Kornimate/medical-research-clean huggingface dataset:
an open label study to evaluate safety, tolerability and clinical utility of ultracet® (37.5mg tramadol hydrochloride/325mg acetaminophen) for the treatment of breakthrough pain in cancer patients

Conditions: Pain

Summary: the purpose of this study is to evaluate the analgesic effectiveness and safety of 37.5mg tramadol hydrochloride/325mg acetaminophen in the treatment of breakthrough pain in cancer patients.

the combination of tramadol hci/acetaminophen provides a more rapid onset of action compared to tramadol hci alone and a longer duration of action than acetaminophen alone. therefore, the combination of tramadol and acetaminophen may be effective for the treatment of cancer pain as well as to allow lower cumulative daily dosages of each medication to be used.this is an open-label study. patients will receive one-dose treatment of 37.5mg tramadol/325mg acetaminophen tablets.this study has been designed to investigate the following hypothesis:tramadol hydrochloride/acetaminophen is effective in the treatment of breakthrough pain in cancer patients.the patients will complete basic questions on side effect at visits on entry, 10, 30 mins, and 1h. the patients will receive only one dose treatment of tramadol hydrochloride/acetaminophen oral tablets throughout the study. the number of oral tablets be given will be depend on the total daily dose of around-clock medications. if around-clock medication is tramadol \ =25 ug/hr, the breakthrough pain medication will be 2 tablets.

Eligibility criteria:
inclusion criteria: * patients with a histologically, radiologically or haematologically confirmed malignancy whose pain is judged by the investigator to be caused by the malignancy * patients must have been on a stable daily dose of weak opioids or strong opioids for at least 72 hours prior to the start the study and must remain at the same dosage for the duration of the study * patients must have a vas (visual analog scale) \>=40mm exclusion criteria: * patients who have taken either morphine with daily dose more than 120mg or fentanyl with daily dose more than 50ug/hr * patients with significant abnormalities in hepatic or renal function which would, in the opinion of the investigator, prevent the patients involvement in the study * patients with significant clinical abnormalities in cns, respiratory or cardiovascular function, which in the investigators judgement prevents participation in the study * patients who have taken antidepressants or anti-epileptic drugs, sedative hypnotics, selective serotonin reuptake inhibitor, short-acting analgesics, topical medications and anesthetics and/or muscle relaxants when taking tramadol/acetaminophen

Keywords: cancer pain breakthrough pain acetaminophen tramadol hydrochloride ultracet
housing, environment, and living conditions for transformed health

Conditions: Lung Diseases; Chronic Disease

Summary: this project will compare the health effects of public housing renovation, neighborhood built and social environment improvements, and indoor air purification, alone and in combination, as well as the cost effectiveness of each approach. study 1: the study will assess the effects of public housing and neighborhood environment (built and social) improvements on health-related behaviors, psychosocial and physiologic stress, and self-reported and physiological markers of lung health and chronic disease. study 2: the study will determine whether indoor air purification can positively impact lung health in public housing sites not undergoing housing renovation, comparing a site near industrial pollution vs one less contaminated.

participants will complete surveys, physical exam, lung function tests, and blood draw. an indoor air purifier with a usage tracker and an indoor air quality monitor will be provided, and used filters will be analyzed.

Eligibility criteria:
inclusion criteria: * adults age 18 years and older * english speaking * residents of one of 4 public housing site in birmingham, alabama exclusion criteria: * individuals who are not 18 years or older * do not speak english * do not meet the residency criteria

Keywords: lung health chronic disease
artificial intelligence in lung cancer screening

Conditions: Lung Cancer Screening; Asbestos

Summary: single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.

the project we propose is a study whose objective was to develop an artificial intelligence program integrated into a web-based platform for the optimization of the performance of lung cancer screening for the diagnosis of lung nodules and risk stratification in subjects exposed to environmental carcinogens and/or cigarette smoke. inclusion criteria: age \&gt; 50; smokers for at least 20 pack-years (20 cigarillos a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos; absence of lung cancer symptoms; who performed lung cancer screening after the year 2000 upon approval of the study by the relevant ec.

