Kornimate/medical-research-clean huggingface dataset:
comparison between efficacy of daily and intermittent low glycemic index therapy diet

Conditions: Drug Resistant Epilepsy

Summary: drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. so less restrictive alternatives like low glycemic index therapy diet is gradually becoming more popular and its effectiveness is well established. still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. in this study, we are planning to compare the efficacy of daily and intermittent low glycemic index therapy diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. the children in intermittent lgit arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.

drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. so less restrictive alternatives like low glycemic index therapy diet is gradually becoming more popular and its effectiveness is well established. still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. in this study, we are planning to compare the efficacy of daily and intermittent low glycemic index therapy diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. the children in intermittent lgit arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week. with a follow up period of 6 months, we are planning to enroll 55 children in each arm. adverse effect profile in each arm will also be monitored during the study. also the effect of the dietary therapy on behavior and cognition in each arm will be assessed.

Eligibility criteria:
inclusion criteria: 1. children aged 1-15 years with drug resistant epilepsy 2. willing to come for regular follow up exclusion criteria: 1. surgically remediable cause for drug resistant epilepsy 2. proven in born error of metabolism except in which dietary therapy for epilepsy is indicated(i.e. pyruvate carboxylase deficiency and glut 1 deficiency) 3. previously received kd, mad or lgit 4. known case of * chronic kidney disease * chronic liver disease/gi illness * chronic heart disease(congenital and acquired) * chronic respiratory illness
a study to evaluate pregnancy outcomes in females treated with oral elagolix tablets and capsules

Conditions: Endometriosis; Uterine Fibrioids

Summary: orilissa is a drug approved for the management of moderate to severe pain associated with endometriosis. oriahnn is approved for heavy menstrual bleeding due to uterine fibroids. elagolix-containing products should not be taken by women who are pregnant or suspected to be pregnant but pregnancies are expected as the medicine does not completely stop ovulation and women may inadvertently continue taking elagolix-containing products until their pregnancy is confirmed. this study will assess pregnancy outcomes (maternal, fetal, and infant) of participants with and without exposure to elagolix-containing products for their endometriosis or other conditions based on approved indications and prescribing patterns of elagolix. around 584 participants will be enrolled (292 participants exposed to elagolix and 292 without exposure) in the united states. participants will not receive elagolix-containing products as part of this study but will be followed for maternal and fetal outcomes up to 1 year after delivery. there may be a higher burden for participants in this study compared to standard of care. participants will be asked to provide additional information by questionnaire during each trimester of pregnancy, and at 0-6 weeks, 26 weeks, and 1 year after delivery. contact bloom pregnancy call center at 1-833-782-7241 or bloompregnancyregistry@iqvia.com or visit https://www.bloompregnancyregistry.com/.


Eligibility criteria:
inclusion criteria: participants exposed to elagolix: * currently pregnant. * documentation that the participant was exposed to elagolix-containing product from 14 days after last menstrual period (lmp) or at any time during pregnancy. * consents to participate in the study. if the participant is a minor, consent will be obtained according to local regulations. internal comparator: * currently pregnant with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of elagolix-containing product. * documentation that the participant was not exposed to elagolix-containing product from 14 days after lmp or any time during pregnancy. * consents to participate in the study. if the participant is a minor, consent will be obtained according to local regulations. exclusion criteria: -none.

Keywords: endometriosis pregnancy orlissa elagolix uterine fibriods oriahnn
a botanical skin care regimen on mild to moderate acne and the microbiome

Conditions: Acne Vulgaris

Summary: the purpose of this study is to analyze changes in acne and changes in the gut and skin microbiome with the use of a multi-step botanical skin care regimen in those with mild to moderate acne.


