Kornimate/medical-research-clean huggingface dataset:
safety of buprenorphine transdermal systems in subjects with chronic nonmalignant pain - a 28-week extension study

Conditions: Chronic Nonmalignant Pain

Summary: the objective of this study was to evaluate the long-term safety and tolerability of 7-day btds in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

upon entering the extension phase (bup3201s), subjects will receive btds 5, regardless of their dose level at discontinuation or completion of the bup3201 core study. subjects are allowed to titrate after 48 hours to btds 10 or 20 that provided stable pain control with minimal tolerability problems. additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. the subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.

Eligibility criteria:
inclusion criteria: include: * subjects of either sex aged 18 years or older. * subjects who have completed or discontinued the double-blind evaluation phase of study bup3201 are eligible to continue to receive open-label btds in the extension. exclusion criteria: include: * subjects currently receiving daily morphine or oxycodone (mono-therapy). * subjects who are discontinued from bup3201 due to adverse events. * subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period. refer to core study for additional inclusion/exclusion information.

Keywords: chronic nonmalignant pain opioid transdermal butrans (btds)
anti-pd-1 in combination with chemotherapy as first-line treatment to lung cancer

Conditions: Locally Advanced Lung Cancer; Metastatic Lung Cancer

Summary: this is a phase ii, open-label, 4-cohort study of the monoclonal antibody bgb-a317 in combination with standard platinum-based chemotherapy in participants with advanced nsclc or sclc. the 4 cohorts will be enrolled concurrently including non-squamous nsclc cohort, squamous nsclc cohort a, squamous nsclc cohort b and sclc cohort. participants with a mixed adenocarcinoma and squamous cell nsclc will be allocated to one of the nsclc cohorts based on the predominant histopathological profile. (e.g., participants with adenocarcinoma component accounting for \> 50% will be allocated to non-squamous nsclc cohort.). participants with squamous nsclc will be sequentially enrolled into either of the 2 squamous nsclc cohorts by the trial stage i.e. the sequence of the enrollment for the squamous nsclc cohorts will be as cohort a safety run-in stage, followed by cohort b safety run-in stage, cohort a dose-expansion stage and cohort b dose-expansion stage.


Eligibility criteria:
key inclusion criteria: 1. male or female, aged 18-75 years on the day of signing informed consent. 2. have histologically or cytologically confirmed locally advanced or metastatic non-squamous nsclc, squamous nsclc, or extensive-stage sclc. note: participants with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors. 3. have had no prior systemic therapy for advanced or metastatic disease. prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease. 4. participants must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded \[ffpe\] blocks or at least 10 unstained ffpe slides) with an associated pathological report. key exclusion criteria: 1. participants with a sensitizing mutation in egfr gene or an alk fusion oncogene (specifically for participants with non- squamous nsclc). participants with unknown mutation/fusion status of egfr and/or alk must take the respective test at the investigational sites (or other designated sites) prior to enrolment. 2. prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast 3. prior therapies targeting pd-1, pd-l1 or pd-l2 note: other protocol defined inclusion/exclusion criteria may apply.
electrical impedance myography as an outcome measure in amyotrophic lateral sclerosis clinical trials

Conditions: Amyotrophic Lateral Sclerosis

Summary: trials evaluating new therapies for stopping or slowing the progression of als depend critically upon the use of outcome measures to assess whether a potential treatment is effective. the more effective an outcome measure, the fewer patients need to be enrolled and the shorter the trial. many outcome measures have been used over the years, including strength assessments, breathing tests, functional status surveys, and nerve testing, but all are far from ideal. a new method, called electrical impedance myography (eim) appears to be especially promising in that it provides very consistent data from one testing session to the next, is sensitive to the muscle deterioration that occurs in als, and is entirely painless and non-invasive. in this study, investigators from multiple institutions plan to compare several different outcome measures, including eim, in approximately 120 als patients, with each patient being followed for a period of one year. all of these measures will be compared to one another and an assessment of their ability to detect disease progression made. our goal will be to determine whether eim can serve as a valuable new outcome measure, ultimately leading to substantially faster, more effective als trials requiring fewer patients.


