Kornimate/medical-research-clean huggingface dataset:
msc303 subcutaneous injection for the treatment of immunologic glomerular disease.

Conditions: Lupus Nephritis (LN); ANCA-Associated Glomerulonephritis

Summary: this study will evaluate the safety and efficacy of msc303 in patients with immune glomerular diseases.

the primary endpoint of phase ib：evaluate the safety of msc303 in patients with lupus nephritis (ln）and anca-associated glomerulonephritis (anca-gn). the primary endpoint of phase ii：evaluate the change of urine protein/creatinine ratio (upcr) in week 12 compared with the baseline of msc303 in patients with lupus nephritis(ln） and anca-associated glomerulonephritis (anca-gn).

Eligibility criteria:
inclusion criteria: 1. aged 18 to 65 years (including boundary values), gender unspecified； 2. willing to participate voluntarily in this clinical study and with good compliance； 3. regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases: 1. diagnosed with lupus nephritis(ln); 2. diagnosed with anca-associated glomerulonephritis (anca-gn); 4. sufficient organ function; exclusion criteria: 1. history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of msc303； 2. active infection requiring antibiotic treatment； 3. concomitant with other serious diseases； 4. patients with congenital immunoglobulin deficiency； 5. infection with human immunodeficiency virus (human immunodeficiency virus (hiv)), hepatitis b or hepatitis c (including hbsag, hbcab positive with abnormal hepatitis b virus dna (hbv dna) or hepatitis c virus rna (hcv rna )); 6. other exclusion criteria may apply.

Keywords: msc303 immune glomerular diseases
pregnancy prediction using anti-müllerian hormone in intrauterine insemination cycles

Conditions: Infertility, Female; Anti-Mullerian Hormone Deficiency

Summary: the goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (iad) in non-sterile women with plasma amh levels \> and \< 1.1 ng/ml.


Eligibility criteria:
inclusion criteria: * iui cycles with sperm donors either due to severe oligoasthenoteratozoospermia in the partner (defined as a motile sperm count (msc) \< 5 million in the ejaculate) or for social reasons, with up to 4 attempts accounted for. exclusion criteria: * bmi \>30 * infertility due to bilateral tubal factor * endometriosis grade ii-iv.

Keywords: anti-mullerian hormone infertility intrauterine insemination sperm donation cumulative pregnancy rates
prognostic role of the uremic toxin indoxyl sulfate on vascular and cardiac functions during acute kidney injury

Conditions: Acute Kidney Injury; Uremic; Toxemia; Vascular Dysfunction; Cardiac Dysfunction; Cardiovascular Prognosis

Summary: acute kidney injury (aki) is a frequent disease in conventional hospital departments and in intensive care units. it's associated with a high risk to develop chronic kidney disease (ckd), even after a single small aki episode. it's also associated with an important morbi-mortality, particularly cardiovascular (cv). some studies have already showed a link between aki and cv risk but pathologic mechanisms implicated are still unknown. in aki and ckd, numerous substances, called uremic toxins (ut) are accumulating in blood. in ckd, those toxins, and particularly indoxyl sulfate (is), are known to have cardiac and vascular deleterious consequences. however, in aki, whether acute accumulation of ut may trigger cv complications is unknown. the purpose of this study is that during aki, a high ut concentration, in particular is, would be associated with early vascular and cardiac dysfunctions that can be characterized by the persistence of an accelerated pulse wave velocity (pwv). the main objective is to evaluate the correlation between ut concentrations (especially is) and arterial stiffness (pwv measurement) at three months of an aki episode in conventional hospital departments and in the intensive care unit of nephrology.


Eligibility criteria:
inclusion criteria: * age over 18 years old. * patients hospitalized in conventional hospital departments and in intensive care units of nephrology. * patients with moderate to severe aki (kdigo 2 or 3) without dialysis. * aki from functional or organic aetiology exclusion criteria: * patients with severe ckd (gfr\<45ml/min/1.73 m2) or with kidney transplants. * patients with aki from septic or obstructive aetiology. * patients with aki from toxic aetiology whose toxic would be also responsable of cardia toxicity. * patients with sepsis or blood inflammation. * patients with severe chronic cardia dysfunction. * patients with arrhythmia or complete heart block. * patients with peripheral artery occlusive disease. * pregnancy. * patients on palliative care.

