Kornimate/medical-research-clean huggingface dataset:
'm'-technique, guided imagery, or standard of care on anxiety and pain pre- & post-operatively in elective joint replacement patients

Conditions: Hip or Knee Replacement

Summary: in the m-tijrp protocol the investigators will utilize two integrative medicine modalities in a randomized, controlled study using either the 'm'-technique® developed by jane buckle, phd or diane l. tusek's guided imagery for pre-procedure/surgery™ with nature sounds to determine their effects on a specific group of pre- and post-operative patients, compared to no integrative medicine intervention - considered standard of care. a total of 225 patients undergoing surgical hip or knee replacement will participate; one third of the patient population will receive the 'm'-technique touch intervention, one third will receive tusek's guided imagery intervention delivered by headsets monitored by therapists from our center for complementary medicine (ccm) and one third will comprise the control group, consisting of routine preoperative \& postoperative care without integrated intervention. patients will be asked to complete pain and anxiety scales at four different timepoints throughout their hospital stay. these will occur at same day surgery (pre-operatively), and post operatively day 0, day 1 \& day 2. rationale: patients are often at their most vulnerable just prior to surgery when their stress and anticipation are high and again immediately afterward when their energy is lower and their bodies are trying to accommodate after an invasive procedure. in addition, the patient and his or her family sense a lack of control and feel a rise in anxiety over the possible outcomes. this stress, anxiety, and pain associated with surgery and recovery can increase complication rates and slow recovery times resulting in longer hospital stays.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. be receiving an initial or subsequent elective hip or knee replacement surgery exclusion criteria: 1. patients with an active infection or open wound in the location of the extremities where the 'm'-technique will be performed 2. patients with touch aversion 3. non-english speaking patients - due to guided imagery recording availability in english only 4. patients who demonstrate insufficient auditory discrimination as determined by their ability to engage in normal conversation 5. patients who lack the sensation of being touched on the hands and/or feet

Keywords: joint replacement hip replacement knee replacement complementary medicine intervention
revascularization of total or sub-total occluded peripheral arteries with bycross® device. post market clinical followup

Conditions: Peripheral Arterial Disease

Summary: post market clinical follow up of bycross® device.

a prospective, multi-center, non-randomized, observational, post market clinical follow-up study of the bycross® device to evaluate the safety, technical performance and effectiveness of the bycross® device and effectiveness of the procedure using the device and adjunctive therapy. the bycross® is a single use, disposable, minimal invasive aspiration rotational atherectomy device. the bycross® is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. in cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. the bycross® can be used in several pathologies: calcified atheroma, old and fresh thrombus and in stent restenosis at peripheral arteries including iliac

Eligibility criteria:
inclusion criteria: * subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aorta bifurcation * candidate for percutaneous intervention * severely stenotic occlusion target vessel (stenosis ≥70%) * subject has been informed on the nature of the study and has provided informed consent * subject is capable of meeting study requirements including presences at follow-up visits exclusion criteria: * patient anatomy excludes use of bycross® device * vessels of the cardiopulmonary, coronary or cerebral circulations * undersized vessel diameters (\<3mm) * perforation of the vessel distally or proximally to the occlusion segment prior atherectomy * subintimal position of the guiding catheter or the guidewire * use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft * target is at vessel segment which includes tortuous course with radius of curvature \<= 40mm * access pathway includes tortuous course with radius of curvature \<= 25mm, in specific extremely sharp aortic bifurcation * in aneurysmatically altered iliac vessel segments * if the introducer sheath, the guide catheter, the guidewire or the bycross® sustains any visible damage, especially kinking * in the fracture areas of broken stents * known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure * persistent vasospasm * during use of a defibrillator on the patient
a study of neoadjuvant chemotherapy plus nivolumab versus neoadjuvant chemotherapy plus placebo, followed by surgical removal and adjuvant treatment with nivolumab or placebo for participants with surgically removable early stage non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * participants with suspected or histologically confirmed stage iia (\> 4 cm) to iiib (t3n2) non-small cell lung carcinoma (nsclc) with disease that is considered resectable * no brain metastasis * treatment-naive for nsclc (no prior systemic anti-cancer treatment) * ability to provide surgical or biopsy tumor tissue for biomarkers * eastern cooperative oncology group (ecog) performance status of ≤ 1 exclusion criteria: * participants with an active, known or suspected autoimmune disease * any positive test for hepatitis b virus or hepatitis c virus or human immunodeficiency virus (hiv) * any previous anti-cancer treatment including cytotoxic, io treatment, targeted agents, or radiotherapy for nsclc * prior treatment with any anti-pd-1, anti-pd-l1, anti-pd-l2, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways other protocol-defined inclusion/exclusion criteria apply
impact of early antibiotics on non-traumatic out of hospital cardiac arrest (ohca)

