Kornimate/medical-research-clean huggingface dataset:
the effects of continuous positive airway pressure on overlap syndrome

Conditions: COPD & OSA

Summary: 1. the first objective of this study is to determine the differences between, while the airway obstruction severity is the same, and the acute continuous positive airway pressure (cpap) effect on chronic obstructive pulmonary disease (copd) patients with overlap syndrome compared with copd patients without in terms of sleep quality, autonomic nerve activity, biologic markers of systemic inflammatory, and exercise performance. 2. the second objective of this study is to evaluate the subacute (3 months treatment) cpap effect on copd patients with overlap syndrome in terms of pulmonary hemodynamic and right heart function, we will also determine the subacute effect of cpap on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as well as exercise performance. 3. the last objective of this study is to evaluate the long term (12 months treatment) cpap effect on copd patients with overlap syndrome. the un-scheduled clinic or emergency department visiting, hospitalization, or mortality will be recorded to see if there is significant treatment effect in terms of reducing morbidity and mortality. the long term cpap effect on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right heart function will be re-evaluation.

copd patients will be disturbed by season 12 months follow up is better than 18 months

Eligibility criteria:
inclusion criteria: * chronic stable copd * fev1/fvc \< 70% * no response to beta-agonist * without acute exacerbation within2 months exclusion criteria: * chronic respiratory failure (pao2\ 50 mmhg) * clinical evidence of congestive heart failure * facial defect and all the other condition that can't tolerate nasal mask * malignancy

Keywords: chronic obstructive airway disease obstructive sleep apnea continuous positive airway pressure
max-40279-01 in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this is a multi-center, non-randomized, open-label, single-arm, dose-escalation phase i study to evaluate the safety and tolerability of max-40279-01 in patients with advanced solid tumor.

this is a two-part study comprised of a dose escalation part and a dose expansion part.

Eligibility criteria:
inclusion criteria: * males and/or females over age 18. * histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available. * at least one measurable lesion by ct or mri according to recist1.1, which is not in irradiated area (only for expansion phase). * recovered from toxicities of prior anti-cancer treatment to grade 1 or less (in case of alopecia, grade 2 is acceptable). * life expectancy of at least 3 months. * female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. a highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly. exclusion criteria: * any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks (3 weeks for chemotherapy; 6 weeks for nitrosoureas or mitomycin c) prior to trial entry. * medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product. * previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 2 years at the trial entry. * major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery. * laboratory values not within the protocol-defined range. * cardiac disease , including congestive heart failure, myocardial infarction, unstable arrhythmia, or symptomatic peripheral arterial vascular disease. * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. * known infection with human immunodeficiency virus (hiv), hepatitis b, or hepatitis c. * concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this trial.

Keywords: advanced solid tumors
open-label study of the safety and efficacy of adalimumab in the treatment of hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (hs).

hs is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. this study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria.

Eligibility criteria:
inclusion criteria: * subjects who previously participated in a prior phase 3 abbvie hidradenitis suppurativa (hs) study (m11-313 or m11-810) and: 1. completed the study; or 2. experienced a loss of response (lor); or 3. experienced worsening or absence of improvement exclusion criteria: * prior treatment with any other anti-tumour necrosis factor (anti-tnf) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior phase 3 abbvie hs study. * subject received any oral antibiotic treatment for hs within 28 days prior to the baseline visit, except for antibiotics permitted in a prior phase 3 abbvie hs study. * subject received prescription topical therapies for the treatment of hs within 14 days prior to the baseline visit of study m12-555.

Keywords: hidradenitis suppurativa open-label acne inversa pioneer (open-label extension) adalimumab hs acne tumor necrosis factor abscess inflammatory nodule
three-min step test and exercise desaturation detection in chronic respiratory insufficiency patients

Conditions: COPD; Chronic Respiratory Disease

Summary: the study project will aim at the evaluation of the occurrence of exercise desaturation phenomenon during two different modalities of exercise (walking and stepping condition). this study will allow determining the sensibility of the 3-minute step test to detect exercise desaturation, in comparison with the gold standard (6-minute walking test). the 3-minute step test could therefore appear as a complementary tool for the evaluation of oxygen desaturation in chronic respiratory disease.

the 6-minute walking test is currently the gold standard for the evaluation of oxygen desaturation phenomenon during exercise and for the adjustment of o2 flow rate. but, due to spatial constraints, this test remains difficult to apply in ecological conditions and the 3-minute step test could be a complementary method to the walking test for the evaluation of chronic respiratory diseases. for this study, patients will perform, during 2 visits, a maximal graded test and two field tests (6-min walking test and 3-min step test) under identical conditions. during these tests, pulsed oxygen saturation and psycho-physiological adaptations to exercise will be monitored.

