Kornimate/medical-research-clean huggingface dataset:
evaluation of efficacy and safety of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in participants with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (arm a) versus daratumumab in combination with bortezomib/dexamethasone (arm b) in the participants with relapsed recurrent multiple myeloma.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma as defined by the international myeloma working group (imwg) criteria. * previously treated with at least 1 prior line of multiple myeloma (mm) therapy, and must have documented disease progression during or after their most recent therapy. * eastern cooperative oncology group (ecog) performance status of 0 to 2. * must have at least 1 aspect of measurable disease, defined as one of the following; 1. urine m-protein excretion \>=200 mg per 24-hour, or 2. serum m-protein concentration \>=0.5 grams per deciliter (g/dl), or 3. serum free light chain (flc) assay: involved flc level \>=10 mg per dl (\>=100 mg per liter) and an abnormal serum free light chain ratio (\ 1.65). * all prior treatment-related toxicities (defined by national cancer institute common toxicity criteria for adverse events \[nci-ctcae\] version 5.0) must be \<=grade 1 at the time of enrollment, except for alopecia. * adequate organ function exclusion criteria: * intolerant to daratumumab. * refractory to daratumumab or any other anti-cd38 therapy (defined as progressive disease during treatment with anti-cd38 therapy, or within 60 days of completing that treatment). * intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. * ongoing grade 2 or higher peripheral neuropathy or neuropathic pain. * prior treatment with anti-b-cell maturation antigen (anti-bcma) therapy. * prior allogenic stem cell transplant. * any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. * corneal epithelial disease.

Keywords: global cohort belantamab mafodotin relapsed/refractory multiple myeloma daratumumab bortezomib dexamethasone multiple myeloma
to study the mechanisms of acupuncture through functional magnetic resonance imaging and peripheral neurosensory testing

Conditions: Healthy

Summary: acupuncture may affect nerve functions. this study assesses the effect of acupuncture on both the peripheral and the central nerve systems


Eligibility criteria:
inclusion criteria: * age 18 to 80 * male and female * no acupuncture treatment for the past 2 weeks * no analgesics for the past 2 weeks * absence of neuropathic pain states exclusion criteria: * history of psychological illness * history of claustrophobia * lack of ability to understand the experimental protocol and to adequately communicate in english * pregnancy * pending litigation * history of head trauma * history of trauma or surgery to lower extremities and pelvic area

Keywords: acupuncture analgesia functional magnetic resonance imaging (fmri) neuronal mechanisms quantitative peripheral sensory testings normal volunteers
safety, tolerability, and pharmacokinetics of raltegravir (mk-0518) in healthy japanese male participants (mk-0518-851)

Conditions: Human Immunodeficiency Virus (HIV) Infection

Summary: this study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (mk-0518, isentress®) in healthy japanese male participants.


Eligibility criteria:
inclusion criteria: * japanese male in good health * body mass index (bmi) between 18.5 and 32.0 kg/m\^2 * nonsmoker and has not used nicotine-containing products for over 3 months at the time of screening test. exclusion criteria: * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or neurological (including cerebrovascular stroke and epilepsy) abnormalities or diseases * significant emotional problem at the time of screening test or suspected to occur during the conduct of the study, or has a history of clinically significant psychiatric disorder within the last 5 years * history of malignancy * history of clinically significant allergies to multiple antigens or severe allergies (e.g., food, drug, and latex \[natural rubber\] allergies), or has had an anaphylactic reaction or significant intolerability (e.g., systemic allergic reaction) to prescription or non-prescription drugs or food * positive for hepatitis b virus surface antigen, hepatitis c virus antibodies, syphilis, or hiv antigen or antibody on the screening test * had surgery or donated or lost blood within 4 weeks prior to the screening test * participated in another study (clinical trial) within 4 months prior to the screening test * consumes greater than 3 glasses of alcoholic beverages (definition of 1 glass: 354 ml for beer, 118 ml for wine, 29.5 ml for distilled spirits) per day * consumes greater than 6 servings (definition of 1 serving: equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day * regular user of cannabis, any illicit drugs, or has a history of drug or alcohol abuse within 2 years at the time of the screening test. participants must have a negative predose urine drug screen * unable to consent to refrain from the consumption of citrus beverages and foods (e.g., grapefruits) beginning 2 weeks prior to administration of the study drug until the end of post-study examination, and the consumption of all fruit beverages and foods for 24 hours predose and after dosing * is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is study site or sponsor staff directly involved with this study.
satin the acute effect of orange nectar with naxus fibre made by novel processing on satiety and satiation

Conditions: Appetite

Summary: a 4 week double blinded parallel design with an intervention condition and a control condition will be employed. after having completed screening procedure and a baseline test day, participants will be randomized to either intervention or control condition. in the following 4 weeks, the participants will have to consume the distributed food product daily before completing another test day.