Eligibility criteria:
inclusion criteria: * definite or probably als by el escorial criteria * muscle strength of at 3.5 in one limb exclusion criteria: * forced vital capacity of less than 70% * atypical forms of motor neuron disease (monomelic amyotrophy, primary lateral sclerosis) * pacemaker

Keywords: amyotrophic lateral sclerosis motor neuron disease outcome measure biomarker impedance
implementation of a diagnostic workflow for personalized diagnosis of nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: nephrotic syndrome (ns) is a clinical picture common to several diseases resulting from damage to podocytes and glomerular filtration barrier. currently, there is limited consensus regarding the diagnostic pathway and management of the specific etiology. some patients show complete response to first-line steroid therapy (steroid-sensitive nephrotic syndrome, ssns), especially in children and young adults. the prognosis of this group is generally favorable. in contrast, patients unresponsive to steroids (steroid-resistant ns, srns) frequently undergo immunosuppressive therapies, which are burdened with numerous side effects. resistance to treatment is associated with a high likelihood of progression to chronic renal disease (ckd) and kidney failure (eskd). recent evidence suggests that immunological mechanisms (including permeabilizing factors) are involved in the pathogenesis of post-transplant ns recurrence and ssns. providing patients with ns with a correct diagnosis is the cornerstone of personalized medicine, reducing morbidity and side effects of therapies, ensuring their appropriate prescription, and slowing or preventing progression to eskd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ns (ssns, srns, or ns relapsed after transplantation regardless of initial response to steroid therapy) * age below 40 years at disease onset * availability of clinical information * signed informed consent form exclusion criteria: * age at onset above 40 years * kidney biopsy proving lesions other than fsgs and mcd
relative-dose-response test (rdr) adaptation for chronic liver disease

Conditions: Chronic Liver Disease

Summary: the relative-dose-response test (rdr) is considered to be the most accurate method for evaluating vitamin a nutritional status (vans) in patients suffering from liver disease, as it infers the reserves of the vitamin in the liver. however, for the rdr test to reflect vans in patients suffering from chronic liver disease, factors inherent to the disease need to be considered, such as possible malabsorption, advanced age, a drop in synthesis and/or the release of retinol binding protein (rbp), which would result in an inadequate response to the rdr test. thus, the objective of present study is to assess the adequacy of two different protocol for using the rdr test in patients with cirrhosis and cirrhosis-related hepatocellular carcinoma. methods: the sample group was comprised of 178 patients at federal university of rio de janeiro university hospital (111 men) with several etiologies of liver cirrhosis at different stages in the progression of the disease. they were sorted into two groups, according to the retinyl palmitate dosage (1500 iu or 2500 iu) received at t0 (blood sample taken following a 12-hour fast). following supplementation, the investigators took further blood samples five and seven hours later (t5 and t7). the investigators assessed vans via concentrations of serum retinol and rbp, as well as by way of the rdr test. the cutoff points the investigators used for denoting inadequacy in the indicators retinol and rdr were, respectively, \< 1.05 µmol/l and ≥ 20%. to classify the degrees of severity of the disease the investigators used the criteria established by child \& pugh (1973).


Eligibility criteria:
inclusion criteria: * diagnosis of liver cirrhosis of viral etiology, alcoholic or metabolic action exclusion criteria: * malabsorption syndromes * moderate or severe infection * diabetes mellitus using insulin renal, cardiac or respiratory * therapeutic doses of vitamin a in the 6 months prior to data collection

Keywords: chronic liver disease cirrhosis vitamin a rdr test retinol-binding protein
diagnostic laparoscopy for unexplained abdominal pain

Conditions: Abdominal Pain

Summary: to evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories in general surgery depatment assuit university hospital

abdominal pain may be a simple thing or it may be a dangerous and life threatening one.it is very difficult to come to a correct diagnosis(1).diagnostic laparoscopy gives many advantages in the management of many intra-abdominal conditions where the correct diagnosis could not establish clinically or even with the help of imaging studies(2).diagnostic laparoscopy can be done under direct vision using simple instruments of laparoscopy. with advances in optics, laparoscopy allows visualization of entire peritoneal cavity and further makes possible histological diagnosis of target biopsy under vision(3).in case of diagnostic uncertainty, laparoscopy may help to avoid unnecessary laparotomy, provides accurate diagnosis, helps to plan surgical treatment, improves the outcome in the majority of patients with abdominal pain and allows surgeons to diagnose and treat many abdominal conditions that cannot be properly managed otherwise(4).many factors like high diagnostic yield, its applicability and therapeutic management in both elective and emergency setups, reduced hospital stay, low morbidity, and expenditure have made this treatment modality most popular(5). on the otherhand there are complications related to laparoscopic surgery up to one-half of complications occur at the time of abdominal access for camera or port placement , others arise from abdominal insufflation, tissue dissection, and hemostasis .conversion to an open procedure may be needed to manage complications (6).recent treatises deficient in evalution of the role of lap in cases with vague abdominal pain for this the interest of our study is to evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories.

