Kornimate/medical-research-clean huggingface dataset:
the effectiveness of personalized colorectal cancer screening based on fecal hemoglobin concentration

Conditions: Colorectal Cancer

Summary: we aim to improve the yield and effectiveness of the dutch colorectal cancer screening program by using a personalized screening strategy based on fecal hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (fit).

a fecal hemoglobin concentration just below the cut-off of the fecal immunochemical test (fit) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. individuals with these higher fecal hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal hemoglobin concentrations could benefit from longer screening intervals. a randomized controlled trial will be conducted within the national crc screening program among individuals with a negative fit in the previous screening round. individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice. the overall aim of this study is to improve the balance between harms and benefits of crc screening, by using a personalized approach based on fecal hemoglobin concentration at previous screening. more specifically, this study has three goals: 1. evaluate the superiority of risk-based fit screening in a randomized controlled study embedded in a running national screening program; 2. evaluate the feasibility and acceptability of risk-based fit screening in a national screening program; 3. estimate the long-term effect of personalized screening versus uniform screening. to achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.

Eligibility criteria:
inclusion criteria: * previous negative fit (below the cut-off of 47 microgram per gram feces) exclusion criteria: * previously tested with fit cut-off of 15 microgram per gram feces
a study to evaluate the efficacy and safety of tocilizumab in hospitalized participants with covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this study (empacta) will a) evaluate the efficacy and safety of tocilizumab (tcz) compared with a placebo in combination with standard of care (soc) in hospitalized participants with covid-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved covid-19 pneumonia.


Eligibility criteria:
inclusion criteria * hospitalized * covid-19 pneumonia confirmed by a positive polymerase chain reaction (pcr) of any specimen and radiographic imaging * spo2 \< 94% while on ambient air inclusion criteria specific to long-term extension * participated in study ml42528 (empacta) (includes participants who completed or discontinued early from the main study) exclusion criteria * known severe allergic reactions to tcz or other monoclonal antibodies * require continuous positive airway pressure (cpap), bilevel positive airway pressure (bipap), or invasive mechanical ventilation * suspected active bacterial, fungal, viral, or other infection (besides covid-19) * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * immunocompromised (besides well-controlled hiv) or on immunosuppressive therapy (except for steroids for covid), advanced cancer * have received oral anti-rejection or immunomodulatory drugs (including tcz) within the past 3 months * participating in another interleukin (il)-6 antagonist clinical trial or other drug clinical trials (participation in covid-19 anti-viral trials may be permitted if approved by medical monitor) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 10 x upper limit of normal (uln) detected within 24 hours at screening (according to local laboratory reference ranges) * absolute neutrophil count (anc) \< 1000/ul at screening (according to local laboratory reference ranges) * platelet count \< 50,000/ul at screening (according to local laboratory reference ranges) * pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination * treatment with an investigational drug within 5 half lives or 30 days (whichever is longer) of randomization (investigational covid-19 antivirals may be permitted if approved by medical monitor) * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * any history of diverticulitis or gi perforation * use of systemic corticosteroids unless on a stable chronic dose
study for rasagiline effect on sleep trial(rest)in parkinson's disease

Conditions: Parkinson's Disease

Summary: the main objective of this study is to evaluate the effect of azilect® on sleep disturbances in parkinson's disease patients, after 2 months of treatment.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease. * eligible to azilect® treatment as per canadian product monograph exclusion criteria: * exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the canadian product monograph. * investigational drug within 30 days prior to study * use of azilect® or selegiline within 60 days prior to study * significant medical condition

Keywords: rasagiline sleep sleepiness parkinson's disease sleep scale epworth sleepiness scale
surgery versus internal radiation in treating patients with stage ii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. it is not yet known whether surgery is more effective than internal radiation in treating prostate cancer. purpose: randomized phase iii trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage ii prostate cancer.

