Kornimate/medical-research-clean huggingface dataset:
evolution of fatigue in patients with inflammatory bowel disease

Conditions: Fatigue; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: the aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent ibd and fatigue included in two previous studies.

fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. fatigue in patients with chronic diseases can be objectified by the facit-f scale. recent publications have tried to assess the prevalence and factors related to fatigue in patients with ibd. in 2017 one study evaluated the prevalence and predictive factors of fatigue in out-patients with inflammatory bowel disease. fatigue was associated with depression, low quality of life and female sex. no association was found with micronutrients or levels of interleukins. as there are no effective treatments for fatigue in ibd, another study, recently published a study evaluating the role of electroacupuncture in 54 patients with quiescent ibd and fatigue, observing that both electroacupuncture and sham acupuncture improved fatigue compared to the control group. the aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent ibd and fatigue included in the two previous studies. patients with inflammatory bowel disease and fatigue (facit-f score \< 40) included in these two previous studies who agree to participate will fill in questionnaires to assess fatigue, anxiety, depression and quality of life in inflammatory bowel disease. moreover, the relationship of other biological factors with ibd-related fatigue will be determined.

Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease and fatigue (defined as a facit-f score \<40 points) previously documented in our two previous studies. * written informed consent after receiving clear and objective information about the purpose and characteristics of the study. * ability to understand the questionnaires. exclusion criteria: * associated tumor disease. * pregnancy or breastfeeding. * anemia (hemoglobin \<12g/dl in women and 14g/dl in men) * any concomitant illness that may justify the presence of fatigue.

Keywords: fatigue; inflammatory bowel diseases crohn disease ulcerative colitis
therapeutic plasma exchange in mg

Conditions: Myasthenia Gravis

Summary: the primary objective of the study is to longitudinally profile immunoglobulin levels and autoantibody levels in subjects with myasthenia gravis (mg) who receive therapeutic plasma exchange (tpe).

this is a prospective, multi-center, pilot biomarker study in subjects receiving tpe for the treatment of mg. no study medications will be given. ten (10) achr antibody positive mg subjects will be enrolled in the study at 2 sites. of these 10 mg subjects, up to 5 may be receiving chronic tpe. the study period will be approximately 3 months and will consist of: * screening/baseline visit, * tpe visit where subjects will undergo clinical evaluations and blood draws for immunological assays, * end of tpe visit where information on the tpe procedure will be recorded, clinical measurements will be performed, and a blood sample will be drawn. * post-tpe period where subjects will undergo clinical evaluations and blood draws for immunological assays at week 1, week 2, week 3, week 6, and week 12 after tpe. study procedures performed outside of usual care will include optional single-fiber electromyography (sfemg) studies, blood draws and optional skin biopsies.

Eligibility criteria:
inclusion criteria: * has the capacity to understand and sign an informed consent form * 18 years or older * diagnosis of mg based on clinical features * has detectable serum autoantibodies to achr * has a clinical indication for the use of tpe to treat mg exclusion criteria: * unable or unwilling to comply with study procedures that include multiple venipunctures * weighs less than 50kg * has a contraindication to treatment with tpe (e.g. clinically significant bleeding disorder) * has muscle specific tyrosine kinase or low-density lipoprotein receptor-related protein 4 (lrp4) antibody positive mg * has prior or current history of thymoma * had a thymectomy in the past 6 months * has received rituximab in the past 12 months * has another coexisting autoimmune disease that is not clinically controlled or may preclude accurate study assessments according to the judgment of the pi * has current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or central nervous system disease * has participated in an interventional clinical trial with a novel therapeutic agent in the past 6 months * is cognitively impaired, a prisoner, or otherwise institutionalized at the time of screening

Keywords: mg
efficacy of pico compared to opsite post-op visible on surgical wound in patients at high risk of local complications, undergoing hip arthroplasty

Conditions: Evaluate Postsurgical Hematoma

Summary: evaluate the effect of the pico medical device, compared to the opsite post-op visible medical device, in reducing the formation of postsurgical hematoma in the surgical wound of patients at high risk of local complications, undergoing hip arthroplasty


