Kornimate/medical-research-clean huggingface dataset:
study of oral atogepant tablets to assess change in disease activity in adult japanese participants with episodic migraine

Conditions: Migraine

Summary: a migraine is a moderate to severe headache on one side of the head. a migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. this study will assess how safe and effective three different doses of atogepant is compared to placebo in adult japanese participants. change in migraine symptoms will be assessed. atogepant (qulipta) is an approved drug to treat adults with episodic migraine in the united states. participants are randomly assigned to one of the 4 treatment groups called arms to receive atogepant or matching placebo. there is 1 in a 4 chance for the participant to receive placebo. this is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across japan. participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. at 12 weeks participants assigned to atogepant dose a, dose b or dose c will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose a, dose b or dose c for 12 additional weeks. all participants will be followed for 30 days following last dose of study drug. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.


Eligibility criteria:
inclusion criteria: * at least a 1-year history of migraine (with or without aura). * less than 50 years of age at the time of migraine onset. * history of 4 to 14 migraine days per month in the 3 months prior to screening. * 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the ediary. exclusion criteria: * difficulty with distinguishing migraine headaches from tension-type or other headaches. * clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Keywords: migraine episodic migraine atogepant
esomeprazole (nexium) vs. surgery

Conditions: Gastroesophageal Reflux

Summary: the study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.


Eligibility criteria:
inclusion criteria: * subjects considered suitable for surgical treatment and long-term management of esomeprazole. * history of chronic reflux esophagitis or symptomatic gerd exclusion criteria: * history of esophageal, gastric, or duodenal surgery predicted to influence negatively on subsequent treatment within the study. * contraindication to the study drug. * pregnancy, lactating or of child-bearing potential.

Keywords: acid reflux disease gastroesophageal reflux disease
families affected by dementia: a survey of caregivers

Conditions: Dementia

Summary: the purpose of our study is to better understand how caregivers of individuals with dementia cope with their family member's illness. if you are eligible for the study and would like to participate, we will schedule a one-time phone interview, which will last approximately 2 hours for which you will be compensated for your time.

eventually, results of this study will be used to develop treatments that will hopefully help caregivers cope more effectively with managing dementia in a loved one.

Eligibility criteria:
inclusion criteria: * caregiver of individual with dementia * relative who is 60 years or older with dementia * live-in, unpaid caregiver * have a working telephone number
group dialectical behavior therapy as add-on treatment for adults with attention deficit/hyperactive disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention-deficit/hyperactive disorder (adhd) in adults is associated with global impairments and deficits in quality of life. the adhd functional impairments during adulthood usually persist even after adequate medication treatment. the skill training group of the dialectical behavioral therapy (dbt) is one of the group therapies that had been adapted for the specific treatment of adhd patients. our primary aim is to explore the feasibility of the approach in different culture and to evaluate the efficacy of the skill training group as an add-on treatment for adults using adhd medication. this is a randomized clinical trial comparing the skill training group added to stimulants to treatment as usual. 52 adults previously diagnosed with adhd and treated with stimulants in our adhd outpatient program will be enrolled. only patients with residual symptoms will be included (adhd-self report scale - asrs ≥ 20). the intervention comprises the standard 12 sessions therapy program. the groups will have between 8 and 12 patients each, and will be conducted by a trained dbt therapist with supervision from a senior dbt therapist. the primary outcome will be the asrs scores. secondary outcomes include scores in adhd quality of life, beck's depression inventory, beck's anxiety inventory, and performance in a neuropsychological test (difference between pre and post-intervention) (stop signal task). adherence to the protocol will also be checked. the recruitment was initially scheduled for beginning in november.


Eligibility criteria:
inclusion criteria: * patients with adhd * medicated with following drugs and minimum daily dosages: methylphenidate ≥ 0.5 mg/kg lisdexamfetamine ≥ 30mg bupropion ≥ 150 mg modafinil ≥ 200mg imipramine ≥ 1mg/kg * at least one month of stabilized dosage for any psychiatric medication. * adhd-self report scale ≥ 20. * knowledge of oral and written communication in portuguese * iq\>85 (intelligence quotient) exclusion criteria: * diagnoses of borderline or anti-social personality disorders. * diagnoses of autism spectrum disorder * current episode of major depression or suicide toughs * current episodes of mania or hypomania * recent episodes of drug abuse (last 6 months) * diagnoses of drug dependence * patients that change their medications or their psychiatric conditions in the exclusion criteria above after the beginning of the protocol will have their data censored, but included in the intention to treat analyses. these patients will keep the right to attend all the sessions in the protocol at their discretion.

Keywords: attention deficit hyperactive disorder skill training group dialectical behavior therapy
paclitaxel coated balloon for the treatment of chronic benign stricture- bowel

Conditions: Bowel; Stricture

Summary: to determine the safety and efficacy of gie medical's protractx3™ tts dcb for the treatment of recurrent benign bowel strictures.


Eligibility criteria:
inclusion criteria: 1. age ≥ 22 2. diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations. 3. willing and able to complete protocol required follow up 4. willing and able to provide written informed consent 5. stricture length ≤ 5 cm exclusion criteria: 1. female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months 2. contraindication to endoscopy, anesthesia, or deep sedation. 3. suspicion of malignant bowel stricture note: biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator. 4. benign stricture due to extrinsic compression 5. stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.) 6. stricture complicated with abscess, fistula, perforation, leakage or varices 7. stricture segment has moderate to severe active inflammation at the time of treatment. moderate to severe inflammation is defined as any one of; ulcers \>0.5cm in diameter, ulcerated surface \>10%, affected (inflamed) surface \>50%, marked erythema, absent vascular pattern, significant friability, or erosions 8. multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) note: clinically significant strictures include those that are unable to be passed by the endoscope. 9. received steroid injections into target stricture in the last 8 weeks 10. stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel 11. diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer) 12. suspected perforation of gastrointestinal tract 13. active systemic infection 14. allergy to paclitaxel 15. severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines 16. chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use 17. condition requiring treatment in urgent setting 18. life expectancy of less than 24 months 19. concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, etc. 20. current participation in another pre-market drug or medical device clinical study unless in long term follow-up

Keywords: dcb bowel stricture drug coated balloon paclitaxel coated balloon
etiology, prevention and treatment of neonatal infections in the community

Conditions: Bacterial Infection; Infectious Disease

Summary: the purpose of this study is to determine what are the major types of bacteria that cause newborn infections in the community in rural bangladesh and whether providing an obstetric and neonatal care package will reduce neonatal deaths by 40%.

the study seeks answers to two questions: 1. what are the major bacterial pathogens responsible for serious neonatal infections in the community in rural bangladesh? 2. can provision of a package of obstetric and neonatal care, including active surveillance for serious neonatal illness and referral to hospital, and identification of barriers to care-seeking and design of strategies to address them reduce neonatal mortality rates by at least 40% compared to communities in which such services are not provided? despite significant decline in infant and child mortality rates in recent decades, neonatal mortality rates remain unacceptably high. of the 8 million infant deaths that occur worldwide each year, approximately 4 million occur in the neonatal period. hence, the specific aims of the study include: 1. identifying the principal agents of serious bacterial infections in bangladeshi neonates in the community 2. evaluating the impact of introducing a package of essential obstetric and neonatal care practices in the community, including identifying barriers to care-seeking and design of strategies to address those barriers and 3. building capacity within bangladesh by training bangladeshi scientists in epidemiological and microbiological techniques, clinical research methods and best clinical practice through an on-going collaboration with dhaka shishu (children) hospital and the international centre for diarrhoeal disease research, bangladesh.

Eligibility criteria:
inclusion criteria: * pregnant women (any age) * newborns exclusion criteria: * children (outside newborn period)

Keywords: neonatal bacterial infection
hipec and systemic chemotherapy combined with apatinib in unresectable peritoneal metastases from gastric cancer

Conditions: Peritoneal Metastases From Gastric Cancer

Summary: the prognosis of patients with unresectable peritoneal metastases from gastric cancer is poor. these patients may obtain survival benefit from radical gastrectomy and cytoreductive surgery (crs). the response rates of previous conversion therapy are low. hyperthermic intraperitoneal chemoperfusion (hipec) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (pci) levels. apatinib, a novel targeted inhibitor of vegf receptor 2 (vegfr2), shows significant antitumor activity in the patients with gastric cancer. the purpose of this study is to investigate the efficacy and safety of hipec and systemic chemotherapy combined with apatinib in the conversion therapy of peritoneal metastases from gastric cancer.

