Kornimate/medical-research-clean huggingface dataset:
effects of behavioral interventions based on sensory cues on fog in pd after stn-dbs

Conditions: Parkinson Disease

Summary: the investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.

freezing of gait (fog) leads to falling and is one of the major determinants of quality of life and prognosis in parkinson's disease (pd). previous evidence suggests that subthalamic nucleus deep brain stimulation (stn-dbs) improve off-medication fog but not on-medication fog in patients with pd. furthermore, off-mediation fog persist or even worsen after stn-dbs in some pd patients. although visual and auditory cues are known to improve fog in research setting, it is unclear whether these cues are effective for fog in real clinical setting. most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice. therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with pd after bilateral stn-dbs. participants undergo clinical evaluations including the mini-mental state examination (mmse), montreal cognitive assessment (moca), frontal assessment battery (fab), unified parkinson 's disease rating scale (updrs), freezing of gait-questionnaire (fog-q), and the average number of falling over the last week. then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. to investigate the education effect, fog-q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.

Eligibility criteria:
inclusion criteria: * patients with parkinson's disease who are aged 30 years or older * patients who underwent bilateral subthalamic nucleus deep brain stimulation * patients who complain of freezing of gait exclusion criteria: * patients who have already used sensory cues for freezing of gait in clinical practice * patients with mmse scores of 18 or lower * patients with hoehn-yahr scale 5 * patients who have neurological symptoms associated with neurological disorders other than parkinson's disease

Keywords: parkinson's disease freezing of gait visual cue auditory cue subthalamic nucleus deep brain stimulation
assessing effectiveness of thoughtfullchat application in improving mental well-being

Conditions: Anxiety; Depression; Stress; Resilience

Summary: * to determine the state of mental health among house officers, imu corporate staff, imu students and imu faculty * to find out the effectiveness and user experience of text-based mental health coaching applications among house officers, imu corporate staff, imu students and imu faculty imu - international medical university

the text-based mental health coaching application that the investigators are using is thoughtfullchat application. thoughtfullchat application provides mental health coaching through text by licensed mental health professionals. participants of this research will be required to answer a set of questionnaires which consists of dass-21, satisfaction with life scale and brief resilience scale at the start of the study. participants will be randomly distributed into 2 groups which are intervention and control groups. participants in the intervention group will be using the application for 3 months. post-intervention questionnaires will be given to all participants after 3 months. data collected from these 2 groups will be analyzed by using spss.

Eligibility criteria:
inclusion criteria: * house officers in malaysia (ud41) * corporate staff in imu, imu faculty members * all students who are currently studying in imu who give their consent * competent in english language * experiencing none to severe stress, anxiety or depression based on dass-21 score exclusion criteria: * medical students, medical officers (ud44) * contract staff, outsourced staff or international staff in imu campuses * students who refuse to give their consent and those that have already or just graduated from imu * competent in other languages except english * experiencing extremely severe stress, anxiety or depression based on the dass-21 score

Keywords: mental health wellbeing text-based mental health coaching application
comparison of two devices using near-infra red spectroscopy during a vascular occlusion test

Conditions: Healthy

Summary: tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two device, invos®(somanetics corporation, usa ) and inspectra™ (hutchinson technology, usa). each probes are attached to both thenar muscles and vascular occlusion test (vot) is performed. the investigators will compare the invos® data to inspectra™ to investigate whether tissue oxygen saturation values by invos® can substitute for inspectra™.

tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two device, invos®(somanetics corporation, usa ) and inspectra™ (hutchinson technology, usa). inspectra™ was introduced later than invos®. with inspectra™, clinicians have used a vascular occlusion test (vot) to evaluate dynamic changes in tissue oxygen saturation during ischemia and reperfusion, and thus, microcirculatory function. there have been little data about vot using invos®, although it is more popular device. we hypothesized that there would be a difference between the values from invos® and inspectra™. the aim of this study is to evaluate changes in tissue oxygen saturation in the thenar muscle during vot using invos® and comapre it to inspectra™ in a normal population.