Eligibility criteria:
inclusion criteria: * age \&gt; 50 years; * smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago; * and/or previous professional exposure to asbestos; * absence of lung cancer symptoms; * who performed lung cancer screening after the year 2000 upon approval of the study by the relevant etical committee exclusion criteria: * age \&lt; 50 years * never smokers * lung cancer symptoms

Keywords: artificial intelligence asbestos lung cancer screening
performance of rpa-lf for cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis (Diagnosis)

Summary: cl is public health in the americas, diagnostic confirmation is required to start treatment, however current diagnostic methods have several limitations and its access is limited. technical requirements of conventional molecular diagnostics and costs preclude their routine use in primary care facilities in rural areas. a recently developed method of isothermal recombinase polymerase amplification (rpa) targeting leishmania kinetoplast dna, has shown high accuracy in detecting leishmania viannia spp. we evaluated the diagnostic performance of the rpa-lf test in a laboratory reference center and field scenario with community participation.

cl is public health in the americas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries, which mainly occur in rural areas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries. diagnostic confirmation is required to start treatment, however current diagnostic methods have several limitations, and sometimes it is necessary to perform confirmatory tests that are not available in endemic areas. several molecular diagnostic tests have been developed for the diagnosis of cl, however, the technical requirements and costs of sample processing by conventional or quantitative pcr preclude their routine use in primary care facilities in resource-constrained settings. a recently developed method of isothermal recombinase polymerase amplification (rpa) targeting leishmania kinetoplast dna, coupled with lateral flow (lf) immunochromatographic strip has shown high accuracy in detecting leishmania viannia spp. we evaluated the diagnostic performance of rpa-lf test in two scenarios: laboratory reference center and field with community participation.

Eligibility criteria:
inclusion criteria: * men or women with 2 years of age and over of any ethnic group * ulcerated skin lesions compatible with cutaneous leishmaniasis with two or more weeks of duration * approval of informed consent exclusion criteria: * mucosal leishmaniasis * clinical presentations of cutaneous leishmaniasis different of ulcerated lesions
bicycle exercise echocardiography to assess physiological significance of mitral annular calcification

Conditions: Mitral Annulus Calcification

Summary: many people develop calcium deposits in the heart as they get older. one of the common places for this to occur is the mitral annulus, the band of tissue that supports the mitral valve (one of four heart valves). the purpose of this study is to examine effects of these deposits (termed mitral annular calcification or "mac") on a person's ability to perform exercise. the research team will use ultrasound of the heart (doppler echocardiography) to study people with mac while they exercise on a specially designed bicycle.

mitral annular calcification (mac) involves build-up of calcium in the mitral annulus, the fibro-muscular band which supports the mitral valve. the annulus aids in valve function, contracting in early systole (contraction phase) and bringing the valve leaflets together. in diastole (filling phase) it enlarges allowing blood to flow freely across the valve. calcification stiffens the annulus and can extend onto the valve leaflets stiffening them. when severe, mac impairs flow across the valve (mitral stenosis). this is characterized by a pressure gradient across the valve which can be detected by doppler echocardiography (ultrasound). routine doppler echocardiography is performed at rest when heart rates and flow across the mitral valve are low. thus, even with severe mac, there may only be a small pressure gradient present. however, with exercise these gradients can rise rapidly, leading to symptoms such as fatigue and shortness of breath. mac is associated with aging and is becoming more prevalent. our hypothesis is that mac is a common cause of shortness of breath with exertion. further, the investigator believes this is under-appreciated because routine doppler echocardiograms are done at rest. therefore, the investigator will study adult subjects with moderate to severe mac during bicycle exercise. doppler echocardiography will be used to measure both the resting gradient across the mitral valve and changes with exercise. symptoms will be measured by borg perceived exertion scale. if the research team is successful, the research team expects to demonstrate convincingly that this commonly encountered finding on doppler echocardiography is an important cause of patient symptoms.

Eligibility criteria:
inclusion criteria: * at least moderate mitral annular calcification as judged by a previously published semi-quantitative echocardiographic score * over 18 years of age * able to use the semi-supine exercise bicycle * should be able to give informed consent. exclusion criteria: * oxygen dependent lung or cardiac disease * moderate or greater aortic valvular disease * moderate or greater mitral regurgitation * reduced left ventricular ejection fraction, \<35% * any diagnosed coronary disease * a resting mean gradient of ≥10 mmhg across the mitral valve.
gastric pacemaker implantation for gastroparesis

Conditions: Gastroparesis

Summary: gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

due to hud status, this protocol is for implant only. this is not a clinical trial.