Eligibility criteria:
inclusion criteria: * patients aged by 18 and more ; * patient with an chronic obstructive respiratory insufficiency, confirmed by clinical and functional criteria ; * patient with exercise-induced oxygen desaturation ; * patient clinical ly stable, with no exacerbation period within the last 2 months before inclusion ; * consent form signed by the patient. exclusion criteria: * patient in exacerbation period at the inclusion time ; * pregnant and breastfeeding women ; * patient with orthopedic disorder that could limit the ability of stair climbing; * any other disease that could influence exercise capacity of the patient or that could impair exercise test realization ; * patient with law protection (guardianship or protection of vulnerable adults)

Keywords: copd exercise oxygen desaturation field tests
reducing pain of lidocaine injection

Conditions: Pain of Anesthesia at Breast Biopsy

Summary: the purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core biopsies. the medicine doctors use to reduce the pain of breast biopsies, lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. it is possible that this pain is caused because lidocaine is acidic. some physicians believe that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of injecting the lidocaine. both approaches - injecting 1% lidocaine alone and injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care by radiologists today. the purpose of this study is to determine if either approach is more comfortable for patients having breast procedures.


Eligibility criteria:
inclusion criteria: * 21 years of age * any patient scheduled for a breast biopsy at duke breast interventional imaging exclusion criteria: * less than 21 years of age * allergic to lidocaine or sodium bicarbonate * not mentally capable of consenting
diagnosis of graft pathology by trugraf

Conditions: Acute Graft Rejection

Summary: the goal of this observational study is to to identify different causes of liver diseases or damage in liver transplant patients and develop a machine learning algorithm as a non-invasive tool leveraging gene expression and patient clinical information to classify transplant liver diseases we will collect blood samples of the participants who had undergone or will undergo the liver biopsy as part of standard of care, and use this blood in trugarf. trugraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to rule out liver damage. researcher will collect the biopsy result from the medical record and this will be compared with the trugarf results.

given the significant investment of healthcare resources into transplantation, it is critical to identify recipients with graft pathologies such as acute cellular rejection (acr), nash, cholestasis, etc. at an earlier stage to implement the appropriate intervention, rather than initiating empiric treatment that could be unsafe. this project will develop a practical machine learning-based tool based on the results of the trugraf assay alongside clinical and laboratory data for non-invasive diagnosis of graft pathology. trugraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to identify patients who are likely to be adequately immunosuppressed and, in doing so, rule out graft damage. trugraf measures the difference in gene expression for a precise panel of specific genes that have been empirically determined to discriminate between allografts that are truly healthy (non-acr), and those in transplant patients that have acute rejection on biopsy (ar). nevertheless, the exact etiology of graft damage may be difficult to discern for the transplant clinician. the clinical characteristics and history of the liver transplant recipient as well as liver enzyme patterns can provide a pre-test probability of one diagnosis being more likely than the other (acute cellular rejection, nash, biliary or viral disease). the proposed tool will leverage our expertise in machine learning tools applied to clinical and molecular data (trugraf assay results) to enable effective clinical implementation of the trugraf assay.

Eligibility criteria:
inclusion criteria: 1. . single-organ liver transplant recipients 2. male or female, age \> 18 years at the time of signing informed consent. 3. willing and able to provide informed consent. 4. patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent. exclusion criteria: 1. repeat transplant 2. recipient of multi organ transplantation 3. any treatment for graft rejection such as iv steroids has been given before biopsy. 4. targeted biopsies for diagnosis of malignancy.

Keywords: liver transplant patients
the expression heparanase in term and preterm placentas

Conditions: Preterm Birth

Summary: heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (hs) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ecm). this study aims to investigate the association between heparanase expression in the human placenta and preterm birth (ptb) . the investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.


Eligibility criteria:
inclusion criteria: * singleton pregnancy exclusion criteria: * high-risk patients * multiple pregnancy * significant maternal illness * significant fetal anomaly
a study of once monthly intravenous mircera for the maintenance treatment of dialysis patients with chronic renal anemia.

Conditions: Anemia

Summary: this single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of mircera in dialysis patients with chronic renal anemia. patients will receive intravenous mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * male or female patients, \>=18 years of age; * chronic renal anemia; * hb concentration 10.5g/dl - 12.5g/dl; * continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months. exclusion criteria: * blood transfusion within the previous 2 months; * poorly controlled hypertension; * significant acute or chronic bleeding; * active malignant disease; * congestive heart failure (nyha class iv).
bacteriotherapy in pediatric inflammatory bowel disease

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; CD

Summary: in this study, the investigators want to see if bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with inflammatory bowel disease (ibd). examples of ibd are crohn's disease and ulcerative colitis. additionally, researchers want to learn whether this experimental therapy delays the need for starting additional medications to treat pediatric ibd.


