Kornimate/medical-research-clean huggingface dataset:
substudy : patients with an acute exacerbation of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a leading cause of morbidity and mortality worldwide. its prevalence is in progression and copd is expected to become the fourth leading cause of death by 2030. copd is characterized by periods of stability interspersed with acute infectious/inflammatory flare-ups, also called acute exacerbations, during which patients deteriorate, sometimes to the point of requiring immediate medical assistance. although most patients eventually recover, repeated episodes of exacerbations may accelerate copd progression. exacerbations may further compromise the integrity of limb muscles by promoting further loss in muscle mass and strength. the overall objective of this substudy is to elucidate how an acute copd exacerbation may affect limb muscles.

focusing our attention during exacerbations, a period of aggravated systemic inflammation, should be more rewarding in terms of understanding the link between inflammation burst and muscle disease in copd. we have recently acquired experimental data supporting a role for the ubiquitin proteasome pathway in the worsening of limb muscle structure and function during an acute exacerbation, providing a solid framework for this investigation. the overall objective of this proposal is to substantiate these preliminary findings and elucidate how systemic inflammation during acute copd exacerbation may affect limb muscles. ultimately, our research could open new therapeutic avenues to minimize the systemic consequences of an acute exacerbation.

Eligibility criteria:
inclusion criteria: * male and female * copd with an fev1 of under 60% of predicted * non-smoker * between 50 and 75 years old * experiencing an acute exacerbation of copd (24-48 hours, before treatment) exclusion criteria: * all inflammatory disease (hiv, cancer, renal and cardiac deficiency) * hormonal dysregulation * inferior limb pathology * neuromuscular pathology * history of tobacco or alcool abuse * oxygen dependent
group intervention for interpersonal trauma

Conditions: Post-Traumatic Stress Disorder; Depression

Summary: this study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.

the aim of this study is to assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder (ptsd) following interpersonal trauma exposure. group participants will be recruited from public sector/safety net primary care clinics. study participants will be randomized to immediate or delayed treatment. participants in both conditions will receive information about ptsd and depression, in the form of a brochures and a dvd about trauma and its emotional consequences. groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. each group session will focus on a different aspect of education. next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier. participants will be free to attend any of the sessions they missed during the first group when the group repeats. participants in the delayed condition will be able to attend the groups after a 12-week waiting period. assessments of ptsd, depression, functioning, and quality of life will be conducted at three time points: baseline (prior to the start of the group), 12 weeks after the start of the group, and 6 months from the start of the group. gift cards will be sent to the women for completing each of the assessments.

Eligibility criteria:
inclusion criteria: * exposure to an interpersonal traumatic event * diagnosis of depression or ptsd (threshold or subthreshold) * functional literacy exclusion criteria: * apparent incoherence or disorientation * apparent intoxication at recruitment * hearing impairment

Keywords: major depression trauma primary care low-income patients
evaluation of treatment efficacy of a modified positive airway pressure device to treat obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this study will investigate the efficacy of the fph modified positive airway pressure (pap) device with or without sensawake; and with different pressure support in osa participants; in both an in-home and in-lab environment. comfort, compliance and the accuracy of the pressure delivery will also be evaluated. the fph device will be compared to a market released product.


Eligibility criteria:
inclusion criteria: * aged 18 and over * diagnosed with osa by a practicing physician and prescribed positive airway pressure (pap) - (continuous positive airway pressure (cpap) or autocpap). participants can be naïve to cpap or experienced users of cpap. * for experienced users of pap (cpap or autocpap): using the pap of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator) exclusion criteria: * contraindicated for pap (cpap or autocpap) therapy * persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea) * persons with obesity hypoventilation syndrome or congestive heart failure. * persons that require supplemental oxygen with their pap (cpap or autocpap) device * persons with implanted electronic medical device (e.g cardiac pacemakers) * persons who are pregnant or think they might be pregnant.
effect of acid reflux on respiratory physiology during exercise in athletes with ger-response to acid suppression

Conditions: Exercise Triggered Asthma; Gastroesophageal Reflux

Summary: we propose that acid reflux affects respiratory dynamics (breathing) in patients who are exercising and that athletes improve their exercise capacity with acid suppression therapy. it is our intent to determine whether treatment of ger with strong acid suppression may alleviate symptoms, improve exercise capacity, and improve quality of life.

