Kornimate/medical-research-clean huggingface dataset:
improving the well-being of caregivers of cystic fibrosis patients during physiotherapy treatment

Conditions: Cystic Fibrosis

Summary: the main objective of the study is to determine the impact of cystic fibrosis affecting a child on the parents' quality of life, their possible anxiety and depressive symptoms, their general fatigue and the feeling of burden in these caregivers.

cystic fibrosis is the most common rare genetic disease in france, and in european countries in general. according to current epidemiological data, 80,000 people worldwide are affected. it represents a major public health issue, as it is a chronic disease that has a major impact on the life expectancy of affected patients. thanks to the latest medical advances, promising treatments are now available, helping to improve patient survival rates to over 40-50 years. among existing treatments, respiratory and musculoskeletal physiotherapy are highly recommended. it will play a key role throughout the life of a cystic fibrosis patient. patients with chronic respiratory diseases are at high risk of developing anxiety and depressive symptoms. as the disease worsens, the patient becomes increasingly dependent, leading to restrictions in participation and activities of daily living. as a result, the presence of family and friends is of paramount importance in ensuring that sick children adhere to treatment and take their medication. however, this workload on the part of a parent, who has to make major changes to their lifestyle in order to adapt to their child's treatment, can have a considerable impact on their well-being, and increase the risk of anxiety/depression, even leading to burnout. psychologists have studied the subject of assessing quality of life in parents of children with cystic fibrosis. at present, knowing that the quality of life of sufferers is as much affected as that of their caregivers, questionnaires have been introduced to assess parents' quality of life, notably the carerqol-7d . the aim of this study would be to raise the issue of exhaustion among parents of children with cystic fibrosis, and to consider how to reduce the impact of this heavy mental burden on them. this would contribute to better therapeutic adherence and improved treatment of children. to this end, questionnaires and interviews could be set up with parents, with the aim of developing a relevant and optimal action strategy for their children.

Eligibility criteria:
inclusion criteria: * parents (father, mother, dyads (father+mother) of children suffering from cystic fibrosis) who agree to answer the various questionnaires. exclusion criteria: -

Keywords: cystic fibrosis caregivers burden
further validation of the memory orientation screening test (most):a 5-minute screening test for dementia in primary care practice

Conditions: Dementia

Summary: the purpose of this study is to apply a recently developed screening test for dementia, the memory orientation screening test (most) to two additional groups. group one is composed of 150 elders who do not have dementia and are residing in the community so that we can determine what is a "normal" most score. these subjects will also be individually administered a one-hour battery composed of other commonly used tests of memory and information processing. group two is composed of 150 elders who are administered the most by a nurse as part of their regular visit to the primary care doctor's office, and their scores will be compared against a rating of their cognitive ability made independently by the doctor or another nurse. their scores will also be compared with a list of their medical problems and medications. our hypothesis for the first group is that the most scores will be higher in the normal group than in the previous clinical groups and that most scores will correlate significantly with other neurocognitive tests. our hypothesis for the second group is that the most can be administered quickly and easily by briefly trained nurses, that it will compare highly with doctor opinions, and that patients with known medical conditions related to dementia, such as hypertension or diabetes, will have lower most scores than patients in better health.


Eligibility criteria:
inclusion criteria: * age 65 or older exclusion criteria: * younger than 65, * diagnosed with dementia, * blind, * non-english speaking

Keywords: dementia screening tests cognition memory most
provoked craving relief study by nrt

Conditions: Smoking Cessation

Summary: this study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.


Eligibility criteria:
inclusion criteria: * smoking status: current cigarette smokers who have smoked regularly for at least a year and smoke their first cigarette more than 30 minutes after waking up. exclusion criteria: * allergy/intolerance: known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation. * prior concomitant medication: a. treatment with known enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit. b. use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit. c. use of any over-the-counter (otc) medication that affects central nervous system such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit. d. use of any nicotine replacement therapy or any other treatment for smoking cessation (e.g. bupropion or varenicline) within one month of screening visit. e. use of any nicotine containing products at any time during the provocation/treatment visit. f. use of any medications noted in the exclusion criteria, or use of any product that would, in the opinion of the investigator, jeopardize the safety of the subject or impact on the validity of the study results. * any disease that, in the opinion of the investigator, may interfere with the absorption, metabolism or excretion of the study product. a medical history that, in the opinion of the investigator, might jeopardise the safety of the subject or the validity of the study results. for example, recent myocardial infarction or cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, prinzmetals angina or severe cardiac arrhythmia. * expired carbon monoxide (co): any subject whose co level rises during the sequestration period (i.e., the subject's expired co assessments immediately prior to the provoked craving paradigm are higher than the mean baseline co assessment) and, in the opinion of the investigator, may have smoked during that time. * alcohol: consumption of any alcoholic beverage within 24 hours of the craving provocation visit, as indicated by a positive breath alcohol test.

