Kornimate/medical-research-clean huggingface dataset:
registrational trial to compare effectiveness of two digital software medical devices as adjunctive oncology treatment

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8

Summary: this is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (samd) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks. study population will consist of up to 553 participants with stage i-iii breast cancer or stage i-iii nsclc. the primary endpoint is percent improvement in anxiety symptoms at week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at week 12. an interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.


Eligibility criteria:
inclusion criteria: * stage i-iii breast cancer or stage i-iii nsclc who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months; * are experiencing at least moderate anxiety (gad-7 \>10) or mild-to-moderate depression (phq-8 score 5-11); * are fluent in english; and * have access to smartphone, or tablet capable of running ios or android software. exclusion criteria: * previous history of cancer; * \<2-yr survival prognosis as determined by treating clinician; * currently participating in investigative cbt trial for treatment of anxiety or depression; * participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study; * recently completed use of blue note therapeutics covid cancer care program or other blue note therapeutics-sponsored study; and * phq-9 q9 response \>0 and columbia suicide severity risk scale (or equivalent) score of category 2- "suicidal ideation" at screening.
research on optimization of rotator cuff injury diagnosis plan

Conditions: Rotator Cuff Injury

Summary: rotator cuff injury is a common cause of shoulder pain and dysfunction. finding out patients with suspected rotator cuff injuries through physical examination of the shoulder joints, mri further assists in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures. how to apply multiple physical examination programs to make judgments sensitively, efficiently and accurately is a clinical problem that needs to be solved urgently.

rotator cuff injury is a common cause of shoulder pain and dysfunction. the common symptoms of rotator cuff injury include shoulder pain, weakness, and limited mobility. arthroscopic exploration is the gold standard for the diagnosis of rotator cuff injury, but it is an invasive examination that is difficult to carry out routinely; mri is sensitive in diagnosing rotator cuff tears both sex and specificity are high, but due to the popularity, cost and waiting time, it is difficult to be used as a routine screening method. therefore, finding patients with suspected rotator cuff injuries through physical examination of the shoulder joints, mri further assisting in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures. however, although there are many physical examination methods for the shoulder joint, the accuracy of each method is different, and each has its own sensitivity and specificity. how to apply multiple examination programs in combination to make it sensitive, efficient and accurate judgment is a problem that needs to be solved clinically. this study is expected to adopt prospective research methods to collect and collect patient medical records, preoperative physical examination results, imaging data, and findings during intraoperative exploration, to understand the impact of various shoulder joint physical examination methods and imaging data on rotator cuff injuries

Eligibility criteria:
inclusion criteria: * patients who are prepared to undergo arthroscopic surgery for shoulder injuries exclusion criteria: * shoulder stiffness, shoulder instability, calcified tendinitis, past surgery, side-to-shoulder disease, hamada osteoarthritis, frozen shoulder, acute joint injury, rheumatoid arthritis, hyperuricemia

Keywords: physical examination rotator cuff lhbt
aromatherapy in providing a semen sample

Conditions: Infertility, Male

Summary: the aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage. the study will be carried out in two different groups. after the men are evaluated in terms of eligibility criteria for the research, the men who are eligible will be informed about the research and written informed consent will be obtained from the men who accept. the random distribution of men to the study groups will be carried out random. the following applications will be made to the groups. aromatherapy/placebo will be applied to the individuals included in the study. during the semen sample giving process, lavender oil/coconut oil (placebo) will be applied with a diffuser.


Eligibility criteria:
inclusion criteria: * having applied to the center where the research will be conducted with a complaint of infertility * being 18 years or older exclusion criteria: * individuals giving up on participating in the study * participant not being able to provide a semen sample * being diagnosed with azoospermia-oligozoospermia
ultrasound for diagnosis of biliary dyskinesia

Conditions: Biliary Dyskinesia

Summary: this is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia. the purpose of this study is to investigate if it is possible to use ultrasound to make a diagnosis of a condition called biliary dyskinesia. the investigators null hypothesis is that there will be no statistical difference between the proposed experimental test (ultrasound) and the hida scan (a nuclear medicine hepatobiliary system scan) in the diagnosis of biliary dyskinesia.


