Kornimate/medical-research-clean huggingface dataset:
a study of chemotherapy treatment for patients with ovarian cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Summary: the primary objective is to determine whether ly573636-sodium (hereafter referred to as ly573636) is effective in treating platinum-resistant ovarian cancer. patients will receive an intravenous infusion of study drug once every 28 days. computed tomography (ct) scans and ca-125 tests will be done before the first dose and then after every other treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer * at least 18 years old * have received at least one but no more than 2 systemic treatment regimens containing platinum (does not include regimens received before surgery for this cancer) * have platinum-resistant disease exclusion criteria: * have received more than 2 systemic treatment regimens for platinum-resistant disease * serious pre-existing medical conditions * actively receiving warfarin (coumadin) for treatment of venous thrombosis or other prothrombotic conditions
a study to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of an intravenous solution of jnj-39588146 or placebo in patients with heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of an intravenous administration of jnj-39588146 or placebo over a 3-hour period in patients with heart failure. the highest tolerated dose received during the first 3 hours of the study will be administered to some patients for an additional 18 hours. there will be up to 3 doses given throughout the administration period over a total of up to 21 hours.

this study will assess the safety, tolerability, pharmacodynamics and pharmacokinetics of jnj-39588146 or placebo (which looks like the drug being studied but has no active ingredients) in patients with heart failure. this study is being conducted in two parts. part 1 is a randomized (study drug will be assigned by chance), double-blind (neither the physician nor patient knows the identity of the assigned drug) study of 3 intravenous doses of jnj-39588146 or placebo administered in 1-hr intervals (for a total of 3 hours) in 60 patients with heart failure. part 2 is an extended infusion of jnj-39588146 and placebo that will administer the highest tolerated dose from part 1 for an additional 18 hours. the entire duration of the infusion could be as long as 21 hours. there is a 1 in 4 chance of getting placebo. the participation period is a maximum of 42 days, including a screening visit, a 2-day in-clinic period and two follow-up visits. for both parts of the study, patients will have a cardiac catheter in place to monitor heart function. safety evaluations, which will include ecg (electrocardiograph, measuring the electrical currents in the heart), vital signs and monitoring of side-effects will be performed. additionally, blood and urine samples will be collected for evaluation. part 1: patients will receive an intravenous (iv) solution of three different doses of jnj-39588146 or placebo administered over 1 hour periods for a total of 3 hours. part 2: patients participating in the sub study will continue receiving an iv solution for 18 more hours for a total of up to 21 hours of administration.

Eligibility criteria:
inclusion criteria: * patients must have been diagnosed with heart failure * women must be either postmenopausal or have been surgically sterilized at least 6 months ago * males must be willing to use an acceptable birth control method for 3 months after the last dose of study medication. exclusion criteria: * patients must not have had an heart-assist device or heart transplant or be in imminent need of one * patients must not have had an ischemic attack within the last 6 months or a heart attack within the last month * patients must not have lung disease or congenital heart failure.

Keywords: heart failure cardiac failure
neonatal precursors of neurodevelopment

Conditions: Premature Birth

Summary: the neoprene project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.


Eligibility criteria:
inclusion criteria: * preterm newborn (born \< 34 weeks + 6days) exclusion criteria: * brain injury * respiratory assistance on measurement day * infection on measurement day * sedation on measurement day * parents \< 18 years old or unable to give informed consent
rifaximin in minimal hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: the purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (mhe) and cirrhosis in a randomized, blinded, placebo-controlled trial.


Eligibility criteria:
inclusion criteria: * age 18-65 years * cirrhosis diagnosed on clinical grounds * mhe diagnosed by abnormalities in a psychometric battery (nct-a, nct-b, ict bdt and dst impaired beyond 2 standard deviations of known control values on any of the above 3 tests will be considered to have mhe) * current drivers (valid driving license and driving at least 20 miles/week) * all women of child-bearing potential will be required to use effective contraception exclusion criteria: * current or recent (\ 0 will be excluded) and a positive blood alcohol level * use of antibiotics within last 6 weeks * allergy to rifaximin, rifabutin, rifampin, or rifapentine * infection or gastrointestinal hemorrhage within the last 6 weeks * renal insufficiency * hepatocellular carcinoma * psychoactive drug use, including interferon concurrently * non-drivers and those who drive less than 20 miles/week * pregnancy and breastfeeding * excluding patients with ohe: * detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation * detailed history-taking from friends/relatives only after taking the patient's permission * mini-mental status examination \> 25 * episode of overt (clinical hepatic encephalopathy) within 6 months * current treatment with lactulose, rifaximin, zinc, or metronidazole

