Kornimate/medical-research-clean huggingface dataset:
kinesio taping versus compression garments for breast cancer-related lymphedema

Conditions: Breast Cancer Lymphedema

Summary: breast cancer-related lymphedema (bcrl) tends to become chronic and progressive. current therapies have modest results for this condition. compression garments (cg) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. kinesio taping(kt) is being recently used for lymphedema, although little evidence backs it. the aim of this study is to compare the reduction of lymphedema volume with both therapies.

primary end points: to evaluate whether the decrease in bcrl volume is different for a 4-week treatment with kt than with cg. research design: randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . the initial sample was selected among the patients of "breast pathology rehabilitation" at hospital universitario 12 de octubre . the planned sample size was 30. cross design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability. open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, cg or kt, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. however, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. statistical study was also made by others (staff of the "clinique investigation unit (i+12)" of hospital universitario 12 de octubre) with coded variables to blind the analyst.

Eligibility criteria:
inclusion criteria: 1. suffering from clinically significant breast cancer-related lymphedema at least since three months ago. 2. having a compression garment suitable for the lymphedema arm exclusion criteria: 1. physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase). 2. metastasis breast cancer or other tumour. 3. treated with systemic chemotherapy and /or radiotherapy at that time 4. heart failure or renal failure. 5. using diuretics. 6. bilateral axillary lymphadenectomy. 7. cognitive impairment or delay that impedes understanding the study's instructions.

Keywords: compression garments kinesio taping breast cancer-related lymphedema
an exploratory tumor biopsy-driven study to understand the relationship between biomarkers and clinical response in melanoma patients receiving regn2810 (anti-pd-1)

Conditions: Melanoma

Summary: this study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.


Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of stage iii (unresectable) or stage iv cutaneous melanoma (non-acral lentiginous) with at least 1 lesion that is measurable by recist 1.1 criteria and accessible for biopsies * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * adequate hepatic function * adequate renal function * adequate bone marrow function * willing and able to comply with clinic visits and study-related procedures * provide signed informed consent * able to understand and complete study-related questionnaires * anticipated life expectancy \>12 weeks key exclusion criteria: * ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (iraes). * prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (pd-1/pd-l1 pathway) * prior treatment with other immune modulating anti-cancer agents, except for remote treatment (\>6 months) in adjuvant setting. * untreated or active brain metastases or spinal cord compression * immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of regn2810 other protocol-defined inclusion/exclusion criteria will apply
the effect of mulligan mobilization technique

Conditions: Orthopedic Disorder of Spine; Manual Therapy; Physical Therapy

Summary: the aim of this study is to investigate the effect of the mulligan mobilization technique on pain intensity and range of motion individuals with neck pain. the patients were randomized into two groups. group 1 is the mulligan mobilization group and the second group is the control group.

the study is designed as a single-center, parallel-group, randomized controlled clinical trial in istanbul medipol university hospital. the study will be conducted on 40 volunteers with mechanical neck pain. the patients were randomized into two groups. groups were determined by randomization method with closed box. a random paper was drawn for the participants included in the study. inclusion criterias are being between age of 25-65 years, having neck pain for at least 2 weeks, participants that were diagnosed with mnp by a doctor, having no contraindicated condition for manual treatment. exclusion criterias were surgical indications and/ or surgery history for cervical region, history of trauma to the cervical region and those with systemic disease, participation of physical therapy and rehabilitation program in the last one year, fibromyalgia, presence of cardiac pacemaker, intra-articular steroid injection in neck joint in the last three months. in the intervention; mulligan mobilization technique, electroterapy and active range of motion and stretching exercises carried out in mulligan group while only electrotherapy agents and exercises are applied as a classical treatment to the control group. goniometer for the range of motion of the neck (rom), visual analogue scale (vas), neck pain and disability scale (npds), short form health survey (sf-36) will be used for evaluation.

Eligibility criteria:
inclusion criteria: * being between age of 25-65 years, * having neck pain for at least 2 weeks, * participants that were diagnosed with mnp by a doctor, * having no contraindicated condition for manual treatment. exclusion criteria: * surgical indications and/ or surgery history for cervical region, * history of trauma to the cervical region and those with systemic disease, * participation of physical therapy and rehabilitation program in the last one year, * fibromyalgia, * presence of cardiac pacemaker, * intra-articular steroid injection in neck joint in the last three months.