Eligibility criteria:
inclusion criteria: * patients with obscure abdominal pain * age from 18 years old up to 70 years old exclusion criteria: 1. current use of narcotics 2. patients have uncontrolled coagulopathy 3. patients are haemodynamically unstable 4. patients have cardiopulmonary problems 5. patients refusing the diagnostic laparoscopy after routine investigations
a multi-centre, comparative, double blind, randomised cross-over trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia a


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * ongoing participation in pathfinder™2 * male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements) exclusion criteria: * fviii inhibitors (≥0.6 bu) at last visit in pathfinder™2 prior to entry in pathfinder™7 * planned surgery during the trial * major surgery performed within 4 weeks prior to screening * previous participation in this trial. participation is defined as signed informed consent * any disorder, except for conditions associated with haemophilia a, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
repetitive trans-cranial magnetic stimulation of the motor cortex in fibromyalgia: a study evaluating the clinical efficiency and the metabolic correlate in 18fdg-pet

Conditions: Fibromyalgia

Summary: fibromyalgia (fm) syndrome is a chronic pain condition.repetitive trans-cranial magnetic stimulation (rtms) was thus suggested in this indication.

we recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. these results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe fm.

Eligibility criteria:
inclusion criteria: * female or male patient, aged from 18 to 65 years * patient presenting a primary fibromyalgia answering the criteria of the acr * at present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10 * patient presenting a stable treatment since at least 1 less exclusion criteria: * patient minor * pregnant woman * women in age to procreate without contraception * patient deprived of freedom further to a court or administrative order * patient presenting a secondary fibromyalgia
acute lung injury in children: epidemiology and natural history. pediatric alien.

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

Summary: the investigators propose to perform a one-year prospective audit of all acute lung injury (ali)and cute respiratory distress syndrome (ards) pediatric patients managed in several icus in spain. the investigators intend to collect data from all children (from 1 month to 18 years of age) admitted with or developing ali/ards with the aim to understand the epidemiology and natural history of acute lung injury in the pediatric setting. these icus are scattered through the spain and are representative of the demographic differences across the country.

acute lung injury (ali) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary edema manifested clinically by hypoxemia (pao2/fio2≤300 mmhg) and bilateral pulmonary infiltrates. when the hypoxemia is severe (pao2/fio2≤200 mmhg) it is termed the acute respiratory distress syndrome (ards). it represents a significant public health issue. patients with ali or ards require admission into critical care units for advanced life support and utilize considerable health care resources. an immense plethora of translational knowledge has been acquired since the first description of ards in 1967. at the present, estimates of the incidence of ards and ali in children are unknown. in adults, the estimates of ali/ards incidence have varied widely, and the true magnitude of this health problem still remains unclear. current estimates of the incidence of adult ali/ards range from 15 to 80 cases per 100.000 population, or almost 40.000 cases per year in spain. combined mortality rates for adult ali/ards range between 30-45% but it is not clear whether this figures can be translated in the pediatric population. ali and ards occur as a complication or as the primary cause of critical illness in patients, usually after severe infection or trauma. published epidemiological studies on ali and ards in the last 20 years are difficult to compare. some reports have used different definitions for ali and ards and others have evaluated the incidence during a short period of time (from days to several weeks) and then extrapolated their data to estimates of a one-year incidence. very few studies have collected information for an entire year, and none of them have evaluated the degree of hypoxemia under standard ventilatory settings, as it has been proposed recently by the help network (am j respir crit care med 2007; 176:795-804).

