Kornimate/medical-research-clean huggingface dataset:
robot-assisted laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma with t1a stage

Conditions: Renal Cell Carcinoma

Summary: to evaluate the feasibility and efﬁciency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of t1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.


Eligibility criteria:
inclusion criteria: * patients with sporadic, unilateral, newly diagnosed t1a presumed renal cell carcinoma * patients scheduled for robot-assisted laparoscopic nephron sparing surgery * patients with normal contralateral renal function (diﬀerential renal function of \>40% as determined by radionuclide scintigraphy) * patients agreeable to participate in this long-term follow-up study exclusion criteria: * patients' aged \>80 years * patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney * patients not able to tolerate the robot-assisted laparoscopic procedure * patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney * patients with the renal tumor involving urinary collecting system
adolescent acts of kindness intervention

Conditions: Inflammation; Mental Health Wellness 1

Summary: adolescents will complete a 4-week intervention, during which they will either complete a kind act for others, complete a kind act for themselves, or report their daily activities three days per week. psychological and physiological measures will be indexed before and after the intervention.

stress and early adversity have been found to influence immune function via enhanced expression of the conserved transcriptional response to adversity (ctra) genetic profile. expression of this genetic profile was reduced in adults who completed a prosocial behavior intervention. this project aims to implement this intervention in adolescents. 90 high school students will be recruited and assigned to one of three groups (30/group). participants will either conduct 3 acts of kindness for themselves, conduct 3 acts of kindness for others, or report about their day 3 times per week for 4 weeks. during this intervention, they will receive text messages 3 days per week instructing them to complete their respective act. participants will provide a brief description of this act that evening, as well as complete brief surveys at the end of the week for each week of the intervention. participants will come into the lab twice, once before and once after the 4-week intervention. during these lab sessions participants will complete survey measures, have their heart rate measured, and have a blood draw conducted by a trained phlebotomist. participants' parents will also complete a brief survey to provide demographic information and an idea of what prosocial behaviors participants witnessed in their home. the investigators will use these data to assess the effects of prosocial behavior on health and the psychological mechanisms underlying these effects. at the second study visit, participants will be given the opportunity to donate part of their study payment to a charity to measure prosociality. any donations will be vetted with the psychology department's accounting group prior to making any donations in the university's name. scott monatlik, director, tax and information practices, at smonatlik@finance.ucla.edu or (310) 794-6724 will be contacted and information regarding the appropriate steps to take to ensure that the donation is made to an acceptable charity prior to any donations. actual helping behavior (donations) is measured to provide an ecologically valid experimental evaluation of prosociality rather than traditional metrics of computerized, fictional giving. conceptual frameworks from developmental and health psychology guide the hypothesis that prosocial behavior will influence adolescents.

Eligibility criteria:
inclusion criteria: * between the ages of 14-17 exclusion criteria: * none

Keywords: adolescence immune function gene expression psychological well-being social connection kindness
clinical and basic research on the treatment of polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. traditional chinese medicine has a good clinical effect in the treatment of pcos. we intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that zishen qingre lishi huayu recipe restores spontaneous ovulation in pcos patients. the overall efficacy of improving the characteristics of kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.


