Kornimate/medical-research-clean huggingface dataset:
a study in the united sates that looks at the safety and effectiveness of pradaxa pellets in children aged 3 months to less than 12 years who need treatment of a blood clot or who have had a blood clot and are at risk of developing another blood clot

Conditions: Venous Thromboembolism

Summary: the main research question of this study is to obtain further safety and effectiveness data on pradaxa pellets in children aged 3 months to less than 12 years in routine clinical practice setting.


Eligibility criteria:
inclusion criteria: pediatric patients aged 3 months to less than 12 years at the time of pradaxa pellets initiation * written informed consent from parents/care givers and patient assent if age appropriate * initiation of pradaxa pellets administration either as initial or subsequent therapy: * treatment of vte * treatment to reduce the risk of recurrence of vte exclusion criteria: * participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion * any contraindications to pradaxa pellets according to the us prescribing information. * previous participation in this study.
timely administration of iv magnesium sulfate in patients with a moderate asthma exacerbation

Conditions: Asthma in Children; Asthma Attack

Summary: this study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ed), decrease length of stay (los) in the general hospital floor vs pediatric intensive care unit (picu), and decrease the need for respiratory support.

patients ages 5-17 presenting to the ou children's hospital emergency department from october 2023 to july 2024 will be assigned a respiratory score (rs) upon presentation. those with a rs between 6-9 (moderate exacerbation) will be screened for inclusion. eligible patient will then be approached for consent. first line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. patients who consent will be randomized to the control vs. experimental group once consent is obtained. the study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based iv magnesium within the first hour (experimental group) or receive standard weight-based iv magnesium sulfate per the provider's clinical judgement (placebo group). magnesium sulfate dosing for the experimental group will be as follows: 15-19 kg: 750 mg 20-29 kg: 1000 mg 30-39 kg: 1500 mg \>40 kg: 2000 mg enrolled patients will have their clinical course reviewed and data obtained regarding los in ed and hospital stay, need for respiratory support, and or picu los if applicable.

Eligibility criteria:
inclusion criteria: * ages 5-17 years old * presents to the ed with a respiratory score in the "moderate" range (6 * parent(s)/caregiver(s) speak english exclusion criteria: * patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients * patients who are pregnant * parent(s)/caregiver(s) do not speak english

Keywords: asthma exacerbation magnesium sulfate asthma asthma attack
doppler ultrasonographic assessment of fetal internal thoracic artery indexes

Conditions: Pregnancy Related; Fetal; Circulation

Summary: the aim of this study is to assess the feasibility of visualizing the internal thoracic artery (ita), establishing the normogram for ita pulsatility index (pi), resistance index (ri) and acceleration/ejection time (at/et) at 24-32 weeks.

background: the internal thoracic artery arises from the subclavian artery as the first branch. it travels downward on the inside of the rib cage and then gives off six main branches; mediastinal, thymic, pericardiacophrenic, sternal, perforating and intercostal branches. in literature, there are so many articles that have been focused on thymus size in pregnancies complicated with diabetes mellitus, fetal growth restriction, preterm rupture of membranes and so on. to the best of our knowledge, there is no paper about fetal ita whose branch are feeding vessel of thymus and ita doppler velocity. the arteries supplying the thymus are branches of the internal thoracic, and inferior thyroid arteries. as far as it has been known, growing of a tissue depends on increased blood flow. before detecting possible blood-flow changes in fetuses complicated with great obstetrics patologies, the investigators should obtain normal values of ita doppler velocity.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * having no fetal anomalies * healthy pregnant women age \>17 and \<45 years * between 24th-32nd gestational weeks exclusion criteria: * fetuses with congenital aneuploidy or structural malformation * underlying chronic diseases * pregnant women complicated with gestational diabetes, type 1-2 dm, hypertension (pregnancy-induced; chronic; preeclampsia), malignancy * pregnancy complicated with preterm premature rupture of membranes, preterm labour, fetal growth restriction and another obstetric complication
morquio's syndrome: a case study

Conditions: Morquio's Disease

Summary: objectives: relating about the benefits proportionated by the physiotherapeutic treatment for the patients that have the morquio's syndrome. methods: this study intends to analyse a patient that presents this syndrome, describing the physiotherapeutic treatment that was proposed and the evolution clinical.


