Kornimate/medical-research-clean huggingface dataset:
the remedē® system for the treatment of central sleep apnea in daily practice

Conditions: Sleep Apnea; Central Sleep Disordered Breathing

Summary: the aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e. with or without implantation of the remedē® system to treat sleep-disordered breathing.

the sponsor of this study, livanova, has a partnership with respicardia, inc who has developed a battery-powered implantable device that treats central sleep apnea. the device is used with a lead that delivers the stimulation therapy which causes the patient to breathe with a regular rhythm and an optional lead that senses breathing. this combination is called the remedē® system. the aim of this study is 1. to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea 2. to collect safety information of all patients diagnosed with central sleep apnea 3. to obtain additional short and lang term information on the safety and performance of the remedē® system, including an evaluation if there's an impact on the quality of life of patients treated with the the remedē® system in daily practice. the information obtained from this study may provide better insight on the symptoms related to central sleep apnea, risk factors related to central sleep apnea therapy and use of the remedē® system which may help to treat other patients with potential sleep disordered breathing more appropriately. approximately 300 patients (to be) implanted with the remedē® system will participate in this study at approximately 40 sites in europe. for this purpose the investigators aim to screen approximately 1500 patients with sleep-disordered breathing. also patients diagnosed with central sleep apnea, but not receiving the device will be followed through phone calls for 2 years.

Eligibility criteria:
inclusion criteria: * all patients screened for sleep disordered breathing * age \> 18 years * signed ethics committee approved informed consent implant inclusion criteria * diagnosis of moderate to severe central sleep apnea and referred for implant of the remedē system / implanted with remedē system implant exclusion criteria: * patients meeting the criteria as referred to in the latest version of the implant manual
back on my feet: emotional recovery from fall injury

Conditions: Posttraumatic Stress Disorder; Subsyndromal Posttraumatic Stress Disorder; Fear of Falling

Summary: we will compare two programs that are designed to help older adults who have had fall injuries manage anxiety and improve their level of functioning. we expect that both programs will provide some benefit, but that one will promote better management.

fall accidents can be frightening experiences that cause life-changing injuries. each year, millions of older americans who fall may develop disabling anxiety and related distress, functional limitations, and poor health. our previous study adapted a well-researched anxiety treatment, exposure-based cognitive behavioral therapy (et), for older adults diagnosed with full posttraumatic stress disorder (ptsd), subsyndromal ptsd, or fear of falling after fall injury. the approach was well-accepted by subjects and they reported both reductions in anxiety and having more fully returned to normal living immediately after the treatment and then three months later. the purpose of this pilot study is to compare et to another active treatment, relaxation training (rt). both study treatments will consist of eight home-based sessions. et consists of education about anxiety, relaxation training, managing distressing thoughts, healthy routine, and confronting avoided memories and situations. rt consists of techniques to ease bodily tension. twenty-four subjects will be randomly assigned to one of the two treatment groups. the study will compare how subjects in each group improve on outcomes such as diagnosis, anxiety severity, and quality of life over the course of treatment, and at three- and six-month follow-up. the findings will provide the basis for larger future studies.

Eligibility criteria:
inclusion criteria: * age 60 years and older * fall accident requiring emergency room or inpatient hospital medical care with return home within past nine months * community dwelling * able to ambulate independently or with an assistive device * english-speaking * diagnosis of ptsd, subsyndromal ptsd, or fear of falling (determined by interview) exclusion criteria: * cognitive impairment * serious or terminal illness * aphasia * current substance abuse * lifetime history of psychotic disorder and/or bipolar disorder * active suicidal or homicidal ideation * prescription psychotropic medication begun \< 6 weeks

Keywords: exposure therapy cognitive behavioral therapy relaxation training older adults fall injury anxiety posttraumatic stress
study in parkinson's disease patients with dyskinesia with combinations of jm-010 and its individual components

Conditions: Dyskinesias; Parkinson Disease

Summary: this is a two-part, double-blind, placebo-controlled, randomized, multicenter phase 2 clinical trial of jm-010 in patients with parkinson's disease.

