Kornimate/medical-research-clean huggingface dataset:
weight-bearing diagnostics in acute lisfranc injury: ct vs x-ray

Conditions: Lisfranc Injury; Foot Sprain

Summary: a prospective, cohort study comparing weight-bearing computed tomography with weight-bearing radiography in patients with an acute lisfranc injury.

injury to the tarsometatarsal (tmt) joint complex in the midfoot is referred to as a lisfranc injury. the broad spectrum of these injuries includes simple sprains to severe fracture-dislocations. variable clinical presentations and radiographic findings make lisfranc injuries notoriously difficult to detect, especially in the case of subtle ligament injuries. nowadays, up to 30% of unstable lisfranc injuries are overlooked or misdiagnosed. this can potentially lead to severe sequelae such as post-traumatic osteoarthritis and foot deformities. for obvious injuries involving diastasis, subluxation, or dislocation, the diagnosis is relatively easy to establish using any imaging modality. however, for subtle injuries without gross bone separation, a dynamic imaging modality facilitating weight-bearing are to be preferred. many consider weight-bearing conventional radiography as the current gold standard in acute lisfranc injury diagnostics. however, conventional radiography is a 2d technique that can neither display nor measure the true dimensions of a detailed 3d object, such as the tarsal bones in the foot. computed tomography (ct) provides greater accuracy in visualizing bone microarchitecture. in combination with weight-bearing, it can be ideal for detecting minor fractures and occult instability caused by load/stress. to this day, there are no prospective studies comparing weight-bearing ct and weight-bearing radiography for acute lisfranc injuries. in the current study, participants will be assigned to non-operative or operative treatment based on lisfranc joint stability evaluation by the initial weight-bearing ct.

Eligibility criteria:
inclusion criteria: * acute trauma to the midfoot * intraarticular fracture and/or avulsion fracture in the tmt joint line (detected on a non-weight-bearing ct) * suspicion of a purely ligamentous lisfranc injury (no radiological fractures but substantial clinical findings in the midfoot region, or evidence of ligamentous damage on a mri) * consent-competent patient exclusion criteria: * obvious acute unstable lisfranc injuries (\>2mm dislocation between the medial cuneiform and second metatarsal) * injury older than four weeks * other major foot/ankle/leg injuries * previous foot infection or foot pathology on the affected side * previous surgery to the tmt joints, and sequelae after a previous foot injury * open injury * bilateral injury * patients with co-morbidities such as neuropathy and peripheral vascular disease
effects of a culturally-sensitive theory-driven advance care planning (acp) game among chinese older adults

Conditions: Advance Care Planning; Game; Older Adults

Summary: this proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (acp) game in increasing the self-efficacy and readiness of acp behaviours among chinese community-dwelling older adults. this is a mixed methods study with the quantitative paradigm being the main research approached used. the quantitative arm will be a randomized controlled trial (rct). the qualitative arm will adopt focus group interviews for data collection. recruited subjects from the community centres will be randomly allocated to the intervention and control group. the older adults in the experimental group will receive an acp board game delivered by trained facilitators, whereas the older adults in the control group will receive another board game about healthy lifestyle. the outcome measures of the older adults will include the acp engagement scale, the life-support preferences questionnaire (lspq), a self-developed acp knowledge questionnaire and those data will be collected at baseline (t0), immediately post-intervention(t1), at 1 month (t2), and 3 month (t3). the qualitative arm of this study will contribute to the understanding of issues and effects of acp game as an intervention. its finding will complement the results obtained from the rct.


Eligibility criteria:
inclusion criteria: * aged 60 years or over; * speak chinese. exclusion criteria: * uncommunicable because of language barrier or sensory impairment; * have been referred to the palliative care service at the time of recruitment.
a study to assess safety and efficacy of asp1941 in combination with nateglinide in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to evaluate long-term safety and efficacy after concomitant administration of asp1941 and nateglinide inhibitor in japanese patients with type 2 diabetes mellitus.

this is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on nateglinide alone more than 4 weeks. dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients receiving with nateglinide mono-therapy for at least 4 weeks * hba1c value between 6.5 and 9.5% * body mass index (bmi) 20.0 - 45.0 kg/m2 exclusion criteria: * type 1 diabetes mellitus patients * serum creatinine \> upper limit of normal * proteinuria (albumin/creatinine ratio \> 300mg/g) * dysuria and/or urinary tract infection, genital infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: asp1941 long-term safety nateglinide diabetes mellitus
cell free preimplantation genetic testing

Conditions: Infertility, Female; Infertility, Male

Summary: this study aims to develop preimplantation genetic testing methods from embryo culture media (cell free). genetic testing of culture media will be compared to conventional methods based on embryo biopsies.

