Kornimate/medical-research-clean huggingface dataset:
feasibility of lecanemab registry and clinical outcome measures

Conditions: Alzheimer Disease

Summary: available fda approved treatments for alzheimer's disease (ad) temporary alleviate symptoms but have no bearing on overall disease progression. however, recent fda approval of lecanemab (july 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with ad. delaying the disease progression may impact not only the person living with dementia (plwd), but also their care partners. it may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. recent secondary analysis of this phase 3 trial suggests quality of life showed less decline in plwd and less increase in burden in care partners. the investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at healthpartners and their care partners. the investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. the outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of plwd and care partners.


Eligibility criteria:
inclusion criteria: * plwd who are eligible to receive lecanemab infusion at our clinics. * care partner who provides care for the plwd who are eligible to receive lecanemab infusion at our clinics. * age \>=18 years for plwd and their care partners * provides informed consent prior to participation. exclusion criteria: * unable to read and speak english

Keywords: lecanemab
comparison between tomofix and bodycad fine osteotomy

Conditions: Osteotomy; Malalignment, Bone; Osteoarthritis, Knee

Summary: this is a single centre, randomised, patient blinded pilot study that will assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge high tibial osteotomy (mowhto) to either current standard of care with tomofix plating system, or utilise patient specific instrumentation and custom-made plate development, with bodycad fine osteotomy. if the definitive study is deemed feasible, an additional 110 participants will be randomized, for a total of 150 participants.

the proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal tibial osteotomy (mowhto) to either current standard of care, with tomofix plating system, or utilise patient specific instrumentation and custom-made plate development, with bodycad fine osteotomy. participants will follow a standardized rehabilitation protocol. outcomes will be assessed over two years postoperatively utilising ct assessment for accuracy of correction, bony union and construct stability as well as proms including koos and eq5d. complications, adverse events, returns to theatre and costs will also be recorded. end of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete. if the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.

Eligibility criteria:
inclusion criteria: * aged 18-70 years old * have medial compartment osteoarthritis, with varus alignment, deemed suitable for a mowhto * able to speak, read and understand english exclusion criteria: * found to have a cruciate ligament deficiency * require multiplanar or rotational alignment correction * have greater than 5 degrees fixed flexion deformity * unable to have ct scans for follow up * evidence of tricompartmental osteoarthritis * evidence of lateral compartment osteoarthritis on arthroscopy * received injection therapy within 3 months of surgery on the operative knee * have a medical history of inflammatory arthropathy, diabetes * actively smoke
early family based intervention in preterm infants

Conditions: Very Low Birth Weight Infants

Summary: this is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from nicu on neurodevelopmental outcome. other than control group of vlbw infants, study population includes term infants to compare neurodevelopmental outcome.


Eligibility criteria:
inclusion criteria: * preterm infants \< 32 weeks of gestation or 1,500 gm of birth weight * normal term infants exclusion criteria: * major congenital anomaly * neuromuscular disease * chromosomal anomaly * triplets or more multiplets
foot reflexology therapy and non-specific low back pain

Conditions: Low Back Pain

Summary: the aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the malaysian low back pain management guidelines.

low back pain is a common health complaint in most societies. many treatments for low back pain aim to reduce suffering quicken recovery and minimize recurrence or development of chronic disability. however, low back pain continues as a societal enigma. the aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to standards care of low back pain according to the malaysian low back pain management guidelines. analysis of health-related quality of life will also be carried out.

Eligibility criteria:
inclusion criteria: * have been medically diagnosed with a non-specific low back pain. * have not received treatment for low back pain within the previous 2 weeks. * are at least 18 years old. * have both feet and all toes intact and free from wounds. * have not undergone any other complementary and alternative therapies during the study. exclusion criteria: * have severe coexistent disease and serious pathology or systemic illness. * have a specific diagnosed cause of back pain (infection, tumour, osteoporosis, fracture, an inflammatory condition or cauda equine syndrome). * have plantar fasciitis. * lack the ability to read and write malaysia language. * had plans to move out of the area.

