Kornimate/medical-research-clean huggingface dataset:
guided self-help for binge eating

Conditions: Bulimia Nervosa; Eating Disorder Not Otherwise Specified; Binge Eating Disorder

Summary: guided self-help (gsh) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. the current study proposes to investigate the effectiveness of providing gsh either face-to-face or via e-mail, also using a delayed treatment control condition. symptom outcomes will be assessed, and an estimate of cost-effectiveness made. results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision. please note that we are only able to offer the intervention to individuals who are currently registered with a general practitioner that is covered by oxford health nhs foundation trust - this is typically restricted to practices in oxfordshire, buckinghamshire, and parts of wiltshire.


Eligibility criteria:
inclusion criteria: * registration with a general practitioner covered by oxford health nhs foundation trust (typically: oxfordshire, buckinghamshire, parts of wiltshire) * primary diagnosis of an eating disorder with recurrent binge eating (bn, ednos \[bn-type\] or bed) * age above 17.5 years (box below requires whole numbers) exclusion criteria: * a severe eating disorder (e.g., one complicated by medical issues that would not be best managed by a self-help intervention) * bmi \<18.5 * rapid weight loss (regardless of bmi) * current excessive drug use * active and untreated psychosis (the latter two are usually exclusion criteria to the eds)
misha post-market clinical study

Conditions: Osteo Arthritis Knee

Summary: prospective evaluation of the safety and effectiveness of the misha knee system. the study will collect data on the procedural and long-term adverse events, womac pain and function scores, kss satisfaction, subsequent surgical interventions, bmi levels, range of motion, ucla activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure. the primary analysis of this study is freedom from device- and procedure-related ssis at five (5) years post-implantation. this study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years. study subjects will be followed over a five-year post-implant period.


Eligibility criteria:
key inclusion criteria: 1. subjects aged 25 to 65 years at time of index procedure 2. body mass index (bmi) of \< 35 3. activity exacerbated knee pain isolated to the medial compartment and not global in nature 4. womac pain ≥ 40 5. failed non-operative oa treatment key exclusion criteria: 1. large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device 2. poor bone quality (e.g., bony erosion, osteopenia, osteoporosis) 3. ligamentous instability 4. active or recent knee infection 5. inflammatory joint disease, including sequalae of viral infections 6. suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals 7. history of keloid, hypertrophic or contracture scaring 8. propensity for restrictive scar formation or adhesions with prior procedures
chronic lymphocytic leukemia responds to dermal chelation

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this clinical trial is to identify 50 participants with chronic lymphocytic leukemia (cll) and follow their total white blood cell (wbc) counts and absolute lymphocyte counts after performing dermal chelation and administering nutritional therapy

the purpose of this clinical trial is to use dermal chelation and hair tissue analysis to identify 50 participants with cll. the total wbc counts and absolute lymphocyte counts of these participants will be followed after serial dermal chelations and nutritional therapy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic lymphocytic leukemia and has a toxic heavy metal load * toxic heavy metal load exclusion criteria: * pregnant * pacemaker implants * organ transplant recipients * psychotic episodes or epileptic seizures

Keywords: chronic lymphocytic leukemia cll dermal chelation nutritional therapy
pubertal blockade and estradiol effects on cardiometabolic health for transitioning youth

Conditions: Transgenderism; Gender Dysphoria; Insulin Sensitivity

Summary: to evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.


Eligibility criteria:
inclusion criteria (transgender females): * identify as a transgender female * age 13-16 years at the time of enrollment * if on a gonadotropin releasing hormone analogue, \> 6 months exposure * plan to start estradiol clinically in \< 4 months inclusion criteria (cisgender males and females): * males and females ages 13-16 years exclusion criteria: * cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures * antipsychotic medication use * type 1 or 2 diabetes (by medical history) * polycystic ovarian syndrome (pcos for cisgender females) * hypertension (resting bp ≥ 140/90 mm/hg) * weight\> 400 lbs * on oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant) * pregnancy (for cisgender females)
viral pathogenesis of early cystic fibrosis lung disease

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to test the hypothesis that early viral infections alter the bacterial flora and inflammatory profile in the airway and accelerate progression of pulmonary disease in infants with cystic fibrosis.

