Kornimate/medical-research-clean huggingface dataset:
treatment of chemotherapy-induced nausea and vomiting

Conditions: Nausea; Vomiting

Summary: delayed nausea is a common problem after high dose chemotherapy for bone marrow transplantation. this study wants to compare standard prophylactic anti-emetic therapy with the same treatment plus the drug aprepitant (emend). the hypothesis is that addition of emend will reduce nausea and vomiting.

a single centre randomized placebo-controlled phase ii-study with a random assignment to experimental (exp) or control (ctr) group. all patients with lymphoproliferative diseases ≥18 years of age, scheduled for myeloablative therapy before autologous stem cell transplantation at the akademiska university hospital in uppsala, sweden, will be included consecutively during one and a half year. a total of 90 patients (45 per treatment arm) will be accrued for this study. they will be invited by mail to participate in the study a couple of weeks before hospital entry. a random assignment to exp or ctr will be performed by research nurses not participating in any other way in the study. patients will be stratified for diagnosis which also means myeloablative therapy (lymphoma (beac) or myeloma (high-dose melphalan)), and the groups are expected to be similar in size. one box for each diagnosis (lymphoma and myeloma) will contain equal numbers of randomisation cards for the experimental and control groups, randomly mixed within each box. cards will be picked consecutively by a research nurse not otherwise involved in the study. the exp group will receive aprepitant (emend®) in combination with standard anti-emetic treatment and the ctr group will receive standard anti-emetic treatment. all treatment will be given in the hospital.

Eligibility criteria:
inclusion criteria: * age ≥18 years * able to communicate in swedish * diagnosis of lymphoproliferative disease * scheduled for myeloablative therapy and autologous stem cell transplantation * written informed consent * able to swallow oral medications exclusion criteria: * nausea at baseline (immediately before start of chemotherapy) * gastrointestinal obstruction or active peptic ulcer * current illness requiring chronic systemic steroids or requirement for chronic use of antiemetic agent(s) * hypersensitivity to any component of the study regimen * pregnancy or nursing * unrelenting hiccups * radiation therapy to pelvis or abdomen within 1 week before or after study day 1 * psychiatric illness or multi-system organ failure * hepatic insufficiency with asat, alat three times over reference value * renal insufficiency with creatinin value three times over reference value.

Keywords: chemotherapy-induced nausea and vomiting cinv
study of branched-chain amino acids in cancer cachexia

Conditions: Cancer Cachexia

Summary: investigate whether supplementation with branched-chain amino acids (bcaas) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (lbm) based on body weight in kilograms (kg) and bioelectrical impedance assessment (bia).


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. eastern cooperative oncology group (ecog) performance status score \ 3 months 3. participants must have evaluable disease by recist 1.1 criteria17 4. at least four (4) weeks from prior major surgery 5. participants must be cachectic as defined by the guidelines below18 * \>5% weight loss over the past 6 months (in absence of simple starvation); or * bmi \ 2%; or * appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men \ 2% 6. participants must be anorexic as defined by reporting one of the following symptoms below3 * early satiety * nausea/vomiting * taste alterations * smell alterations * meat aversion exclusion criteria: 1. patients taking levadopa 2. patients with amyotrophic lateral sclerosis (als) 3. patients utilizing a percutaneous gastrostomy tube for drainage 4. patients unable to consume food or beverage orally 5. patients on any form of parenteral nutrition which contains bcaa. 6. serious non-healing wound, ulcer, or burn 7. patients who are pregnant or lactating 8. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements 9. concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

Keywords: oncology, cancer cachexia, cachexia anorexia,
use of a rapid diagnostic test for antibiotic de-escalation in severe community acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: the purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (scap). we hypothesize that when results from a rapid diagnostic test (rdt) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with scap without an increase in adverse events.

the purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (scap). we hypothesize that when results from a rapid diagnostic test (rdt) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with scap without an increase in adverse events.

