Kornimate/medical-research-clean huggingface dataset:
markers of oxidative stress in a early week miscarriage: ischemia of modified albumin

Conditions: First Trimester Pregnancy; Fetal Heart Activity Absent; Absence of Fetal Pole on Ultrasonographic Examination.

Summary: the finding that ischemia-modified albumin (ima) is increased in pre-eclamptic pregnancy suggests a role for ima as a potential biomarker for abnormal placental development related to miscarriage.this study was undertaken to evaluate ima levels in women with recurrent pregnancy loss (rpl).

ischemia-modified albumin (ima) measured by the albumin cobalt binding test is a relatively new biomarker in the identification of myocardial ischemia. experimental studies have shown that pregnancies normally develop in a relatively hypoxic intrauterine environment, and the subsequent reperfusion and oxidative stress is important for physiological trophoblast development. the finding that maternal serum ima levels are raised so early in pregnancy provides further support for ima as a potential marker for abnormal placental development that may be related to early pregnancy loss. in this study, we aimed to evaluate maternal circulating ima levels in women with rpl by comparing them with healthy controls.

Eligibility criteria:
inclusion criteria: * first trimester pregnancy * absence of fetal cardiac activity * absence of fetal pole * history of two or more unexplained first trimester miscarriages * no live births * apparently healthy women attending for antenatal care in the first trimester with at least one previous uneventful natural pregnancy exclusion criteria: * pre-existing diabetes or vascular disease were excluded * diagnosis of chromosomal, anatomic, endocrinologic and autoimmunologic etiology of recurrent pregnancy loss * women with multiple pregnancy * any major or minor fetal anomaly * current smokers

Keywords: ischemia-modified albumin recurrent pregnancy loss abnormal placenta
aromatherapy for prevention of intrathecal morphine induced nausea and vomiting

Conditions: Post Operative Nausea and Vomiting

Summary: this study evaluates the effect of combining non pharmacological anti emetic prophylaxis, namely peppermint essential oil to granisetron and dexamethasone in patient who receive intrathecal morphine for lower segment cesarean section. half of the patient will receive nasal strip containing peppermint essential oil in addition to granisetron and dexamethasone while the other half will only receive granisetron and dexamethasone.

it is not uncommon to use different group of anti emetic in order to achieve high successful rate in the prevention of opioid induced nausea and vomiting. this study evaluates the effect of combining non pharmacological and pharmacological method to prevent such condition. aromatherapy has been used since many years to treat nausea and vomiting. one of the proposed mechanism is by the activation of olfactory receptor when the molecules of essential oil absorb in the mucus lining olfactory epithelium. the signal is then carried by olfactory sensory neuron to the olfactory bulb which filters and send signal to olfactory cortex as well as limbic system to give the feeling of well being. granisetron is a serotonin 3 receptor antagonist prevent or treat nausea and vomiting by competitively blocks the action of serotonin at 5-hydroxytryptamine 3 (5ht3) receptors while the mechanism of action of dexamethasone; which is a glucocorticoids is not fully understood.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i and ii. * non-smoker. * bmi =\< 40 * singleton pregnancy exclusion criteria: * patient with known allergy to granisetron, dexamethasone, bupivacaine, fentanyl, morphine, paracetamol, celecoxib, ginger oil. * patient who has inability to breathe through nose. * patient with history of post-operative nausea and vomiting (ponv) or motion sickness

Keywords: peppermint oil intrathecal morphine ponv lower segment cesarean section dexamethasone granisetron
oral metformin for treating melasma in latin american women

Conditions: Melasma

Summary: the goal of this clinical trial is to learn if metformin can treat melasma in latin american women. the main question it aims to answer is: - can metformin help reduce the dark patches of melasma? researchers will test two different doses of metformin (500 mg and 1000 mg) to see if either one helps improve melasma. participants will: * take a metformin pill every day for three months. * go to the clinic twice: once at the beginning and once at the end of the study. * get a phone call from the researchers to check how they're doing and ask about any changes or side effects.


