Kornimate/medical-research-clean huggingface dataset:
clinical study to investigate the pk profiles and safety of ckd-385 in healthy volunteers under fed conditions

Conditions: Cardiovascular Diseases

Summary: clinical study to investigate the pharmacokinetic profiles and safety of high-dose ckd-385 in healthy volunteers under fed conditions

a randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose ckd-385 in healthy volunteers under fed conditions

Eligibility criteria:
inclusion criteria: 1. healthy adult aged more than 19 at the time of screening 2. those who had 18.0kg/m² ≤ body mass index (bmi) \< 30.0kg/m² # bmi=weight(kg) / height(m)² 3. those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination. 4. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ecg results at screening. 5. those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations. 6. those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product. exclusion criteria: 1. those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth). 2. those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug. 3. those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening. 4. those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs. 5. those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products. 6. those who have taken any drugs that may affect the clinical trial within 10 days. 7. those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products. 8. those who is unable to consume a high-fat meal provided during the study. 9. those who are deemed insufficient to participate in this clinical study by investigators.
the united kingdom thrombotic thrombocytopenic purpura registry (uk ttp registry)

Conditions: TTP - Thrombotic Thrombocytopenic Purpura

Summary: this is a uk (united kingdom) based registry, involving all sites treating newly presenting thrombotic thrombocytopenic purpura (ttp). from this registry, important epidemiological data will be obtained. admission and remission samples will be collected. dna will be collected and analysed from patients wishing to participate to determine if any link exists between mutations/polymorphisms and the risk of ttp. as part of nhs commissioning, we will be undertaking long term follow up, to understand the impact of acute ttp on morbidity and mortality.

the uk ttp registry started in january 2009, following 3 years mrc funding, involving uk collaboration from all sites treating ttp patients. it has resulted in a cohort of data and samples from uk ttp cases. the registry promotes a collaborative approach with all uk patients and physicians involved with this life threatening disorder. the uk ttp registry has been used to provide information for highly specialist commissioning via nhs england and moving forward will be required to provide data relevant to the uk ttp group and commissioners. university college london (ucl) haemostasis research unit (hru) will collect and collate the data and help administrate for those sites participating in the registry. however, adamts13 assays will no longer be subsidised. for those sites undertaking local assays, a record of cases will be shared centrally. the uk ttp registry will be part of the uk ttp group.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of ttp, defined by thrombocytopenia, maha which may be associated with clinical evidence of organ compromise.confirmed by severely reduced adamts13 levels and/or a positive antibody screen. * no age restriction. * consent for addition to the registry and collection/storage of admission information once in remission. * consent to collect, analyse and store edta sample once in remission. * consent to store samples once in remission (sample taken as part of standard care). * for sites undertaking adamts13 analysis, consent to send admission and remission samples for analysis relating to ttp. * follow up laboratory and clinical data at least yearly to identify any changes. exclusion criteria: * patients with cancer or transplant associated maha will not be included. * patients not wishing to be involved with the registry.
effects of phosphate binding with sevelamer in stage 3 chronic kidney disease

Conditions: Kidney Failure, Chronic; Cardiovascular Diseases

Summary: the purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patients aged 18 to 80 years * chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60 ml/min/1.73m2) * office blood pressure controlled to less than 140/90 mmhg for 12 months before entry into the study * total cholesterol less than 5.5 mmol/l exclusion criteria: * existing or previous treatment within 1 year with a phosphate binder or vitamin d analogue * uncontrolled hyperphosphataemia (serum phosphate \>1.8 mmol/l) * uncontrolled secondary hyperparathyroidism (pth \>80 pg/ml) * diabetes mellitus * pregnancy * moderate-severe cardiac valvular disease

Keywords: phosphate
efficacy and safety of ultrapulse carbon dioxide laser treatment in eyelid tumors

Conditions: Eyelid Tumor; Xanthelasma Palpebrarum; Pigmented Nevi; Keratosis

Summary: this study aims to assess the long-term efficacy and safety of ultrapulse carbon dioxide (co₂) laser excision in the treatment of eyelid tumors, including xanthelasma, pigmented nevi, keratoses, and so on.