Eligibility criteria:
inclusion criteria: 1. adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the micu service 2. meets one of the following: 1. have or plan to obtain a bronchoalveolar lavage (bal) 2. have or plan to obtain a quantitative endotracheal aspirate sample 3. have already produced a high-quality sputum sample if not intubated 3. primary micu attending and fellow willing to base antibiotic therapy on results of rdt exclusion criteria: 1. subjects with confirmed extrapulmonary infection requiring antibiotics outside the usual treatment for scap, with the exception of suspected uncomplicated urinary tract infection 2. neutropenic fever, defined as absolute neutrophil count \<1000/mm3 and absence of infiltrate on available chest imaging 3. chronic airway infection, defined as cystic fibrosis, lung transplant, or non-cf bronchiectasis 4. patient/surrogate refusal 5. inability to perform bal, nbbal, quantitative eta, or produce a high-quality sputum sample prior to 48 hours from hospital admission
evaluation of the peritoneal dialysis program in a hospital in chinandega, nicaragua.

Conditions: Chronic Kidney Disease; Peritoneal Dialysis

Summary: the purpose of this study is to develop recommendations to assist in improving the current peritoneal dialysis (pd) program in a hospital in chinandega, nicaragua. this project will consist of a needs assessment, a review of aggregate quantitative patient data from hospital records, and a knowledge, attitudes, and practices (kap) assessment for medical providers, laboratory technicians, patients and primary caregivers. the final report will be used to obtain funding for the implementation of the recommendations.


Eligibility criteria:
inclusion criteria: 1. participants must be affiliated with the pd program that is under evaluation exclusion criteria: 1. being physically unable to participate in an interview of approximately one hour 2. being younger than 18 years of age 3. refusal to participate
effect of brief mindfulness and relaxation inductions on anxiety, affect and brain activation in athletes

Conditions: State Anxiety; Affect; Electroencephalography

Summary: the athlete population has a high risk of suffering from mental health problems (e.g., anxiety), especially for athletes with individual sports. as such, various forms of mental training were used to maintain the mental health of athletes, such as mindfulness training or relaxation training. however, differences pertaining to the electrophysiological mechanisms resulting from both mental training in athletes are unknown. therefore, the purpose of the current study was to examine the differential effects between the brief mindfulness induction (mi) and relaxation induction (ri) on state anxiety, affect and the activation of the brain in track and field athletes.

the purposes of this study are: (1) examining the effect of brief mindfulness induction (mi) and relaxation induction (ri) on anxiety and affect in athletes with individual sports, (2) and we sought to identify the different brain activity (i.e., theta, alpha) changes between mi and ri using eeg. in the present study, subjects were contrasted using a within-subject comparison across mi, ri, and control condition. according to past works on the comparison of mindfulness and psychological skill training, we hypothesized that mi and ri would both improve anxiety and affect, compared with control condition. furthermore, we also hypothesized that ri would elicit greater theta power (i.e., more cognitive control) than mi. in addition, when compared with control condition, participants might be elicited greater alpha power during the mi and ri.

Eligibility criteria:
inclusion criteria: 1. track and field athletes with regular training 2. right-handedness 3. no history of neurological illness 4. no regular training experience in mindfulness or relaxation interventions exclusion criteria: -

Keywords: mindfulness relaxation mental health eeg cognitive resource
effects of moderate consumption of lean fish on weight loss

Conditions: Obesity; Overweight

Summary: the aim of present study is to compare the specific effects moderate consumption of lean fish on weight loss of healthy obese and overweight female adults, while participants follow energy-restricted diets also to investigate the effects of this intervention on carbohydrate and lipid profiles, as cardiometabolic risk factors.