this is a two-part, phase 2, double-blind, placebo-controlled, randomized, multicentre study. subjects with a diagnosis of pd and dyskinesias in pd will complete a screening visit to assess eligibility to participate in the 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 85 years of age at screening visit. * is diagnosed with idiopathic pd that meets uk parkinson's disease society (ukpds) brain bank clinical diagnostic criteria * has experienced dyskinesia * has stable peak-effect dyskinesia * has more than one hour of "on" time with troublesome dyskinesia exclusion criteria: * has undergone surgery for the treatment of pd * has a current diagnosis of substance use * has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses * has current seizure disorders requiring treatment with anticonvulsants. other criteria related to other medical conditions to be referred to the protocol.
a dose-escalation study of spyk04 in patients with locally advanced or metastatic solid tumors (with expansion).

Conditions: Locally Advanced or Metastatic Solid Tumors

Summary: phase i, open-label, multi-center study


Eligibility criteria:
inclusion criteria: (both part i and part ii) * age \>= 18 years at time of signing informed consent form * ecog performance status of 0 or 1 * patients with a locally advanced, recurrent, or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable (part i only) * patients with measurable and/or evaluable disease per recist v1.1 * patients with mapk pathway alterations positive solid tumor (i.e., braf, k/n/h-ras mutations) (part ii only) * patients with measurable disease per recist v1.1 * patients with kras mutated nsclc (nsclc cohort) * patients with kras mutated ovarian cancer (ovarian cancer cohort) * patients with ras mutated solid tumor (biopsy cohort) exclusion criteria: (both part i and part ii) * significant cardiovascular disease, such as new york heart association (nyha) cardiac disease (class ii or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months * patients with primary central nervous system (cns) malignancy, untreated cns metastases requiring any anti-tumor treatment, or active cns metastases * patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection) * patients with a history or complication of interstitial lung disease (ild)
usage of artificial intelligence-integrated usg in application of pectoral block in mastectomies

Conditions: Breast Neoplasms

Summary: the investigator's goal in this study is to apply pecs ii block, before starting surgery, by either conventional usg or artificial intelligence integrated usg to patients who will undergo mastectomy under general anesthesia to determine the effect of the block on hemodynamics and opioid consumption in the intraoperative period. besides, the investigatorwanted to investigate the contribution of artificial intelligence integrated usg use in the success of a 4-year anesthesiology resident for imaging the injection site.

after receiving the approval of the clinical research ethics committee of başkent university (ka21/353), 70 patients with asa i-ii, between the ages of 18-75, who were scheduled for mastectomy surgery were included in the study. a 4. year anesthesiology resident under the supervision of two senior anesthesiologists, performed a pecs ii block with ai-integrated usg or conventional usg (group ai-usg and group usg) after randomization. although the resident had no experience with pectoral blocks, she had experience with the use of usg and regional anesthesia related to other trunk-area and peripheral blocks. the block was performed after induction of general anesthesia. patient data in terms of hemodynamic changes in the intraoperative period, opioid (remifentanil) consumption, and postoperatively hemodynamics, pain scores (vas), postoperative opioid \[tramadol administered with a patient-controlled analgesia pump (pca)\] and, if necessary, rescue analgesic agent (non-steroidal antiinflammatory agent) consumption were monitored in the post anesthesia care unit (pacu), and at postoperative 6., 12. and 24.hours.

Eligibility criteria:
inclusion criteria: * 18-70 years * asa i and ii * female * underwent mastectomy surgery * without local anesthetic allergy exclusion criteria: * patients with asa iii and above * obesity (body mass index \>30) * psychotropic drug use * bleeding diathesis * local anesthetic allergy * chest wall deformity * infection at the injection site * chronic analgesic usage

Keywords: mastectomy pectoral nerve block usg artificial intelligence
a bioavailability study of two different peg-rhgh preparations.

Conditions: Pediatric Growth Hormone Deficiency (PGHD)

Summary: the purpose of this study is to compare the pharmacokinetics of the two different peg-rhgh preparations.