Eligibility criteria:
inclusion criteria: 1. diagnosed as pcos patients, the diagnostic criteria is: modify the rotterdam criteria. all subjects must have: no ovulation, combined with polycystic ovarian or / and hyperandrogenism. 2. age: 20 to 40 years old, no maternity requirements. 3. willing to be treated according to the treatment plan specified in this study. exclusion criteria: 1. hyperprolactinemia: in the past year, patients with normal levels can be included. 2. menopausal fsh levels：fsh \> 15 miu/ml. in the past year, patients with normal levels can be included. 3. patients with thyroid disease: tsh \ 5.5 miu/ml. in the past year, patients with normal levels can be included. 4. patients with poorly controlled type 2 diabetes:hba1c\>7.0%, or patients receiving antidiabetic drugs. 5. patients currently diagnosed with severe anemia (hgb \<10 g/dl). 6. patients with a history of alcohol abuse: alcohol is defined as drinking 14 times a week or more or binge drinking. 7. currently suspected cushing's syndrome patients. 8. patients suspected of having adrenal or ovarian tumors secreting androgen. 9. in patients with hypertension who are currently untreated or have poor blood pressure control, the interval between two blood pressure measurements is ≥ 60 min, systolic blood pressure ≥ 160 mm hg or diastolic blood pressure ≥ 100 mm hg. 10. patients currently diagnosed with metabolic syndrome 11. take hormonal drugs, chinese medicine prescriptions and proprietary chinese medicines in the last 3 months. 12. there is a history of pregnancy in the last 6 weeks. 13. abortion or production history in the last 6 weeks. 14. a history of breastfeeding in the last 6 months. 15. patients with a history of deep vein thrombosis, pulmonary embolism or cerebrovascular disease. 16. patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental patients 17. patients who are expected to discontinue treatment during the trial or who are unable to adhere to treatment for 3 months should be excluded. 18. reluctant to sign the informed consent form for this study.
hirrem for stage 1 primary hypertension

Conditions: Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular Risk Factor; Autonomic Nervous System Imbalance

Summary: the purpose of this study is to determine that effects of an intervention called high-resolution, relational, resonance-based, electroencephalic mirroring (hirrem), on stage 1 primary hypertension (systolic bp 130-139, and/or diastolic bp 80-89).

the purpose of this research study is to determine the effects of a technique called high-resolution, relational, resonance-based, electroencephalic mirroring (hirrem®), for hypertension. hirrem uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern. this study will compare acoustic stimulation linked to brainwave activity (hirrem, along with continued current care, hcc), with continued current clinical care alone (ccc). both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.

Eligibility criteria:
inclusion criteria: * adults, age 18 and above * systolic bp ranging from 130-139mmhg and/or diastolic bp ranging from 80-89mmhg exclusion criteria: * unable, unwilling, or incompetent to provide informed consent * physically unable to come to the study visits, or to sit comfortably in a chair for up to two hours at a time * weight is over the chair limit (285 pounds) * known atherosclerotic cardiovascular disease * cardiovascular risk score of ≥ 10% (per http://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/) * prior diagnosis of stage 2 hypertension * ongoing need for treatment of hypertension with medications * known seizure disorder * known or anticipated pregnancy * severe hearing impairment (because the subject will be using headphones during the interventions) * ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as ssri, snri, or tricyclic, and sleep medications such as zolpidem or eszopiclone * anticipated and ongoing use of recreational drugs, alcohol, or energy drinks * ongoing need for treatment with thyroid medications * are enrolled in another research study that includes an active intervention * have previously received brainwave optimization (bwo), used a b2 or b2v2 wearable device, or previously participated in a hirrem research study

Keywords: hirrem neurotechnology closed-loop allostasis stress autonomic dysregulation hyperarousal brain electrical activity acoustic stimulation primary hypertension high blood pressure
a prospective study to evaluate robot assisted total knee replacement outcomes

Conditions: Primary Osteoarthritis of Knee Nos

Summary: this study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. the outcomes we will be tracking include: 1. patients' self-reported awareness of their artificial joints during activities of daily living; 2. patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life; 3. patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; 4. the accuracy of implant placement and limb alignment


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the virtua jri 3. willing to provide informed consent, participate in study, and comply with study protocol exclusion criteria: 1. pregnant or contemplating pregnancy prior to surgery; 2. worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement) 3. post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups) 4. self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative ct scans
assessment of the mri solution: kora 100 and beflex pacing leads system

Conditions: Bradycardia

Summary: the purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the mri exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.


