Kornimate/medical-research-clean huggingface dataset:
a comparative trial of improving care for underserved asian americans infected with hbv

Conditions: Hepatitis B

Summary: asian americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (hcc) among all u.s. racial and ethnic groups. the goal of this study is to investigate the efficacy of a patient navigator-led mobile phone text messaging intervention (pnmi) in improving hepatitis b follow-up care management for asian americans with chronic hepatitis b infection through a randomized controlled trial.

asian americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (hcc) among all u.s. racial and ethnic groups. inadequate chronic hepatitis b (chb) monitoring and care are also likely to contribute to poorer outcomes and increased healthcare costs. the goal of this study is to investigate the efficacy of a patient navigator-led mobile phone text messaging intervention (pnmi) in improving hepatitis b follow-up care management for asian americans with chronic hepatitis b infection through a randomized controlled trial. the primary outcome of the study is asian chb patient adherence (measured as "having seen a doctor for chb monitoring") to hepatitis b (hbv) monitoring guidelines at 6-month and 12-month assessments post-intervention. patient partners and stakeholders were engaged in all study stages. the findings of this study provided unique and promising opportunities for broadly disseminating and implementing the evidence-based intervention in the real-world practice, thus further preventing chronic liver diseases and reducing health disparities among high-risk underserved populations.

Eligibility criteria:
inclusion criteria: 1. self-identified chinese, korean and vietnamese ethnicity 2. age 18 and above 3. accessible by telephone with text message feature 4. presence in the same geographic study area for a period of one year 5. not enrolled in any chronic hbv adherence management intervention 6. medically diagnosed chronic hbv infection with positive for hepatitis b surface antigen (hbsag) for more than six months, and 7. never or non compliant with hbv monitoring guidelines. exclusion criteria: patients were excluded from the study for the following conditions: 1. diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer 2. concurrent hepatitis c infection, and 3. concurrent hiv infection
replacing protein via enteral nutrition in critically ill patients

Conditions: Critical Illness; Nutrition Disorders

Summary: the investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from icu day 5 until icu discharge up to icu day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.

the replenish is a multicentric, international, open label, randomized controlled trial which will enroll subjects in intensive care unit. patients will be randomized on day 4 of icu admission. until icu day 4, protein requirement will be provided according to the local practice as long as no intravenous amino acids are given and the average protein intake in the first 4 days does not exceed 0.8 g/kg/day. on icu day 4, patients will be randomized to one of the two treatment groups: one with standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula and another group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula and supplemental protein at 1.2 g/kg/day. randomization will be stratified by suspected covid-19 and then by site and the use of renal replacement therapy at the time of randomization (intermittent hemodialysis or continuous renal replacement therapy.

Eligibility criteria:
inclusion criteria(on icu calendar day 4 or the morning of day 5) 1. age ≥18-years old 2. patient started on enteral nutrition (en) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (peg) or jejunostomy tubes. 3. the patient is on invasive mechanical ventilation and unlikely to be discharged from icu next day. exclusion criteria: 1. lack of commitment to full life support or brain death. patients with "do not resuscitate" order but with commitment to ongoing life support can be enrolled. 2. patients on any amount of parenteral nutrition (pn) in icu at the time of screening, whether pn is used alone or in combination with enteral nutrition. non-nutritional calories (dextrose, propofol, citrate) not considered as pn. 3. patients who received an average protein of more than 0.8g/kg/day in the first 4 icu days. 4. patients being fed entirely through oral route - i.e. those who are eating. 5. pregnancy. 6. burn patients. 7. prisoners or those undergoing forced treatment. 8. patients with hepatic encephalopathy or child c liver cirrhosis 9. inherited defect of amino acid metabolism. 10. allergies to protein supplement
a study of glycopyrronium cloth, 2.4% in patients with palmar hyperhidrosis

