Kornimate/medical-research-clean huggingface dataset:
the ventriloquist puppet method for children under the inhaler treatment

Conditions: Hospitalism in Children

Summary: this study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on anxiety and fear level of children aged 4-6

although treatment methods appropriate to the disease are applied in respiratory system diseases, healthcare professionals must cooperate with the child and family regarding compliance with the treatment (oral, nebulizer, inhaler) and management of the disease. children may experience anxiety and fear from the moment they enter the hospital. they may react to being in the hospital and medical procedures such as crying, running away, or withdrawing. age, previous negative hospitalization experiences, and fear of getting sick are factors that shape children's medical fears. the majority of children have 'a little' or 'a lot' of fear about medical procedures. children have adaptation problems to the inhaler treatment and often reject it. to provide effective treatment, compliance of the child and family with the treatment and suitable application techniques are crucial. in this process, it is important to minimize the anxiety and fear of children and ensure that they receive the treatment in the best possible way. therapeutic approaches such as distraction cards, musical toys, and puppets during the preparation of the child for the procedure before the treatment can increase the child's compliance with the treatment and reduce the level of anxiety. in a study, puppet shows were useful in reducing the fears of children with 'a lot' fear. in another study, finger puppets as a play enhanced communication with children with cancer and were suitable for use in the hospital environment. it has been concluded that the use of puppets is beneficial because it gives children the opportunity to express themselves freely. an effort should be made to reduce the child's anxiety and fear by taking a therapeutic approach not only for invasive procedures but also for non-invasive procedures. therapeutic approaches can be applied to the child and family before, during, and after treatment. this study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on the anxiety and fear levels of children aged 4-6.

Eligibility criteria:
inclusion criteria: * children between the ages of 4-6, * children receiving inhaler therapy, * children and families who can speak turkish, * children and families who volunteer to participate in the research, exclusion criteria: * children with cognitive or mental problems, * children with life-threatening conditions, * children with hearing, vision and/or speech impairments

Keywords: children nursing puppet ventriloquist inhaler treatment therapeutic approach
human umbilical cord mesenchymal stem cell therapy (19#isclife®-ci) for cerebral infarction patients in convalescent period.

Conditions: Cerebral Infarction

Summary: this is a randomized, double-blind study. human umbilical cord mesenchymal stem cells (huc-msc) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. all participants will sign informed consent form, monitor vital signs, laboratory examination (ct/mri, blood routine examination, urine routine examination, liver function, renal function, etc.), nihss, fugl-meyer analysis (fma) 0-3 days before treatment. all of them will receive basic treatment with aspirin enteric-coated tablets and atorvastatin calcium. and experimental group will treat with huc-msc, control group with placebo (normal saline) on the 7th and 14th day. after the treatment, investigator will follow-up, monitor vital signs, laboratory examination, nihss, fma analysis on 2 weeks, 1 month, and 6 months after the treatment.

Eligibility criteria:
inclusion criteria: * proved cerebral infarction by ct or mri. * no cerebrovascular disease before * signed informed consent form exclusion criteria: * serious body and intracranial lesions (tumor, infection, etc.) * patients repeated cerebral infarction attacks * multi-foci of cerebral infarction * history of drug dependence and mental disease * disturbance of consciousness and non-compliance patients * subjects who are hiv positive * pregnant or lactation * donor: hiv infected, active hepatitis b/c infected, syphilis antibody positive * subjects/ donor: alcoholism, drug addicts or mental disease

Keywords: cerebral infarction umbilical cord mesenchymal stem cells
functional outcomes and quality of life in musculoskeletal tumor patients with distal femoral megaprostheses

Conditions: Distal Femoral Musculoskeletal Tumors

Summary: this study aims to evaluate the functional outcomes of patients with distal femur tumor prostheses in comparison to a matched control group.

