Kornimate/medical-research-clean huggingface dataset:
short pulse width versus low frequency dbs in parkinson's disease

Conditions: Parkinson's Disease

Summary: the aim is to compare the effect of reducing the conventional pulse width or frequency of stimulation for axial symptoms occurring after subthalamic nucleus deep brain stimulation (stn dbs) treatment. the participants will be assessed with chronic stimulation with conventional stimulation parameters, namely 60 us and 130 hz, and after random allocation to short pulse width (30 us) or low frequency (80 hz).

stn-dbs implanted patient frequently develop axial symptoms, such as gait and speech disorders, after this surgical procedure, which dampens long-term quality of life of parkinson's disease patients. the pathogenesis is not completely understood, as it could be either due to a long-term stimulation side effect or a symptom with later onset in disease progression which is not well controlled with actual stimulation program. in case of freezing of gait onset in stn-dbs, literature suggest reducing stimulation frequency. although, low pulse width is a promising option to tackle speech disorders after stn implant, it is not known its potential therapeutic potential on freezing of gait. the aim of this investigation is to compare the effect of low frequency and short pulse width stimulation in patients, who develop axial symptoms during long-term follow-up in chronic conventional stn dbs. as per protocol, participants will be assessed at baseline with chronic standard stimulation parameters (60 us and 130 hz) then they will be randomly allocated either to a low-frequency (80hz) or a low-pulse arm (30 us). the study is designed such that after scheduled re-assessment the participant will be switched from low frequency arm to short pulse width and vice versa according to the crossover nature of protocol design. both the rating investigator and the participant are blinded to the allocation, whereas an unblinded investigator will modify the parameters according to allocation arm.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease * subthalamic nucleus deep brain stimulation with chronic conventional stimulation at 60 usec and 130 hz for at least 3 months * movement disorder society updrs part iii 3.11 \>1 * freezing of gait questionnaire item-3 \>1 * movement disorder society updrs part iii 3.1 \>1 * montreal cognitive assessment \> 26 * no psychiatric disorders * all patients will be ≥ 18 years of age * documented informed consent exclusion criteria: * no documented informed consent * axial disorders not related to parkinson's disease

Keywords: dbs parkinson's disease low frequency short pulse width axial symptoms
using induced-pluripotent stem cells to model cancer therapy-related adverse events

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this study is being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects.

primary objectives: i. generate induced pluripotent stem cells (ipsc's) from patients receiving cancer treatment. ii. differentiate patient ipsc's into cardiomyocytes and/or neurons or other cell types that may be relevant to modeling cancer therapy-related adverse effects, such as cardiotoxicity and neurotoxicity. iii. use patient specific ipsc-derived cells to: iiia. model cancer therapy-related toxicities; iiib. better understand the mechanisms of toxicities; iiic. determine if patient specific genetic variants are causative of toxicities; iiid. screen novel protective therapies for cancer therapy-related toxicities. outline: this is an observational study. patients undergo blood sample collection and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * \* any patient \>= 18 years of age * planned or receiving any potentially toxic cancer therapy including but not limited to chemotherapy, targeted and immunotherapies exclusion criteria: * inability on the part of the patient to understand the informed consent or be compliant with the protocol
longitudinal assessment of bariatric surgery

Conditions: Morbid Obesity

Summary: the goal of the labs-1 study is to assess the short-term safety of bariatric surgery.

the primary objectives of this study are to assess the safety of bariatric surgery by estimating the prevalence of short term adverse outcomes in a multicenter cohort of patients undergoing bariatric surgical procedures and to determine the associations between short term adverse outcomes after bariatric surgery and both clinical/demographic patient characteristics and features of operative/perioperative care funds are not available to pay for the surgery for patients, only to address research questions.

Eligibility criteria:
inclusion criteria: * all patients age 18 years or older, eligible and undergoing bariatric surgery performed by a labs-certified surgeon. exclusion criteria: * patients who do not provide informed consent

Keywords: obesity bariatric surgery 30-day mortality
umbilical cord milking vs delayed cord clamping in preterm infants born by cesarean section

Conditions: Premature Infant; Umbilical Cord; Milking; Delayed Clamping

Summary: the purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.