Eligibility criteria:
inclusion criteria: * used only if patients have tried and failed conventional treatment ( drug therapy and dietary modification)due to intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Keywords: gastroparesis gastric electrical stimulator
study to evaluate tumour response in cancer patients with advanced hepatocellular carcinoma (liver cancer) with amt2003

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the study is to evaluate the efficacy and the safety of amt2003 in cancer patients with advanced primary hepatocellular carcinoma the primary endpoint is best overall response rate within 20 weeks after registration

the study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists. the best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.

Eligibility criteria:
inclusion criteria: * cancer confirmed by histology or cytology * at least one measurable lesion * advanced disease refractory to standard therapy or for which no standard therapy exists * life expectancy of at least 3 months exclusion criteria: * known secondary neoplasia or central nervous system (cns) metastases; acute or chronic leukemia, lymphoma or multiple myeloma * body weight below 45 kg * female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control * confirmed diagnosis of hiv * insulin dependent diabetes mellitus / abnormal glucose tolerance test (gtt) / latent diabetes mellitus type i or ii * chemotherapy or radiotherapy less than 4 weeks prior to entry * surgery less than 2 weeks prior to entry (or not recovered from effects of surgery) * participation in a clinical trial less than 30 days prior to entry into study

Keywords: primary hepatocellular carcinoma liver cancer tumour response quality of life
compare bosutinib to imatinib in subjects with newly diagnosed chronic phase philadelphia chromosome positive cml

Conditions: Chronic Myeloid Leukemia

Summary: two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase chronic myelogenous leukemia (cml). the primary endpoint is cytogenetic response rate at one year.


Eligibility criteria:
inclusion criteria: * cytogenetic diagnosis of chronic phase ph+ cml diagnosed less than 6 months. * diagnosis of cml chronic phase confirmed. * adequate hepatic and renal function. * able to take oral tablets. exclusion criteria: * exclusions include philadelphia negative cml. * prior anti-leukemia treatment. * prior stem cell transplant.

Keywords: bosutinib imatinib cml
interventional study exploring the occurrence of surgical site infections.

Conditions: Total Knee Arthroplasty; Total Hip Arthroplasty Revision; Total Knee Arthroplasty Revision

Summary: interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing tka or tha using npwt.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. patient ≥ 18 years 3. elective unilateral revision tha or tka. 4. high risk patients for surgical wound complications as deemed by investigators 5. primary closure technique by suture or staples 6. linear or curvilinear incisions ≤ 25 cm in length 7. the patient able to understand the study and is willing to consent to the clinical investigation 8. patients able to understand how to operate with the negative pressure system at home exclusion criteria: 1. the need for emergency surgery 2. multiple incision approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted) 3. patients requiring bilateral revision total hip or knee arthroplasty surgery 4. active infections of the offending joint. 5. history of multiple infections in the offending joint 6. patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and superabsorbent powders (polyacrylates) (within the dressing) 7. subjects with contraindications (as per the avance solo instructions for use) 8. pregnant, breastfeeding females, or females of childbearing potential not willing to use contraception for the duration of the investigation 9. patients with presence of remote skin infection or active systemic infection at the time of revision surgery. 10. patient with incisions \> 25cm in length or type of incisions that cannot be sufficiently covered by avance solo border dressing (i.e., the wound pad does not overlap the edges of the incision by at least 1.5 cm as per the ifu) 11. use of surgical glue as part of incisional closure method 12. patients who in the opinion of the investigator may not complete or comply with follow up treatment for any reason 13. patients participating in ongoing clinical investigations, or during the past 30 days, that may impact the outcome of this investigation based on the judgement of the investigator. 14. any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study

Keywords: high risk tka revision high risk tha revision npwt
nutrition intervention to measure metabolic response in children

Conditions: Obesity, Childhood

Summary: the long-term objective of this study is to determine if habitual consumption of high-quality protein at breakfast will lead to improved energy metabolism and decreased daily energy intake in normal weight and overweight children. the investigators hypothesize that increasing protein intake at breakfast will improve energy metabolism and reduce energy intake throughout the day in overweight/obese school-aged children. the significance of the study is that improving nutrient intake at breakfast can potentially lead to a future reduction in childhood obesity rates.


