Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and kinetics study of octagam 10% in primary immunodeficiency diseases

Conditions: Immunologic Deficiency Syndromes

Summary: octagam is a human normal immunoglobulin (igiv) solution for intravenous administration. octagam 5% is currently registered in more than 60 countries. this study will evaluate the efficacy, safety and the kinetics of octagam 10% for replacement therapy in primary immunodeficiency diseases.

the primary objective of the study is to investigate the safety of octagam 10% in replacement therapy in pid and to compare the pharmacokinetic profile of octagam 10% with that of the previously used octagam 5%. the secondary objective is to investigate the efficacy of octagam 10% in replacement therapy in pid by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum igg and igg subclasses (igg1, igg2, igg3 and igg4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of primary immunodeficiency (acc. who) * previous treatment with commercial octagam 5% every 3-4 weeks for at least 6 infusions intervals * documented igg trough levels of the two previous infusions before enrollment with a value of at least 5.5 g/l for both exclusion criteria: * acute infection requiring intravenous antibiotic treatment within two weeks before screening * exposure to blood or any blood product or derivative other than commercially available octagam 5%, within the past 3 months * history of hypersensitivity to blood or plasma derived products * requirement of any routine premedication for igiv treatment * history of congenital impairment of pulmonary function * severe liver function impairment * severe renal function impairment or predisposition for acute renal failure * history of autoimmune haemolytic anaemia * history of diabetes mellitus * congestive heart failure nyha iii or iv * non-controlled arterial hypertension * history of dvt or thrombotic complications with igiv treatment * known infection with hiv, hcv or hbv * treatment with steroids, immunosuppressive or immunomodulatory drugs * planned vaccination during study period * pregnant or nursing woman
detection of circulating tumor dna through liquid biopsies in ovarian cancer patients and evaluation of prognostic and predictive values of circulating tumor dna assay.

Conditions: Ovarian Cancer

Summary: ovarian cancer is the eighth most common cancer in women in korea, with 2,600 cases occurring annually, and the number of cases is steadily increasing. there is no practical method for early detection of ovarian cancer, and 75 percent of patients are diagnosed with advanced stage. the treatment of ovarian cancer is based on surgical removal and platinum-based chemotherapy. the cell-free dna (cfdna) test has the advantage of being able to track and monitor mutations of tumor origin noninvasive. the objective of this study was to assess the feasibility of circulating tumor dna (ctdna) as a biomarker for cancer recurrence in ovarian cancer after surgery. diagnosis and prognosis evaluation using conventional methods such as ca-125, radiologic examination (ct), had limitations in diagnosing and prognostic observation of ovarian cancer. for precise diagnostic purposes, ca-125 had limitations because it was detected as positive value when the tumor size is enough large or states of metastasis, and ct-based diagnosis is practicable only when the size of tumor is detectable. however, cell-free dna can be detected even if the tumor size is small because it detects very small amount of mutation gene in the blood. in addition, the detection of tumor cell dna from circulating blood can be a clinical decision making point whether to continue or stop chemotherapy. in this study, the investigators collect whole blood from patients with ovarian cancer undergoing surgery. control samples will be obtained from patients undergoing surgery for benign adnexal disease with ca125 \>35u/ml. in ovarian cancer patients, blood samples will be collected prospectively every 3 months after surgery. mutations found at the initial sample will be monitored during chemotherapy to investigate the ctdna pattern. the primary outcome will be progression free survival (pfs).


Eligibility criteria:
inclusion criteria: 1. female, over 19 years of age; 2. patients with epithelial ovarian cancer 3. patients with serum ca-125 \>35 u/ml exclusion criteria: 1. patients in pregnancy 2. patients being treated for cancer of other organs, including gynecological cancer. 3. patients who has difficulty reading and understanding korean. 4. the tester's determination that the patient will not be able to comply with the clinical trial procedures. 5. patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.
immune responses to the flu shot during pregnancy

Conditions: Pregnancy

Summary: this study will examine effects of everyday life stress and obesity on immune responses to influenza virus vaccine (the flu shot) during pregnancy. following vaccination, antibody levels against influenza (the flu) increase. higher antibody levels indicate better immune protection from influenza. in addition to providing protection from the flu for yourself, being vaccinated during pregnancy may protect your baby from the flu during the first six months of life during which time infants cannot be vaccinated. our primary goals are to determine whether greater life stress and obesity reduce 1) antibody responses to the flu shot in women and 2) antibody levels in the newborn at the time of delivery.


