Kornimate/medical-research-clean huggingface dataset:
acceptability study of nutritional supplements in hospitalized elderly patients

Conditions: Malnutrition

Summary: malnutrition is a major health problem with serious consequences for the quality of life of elderly people: it increases the number of hospitalizations and lengths of stay, worsens functional dependency and increases morbidity and mortality rates there are numerous recommendations and tools to detect or to manage malnutrition and the prescription of oral nutritional supplements (ons) can be a solution. as the elderly suffer from food monotony, as well as age-related changes, which may or may not be associated with the presence of disease, it is necessary to ensure full ingestion of the prescribed supplements to optimize the benefits provided by these products. to achieve this it is necessary to know the chemosensory characteristics of foods enjoyed by hospitalized elderly people who are malnourished or at risk of malnutrition. the investigators make the hypothesis that by further optimizing taste and energy content of foods, consumption by the elderly and the health benefits would be improved.


Eligibility criteria:
inclusion criteria: * person who have given their written informed consent * person aged more than 65 years * person cognitively able to participate in tests and to answer questionnaires (mini mental statement estimation score (mmse) equal to or greater than 21) * person with an mini nutritional status score (mna) lower than 23.5/30 for risk of malnutrition or malnourished * person without known unstable cardiac disease * person without high blood pressure exclusion criteria: * person who are not covered by national health insurance * person suffering from severe illness during the test * person with a life expectancy lower than 6 months or with a cancer * every person with proven anosmia (total loss of olfaction) from birth or due to physical trauma (head trauma) or disease (acute rhinitis) * person with allergy (soya milk) or severe aversion to one of the foods that will be used during the study * person with swallowing disorders * person with a prescribed strict food diet * person with an instable diabetes
efficacy and safety of lu aa34893 in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of lu aa34893 compared to placebo in the treatment of patients with major depressive disorder.

major depressive disorder (mdd) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. mdd is characterised by the presence of one or more major depressive episodes (mdes) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. mdd is a disabling, severe illness that tends to be chronic, and repeated episodes are common. despite the availability of a range of effective treatments in mdd, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. lu aa34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in mdd.

Eligibility criteria:
in- and out-patients with moderate to severe major depressive disorder inclusion criteria: * major depressive episode (mde) as primary diagnosis according to dsm-iv (classification code 296.xx) * moderate to severe depression * current mde duration of at least 3 months exclusion criteria: * any current psychiatric disorder other than mdd as defined in the dsm-iv tr * any substance disorder within the previous 6 months * females of childbearing potential and not using adequate contraception * use of any psychoactive medication within 2 weeks before randomisation and during the study

Keywords: efficacy safety depression interventional placebo short-term major depressive disorder major depressive episode
primary pain palliation in bone metastases treated with magnetic resonance-guided focused ultrasound

Conditions: Secondary Malignant Neoplasm of Bone

Summary: magnetic resonance guided focused ultrasound (mrgfus) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. there is also evidence that a high intensity focused ultrasound beam can penetrate through the cortical bone to the medullary space, producing thermal necrosis of cancer tissue. however, little is known about the potential effects of mrgfus as first line therapeutic modality for pain palliation in skeletal metastases. our hypothesis sought to assess the clinical performance of mrgfus primary treatment of painful bone metastases and determine the potential of this technique for local tumor control.

unlike previous studies, in which patients were enrolled for mrgfus treatment because of the failure of other therapies, our study will be conducted in patients not previously treated with ebrt to the targeted lesion. this is an important new feature, especially given the advantages of mrgfus, such as lack of ionizing radiation, the ability to conduct treatment on an outpatient basis and the possibility to repeat the treatment as necessary.

Eligibility criteria:
inclusion criteria: * the presence of a known primary cancer and bone metastases confirmed by two or more imaging modalities; * exhaustion or refusal of all other pain palliation methods including ebrt; * confirmation of mrgfus treatment feasibility at a preliminary mr planning examination (presence of an adequate acoustic window between the transducer, skin and target lesion and absence of bowel loops across the planned ultrasound path) exclusion criteria: * general contraindication to mr imaging (including pacemaker, ferromagnetic devices or implants) * general contraindication to gadolinium-based contrast agents (intolerance and/or clinically proven chronic renal failure) * general contraindication to general/epidural anesthesia or deep sedation

Keywords: bone metastasis pain palliation high intensity focused ultrasound
a long term safety and efficacy study of fabrazyme replacement therapy in japanese patients with fabry disease.