Eligibility criteria:
inclusion criteria: latin american women aged 21 years or older, diagnosed epidermal or mixed melasma exclusion criteria: pregnancy, breastfeeding, use of hydroquinone or tretinoin within 2 months before the study, or undergoing laser treatment, peels, microdermabrasion, or microneedling within 2 months of the study. patients with a history of renal or liver disease, metformin allergy, diabetes, hypoglycemia, or those on medications that could interact with metformin will also be excluded.

Keywords: melasma metformin
a safety, tolerability and pharmacodynamics study of ace-011 (actriia-igg1) in healthy postmenopausal women

Conditions: Osteoporosis

Summary: this is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ace-011 in healthy postmenopausal women.


Eligibility criteria:
inclusion criteria: 1. subject is a postmenopausal woman, 45-85 years old (inclusive). 2. subject has had 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (fsh) levels \>40 iu/l or is 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 3. subject is taking at least 500 mg of calcium supplement and 400 iu of vitamin d daily and has been following this regimen for at least 4 weeks prior to the first dose of study drug administration. 4. subject has a body mass index (bmi) of ≥ 18.5 to \< 30. 5. subject must give written informed consent. if required by local law, candidates must also authorize the release and use of protected health information (phi). exclusion criteria: 1. subject has a history of clinically significant major disease (as determined by the investigator). 2. subject has a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, paget's disease of the bone, or osteomalacia. 3. subject has had a long bone fracture within the past 6 months prior to enrollment, or an osteoporosis-related fracture within the previous 2 years. 4. subject has a history of opportunistic infection, or has had a serious local or systemic infection within 3 months prior to screening. 5. subject has a history of severe allergic or anaphylactic reactions. 6. subject had major surgery within the previous 3 months. 7. subject has a history of drug or alcohol abuse, or tests positive in a drug and alcohol screen at screening or on day 1 prior to dosing. 8. subject consumed any alcohol within 72 hours prior to dosing. 9. subject gave a blood donation (one unit or more) within 1 month prior to dosing, or plans to give a blood donation during the course of the study. 10. subject has taken any of the following bone active medications: * teriparatide at any time in their lifetime. * fluoride therapy for more than 3 months during the previous 2 years. * estrogen, androgen, anabolic steroids, corticosteroids (excluding inhaled, topical or local injections for joint pain), calcitonin, or other bone active drugs (e.g. selective estrogen receptor modulators) within the 4 months prior to screening. bisphosphonates: * if treated for more than 6 months at any time in their lifetime. * if treated for 3 to 6 months within 2 years of screening. * if treated for less than 3 months within 6 months of screening. 11. subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry.
pediatric sleep questionnaire: normalization and validation study

Conditions: Sleep Disorders

Summary: the information gathered from normal pediatric patients seen at the pediatric neurology clinic in the dcam and larabida children's hospital will be used to standardize and validate the information gathered from pediatric patients with sleep disorders. this will serve as the information source for a pediatric sleep database.

a sleep questionnaire will be administered to patients who present to the pediatric neurology clinic and larabida children's hospital. the questions asked are those routinely obtained in the clinical practice of sleep medicine. medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. the database will be maintained in filemaker pro program for future research purposes. collection of the data will require approximately 15 minutes. a database file number not related to the patient medical record number will be assigned to each patient. the investigator will keep a separate log linking patient database number and patient medical record number. the logbook will be kept under lock and key by the investigator.

Eligibility criteria:
inclusion criteria: * all patients seen in the pediatric neurology clinic and at larabida children's hospital exclusion criteria: * adults

Keywords: sleep disorders
immunogenicity and safety of an inactivated split-virion 2009 pandemic influenza a h1n1 vaccine in infants

Conditions: Influenza

Summary: the aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.


Eligibility criteria:
inclusion criteria: 1. healthy infants aged between 6 and 35 months 2. full-term birth with birth weight above 2,500 grams 3. subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures exclusion criteria: 1. volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination 2. volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg 3. history of progressive or severe neurologic disorder 4. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 5. known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation 6. asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids 7. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws 8. history of thyroidectomy or thyroid disease that required medication within the past 12 months 9. serious angioedema episodes within the previous 3 years or requiring medication in the previous two years 10. guillain-barre syndrome 11. self-reported seropositivity for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c 12. any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment 13. axillary temperature ≥ 38.0 degrees celsius within 3 days of intended study vaccination 14. any conditions may influence the evaluation

Keywords: h1n1 vaccine immunogenicity safety infants
a retrospective observational study to evaluate the utilization, outcomes, and adverse events in participants treated with minocin® (minocycline) for infections caused by gram-negative bacteria in a real world setting

Conditions: Gram-Negative Bacterial Infections

Summary: this study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.

this study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.

