy; and immune-mediated neuropathies) 4. active substance abuse within past year using "the substance abuse module of diagnostic interview schedule for dsm-iv 5. pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test 6. currently on probation or parole. 7. hx of schizophrenia, bipolar depression with mania, current suicidal ideation or past history of suicide attempt 8. severe depression (patient health questionnaire-9 ≥ 15) 9. current suicidal ideation

Keywords: cannabis central neuropathic pain analgesia
self-compassion and acute pain

Conditions: Acute Pain

Summary: research on self-compassion suggests its impact in the context of pain. in the current study, the investigators evaluate a short self-compassion intervention for coping with acute pain.

self-compassion comprises three components: self-kindness, common humanity and mindfulness. empirical evidence shows the relevance of self-compassion in the context of negative emotions such as depression, anxiety and anger. research on chronic pain is promising yet limited. self-compassion is associated with better pain-coping, pain-acceptance and quality of life, as well as reduced pain-related disability and burdening emotions. experimental investigations on induced pain are missing. the aim of the current study is to evaluate a short self-compassion intervention for pain. first, a heat stimulus is induced to all participants which is to be tolerated as long as possible and evaluated in intensity and unpleasantness. next, participants receive a coping-strategy which they are randomly assigned to. three different strategies are evaluated: (1) self-compassion, treating oneself with kindness while being mindfully aware of the painful stimulus, (2) acceptance, accepting the painful stimulus as well as pain-related thoughts, not trying to change, (3) distraction, distracting oneself from the painful stimulus and trying not to perceive the pain or painful thoughts. participants practice the strategy with the painful heat stimulus three times. then, they receive another heat stimulus which is to be tolerated as long as possible and evaluated. during the next week, participants obtain daily practices via e-mail for further fostering of the learned strategy. finally, participants receive, tolerate and evaluate pain again in the laboratory.

Eligibility criteria:
inclusion criteria: * sufficient german language knowledge * at least 18 years old exclusion criteria: * acute or chronic pain conditions * drug or pain-medication (last 24 hours) * raynaud's disease * high blood pressure * neuropathy, coronary diseases * diabetes, current alcohol * studying psychology longer than two years
intraneural facilitation as a treatment for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: we hypothesize that a standard course of inf can result in significant improvement in cts as measured by clinical, electrodiagnostic, or ultrasound measures.

inf is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve. his therapy has been shown to improve clinical function in patients with diabetic-associated polyneuropathy, a model for various forms of ischemic neuropathy. cts is a common condition where regional compression at the wrist results in ischemic focal demyelination of the distal median nerve. this results in sensory dysfunction, pain, and eventually axon loss and weakness if the compression is sufficiently severe and prolonged. standard therapy for cts includes wrist splints, regional lidocaine injections, ergonomic adjustments, various forms of occupation therapy, and ultimately surgical release of the carpal tunnel ligament. however, all of these are either temporary in their effect or invasive. the diagnosis of cts relies on clinical, electrodiagnostic or ncs, and ultrasound methods.

Eligibility criteria:
inclusion criteria: 1. patients referred to the lluh neurology electrodiagnostic laboratory with electrodiagnostic and clinical evidence of cts (uni- or bilateral) 2. ages \>18 and \< 75 (irrespective of gender) 3. current use of splints as long as the frequency of treatment is unaltered and onset of use is \> 1 week in duration exclusion criteria: 1. prior carpal tunnel release \> 2 years ago 2. the presence of any condition that would prevent ncs from accurately diagnosing cts (e.g., hereditary polyneuropathy or acquired demyelinating polyneuropathy) 3. workman's compensation cases 4. pregnancy 5. undergoing conservative or surgical/injection therapy (physical or occupational therapy, injections) 6. clinically silent cts in face of positive electrodiagnostic results 7. sufficiently severe clinical symptoms that warrant more aggressive therapy i.e., carpal injections or release 8. any confounding medical condition that the investigator deems may adversely affect subject participation or outcomes
comparison of continuous intravenous lidocaine infusion versus esp block for rib fracture analgesia

