Kornimate/medical-research-clean huggingface dataset:
a study in the us based on pharmacy and medical claims that compares how well stiolto® and trelegy® work in people with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study looks at data from people with chronic obstructive pulmonary disease (copd). some used stiolto respimat and the others trelegy ellipta as their first treatment for copd. the purpose of this study is to find out how well the treatments worked. researchers compare the time to first copd flare-up (exacerbation) between the 2 treatments. the study analyses anonymous data from pharmacy claims collected over 3.5 years.


Eligibility criteria:
inclusion criteria: * ≥40 years of age as of the year of the index date * at least one pharmacy claim for stiolto respimat or trelegy ellipta. * for stiolto respimat users, the first pharmacy claim of fixed dose combination (fdc) of tiotropium + olodaterol (5/5 micrograms (mcg)) will be defined as the index date. * for trelegy ellipta users, the first pharmacy claim of fdc of fluticasone furoate + umeclidinium + vilanterol (100/62.5/25 mcg), will be defined as the index date. * two medical claims (at least one claim on index date or before in the baseline period) with an international statistical classification of diseases and related health problems (icd)-9/10 diagnosis code(s) for chronic obstructive pulmonary disease (copd) in any position during the study period (baseline ± post index date). * at least one year of continuous medical and pharmacy health plan eligibility prior to the index date is required (to allow a baseline period for the covariates and characterizing the study population). exclusion criteria: * to increase the likelihood of a true diagnosis of copd, we will exclude all patients with two medical claims of asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the study period. * to restrict the cohort to first line maintenance therapy of stiolto respimat or first line maintenance therapy of trelegy ellipta we will exclude: patients on long-acting muscarinic antagonists (lama) monotherapy; long-acting beta2 agonists (laba) monotherapy; inhaled corticosteroids (ics) monotherapy; free or fdc of: ics+laba, lama+laba, ics+laba+lama therapy within six months prior to index date. * pharmacy claims for multiple index medications on the index date. * pharmacy claims for non-index copd maintenance medications on the index date.
the must-pc: a feasibility study on intent to use a tool with regard to symptom management

Conditions: Palliative Medicine

Summary: a study on the intent to use a tool (must-pc) to manage symptoms of patients in a palliative care trajectory.

a survey study will be conducted to evaluate if ghcps have the intention to use (iu) must- pc in daily practice. ghcps are recruited via the connections of the seven centers of expertise in palliative care. to invite them to participate in the study, the ghcps are approached directly via e-mail or telephone. participating ghcps will be educated on how to use must-pc (educational materials and instruction webinar). ghcps will be asked to use the cdss for five individual patients. every time after using must-pc they will be asked to answer additional questions about their experience with using must-pc in that specific instance. after using must-pc for five patients, they are requested to fill out a comprehensive questionnaire about their overall experiences with using the cdss.

Eligibility criteria:
inclusion criteria: residents (in dutch: arts in opleiding tot specialist (aios) or arts niet in opleiding tot specialist (anios)), medical specialists and nurse practitioners working in the following disciplines are invited to participate: * general practice * nursing home * hospital: * clinical geriatrics * medical oncology * radiation oncology * pulmonology * cardiology exclusion criteria: hcps who were formally trained in palliative care ("kaderopleiding palliatieve zorg", "masteropleiding palliative medicine for health care professionals at cardiff university" or "post-hbo opleiding palliatieve zorg") and/or who have been or are currently a consultant of a palliative care consultation team are considered specialists in palliative care, are excluded from participation. ghcps (e.g. nurses) who cannot independently decide about cdss recommendation adherence, including drug interventions, are excluded from participation.
effectiveness of cognitive behavioural therapy and physical therapy for provoked vestibulodynia

Conditions: Vulvar Vestibulitis

Summary: the purpose of the study was to compare the effectiveness of cognitive behavioural therapy (cbt) and physical therapy (pt) on pain and psychosexual outcomes in women with provoked vestibulodynia (pvd).

provoked vestibulodynia (pvd) is the most common condition leading to painful intercourse and is currently best understood within a biopsychosocial framework. although the usefulness of non-medical treatment options for vulvar pain is recognized by many, there is limited research investigating the effectiveness of these treatments using a biopsychosocial approach to outcome measurement. furthermore, there is little evidence to support the mechanisms by which these treatments lead to pain reduction. this study aimed to address these gaps by investigating two non-medical treatment options: individual cognitive-behavioural therapy (cbt) and physical therapy (pt).

