Kornimate/medical-research-clean huggingface dataset:
use of tens unit in the management of endometriosis pain

Conditions: Endometriosis; Pelvic Pain

Summary: the purpose of this study is see if transcutaneous electrical nerve stimulator (tens) units help decrease endometriosis flare pain. tens units have a 510k and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the tens unit. after the first 3 month period of time, a tens unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the tens unit.

the investigators propose to conduct a cross-over clinical study to evaluate the effectiveness of tens units on the management of endometriosis flare-related pain. subjects will participate in a 3-month "baseline" period (no tens unit use for endometriosis flares) and then cross-over to a 3-month "treatment" period (tens unit use for endometriosis flares). potential subjects will be pre-screened in the penn state minimally invasive gyn (migs) surgery clinic for pathologically diagnosed endometriosis and from the penn state migs endometriosis database. potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. if fulfilled, potential subjects will follow up at the enrollment visit (visit 1) where consent is reviewed and signed. the baseline qol and fsfi redcap surveys will be completed at this visit. subjects will be set up to receive automated links to complete diary entries and surveys directly in redcap. prior to initiating tens unit use for endometriosis flare-related pain, subjects will record daily entries into redcap during episodes of endometriosis flares for 3 months. each entry will record their vas pain score as well as medication intake and bleeding profile. subjects will then be mailed the tens unit at the 3 months mark into the study. subjects will then complete entries with tens use at their discretion for the following 3 months and record tens unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. at the end of the study, subjects will complete a qol and fsfi survey.

Eligibility criteria:
inclusion criteria: 1. females ages 18-45 years at time of enrollment 2. a surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis 3. average monthly endometriosis pain flare 4. naïve tens user exclusion criteria: 1. tens device exclusion: 1. implantable devices (pacemaker, interstim, etc.) 2. cardiac arrhythmia 3. open skin sores over areas of placement 2. pregnancy 3. nursing or trying to conceive at this time 4. post-operative \<12 weeks from abdominal or pelvic surgery 5. planned surgery or hormonal medication changes for duration of study if applicable 6. non-english speaking or inability to read and understand english 7. prisoners
a study to evaluate the long-term safety and tolerability of lu af20513 and the antibody response in patients with alzheimer's disease (ad)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the long-term safety, tolerability and antibody response of lu af20513 in patients with alzheimer's disease who have completed the 16026a study.


Eligibility criteria:
main inclusion criteria: * the patient has completed the 16026a study and has received the last study treatment within 12 months of the screening visit for the present study. * the patient has an mri scan done in relation to study 16026a performed within 9 months before first study visit in the extension study. * the patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor immunisation-related events after each immunisation, and participate with the patient at phone visits during the study main exclusion criteria: * the patient uses or has recently used (pre-trial time limits specified in appendix ii) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (appendix ii) during the study. * the patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability more inclusion and exclusion criteria may apply
natural history of asymptomatic superior mesenteric arterial stenosis.

Conditions: Stenosis

Summary: the aim of this study was to evaluate asymptomatic superior mesenteric artery (sma) stenosis prognosis according to the presence of coeliac artery (ca) and/or inferior mesenteric artery (ima) associated stenosis.

background: the benefit of preventive treatment for sma stenosis remains uncertain. the latest guidelines remain unclear given the lack of data in the literature.

Eligibility criteria:
inclusion criteria: * the presence of coeliac artery (ca) and/or inferior mesenteric artery (ima) associated stenosis. exclusion criteria: -

Keywords: sma stenosis stenosis on scanner
a study of folatescan in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate 99mtc - ec20 imaging (folatescan), a nuclear medicine imaging technology that enables localization of activated macrophages in the joints of participants with knee osteoarthritis (oa). twenty five participants with symptomatic unilateral or bilateral knee oa will undergo a one-time evaluation of the knee as follows: knee radiography, folatescan of the knees and whole body, musculoskeletal exam, questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory markers. data analysis will be cross-sectional and include a comparison of the location and intensity of ec20 uptake with the following: radiographic knee oa severity, clinical measures of disease severity, cytokine expression, and synovial fluid cell count.

each study day will on average last one day per individual and each individual will be followed for development of an adverse event for 7 days