objectives: * compare overall survival in patients with stage ii prostate cancer treated with radical prostatectomy vs brachytherapy. * compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens. * compare the side effects of these treatment regimens in these patients. outline: this is a randomized study. patients are randomized to one of two treatment arms. * arm i: patients undergo radical prostatectomy. * arm ii: patients undergo brachytherapy with implanted iodine i 125 or palladium pd 103 seeds patients are followed every 6 months for 5 years and then annually thereafter. projected accrual: a total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate within the past 120 days * t1c-t2a, n0, m0 * no bilateral disease * prostate-specific antigen (psa) no greater than 10 ng/ml * in patients with prior neoadjuvant hormonal therapy (nht), psa must be less than 10 ng/ml prior to therapy * gleason score no greater than 6 * prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference or * prostate gland 60 cc or greater prior to nht allowed if prostate size has been reduced to less than 60 cc by nht patient characteristics: age: * 75 and under performance status: * ecog 0-2 or * zubrod 0-2 renal: * creatinine no greater than 3 mg/dl cardiovascular: * no significant cardiovascular disease * no new york heart association class iii or iv heart disease other: * no other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence * no other condition that would preclude study prior concurrent therapy: endocrine therapy: * see disease characteristics * at least 90 days since prior nht * duration of therapy no greater than 120 days * no concurrent nht radiotherapy: * no prior radiotherapy to pelvis surgery: * no prior surgery for prostate cancer or benign disease, including: * transurethral resection of the prostate * transurethral resection of the bladder neck * cryotherapy * laser ablation * microwave therapy

Keywords: adenocarcinoma of the prostate stage iib prostate cancer stage iia prostate cancer
the efficacy and safety of flurbiprofen chip versus chlorhexidine chip (periochip®) in therapy of adult chronic periodontitis

Conditions: Periodontitis

Summary: the purpose of the study is to assess efficacy and safety of flurbiprofen chip versus chlorhexidine chip (periochip®) in therapy of adult chronic periodontitis.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form 2. good general health 3. male or female subjects aged \>21 years old 4. availability for the 9 week duration of the study 5. chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 5-9 mm in depth (potential target teeth) demonstrating bleeding on probing without involving the apex of the tooth and confirmed by dental x-ray. 6. females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method (oral or parenteral hormonal contraceptive; intrauterine device; barrier and spermicide) of birth control during the study. exclusion criteria: 1. an existing aggressive periodontitis. 2. presence of oral local mechanical factors that could (in the opinion of the investigator) influence the outcome of the study. 3. presence of orthodontic appliances, or any removable appliances, that impinge on the tissues being assessed. 4. soft or hard tissue tumours of the oral cavity. 5. presence of dental implant adjacent to target tooth. 6. presence of more than 2 adjacent periodontal pockets on the same potential target tooth. 7. periodontal pockets of more than 9 mm in depth, and/or with class 2 or 3 furcation involvement, on the potential target tooth. 8. systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration. 9. history of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (nsaids). 10. subjects taking phenytoin, calcium channel blockers drugs (ccbs) and/or cyclosporine, which might influence the pattern of tissue response. 11. subjects treated with non-steroidal anti-inflammatory drugs (nsaids) within 14 days prior to entry into the study and throughout the study duration. 12. presence of the following conditions: type 1 diabetes, major recurrent aphtae, stomatitis, abscesses and related oral pathologies. 13. the presence of any medical or psychiatric condition that in the opinion of the investigator could affect the successful participation of the subject in the study. 14. subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration. 15. subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.

Keywords: subjects, age>21, with chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 5-9 mm in depth demonstrating bleeding on probing without involving the apex of the tooth and confirmed by dental x-ray.
immunogenicity and safety study of pneumococcal 7-valent conjugate vaccine in sickle cell disease infants.

Conditions: Pneumococcal Infections

Summary: the primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.


Eligibility criteria:
inclusion criteria infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis. exclusion criteria previous immunization with pneumococcal-containing vaccines. history of pneumococcal invasive disease (meningitis, bacteremia, pneumonia). known or suspected impairments of the immune system (including hiv infection) or recipients of immuno-suppressant agents. other exclusions apply.
comparative analysis of pcm with rotem in the measurement of viscoelastic coagulation parameters

Conditions: Hemostasis Monitoring

Summary: to determine if pmc viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications

the primary aim of this study is a performance evaluation of the pcm coagulation monitor in comparison to the rotem thromboelastometry system. to include a measurement of the entire range of the test system, subjects with a medical management need that requires the measurement of their hemostasis status (such as pt/ptt, inr) or are at risk for being hypo-coagulable or hyper-coagulable will be included in this study.