Eligibility criteria:
inclusion criteria: * fluent in english * vulvar pain with attempted vaginal penetration for at least 6 months * pain limited to vulvar vestibule during cotton swab test exclusion criteria: * other serious medical, psychiatric, or other pain conditions * generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally) * current pregnancy, breastfeeding, or being less than 6 months postpartum * unwillingness to abstain from other treatments for their pvd pain during the course of the study
oncologic outcomes based on clinical pattern of preoperative pet-ct in resected pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the 18f-fdg-pet scan is currently being used for cancer diagnosis, staging, identifying hidden metastasis, and assessment of treatment responses in clinical oncology. although there are important studies suggesting potential associations between pet-based parameters and oncologic outcomes, the calculation and official documentation of individual pet-based parameters might not be routine in clinical practice because these processes usually require time- and labor-consuming processes for the radiologists. in this study, the investigators prospectively determined clinical 18f-fdg-pet type according to degree of fdg-uptake in pancreatic cancer and compare oncologic outcomes between the types.


Eligibility criteria:
inclusion criteria: * candidate for radical pancreatectomy due to pancreatic cancer without neoadjuvant treatment * age between 20 years old and 80 years old * general performance status greater than 70 * results of peroperative pet-ct available exclusion criteria: * unresectable, locally advance and metastatic pancreatic cancer * patients not wanting operation * asa score of greater than 3 * history of chronic alcoholism ot drug abuse * lack of patient compliance * patients not agreeing to enroll in the study. * patients unable to understand and sign the study agreement. * history of neoadjuvant treatment
a study looking to improve sleep and reduce sedentary behaviour in those living with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Insomnia; Sedentary Behavior

Summary: the goal of this clinical feasibility trial is to learn whether the investigators can improve sleep and reduce sedentary behaviour in people living with type 2 diabetes mellitus with sleep problems. the main questions it aims to answer are: • question 1, can objectively measured sleep and sedentary behaviour be improved in the participants and • question 2, what effect will this have on a number of physical and physiological markers. participants in the intervention group will be asked to keep sleep diaries and attend regular meetings with a qualified coach who will use a specific talking therapy to try to improve sleep and with use behaviour change techniques to help them be less sedentary. researchers will compare the control group to the intervention group to see if effects differ between groups.


Eligibility criteria:
inclusion criteria: * diagnosed with diabetes mellitus type 2 for longer than 3 months * participant is willing and able to give informed consent to take part in the study. * sleep disorder symptom checklist 25 (sds-cl-25) of ≥5 on insomnia criteria. * not at high risk of undiagnosed obstructive sleep apnoea (osa), scoring ≥5 on stop bang scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated osa is acceptable. * glycated haemoglobin (hba1c) of 10% or less (86 mmol/mol) or less * male or females. * ≥ 18 ≤ 75 years of age. * able to walk without the use of an assistive device or requiring assistance from another person. * not undertaking more than 75 minutes a week of strenuous exercise or sport. * not taking opioids * be treatment stable for at least 3 months * accelerometer measurement of se ≤ 85% * an understanding that cbti may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life. exclusion criteria: * individuals living with narcolepsy or diagnosed parasomnia * individuals with type 1 diabetes or gestational diabetes * recent cardiovascular event (within the last 6 months). * currently on opioids * diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (adhd) or schizophrenia (self-reported). * individuals living with epilepsy or seizures. * shift workers * female participant planning to become pregnant with the timeframe of the study or is currently pregnant. * terminal illness.

