Kornimate/medical-research-clean huggingface dataset:
mind-body skills groups for the treatment of war zone stress in military and veteran populations

Conditions: Stress Disorders, Post Traumatic; Brain Injuries; Depressive Disorder; Anxiety Disorders; Anger

Summary: the purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (ptsd), will improve symptoms of ptsd, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).

the study will be a randomized controlled study where participants will be randomly selected to either participate in the mind-body skills program and to answer questionnaires before and after the program and again 6 months later or, if they are not randomized to the mind-body skills group program, they will answer the questionnaires during the same time periods without participating in the program. both groups will also continue their medical treatment as usual. the mind-body skills group intervention consists of groups of 8-10 participants. two formats will be offered. (1) a 2 hour group session once a week for 10 weeks or (2) weekend groups which will be run on alternating saturdays, with a 2 hour session in the morning and another 2 hour session in the afternoon. the groups will be run for a total of 5 saturday sessions. additional "reunion" groups will be held at 1 month, 3 months, and 6 months in order to reinforce skills and to provide continuing social support.

Eligibility criteria:
inclusion criteria: * having experienced a deployment-related criterion a stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (ptsd), or subthreshold ptsd symptoms * comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety. exclusion criteria: * current uncontrolled psychotic or bipolar disorder * significant cognitive impairment * moderate or severe tbi * substance dependence * suicidal or homicidal ideation

Keywords: mind-body therapies
effectiveness of multicomponent lipid emulsion in preterm infants requiring parenteral nutrition

Conditions: Cholestasis

Summary: the purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.

intravenous lipid emulsions are the major sources of non-protein energy and provision of required essential fatty acids. the reference lipid emulsion, widely used for many years, is prepared from soybean oil, which is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production. existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress on parenteral nutrition associated liver disease. subsequent development of lipid emulsions has focused on reducing the amount of soybean oil and replacing it with other oils.moreover the omega 3 fatty acids from fish oil are metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses. a novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease morbidity in preterm infants.

Eligibility criteria:
inclusion criteria: * inborn infants with a gestational age of less than 30 weeks * who required parenteral nutrition for at least 7 days exclusion criteria: * evidence of congenital infection * perinatal asphyxia * congenital anomalies * severe ivh * thrombocytopenia * shock or circulation failure * renal or hepatic disorders.

Keywords: preterm parenteral nutrition cholestasis fish oil
a randomised clinical trial in a population of health care workers with hand eczema

Conditions: Eczema; Dermatitis; Skin Disease

Summary: objectives and perspective: 1. to estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . to investigate the knowledge of skin protection among health care workers. 2. to classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema 3. to evaluate the effect of a combination of classification of hand eczema and individual work-related counseling in skin protective behavior. the overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers. hypotheses: * irritant contact dermatitis is more common than allergic contact dermatitis. * the combination of precise classification (subtyping of he) and individual counseling will have a positive impact on the prognosis of hand eczema. * the positive impact on the prognosis of hand eczema will have a positive impact on quality of life (qol). * the knowledge of protective behavior will increase. * education in a skin care program will have a positive impact on skin protective behavior.


Eligibility criteria:
inclusion criteria: * participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 hcw in three danish hospitals in the same region. participants who have answered "yes" to the validated question "have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial. * informed written consent must be present in order to participate. exclusion criteria: * pregnancy * systemic use of immunosuppressive drugs * systemic use of retinoids * active psoriatic lesions on the hands * any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results * lack of informed written consent

Keywords: hand eczema hand dermatitis occupational skin disease skindisease in health care workers occupational hand dermatitis occupational hand eczema
study to collect sera for immunogenicity testing in children vaccinated with fluzone®

Conditions: Influenza

Summary: to describe the safety findings from days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine fluzone®, given in the two-dose schedule in accordance with the package insert, in children aged ≥ 6 months to \< 36 months. to describe the immunogenicity findings from days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine fluzone®, given in the two-dose schedule in accordance with the package insert, in children aged ≥ 6 months to \< 36 months

the study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine fluzone®.