Eligibility criteria:
inclusion criteria: * patient who is already implanted with following system kora 100 (sr or dr) pacemaker and beflex rf45d and/or rf46d pacing leads in the left or right pectoral region * patient who is able and willing out-of-chest non medical indicated mri scanning or patients with planned medical indicated out of chest mri scanning * patient who fulfils mri solutions conditions * patient who provides signed and dated informed consent exclusion criteria: * implanted or planned to be implanted non mr-compatible device or material * permanent atrial fibrillation (for dr devices) * diaphragmatic/phrenic stimulation * claustrophobia * incessant ventricular tachyarrhythmia * inability to understand the purpose of the study or refusal to co-operate * unavailability for scheduled follow-ups at the implanting centre * already included in another clinical trial that could affect the results of this study * patient is minor (less than 18-years old) * patient is pregnant - patient is forfeiture of freedom or under guardianship

Keywords: pacemaker, leads and mri exam
phase 3 study of fibrinogen concentrate (csl511) in subjects with pseudomyxoma peritonei undergoing cytoreductive surgery

Conditions: Acquired Fibrinogen Deficiency

Summary: this study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of csl511, in participants undergoing cytoreductive surgery (crs) with hyperthermic intraperitoneal chemotherapy (hipec) for pseudomyxoma peritonei (pmp) with predicted intraoperative blood loss of greater than or equal to (\>=) 2 liter (l). eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive csl511 or cryoprecipitate.


Eligibility criteria:
inclusion criteria: * aged \>= 18 years at the time of providing written informed consent. * diagnosis of pmp requiring crs with hipec. * bleeding risk: predicted intraoperative blood loss of \>=2l, assessed within 60 and 100 mins after start of study surgery (assessment made before 2 l of blood is lost) exclusion criteria: * confirmed or suspected congenital or acquired coagulation disorder or a prothrombotic disorder * myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery. * known history of chronic hepatitis. * clopidogrel or ticagrelor administration within 5 days before study surgery. * prasugrel administration within 7 days before study surgery. * oral factor xa inhibitor administration within 2 days before study surgery. * glycoprotein iib / iiia antagonist administration within 24 hours before study surgery. * oral direct thrombin inhibitor administration within 3 days before study surgery. * vitamin k antagonists within 5 days before study surgery.

Keywords: fibrinogen deficiency pseudomyxoma peritonei cytoreductive surgery hyperthermic intraperitoneal chemotherapy blood coagulation disorder
cross-over comparison of the v60 system to other bi-level noninvasive ventilators

Conditions: Respiratory Insufficiency; Respiratory Failure

Summary: the purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.

the primary objective of this study was to compare the performance (i.e., patient self-reported comfort score) of the v60 device and a conventional noninvasive ventilator (patient's current ventilator). for the user needs assessment, the primary objective of the study was to validate the v60 to user needs. all patients were volunteers from the respiratory section of the health sciences centre at the university of manitoba. the study utilized a randomized 2-period cross-over study design to compare the v60 system to the patients' existing conventional noninvasive ventilator in different ventilation modes.

Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 85 years * weight \> 20 kg (44 lbs) * respiratory failure or respiratory insufficiency * ability to cooperate with the investigators exclusion criteria: * an endotracheal tube or tracheostomy in place * hemodynamic instability * prolonged apnea * inability to maintain the airway * a recent history of cardiac and or respiratory arrest * acute hemorrhage * multiple organ system failure * undrained pneumothorax * high risk for aspiration * metastatic or terminal cancer * do-not-resuscitate orders * inability to clear respiratory secretions * inability to fit a mask * facial surgery, trauma, or deformity * upper gastrointestinal or airway surgery * pregnancy * refractory delirium * inability or unwillingness to provide informed consent * pao2 \< 50 mmhg

Keywords: noninvasive ventilation
vibe - virtual image guided brachytherapy emulation for locally advanced cervical cancer (lacc)

Conditions: Cervical Cancer

Summary: this study will evaluate the role of sbrt with the aim to reproduce high dose rate brachytherapy (hdr bt) dose distribution by means of external beam radiotherapy in the radical treatment in patients with lacc. the study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.

this is a phase i/ii feasibility study of hypofractionated, image-guided volumetric modulated arc therapy (vmat) stereotactic body radiotherapy (sbrt) to lacc with the aim to reproduce hdr bt dose distribution by means of external beam radiotherapy in the radical treatment in patients with lacc. the study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking. eligible patients who consent to participate in the current study will receive 4 image-guided sbrt sessions to a prescription of 7 gray per fraction to the lacc (hr-ctv) following whole pelvis external beam radiotherapy. sbrt will start within one week after whole pelvis external beam radiotherapy. the study will enroll a total of 30 patients. after treatment, patients will be followed-up at 1 month, at 3 months (+/- 1 week), at 6 months (+/- 4 weeks), and then every 6 months (+/- 6 weeks) until the end of the 3rd year, then annually until the 5th year. the equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. patients' oncological outcomes, toxicity and quality of life data will be reported.

