Kornimate/medical-research-clean huggingface dataset:
a clinical study of mk-8527 in participants with mild and moderate hepatic impairment (mk-8527-015)

Conditions: Hepatic Impairment; Healthy Participants

Summary: the purpose of this study is to learn what happens to mk-8527 in a person's body over time (a pharmacokinetic \[pk\] study). researchers will compare what happens to mk-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: all participants: * is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing * has body mass index (bmi) ≥ 18.0 and ≤ 40.0 kg/m\^2 * has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology participants with mild hi (group 1) and moderate hi (group 2): * has mild or moderate hepatic impairment * is generally in good health with the exception of hi healthy control participants (group 3): - healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ecgs exclusion criteria: the main exclusion criteria include but are not limited to the following: all participants: * has a history of cancer (malignancy) * has positive results for human immunodeficiency virus (hiv) * has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing participants with mild hi (group 1) and moderate hi (group 2): * with the exception of hi, has a history or presence of clinically significant medical or psychiatric condition or disease * is positive for hepatitis b virus (hbv) * is positive for hepatitis c virus (hcv)
exercise program on quality of life and stress in children undergoing hemodialysis

Conditions: Quality of Life

Summary: despite the benefits of physical exercises among children with chronic illness, the children avoid to engage in different physical activities because their parent and the child also were faired to happen any complication to child. the lack of activity and sedentary life style among these children result in reduced quality of life in addition to behavioral and social problems and finally become independent in most of activities of daily living. therefore, the primary aim of this study will to practice and teach the children exercise programs in order to improve the quality of life and reduce stress in children undergoing hemodialysis. therefore aim of this study is to: determine the effect of exercise program on quality of life and stress in children undergoing hemodialysis.

* the researcher will go to hospital and will take all children that present in hemodialysis unit, then will make random assignment of children to study or control group .the control group will receive routine care while the study group will receive exercise program. * the exercise program will conduct three days per week giving an interval of 24 hours between sessions. in the first hour the child not make any activity, then first 20 min from second hour of hemodialysis the child will receive stretching exercise, first 20 min from third hour the child will receive range of motion exercise finally first 20 min from forth hour the child will practice isometric exercise. * this procedure will continue for 2 months and the end of time the research will make posttest for both groups. the intensity for resistance training will determined individually. depending up on the child exercise tolerance, each set will performed 10 gradually increase to 15 repetitions.

Eligibility criteria:
inclusion criteria: * children aged from 6-18years with chronic renal failure. * all children are stable on dialysis for 2 months (blood pressure under medical control and stable blood sugar). * all children are free from lower extremity graft and any lower limb pathology. * children do not take exercise in 6 months before treatment. * willing to participate in the study and attend the exercise schedule. * children able to follow verbal commands. exclusion criteria: * children with physical disabilities. * children on tranquilizers or sedative medications. * children with a femoral dialysis catheter\& internal jugular vein catheter

Keywords: exercise quality of life stress hemodialysis children
extension study of abp-19000 to evaluate safety and efficacy of repeat treatments of abp-450 in cervical dystonia

Conditions: Cervical Dystonia

Summary: this open-label extension trial will evaluate the safety and efficacy of abp-450 for the treatment of cervical dystonia in adults. the study will enroll 60 patients across approximately 42 sites in the united states from phase 2 (abp-19000) trial. study subjects who had their initial dose of study drug in the phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this ole study.

this open-label extension trial will evaluate the safety and efficacy of abp-450 for the treatment of cervical dystonia in adults. the study will enroll 60 patients across approximately 42 sites in the united states from phase 2 (abp-19000) trial. study subjects who had their initial dose of study drug in the phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this ole study. study subjects will receive a predetermined dose of abp-450 between the low dose and high dose, based on the investigator's discretion and clinical judgment.

Eligibility criteria:
inclusion criteria: 1. qualified for and had their initial dose of study drug in the abp-19000 study. 2. provided written informed consent to being treated for cervical dystonia with abp-450. 3. were a male or female patient between 18 and 75 years of age (inclusive) when they entered the abp-19000 study. 4. stated willingness to comply with all study procedures, including attendance at the study center for all study visits as scheduled and have technological capabilities to have tele visits. exclusion criteria: 1. participated in another interventional study during participation in this study. 2. were a pregnant or lactating female, or female of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence). 3. would not benefit from treatment with abp-450 for their cervical dystonia, in the investigator's opinion. 4. viral or other active infection or any medical condition that, in the opinion of the investigator, classifies the patient as unsuitable for participation in the study or patients who do not seem to be in good general health at the time of day 0 "rollover", and prior to any investigational study drug administration.
general anesthesia or combined spinal-epidural anesthesia with ketofol sedation in colon cancer surgery?

