Kornimate/medical-research-clean huggingface dataset:
patient engagement in perioperative pain management project

Conditions: Pain, Postoperative; Opioid Use Disorder

Summary: previously, the study team evaluated the implementation and effectiveness of the johns hopkins perioperative pain program (ppp), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. based on the findings of that project, the study team developed an educational intervention intended to improve patient engagement in perioperative pain management. in this project, the study team will formally implement a randomized controlled trial to evaluate the effectiveness of the intervention developed.


Eligibility criteria:
inclusion criteria: * all patients in johns hopkins personalized pain program clinic exclusion criteria: * active suicidal ideation at study entry * primary psychotic disorder * non-english speaker

Keywords: patient engagement patient activation
effects of klapp method exercises in breast feeding females with kyphotic posture

Conditions: Postural; Defect; Breast Feeding

Summary: group a will be given klapp method exercises to the participant for a period of 1 month twice in a week for 50min. group b will be given printed information on an at-home exercise program, such, posture correction,corrective exercises and breathing exercises. they will be asked to perform the exercises twice weekly during the study and follow-up period. all these sessions will be of 50 minute for 2 session per week for 4 weeks

the klapp exercises program, is an active therapeutic exercise that aims to stretch, mobilize, and strengthen the spine, offering both pain reduction and postural improvement. this method is widely applied, for the correction of vertebral deformities such as kyphosis, lordosis and scoliosis, to the treatment of thoracic cage abnormalities and thoracic cage shape changes after thoracoplasty, as well as in the treatment of spinal muscle interference from polio and spinal osteochondrosis. the aim of this study to investigate the effects of klapp method exercises on pain, posture correction and self-efficacy in breast feeding females with kyphotic posture. this will be a randomized controlled trial conducted on (32) participants. data will be collected from civil hospital and al-siddique hospital, sialkot by using non-probability convenience sampling technique. breast feeding females between the age of 22 to 30 with kyphotic posture. participants who had a history orthopedic disorder, orthopedic surgery, history of recent fracture, non-lactating females will be excluded from this study. a sample of (32) will be divided in to two groups with (16) participants in each group. group a will be given klapp method exercises to the participant for a period of 1 month twice in a week for 50min. group b will be given printed information on an at-home exercise program, such, posture correction, corrective exercises and breathing exercises. they will be asked to perform the exercises twice weekly during the study and follow-up period. all these sessions will be of 50 minute for 2 session per week for 4 weeks. pre and post assessment of pain, pain will be assessed by visual analogue scale, posture will be evaluated by inclinometer, self-efficacy breast feeding will be assessed self-efficacy breastfeeding scale (bses-sf). data will be analyzed by using spss version 26.0

Eligibility criteria:
inclusion criteria: * primiparous females * female who had c-section * lactating females (females who have had feed their babies for last 6 months) * pain in neck (pain score 4-6 in visual analogue scale) * female with kyphotic angle greater than 45 degrees (assess by inclinometer) exclusion criteria: * history of orthopedic surgery (spinal fusion) * orthopedic disorder (disk degeneration, osteoporosis) * history of vertebral fracture * female who had given vaginal birth * breast feeding issues (lactation failure, nipple failure)

Keywords: exercises pain posture female self-efficacy
a new cochlear implant electrode for inner ear malformations

Conditions: Inner Ear Malformations

Summary: the custom made device was produced by med-el company. it has a "cork" like stopper instead of the usual silicon ring to prevent gusher. there are two types of electrodes consisting of different length. standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm (contact space 1.3 mm). it was used in 50 patients with different inner ear malformations. thirteen patients had gusher, and 11 patients oozing during cochleostomy. one patient with initial prototype of the cork electrode had to be revised because of persistent oozing around the electrode. another patient had slow extrusion of the electrode most probably due to csf (cerebrospinal fluid) pulsation and had to be revised. both patients had no more csf fistula. csf fistula in inner ear malformations is a serious situation which may lead to recurrent meningitis. the new cochlear implant electrode with "cork" stopper looks promising in preventing the postoperative csf leak around the electrode.