Eligibility criteria:
inclusion criteria: * healthy subject exclusion criteria: * age under 18 years old * with arteriovenous fistula * with peripheral vessel disease * taking vasoactive drug * with a skin ailment * with htn, dm * with diagnosed heart disease

Keywords: measures near-infrared spectroscopy ischemia reperfusion
hypotension prediction index (hpi) smart-bp trial

Conditions: Moderate to High-risk Noncardiac Surgery

Summary: a multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing hypotension prediction index (hpi) software guidance during moderate-to-high-risk noncardiac surgery.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. age \>18 years 3. asa physical status \> 2 4. noncardiac surgery with expected surgery duration \> 2 hours (example include: orthopedic, spine, urology, and general surgery) 5. planned blood pressure monitoring with an arterial line catheter; 6. general anesthesia; exclusion criteria: 1. participating in another interventional trial; 2. contraindication to arterial blood pressure monitoring; 3. subjects with a physical site area too limited for proper sensor placement 4. serum creatine \> 175 μmol/l (\>2.0 mg/dl) or ckd stage \> 3a 5. scheduled for intracranial surgery with permissive hypotension; 6. patient who is confirmed to be pregnant and/or nursing mothers; 7. patients with an intra-aortic balloon pump (iabp) or ventricular assist device(s); 8. have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension; 9. emergency surgery; 10. require beach-chair positioning; 11. scheduled for cardiac surgeries 12. have previously participated in the smart-bp trial.
phase 3 study of intranasal carbetocin (lv-101) in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: this phase 3 study is designed to test the effectiveness of intranasal carbetocin (lv-101) in participants with prader-willi syndrome (pws). carbetocin is an oxytocin analog (a man-made chemical that is like oxytocin). this study will also evaluate the safety and tolerability of lv-101.

this is a phase 3 randomized, double-blind study with an 8-week, placebo-controlled period designed to test the effectiveness, safety, and tolerability of lv-101 in participants with pws. effectiveness will be measured using both caregiver-reported and clinician-reported measures of hyperphagia (extreme hunger), obsessive and compulsive behaviors, and anxiety. safety and tolerability will be measured by adverse events, laboratory tests, and physical exams. after the 8-week placebo-controlled period, there will be a long-term follow-up period of 56 weeks and an optional extension period after study week 64 during which all participants will receive active treatment with lv-101. at week 8, participants who were randomized to placebo in the placebo-controlled period will be randomized to one of the two lv-101 doses, administered three times per day before meals.

Eligibility criteria:
inclusion criteria: * genetically-confirmed prader-willi syndrome * provide voluntary, written informed consent (parent(s) / legal guardian(s) of participant); provide voluntary, written assent (participants, as appropriate) * pws nutritional phase 3 (hyperphagic, rarely feels full) exclusion criteria: * living in a group home * genetically diagnosed schaaf-yang syndrome or other genetic, hormonal, or chromosomal cognitive impairment * new food-related interventions, including environment or dietary restrictions, within 1 month of screening * dose of any allowed chronic concomitant medications or supplements that have not been stable for ≥3 months prior to the study or is not expected to remain stable while participating in the study; adjustments in growth hormone dose ≤10% are not exclusionary * presence of cardiovascular disorders, epilepsy, frequent migraines, or severe asthma * more than 3 episodes of sinusitis in the 12 months prior to screening visit or presence of nasal diseases that may affect deposition of intranasal medication * unwilling to abstain from nasal saline, other nasal irrigation, or other intranasal medications for 2 weeks prior to the baseline visit and during the 8-week, placebo-controlled period of the study * use of weight loss medication, oxytocin, carbetocin, or vasopressin in the 6 months prior to screening * participation in an interventional research study involving another investigational medication or device in the 6 months prior to screening or during the study * based on the judgment of the investigator, is unsuitable for the study for any reason, including but not limited to unstable medical condition, inability to comply with the protocol, or other risk to subject or to the integrity of the study

Keywords: pws prader-willi syndrome carbetocin
study of ono-2506 in patients with acute ischemic stroke

Conditions: Stroke

Summary: the purpose of this study is to determine the efficacy and safety of ono-2506 compared to placebo in patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: 1. subjects who have a clinical diagnosis of acute ischemic stroke 2. subjects within 72 hours after onset of the stroke 3. other inclusion criteria may apply. exclusion criteria: 1. subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction) 2. subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant. 3. other exclusion criteria may apply.