Eligibility criteria:
inclusion criteria: * aged between 55 and 85 years inclusive, * patients with bmi ≥ 30 + asa 3 + diabetes mellitus * patients suffering from coxarthrosis candidates for hip arthroplasty surgery or revision of hip arthroplasty exclusion criteria: * age\> 85 years, \<55 years * patients who are unable to understand and want. * patients with severe neurological disorders or with severe disabilities. * oncological patients and patients with malignant tumor at the edge of the wound * patients who have undergone radiotherapy treatment * patients with bleeding disorders * patients on anticoagulant treatment with warfarin or nao * previously confirmed osteomyelitis * patients with liver cirrhosis * patients with non-enteric fistulas * patients with necrotic tissue with the presence of eschar at the intervention site * patients with autoimmune thrombocytopenia.
evaluation of analgesia by peng block versus intra-articular infiltration in prosthetic hip surgery (api)

Conditions: Hip Prosthesis; Analgesia; PENG Block

Summary: the main objective of this study is to compare the effectiveness of the ultrasound-guided peng block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.


Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years old. * patient scheduled for anterior hip prosthesis. * affiliated patient or beneficiary of a social security scheme. * patient having been informed and having signed a free and informed consent. exclusion criteria: * patient with a contraindication to local anesthesia. * patient with a high level of dependence, defined by level 1 or 2 of the iso-ressources group (gir). * patient participating in another clinical study. * protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision. * pregnant, breastfeeding or parturient woman. * patient hospitalized without consent.
exercise challenge in a cold chamber

Conditions: Exercise-induced Asthma

Summary: the purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°c to the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced bronchoconstriction. the sensitivity and repeatability of the exercise test will be measured.

subjects suffering form exercise-induced bronchoconstriction (eib) usually have a normal lung function testing at rest. to provoke asthma symptoms a provocation test is necessary, e.g., by bronchial methacholine testing or by a standardised exercise test on a treadmill. the correlation between methacholine and exercise test is fair, possibly because both methods measure different kinds of bronchial hyperresponsiveness. moreover, the sensitivity and the repeatability of the exercise test is fair. the value of the methacholine test to predict a positive exercise test will be measured. we hypothesize that the exercise test in a cold chamber, a combination of two provocation methods cold air and exercise, is more sensitive to detect eib and that the test has a better repeatability.

Eligibility criteria:
inclusion criteria: * informed consent * patients: age \>6 and \<18 years * subjects: age \>/=18 and \<45 years * sportive, 1-2x exercise per week * bronchial hyperresponsiveness in the medical history exclusion criteria: * lung function forced vital capacity (fvc) \<80% and forced expiratory volume in 1 second (fev1) \<75% * chronic diseases or infections (e.g. hiv, tbc) * pregnancy * systemic corticosteroid-treatment * inhalative corticosteroid therapy or leukotriene antagonists \<14d * alcohol, substance or drug abuse * smokers * inability to capture extend and consequences of the study

Keywords: exercise-induced bronchoconstriction exercise-induced asthma cold chamber exercise challenge cold air challenge combined exercise- and cold-air challenge methacholine challenge
person-centered approaches to viremia: connection, rapport, and engagement study

Conditions: HIV Viremia; HIV -1 Infection

Summary: the study aims to increase the reach of the person-centred interpersonal practices by developing and accessing a tailored, scalable, and sustainable approach that meets the distinctive needs of populations identified as most disproportionately affected by viremia in zambia. the study population include pregnant and breastfeeding women, children, adolescents and adult that are more than thirty -30 days late for their next hospital appointments.the study will be implemented over a period of 36 months in 24 facilities in lusaka and central province, zambia.

the study has three aims, that include (1) to assess barriers to sustained viral suppression through identifying prevailing pathways to viremia (2) apply human centred design methods with stakeholders to co-create person-centred pathways to strengthen viral suppression, with particular attention to vulnerable groups (3) to test p-core package with a focus on high- priority populations contributing to remaining viremia.