Eligibility criteria:
inclusion criteria: * less than 29 weeks pregnant * ages 18-42 * planning to deliver at the ohio state university wexner medical center exclusion criteria: * prior serious adverse reaction to seasonal influenza vaccine

Keywords: pregnant flu shot influenza vaccine
a pilot study of needle size and pain perception with botulinum toxin a injections

Conditions: Pain

Summary: the purpose of this study is to compare the levels of pain resulting from injections of botox® for wrinkles on the forehead and between the eyes using two different sized needles (32 gauge and 30 gauge needles).

subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin a using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. this study is a pilot study designed to determine feasibility of these procedures.

Eligibility criteria:
inclusion criteria: 1. in good health 2. is a female 3. is 25-70 years of age 4. has moderate dynamic forehead/glabellar wrinkles 5. has willingness and the ability to understand and provide informed consent and communicate with the study staff exclusion criteria: 1. younger than 25 or older than 70 years of age 2. pregnant or lactating 3. is a male 4. has received the following treatments in the forehead or glabellar region: 1. botulinum toxin injections in the past 6 months 2. ablative laser procedure in the past 6 months 3. radiofrequency device treatment in the past 6 months 4. ultrasound device treatment in the past 6 months 5. medium to deep chemical peel in the past 6 months 6. temporary soft tissue augmentation material in the area to be treated in the past year 7. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years 8. permanent soft tissue augmentation material in the area to be treated 5. has an active infection in the forehead or glabellar region (excluding mild acne) 6. is allergic to cow's-milk protein 7. is allergic to albumin 8. taking aminoglycoside 9. is currently using anticoagulation therapy 10. has a history of bleeding disorders 11. has a mental illness 12. unable to understand the protocol or to give informed consent
mental practice and manipulative skills training in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: introduction: multiple sclerosis (ms) is a demyelinating disease of the central nervous system which produces both motor and cognitive dysfunctions. ms causes a decline in the performance of activities of daily living (adl) due to impairments affecting limb function. aim: this pilot study sought to determine whether the use of mental practice (mp) or the combined use of mp and the training of manipulative skills would improve the manipulation motor skills and treatment satisfaction among people with ms. methods: the study participants were people with ms. blinded evaluators performed three assessments for each patient (pre-treatment, post-treatment and at a three month follow up). the patients were divided into three groups with alternate allocation: (a) mental practice, (b) mental practice + skills training and (c) control group. keywords: activities of daily living; manual dexterity; mental practice, motor image; multiple sclerosis.


Eligibility criteria:
inclusion criteria: * patients diagnosed with ms of the rrms and spms subtypes, without the presence of flare-ups during the past three months and aged between 25 and 60 years; * an expanded disability status scale (edss) score of ≤7, * not presenting depressive symptoms (measured using the beck depression inventory, bdi), * not presenting cognitive decline, measured using the montreal cognitive assessment (moca) or minimental status examination. * in addition, they had to be regularly attending physical therapy and/or occupational therapy rehabilitation treatments.
povidone-iodine versus saline in vaginal cleansing before office hysteroscopy

Conditions: Postoperative Infection

Summary: the normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. it is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. it is available and inexpensive in comparison to povidone iodine.


Eligibility criteria:
inclusion criteria: 1 - all women who will subject to office hysterosocpy for gynecological problems exclusion criteria: 1. all patients have current vaginitis or urinary tract infection before the hysteroscopy 2. diabetic women. 3. women with body mass index \> 25 kg/m2.
short term statin treatment and endothelial dysfunction due to ischemia and reperfusion injury