Conditions: Fabry Disease

Summary: the purpose of this survey is to identify any concerns regarding the following efficacy and safety-related issues in clinical practice with the new drugs "fabrazyme for intravenous infusion 5mg" and "fabrazyme for intravenous infusion 35mg" and to confirm the safety of these products in long-term use in the clinical setting. 1. new adverse drug reactions (adrs) that cannot be predicted from the precautions (in particular, clinically significant adrs) 2. the incidence of adrs under the actual conditions of use of the drug 3. causal factors that might potentially affect safety 4. efficacy evaluation in long-term use this survey will be conducted in accordance with the approval condition established for fabrazyme: "to conduct a special surveillance of efficacy and safety in long term treatment and pediatric with the drug."

medical institutions or physicians will be asked to periodically complete the survey forms for all patients registered. survey forms include baseline information available, and then data collected every 6 months, as available including: demographic information, concomitant medications/therapy, treatment record, ecg, echocardiogram, computed tomography scan / magnetic resonance imaging (ct/mri), fabry symptoms, labs, functional disorder, blood concentration of gl-3, and anti-agalsidase beta antibody test (ige testing) to survey whether the productions of antibodies to agalsidase beta is a causal factor of treatment-related reactions. the survey period shall be approximately 7 years from june 1, 2004 during which survey shall be undertaken as follows: * the observation period for each patient shall range from 1 to about 7 years after starting treatment * registration period: june 1, 2004 to march 31, 2010 * survey period: june 1, 2004 to march 31, 2011 in institutions for which retrospective surveys are feasible, the survey period will trace back to the date of approval (january 29, 2004), as far as possible.

Eligibility criteria:
inclusion criteria: * patients in japan with the indication of "fabry disease" and for whom the usual dosage and administration is 1mg of agalsidase beta (recombinant) per 1 kg body weight each time, administered by intravenous infusion every 2 weeks * because the efficacy evaluation of enzyme replacement therapy with fabrazyme \[agalsidase beta (recombinant form)\] will require the comparison of findings before and after the start of enzyme replacement therapy, the efficacy evaluation set will be defined as including patients using fabrazyme \[agalsidase beta (recombinant form)\] for the first time in the post-marketing setting and those for whom it is possible to obtain retrospective data for before the start of enzyme replacement therapy. exclusion criteria: * patients registered in the post-marketing trials during the post-marketing clinical trial period.
osteoarthritis in older adults: recovery of mobility and pain with a topical analgesic

Conditions: Knee Osteoarthritis

Summary: biofreeze® is a topical ointment that has menthol and alcamphor. its analgesic effect lies in the stimulation of a and c fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor trpm8 (transient receptor potential melastatin-8) the aim of this study is to investigate if biofreeze ® treatment (performance health inc., export, pa) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.


Eligibility criteria:
inclusion criteria: * moderate osteoarthritis of the knee * age 60 to 80 years * ambulatory exclusion criteria: * other conditions that affect mobility * severe chronic diseases such as cardiac or renal failure * cancer * presence of gout * cognitive impairment

Keywords: osteoarthritis pain quality of life
comparison open lichtenstein repair and totally extraperitoneal herniorrhaphy

Conditions: Inguinal Hernia

Summary: comparison of early and long term results of open lichtenstein repair and totally extraperitoneal herniorrhaphy for primary inguinal hernias.

early results such as postoperative pain, operation time and long term results such as chronic pain and recurrence will be compared.

Eligibility criteria:
inclusion criteria: * inguinal hernia exclusion criteria: * recurrent hernia
a study of the pharmacokinetics, pharmacodynamics, and safety of opicapone in subjects with parkinson's disease taking levodopa.

Conditions: Parkinson Disease

Summary: this is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with parkinson's disease.


Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of idiopathic parkinson's disease (pd) for at least 3 years with clear improvement with levodopa treatment 2. be at a stable dose of maintenance medication(s) for pd, including stable doses of cd/ld 3. subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study 4. have a body mass index (bmi) of 18 to 40 kg/m2 5. have a modified hoehn and yahr stage of ≤4 in the off state 6. be able to tolerate an overnight period of 12 hours without cd/ld 7. be in good general health and expected to complete the clinical study as designed exclusion criteria: 1. are currently pregnant or breastfeeding 2. more than 2 alcoholic beverages daily or more than 14 alcoholic beverages weekly within 7 days of day -1 or consume any alcohol within 48 hours of day -1. 3. have motor fluctuations during the day (ie, effect of levodopa "wearing off" or having unpredictable "off" periods), or severe or intolerable levodopa-induced dyskinesia 4. have had previous exposure to opicapone, or have an allergy, hypersensitivity, or intolerance to opicapone or other comt inhibitor. 5. have a history of a medical condition or surgical procedure that might interfere with absorption or metabolism. 6. have a known history of neuroleptic malignant syndrome 7. have an unstable medical condition or chronic disease 8. have taken certain prohibited medications within 28 days of day -1. 9. have a known or suspected diagnosis of aids, or have tested seropositive for hiv 10. have hepatitis a or b 11. have a significant risk of suicidal or violent behavior
ba duan jin for depression and anxiety

Conditions: Depression, Anxiety

Summary: in recent years, the number of people with symptoms of depression or anxiety are on the rise. the aims of the present study is to examine the effects of ba duan jin on reducing symptoms of depression or anxiety.

there is growing interest in mind-body therapy that could potentially improve patients' psychological health. ba duan jin, a traditional chinese health-preserving technique, combines techniques regulating body, breath and spirit. the effects of ba duan jin on patients with symptoms of depression and anxiety are yet to be further investigated. the present pilot clinical study aims to apply ba duan jin to patients with symptoms of depression and anxiety, and to evaluate the psychological effects. participants allocated to the health education group take part in the 16-week health education including work, rest, diet and other basic programs according to the different conditions of participants. participants allocated to the ba duan jin group take part in the 16-week ba duan jin plus health education program. the study plans to enroll 60 participants (30 for ba duan jin plus health education program, and 30 for health education program), expecting that ba duan jin has a better effect on improving psychological condition.

Eligibility criteria:
inclusion criteria: * subject with depression or anxiety symptom diagnosed by icd-10. * subject is male or female, age 18 to 75. * subject has a clear mind and the ability to read, to talk and to communicate. * subject agrees to participate in this study and sign to the informed consent exclusion criteria: * subject has severe somatic disease. * subject has history of organic mental disorder, epilepsy, schizophrenia. * subject takes any medication of food having effect on gut microbiota within 1 month of screening. * subject has history of alcohol abuse. * subject is pregnant, lactating or breast-feeding women.
study to evaluate the safety and efficacy of selgantolimod (slgn)-containing combination therapies for the treatment of chronic hepatitis b (chb)

Conditions: Chronic Hepatitis B

Summary: the primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis b surface antigen (hbsag) loss and hepatitis b virus (hbv)deoxyribonucleic acid (dna) \< lower limit of quantitation (lloq) at follow-up (fu) week 24 in participants with chronic hepatitis b (chb).


Eligibility criteria:
key inclusion criteria: * willing and able to provide informed consent * chronic hbv infection for at least 6 months * willing to follow protocol-specified contraception requirement key exclusion criteria: * have extensive fibrosis or cirrhosis in the liver * have or had liver cancer (hepatocellular carcinoma) * have an autoimmune disease * have chronic liver disease other than hbv * females who are breastfeeding, pregnant, or who wish to become pregnant during the study note: other protocol defined inclusion/exclusion criteria may apply.
interactive study to increase glaucoma adherence to treatment

Conditions: Glaucoma

Summary: study participants who receive the i-sight intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.

the intervention is telephone-based and individually-tailored to participants' compliance knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy; race and culture; and prescribed medication regimen. the intervention calls utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients. we evaluated the intervention in a randomized controlled trial with telephone interviews administered to all participants at baseline, 6, 9, and 12-months

