Kornimate/medical-research-clean huggingface dataset:
confocal laser endomicroscopy based diet in functional dyspepsia

Conditions: Functional Dyspepsia

Summary: after a thorough baseline evaluation, functional dyspepsia (fd) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (cle). patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion. the aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in cle upon nutrient exposure.


Eligibility criteria:
inclusion criteria: * age 18-70 y/o (70 years included) * male or female subjects * fd (pds, eps or overlap) according to rome iv criteria * provide written informed consent to participate in the study * women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (iuds), sexual abstinence, or vasectomized partner. women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. * subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. exclusion criteria: * pregnant or breastfeeding women * history of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed) * symptoms predominantly associated with irritable bowel syndrome or gastro-esophageal reflux disease * ige-mediated food allergies identified by immunocaps blood tests * known underlying organic gastrointestinal disease * current use of nsaids, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). use of antibiotics in the past 6 weeks. * allergy to fluorescein or propofol * known celiac disease * following a diet, interfering with the study diet in opinion to the investigators
induction of labor in morbidly obese patients

Conditions: Morbid Obesity; Pregnancy

Summary: the goal of this randomized control trial is to compare different doses of misoprostol (25 mcg vs 50 mcg) in induction of labor (iol) in morbidly obese patients with bmi \>40. it is known that morbid obesity is a risk factor for failed iol and ultimately cesarean delivery (cd.) if the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.

the rate of iol continues to increase, from about 10% in 1990 to 23% in 2018. patients with bmi \>40 are at increased risk for failed iol and needing a cd. studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity. the investigators plan to conduct a randomized controlled double blinded trial. patients who are scheduled for induction of labor after 34 weeks gestation, have a bmi \>40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.

Eligibility criteria:
inclusion criteria: * morbidly obese (bmi ≥ 40 kg/m2) at admission for induction of labor * speaks english or spanish * gestational age between 34 weeks and 0 days and 42 weeks and 6 days * age 18 years old or older * viable, single, cephalic fetus * intent to proceed with cervical ripening - cervical exam: dilation \< 5 cm * contractions \< 5 per 10 minutes exclusion criteria: * history of cesarean delivery * contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery) * contraindication to vaginal delivery (placenta previa, vasa previa, hiv with high viral load) * contraindications to labor (cardiac, neurosurgical, need for cesarean) * age \< 18yo * fetal growth restriction with abnormal umbilical artery doppler indices * cervical dilation \>5 cm * contractions \>5 per 10 minutes * significant vaginal bleeding with concern for placental abruption * non-reassuring fetal status or fetal heart rate decelerations * fetal demise or major fetal anomaly * inability to give consent

Keywords: induction of labor morbid obesity misoprostol
evaluation of effectiveness of acetylsalicylic acid on markers of vascular dysfunction in scleroderma patients

Conditions: Systemic Sclerosis

Summary: systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. it is believed that vascular changes, expressed early by the raynaud phenomenon, precede fibrosis and organic dysfunction. there is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. acetylsalicylic acid (asa) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. this study aims to evaluate the effectiveness of asa on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser doppler imaging. in addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.


Eligibility criteria:
inclusion criteria: * fulfill systemic sclerosis eular/american college of rheumatology 2013 classification criteria; * pharmacological treatment with stable dosages for the last three months. exclusion criteria: * pregnancy; * use of anticoagulants, nsaids or antiplatelets drugs; * diagnose of other autoimmune rheumatic diseases, coronary diseases, cerebrovascular diseases and severe peripheral artery diseases; * active infection; * contraindication to acetylsalicylic acid use.

Keywords: systemic sclerosis acetylsalicylic acid vascular dysfunction
prospective study to measure vascular parameters (ancillary study of adequate)

Conditions: De Novo Transplant Disease

Summary: the purpose of this study is to compare parallel-group effects between 4 months and 12 months post-transplantation 2 values of target residual concentrations of advagraf on vascular parameters in de novo renal transplant patients.