Keywords: minimal hepatic encephalopathy
special investigation for booster dose of comirnaty in children ages 6 months though 4 years

Conditions: SARS-CoV-2; COVID-19

Summary: the purpose of this post-marketing study is to assess the safety of comirnaty monovalent xbb.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.


Eligibility criteria:
inclusion criteria: * children aged 6 months to 4 years at the time of the booster vaccination (4th dose) who (or whose representative) gave written consent to take part in the study. exclusion criteria: -there are no exclusion criteria for this study.

Keywords: covid-19 sars-cov-2 children (6 months though 4 years old) rna vaccine post-marketing study pediatric
vagal nerve stimulation in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this randomized control trial aims to evaluate the effect of transcutaneous auricular vagal nerve stimulation in patients with irritable bowel syndrome. the intervention will be 8 weeks of treatment with a vagal nerve stimulator. the main objectives are: * to evaluate the clinical response, defined as a decrease of at least 50 points on the ibs-sss questionnaire, of the treatment. * to ascertain whether the autonomic-vagal neurosignature, derived from pre-treatment registration of symptom profiles, autonomic responses and imaging of neuronal activity as a reaction to stress is able to predict therapeutic response to tvns accurately. * to evaluate the effect of treatment on quality of life * to evaluate the effect of treatment on depression * to evaluate the effect of treatment on anxiety participants will be asked to wear a wearable (fitbit) and fill out a daily questionnaire for one week. thereafter, a functional brain mri will be performed. in the intervention group patients will receive transcutaneous nerve stimulation for 8-weeks at home. the comparison group will receive the same device but with a non-conducting electrode. patients fill out weekly questionnaires during the treatment period and at follow-up moments 3 and 6 months after finishing the treatment period.


Eligibility criteria:
inclusion criteria: * a diagnosis of ibs according to rome iv criteria (3), as follows: * recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: * related to defecation. * associated with a change in stool frequency. * associated with a change in stool from (appearance). * criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. * age between 18 and 75 years; * ability to understand and speak the dutch language. * ability to understand how to utilize the esm application. exclusion criteria: * a history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present or otherwise based on the principal investigator's judgement. * presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device (with the exception of the mirena iud), metal braces, facial tattoos and/or metal objects. * history of major head trauma or head/brain surgery * history of claustrophobia * pregnancy, lactation, intention to become pregnant during the study period * students and employees of maastricht university are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department. * if the subject has a cardiac arrhythmia, the attending physician will be consulted before participation.

Keywords: vagal nerve stimulation
evaluation of gixam's efficacy predicting pre-cancerous colorectal polyps and colorectal cancer

Conditions: Colorectal Cancer; Colorectal Adenomatous Polyp; Colorectal Neoplasms

Summary: this is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (crc) in a fecal immunochemical test (fit) positive population.

1. average risk persons eligible for crc screening that have received a positive fit outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study. 2. following the informed consent process, subjects will undergo the gixam test. 1. a subset of 50 subjects will participate in the repeatability assessment. they will undergo three (3) repetitive gixam tests one after the other, by the same operator. 2. both the subject and the endoscopist will be blinded to the gixam outcome 3. all subjects will thereafter undergo a standard of care hd-wl colonoscopy procedure. 4. all resected and retrieved lesions will be sent separately for histopathological evaluation.