Conditions: Ischemia Reperfusion Injury; Endothelial Dysfunction

Summary: rationale: apart from their cholesterol lowering effects, statins have cholesterol-independent pleiotropic actions, such as upregulation of 5'-ectonucleotidase and up-regulation of no-synthase that may increase tolerance against ischemia-reperfusion injury (ir-injury). several animal studies have shown reduction of ir-injury as a result of statin treatment in both the heart and the kidney. recently the investigators have shown, using annexin a5 targeting after voluntary ischemic exercise to assess ir-injury, a protective effect of a 7 day oral rosuvastatin treatment. a three day treatment with atorvastatin however failed to reduce annexin targeting. assessment of the flow mediated dilation of the brachial artery as measure of endothelial (dys)function, is a validated model to research effects of possible protective strategies and perform mechanistic experiments on ir-injury in humans in vivo. the investigators hypothesize that pretreatment with statins can increase endothelial tolerance against ischemia and reperfusion injury. objective: to study the protective effect of pretreatment (both 3 day and 7 day) with rosuvastatin and atorvastatin on flow mediated dilation after 15 minutes ischemia and 15 minutes reperfusion. study design: placebo-controlled randomised double-blind trial study population: healthy volunteers, age 18-50 intervention: treatment with either rosuvastatin 20 mg, atorvastatin 80mg or placebo during either 3 or 7 days main study parameters: difference in flow mediated dilation before and after 15 minutes ischemia. nature and extent of the burden and risks associated with participation, benefit and group relatedness: treatment with rosuvastatin or atorvastatin is not expected to harm the volunteers. most reported side effects of rosuvastatin and atorvastatin are gastro-intestinal complains and myalgia. the volunteers will not benefit directly from participating in this study.


Eligibility criteria:
inclusion criteria: * age 18-50 * written informed consent exclusion criteria: * smoking * history of any cardiovascular disease * hypertension (in supine position: systole \>140 mmhg, diastole \>90 mmhg) * diabetes mellitus (fasting glucose \>7.0 mmol/l or random glucose \>11.0 mmol/l) * hyperlipidaemia (fasting total cholesterol \>5.5 mmol/l or random cholesterol \>6.5 mmol/l) * alanine amino transferase \>90 u/l * creatine kinase \>440 u/l * raised rhabdomyolysis risk * gfr \<60 ml/min * overt clinical signs of hypothyroidism * myopathy in family history * alcohol abuse * concomitant chronic use of medication * participation to any drug-investigation during the previous 60 days as checked with vip check. * professional athletes

Keywords: ischemia reperfusion injury endothelial dysfunction statins rosuvastatin atorvastatin placebo ecto-5'-nucleotidase flow mediated dilation
mail outreach to increase vaccination acceptance through engagement

Conditions: Influenza, Human; Influenza; Human Flu

Summary: the aim of this study is to determine whether receiving a core letter signed by the surgeon general or the director of the national vaccine program that provides only information about influenza, or a core letter signed by the surgeon general with an added basic or enhanced implementation prompt, will increase rates of influenza vaccination among medicare beneficiaries when compared to a control group.


Eligibility criteria:
medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. there will be no additional exclusion criteria.

Keywords: vaccination immunization randomized controlled trial prevention & control preventive measures health promotion medicare intention prompts letters
quality of life, nutritional status and functional capacity in people with advanced chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: this study evaluates the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced ckd patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.

randomized study including two parallel groups: patients from the advanced chronic kidney disease (ckd) consulting room of the malaga university regional hospital and controls. the main objective is to assess the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced ckd patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit. both groups will be composed of 54 participants. the control group will be provided general dietary and lifestyle recommendations (standard procedure in the nephrology consulting room), whereas the intervention group will receive treatment and individualized dietary follow-up using coaching techniques, supported by information and communication technologies, and will participate in a nutritional education program composed of four on-line sessions. two visits (basal and three months after) will be scheduled during the study to obtain and analyse the data. moreover, in these visits researchers will collect a blood sample in order to perform an assessment of the metabolism, inflammation, and oxidation, and a stool sample in order to evaluate the gut microbiota.

