Kornimate/medical-research-clean huggingface dataset:
a phase 1 study in patients with relapsed or refractory hodgkin lymphoma or systemic anaplastic large cell lymphoma

Conditions: Hodgkin Lymphoma; Anaplastic Large-cell Lymphoma

Summary: this is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory hodgkin lymphoma (hl) or relapsed/refractory systemic anaplastic large cell lymphoma (salcl) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.


Eligibility criteria:
inclusion criteria: * male or female participants between 18 years and 75 years old, with relapsed or refractory hl or relapsed or refractory salcl who have previously received at least 1 multiagent chemotherapy * measurable disease * an eastern cooperative oncology group (ecog) performance of 0 or 1 * female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence * male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence * clinical laboratory values as specified in the study protocol exclusion criteria: * participants for whom rifampicin is contraindicated * previously received an allogeneic transplant. * participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma (alcl) (participants whose alcl has transformed to salcl are eligible). * known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (pml) * female participants who are lactating and breastfeeding or pregnant * known human immunodeficiency virus (hiv) positive, * known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection

Keywords: lymphoma hodgkin anaplastic large-cell relapsed refractory antigens, cd30 antibody-drug conjugate antibodies, monoclonal lymphoma, non-hodgkin lymphoma, large-cell, anaplastic monomethyl auristatin e drug therapy immunotherapy hematologic diseases
developing and testing delicious and nutritious for the old people

Conditions: Quality of Life; Nutritional Deficiency; Physical Performance

Summary: meals-on wheels may play a major role in contributing to better nourishment and quality of life in older people, thus delaying costly hospitalisation. still, dwelling, old adults who receive meals-on-wheels are a population at risk of undernutrition leading to a decreased quality of life. hypothesis offering nutritious eldorado meals as meals-on-wheels to nursing home residents in 3 months is an effective way to increase quality of life. aim to improve quality of life and functional abilities in nursing home residents by offering nutritious eldorado meals.

intervention the intervention group (n=50) will receive an optimized menu (in both sensory and nutritious aspects) for 12 weeks. in cooperation with the copenhagen house of food and sensory staff, 19 main meals and 12 between-meals have been optimized based on nursing home residents' evaluations of sensory aspects. on a daily basis the menu will consist of 1 optimized main meal and 1 optimized between-meal, served for dinner. there will be no selective choice for the elderly. if a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen. control in comparison, the control group (n=50) will receive the same menu as the intervention group, however, the meals are not optimized on sensory and nutritious aspects. on a daily basis this menu also includes 1 main meal and 1 between-meal in 12 weeks. if a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Eligibility criteria:
inclusion criteria: * living at skovhuset, nursing home in hillerød municipality, denmark. * collecting the "energy-dense diet" "ældrekost" with 40 % fat, with a main meal and a dessert/starter. * able to understand and follow instructions for the procedures of the study. * above 65 years. exclusion criteria: * have chewing or swallowing difficulties. * have acute disease or acute change in chronic disease. * living after special nutritional standards e.g. vegetarian, have any food allergies, or if a participant is excluding common foods from their diet because of other reasons. * not able or willing to give informed consent.
transversus abdominis plane blocks with abdominoplasty

Conditions: Post Operative Pain

Summary: comparing morphine consumption and recovery with two different tap block techniques after abdominoplasty.

tap blocks have the potential to become an important part of multi-modal analgesia after abdominal surgery (1,2). originally dr j mcdonnell described a blind double pop technique, trough the triangle of petit, with up to 48 hours of analgesia (3,4). dr p hebbard described an ultrasound based technique with a subcostal (for supra-umbilical analgesia) and an axillary mid-line injection (for sub-umbilical analgesia) in the tap, with reported analgesia for up to 8 hours (5,6). recently dr j mcdonnell presented data showing para vertebral spread (up to l5) of the (high dose, low concentration) local anaesthetic explaining the prolonged analgesic effect (7,8). in 2007 dr blanco described an ultrasound guided technique for the posterior inﬁltration as performed by mcdonnell (9). our limited observational comparison between both block techniques conﬁrms this difference. we decided to compare both techniques (the ultrasound guided single shot subcostal injection, the atap-group (hebbard is from australia) and the ultrasound guided posterior injection, the itap-group (mcdonnell is from ireland). we will use the same volume and concentration of local anesthetic and we will asses their analgesic efﬁcacy and improvement in quality of recovery.