Eligibility criteria:
inclusion criteria: * receive treatment at the atlanta va medical center or grady eye clinic for their eye condition * be between the ages of 18-80 * be caucasian or african american * possess a telephone (home telephone or cellular phone) * speak and understand english * be diagnosed with open angle glaucoma, be glaucoma suspect, or be ocular hypertensive for at least one year * be prescribed daily doses of topical treatments for at least one year * be able to read or have someone who can help the participant with reading written materials that we give to the participant exclusion criteria: * having eye surgery within 3 months of baseline interview and enrollment * being legally blind (20/200 or worse)

Keywords: treatment compliance
an investigation of the cervical region biomechanics in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Postural; Defect; Cervical Pain; Cough

Summary: the aim of this study is to investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with chronic obstructive pulmonary disease (copd) compared to healthy subjects.

the secondary purposes are to investigate the correlation between cervical region biomechanics and posture, functional exercise capacity, depression \&anxiety level,neck disability, cough severity. in accordance with this purposes, 17 patients with copd who have global initiative for chronic obstruction lung disease (gold) stage 1-2-3-4, being clinically stable for 4 weeks and 17 healthy controls will be included ages\>40. tests and questionnaires will be used in order to determine the severity of copd and to evaluate posture. photographical analysis in lateral and posterior views will be used for evaluation of cranioservical region static and dynamic biomechanics. to analyze of chest wall, radiographic evaluation will be performed. goniometry will be used for evaluation dynamic craniocervical kinematic analysis. cranioservical region muscle strength and endurance tests will be performed. respiratory muscle strength tests and cough evaluation test will be performed. neck disability index, cough evaluation test questionnare, beck depression and anxiety questionnares, nordic musculoskeletal questionnare will be used. 6 minute pegboard and ring test, 6 minute walk test will be performed. according to the results to be obtained, relationship between cranioservical region biomechanics and posture will be investigated based on the severity of disease in patients with copd. it will guide professional working in the field.

Eligibility criteria:
inclusion criteria: * • being diagnosed with stage 1-2-3-4 according to the classification of airflow limitation in copd (gold) system, * being \>40 years old, * being cognitively competent to understand and answer evaluation questions. * being clinically stable for the last 4 weeks, * being under control of accompanying comorbid conditions (such as hypertension, diabetes), * volunteering to participate in the research. exclusion criteria: * • having been hospitalized due to exacerbation in the last 3 months, * having a musculoskeletal, neurological, rheumatological or oncological disease that affects the craniocervical \& cervicothoracic joints and/or may prevent evaluation, * having undergone any surgical intervention on the craniocervicofacial region and spine in the last six months, * having lung malignancy, neoplasm, adenocarcinoma, * being a lung cancer patient or having received cancer treatment (head and neck lung radiotherapy), having undergone pneumonectemia, lobectomy or resection surgery, * being treated for anxiety and depression, * having scoliosis, * having a congenital anomaly of the craniocervicofacial region. * having 3 out of 4 findings according to the diagnostic criteria for cervical radiculopathy, * having thoracic outlet syndrome (tos)
shiatsu adjuvant therapy and placebo for schizophrenia

Conditions: Schizophrenia

Summary: in the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.

acupressure, also known as shiatsu, is a holistic form of medicine originating in japan but now widely practiced throughout the world. the theory is based on traditional chinese medicine (tcm), which sees meridians of life force (chi) running through the body, and aims to optimize health through manipulating the body into maximal alignment. we are proposing a randomized double-blind placebo-controlled trial to examine the efficacy of acupressure as adjuvant therapy added to antipsychotics in the treatment of patients with schizophrenia. the goals of this study are twofold: 1. to assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia. 2. to furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.

Eligibility criteria:
inclusion criteria: 1. dsm-iv diagnosis of schizophrenia or schizoaffective disorder 2. ages 18 and over 3. clinical status stable, as reflected by changes in brief psychiatric rating scale (bprs) (overall \& gorham, 1961) of less than 20% during a one month period prior to randomization, and at least one month of drug treatment without change of anti-psychotic drug or dosage. 4. ability to cooperate with 40-minute sessions exclusion criteria: 1. unstable general medical conditions 2. active bone fracture or other orthopedic problem 3. skin condition that renders treatment unsafe or painful 4. active infection in skin or soft tissues, such as cellulitis 5. solid tissue malignancy

Keywords: acupressure shiatsu schizophrenia