Kornimate/medical-research-clean huggingface dataset:
the effect of low frequency stn dbs on sleep and vigilance in parkinson's disease (pd) patients

Conditions: Parkinson's Disease

Summary: the study design is a within-subject randomized cross-over design to evaluate the effects of dbs on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as measured by a virtual reality street-crossing simulator.

in the proposed study, we will use a within-subject randomized clinical trial to measure objective changes in sleep architecture with dbs "on" and to compare effects of different dbs stimulation parameters on sleep architecture as measured by sleep studies. the study design will allow us to address our hypothesis that low frequency deep brain stimulation parameters are more effective than the conventional settings at improving sleep architecture and wake-time vigilance. if our hypothesis is correct, low frequency settings could be used during sleep and this would prolong stimulator battery life, therefore decreasing the frequency of required surgical battery changes for dbs. these data will be valuable in considering clinical treatment strategies and provide insight into the basic mechanisms of sleep dysfunction in pd. the study may also contribute to understanding how to achieve maximum clinical benefit from dbs while minimizing morbidity and cost.

Eligibility criteria:
inclusion criteria: 1. subjects who have undergone bilateral subthalamic nucleus (stn) dbs surgery for treatment of pd. 2. stable dbs stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies. 3. sleep dysfunction as measured by the pittsburgh sleep quality index (psqi) (score \>5) 4. 19 years of age or older 5. ability to walk up and down stairs exclusion criteria: 1. known narcolepsy 2. other previous surgical treatment of parkinson's disease(with the exception of unilateral stn dbs) including pallidotomy, thalamotomy, or gene therapy procedures. 3. pregnant women will be excluded from this study. 4. untreated obstructive sleep apnea. if obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. after they have been treated for at least 6 weeks with continuous positive airway pressure (cpap), they can re-start the study. 5. inability to walk without assistance, including a cane, wheelchair, or walker 6. cognitive dysfunction that would prevent subject's ability to participate in the study. 7. blindness

Keywords: pd parkinson's disease dbs deep brain stimulation
comparison azathioprine to mesalazine for the prevention of postoperative recurrence in the crohn disease

Conditions: Crohn Disease

Summary: to show the superiority of azathioprine comparing mesalazine in the prevention of postoperative recurrence in crohn's disease.


Eligibility criteria:
inclusion criteria: * more than 18 years old * clinical remission at inclusion time (cdai\<150) * having ileocolonic or colon resection 21 days before inclusion * resection \> 50cm or subtotal colectomy with ileorectal anastomosis exclusion criteria: * intolerance to one of both study treatment * liver failure (tp\<60%) * renal failure (creatinine \< lab results)

Keywords: crohn's disease ileocolic resection endoscopic recurrence ileocolic or colon resection (>50cm)
treatment of cerebral arteriovenous malformations with squid™ liquid embolic agent

Conditions: Cerebral Arteriovenous Malformations

Summary: a non-interventional multicentric study for patients with a cerebral avm for which endovascular treatment is indicated.

this observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated avm's. primary endpoint is safety. safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization. secondary endpoint is efficacy. efficacy will be assessed by angiography and clinical outcome assessments (mrs). for each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.

Eligibility criteria:
inclusion criteria: 1. patient must sign the informed consent form prior to the index-procedure. if patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested. 2. the patient has an untreated or endovascular previously treated cerebral avm for which endovascular treatment is indicated. 3. the patient is at least 18 years old. exclusion criteria: 1. patient is pregnant. 2. patient with renal insufficiency (gfr \< 45 ml/min/1.73 m²)

Keywords: cerebral arteriovenous malformation embolization endovascular
liberty extension: efficacy and safety extension study of relugolix in women with heavy menstrual bleeding associated with uterine fibroids

Conditions: Heavy Menstrual Bleeding; Uterine Fibroid

Summary: the purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (e2) and norethindrone acetate (neta) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (mvt-601-3001 or mvt-601-3002).