Eligibility criteria:
inclusion criteria: * eligible for abdominoplasty * asa 1-2 * fluent french/dutch/english exclusion criteria: * history of allergy to local anaesthetics * chronic opioids abuse * pregnant patients

Keywords: transversus abdominis plane block ultrasound guided abdominoplasty
exercise during chemotherapy for patients with hematological malignancies

Conditions: Hematological Diseases; Hematological Malignancies

Summary: the trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.


Eligibility criteria:
inclusion criteria: * hematological malignant disease * current chemotherapy * understanding of written german exclusion criteria: * cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise * pathological stress-ecg at recruitment

Keywords: lymphoma leukemia multiple myeloma hodgkin´s disease exercise sport fatigue hematological neoplastic diseases
efficacy of aponeurectomy on the 2-year recurrence rate of dupuytren's disease

Conditions: Dupuytren's Disease

Summary: dupuytren's disease is a frequent hereditary disease in northern europe. it is a degenerative disease affecting the palmar aponeurosis of the hand. it develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence. various medical and surgical treatments are available.

among these treatments, none to date can eliminate recurrences, which are still too frequent. open aponeurectomy (consisting of surgical curettage of the fibrotic cords) remains for the moment the reference technique for treating dupuytren's disease, with recurrences (between 12 and 39%), but less frequent than the needle technique (50 to 85%). could the addition of adipose tissue in the resection areas of dupytren's fibrosis reduce the rate of recurrence (by the inhibitory action of adcs on myofibroblasts) in addition to reconstructing the hypodermis in the cavity left by the resection of the cords and improving the quality of the scars? the investigators insist on the fact that this is a homotopic and homologous adipose tissue graft, in closed circuit without denaturation or adjuvant products. since, to our knowledge, no other team has used "lipofilling" as an adjuvant treatment to the open resection technique of dupuytren's cords (aponeurectomy), the investigators first conducted a clinical feasibility and safety study on 70 patients between 2012 and 2017 (currently being published by springer editions). the investigators now wish to conduct a prospective comparative study between patients operated by aponeurectomy with (experimental group) and without (control group) addition of autologous adipose tissue in the resection areas of dupuytren's cords.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * carrier of tubiana stage ii-iv dupuytren's disease on at least one or more rays, not previously operated * indication of a surgery by aponeurectomy * skin pinch of the posterior aspect of the arm of more than 1cm * affiliation to a social security system * patient informed of the study and having given informed consent exclusion criteria: * previous surgery of any kind for dupuytren's disease * involvement on the thumb only * need for a total skin graft or a pedicle flap on all the rays to be treated * active autoimmune disease * previous treatment with collagenase * pregnant and breastfeeding women * patient under legal protection * contraindications to mri (criteria applicable only for patients from the coordinating center, not applicable for other centers)
double-bundle versus single-bundle anterior cruciate ligament reconstruction

Conditions: ACL Injury

Summary: the purpose of this study is to compare double-bundle and single-bundle techniques for acl reconstruction in a long-term 15-year follow-up. our hypothesis is that the db technique is better than the sb technique.


Eligibility criteria:
inclusion criteria: * to be eligible for the study, patients had to meet certain criteria, including primary acl reconstruction, closed growth plates, and no ligamentous injuries to the contralateral knee. exclusion criteria: -
biomechanics of lumbar region in low back pain

Conditions: Low Back Pain

Summary: the purpose of this study was to examine the relationship between non-specific low back pain (nslbp) and lumbar lordosis angle (lla) and lumbar muscle thickness (lmt) by evaluating magnetic resonance images (mri) in individuals with lbp.

the study included a total of 96 individuals, 43 males, and 53 females, who applied to the department of radiology of the karabuk university training and research hospital between march-june 2019 with complaints of lbp. individuals' sociodemographic information and medical history were recorded using the lbp assessment form. the oswestry lbp disability questionnaire was used for lbp. thickness measurements of muscle (m.) psoas major, m. multifidus, m. quadratus lumborum and m. erector spinae were taken on mri corresponding to the l3-l4 vertebra level. cobb angle method was used for lla determination. measurements were made in three repetitions using the radiant dicom viewer program, and their averages were recorded.