Eligibility criteria:
inclusion criteria: * all patients, age ranging from 1 month to 15 years old * must be able to meet the american european consensus definition of ali and ards(no indication of heart failure or a pulmonary capillary wedge pressure of greater than 18 mmhg, with pulmonary infiltrates in all four quadrants and a pao2/fio2 of \> 200 to \<300 mmhg (ali) or ? 200 mmhg (ards). exclusion criteria: * younger than 1 month or older than 15 years old * cardiac disease

Keywords: ali sdra
plasma free amino acids in patients with hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: this is study to investigate the plasma free amino acids profile in patients with decompensated liver cirrhosis and hepatic encephalopathy and its relation to the nutritional state of these patients. * to investigate the plasma free amino acids relation to the nutritional state of patients with liver cirrhosis and hepatic encephalopathy. * to determine the effectiveness, cost, cost-benefit and in-hospital prognosis of branched chain amino acid (bcaa) infusion as an adjuvant to conventional mainstay therapy in the treatment of hepatic encephalopathy due to liver cirrhosis. * to determine the effectiveness of branched chain amino acid (bcaa) infusion on improving amino acid imbalance and fischer ratio (branched chain amino acids/aromatic amino acids ratio).

alterations in amino acid profiles observed in patients with liver cirrhosis are very specific and markedly differ from those observed in other disorders.. until present time the treatment of hepatic encephalopathy is mainly aimed at reducing the production and intestinal absorption of ammonia by antibiotics and non-absorbable disaccharides, although the available data indicate a low success rate of these strategies. beneficial effects of branched chain amino acids supplementation (bcaa) may be more pronounced in patients with marked depression of bcaa and/or low branched chain amino acids/aromatic amino acids (bcaa/aaa) ratio in extracellular fluid. it also may be suggested that the beneficial effect of long term intake of bcaa on hepatic encephalopathy demonstrated in clinical studies is related to improved muscle mass and nutritional status. the current recommendation only includes oral bcaa to patients with liver disease who are intolerant to standard protein intake. the rationale for this limitation is based on the fact that in the mentioned randomized trials, hepatic encephalopathy was not part of the inclusion criteria. additionally, the positive effect was difficult to interpret as it was observed on compound end points, which combine survival, hospitalization, and cirrhosis complications. from these results, it is not possible to ascertain the role of bcaa in hepatic encephalopathy, which patients benefit and to what extent . for this reason, the investigators designed this study to assess effectiveness of bcaa in improving clinical, nutritional and laboratory status of these patients.

Eligibility criteria:
inclusion criteria: * patient has decompensated liver cirrhosis * patient has overt hepatic encephalopathy exclusion criteria: 1. protein losing enteropathy. 2. neurological conditions that make the assessment of hepatic encephalopathy difficult 1. parkinson's disease 2. alzheimer's disease 3. concomitant stroke 3. gastrointestinal bleeding requiring blood transfusion -

Keywords: plasma free amino acids
negative pressure wound therapy registry

Conditions: Diabetic Foot Ulcers; Venous Stasis Ulcer; Pressure Ulcer; Surgical Wound Dehiscence; Burns; Other Types of Chronic Non Healing Wounds

Summary: the goal of the negative pressure wound therapy registry (npwtr) for wounds is to provide real world patient data from electronic health records submitted to meet stage 2 meaningful use in order to understand the effectiveness and safety of various npwt devices and methods among patients with chronic wounds and ulcers. randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these randomized controlled trials (rcts) tend to be non-generalizable. little is known about the effectiveness of npwt among typical patients. patient registries are also ideal for assessing long term safety issues in these devices.

the purpose of the negative pressure wound therapy registry (npwtr)) for wounds and ulcers is to provide comparative effectiveness data on npwt including different npwt devices, and safety data on npwt (e.g. the frequency of adverse events experienced by typical npwt patients). npwt promotes wound healing by applying a vacuum through a special sealed dressing. the mechanical micro-deformation of the wound bed in response to suction has been shown to stimulate and accelerate the formation of new blood vessels (angiogenesis). the continuous vacuum removes fluid and reduces edema, thereby increasing tissue oxygen levels. the vacuum may be applied continuously or intermittently, depending on the type of wound being treated and the clinical objectives. depending on the npwt device, a variety of dressings are placed into the wound bed in conjunction with npwt, and a variety of suction pressures may be applied. the diversity of npwt devices and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. effectiveness in real world patients is the best current option to understand the role of npwt in wound healing. hospital based outpatient wound centers participating in the us wound registry agree to provide data as part of quality initiatives including participation in pqrs, and to meet their stage 2 meaningful use criteria. the npwtr is a subset of the uswr (chronic disease registry) data. all patient data from all participating outpatient clinics are transmitted to the uswr where data are available for benchmarking, pqrs and other initiatives. data used for comparative effectiveness research is hipaa de-identified.

Eligibility criteria:
inclusion criteria: * provision of npwt exclusion criteria: * patients not undergoing npwt

Keywords: meaningful use electronic health records structured language npwt pqrs