gusher in inner ear malformations is common in patients with incomplete partition type-i, and iii. it is also common in less severe form as oozing in incomplete partition type ii and large vestibular aqueduct. it is important to prevent csf escape around the cochlear implant electrode to prevent meningitis. the custom made device was produced by med-el company. it has a "cork" like stopper instead of the usual silicon ring to prevent gusher. there are two types of electrodes consisting of different length. standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm (contact space 1.3 mm). it was used in 50 patients with different inner ear malformations. thirteen patients had gusher, and 11 patients oozing during cochleostomy. one patient with initial prototype of the cork electrode had to be revised because of persistent oozing around the electrode. another patient had slow extrusion of the electrode most probably due to csf pulsation and had to be revised. both patients had no more csf fistula. csf fistula in inner ear malformations is a serious situation which may lead to recurrent meningitis. the new cochlear implant electrode with "cork" stopper looks promising in preventing the postoperative csf leak around the electrode.

Eligibility criteria:
inclusion criteria: * must have an inner ear malformation * must meet the criteria for cochlear implantation exclusion criteria: * prior cochlear implantation surgery

Keywords: inner ear malformations gusher cochlear implantation
a study of saquinavir soft gelatin capsules plus zidovudine plus lamivudine in the treatment of hiv-1 infected patients who have never taken anti-hiv drugs

Conditions: HIV Infections

Summary: to evaluate the efficacy of saquinavir-sgc combination with zidovudine and lamivudine in the treatment of hiv-1 infected patients with no previous anti-retroviral drug therapy.

all enrolled patients will receive the following 3 drug combination: saquinavir, zidovudine and lamivudine. efficacy and duration of anti-viral response will be evaluated by monitoring of hiv-1 rna levels. patients below the detectable limit of 200 copies/ml will be analyzed using the ultra-direct method with a detection limit of 20 copies/ml. cd4 and cd8 cell counts will also be analyzed.

Eligibility criteria:
inclusion criteria patients must have: * plasma hiv-1 rna titers \> 10,000 copies/ml. * cd4 cell count \> 100 cells/mm3. exclusion criteria co-existing condition: patients with any of the following conditions will be excluded: * any prior anti-retroviral drug therapy. prior medication: excluded: previous anti-retroviral drug therapy.

Keywords: drug therapy, combination acquired immunodeficiency syndrome zidovudine hiv protease inhibitors lamivudine saquinavir reverse transcriptase inhibitors anti-hiv agents
depression decision aid: feasibility pilot

Conditions: Depression

Summary: the goal of this proposed pilot study is to test the feasibility and acceptability of a depression decision aid (dda) protocol integrated into the electronic health record (ehr) and used by nurses with depressed ambulatory care patients. the depression decision aid protocol is a streamlined adaptation of an in-person shared decision-making (sdm) intervention, and its goal is to increase patient involvement in clinically appropriate treatment decision-making as a way of strengthening treatment engagement and outcomes. the protocol guides ambulatory care nurses in helping depressed patients (patient health questionnaire-9 \[phq-9\] \>10) develop informed treatment preferences through a process of education and values clarification. we will target patients in the general medical clinic, whether currently receiving depression treatment or not, because depression is highly prevalent but often poorly managed in this population.

the aims of this project are to evaluate the acceptability and feasibility of an electronic depression decision aid protocol with nurses and patients using questionnaire and administrative data. one to two nurses will deliver the decision aid protocol to 40 low-income patients (aged 21 and over) scoring \>10 via routine phq-9 screening. consenting nurses will be assessed regarding their satisfaction with the protocol following its use with each patient subject. nurse fidelity to the protocol will be evaluated via their documentation of protocol use in the ehr. consenting patient subjects will be assessed at baseline; week 1 to determine their decision about depression treatment, satisfaction with the decision-making process; and week 12 to determine treatment initiation or change, treatment adherence, and depressive status. medical records will also be examined for documentation of medication prescription and other depression treatments. the study will test the following hypothesis concerning the depression decision aid protocol: 1. feasibility and acceptability: a) at least 85% of each nurse's intervention sessions will meet fidelity standards via electronic health record (ehr) data; b) nurses will report high levels of satisfaction with the decision aid; c) patients will report high levels of satisfaction with the decision-making process;

Eligibility criteria:
inclusion criteria: * 21 years and older * medical outpatient presenting to the lincoln hospital ambulatory care clinic or geriatric sub-specialty clinic * screen positive for depression (patient health questionnaire-9 score of 10 or greater) exclusion criteria: * presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder * high suicide risk * cognitive impairment: mini mental status exam (mmse) score less than 24. * acute or severe medical illness (ie. delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke, or myocardial infarction during the three months prior to entry. * inability to speak english or spanish * aphasia interfering with communication
diaphragmatic myofascial release for hyperkyphotic subjects

Conditions: Hyperkyphosis

Summary: kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction. although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects.