Eligibility criteria:
inclusion criteria: * female * 18-45 years of age. * body mass index (bmi) between 27.5-35 kg/m² * must be able to have moderate exercise. * must be interested to lose weight exclusion criteria: * pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. * taking medications that could affect metabolism or change body weight. * report heart problems, chest pain, and cancer within the last five years. * use of supplements containing n-3 fatty acids, calcium or vitamin-d during the last 3 months. * consumption of fish and sea foods regularly * smoking * menopause * diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Keywords: lean fish weight loss diet
essence 2: cyclasol for the treatment of signs and symptoms of dry eye disease (ded)

Conditions: Dry Eye Disease

Summary: the objective of this pivotal trial is to assess the efficacy, safety and tolerability of cyclasol in comparison to the vehicle for the treatment of signs and symptoms of dry eye disease (ded).

this phase 3 study will assess the efficacy, safety and tolerability of cyclasol 0.1% ophthalmic solution administered bilaterally twice daily versus vehicle.

Eligibility criteria:
inclusion criteria: * signed icf (informed consent form) * patient-reported history of ded in both eyes * current use of otc (over-the-counter) and/or artificial tears for dry eye symptoms * ability and willingness to follow instructions, including participation in all study assessments and visits exclusion criteria: * women who are pregnant, nursing or planning a pregnancy * unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control * clinically significant slit-lamp findings or abnormal lid anatomy at screening * ocular/periocular malignancy * history of herpetic keratitis * active ocular allergies or ocular allergies that may become active during the study period * ongoing ocular or systemic infection at screening or baseline * wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study * use of topical cyclosporine a or liftigrast within 2 months prior to screening * intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period * presence of uncontrolled systemic diseases * presence of known allergy and/or sensitivity to the study drug or its components * randomized in a previous cyclasol trial
study on the effectiveness and differential usability of the up in spanish university students

Conditions: Emotional Disorder; Depression, Anxiety; Emotion Regulation

Summary: the present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the unified protocol (up) in its application in two cost-effective formats, the online group and the blended online group for the treatment of emotional disorders in university students in spain.

introduction: emotional disorders (eds) are the most common disorders among the young population. despite their high prevalence in university students, data suggest that only 16.4% of students suffering from a mental health disorder receive treatment. therefore, the present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the unified protocol (up) in its application in two cost-effective formats, the online group and the blended online group. method: the study population will be university students who meet diagnostic criteria for eds. we estimate a sample of 70 students, 35 per condition. the intervention will consist of the application of the 8 modules of the up in two formats: online group format of 8 weekly sessions of 2 hours duration and blended format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the up + autonomous work through the up-app). the variables evaluated will be collected before the intervention, in the post-treatment and in the follow-ups at one month and 3 months. this study responds to the need to implement services that improve the availability and access to the treatment of eds in the university context in spain, and in this particular case, through the formats offered by a transdiagnostic intervention such as the up.

Eligibility criteria:
inclusion criteria: * be enrolled at the university of cordoba (spain), in any of the degrees * have a diagnosis of anxiety or mood disorder from the structured interview for anxiety and related disorders, according to the dsm-5 (adis-5)\* * be at least 18 years old * be fluent in the spanish language * have a technological device (computer, tablet, cell phone) with internet connection * have a smartphone device with android operating system * in the case of taking pharmacological treatment for the treatment of their ed, maintenance of the same doses and medications for at least 3 months before starting their participation in the study and throughout the treatment * signature of the informed consent exclusion criteria: * have a diagnosis of obsessive compulsive disorder or post traumatic stress disorder * have a severe condition that requires priority for treatment will not be able to participate in the study. this includes a serious mental disorder (personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance abuse within the past three months.

Keywords: emotional disorders university students unified protocol blended format online interventions group formats
peripheral metabolic effects of somatostatin

Conditions: Acromegaly; Growth Hormone Deficiency; Diabetes

Summary: the aim of this study is to investigate peripheral effects of somatostatin on glucose metabolism and growth hormone (gh) signalling in healthy men. eight subjects will be enrolled. the hypothesis is that somatostatin infusion reverses insulin resistance caused by gh.