-background: the assessment of the efficacy and safety of ultrapulse co₂ laser in treating eyelid lesions is crucial for clinical applications. this study aims to evaluate the effectiveness of super-pulsed co₂ laser in treating different types of eyelid lesions, particularly marginal and large lesions, to provide comprehensive clinical guidance and decision support. -main objectives: a retrospective analysis of the efficacy and safety of ultrapulse co₂ laser treatment for various types of eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. -study design: this study will include 1000 patients diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. all patients undergoing ultrapulse co₂ laser treatment. the evaluation will focus on the efficacy and safety of ultrapulse co₂ laser treatment for different types of eyelid lesions. -study population and anticipated enrollment: patients with eyelid lesions (n=1000) -inclusion criteria: clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. no history of photosensitivity, bleeding, or coagulation disorders willing to attend follow-up appointments as scheduled -exclusion criteria: presence of infection in the target area allergy to lidocaine keloid-prone or poor skin repair ability pregnant or lactating recent history of severe infectious diseases, active skin diseases, or major diseases affecting the cardiovascular, liver, kidney, endocrine, and hematopoietic systems history of malignant tumors or immune system disorders

Eligibility criteria:
inclusion criteria: * clinically diagnosed with eyelid lesions, including xanthelasma, pigmented nevi, keratoses, and so on. * no history of photosensitivity, bleeding, or coagulation disorders * willing to attend follow-up appointments as scheduled exclusion criteria: * presence of infection in the target area * allergy to lidocaine * keloid-prone or poor skin repair ability * pregnant or lactating * recent history of severe infectious diseases, active skin diseases, or major diseases affecting the cardiovascular, liver, kidney, endocrine, and hematopoietic systems * history of malignant tumors or immune system disorders
long-term follow-up of patients with alcoholic liver cirrhosis who had administered cellgram-lc in pmc-p-07 study

Conditions: Alcoholic Cirrhosis

Summary: this long-term follow-up is designed to evaluate the safety of patient with alcoholic liver cirrhosis who had administered cellgram-lc in pmc-p-07 study.

to evaluate the safety for 60 months after a single dose of cellgram-lc in patients with alcoholic liver cirrhosis.

Eligibility criteria:
inclusion criteria: 1. those who participated in pmc-p-07 clinical trials and received cellgram-lc 2. those who voluntarily agreed in writing to participate in this investigation exclusion criteria: -
liberal versus restrictive transfusion during symptomatic moderate anemia after hip arthroplasty

Conditions: Arthroplasty, Hip

Summary: the purpose of this study is to evaluate the effects of transfusion of red blood cells in treating postoperative dizziness in patients with moderate postoperative anemia after total hip arthroplasty.

hip arthroplasty is associated with bleeding and postoperative anemia. however, the optimal strategy for transfusing red blood cells (rbc) remains to be elucidated. postoperative anemia may cause dizziness and fatigue which delays early mobilization after surgery and may trigger the transfusion of one or more rbc units. however, it is not known whether the administration of 1-2 units of rbc to patients suffering from moderate postoperative anemia (hb 7.5 - 10 g/dl) will improve postoperative dizziness. thus, this randomized controlled study aims to evaluate whether the administration of 1-2 rbc units on the first postoperative day improves postoperative dizziness in patients undergoing total hip arthroplasty.

Eligibility criteria:
inclusion criteria: * age \> 18 and able to give consent * hip arthroplasty or hip revision arthroplasty * haemoglobin \> 4.8 mmol/l and \< 6.0 mmol/l on the first postoperative day * dizziness score ≥ 2. exclusion criteria: * large ongoing bleeding * has already received rbc during the current admission * new onset of cardiac arrhythmia suspected to be related to anemia * severe ischemic heart disease * renal failure with dialyses or oligouria / anuria.

Keywords: transfusion red blood cells postoperative dizziness hip arthroplasty
pain-relieving methods after laparoscopic hemicolectomy

Conditions: Postoperative Pain; Nerve Block

Summary: effects of transabdominal plain block and quadratus lumborum block after laparoscopic hemicolectomy. the pain relief, bowel function and discharge.

this study is proposed to explore the effects of transabdominal plane block and quadratus lumborum block after laparoscopic hemicolectomy. after laparoscopic hemicolectomy there is a need for good analgesia. when the analgesia is adequate the patients mobilisation, bowel function and discharge is faster. earlier, epidural block has been used for the analgesia but now the hemicolectomy is laparoscopic procedure and there is no need for central block anymore. still patients needs opioids after the operation. because of the opioids side effects, there is a need to find better analgesia methods. in this study investigators compare peripheral nerve blocks, transabdominal plane and quadratus lumborum, for analgesia after laparoscopic hemicolectomy. also investigators are comparing these analgesia methods and traditional orally analgesics. patients receive transabdominal or quadratus lumborum block after induction using ropivacaine 5 mg/ml 20 ml per side. the third group is a control group witch analgesia is taken care with traditional orally analgesics. after surgery investigators follow postoperative pain, opiate consumption, bowel function, nausea and mobilisation. investigators coal is to find if the transabdominal plain block or quadratus lumborum block prefer traditional analgesia methods after laparoscopic hemicolectomy.