Eligibility criteria:
inclusion criteria : * aged ≥ 6 months to \< 36 months. * considered to be in good health on the basis of reported medical history and limited physical examination. * available for the duration of the study (44 days +4 days). * parent/guardian is willing and able to provide informed consent. * parent/guardian is willing and able to meet protocol requirements. exclusion criteria : * reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. * previous history of influenza vaccination or documented history of influenza infection. * an acute illness with or without fever (temperature \> 100.4 °f rectal) in the 72 hours preceding enrollment in the trial (defer enrollment). * clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). * participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study. * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth. * personal or immediate family history of congenital immune deficiency. * developmental delay, neurologic disorder, or seizure disorder. * chronic medical, congenital, or developmental disorder. * known human immunodeficiency virus (hiv)-positive mother. * prior history of guillain-barré syndrome. * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Keywords: influenza fluzone® children
internet-delivered cbt for adolescents with gad

Conditions: Generalized Anxiety Disorder

Summary: this multiple baseline evaluation aims to test the feasibility and preliminary effectiveness of internet-delivered cognitive behavioral therapy (icbt) for adolescents with generalized anxiety disorder (gad).

this pilot study aims to test internet-delivered cognitive behavioral therapy (icbt) for adolescents with generalized anxiety disorder (gad) the study has a single case research design (multiple baseline) and will include 12 participants with gad according to a semi structured diagnostic interview. participants will be randomized to either two, six or ten weeks baseline measurements prior to starting treatment, and will thus work as their own controls. primary outcome measures will be collected at 10 weeks after treatment start. follow-up assessments will be made three month after treatment.

Eligibility criteria:
inclusion criteria: * a score on the penn state worry questionnaire for children (pswq-c) of \> 30 * fulfilling dsm-5 criteria for generalized anxiety disorder * no other disorder or symptoms present in need of more urgent treatment * aged between 13 and 17 years * ability to read and write in swedish * a parent or caregiver that is able to participate in the treatment * participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment * no other ongoing psychological treatment for any disorder exclusion criteria: * the presence of symptoms suggestive of a current diagnosis of autistic spectrum disorder, schizophrenia, bipolar disorder, anorexia nervosa, bulimia, or substance use disorder * present risk of suicide * present occurrence of domestic violence * completed cbt for any anxiety disorder within the last 6 months (defined as at least 5 sessions of cbt including in vivo exposure sessions)

Keywords: gad adolescents internet-delivered cognitive behavioral therapy icbt cbt
impact of bright light therapy on prader-willi syndrome

Conditions: Prader-Willi Syndrome; Excessive Daytime Sleepiness; Hyperphagia; Body Weight; Mood; Behavior

Summary: this is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with prader-willi syndrome

this is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with prader-willi syndrome. subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. all visits are conducted remotely. there are a total of 8 visits occurring over the course of 8 weeks. after the first visit, all study visits occur on a weekly basis. individuals between the ages of 6-18 years old with diagnosis of pws confirmed by genetic testing will be screened for enrolment by the study team.

Eligibility criteria:
inclusion criteria: * diagnosis of pws confirmed by genetic testing * score of 12 or above on the epworth sleepiness scale (ess). exclusion criteria: * subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications * a history of previous treatment with lt * patients presenting with active psychosis or mania

Keywords: light therapy aberrant behavior checklist clinical global impression- improvement fitbit actigraphy reports epworth sleepiness scale hyperphagia questionnaire (hqct) modified overt aggression scale (moas)
communicating smoking risks through graphic warning labels

Conditions: Lung Cancer; Heart Disease

Summary: smoking is the largest preventable health risk in the u.s. the family smoking prevention and tobacco control act of 2010 mandated the placement of larger pictorial warnings on cigarette packs as well as nine new statements of smoking risks. this trial tests the effectiveness of the warnings proposed by the food and drug administration by providing cigarettes with the proposed labels to 320 smokers across two sites (philadelphia, pa and columbus, oh). in addition, the trial tests the effects of different warning label components.


