Kornimate/medical-research-clean huggingface dataset:
primer aligner study

Conditions: Malocclusion

Summary: to demonstrate that a primer aligner product can achieve similar results to the currently marketed product.

the invisalign® system consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. for years, orthodontists and dentists have used removable appliances for orthodontic treatment. today, with the application of computer technology and custom manufacturing, invisalign treats a broader range of cases with greater precision.

Eligibility criteria:
inclusion criteria: * subject must have fully erupted dentition * age range ≥18 years old (adult subject) * subjects who are indicated for either: 5, 7, 10, or 12 aligner sets exclusion criteria: * subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars) * subject who has mixed dentition * subject with periodontal disease * subject with active caries * subject with temporomandibular joint disorders symptoms * subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment * subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study * subject has known allergy to latex or plastic * subjects who are pregnant or will become pregnant during treatment
effect of massage therapy on muscle fatigue

Conditions: Low Back Pain

Summary: the main objective of the current proposal is to investigate the clinical and physiological changes triggered by massage therapy in a group of individuals with chronic low back pain experiencing muscular fatigue. the investigators believe these objectives are in line with the "2014 massage therapy research fund research priorities", since the results produced by these investigations will generate knowledge with regard to the short term clinical efficacy of massage therapy and will provide critical information related to the physiological mechanisms underlying massage therapy clinical effects. most importantly, the combined assessment of clinical and physiological outcomes will also yield key information to identify specific biological components of the massage therapy intervention. determining the presence of a biological mechanism is, as for any treatment, considered one of the necessary criteria to declare a causal relationship between a specific intervention and its associated clinical effects. the investigators strongly believe that the proposed research will contribute to the identification of specific mechanisms that will complement the emerging clinical evidence supporting massage therapy in the treatment of chronic low back pain. the proposed research project will involve researchers and future practitioners of massage therapy. in conjunction with a high quality research environment, it is the goal of the investigators to create an educational environment for undergraduate and graduate students that will foster interdisciplinary collaboration in order to ensure a diversified; high quality training of young researchers and clinician scientists working in the field of manual therapies.


Eligibility criteria:
inclusion criteria: * non specific low back pain exclusion criteria: * low back pain of specific origin including but not limited to: herniated disk fractures spondylolisthesis * inflammatory rheumatic disease * infectious disease * neuromuscular disease * vascular disease * connective tissue disease * severe disabling pain * neurologic signs and symptoms * pregnancy

Keywords: massage
fourteen day safety of low-dose tamoxifen in patients with chronic hepatitis c who have failed standard medical therapy

Conditions: Chronic Hepatitis C

Summary: a short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic hcv patients who have failed standard treatment of peginterferon and ribavirin.

six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.

Eligibility criteria:
inclusion criteria: 1. hcv rna positive. 2. failed standard therapy exclusion criteria: 1. cirrhosis on biopsy 2. severe medical or psychiatric conditions that would make the evaluation difficult 3. tamoxifen is a pregnancy category d drug so pregnant women must be excluded. 4. patients with coumadin cannot be used from a drug interaction. 5. active use of alcohol or illegal substances -

Keywords: hepatitis c, tamoxifen
heritability of opioid effects: a twin study

Conditions: Pain

Summary: proposed twin study will test to what degree inter-individual differences in pain sensitivity and amount of pain relief in response to opioid therapy are inherited or alternatively, are due to environmental factors. this knowledge is important to guide future studies trying to explain such inter-individual differences. for example, finding that differences are largely due to environmental factors would discourage genomic studies and emphasize epidemiological studies.

the principal hypothesis to be evaluated is that the degree of analgesia provided by opioids in humans displays substantial familial aggregation, and is, in fact, heritable. these studies will use a classical twin paradigm to determine the role of genetics and the environment in influencing analgesia and a range of other opioid effects. specific aims: (1) determine the degree to which opioid analgesic responses show familial aggregation and make preliminary estimates of heritability using both a heat and cold pressor pain model, and (2) determine the degree to which non-analgesic opioid responses show familial aggregation and make preliminary estimates of heritability. side effects such as sedation, nausea, respiratory depression, and pruritus, as well as the positive affective response, a measure of abuse potential, will be monitored. monozygotic (mz) and dizygotic (dz) twin pairs (125 total pairs) will be tested under controlled pain laboratory conditions for their responses to opioid infusion using the complementary pain models while monitoring side effects and additional psychometric indices of mood, sleep, and abuse potential. the selected models provide unique mechanistic information because they involve different peripheral and/or central pain pathways. dna samples will be collected for zygosity testing and banked for future studies.