Eligibility criteria:
inclusion criteria: * age 18 years or older * in opinion of investigator, absence of anything that precludes subject from being good study candidate * informed consent * order for measurement of hemostasis status of patients who are at risk for being hyper-coagulable or hypo-coagulable due to clinical diagnosis or medical need exclusion criteria: * previous enrollment in study * incarcerated * heparin infusion in prior 24 hours

Keywords: coagulation
evaluation of benefit for treatment of single sided deafness (ssd) between two bone conduction prosthetic devices; osseointegrated implant versus maxilla anchored removable oral appliance ("soundbite")

Conditions: Single Sided Deafness

Summary: the primary objective of this study is to compare the soundbite™ hearing system to surgically implanted bcd systems.


Eligibility criteria:
inclusion criteria: * must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device * must be \>18, \<80 years old * must be fluent in english, as determined by the pi * must have diagnosis of ssd, time since onset (≥3 months) * must have at least two contiguous molar or premolar teeth with no untreated tooth decay. patients with tooth decay present are to first have restorations before being fitted for soundbite * healthy attachment to those teeth with tooth pockets limited to no more than 5mm exclusion criteria: * subjects with known hypersensitivity to any of the components including allergies to polymers. * subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling. * subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss

Keywords: single sided deafness ssd unilateral hearing loss
capsule endoscopy or mesenteric angiogram in patients with overt gastrointestinal bleeding (gib) of obscure origin

Conditions: Gastrointestinal Hemorrhage

Summary: to compare the diagnostic yield of mesenteric angiogram with ce in patients with active obscure gib.

gastrointestinal bleeding (gib) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. mesenteric angiogram is one of the standard radiological investigations for gib of obscure origin, and its diagnostic yield ranged from 40-80%. capsule endoscopy (ce) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. the diagnostic yield is particularly high in patients with ongoing bleeding. this is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with ce in patients with overt gib of obscure origin. the results will help to define the optimal management strategy for this group of patients.

Eligibility criteria:
inclusion criteria: * all patients admitted to pwh medical or surgical wards with melena or hematochezia in whom ogd and colonoscopy fail to identify site of bleeding. * normal or non-diagnostic ogd and colonoscopy * informed consent * patients presented with shock will be resuscitated for urgent endoscopy exclusion criteria: * patients remained in shock despite resuscitation. * moribund patients * terminal malignancy * presence of pacemaker or icd * suspected or confirmed intestinal obstruction * swallowing difficulties * renal failure that preclude angiographic examination * pregnancy * age \<18 * refused consent

Keywords: capsule endoscopy mesenteric angiogram
psychophysical and neural mechanisms contributing to chronic post-surgical pain in adolescents and adults

Conditions: Chronic Post-surgical Pain

Summary: the current project will (1) enhance our understanding of the neurobiology of chronic post-surgical pain (cpsp); (2) provide a metric to follow patients with cpsp in the clinic; (3) provide a metric for those who will chronify; and (4) understand the age-related differences in cpsp. ultimately, an improved comprehension of mechanisms linked to cpsp will provide finer tools for optimizing the selection of treatments for individual patients. moreover, data that demonstrates the underlying pathobiological pain mechanism(s) active in cpsp, particularly those non-responsive to current therapies, may be used to validate novel strategies both pharmacological and non-pharmacological.

in this mechanistic clinical trial, participants will be randomized into either a one-day (5 hours) group workshop based on acceptance and commitment therapy (act) and a one-month post workshop zoom individual booster session or treatment as usual (tau). dr. sieberg will conduct the groups with assistance from the ra. dr. sieberg is a licensed clinical psychologist, who has delivered manualized act for chronic pain in her clinical practice. the intervention follows a manual patterned after an existing 1-day act intervention for chronic pain and will be adapted to meet the needs of patients with ongoing cpsp. topics covered in the workshop include: (1) mindfulness of troublesome thoughts, feelings, and physical sensations; (2) willingness to face and accept experiences that cannot be changed; (3) identifying values; and (4) promoting behavior changes that support value-based action. the goal of the act intervention is to increase awareness of thoughts, feelings, and behaviors that exacerbate pain while minimizing avoidance that interferes with engagement in valued action. participants will also receive an individually tailored 30-minute booster session via zoom one month following the workshop. during the booster session, act principles will be reinforced and the participant will work together with dr. sieberg to problem-solve and address any difficulties engaging in act exercises and practices.