Eligibility criteria:
inclusion criteria: * smoke between 5 and 40 cigarettes per day and 100 in lifetime * not currently trying to quit * between 18 and 65 years of age exclusion criteria: * smokes 120's or roll-your own or noncommercial cigarettes * pregnant or breastfeeding * history of substance abuse past 5 years * more than 25 standard alcohol drinks per week * use of other nicotine products, such as cigars, nicotine gum * current treatment for copd, cancer, pulmonary disease, alcohol/drug dependence * current treatment for a psychiatric condition * physical/visual/mental impairment that prevents reading from a computer screen * not us resident * unable to read english * english not main language * other member of household in study * friend who smokes in study * unable to attend weekly appointments between 9 am and 6 pm monday-friday * unable to use hand-held computer to enter daily mood ratings
immediate effects of posterior mobilization versus caudal mobilization in patients with temporomandibular disorders

Conditions: Temporomandibular Disorders

Summary: the temporomandibular joint (tmj) is one of the most complex joints in the individual. it is composed of the mandibular condyle is positioned within the glenoid fossa of the temporal bone, and the articular disk that separates these two bones. the normal biomechanics of the tmj is the concave / convex relationship between the condyles and the articular disc. the movements of the tmj joint are: mandibular depression and elevation (opening and closing of the mouth), mandibular protrusion and retraction, and lateral deviations. the dtm is a musculoskeletal disorder of the masticatory system that affects over 25% of the population. physical therapy can be adopted this treatment in order to relieve musculoskeletal pain, reduce inflammation and restore normal motor functions. the physical therapy interventions taken include electrotherapy, exercise therapy, acupuncture and manual therapy. overall objective is to assess the immediate effects of previous mobilization versus flow amplitude of mandibular depression in patients with temporomandibular dysfunction. the type of study will be a randomized study of two parallel groups balanced distribution (1: 1) and double-blind. the research will be conducted in the laboratory of human movement analysis of physiotherapy, faculty of medicine, federal university of ceará. the study population will consist of residents in the city of fortaleza-ce individuals who voluntarily seek to participate in the study due to symptoms of tmd. data, anthropometry, application of research diagnostic criteria for temporomandibular disorders will be collected. the physiotherapist responsible for the assessment before and after the interventions will be blind with respect to the distribution of the treatment groups. the patient will also be blind, because you will not know whether or caudal anterior mobilization was performed. randomization codes are generated by computer using random allocation software (version 1.0.0) at a ratio of 1: 1 by a researcher not involved in the data collection. these codes will be placed in sealed, opaque envelopes being numbered consecutively, which will ensure the covert allocation of study participants. our data are considered confidential as joint property of the parties involved.


Eligibility criteria:
inclusion criteria: * individuals have not received the last 3 months treatment for tmd, who are not taking anti-inflammatory and / or analgesic for at least two weeks, you are not in the period of postoperative head and / or neck and to accept the participation in the study and signed the instrument of consent exclusion criteria: * subjects with no teeth, history of metabolic diseases (such as hyper / hypothyroidism), neurological disorders, history of cancer in the last five years, active inflammatory arthritis, fractures, dislocations of the jaw or neck.
personalized therapy of molecular tumor board participation with the guidance of next generation sequencing

Conditions: Solid Tumor, Adult

Summary: this study seeks to evaluate the clinical value of the personalized therapy model with the guidance of molecular tumor board (mtb) after next generation sequencing(ngs), and to track patient outcomes.

this is a study from the real world. advanced refractory solid tumors patients with no standard treatment options have a very poor prognosis. in recent years, the application of s next generation sequencing (ngs) has rapidly expanded the breadth and depth of understanding of the molecular mechanism of tumors, laying a foundation for the development of precision medicine for tumors. researchers can build a molecular phenotype of advanced refractory solid tumors by ngs. some retrospective study shows that molecular tumor board (mtb) therapy model brings therapeutic hope. so, investigators hope that this therapy model combined with ngs may provide treatment recommendations for advanced refractory solid tumors patients. those recommendations may include some off-label targeted therapies. this study seeks to evaluate the clinical value of the personalized therapy model with the guidance of mtb after ngs, and to track patient outcomes, including orr (objective response rate), pfs (progression free survival), os (overall survival) and adr (adverse drug reaction).