Conditions: Rib Fractures

Summary: recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (espb). since its development for thoracic neuropathic pain, the espb has been shown to be effective in pain control in multiple procedures including thoracotomies. however, there have been a few published case reports of using espb for analgesia in rib fracture management and only one retrospective study which demonstrated improved nrs pain scores and increased incentive spirometry volumes (icv) post-espb compared to pre-espb values. the goal of this study is to compare the effectiveness of espb as an alternative method to the current standard of care at stanford health care (shc) for pain management in traumatic rib fractures. at the investigator's institution, the current standard of care is intravenous (iv) and enteral multimodal analgesia that consists primarily of opioids and a continuous iv lidocaine infusion. although iv lidocaine has shown some benefit in improving post-surgical pain scores, evidence for its use in mrf is lacking. the purpose of this study is to perform a randomized clinical trial comparing outcomes in pain control and incentive spirometry volumes between continuous espb catheters and iv lidocaine infusions in adult patients with acute traumatic rib fractures. the investigators want to determine if espb can provide improved pain control in patients admitted for traumatic rib fractures compared to iv lidocaine. the aim is to evaluate the clinical effectiveness of espb on ome consumption, pain scores, incentive spirometry volumes, cough strength, respiratory complications, inflammatory biomarkers and hospital los. findings from this study can help improve analgesia, quality of care, and patient satisfaction at stanford healthcare and for other acute pain and trauma surgery providers. the aim of this study involves pain management for patients with acute traumatic rib fractures and therefore must involve human subjects.


Eligibility criteria:
inclusion criteria: - all adult patients admitted to stanford health care with two or more acute traumatic rib fractures. exclusion criteria: * hemodynamically instability, * mechanical ventilation, * polytrauma (defined as bone or organ injury outside the thorax), * pregnancy, * incarceration * local anesthetic allergy or contraindications to lidocaine (stokes-adams syndrome, wolff-parkinson-white syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block) * chronic opioid use.
efficacy of lansoprazole in chronic post nasal drip

Conditions: Larynx Disease

Summary: the purpose of this study is to determine whether aggressive acid suppression with lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters.

postnasal drip (pnd) is a common complaint that brings patients to the attention of their primary care physicians. it is also one of the most common reasons for patients to seek care from otolaryngologists. traditionally, pnd has been considered and treated as a symptom of sinonasal pathology. it has also been shown, along with gastroesophageal reflux disease (gerd) and asthma, to be a major contributor to the development of chronic cough. pnd refractory to treatment aimed at sinonasal disease is sometimes treated with anti-gerd therapy. this treatment modality is based on clinical experience. to date, there are no studies in the literature to support a causal relationship between pnd and extraesophageal reflux (eer). in a case control study of patients with and without esophagitis el-serag et al reported a significant association (odds ratio 1.6, 95%ci 1.4-1.8) between sinusitis and gerd. a later study by ulualp et al in 11 ct confirmed cases of chronic sinusitis resistant to therapy with conventional sinus therapies they found a significantly higher prevalence of hypopharyngeal acid exposure in the sinusitis group than controls. recently, in an open label prospective pilot trial, dibaise et al treated 11 patients with sinusitis and 19 gerd patients with omeprazole 20mg bid for 3-months. 9/11 sinusitis patients were found to have gerd by ph monitoring and there was moderate (25-89%) improvement in the sinus symptoms in the omeprazole treated group. however, there are currently no placebo-controlled trials assessing efficacy of ppi's in patients with pnd.

Eligibility criteria:
inclusion criteria: * negative rast inhalant allergy panel or negative skin testing (group a) * positive rast or positive skin testing and insufficient response to all of the following: (group b) * allergen avoidance * topical nasal steroids * allergy shots if indicated * antihistamines * negative ct sinuses (coronal) * \< 4mm of mucosal thickening and \< 3 sinus sites * absence of air-fluid levels * negative anterior rhinoscopy * absence of pus, crusts on mucosal surfaces exclusion criteria: * age \< 18 * pregnancy, confirmed by urine pregnancy test at day of randomization * ciliary dyskinesia * immune deficiency * cystic fibrosis * diagnosis of acute sinusitis or chronic rs (aao-hns) * active use of topical decongestant * use of ppi within the last 30 days * previous fundoplication * uncontrolled thyroid disease * isolated chronic cough without the symptom of post nasal drip
dyslipidemia management in chinese post stroke patients

Conditions: Brain Ischemia,Stoke

Summary: the purpose of this study is to provide current and reliable data of dyslipidimia management together with control situation of blood pressure and glucose for post-stroke patients within 6-12 months from attack, and also the association between patient characteristics and control rate of lipids in this population. it is an non-interventional study, no study specified treatment is required.approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. fifty centres from different regions of china will participate in this study.

this is a multicentre, cross-sectional, observational study, aiming to investigate the prevalence and control situation of dyslipidimia in china post ischemic stroke patients within 6-12 months from attack. patients will be screened consecutively, eligible subjects will be interviewed by investigator and finish a questionire during the visit. investigator will collect relevant medical history, physical exam results and lab test results including blood lipid (i.e. triglyceride, total cholesterol, ldl-c, hdl-c) and glucose(hba1c if available).approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. fifty centres from different regions of china will participate in this study.