Eligibility criteria:
inclusion criteria: * preterm infants less than 34 weeks' gestation born by cesarean section exclusion criteria: * inability to obtain informed consent from the mother state * monochorionic-monoamniotic twin gestation * placenta abruption * uterine rupture * transplacental cesarean * hydrops fetalis

Keywords: hemodynamics premature infant umbilical cord milking delayed clamping
gastric and autonomic functions in patients with intragastric balloon

Conditions: Obesity; Obesity, Morbid

Summary: the study aims to measure the effect of intragastric balloon on gastric function, particularly gastric accommodation and pace making, and the possible underlying changes in autonomic function

the intragastric balloon is a space-occupying device that is hypothesized to function by inducing early satiety. additionally, insertion of an intragastric balloon causes delayed gastric emptying; longer gastric emptying times after balloon insertion are correlated with more weight loss. the exact mechanism of function, however, is not clear and likely multifactorial. the investigators hypothesize that the intragastric balloon causes weight loss by affecting gastric and autonomic function, including pace-making and accommodation, and that the difference in responsiveness among patients may be mediated by differences in gastric function.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo intragastric balloon implantation * ability to comply to study schedule. exclusion criteria: * unable to give informed consent * currently taking prokinetic, anticholinergic or dopaminergic agents which could potentially modify gastric motility * have a history of bariatric or gastrointestinal surgery * pregnant or preparing to conceive a child.
phlebotomy to prevent blood loss in major hepatic resections

Conditions: Liver Neoplasms; Hepatectomy

Summary: major liver resection is associated with substantial intraoperative blood loss. blood loss in elective liver surgery is a significant factor of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. the purpose of this study is to use whole blood phlebotomy to decrease the central venous pressure, resulting in a state of relative hypovolemia. it is hypothesized that this intervention will lead to a decrease in blood loss at the time of liver resection.

major liver resection is associated with significant intraoperative blood loss. blood loss in elective liver surgery is a key determinant of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. whole blood phlebotomy is a simple intervention, whose aim is to decrease the central venous pressure yielding a state of relative hypovolemia and thus lead to decreased blood loss. small studies, mostly from the liver transplant literature, would suggest that phlebotomy with controlled hypovolemia can result in decreased blood loss and blood transfusion. since blood loss is an important issue in liver surgery, and the benefits of phlebotomy and controlled hypovolemia are unknown in liver resection patients, a rigorously conducted trial in a representative population of patients undergoing liver resection is warranted, and feasible. in this proposal, it is hypothesized that by the use of phlebotomy and controlled hypovolemia, it is possible to decrease blood loss and blood transfusions. to test this hypothesis the investigators plan to randomly allocate participants to phlebotomy plus standard of care or to standard of care. participants will be those patients undergoing elective major liver resection at the ottawa hospital for any indication. the primary outcome will be intraoperative blood loss. secondary outcomes will include transfusion requirements, perioperative morbidity and mortality, safety, physiologic parameters, and feasibility elements. a total of 62 patients will be randomized. the efficacy of phlebotomy in terms of blood loss prevention will be assessed.

Eligibility criteria:
inclusion criteria: * any patient being considered for a major elective liver resection will be considered for trial enrollment. patients who are undergoing a concurrent additional abdominal or thoracic procedure (eg. colonic resection) will also be included. exclusion criteria: * age \<18 years * pregnancy * refusal of blood products * active cardiac conditions: unstable coronary syndromes, decompensated heart failure (nyha functional class iv; worsening or new-onset heart failure), significant arrhythmias, severe valvular disease * history of significant cerebrovascular disease * renal dysfunction (patients with an estimated gfr \<60 ml/min) * abnormal coagulation parameters (inr \>1.5 not on warfarin and/or platelets count \<100 x109/l ) * evidence of hepatic metabolic disorder (bilirubin \>35 umol/l) * presence of active infection * preoperative autologous blood donation * hemoglobin \<100 g/l
shanghai at risk for alzheimer's disease: a cohort study

Conditions: Alzheimer Disease; Dementia; Neurodegenerative Diseases; Cognitive Impairment; Neurocognitive Disorders

Summary: the goal of this cohort study is to estimate the incidence of ad in the first-degree relatives of patients with ad. the main questions it aims to answer are: * cognitive changes of subjects at high risk of ad as ageing; * environmental and behavioral factors affecting ad incidence.

this study is a prospective cohort study focusing on the first-degree relatives of patients with alzheimer's disease (ad). multiple methods including the neuropsychiatric assessment battery, magnetic resonance imaging (mri) and fluid biomarkers (blood and urine) are used to estimate the longitudinal changes of the participants at high risk of ad. besides, a structured questionnaire is designed to investigate how environmental, behavioral and other factors influence the incidence of ad. this study is of great significance in establishing novel guidelines for the prevention and treatment of dementia suitable for chinese population, and for clinicians to predict the risk of ad in first-degree relatives.