Eligibility criteria:
inclusion criteria: 1. is equal to or greater than 18 years of age. 2. histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (eastern cooperative oncology group (ecog) 3 and 4). 3. patients with measurable or evaluable disease per response evaluation criteria in solid tumors (recist) version 1.1. 4. patients must be able to provide blood samples or tissue samples for ngs (next generation sequencing) testing. the amount of blood and tissue samples should be able to meet the requirements of dna extraction and quality control. 5. adequate baseline organ system function. 6. patients could receive treatment program from mtb (molecular tumor board). 7. ability to understand and the willingness to provide a written informed consent document. exclusion criteria: 1.according to the investigator' judgment, there are serious, uncontrollable risks to patients' safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.

Keywords: next generation sequencing personalized therapy molecular tumor board
a study to evaluate the safety and efficacy of vgb-r04 in adult hemophilia b patients

Conditions: Hemophilia B

Summary: a multicenter, open, non-randomized, phase i/ii, two-phase clinical study. the dose exploration phase was phase i, and the dose extension phase was phase ii.

hemophilia b is a genetic bleeding disorder caused by pathogenic variants (eg, mutations, deletion) in the fix gene. hb patients have frequent and potentially life-threatening bleeding and often develop progressive physical disability and pain from chronic haemarthropathy. current replacement therapy needs regular treatment in the life-long time, bringing heavy economic and social burdens. vgb-r04 is a novel aav vector carrying a high specific activity factor ix variant. this study is intended to evaluate the safety, tolerability and efficacy of a single iv infusion of vgb-r04. all subjects in this study will provide informed consent and then undergo screening assessments up to 6 weeks before administration of vgb-r04. all subjects will undergo 52 weeks of safety observation and will be encouraged to enroll in an long-term follow-up study to evaluate the long-term safety of vgb-r04 for a total of five years.

Eligibility criteria:
inclusion criteria: 1. male ≥18 years and ≤65years of age; 2. confirmed diagnosis of hemophilia b (baseline fix activity ≤ 2% of normal); 3. at least 100 days exposure history to fix; 4. currently receiving fix prophylaxis therapy or on-demand treatment to prevent bleeding; 5. have acceptable laboratory values: 1. hemoglobin ≥110 g/l; 2. platelets ≥100×109 /l; 3. ast, alt, alkaline phosphatase ≤2×upper limit of normal (uln) at the testing laboratory; 4. bilirubin ≤3× uln ; 5. creatinine ≤1.5× uln. 6. no measurable factor ix inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor ix protein; 7. agree to use reliable contraception until 2 consecutive samples are negative for vector sequences; exclusion criteria: 1. have significant underlying liver disease within the past 6 months prior to or at screening, including but not limited to: 1. preexisting diagnosis of portal hypertension; 2. splenomegaly; 3. encephalopathy; 4. reduction of serum albumin; 5. evidence of significant liver fibrosis; 2. have anti-vgb-r04 neutralizing antibody titers ≥1:5; 3. evidence of severe infection disease, i.e., human immunodeficiency virus (hiv) infection, syphilis, tuberculosis, etc.; 4. novel coronavirus infection occurred in the 6 weeks prior to entry into the group 5. evidence of active hepatitis b virus infection (hbsag positive) or hepatitis c virus infection (hcv-rna positive); 6. evidence of malignant tumours or those with a previous history of malignant tumours; 7. have a history of chronic infection or other chronic diseases that the investigator considers to constitute an unacceptable risk; 8. any immunodeficiency; 9. planned surgery may be required within one year; 10. past thromboembolic events (arterial or venous thromboembolic events); 11. hypertensive patients with poor blood pressure control (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥90mmhg after antihypertensive drug treatment);