Eligibility criteria:
inclusion criteria: * healthy male aged ≥18 years old and≤45 years old; * the body mass index (bmi): 19-26 kg/m2 (inclusive), and body weight ≥50 kg; * normal results of physical examination, vital signs, laboratory tests, 12 lead-ecg, chest x-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above. exclusion criteria: * subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; * subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators; * subjects with severe infection, severe trauma, or major surgery prior to screening; * subjects who have received blood transfusions, had blood donors, or lost blood before screening; * subjects who have positive results of human immunodeficiency virus antibodies (hiv-ab), or hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv-ab), or syphilis specific antibodies (tppa); * subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
bax 802 in cha with inhibitors

Conditions: Hemophilia A

Summary: the purpose of this study is to evaluate the efficacy and safety of bax 802 in males with congenital hemophilia a (cha) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.


Eligibility criteria:
inclusion criteria 1. participant requires a major or minor elective surgical, dental or other invasive procedure 2. participant is male and ≥ 12 to ≤ 75 years old at the time of screening 3. participant has provided signed informed consent (and assent for adolescent participants, as applicable) in accordance with local regulatory requirements 4. participant has severe (factor viii (fviii) level \< 1%) or moderately severe (fviii level ≤ 2%) congenital hemophilia a (cha) with inhibitors to human factor viii (hfviii) of ≥ 0.6 bethesda units (bu), as tested at screening at the central laboratory 5. participant is not currently receiving or has recently received (\< 30 days) immune tolerance induction (iti) therapy 6. participant has a karnofsky performance score of ≥ 60 at screening 7. participant is human immunodeficiency virus negative (hiv-); or hiv+ with stable disease and cd4+ count ≥ 200 cells/mm\^3 at screening 8. participant is hepatitis c virus negative (hcv-) by antibody or polymerase chain reaction (pcr) testing; or hcv+ with chronic stable hepatitis disease. positive serologies will be confirmed by pcr testing. 9. participant is willing and able to comply with the requirements of the protocol. exclusion criteria 1. the participant requires emergency surgery 2. severe chronic liver dysfunction or disease (e.g., ≥ 5 × upper limit of normal \[uln\] alanine aminotransferase \[alt\], as confirmed by central laboratory at screening or a documented prothrombin time/international normalized ratio \[pt/inr\] \> 1.5) 3. clinically symptomatic renal disease (serum creatinine \> 2.0 mg/dl), as confirmed by central laboratory at screening 4. anti-porcine factor viii (pfviii) inhibitor \> 10 bu prior to surgery 5. platelet count \< 100,000/μl at screening 6. participant has another active coagulation disorder, other than hemophilia a, as per the medical history 7. planned use of α-interferon with or without ribavirin for hcv infected patients or planned use of a protease inhibitor for hiv infected patients. patients currently taking any of these medications for ≥ 30 days are eligible 8. known hypersensitivity to recombinant porcine factor viii (rpfviii), or hamster or murine proteins 9. participant has an ongoing or recent (within 3 months of screening) thrombo-embolic disease, fibrinolysis or disseminated intravascular coagulation (dic) 10. participant has been exposed to an ip within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product (ip) or investigational device during the course of this study 11. participant is unable to tolerate quantity of blood to be drawn for protocol procedures 12. participant is a family member or employee of the investigator.
transplanting lungs from uncontrolled donation after circulatory death

Conditions: Lung Transplantation

Summary: the study team developed an uncontrolled donation after circulatory death (udcd) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (peep) and supplemental oxygen. the study will assess lung udcd program safety by continuous review of operations/clinical records from each case activation and transplantation. attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (evlp) performance testing, and lung transplantation. planned viability assessments also include macroscopic determination, radiology (x-ray), and fiber optic bronchoscopy before initiating evlp. we expect \~50% of lungs assessed with evlp will be transplanted to meet sustainability targets. safety outcomes include the primary outcome, primary graft dysfunction (pgd) grade iii at 72 hours, and secondarily survival one year after transplantation.