this study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that enrolled eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled pivotal studies, mvt-601-3001 (liberty 1 - nct03049735) or mvt-601-3002 (liberty 2 - nct 03103087). all participants received relugolix 40 mg orally once daily co-administered with e2 (1 mg) and neta (0.5 mg) for 28 weeks. approximately 600 women with heavy menstrual bleeding associated with uterine fibroids were to be enrolled, after having completed a 24-week treatment period in one of the pivotal studies. the objectives of the study were to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the pivotal study) of relugolix co-administered with e2/neta. screening and baseline procedures were to be done at the same visit for this extension study (referred to as the "week 24/baseline visit"), which coincided with the week 24 visit from the pivotal study and was to be defined as the date of completion of the last week 24 procedure in the pivotal study. participants will have received their last dose of study drug in the pivotal study on the day prior to the week 24/baseline visit and were to receive their first dose of study drug for this extension study in the clinic after the participant was determined to be eligible for this extension study and provided informed consent to participate. the administration of the first dose of study drug for mvt-601-3003 was to define enrollment into this study. study participants were to then take the open-label study treatment orally once daily for 28 weeks.

Eligibility criteria:
key inclusion criteria: 1. completed 24 weeks of study drug treatment and study participation in either pivotal study, mvt-601-3001 or mvt-601-3002 key exclusion criteria: 1. has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the pivotal study (mvt-601-3001 or mvt-601-3002) 2. met a withdrawal criterion in the pivotal study (mvt-601-3001 or mvt-601-3002).

Keywords: uterine fibroid heavy menstrual bleeding menstrual blood volume
efficacy and tolerability of symbicort as an add-on treatment to spiriva compare with spiriva alone in patients with severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is a multicentre study with a randomised, parallel group, open-label, 3-month phase iv design to assess the efficacy and tolerability of symbicort as an add-on treatment to spiriva compare with spiriva alone in patients with severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * men or women patients ≥40 years of age * diagnosis of copd with symptoms for more than 2 years and there is a history of at least one copd exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before visit 2 * forced expiratory volume in 1 second (fev1) ≤50% of predicted normal value, pre-bronchodilator and forced expiratory volume in 1 second (fev1) / forced vital capacity (fvc) \< 70%, pre-bronchodilator * total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of digital peak flow meter data at least 7 out of the last 10 days of the run-in period exclusion criteria: * a history of asthma and seasonal allergic rhinitis before 40 years of age * patients who have experienced exacerbation of copd requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (gcs) within 4 weeks and/or inhaled gcs within 2 weeks prior to visit 2 and/or during run-in period * patients with relevant cardiovascular disorder judged by the investigator * patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator * women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator

Keywords: severe chronic obstructive pulmonary disease (copd) patients
absorb first is a registry designed to evaluate the safety and performance of absorb bioresorbable vascular scaffold (absorb bvs) used in real-world patients.

Conditions: Chronic Total Occlusion of Coronary Artery; Coronary Occlusion; Coronary Artery Disease; Coronary Artery Restenosis; Coronary Artery Stenosis; Coronary Disease; Coronary Restenosis

Summary: absorb first is a prospective, multi-center registry. the objectives of the study are to: * provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the absorb bvs (bioresorbable vascular scaffold) system in daily percutaneous coronary intervention (pci) practice per instructions for use (ifu, on-label use). * to evaluate the safety and performance of 12 mm or shorter absorb bvs in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s) * collect additional information (e.g. acute success) to evaluate handling and implantation of absorb bvs by physicians under a wide range of commercial use conditions and following routine clinical practice.

the absorb first registry is intended to provide an assessment of the safety and performance of the absorb bvs device in accordance to the ifu in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.). the absorb first study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where absorb bvs has regulatory approval or is commercially available.

Eligibility criteria:
inclusion criteria: * the inclusion criteria must follow the most recent ifu which may include but are not limited to the following: * patient must be at least 18 years of age at the time of signing the informed consent form * patient is to be treated for de novo lesions located in previously untreated vessels. * patient must agree to undergo all required follow-up visits and data collection. exclusion criteria: * the exclusion criteria must follow the most recent ifu which may include but are not limited to the following: * inability to obtain a signed informed consent from potential patient. * patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry doctor or the registry sponsor).