Eligibility criteria:
inclusion criteria: 1. the ad diagnostic criteria of probands meet the 2011 national institute on aging - alzheimer's association framework, and participants are the first-degree relatives (including parents, children and siblings of the same father and mother) of the proband; 2. not patients with dementia; 3. ≥ 50 years, males and females; 4. subjects have lived in shanghai for more than 1 year and have no plan to move out of shanghai within 5 years; 5. subjects are able to complete investigation, physical examination, imaging examination and biological specimen collection. exclusion criteria: individuals will be excluded if they have: 1. other diseases which could cause cognitive decline, e.g. cerebrovascular diseases, creutzfeldt-jakob disease and parkinsons disease; 2. history of psychological disorders (according to diagnostic and statistical manual of mental disorders, 5th edition); 3. uncorrectable visual or auditory impairment that hampers the completion of related examination. 4. pre-menopausal women will also be excluded.
efficacy of dose intensified radiotherapy of spinal metastases by hypofractionated radiation and igrt hfsrt mediated boost

Conditions: Spinal Metastases

Summary: spinal metastases indicate for an incurable course of disease. local tumor control after palliative radiotherapy of spinal metastases (10x3 gy, 1x8gy) is between 61 to 81%. in 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. this trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (igrt \& hfsrt) and by elevation of elective dose in vertebral body with 12x3 gy (standard: 10x3 gy). primary endpoint is local tumor control (time up to progression). secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. it is planned to recruit a total number of 155 patients.


Eligibility criteria:
inclusion criteria: * minimum age 18 * expectance of life at least 6 months * karnofsky-score \> 50 * 1-3 vertebral body metastases * up to 5 other, macroscopic metastases * effective contraception * geographic reachability of patients * signed study-specific consent form prior to therapy * no on-treatment participation on other trials exclusion criteria: * initial required neurosurgical decompression * rapid, neurological deterioration * prior radiotherapy of region for planned radiation * conditions that preclude the application of magnetic resonance tomography * malignancy: multiple myeloma or lymphoma * technical conditions preclude stereotactic irradiation (technical limitations of device) * pregnant or nursing women * fertile patients who refuse effective contraception during study treatment * persistent drug and/or alcohol abuse * patients that are not able or willing to behave according to study protocol * absent attendance for personal, disease related data storage and transfer * on-treatment participation on other trials

Keywords: spinal metastases vertebral body stereotaxis image-guided radiotherapy hypofractionated dose intensified dose elevation
study of palifosfamide-tris in combination with carboplatin and etoposide in chemotherapy naïve patients with extensive-stage small cell lung cancer (the matisse study)

Conditions: Extensive-Stage Small Cell Lung Cancer

Summary: this is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of pace chemotherapy in chemotherapy naive subjects with extensive-stage sclc. eligible subjects will be stratified according to age, gender, and eastern cooperative oncology group (ecog) performance status, and randomized in a 1:1 ratio to receive either pace or ce chemotherapy. the study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. secondary efficacy endpoints include orr, pfs, duration of response and changes in qol and disease-related symptoms. tumor-related endpoints will be assessed according to the response evaluation criteria in solid tumors (recist) v1.1 guidelines. the safety of study treatments will be assessed by the frequency and severity of adverse events as determined by national cancer institute (nci) common terminology criteria for adverse events (ctcae) v4.03. to provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. an independent data monitoring committee (dmc) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.