Eligibility criteria:
inclusion criteria: * the parents agreed with the study; * the parents signed a consent term exclusion criteria: * the treatment disturbed the patient physically or emotionally; * the parents didn't signed the consent term; * the patient refused to be treated.

Keywords: morquio's disease; physiotherapy; results
novel 13c carotenoids for absorption and metabolism studies in humans

Conditions: Healthy

Summary: tomatoes contain several compounds which may be beneficial for human health and prevention of disease, although this relationship is poorly understood and very controversial. this study uses a new technology to study the absorption and metabolism of three different compounds found in tomatoes. these compounds are called: phytoene, phytofluene, and lycopene. we hypothesize that by studying the absorption and metabolism of these compounds, we may be able to understand how the compounds may influence health and disease processes.


Eligibility criteria:
inclusion criteria: * between ages of 21-70 years old. * body mass index of between 18 and 27 kg/m2 (inclusive). * eastern cooperative oncology group (ecog)performance status of o. * not currently be taking carotenoid supplements * have blood urea nitrogen (bun)/creatinine (cr), liver enzymes, complete blood count (cbc), and prothrombin time (pt/ptt/inr) within normal limits. * have a hemoglobin level of at least 11 g /dl at the time of randomization. * voluntarily agree to participate and sign an informed consent document. exclusion criteria: * have a known allergy or intolerance to tomatoes. * have a history of a nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations. * have uncontrolled hyperlipidemia (total cholesterol \> 200 mg/dl, ldl \> 160 mg/dl and serum triglycerides \> 200 mg/dl) or lipidemia that may influence carotenoid pharmacokinetics or transport. * smoke tobacco products * have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, acth, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis. * are taking certain medications (prescription or over-the-counter) such as orlistat, which interfere with dietary fat absorption. * are taking complementary and alternative medications that at the discretion of the study physician steven k. clinton(skc) may interfere with carotenoid absorption or metabolism.

Keywords: tomato prostate cancer metabolism
a drug-drug interaction study of env-101 (taladegib) on nintedanib pharmacokinetics in healthy subjects

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the goal of this clinical trial is to learn about the potential effect of env-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. participants in this study will receive env-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥18 and ≤32 kg/m\^2 * body weight ≤120kg * subjects must be willing to be sequestered for 10 consecutive days. exclusion criteria: * chronic or current use of any prescription medications or acute use within the preceding 30 days or 5 half-lives, whichever is longer, with the exception of contraceptives, prior to study start * subject has an active infection of hepatitis b or c, or human immunodeficiency virus (hiv) at study start * subject has a history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers, within 5 years before study start * participation in a clinical research trial that included the receipt of an investigational agent or any experimental procedure within 30 days or 5 half-lives, whichever is longer, prior to the screening visit, or planned participation in any such trial at time of study start * subject has a pulse \ 100 bpm; systolic blood pressure \>160 mmhg, or diastolic blood pressure \>95 mmhg at study start * subject has pacemaker; is not in sinus rhythm; has a corrected qt interval (qtc; using fridericia's \[qtcf\] formula) of \>450 ms (for males) and \>470 ms (for females) during the screening period; or has a left bundle branch block or bifascicular block. * females and males of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 90 days after their final study dose * females that are pregnant or lactating * females and males that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final study dose * males who are unwilling to refrain from sperm donation for the duration of the study and for 90 days after their final study dose * females who are unwilling to refrain from egg donation for the duration of the study and for 90 days after their final study dose * subjects with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of env-101 (taladegib) or nintedanib * subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study sponsor

Keywords: smoothened hedgehog pulmonary fibrosis
early diagnosis of premature births by analysis of the vaginal microbiota

Conditions: Premature Birth; Vaginal Flora

Summary: objectives: to assess the relevance of the ribotaxa algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population. study description: longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth).

there is currently no reliable clinical or biological diagnosis to predict premature birth. recent work using metagenomic data analysis coupled with artificial intelligence approaches suggests that there may be a vaginal microbiota signature during pregnancy that correlates with the occurrence of preterm birth. the aim of the study is to use biological samples to confirm the identification of these vaginal microbiota signatures as a means of predicting preterm birth.

