Kornimate/medical-research-clean huggingface dataset:
palonosetron, ondansetron, and dexamethasone for delayed nausea and vomiting in autologous transplant patients

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: in this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. on the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. if the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.

in order to decrease this delayed cinv, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). in this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. on the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. if the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. the investigators hypothesize that this antiemetic schedule will significantly reduce the delayed cinv compared to historical controls

Eligibility criteria:
inclusion criteria: * candidate for high-dose chemotherapy and autologous hematopoietic stem cell transplantation * karnofsky performance status \>/= 60% * scheduled to receive one of the following conditioning regimens * beam * oral busulfan/cyclophosphamide with or without etoposide * carboplatin/etoposide * melphalan * negative pregnancy test * must be able to complete a daily nausea/vomiting questionnaire and quality of life exclusion criteria: * active infection requiring iv antibiotics * known active hepatitis b and/or hepatitis c or hiv infection * prior non-hematological malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer or other cancer from which the patient had been disease free for \>/= 5 years * uncontrolled medical problems including any of the following * diabetes mellitus * cardiac, pulmonary, hepatic or renal disease * myocardial infarction within the past 6 months * morbid obesity (bmt \>40) * history of cns metastases, psychiatric or cns disorders interfering with the ability to comply with the study * known hypersensitivity to 5-ht3 antagonists, dexamethasone and/or their components * intrathecal therapy within 24 hours before starting preparative regimen * receiving any antiemetic therapy 24 hours before starting preparative regimen * any 5-ht3 antagonist used as a rescue medication

Keywords: autologous stem cell transplant beam oral busulfan cyclophosphamide etoposide carboplatin melphalan
the influence of significant weight lost on the quality of voice

Conditions: Obesity, Morbid; Voice Alteration

Summary: the rate of obesity and bariatric surgery is rising steadily. though bariatric surgery influences on aspects such as endocrin analysis, finance, etc are well tested, quantitative and quality voice impacts have not been evaluated. the aim of the study is to recruit 50 patients who underwent bariatric surgery and compare voice quality in each of these patients before and after surgery.


Eligibility criteria:
inclusion criteria: * morbid obese * candidates for bariatric surgery exclusion criteria: * history of benign \\ malignant disease of the larynx. * history of head and neck tumors * history of radiation therapy of the neck * bmi under 30 pre-surgery

Keywords: obesity voice
perfluorocarbon perfused vitrectomy and 3d vitrectomy system in advanced diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: to investigate the feasibility and advantages of using perfluorocarbon liquid (pcl) perfusion to remove vitreous during suction-cutting vitrectomy using a dual, dynamic drive (3d)technology. in complicated surgeries in advanced diabetic retinopathy and retinal detachment


Eligibility criteria:
inclusion criteria: * advanced diabetic retinopathy with retinal detachment exclusion criteria: * retinal detachments of more than 6 months

Keywords: vitreoretinal surgery
a phase iii study of entecavir vs lamivudine in chronic hepatitis b subjects with incomplete response to lamivudine

Conditions: Chronic Hepatitis B

Summary: the purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis b.


Eligibility criteria:
* male and female subjects =/\> 16 years of age (or minimum age required in a given country) with history of hbeag-positive chronic hepatitis b infection; * incomplete response to current lamivudine therapy; * hbeag-positive; * absence of coinfection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis d virus (hdv); * absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease.
impact of immediate versus south african recommendations guided art initiation on hiv incidence

Conditions: HIV Infection

Summary: this trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of hiv at a population-level. the proposed strategy is a two steps process: * extensive hiv counselling and testing, and comprehensive prevention programme among a target population * immediate art initiation after hiv diagnosis, irrespective of cd4 count criteria. the underlaying trial hypothesis is that hiv testing followed by immediate art initiation of all hiv-infected individuals will prevent onward transmission and reduce hiv incidence in the population. this is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation. enrolment of a population of 22 000 individuals among which 4 400 are expected to be hiv-infected.