Keywords: craving, provoked craving, smoking cessation, nicotine replacement therapy, nrt
neo-nervegenesis in inguinal hernia implant proflor

Conditions: Inguinal Hernia

Summary: the investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3d dynamic responsive implant for inguinal hernia repair.

biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3d prosthesis named proflor. scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. in the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. the development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. this kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

Eligibility criteria:
inclusion criteria: * patients who underwent inguinal hernia repair with the prosthetic device named proflor * patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named proflor * patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named proflor exclusion criteria: * patients who underwent inguinal hernia repair with conventional flat meshes

Keywords: hernia implants biologic response neo-nervegenesis regenerative scaffold
glucose levels in early pregnancy and feto-maternal outcome

Conditions: Maternal Diabetes

Summary: to find out whether variations in the fasting blood glucose in early pregnancy affect the fetomaternal outcome

retrospective study conducted on the records of patients who were seen at jordan university hospital in the period january 2016 to december 2020. all primigravid women with fbs that were done in early pregnancy before completed 20 weeks of gestation were included. exclusion criteria were known diabetics, multiple pregnancies, thyroid dysfunction, patients taking steroids or any other medications for chronic illness (s) and those with missing data. patients were divided into 2 groups; group had a fbs 80-120 mg/dl and group 2 with fbs less than 80 mg/dl. pregnancy outcomes were then compared between the 2 groups. gestational age was confirmed by early ultra-sound (us) scan before 16 weeks gestation. all fbs samples were measured at our laboratory. investigators collected data regarding patients' age, body mass index (bmi), fbs early in pregnancy, any complication in the pregnancy or the pregnancy outcome including miscarriage (defined as pregnancy loss before completed 24 weeks gestation), preterm delivery (defined as spontaneous vaginal delivery before completed 37 weeks gestation), gestational age at delivery, polyhydramnios, congenital abnormality (minor or major), stillbirth, intra-uterine fetal death (iufd), neonatal death and mode of delivery. for those who underwent cesarean section, the indications were also identified. fetal outcome included birth weight; apgar score at 1 minute and apgar score at 5 minutes. the apgar score was determined by the neonatologists who routinely attend deliveries at our hospital. investigators also identified those who were diagnosed to have gdm with any intervention (metformin or insulin and their dosages). diagnosis of gdm was based on a standard 75 gm glucose tolerance test (gtt) at 26-28 weeks gestation. a normal fbs level is lower than 95 mg/dl, one hour lower than 180 mg/dl, two hours lower than 155 mg/dl three hours after drinking the glucose solution, a normal blood glucose level is lower than 140 mg/dl.

Eligibility criteria:
inclusion criteria: * pregnant exclusion criteria: * thyroid disorder * diabetes mellitus * taking steroids
predictive value of serum and tissue molecular markers and imaging features in the invasiveness and prognosis of pituitary neuroendocrine tumors

Conditions: Pituitary Adenoma; Neuroendocrine Tumors

Summary: as the clinical manifestations of pituitary neuroendocrine tumors vary greatly, 2.7-15% of them are resistant to conventional treatments such as surgery, drug therapy and radiotherapy, and often relapse or regrow in the early postoperative period, which is invasive and has a poor prognosis. therefore, it is important to find imaging, histological or serum molecular markers for early prediction of the invasiveness and clinical prognosis of pituitary neuroendocrine tumors. the aim of this study is to observe the changes of biomarkers and imaging features in serum or tissues of pituitary neuroendocrine tumors during the course of disease and treatment, and to explore the biomarkers and imaging features that can predict the proliferation, progression and recurrence risk of pituitary neuroendocrine tumors after medical or surgical treatment.


Eligibility criteria:
inclusion criteria: patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by clinical imaging, with or without pituitary hormone secretion function was confirmed by pituitary hormone detection. exclusion criteria: 1. previous pathological specimen suggested pituitary carcinoma. 2. always have received radiation and chemotherapy or immune and targeted therapy of the patients. 3. with known genetic syndrome can cause excessive secretion of hormones (such as carney syndrome, mccune - albright syndrome, multiple endocrine neoplasia type 1, acute interstitial pneumonia) patients. 4. there are ectopic neuroendocrine tumor patients. 5. within one month before the screening for major surgery, or within 3 months before screening for patients with sphenoid pituitary surgery. 6. crisis of gland function (the pituitary gland, thyroid crisis, adrenal crisis). 7. peripheral glands or other solid tumors in patients with severe disease or blood system. 8. serious organ damage such as heart, kidney, liver, etc. 9. with severe mental or nervous system disease. 10. serious high blood glucose or poorly controlled hypertension or emergency patients.
an observational study of roactemra/actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this multicenter observational study will evaluate the use of roactemra/actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. eligible patients initiated on roactemra/actemra treatment will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis according to the revised (1987) acr criteria * patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe roactemra/actemra as monotherapy; patients who commenced roactemra/actemra as monotherapy within 8 weeks prior to the enrolment visit may be included * concomitant treatment with non-steroidal anti-inflammatory drug (nsaid) or corticosteroids (orally or intra-articularly) is allowed exclusion criteria: * patients who have received roactemra/actemra more than 8 weeks prior to enrolment visit * previous roactemra/actemra treatment in a clinical trial or for compassionate use * concomitant dmard treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) * treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting roactemra/actemra treatment * history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
assessing foot injuries in infantry recruits wearing different boots