Eligibility criteria:
inclusion criteria: unilateral or bilateral knee oa; kellgren lawrence grade 1-4; knee pain on most days of any one-month in the last year in at least one knee; age \> 18 years old. exclusion criteria: arthroscopic knee surgery within the previous 12 months; intra-articular injection or systemic (oral, iv, im) steroid within previous 6 months; any knee replacement; current enrollment in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study); pregnancy; positive serum beta hcg within 48 hours prior to 99mtc-ec20 administration and/or lactation; rheumatoid arthritis or other inflammatory arthropathy; avascular necrosis; periarticular fracture; current anticoagulant therapy; current immune modulator therapy, or any such therapy within 4 weeks of study procedures; inability to discontinue use of nsaids within 3 days of study procedures (low dose aspirin of up to 325 mg per day is permitted); must be able to stop folic acid containing vitamins 24 hrs before study; paget's disease; villonodular synovitis; joint infection; ochronosis; neuropathic arthropathy; acromegaly; hemochromatosis; wilson's disease; osteochondromatosis; personnel directly affiliated with this study or their immediate family members; concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Keywords: osteoarthritis nuclear medicine macrophages
an audit on management of chronic diarrhea

Conditions: Chronic Diarrhea

Summary: the study is to assess whether the staff in gastroenterology unit are sticking to the agreed up on unit's protocol in management of chronic diarrhea over the period of one year(september 2017-september 2018)

chronic diarrhea is defined as having loose or watery stools more than three times aday.awakening at night to pass stools us often sign of an organic cause of diarrhea.in some cases chronic diarrhea is the result of intestinal infection that persists longer than expected. in other cases chronic diarrhea is apart of a systemic illness. etiology: 1. post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after acute gastroenteritis.also secondary disaccharidase deficiency and reinfection may be a cause. 2. infectious causes:enteric infection is an important cause.associated conditions may be t.b or impaired immunity as in malnutrition potentiating the likely-hood of prolonging or acquiring another infection.viral infection like rota virus,parasites as e.coli,giardia lamblia as well as amebiasis have been implicated in chronic diarrhea. 3. cytomegalovirus on the other hand may act as an opportunistic agent in immuno compromised patients. 4. non infectious causes include cow's milk allergy,lactose intolerance and inflammatory bowel disease,all of which may cause chronic diarrhea that is often associated with abdominal pain with or without elevated levels of inflammatory markers. 5. malabsorption syndrome e.g celiac disease,cystic fibrosis where the stools are usually fatty in nature and bulky in amount. good management of chronic diarrhea must include investigations and treatment.a protocol must be followed accurately therefore. methodology: measurment of the degree of sticking of staff in gastro-enterology unit to the agreed upon unit's protocol in management of chronic diarrhea over the period of one year (september 2017-september 2018).

Eligibility criteria:
inclusion criteria: * age group from 2 months to 18 years * cases with diarrhea lasts 2 weeks or more * genetically free exclusion criteria: * age group from 0-2 months * age group above 18 years * cases with diarrhea less than 2 weeks * gentic disease
gratitude interventions for academic stress among pakistani adolescents

Conditions: Stress, Psychological

Summary: the experimental nature of this study will provide the empirical data in analyzing the effectiveness of gratitude exercises which later can be adapted in stress reduction programs at school level. this research will focus on the school related positive life experiences for example thinking about a teacher/mentor kindness and contribution in their lives, then write a letter that describes their gratitude \& letter will be delivered to that person indirectly. this may help in focusing on the positive aspects of school life. this modification will serve as testing this new model for assessing the combined effect of gratitude interventions.

academic stress is an inevitable part of students' lives with long-term negative consequences on physical health, mental well-being, and social relations. in asian cultures, expectations of parents and teachers are additional components of academic stress which have not been addressed in different stress management programs. therefore, the present research addresses these contributory stress factors by using gratitude interventions in pakistani high schools. the study employs broaden and build theory and cognitive appraisal theory in formulating the intervention model and variables being tested through pretest-posttest experimental research design with a control group. a total of 102 high school students from two genders segregated schools of rawalpindi city, pakistan, served as the participants. they were randomly assigned into experimental and control groups, with 51 participants in each group. there were 41 boys and 61 girls with a mean age of 15.71+ 0.92 years. the measures included academic expectations stress inventory (aesi), inventory of high-school students' recent life experiences (ihssrle), modified differential emotions scale (mdes), gratitude questionnaire-6 (gq-6) and gratitude adjective checklist (gac). three gratitude interventions, including count your blessings, gratitude letters and loving-kindness meditation, were modified to focus on school-related experiences. the model consisted of nine sessions applied in schools for four weeks with 30-40 minutes each day. the research protocol and intervention model were adapted into urdu for better understanding among participants. the data were analyzed through descriptive and inferential statistics (frequency, percentage, mean, sd, paired sample t-test, independent sample t-test, multivariate analysis of variance and effect size).

