Kornimate/medical-research-clean huggingface dataset:
cbt-i for cannabis use

Conditions: Marijuana Abuse; Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to investigate the efficacy of a group-based behavioral sleep intervention, and the incremental benefit provided by an adjunct sleep mobile app, on cannabis and sleep outcomes among cannabis dependent veterans.

the prevalence of cannabis use disorder (cud) has been steadily increasing within the veteran health administration (vha), along with the related significant physical, cognitive, and psychological sequelae. even in patients with a strong motivation to quit and the presence of empirically-supported interventions, veterans who receive treatment for cud have high rates of lapse (63% by 6-months post-treatment) and relapse (71% within 6-months post-treatment). thus, identifying strategies to improve response to cud treatment is in the interest of all vha stakeholders. disturbed sleep is common among individuals with cud and has been shown to result in increased rates of lapse/relapse to cannabis. providing a behavioral sleep intervention within the context of cud treatment, and prior to a cessation attempt, has the potential to improve these cessation outcomes. cognitive behavioral therapy for insomnia (cbt-i) is a well-established first-line treatment for insomnia. while cbt-i is being disseminated throughout vha, it is rarely received by veterans with substance use disorders (suds) and, among those that do receive it, it is almost always delivered following a cessation attempt. while cbt-i has been shown to be an effective treatment for improving sleep among individuals with insomnia and co-occurring conditions, including suds, there has yet to be an investigation of the impact of providing cbt-i prior to cud treatment with the goal of improving cessation outcomes. in addition, the development of an adjunct behavioral intervention delivered via mobile app technology within va holds great promise to bolster outcomes. the current study seeks to fill this gap by conducting a randomized prospective study designed to evaluate the efficacy of cbt-i, as well as the incremental benefit of including an adjunct sleep mobile app (cbt-i-ma), on both cannabis and sleep outcomes among veterans with cud.

Eligibility criteria:
inclusion criteria: to be included in the current study individuals must * be a veteran 18 years or older * meet diagnostic and statistical manual of mental disorders-5 diagnostic criteria for cannabis use disorder; * meet diagnostic and statistical manual of mental disorders diagnostic criteria for insomnia; exclusion criteria: individuals will be excluded based on evidence of the following: * inability to provide fully-informed written consent to participate; * history of, or current, psychotic symptoms; * current pregnancy; * sleep apnea (\>5 on the stop-bang assessment); * active suicidal/homicidal intent.

Keywords: sleep initiation and maintenance disorders marijuana abuse veterans
efficacy and safety of pasireotide long acting release vs. octreotide long acting release in patients with metastatic carcinoid disease

Conditions: Symptomatic Refractory Resistant Carcinoid Disease

Summary: the purpose of this randomized, multicenter, phase iii study was to compare the efficacy of paseriotide lar and octreotide lar in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.


Eligibility criteria:
inclusion criteria: * male or female patients aged 18 or greater * patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues. * female patients of child bearing potential must have a negative pregnancy test at baseline. * patients for whom written informed consent to participate in the study has been obtained. exclusion criteria: * patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization * diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by hba1c \> 8% * patients with symptomatic cholelithiasis * patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means. other protocol-defined inclusion/exclusion criteria may apply

Keywords: carcinoid neuroendocrine gastroenteropancreatic somatostatin analogue symptomatic refractory resistant carcinoid disease
effects of low-frequency electrical stimulation in patients with advanced hf

Conditions: Heart Failure

Summary: the purpose of this study is to verify the effects of low frequency functional electrical stimulation in heart failure patients hospitalized for treatment of the syndrome.

the aim of this study is to assess the effects of low frequency functional electrical stimulation on control autonomic and peripheral function in heart failure patients hospitalized for treatment of the syndrome. a randomized clinical trial with 30 advanced heart failure patients will be randomly assigned to functional electrical stimulation (functional ee, n= 15) e 2) sensory electrical stimulation (sensory ee, n=15). the functional electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with frequency of 10 hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds, resting time (time off) of 20 seconds and intensity according to the discomfort threshold of the patient , checked every day until achieve a maximum of 70ma. the session will last 60 minuts. it will be held every weekday for a period of 10 days. the effects of interventions on functional capacity, autonomic control, peripheral function, peripheral muscle strength and quality of life will be analyzed at baseline and at the end of the protocol.