Conditions: Palmar Hyperhidrosis

Summary: the objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

this is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis

Eligibility criteria:
inclusion criteria: 1. signed informed consent and assent (for subjects under legal adult age). 2. age ≥9 years. 3. primary palmar hyperhidrosis for at least 6 months duration. 4. average sweat severity score of ≥4 at baseline. 5. hyperhidrosis disease severity scale of 3 or 4 at baseline. 6. willing to comply with the protocol. subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol. 7. male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females. exclusion criteria: 1. subjects who have taken or are currently taking glycopyrronium cloth, 2.4%. 2. prior surgical procedure for hyperhidrosis. 3. iontophoresis for the palms within 4 weeks of baseline. 4. treatment with botulinum toxin (e.g., botox®) for palmar hyperhidrosis within 1 year of baseline. 5. open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands. 6. secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism). 7. known history of sjögren's syndrome or sicca syndrome. 8. history of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis. 9. men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
impact of rehabilitation program on pah patients treated with macitentan.

Conditions: Pulmonary Arterial Hypertension

Summary: 48 patients, over the age of 18, with pulmonary arterial hypertension (pah) classified as who iii-iv, that are all stable under macitentan therapy ( medication for treating pah patients), will be recruited to the study through the pulmonary hypertension (ph) clinic at soroka medical center. the patients will be randomly divided into an intervention group, which will exercise twice a week for 12 weeks, supervised by physiotherapists, and a control group, which will only receive the medication. tests will be performed before the beginning of the intervention program, 6 weeks after it has begun, at the end of the 12 week program, and 3 months after finishing the program.

48 patients, over the age of 18, with pah classified as who iii-iv, that are all stable under macitentan therapy, will be recruited to the study through the ph clinic at soroka medical center. the patients will be randomly divided into intervention and control groups. the intervention group will exercise in a pulmonary rehabilitation program twice a week, for 12 weeks. the exercise protocol will include circuit training, with 2-3 minutes exercise intervals, including aerobic and strength training, and will be supervised by physiotherapists. the control group will continue to receive their usual macitentan treatment. all study participants will undergo tests before the beginning of the intervention program, 6 weeks after it has begun, at the end of the 12 week program, and 3 months after finishing the program. the tests will include a cardio-pulmonary exercise test, 6 minute walk distance measurement, who functional class evaluation, levels of brain natriuretic peptide (bnp), emphasis10 questionnaire (emphasis-10 questionnaire is a short questionnaire for assessing health related quality of life in pulmonary arterial hypertension), short form-36 (sf-36) quality of life questionnaire and echocardiography. once data collection is completed, two way anova repeated measures will be used to assess the changes in outcome measures.

Eligibility criteria:
inclusion criteria: 1. pah patients group 1 2. patients age \> 18 years, 3. patients with who iii 4. patients on macitentan treatment who are stable on disease-targeted medication for at least 2 months prior to inclusion. exclusion criteria: 1. patients with other significant comorbidity such as pulmonary veno-occlusive disease (pvod) or pulmonary capillary haemangiomatosis, malignancy, recent myocardial infarction in the last 2 weeks. 2. patients on other pah specific medications treatment.
fall frequency in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of this cross-sectional clinical study is to evaluate the frequency of falls in children diagnosed with cerebral palsy and compare it with healthy controls.

our study is designed as a cross-sectional controlled study. a total of 23 children aged 5-12 years diagnosed with cerebral palsy, who can ambulate indoors or in the community either independently or with assistive devices, and 23 healthy children of the same age range will be included. data will be collected on the age of the patients and healthy volunteers, information about their caregivers, frequency of falls, location and time of falls, education level, type of mobilization, presence of additional conditions, whether they receive rehabilitation, frequency of rehabilitation, duration of hospitalization if applicable, occurrence of falls during hospitalization, and presence of injuries. the collected data will be compared with the healthy controls.