Eligibility criteria:
inclusion criteria: * participants who have provided written informed consent * bmi between 23.0-27.9 kg/m2 * regular breakfast eaters (eating breakfast ≥ 4 times a week) * regular menstrual periods exclusion criteria: * significant health problems as judged by the investigator * taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator * pregnant, planning to become pregnant within the next 4 weeks or breastfeeding * history of anaphylaxis to food * any known food allergies or food intolerance, specifically the below listed: 1. cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof; 2. crustaceans and products thereof; 3. eggs and products thereof; 4. fish and products thereof; 5. peanuts and products thereof; 6. soybeans and products thereof; 7. milk and products thereof (including lactose); 8. nuts, namely: almonds (amygdalus communis l.), hazelnuts (corylus avellana), walnuts (juglans regia), cashews (anacardium occidentale), pecan nuts (carya illinoinensis (wangenh.) k. koch), brazil nuts (bertholletia excelsa), pistachio nuts (pistacia vera), macadamia or queensland nuts (macadamia ternifolia), and products thereof, except for nuts used for making alcoholic distillates including ethyl alcohol of agricultural origin; 9. celery and products thereof; 10. mustard and products thereof; 11. sesame seeds and products thereof; 12. sulphur dioxide and sulphites; 13. lupin 14. molluscs * smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes) * self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months * significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator * significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator * use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator * participants who work in appetite or feeding related areas * participants not able to comply with the study protocol * post-menopausal

Keywords: ad libitum energy intake appetite sensation
patients' perception of climate change and healthcare

Conditions: Perception, Self

Summary: this study aims to investigate the patients' perception of the negative impact of the healthcare industry on climate change, their attitude of climate change and their health, and their view of seeing a change in the healthcare system to reduce climate change.

climate change is a threat to human health which in turn increases burden on our healthcare system. healthcare is also a very polluted industry which has a huge contribution to climate change. it is important to take action and the intergovernmental panel on climate change (ipcc) has put out a warning of 'code red for humanity' urging immediate action from all of humanity to combat climate change. this is important because if no action is taken, irreversible damage might result on our planet which will become a challenge in terms of living conditions, food source, and health. therefore, this study aims to investigate the patients' perception of the negative impact of the healthcare industry on climate change, their attitude of climate change and their health, and their view of seeing a change in the healthcare system to reduce climate change. this will produce data on the knowledge gap in our patients and thereby empower them to request and target our education for patients, and in turn encourage the healthcare system to reflect on their environmental sustainable practices.

Eligibility criteria:
inclusion criteria: * all adult patients \> age of 18 years old * willing and able to read/listen and understand english, on the hospital ward ie. not emergency department exclusion criteria: * patient refusal * patients are unable to consent * confusion or disorientated in time, space and person

Keywords: environmental sustainability anesthesia healthcare
follicular fluid fetuins in in vitro fertilization

Conditions: Infertility; Infertility, Female

Summary: this study aims to investigate whether follicular fluid concentrations of fetuin a and fetuin b are associated with the clinical pregnancy and live birth rates in in vitro fertilization (ivf) cycles.twenty-nine women with poor ovarian reserve (poor responders) and 33 women with polycystic ovary syndrome (hyper responders) who consecutively underwent ivf at a private hospital between may 2018 and february 2019.fetuin a and fetuin b in follicular fluid were significantly lower in women who had clinical pregnancy than women who had no clinical pregnancy (p=0.001 for both)


Eligibility criteria:
inclusion criteria: poor ovarian reserve patients and patient with polycystic ovary syndrome exclusion criteria: normoresponders
risankizumab therapy versus placebo for subjects with psoriasis in the russian federation

Conditions: Psoriasis

Summary: the purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the russian federation.