Keywords: sleep insomnia sedentary behaviour diabetes mellitus, type 2 cognitive behaviour therapy insomnia (cbti) behaviour change
mindfulness yoga and sexual functioning

Conditions: Breast Cancer; Sexual Dysfunction

Summary: female breast cancer survivors with sexual dysfunction were randomly divided into a mindfulness yoga intervention group and a control group, and the investigators aimed to evaluate the effects of mindfulness yoga on sexual function in breast cancer survivors.


Eligibility criteria:
inclusion criteria: age 18-65 years; diagnosed with primary breast cancer (stages:t1-t4, n0-n1, m0); individuals who have completed surgery, chemotherapy and radiotherapy (with the exception of immunotherapy and endocrine therapy); without cognitive impairment; diagnosed with sexual dysfunction. exclusion criteria: without sexual experience; in pregnancy or lactation; individuals with serious cognitive or psychiatric issues (i.e., depression, alcohol dependency, or psychotic disorders); individuals who are illiterate, with hearing disorder or communication difficulties; individuals with other type of tumors or other serious acute or chronic diseases at the time of enrollment; individuals participate in a concurrent medical treatment or nonmedical treatment targeting sexual problems; individuals participate in a concurrent psychotherapy; individuals with experience in mindfulness or yoga.
safety and tolerability of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (ssc-ild) (lotuss)

Conditions: Systemic Sclerosis

Summary: pssc-001 (lotuss) this study is a phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (ssc-ild).


Eligibility criteria:
inclusion criteria: 1. diagnosis of systemic sclerosis-related (ssc) confirmed by the american college of rheumatology classification criteria of systemic sclerosis (masi 1980); duration of diagnosis less than (\<) 7 years 2. diagnosis of ssc-ild based on an high-resolution computed tomography (hrct) scan 3. screening forced vital capacity (fvc) greater than equal to (\>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (dlco) \>=40% of the predicted value 4. at study entry, the participant either was not taking ssc-ild medication or was taking cyclophosphamide or mycophenolate exclusion criteria: 1. clinically significant pulmonary hypertension 2. known underlying liver disease 3. clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux 4. history of clinically significant asthma or chronic obstructive pulmonary disease 5. active infection 6. diagnosis of another connective tissue disorder 7. evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention 8. history of unstable or deteriorating cardiac or pulmonary disease (other than ssc-ild) 9. pregnancy or lactation 10. creatinine clearance \<40 milliliters per minute (ml/min) 11. prior use of pirfenidone 12. unsuitable for enrollment or unlikely to comply with study requirements

Keywords: pirfenidone ssc-ild scleroderma systemic sclerosis interstitial lung disease
a comparison of telemedical and conventional antihypertensive treatment

Conditions: Hypertension

Summary: the aim of the study is to compare telemedical antihypertensive treatment based on home blood pressure monitoring and conventional antihypertensive treatment based on monitoring of blood pressure in the doctor's office. we want to test the hypotheses that telemedical treatment is more effective in lowering blood pressure, provide better quality of life and is more cost-effective.


Eligibility criteria:
inclusion criteria: * age 20 - 80 years * office blood pressure \> 150/95 mmhg or systolic blood pressure \>150 mmhg and diastolic blood pressure \< 90 mmhg exclusion criteria: * not able to perform home blood pressure measurements * low compliance * abuse of alcohol/ medicine * unwillingness to participate

Keywords: telemedicine blood pressure quality of life cost-effectiveness
prevalence of cytomegalovirus infection in patients with quiescent ulcerative colitis