the proposed study is a unique international collaboration between three large cf research centers. this proposal will determine the impact of early respiratory viral infections on bacterial flora and inflammatory profiles in the cf airway as well as the impact of these pathogens on clinical, physiologic and structural markers of disease.the proposed study is designed to follow infants diagnosed with cf through newborn screening to determine the effect of viral infections on the lower airway microbiome, clinical symptoms, pulmonary function and structural changes during the first year of life. the proposed study will measure lower airway inflammation and infection using bal, oral swabs, and nasal swabs; outcomes will be assessed through infant lung function testing, computerized tomography scans of the chest, and pulmonary exacerbation rate.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cf by newborn screening, at least one clinical feature of cf, and documented sweat chloride greater than 60 meq/l by quantitative pilocarpine iontophoresis or compatible genotype with two identifiable mutant cftr alleles. 2. less than 4 months of age at screening visit 3. ability to comply with study visits and study procedures as judged by site investigator. exclusion criteria: 1. intercurrent respiratory illness, defined as increase in cough, wheezing, or respiratory rate with onset 14 days before ipft-bronchoscopy visit. 2. measured hemoglobin oxygen saturation less than 95% during the ipft-bronchoscopy visit. 3. history of adverse reaction to sedation. 4. clinically significant upper airway obstruction as determined by the site investigator. 5. severe gastroesophageal reflux, defined as persistent frequent emesis despite therapy. 6. major organ dysfunction, not including pancreatic dysfunction. 7. physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator.
analysis of brain activity to uncover brain-behavior relationships related to therapy outcomes in aphasia

Conditions: Aphasia

Summary: aphasia is a loss of language due to stroke or other brain injury. word-finding in conversation is a universal and persistent difficulty in aphasia. while several techniques exist to improve word-finding in aphasia, it is unclear how the brain changes in response to behavioral therapy. in this study, persons with aphasia will receive behavioral therapy aimed at helping them to be more successful at finding words. twenty therapy sessions will be provided in a 10-week period. each therapy session will last about 2 hours and will include a variety of language tasks. prior to beginning word-finding therapy, each participant will receive two fmri scans, spaced 10 weeks apart. after finishing therapy, each participant will receive two additional fmri scans, spaced 10 weeks apart. for a portion of the mri scan, participants will complete language tasks. the purpose of these fmri scans is to measure brain changes that may occur due to successful behavioral therapy. the hypotheses are as follows: first, that the behavioral therapy will improve word-finding as it has been shown to do in the past. second, that the brain will change in a couple of different ways. it is expected that the network of regions that support word-finding will be more connected and work together more efficiently after therapy. it is also expected that the networks of regions that support other aspects of cognitive function, such as attention and executive function, will also be more connected and work together more efficiently.


Eligibility criteria:
inclusion criteria: 1. diagnosis of aphasia 2. sustained stroke more than 6 months prior to consent 3. right-handed 4. native speakers of english 5. completed at least a high school education 6. normal or corrected-to-normal vision and hearing 7. provide written informed consent 8. participants will be medically stable and at least wheelchair ambulatory at the time of participation with uncompromised use of the left hand exclusion criteria: 1. history of degenerative neurological disorders (e.g., alzheimer's disease), acquired neurological disorders other than aphasia from stroke (e.g., traumatic brain injury), developmental neurological disorders (e.g., autism), or psychiatric disorders 2. an active medical condition that could compromise participation (e.g., cancer undergoing acute treatment) 3. not safe to enter the bore of the magnet (e.g., pacemaker) 4. taking medications that are known to exert significant effects on cognitive processes 5. pregnancy or possibility of pregnancy 6. do not meet the above inclusionary criteria

Keywords: aphasia treatment therapy anomia fmri neuroimaging semantics
tudca as a therapy for ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: this is a phase i open label study examining the efficacy and safety of tudca (tauroursodeoxycholic acid) in ulcerative colitis treatment.

tudca (tauroursodeoxycholic acid) is a dietary supplement that has shown to reduce cellular stress related to inflammation. in this phase i study, patients with active ulcerative colitis will be receive tudca for six weeks. safety and tolerability will be assessed. efficacy will be assessed using ulcerative colitis disease activity measurements as well as markers of intestinal inflammation before and after treatment. the overall goal of this project is to determine tudca can provide a new therapeutic option with a desirable safety profile for patients with ulcerative colitis focused on the inflamed intestinal epithelium.