Eligibility criteria:
inclusion criteria: * age between 18 et 70 years * patient accepting to give a written informed consent * recipients of a first renal allograft (deceased or living, non hla identical donor with compatible abo blood type) * randomized in the adequate study * patients must have at j112 +/- 3 days a stable renal function (mdrd 4) with an absence of dsa since transplantation. * negative t cross-match in cytotoxicity * tolerate a daily dose of mmf at 1g exclusion criteria: * acute rejection during the first months * existence of a bk infection since m3 * proteinuria/reatininuria ratio \> 1g/g since m3

Keywords: renal transplantation tacrolimus arterial stiffness vascular fibrose plasma markers
microbiota in acute pancreatitis: prospective multicenter study

Conditions: Acute Pancreatitis; Microbial Colonization

Summary: the objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. at the same time, the investigators pretend to determine if there are differences according to the etiology and severity of the disease and if the disregulation is temporary or is maintained after one month of discharge. to carry out this purpose, the investigators have designed a prospective and multicentre observational study where samples of feces and saliva of patients admitted for acute pancreatitis of different etiologies and severity will be analyzed.

the study of the human microbiota is gaining importance given its relationship with the homeostasis of the organism as well as with certain pathologies. specifically in the case of acute and chronic pancreatitis, recent studies suggest the disregulation of the intestinal flora as a possible determinant in the development and evolution of the disease. if this hypothesis is confirmed, hygienic-dietetic measures, as well as the administration of antibiotics, probiotics or fecal transplantation, may have therapeutic implications. the objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. at the same time, the investigators also intend to determine if there are differences according to the etiology and severity of the disease and if the disregulation is temporary or is maintained after one month of discharge. to carry out this purpose, it has been designed a prospective and multicentre observational study where samples of feces and saliva of patients admitted for acute pancreatitis of different etiologies and severity will be analyzed .

Eligibility criteria:
inclusion criteria: * case patients: adult patients diagnosed of acute pancreatitis according to atlanta 2012 criteria * healthy controls: healthy people with a proximity relationship with case patients and similar age (+/- 5 years. doesn't have to be a parental relationship. exclusion criteria: -
effects of administration of fostamatinib on blood concentrations of digoxin in healthy subjects

Conditions: Healthy Volunteers; Rheumatoid Arthritis

Summary: the purpose of this study is to investigate the drug interaction between fostamatinib and digoxin by comparing the safety, tolerability and plasma concentration of digoxin when administered alone and with fostamatinib in healthy subjects.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * male or female subjects aged 18 to 45 years (inclusive) * minimum weight of 50 kg and body mass index (bmi) between 18 and 30 kg/m2 (inclusive) * female subjects must have a negative pregnancy test at screening and on day -1,must not be lactating, and must be of non-childbearing potential exclusion criteria: * history or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy) * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product * subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day * absolute neutrophil count of \<2500/mm3 or 2.5 x 109/l * previous treatment with fostamatinib or digoxin in the present study

Keywords: phase 1 healthy volunteers pharmacokinetics rheumatoid arthritis ra, fostamatinib digoxin, drug-drug interaction scientific terminology: rheumatoid arthritis fostamatinib digoxin drug-drug interaction laymen terminology: rheumatoid arthritis amount of digoxin in blood
a study to evaluate the effect of musashino diabetes diet in type ii diabetes mellitus disease

Conditions: Type II Diabetes Mellitus

Summary: evaluation the change of patients' glycosylated hemoglobin (hba1c) after 12 weeks diet control

in this study, we provide the delivery service of musashino t2dm diet for 12 weeks to patients with t2dm, to evaluate the effect on glycosylated hemoglobin (hba1c), progression and compliance during study period.

Eligibility criteria:
inclusion criteria: * a baseline of glycosylated hemoglobin(hba1c) is, 10%≥hba1c≥7%, during past 1 month * the subject is able to understand and comply with protocol requirements, instrument * the subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess * signed and dated written informed consent exclusion criteria: * pregnancy, breastfeeding or planning to become pregnant during the study * acute illness or infection requiring treatment within 14 days of study entry * other serious disease (e.g. heart, lung, brain, liver) within 3 months * presence of malignancies * participate in other clinical trial within 30 days prior to this study * alcohol or drug abuse that would interfere with the ability to meet study requirements (opinion of investigator) * concurrent significant medical condition that would limit ability to participate in the study * consider by the investigator to be unsuitable for study participation, for any reason

Keywords: t2dm, type ii diabetes mellitus, hba1c
evaluation of an investigational multifocal lens

Conditions: Presbyopia

Summary: the purpose of this study is to test the performance of an investigational multifocal test soft contact lens.