Conditions: Infection, Bacterial; Out-Of-Hospital Cardiac Arrest

Summary: specific aim : the specific aim is to conduct a randomized prospective clinical trial to determine whether no antibiotics in ohca patients in the ed with very low likelihood of infection is non-inferior to early antibiotic treatment. hypothesis a: 28-day all-cause mortality will be non-inferior in ohca patients with very low likelihood of infection who do not receive antibiotic therapy compared with those who receive early antibiotic therapy hypothesis b: there will be no difference in subsequent incidence of proven infections in the no antibiotics vs, early antibiotics groups hypothesis c: there will be no difference in the length of icu stay and overall hospital stay in the early antibiotics vs. no antibiotics groups

as above

Eligibility criteria:
inclusion criteria: * ● adults aged \>18 years, presenting to hgh ed after out-of-hospital cardiac arrest * patients with low likelihood of infection as per the definitions provided above * ability to obtain informed consent from the subjects or their next of kin/family member/legal surrogate in case of incapacitation due to sedation, mechanical ventilation, etc. in case the next of kin is not available, an independent physician who is not a part of the investigative team will complete and sign the checklist as per hmc policy "res 11026_appendix 6.5". (see section 4.1.3 for details) a member of the investigative team and a witness will also sign this form before the potential subject is enrolled in the study. exclusion criteria: * patients who have clear evidence of infection, as defined by criteria for the study. * patients who have received antibiotics within the last 1 week prior to admission. * patients with malignancy, except those who have been cured or in complete remission. * females with known pregnancy. * known immunocompromised states (including hiv/aids, transplant recipients on immunosuppressant drugs, long-term \[\> 3 weeks of prednisone \>5mg/day equivalent\] steroid therapy). * patients on immunologic disease modifying agents (commonly known as "biologics") * patients considered "brain-dead" or "vegetative state" * patients transferred from another hospital, long term care facility or institution * neutropenia (total wbc \<1,500/mm3 or absolute neutrophil count of \<1,000/mm3)
optimization of initial energy for cardioversion of atrial fibrillation with biphasic shocks

Conditions: Atrial Fibrillation; Cardioversion

Summary: use of higher energy doses (120-150 j) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 j) of biphasic shock for atrial fibrillation cardioversion. in this prospective open-label randomized trial consecutive patients with af and candidate to af electrical cardioversion will be randomized to receive 100j or 120 j as initial dose of biphasic shock. patients will be also randomized in each group to anterolateral or postero-anteriore placement of defibrillator electrodes.

open-label randomized trial to assess the efficacy of alternative initial biphasic shocks (100 versus 120 j) for cardioversion of atrial fibrillation including alternative option for electrode placement (anterolateral or postero-anterior in each group).

Eligibility criteria:
inclusion criteria: * adult (age\>18 years) * candidate to cardioversion for recent onset, persistent atrial fibrillation (\>48 hours but \< 12 months) * informed consent exclusion criteria: * atrial flutter or other arrythmias

Keywords: atrial fibrillation cardioversion biphasic shock
feasibility and efficacy of a combination of a sems and vacuum wound treatment (vacstent)

Conditions: Perforation Esophagus; Esophageal Cancer; Esophageal Achalasia; Esophageal Diseases

Summary: open, prospective, one-arm feasibility and efficacy study of a european conformity (ce) certified combination product of two ce certified medical devices in the intended indication. evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

the investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (sems) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract

Eligibility criteria:
inclusion criteria: * patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination * accessibility of the leak with the delivery system of the vac stent exclusion criteria: * simultaneous participation in other interventional exams * endoscopic inaccessibility of the affected section * full anticoagulation with international normalized ratio (inr) \> 1.5 and / or partial thromboplastin time (ptt) \> 50 sec, or platelets \<20.000 / μl (after therapeutic correction an inclusion is possible) * unstable patients with severe septic disease, who have a clinical history * assessment an immediate operation for safe focus switch-off requires * ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible) * persons who are in a dependency / employment relationship with the sponsor or examiner stand * accommodation in an institution for judicial or regulatory purposes arrangement

Keywords: perforation esophagus, esophageal anastomotic leak,
magik for femoral/tibial shaft fractures

Conditions: Femoral Shaft Fracture; Tibial Shaft Fracture

Summary: the purpose of this phase 2 randomized control trial will be to evaluate the effect of glucose-insulin-potassium (gik) therapy in the setting of lower extremity trauma to reduce short- and long-term muscle damage, acute rhabdomyolysis, and acute kidney injury. the study will consist of 40 patients with femur or tibial shaft fractures randomized to the gik arm (using a well-described systemic gik protocol; n = 20) or the control arm (using isotonic saline; n = 20). the use of systemic gik is expected to decrease the overall amount of lower extremity muscle cell death and result in improved muscle function in the postoperative period. additionally, the investigators hypothesize that gik will lead to less severe rhabdomyolysis and a concomitant decrease in the incidence of aki that results from the byproducts of muscle cell death.


Eligibility criteria:
inclusion criteria: 1. femoral shaft fracture or tibial shaft fracture 2. survival \> 72 hours after definitive femur fracture fixation exclusion criteria: 1. pregnant women as the safety of gik therapy in pregnant women has not been studied. 2. age below 18 years 3. survival \< 72 hours after definitive femur fixation. 4. pathologic fracture 5. low energy bisphosphonate related atypical fracture 6. patients with a contraindication to any of the medications on the study list 7. patients with prior extremity weakness resulting from stroke or other neurological condition 8. patients with absolute contraindications to undergoing mri (implanted defibrillator or pacemaker, implanted deep brain stimulator, bullets or gunshot pellets near great vessels or vital organs, cerebral aneurysm clips, cochlear implants, magnetic dental implants).
prevention of catheter-related bloodstream infection in patients with haemato-oncological disease

Conditions: Infection

Summary: we, the researchers at centre national de greffe de moelle osseuse, have shown in a randomised study (in press), that a low dose of unfractionated heparin (100 iu/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. the aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease: * group a: heparin impregnated catheters * group b: low-dose unfractionated heparin (100 iu/kg/daily)

studies have shown that catheter-related infection may be due to fibrin deposition associated with catheters. interventions designed to decrease fibrin deposition and thrombus formation have the potential to reduce catheter-related infections. seven randomised studies have been performed to assess the safety and efficacy of heparin (either as an infusion or bonded to central venous catheter) on central venous catheter-related bloodstream infections. although a meta-analysis of 4 studies looking at heparin either as an infusion or bonded to central venous catheter showed a strong trend for a reduction in catheter-related bloodstream infection with the use of heparin, these studies used variable definitions of catheter-related infections. we have shown in a randomised study (in press), that low dose of unfractionated heparin (100 iu/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. the aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease: * group a: heparin impregnated catheters * group b: low-dose unfractionated heparin (100 iu/kg/daily)

Eligibility criteria:
inclusion criteria: * age between 4 and 60 years * short term non-tunneled percutaneous central venous catheter exclusion criteria: * presence of a central venous catheter at admission * major blood coagulation disorders (platelet count \< 50 x 10\^9, disseminated intravascular coagulation) * absence of catheter-tip culture at the time of catheter removal

Keywords: central venous catheter catheter related bloodstream infection heparin
a study in parkinson's disease in patients with moderate to severe dyskinesia

Conditions: Dyskinesias

Summary: the current study will explore the efficacy, safety and tolerability of 2 dose combinations of jm-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.

this is a phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study. subjects with a diagnosis of moderate to severe dyskinesia in parkinson's disease (pd) will complete a screening visit to assess eligibility to participate in the study. subjects will continue with their usual levodopa treatment regimen for the duration of study participation. the screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. subjects deemed to be eligible at the end of the screening visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of jm-010 and 1 placebo, or 2 placebos as per the double-dummy study design. the randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (pk) sub-study.