Eligibility criteria:
inclusion criteria: * subjects 15 years of age until 45 years of age. * the presence of mild to moderate acne based on investigator global assessment. exclusion criteria: * the presence of severe acne as noted by the investigator global assessment. * those with a nut allergy. * those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling. * those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling. * individuals who are unwilling to discontinue vitamin e containing supplements during the washout and intervention. * individuals who have been on an oral antibiotic for acne within the previous 1 month. * individuals who are pregnant or breastfeeding. * individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study. * oral supplementation that has nuts in it. * use of isotretinoin within the three months prior to joining the study. * current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Keywords: botanical microbiome skin care
immunogenicity, safety and tolerability of a fully liquid pentavalent (dtwp-hib-hep b) vaccine in infants 6-8 weeks of age

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Hemophilus Influenzae B

Summary: this study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (dtwp-hib-hepb vaccine) in infants 6-8 weeks of age.


Eligibility criteria:
inclusion criteria: 1. male and female subjects ≥ 42 days to ≤ 64 days of age. 2. written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements exclusion criteria: 1. subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study. 2. history of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine. 3. history of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component. 4. administration of parenteral immunoglobulin preparation and/or blood products since birth.

Keywords: infants, immunogenicity, safety
role of magnesium supplementation in the treatment of depression

Conditions: Depression

Summary: the objective of this project is to test the hypothesis that magnesium supplementation will decrease depressive symptoms in adults. this study takes place over 12 consecutive weeks. while the investigators will follow the volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6 consecutive weeks. volunteers will be randomly assigned to start the supplement at week 1 or week 7. volunteers will take two supplement two times a day for a total of 248 mg elemental magnesium daily in the form of magnesium chloride. this amount of magnesium is less than the tolerable upper limit of 350 mg per day. the supplements will be provided. volunteers will be asked to maintain their normal diet for the 12 weeks of the study. the primary outcome measure is the phq-9 questionnaire, a validated measure of depression. secondary measures include the gad-7 for anxiety and side effects.


Eligibility criteria:
inclusion criteria: * all adults at least 18 years of age * a patient health questionnaire-9 (phq-9) score of greater or equal to 5 but less than 20 * people who are currently being treated for depression are still eligible to participate but their treatment must be stable (no changes in medication dose or brand and/or no changes in therapy regimen for at least 2 months). exclusion criteria: * active delirium or dementia * medicinal treatment for bipolar disorder, personality disorder or schizophrenia, * glomerular filtration rate of less than 60 * irritable bowel disease * inflammatory bowel disease * gerd * gastritis * pregnant as reported by potential volunteer * myasthenia gravis * planned elective surgery * currently taking * long term antibiotics * fluoroquinolone * trientine or penicillamine * long term antivirals * digoxin * bisphosphonates * eltrombopag * opiods * calcium channel blockers * deferiprone * doxercalciferol * unable or unwilling to stop taking a magnesium supplement
ema of substance use in homeless youth

Conditions: Substance Use

Summary: the proposed study will provide critical information on ecological momentary assessment (ema) design characteristics that promote retention in a vulnerable and under-represented population in research-youth experiencing homelessness. the study will use an ema app to collect substance use, mood, craving, social surroundings, and trauma measures over a 14-day period in youth age 18-24 (n=40) recruited from star house, a homeless youth drop-in center. youth will be randomized in 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day).


Eligibility criteria:
inclusion criteria: * currently homeless, defined as lacking a fixed, regular, and adequate nighttime residence. * report any of the following past-month frequencies of substance use (nida assist screen) used in prior ema studies: a) heavy episodic or "binge" drinking (≥4 drinks per day for women/≥5 drinks for men) ≥2 days per month ; b) marijuana use ≥2 days per week; or c) any illicit drug use. exclusion criteria: -
a research study looking at long-term blood sugar control in people with type 2 diabetes being treated with xultophy® in a real-world setting in italy