Eligibility criteria:
inclusion criteria: * habitual breakfast consumer * no known medical issues exclusion criteria: * food allergies * medication * claustrophobic * dietary restrictions * picky eater (determined by parent/guardian)
angioplasty of left main - lariboisiere registry

Conditions: Coronary Artery Disease

Summary: in patients with unprotected left main disease (ulmd), angioplasty is emerging as an alternative technique. the investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ulmd in a "real world" registry.

current guidelines recommend coronary artery bypass graft surgery as the "gold standard" treatment in patients with unprotected left main disease. however, patients with ulmd and high surgical risk score or favourable anatomy are still referred for angioplasty. recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease. the aim of the study is to evaluate major cardiovascular events in a "real world" registry.

Eligibility criteria:
inclusion criteria: * stable or unstable angina and/or documented ischemia * 50% de novo ulmd referred for angioplasty exclusion criteria: * acute coronary syndrome with st elevation, * cardiogenic shock or out of hospital cardiac arrest

Keywords: left main, stent,angioplasty
comprehensive-care for multimorbid adults effectiveness study

Conditions: Chronic Disease

Summary: this study is intended to examine whether directed care of a nurse working jointly with the patient's primary care physician, including a comprehensive assessment, creation of a tailored care plan, proactive follow-up, self management support and caregiver support and care coordination, can reduce hospital admissions for patients with multiple chronic conditions.

patients with multi-morbidities pose a significant challenge for healthcare organizations because they require continuity of care among a wide range of long-term therapeutic paradigms for many different types of diseases. the current study is based on a treatment model entailing a nurse-primary care physician team to provide care for patients with multiple morbidities. patients in the intervention group who agreed and signed the consent form to participate in the study will receive treatment by the physician - nurse team in accordance with the components of the clalit's comprehensive care for mutlimorbid adults project model. components of the intervention include: 1. comprehensive assessment of the patient's and family's needs 2. coordinated care plan based on integrated care guides 3. "multimorbid action plan" for patients 4. all-inclussive patient centered care and caregiver support 5. proactive monitoring according to the plan. patients in the control groups will receive usual care in their primary care clinics. the usual care survey control group will complete study questionnaires at 6, 12 and 24 months after enrollement. the usual care blinded group will be assessed only retrospectively based on deidentified information from clalit's admistrative databases.

Eligibility criteria:
inclusion criteria: * acg system high risk probabilty score - 4% highest risk score * age 18 and older * 2 or more chronic conditions exclusion criteria: * patients already included in a controlled disease management program (e.g., copd disease management and telehealth). * participation in any medical research. * confined to bed. * inpatient nursing care, nursing homes. * kidney, liver or heart transplant patients. * active (receipt of oncology chemotherapy , radiotherapy or other oncology treatment during the past 3 years). * dialysis patients. * clalit healthcare services employees. * patients with major active mental illness, such as schizophrenia. * cognitive failure. * non hebrew speaking patients without hebrew speaking primary informal caregiver. * bedridden patients * housebound patients

Keywords: multimorbidity primary care physician - nurse team proactive monitoring support for self-care primary caregiver
effect of donor chose on the outcomes of gvhd prophylaxis underwent the combined treatment of atg/ptcy for haplo-hsct

Conditions: High-Risk Acute Myeloid Leukemia; Relapse And/or Refractory AML

Summary: this is a prospective, multicenter, cohort study. the high-risk, relapse and refractory aml patients were enrolled in this study. and the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (gvhd) prophylaxis underwent the combination of atg and ptcy for haploidentical peripheral blood stem cell transplantation


Eligibility criteria:
inclusion criteria: 1. acute myeloid leukemia was diagnosed according to the 2016eln criteria with any of the following: 1. eln prognostic stratification high-risk group (see appendix for criteria) 2. non-remission (nr) aml: including primary refractory aml and nr patients after relapse. 2. patients must have a suitable hematopoietic stem-cell donor. 1. patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy; 2. related donors had to be related donors matched 5/10-7/10 for hla-a, -b, -c, -dqb1 and -drb1 3. all the enrolled patients received a unified gvhd prevention regimen based on atg and ptcy exclusion criteria: 1. intermediate-low risk aml patients (eln criteria); 2. patients with extramedullary active lesions at the time of transplantation; 3. haploidentical collateral donors; 4. patients who refused allogeneic hematopoietic stem cell transplantation;