Kornimate/medical-research-clean huggingface dataset:
a safety and effectiveness study of prolonged release tapentadol hydrochloride among filipino patients with moderate to severe chronic non-cancer pain

Conditions: Moderate to Severe Chronic Non-cancer Pain

Summary: the purpose of this study is to evaluate the safety and effectiveness of prolonged release tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among filipino patients.

this is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes). the study will enroll approximately 100 patients who will be taking prolonged release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. as this is an observational study, assessment of patient will be based on the accepted clinical practice in the philippines. patients will be monitored at baseline (day 1) and throughout the 84-day treatment period of prolonged release tapentadol hydrochloride (every 7 days for the first two weeks, and thereafter every 28 days for the next three months) for effectiveness with the help of short form brief pain inventory (bpi) questionnaire. safety evaluations will include assessment of adverse events, clinical laboratory tests, and co-morbid conditions. the total study will be conducted for 3 years and the duration of treatment will be for 84 days.

Eligibility criteria:
inclusion criteria: * filipino patients with moderate to severe non-cancer pain with an onset of 12 weeks or less from the baseline visit and pain requires schedule 2 opioid treatment as per assessment of the prescribing physician * patients who able to independently communicate pain characteristics, understand and complete self administered questionnaires * medically stable on the basis of routine physical examination, medical history, and vital signs at the time of baseline visit exclusion criteria: * refuse to protocol-defined use of effective contraception * pregnant and lactating women * patients with severe renal and hepatic impairment, significant respiratory depression, acute or severe bronchial asthma or hypercapnia, and having or suspected paralytic ileus * patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs or receiving other mu-opioid receptor agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, and sedatives * patients who are receiving monoamine oxidase (mao) inhibitors or who have taken them within the last 14 days * patients with documented history of increased intracranial pressure, impaired consciousness, coma and seizure

Keywords: moderate to severe chronic non-cancer pain prolonged release tapentadol hydrochloride tapentadol pr extended release tapentadol hydrochloride nucynta pr
effect of bariatric surgery on physical activity, gait, flexibility and quality of life

Conditions: Obesity; Bariatric Surgery; Gait

Summary: this study aimed to analyze spatio-temporal characteristics of gait, physical activity level and changes in quality of life in patients by measuring conditions before bariatric surgery and third-month after the surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of obesity * body mass index \> 35 * speak and understand turkish * ability of read and write exclusion criteria: * history of lower extremity surgery * musculoskeletal/systemic/neurological/psychiatric problems * urinary syndromes * limited gait due to cardio-pulmonary insufficiency * unwillingness to participate
radiation therapy or standard therapy in treating women with stage ii breast cancer who have undergone mastectomy

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. giving radiation therapy after surgery may kill any tumor cells that remain after surgery. it is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage ii breast cancer. purpose: this randomized phase iii trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage ii breast cancer who have undergone mastectomy.

objectives: * determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy. outline: this is a multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity. * arm ii: patients receive standard of care and observation only. after completion of study therapy, patients are followed up twice in the first year, and then annually for up to 10 years.

Eligibility criteria:
disease characteristics: * histologically confirmed unilateral invasive breast cancer * pt1, pn1, m0 disease * pt2, pn1, m0 disease * pt2, pn0 disease with grade iii histology and/or lymphovascular invasion * multifocal breast cancer meeting both of the following criteria: * largest discrete tumor ≥ 2 cm if n0 * grade iii histology and/or lymphovascular invasion * no bilateral breast cancer * axillary node negative status by axillary clearance, axillary node sampling, or sentinel node biopsy * patients with axillary node positive (1-3 positive nodes, including micrometastases\* \> 0.2 mm and ≤ 2 mm) must have had an axillary node clearance (minimum of 10 nodes removed) performed * no more than 3 pathologically involved lymph nodes * no internal mammary nodes visible on sentinel node scintigraphy in the absence of negative histology note: \*isolated tumor cells not counted as micrometastases * underwent total mastectomy (with minimum of 1 mm margin clear of invasive cancer and dcis) and axillary surgery with staging procedure * must have undergone adjuvant systemic chemotherapy if indicated for intermediate-risk breast cancer * patients undergoing immediate breast reconstruction allowed * no known brca1 and brca2 carriers * hormone receptor status not specified patient characteristics: * menopausal status not specified * not pregnant * fit for adjuvant chemotherapy, adjuvant endocrine therapy, and post-operative radiotherapy * no prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix prior concurrent therapy: * see disease characteristics * no concurrent trastuzumab * no prior neoadjuvant systemic therapy

Keywords: stage ii breast cancer
real-world use of selinexor, daratumumab and dexamethasone in chinese patients with multiple myeloma at first relapse

Conditions: Multiple Myeloma at First Relapse

Summary: this is a single-arm, prospective, non-interventional, real-world study to observe and evaluate the efficacy and safety of selinexor in combination with daratumumab and dexamethasone in patients with multiple myeloma at first relapse.

this is a non-interventional, prospective, observational post-marketing surveillance study of selinexor, daratumumab and dexamethasone in participants with multiple myeloma (mm). the study will assess the safety and effectiveness of selinexor in combination with daratumumab and dexamethasone (xdd) for first relapse mm patients under real-world conditions. the study will enroll approximately 34 participants. the data will be prospectively collected, at our center from medical files and recorded into electronic case report forms (e-crfs). the overall duration of the study will be approximately 3 years. data will be collected over and up to a 12 months-surveillance period (per participant) once enrolled.