to determine the efficacy and safety of hipec and systemic chemotherapy combined with apatinib in the conversion therapy of peritoneal metastases from gastric cancer, patients undergo hipec with docetaxel/ lobaplatin at the time of fist surgery and twice repeat within one week after the surgery, following 2 cycles of 3-week oxaliplatin/s1 chemotherapy combined with apatinib and 1 cycles of 3-week oxaliplatin/s1 chemotherapy. the second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Eligibility criteria:
inclusion criteria: * histological proved diagnosis of gastric cancer. * unresectable peritoneal metastases and primary tumor proved at surgery. * no evidence of distant metastases. * have not received radiotherapy, chemotherapy or immunotherapy. * ecog score: 0\~2. * written informed consent is obtained prior to commencement of trial treatment. exclusion criteria: * existence of distant metastasis outside the abdomen. * any previous radiotherapy, chemotherapy or immunotherapy. * active systemic infections. * inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * female patients who are pregnant or breast feeding
comparison of two different doses of bemiparin in covid-19

Conditions: COVID-19

Summary: patients requiring hospitalization due to covid-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a lmwh) for 10 days.


Eligibility criteria:
inclusion criteria: * age (equal or more than 18 yo) * hospitalization at conventional wards due to covid-19 related mild or moderate pneumonia (curb65\ 90%) * 3-4 points according to the who ordinal scale. * confirmed covid-19 (pcr or other validated test) * d-dimer \>500 ng/ml * sign of informed consent * the patient is able, according to investigator's opinion, to deal with all the requirements of the clinical trial. exclusion criteria:
galactose - the ideal carbohydrate supplement for exercise in type 1 diabetes

Conditions: Type1diabetes; Hypoglycemia; Hyperglycemia

Summary: in this study, 14 subjects with type 1 diabetes are studied in a randomized crossover study in which the subjects cycle at a fixed intensity at 60% of their maximum oxygen capacity (vo2 max) for 1 hour. thirty minutes before each cycling test, participants consume a 200 ml beverage, consisting of either: 1) dextrose (20 g), 2) galactose (20 g), 3) lactose (20 g) or 4) water (sweetened). if blood sugar drops below 3.9 mmol/l, glucose infusion is given and blood sugar is kept just above 5 mmol/l. the trial days take place at least 4 days apart.

on study days, a catheter is placed in two antecubital veins for regular blood sampling and for glucose infusion (if needed). the participant will rest in a bed, when not performing the 1-hour bicycle ergometer test. thirty minutes before the leg-cycle ergometer test, the participants consume a 300 ml beverage containing either: 1) dextrose (20 g), 2) galactose (20 g) 3) lactose (20 g) or 4) water (sweetened). at t=0, the ergometer test is started and continued for 1 hour (fixed intensity cycling at 60% of vo2-max). if blood glucose drops below 3.9 mmol/l, glucose infusion (5 % glucose) will be administered, and blood glucose is kept just above 5 mmol/l and infused volume is registered. blood samples are collected at t= -40, 0, 30, 60, 90, 120 for measurement of plasma lactate, non-esterified fatty acids (nefa), plasma triglyceride and hormonal concentrations (epinephrine, norepinephrine, cortisol, and glucagon). plasma blood glucose measurements are performed at t = -40 and every 10-15 minutes until the end of the study day. respiratory exchange ratio is measured by indirect calorimetry (collection of respiratory gasses vo2 and vco2) pre-exercise, at the end of the exercise bout, and 30 minutes post-exercise. protein oxidation rate is estimated from urinary urea excretion, and net lipid and glucose oxidation rates are calculated from indirect calorimetry measurements with correction for protein oxidation. therefor a urine sample will also be collected at the end of the study day. the bicycle ergometer test is discontinued after 1 hour of bicycling and the participant is observed until 2 hour post exercise where the study day is ended.

Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 2 years * age between 18 and 65 years * hba1c less than 70 mmol/mol * physically active (at least 150 minutes of moderate-to-vigorous intensity activity weekly) * insulin pen and pump treatment * men and women are eligible, but women will have to perform study days in the mid-cycle phase of the menstrual cycle. exclusion criteria: * - diabetic nephropathy, neuropathy, and proliferative retinopathy * hypoglycemia unawareness * lactose intolerance * heart disease and other conditions which may be negatively affected by the vo2 max test and 1-hour cycling on study days
double-blind extension of horizon pivotal fracture trial (zoledronic acid in the treatment of postmenopausal osteoporosis)

Conditions: Osteoporosis

Summary: this extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the czol446h2301 (nct00049829): horizon pivotal fracture trial. this extension study began after the 3-year core study ended. baseline is the same as year 3.


Eligibility criteria:
inclusion criteria: * patients who have received 3 infusions in the horizon-pivotal fracture (pft) study. exclusion criteria: * poor kidney, eye, or liver health * use of certain therapies for osteoporosis in the horizon-pft study (other than the study medication) * abnormal calcium levels in the blood other protocol-defined inclusion/exclusion criteria may apply.

Keywords: osteoporosis, zoledronic acid
effects of platelet rich plasma injections on biomarkers after anterior cruciate ligament tears

Conditions: Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture

Summary: a potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. there are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis. the main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. we hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.

a non-surgical treatment option for the management of osteoarthritis include injectables such as corticosteroids and platelet rich plasma. these injectables work by positively affecting cartilage cells, also known as chondrocytes, and the cells of the joint lining tissue, also known as synoviocytes. platelet rich plasma is an autologous derived blood product, i.e. a joint injectable made from the patient's own blood at the time and location of injection with simple blood centrifugation. studies in the bench-top laboratory setting have provided in-vitro evidence that platelet rich plasma decreases synoviocyte production of metallometal proteases, an inflammatory protein with negative effects on cartilage and decreases the effects of inflammatory proteins.

Eligibility criteria:
inclusion criteria: * no history of previous traumatic ipsilateral knee injury * bone bruise visualized on mri * no clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or lateral collateral ligament injury exclusion criteria: * patients without a palpable knee effusion * an injury occurring more than 10 days before enrollment * previous ipsilateral knee surgery * intra-articular cortisone or platelet rich plasma injection into either knee within 3 months of injury * participation in another clinical drug trial within the 4 weeks before injury * a history of any inflammatory disease or immune-comprised
ctffr and prediction of non-significant cad lesions

Conditions: Chronic Coronary Syndrome

Summary: in this prospective cohort study, 250 patients with suspected or known cad and at least one intermediate coronary lesion (50-70% stenosis) who had a niffr value greater than 0.80 underwent coronary computed tomography angiography (ccta) with niffr assessment. patients were followed for one year to monitor for mace

this prospective cohort includes people with known or suspected cad who had both ccta and ica with this index (ffr) measurements. patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on ccta and then underwent ffr testing. data about the patients was acquired from the professor kojuri registry. the database provided demographic information for instance age, gender, cad family history, prior cad history, hypertension (htn), diabetes mellitus (dm), and hyperlipidaemia (hlp). the prevalence of cigarette smoking and the ejection fraction of the left ventricle. lesion and vessel characteristics were also collected from registry. the target vessel was identified (lad, rca, lcx, or lmc), the lesion was located (proximal, mid, or bifurcation), the vessel diameters were measured (proximal, distal, stenotic), and the lesion length was determined. measurements were taken using ccta datasets using semi-automated software methods. patients were clinically monitored for one year after examination. the primary outcome was the occurrence of major cardiovascular consequences, or mace, which included cardiac-related death, acute coronary syndrome (acs), unexpected revascularisation, and hospitalization for cardiac reasons. throughout the one-year study period, all participants were visited every three months and followed up with phone calls.

Eligibility criteria:
inclusion criteria: * patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on ccta and then underwent ffr testing exclusion criteria: * patients having past coronary artery bypass graft surgery (cabg) * previous pci in the target vascular * significant renal impairment define with egfr \< 30 ml/min/1.73 m² * contrast allergy * poor image quality that prevented appropriate ccta or ct-ffr analysis

Keywords: chronic coronary syndrome major adverse coronary events (mace) fractional flow reserve coronary ct angiography