Eligibility criteria:
inclusion criteria:monozygotic or dizygotic twins ages 18-70 exclusion criteria:(1) clinically relevant systemic diseases such as psychiatric, neurological, and dermatological conditions interfering with the collection and interpretation of study data (2) history of addiction (3) allergy to study medication (4) chronic intake of medication potentially interfering with pain processing (except oral contraceptives) (5) intake of over-the-counter analgesics within the two days prior to study (6) reynaud's disease (7) pregnancy (8) participation in other study within last 30 days (9) personnel with direct access to addicting drugs
effect of music intervention on intravitreal injection

Conditions: Music Intervention

Summary: the objective of this study was to examine the effect of music intervention in the before-intravitreal injection (ivti) and during-ivti periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. the study used a randomized controlled experimental design. the study was conducted with a total of three groups: two experimental (before-ivti (group1) and during-ivti music intervention group (group 2)) and one control group. each of the experimental and control groups consisted of 75 patients. the patients' anxiety was evaluated using the vas anxiety scale, pain using the vas pain scale; surgeon-patient cooperation using the numeric rating scale; and patient satisfaction with a 5-point likert-type satisfaction scale.


Eligibility criteria:
inclusion criteria: * the participants were patients aged 18 or above, * who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective ivti was carried out, or who had undergone ivti previously. exclusion criteria: * the participants were patients aged under 18 years * who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone ivti previously.
the effect of acute exercise on cardiac autonomic, cerebrovascular, and cognitive function in spinal cord injury

Conditions: Spinal Cord Injuries; Cardiovascular Abnormalities; Cerebrovascular Disease; Sequelae; Cognitive Impairment

Summary: the aims of this proposal are to: 1) investigate whether individuals with spinal cord injury (sci) demonstrate cardiac autonomic, cerebrovascular, and cognitive dysfunctions compared to non-injured age- and sex-matched controls in the following conditions: supine rest and head-up tilt/face-cooling test; 2) examine if autonomic completeness/ incompleteness, physical activity, and psychological distress are predictors for dysfunctions during supine rest and head-up tilt/face cooling conditions in sci individuals; 3) examine if one bout of moderate-intensity aerobic exercise temporarily improves cardiac autonomic and cerebrovascular functions and thereby improves cognition when in supine rest and head- up tilt/face cooling conditions. the study will include an initial visit and an experimental visit to our lab. three groups of participants will be included in this study: group 1, sci with acute exercise; group 2, sci with rest-control; and group 3, age- and sex-matched non-injured individuals. cardiovascular variables, such as heart rate variability, blood pressure variability, and cerebrovascular variables, such as cerebral blood flow velocity and oxygenated hemoglobin, and cognitive performance will be examined. the investigator hypothesizes that individuals with sci will have impaired cardiac autonomic, cerebrovascular, and cognitive functions compared to the non-injured controls, and an acute exercise can improve those functions. autonomic completeness/incompleteness, physical activity, and psychological distress are significant factors that predict cardiac autonomic, cerebrovascular, and cognitive functions in individuals with sci.


Eligibility criteria:
inclusion criteria: spinal cord injury group: * males or females with chronic sci (i.e. at least 6 months after the initial injury) * international standard for neurological classification of sci (isncsci) a-d * neurological level of injury c6 or below * 18-55 years old * proficient in english * able to detect middle cerebral artery blood velocity (mcav) and/or posterior cerebral artery blood velocity (pcav) signals through tcd non-injured controls: * males or females without sci * 18-55 years old * proficient in english * able to detect mcav and/or pcav signals through tcd exclusion criteria: * cardiovascular, pulmonary or respiratory diseases, or diabetes mellitus, any other diseases/disorders affecting cardiac autonomic nervous system, such as glaucoma and attention deficit hyperactivity disorder (adhd) * color blindness * pregnancy
long term follow up of spinal stenosis inpatients treated with korean integrative medicine treatment.