Eligibility criteria:
inclusion criteria: 1. all subjects will have a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of \< 3 mm, and no gallstones present. 2. written informed consent document. 3. males and females age \> 18 years exclusion criteria: 1. subjects without a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of \> 3 mm, and/or gallstones present. 2. pregnant or breastfeeding women 3. subjects who do not consent to take part in the study.

Keywords: biliary dyskinesia gallbladder cholecystitis
video game balance training for patients with diabetic neuropathy

Conditions: Diabetic Neuropathy Peripheral

Summary: this study evaluated the effects of interactive video game-based exercise (ivgb) on balance in diabetic patients with peripheral neuropathy. twenty-four patients were randomly assigned to two groups (12 participants per group). group a received ivgb training for the first 6 weeks, with no exercise in the subsequent 6 weeks. group b had no exercise for the first 6 weeks and then underwent ivgb training in the subsequent 6 weeks. both subjective and objective measures were used to determine whether ivgb exercise improves balance function.

participants in group a received ivgb intervention for the first 6 weeks (intervention phase), with no exercise in the subsequent 6 weeks (control phase), whereas participants in group b received no ivgb intervention in the first 6 weeks (control phase), followed by 6 weeks of ivgb intervention (intervention phase). the ivgb intervention protocol consisted of 30-minute training sessions comprising four tasks designed to focus on lower limb strength, balance, and coordination training. balance assessments consisted of both subjective and objective measures, including the modified falls efficacy scale (mfes), time up and go (tug) test, berg balance scale (bbs), and unipedal stance test (ust). for all participants, these tests were conducted at weeks 0, 6, and 12 of the experiment.

Eligibility criteria:
inclusion criteria: * 40-80 years of age * medical diagnoses of diabetes under regular medication control and diabetic peripheral neuropathy confirmed using an electrodiagnostic test * independent community ambulatory individuals * intact cognition (mini-mental state examination score of \>24). exclusion criteria: * other neurological diseases such as dementia, parkinson's disease, spinal cord injury, or stroke; * severe visual impairment, musculoskeletal disorders, unhealed plantar ulceration, lower limb amputation, poor cardiopulmonary function, or other diseases affecting walking ability or any other disease due to which individuals were unable to walk without assistance * any other condition associated with a high risk of falling. * inability to follow simple instructions
evolocumab compared to ldl-c apheresis in patients receiving ldl-c apheresis prior to study enrollment

Conditions: Hypercholesterolemia

Summary: to evaluate the efficacy of subcutaneous (sc) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (ldl-c) apheresis, on reducing the need for future apheresis.


Eligibility criteria:
inclusion criteria: * male or female, ≥ 18 years of age * subject has been receiving regular apheresis for ldl-c lowering for at least 3 months immediately prior to lipid screening and has a treatment goal of ldl-c \< 100 mg/dl (2.6 mmol/l), and has been receiving ldl-c apheresis during the last ≥ 4 weeks prior to lipid screening at regular qw or q2w schedule and with no changes in apheresis type * subject is receiving lipid-lowering pharmacological background therapy which includes a high-intensity statin dose (moderate-intensity statin dose with attestation that a higher dose is not appropriate for the subject) unless the subject has a history of statin intolerance * lipid-lowering therapy status (ie, any therapy for lowering lipids, including apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to ldl-c screening * pre-apheresis ldl-c is ≥ 100 mg/dl (≥ 2.6 mmol/l) and ≤ 190 mg/dl (≤ 4.9 mmol/l) at screening * fasting triglycerides ≤ 400 mg/dl (4.5 mmol/l) at screening. exclusion criteria: * known homozygous familial hypercholesterolemia * missing any apheresis session is medically contraindicated or inappropriate * stopping apheresis would be inappropriate in the opinion of the investigator even if ldl-c is controlled to \< 100 mg/dl with other therapies * myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 3 months prior to randomization. * uncontrolled hypertension

Keywords: ldl-c apheresis hypercholesterolemia elevated cholesterol high cholesterol pcsk9 mutations severe familial hypercholesterolemia evolocumab repatha
efficacy and safety of rivastigmine in patients with traumatic brain injury and cognitive impairment

Conditions: Traumatic Brain Injury

Summary: this study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.