Eligibility criteria:
inclusion criteria: * the age range of 18-65 * having non-specific lbp * volunteering to participate in the study exclusion criteria: * having any psychiatric and mental problems * the presence of any disc, bone, and muscular pathology in the lumbar region * having any previous operation on the lumbar region

Keywords: low back pain lumbar lordosis angle magnetic resonance imaging muscle thickness
the effect of radiaace gel in the prevention and treatment of radiation dermatitis in breast cancer patients

Conditions: Breast Cancer; Radiation Dermatitis

Summary: radiation dermatitis (rd) is one of the most common side effects of radiation therapy (rt) and 95% of patients receiving rt may experience some form of radiation dermatitis. a wide variety of topical, oral, and intravenous agents are used to prevent/treat radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended. radiaace gel is a wound dressing hydrogel (acemannan hydrogel) for the management of rd which provides optimal moist wound environment necessary to the healing process. based on its composition as well as the supporting data on safety and performance of the functional ingredient acemannan in wound healing, radiaace may well be suited to complement the prevention and therapy of radiation dermatitis. the primary aim of the study is to evaluate the safety and performance of radiaace as compare to biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher rd as measured by the rtog scoring system


Eligibility criteria:
inclusion criteria: 1. female patients 2. age \> 18 3. patients with histologically-confirmed diagnosis of breast cancer 4. patients after breast lumpectomy and that scheduled to receive radiotherapy 5. patients to receive minimum of 40.05 gy to primary field 6. must be able to comply with treatment schedule 7. study-specific signed informed consent prior to randomization exclusion criteria: 1. inflammatory or connective tissue disorders of the skin 2. mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires 3. previous radiation therapy to the breast 4. tumour involvement of the skin 5. rash, ulceration or open wound in treatment field 6. known skin allergy or sensitivity to aloe vera or biafine 7. current lactation 8. pregnancy 9. any other reason that, in the opinion of the investigator, prevents the subject from

Keywords: radiation dermatitis breast cancer
evaluation of the nasal and conjunctival response in subjects allergic to birch pollen in the alyatec environmental exposure chamber

Conditions: Allergic Rhinitis; Allergy to Pollen; Rhinoconjunctivitis

Summary: the aim of this study is to assess the nasal and conjunctival response in subjects allergic to birch pollen during controlled exposures in the alyatec environmental exposure chamber (eec)

this is a single-center, single-blind, placebo-controlled study. the first part of the study consists of 6 exposure sessions in alyatec eec, including placebo and birch pollen allergen exposures. the second part of the study involves in-field evaluations of rhinitis and conjunctivitis symptoms during birch pollen season. alyatec environmental exposure chamber, also called allergen challenge chamber, allows to evaluate allergic symptoms in standardized and reproducible conditions. all the metrological parameters (temperature, air flow, hygrometry ...) are controlled as well as the allergen concentration diffused in the room. this enables to induce and observe rhinitis, conjunctivitis and asthma symptoms for up to 20 patients at the same time, in a reproducible way and without the potential perturbations or contaminations of the natural environment. the current study aims to get specific information about allergic symptoms induced in the alyatec eec chamber in patients sensitized to birch pollen allergen.

Eligibility criteria:
inclusion criteria: * a clinical history of allergic rhinitis to birch pollen for at least 2 consecutive pollen seasons requiring the taking of a symptomatic drug with or without associated asthma * positive skin prick tests for birch pollen (\> 3 mm) * ige specific to birch \> 0.75 kui / l. * positive unit rapid nasal provocation test for birch pollen * subjects having signed informed consent * subjects affiliated to a social security scheme * subjects able to understand and complete the procedures related to the study * women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception exclusion criteria: * specific immunotherapy (sit) for birch allergens for more than a month in the 3 years preceding the screening * current use of specific immunotherapy for another allergen * medical history of anaphylaxis following exposure to birch pollen * medical history of anaphylaxis linked to another allergen in the last 6 weeks * nasal polyps, nasal septum deviation or diagnosis of non-allergic rhinitis * subjects allergic to indoor environmental allergens (cat allergens, mold, dust mites) with - obvious exposure to these allergens. * uncontrolled allergic pathology (rhinitis, conjunctivitis) * forced expiratory volume in 1 second (fev1) \<70% of predicted normal values * moderate to severe asthma (gina 3 to 5)