Keywords: mulligan mobilization mechanical neck pain
rapid identification of mycobacteria in acid-fast bacilli smear-positive respiratory specimens

Conditions: Atypical Mycobacteria; Mycobacterium Infections

Summary: the aim of the study is to evaluate the polymerase chain reaction (pcr)-reverse blot hybridization assay (reba) for identification of nontuberculous mycobacteria (ntm) species in acid-fast bacilli (afb) smear-positive respiratory specimens.


Eligibility criteria:
inclusion criteria: * patients with afb-smear positive sputum exclusion criteria: * non-applicable
treating climacteric symptoms with a complex homeopathic remedy

Conditions: Menopause; Anxiety Disorders; Depression

Summary: the purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.

complementary treatments for climacteric symptoms are used by many women although their efficacy and safety is mostly unproven. the use of the complex homeopathic remedy ovaria comp. for the relief of climacteric symptoms will be examined in this three-armed intervention trial and measured with the menopause rating scale ii before and after each study phase of 12 weeks. participants will receive the verum during two treatment phases of 12 weeks and the placebo during one treatment phase of 12 weeks in different sequences and are stratified for post- and perimenopausal status.

Eligibility criteria:
inclusion criteria: * climacteric symptoms\>=3 points in menopause rating scale (mrs) ii * communication possible exclusion criteria: * hormone replacement therapy within 2 weeks prior to study inclusion * other complementary treatments 7 days before and during the study * climacteric symptoms caused by operation, chemotherapy or hormonal therapy of cancer * allergy to components of the remedy, especially bee poison

Keywords: menopausal symptoms complementary medicine
89zr-labeled ny008 pet imaging in patients

Conditions: Multiple Myeloma

Summary: this is a single arm study to evaluate the safety and biodistribution of 89zr-labeled ny008 pet imaging in patients with multiple myeloma


Eligibility criteria:
inclusion criteria: 1. older than 18 years old, male or female; 2. patients diagnosed with relapsing or refractory multiple myeloma； 3. lvef≥50%； 4. ecog score 0\~2； exclusion criteria: 1. life expectancy of less than 3 months; 2. participated in other clinical research within 1 month; 3. recovery from major trauma (including surgery) within 28 days prior to study treatment; 4. patients with systemic or locally severe infections, or other serious coexisting diseases; 5. patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; 6. patients with autoimmune diseases, including rheumatoid arthritis; 7. inadequate control of arrhythmias, including atrial fibrillation; 8. uncontrolled hypertension; 9. patients with allergies or allergies to any component of the imaging agent or antibody; 10. patients who cannot undergo pet/ct imaging scan; 11. syphilis, hbv, hcv, or hiv positive subjects; 12. male and female subjects of reproductive age cannot take effective contraceptive measures; 13. pregnant or lactating women; 14. patients with a history of mental illness or related conditions; 15. other subjects considered unsuitable by researchers.
blinded, randomized study of gabapentin (neurontin®) and gabapentin enacarbil (horizant™) in restless leg syndrome

Conditions: Restless Leg Syndrome

Summary: the study will compare the safety, effectiveness and tolerability of gabapentin (neurontin) versus gabapentin enacarbil (horizant) as treatment restless leg syndrome.

the study will compare the safety, effectiveness and tolerability of gabapentin (neurontin) versus gabapentin enacarbil (horizant) as treatment restless leg syndrome. subjects will be randomized to gabapentin (ir) or horizant™ (er). dosing will be blinded to both patient and study team members. once study medication dosing has been optimized, subjects will then remain on a stable dose for six weeks until study endpoint, after which subjects will be down-titrated off of study medications.

Eligibility criteria:
inclusion criteria: 1. outpatients with a diagnosis of primary restless leg syndrome using the international restless legs syndrome study group (irlssg) diagnostic criteria8. 2. rls symptoms ≥ 15 nights of the month prior to study enrollment and for ≥ 4 of 7 consecutive nights in the week prior to study enrollment (if untreated). 3. age 18 years to 80 years. 4. international restless legs scale (irls) total severity score of ≥ 15 (moderate to severe severity). 8 5. had significant sleep disturbance on item 4 of irls.8 6. women of child-bearing potential must use a reliable method of contraception. 7. informed consent. subject must be willing and able to complete all study procedures. exclusion criteria: 1. any illness that in the investigator's opinion preclude participation in this study. 2. subjects with non-rls-related sleep disorders (e.g., sleep apnea) 3. subjects with neurological diseases or movement disorders other than rls (e.g., diabetic neuropathy, parkinson's disease, multiple sclerosis, dyskinesias, and dystonias) 4. pregnancy or lactation. 5. concurrent participation in another clinical study. 6. dementia or other psychiatric illness that prevents the patient from giving informed consent (mini-mental state examination scores less than 27). 7. legal incapacity or limited legal capacity. 8. history of rls symptom augmentation or early-morning rebound with previous dopamine-agonist treatment. 9. clinically significant abnormalities in renal function. 3,8,10 10. presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease. 11. concomitant treatment with drugs known to affect sleep/wake, rls or periodic limb movements, including antidepressants. subjects receiving treatment for rls at screening will be required to discontinue and wash out for a minimum of 5 half-lives. 12. body mass index greater than 34 kg/m2.

Keywords: restless leg syndrome rls gabapentin gabapentin enacarbil neurontin horizant
a brief intervention

Conditions: Dating Violence; Dating Abuse

Summary: this randomized controlled trial (rct) study is a small scale test of the feasibility and preliminary efficacy of a brief motivational interview-style intervention. the intervention took place in the pediatric emergency departments by a trained interventionist and will followed an intervention algorithm developed by a team of dating abuse and brief intervention experts. the research design is as follows: the investigators will randomize youth ages 12-19 years old to one of two groups: one group who receives the intervention (n=\~18), and the other which does not (n=\~18). the investigators compared changes in outcomes from baseline to 1-month follow-up for those in both groups. the investigators looked at outcomes including dating abuse-related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization). statement of study hypothesis: youth who receive the intervention will show improvements in dating abuse-related knowledge, attitudes and behavior that are maintained for 1 month, while those in the comparison group will show no similar change.


Eligibility criteria:
inclusion criteria: * 15-19 years old * english-speaking * have used at least one form of physical or sexual aggression against a dating or sexual partner in the past three months exclusion criteria: * patient's reason for ed visit is an acute mental health problem (e.g., suicidal ideation or attempt, severe anxiety attack) * patient is a prisoner * patient is determined to be potentially lethal * patient attends batterer intervention classes

Keywords: dating abuse dating violence domestic violence sexual violence sexual assault youth violence underage alcohol use alcohol use
conditioning with volatile anesthetics in liver transplantation

Conditions: End-stage Liver Disease

Summary: the gap between the number of candidates for orthotopic liver transplantation and the availability of suitable liver grafts has led to a rise in deaths on most waiting lists. strategies applied in many centers to minimize this deficit include living donation or split of a cadaveric organ for two recipients, domino transplantation, and the use of so-called expanded criteria donors. alternatively, conditioning of an organ would also allow protec-tion of the liver upon ischemia-reperfusion injury, possibly decreasing postoperative liver function and im-proving clinical outcome. the technique of conditioning with the volatile anesthetic sevoflurane is an easily applicable procedure which could be performed in any center worldwide. data and experience with sevoflurane attenuating ischemic-reperfusion injury in liver resection lead to the hypothesis of a beneficial effect of volatile anesthetics in liver transplantation. in this randomized controlled trial, patients will be randomly assigned to liver transplantation with propofol anesthesia (propofol group) or sevoflurane conditioning with the volatile anesthetic (sevoflurane group). primary endpoint is postoperative peak of the transaminase (ast), secondary endpoints are complications, primary liver graft function, icu and hospital stay. we hypothesis that patients with conditioning have an attenuated increase of transaminases as well as a better outcome.


Eligibility criteria:
inclusion criteria: * older than 18 years * patients undergoing liver transplantation * total or partial cadaveric liver transplantation * living related liver transplantation exclusion criteria: * patients unable to understand the german or italian language * patients with known or suspected allergy to propofol, soja or egg * patients with norepinephrine infusion above 15 microg/min * intensive care patients with severe impairment of renal or pulmonary function (e.g. dialysis, hemofiltration, fio2\>0.5)
an observational study of pegasys (peginterferon alfa-2a) plus ribavirin based regimens in patients with chronic hepatitis c with previous treatment failure

Conditions: Hepatitis C, Chronic

Summary: this prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis c who failed previous treatment. participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.