Keywords: acute kidney injury uremic; toxemia vascular dysfunction cardiac dysfunction cardiovascular prognosis
reactive oxygen species in the pathogenesis of diabetic complications

Conditions: Type 1 Diabetes

Summary: benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy and incipient nephropathy in these models. in cultured vascular cells, it also reduces aldose reductase gene expression, activity, and sorbitol levels. it does so by activating the enzyme transketolase. α-lipoic acid, a potent antioxidant, has also been reported to reduce both diabetic microvascular and macrovascular complications in animal models. to determine whether benfotiamine in combination with α-lipoic acid would normalize markers of ros-induced pathways of complications in humans, we performed a pilot study in subjects with type 1 diabetes using one daily dose of benfotiamine in combination with α-lipoic acid.

the glycemic status of study patients was assessed by measuring baseline values of hba1c, fructosamine, and fasting plasma glucose. mean hba1c was 8.7+ 0.7%, mean fructosamine was 421+29 mg/dl (normal range 174-286 mg/dl), and mean fasting blood glucose was 198+44 mg/dl. at day 0, subjects levels of markers of two benfotiamine-sensitive pathways were determined: intracellular advanced glycation endproduct (age) formation, as reflected by a marker of increased intracellular methylglyoxal adducts in endothelial cells, angiopoietin 2 and hexosamine pathway activity, measured by determination of n-acetylglucosamine-modified protein in circulating monocytes. pkc activity in circulating monocytes could not be measured because the amount of blood required exceeded that approved by the committee on clinical investigations. serum levels of 6-keto-pgf-1 , a stable product produced by the nonenzymatic hydration of the antiatherogenic mediator prostacyclin were also determined. subjects then took benfotiamine 300 mg twice a day, (advanced orthomolecular research, calgary, ab,canada) and slow-release α-lipoic acid (600 mg twice a day) (mri, san francisco, ca) for 28 days. blood was obtained at day 0, day 15, and day 28. data were analyzed using 1-factor analysis of variance to compare the means of all the groups. the tukey-kramer multiple comparisons procedure was used to determine which pairs of means were different.

Eligibility criteria:
inclusion criteria: * male * type 1 diabetes duration between zero and fifteen years * current insulin therapy exclusion criteria: * female * proliferative retinopathy * microalbuminuria * symptomatic diabetic neuropathy * cardiovascular disease * taking medications * smoking

Keywords: hyperglycemia diabetic complications advanced glycation endproducts hexosamine pathway prostacyclin synthase reactive oxygen species
fitting children with contact lenses

Conditions: Refractive Error

Summary: the purpose of this three-month study is to compare the quality of life and ease of fit among children wearing investigational single-vision contact lenses, commercially marketed single-vision contact lenses, and commercially marketed multifocal contact lenses.


Eligibility criteria:
inclusion criteria: * is between 8 and 16 years of age. * has the permission of a parent/legal guardian. * is willing and able to, or has a parent/legal guardian who is willing and able to help them, follow instructions and maintain the appointment schedule. * has had an ocular examination in the last two years. * has never worn contact lenses before. * has clear corneas and no active ocular disease. * can be successfully fit with the lenses to be used in the study. * has 20/25 or better best corrected visual acuity in each eye. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * has any ocular disease. * has a systemic condition that may affect a study outcome variable. * is using any systemic or topical medications that may affect ocular health. * has ocular or systemic allergies that could interfere with contact lens wear. * has any ocular pathology or condition that would affect the wearing of contact lenses. * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myopia contact lenses children
taste and palatability of orfadin suspension

Conditions: Hereditary Tyrosinemia, Type I

Summary: the purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

this is an open, non-randomized, non-controlled, multiple-dose study in 18 pediatric patients. the treatment period is three days, and during the study the subjects will rate the taste and palatability of the suspension or (for younger children) their parents will rate the child´s acceptance of the suspension. the study consists of a screening period, a 3 day treatment period and a 1 week follow-up period.

Eligibility criteria:
inclusion criteria: * patients with ht-1 currently managed on orfadin (nitisinone) capsules. * age from 1 month to less than 18 years. * signed informed consent. exclusion criteria: * any medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion. * enrollment in another concurrent clinical study, or intake of an investigational medicinal product (imp), within one month prior to inclusion in this study. * foreseeable inability to cooperate with given instructions or study procedures.

Keywords: nitisinone orfadin suspension taste acceptability
acute caffeine effects on cardiac autonomic and cardiorespiratory parameters responses after aerobic exercise

Conditions: Autonomic Nervous System; Cardiorespiratory Parameters

Summary: check the acute influence of caffeine on the autonomic modulation and cardiorespiratory parameters after aerobic exercise. hypothesized that caffeine can promote a slower recovery of the cardiorespiratory parameters and the sna recovery after aerobic exercise.

the experimental procedure is divided into three phases, all performed on a treadmill, with a minimum interval of 48 hours between them, in order to allow adequate recovery of the participants. before the start of the first stage of the experimental protocol or control anthropometric measurements will be carried out, body weight by a digital scale (plenna, tin 00139 maxima, brazil)) and then, using a stadiometer (plenna, tin 00139 maxima, brazil)). the protocols are: i) maximum stress test protocol: assessment of the maximum oxygen consumption (vo2max) on a treadmill (inbrasport / millennium), using the bruce protocol. ii) control protocol (pc): at this stage the volunteer will ingest compressed form of placebo similar to protocol iii and remained at rest after 15 minutes in the supine position, followed by 30 minutes of aerobic exercise on a treadmill, 5 minutes with speed 6.0 km / h followed by 25 minutes with 60% of vo2max and the final 60 minutes lying recovery. iii) experimental protocol (pe): in this stage, the volunteer had performed activities similar to the pc, but will make the tablet intake consists of 300mg of caffeine, a value that is within the maximum daily amount allowed under the fda.

Eligibility criteria:
inclusion criteria: * healthy men. exclusion criteria: * cardiovascular, orthopedic, respiratory and neurological disorders reported or other pathological conditions that prevent the subject to perform the protocols; * smokers, alcoholics, or who use drugs that influence the activity of the heart.

Keywords: caffeine autonomic nervous system recovery aerobic exercise
a conversational agent (cecebot) to improve insomnia in stage i-iii breast cancer survivors

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Insomnia

Summary: this clinical trial evaluates the effect of conversational agent, cecebot, on improving insomnia in stage i-iii breast cancer survivors. sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. cognitive behavioral therapy for insomnia (cbti) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. cecebot is a personalized short messaging service (sms)-based behavioral intervention that combines cbti and physical activity strategies that may improve sleep for breast cancer survivors.

outline: patients are randomized to 1 of 2 groups. group i (intervention): patients receive sleep education sms conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression sms conversations once weekly (qw), and wear activity tracker daily on weeks 1-6. group ii (waitlist control): patients receive sleep education sms conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression sms conversations qw, and wear activity tracker daily on weeks 7-12.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * prior diagnosis of stage i-iii invasive breast cancer * female gender * clinically significant insomnia symptoms, defined as a patient reported outcomes measurement information system (promis) sleep disturbance 8 t-score of 60 or greater * insomnia complaints lasting ≥ 3 months * eastern cooperative oncology group (ecog) performance status of 0-2, indicating ability to perform activities of daily living * own a smartphone with internet connectivity * willing and able to complete the intervention with personal smartphone * proficient in speaking and reading english exclusion criteria: * prior diagnosis of restless leg syndrome, periodic leg movement disorder, narcolepsy, or rapid eye movement (rem) behavior disorder * current sleep apnea (treated or untreated) * current shiftwork * actively receiving chemotherapy or radiation (endocrine therapy permitted) * previously received cbti therapy with a professional therapist * contraindications to cbti including: * active psychosis * uncontrolled bipolar disorder * severe depression * active substance use disorder (moderate or greater severity) * use of prescribed sleep medication \> 3 times per week * previously participated in user testing of the study intervention (cecebot) * unwilling or unable to complete study procedures
a pharmacokinetic study to evaluate bbi-5000 capsules and food effect in healthy adult subjects

Conditions: Dermatitis, Atopic

Summary: to assess the pharmacokinetics of 3 doses and the food effect of a single high dose of bbi-5000 capsules in healthy adult subjects.

this is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (pk) and food effect of bbi-5000 capsules in healthy adult subjects. participating subjects will receive a single oral dose of bbi-5000 followed by a washout period of 7-14 days between doses. the treatment period will be followed by 5-10 day follow-up period. pk and pd will be assessed by blood sampling through 72 hours postdose. safety will be assessed through collection of vital signs, adverse events, physical examination, ecgs and clinical laboratory tests.