Eligibility criteria:
inclusion criteria: * traumatic brain injury confirmed by available brain imaging (ct or mri) and be at least 52 weeks post injury * neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (sd) of the mean on the california verbal learning test (cvlt) and impaired executive function (reduction of below 1 standard deviation (sd) of the mean on the verbal memory learning test (vlmt) and tower of london test (tol) and impaired attention (reduction of below 1 standard deviation (sd) of the mean on the test battery for attentional performance (tap) * be required to have had sufficient education to read, write, and effectively communicate * be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement exclusion criteria: * a current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances * a current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication * an advanced, severe or unstable disease of any type that may interfere with efficacy evaluations * female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception other protocol-defined inclusion/exclusion criteria may apply.

Keywords: traumatic brain injury, cognitive impairment, rivastigmine
prophylactic antibiotics in admitted cirrhotics

Conditions: Cirrhosis, Liver

Summary: in this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. subjects will be randomly assigned to receive antibiotics vs placebo.

cirrhosis is associated with a state of immune-compromise and progressive decompensation, acute on chronic liver failure (aclf), and death are often caused by bacterial infections. different sub-groups of patients with cirrhosis at increased risk, i.e. active upper gastrointestinal hemorrhage, low protein ascites, history of spontaneous bacterial peritonitis (sbp), are known to benefit from prophylactic antibiotics. the investigators hypothesize that hospitalized patients with advanced cirrhosis are also at increased risk and thus may benefit from preventive treatment. subjects will be randomly assigned to receive an antibiotic vs placebo.

Eligibility criteria:
inclusion criteria: * meld-na \>= 18 * cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies exclusion criteria: * inability to obtain consent (from subject or next of kin/legal authorized representative (lar) * allergy to cephalosporins * pregnancy (due to limited prospective data regarding safety of ceftriaxone) * existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection * use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant) * h/o recurrent c difficile infection within the past year (\>2) or requiring fecal microbiota transplant (fmt) * enrollment in the study protocol during a previous admission
evaluation of musculoskeletal system in caregivers of rehabilitation patients

Conditions: Caregiver Burden; Stroke; Cerebral Palsy; Neurologic Disorder; Pediatric Disorder; Orthopedic Disorder

Summary: in this study, musculoskeletal-related pain, posture, spine function, the condition of the low back and neck regions, musculoskeletal system disorders, fatigue, and quality of life will be examined in caregivers of rehabilitation patients.

there are studies examining musculoskeletal disorders, physical demands and care activities of unpaid caregivers, musculoskeletal pain and related factors in unpaid caregivers of individuals with stroke, the effect of the functional status of stroke individuals on caregiver pain, musculoskeletal pain and related factors in mothers of children with cerebral palsy, musculoskeletal symptoms in caregivers of individuals with stroke, the prevalence of musculoskeletal disorders in caregivers of individuals with disabilities in a rehabilitation center, and the prevalence and characteristics of low back pain in caregivers of individuals with stroke in the literature. however, no study was found in which the musculoskeletal system was comprehensively evaluated in the caregivers of rehabilitation patients and the musculoskeletal system characteristics were compared in the caregivers of individuals with cerebral palsy and stroke. therefore, musculoskeletal-related pain, posture, spine function, the condition of the low back and neck regions, musculoskeletal system disorders, fatigue, and quality of life will be examined in caregivers of rehabilitation patients in this study.

Eligibility criteria:
inclusion criteria: * the caregiver of the rehabilitation patient, * can speak, read, write turkish, * over 18 years old. exclusion criteria: * pregnant, * can't speak, read or write turkish.