Eligibility criteria:
inclusion criteria: * adult participants, \>/= 18 years of age * participants with chronic hepatitis c who have been previously treated with pegylated interferon, standard interferon, ribavirin * no contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing daas as detailed in the local label * treatment in line with summary of product characteristics/local labeling for pegasys/ribavirin and daas, in particular: * positive serum hepatitis c virus (hcv) ribonucleic acid (rna) * fertile males and females receiving ribavirin must use two forms of contraception during treatment with pegasys/ribavirin and until 6 months post-treatment * no co-infection with hepatitis b or human immunodeficiency virus (hiv) exclusion criteria: * history or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis c * history of neurological disease * history of severe psychiatric disease * decompensated diabetes * history of immunologically mediated disease * history of severe cardiac disease * history or evidence of severe chronic pulmonary disease * inadequate hematologic function * pregnant or breastfeeding women * male partners of pregnant women
investigating the adhesion of new adhesive to the skin

Conditions: Ileostomy - Stoma

Summary: the adhesion of the new adhesive strips is investigated on healthy volunteers

inclusion visit: * introduction to the study * inclusion in study * baseline information is obtained * instruct subject to pre-strip of abdominal skin test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin): * baseline measurements are conducted on both sides of the stomach (tewl, hydration, erythema, ph - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip) * potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (tewl, hydration, erythema, ph - 3 times/strips (upper, middle and bottom of adhesive strip)) * adhesive strips are weighted and applied * potential shower/bicycle exercise (max 60 minutes) * adhesive strips are removed at pre-defined timeslots (peel force measured) * discomfort when strip was peeled of is evaluated by subject (vas) * measurements are conducted (tewl, hydration, erythema, ph - 3 times/strips (upper, middle and bottom of adhesive strip)) * acclimatization ½ * measurements are conducted (tewl, hydration, erythema, ph - 3 times/strips (upper, middle and bottom of adhesive strip)) * adhesive strips are weighed * photo of adhesive strips the subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. the strips should be applied at the same place every time.

Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. be at least 18 years of age and have full legal capacity 3. have intact skin on the area used in the investigation exclusion criteria: 1. currently receiving or have within the past 2 months received radio- and/or chemotherapy 2. currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment. 3. are pregnant or breastfeeding 4. have dermatological problems in the abdominal area (assessed by investigator)
evaluation of orlistat as adjuvant treatment of obesity in adults

Conditions: Obesity

Summary: the purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of obesity in adults.


Eligibility criteria:
inclusion criteria: * signed informed consent; * adults male and female ≥ 18 years old; * obesity (bmi ≥ 30kg/m2 or ≥ 27 kg/m2 with associate risk); exclusion criteria: * pregnancy and lactation or women without effective contraception; * relevant clinical diseases; * obesity associated to genetic syndrome; * decompensated diabetes; * psychiatric disorders; * alimentary disorders; * use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days; * patients using cyclosporine or amiodarone; * patients with bowel disease; * prior bariatric surgery; * anemia; * hemoglobinopathies and coagulopathy; * history of cancer in the past five years; * use of corticosteroids, oral or injectable, in the last 30 days.
long-term immune persistence of glaxosmithkline biologicals' inactivated hepatitis a vaccine injected according to a 0, 12-month schedule

Conditions: Hepatitis A

Summary: the aim of this study is to evaluate the persistence of hepatitis a antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis a vaccine. this protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 20. no additional subjects will be recruited during this long-term follow-up.

this is a long-term follow-up study at years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with gsk biologicals' hepatitis a vaccine (two-dose schedule). to evaluate the long-term antibody persistence, volunteers will donate a blood sample at years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis a (anti-hav) antibody concentrations. if a subject has become seronegative for anti-hav antibodies during any of the long-term blood sampling time point (i.e. months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. a blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007 and to extend the follow up until year 20. the study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.

Eligibility criteria:
inclusion criteria: * subjects who had received at least one dose of the study vaccine in the primary study * written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Keywords: havrix™ hepatitis a