consenting patients will receive standard clinical ivf and pgt. culture media from embryos will be collected for analysis. collection of media will include laser assisted collapse of the blastocyst on day 5, 6, or 7 in order to release blastocoel fluid into the culture media. embryos diagnosed as aneuploid or monogenic disorder affected (abnormal embryos) will be donated for additional analysis with patient consent. results obtained from culture media will not be provided to the patients. the information obtained from cf-pgt will be compared to results obtained from embryo biopsies obtained as part of routine pgt and evaluated for concordance and reliability. abnormal embryos will be rebiopsied (\~3 to 4 times) to evaluate concordance with cf-pgt and the original clinical trophectoderm biopsy pgt results. all cases will be labelled using a 5-digit barcode and embryo number or saliva source code. because pgt will be conducted under clinical regulatory approval (cap and clia), patient information will be protected under hipaa guidelines, including sending reports in encrypted secure email per standard operating procedures. all publications and presentations will maintain de-identification of any patient data used. patients may withdraw from the study at any time by contacting the principal investigator of their respective recruiting site. they will continue to receive standard of care through their treating ivf center. a recruitment target of 200 patients is intended for this study.

Eligibility criteria:
inclusion criteria: * patients undergoing ivf electing to utilize lifeview testing (pgt) will be offered participation in this study. exclusion criteria: * none

Keywords: pgt noninvasive
functional magnetic resonance imaging of opioid withdrawal in healthy human volunteers

Conditions: Substance-Related Disorders

Summary: opioid medications are commonly used for pain relief. when given over time, physical dependence can occur. this results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. however, we do not know how withdrawal affects the brain. we know that a medication named ondansetron can help ease or prevent symptoms associated with opioid withdrawal. through imaging of the brain by fmri, we hope to see how opioid withdrawal, with and without the administration of ondansetron, affects brain activity.

during the study, each participant attended three separate lab-based acute opioid withdrawal sessions. the first session was undertaken in a mock mri scanner and was designed to determine if participants could tolerate withdrawal in the scanning environment. participants who were able to successfully and safely tolerate opioid withdrawal while in the scanner were approved to continue with the following study sessions. participants were then pretreated intravenously (iv) with either 0.9% normal saline placebo or 8mg ondansetron. later, participants in all sessions received iv naloxone (10mg/70kg) to precipitate opioid withdrawal. participants were assigned to ondansetron or placebo pretreatment conditions in a randomized, double-blinded, and counter-balanced order. objective opioid withdrawal scale (oows) and subjective opioid withdrawal scale (sows) were assessed throughout the study to quantify withdrawal. study timeline progressed as follows: t=-165, 8mg ondansetron or placebo infusion, t=-135, morphine infusion (10mg/70kg), t=-41 preparation for mri, t=-21, start mri, t=-13, baseline oows/sows, t=-9, start of fmri, t=0 naloxone induced withdrawal, t=5, oows, t=15, oows, t=20, retrospective oows.

Eligibility criteria:
inclusion criteria * patients will be healthy male volunteers, ages 18-35. exclusion criteria * females were excluded due to menstrual cycle modulation of opioid response. * we will exclude individuals with raynaud's disease or a history of coronary artery disease.
rotator cuff injury managed with eras and internet plus nursing

Conditions: Rotator Cuff Injuries

Summary: rotator cuff injury patients treated with eras were included. the control group was given routine nursing. the observation group was given the internet plus nursing home rehabilitation mode. relying on mobile app and wechat, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time.


Eligibility criteria:
inclusion criteria: * rotator cuff injury * eras surgery treatment * full thickness tear of rotator cuff, the range of tear is 1cm-3cm exclusion criteria: * surgery not applicable * combined with other injuries, malignant tumor, disabilities, mental illness, critically ill patients, pregnant women, illiteracy, minors, cognitive impairment
study of phantom limb pain suppression using neuromodulation methods

Conditions: Phantom Limb Pain

Summary: this study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. the research involves implanting electrodes for test stimulation of peripheral nerves (pns - peripheral nerve stimulation), spinal cord (scs - spinal cord stimulation), dorsal root ganglia (drgs - dorsal root ganglion stimulation), and motor cortex (mcs - motor cortex stimulation). the study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.


Eligibility criteria:
inclusion criteria: * amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh. * age between 18 and 65 years. * duration since amputation is at least 6 months. * presence of persistent chronic pain syndrome rated between 4 and 10 on the visual analog scale (vas). * absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only). * signed consent to participate in the study. exclusion criteria: * presence of severe somatic pathology that hinders surgical treatment and participation in the study. * presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts. * presence of severe orthopedic deformity in the limb above the level of amputation. * history of cancer. * history of epilepsy. * complicated traumatic brain injury (tbi) or a history of stroke. * inability to undergo electrostimulation due to other somatic pathology. * purulent-septic pathology. * drug addiction (including a history of). * congenital anomaly of upper limb development. * anomalies in the development of the central and peripheral nervous systems.