Eligibility criteria:
inclusion criteria: * high school students * studying in same school for at least last six months * within 14-17 years of age * not having severe physical health issue or going under treatment for chronic illness exclusion criteria: * not able to understand urdu language * above 17 years of age or below 14 years * recently enrolled in the particular school

Keywords: academic expectations emotional experiences
chronic inflammatory activation in fat tissue: an atherogenic factor in severe coronary artery disease

Conditions: Severe Coronary Artery Disease; Obesity; Impaired Glucose Tolerance

Summary: chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. the aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or metformin) in obese patients with severe coronary artery disease (cad) and impaired glucose tolerance.


Eligibility criteria:
inclusion criteria: * either impaired glucose tolerance (2 hour plasma glucose concentration \> 7.8 and \ 6.0 and \< 7.0 mmol/l) * body mass index (bmi) \> 25 * severe coronary artery disease determined by coronary angiography * male patients aged 35-75 years exclusion criteria: * diabetes mellitus type i * diabetes mellitus type ii in combination with glycosylates hemoglobin \> 6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \> 11.0 mmol/l * unstable angina pectoris * myocardial infarction within the last 4 weeks * reduced left-ventricular systolic function \< 30%

Keywords: adiposity
prospective cohort study of intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of chinese hospitalised adult patients with intracerebral hemorrhage.

intracerebral hemorrhage (ich) remains a devastating disease with high mortality, yet few therapeutic managements have been proved effective. large quantities of work needs to be done to fully delineate the prevalence and prognosis of ich. hence, the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective, treatments and prognosis of chinese hospitalised adult patients with ich.

Eligibility criteria:
inclusion criteria: * hospitalized patients over 18 years old of primary intracerebral hemorrhage. exclusion criteria: 1. patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor. 2. isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients； 3. surgical evacuation of hematoma； 4. unavailability to get complete blood cell samples and presenting contraindications or refusal to mri 5. patients cannot be followed up for any reasons. 6. patients death in 24 hours 7. pregnant patients

Keywords: primary intracerebral hemorrhage hypertension perihematomal edema secondary brain injury remote diffusion-weighted imaging lesions (r-dwils) immune response multimodel image cohort mri
opioid-sparing protocol comparing with opioid-based protocol after bilateral total knee arthroplasty

Conditions: Knee Replacement; Postoperative Pain; Opioid Use

Summary: the concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. compared to the opioid-based patient controlled analgesia(pca), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. the purpose of this trial in to provide a novel opioid-sparing protocol (osp) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.


Eligibility criteria:
inclusion criteria: * patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery * willing to participate in this study and randomly allocated to either opioid-sparing protocol or pca protocol. exclusion criteria: * patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs * chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment) * substance abuse (e.g. alcoholism) * severe renal impairment.

Keywords: bilateral total knee arthroplasty opioid use opioid sparing postoperative pain
a study to evaluate the safety, efficacy, pk, pd and immunogenicity of cipaglucosidase alfa/miglustat in iopd subjects aged 0 to <18

Conditions: Glycogen Storage Disease Type II Infantile Onset

Summary: this is a phase 3, open-label, multicenter study to evaluate the safety, efficacy, pk, pd, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ert-experienced and ert-naïve pediatric subjects with iopd.