Eligibility criteria:
inclusion criteria: * patients with advanced heart failure, * class functional iv, according to the criteria of new york heart association (nyha), * aged over 18 years, * etiology hypertensive, ischemic, idiopathic or chagas disease, * left ventricular ejection fraction ≤ 30%. exclusion criteria: * patients with hypertension lung disease and oxygen-dependent, * neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs, * insulin-dependent diabetes mellitus (type i), * peripheral arterial occlusive disease, * peripheral neuropathy, * use of pacemaker or implantable cardiodefibrillator.
intervention to reduce injection drug use

Conditions: Substance Abuse

Summary: this is a five-year prospective randomized trial comparing two intervention conditions designed to facilitate substance abuse treatment entry and enhance retention in order to reduce the behaviors associated with hiv and hcv risk among injection drug users (idus) and to improve client overall functioning. the overall goal of this project is to compare strengths-based case-management (cm) to an enhanced version of cm that uses case managers to facilitate a therapeutic alliance (cm/fta) among out-of-treatment idus in denver.


Eligibility criteria:
inclusion criteria: * opiate injection at least 3 times a week during the last 6-months * 18 years of age or older * no drug abuse treatment in the 30-days prior to the interview * not transient * no known reason (e.g. pending jail time) why they will not be available for follow-up interviews * not involved in project safe research activities in the previous 12 months * willing to meet with an addiction research and treatment services (methadone clinic) counselor * eligible to be treated at arts exclusion criteria: * too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview

Keywords: drug treatment entry and retention drug injection frequency hiv risk behaviors hepatitis c risk behaviors
injection of autologous adipose tissue for treatment of osteoarthritis in the knee

Conditions: Osteo Arthritis Knee

Summary: evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.

this clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint oa. the hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of oa of the knee joint with autologous adipose tissue will be superior to a placebo control treatment.

Eligibility criteria:
inclusion criteria: 1. bilateral k-l grade ii through grade iv osteoarthritis as diagnosed by physician review of weight bearing x-ray or mri excluding subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans. 2. study participants must be willing to voluntarily give written informed consent to participate in the study and sign the health insurance portability and accountability act (hipaa) authorization before any study procedures are performed. 3. males and females 40-75 years old. 4. participants will be in good health (asa class i-ii) with a bmi \< 35. 5. continued pain in the knee despite conservative therapies for at least 6 months. 6. participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form womac pain (a1 subscale, 20 total points). 7. must speak, read and understand english. 8. subjects must be reasonably able to return for multiple follow-up visits. exclusion criteria: 1. participants who have had surgery of either knee within 6 months prior to the screening visit. 2. participants who have had a major injury to either knee within 12 months prior to enrolling in the study. 3. participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (prp). 4. participants who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication. 5. participants who have symptomatic oa of the hips, spine, or ankle that would interfere with the evaluation of the treated knee. 6. participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit. 7. participants that are allergic to lidocaine, epinephrine or valium 8. history of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection 9. subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months

Keywords: osteo arthritis knee autologous adipose tissue
stepped care for depression and musculoskeletal pain

Conditions: Pain; Depression

Summary: this study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.