Eligibility criteria:
inclusion criteria: * non-smoker * medically healthy * 32.0 \>= bmi \>= 18.5 kg/m\^2 * weight \>= 50 kg for males * weight \>= 45 kg for females * for a female of childbearing potential: either be sexually inactive for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method as dictated by the study * willing to comply with protocol and understands study procedures outlined in the icf exclusion criteria: * subject is mentally or legally incapacitated or has significant emotional problems * history or presence of medical or psychiatric disease * history of any illness that might confound the results of the study * history or presence of alcoholism or drug abuse * history or presence of hypersensitivity or idiosyncratic reaction the the study drug excipient * history or presence of lactose intolerance * pregnant or lactating females * seated blood pressure less than 90/40 mmhg or greater than 140/90 mmhg * seated heart rate lower than 40 bpm or higher than 99 bpm * unable to refrain from or anticipates the use of any drug * diet incompatible with the on-study diet * donation of blood or significant blood loss within 56 days prior to the first study dose * participation in another clinical trial within 28 days prior to the first study dose
a study of lanadelumab in teenagers and adults with hereditary angioedema (hae)

Conditions: Hereditary Angioedema (HAE)

Summary: the main aim of this study is to compare the hae attacks (both total and those requiring on-demand treatment) in the 12 months before and up to 24 months after initiation of treatment with lanadelumab. this study is conducted in the united kingdom where participants were treated or about to be treated with landelumab according to their routine practice at hospitals. data will be directly collected from participants via study diaries, questionnaires, their medical records, and study doctors treating them. participants will be contacted every 3 months during study participation (via phone).


Eligibility criteria:
inclusion: * documented diagnosis of hae type i or ii (confirmed through laboratory testing) * documented initiation of treatment with lanadelumab or due to be initiated within next 4 weeks * greater than or equal to (≥)12 years of age at initiation of treatment with lanadelumab * ≥12 months of continuous medical record data before initiation of treatment with lanadelumab exclusion: • exposure to lanadelumab administered as an investigation product in a clinical trial setting at any point in time

Keywords: drug therapy
an effectiveness and safety study of cyclobenzaprine hcl alone or in combination with ibuprofen for acute back or neck muscle pain with muscle spasm

Conditions: Pain; Spasm

Summary: the purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine hcl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.

the objective of this multicenter, randomized, open-label, parallel-group, one-week study is to evaluate the effectiveness and safety of cyclobenzaprine hcl 5 mg three times a day for one week, alone or in combination with ibuprofen 400 mg or 800 mg taken three times a day, for acute back or neck muscle pain with muscle spasm. the primary measurement of efficacy is the subject-rated global impression of change after seven days of treatment, compared to baseline. safety assessments during the study include the monitoring of adverse events, and a physical examination, assessment of vital signs and medical history of any present illnesses conducted during the baseline visit. the study hypothesis is that there will not be a statistically significant difference in patient ratings of global impression of change, muscle spasm, muscle pain, medication helpfulness, and functional ability, between the cyclobenzaprine hcl monotherapy group versus the cyclobenzaprine hcl/ibuprofen 400 mg and cyclobenzaprine hcl/ibuprofen 800 mg groups, for the treatment for acute back or neck muscle pain with spasm. patients receive cyclobenzaprine hcl 5 mg administered orally three times a day for one week, or cyclobenzaprine hcl 5 mg with ibuprofen 400 mg administered orally three times a day for one week, or cyclobenzaprine hcl 5 mg with ibuprofen 800 mg administered orally three times a day for one week.

Eligibility criteria:
inclusion criteria: * experiencing neck or back pain for no more than 14 days * physician rating of the muscle spasm of the neck or back region as mild, moderate or severe * ability to discontinue all muscle relaxants, nsaids (anti-inflammatory drugs) and pain relievers, other than the study medications during the 7-day treatment period. (cardioprotective doses of aspirin (\<= 325 mg / day) may be taken.) exclusion criteria: * history of physician-diagnosed musculoskeletal neck or back muscle spasms within 12 months prior to the study * neck or back pain radiating into the arms or legs * history of serious medical conditions * taken a narcotic or muscle relaxant within 12 hours of the baseline physician visit * allergies to aspirin, nsaids or cyclobenzaprine hcl.

Keywords: muscle spasm cyclobenzaprine hydrochloride