Keywords: foot reflexology pain intensity health-related quality of life
camp nerf: methods of a summer nutrition ed rec & fitness program to prevent unhealthy weight gain in children

Conditions: Childhood Obesity

Summary: the primary aims of this research project are to: 1. evaluate the efficacy of camp nerf to improve child nutrition, physical activity, mental health, and anthropometric outcomes. 2. evaluate the efficacy of camp nerf to improve caregiver self-efficacy for establishing healthy family nutrition and physical activity practices, amount of physical activity, and bmi. 3. evaluate the efficacy of camp nerf to improve youth mentor nutrition, physical activity, and anthropometric outcomes.

background: the number of obese children in the us remains high, which is problematic due to the mental, physical, and academic effects of obesity on child health. data indicate that school-age children, particularly underserved children, experience unhealthy gains in bmi at a rate nearly twice as fast during the summer months. few efforts have been directed at implementing evidence-based programming to prevent excess weight gain during the summer recess. methods: camp nerf is an 8-week, multi-component (nutrition, physical activity, and mental health), theory-based program for underserved school-age children in grades kindergarten - 5th grade coupled with the usda summer food service program. twelve eligible elementary school sites will be randomized to one of the three programming groups: 1) active control (non-nutrition, physical activity, or mental health \[4h curricula\]); 2) standard care (nutrition and physical activity); or 3) enhanced care (nutrition, physical activity, and mental health) programming. anthropometric, behavioral, and psychosocial data will be collected from child-caregiver dyads pre- and post-intervention. site-specific characteristics and process evaluation measures will also be collected. discussion: this is the first, evidence-based intervention to address the issue of weight gain during the summer months among underserved, school-aged children. results from this study will provide researchers, practitioners, and public health professionals with insight on evidence-based programming to aid in childhood obesity prevention during this particular window of risk.

Eligibility criteria:
inclusion criteria (site level): * elementary school; usda summer food service program open site; and 3) lacking structured programming exclusion criteria: -
a clinical study on the effect of discontinuing alendronate in postmenopausal women with osteoporosis after a treatment period without fractures

Conditions: Osteoporosis in Post-menopausal Women

Summary: the goal of this clinical trial is to study the effects of discontinuation of alendronate treatment for three years. the participants are postmenopausal women with osteoporosis, who have had a treatment period without fractures. the study will answer: * what is the rate of fragility fractures during the study? the hypothesis is that discontinuation of alendronate after a fracture-free period does not raise the 3-year fracture risk. * are there predictors of significant bone loss after discontinuation of alendronate? the hypothesis is that clinical, biochemical, cellular, or molecular characteristics can predict bone loss. researchers will compare the outcomes of discontinuation of alendronate with continuing treatment. participants will be randomly assigned to a group. participants will: * either take alendronate once weekly for three years or discontinue their treatment * visit the clinic at 6 and 18 months for blood samples * visit the clinic at the start of the study and after 1, 2, and 3 years for bone scans and blood samples.


Eligibility criteria:
inclusion criteria: * female * postmenopausal * current treatment with alendronate * alendronate treatment \>3 år and no fracture or * alendronate treatment \>5 år and latest low energy fracture \> 3 years ago exclusion criteria: * t-score \< - 3,5 in hip (total hip or femoral neck) or lumbar spine * treatment with systemic glucocorticoids, ongoing or within 12 months * uncontrolled inflammatory disease * active malignancy * egfr \< 40 ml/min * atypical femur fracture (ever) * osteonecrosis of the jaw (active) * unable to give inform consent

Keywords: alendronate discontinuation osteoporosis bone mineral density post-menopausal
comparing two diets in patients undergoing hsct or remission induction chemo for acute leukemia and mds (uf-bmt-ldnd-101)

Conditions: Leukemia; Myelodysplastic Syndromes

Summary: this is an open-label, two-arm, phase iii non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. both cohorts and diets will adhere to the hygiene and common sense advice listed in the fda-endorsed food safety guidelines.