Eligibility criteria:
inclusion criteria: * bmi \< 27 kg/m2 * written informed consent * healthy exclusion criteria: * any disease * any use of medications * present or previous malignancy * alcohol dependency * allergy to trial medication

Keywords: gh signalling insulin resistance somatostatin acromegaly
study of intramuscular injections of onabotulinumtoxina to assess change in disease activity in pediatric participants with spasticity associated with cerebral palsy

Conditions: Spasticity

Summary: spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. this study will assess how effective onabotulinumtoxina is in treating pediatric participants with spasticity. change in disease activity will be evaluated. onabotulinumtoxina is approved drug for treatment of spasticity. approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across mexico. participants will receive onabotulinumtoxina as prescribed by their physician in accordance to local label and followed for 12 months. there is expected to be no additional burden for participants in this trial. participants will attend regular visits to a hospital or clinic in their routine practice.


Eligibility criteria:
inclusion criteria: * unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy. * naïve to onabotulinumtoxina treatment and who, according to medical and to the standard clinical practice criteria, will receive onabotulinumtoxina. * treated only with stable doses of short-acting muscle relaxants can be included in the study, at the investigator's discretion, for at least 30 days prior to treatment starting, under the concept that at the time the steady state of the drug (stable plasma concentrations) will theoretically have been reached. * under adjuvant treatment with orthoses and other orthopedic devices can be included in the study. * participants with physio/physical therapy can be included. exclusion criteria: * previously treated with botulinum toxin for spasticity related to cerebral palsy. * diagnosed with eaton-lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission. * history of hypersensitivity to the study drug or to any of the excipients in the formulation. * evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration. * participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate onabotulinumtoxina concomitant administration. * have had orthopedic surgery in the segment to be infiltrated in the 12 months prior to drug application.

Keywords: spasticity cerebral palsy onabotulinumtoxina
cvd nutrition education for low literacy esl students

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to promote cardiovascular health through nutritional education in a low literacy population enrolled in english as a second language (esl) courses in the san diego community college district.

background: the investigator originally applied for the grant in response to an nhlbi initiative on "cvd nutrition education for low literacy skills". the initiative originated within the prevention and demonstration branch of the deca, was approved by the september 1988 national heart, lung, and blood advisory council, and released in july 1990. however, the grant was not awarded as part of the rfa. design narrative: an estimated 1,800 students in 90 different classes were randomly assigned to the special nutritional intervention or an attention-control condition where a certification course in cardiopulmonary resuscitation (cpr) was taught. specially trained esl teachers actually led the intervention classes, which were designed in accordance with the nhlbi and american red cross guidelines, respectively. specific educational content for the intervention group included sources of dietary fat and cholesterol nutrients affecting blood pressure, basic shopping skills, food preparation skills , and dealing with special occasions, i.e., potlucks. a booster session was held to monitor progress, provide reinforcement for success or additional problem solving for difficulties, review materials, and plan maintenance. consistent with a social learning (cognitive) theory (slt) framework, all sessions included modeling\*, role playing, corrective feedback and social reinforcement, homework, and confidence building activities. with attention to the specific needs of this population which was low in literacy (at least in english), the smallest amount of information necessary was presented, each point was made as vividly as possible, participants restated and otherwise demonstrated their mastery of the material, and frequent repetition was used. a substantial period of formative research emphasized specific adaptations of existing material to make it appropriate for this population. measurement occurred at baseline, at three months and at a six months follow-up. measures included blood pressure, total cholesterol, height/weight, waist and hip circumference, 24-hour dietary recall, slt-based knowledge, attitude and behavior variables, the comprehensive adult student assessment system (casas) life skills reading test and spanish literacy through the cloze technique. all self-report measurement except the casas was conducted in english or spanish, primarily through oral interview. slt knowledge, attitude, and behavioral measures of instructors in study and non-study classes were also assessed.

Eligibility criteria:
no eligibility criteria
quality of life after bariatric surgery

Conditions: Bariatric Surgery Candidate; Obesity; Obesity, Morbid; Quality of Life

Summary: this study aims to assess long term outcomes for patients who have underwent bariatric surgery. in particular, it aims to assess the quality of life of these participants.


Eligibility criteria:
inclusion criteria: * obese, either received bariatric surgery or have been referred for bariatric surgery. exclusion criteria: * emergency cases, obese patients who have not been referred for bariatric surgery.