Eligibility criteria:
inclusion criteria: * the participant's age ranged from 20 to 40 years. * kyphosis angle 40-50◦ * reporting pain on palpation of the diaphragm exclusion criteria: * a history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension. * history of any trauma or fracture to the thoracic spine. * inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit * restrictive respiratory disease, smokers.
effect of serum ldl cholesterol concentration on pancreatic insulin secretion

Conditions: Hypercholesterolemia; Insulin Resistance; Insulin Secretion

Summary: dyslipidemia is characterized by low levels of hdls, hypertriglyceridemia as well as an increases proportion of small dense ldls. changes in lipoprotein particles and its concentrations, especially increased levels of pro-atherogenic ldl particles play an important role in the development of cardiovascular diseases. it is well established that statin/pcsk9-inhibitor treatment is very effective in lowering ldl cholesterol levels and therefore in preventing cardiovascular events. besides the beneficial effects on cardiovascular system, these therapies are unfortunately linked to increased risk for type 2 diabetes. however underlying mechanisms for the association between ldl cholesterol levels and the risk for type 2 diabetes remains largely unknown.type 2 diabetes is especially characterized by insulin resistance and impaired insulin secretion from pancreatic beta-cells. insulin resistance alone is insufficient to cause type 2 diabetes, as long as the ß-cell is able to compensate for the increased demand for insulin. once this compensatory mechanism reaches its physiological limits, individuals progress to type 2 diabetes. accordingly we aimed to investigate the associations between ldl cholesterol concentrations and the key issue in the pathogenesis of type 2 diabetes, insulin secretion before and after lowering cholesterol concentration by treatment with evolocumab for 12 weeks in patients with medical indication for a treatment with a pcsk9-inhibitor. therefore, patients will either undergo a hyperglycemic clamp or a oral glucose tolerance test in randomized manner.


Eligibility criteria:
inclusion criteria: * understand and voluntarily sign an informed consent document prior to any study related assessments/procedures * medical indication for the treatment with a pcsk9-inhibitor * hba1c \< 6,5% exclusion criteria: * diabetes mellitus * pregnant women or breastfeeding * hb \< 11.5 g/dl (males) or hb \< 10.5 g/dl (females) * treatment with any medication that effects on blood glucose concentrations, e.g. antidiabetic drugs or steroids * any pancreatic disease
online intervention to promote resilience to traumatic stress during pregnancy

Conditions: Posttraumatic Stress Disorder; Pregnancy Related

Summary: the investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "sunnysideflex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of ptsd and better manage mood during and after pregnancy. sunnysideflex will build upon the previously irb-approved "sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. women in weeks 16-28 of their pregnancy who self-report symptoms of ptsd will be randomized to one of three study groups: (1) sunnysideflex, (2) the original sunnyside intervention (active control), or (3) treatment as usual (tau). the sunnysideflex intervention will consist of 6 weeks of trauma-informed online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. outcomes will be measured at baseline, post-intervention, 6 weeks postpartum, and 12 weeks postpartum. sunnysideflex has the potential to provide a novel paradigm for improving maternal and child health outcomes in high-risk, trauma-exposed women.


Eligibility criteria:
inclusion criteria: * female * 18 years and older * pregnant and between 16-28 weeks gestation * are currently engaged in prenatal care with a healthcare provider (ob/gyn, nurse, midwife, etc.) * endorse a history of one or more potentially traumatic events meeting diagnostic and statistical manual of mental disorders-5 (dsm-5) criterion a for ptsd (i.e., "exposure to actual or threatened death, serious injury, or sexual violence," american psychological association \[apa\], p. 271) that is interpersonal in nature (e.g., sexual or physical assault, child abuse/maltreatment, witnessing family violence) * endorse a score of 33 or greater on the ptsd checklist for dsm-5 (pcl-5) * have access to a broadband internet connection * able to read and speak english exclusion criteria: * pregnant with multiples * have visual, hearing, voice, or motor impairment that would prevent completion of study procedures * have been diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report * report currently being in an abusive or unsafe relationship * currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)
hydroxychloroquine use in hospitalized patients with covid-19: impact on progression to severe or critical disease