Eligibility criteria:
inclusion criteria: * age 18 years or older * undergoing treatment for hematologic malignancies or hsct as outlined below: * underlying diagnosis for non-hsct patients: * acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) receiving induction or reinduction chemotherapy; or * acute lymphoblastic leukemia (all) receiving an intensive induction chemotherapy (e.g., hypercvad±r, calgb9251, larsons protocol) with an expected duration of neutropenia of ≥7 days; or * allogeneic or autologous hsct for any indication. for patients undergoing reduced intensity conditioning, only those regimens in which the expected neutropenia is ≥ 7 days are permitted and the patient must reside in the hospital * expected duration of neutropenia of ≥ 7 days exclusion criteria: * use of anti infectives for treatment of active systemic infections within 7 days prior to initiation of study diet * untreated major infection at presentation * patients with uncontrolled invasive fungal infection (defined as those who have not completed at least 6 weeks of treatment; or who are symptomatic with two ct scans, at least 1 week apart showing uncontrolled disease at the time of initiation of study diet) * uncontrolled hiv, hepatitis b and c infection * receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment * patients unwilling to eat fresh fruit and/or vegetables * planned management of neutropenia in the outpatient setting

Keywords: leukemia myelodysplastic myeloid lymphoblastic diet infection hematopoietic stem cell transplant
flumazenil reversal of oral triazolam

Conditions: Dental Anxiety

Summary: an increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. this has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the us population and the evidence of oral health disparities among those who are fearful . given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities. this study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (cns) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).


Eligibility criteria:
inclusion criteria: * asa i exclusion criteria: * use of benzodiazepines, anxiolytics or any other medications that would interact with either triazolam's or flumazenil's metabolism or clinical effect (including herbals) within four weeks of the study * body mass index (bmi) no less than 15 kg/m2 and no greater than 30 kg/m2 * pregnancy or not currently using pharmacologic methods of birth control * allergy or sensitivity to benzodiazepines * history of a seizure disorder; and * chronic tobacco use.

Keywords: conscious sedation dental anxiety/drug therapy behavior/drug effects
phase 1b/2a study of abi-h0731 in patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on abi-h0731 and to provide the opportunity for preliminary evaluation of combination therapy of abi-h0731 with currently approved antiviral treatment for chronic hepatitis b.

the phase 1b/2a assessments of the dose-related safety, pk, and initial antiviral efficacy of abi-h0731 in hepatitis b patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis b patients.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 65 years of age * chronic hbv infection * body mass index (bmi) 18-38 kg/m2 and a minimum body weight of 45 kg exclusion criteria: * seropositive for hiv, hcv, or hdv antibody at screen * previous treatment with any investigational hbv antiviral treatments within the last 6 months * other known cause of liver disease, including nash * other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention
evaluation of liver fibrosis staging with acoustic radiation force impulse elastography

Conditions: Chronic Liver Disease

Summary: this is a prospective cohort study for evaluation of liver fibrosis staging with acoustic radiation force impulse elastography in patients with chronic liver disease and healthy liver/kidney donors.

a recent new method for liver fibrosis assessment based on similar technology to transient elastography is acoustic radiation force impulse (arfi) imaging. arfi has the advantages which can be conducted in parallel ways of measuring points in the patients with chronic liver disease when they underwent routine ultrasound examination. thus, the aim of this study was to identify the normal range of arfi velocity and assess the best cut-off value by recruiting healthy living liver and kidney donors.

Eligibility criteria:
inclusion criteria: * age \> 20 years * chronic liver disease (hepatitis b, hepatitis c, liver cirrhosis) patients who are planned to liver biopsy * healthy liver and kidney donors * the patients who is willing and able to provide written informed consent to participate in this study exclusion criteria: * decompensated liver cirrhosis * patients with liver congestion due to heart dysfunction * patients who previously take antiviral agent and antifibrotic agent * healthy liver and kidney donors with any laboratory abnormalities regarding liver condition (platelet count \ 110 mg/dl, ast \> 40 iu/l, alt\> 40 iu/l, albumin \ 1.2 mg/dl, ggt\> 54 iu/l, alp \> 115 iu/l , ferritin \> 322 ng/ml) * a history of any other medical disease or condition that would make the patients unsuitable for this study

Keywords: arfi imaging normal values chronic liver disease liver donors kidney donors
a danish icd-study in patients with coronary artery disease resuscitated from ventricular fibrillation

Conditions: Coronary Artery Disease; Acute Myocardial Infarction; Ventricular Fibrillation; Ventricular Tachycardia, Sustained; Out-Of-Hospital Cardiac Arrest

Summary: danicd is a randomized, controlled study to with the aim to assess whether there is a benefit of icd-implantation in patients with coronary artery disease (including acute myocardial infarction), who survive cardiac arrest due to ventricular fibrillation/sustained ventricular tachycardia and undergo revascularization and with an lvef above 35%.