Keywords: pain caregiver low back neck musculoskeletal system
posterior transversus abdominis plane block versus erector spinae plane block as a part of multimodal analgesia in patients undergoing percutaneous nephrolithotomy

Conditions: Analgesia

Summary: to compare the analgesic efficacy of posterior tap block versus espb after pcnl surgery. the hypothesis is that posterior tap block, as a part of multimodal analgesia, will reduce pain and opioid consumption like espb

percutaneous nephrolithotomy (pcnl) is currently the gold standard for treatment of patients with large and complex renal calculi because it is less invasive than open surgery. the sources of acute pain after pcnl are visceral pain originating from kidneys and ureters, and somatic pain from the site incision. pcnl is usually done in 10th to 11th intercostal space or in the subcostal area. complete blockade of unilateral spinal nerves from t10 to l2 can provide sufficient analgesia during pcnl. this can be achieved by several regional techniques such as thoracic paravertebral block, transversus abdominis plane (tap) block, erector spinae plane block (espb). espb is an interfascial block which can provide wide sensory blockade from t2-4 to l1-2 that was first described in 2016. espb can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle with nearly one dermatome for each 3.4 ml of the injected volume. this allows espb to provide both visceral and somatic analgesia. tap block is a regional injection of a local anesthetic agent between the transversus abdominis and internal oblique muscle planes. tap block affects the sensory nerves of the anterolateral abdominal wall (t6-l1). various technical modifications in tap block have been described including lateral, posterior, subcostal, and continuous catheter techniques. the posterior approach should be the preferred technique in clinical practice as it provides longer somatic and visceral analgesia that are not offered with the lateral approach.

Eligibility criteria:
inclusion criteria: * patients scheduled for pcnl under general anesthesia * asa status i-ii exclusion criteria: 1. contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics) 2. patient who has difficulty understanding the study protocol or patient refusal. 3. chronic respiratory disease patients. 4. diabetic patients. 5. body mass index (bmi) \> 30 kg/m2 6. routine corticosteroids, pain medication, or anticonvulsant. 7. psychiatric diseases.

Keywords: percutaneous nephrolithotomy erector spinae plane block transversus abdominis plane block
the virtual visit for women with gestational diabetes

Conditions: Diabetes, Gestational

Summary: this is a feasibility study of care for women with gestational diabetes (gdm) using electronic equipment to participate in virtual office visits. participants will be trained in the use of glucose meters, scales, and sphygmomanometers which are bluetooth connected to an app on their cellphones. fetal well-being will be assessed with dopplers and kick counts. care will be delivered by alternate in-office and telephone visits.

the core elements of a prenatal visit for any pregnant woman include assessment of bp, weight, and presence of fetal heart activity. the treatment of gdm additionally requires the measurement of and review of maternal glycemia. technology exists for patients to measure these parameters and to relay this information securely directly from these devices via the internet to the healthcare provider's office. a key element of antepartum care for gdm, self-monitoring of blood glucose (smbg), has for some years been conducted with memory-based portable glucose meters. to assure accuracy in reports of patient measurements, it is important that all devices be of a design wherein results of measures of patient parameters are transmitted in unedited fashion directly devices to the health care provider. while no data exists about the accuracy of self-reporting of patient weight and blood pressure, intentional or unintentional alteration in reports of self-monitored glucose results is a known risk of reliance on patient self-reported data. this pilot study will explore the feasibility of the use of this technology from patients' homes in lieu of an office visit.

Eligibility criteria:
inclusion criteria: 1. diagnosis of gestational diabetes 2. singleton pregnancy 3. \<32 weeks gestation 4. age 18-45 years 5. fluent and literate in english or spanish 6. have a cellphone with capability of internet access. exclusion criteria: 1. multiple gestations (twins or higher) 2. have a history of fetal demise 3. have a history of chronic health problems that might affect outcomes (such as hiv, treatment with steroids, significant cardiac or renal disease, or chronic hypertension), and those who had bariatric surgery.