Eligibility criteria:
inclusion criteria: * children aged 5-12 years. * diagnosed with cerebral palsy (study group) or healthy without cerebral palsy (control group). * ability to ambulate either independently or with assistance indoors or in the community. * consent obtained from the participant or their caregiver (parent or guardian). exclusion criteria: * refusal to participate in the study. * presence of cognitive impairments. * existence of neuromuscular diseases, other than cerebral palsy, that would impair walking ability or increase fall frequency.
effect of protein composition on gastric emptying

Conditions: Cerebral Palsy; Gastric Dysmotility; Enteral Feeding

Summary: the protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. this is espesially important in children with neurologic impariment, who commonly rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and delayed gastric emptying. we aim to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children.

several factors in nutrition are known to affect gastric emptying rate, such as energy content, temperature, viscosity etc. in infants the protein composition affects gastric emptying. children with cerebral pasly commonly have foregut dysmotility - with nausea, vomiting, feeding intolerance and gastroesophageal reflux. tube feedings, usually based on cows milk are commonly used. our hypothesis is that the source and thus protein composition of feeding affects gastric emptying rate and electrofysiology. using four different tube feedings, standardized for content of fat, glucose and calories, we will measure gastric emptying rate using c13 octanoic acid as well as electrogastrography will be recorded. the protein modules are derived from casein, whey/casein mixture, hydrolyzed whey and aminoacids. children with cerebral paresis and gastrostomy will be included. each serves as his / her own control. the primary endpoint is gastric emptying rate, the secondary endpoint electrogastrography.

Eligibility criteria:
inclusion criteria: cerebral paresis, user of tube feedings through gastrostomy - exclusion criteria: use of valproic acid (interferes with breath test). age \>16 y. -

Keywords: cerebral palsy protein composition gastric emptying rate tube feeding
coffee against obstipation in intensive care treatment

Conditions: Obstipation

Summary: coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (icu) patients.

critically ill patients requiring ventilator support frequently suffer from obstipation. we hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.

Eligibility criteria:
inclusion criteria: * admission to the medical intensive care unit of the dept. of gastroenterology at the university hospital heidelberg * requires ventilator support for an anticipated more than 72 hours * age older than 18 years exclusion criteria: * pregnancy * known allergy to coffee * mechanical ileus * presence of enterostoma
study to determine if bhv-7000 is effective and safe in adults with refractory focal onset epilepsy

Conditions: Focal Epilepsy

Summary: the purpose of this study is to determine whether bhv-7000 is effective in the treatment of refractory focal epilepsy.


Eligibility criteria:
key inclusion criteria: 1. male and female participants 18 to 75 years of age at time of consent. 2. diagnosis of focal onset epilepsy at least 1 year prior to screening visit defined by 2017 international league against epilepsy (ilae) classification and based on requirements of epilepsy adjudication criteria. a. focal seizures i. focal aware seizures with clinically observable signs and/or symptoms ii. focal impaired awareness seizures with clinically observable signs and/or symptoms iii. focal to bilateral tonic-clonic seizures 3. subject meets the 2009 ilae definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (asm) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 4. ability to keep accurate seizure diaries 5. current treatment with at least 1 and up to 3 asms and 4 epilepsy treatments in total key exclusion criteria: 1. history of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure. 2. history of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase. 3. resection neurosurgery for seizures \<4 months prior to the screening visit. 4. radiosurgery performed \<2 years prior to the screening visit. 5. subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal eeg correlation with clinical symptoms. 6. any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the investigator

Keywords: focal epilepsy epilepsy seizure refractory epilepsy partial epilepsy
dce-mri based on 4d free breathing for predicting preoperative neoadjuvant chemoradiotherapy for esophageal cancer

Conditions: Esophageal Cancer

Summary: to prospectively collect medical images and clinical data related to esophageal cancer using 4d free breathing dce-mri technology, to evaluate the image quality in the diagnosis of esophageal cancer, and to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer.


Eligibility criteria:
inclusion criteria: 1. be 18 years of age and older; 2. first diagnosis of esophageal squamous cell carcinoma confirmed by histopathological biopsy; 3. the clinical stage is ct1b\~ct2n+; or the clinical stage is ct3\~ct4 any n, (thoracic esophageal cancer, esophagogastric junction cancer); 4. there are no contraindications to mri examination exclusion criteria: 1. have other primary tumors; 2. the image quality does not meet the diagnostic criteria; 3. those who do not cooperate with the inspection; 4. patients who have received prior chemoradiotherapy
safety study of abatacept to treat rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis * receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug * age 18 years or older exclusion criteria: * below 18 years of age
orphan drugs for inherited metabolic diseases