Eligibility criteria:
inclusion criteria: - patients \>18 years old with advanced ckd (gfr \<30ml/min) starting follow-up in the advanced ckd consulting room of the malaga university regional hospital and who clearly understand the study and give their informed consent. exclusion criteria: * patients presenting any of these conditions: * active cancer * being already participants of another study that may affect the results * pregnancy or possible pregnancy * informed consent refusal * hospital admission during one month previous to the study * severe mental disorders (smd), prolonged mental disorders involving a high level of disability and social dysfunction, which requires attendance by the mental health and social care network * alcohol or any other substance abuse that, in the researcher's opinion, may interfere with the study

Keywords: advanced ckd diet nutritional education coaching quality of life (qol) nutritional status functional capacity
placenta accreta&its complications in placenta previa cases

Conditions: Placenta Accreta in Placenta Previa Anterior

Summary: cases of previous cesarean with placenta previa anterior underwent cesarean section. placenta accreta is diagnosed during cesarean section \&confirmed by pathology. all complications are monitored in cases with placenta accreta and without.

100 cases of gestational age 30 weeks or more with placenta previa anterior with previous one or more cesarean section will be enrolled. history,examination \&routine investigations will be taken. colour doppler will be done to diagnose cases with suspected placenta accreta. pre \& postoperative hb concentration will be taken. cases with nonseparation of the placenta will be diagnosed as accreta \& confirmed by pathology. operative time \& complications like bladder or intestinal injury will be noted. all data will be analyzed.

Eligibility criteria:
inclusion criteria: * all pregnant women more than 30 weeks with previous one or more cesarean section with placenta previa anterior exclusion criteria: * pregnant with unscarred uterus * scars other than cesarean section
description of tolerability of lcz696 (sacubitril / valsartan) in heart failure with reduced ejection fraction (hfref) treated in real life setting

Conditions: Hearth Failure With Reduced Ejection Fraction (HFrEF)

Summary: the primary purpose of the study was to describe the tolerability of treatment with the optimal dose of lcz696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (hfref) in canada. the study was also to describe the overall tolerability, effectiveness and safety of lcz696 for the management of hfref over 12 months of treatment, as well as describe the patterns of lcz696 up and down dose titrations occurring during the management of patients with hfref.


Eligibility criteria:
key inclusion criteria: 1. written informed consent must be obtained before any assessment is performed. 2. age ≥ 18 years and ≤ 80 years. 3. males or females. 4. diagnosis of heart failure nyha class ii-iii. 5. diagnosis of heart failure with reduced ejection fraction (lvef =\< 40%) and nyha class ii or iii. 6. stable on any dose of acei or arb prior to enrolment in the study 7. stable on any dose of a beta-blocker prior to enrolment in the study. 8. eligible for treatment with lcz696 as per canadian product monograph. 9. treated as an outpatient. 10. signed an informed consent agreeing to participate in the study. key exclusion criteria: 1. symptomatic hypotension and/or a sbp \< 100 mmhg at baseline visit. 2. estimated gfr \< 30 ml/min/1.73m\^2 as measured by the simplified modification of diet in renal disease (mdrd) formula at baseline visit. 3. known history of angioedema related to previous acei or arbs therapy, or history of hereditary or idiopathic angioedema. 4. requirement of concomitant treatment with both aceis and arbs. 5. concurrent participation in other clinical trials or receiving other investigational drugs within 30 days of enrollment. 6. hypersensitivity to the active substances, sacubitril or valsartan, or to any of the excipients. 7. concomitant use of aliskiren-containing drugs in patients with diabetes mellitus (type 1 or type 2) or moderate to severe renal impairment (gfr \<60ml/min/1.73m\^2). 8. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 9. history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 10. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test. 11. women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. effective contraception methods are described in the protocol.

Keywords: hfref, acei, ace inhibitor, arbs, systolic heart failure, chronic heart failure, chf, reduced ef, ejection fraction
open-label extension study of dccr in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: the purpose of this is study is to evaluate the long-term safety of dccr (diazoxide choline) extended-release tablets) in patients with prader-willi syndrome.


Eligibility criteria:
inclusion criteria: 1. provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate) 2. participant must: 1. have participated in and completed the study c602 randomized withdrawal (rw) period; 2. have participated in but discontinued from the study c602 rw period and at least 16 weeks have elapsed since the date of their randomization into the c602 rw period; or 3. have participated in study c602 ole period, did not consent to participate in the rw period, and at least 16 weeks have elapsed since the date of their c602 open-label extension end of treatment visit. exclusion criteria: 1. positive urine pregnancy test (in females of child-bearing potential) 2. females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation. 3. participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the c602 open-label extension end of treatment visit.