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how xultophy® works in patients like them with type 2 diabetes. participants will get xultophy® as prescribed to them by the study doctor. the study will last for about 18 months. participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities (study-related activities include any procedure related to recording of data according to the protocol). * male or female, age greater than or equal to 18 years at the time of signing informed consent. * patient diagnosed with t2d greater than or equal to 12 months prior to signing informed consent. * the decision to initiate treatment with commercially available xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study. * treated with basal insulin with or without use of oral antidiabetics (oads), with or without use of bolus insulin prior to initiating xultophy®. * for patients transferring from a regimen including bolus insulin, upon initiation of xultophy® the bolus insulin component of the treatment regimen was stopped. * the patient initiated xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent. * available and documented hba1c measurement no more than 3 months prior to xultophy® initiation. exclusion criteria: * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than t2d. * women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study. * previous participation in this study. participation is defined as having given informed consent in this study. * participation in another t2d clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study. * any contraindications for xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the xultophy® local label.
cyclosporine in hepatitis c infection viral clearance following liver transplantation

Conditions: Hepatitis C

Summary: the purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis c virus in liver transplant subjects being treated with peg-interferon and ribavirin.

this is a randomized, single-center controlled study comparing two different immunosuppression regimens (csa and tac) in patients with recurrent hcv after lt undergoing antiviral therapy for hcv.

Eligibility criteria:
inclusion criteria: * males and females age 18 years and older * hcv rna positive by pcr after liver transplantation * elevated alt at any time point after liver transplantation * protocol liver biopsy (standard of care) consistent with stage greater than or equal to 2 of ishak fibrosis score after liver transplantation * able to provide written informed consent * willing to practice acceptable birth control during the study period. exclusion criteria: * decompensated cirrhosis * hemoglobin \< 12 g/dl * wbc \< 3,500/cubic mm * platelets \< 75,000/cubic mm * human immunodeficiency virus infection * pregnancy * positive hbsag * history of coronary artery disease, history of seizure disorder, poorly controlled autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis, intolerance to previous interferon-based therapy other than anemia or neutropenia * history of suicidal ideation or suicidal attempts * creatinine \> 2.0 mg/dl * severe non-hepatic illnesses

Keywords: hepatitis c post liver transplant
pancreatic enzyme suppletion in pancreatic cancer

Conditions: Adenocarcinoma of the Pancreas; Normal Pancreatic Exocrine Function

Summary: this study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.

weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side effects of treatment, mechanical and intestinal obstruction). in pancreatic cancer, additional weight loss and malnutrition may be due to the development of exocrine pancreatic insufficiency (epi). the presence of epi in pancreatic cancer is frequently overlooked, because the focus of treatment is directed at possible surgery or chemotherapy and its potential side effects. although studies have proven that pancreatic enzymes may prevent or decrease weight loss, they are seldom being prescribed.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the pancreas (histologically confirmed) * normal exocrine pancreatic function (fecal elastase test \> 0.2 mg/g) * capable and willing to follow instructions given by the physician. exclusion criteria: * other causes of fat malabsorption (celiac disease, ibd, and major gastrointestinal surgery). * \< 18 years.
deciphering circulating signatures of infected pancreatic necrosis

Conditions: Acute Pancreatitis

Summary: the purpose of the study is to identify novel blood-based biomarkers for prediction and diagnosis of infected pancreatic necrosis (ipn) in patients with necrotizing pancreatitis (np). acute pancreatitis (ap) is the leading cause of gastrointestinal hospital admissions, accounting for over 300,000 emergency department visits annually and imposing a significant socio-economic burden. it is an acute inflammatory condition of the pancreas characterized by damage to the acinar cells, which triggers an inflammatory response and causes widespread systemic damage. in about 20% of cases, the disease progresses to necrotizing pancreatitis (np), a severe form characterized by tissue necrosis. np poses serious health risks, especially when the necrotic tissue becomes infected, leading to infected (peri-)pancreatic necrosis (ipn), which is associated with secondary organ failure (of), sepsis, and mortality rates as high as 40%. while patients with sterile (peri-)pancreatic necrosis (spn) can often be managed conservatively, those with ipn typically require antibiotics and therapeutic interventions such as endoscopic drainage or surgery. timely recognition and treatment of ipn are crucial for improving patient outcomes, yet current diagnostic methods based on clinical symptoms and routine lab markers lack the specificity to reliably distinguish spn from ipn in the early stages. furthermore, while multifactorial scoring systems like ranson, imrie, and apache ii predict necrosis and overall severity in ap, they are not accurate for identifying ipn or predicting mortality in np. the diagnostic gap delays appropriate treatment, allowing the infection to advance and limiting available therapeutic options. the growing incidence and significant impact of ap and np in the general population underscore the urgent need to better understand ipn pathophysiology and to develop specific diagnostic biomarkers that can improve prognosis, guide therapeutic decisions, and enhance patient outcomes.