Eligibility criteria:
inclusion criteria: * cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy * biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * pelvic mri. * mri and positron emission tomography (pet-ct) of the retroperitoneal space and abdomen at diagnosis is performed. * stage iib to iva according to international federation of gynecological and obstetrics (figo) and tnm guidelines. * planning mri with the applicator in place for the sbrt boost. * para-aortic metastatic nodes below l1-l2 are allowed. * study specific signed patient informed consent. exclusion criteria: * other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin. * small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix. * metastatic disease above and beyond the retroperitoneal paraaortic l1-l2 interspace. * previous pelvic or abdominal radiotherapy. * previous total or partial hysterectomy. * contra-indications to mri. * severe psychiatric condition. * severe, active co-morbidity.

Keywords: cervical cancer stereotactic body radiotherapy (sbrt) stereotactic ablative body radiotherapy (sabr) brachytherapy
a phase 2 study of cin-102 in adults with idiopathic and diabetic gastroparesis

Conditions: Gastroparesis

Summary: this is a randomized, double-blind, placebo-controlled phase 2a study to evaluate safety, efficacy, pk, and dose response of oral cin-102 in adults with idiopathic and diabetic gastroparesis. the study will assess three oral doses of cin-102 versus placebo in three separate cohorts.


Eligibility criteria:
inclusion criteria: * male and female patients 18 to 70 years old. * current diagnosis of idiopathic or diabetic gastroparesis or documented delayed gastric emptying. * presence of moderate to severe nausea. * body mass index (bmi) between 18 and 40 kg/m2, inclusive. * glycosylated hemoglobin level \<11% at screening. * willing to washout from ongoing treatment for gastroparesis. * able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines. exclusion criteria: * other known disorder or treatment which could explain or contribute to symptoms of gastroparesis. * positive test for drugs of abuse at the screening or evaluation visits. * personal or family history of prolonged heart rate-corrected qt. * history or evidence of clinically significant arrhythmia. * history of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery. * females who are pregnant, nursing, or planning on becoming pregnant during the study.
kinematic-based bont-a bilateral upper limb pd therapy

Conditions: Parkinson's Disease

Summary: the primary objective is to study the efficacy of botulinum toxin type a (bont-a) injected via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in parkinson's disease (pd) tremor. kinematic assessment tools already developed in past clinical studies will be used in determining injection parameters. the objective is to study the composition of pd tremor using kinematic tools which may contribute to the knowledge of tremor complexity and contribute information that would benefit the development of injection parameters to improve efficacy and optimization of bont-a in tremor management. by injecting all bothersome tremulous upper limbs in parkinson's disease patients, the investigators believe a greater improvement in quality of life on more daily tasks can be achieved compared to the investigator's earlier study in unilateral injections (reb#101749), which already showed significant improvement.


Eligibility criteria:
inclusion criteria: * pd individuals diagnosed by uk brain bank criteria with stage h\&y2-3 disease * pd participants who are naïve to pd medications will be grouped into the "de novo" pd group * pd participants stable on a low dose of levodopa or on their pd medications for at least 3 months prior to their study enrolment will be grouped into the "l-dopa" pd group * participants who are botulinum toxin naïve for tremor management * patients will be screened for pregnancy by the physician * individuals with pd will be eligible for the study only if tremor is their primary and most bothersome symptom as determined by clinical exam and patient report denoting tremor-dominant phenotype * participants must be able to provide informed consent and to complete all study assessment scales and tasks. exclusion criteria: * history of stroke * history of als or myasthenia gravis * history of copd or emphysema * underlying arm muscle weakness or any related compartmental muscle syndrome * offending medications (lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol). * persons prescribed zonisamide * history of allergic or side effect reaction to botulinum toxin * contraindications per the bont-a drug monograph * women reporting that they are pregnant

Keywords: movement disorders botulinum toxin type a tremor kinematics