Eligibility criteria:
inclusion criteria: * the participant was treated with minocin iv for a presumed or culture-confirmed gram-negative infection, as monotherapy or part of a broader regimen, for at least 48 hours. * the participant treatment for gram-negative infection was initiated may 1, 2015, or later. * the participant was at least 18 years old. * this was the first course of minocin iv administered to the participant within the study period for the treatment of gram-negative infection. * at least 60 days has elapsed since the participant received the last dose of minocin iv therapy for a presumed or confirmed gram-negative infection (prior to data entry into the electronic case report form, including step-down to oral therapy. exclusion criteria: * the participant received minocin iv as a part of a controlled clinical trial. * the participant received minocin iv as a part of a medicines company- or rempex company-sponsored pharmacoeconomic outcomes study. * pregnancy (in the participant's or participant's partner) occurred after the first dose of minocin iv through hospital discharge. * female participants were pregnant or nursing at the time of enrollment.
observational, multi-center study of the real world evidence of the effectiveness of paritaprevir/r - ombitasvir, ± dasabuvir, ± ribavirin in patients with chronic hepatitis c in the russian federation

Conditions: Chronic Hepatitis C; Genotype 1

Summary: this study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (rbv) in participants with chronic hepatitis c in a real life setting across clinical practice populations.


Eligibility criteria:
inclusion criteria: patients are eligible for observation in this cohort if the following applies: * treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis c, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± rbv according to standard of care and in line with the current local label * if rbv is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * patients must voluntarily sign and date informed consent prior to inclusion into the study exclusion criteria: * patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Keywords: ombitasvir dasabuvir paritaprevir
maternal cardiovascular adaption to pregnancy in ivf patients following frozen embryo transfer (fet)

Conditions: IVF; Frozen Embryo Transfer (FET); Cardiovascular Adaption; Magnetic Resonance Imaging (MRI); Preeclampsia

Summary: aim of the study is to explore the effect of a lacking corpus luteum on maternal cardiovascular and metabolic adaption to pregnancy by the use of magnetic resonance imaging (mri).

the use of programmed frozen embryo transfer cycle (fet) in ivf women is associated with an increased risk of obstetric complications (pregnancy-induced hypertension, preeclampsia, postpartum hemorrhage and placenta accreta) compared to fet in natural cycle. the lack of corpus luteum in programmed cycles and the subsequent absence of circulating vasoactive substances may lead to an impaired cardio-vascular adaption to pregnancy and thereby an increased risk of pregnancy-induced hypertension and preeclampsia. the cardiovascular and metabolic adaption to pregnancy is evaluated throughout pregnancy by use of magnetic resonance imaging (mri) as well as non-invasive measurements by use of elastography and seismocardiography. patients are screened for preeclampsia throughout pregnancy with measurements of blood pressure, urine samples as well as blood samples.

Eligibility criteria:
inclusion criteria: * autologous embryo transfer in programmed fet-cycle or modified-natural fet-cycle or * planned donor egg transfer in programmed fet-cycle or modified-natural fet-cycle * age \< 40 years * bmi \< 35 * primary diagnosis being unexplained infertility, male infertility or tubal factor * singleton blastocyst transfer exclusion criteria: * pcos * essential hypertension * diabetes mellitus (type 1 or 2) * known cardiac disease * antiphospholipid syndrome, lupus erythematosus, rheumatoid disease * preelampsia, gestational hypertension, gestational diabetes or severe intrauterine growth restriction (iugr) in any previous pregnancy * smoking * multiple pregnancy * severe claustrophobia or any other contraindications to mri
dual-energy contrast-enhanced (2d and 3d mammography versus contrast-enhanced mri)- a pilot study

Conditions: Breast Cancer

Summary: this is a pilot study to evaluate 2d contrast-enhanced mammography image and 3d (tomosynthesis) contrast-enhanced images to contrast enhanced mri in women with greater than 95% probability of breast cancer (birads 5) or confirmed breast cancer (birads 6).this study will then be used to design additional studies.