Eligibility criteria:
inclusion criteria: * pregnant women admitted to the clermont-ferrand university hospital maternity ward from 14 weeks' gestation onwards * for threat of preterm birth (ptb) characterized by contractile activity and/or cervical changes, or for premature rupture of fetal membranes (prom) * and in need of vaginal swabbing * single or multiple pregnancy * able to understand and object to the study * covered by a french social security scheme. * give informed consent for the study exclusion criteria: * patient under guardianship, curatorship or safeguard of justice * patient having received antibiotic therapy in the 2 weeks prior to admission
a study and 12 month extension to evaluate two investigational drugs in postmenopausal women with osteoporosis (mk-0217-907)

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.


Eligibility criteria:
inclusion criteria: * postmenopausal women with osteoporosis exclusion criteria: * any known allergy to the study drug
surgical treatment for ods with rectal prolapse surgical treatment for rectal prolapse

Conditions: Constipation by Outlet Obstruction

Summary: chronic obstinate constipation is hard to deal with in clinic. especially for obstructed defecation syndrome(ods). rectal prolapse is the most common type of ods. lots of surgical procedures have been suggested for it but with unsatisfactory results.to develop new surgical treatment and to provide higher quality proof for this intractable condition is of significance.


Eligibility criteria:
inclusion criteria: * diagnosed with ods by defecography, coloscopy, barium enema and dynamic mri. * patients should accord with rome iv criteria. exclusion criteria: * severe heart or other organ disease. * test.

Keywords: constipation, surgery
haemodynamics of mitral regurgitation reduction

Conditions: Mitral Regurgitation

Summary: there is uncertainty in terms of the superiority of conventional valve surgery or percutaneous transcatheter intervention for the treatment of severe mitral regurgitation (mr) in high risk patients. the post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood. this study seeks to characterise the physiological changes and functional outcomes of patients undergoing either surgery or transcatheter intervention.

conventional surgery for mitral regurgitation (mr) in high risk patients is associated with reduced benefit and increased risk of perioperative complications.percutaneous transcatheter intervention (edge to edge repair) is an alternative treatment option is associated with clinical benefit and reduced peri-procedural risk. the post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood. this is a a prospective observational study, involving patients with severe mr undergoing mitral valve surgery (mvrr) and transcatheter intervention (tmvi) as standard of care being recruited into two separate cohorts. patients will undergo investigations at baseline, in hospital post-operative, and at 6 months to characterise cardiac structure and function.

Eligibility criteria:
inclusion criteria: * severe mitral regurgitation as per european society of cardiology guidelines * patients undergoing mvrr or tmvi as standard of care * patients at high, prohibitive surgical risk as judged by the heart team exclusion criteria: * pregnancy and patients under the age of 18 years * congenital heart disease * moderate or severe mitral stenosis, aortic, pulmonary valve disease * patients currently enrolled in any other study where involvement in this study would involve deviation from either protocol
a randomized, prospective, double-blind study comparing fluconazole with placebo for primary and secondary prophylaxis of mucosal candidiasis in hiv-infected women

Conditions: Candidiasis; Candidiasis, Esophageal; HIV Infections

Summary: to compare the efficacy of fluconazole versus placebo for the prevention of candida esophagitis and vaginal/oropharyngeal candidiasis, including a comparison of the development of clinical resistance. fluconazole has been shown to be effective in preventing or suppressing candidiasis in hiv-negative women. an increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons.

fluconazole has been shown to be effective in preventing or suppressing candidiasis in hiv-negative women. an increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons. four hundred hiv-infected women are randomized to receive fluconazole or placebo weekly for up to 2 years. patients undergo follow-up every 3 months or more often if signs and symptoms of mucosal candidiasis occur.

Eligibility criteria:
inclusion criteria patients must have: * evidence of hiv infection. * cd4+ count \<= 300 cells/mm3 or \<= 20 percent of total lymphocyte count. * reasonably good health with a life expectancy of at least 6 months. * pelvic exam including pap smear or colposcopy performed within the past 90 days. prior medication: allowed: * topical or systemic treatment or prophylaxis with an antifungal agent. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * current diagnosis of candida esophagitis. * known intolerance to azoles. concurrent medication: excluded: * systemic treatment or prophylaxis with an antifungal agent. patients with the following prior conditions are excluded: * past history of candida esophagitis.