Eligibility criteria:
inclusion criteria: * adults aged \>18 years. * diagnosis of np based on cect. exclusion criteria: * recurrent ap * pancreatic cancer * pregnancy, lactation * solid organ transplant * immunodeficiency disorders like aids.
benefits of cto-pci in selected cases with hfref (ctohfref)

Conditions: Chronic Total Occlusion Vessel

Summary: the investigators studied the effect of cto-pci on left ventricular function and clinical parameters in patients with hfref.

observational studies have shown that chronic total coronary occlusion percutaneous intervention (cto-pci) improves angina, left ventricular ejection fraction (lvef), and survival. none of these studies aimed to assess the benefits in populations with heart failure with reduced ejection fraction (hfref). the investigators studied the effect of cto-pci on left ventricular function and clinical parameters in patients with hfref. using cardiac magnetic resonance (cmr), the investigators studied 29 patients with hfref and evidence of viability and/or ischemia in the territory supplied by an occluded vessel who were successfully treated with cto-pci. non-cto pci was also performed in patients with multi-vessel disease, . imaging parameters, clinical status, and brain natriuretic peptide (bnp) levels were evaluated before and six months after cto-pci.

Eligibility criteria:
inclusion criteria: * at least one chronic total coronary occlusion * lvef ≤40% by cmr * evidence of myocardial viability and/or ischemia in at least two contiguous segments subtended by the occluded vessel. exclusion criteria: * women of childbearing age or pregnant * claustrophobia * admission to hospital within the previous 90 days due to decompensated heart failure, myocardial infarction or unstable angina. * severe valvulopathy * pacemaker or implantable cardioverter defibrillator * indication for coronary artery bypass surgery * heart transplantation waiting list * follow-up not feasible * life expectancy shorter than 12 months. * iodine contrast or gadolinium allergy * aspirin or clopidogrel allergy * asthma * nyha iv class * liver cirrosis * noncompliance with medical treatment * chronic kidney disease with serum creatinine levels ≥ 2.5 mg/dl or glomerular filtration rate ≤30 ml/min/1.73m2 * evidence of active bleeding * high risk of bleeding * cto distal vessel not visible through collateral circulation * cto distal vessel diameter \<2mm * absence of acceptable vascular access

Keywords: coronary chronictotal occlusion coronary angioplasty reduced ejection fraction
trial of panitumumab/cisplatin/fluorouracil combined with radiation in esophageal cancer

Conditions: Cancer

Summary: the overall study objective is to evaluate the dose limiting toxicities and the recommended phase ii dose of panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. the investigators will also be assessing the ability of pet (positron emission tomography) imaging to predict the degree of pathologic response. all patients will have a pre-study fdg (f-18 fluorodeoxyglucose) pet scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a pet/ct scan. it is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. the surgery will allow us to compare this study regimen to the historical standard of care (cisplatin/fluorouracil chemotherapy with radiation therapy).


Eligibility criteria:
inclusion criteria: 1. locally advanced esophageal cancer (stages t1n1 or t2-4 any n) 2. histology must be adenocarcinoma or squamous cell carcinoma 3. must be surgical candidate based on evaluation by a thoracic surgeon 4. must have adequate organ function as defined by routine lab tests exclusion criteria: 1. insitu carcinoma 2. prior chemotherapy for esophageal cancer 3. metastatic (stage iv disease) 4. tumors \ 75% of tumor located within the stomach 5. active, uncontrolled cardiac disease 6. subjects with \>grade 2 neuropathies. -

Keywords: esophageal cancer locally advanced esophageal cancer