Conditions: Colon Cancer; Anesthesia

Summary: anesthesia management in colon cancer surgery affects the postoperative mobilization, discharge and oral intake times of the patients. due to the side effects of opioids, their use is tried to be reduced and therefore regional anesthesia methods are preferred in suitable patients. especially in the preoperative period, opioid use has a negative effect on the recovery processes, morbidity and mortality of the patients. epidural analgesia, a central block method, is recommended for postoperative pain control in eras protocols. opioids suppress cellular and humoral immunity. epidural analgesia reduces both opioid consumption and surgical stress response. it has been shown that epidural analgesia maintains the immune functions of patients and is associated with a decrease in tumor recurrence. it has also been shown to reduce postoperative pain, hypercoagulability and pulmonary complications, increase exercise capacity and accelerate the return of intestinal functions to normal. in line with this information, in this study, it was aimed to investigate the differences in the postoperative period in patients managed with regional anesthesia. in the study, it was planned to create two groups who underwent open surgery for colon cancer. the first group will be operated under general anesthesia and the second group will be operated under combined spinal-epidural anesthesia with ketofol sedation. an epidural catheter will be inserted in both groups for postoperative pain management. in the study, patients' age, gender, weight, comorbidity, asa score, amount of local anesthetic used, postoperative vas scores, mobilization time, time to start oral intake, nasogastric withdrawal time, drain removal time, urinary catheter withdrawal time, hospitalization time and total cost will be evaluated.


Eligibility criteria:
inclusion criteria: * patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer exclusion criteria: * local anesthetic allergy * patients scheduled for laparoscopic surgery
efficacy, safety, and pharmacokinetic profile of etokimab (anb020) in adult participants with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study is designed to evaluate the efficacy, safety, and pharmacokinetic (pk) profiles of multiple doses of etokimab in adult participants with atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: 1. male or female participants must be 18 to 75 years of age, at the time of signing the informed consent. 2. body mass index (bmi) of 18 to ≤ 35 kilogram per square meter (kg/m\^2) at screening. 3. clinically confirmed diagnosis of ad. 4. eczema area and severity index (easi) score ≥ 16, body surface area (bsa) involvement ≥ 10%, and an investigator's global assessment (iga) score (5-point scale) ≥ 3 at baseline. 5. participants with a history of inadequate response to topical treatment, use of systemic treatments to treat ad, and/or for whom topical treatments are otherwise medically inadvisable. 6. daily use of non-medicated emollient for at least 7 days prior to baseline. exclusion criteria: 1. treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing. 2. prior exposure to an anti-interleukin (il)-33 antibody. 3. exposure to an investigational or licensed or other anti t-helper 2 (th2) type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer. 4. history of prior exposure to any investigational or biologic systemic treatment within 5 half lives of the screening or is currently enrolled in another clinical study. 5. have received systemic treatment for ad (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening. 6. history of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: anb020 etokimab eczema moderate to severe
study on the oral immune tolerance of cmpa infants using amino acid formula

Conditions: Cow's Milk Protein Allergy

Summary: the main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and open food challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.

this is a multi-center, prospective cohort study. this study plans to recruit 200 subjects. the suitable subject will be enrolled and there are seven visits through the 6-month study. efficacy parameters are the positive incidence of open food challenge test, growth and development index (weight, height, head circumference;), and the improvement of cmpa symptoms (such as scorad, gastrointestinal tract, respiratory, comfort scores).

Eligibility criteria:
inclusion criteria: * age: 0 to 6 months; * subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract) * unable to breastfeed; * vital signs are stable; * legal guardian has signed the informed consent. exclusion criteria: * subject with congenital and hereditary metabolic diseases; * digestive tract obstruction; * subject with immunodeficiency diseases; * subject who is allergic to known components of amino acid formula powder; * the investigator judges it is not suitable for the subject to participate in this study.

Keywords: cow's milk protein allergy open food challenge test immune tolerance amino acid formula
a study of eltrombopag and recombinant human thrombopoietin in primary immune thrombocytopenia

Conditions: Corticosteroid-resistant or Relapsed ITP

Summary: thrombopoietin receptor agonists (tpo-ra) are novel treatments for patients with refractory primary immune thrombocytopenia (itp). rh-tpo and eltrombopag increase the number of platelets through different mechanism. if there is cross-resistance between 2 drugs for the treatment of adult itp is still no answer. the purpose of this study is to investigate the efficacy and safety of switching eltrombopag and rh-tpo in adults with itp.

non-interventional study. patients who fail previous steroids and receive rh-tpo and then switch to epag or vice versa will be enrolled. the reason for switch will be recorded. patients in the rh-tpo group were given rh-tpo 300 u/kg once daily for 21 days, and those in the eltrombopag group were given eltrombopag 50mg once daily for 6 weeks. rh-tpo and eltrombopag were terminated any time the platelet counts increased above 100 × 10\^9/l in the rh-tpo group and 300 × 10\^9/l in the eltrombopag group. the efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.