the trial objective is to estimate the effect of art initiated immediately after hiv diagnosis on the reduction in incidence of new hiv infections in the general population. it will be conducted in two phases: * first phase: aiming to evaluate the feasibility and acceptability of extensive hiv testing and early arv treatment initiation on a subset of the target population (hlabisa sub-district in kwazulu natal, south africa); completion on february 2014. * second phase: full implementation of the trial in the target population from may 2014. the proposed intervention has two components : * component 1 "test": hiv counselling and testing, and comprehensive prevention programme among the entire target population * component 2 "treat": art treatment initiation for hiv infected individuals following two strategies * control group: art initiation when eligible for treatment as per who guidelines * intervention group: immediate art initiation regardless of immunological and clinical staging

Eligibility criteria:
inclusion criteria: * aged 16 and more * member of a household in the designated cluster within the hlabisa sub-district of kwazulu natal in south africa * able and willing to give written informed consent for trial participation and/or hiv counselling and testing

Keywords: hiv prevention treatment south africa
adult providing access to the visual environment (pave) - glaucoma pilot

Conditions: Glaucoma

Summary: we wish to evaluate a potential training program for patients with glaucoma, to become more efficient users of prescribed low vision devices for distance and near vision tasks. we hypothesize that the devices will improve efficiency. prescribed devices will include a stand magnifier, a handheld magnifier, spectacle magnifiers for near vision, and a handheld monocular (telescope) and a bioptic telescope (spectacle-mounted telescope) for distance vision. the success of being able to use optical devices is dependent upon training. optical devices are currently accepted and used for patients with visual conditions that decrease their central vision. the bioptic telescope is a pair of glasses with a small telescope mounted within the carrier lens. the glasses look and feel like a normal pair of glasses, but have a black device (telescope) protruding from the top of one lens for better identifying distance objects. the spectacle magnifier is mounted in a pair of glasses also for near vision

you will be asked a series of oral questions regarding your health status and vision level of functioning (expectations of visual functioning form, nei-vfq, linear rating scale, and geriatric depression scale) in the vanderbilt eye clinic. you will undergo a mobility pre-test to assess your ability to find objects in the distance as well as read . you will undergo a low vision examination in the eye clinic. you will receive the optical devices and then receive brief instructions on the use of the devices . you will then undergo a pre-training evaluation. you will receive approximately 6 training sessions with your prescribed devices for up to 1 hour each time. you will return to the vanderbilt eye clinic for the post-training distance and near vision assessments with the devices . you will be asked the series of oral questions again regarding your health status and vision level of functioning .

Eligibility criteria:
inclusion criteria: * glaucoma patients with vision less than 20/40 exclusion criteria: - subjects must not have any significant physical mobility limitations and be willing to participate in the testing and training sessions.

Keywords: low vision glaucoma
ameliorating the obstacle of pap smear

Conditions: Pain

Summary: to reduce the procedural pain of pap smear, this study expects to apply the peak-end rule to pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. this study aims to conduct a randomized controlled study at a tertiary center, national taiwan university hospital (ntuh). the investigators expect to compare the recalled pain intensity of the intervention and control groups.

purpose: in order to reduce the procedural pain, this study expects to apply the peak-end rule to pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. methods: this study aims to conduct a randomized controlled study at ntuh. approximately 200 subjects are expected to be recruited. the investigators will utilize the peak-end rule by adding a non-painful step right after the most uncomfortable phase in the intervention group. all study subjects are requested to score on a numeric pain scale during the pap test. all operators experienced in techniques for performing a pap test should attend workshops for a standard operating procedure. a well-trained research assistant is also responsible for ensuring standardization of procedures to eliminate interoperator variability. the primary outcome was the recalled pain intensity at five minutes after the pap smear test.

Eligibility criteria:
inclusion criteria: * biological female * aged 30-70 * provision of written informed consent exclusion criteria: * pregnancy * active vaginal or uterus infection * incapable of understanding the numeric pain scales * prior cervical cancer diagnosis * prior hysterectomy, pelvic or vaginal surgery * ongoing menstruation * use of painkillers within 24 hours

Keywords: cervical cancer screening pap smear procedural pain peak-end rule
risk factors for covid-19 mortality

Conditions: COVID-19 Virus Infection; Population at Risk; Acute Respiratory Distress Syndrome

Summary: covid-19 pandemic has deeply burdened hospitals all over the world. a two-stage disease has been hypothesized due to quick worsening of clinical status after 7-10 days from the beginning of first symptoms, generally flu-like symptoms. predicting clinical worsening could help to address major efforts towards higher risk patients. during the last year most observational studies, generally retrospective, has been conducted, identifying some risk factors such as age, obesity, male gender, cardiovascular disease, copd, diabetes etc. the study goal is to collect systematically a variegate amount of clinical, biometric, laboratory and radiological data from patients admitted to the emergency medicine ward of piacenza hospital (italy), in order to prospectively analyze what characteristics are associated to higher risk of mortality.