Keywords: angioplasty bioabsorbable bioresorbable bvs coronary artery endothelial responsiveness coronary scaffold coronary stent
6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer.

objectives: i. evaluate the efficacy of 6-hydroxymethylacylfulvene (hmaf) in patients with metastatic renal cell carcinoma. ii. investigate the safety of hmaf given to this patient population. outline: patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days. treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed after every 2 treatment courses. projected accrual: approximately 12-37 patients will be accrued for this study within 6-19 months.

Eligibility criteria:
disease characteristics: histologically confirmed renal cell carcinoma and evidence of metastatic disease bidimensionally measurable disease no active brain metastases patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: greater than 3 months hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin within normal range alt/ast no greater than 2.5 times upper limit of normal (uln) renal: creatinine within 1.5 times uln and creatinine clearance at least 50 ml/min other: not pregnant or lactating fertile patients must use effective contraception no prior malignancy within 5 years and at low risk for recurrence must have undergone potentially curative therapy for prior malignancy prior concurrent therapy: biologic therapy: at least 4 weeks since biological therapy and recovered chemotherapy: no prior cytotoxic chemotherapy endocrine therapy: at least 4 weeks since hormone therapy and recovered radiotherapy: at least 4 weeks since radiotherapy surgery: at least 4 weeks since major surgery

Keywords: stage iv renal cell cancer recurrent renal cell cancer
tipifarnib versus best supportive care in the treatment of newly diagnosed acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70 or more with acute myeloid leukemia. tipifarnib belongs to a class of drugs called farnesyl transferase inhibitors (fti). it blocks proteins that make leukemia cells grow.

this study tests the safety and effectiveness of the experimental drug, tipifarnib in older patients who have acute myeloid leukemia (aml). the purpose of this study is to test if tipifarnib can make patients with leukemia live longer. in this study, half the patients will receive tipifarnib and half of the patients will receive the standard treatment. the standard treatment will help to control the symptoms of aml and may include hydroxyurea to lower levels of circulating leukemia cells. tipifarnib or the standard treatment will be given until the patient's leukemia gets better, or until they experience unacceptable side effects, or until the patient or study doctor decide to stop the study medication. patients assigned to tipifarnib will be given tipifarnib tablets. patients should take 6 tablets with food in the morning and 6 tablets with food in the evening, for 21 days in a row. patients will not take tipifarnib for the next 7 days. this 28 day period is called a cycle. the rest period may be extended beyond 7 days depending on how well the patients tolerate the treatment. patients will return to the study clinic every week and to visit their study doctor at least every two weeks. a blood draw for routine tests will be done every week. depending on how your disease is doing, a bone marrow aspiration may be done at the end of every cycle. when patients finish treatment with the study medication, or if they leave the study early, they will be asked to see your doctor for one last visit. routine laboratory tests will be done. after this visit the study doctor will continue to check with patients to see how they are doing and if they have started a new treatment for leukemia. this check will be made every 30 days and may be made by phone to the patient or to their health care provider. tipifarnib; six 100 mg in a film coated, compressed tablets are given orally twice a day at for 21 consecutive days on a 28-day cycle schedule.

Eligibility criteria:
inclusion criteria: * newly diagnosed or re-lapsing aml * patient not medically fit for combination induction chemotherapy * pathologic confirmation of aml (= or \> 20% bone marrow leukemic blasts) * eastern cooperative oncology group (ecog) performance status 0, 1, or 2. exclusion criteria: * previous cytotoxic or biologic treatment for aml * acute promyelocytic leukemia (apl) * central nervous system leukemia * uncontrolled systemic infection * uncompensated disseminated intravascular coagulation * symptomatic neuropathy of grade 2 or worse * known allergy to imidazole drugs.