Eligibility criteria:
inclusion criteria: 1. according to the multiple myeloma diagnostic criteria of the international myeloma working group (imwg), there is the initial diagnosis of multiple myeloma. 2. subjects must have previously received 1 anti-myeloma regimens. subjects must have documented disease progression 3. age ≥18 years; 4. life expectancy \> 6 months; 5. patients should provide available clinical case files and/or detailed records of medical history, diagnosis and treatment information, and cooperate with clinical management; 6. fertile women and men whose partner is of childbearing potential or pregnant should agree to practice complete abstinence or to use a condom during therapy and dose interruptions and for 90 days after the last treatment. exclusion criteria: 1. patients who are contraindicated as per product label of xdd; 2. known positive for hiv or active hepatitis b or c or other infectious diseases; 3. pregnancy or lactation; 4. patients with a history of malignant tumor that may affect the implementation or results analysis of this study (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, intramucosal carcinoma of the gastrointestinal tract in situ, and localized prostate cancer); 5. any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results; 6. patients who are unsuitable for this study judged by clinicians.
a mucosal contouring method based on swallowing-induced breakthrough pain for radiation-induced oropharyngeal mucositis

Conditions: Radiation-induced Oropharyngeal Mucositis; Swallowing-induced Breakthrough Pain

Summary: the performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal contouring method was unsatisfactory in nasopharyngeal carcinoma (npc). whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance. the aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in npc.

nasopharyngeal carcinoma (npc) is particularly prevalent in southern china. radiation-induced oropharyngeal mucositis is one of the most common acute toxicities in patients with npc receiving radiotherapy. swallowing-induced breakthrough pain is a prominent clinical challenge for radiation-induced oropharyngeal mucositis, which has a great impact on patients' quality of life and treatment outcomes. nonetheless, no particularly effective therapeutic methods or medication are available currently, thus making timely and accurate prediction, identifying high-risk patients, and providing appropriate interventions are critical in reducing or delaying the occurrence of severe oropharyngeal mucositis. it has been found that the performance of the predictive models for severe oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in npc. the investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced npc, and our preliminary results demonstrated that the predictive model exhibited better overall performance. therefore, the investigators aimed to conduct a prospective, multicenter, observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in npc.

Eligibility criteria:
inclusion criteria: 1. provide informed written consent. 2. age ≥ 18 years. 3. histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy. 4. complete and continuous records of oral / oropharyngeal mucositis grading, and self-reported swallowing-induced breakthrough pain. exclusion criteria: 1. existence of poor oral hygiene, untreated dental or periodontal diseases, and metal dental restorations. 2. current untreated or unresolved conditions like unstable heart diseases requiring treatment, and poorly controlled diabetes mellitus. 3. body mass index (bmi) \<18.5. 4. unsuitable to participate in current study, according to researchers' assessment.

Keywords: nasopharyngeal carcinoma radiation oropharyngeal mucositis swallowing-induced breakthrough pain delineation method
anabolic effects of whey and casein after strength training in young and elderly

Conditions: Healthy; Young; Elderly

Summary: the aim of this study is to investigate the acute anabolic effects of native whey, whey protein concentrate 80 (wpc-80) and milk after a bout of strength training in young and elderly. the investigators hypothesize that native whey will give a greater stimulation of muscle protein synthesis and intracellular anabolic signaling than wpc-80, and that wpc-80 will give a stronger stimulus than milk.

increasing or maintaining muscle mass is of great importance for populations ranging from athletes to patients and elderly. resistance exercise and protein ingestion are two of the most potent stimulators of muscle protein synthesis. both the physical characteristic of proteins (e.g. different digestion rates of whey and casein) and the amino acid composition, affects the potential of a certain protein to stimulate muscle protein synthesis. given its superior ability to rapidly increase blood leucine concentrations to high levels, whey is often considered the most potent protein source to stimulate muscle protein synthesis. native whey protein is produced by filtration of unprocessed milk. consequently, native whey has different characteristics than wpc-80, which is exposed to heating and acidification. because of the direct filtration of unprocessed milk, native whey is a more intact protein compared with wpc-80. of special interest is the higher amounts of the highly anabolic amino acid leucine in native whey. the higher levels of leucine can be of great interest for elderly individuals as some studies in elderly has shown an anabolic resistance to the effects of protein feeding and strength training. by increasing levels of leucine one might overcome this anabolic resistance in the elderly. the aim of this double-blinded, randomized, partial cross-over study is to compare the acute fractional protein synthesis and intracellular signaling response to a bout of strength training and intake of 20 grams of protein from either native whey, whey protein concentrate 80 or milk, in young and old individuals. furthermore, the investigators wil investigate fractional protein breakdown, markers of protein breakdown, amino acid concentrations in blood. the investigators hypothesize that native whey will induce a greater anabolic response than whey protein concentrate 80, and that whey protein concentrate 80 will give a stronger anabolic response than milk.