Eligibility criteria:
inclusion criteria: * admission to the emergency medicine ward from the emergency department of piacenza hospital (italy) * confirmed covid-19 diagnosis through molecular test obtained from nasal-pharyngeal swabs in the emergency department * age above 18 exclusion criteria: * inability to obtain an informed consent due to neurological conditions. * patient's refusal to sign the informed consent * inability of researchers to recruit the patient in the first 24 hours from the admission.
foot and lower extremity exercises in adolescents with pes planovalgus

Conditions: Flat Foot

Summary: the study aims to determine and compare the effects of 8-week intrinsic foot muscle-strengthening exercises and lower extremity strengthening exercises in adolescents with pes planovalgus.


Eligibility criteria:
inclusion criteria: * age between the 12-18 years, * foot posture index-6 score \> 6, * navicular drop test value \> 1 cm, * body mass index between 18.5 - 25 kg/m2, * children with flexible pes planovalgus exclusion criteria: * presence of any pathology that prevents participation in exercises * diagnosis of any neurological, psychological, or metabolic disease * history of orthopedic surgery * use of insoles in the last 1 year * leg length discrepancy and scoliosis

Keywords: exercise foot posture foot kinematic
sutures versus polyglactin mesh in hiatal hernia repair

Conditions: Paraesophageal Hernia; Hiatal Hernia; Hiatal Hernia, Paraesophageal; Recurrence

Summary: paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. for symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. however, recurrence rates are high between 12 and 42%. in order to reduce recurrences, mesh has been used with various materials and techniques with conflicting results. non-absorbable mesh has been linked with adverse events including erosion of esophageal wall. traditionally used biological mesh materials are expensive and therefore problematic in routine use. use of polyglactin (vicryl®) mesh, which degrades in 6-8 week, has been reported in paraesophageal hernia surgery. previously, no randomized controlled trial comparing sutures only and polyglactin mesh has been performed. in this trial, the aim was to randomize total of 110 patients to receive sutures only or mesh repair. primary outcome was recurrence of paraesophageal hernia at 6 months after the repair based on computed tomography scan. secondary outcomes included symptomatic recurrences, reoperation rate, quality of life, reoperations up to 20-years after surgery and use of proton pump inhibitors up to 20-years after surgery.


Eligibility criteria:
inclusion criteria: * over 18 years old * type iii-iv peh with either radiologic or endoscopic confirmation * scheduled for laparoscopic peh repair * the informed consent is acquired exclusion criteria: * need for esophagus lengthening procedure (collis gastroplasty) * recurrent peh * emergency surgery * no written consent
hypothalamic functional magnetic resonance imaging (fmri) response to nutrients

Conditions: Obesity

Summary: the purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.

to measure fmri signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to iv glucose, fructose, and saline. the fmri response to these nutrients will then be compared in obese vs. lean subjects. frequently timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols, and to test associations between these levels and the fmri response.

Eligibility criteria:
inclusion criteria: * age 18 year to 45 years of age * bmi 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex. * at maximal lifetime weight. * weight stable for at least 3 months. exclusion criteria: * those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes. * subjects taking psychiatric or centrally-acting (cns) medications, or who are diagnosed with a psychiatric or neurological illness, including: depression, anorexia, bulimia, and seizure disorder. * subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery. * weight \> 350 lbs or girth \> 60 inches (the limits of the mr machine) * exercise \> 30 minutes, 3 times a week. * alcohol consumption \> 2 drinks / day. * weight \> 300 lbs (150 kg) (weight limit for mr machine). * blood glucose \> 100 mg/dl, abnormal creatinine or liver function tests. * illicit drug use. * pregnancy. * extreme dietary habits as determined by a gcrc nutritionist: very high or low dietary carbohydrate, protein, or fat intakes. * those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips. * those with claustrophobia.