Eligibility criteria:
inclusion criteria: 1. the subjects were required to have read, understand, and signed the statement of informed consent and receive a fully executed copy of the form. 2. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. between 40 and 70 years of age. 4. subjects must own a wearable pair of spectacles, if required for their distance vision. 5. be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration) 6. already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "presbyopic symptoms questionnaire"\* 7. the subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye. 8. refractive cylinder ≤ -0.75 d in each eye. 9. add power in the range +0.75 d to +2.50 d in each eye. 10. best corrected visual acuity of 20/20-3 or better in each eye. exclusion criteria: 1. currently pregnant or lactating (subjects who became pregnant during the study were discontinued). 2. any ocular or systemic allergies that may have contraindicated contact lens wear. 3. any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear. 4. any ocular abnormality that may have interfered with contact lens wear. 5. use of any ocular medication, with the exception of rewetting drops. 6. any previous intraocular surgery (e.g., radial keratotomy, prk, lasik, etc.). 7. history of herpetic keratitis. 8. history of binocular vision abnormality or strabismus. 9. any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., hiv). 10. history of diabetes. 11. participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 12. any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. 13. any ocular infection or inflammation. 14. any corneal distortion or irregular cornea.
a study evaluating the safety and efficacy of long-term dosing of romiplostim in thrombocytopenic pediatric patients with immune (idiopathic) thrombocytopenia purpura

Conditions: Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP

Summary: this is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (idiopathic) thrombocytopenia purpura. this study is available to pediatric patients who have completed a previous romiplostim itp study and meet the eligibility criteria of this study.


Eligibility criteria:
inclusion criteria: * subject or subject's legally acceptable representative has provided informed consent. * subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with itp. exclusion criteria: * subject has or previously had any bone marrow stem cell disorder (any abnormal bone marrow findings other than those typical of itp must be approved by amgen before a subject may be enrolled in the study). * subject has any new active malignancy diagnosed since enrollment in the previous romiplostim itp study. * subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study. * other investigational medications are excluded. * currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) (with the exception of romiplostim in a previous clinical study). * female subject of child bearing potential (defined as having first menses) is not willing to use highly effective contraception during treatment and for 4 weeks after the end of treatment. * female subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment. * subject has known sensitivity to any of the products to be administered during dosing. * subject previously has entered this study (this will depend on the type of study). * subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge. * subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

Keywords: immune thrombocytopenic purpura pediatric thrombocytopenia
espb versus inb with pcia in video-assisted thoracic surgery

Conditions: Lung Diseases

Summary: a randomized prospective trial to test the non-inferiority of erector spinae plane block (espb) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in thoracoscopic lung surgery

for patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.multimodal analgesia have shown good efficacy but without reaching full pain relief. the primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.

Eligibility criteria:
inclusion criteria: * patients to receive video assisted thoracoscopic lobectomy or bullectomy . exclusion criteria: * 1. patient refusal 2. heavy skin eruption and infection at site of injection. 3. coagulopathy. 4. allergy to local anesthetics. 5. taking analgesics.

Keywords: erector spinae plane block video-assisted thoracic surgery; intercostal nerve block patient-controlled intravenous analgesia
effectiveness of music during cardiac catheterization

Conditions: Angiography

Summary: the research was planned on a randomized controlled experimental basis. simple stratified randomization will be performed according to gender and age. consent will be obtained from children and parents who agree to participate in the research. before angiography, "child fear scale", "state-trait anxiety scale (stai-tx)", and "vital signs follow-up form" will be applied to all children taking part in the study and life signs will be recorded. during angiography, the first group will listen to the music that the child wants to listen to. the second group will listen to the music which determined by the researchers. no music will be played to the control group. during angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute. "numerical pain scale", "child fear scale", "state anxiety scale", and "vital signs follow-up form" will be re-evaluated to all three groups after angiography.

this study was planned to determine the effect of music during angiography on pain, fear, anxiety and life signs in children aged 7-18. the research was planned on a randomized controlled experimental basis. simple stratified randomization will be performed according to gender and age. consent will be obtained from children and parents who agree to participate in the research. before angiography, "child fear scale", "state-trait anxiety scale (stai-tx)", and "vital signs follow-up form" will be applied to all children taking part in the study and life signs will be recorded. the sample size of the study was determined and the effect size was 0.25 based on the standard effect sizes determined by cohen. in the study, the sample number of 0.84 in the statistical power α=0.05 confidence interval was calculated as 36 for each group. during angiography, the first group will listen to the music that the child wants to listen to. the second group will listen to the music which determined by the researchers. no music will be played to the control group. during angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute. "numerical pain scale", "child fear scale", "state anxiety scale", and "vital signs follow-up form" will be re-evaluated to all three groups after angiography.

Eligibility criteria:
inclusion criteria: * volunteering to participate in research * being between 7-18 years of age * lack of communication problems (vision, hearing, mental) * being informed about surgical intervention * lack of prior surgical intervention experience * receiving sedoanalgesia during angiography exclusion criteria: * intubation of the child during angiography * parent's refusal to take part in the study