this is a randomized, blinded, cross-over trial. we plan to take athletes with classical ger, cough, shortness of breath, chest tightness during exercise and subject them to complete pulmonary function testing in conjunction with exercise and ph testing. we will assess whether such athletes experience an increase in reflux duration and episodes during exercise. the athletes will be randomized (in a cross over fashion) to acid suppression (bid nexium 40 mg) or placebo for 10-12 weeks. both the athletes and investigators will be blinded. after 10-12 weeks, exercise testing (ramp protocol with vo2 and anaerobic threshold) with concurrent respiratory function testing will be repeated along with symptom assessment. after a brief washout period of 1-2 weeks, the athletes will then cross-over to the other study medication for 10-12 weeks. again, at the end of the study period, symptomatic relief as well as respiratory function improvement will be assessed by repeating the initial exercise regimen. the exercise regimens during these medication regimens will not be held stable as indirectly, as a results of "feeling better or worse" from the medication/placebo, these patients may increase/ decrease their exercise routine, resulting in changes in their overall endurance, anaerobic threshold, etc (our endpoints). by keeping the regimen stable, we do not allow for the changes to occur which are large enough to detect.

Eligibility criteria:
inclusion criteria: * we plan to take athletes (cyclists) with ger (heartburn symptoms on a daily-weekly basis which are either improved by a trial of acid suppression or objectively documented via ph/endoscopic testing- this may include during exercise) who experience one or more of the following symptoms during exercise, limiting their perceived ability to exercise to full capacity: * choking * cough * wheezing * shortness of breath * chest tightness during exercise * athletes will be defined as persons who exercise on a routine basis (at least 3 times a week on average) for at least the past 6 months. * subjects must be at least 18 years old. exclusion criteria: * pregnancy * age less than 18 years or greater than 65 years * abnormal methacholine challenge tests will not exclude one from enrollment as (has been documented in a prior study) often patients with ger will have heightened bronchial reactivity.

Keywords: asthma gerd reflux exercise
a study to determine the pharmacokinetics, pharmacodynamics, and tolerabiltiy of betrixaban in patients with mild, moderate, and severe renal impairment

Conditions: Renal Impairment

Summary: the purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.


Eligibility criteria:
inclusion criteria: * able to understand and sign the written informed consent. * subjects should have either normal renal function or have stable renal disease exclusion criteria: * subjects require dialysis * evidence of active bleeding or bleeding disorder * unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Keywords: betrixaban renal impairment healthy kidney dysfunction
lymphocytes cut off values of induced sputum samples in healthy and non-healthy patients- a cross sectional study

Conditions: Respiratory Tract Diseases; Occupational Diseases; Disorders of Environmental Origin

Summary: background: induced sputum (is) is a noninvasive methodology for evaluating airway inflammation in a large number of pulmonary diseases, i.e, asthma, chronic obstructive pulmonary disease and interstitial lung diseases. several studies have defined normal values and cut-off points for this technique based on cellular components of is, such as percentages of eosinophils, neutrophils, macrophages and cd4/cd8 ratio of t cell lymphocytes. however, normal values and cut-off points for lymphocyte percentages indicative of pathology have not yet been established or validated. this component of is has considerable clinical value. similar to other constituents of is, it can provide biological insights into the pathogenesis of respiratory disorders and contribute to establishing the diagnosis and guiding treatment management of a variety of airway diseases. the purposes of this study are to define normal values and cut-off points of lymphocytes in is among individuals with respiratory disorders and healthy volunteers, and to verify the current reference values of the percentage of eosinophils, neutrophils and cd4/cd8 ratio in is. methods: a cross sectional study which includes a database on up to 900 patients who participated in various studies conducted in the pulmonary laboratory of tel aviv sourasky medical center between 2005 to 2012 will be established. the study population will include patients diagnosed as having various pulmonary diseases and a group of healthy volunteers who will serve as controls. the cut-off for normal values of lymphocyte, eosinophil and neutrophil percentages and cd4/cd8 ratio in is will be defined by using roc curves and evaluating sensitivity and specificity. the comparison of the different values to those in the literature will be done by using the spearman rank correlation. the results of this study will provide supplementary information on lymphocyte counts in is for identifying and treating various respiratory diseases.