Keywords: obesity
french renal epidemiology and information network (rein) registry

Conditions: End-stage Renal Disease

Summary: the renal epidemiology and information network (rein) registry was created in 2002 (after study pilot in 2001) to contribute to the development and evaluation of health strategies aiming at improving prevention and management of end-stage renal disease, and promoting clinical and epidemiological research in this field. it relies on a network of nephrologists, epidemiologists, patients and public health representatives, coordinated regionally and nationally.

the rein registry is intended to include all end stage renal disease patients on renal replacement therapy (rrt) - either dialysis or transplantation - living in lorraine area. new (incident) patients are reported from the first day of rrt. patients with a diagnosis of acute renal failure are excluded, i.e. those who recover all or some renal function within 45 days or are considered as such by experts when they die before 45 days. patients with pre-emptive grafts and those living with a functioning graft are identified from the transplant database. a set of basic items, including fixed and annually updateable items, was defined for all dialysis patients. five types of events are reported to the registry on occurrence from the first day of any treatment: (1) renal transplantation, (2) changes in dialysis setting, (3) changes in type of dialysis, (4) transient recovery of renal function and (5) death. the participation rate of centres in lorraine is 100%. a clinical research assistant visits every dialysis centre to verify the completeness of patient and event registration, by comparing reports to the registry with centre administration files. the rein guide defines all items to be recorded, includes coding instructions, and serves as a standard for all participating regions. rein consists of a partnership network and professionals whose biomedicine agency is the institutional support. the national level consists of a national coordination, a steering group and a scientific board. regional level includes a regional steering group led by nephrologist and epidemiological coordinators and an epidemiological unit.

Eligibility criteria:
inclusion criteria: * all patients with end stage renal disease on renal replacement therapy exclusion criteria: * patients with acute renal failure ( i.e. those who recover all or some renal function within 45 days or are considered as such by experts when they die before 45 days) * patient's refusal

Keywords: registry renal replacement therapy
written self-disclosure for youth abdominal pain

Conditions: Abdominal Pain

Summary: the aims are to evaluate: (1) the effectiveness of written self-disclosure (wsd) on health status of youth ages 12-18 with functional recurrent abdominal pain (rap); (2) whether effectiveness of wsd is similar for younger (12-14) and older (15-18) youth with functional rap; and (3) the feasibility and acceptability of wsd when extended to the pediatric health care setting.we will implement a randomized, controlled trial (rct) designed to compare health status in 140 youths (ages 12-18) with functional rap assigned either to standard medical care (smc) or wsd provided in the health care setting in addition to smc. health status will be measured at baseline and 3- and 6-months thereafter. primary measures of health status are symptom severity and episode frequency, consistent with the definition of rap. secondary measures of health are functional health, psychological distress, health-related quality of life, and health care utilization. total use and diagnostic tests will index health care utilization, collected for the 6-mos prior to and following baseline. mixed model anova or manova will be used to test directional hypotheses corresponding to the specific aims.


Eligibility criteria:
* ages 12-18. * diagnosis of rap by the examining pediatric gastroenterologist using apley's (1975) criteria: (a) 3 episodes of abdominal pain, (b) severe enough to interrupt activities and occurring, (c) over a period of at least 3 months, (d) without an identifiable organic cause (if an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis). * free of a known chronic health condition. * physical and mental ability to complete the procedures, as judged by dr. madan-swain. * consents to complete the protocol over the next 6 months. * parent(s) consents to participate and agrees to support the youth in completing the protocol. * access to a phone on the days writing sessions are to be completed at home.

Keywords: abdominal
study to examine safety, tolerability and effect on body weight of subcutaneous ac2307 in obese or overweight subjects

Conditions: Obesity; Overweight

Summary: a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous ac2307 in obese or overweight subjects.


Eligibility criteria:
inclusion criteria: - is obese with a body mass index (bmi) ≥30 kg/m\^2 to ≤45 kg/m\^2, or is overweight with a bmi ≥27 kg/m\^2 to \<30 kg/m\^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis) exclusion criteria: * has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start * has received ac2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (symlin®) or calcitonin * has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start * has donated blood within 2 months before study start or is planning to donate blood during the study

Keywords: obesity overweight weight loss amylin ac2307