Kornimate/medical-research-clean huggingface dataset:
left atrial pacing in diastolic heart failure

Conditions: Heart Failure With Preserved Ejection Fraction; Atrial Dyssynchrony Syndrome; Left Atrio-ventricular Asynchrony

Summary: the purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.


Eligibility criteria:
inclusion criteria: * age ≥ 65 * sinus rhythm, pr \< 220ms, qrs \< 110ms * heart failure (nyha class iii-iv or ii with hospitalization for heart failure) * ejection fraction \> 50%, restrictive mitral inflow, lateral e/e' \> 12 or septal e/e' \> 15, left atrial index volume \> 34 ml/m² * atrial dyssynchrony syndrome: (tte) inter-atrial time delay ≥ 70ms (difference between tricuspid and mitral p-a intervals or between mitral and tricupsid p-a' intervals with dti) * left atrio-ventricular asynchrony: time difference between tricupsid and mitral a wave duration ≥ 35ms.

Keywords: heart failure with preserved ejection fraction atrial dyssynchrony syndrome left atrio-ventricular asynchrony pacemaker left atrial pacing therapy
the effectiveness of 18f-fluorocholine positron emission tomography (pet) in detecting, staging and following-up prostate cancer

Conditions: Prostate Cancer

Summary: choline is one of the components of phosphatidylcholine, an essential element of phospholipids in the cell membrane. some malignant cells show their ability to actively incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor cell duplication. the efficacy of 18f-fluorocholine (18f-fch) for localizing primary or metastatic prostate cancer has been recently reported in limited studies. this study will be conducted to delineate the effectiveness of 18f-fch pet in (1) differentiating benign prostate hypertrophy (bph) from prostate cancer, (2) staging prostate cancer, (3) following-up patients with prostate cancer after initial curative therapy.

background: prostate cancer is a leading cause of cancer death for male in taiwan. although 18f-fdg pet has been shown to be an effective tool in diagnosing many malignancies, previous studies have shown that 18f-fdg is not a suitable pet tracer for detecting prostate cancer. choline is one of the components of phosphatidylcholine, an essential element of phospholipids in the cell membrane. some malignant cells show their ability to actively incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor cell duplication. the efficacy of 18f-fluorocholine (18f-fch) for localizing primary or metastatic prostate cancer has been recently reported in limited studies. purpose: this study will be conducted to delineate the effectiveness of 18f-fch pet in (1) differentiating benign prostate hypertrophy (bph) from prostate cancer, (2) staging prostate cancer, (3) following-up patients with prostate cancer after initial curative therapy. patients and methods: this study will include 1. group 1: 50 patients with bph 2. group 2: 50 patients with newly diagnosed prostate cancer and 3. group 3: 50 patients who have received curative treatment for prostate cancer and are suspicious of recurrence/metastases because of a persistent increase in their serum psa. 18f-fch whole-body pet will be performed for each patient expected results: to evaluate the effectiveness of 18f-fch in the diagnosis, staging and follow-up of prostate cancer.

Eligibility criteria:
inclusion criteria: group 1: 50 patients with bph 1. age above 35 years old 2. histologically confirmed bph 3. informed consent signed group 2: 50 patients with newly diagnosed prostate cancer and 1. age above 35 years old 2. histologically confirmed prostate cancer 3. informed consent signed group 3: 50 patients who have 1. age above 35 years old 2. histologically confirmed prostate cancer and had received curative treatment for prostate cancer 3. suspicious of recurrence/metastases because of a persistent increase in their serum psa 4. informed consent signed exclusion criteria: * patients with other known malignancies will be excluded.

Keywords: prostate cancer 18f-fluorocholine pet recurrence metastases
nifty feeding cup versus generic medicine cup preterm infants who have difficulty breastfeeding

Conditions: Infant,Premature; Feeding; Difficult, Newborn

Summary: the investigators will establish an evidence base for the nifty feeding cup by evaluating its effectiveness and caregiver satisfaction. the investigators will conduct a randomized crossover trial that compares the nifty feeding cup to a standardized, generic medicine cup used to feed preterm infants with breastfeeding difficulties at komfo anokye teaching hospital (kath) in kumasi, ghana.

the investigators aim to compare the nifty feeding cup to a standardized, generic cup in up to 200 preterm infants. the aim and hypotheses were selected based on the most informative outcomes given the scope of the funding. the investigators will test the hypotheses that nifty feeding cup feeding compared to generic cup feeding will result in: 1. less spillage 2. greater caregiver satisfaction 3. shorter duration of feeds