Eligibility criteria:
inclusion criteria: * patients suffering from pulmonary symptoms or diseases * patients with occupational or environmental exposure exclusion criteria: * indefinite spirometry tests

Keywords: airway inflammation induced sputum normal values lymphocyte eosinophil neutrophil
serratus anterior plane block for management of post thoracotomy pain

Conditions: Opioid Use; Post-thoracotomy Pain Syndrome; Local Anaesthetic Agent Overdose; Local Anesthetic Complication; Pain, Postoperative

Summary: this is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. the hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.

this is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. there is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. this protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management. routine preoperative evaluation will be performed to establish eligibility for study inclusion. all patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. the serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution. group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. group 2 will not receive a serratus anterior block. postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.

Eligibility criteria:
inclusion criteria: * 12 months of age or less * infants undergoing cardiac surgery through a thoracotomy incision * infants having surgery performed by a pediatric cardiac surgeon at riley hospital exclusion criteria: * infants requiring sternotomy or emergency surgery * allergy to local anesthetics * neonates less that 37 weeks gestation * infants intubated prior to surgery * infection at the site of the serratus anterior plane block 6. bleeding diathesis with increased risk of hematoma at the block site 7. allergy to morphine 8. active pulmonary infection

Keywords: post thoractomy pain fascial plane blocks early recovery after thoractomy serratus anterior fascial block
evaluation of sarilumab (sar153191/regn88) on top of methotrexate in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: primary objectives: part a (dose ranging study): to demonstrate that sarilumab (sar153191/regn88) on top of mtx was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. part b (pivotal study): to demonstrate that sarilumab added to mtx was effective in: * reduction of signs and symptoms of rheumatoid arthritis at 24 weeks * inhibition of progression of structural damage at 52 weeks * improvement in physical function at 16 weeks secondary objectives: part b: to demonstrate that sarilumab added to mtx was effective in induction of a major clinical response at 52 weeks to assess the safety of sarilumab added to mtx to document the pharmacokinetic profile of sarilumab added to mtx in participants with active rheumatoid arthritis who were inadequate responders to mtx therapy.

the total study duration for a participant was 16-22 weeks (part a) and 56-62 weeks (part b) broken down as follows: * screening: up to 4 weeks * treatment: 12 weeks (part a) and 52 weeks (part b)\* * follow-up: 6 weeks (for participants who would not continue in the long-term extension study). '\*' participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study lts11210 (saril-ra-extend) (nct01146652).

Eligibility criteria:
inclusion criteria : * diagnosis of rheumatoid arthritis ≥3 months duration * active disease defined as: * at least 8/68 tender joints and 6/66 swollen joints, * high sensitivity c-reactive protein (hs-crp) \>6 mg/l, * continuous treatment with mtx for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit. part b only: * bone erosion based on documented x-ray prior to first study drug intake, or * cyclic citrullinated peptide (ccp) positive, or * rheumatoid factor (rf) positive. exclusion criteria: * age \ 75 years. * treatment with disease-modifying antirheumatic drugs (dmards) other than mtx within 4 weeks or 12 weeks prior to screening (depending on dmards). * past history of non-response to prior tumor necrosis factor (tnf) or biologic treatment. * any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months. * use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit. * use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
early detection of cancers in low resource countries

Conditions: Breast Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms

Summary: the purpose of this study is to implement a community-based combined program for early detection of breast, cervical, ovarian and endometrial cancer in low-resource countries delivered through a free standing or a mobile well woman clinic. the goals of this program are to downstage cancers and improve mortality rates using low-cost early detection methods. these programs will be implemented in regions where early cancer detection strategies are not in place and cancers present at advanced stages with resultant high mortality. currently, there are three target project sites: cambodia (june 2011), india (june 2011), and brazil (march 2011). memorandums of understanding have been secured with local health organizations in each region to establish clinic operations. each clinic would serve an approximate target population of 100,000 amongst whom about 12,000 eligible women (4-5,000 annually) will be invited to be screened for breast and cervical cancer over a three-year time span.

we will study the use of sonographic screening in addition to clinical breast examination in low resource settings where screening programs are not currently in place and establishing a population based mammographic screening would be expensive, resource intensive, and difficult if not impossible to implement. the effectiveness of the screening and diagnostic methodology used for early detection of breast, cervical, ovarian and endometrial cancers in low resource settings will be studied. the program would involve screening of asymptomatic women for breast and cervical cancer and diagnostic assessment of symptomatic women for ovarian and endometrial cancer. women in the age group of 30-59 yrs will be screened once every three years utilizing the following methods: breast - clinical breast examination \[cbe\] and sonography, followed by fine needle aspiration biopsy (fnab) of screen positive cases; cervical - human papilloma virus dna testing followed by cryotherapy of screen positive cases (single visit, screen and treat approach); ovarian - transvaginal sonogram and clinical evaluation; endometrial - transvaginal sonographic assessment of the endometrial stripe.