Eligibility criteria:
inclusion criteria: * subject is a female of any race and ethnicity. * subject is at least 25 years old * subject has or will have a contrast enhanced breast mri +/- 31 days of enrollment with no interval treatment or procedure between the two studies * subject has birads 6 or birads 5 cancer or as determined by the radiologist * \>50% of the biopsied cancer mass must remain following biopsy or * a calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy exclusion criteria: * subject is unable or unwilling to undergo informed consent * subject has breast implant in the breast to be imaged * subject is pregnant * subject is breast feeding or lactating * subject has a known allergy to gadolinium contrast agents. * subject has a contraindication for mri. * subject suspected to be at risk to complication from the contrast agents. * subject has a documented renal insufficiency, * subject requires renal dialysis. * subject has had a prior reaction to iodinated contrast. * subject has had a prior episode of anaphylactic reaction to any substance. * subject has taken metformin (glucophage) within 48 hours of study procedures. * subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).

Keywords: image on multi-modalities visualize cancer lesions highly suspicious lesions
evaluate long-term safety, tolerability and efficacy of iptacopan in study participants with ahus

Conditions: Atypical Hemolytic Uremic Syndrome

Summary: this is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with ahus.

the extension study baseline/day 1 visit is equivalent to the end of treatment visit of the parent study. the study will begin on day 1 followed by on-site visits every 4 months during the study treatment period. a safety follow up tele-visit must be conducted 7 days after last study treatment to collect information on adverse events.

Eligibility criteria:
inclusion criteria: 1. signed informed consent must be obtained prior to participation in the open label extension study 2. willing and able to comply with the study schedule of activities 3. participants who have completed the full study treatment period of any prior "novartis sponsored" iptacopan phase 3 clinical trial in ahus, are still on iptacopan study treatment and derive benefit from it as per investigator's judgement 4. prior vaccinations against neisseria meningitidis, streptococcus pneumoniae and haemophilus influenzae infections should be up to date (i.e., any boosters required should be administered according to local guidelines) exclusion criteria: 1. concomitant treatment with any complement inhibitor as well as concomitant treatment with any of the prohibited drugs 2. any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator could put the participant at risk 3. active infection or history of recurrent invasive infections caused by encapsulated bacteria such as neisseria meningitidis, streptococcus pneumoniae or haemophilus influenzae 4. history of hypersensitivity to iptacopan or its excipients or to drugs of similar chemical classes 5. pregnant or nursing (lactating) women 6. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of investigational drug and for 1 week after stopping of investigational drug. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: ahus iptacopan atypical hemolytic uremic syndrome thrombotic microangiopathy tma dialysis ckd egfr pe/pi complement 3 glomerulopathy (c3g) igan pnh
study of drug therapy for pediatric heart failure

Conditions: Heart Failure Congenital

Summary: the goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric heart failure patients. the main questions it aims to answer are: * can a modified drug therapy improve left ventricular function in pediatric heart failure patients? * can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? participants will be assigned to either the modified drug therapy group (comprising angiotensin-converting enzyme inhibitor (ace-i), beta-blockers, diuretics, potassium supplements, and spironolactone) or the traditional drug therapy group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. they will undergo a 6-months course of medication. additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of n-terminal pro-brain natriuretic peptide (nt-probnp) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. researchers will compare the modified drug therapy group and the traditional drug therapy group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.


Eligibility criteria:
inclusion criteria: * patients younger than 14 years of age * heart failure after congenital heart surgery * ross \> 2 or nyha \> 2 * lvef\<55%, or lvfs\<25% exclusion criteria: * single ventricle * congenital heart disease without anatomical correction * patients with heart failure requiring ventricular assist or cardiac synchronization therapy * patients with severe pulmonary hypertension (pulmonary arterial pressure \>6 wood·u) * patients with severe liver and kidney failure * patients who are allergic to related medications * patients with symptomatic hypotension who cannot tolerate related drugs * refuse to sign the informed consent or refuse to participate in this experiment

Keywords: congenital heart failure drug therapy congenital heart disease postoperative