Conditions: Blister; Abrasion; Stress Fracture; Ankle Sprain; Patellofemoral Pain Syndrome; Back Pain

Summary: one hundred infantry recruits will be randomly assigned to two groups. injuries will be monitored.

one hundred infantry recruits will be randomly assigned to receive experimental infantry boots (definite-regulator) or standard issued boots (modified belleville 390 trop). overuse injuries and foot injuries will be monitored over a period of 14 weeks. the intervention group will wear experimental infantry boots and the controls will wear standard issue boots.

Eligibility criteria:
inclusion criteria: * infantry recruits on selected base exclusion criteria: * none
safety and tolerability of nnc0141-0000-0100 in subjects with rheumatoid arthritis

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe. the aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of nnc141-0100 in subjects with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * a diagnosis of rheumatoid arthritis (ra) according to the american college of rheumatology (acr1987 classification) of at least 3 months duration prior to randomisation * active rheumatoid arthritis (ra) characterised by a das28-crp (disease activity score of 28 joints, calculated with crp (c-reactive protein) value) greater than or equal to 3.2 * females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control * males must be willing to use highly effective contraception * subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation
phase ii study of single agent osi-7904l in patients with gastric or gastroesophageal (gej) cancer

Conditions: Gastroesophageal Adenocarcinoma; Gastric Adenocarcinoma

Summary: multi-center, open-label, non-randomized phase ii study to evaluate the efficacy and safety of osi-7904l in gastric and gej cancers. those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.


Eligibility criteria:
inclusion criteria: documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction no prior chemotherapy for locally advanced or metastatic disease adequate baseline bone marrow, hepatic and renal function age \>= 18 years at least one target lesion exclusion criteria: active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, hiv, chronic alcohol abuse) symptomatic brain metastases which are not stable
study of experimental models of pain and inflammation.

Conditions: Pain; Inflammation

Summary: the experimental pain model studied in this proposal show characteristics of an inflamed wound with a pro-inflammatory response. this study will help discover candidate genetic and/or proteomic pain biomarkers that could provide objective and mechanism based tests to diagnose, monitor or quantify pain. we also hope to determine the measurable effects of a known non-steroidal anti-inflammatory drug (nsaid) on biomarkers of pain and inflammation.


Eligibility criteria:
inclusion criteria:1) age 18-60 2) skin type ii or iii according to classification of fitzpatrick 3) negative pregnancy test (women of childbearing potential) 4) willing and able to sign an informed consent form and health insurance portability and accountability act (hipaa) authorization and to comply with study procedures exclusion criteria:1) history of acute or chronic illness that may hinder study procedures or confuse interpretation of the data (e.g. dermatological, neurological, psychiatric or addictive diseases) 2) clinically significant cardiovascular, pulmonary, hepatic or renal diseases 3) major bodily injury within 3 months of study participation 4) surgery within 3 months of study participation 5) pregnancy or breast-feeding 6) intake of prescription drugs with anti/pro-inflammatory action 7) intake of prescription drugs with anti/pro-analgesic action 8) inability to abstain from any anti/pro inflammatory drugs during the 24-hour period preceding a study session 9) inability to abstain from any anti/pro-analgesic drugs during the 24-hour period preceding a study session 10) prior medical history that would contraindicate the use of nsaid, or previous negative reaction to nsaids or aspirin 11) inability to obtain at least 6 hours of sleep during the night preceding a study session
study of safety, tolerability and pharmacokinetics of serelaxin in japanese acute heart failure (ahf) patients

Conditions: Acute Heart Failure

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of iv infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 japanese ahf patients.


Eligibility criteria:
key inclusion criteria: * written informed consent must be obtained before any study-specific assessment is performed. * male or female ≥20 years of age, with body weight ≥30 kg and ≤160 kg * hospitalized for ahf; ahf is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening: * dyspnea at rest or with minimal exertion * pulmonary congestion on chest radiograph * bnp ≥350 pg/ml or nt-probnp ≥1,400 pg/ml * sbp ≥125 mmhg at the start and at the end of screening * able to be randomized within 16 hours from presentation to the hospital, including the emergency department * received intravenous (iv) furosemide of at least 40 mg (or equivalent) at any time between presentation (this include outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute heart failure (hf) episode. * impaired renal function defined as an estimated glomerular filtration rate (egfr) between presentation and randomization of ≥ 25 and≤ 75 ml/min/1.73 m2, calculated using the japanese formula key exclusion criteria: * dyspnea primarily due to non-cardiac causes * temperature \>38.5°c (oral or equivalent) or sepsis or active infection requiring iv anti-microbial treatment * clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment. * ahf due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \ 130 beats per minute.

Keywords: acute heart failure (ahf), japanese, safety and tolerability, pharmacokinetics, renal impairment