Eligibility criteria:
inclusion criteria: adult elective hemicolectomy patients exclusion criteria: age under 18 years complicated diabetes mellitus lack of finnish language skill and/or co-operation chronic pain use of drugs that significantly influences the metabolism of paracetamol or opiate steroid medication in regular use significant liver-, lung- or kidney disfunction
low dose radiation therapy for severe-acute-respiratory-syndrome-coronavirus-2 (sars-cov-2), covid-19

Conditions: Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)

Summary: this study is to analyse the efficacy of ld-rt for treatment of severe-acute-respiratory-syndrome-coronavirus-2 (sars-cov-2).

management of patients with sars-cov-2 presents a great challenge in the ongoing pandemic. the inflammatory reaction, evident in the later stages of the disease, is linked with high mortality rates. pharmaceutical interventions at this stage often do not achieve the desired effects. low dose radiation therapy (ld-rt) has been utilized for treatment of inflammatory conditions because of its immunomodulatory effects. thus, ld-rt may be an option in sars-cov-2 based on pre-clinical models and early clinical data. this study is to analyse the efficacy of ld-rt for treatment of severe-acute-respiratory-syndrome-coronavirus-2 (sars-cov-2).

Eligibility criteria:
inclusion criteria: * age of male patients \>40 years * age of female patients \>50 years * patients with sars-cov-2 requiring mechanical ventilation * informed consent obtained by the legal representative of the patient exclusion criteria: * pregnancy

Keywords: low dose radiation therapy (ld-rt)
rhinitis, cognition and driving performance

Conditions: Seasonal Allergic Rhinitis; Driving Ability; Cognition

Summary: this study investigates the effects of allergic rhinitis (ar) on driving ability and memory functions. our group has previously shown that patients suffering from ar symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from ar symptoms. we will compare the driving performance of untreated, symptomatic ar patients with the performance of symptomatic patients that have been treated with either a systemic ar medication (a pill) or a topical medication (nasal spray)


Eligibility criteria:
inclusion criteria: * healthy volunteers known with seasonal allergic rhinitis * experienced drivers holding a license * 21- 45 years of age exclusion criteria: * asthma or other chronic illness * current psychoactive medication * history of drug abuse

Keywords: driving, memory, cognition
acuity functional impact and implementation outcomes evaluation

Conditions: Autism

Summary: this study will test feature enhancements to a behavioral therapy data collection software (motivity) that will add a new clinical decision support module, called acuity. acuity is a quality improvement (qi) intervention targeted at behavior analysts (bas) and behavior technicians (bts) that aims to improve the delivery of autism behavioral therapy. subjects will be staff recruited from existing motivity customers.

acuity is intended to provide significant improvements in treatment planning, progress tracking, trend monitoring, and dosage management. if successful, acuity will provide applied behavior analysis (aba) practitioners with a higher level of real-time insight into their clinical data, enabling more efficient and productive treatment. research has shown that first-generation systems fall short in supporting overworked bas who are overwhelmed with data. acuity will address critical shortfalls by enabling more agile corrective actions and data-driven planning across multiple aspects of treatment, providing practitioners with new levels of rigorous, real-time insight into their clinical data. acuity will help bas establish and adhere to realistic treatment timelines, and will proactively alert the ba to noteworthy trends in the data as they occur, such as learner performance issues, missed dosages, and significant changes in tracked behaviors. in doing so, acuity will support more responsive and effective treatment.

Eligibility criteria:
inclusion criteria: * behavior analysts and behavior technicians treating kids with autism * must be employed by one of the autism treatment clinics that have agreed to participate in the study. * must be employed by experiad customers who are using motivity software as part of their practice. exclusion criteria: * all people not listed above
amiodarone prophylaxis for atrial fibrillation in patients undergoing surgery for lung cancer

Conditions: Atrial Fibrillation

Summary: patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation. a retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period. amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population. amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.