Keywords: ono-2506 stroke acute ischemic stroke
coronary calcification study - intravascular lithotripsy for calcified lesions

Conditions: Coronary Artery Calcification

Summary: the aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (ivl) to the standard therapy of calcified coronary lesions.

the study will include a total of 40 patients with calcified coronary lesions who will be randomised 1:1 to the treatment with ivl (shockwave; shockwave medical, inc, santa clara, usa) or the standard therapy (non-compliat high-pressure or scoreflex predilatation, rotational atherectomy, etc). appropriate preparation of the lesions will be followed by des implantation.

Eligibility criteria:
inclusion criteria: * age ≥18 years * informed, written consent by the patient * ability to comply fully with the study protocol * negative pregnancy test (and effective contraception) in women with childbearing potential angiographic inclusion criteria: * native coronary artery lesion with diameter stenosis ≥50% suitable for pci * heavy calcification, defined as calcification within the lesion on both sides of the vessel assessed during angiography * reference vessel diameter (rvd) ≥2.5 mm with lesion length \<32 mm * timi flow 3 of the target vessel at baseline * no visible thrombus at target lesion site exclusion criteria: * cardiogenic shock or haemodynamic instability requiring mechanical circulatory support * active malignancy or other comorbidities with a life expectancy of 12 months * limited the possibility of control coronaro angiography (e.g., advanced renal failure) * known allergy to contrast agents (that cannot be adequately premedicated) or required concomitant dual antiplatelet therapy * current problems with substance abuse (e.g., alcohol or drugs) * subject is participating in another investigational drug or device clinical study

Keywords: coronary artery calcification intravascular lithotripsy
emotional distress in patients with metastatic breast cancer in first line of therapy

Conditions: Metastatic Breast Cancer

Summary: few data about the impact of emotional distress (ed) on treatment efficacy in patients with metastatic breast cancer (mbc) are available. aim of this study is to assess the outcomes of patients with mbc receiving first-line treatment according to the presence of baseline ed.

metastatic breast cancer (mbc) is the most incident and prevalent cancer in the world and, according to a recent meta-analysis, 50% of patients with bc report emotional distress (ed). in patients with cancer, ed negatively impacts treatment adherence, ability to self-manage the physical and emotional consequences of cancer symptoms and treatment-related adverse events, and overall quality of life. ed has been shown to directly affect treatment outcomes in patients with breast cancer, with studies demonstrating that psychological well-being plays a critical role in therapeutic success. furthermore, recent studies showed that baseline ed is associated with a lower efficacy of immunotherapy in patients with non-small cell lung cancer (nsclc) or melanoma. few data about the impact of ed on treatment efficacy in patients with mbc are available. in the first line setting patients receive endocrine therapy, chemotherapy, immunotherapy and/or targeted therapy according to the disease subtype. these agents display different mechanisms of action, which involve the immune system at different levels. however, the role of ed on the efficacy of these treatments according to the bc subtype is unknown. aim of this study is to assess the outcomes of patients with mbc receiving first-line treatment according to the presence of baseline ed.

Eligibility criteria:
inclusion criteria: * age over 18 years * confirmed histological diagnosis of breast cancer * no prior treatment for advanced/metastatic cancer * indication to receive first-line therapy as per standard clinical practice based on the disease subtype: 1. cohort a (hr-/her2-, pd-l1+): pembrolizumab or atezolizumab + chemotherapy 2. cohort b (hr-/her2-, pd-l1-): chemotherapy 3. cohort c (hr+/her2-): cdk4/6 inhibitor + endocrine therapy 4. cohort d (her2+): chemotherapy + trastuzumab and pertuzumab * presence of measurable disease according to response evaluation criteria in solid tumors (recist) v.1.1 and/or positron emission tomography response criteria in solid tumors (percist) criteria * able to provide full informed consent for the study exclusion criteria: * pre-existing severe psychiatric disorders or other conditions that could impair the ability to provide informed consent * inability to complete questionnaires * presence of another malignancy in the previous 3 years * symptomatic brain metastases * ongoing treatment with antidepressant and/or anxiolytic drugs

Keywords: metastatic breast cancer emotional distress first line therapy
phase i/iia study of br790 in combination with tislelizumab in adult subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this study is a phase i/iia, multi-center, open-label study of br790 in combination with tislelizumab with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. these treatment to characterize the safety, tolerability, pk, pd and preliminary antitumor activity. the study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the investigator or the subject, or due to withdrawal of consent.

phase 1 (dose escalation phase of br790 tablets combined with tislelizumab injection): according to the incidence of dlt in br790 tablets combined with tislelizumab injection monoclonal antibody in the treatment of advanced solid tumors, mtd and the phase 2 clinical trial dose (rp2d) combining pk , efficacy and safety data were determined. stage ii (br790 tablets combined with tislelizumab injection dose expansion stage): evaluate the objective response rate (orr) of br790 tablets combined with tislelizumab injection according to response evaluation criteria in solid tumors (recist) v1.1 .