in the united states, pain accounts for nearly 20% of all primary health care visits. in the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. studies have shown that at least one-third of patients with pain also suffer from depression. it has not been determined whether treatments for depression are effective in patients with comorbid pain and depression. the "stepped care for affective disorders and musculoskeletal pain" (scamp) study will determine the most effective treatment for patients with pain and depression. this study will last 12 months and will comprise depressed and nondepressed participants. nondepressed participants will receive no treatment. depressed patients will be randomly assigned to receive standard of care or stepped care for 12 weeks. standard of care may include cognitive therapy, antidepressant treatment, or other treatments. the stepped care group will receive 12 weeks of antidepressant treatment. participants who respond to antidepressant treatment will continue their treatment for the duration of the study. participants who do not respond to the treatment after 12 weeks will receive 6 weekly pain self-management sessions. during these sessions, an educator will teach participants how to manage their pain through exercise and relaxation techniques. self-report scales and questionnaires will be used to assess participants' pain, depressive symptoms, health care usage and costs, and quality of life. depressed participants will undergo assessments at study start and at months 1, 3, 6, and 12. nondepressed participants will undergo assessments at study start and at months 3 and 12. study hypotheses: 1) stepped care is more effective than usual care in improving depression and pain. 2) stepped care is more effective than usual care in improving health-related quality of life, negative pain beliefs and behaviors, reduced opiate use, and health care costs. 3) patients with musculoskeletal pain who are not depressed at baseline will have an incidence of depression less than 20% over 12 months of follow-up, characteristics that can be identified as risk factors for incident depression, baseline characteristics distinguishing them from depressed patients, and better pain and health status outcomes, compared to depressed patients.

Eligibility criteria:
inclusion criteria: * moderate or severe pain in the back, hips, or knees for at least 3 months prior to study entry * history of or current use of at least one medication for pain * english-speaking exclusion criteria: * moderate to severe cognitive impairment * schizophrenia or other psychotic disorders * receiving disability benefits for pain * anticipated life expectancy less than 12 months * pregnancy

Keywords: back pain knee pain hip pain stepped care antidepressant relaxation techniques exercise
humanistic care in patients with coronavirus disease 2019

Conditions: Coronavirus Disease 2019

Summary: as of february 17th, 2020, china has 76396 confirmed cases of coronavirus disease 2019 (covid-19), including 2348 deaths. although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown the potency in the treatment of severe cases. investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of covid-2019.

as of february 17th, 2020, china has 76396 confirmed cases of coronavirus disease 2019 (covid-19), including 2348 deaths. although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown their potency in the treatment of severe cases. investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of covid-2019. as the national medical team sent to wuhan, investigators proposed a psychological and physical rehabilitation based humanistic care regimen generated from our experience in treating patients with covid-2019. in addition to routine therapy, investigators will apply this comprehensive humanistic care regimen to the patients according to their condition to see the efficacy to this regimen.

Eligibility criteria:
inclusion criteria: * inpatients with 2019 novel coronavirus infection exclusion criteria: * patients can not follow-up; * investigator considering inappropriate.

Keywords: coronavirus disease 2019 physical rehabilitation psychological rehabilitation
cytotoxicity of yellow fever specific cd8 t cells following yf-17d vaccination

Conditions: Healthy; Cytotoxicity; Yellow Fever Vaccination Reaction

Summary: investigating cytotoxicity of yellow fever specific cd8 t cells following yf-17d vaccination and the following licensing of these epitope-specific cd8 t cells

cd: cluster of differentiation yf: yellow fever

Eligibility criteria:
inclusion criteria: * age between 18 to 60 years * informed consent given exclusion criteria: * fever (orally \>37,5 c) on day of vaccination * immunosuppressants * pregnant or breast feeding * severe immunodeficiency * known thymus dysfunction * allergy against egg * known haemophilia * previous severe reaction to vaccine * not willing to use anticonceptives 4 weeks after vaccination
postural management for hip luxation in quadriplegic cerebral palsy