Conditions: Spinal Stenosis Lumbar; Medicine, Korean Traditional

Summary: the purpose of this study is to reveal the effectiveness and safety of integrative korean medicine for spinal stenosis by observation inpatients treated with integrative korean medicine.

this study is a prospective observational study. the subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four jaseng hospital of korean medicine (gangnam, bucheon, daejeon, and haeundae) for 2015.01-2018.12. medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. the survey questions are numeric rating scale (nrs), oswestry disability index (odi), quality of life, and patient global impression of change (pgic), etc.

Eligibility criteria:
inclusion criteria: * patients diagnosed with spinal stenosis by an korean medicine doctor and was admitted to jaseng hospital of korean medicien. * patients undergone mri readings of central spinal stenosis * patients have no communication problems * patients have agreed to participate the study. exclusion criteria: * patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on) * patient hospitalized for pain caused by a traffic accident * patients with serious mental illness * patients deemed unable to participate in the clinical research by other researchers

Keywords: acupuncture therapy herbal medicine
efficacy of two ons in patients at nutritional risk with type 2 diabetes mellitus

Conditions: Type 2 Diabetes; Malnutrition

Summary: rationale: the aim of the study was to compare the glycemic and insulinemic response of malnourished patients with type 2 diabetes after oral feed between a diabetic oral nutritional supplements (ons) and a standard one. methods: randomized, double-blind, crossover, multicenter clinical trial, conducted in patients with type 2 diabetes and a diagnosis of malnutrition (sga). patients were randomized to receive two ons: diabetic (bi1 diacare hp/hc) or control (standard, isocaloric and isoproteic), a week apart. a glycemia and insulinemia curve was made at times: 0', 30', 60', 90', 120', and 180', after drank 200 ml of the ons. the analyzed variables were the area under the curve (auc 0-t) of glucosa and insulin, and the maximum concentration of glucose (cmax).


Eligibility criteria:
inclusion criteria: * diagnosed with dm2 (confirmed by the use of oral hypoglycemic agents for at least two months). * patients at nutritional risk diagnosed through the subjective global assessment. * adequate cultural level and understanding of the clinical study. * agree to voluntarily participate in the study and give their informed consent in writing. * non-pregnant and non-lactating women or women who have given birth at least six weeks prior to the screening visit. exclusion criteria: 1. type 1 dm, dm2 with insulin treatment and dm secondary to steroids. 2. consumption of alpha-glucosidase inhibitors. 3. current infection (requiring medication or hospitalization), patients undergoing inpatient surgery, or receiving corticosteroids within the past three months or antibiotics within the past three weeks prior to screening visit. 4. bmi \> 35 kg/m2. 5. active malignant neoplasm (except the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the cervix uteri). 6. end-stage organ failure (such as end-stage renal disease) or organ transplant. 7. advanced chronic kidney disease (glomerular filtration rate \< 30 ml/min). 8. severe liver disease. 9. severe gastroparesis. 10. chronic infectious disease, such as active tuberculosis, hepatitis b or c, or hiv infection. 11. consumption of phytotherapy products, dietary supplements or medications except oral hypoglycemic agents, during the four weeks prior to the screening visit, which could profoundly affect (in the opinion of the pi) blood glucose. 12. allergy or intolerance to any component of the products under study. 13. participation in a concurrent trial that conflicts with this study.

Keywords: ons type 2 diabetes malnutrition evoo carbohydrates glycemic index
high omega-3/low omega-6 treatment diet for aspirin-exacerbated respiratory disease (aerd)

Conditions: ASA Triad; Asthma, Nasal Polyps, And Aspirin Intolerance

Summary: the purpose of this trial is to test the hypothesis that a treatment diet low in omega-6 fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease (aerd).