Keywords: environmental exposure chamber allergen exposure chamber allergen provocation test birch pollen
preemptive analgesia for postoperative pain control for dental treatment under general anesthesia

Conditions: Pain, Postoperative

Summary: the aim of this study was to compare the analgesic-treated children with analgesic prior to the treatment and to compare the postoperative analgesic needs of children undergoing dental treatment under general anesthesia.

the investigator's study included patients who were admitted to inonu university and adnan menderes university, faculty of dentistry, department of pediatric dentistry in 2019 and decided to perform dental treatment under general anesthesia. patients 1 to 7 years of age with dental treatment between february 28 and june 1, 2019 will be included. patients who underwent analgesic 15 minutes after the induction of general anesthesia from the patients, and those who made painkillers 15 minutes before the end of the treatment will constitute the control group. paracetamol 15 mg / kg iv will be given in 50 ml of saline. the demographic data of the children to be included in the study such as age, gender, type of dental intervention, duration of operation, postoperative pain scores, recovery times will be recorded and compared.

Eligibility criteria:
inclusion criteria: * to be treated under general anesthesia * no systemic disease * to have at least one painful dental procedure in the upper and lower jaw (pulpectomy, pulpotomy exclusion criteria: * patients with mental or physical disabilities of any disease * patients who have not undergone painful dental intervention under general anesthesia
phase 3 evaluation of efficacy and safety of ar882 in gout patients (ar882-302)

Conditions: Gout; Arthritis, Gouty; Hyperuricemia; Gout Chronic

Summary: this study will assess the serum uric acid lowering effect and safety of ar882 in gout patients at two doses compared to placebo over 12 months


Eligibility criteria:
inclusion criteria: * history of gout * occurrence of ≥ 2 self-reported gout flares in the last 12 months * body weight no less than 50 kg * patients who are not on approved urate-lowering therapy (ult) must have sua ≥ 7 mg/dl * patients who are on medically appropriate ult must have sua \> 6 mg/dl * serum creatinine must be \< 3.0 mg/dl and estimated clcr ≥ 30 ml/min exclusion criteria: * malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * pregnant or breastfeeding * history of symptomatic kidney stones within the past 6 months
bioequivalence study of torrent pharmaceuticals ltd's felodipine extended-release tablets under fed condition

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioavailability of torrent's felodipine extended-release tablets usp 10 mg and innovator's (mylan pharmaceuticals inc., usa) felodipine extended-release tablets usp 10 mg. dosing periods were separated by a washout period of 21 days during fasting study. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. pulse rate less than 50/minute or more than 100/minute. * oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
predictors for retreatement of oab after dc mirabegron

Conditions: Recurrence of Overactive Bladder Syndrome

Summary: recurrence of female overactive bladder syndrome (oab) is not uncommon. it is important to decrease the recurrence of female oab. however, factors predicting recurrence of female oab, especially for those women who need retreatment is undetermined. thus, the aim of this study was to elucidate factors predicting retreatment of female oab.

the medical records, including pad testing, urodynamic studies, lower urinary tract symptoms related questionnaires and bladder diaries of all consecutive women with oab, who visited urogynecologic clinics in a tertiary referral center, were reviewed. persistence interval was defined from the date of prescription of mirabegron to the date of discontinuation of mirabegron treatment. statistical analysis was performed with kaplan-meier estimator. multivariable cox proportional-hazard model with all variables with p \< 0.25 in the univariate analysis was performed to predict oab retreatment probability.

Eligibility criteria:
inclusion criteria: * women with overactive bladder syndrome * women complete urodynamic study and bladder diary exclusion criteria: * pregnant women * incomplete data * loss of follow-up * acute or chronic urinary tract infection

Keywords: overactive bladder syndrome beta-3 agonist retreatment