Eligibility criteria:
inclusion criteria: 1. subjects aged ≥50 - ≤80 years. 2. able to provide a signed informed consent. 3. underwent fit screening within the past 6 months with a positive result. 4. scheduled for a fit positive screening colonoscopy at investigational site. exclusion criteria: 1. has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention. 2. personal history of crc. 3. family history of crc, defined as having one or more first-degree relatives (parent, sibling, or child) with crc at any age. 4. subject has a diagnosis or medical / family history of any of the following conditions, including: * familial adenomatous polyposis (also referred to as "fap", including attenuated fap and gardner's syndrome), * hereditary non-polyposis crc syndrome (also referred to as "hnpcc" or "lynch syndrome"), * other hereditary cancer syndromes including but are not limited to peutz-jeghers syndrome, myh-associated polyposis (map), turcot's (or crail's) syndrome, cowden's syndrome, juvenile polyposis, neurofibromatosis, or familial hyperplastic polyposis. 5. subject has a diagnosis or personal history of inflammatory bowel disease (ibd) including chronic ulcerative colitis, and/or crohn's disease, and/or ibd-undefined. 6. subjects with the disability to extend their tongue. 7. subjects with tongue piercing. 8. dental visit in the 7 days prior to the gixam test. 9. intake of pro-biotics over the past 3 months pre-gixam test. 10. subject has any condition that in the opinion of the investigator should preclude participation in the study.
pulse oximetry errors in hospitalized patients across varying skin pigmentation

Conditions: Hypoxemia; Pulse Oximetry; Skin Pigment

Summary: this is a prospective observational study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. it is driven by three recent retrospective studies showing missed diagnosis of hypoxemia in patients across a spectrum of skin pigmentation, defined as blood sao2 \<90% when their pulse oximeter reads 92% or greater.

this prospective study will overcome the limitations of earlier retrospective studies using three important study protocols: 1. precise time-matching paired blood gas samples to stable periods of pulse oximeter readings 2. objective quantification of skin pigmentation rather than using documented or self-reported race 3. collection of high quality pulse oximeter tracing data, and identifying potential mediators of discordance of noninvasive and invasive measurements such as low perfusion states. the primary aim is to quantify the bias in spo2 measurements across skin pigmentation groups in a real-world setting against the gold standard of invasive measurements of arterial blood oxygen saturation measurements across categories of skin pigmentation. these data are essential to addressing health equity and patient safety for people of all skin pigmentations.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * hospitalized and at high risk of hypoxemia, defined as saturations \< 90%, * patients with arterial line in place for clinical purposes exclusion criteria: * profound anemia, defined as hemoglobin \< 8 g/dl will preclude blood draws for research purposes * known pregnancy * in custody of law enforcement officials

Keywords: hospitalized patients
light protection of tpn and oxidative stress in preterm infants

Conditions: Oxidative Stress in Preterm Infants

Summary: urinary peroxides and plasma glutathione/glutathione disulfide (gsh/gssg) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either light-protected (group 1) or light-exposed (group 2) total parenteral nutrition (tpn) solutions.

this study will be a prospective single blinded randomized control trial. inborn preterm infant less than 32 wks gestational age, receiving tpn in neonatal intensive care unit (nicu) of mansoura university children's hospital as a part of their care will be included. preterm infant will be randomly divided into 2group:- group 1 includes preterm infant who will receive their tpn through bags and tubing system that are protected from light by aluminum foil. group 2 includes preterm infant who will receive their tpn through bags and tubing system that are exposed to light. randomization will be done using random table technique with opaque sealed envelopes containing the serial number and the group to which the subject will be enrolled. these envelopes will be kept in the unit ready for use at any time; each one has a number which is the serial number of the baby and group of tpn to which the baby will be enrolled. the urine sample will be sent to the laboratory with this serial number with no information about the group of study to which this sample follows for peroxide level as well as blood sample for gsh\\gssg. two blood samples and two urine samples will be collected. the first one will be at 0 hour before starting tpn regimen as a base line and the second will be at 7 days of starting tpn regimen. blood sample will be at least 1cc of blood for gsh/gssg assay. urine collection bag will be placed on the infant to obtain minimum of 1cc of urine for urinary peroxide level assay. other secondary outcomes will be assessed with duration of nicu admission including death and /or bronchopulmonary dysplasia in preterm infant at time of hospital discharge, necrotizing enterocolitis (nec), sepsis with positive blood cultures, length of hospital stay, retinopathy of prematurity (rop), time to full enteral feeding, duration of respiratory support, liver function, cholestasis defined as an elevated serum conjugated bilirubin \>2 mg/dl, and metabolic response.