Keywords: neuromodulation phantom limb pain neuropathic pain neurostimulation chronic pain peripheral nerve stimulation pns spinal cord stimulation scs dorsal root ganglion stimulation drg cortical stimulation amputation amputees upper-limb injury
effects of betalains on cardiovascular health and quality of life

Conditions: Vascular Stiffness; Vasodilation; Sleep; Quality of Life

Summary: the goal of this randomized, double-blind, placebo-controlled, cross-over trial is to investigate the effects of beetroot-derived betalains on cardiovascular health, sleep and quality of life in healthy middle-aged individuals. the main question\[s\] it aims to answer are: * do betalains improve vascular function? * do betalains improve sleep? * do betalains improve quality of life? participants will be involved with the following: * consuming a daily betalain-rich or placebo capsule for a month * non-invasive cardiovascular measurements * wearing a fitness tracker for tracking physical activity and sleep * answering questionnaires regarding quality of life researchers will compare results between the intervention versus the placebo group to see if any of the study outcomes are significantly different.


Eligibility criteria:
inclusion criteria: * aged between 40 and 65 years * bmi between 25-29.9 kg/m2 * own a smartphone. * able to understand the nature of the study and give informed consent * have not gained or lost more than 10% of body weight (within the past 3 months) * not currently involved or have participated in another biomedical study (within the last 3 months) exclusion criteria: * smoking or vaping (within the last 2 years) * vegetarian or vegan (due to capsule material) * medical history of chronic disease \[coronary artery disease, previous myocardial infarction (heart attack), stroke, peripheral artery disease, diabetes mellitus, chronic kidney disease, metabolic syndrome, malignancies, etc\] * grade ii hypertension (blood pressure: \>160/100 mmhg) * under medication that can affect the cardiovascular system (within the last 2 months) * taking supplements (except vitamin d and iron) (within the last month) * intolerances or allergies toward beetroots, dragon fruit or rice hulls * history of excess alcohol intake or substance abuse. * pregnant or planning to become pregnant in the next 6 months * under hormonal replacement therapy (contraceptives are allowed)

Keywords: betalains beetroot vascular health sleep quality of life
salivary cortisol in intensive care unit

Conditions: Critically Ill

Summary: in critical illness, patients are highly stressed and should have elevated cortisol (stress hormone) secretion to adapt to stress. dysfunction of this system is referred to as critical illness-related corticosteroid insufficiency. free cortisol (unbound form) which is mainly responsible for its physiologic function is difficult to measure. we hypothesized that the salivary cortisol, which can be obtained by noninvasive methods, can more accurately evaluate adrenal function of critically ill patients.


Eligibility criteria:
inclusion criteria: * patients who agreed to participate exclusion criteria: * known adrenal or pituitary disease * oral bleeding * currently on systemic or inhaled corticosteroids
a randomized trial for patients with platinum resistant ovarian, fallopian or primary peritoneal cancer.

Conditions: Genital Neoplasms, Female; Fallopian Tube Neoplasms; Ovarian Neoplasms; Pelvic Neoplasms; Peritoneal Neoplasms

Summary: this trial compares two chemotherapy agents for the treatment of recurrent ovarian, fallopian or primary peritoneal cancer in patients that have received and are no longer responding to platinum based treatment. the purpose of this trial is to compare progression free survival between gemcitabine and liposomal doxorubicin. progression free survival (pfs) is defined as the period from study entry until disease progression


Eligibility criteria:
inclusion criteria: * all patients must have a documented pathologic diagnosis of epithelial ovarian (figo stage i-iv), fallopian tube or primary peritoneal carcinoma * patients must have received platinum-based, first-line chemotherapy but no more than one additional prior chemotherapy regimen. patients must have recovered from the acute side effects of prior chemotherapy prior to enrollment in this trial. * patients must be considered to have platinum resistant disease based on the most recent platinum-based regimen given, i.e., have had a treatment-free interval in response to platinum of less than six months, or have progressed during platinum-based therapy * presence of measurable disease or ca-125 \> or = to 100 on two separate occasions at least one week apart is required for this study * patient must have a zubrod performance status of 0, 1 or 2 exclusion * patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who have subsequently developed invasive adenocarcinoma are eligible. * patients who are currently undergoing abdominal or pelvic radiation therapy or patients who have received prior abdominal or pelvic radiation therapy are excluded. * patients with unstable angina or who have had a heart attack within the past six months are not eligible to participate. * patients who have received prior gemzar or doxil therapy are ineligible.
clinical study of 18f -fapi-rgd in renal tumor