Eligibility criteria:
inclusion criteria: * resection of the lung due to confirmed diagnosis of cancer pulmones. * elective operation (scheduled operation for at least one day) * ready to be randomized * patient must be at least 18 at time of operation exclusion criteria: * former operation of the lung * former heart surgery * bradycardia below 40 beats/ min * hypotension with systolic blood pressure below 80 mmhg * av-blockage of any degree or sick sinus node * qtc interval above 440 ms for men or above 460 ms for women * paroxysmal, persistent or permanent atrial fibrillation or flutter * former atrial fibrillation or flutter for more than a month. * pregnant or positive pregnancy test * breastfeeding * alat of more than twice the normal over limit * treatment with monoamineoxidase inhibitors (maoi) * allergy to one or more components in amiodarone

Keywords: atrial fibrillation, amiodarone
gabapentin versus estrogen for the treatment of hot flashes

Conditions: Hot Flashes

Summary: to compare the efficacy and safety of gabapentin, estrogen and placebo in the treatment of hot flashes and other climacteric symptoms.

hrt is associated with an increased risk of thrombo-embolic events, breast cancer and cardiovascular events. safe, effective, and well-tolerated alternative therapies for hot flashes are needed. gabapentin is a gamma-aminobutyric acid (gaba)-analog that we have reported is associated with a reduction in the frequency of hot flashes in postmenopausal women who were taking gabapentin for other indications. however, it is not known whether the efficacy of gabapentin in the treatment of hot flashes and other menopausal symptoms is comparable to that of estrogen, the gold standard. for this study, 60 subjects are to be recruited and randomized into 3 arms of 20 each (gabapentin, estrogen and placebo).we will perform an analysis of the results after all 60 subjects have been recruited, screened, enrolled and completed the study. the investigators of the study continue to be blinded to the study groups and their randomization. to determine if gabapentin approaches the efficacy of estrogen in the treatment of hot flashes,postmenopausal women between ages 35 and 60 with 7-20 moderate-severe postmenopausal hot flashes/day will be randomized into a double-blinded placebo controlled trial of estrogen, gabapentin and placebo. all patients must meet stringent inclusion and exclusion criteria. pre- and post-study hot flash diaries, depression and climacteria scales will be collected. patients are required to undergo physical examination and blood work and to complete a daily hot flash and medication compliance records. hot flash frequency and composite score for hot flashes will be calculated for the three groups based on the hot flash diary. side effects, climacteric scale and depression scales will also be used.

Eligibility criteria:
inclusion criteria: 1. menopausal women between ages 35-60 2. must experience 7-20, moderate-severe hot flashes/day or 50-140 moderate-severe hot flashes/week for greater than two months 3. must have had a bilateral salpingo-oopherectomy for \>12 months or amenorrhea\>6 months or #4 (below) 4. has an fsh\>30 miu/ml 5. must have a signed informed consent 6. able to function independent in all activities of daily living and be capable of reliable documentation exclusion criteria: 1. any contraindication to estrogen and progesterone replacement therapy 2. history of an mi, stroke, and/or functional decline. 3. fails to record data in the hot flash diary\>3 days during the 2 week baseline period. 4. unable or willing to make required visits at the specified times over the course of therapy. 5. history of any malignancies or undiagnosed vaginal bleeding. 6. history of chronic liver, gallbladder, chronic renal, cardiac or endocrine diseases

Keywords: hot flashes postmenopausal climacteric symptoms hormone replacement therapy gabapentin
effects of a pedometer-based unsupervised exercise program upon lifestyle physical activity of asthmatic adults

Conditions: Asthma

Summary: the purpose of this study is to determine whether a pedometer-based unsupervised exercise program is more effective than a general exercise recommendation to increase lifestyle physical activity in adult patients with asthma.

the patients will be randomized in two groups: the intervention group will receive a standardized advice to physical activity practice plus pedometers and step goals to achieve over the next twelve weeks and the control group will receive the same standardized advice to physical activity practice and usual care.

Eligibility criteria:
inclusion criteria: * asthma diagnosis for at least 6 months (according to global initiative for asthma criteria) * regular drug therapy (inhaled corticosteroids or inhaled corticosteroids plus long-acting beta-agonists) * clinical stability during the run-in period (3 weeks) exclusion criteria: * physical activity practice over once a week * disabling musculoskeletal disease * cardiopathy * other lung disease * more than 10 pack-years of smoking * pregnancy * refusal to participate

Keywords: physical activity pedometers quality of life