Eligibility criteria:
inclusion criteria: * documented extensive-stage small cell lung cancer. * patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer. * ecog performance status of 0, 1 or 2. * adequate bone marrow and organ function based on the results of protocol- specified laboratory tests. * male and female patients must agree to use a highly reliable method of birth control during study participation. * able to provide informed consent exclusion criteria: * previously untreated (non-irradiated), symptomatic brain metastases. * known allergy to any of the study drugs or their excipients. * any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol). * any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (ta, tis, or t1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (exception: subjects with a history of malignancy other than small cell lung cancer may be enrolled after consultation with the medical monitor provided the patient's prognosis is best defined by the extensive-stage small cell lung cancer). * currently pregnant or nursing.
anastrozole plus lonafarnib (sch 66336) or plus placebo for the treatment of advanced breast cancer (p03480)

Conditions: Breast Cancer

Summary: primary objective(s): * to compare the activity (progression-free survival \[pfs\]) of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive advanced breast cancer. secondary objective(s): * to determine the effects of anastrozole in combination with lonafarnib on objective response, duration of response, overall survival, and safety in subjects with advanced breast cancer. to assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population.


Eligibility criteria:
inclusion criteria: * postmenopausal women who have histologically-confirmed breast cancer with the following characteristics: * estrogen and/or progesterone receptor positive, * locally advanced disease * distant metastatic disease, stage 4 * subjects eligible for single-agent treatment with aromatase inhibitors for current disease. * subjects taking biophosphonates are allowed if they begin bisphosphonate therapy at least two weeks prior to randomization. * measurable disease (masses with clearly defined margins on radiological images and at least one diameter \>=20 mm\[\>=10 mm if spiral ct\]) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter \>= 20 mm). subjects with bone disease only are permitted if disease is evaluable. * ecog performance status of 0 or 1. * sufficient bone marrow reserve. * adequate hepatic and renal function: laboratory values within protocol requirements. exclusion criteria: * subjects who have received more than one regimen of cytotoxic chemotherapy for advanced disease. * subjects with with clinically apparent brain metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphangitic spread of tumor. * subjects with prior treatments with ftis. * subjects with a known or suspected hypersensitivity to any excipients in the lonafarnib formulation (providone, poloxamer 188, croscarmellose sodium, silicon dioxide, and magnesium stearate).
enhancing exercise and psychotherapy to treat pain and addiction in adults with an opioid use disorder (expo; r33 phase)

Conditions: Opioid Use Disorder; Pain

Summary: this work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. the investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and i-stop on secondary outcomes including depression, anxiety and sleep.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center * must be diagnosed with an opioid use disorder (oud; icd-10 f11.20) or a poly-substance drug use that includes an opioid component (icd-10,f19.xx) * must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder * must be approved to exercise in the study by the drug treatment center (medical director, physician or other relevant clinical staff or primary care physician (pcp)) exclusion criteria: * any substantive contraindications to exercise * psychiatrically unstable * pregnant women * non-english speaking adults * adults unable to provide informed written consent
choosing the best antibiotic to protect friendly gut bacteria during the course of stem cell transplant

Conditions: Intestinal Microbiome; Febrile Neutropenia

Summary: the purpose of this study is to see how different antibiotics affect the community of friendly bacteria existing in the intestinal tract (gut). under normal circumstances, these friendly bacteria are not harmful and they help with normal bodily functions such as digestion. when these bacteria are absent, several complications may occur, such as infections with harmful bacteria or other inflammatory reactions, that can complicate the stem cell transplant course. treatment with antibiotics or chemotherapy is known to kill off these friendly bacteria. in this study we compare the effects of different antibiotics on the community of friendly bacteria in the gut. for microbiota-related biomarker analysis, optional urine samples (mskcc patients only) will be collected at baseline, 7 +/-2 days after initiation of antibiotic therapy, and on post-transplant days +28, +56 and +100 (+/- 7days).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with any hematologic malignancy undergoing exclusion criteria: * patients with severe allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin. severe reactions include anaphylaxis and stevens-johnson syndrome (sjs)/toxic epidermal necrolysis (ten). * patients with unconfirmed allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin can be evaluated by an allergy/immunology specialist, after which they may become eligible by a consensus of the treating physician, trial investigator and and the allery * prolonged antibiotic treatment ( ≥10 days, within 3 weeks of enrollment) as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing anti anaerobic antibiotics * patients with history of infection with extended-spectrum beta-lactamase producing organism. patients known to be colonized with multi-drug resistant gram-negative organisms or with history of infection with multi-drug resistant organisms will be evaluated case by case and discussed with infectious disease specialist before enrollment * febrile patients * patients with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m\^2

Keywords: antibiotic piperacillin-tazobactam cefepime aztreonam 17-097