Eligibility criteria:
inclusion criteria: * history of physician-diagnosed asthma * history of nasal polyposis * history of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or diagnosis of aerd via a physician-conducted challenge to aspirin * age between 18 and 70 years exclusion criteria: * current smoking, defined as daily tobacco smoking in the last 6 months and at least one instance of tobacco smoking in the last 3 months. * current pregnancy or breastfeeding * bmi \<20 * history of allergy to fish or any unwillingness to eat fish as a regular part of the diet * use of zyflo (zileuton) in the last two weeks * presence of an implantable cardioverter-defibrillator * use of oral steroids in the last two weeks * participation in any other clinical trial in the last month * any use of nonsteroidal antiinflammatory drugs (nsaids) or any drug that inhibits the cyclooxygenase enzyme during the course of the study

Keywords: omega-3 fatty acids omega-6 fatty acids aspirin exacerbated respiratory disease aerd samter's triad nasal polyp aspirin diet leukotriene
letrozole in treating postmenopausal women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: estrogen can stimulate the growth of cancer cells. letrozole may fight breast cancer by reducing the production of estrogen. purpose: phase iv trial to study the effectiveness of letrozole in treating postmenopausal women who have metastatic breast cancer that has been previously treated with tamoxifen.

objectives: i. determine the time to progression of postmenopausal women with metastatic breast cancer treated with letrozole (femara) as first-line therapy. ii. determine the objective response rate, time to treatment failure, survival rate, and changes in symptom distress in patients treated with this regimen. outline: this is a multicenter study. patients are stratified according to time to diagnosis of metastatic disease. patients receive oral letrozole (femara) daily. treatment continues in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 590 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: diagnosis of metastatic breast cancer measurable or evaluable disease postmenopausal no spontaneous menses for at least 5 years (including chemotherapy-induced amenorrhea) spontaneous menses within the past 5 years allowed if amenorrheic for at least 12 months and lh and fsh in postmenopausal normal range (including chemotherapy-induced amenorrhea) bilateral oophorectomy radiotherapy castration and amenorrheic for at least 3 months hormone receptor status: estrogen-receptor (er) and/or progesterone-receptor (pr) positive no er and pr negative or unknown tumors patient characteristics: age: 18 and over sex: female menopausal status: see disease characteristics performance status: karnofsky 50-100% who 0-2 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: corrected serum calcium less than 11.6 mg/dl other: no known hypersensitivity to any of the constituents of the study drug no history of noncompliance to medical regimens no unreliability not pregnant or nursing fertile patients must use effective contraception hiv negative prior concurrent therapy: biologic therapy: no concurrent anticancer immunotherapy or biological response modifiers chemotherapy: see disease characteristics prior adjuvant or neoadjuvant chemotherapy with adjuvant tamoxifen allowed no concurrent anticancer chemotherapy endocrine therapy: see chemotherapy no other concurrent anticancer endocrine therapy (including steroids) radiotherapy: see disease characteristics no concurrent radiotherapy to sole site of disease concurrent radiotherapy to a limited area (e.g., for painful disease) allowed surgery: see disease characteristics no prior adrenalectomy or hypophysectomy other: at least 30 days since prior systemic investigational drugs at least 7 days since prior topical investigational drugs no other concurrent investigational drugs concurrent bisphosphonates (e.g., zoledronic acid) for bone metastasis allowed

Keywords: stage iv breast cancer recurrent breast cancer
kinetics of fluvoxamine and digoxin in subjects with different mdr1 genotypes

Conditions: Depression

Summary: the investigators will compare plasma kinetics of two marker drugs in individuals with different genetic variations in the mdr1-gene. the hypothesis is that one group will have higher exposure than the other.


Eligibility criteria:
inclusion criteria: * - healthy volunteer ≥ 18 years of age * normal kidney function as measured by gfr according to cockroft-gault (70-120 ml/min) * normal p-potassiumvalue (3,6-4,6 mmol/l) * hf\>50 and no av-block on resting ecg. no other significant abnormalities as judged by the investigator. * subject giving written informed consent * subject capable of understanding instructions exclusion criteria: * - pregnancy * ongoing infection * intake of medication, including natural remedies (for example st john´s wort), within one month prior to starting study except for paracetamol. * active drug or alcohol abuse