Eligibility criteria:
inclusion criteria: 1.18 years or older 2.primary itp 3.platelet count ≤ 30 × 109/l 4.normal neutrophils, reticulocyte count, creatinine and liver enzyme values 5.available follow-up of 2 months at least for each period 6.failed initial glucocorticosteroid treatment 7.unwillingness to accept splenectomy or failed splenectomy - exclusion criteria: 1. hiv, hepatitis b or c, helicobacter pylori infection 2. malignancy 3. congenital or acquired immunologic deficit 4. history of thrombosis plus two or more risk factors 5. nursing or pregnant women 6. abnormal liver and renal functions: ast/alt/total bilirubin ≥1.5 × uln, creatinine ≥1.5 mg/dl 7. severe heart and lung dysfunctions -

Keywords: immune thrombocytopenia recombinant human thrombopoietin eltrombopag switching
levosimendan in patients undergoing lvad implantation

Conditions: Left Ventricular Dysfunction; Right Ventricular Dysfunction; Biventricular Failure

Summary: according to the results from the literature, it has been shown that levosimendan usage 24-48 hours before lvad implementation can improve short and long-term outcome in these patients regarding to the patients without preoperative pretreatment. the aim is to compare short and long-term outcome in patients who underwent to lvad implementation and pretreated with levosimendan regarding the patient without pretreatment or with other medications.

left ventricular assist device (lvad) implantation is accepted for treatment of end-stage heart failure, in both as the bridging to heart transplantation or as the destination therapy. these patients have highly impaired systolic function which contributes to global heart dysfunction. the main complication is arising of pulmonary vascular pressures and pulmonary vascular resistance (pvr) and, consequently, right heart dysfunction. from the data in literature, rv dysfunction exist in approximately 25%-40% of patients with implanted lvad, and in approximately 20%-30% of those died or have need for the rv assist device due to rv failure refractory to medications. capability of the rv to maintain appropriate output and the fill of the lvad is the main point for correct lvad functioning and patients' early and late postoperative outcome. preimplantation evaluation by echocardiography estimation of rv function, geometry and tricuspid valve function are the criteria for the diagnose of rv dysfunction. laboratory analysis which can lead to the diagnose of rv dysfunction are also included in preimplantation evaluation. specific inotropic therapy in patients with moderate or severe rv dysfunction and/or dilatation can improve rv function in preimplantation period. this is predominantly important in patients who were on the prolonged inotropic support with beta-agonist therapy before lvad implantation and in whom their beta receptors are exhausted. the investigators will exam the hemodynamic effects of levosimendan administrated day before in patients underwent lvad implantation. further, investigators will analyze and evaluate early and late outcome in participants with implanted lvad.

Eligibility criteria:
inclusion criteria: * all patients scheduled for lvad implantation exclusion criteria: * known patient's allergy on medication * patient's disagreement for the procedure

Keywords: heart failure left ventricular dysfunction
non cardiac chest pain and benign palpitations

Conditions: Anxiety/Depression in Cardiological Unit

Summary: all patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at cardiological out-patient clinic, molde hospital, about if they still have symptoms of chest pain or palpitation. if they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms. the coping course consist of three sessions of cognitive behaviour therapy.


Eligibility criteria:
inclusion criteria: * investigated for chest pain or palpitation 6 month ago at cardiological out-patient clinic, molde hospital * suffer of chest pain or palpitations exclusion criteria: * do not speak norwegian properly * mentally retarded * psychosis last 6 month * current alcohol or drug misuse

Keywords: anxiety panic disorder chest pain palpitations
assessing sleep in infants with atopic dermatitis by longitudinal evaluation

Conditions: Atopic Dermatitis; Sleep Disturbance

Summary: the spindle study will examine sleep in infants with atopic dermatitis by serial assessment over the first year of life, in comparison to infants without atopic dermatitis. sleep will be assessed using electroencephalography, actigraphy, and sleep questionnaires.

infants will be recruited at 6 to 8 months and followed up until 18 months of age. sleep electroencephalography will be performed at 6 to 8 months. sleep actigraphy will be performed at 6 to 8 months and 12 months. infant sleep questionnaires will be completed on a monthly basis, and parental sleep questionnaires will be completed at 6 to 8 months, 9 to 10 months, and 12 months. a neurodevelopmental assessment will be performed at 18 months.