the aim of this case-control study will be to compare functional outcomes-including results from the tug and 6mwt, knee flexor and extensor muscle strength, sagittal knee range of motion-and health-related quality of life between patients with distal femoral megaprostheses and healthy controls. by employing both traditional assessments and imu technology, the investigators will provide a comprehensive evaluation of functional recovery in this population, thereby informing clinical practice and rehabilitation strategies. two functional tests that will be conducted are the time up and go test and the 6-minute walk test. these tests will be administered using a non-invasive inertial measurement unit (imu), specifically the bts g-sensor inertial sensor (bts bioengineering, garbagnate milanese, italy), positioned at the s1 level to collect spatiotemporal gait data. these data will then be analyzed in comparison to values obtained from healthy participants. the assessment will include anamnesis and a complete clinical examination of tumor patients with distal femur megaprostheses undergoing surgery at hospital la fe in valencia, focusing on knee joint mobility and muscle group strength. subjective function will be evaluated using questionnaires such as the sf-36 for both cases and controls and the msts (musculoskeletal tumor society score) for cases.

Eligibility criteria:
inclusion criteria (cases group): * megaprosthesis of unilateral distal femur * tumor cause * ambulation capacity exclusion criteria (cases group): * neurological alterations prior to the inervention than affect the lower limbs or general movement * patient incapable of ambulation due to progression of his/her pathology * patient with palliative treatment for advanced tumor diseas * more than one ipsilateral or contralateral prosthesis * infection, traumatic or sequel to revision surgery cause

Keywords: megaprosthesis musculoskeletal tumor distal femur lower limb functional mobility quality of life case-control study inertial measurement unit
an investigation of the effects of erythromycin on the pharmacokinetics of the pregabalin controlled release tablet

Conditions: Healthy

Summary: the purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.

evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin cr tablet with and without erythromycin

Eligibility criteria:
inclusion criteria: * healthy male or females * between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 17.5 to 30.5 kg/m2 exclusion criteria: * illicit drug use * pregnant or nursing females * females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Keywords: pregabalin pharmacokinetics bioavailability bioequivalence
omarigliptin & trelagliptin in twelve healthy egyptian volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: the proposed study will consider the lc-ms/ms quantitative determination of omarigliptin \& trelagliptin after administration to twelve egyptian volunteers. the main aim of the study is to confirm that the developed lc-ms/ms method is applicable for the bio-assay of the drugs in the actual biological samples at the time of cmax (nearly about 1.5 hours). the design of the study is open labeled, randomized, one treatment, one period, single dose study. the concentration of the drugs after 1.5 h will be determined in healthy human subjects according to the ethical regulations of world medical association declaration of helsinki (october 1996) and the international conference of harmonisation tripartite guideline for good clinical practice. written informed consent was provided (attached and signed by the twelve volunteers) in order to be approved by the ethics committee of the faculty of pharmacy, the british university in egypt. the good health of the human subjects was confirmed by a complete medical history and physical examination. samples from twelve, healthy, adult, male, smoking, egyptian volunteers (age: 23-37 years, average weight: 81.6 kg, average bmi: 30.4) will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be analyzed by lc-ms/ms study (developed \& validated) after single oral dose administration of one marizev® tablet nominally containing 25 mg of omarigliptin (first arm as 6 volunteers) or one zafatek® tablet nominally containing 100 mg of trelagliptin (second arm as 6 volunteers). the blood samples (0.5 ml of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µl of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and lc-ms/ms determination will be applied. blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. the study will be conducted as per fda guidelines \& the evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.


Eligibility criteria:
inclusion criteria: * healthy volunteers * must be able to swallow tablets exclusion criteria: * insulin dependent diabetes * type-2 diabetes * hospitalized within 1 week
theta burst stimulation in pharmacologically untreated patients as sole antidepressant treatment

Conditions: Depression

Summary: this is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (itbs). this is a wait-list control study, and the arms differ in the start of the four-week treatment (either promptly i.e., at the beginning of the next week of work) or delayed (start of treatment in four weeks). the patients to be treated are those who refuse treatment with antidepressant medications. the effectiveness of the four-week itbs treatment is to be evaluated in comparison to a "watchful waiting" after 4 weeks. a interim analysis is planned after 36 patients.