Conditions: Inborn Errors of Metabolism

Summary: the aim of this study is to report and describe all the patients with confirmed diagnosis of inherited metabolic disease (imd) treated with orphan medicinal products (omps) in a cohort of adult patients followed in a reference center for rare diseases (lausanne university hospital, chuv) from 2017-2022.

the development of novel therapies for inherited metabolic diseases, considered has omps, has improved the care of these patients. omps include a wide range of therapies from dietary products, enzyme replacement, substrate inhibitors, coenzyme replacement to more recently, gene therapy. despite an increasing use of these therapies, they are still considered highly specialized treatments for very small groups of patients and share the characteristic of aiming to treat small populations with targeted therapies, which leads to higher costs and difficulties in obtaining clinical evidence. drugs are approved for marketing and orphan designation by medical agencies based on their efficacy and safety. in switzerland, a separate country-specific process decides whether an approved drug is reimbursed. because of the growing number of expensive omps, their reimbursement through public health insurances is increasingly manifesting itself as a moral dilemma for decision-makers. it may take a median of several years after submission of the first application by a pharmaceutical company for an orphan drug to become available to patients. considering the increasing number of omp approvals and the still ethical challenge concerning their reimbursement, this study aims to share the experience of a single center in treating adult imds with omps but also in implementing novel therapies for rare diseases not yet covered by health insurers in switzerland. a database was created in 2017 including all patients with imd followed at the adult metabolic clinic in the chuv. this database was part of a protocol submitted and approved by the ethics committee (# 2017-02328). the results of this first analysis were published in the journal of orphan rare diseases. investigators will use this database to identify all the patients treated with omps. electronic and paper patient charts from the division of genetic medicine will be reviewed for type of imd and treatment. all variables will be entered in an excel database.

Eligibility criteria:
inclusion criteria: * age = or \> 16 years * biological and/or genetically confirmed diagnosis of imd exclusion criteria: * age \< 16 years * document attesting refusal to participate

Keywords: orphan drugs inherited metabolic diseases
comparing skin conductance and nol-index

Conditions: Analgesia; Anesthesia; Monitoring; Vascular Diseases; Cardiac Disease

Summary: comparison of twà different nociception monitors during general anesthesia

analgesia remains a challenge in anesthesia. several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. in this study, we will compare skin conductance (medstorm, norway) and nol-index (medasense, israel) w during noxious and non-noxious stimuli. this study is carried out on patients included in another study (nol-index guided remifentanil analgesia versus standard analgesia during moderate-to-high risk cardiovascular surgery).

Eligibility criteria:
inclusion criteria: * moderate-to-high risk cardiac or vascular surgery * asa 2-4 exclusion criteria: * chronic arrhythmia (e.g. atrial fibrillation) * aortic insufficiency * pacemaker * implanted defibrillator * valve surgery
study of the efficacy and safety of secukinumab in participants with active psoriatic arthritis with axial skeleton involvement

Conditions: Axial Psoratic Arthritis

Summary: the purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in psa patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (nsaids) over a 4-week period, according to assessment of spondyloarthritis international society (asas) recommendations for the treatment of axial spondyloarthritis (axspa).

in the anlalysis (csr), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. so there were 498 participants, and not 503

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed * diagnosis of psoriatic arthritis classified by classification criteria for psoriatic arthritis (caspar) criteria * active spinal disease defined by bath ankylosing spondylitis disease activity index (basdai) score ≥ 4 * spinal pain visual analog scale (vas) ≥ 40 (on a vas 100 scale) * inadequate response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period exclusion criteria: * history of exposure to other il-17 or il-23 inhibitor biologic drug * history of exposure to previous biologic disease modifying anti-rheumatic drugs (dmards) (tumor necrosis factor (tnf) blockers or ustekinumab) * current treatment with disease modifying anti-rheumatic drugs (dmards) other than methotrexate * subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) * chest x-ray or chest magnetic resonance imaging (mri) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician other protocol-defined inclusion and exclusion criteria may have applied.

Keywords: assessment of spondyloarthritis international society asas axial psoriatic arthritis psa magnetic resonance imaging mri