Eligibility criteria:
inclusion criteria: * is able to read, understand, and provide written, dated informed consent prior to screening visit. * is male or female, between 18 and 80 years of age at screening visit. * is diagnosed with idiopathic pd that meets uk parkinson's disease society (ukpds) brain bank clinical diagnostic criteria and requires treatment with and shows responsiveness to levodopa. * has experienced dyskinesia over a period of at least 3 months prior to screening visit * has stable peak-effect dyskinesia * has more than one hour of "on" time with troublesome dyskinesia during daily waking hours on a 24-hour pd subject diary * is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day exclusion criteria: * has undergone surgery for the treatment of pd * has a current diagnosis of substance use (including alcohol) disorder (abuse or dependence, as defined by diagnostic and statistical manual, fifth edition \[dsm 5\]), * has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses * has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study * has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants. * has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior visit 2, week 0 (baseline visit). * has a history of exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia. other criteria related to other medical conditions to be referred to the protocol.
hepatitis c virus (hcv) positive kidney grafts in hcv negative recipients

Conditions: Kidney Failure

Summary: to determine the efficacy and safety of transplanting hcv positive kidney allografts to hcv sero-negative patients who are on the waiting list.


Eligibility criteria:
inclusion criteria: * male or female * age 18 and older * english and spanish speaking patients * active on the waiting list for kidney transplantation * donor organ with antibody and nat (nucleic acid test) positive for hcv * hcv negative recipient; this includes patients who never had hcv and those with hcv previously eradicated with antiviral therapy. the latter is defined as those with undetectable hcv viral load at least 3 months since stopping therapy. * willing and able to provide written informed consent exclusion criteria: * participants co-infected with hiv * donor previously treated with an ns5a containing regimen (if treatment history of donor known) * known allergies or hypersensitivity to daa or rbv * pregnancy and/or actively breastfeeding

Keywords: hcv
issues in palliative care for people in advanced and terminal stages of young-onset and late-onset dementia in germany

Conditions: Advanced Dementia Stages; Palliative Care

Summary: from a scientific view, palliative care issues in dementia are neglected in germany. neither in germany nor internationally research has been conducted on palliative care issues in young onset dementia (yod), although significant differences compared to late onset dementia (lod) are expected. most international studies have focused on patients in long term care (ltc) facilities but have neglected patients that are cared for at home. we hypothesize that in advanced and terminal stages of yod and lod unmet care needs exist and that they differ between yod and lod. by prospectively assessing and surveying 200 patients with yod and lod in advanced stages who are cared for in ltc facilities and at home and investigating circumstances of death of 100 yod- and lod-patients, it is possible 1) to describe symptoms and management, health care utilization, palliative care provision, quality of life and death, elements of advance care planning, family caregivers' needs and satisfaction; 2) to compare yod and lod; 3) to develop expert-consensus recommendations derived from study results for the improvement and implementation of strategies and interventions for palliative care provision. 4) to communicate the recommendations nationally and internationally in order to improve and adapt guidelines, to implement the recommendations into daily practice and to give a basis and perspectives for future research projects; to communicate the results to patients and their families in order to counsel and support them in their decision making processes and their dialogue with professional caregivers and physicians.


Eligibility criteria:
inclusion criteria: * patient with moderate or severe dementia (cdr = 2 or 3) * patient lives at home or in long term care * patient has got a family caregiver \> 18 years * family caregiver has sufficient knowledge of german language * written informed consent of family caregiver * written informed consent of patient or legal representative, respectively * documents of legal representative/ power of attorney exclusion criteria • at least one inclusion criterion is not met

Keywords: dementia young onset dementia quality of death late onset dementia palliative care