Eligibility criteria:
inclusion criteria: - moderate to severe atopic dermatitis exclusion criteria: * premature birth (under 37 weeks gestation) * severe medical condition (such as epidermolysis bullosa or ichthyosis) at time of enrolment that would complicate assessment for ad or preclude the use of investigational tools, or other major health problems (especially genetic or metabolic) that would have implications for neurodevelopment * any medical condition requiring the using of sedating medications (eg antihistamines)
effect of vitamin d treatment in primary hyperparathyroidism

Conditions: Vitamin D Deficiency; Primary Hyperparathyroidism; Hypercalcemia

Summary: the primary aim of the study is to assess whether 6-months of vitamin d supplements can decrease pth compared with placebo treatment in primary hyperparathyroidism.

the study investigates effects and safety of six months of vitamin d supplementation before and after surgery in primary hyperparathyroidism. effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.

Eligibility criteria:
inclusion criteria: * p-ca-ion \> 1,30 mmol/l * p-pth \> 5 pmol/l * p-oh25-vitamin d \< 80 nmol/l exclusion criteria: * p-creatinin \> 120 mumol/l * usage of etalpha, mimpara * cancer * sarcoidosis * malabsorption * pancreatitis * alcohol abuse * pregnancy

Keywords: vitamin d primary hyperparathyroidism hypercalcemia
development of a questionnaire to assess patient knowledge about non-vitamin k anticoagulants (noac)

Conditions: Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis

Summary: pharmacists are in the best position to counsel and educate patients on anticoagulant agents such as noacs. this should enable patients to play a more active role in their treatment and ultimately enhance adherence behaviour. however, educational elements should be targeted to knowledge. thus, the investigators will develop and validate a questionnaire that can assess knowledge about noacs


Eligibility criteria:
inclusion criteria: * intake of a noacs (rivaroxaban, edoxaban, dabigatran, apixaban) * ≥18 years * able to give written informed consent in german exclusion criteria: * noacs for orthopaedic indication * dementia in medical history
effect of adding blood flow restriction to strengthening exercise in patients with patellofemoral pain syndrome

Conditions: BFR; PFPS; Strengthening Exercises; Quadriceps Strength; Dynamic Balance; Joint Position Sense

Summary: to study the effect of adding bfrt to strengthening exercises and compare it with strengthening exercises alone in improving, muscular strength, pain, function, joint position sense, and dynamic balance test (star excursion test). in patients with pfps.

background: patellofemoral pain syndrome (pfps) is a common condition characterized by anterior knee pain, particularly affecting individuals aged 15-30. it often involves lower limb muscle weakness, particularly in the quadriceps, which can exacerbate symptoms and affect functional performance. blood flow restriction training (bfrt) has shown promise in enhancing muscle strength and functional outcomes with reduced intensity compared to traditional high-intensity training. purpose: this study aims to compare the efficacy of combining bfrt with traditional strengthening exercises versus using strengthening exercises alone in improving muscular strength, pain, function, joint position sense, and dynamic balance in patients with pfps. methods: a triple-blinded, randomized controlled trial was conducted at the almenshawy general hospital, tanta, egypt. fifty patients with unilateral non-traumatic pfps, aged 18-35, were randomly assigned to either a strengthening exercises group (se group) or a bfrt plus strengthening exercises group (bfrt group). both groups underwent a 6-week intervention with three sessions per week. outcomes assessed included quadriceps and hip abductors strength, pain severity (visual analog scale), functional status (kujala patellofemoral score), joint position sense (measured by digital inclinometer), and dynamic balance (star excursion balance test).

Eligibility criteria:
inclusion criteria: * patient referred from orthopedic surgeon with diagnosis of patellofemoral pain syndrome pfps. * both genders. * bmi ranges from 18.5 to 29.9. * age ranges between 18 and 40 years experienced non-traumatic pfps onset of anterior knee pain for greater than 2 weeks. * pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting. exclusion criteria: * coexisting pathology around the knee, including patellar subluxation or dislocation. * other sources of anterior knee pain (bursa, fat pad). * previous knee surgery. * suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon. * any cardiovascular disease. * uncontrolled hypertension. * any lower limb trauma. * hip and ankle pathology. * bmi more than 30%. * pregnancy.

Keywords: pfps patellofemoral pain syndrome blood flow restriction training strengthening exercises dynamic balance