Conditions: Ulcerative Colitis; Cytomegalovirus Infections

Summary: colitis from reactivation of established cytomegalovirus (cmv) colonization can complicate the clinical course in patients with an acute flare of ulcerative colitis (uc). accurate and timely detection of active cmv infection or disease with appropriate anti-viral therapy may reduce complications associated with acute uc flare. limited information is available on the presence of colonic cmv infection in patients with quiescent ulcerative colitis. prospective studies on factors associated with reactivation of cmv infection during active uc flare and its impact on disease progression are lacking. the hypothesis of this study are as follows: 1) cmv infection is prevalent in patients with ulcerative colitis irrespective of disease severity; 2) the degree of immunosuppression directly impacts cmv infection status in patients with ulcerative colitis

this is cross sectional study at st. paul's hospital, a tertiary academic teaching hospital. subjects ages 19 or greater with quiescent ulcerative colitis present for routine elective surveillance endoscopy will be invited for the study. at enrollment, subjects will be evaluated for clinical and endoscopic disease severity using mayo score. to be eligible for the study, mayo score must be \<2. supplemental blood tests, diagnostic test to determine cmv status, physical examination for extra-intestinal manifestation of cmv and inflammatory bowel disease, and surveillance colonoscopy with colonic biopsy will be done. patients will be followed longitudinally. patients will be contacted every three months via their preferred method (telephone or email) until disease flare (clinical partial mayo score \> 2) or one year from enrolment. patients will be asked to contact study coordinator when they are experiencing uc flare.

Eligibility criteria:
inclusion criteria: * patients ages 19 or greater with quiescent ulcerative colitis present for routine elective surveillance endoscopy * at enrolment: clinical partial mayo score \< 2 prior to endoscopic evaluation * at endoscopy: endoscopic mayo score \< 2 exclusion criteria: * patient age less than 19 * clinical partial mayo score at enrollment ≥ 2 * endoscopic mayo score ≥ 2 * overall mayo score \> 5 * patients with known current or previous cmv infection * patients with hiv, solid organ or bone marrow transplantation, immunoglobulin deficiency, and who are otherwise immunosuppressed for reasons other than treatment of ulcerative colitis, or * pregnant patients

Keywords: ulcerative colitis uc cytomegalovirus cmv
telerehabilitation in oncology patients

Conditions: Cancer Metastatic; Cancer; Survivorship

Summary: the aim is to analyze the feasibility and effect of an online therapeutic exercise and education programme (teep) in cancer patient and survivors

current literature shows that therapeutic exercise has multiple benefits in oncology patients, such as improvements in function and quality of life, and ameliorates symptoms such as cancer-related fatigue. furthermore, given the risk of obesity, both exercise and diet play a key role in recovery from cancer. in fact, current guidelines support the use of exercise with therapeutic purposes as a complement to cancer treatment. as a consequence of the covid-19 pandemic, oncology patients present more difficulties to attend programs, as the vast majority are immunosuppressed, and they are considered risk population. therefore, new online (teep) must be developed to facilitate the benefits of these programs in the post-covid era. this study analyses the feasibility (in terms of suitability and verification of exercise prescription, absence and attendance type, and total days of attendance) and the effect (in weight, physical function, and symptoms) in cancer patients and survivors.

Eligibility criteria:
inclusion criteria: * metastatic breast patient, gynecological cancer patient, or breast cancer survivor under adjuvant treatment after surgical intervention. * having given informed consent to participate voluntarily in the program and to be in contact via telematics (email or messaging platform). * have a good internet connection * be accompanied by an adult on the day of assessment. * availability to access the computer on during the intervention. exclusion criteria: * technophobia * domatophobia or self-report of adversity to be at home. * lack of logistical requirements (internet and lack of skill in its use).

Keywords: cancer oncology metastasis survivors exercise therapy therapeutics complementary therapies covid-19
antiphospholipid antibodies and fetal growth restriction

Conditions: Fetal Growth Restriction; Antiphospholipid Syndrome

Summary: the antiphospholipid syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). since 1999 the sapporo criteria for antiphospholipid syndrome diagnosis includes the development of fetal growth restriction (diagnosed postpartum), but this was done without solid evidence of a relation between the two or using the most common form of fetal growth restriction diagnosis (ultrasound). our study will try to add information to this particular point.