Conditions: Quadriplegic Cerebral Palsy

Summary: cerebral palsy (cp) is the most common motor disability in childhood. among these, hip luxation represents the most frequent and clinically relevant one, affecting 72% of non-ambulatory cp children. reconstructive surgical treatment is debated in severe cp children, for whom it is crucial to identify an effective preventive approach. the aim of our study is to verify if keeping a sitting position centering femoral heads is more effective than usual postural management (sitting with the trunk aligned and hips abducted), in preventing hip luxation in quadriplegic cp children. it's a multicenter randomized controlled study (13 sites involved). a total of 102 quadriplegic cp children, aged 1-6 years-old, classified as gross motor function measure system 4 or 5, will be recruited and randomized to usual or experimental sitting, at least 5 hours a day, for 2 years. the primary outcome will be the degree of luxation, measured by means of the migration percentage (mp), on pelvic radiography, at 12 and 24 months. secondary outcomes will include compliance and health related-quality of life, using validated tools, hip pain, device cost, mri lesions, concurrent direct neuromotor treatment, use of standing devices and spasticity treatments (botulinum toxin, per os or intrathecal baclofen, selective dorsal rhizotomy). experimental sitting is expected to reduce the mp change compared to usual care. it will be of interest to compare compliance, qol and costs in either groups: aspects affecting the effectiveness. furthermore to evaluate correlations between mp and spasticity treatments, mri lesion type, and other clinical features.


Eligibility criteria:
inclusion criteria: * cerebral palsy spastic or dyskinetic * gmfcs 4 or 5 * mp\<41% * informed consent acquired exclusion criteria: * muscle contracture overcoming defined passive range of motion (rom)limits * anterior hip luxation * previous reconstructive hip surgery * preventive surgery in previous 12 months * lumbar scoliosis \>20° cobb

Keywords: hip luxation
comparison of liraglutide injected at three different injection sites in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to compare the pharmacokinetic profile of liraglutide between administrations in the thigh versus the abdomen and between administrations in the upper arm versus the abdomen.


Eligibility criteria:
inclusion criteria: * healthy * good general health as judged by the investigator based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs and blood and urinary laboratory assessments * bmi (body mass index): 18.5-27.5 kg/m\^2, both inclusive exclusion criteria: * known or suspected allergy to trial product(s) or related products * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods as required by local law or practice * the receipt of any investigational drug within 3 months prior to this trial * history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator * impaired renal function * active hepatitis b and/or active hepatitis c * positive human immunodeficiency virus (hiv) antibodies * use of any prescription or non-prescription medication, except for paracetamol and vitamins * history of alcoholism or drug abuse during the last 12 months. * smoking * habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator * excessive consumption of a diet deviating from a normal diet as judged by the investigator * blood donation within the last 3 months * plasma donation within the last month
effect of perilla extract on improvement on gastrointestinal discomfort

Conditions: Abdominal Pain/ Discomfort; Slightly Constipation

Summary: in the current study the effects of proprietary perilla frutescens leaf extract in comparison to maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal discomfort and bowel function were investigated. the study was performed double-blind and placebo-controlled with a 4 week intervention period. study products were taken two times daily (each one capsule before breakfast and dinner).


Eligibility criteria:
inclusion criteria: * healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility. * bmi: 19-30 kg/m2 * reduced bowel movements defined as an average of \>1 and ≤ 3.5 stools per week for at least the previous 6 months * gastrointestinal symptoms of at least 5 points * male or female * age ≥ 30 and ≤ 70 years * nonsmoker * written consent to participate in the study * able and willing to follow the study protocol procedures exclusion criteria: * subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries * relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening * subjects with stool frequency of ≤ 1 stool every 7 days or \> 3,5 stools per week * subjects not willing to avoid pre- and probiotics for the duration of the study * intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks * change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers) * pregnant subject or subject planning to become pregnant during the study; breast-feeding subject. * subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study. * participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results. * known food intolerance or allergy. * subject involved in any clinical or food study within the preceding month

Keywords: gastrointestinal discomfort perilla frutescens bloating abdominal discomfort human study healthy subjects