Eligibility criteria:
inclusion criteria: 1. male or female with age ≥ 18 years 2. post ischemic stroke patients within 6-12 months from attack 3. written informed consent is provided to participant in the study exclusion criteria: 1. significant medical or psychological condition that make patients can not finish the questionnaire independently or with the aids of his/her legal representatives 2. the patient is or will be in another clinical study 3. previous enrolment in the present study
the analgesic efficacy of δ9-thc (namisol®) in patients with persistent postsurgical abdominal pain

Conditions: Postsurgical Pain; Abdominal Pain; Chronic Pain

Summary: persistent postsurgical abdominal pain (ppap) is a very difficult to treat pain. this pain can persist for months or even years and significantly diminishes quality of life. the exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. the promising analgesic effects of δ9-thc in previous research, plus the improved bioavailability of namisol® in comparison with previous δ9-thc substances form the basis of the present research proposal. the current study aims to investigate the analgesic efficacy of namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * pain should have developed after a surgical procedure * pain duration exceeding 3 months, and average nrs≥3 * stable doses intake of analgesics for the past 2 months * the patient has been informed about the study, understood the information and signed the informed consent form exclusion criteria: * diagnosed irritated bowel syndrome (ibs) or chronic pancreatitis * patient took cannabinoids on a regular basis for at least one year * patient does not feel a pinprick test in the lower extremities * patient has a body mass index (bmi) above 36,0 kg/m2 * patient suffers from serious painful conditions other than chronic pancreatitis * patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient * patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient * patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons * patient demonstrates clinical relevant deviations in the electrocardiogram (ecg) * patient has an actual moderate to severe renal impairment * patient has an actual moderate to severe hepatic impairment * patient has a presence or history of major psychiatric illness * patient has experienced an epileptic seizure in the past * patient demonstrates clinically significant laboratory abnormalities * patient demonstrates a positive urine drug screen for thc, cocaine, mdma, and amphetamines * patient demonstrates a positive test result on hepatitis b surface antigen, hepatitis c antibody or hiv antibody test * patient has a history of sensitivity / idiosyncrasy to thc * patient has a known or suspected lactose intolerance * female patient is pregnant or breastfeeding * patient intends to conceive a child during the course of the study * patient participates in another investigational drug study * patient has a clinical significant exacerbation in illness * patient is unwilling or unable to comply with the lifestyle guidelines

Keywords: postsurgical pain abdominal pain visceral pain chronic pain
a clinical study to evaluate the efficacy and satisfaction of the skinceuticals skin care product (ce) for skin repair post fraxel laser treatment

Conditions: Photo-damaging

Summary: a prospective, single-center, single-blind, randomized split-face, controlled trial will be conducted. the goal of this clinical trial is to evaluate the efficacy and satisfaction of the skinceuticals skin care product (ce) for skin repair following fraxel laser treatment and explore the medical value of fraxel laser therapy combined with skinceuticals skin care product


Eligibility criteria:
inclusion criteria: 1. chinese subjects aged 18-65 years (inclusive); 2. subjects with fitzpatrick skin type ii-iv; 3. subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment; 4. subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures; 5. subjects understand the nature of the study and sign the informed consent form (icf). exclusion criteria: 1. subjects with photosensitive skin or photosensitization-related diseases; 2. subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives); 3. subjects with hypertrophic scar or scar constitution; 4. subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes; 5. subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment; 6. subjects with a history of sun exposure within 2 weeks prior to enrollment; 7. subjects who are known to be contraindicated to fraxel laser therapy or ce (or allergic to other skin care components); 8. subjects with known infection and inflammation in the intended treatment site; 9. female subjects who are pregnant, lactating or plan to become pregnant; 10. subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment; 11. subjects who are participating in other drug or medical device clinical trials; 12. other subjects who are not suitable for this study as assessed by the investigator
new tumor models in three dimensions and in a human skin environment for personalized melanoma therapy

Conditions: Melanoma (Skin)

Summary: the choice of treatment of patients with metastatic melanoma depends on the status of b-raf of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-pd1) is proposed in the first line; when b-raf is mutated, treatment with targeted therapies is retained: b-raf and mek inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib). patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. there are currently no predictive biomarkers of patients' response to targeted therapy molecules. the in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. the cutaneous metastases are chosen in the model because of easy access to collect tumor tissue. the most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.


Eligibility criteria:
inclusion criteria: * major patients, * patients with melanoma (stage iv) with cutaneous metastases, * seronegative hiv, hbv, hcv, htlv1. exclusion criteria: * absence of cutaneous metastasis or in transit * hiv or hbv or hcv or htlv1 seropositivity * patient minor, patient under guardianship or curatorship