Eligibility criteria:
inclusion criteria: * ages eligible for study: 18 years to 65 years; * confirmed ulcerative colitis disease through radiographic, endoscopic and/or histologic criteria; * confirmed with active ulcerative colitis (defined as a complete mayo score ≥ 5 with endoscopic subscore of ≥ 1) see appendix for mayo score using recent adaptation to include any friability on endoscopy to be scored as "2". * on a stable dose of medications for inflammatory bowel disease (ibd) (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than tudca. exclusion criteria: * those that received other chemical chaperone therapies in the 3 months prior to screening; * individuals accompanied by gallstones, other intestinal disorders or cancers, or any possible cholestatic pathologies that could alter the enterohepatic circulation of the bile acids, including previous cholecystectomy or short bowel syndrome; * subjects with alcohol or drug abuse within the recent year; * serious heart, lung, kidney, digestive, nervous, mental, or autoimmune diseases * those with plans for abdominal surgery; * those unable or unwilling to provide informed consent or failure to comply with the test requirements; * pregnant, lactating women; * those receiving or planning to receive medicines that inhibit the absorption of the bile acids in the intestine; * all female subjects must have birth control and not plan to become pregnant during the study. as tudca may interfere in the absorption of oral contraceptives, the acceptable methods of birth control should include abstinence or 2 of the following intrauterine device (iud-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, and /or condoms. * subjects with baseline liver transamines (ast or alt) \> 1.5 x the upper limit of normal. * patients with complete biliary obstruction and known hypersensitivity or intolerance to tudca or any of the components of tudcabil (or to other bile acids). * patients with moderate-to-severe hepatic impairment. * evidence of worsening liver function based on the 2 initial laboratory values used to establish the baseline.

Keywords: ulcerative colitis tudca tauroursodeoxycholic acid
a study to assess the use of the sentinel device during atrial fibrillation ablation

Conditions: Atrial Fibrillation

Summary: researchers are determining whether the use of the sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain mri. we are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (af) ablation procedures with and without use of the sentinel device.

patients currently participating in the research study titled: "a pilot randomized study of the use of the sentinel device for cerebral protection during atrial fibrillation ablation" will be asked to participate in this sub-study to collect additional mri and laboratory data to support the main study. this study will assess the number, size and volume of new cerebral emboli in protected territories detected using mri of the brain within 7 days after af ablation in patients treated with the sentinel device compared to controls not receiving the sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for af who provide informed consent will be included exclusion criteria: * severe peripheral arterial disease that precludes deployment of sentinel device * unable to undergo mri brain due to the presence of an mri noncompatible implanted device * unable or unwilling to provide informed consent. * known history of dementia.
assessment of efficacy and safety in relieving opioid-induced constipation in patients with cancer-related pain

Conditions: Opioid-Induced Constipation

Summary: the purpose of this study is to compare the effect of nktr-118 with placebo in the treatment of opioid-induced constipation (oic) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (lir). the study consists of 2 parts; a initial 4-week treatment period (part a) and then a 12 week extension with active treatment (part b).


Eligibility criteria:
inclusion criteria: * provision of written informed consent prior to any study-specific procedures. * men and women aged 18 or older. * histologically or cytologically confirmed neoplasm causing pain and requiring management with opioids. * self-reported active symptoms of oic at screening (\ 1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of bms over the previous 4 weeks); and documented confirmed oic (\<3 rfbms/week on average aver the 2-week oic confirmation period. * receiving a stable maintenance opioid regimen consisting of a total daily dose of \>30 mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a minimum of 4 weeks prior to screening for cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression. exclusion criteria: * patients receiving opioid regimen for treatment of pain other than related to cancer. * any condition that may have affected the permeability of the blood-brain barrier, eg, known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy. * patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are excluded. patients with multiple myeloma will be allowed. * patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to visit 1 (screening) and/or during part a of the study are excluded. any patients with suspected clinically relevant radiation-induced injury of small or large intestine are excluded. * pregnancy or lactation.