Conditions: COVID-19

Summary: the primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with covid-19 and risk factors for severe/critical disease.

this study will utilize a randomized, placebo-controlled, double-blinded design. patients admitted with confirmed covid-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on ct/cxr, age \>65, diabetes, hypertension, bmi \> 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg po bid x 2 doses, then 200 mg po bid x 8 doses or placebo at a matching schedule.

Eligibility criteria:
inclusion criteria: * admitted to wellstar kennestone hospital * age 18 years or older * laboratory-confirmed covid-19 * at least 1 of the following: 1. requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline 2. bilateral infiltrates on cxr or ct of chest 3. age 65 or older 4. diabetes 5. hypertension 6. bmi \> 35 7. chronic lung disease 8. cardiovascular disease 9. chronic kidney disease 10. cancer (hematologic malignancies, lung cancer, and metastatic disease) exclusion criteria: * unable to provide informed consent * unable to take oral medication * severe/critical covid-19 disease at presentation 1. intensive care or intermediate care required at admission or within 48 hours 2. requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours * likelihood of survival \<48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission * inability to take hydroxychloroquine due to allergy, qtc \> 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known g6pd deficiency, known porphyria, or significant drug- drug interactions * pregnant or breastfeeding * severe liver disease (child-pugh class c)
azelnidipine anti-coronary atherosclerotic trial in hypertensive patients by serial volumetric ivus analysis(alps-j)

Conditions: Hypertension; Coronary Atherosclerosis

Summary: in patients with hypertension who undergo elective pci, the effects of long-term administration of calblock (azelnidipine) on plaque volume will be determined quantitatively by 3d-ivus and compared with those of amlodipine besilate (norvasc or amlodin).

clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events in patients with coronary artery disease. recently, suppression of the development of coronary atherosclerotic plaque by calcium antagonists has been reported as one of the mechanisms involved. thus, calcium antagonists have been promising strategy for preventing the progression of the coronary atherosclerosis. various calcium antagonists are clinically available at present and these drugs may differ from each other with respect to the anti-atherosclerotic effects. consequently, we plan to perform the alps-j study to compare the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque quantitatively by ivus. in this study, azelnidipine (16 mg/day) or amlodipine besilate (5 mg/day) will be administered to patients with hypertension for 48 weeks after elective pci. the plaque volume will be measured in each patient by ivus at the time of pci and 48 weeks after pci. percent change in plaque volume from the baseline value will be used as the primary endpoints for evaluation of efficacy. we plan to enroll 100 patients in each group for a total of 200 patients.

Eligibility criteria:
inclusion criteria: * age: between 20 and 79 years (at the time of giving informed consent). * sex: either sex. * admission status: outpatients. * patients requiring treatment for hypertension according to the jsh 2004 hypertension therapy guidelines before beginning this study * patients who have not used any calcium antagonists for at least 4 weeks before the beginning of this study. * patients who are scheduled to undergo elective pci. exclusion criteria: * patients with acute coronary syndrome (acs). * patients who have experienced q-wave myocardial infarction within 4 weeks before beginning this study. * patients with renal dysfunction (serum creatinine \>2.0 mg/dl). * patients in whom pci is unsuccessful. * patients with cardiogenic shock. * patients with moderate or severe congestive heart failure. * patients with 50% or more stenosis of the main trunk of the left coronary artery. * patients with other problems whom the investigator considers unsuitable for this study.

Keywords: hypertension pci calcium channel blockers ivus plaque
subject reported target-lesion numeric rating scale evaluation by subjects with plaque psoriasis treated with clobex® (clobetasol propionate) spray 0.05%

Conditions: Plaque Psoriasis

Summary: the aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with clobex spray treatment.


Eligibility criteria:
inclusion criteria: * subjects 18 years of age or older. * subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray. * subjects with a target lesion of at least 1 cm x 1 cm * subjects who agree to be photographed at each visit exclusion criteria: * subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study. * subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink. * subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial. * subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any galderma employee. * subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.