Eligibility criteria:
inclusion criteria: * patients waiting for lung transplants * willing to participate in the research study exclusion criteria: * unable to be followed for 1 year after transplantation * unable to provide written informed consent to participate in the research (or designate a surrogate)
hirschsprung disease trends in the united states: analysis of the national inpatient sample

Conditions: Hirschsprung Disease

Summary: hirschsprung disease (hd) is associated with significant morbidities including long-term bowel dysfunction. the aim of this study was to update national and regional trends in the epidemiology and inpatient care utilization of hd in the united states between 2009 and 2014 using the national inpatient sample (nis).

hirschsprung disease (hd) is a congenital condition characterized by the absence of ganglion cells in the myenteric and submucosal plexuses of the distal intestine, which results in lack of peristalsis and functional intestinal obstruction. the aganglionosis involves the rectum or rectosigmoid in most cases, but it can extend for varying lengths, and in 5-10% of cases can involve the entire colon or even a significant amount of the small intestine. the incidence of this disease is approximately 1 in 5000 live births and is approximately three times more common in males. hd is a multifactorial disease caused by both genetic and environmental factors, and hd may also be part of a syndrome, most commonly trisomy 21. the principal purpose of surgical management of hd is to remove aganglionic bowel and reconstruct the intestinal tract by connecting the normally innervated bowel just above the anus so that normal sphincter function is preserved. over the last decades, surgical management has changed from original three-stage approach to recent introduction of minimally invasive one-stage procedures, which appears to be safe, and facilitates early feeding and discharge. although surgical treatment definitively removes the histologically defined pathological intestinal segment, many patients with hd continue to experience bowel dysfunction, obstructive symptoms and recurrent enterocolitis requiring frequent hospitalizations. huang et al had shown that hd discharges, associated demographics, and numbers of pull-through procedures remained stable from 1997 to 2006. there is a paucity in the literature regarding cost components associated with care of hospitalized patients with the primary diagnosis of hd. an information update regarding inpatient care utilization for hd is needed to better understand current hd disease burden and inpatient care practice. the primary objective of this study was to analyze cost of hd-related admissions in the united states between 2009 and 2014 using the national inpatient sample (nis) database. secondary objectives were to update national and regional trends in the epidemiology of hd related hospital utilization, and to examine changing demographics, hospital mortality and length of hospital stay (los) in these hd patients.

Eligibility criteria:
inclusion criteria: * we included all patients who were 18 years or younger with an icd-9-cm code of 751.3 for hd among the first 10 diagnosis. exclusion criteria: * data from 2015 to 2018 were not included since diagnoses and procedures were reported using the icd-10-cm coding system.
genasense as a 2-hour intravenous infusion in subjects with solid tumors

Conditions: Solid Tumors

Summary: the primary objective is to determine the safety and maximum tolerated dose (mtd) of genasense administered as a 2-hour intravenous infusion once weekly (part 1) and twice weekly (part 2) to patients with solid tumors.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available * adequate organ function as determined ≤ 7 days prior to starting study medication * eastern cooperative oncology group performance status 0 to 2 * at least 3 weeks and recovery from effects of major prior surgery or other therapy, including chemotherapy, radiation therapy, immunotherapy, or cytokine, biologic, or vaccine therapy exclusion criteria * other significant medical disease * history or presence of leptomeningeal disease * coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function * pregnant or lactating

Keywords: genasense oblimersen antisense bcl-2 antisense solid tumors
survivorship care planning in improving the quality of life in breast cancer survivors

Conditions: Breast Cancer; Cancer Survivor

Summary: this randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors.

primary objectives: i. test the effectiveness of the navigation intervention and survivorship care plan (scp)-breast cancer survivors (bcs) template booklet on accessing and adhering to scp-bcs guidelines compared to the control group receiving usual care and the scp-bcs template booklet. secondary objectives: i. develop a clinically and psychosocially responsive scp-breast cancer survivors (scp-bcs) template in english and english-spanish adopted from american society of clinical oncology (asco)-scp. ii. assess the acceptability, utility and format preference (electronic vs paper) of the scp-bcs template. outline: participants are randomized to 1 of 2 arms. arm i: participants receive scp-bcs template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions. arm ii: participants receive scp-bcs template booklet and receive standard follow-up care. after completion so study treatment, participants are followed up at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * in early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (bca) * reside in southern california * bcs treated at kaiser, an health maintenance organization (hmo) provider, will be excluded since their scp implementation project is underway * bcs will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes