Kornimate/medical-research-clean huggingface dataset:
varenicline treatment for excessive daytime sleepiness in parkinson's disease

Conditions: Parkinson's Disease

Summary: the effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive daytime sleepiness in parkinson's disease will be studied in a randomized, double blind, placebo-controlled clinical trial with a within-subject crossover design.

sleep disturbances are common in parkinson's disease and include excessive daytime sleepiness that has been reported in up to 50% of patients. relatively little therapeutic research has addressed the problem of excessive daytime sleepiness and current treatment is largely aimed at reducing the dose of dopaminergic medication while trying to maintain sufficient motor control which unfortunately often fails. apart from degeneration of dopaminergic neurons, a decrease in cholinergic projections to the brain arousal areas may be at least partly responsible for the occurrence of excessive daytime sleepiness in parkinson's disease. smoking in narcoleptic patients diminishes sleep attacks and excessive daytime sleepiness , thus one may hypothesize that nicotinergic stimulation of the brain arousal areas may improve excessive daytime sleepiness in parkinson's disease. therefore the effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist, on excessive daytime sleepiness in parkinson's disease will be studied in a placebo-controlled cross-over study.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease according to clinical diagnostic criteria united kingdom parkinson's disease society brain bank * receiving stable parkinson's medications for at least four weeks before and throughout study * suffering excessive daytime sleepiness, defined by a score of \>10 on the epworth sleeping scale * written informed consent exclusion criteria: * parkinson's disease patients receiving medications with known central depressant effects (benzodiazepines, neuroleptics, anticholinergics) * dementia defined by a mini mental state examination \<24 * depression defined by a beck depression inventory \>16 * a known diagnosis of sleep apnea or narcolepsy * current smoking or smoking cessation in past 6 months * presence of contra-indications for treatment with varenicline, including: * known psychiatric diseases such as panic disorder, psychosis, bipolar disorder, eating disorder and alcohol or drug abuse * unstable angina, a history of cardiac disease or stroke in previous 6 months * severe renal failure (glomerular filtration rate ≤ 30 ml/min) * insulin-dependent diabetes

Keywords: parkinson's disease varenicline excessive daytime sleepiness
effect of a proton pump inhibitor on the pk of tepotinib

Conditions: Healthy

Summary: this study was investigated in healthy participants (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose pharmacokinetics (pk) of tepotinib under fed conditions, and (ii) the effect of food on the single dose pk of tepotinib after co-administration of omeprazole and tepotinib. furthermore, the study assessed the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.


Eligibility criteria:
inclusion criteria: * healthy participants of non-child bearing potential * body mass index (bmi) between 18.5 and 29.9 kilogram per meter square (kg/m\^2) * body weight between 50 to 100 kilogram (kg) * other protocol defined inclusion criteria could apply exclusion criteria: * participation in a clinical study within 60 days prior to first drug administration * whole blood donation or loss of greater than (\>) 450 milliliter (ml) within 60 days prior to first drug administration * any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation * other protocol defined exclusion criteria could apply

Keywords: proton pump inhibitor omeprazole tepotinib non-small cell lung cancer (nsclc) pharmacokinetics
a study evaluating duloxetine in patients hospitalized for severe depression

Conditions: Major Depressive Disorder

Summary: an eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.


Eligibility criteria:
inclusion criteria: male or female patients of ≥ 18 years of age that meet criteria for severe major depressive disorder, without psychotic features (according to diagnostic and statistical manual of mental disorders fourth edition, \[dsm-iv\] and confirmed by mini international neuropsychiatric interview \[mini\]). * with a total score montgomery-asberg depression rating scale (madrs) ≥ 30 and 6-item hamilton depression rating scale (hamd-6) ≥ 12 and clinical global impression of severity (cgi-severity) ≥ 4 at both screening and baseline. * requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to visit 4. * patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol. * informed consent document must be signed at screening visit, in accordance with good clinical practice (gcp) and local regulatory requirements, prior to any study procedure. exclusion criteria: * more than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration of two different antidepressant therapies. * lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode. * concurrent presence of symptoms fulfilling criteria for any axis i disorder other than anxiety disorders (with exception of the obsessive-compulsive disorder (ocd)) or major depressive disorder, in the investigator's judgment. * any previous diagnosis of a bipolar disorder, schizophrenia or ocd. * depression with catatonic features (according to dsm-iv), depression with post-partum onset, or organic mental disorders. * the presence of an axis ii disorder
microwave ablation for leiomyoma

Conditions: Uterine Fibroid

Summary: this prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment of symptoms related to uterine fibroids. we will include 200 women.


Eligibility criteria:
inclusion criteria: * premenopausal * no future child wish * acceptable risks for general anestesia or sedation * willing to comply with protocol exclusion criteria: * current or future child wish * bleeding disorder with increased risk of bleeding
phase i study of krn330 monoclonal antibody in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: the primary objective of this study is to assess the safety and tolerability of krn330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease. 2. are not candidates for a surgically curative procedure. 3. have progressed despite, are intolerant of, or are not appropriate for current therapies. exclusion criteria: 1. have an active, uncontrolled infection. 2. have known or suspected cerebral metastasis. 3. have had a myocardial infarction (mi) or cerebrovascular accident (cva) within the last 6 months; or meet the criteria for aha class iii or iv congestive heart failure (chf). 4. have any significant concurrent disease or illness that would interfere with the interpretation of study results. 5. pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study. -
vigorous or moderate exercise in enhancing active surveillance in patients with localized prostate cancer

Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Summary: this randomized pilot clinical trial compares vigorous or moderate exercise in enhancing active surveillance in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. active surveillance involves watching the patient's condition but not giving any treatment unless test results show that the patient's condition is getting worse. exercise may improve fitness, quality of life, brain health, and blood biomarkers in patients with prostate cancer on active surveillance. it is not yet known whether vigorous or moderate exercise works better in enhancing active surveillance in patients with localized prostate cancer.

primary objectives: i. to determine the feasibility of performing vigorous intensity aerobic exercise using progressive, high-intensity interval training (hiit) with standard stationary cycling and 'cybercycling' compared to moderate intensity aerobic exercise with standard stationary cycling in prostate cancer (pca) survivors on active surveillance (as). ii. to explore the potential effects of vigorous intensity aerobic exercise (hiit) using standard cycling and 'cybercycling' compared to moderate intensity standard cycling on changes in quality of life (qol), cognition, fitness circulating inflammatory biomarkers and pca-specific markers of progression (prostate specific antigen \[psa\], time to at) in pca survivors in active surveillance (as); and, to explore if these effects may be mediated by changes in body fat. outline: patients are randomized to 1 of 3 arms. arm i: patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks. arm ii: patients perform hiit exercise on a standard stationary bike, three days a week for 16 weeks. arm iii: patients perform hiit exercise on a cybercycle using racing or other games, three days a week for 16 weeks. after completion of study, patients are followed up at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * adult men of all races and body size with histologically confirmed localized pca on as * approved to be contacted by the treating urologist * meet screening criteria * complete american heart association (aha)/american college of sports medicine (acsm) exercise questionnaire * undergo cardiopulmonary exercise (cpx) testing utilizing a cycle ergometer. if the cpx test is terminated secondary to hemodynamic instability, arrhythmias or ischemic signs, the patient will be ineligible. exclusion criteria: * patients unable to provide informed consent * patients participating in a structured exercise program in the past 6 months * patients not available for follow-up tests * patients with pre-existing medical conditions that would be a barrier to exercise

Keywords: cancer survivor prostate cancer exercise active surveillance ease
role of fdg pet, immune and hypoxic marker in nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with nsclc treated with surgery with radical intent at our center.

this is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 130 patients with nsclc treated with surgery with radical intent at our center. we will review fdg-pet acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to hypoxic and immune-related markers at immunohistochemistry (ihc). these markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Eligibility criteria:
inclusion criteria: * diagnosis of nsclc (stage i-iii) * fdg pet before surgery exclusion criteria: * absence of tumor specimen * no clinical data * fdg-pet can not be evaluated

Keywords: carcinoma non-small-cell lung fdg pet hypoxia markers immune markers
study to evaluate if the drug vasopressin protects the kidneys for patients undergoing liver transplant

Conditions: Liver Failure

Summary: the purpose of this study is evaluate the medication vasopressin for its ability to preserve kidney function in patients undergoing liver transplantation.

renal failure is a common complication of liver disease. hepatorenal syndrome is caused by a dysfunctional global circulation in the setting of liver disease: increased flow to the mesenteric circulation is a contributor to decreased blood flow to the kidneys (1). renal failure often worsens in the perioperative period of liver transplantation since the kidneys are further stressed by reduced flow due to inferior venacava occlusion, decreased blood flow to the kidneys from anesthetics, as well as hypotension from volume shifts, such as when large volumes of ascites are removed. renal failure is a cause of major morbidity and mortality in patients undergoing liver transplantation. vasopressin is a logical choice of therapy in this context as the effects of the drug work to particularly increase renal blood flow and glomerular filtration rate due to the location of specific vasopressin receptors within the renal vasculature. it has been suggested that the use of splanchnic (and systemic) vasoconstrictors such as terlipressin (a vasopressin analog) or alpha-1-adrenoceptor agonists (midodrine or noradrenaline) may improve renal function in patients with type 1 hepatorenal syndrome. six studies (with only one randomized study in a small series of patients) have shown that terlipressin improves renal function in these patients (2-7). this drug is available in europe, but not in the united states. however, while anesthesiologists commonly use vasopressin during liver transplantation in the setting of hepatorenal syndrome or vasodilatory shock, the validity of this practice for its effects on renal function and outcomes has not been rigorously studied (8-10). therefore, the purpose of this study is to evaluate the effects of low-dose vasopressin on intraoperative and perioperative renal function in liver transplant patients. this study will be a randomized, double-blind controlled trial performed in adult liver transplant patients coming to surgery for chronic liver disease; the major end-points of analyses are renal function tests in the perioperative period.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * undergoing liver transplant * ability to provide informed consent. if patient is unable to give informed consent i.e. hepatic encephalopathy, consent may be obtained from the patient's legally authorized representative exclusion criteria: * \< 18 years of age * renal failure

Keywords: liver transplantation vasopressin renal function hypotension creatinine urine output diuretics vasopressors hemodynamic stability
establishing guidelines for manual lymphatic drainage

Conditions: Lymphedema of Leg

Summary: the purpose of this study is to establish optimal guidelines for manual lymphatic drainage in participants with lower extremity lymphedema.

to determine if there is a difference in l-dex score and segmental limb volume in participants with lower extremity lymphedema as measured in liters by the sozo machine between participants who receive manual lymphatic drainage (mld) techniques utilizing light tactile pressure with 5-10 mmhg without skin stretch versus medium tactile pressure of 11-20 mmhg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (\> 21 mmhg) and maximal skin stretch with therapist weight shift.

Eligibility criteria:
inclusion criteria: * all adults between the age of 30 - 75 years * lower extremity lymphedema exclusion criteria: * pregnant women * participants who are unable to stand independently for up to 2 mins * participants who cannot make their own decisions * participants undergoing cancer treatment * participants with an infection (active cellulitis) * participants with a known iodine allergy * participants who weigh more than 375 lbs * participants with cardiac arrhythmias or implanted electronic equipment * participants who have undergone joint replacement in involved extremity * participants with cardiac insufficiency
early enteral tube feedings in children receiving chemo for aml/mds & high risk solid tumors

Conditions: Brain and Central Nervous System Tumors; Kidney Cancer; Leukemia; Liver Cancer; Neuroblastoma; Sarcoma; Solid Tumor

Summary: rationale: tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer. purpose: this clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or high-risk solid tumors.

objectives: primary * to determine the feasibility and acceptance of undertaking early enteral tube feedings in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia or myelodysplastic syndromes, primary cancers of the central nervous system, or high-risk solid tumors. secondary * to determine the safety of proactive enteral nutrition in these patients. * to evaluate the effect of enteral nutrition on nutritional status in these patients. outline: patients have a small (6 or 8 french) nasogastral feeding tube or enterostomy tube inserted after diagnosis. peptamen® af tube feeding is administered via the enteral tube. tube feedings are started as a continuous drip using an enteral feeding pump with a subsequent steady daily rate increase. patients receive enteral feeding during courses 1-4 of chemotherapy.

Eligibility criteria:
inclusion criteria: * newly confirmed diagnosis of 1 of the following: * acute myeloid leukemia * myelodysplastic syndromes * sarcoma * any other stage iv solid tumor including: * wilms * neuroblastoma * hepatoblastoma * any primary cancer of the central nervous system including: * cerebellar astrocytoma * medulloblastoma * ependymoma * spine tumors exclusion criteria: * no contraindication to enteral tube feeding including, but not limited to, any of the following: * gastrointestinal tract dysfunction (i.e., ileus, peritonitis, obstruction) * active sinusitis (can be waived for patients with gastrostomy tubes) * obstructive tumor in the nasopharynx prior concurrent therapy: * no prior hematopoietic stem cell transplant * all clinically indicated medications are permitted during the course of the study * no other concurrent nutritional supplements

Keywords: childhood soft tissue sarcoma neuroblastoma childhood hepatoblastoma childhood cerebellar astrocytoma childhood ependymoma childhood brain stem glioma childhood meningioma childhood myelodysplastic syndromes unspecified childhood solid tumor, protocol specific childhood acute myeloid leukemia/other myeloid malignancies central nervous system neoplasm wilms tumor and other childhood kidney tumors childhood brain tumor childhood medulloblastoma
a research study of an investigational drug alo-02 (oxycodone hydrochloride and naltrexone hydrochloride) in patients with moderate to severe chronic low back pain

Conditions: Chronic Pain; Low Back Pain; Analgesia

Summary: the primary objective of the study is to determine the analgesic efficacy and safety of alo-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.


Eligibility criteria:
inclusion criteria: * moderate-to-severe chronic low back pain present for at least 3 months. * require a continuous around-the-clock opioid analgesic for an extended period of time. * refrain from taking other opioid and non-opioid medications during the study. exclusion criteria: * active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention. * documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain. * active or ongoing or history of alcohol or drug abuse.

Keywords: oxycodone naltrexone chronic pain low back pain
effects of an innovative balance training programme in enhancing postural control and reducing falls in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: falling is a complex and most disabling feature for patients with parkinson's disease (pd). previous studies suggested that falls in patients with pd are related to postural instability characterized by deficits in anticipatory postural adjustment (apa) for postural orientation in walking and standing and inadequate postural response to perturbation. the present study developed an innovative balance treatment with focus of anticipatory and compensatory postural control and examined its effects on enhancing balance and gait performance and decreasing fall rate in people with pd.

participants: forty-two eligible subjects with pd were randomly allocated into balance with focus of anticipatory and compensatory postural control (exp) or control (con) group with strength-focused training, with 26 subjects in each group. methods: subjects in the exp group were trained the speed and amplitude of anticipatory postural adjustment during stepping and walking and postural response to perturbation during walking. subjects in the con group were trained to improve the strength of lower limb muscles. treatment period in both groups lasted for 12 weeks, which consisted of 4-week laboratory-based training (phase 1), 4-week home-based exercise (phase 2) and final 4-week laboratory-based training (phase 3). outcome measures included reaction time(rt), movement velocity (mv) and endpoint excursion (epe) of limit-of-stability test, one-leg-stance (ols) time, gait velocity, stride length (sl), cadence, and fall rate. all tests were conducted for 6 time intervals including baseline, after each training phase, at 3-month follow-up and at 12-month follow-up.

Eligibility criteria:
inclusion criteria: 1. diagnosed as parkinson's disease 2. 45 years old or above 3. stable on anti-parkinsonian medications for at least 6 weeks prior to entry into the study, which will remain unchanged for the duration of the study 4. able to walk a 10 meter distance at least 3 times with or without walking aids independently 5. at stage 2 or 3 of the hoehn and yahr staging 6. able to provide informed consent exclusion criteria: 1. neurological conditions other than pd 2. uncompensated cardiovascular disease 3. less than 23 score on the mini-mental state examination, 4. history of fracture or recent musculoskeletal disorders in back or lower limbs which would interfere with the balance during exercise and daily activities 5. visual disturbance or vestibular dysfunction limiting locomotion or balance 6. participation in other balance-related training program more than one time per week

Keywords: parkinson's disease balance anticipatory postural adjustment componsatory postural adjustment falls