Eligibility criteria:
inclusion criteria: * patients with cad and cardiac arrest due to vf/vt, where angiogram is performed with complete revascularization (pci, cabg or hybrid coronary revascularization) before icd implantation. unfavorable artery for pci (i.e., excessive vessel tortuosity or chronic total occlusion) or high-risk invasive treatment is not mandatory in order to achive complete revascularization. * age ≥18 years * lvef \>35% at the time of discharge. the most recent lvef assessment on which the current medical treatment will be based at the time of entry into the study will be used as baseline lvef. exclusion criteria: * non-ischemic cause of cardiac arrest (i.e. ion channel diseases, non-ischemic cardiomyopathy) * previous cabg within the last 3 months before index hospitalization * life expectancy less than 1 year or severe neurologic outcome * unable or unwilling to give informed consent * pregnancy

Keywords: revascularization percutaneous coronary intervention implantable cardioverter defibrillator
bioequivalence of the tablet and liquid-filled capsule forms of mk0974 (0974-042)

Conditions: Migraine

Summary: this study will demonstrate the definitive bioequivalence of a solid dose formulation of mk0974 to the liquid filled capsule formulation of mk0974.


Eligibility criteria:
inclusion criteria: * subject is in good health * subject is a nonsmoker * subject is willing to comply with the study restrictions exclusion criteria: * subject has history of stroke, chronic seizures, or any major neurological disorder * subject has a history of cancer * subject is a nursing mother * subject has uncontrolled high blood pressure * subject has or has a history of any disease or condition that might made participation in the study unsafe or confound the study results
the influence of cancer stem-cells on risk of relapse in patients harboring adenocarcinoma and squamous cell carcinoma of the lung

Conditions: Lung Cancer, Nonsmall Cell; Relapse/Recurrence; CSC

Summary: the present study is a prospective cohort study. the aim is to assess the relationship between the presence of cancer stem-cells (csc) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung


Eligibility criteria:
inclusion criteria: * patients with stage i, ii or iiia adenocarcinoma of squamous cell carcinoma of the lung * age between 18 and 85 * r0 resection * availability of formalin-fixed, paraffin-embedded surgery specimen from the primary tumor * availability of fresh surgical specimen for cytofluorimetric analysis exclusion criteria: * incomplete resection * unknown tumor, node or metastasis status * synchronous tumors * previous lung cancer

Keywords: non small cell lung cancer cancer stem cells
urinary concentration and diluting ability in patients with chronic renal disease and/ or hypertension

Conditions: Renal Insufficiency, Chronic; Hypertension

Summary: the investigators want to test the hypothesis that patients with chronic renal disease have a poorer ability to preserve water after being thirsty and a poorer ability to excrete water after a load of fluid. they presume that these abilities become poorer when renal insufficiency progresses. the investigators further hypothesize that patients with hypertension also have a decreased ability to concentrate and dilute urine.


Eligibility criteria:
inclusion criteria: * patients with chronic renal insufficiency, aged between 18 and 65, both men and women * creatinine clearance between 30-59 ml/min * patients with hypertension, aged between 18 and 65, both men and women; hypertension is defined as a mean arterial blood pressure in the daytime that is more than 140/90 mm hg. * healthy volunteers, aged between 18 and 65, both men and women exclusion criteria: * clinical signs or history of disease in the heart, lungs, liver, brain, and endocrine organs * cancer * alcohol abuse * medicine abuse * pregnancy

Keywords: urine concentration ability chronic renal insufficiency hypertension aquaporin2 patients with chronic renal insufficiency patients with hypertension healthy volunteers