Eligibility criteria:
inclusion criteria: 1. patients that are lost to follow up (\[ltfu\] from hiv care i.e. confirmed \>30 days late for a scheduled appointment) at the time of sampling. (i.e. not people who were previously ltfu but then returned and have a documented vl.) 2. individuals returning to care after being out of care and not taking art with no vl measure (i.e., unmeasured viremia) 3. patients that are 6 months late for a scheduled viral load (vl) according to ministry of health guidelines at the time of sampling (regardless of care status) 4. patients that have a last documented vl that is elevated, \> 1000 copies/ml at time of sampling in current clinic population (ccp) (regardless of care status) 5. participant that are willing to provide written informed consent in english, or any of the local languages that include nyanja or bemba. exclusion criteria: 1. patients that are unable to provide consent or unwilling to participate in the study 2. participant who is not living with hiv/aids; 3. participant is too sick i.e., failing to talk, general discomfort and emergency cases);

Keywords: uncontrolled viremia person centred care unmonitored viral load
comparison of tissue retractors during cesarean delivery in obese women

Conditions: Cesarean Section; Obesity

Summary: this is a randomized controlled trial comparing the use of the mobius™ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. the mobius™ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at thomas jefferson university hospital. we hypothesize that the use of the mobius™ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.

the mobius™ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. there have been no clinical trials to determine if this "added" exposure offers any measurable significant benefits to justify the added cost. this study will determine if the mobius™ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.

Eligibility criteria:
inclusion criteria: * pregnant women undergoing non-urgent cesarean delivery exclusion criteria: * women undergoing urgent cesarean delivery * bmi \<35kg/m2 * women undergoing vaginal delivery * positive urine drug screen or known history of methadone maintenance or substance abuse

Keywords: surgical instruments cesarean section obesity
tolerance, safety, and activity of rifapentine alone and in combination therapy in aids patients with mycobacterium avium complex bacteremia.

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with aids and disseminated mycobacterium avium complex (mac) bacteremia. to determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. to determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-oh metabolite) in combination therapy.

this open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase. in the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy. in the combination treatment phase, 12 patients each are randomized to one of three arms: arm i: rifapentine (assigned dose level based on monotherapy phase) plus azithromycin. arm ii: rifapentine (assigned dose level) plus clarithromycin. arm iii: rifapentine (assigned dose level) plus ethambutol.

Eligibility criteria:
inclusion criteria patients must have: * documented positive hiv serology status. * documented aids. * positive blood culture for mac from the study-designated microbiology laboratory. note: * patients with presumed mac bacteremia, as evidenced by positive blood, bone marrow, or liver biopsy culture analyzed locally, may be enrolled pending confirmation. * minimum of two mac-associated symptoms, defined as \>= grade 1 fever; \> grade 1 night sweats, fatigue, diarrhea, abdominal pain, or anorexia; or weight loss \> 5% reported within 4 weeks prior to study entry. * life expectancy of at least 3 months. prior medication: allowed: mac prophylaxis with medications other than study drugs (5-day washout period required). exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * pulmonary tuberculosis. * infections requiring the use of disallowed medications. * serious diseases that introduce undue risks for adverse reactions to study medication. concurrent medication: excluded: * terfenadine. * treatment for pulmonary tb. * study drugs from an outside source. * medications with anti-mac activity (i.e., amikacin, ciprofloxacin, clofazimine, rifampin, and rifabutin). patients with the following prior conditions are excluded: * history of hypersensitivity to rifabutin, rifampin, clarithromycin, erythromycin, azithromycin, or ethambutol. * previous episode of uveitis. prior medication: excluded: * prophylactic treatment for mac with rifabutin or any of the study medications. * azithromycin within the 3 weeks prior to randomization. * any investigational drug during the 4 weeks prior to randomization.

Keywords: aids-related opportunistic infections mycobacterium avium-intracellulare infection drug therapy, combination antitubercular agents azithromycin clarithromycin bacteremia rifapentine
camrelizumab combined with local treatment in nsclc patients with bm

Conditions: NSCLC Stage IV; Brain Metastases; Immunotherapy

Summary: to evaluate the efficacy and safety of camrelizumab combined with chemotherapy and local treatment in non-small cell lung cancer with brain metastases.

to evaluate the efficacy and safety of camrelizumab combined with chemotherapy and local treatment of brain metastases (wbrt, r-knife, srs, etc.) in non-small cell lung cancer patients with brain metastases .