Conditions: Renal Tumor

Summary: the goal of this observational study is to learn about the value of 18f-fapi-rgd pet/ct imaging in renal tumor. participants will undergo clinical evaluation and 18f-fapi-rgd pet/ct examination.

early detection, accurate diagnosis and staging are the keys to effective treatment of kidney cancer patients.pathological diagnosis is still the gold standard, but renal perforation is invasive examination, there are certain complications, the most common is bleeding and hematoma, rare renal arteriovenous fistula formation and infection.a non-invasive test with high accuracy is expected.68ga-fapi-04 has been reported to be superior to 18f-fdg in the study of bone metastases in rcc patients, and in addition to detecting more metastases than 18f-fdgpet/ct, uptake is 3-4 times higher than 18f-fdg.there are also many literatures reporting that apipet/ct may be better than 18f-fdgpet/ct in the detection of various malignant tumors, and fapi targeted imaging is a promising way in the diagnosis and treatment of papillary renal cell carcinoma. 18f-fpprgd2pet/ct may be a useful tool for monitoring early response to anti-angiogenic therapy in patients with mrcc.18f-fprgd2pet/ct reliably estimated the expression of integrin αvβ3 in renal tumors, and in clear cell rcc(ccrcc) groups, 18f-fprgd2pet signal correlated with the expression of integrin αvβ3 in tumor cells.in the papillary rcc(prcc) group, the signal was correlated with the expression of αvβ3.the expression of integrin αvβ3 in ccrcc cells was significantly higher than that in prcc cells.these findings are consistent with results obtained with other rgd-based tracers in various cancers.the expression level of integrin αvβ3 in tumor cells is associated with invasiveness and metastasis potential, and quantifying it with pet may contribute to the study of integrin αvβ3 as a prognostic factor. heterodimer peptide fapi-rgd was synthesized from fapi and rgd.fapi-rgd is a heterodimeric peptide that targets fap and αvβ3-integrin receptors, 68ga-fapi-rgdpet/ct imaging has been used in clinical imaging studies of patients with various tumors.so, we plan to use 18f-fapi-rgd pet/ct imaging is used in the diagnosis and treatment of renal cancer, and preliminary experiments have confirmed that this examination has a good imaging effect.

Eligibility criteria:
inclusion criteria: * age 18 and above * no gender difference * patients who have been diagnosed with, or are clinically highly suspected of, renal tumors and have had no other treatment within 3 months exclusion criteria: * patients with a second primary tumor * pregnant or breastfeeding * severe liver or kidney disease * claustrophobia or other pet/ct scan contraindications
home or away from home - descriptive interviews (aim 2)

Conditions: Pediatric Acute Myeloid Leukemia

Summary: the primary objectives of this study are to identify what outcomes related to the management of neutropenia are most important to children with aml and their caregivers. patients who have completed treatment for aml and their caregivers will be interviewed in order to better understand the impact of neutropenia management on children with aml and their families. the primary outcome of these interviews is to identify patient-centered outcomes related to neutropenia management to include in a subsequent comparative-effectiveness analysis. investigators will use these data to develop a structured survey for administration to prospectively identified patients in subsequent studies.

treatment for pediatric acute myeloid leukemia (aml) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. there are little clinical data to inform whether management of neutropenia post aml chemotherapy should occur in an outpatient or inpatient setting. further, no studies have been conducted that assess the impact of neutropenia management strategy on the quality of life of pediatric patients with aml. given that infectious complications are the leading cause of treatment related mortality among aml patients, it is important to identify the neutropenia management strategy that will lead to the best clinician- and patient- identified outcomes in order to improve the care of these patients. this is a qualitative interview study where interviews of patients and/or caregivers will be performed. participants will be patients less than 19 years of age at diagnosis (and their caregivers) receiving or having received chemotherapy for aml from eleven participating pediatric hospitals across the united states. participants (children and caregivers) will be interviewed in an effort to develop a survey that captures patient- and caregiver- identified outcomes related to neutropenia management.

Eligibility criteria:
inclusion criteria: 1. to be enrolled in this study, patients must be: * a male or female between 8 and 22 years of age * have a diagnosis of aml * be either within 6-12 months of completion of the second course of chemotherapy for aml or out of aml therapy for up to 3 years 2. to be enrolled in this study, caregivers must be: * a male or female 18 years of age or older * be the parent/legal guardian of a child that meets the inclusion criteria detailed above (#1) or * be the parent/legal guardian of a male or female child younger than 8 years of age with aml and who is within 6-12 months of completion of their second course of chemotherapy * be the parent/legal guardian of a male or female child younger than 8 years of age with aml and who is out of aml therapy for up to 3 years 3. parental/guardian informed consent and, if appropriate, child assent. exclusion criteria: 1) none

Keywords: pediatric cancer aml qualitative interview