Eligibility criteria:
inclusion criteria: * preterm infant less than 32 weeks gestational age exclusion criteria: * infant with major congenital anomalies * infant of diabetic or hypertensive mother

Keywords: preterm infants oxidative stress parenteral nutrition
long term stability, survival and tolerability of a (novel) baha® implant system

Conditions: Conductive Hearing Loss

Summary: an international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.

two implant products, the standard implant and abutment and the novel implant and abutment, both developed by cochlear bone anchored solutions ab were tested in the cag5173 clinical investigation that was completed in december 2012. the primary objective was to show superiority of the novel implant compared to standard implant in terms of implant stability quotient (isq) as as measured by resonance frequency analysis1. results after 6 and 36 months after implantation showed that the new design, the novel implant and abutment, provided statistically significantly higher stability at the time of insertion and over time compared to the standard baha implant2,3,4. in the investigation, sound processor fitting was performed from 6 weeks post-implantation. no reduction in implant stability following sound processor fitting was recorded, suggesting that it is safe to load the implant 6 weeks after implantation. the investigation also showed improved soft tissue outcomes, in terms of lower holgers index5 scores for the novel implant and abutment compared to the standard implant and abutment. after initiation of the 3-year cag5173 investigation, cochlear bone anchored solutions ab launched the cochlear baha bia300 implant and abutment, which in all critical aspects are identical to the novel implant used in the investigation. the 36-month visit was the last visit of the investigation. hence, no further visits were planned or scheduled for the subjects participating in that investigation.participating subjects. it is of clinical and scientific interest to evaluate the clinical performance and safety data of the implants in these subjects after an additional two-year period, in order to gain additional understanding of how implant stability and soft tissue status evolves over time with the two implant and abutment designs, and in order to evaluate long-term implant survival. no randomised controlled investigation of baha implants with a 5-year follow-up has been conducted to date. the rationale behind this clinical investigation is to collect long term stability, survival and tolerability data of a novel baha implant system 5 years after implantation in a population that previously have been followed in a completed controlled investigation during a 3 year period. the collected data will enable comparison with the data gathered in the previous completed cag5173 clinical investigation.

Eligibility criteria:
inclusion criteria: * participated in the cag5173 investigation * signed informed consent exclusion criteria: * unable to follow investigational procedure * any factor, at the discretion of the investigator, that is considered to contraindicate participation
assessment of changes of periocular skin sensation following eyelid and ocular surface surgeries

Conditions: Blepharoptosis; Blepharochalasis, Superior; Ectropion; Entropion

Summary: the aim of the study: assessment of changes of periocular skin sensation following eyelid and ocular surface surgeries. study design: an interventional study that will be conducted at the ophthalmology department, meir hospital, kfar saba, israel. the study will include 60 healthy patients, at the ages of 40-80, which are candidates for eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion repair. the patients will be recruited from meir's ophthalmology outpatient clinic. each patient will undergo a full ophthalmologic examination including relevant assessment of the specific eyelid pathology. the eyelid's sensation will be assessed at 6 points of the eyelid using the cochet-bonnet filament-type aesthesiometer (luneau ophtalmologie, paris, france). measurements will take place before surgery, and two weeks, three months and six months after surgery.


Eligibility criteria:
inclusion criteria: * ability to give consent * eyelid pathology: blepharoptosis, blepharochalasis, ectropion or entropion, with no additional eyelid pathology exclusion criteria: * children and pregnant women * previous eyelid surgery * a systemic disease influencing eyelid position * any neurologic disease * previous facial herpetic infection
feasibility study for a web based health coaching program

Conditions: Obesity

Summary: this study is designed to compare an intensive lifestyle and activity coaching program (\&quot;sessions\&quot;) to usual care for diabetic patients who are sedentary. the question to be answered is whether the sessions program improves clinical or patient centric outcomes. recruitment is through invitiation only.


Eligibility criteria:
inclusion criteria: * diabetic patients age 18 or greater exclusion criteria: * patients aged 17 or less, * patients with cognition impaired such that they could not comprehend enrollment materials.