Eligibility criteria:
inclusion criteria: * children ages 12-21 years old with a diagnosis of mild to moderate ulcerative colitis or crohn's disease * willing parent to donate stool for the transplant exclusion criteria: * severe disease * history of intra-abdominal abscess, intra-abdominal fistula or stricturing * history of other systemic diseases * the patient has received tnf inhibitors to treat their ibd within two months of transplant

Keywords: crohns disease ulcerative colitis inflammatory bowel disease ibd
platform-based mild cognitive impairment (mci) trial

Conditions: Mild Cognitive Impairment

Summary: the process of receiving a diagnosis of mild cognitive impairment (mci) is recognized to induce behavioral responses that can be either adaptive or maladaptive. five specific areas of concern have been identified, including: 1) failure to plan for future decline, decreased compliance and interaction with medical care providers, 3) decreased confidence and reduced social engagement, 4) increased physical limitations and 5) decreased medication compliance. in this pilot study, participants with mci and their study partners will participate in behavioral interventions (primarily training workshops and classes) targeting each of these five areas of potential maladaptive behaviors.

following the approval of an application reviewed by the university's institutional review board, the researcher will evaluate the intervention using a complimentary mixed methods approach. the study will consist of a single-site platform trial examining the intervention group. there are many benefits to using a platform trial approach. first, using a platform trial allows the 18 participants to explore different arms of the intervention. second, the platform design will allow us to also determine the effects of the interventions on patient help-seeking and adherence behavior in real-world care is critical to estimates of cost-effectiveness. as one of the specific aims of this study is to determine user feedback about modifying behaviors from various interventions, as opposed to determining which intervention is most effective, a platform trial will accomplish this.

Eligibility criteria:
inclusion criteria: * current subjects of the university of kentucky alzheimer's disease center (adc) * meet consensus guidelines for mild cognitive impairment (mci) developed by the second international working group on mci * have been diagnosed within the last year * able to provide informed consent * have a study partner willing to participate exclusion criteria: * history of stroke * significant neurological or psychiatric conditions * brain injury * residence in institutional setting

Keywords: alzheimer's disease maladaptive behavior
safe return to play after acl reconstruction

Conditions: ACL Tear

Summary: recent studies report that as few as 44% of athletes undergoing acl reconstruction were able to return to their prior level of competitive level of sports. early return may predispose an individual to re-injury including graft re-tear, meniscal tears, chondral injuries, and contralateral knee injuries. criteria governing clearance to return to sports after acl reconstruction has been traditionally defined using time from surgery and one or two objective criteria, often solely isokinetic quad/hamstring strength. several studies have suggested that historical criteria used to assess readiness to return to play (rtp) are insufficient in identifying individuals at risk of a re-injury. they advocate for additional functional and dynamic testing, which may better reflect the complex kinematics required in high level athletic competition. we previously developed a "safe return to play following acl reconstruction checklist" based on a systematic review of the literature and expert survey. seven objective measures were developed as part of the checklist. the checklist is performed by a certified physical therapist trained in these performance tests. the purpose of this study is to validate the utility of our "return to play checklist" by evaluating our patients prospectively for return to play following acl reconstruction by comparing a cohort of patient undergoing testing with the checklist versus "clinical judgement."


Eligibility criteria:
inclusion criteria: * all patients ages 15-35 undergoing primary acl reconstruction exclusion criteria: * patients who are undergoing revision acl surgery
the involvement of breast cancer patients during oncological consultations

Conditions: Breast Cancer

Summary: the main aim of the study is to assess if a pre consultation intervention facilitates greater participation of patients (and accompanying key persons when present) in the consultation process by determining an increase in questioning and/or in the number of different illness related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist. other aims are to assess the effect of the intervention on the oncologist's level of patient involvement, on patient satisfaction and coping and to explore the role of key persons accompanying the patient. the investigators expect that patients who have the opportunity to rehearse their informative needs before the consultation will ask a greater number of questions which in turn will determine their greater involvement by the physician and a greater number of satisfied needs. the investigators expect also that the straightforward use of a list of printed questions of potential relevance for cancer patients and their companions at an early stage of illness, by modifying the process of information exchange, increases their participation and satisfaction with the consultation, with potential benefits for treatment adherence and consequently treatment efficacy.


Eligibility criteria:
inclusion criteria: * all consecutive patients * age between 18 and 75 years * attending the oncology out-patient clinics of the participating centres * recent diagnosis of breast cancer at an early stage exclusion criteria: * presence of metastasis or relapse * severe mental deterioration * comprehension difficulties of the italian language.

Keywords: breast cancer patient involvement question prompt-sheet doctor-patient communication rct
toxoplasmic encephalitis in patients with aids. treatment and prevention of relapse

Conditions: Toxoplasmosis, Cerebral; HIV Infections

Summary: to compare pyrimethamine and intravenous (iv) clindamycin vs. pyrimethamine and sulfonamides in the treatment of aids patients with central nervous system (cns) toxoplasma gondii.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following conditions are excluded: * opportunistic infection (pneumocystis carinii pneumonia (pcp), cryptococcal meningitis) or other conditions (brain abscess) which would make treatment results difficult to interpret due to concurrent infection, disease, or therapy. patients with other opportunistic infections or brain diseases are excluded. patients with aids and cerebral toxoplasmosis.

Keywords: sulfonamides toxoplasmosis aids-related opportunistic infections pyrimethamine drug therapy, combination encephalitis acquired immunodeficiency syndrome clindamycin