Kornimate/medical-research-clean huggingface dataset:
assessment of molecular remission by aso-qpcr after bortezomib-dexamethasone (vel/dex) followed by asct

Conditions: Multiple Myeloma

Summary: the primary objective of this study is to determine the rate of molecular remissions (molr) assessed by aso-rq-pcr technique after induction treatment with bortezomib and dexamethasone (vel/dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (hdt-asct), and after hdt-asct in patients with multiple myeloma.

hdt-asct is so far considered the standard of care for younger patients with multiple myeloma (mm). current evidence indicates that quality of response is an important prognostic factor for long-term survival in mm. there are only very few data on molecular remissions (molr) determined by the most sensitive technique, allele-specific-oligonucleotide - real-time quantitative - polymerase chain reaction (aso-rq-pcr) in mm, and there are no data available on molecular responses after bortezomib-based induction therapy followed by hdt-asct. the main aim of this study is to determine molecular response rate after asct following bortezomib-based induction treatment compared to a historical control group with conventional vad induction treatment. a sensitivity of aso-rq-pcr technique will be compared to immunofixation and with immunophenotyping by flow cytometry.

Eligibility criteria:
inclusion criteria: * symptomatic multiple myeloma * age 18-65 years * written informed consent exclusion criteria: * who performance status ≥ 2, unless related to mm * severe cardiac dysfunction * history of hypotension * serious medical or psychiatric illness * severe hepatic dysfunction * severe polyneuropathy ≥ grade 2 * active, uncontrolled infection * previously treated with chemotherapy or extensive radiotherapy for mm * known hiv positivity * severe renal dysfunction with need of dialyses * history of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer * female patients who are pregnant or nursing * male or female patients of reproductive potential who are not practising effective means of contraception

Keywords: bortezomib plus dexamethasone induction therapy autologous stem cell transplantation molecular remission
comparison of atomoxetine plus either comparator or placebo in children with adhd who haven't responded to stimulant therapy

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release mph in children with treatment-resistant adhd.


Eligibility criteria:
inclusion criteria: * patients will be at least 6 years of age and not more than 12 years of age at visit 1 * patients must meet dsm-iv diagnostic criteria for adhd * patients must be retrospectively identified as stimulant non-responders * patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an iq test) * patients must be able to swallow capsules exclusion criteria: * patients who weigh less than 22 kg or more than 60 kg at study entry * patients who have a history of bipolar i or bipolar ii disorder, psychosis, or pervasive developmental disorder * patients who meet dsm-iv criteria for anxiety disorder or autism * patients with a history of any seizure disorder and/or rolandic seizures (other than febrile seizures) or prior electroencephalogram (ecg) abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control * patients with a history of severe allergies to more than one class of medication or multiple adverse drug reactions, including hypersensitivity to mph
safety, tolerability, pharmacokinetics, and pharmacodynamics of ionis angptl3-lrx in healthy volunteers with elevated triglycerides and participants with familial hypercholesterolemia

Conditions: Hypertriglyceridemia; Familial Hypercholesterolemia

Summary: the purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ionis angptl3-lrx (isis 703802) given to healthy volunteer subjects with elevated triglycerides and subjects with familial hypercholesterolemia.