Keywords: myeloid leukemia acute disease tipifarnib bone marrow aspirate
educational intervention for sodium restriction in patients with hypertension

Conditions: Hypertension,

Summary: this parallel, randomized clinical trial will include 120 participants. they will be allocated to a sodium restriction educational intervention or usual care groups. the educational intervention will be planned based on the dsrq application and sessions will be conducted once a month for the period of six months. both spot urine collection to estimate sodium intake and the dsrq will be applied at the baseline, in the eighth week and at the end of the follow-up. blood sample and 24-hour ambulatory blood pressure monitoring (abpm) will be conducted at the beginning and at the end of the follow-up. anthropometric measurements, blood pressure measurement and 24-hour food recall will be collected during follow-up.

this parallel, randomized clinical trial will include 120 participants. they will be allocated to a sodium restriction educational intervention or usual care groups. the educational intervention will be planned based on the dsrq application and sessions will be conducted once a month for the period of six months. both spot urine collection to estimate sodium intake and the dsrq will be applied at the baseline, in the eighth week and at the end of the follow-up. blood sample and 24-hour ambulatory blood pressure monitoring (abpm) will be conducted at the beginning and at the end of the follow-up. anthropometric measurements, blood pressure measurement and 24-hour food recall will be collected during follow-up. the study 'the effectiveness of an educational intervention to sodium restriction in patients with hypertension' is based on the results of the dsrq application, whose objective is to evaluate aspects related to non-adherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, better hypertension control.

Eligibility criteria:
inclusion criteria: * female and male individuals, ageing from 40 to 80 years old, in treatment and monitored at the hypertensive outpatient department of hcpa. participants must not have been monitored by a nutritionist or followed a nutritional orientation for over than six months exclusion criteria: * pregnancy or lactating; gastrointestinal tract disease; inflammatory disease; chemotherapy treatment; diabetes diagnosis; incapacity to follow an interview and/or to participate in the intervention program without the need of a third party involvement

Keywords: sodium restriction dietary sodium restriction questionnaire (dsrq) low-sodium diet adherence educational intervention
ethanol lock for prevention of central line-associated blood stream infections

Conditions: Central Lines in ICU Patients

Summary: vascular access via central venous lines (cvl) is essential to the care of many patients in the intensive care setting. while the value of these lines for the management of critically ill patients is generally accepted, the potential for line-associated blood stream infection is a known complication of the use of this intervention. ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens. the purpose of this study is to evaluate the effectiveness of daily treatment of the catheter lumen with ethanol to prevent central line associated blood stream infections (clabsi). the hypothesis is that this treatment will reduce the incidence of clabsi compared to maintenance of the lines with normal saline alone.

blood stream infections are an important complication of the use of central venous lines (cvls) and result in increased morbidity, mortality, and cost. blood stream infections related to cvls may be the result of migration of skin organisms along the catheter tract or introduction of organisms into the lumen of the catheter. the extraluminal route of infection appears to be most common early after catheter insertion while the frequency of infection acquired by the intraluminal route appears to increase the longer the catheter is in place. meticulous attention to best practices for insertion and the subsequent care of the insertion site reduces infection by the extraluminal route. adherence to good technique for entering the line may similarly reduce infection by the intraluminal route. ethanol is an effective antimicrobial agent with activity against a broad spectrum of human pathogens; including the bacteria and fungi which most commonly infect cvls. the mechanism of the antimicrobial activity of ethanol is attributed to the ability to denature proteins and induced resistance to the effect of ethanol has not been reported. these features suggest that ethanol-lock is a promising approach to the prevention of acquisition of central line associated blood stream infections by the intraluminal route.

Eligibility criteria:
although this study is done in the patient-care setting, patients are not the subject of the study. the outcome of interest involves the development of clabsi in patients but the intervention is directed at the patient's central lines rather than the patient. there are no inclusion or exclusion criteria; the determination of the line care regimen will be determined by the bed assignment rather than any characteristics of the patient occupying the bed. all central line will be included in this study. use of ethanol will be suspended whenever the usage of the line precludes instillation of ethanol with a dwell time of al least one hour.

Keywords: central line associated blood stream infections