Eligibility criteria:
inclusion criteria: 1. age ≥18; 2. ecog is 0-1; 3. non-small cell lung cancer confirmed by histology; egfr、alk and ros1 negative; 4. the presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases; 5. according to recist 1.1, there is at least one measurable extracranial and intracranial target lesion each; 6. sign informed consent and agree to collect the clinical efficacy and information of the patient. exclusion criteria: 1. immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.) 2. active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.) 3. patients with active hepatitis b or c, hiv, active tuberculosis, etc.; 4. active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal); 5. history of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation; 6. patients with interstitial lung disease or previous history of interstitial pneumonia; 7. having a history of substance abuse and unable to abstain from it or having mental disorders; 8. who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group; 9. having used pd-1/pd-l1 and other immunotherapy drugs before entering the group; 10. previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer; 11. (a) pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception; 12. the researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.

Keywords: lung cancer brain metastases camrelizumab wbrt srs
study to evaluate the prospective payment system

Conditions: Chronic Kidney Disease

Summary: to describe trends in treatment patterns of small dialysis organizations (sdos) prior to and during the implementation of the centers for medicare and medicaid services' (cms') policy \[end stage renal disease (esrd) prospective payment system (pps)\] to bundle reimbursement for all dialysis services. specifically, to describe cms esrd pps quality performance measures for dialysis centers over time.


Eligibility criteria:
patient inclusion criteria: * adults ≥ 18 years of age who have given written informed consent * documented physician diagnosis of esrd requiring dialysis and receiving care at a participating dialysis center * undergoing dialysis on the dialysis schedule assigned to the site patient exclusion criteria: * patients will be ineligible for the study if they do not consent to have their data collected for research purposes.

Keywords: dialysis prospective payment system center for medicare and medicaide services end stage renal disease concomitant medications dosage /treatment patterns
follow-up study on chronic myeloid leukemia patients achieving treatment-free remission

Conditions: Chronic Myeloid Leukemia, BCR/ABL-Positive

Summary: in recent years, the goal of stopping drug therapy, also known as treatment-free remission (tfr), is emerging as one of the management goals of chronic myeloid leukemia (cml) therapy. because there is no available data on asian patients with cml undergoing tyrosine kinase inhibitor discontinuation (tki), the investigators plan to recruit chronic phase cml patients with deep treatment response and good medical compliance in taiwan to evaluate the feasibility, safety and clinical consequences of tki discontinuation.

1. primary goal: to evaluate the feasibility, safety and clinical consequences of tki discontinuation in chronic phase cml(cp-cml) patients with deep treatment response and good medical compliance in taiwan 2. molecular response monitoring: 1. after discontinuation of tki therapy, participants will receive monthly molecular monitoring of bcr-abl transcript levels by real-time quantitative polymerase chain reaction (rt-qpcr) for one year, every two months for the second year and every three months thereafter. 2. if loss of major molecular response (mmr) (bcr-abl transcript level ⩽ 0.1% is) is detected at any time point post tki discontinuation, the participant should receive repeated testing within two weeks. if loss of mmr is confirmed, tki should be resumed within four weeks 3. rt-qpcr of bcr-abl would be ordered every four weeks until mr4 (bcr-abl transcript level ⩽ 0.01% is) is re-established, and then every 12 weeks indefinitely. 4. for patients who fails to achieve mmr again within three months after tki is re-initiated, bcr-abl kinase domain mutation testing would be performed

Eligibility criteria:
inclusion criteria: 1. the participant should be an adult (age ⩾20 years) with cp-cml. 2. the bcr-abl fusion should be in the form of either e13a2 or e14a2 (p210) 3. the participant should not have documented resistance to a 2nd-generation tki (nilotinib or dasatinib) 4. the participant should have received ≥ 5 years of consecutive treatment with imatinib, or ≥ 4 years of consecutive treatment with a 2nd-generation tki (nilotinib or dasatinib) 5. the participant should have achieved mr4.5 (bcr-abl ⩽0.0032% is) or undetectable disease in the peripheral blood or bone marrow, for ≥ 2 years, which is documented on ≥ 4 separate tests performed ≥ 3 months apart. 6. access to a reliable qpcr-based bcr-abl test with a sensitivity of detecting of at least mr4.5. exclusion criteria: 1. after evaluation, the participant is deemed to be ineligible by the investigator of this study. 2. the participant has no intention to be recruited into this study.

Keywords: chronic myeloid leukemia treatment free remission