Eligibility criteria:
inclusion criteria for all cohorts: * must have given written informed consent and be able to comply with all study requirements * males or females 18 to 65 years, inclusive, at the time of informed consent * body mass index (bmi) ≤ 35.0 kg/m2 * females must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal. * males must be surgically sterile, abstinent or using an acceptable contraceptive method inclusion criteria for cohorts, a, d, and aa to dd only: * fasting triglycerides (tg) ≥ 150 mg/dl at screening * fasting low density lipoprotein cholesterol (ldl-c) \> 70 mg/dl at screening inclusion criteria for cohorts b and c only: * fasting tg 90 - 150 mg/dl at screening * fasting ldl-c \> 70 mg/dl at screening inclusion criteria for cohort ee only: * homozygous fh diagnosis and fasting ldl-c ≥ 190 mg/dl (4.9 mmol/l) inclusion criteria for cohort ff only: * heterozygous fh diagnosis and fasting ldl-c ≥ 160 mg/dl (4.1 mmol/l) inclusion criteria for cohorts ee and ff only: * maximally tolerated stable ldl-c lowering agents (stable for at least 12 weeks) * on stable low-fat diet * stable weight (± 4 kg) for ≥ 6 weeks prior to screening exclusion criteria for all cohorts: * known history or positive test for human immunodeficiency virus (hiv), hepatitis c (hcv), or hepatitis b (hbv) * treatment with another study drug, biological agent, or device within one-month or 5-half-lives of screening * regular use of alcohol within 6 months of screening * use of concomitant drugs unless authorized by the sponsor medical monitor * known contraindication and/or allergy to heparin * smoking \> 10 cigarettes a day * considered unsuitable for inclusion by the principal investigator exclusion criteria for cohorts ee and ff: * myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to screening, or cerebrovascular accident within 24 weeks prior to screening. participants with adequately treated stable angina, per investigator assessment, may be included * congestive heart failure defined by nyha classes iii or iv * type 2 diabetes mellitus (t2dm) with hba1c \> 8.0% * prior treatment with gene therapy * currently receiving apheresis treatments or last apheresis treatment was within 8 weeks of screening

Keywords: angptl-3
effect of the copenhagen plank on aductional strenght and vertical jump in female football players

Conditions: Groin Injury; Muscle Injury

Summary: there is enough evidence to know the high incidence of groin injuries in soccer. despite this, there is not enough about these in women's football. the researchers perform the copenhagen plank to obtain an improvement in the improvement of adductor strength and the reduction of groin injuries

at present, there is enough evidence to know the high incidence of groin injuries in soccer. despite this, there is not enough about them in women's football. strengthening the adductor muscles is beneficial in preventing these injuries. the copenhagen plank is beneficial in programs for the prevention and treatment of groin injuries. a randomized controlled trial was carried out. the sample was made up of 26 players between 18 and 31 years of age from the cap ciudad de murcia soccer team. the experimental group (n=12) performed the copenhagen plank protocol for 4 weeks, the control group continued their training as normal. performance was assessed using the cmj jump and the hip adduction strength test using manual dynamometry. 3 measurements were made.

Eligibility criteria:
inclusion criteria: * girls of legal age * at least 4.5 hours of weekly training * active female soccer team players exclusion criteria: * current injury * injury in the previous 6 months

Keywords: groin pain adductors copenhagen plank strength
managing side effects in clinical practice

Conditions: Functional Gastrointestinal Disorders

Summary: this is a quality improvement health services study in the division of gastroenterology at beth israel deaconess medical center (bidmc).

the purpose of this study is to evaluate patients' reported experiences with regularly prescribed medications. no medications are prescribed as part of this study. rather, if a patient are prescribed a new medication during their regularly scheduled clinic visit, he/she may be eligible to participate. patients who agree to participate and who are prescribed a medication in clinic will be contacted by telephone or email 3 weeks after their appointment to evaluate positive and negative experiences with the medication.

Eligibility criteria:
inclusion criteria: * patient is seen in the division of gastroenterology at bidmc * patient is prescribed a medication for the treatment of functional gastrointestinal disorders that has not previously been tried by the patient exclusion criteria: * patient is not seen in the division of gastroenterology at bidmc * patient has previously taken the drug that is prescribed
spinal or epidural fentanyl or sufentanil for labour pain in early phase of the labour

Conditions: Labor Pain

Summary: in this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.


Eligibility criteria:
inclusion criteria: * primiparous parturients * in early phase of labour (cervical dilatation at or under 5 cm) * no prior opioids by any route of administration within past 120 min * pain at or over 80 mm on 0-100 mm visual analog scale during contraction exclusion criteria: * allergy for any of the medications used * contraindications for epidural/spinal analgesia * bmi at the time of delivery under 20 or over 35 kg/m2
comparison of regional block, caudal block and wound infiltration in inguinal hernitomy

Conditions: Postoperative Pain

Summary: background: although inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known. objective: the objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy

three hundred patients rom the department of pediatric surgery, kemu/mayo hospital, were randomized in three study groups by a computer generated table. regional block group (group a), wound infiltration group (group b), caudal block group (group c). . patients were assessed for postoperative pain intensity using flacc pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children less than 8 years of age. wong-baker faces pain scale at 0, 1, 2, 4, 8, 24 hours after surgery in children more than 8 years of age. patients were discharged after 24 hours. if pain score ≥ 4 was given intravenously, ketoralac. urinary retention was observed after 24 hours, wound infection was observed after 7 days.