Keywords: cancer-related pain opioid-induced constipation oic
evaluation of irise mhealth app on healthcare workers' (hcws') self-efficacy and willingness to respond during public health emergencies in pakistan

Conditions: Behavior Change; Self Efficacy

Summary: the purpose of this study is to assess the effectiveness of a novel mhealth intervention that is being designed to promote self-efficacy and response willingness among pakistan-based emergency department health care workers (hcws) in public health emergencies and disasters. this application seeks approval for the trial of the intervention. the purpose of this trial is to gauge short-term (1-month), medium-term (6-months), and longer-term (12-months) impacts of irise mhealth app on low and middle income based countries hcws' self-efficacy and willingness to respond (wtr) during public health emergencies and disasters. the investigators will test the hypothesis that the irise app would yield an increased 12-months wtr in aga khan university hospital (akuh) and jinnah postgraduate medical center (jmpc) emergency departments.


Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study if * aged 18 years or older, * have worked in the current job position for at least three months, * current emergency department clinical staff/employee involved in direct patient care (doctors, nurses, and technicians) at a participating institution (aga khan university hospital (akuh), jinnah postgraduate medical centre (jpmc) * understand and write english, * own a smart phone and have access to the internet to download the app. exclusion criteria: participants will not be eligible to participate if * younger than 18 years of age, * have worked in the current job position for less than three months, * are not a current employee or staff member as described above, * are auxiliary personnel such as registration staff, housekeeping, porters, and security personnel, * don't understand and write english, or * don't own a smart phone or have access to the internet to download the app.
stress and anxiety affect residents' performance

Conditions: Stress; Stress Disorder; Work Related Stress

Summary: being an anesthesiologist implies huge dedication and both physical and psychological efforts. none has ever studied the impact of a working day on anxiety, perceived stress levels, physiological data, and executive functions.

during a working day, trainees will have their physiological and psychological data recorded before starting their clinical activity and after them. electrodermal activity with the esense device, executive functions through the tol-r and all the questionnaires and scales will be sampled at the beginning of the day and at the end of the day the same procedure will be applied again (exclusion for pss-10 scale, stay-y trait anxiety and gad-7) esense and tol-r, are useful tools to understand sympathetic activity and executive functions. the galvanometer it is the gold standard to measure eda; i.e. electrodermal activity, which is a pure sympathetic index, while tower of london it is the gold standard to assess planning, monitoring and programming skills, both data are supposed to be heavily involved in an anesthesiologist trainee during the all day. the aims of the study are to evaluate executive functions at the start and at the end of a working day and to understand theirs relationship with anxiety, perceived stress levels and physiological changes in sympathetic activity.

Eligibility criteria:
inclusion criteria: * being an anesthesiologist residents * written informed consent obtained exclusion criteria: * psychiatric disorders * neurological disorders * suffering from high blood pressure
ultrasonic wound debridement vs. standard sharp debridement

Conditions: Chronic Skin Ulcers

Summary: a single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.


Eligibility criteria:
inclusion criteria: * chronic wound needing debridement \>3 cm2 * ulcer history \>4mo * adequate arterial blood flow (abi\>0.7) * venous, inflammatory, pressure, diabetic exclusion criteria: * bleeding disorder * abi\<0.7 * uncontrolled diabetes * taking systemic corticosteroids * chemotherapy * participating in another study * treatment with apligraft, dermagraft, or regranex within 90 days

Keywords: wound debridement requiring debridement
to compare efficacy and safety of ct-p16 and european union-approved avastin as first-line treatment for metastatic or recurrent non-squamous non-small cell lung cancer

Conditions: Adenocarcinoma of Lung

Summary: to demonstrate that ct-p16 is similar to eu-approved avastin in terms of efficacy as determined by objective response rate (orr) during the induction study period


Eligibility criteria:
inclusion criteria: * diagnosed as recurrent disease or stage iv * has at least 1 measurable lesion by response evaluation criteria in solid tumor (recist) version 1.1 exclusion criteria: * has predominantly squamous cell histology non-small cell lung cancer * had surgery for metastatic non-squamous non-small cell lung cancer (nsnsclc)