Eligibility criteria:
inclusion criteria: * a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. * moderate to severe chronic plaque psoriasis at both screening and baseline (randomization) visits * candidates for systemic therapy or phototherapy for psoriasis treatment as assessed by the investigator exclusion criteria: * prior therapy with an anti-interleukin (il)-17 or anti-il12/23p40 or anti-il-23p19 inhibitor * concurrent therapy with a biologic and/or other systemic therapy

Keywords: plaque psoriasis
pilot study of an intimacy enhancement intervention for couples facing breast cancer

Conditions: Breast Cancer

Summary: the central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the ie intervention on patient and partner sexual qol and relationship outcomes, and on patient psychosocial outcomes. we expect that the ie will show adequate feasibility, acceptability, and preliminary efficacy. secondarily, based on the rationale that barriers exist that limit participation in intensive sexual qol interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. we expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.


Eligibility criteria:
inclusion criteria: 1. female 2. age \> 21 years 3. has diagnosis of non-recurrent stage i-iii breast cancer 4. completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable) 5. has a partner or spouse who is \> 21 6. lives with a romantic partner \> 6 months 7. score of \> 3 on patient care monitor sexual concerns screening item 8. no hearing impairment in patient or partner exclusion criteria: 1. not able to speak english, as stated in medical record or as observed by study team member 2. ecog performance score \> 2 or too ill to participate as judged by physician/in medical record 3. overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer. 4. past history of any cancer other than non-melanoma skin cancer 5. currently participating in couple/marital therapy 6. currently pregnant
ventrassisttm lvad as a bridge to cardiac transplantation - feasibility trial

Conditions: End-Stage Heart Failure; Cardiomyopathies

Summary: the purpose of this trial is to determine the safety and feasibility of the ventrassist lvad in providing circulatory support for patients who require an lvad as a bridge to cardiac transplantation.


Eligibility criteria:
inclusion criteria (the following are general criteria; more specific criteria are included in the study protocol): * approved and listed for cardiac transplantation. * patient for whom lvad implantation is planned as a clinically indicated bridge to cardiac transplantation. exclusion criteria(the following are general criteria; more specific criteria are included in the study protocol): * presence of heart conditions that would contraindicate lvad implantation by adversely affecting patient survival or lvad function. * primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents. * presence of any mechanical circulatory support other than intra-aortic balloon pump. * therapy with an investigational intervention at the time of screening.

Keywords: ventrassisttm lvad end-stage heart failure cardiomyopathy
oxytocin in adolescents with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: this study is design to evaluate the influence of oxytocin in some aspects of autism spectrum disorder (asd), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors. null hypothesis: social skills, quality of life, disruptive behaviors and repetitive behaviors do not improve with the use of oxytocin. experimental hypothesis: social skills, quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with the use of oxytocin.

individuals with asd have impaired social interaction, repetitive and disruptive behaviors. oxytocin has been described to improve those skills and studies suggest that administration can reduce repetitive behaviors as well as enhance social interaction and communication deficits. this study is design to evaluate the influence of oxytocin in some aspects of autism spectrum disorder (asd), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors. instruments: 1. evaluation of social skills: matson evaluation of social skills (messy): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification. 2. evaluation of repetitive behavior: repetitive behavior scale (rbs): consists of 43 items divided into six subscales: stereotyped behavior, self-harm behavior, compulsive behavior, ritualistic behavior, behavior monotonous and restricted behavior. this scale is able to measure the presence and severity of repetitive behaviors as common in individuals on the autism spectrum. 3. evaluation disruptive behavior: vineland, just the part that assess disruptive behavior 4. multidimensional student's life satisfaction scale (mslss)

Eligibility criteria:
inclusion criteria: * male * age between 11 years 11 months and 17 years 11 months * autism spectrum disorder according to dsm v * adi \> 10 * wisc \> 70 * cars \> 30 exclusion criteria: * female * presence of genetic and neurological syndromes * changes in drugs or in any intervention during the study

Keywords: autism, oxytocin, autism spectrum disorder, social skills.
a neurofeedback treatment for chronic musculoskeletal pain

Conditions: Chronic Musculoskeletal Pain; Tennis Elbow; Musculoskeletal Pain; Lateral Epicondylitis

Summary: this study evaluates the effects of a novel neurofeedback treatment on pain specific brainwaves in adults. chronic pain patients enrolled in this study will be randomized into a treatment group and a sham group.

recent research has underlined that central nervous system structures play a key role in the development of pain with significant maladaptive plasticity occurring in several brain areas. non-pharmacological treatments, such as neurofeedback, are designed to restore normal brain function alongside with relieving pain symptoms. with a neurofeedback approach, the patient is provided with a feedback on specific brain waves recorded using non-invasive recording techniques (electroencephalography - eeg) and visualized on a screen.