Eligibility criteria:
inclusion criteria: * both male and female inguinal hernia patients * patients from 3-12 years age exclusion criteria * history of allergy to any drugs used in study documented on history .infection at the site of regional, caudal or local infiltration, documented on clinical examination. .irreducible, obstructed or strangulated hernia, documented on clinical examination.

Keywords: postoperative pain inguinal herniotomy children regional block caudal block wound infilteration
value-based care in type 2 diabetes (enhancing t2d care)

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes. this will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (tpe), as well as group and/or individual tpe-related activities/tools made available to patients, funded and encouraged for individualized planning. intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed type 2 diabetes (less than 10 years) * age (between 40 and 65) exclusion criteria: * significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician. * pregnant or breast-feeding women * persons who are unable to give signed informed consent
a study investigating routine practice of chronic thromboembolic pulmonary hypertension management in emea countries

Conditions: Hypertension, Pulmonary

Summary: the aim of the registry is the assessment of the diagnosis and treatment of cteph (chronic thromboembolic pulmonary hypertension) in emea (europe/middle east/africa) countries.


Eligibility criteria:
inclusion criteria: * female and male patients ≥ 18 years of age, diagnosed with cteph regardless of the current treatment * availability of a signed informed consent * who pulmonary hypertension clinical classification group iv (cteph): 1. right heart catheterization (rhc) results that are in line with both of the following haemodynamic levels: * mean pulmonary arterial pressure (pap) ≥ 25 mmhg at rest * pulmonary arterial wedge pressure (pawp) ≤ 15 mmhg 2. confirmation of cteph diagnosis by one of the following as recommended by standard guidelines: * at least 1 (segmental) perfusion defect(s) in ventilation/perfusion (v/q) scan or * pulmonary artery obstruction seen by mdct (multidetector computed tomography) angiography or * pulmonary artery obstruction seen by conventional pulmonary cineangiography (in case of suspicion/diagnosis of 'sub-acute' pulmonary embolism: patients who are treated with anti-coagulation for at least 3 months before diagnosis of cteph) exclusion criteria: * patients with an underlying medical disorder with an anticipated life expectancy less than 6 months * any medical condition which, in the opinion of the investigator, could jeopardize the safety of the patient or his/her compliance in the study, or otherwise make the patient inappropriate for study participation

Keywords: type iv pulmonary hypertension chronic thromboembolic pulmonary hypertension cteph
modified thoracoabdominal nerve block(m-tapa) in pediatric laparoscopic appendectomies

Conditions: Post Operative Pain; Laparoscopic Surgery; Pediatrics; Regional Anesthesia; Local Anesthetic

Summary: to compare the effect of m-tapa block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. the main questions it aims to answer are: * is m-tapa block more effective in reducing pain? * how m-tapa block affects the use of rescue analgesics in the postoperative period? participants will have the same anaesthetic agents during surgery, before extubation they will have same analgesic agent for postoperative pain. participants in the m-tapa group will undergo usg-guided m-tapa block bilaterally with % 0.025 bupivacaine max dose of 2 mg/kg by the same experienced anesthesiologist before extubation. participants in the lai group will be administered 0.025% bupivacaine at a maximum dose of 2mg/kg divided equally and administered by the surgeon at 3 port entry sites before the patient is extubated.


Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists (asa) physical status i-ii, * patients which will undergo laparoscopic appendectomy due to the diagnosis of acute appendicitis, * patients whose parents or legal heirs have consented to participate in the study exclusion criteria: * patients with society of anesthesiologists (asa) iii-iv status, * patients whose parents or legal heirs' disapproval, * patients inability to cooperate, * patients who have allergy to any of the medications used in the study, * patients with perforated appendix * when the laparoscopic surgery returns to open shape
an open-label safety and efficacy study of recombinant fviii in patients with severe hemophilia a

Conditions: Hemophilia A; Severe Hemophilia A

Summary: this multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rviii-singlechain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (ptps) with severe congenital hemophilia a and previous exposure to fviii products who achieve at least 100 exposure days (eds) to rviii-singlechain in this study, as well as in previously untreated patients (pups) with no previous exposure to any fviii product who achieve at least 50 eds to rviii-singlechain in this study. a substudy (open to both ptps and pups) will investigate the use of rviii-singlechain in surgery. a substudy (open to pups who develop an inhibitor to rviii-singlechain) will investigate the use of rviii-singlechain in immune tolerance induction (iti) therapy.