Eligibility criteria:
inclusion criteria: * uni- or bipolar depression according to icd-10 * present episode at least four weeks * 18-70 years old * no intake and rejection of anti-depressant medication and * no adequate anti-depressant medication in the present episode * no or stable non-drug anti-depressant treatment (e.g. psychotherapy) * residency in germany, german speaking exclusion criteria: * contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker * relevant neurological or internistic diseases according to study investigator * participation in other trials during treatment * pregnancy or breatfeeding * legal care and placement in a psychiatric hospital * active suicidality
liposomal irinotecan with tas102 and bevacizumab for patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this study is being done to see if combining liposomal irinotecan with tas102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

this prospective phase ii, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-iri), tas102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if ras wild-type an anti-egfr agent. a total of 25 patients will be accrued at uw carbone cancer center. subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years. primary objective * to determine the progression free survival (pfs) of patients with metastatic colorectal cancer treated in the treatment refractory setting with liposomal irinotecan in combination with tas102 and bevacizumab. secondary objectives * to evaluate the objective response rate (orr) of liposomal irinotecan in combination with bevacizumab and tas102. * to assess the safety and tolerability of these regimens in this setting. * to determine the impact of the timing of irinotecan use in prior lines of therapy on the orr and pfs observed with these nal-iri containing treatment regimens

Eligibility criteria:
inclusion criteria: * patients must be ≥ 18 years of age * eastern cooperative oncology group (ecog) performance must be 0 or 1. * patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable. * the cancer must be mismatch repair proficient. * patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. if ras wild-type must have received prior anti-egfr therapy with either cetuximab or panitumumab. if ras wild-type and her2 positive then must have had a prior her2 targeted therapy. exclusion criteria: * uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy. * patients whose cancers possess braf v600 mutations are excluded. * patients must stop the use of strong inducers/inhibitors of cyp3a4 at least 2 weeks before initiating therapy. * patients must not have mismatch repair deficient or microsatellite instability high cancers. * patients must not have received prior tas102.
the effects of atorvastatin on the nitric oxide-system in patients with non-diabetic nephropathy

Conditions: Nephropathy; Cardiovascular Diseases

Summary: it has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. this effect can partly be related to a reduction in cholesterol levels in blood. nitric oxide (no) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. the purpose of this study is to investigate the effect of atorvastatin treatment on the no-system measuring renal and cardiovascular variables in patients witk chronic kidney disease.

subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. during treatment periods subject are given a standardized diet. on the examination days subject are given l-nmma(l-ng-monomethyl arginine citrate), a no inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after l-nmma infusion. renal function is measured by renal clearance of 51chromium-edta and urinary sodium, potassium and albumin concentration. urinary excretion of protein from ncc, nkcc and enac will be measured to evaluate channel activity in the nephron. central blood pressure, pulse wave analysis, and augmentation index are measured using sphygmocor® from atcor.

Eligibility criteria:
inclusion criteria: * men and women * minimum 20 years * chronic kidney disease * estimated gfr (egfr) between 30 and 90 ml/min exclusion criteria: * nephrotic syndrome * diabetes mellitus * anamnestic or clinical signs of significant heart, lung, lever, kidney, thyroid and brain disease * neoplastic disease * alcohol abuse, * drug abuse * pregnancy or nursing * blood donation within a month before examination * hgb \< 6,0

Keywords: nephrology atorvastatin l-nmma no
progrip versus proflor: two fixation free devices for laparoscopic inguinal hernia repair

Conditions: Hernia, Inguinal; Laparoscopic Surgery

Summary: there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. the progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. in contrast, the proflor concept introduces a 3d dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. this report presents the outcomes of laparoscopic techniques employing progrip and proflor in randomized clinical trial. the results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.