Eligibility criteria:
inclusion criteria: 1. sign informed consent voluntarily. 2. age ≥18 and ≤75 years old. 3. subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment. 4. had at least one measurable lesion. 5. ecog≤1. 6. expected survival period ≥ 3 months. exclusion criteria: 1. any previous treatment with shp-2 inhibitor. 2. symptomatic brain metastases. 3. subjects with thoracic/ascites fluid that need drainage or intervention. 4. subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： anc\ 1.5×uln alt, ast\>2.5×uln (without liver metastases) or alt, ast\>5×uln (with liver metastases), cr \>1.5×uln. 5. with uncontrolled severe disease.

Keywords: br790,shp2, checkpoint inhibitor, pd-1, nsclc, crc, hnscc
detection of kras, nras et braf mutations in plasma circulating dna from patients with metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: ras genotyping is mandatory for the prescription of anti-egfr (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. the standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. this study compares ras and braf genotyping results achieved in analyzing circulating plasma dna using oncobeam™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

the study will be proposed to all patients with a metastatic colorectal cancer. study information will be given to the patient during a routine medical examination. the patient will be included after checking inclusion criteria and signature of the informed consent form blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.

Eligibility criteria:
inclusion criteria: * adult subjects with newly diagnosed, anti egfr treatment naïve metastatic colorectal cancer * standard of care ras/raf tests performed on ffpe tumor sample as part of routine * patient information and written informed consent form signed * patient must be affiliated to a social security system * age : 18 years and older exclusion criteria: * patient bearing non-metastatic colorectal cancer * patient with local relapse only * patient with exclusive nodal metastases * patient whose health contraindicates a 30 ml blood sample * blood transfusion within 1 week prior blood collection * patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection * history of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix * persons deprived of liberty or under supervision

Keywords: kras gene mutation nras gene mutation braf gene mutation
mechanical massage chair on musculoskeletal pain improvement

Conditions: Massage Therapy

Summary: the effect of mechanical massage chair on musculoskeletal pain improvement for endoscopists and endoscopy nurses

randomized, open-label, cross-over study 1. 1st phase massage chair group (20 minutes/session, 3 sessions/week, 3 weeks), vs. control (no use of massage chair) 2. wash-out period (9 weeks) 3. 2nd phase (cross-over) massage chair group (20 minutes/session, 3 sessions/week, 3 weeks), vs. control (no use of massage chair) * msculoskeletal pain questionnaires (vas, ndi, spadi) 1) 1st phase: at baseline, 1.5 wk, 3 wk 2) 2nd phase: at baseline, 1.5 wk, 3 wk, 9wk after the end of treatment

Eligibility criteria:
inclusion criteria: * endoscopists or endoscopic nurses working at seoul national university hospital gangnam center exclusion criteria: * spine disease, skin disease, acute inflammation, electrical heart device, thromboembolism, fracture, osteoporosis, varicose vein * pregnancy

Keywords: massage chair mulsculoskeletal pain
patient perception of mammogram guidelines

Conditions: Attitude; Practice Guideline; Breast Cancer

Summary: the purpose of this study was to determine attitudes regarding the 2009 uspstf guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. the population studied was women seeing their private gynecologist for annual exams in the 39-49 year old age group.

subjects completed a baseline questionnaire listing demographics, previous experience with mammograms, and acquaintances with breast cancer. they then were randomly assigned one of two articles (one favorable and one unfavorable) that had been published in the newspaper regarding the uspstf breast cancer screening guidelines. their attitudes towards the safety of the guidelines and their willingness to comply with them was then measured.

Eligibility criteria:
inclusion criteria: * women aged 39-49 seeing their gynecologist for routine preventive care exclusion criteria: * women not aged 39-49 * women with breast cancer * women not able to read english

Keywords: u.s. preventive services task force patient attitude mammogram guideline