Keywords: fluconazole acquired immunodeficiency syndrome aids-related complex candidiasis
ds-8201a in human epidermal growth factor receptor2 (her2)-expressing colorectal cancer (destiny-crc01)

Conditions: Colorectal Neoplasm

Summary: the main objective of this study is to test the safety and effectiveness of ds-8201a for participants with her2-expressing advanced colorectal cancer.

at study start, only cohort a is active. if, and when, cohort b and c become active depends on the assessment of benefit and risk observed in the program. the sponsor will inform the investigators if, and when, cohort b and c are active.

Eligibility criteria:
inclusion criteria: * has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a ras/braf wild-type cancer) * has received at least 2 prior regimens of standard treatment * has measurable disease assessed by the investigator based on recist version 1.1. * has an eastern cooperative oncology group performance status (ecog ps) of 0 to 1 exclusion criteria: * has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure * has a medical history of clinically significant lung disease * has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy

Keywords: oncology her2 colorectal cancer antibody drug conjugate adc
the safety, tolerability, and pharmacokinetic study of sc1011 in healthy subjects.

Conditions: Diopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Summary: the goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of sc1011,in health conditions. the main questions it aims to answer are: safety and tolerability profiles in healthy subjects.pharmacokinetic profiles in healthy subjects.food effect in healthy subjects.participants will complete the study including screening period, dosing period, and observation period. researchers will compare the inhibitory activity of sc1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood tnfα) to see if they are different between the two drugs.

this is a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.part a will comprise a single-dose, sequential-group study incorporating a food effect evaluation. part b will comprise a multiple-dose, sequential-group study.

Eligibility criteria:
inclusion criteria: * males or females, of any race, between 18 and 45 years of age, inclusive, at screening. * body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. * in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ecg, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in as assessed by the investigator. * females will be nonpregnant and nonlactating. females of childbearing potential and male subjects will agree to use contraception. * able to comprehend and willing to sign an informed consent form (icf) and to abide by the study restrictions. exclusion criteria: * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. * alcohol consumption of \> 21 units per week for males and \> 14 units for females. one unit of alcohol equals 12 oz (360 ml) beer, 1½ oz (45 ml) liquor, or 5 oz (150 ml wine), or a positive alcohol breath test at check-in. * any screening laboratory or ecg results are not within the normal reference range and are considered clinically significant. * participants who participated in other clinical trials within 3 months prior to administration. * blood donation or blood loss exceeding 400 ml within 2 months prior to administration. * participants who smoked, drank alcohol, tea, food or drink containing xanthine or caffeine, or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion 2 days before drug administration. * subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Keywords: pulmonary fibrosis idiopathic pulmonary fibrosis lung diseases respiratory tract diseases
iron-chelating therapy and friedreich ataxia

Conditions: Friedreich Ataxia

Summary: friedreich ataxia, an autosomal recessive condition, ascribed to frataxin gene expansion, has been shown to result from an iron- induced injury to the mitochondrial respiratory chain. buffering free radicals with short-chain quinones (idebenone) protects the patients against cardiomyopathy but not cns involvement. removing cns iron should limit the impact of the neurological symptoms of the disease.

the current clinical trial is a monocentric open phase1-2 trial in the context of rare diseases framework, aimed to the goal of defining the tolerance/efficacy of the treatment. inclusion criteria: minimum age: 13 years follow up in the dept of genetics, hospital necker-enfants malades, paris, france

Eligibility criteria:
inclusion criteria: 1. minimum age: 13 years 2. molecular confirmation of frataxin gene mutation 3. iron overload evaluation 4. presence of lactate 5. echography response to idebenone treatment 6. urinary test of pregnancy for girls 7. sexual abstinence for men 8. information consent exclusion criteria: 1. no disturbance of iron metabolism 2. no response to idebenone 3. friedreich not confirmed 4. polynuclear neutrophils \<2 x 109/l or hemoglobin \< 8g/dl 5. no participation to other trial 6. doubt regarding the compliance of the patient to protocol 7. impossibility to undergo x-ray examination or presence of iron material in the backbone 8. pregnant women 9. absence of social insurance.

Keywords: iron-chelating treatment