Eligibility criteria:
inclusion criteria: * bilateral inguinal hernia exclusion criteria: * recurrent inguinal hernia * incarcerated inguinal hernia * hernia not in the inguinal area * signs of obvious local or systemic infection * asa score \> 4 * presenting with unstable angina or nyha class of iv * pregnant * active drug user * immunosuppression, chemotherapy * chronic renal insufficiency * abdominal ascites * infection in area of the surgical field * bmi \>34

Keywords: hernia surgery inguinal hernia fixation free repair tapp laparoscopic surgery
pain sensitivity evaluation in respiratory patients

Conditions: Asthma; Pain, Chronic; Allergy

Summary: previous studies have reported that asthmatic or chronic pulmonary obstructive disease patients have an increased response to pain stimulus. however, this aspect has not been evaluated in allergic patients. additionally, the difference in pain sensitivity between asymptomatic period crisis have not been evaluated yet.


Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age. * accepted to sign the informed consent. * diagnosis of asthma or allergy. exclusion criteria: * cognitive impairment. * orthopedic pathologies limiting test performance. * active smokers. * neurologic pathologies limiting voluntary mobility.
efficacy of tpi asm8 during a 14-day allergen challenge

Conditions: Asthma

Summary: this is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled tpi asm8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.

two doses of tpi asm8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. sputum inflammation , mrna gene expression on target receptors, ecp , biomarkers of mast cells activation et pk profile will be studied.

Eligibility criteria:
inclusion criteria: * mild asthma, male and female aged 18-55 y.old * steroid-naive, non-smoker * dual responders exclusion criteria: * any chronic disease(unstable) * immunosuppressed, recent or ongoing steroid intake * methacholine pc 20 \> 16 mg/ml

Keywords: mild to moderate asthma allergen inhalation challenge
life enhancing activities for family caregivers (leaf 2.0)

Conditions: Caregivers

Summary: the goal of the proposed intervention, called leaf (life enhancing activities for family caregivers) is to reduce burden and increase well-being in alzheimer's disease caregivers through the practice of positive emotion skills. we will evaluate two methods of online delivery of leaf: facilitated and self-guided and compare them to an emotion-reporting waitlist control condition. if effective, the leaf program can be disseminated to alzheimer caregivers nation wide.

leaf 2.0 is a 3-arm, technology-based, randomized controlled trial (n = 500) in which family caregivers of patients with alzheimer's disease (ad) are randomly assigned to 1) the leaf intervention facilitated remotely via web (n = 200), 2) the leaf intervention self-guided online (n = 200), or 3) an emotion reporting control (n = 100) which will then cross over to the intervention after approximately 7 months, half to the facilitated arm and half to the self-guided arm. participants will complete a program that teaches them eight positive emotion skills which aim to reduce stress and burden, and increase positive affect. all aspects of the study (recruitment, consent, intervention, and assessments) are conducted online. to be eligible for participation in leaf 2.0, participants must identify as the primary family caregiver of someone with alzheimer's disease or alzheimer's-related dementia, and whose care recipient is not living in a care facility at the time of enrollment. "primary family caregiver" is defined as the person who spends the most time caring for the individual with alzheimer's disease in a non-professional capacity. participants must also be able to speak and read english, live in the united states, be at least 18 years of age, and have access to a reliable wi-fi connection. respondents are ineligible if they have already participated in a prior version of leaf.

Eligibility criteria:
inclusion criteria: * adult age 18 and over who identifies as the primary caregiver of a family member with alzheimer's disease or probable alzheimer's * care recipient does not reside in care facility * speaks and reads english * has access to high speed internet connection at home or a location where they can speak privately with a facilitator exclusion criteria: * care recipient lives in care facility * does not speak/read english * does not have access to internet * care recipient does not have alzheimer's disease

Keywords: caregiving psychological well-being alzheimer's disease positive emotion