Eligibility criteria:
inclusion criteria: * patients suffering from chronic pain due to tennis elbow for at least 3 months * a clinical diagnosis of chronic lateral epicondylalgia, * pain associated with functional activities such as gripping and pain with resisted contraction of the wrist extensors or extensor carpi radialis brevis, or with passive stretching of the wrist extensors. exclusion criteria: * clinical diagnosis of chronic lateral epicondylalgia on both sides, cervicothoracic spinal pathology, other upper limb musculoskeletal disorders or neurological disorders * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous or current neurologic, musculoskeletal or mental illnesses defined as an on-going systemic condition * lack of ability to cooperate * current use of medications that may affect the trial e.g. analgesics, anti- inflammatory drugs * consumption of alcohol, caffeine, nicotine or painkillers throughout the study period * past history of chronic pain, neurological or psychiatric conditions * participation in other pain trials throughout the study period and one month prior to participation * participation in more than two sessions of muscle training exercises per week involving the upper limb and/or lower back * evidence of other sources of elbow pain such as exacerbation of pain with neck movement or manual examination * sensory disturbances * history of fractures * elbow surgery * contraindications to the use of tms

Keywords: pain chronic pain musculoskeletal pain treatment neurofeedback brain activity brain oscillation brain computer interface
empagliflozin and acei- effects on hyperfiltration: between study

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Obesity

Summary: this is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial with empagliflozin compared to placebo that is added to open-label ramipril.


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent. * male or female patients diagnosed with type 1 diabetes (t1d) at least 6 months prior to informed consent or type 2 diabetes (t2d) or non-diabetic obese patients. * t1d patients must use and be willing of and be willing to continue throughout the duration of the trial either: * multiple daily injections of insulin or * continuous sub-cutaneous insulin infusion of any insulin type, with at least 3 months experience * for patients with t1d or t2d,hba1c of 6.5 - 11% * age at least 18 years of age * body mass index of \>=18.5 kg/m\^2 * estimated glomerular filtration rate greater than or equal to 60 ml/min/1.73m2 * blood pressure greater than 90 /60 mmhg and less than or equal to 140 / 90 mmhg * use of a highly effective method of contraception. * further inclusion criteria apply exclusion criteria: * for patients with t1d, treatment with an antihyperglycaemic agent within 3 months prior to visit 1 * occurrence of severe hypoglycaemia within 3 months prior to visit 1 * hypoglycaemic unawareness within 3 months prior to visit 1 * occurrence of diabetic ketoacidosis within 3 months of visit 1 and until visit 3 further exclusion criteria apply
prp gel in wound closure in recurrent cs

Conditions: Previous Incision; Scar; Previous Cesarean Section

Summary: there is limited application of the use of prp in obstetrics, therefore there is a need for assessment if it is efficacy in improving skin wound healing in cesarean section.

this study aims to assess the efficacy of injection of platelet rich plasma into the wound of recurrent cesarean section for improving wound healing and enhancing the shape of the wound in women undergoing cesarean section.

Eligibility criteria:
inclusion criteria: * elective cesarean section * body mass index 18:25 * hemoglobin more than 10.5 g/d * albumin within normal more than or equal 3.5 g/d exclusion criteria: * medical disorders(diabetes mellitus,heart disease,hypertension,systemic lupus erythematosus) * high risk pregnancy as (placenta previa,placenta accreta) * patient on corticosteroids medication * primigravida subjected cesarean section * complicated cesarean section (increased operation time,blood transfusion, drain, scrubbing of multiple surgeons) * cesarean section due to chorioaminionitis * postoperative complication such as:postpartum hemorrhage, paralytic ileus, sever distention..) will be dropped out from the study
an imaging trial of the distribution of topical gel formulations in the human vagina

Conditions: HIV Infections

Summary: this study is designed to assess the distribution and spread of four different vehicle formulations in the vagina. in-vivo data will be obtained regarding each vehicle formulation at various time points after insertion of the gel into the vagina.


Eligibility criteria:
inclusion criteria: * 18 to 45 year old women * non-pregnant * healthy exclusion criteria: * abnormal finding on pelvic exam * pregnant or breastfeeding * allergy to intravaginal products * history of claustrophobia

Keywords: hiv seronegativity hiv