Eligibility criteria:
inclusion criteria: --females and males aged 12 and older who have previously undergone surgery at least 6 months ago and have chronic post surgical pain (3 months after surgery or longer) exclusion criteria: * inability to speak sufficient english or another language that can be interpreted orally and for questionnaires with the research team * severe cognitive impairment by history (e.g., intellectual disability, severe head injury) * patients with significant psychiatric disorders * use of illegal hard drugs including mdma, heroin, methamphetimes, amphetamines, cocaine, ketamine, benzodiazepines, and phencyclidine. absence of such drugs will be confirmed in a urine drug screen during the visit. if prescription medication includes any of these compounds, that medication is not exclusionary.
vitamin d deficiency: bone loss and vascular dysfunction

Conditions: Postmenopausal Women

Summary: to learn if there is a connection between low vitamin d level and hardening of the arteries.

osteoporosis and vascular disease are two of the most common disorders affecting postmenopausal women. a potential association, beyond aging, has long been speculated. our previous study revealed evidence of loss of vascular compliance in postmenopausal women with lower bone density, suggesting women with lower bone density had "stiffer" blood vessels. this proposal further investigates that association and a potential role of vitamin d deficiency as a possible common link between both bone loss and "hardening of the arteries".

Eligibility criteria:
inclusion criteria: * females ages 50-70 with ability to give informed consent * one year past last menstrual period * 20 women with vitamin d levels \< 15 mg/ml * 20 women with vitamin d levels \> 30 mg/ml exclusion criteria: * women receiving hormone replacement therapy * women receiving medication known to effect vascular compliance, including anti-hypertension medications * subjects receiving therapy for osteoporosis * hyperthyroidism * untreated hypothyroidism * history of metabolic bone disease * current or previous use of medications known to accelerate bone loss * chronic liver disease * chronic renal disease * diabetes mellitus * obesity, bmi \> 24

Keywords: vitamin d deficiency postmenopausal women
relationship of preoperative parathyroid hormone (pth) and ex-vivo gamma counts in minimally invasive parathyroidectomy

Conditions: Parathyroid Disease

Summary: the intent for this study is to do a retrospective chart review of all patients who have undergone minimally invasive parathyroidectomy for primary hyperthyroidism. all data collected will be recorded under assigned identification numbers that will have no association with medical record or hospital numbers. identifying characteristics will include age and sex. anonymity will be upheld. the patient/family will not be contacted directly. all information will be obtained from the medical chart. demographics, location, preoperative pth levels and intraoperative ex-vivo gamma counts, co-morbid conditions, and the outcome based on the hospital notes will be obtained from patients' charts and will be transferred to a secure database. it is our hypothesis that there is a linear relationship between immediate preoperative parathyroid hormone (pth) levels and ex-vivo gamma counts and the aim of this study is to better describe this relationship.


Eligibility criteria:
inclusion criteria: * patients must be between the ages of 18 and 90 years old who have documented primary hyperparathyroidism and have undergone minimally invasive parathyroidectomy. exclusion criteria: * patients who have not had both intraoperative parathyroid hormone (pth) levels and gamma counts during their parathyroidectomy * patients who have parathyroidectomies for reasons other than primary hyperparathyroidism.
post-approval study to investigate the long term (8 year) survivorship of star ankle among continued access study patients

Conditions: Primary Arthrosis

Summary: the purpose of this study is to examine the long term survivorship of the scandinavian total ankle replacement (star). specifically, this study focuses on the revision and/or removal rate of any component of the star ankle.


Eligibility criteria:
the study population consists of all living subjects who participated in the continued access arm of the ide clinical trial. inclusion criteria: * only patients that participated in the continued access study make up the patient cohort for this long-term follow-up study. * willing and able to give informed consent. exclusion criteria: * subjects who were withdrawn or withdrew consent to participate in the investigation * subjects who do not consent to participate in long-term or provide personal contact information to the sponsor(solely for the purposes of tracking subjects to help ensure follow-up compliance)

Keywords: post traumatic arthritis rheumatoid arthritis osteoarthritis