Eligibility criteria:
inclusion criteria: * gestational age between 24-34 weeks. * ultrasonographic evidence of fetal growth restriction * abdominal circumference \< 3rd percentile. * doppler with increase of placental resistance. exclusion criteria: * known antiphospholipid syndrome. * known presence of antiphospholipid antibodies. * patients with systemic lupus erythematosus.

Keywords: antibodies, anticardiolipin antibodies, b2 glycoprotein i lupus anticoagulant fetal growth restriction
efficacy of botox in patients with idiopathic clubfoot

Conditions: Idiopathic Clubfoot (Talipes Equinovarus)

Summary: the purpose of this study was to determine the efficacy of adding botox injection to serial manipulations and castings in patients with clubfoot. the study hypothesis was that the use of botox in the setting of serial manipulations and castings is an effective treatment for clubfoot.

all patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. at hindfoot stall, subjects received botox injections at 10 iu/kg into the gastrosoleus muscle complex. following injections, subjects were recasted.

Eligibility criteria:
inclusion criteria: 1. children presenting with idiopathic clubfoot/feet at bc children's hospital 2. children ranging in age from 1 day to 2 years old at initial treatment children who have had previous intervention for their clubfoot (methods including surgery, ponseti method, kite method, physical therapy method) and had a clubfoot recurrence requiring re-intervention

Keywords: efficacy study assessment of patient outcomes following treatment
the effect of vitamin d supplement as adjuvant therapy in eradication of helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: helicobacter pylori (h. pylori) is one of the most common chronic infections worldwide. the mode of transmission of h. pylori is through the fecal-oral or oral-oral routes. chronic gastritis has been linked to helicobacter pylori (h. pylori) infection. peptic ulcer disease, gastric adenocarcinoma, and gastric lymphoma are all linked to this condition . in egypt, a high prevalence of h. pylori infections has been reported, ranging from 70% in the general population , 73% among school children , up to 88% in patients with chronic active hcv . in 2007, the american college of gastroenterology estimated that the cure rate for h. pylori infections was 70-85 percent with the use of a proton pump inhibitor (ppi), clarithromycin, and amoxicillin or metronidazole . children with h. pylori infection do not have severe digestive symptoms. pylori infection represents a key factor in the pathogenesis of duodenal ulcer and chronic gastritis in children. in addition, h. pylori infection has also been reported to have extra-digestive consequences . a recent comprehensive evaluation found that sequential and conventional triple treatment had a cure rate of 84% . the infected macrophage is unable to create enough 1,25-(oh)2d to control the synthesis of amp cathelicidin when it is vitamin d deficient . vitamin d has a powerful systemic antibacterial impact by enhancing the activity of monocytes and macrophages. most illnesses seem to benefit from a vitamin d-rich condition . vitamin d-deficient subjects might be more prone to developing h. pylori infection .

to assess the efficacy of adding vitamin d supplement as adjuvant therapy in eliminating helicobacter pylori infection.

Eligibility criteria:
inclusion criteria: * patients aged between 1 to 16 years old who present with helicobacter pylori infection diagnosed by positive stool antigen test for helicobacter pylori infection presented with weight loss, abdominal pain, or failure to surive symptoms for at least 1 month. exclusion criteria: - 1. known hypersensitivity to ppis or antibiotics. 2. patients who have previously received helicobacter pylori eradication treatment, corticosteroids/immunosuppressive treatment and acid suppressive treatment in the prior 2 months. 3. history of systemic inflammatory or autoimmune disorders, gastric surgery, renal failure, liver cirrhosis and malignancies 4. abnormal birth history such as premature birth and asphyxia or with severe disease history, such as genetic metabolic disease, congenital dysplasia, feeding difficulties, severe malnutrition, repeated respiratory diseases.