Eligibility criteria:
inclusion criteria: cohort 1: 1. male or female subjects who are aged 6 months to \< 18 years on day 1 2. subject must have documentation of iopd genotype 3. subject must have had hypertrophic cardiomyopathy at the time of diagnosis 4. subject must have received ert for at least 6 months immediately before enrollment. for subjects whose ert dosage has been modified, the subject must have been on the modified dosage and regimen for at least 3 months before enrollment 5. subjects aged ≥ 12 to \< 18 years must perform one valid 6-minute walk test (6mwt) (≥ 75 meters) at screening; subjects aged ≥ 5 to \< 12 years must perform one valid 6mwt (≥ 40 meters) at screening; subjects aged 18 months to \< 5 years must be ambulatory and assessed to be likely to be able to perform 6mwt (≥ 40 meters) when they turn 5 years old 6. subjects must have experienced a clinical decline on their current rhgaa dose and frequency cohort 2: 1. male or female subjects who are aged 0 to \<6 months at day 1 2. subject must have documentation of iopd genotype 3. subject must have had hypertrophic cardiomyopathy at the time of diagnosis 4. subject is ert-naïve long-term extension (cohort 1 or cohort 2): 1. subject must have, in the opinion of the investigator, benefited from therapy with cipaglucosidase alfa/miglustat during the 104-week primary treatment period with no significant safety concerns. exclusion criteria: cohort 1 and cohort 2, unless specified 1. subject requires invasive ventilation (eg, tracheostomy) 2. subject is crim negative and has not received prophylactic immunomodulation (cohort 1); subject is crim negative and will not be receiving prophylactic immunomodulation (cohort 2) 3. subject has a history of life-threatening iars/hypersensitivity (eg, anaphylaxis and severe cutaneous reactions) to ert (eg, alglucosidase alfa, cipaglucosidase alfa, miglustat) or other iminosugars, or to any of the excipients, where rechallenge was unsuccessful 4. subject has prior history of illness or condition known to affect motor function 5. female subject is pregnant (or intends to get pregnant) or breastfeeding at screening (cohort 1)
zoledronic acid treatment (every 4 or 12 weeks) to prevent skeletal complications in advanced multiple myeloma participants

Conditions: Multiple Myeloma

Summary: this study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (iv) bisphosphonate for about one to two years.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma * have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma * stable renal function exclusion criteria: * known sensitivity to bisphosphonates * receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover * current active dental problems * had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple myeloma zoledronic acid skeletal complications bone
anti-human cd45 monoclonal antibodies in patients with advanced leukemia prior to allogeneic stem cell transplantation

Conditions: LEUKEMIA

Summary: participants in this study have a hematologic malignancy which is a disorder in the bone marrow that affects the body's ability to create blood. participants might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor). the participants donor is a family member. stem cells are cells in the bone marrow and blood that can form a whole new blood system.

patients are given high doses of chemotherapy before receiving a stem cell transplant to keep their immune system from rejecting the donor stem cells and to kill any diseased cells that remain in the body. to try and improve on the results of transplants that use high dose chemotherapy alone, we are adding an agent called anti-cd45 to the treatment prior to the stem cell transplant. anti-cd45 is an antibody that specifically finds and destroys leukemia cells. patients will receive the anti-cd45 with high dose chemotherapy (including ara-c and cyclophosphamide) and radiotherapy. patients will also receive mesna which is a drug that helps prevent bladder damage which can be caused by the cyclophosphamide. high dose radiotherapy is also known as total body irradiation or tbi. patients will receive the anti-cd45, high dose chemotherapy, and high dose radiotherapy before the stem cell transplant. we expect participation in this study will last 2 years. a summary of the treatment follows: * day - 7: ara-c, cyclophosphamide, mesna * day - 6: ara-c, cyclophosphamide, mesna * day - 5: ara-c, anti-cd45 * day - 4: anti-cd45, tbi * day - 3: anti-cd45, tbi * day - 2: anti-cd45, tbi * day - 1: tbi * day 0: stem cell infusion (transplant)

Eligibility criteria:
inclusion criteria: 1. patients with advanced leukemia or other hematologic malignancy including aml, all, cml, and mds. advanced features include: a) induction failure, prolonged induction beyond 6 weeks b) incomplete response to salvage therapy c) cml in blast crisis or acute leukemia in chemotherapy resistant relapse d) secondary leukemia or secondary myelodysplastic disease 2. patients must have a suitable hla identical sibling donor or 5/6 matched related donor, or fully matched or 5/6 matched unrelated donor, or haploidentical related donor. exclusion criteria: 1. patients with a life expectancy (2x normal for age) 7. patients with known allergy to rat serum products 8. patients with a lansky score \<60% or karnofsky score \<60%. 9. patients with severe infection that on evaluation by the pi precludes ablative radio/chemotherapy or successful transplantation. 10. patients with sever personality disorder or mental illness. 11. patients with documented hiv positivity 12. pregnant or lactating females

Keywords: leukemia