Eligibility criteria:
inclusion criteria: * breast cancer: women age 35-64 * cervical cancer: women age 30-59 * ovarian cancer: symptomatic post menopausal women age 50-64 * endometrial cancer: symptomatic post menopausal women age 50-64 exclusion criteria: * women under the age of 30

Keywords: neoplasms
open clinical trial of cbt-based multiprofessional rehabilitation for exhaustion disorder

Conditions: Exhaustion; Syndrome; Burnout, Professional; Burnout Syndrome; Adjustment Disorders

Summary: stress-related mental disorders are today the leading cause of long-term sick leave in sweden, and a large part of this increase is due to clinical burnout, in sweden called "exhaustion disorder" (ed). even though clinical guidelines recommend multi-professional rehabilitation (mpr) for ed, few studies have evaluated the effects of these treatment programs in clinical practice. this large-scale open clinical trial investigates whether mpr for ed seems to alleviate symptoms of ed and if it results in return-to-work.

this study is carried out at two specialized stress rehabilitation centers in stockholm. all patients included in the clinics stress rehabilitation program are asked to participate in the study and are recruited consecutively from october 2017 throughout december 2018. an estimate of 400 patients will be included. the treatment program is a 24-week multiprofessional standardized cbt-rehabilitation consisting of a nine-session cbt group treatment (stress management) followed by a seven-session group treatment in applied relaxation. parallel to the group treatments patients receives nine sessions of individual cbt, three visits to an md (for medication, follow-up, and sick-listing), two individual sessions to a physiotherapist and a three session-exercise group. also, vocational measures are taken through rehabilitation meetings together with the patient's employer (if an employer exists). primary treatment outcomes will be return-to-work (rtw) and symptoms of ed, anxiety, and depression. secondary treatment outcomes will be quality of life, pathological worry, psychological flexibility, clinical perfectionism, insomnia, burnout, and symptoms. predictors of symptom development and rtw will be explored. also, comorbidity of chronic pain, negative effects of psychotherapy and treatment credibility will be investigated.

Eligibility criteria:
inclusion criteria: * confirmed exhaustion disorder according to criteria established by the swedish national board of health and welfare * 18 - 64 years of age * considered suitable for multimodal rehabilitation in group * self-rating of \> 4,5 på smbq exclusion criteria: * abuse of alcohol or drugs * moderate-high suicidal risk * severe psychiatric illness (severe depression, bipolar, schizophrenia etc.) * untreated ptsd

Keywords: exhaustion disorder burnout clinical burnout
expanded access for atb200/at2221 for the treatment of pompe disease

Conditions: Pompe Disease

Summary: this is an expanded access program (eap) for eligible participants designed to provide access to atb200/at2221.

this program is being offered on a patient by patient basis and will require company, irb/iec and single patient ind approval.

Eligibility criteria:
inclusion criteria: 1. subject must have a diagnosis of pompe disease based on documentation of one of the following: 1. deficiency of gaa enzyme 2. gaa genotyping 2. patient does not currently qualify for an amicus sponsored on-going clinical trial or is declining on currently approved ert (e.g. myozyme) 3. the patient must be willing to receive treatment with atb200/at2221 via this program, which includes signing an authorization form for sharing clinical data with amicus therapeutics, and its agent early access care llc. exclusion criteria: 1. patient, whether male or female, is planning to conceive a child during the treatment program. 2. patient has a hypersensitivity to any of the excipients in atb200, alglucosidase alfa, or at2221 3. patient has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator, pose an undue safety risk to the subject or compromise his/her ability to comply with or adversely impact protocol requirements. 4. patient has received any gene therapy at any time. 5. concomitant use of miglitol (eg, glyset), non-at2221 form of miglustat (eg, zavesca), acarbose (eg, precose or glucobay), voglibose (eg, volix, vocarb, or volibo)

Keywords: expanded access compassionate use