Eligibility criteria:
inclusion criteria: ptps: * males of any age who have been diagnosed with severe congenital hemophilia a (fviii activity levels \< 1%) and who participated in a previous csl-sponsored clinical study with rviii-singlechain. * males 0 to \<65 years age who have been diagnosed with severe congenital hemophilia a (fviii activity levels \< 1%), who have at least 50 eds to any fviii product, and who are not currently enrolled in a csl-sponsored clinical study with rviii-singlechain. pups: * males 0 to \<18 years of who have been diagnosed with severe congenital hemophilia a (fviii activity levels \< 1%) * no prior exposure to any factor viii product (with the exception of short-term use of blood products). iti substudy: * pups who have developed a confirmed inhibitor to rviii-singlechain in the main study. exclusion criteria: * known or suspected hypersensitivity to rviii-singlechain or to any excipients of rviii-singlechain or chinese hamster ovary (cho) proteins. * currently receiving a therapy not permitted during the study. * serum creatinine \> 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase \> 5 x upper limit of normal at screening (if specified) * any first-order family (eg, siblings) history of fviii inhibitors * for ptps not rolling over directly from a csl-sponsored clinical study with rviii-singlechain: any history of or current fviii inhibitors
irbesartan/hydrochlorothiazide (hctz) combination therapy for patients with moderate hypertension

Conditions: Hypertension

Summary: the purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (irbesartan/hctz), in patients who are unlikely to achieve blood pressure (b/p) control with only one drug. in addition, the study will also evaluate the safety and tolerability of the drugs.


Eligibility criteria:
inclusion criteria: * willing to provide written informed consent * subjects must have uncontrolled hypertension defined as: * average systolic blood pressure between 160 mmhg and 180 mmhg (while diastolic blood pressure is less than 110 mmhg) or * average diastolic blood pressure between 100 mmhg and 110 mmhg (while systolic blood pressure is between 130 mmhg and 180 mmhg) * subjects must be willing to discontinue their antihypertensive medication, if applicable. * men and women, ages 18 and older will be included. * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized. wocbp must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication. exclusion criteria: * women who are pregnant or breastfeeding * known or suspected secondary hypertension * hypertension emergencies or stroke within the past 12 months. * heart attack, angina or bypass surgery within the past six months. * significant kidney disease * significant liver disease * systemic lupus erythematosus * gastrointestinal disease or surgery that interfere with drug absorption * cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin * currently pregnant or lactating * mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study * drug or alcohol abuse within the last five years * known allergy to irbesartan or diuretics

Keywords: moderate hypertension
left atrial appendage arrhythmogenic and thrombogenic substrate

Conditions: Atrial Fibrillation; Stroke

Summary: the purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram. in connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. this procedure is common in patients with atrial fibrillation to protect the brain from stroke. in the project, all patients will have this auricle closed if they agree to participate in the project. after closure, the auricle is usually discarded. we will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.

patients scheduled for elective heart surgery are invited to participate. after informed consent is signed, an ecg and blood samples are gathered the day before surgery or the same day of the surgery is planned. during surgery, the patients undergo closure of the left atrial appendage (laa). the choice of the device is at the discretion of the surgeon. if possible, the entire laa is removed and processed for further analysis. the right atrial appendage is likewise removed and follows the same procedure as the laa. the analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers. the right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.

Eligibility criteria:
inclusion criteria: * signed informed consent and * planned any open-heart surgery: * cabg * valve repair or replacement * aorta surgery * any combination of the above exclusion criteria: * current endocarditis * follow-up not possible

Keywords: heart surgery atrial myocardiopathy arrhythmogenic substrate stroke cerebral transitory ischemic attack thrombogenesis cardiac embolism