Eligibility criteria:
inclusion criteria: * healthy in the sense that they can conduct training and testing * able to understand norwegian language written and oral * between 18 and 45, or above 70 years of age exclusion criteria: * diseases or injuries contraindicating participation * use of dietary supplements (e.g. proteins, vitamins and creatine) * lactose intolerance * allergy to milk * allergy towards local anesthetics (xylocain)
advancing vr-based attentional bias as a biomarker for tobacco use disorder

Conditions: Nicotine Addiction; Craving

Summary: the proposed project will include enrollment of 200 daily tobacco cigarette users, ages 22+, from the san diego community. participants will be assessed on the vr nicotine cue exposure paradigm then randomized (stratified on age and sex) to receive varenicline (target dose 1mg twice daily) or placebo (n per group=100; total n=200). following eight days of titration, participants will be assessed again on the vr nicotine cue exposure paradigm. they will then be followed via mobile assessments for eight days on target dose of varenicline, and 30-days post assessment by phone, to assess short-term nicotine use behaviors.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. persons, aged 22+ 4. ability to take oral medication and be willing to adhere to the dosing regimen 5. for participants able to become pregnant: use of highly effective contraception during study enrollment 6. current daily tobacco use (use on 7 days per week, on average, ≥5 cigarettes per day, in the previous 3 months) 7. tobacco use history ≥3 years 8. endorsement of past week nicotine craving exclusion criteria: 1. contraindications/conditions with special precautions for varenicline treatment (i.e., history of serious hypersensitivity or skin reactions to varenicline, history of severe renal impairment, seizures, severe cardiovascular disease, chronic or severe nausea, stevens-johnson syndrome, erythema multiforme, pregnancy or nursing) 2. medical or psychiatric history affecting brain development (i.e., history and/or treatment of neurologic disorders, severe head trauma with loss of consciousness \>2 minutes, or current severe diagnostic and statistical manual 5th edition (dsm-5) psychiatric disorders other than tobacco use disorders) 3. current suicidal ideation or history of suicide attempt or self-mutilatory acts in the past 12 months 4. other recreational drug use in the past 30 days (besides alcohol and cannabis) verified by oral and urine fluid toxicology 5. visual/vestibular problems that may make task completion difficult (i.e., motion sickness, difficulty balancing, blindness) 6. treatment seeking for tobacco use disorder/intent to quit within 30 days
effects of diet interventions on monocytes in metabolic syndrome

Conditions: Metabolic Syndrome; Hypertriglyceridemia

Summary: subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. blood samples are collected on day 1 and day 5 to examine lipid levels and circulating monocyte phenotypes.

subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. blood samples are collected on day 1 at fasting state and on day 5 at fasting state and 4 and 6 hours after the breakfast to examine lipid levels and circulating monocyte phenotypes.

Eligibility criteria:
inclusion criteria: * obese women and men with metabolic syndrome (ms) * fasting triglyceride (tg) equal to or greater than 150 mg/dl exclusion criteria: * \<21 years of age * perimenopausal, pregnant or breastfeeding women * current smokers * obvious inflammation or other acute illnesses * obesity due to endocrinologic disorders including polycystic ovary syndrome * partial lipodystrophy * diabetes requiring insulin or \>1 oral medication * fasting tg ≥650 mg/dl * a history of pancreatitis * myocardial infarction within the past 3 years * any hospitalization within the past 2 months * takes steroids.
the effect of therapeutic play on pain, fear, anxiety and physiological parameters and parents' satisfaction

Conditions: Child Behavior; Pain, Acute; Anxiety and Fear

Summary: in this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.

therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. this method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. in the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. no study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.

Eligibility criteria:
for the child; inclusion criteria: * being in the 3-6 age group, * at least one day of inpatient treatment in the pediatric clinics of selçuk medical faculty hospital * at least one invasive intervention in the treatment plan * to be able to understand and speak turkish * staying in a room with at least two beds exclusion criteria: * having a neurological disorder * not having a parent as a companion * receiving oral treatment only * hearing and vision problems * single bed capacity room or isolated room for the parent inclusion criteria: * staying with their child as a constant companion * to be able to understand and speak turkish * accepting to participate in the study the exclusion criteria: * not staying with your child all the time

Keywords: pain anxiety children nursing therapeutic play
a study to improve the awareness of mucopolysaccharidosis type ii in brazil

Conditions: Mucopolysaccharidosis (MPS)

Summary: the main aims of the study are to learn about the percentage of mucopolysaccharidosis type ii (mps ii) in adults in brazil as well as about the diagnosis process. no study medicines will be provided to participants in this study. the data available for participants diagnosed with mps ii in datasus (a database of the informatics department of brazilian health system) will be reviewed. no clinic visits will be required as part of participation in this study.


Eligibility criteria:
inclusion criteria: all mps ii cases of (international classification of diseases, 10th revision \[icd-10\] e76.1) at any age reported in datasus from january 1st, 2008 to september 30th, 2020 will be included. exclusion criteria: mps ii cases reported outside this period will be excluded.