Eligibility criteria:
inclusion criteria: infant * born preterm (\<37 weeks gestational age) at time of birth * corrected gestational age is \<37 weeks per the modified dubowitz score on date of enrollment * diagnosed with feeding difficulties * patient in the mother-baby unit at kath * clinically indicated to start cup feeding (including an infant who has a nasogastric tube and is cup feeding or indicated to start cup feeding) * has an anticipated hospital stay that is at least 48 hours caregiver: * at least 18 years of age * one of the following biologic family members of the infant (mother, grandmother, aunt) * self-identifies as the primary feeder of the infant * prior experience feeding the potential infant participant with nipple feeding (e.g. breast feeding, bottle feeding) or nasogastric \[ng\] tube * verifies willingness to comply with all study procedures exclusion criteria: infant * congenital anomaly except for minor anomalies (e.g. an extra digit or ear tag is okay) * other condition or situation that makes infant unlikely to be able to comply with study procedures. examples include the infant anticipated to not be in hospital long enough, infant has a suspected intestinal obstruction, or necrotizing enterocolitis. * no mother, grandmother, or aunt caregiver available to participate in study * enrolled in another study at kath that would interfere with his/her ability to participate in this study.

Keywords: nifty cup breastfeeding difficulties preterm infant cup feeding
pharmacogenomics of paclitaxel in ovarian cancer

Conditions: Ovarian Neoplasms; Fallopian Tube Neoplasms

Summary: this study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). specifically we will study this in patients with ovarian cancer who receive paclitaxel/carboplatin chemotherapy after primary surgery.

paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. the effect and toxicity is unpredictable in the individual patient. paclitaxel is removed (eliminated) from the organism by oxidation. cyp2c8 is the enzyme mainly responsible. p-glycoprotein (pgp) is an efflux transport protein natural to the human organism. pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. paclitaxel is substrate for pgp. single nucleotide polymorphisms are possible causes for variation in both cyp2c8 and pgp expression/function. we will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future. we want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes, acute toxicity(eg. bone marrow suppression and neuropathy) and response to treatment(ie. ca125 response, progression free survival and overall survival). the metabolic capacity is estimated using a "sparse sampling" approach applying advanced computerized pharmacokinetic/dynamic modelling as opposed to traditional "frequent sampling" pharmacokinetic studies which burden the individual patient more. patients are recruited in collaboration with oncological departments throughout scandinavia.

Eligibility criteria:
inclusion criteria: * clinical diagnose and histology of invasive epithelial ovarian/tuba or peritoneal cancer * figo stage iib-iv any grade or figo ia-iia only grade 3 or clear cell carcinoma (any stage and grade) * natural candidate for paclitaxel 175mg/m2 + carboplatin (auc=5-6) * baseline ca125≥70 and/or evaluable disease after recist (incl ultrasound) * 18 years or older * caucasian (ie.parents and grandparents are caucasian) * performance status 2 or lower (after who/ecog) exclusion criteria: * prior malignant disease apart from cervical carcinoma in situ and basal cell carcinoma of the skin * prior chemo / radiotherapy * ongoing or imminent other chemotherapies * pregnant or lactating * fertile woman of childbearing potential not willing to use adequate contraception * neurological symptoms (any kind) worse than ctcae grade 1 * active infection or other serious disease that could impair on treatment and/or follow-up

Keywords: cyp2c8 mdr1 pharmacogenetics paclitaxel
aimovig pregnancy exposure registry

Conditions: Migraine

Summary: the primary objective of this study is to estimate the proportion of major congenital malformations in infants of women with migraine exposed to erenumab-aooe during pregnancy compared to infants of women with migraine unexposed to erenumeb-aooe.


Eligibility criteria:
inclusion criteria: * age 18 years or older (at time of signing the informed consent) * currently pregnant * the outcome of the pregnancy must not be known * confirmed clinical diagnosis of migraine exclusion criteria: * women currently participating in another investigational device or investigational drug study, currently taking an investigational medicinal product, or having taken an investigational product within 3 months prior to last menstrual period (lmp) or during pregnancy. other investigational procedures while participating in this study are excluded. * women exposed to any medications that target the calcitonin gene-related peptide (cgrp) pathway (ie, cgrp monoclonal antibody \[mab\] or gepants) in the period from 5 half-lives prior to lmp through the end of pregnancy.

Keywords: erenumab-aooe aimovig®
comparison between the effects of mulligan and maitland mobilization on patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: this study is a randomised control trial and the purpose of this study is to investigate and compare the "effects of maitland mobilizations and mulligan mobilization with movement (mwm) in patients with patellofemoral pain syndrome

this study is a randomised control trial just used to investigate and compare the effects of maitland mobilizations and mulligan's mobilization with movement ; with respect to: 1. pain 2. range of motion and 3. function in patients with patellofemoral pain syndrome all males and females with ages of 18 to 40 years having the patellofemoral pain syndrome can be included in this study. a total number of 40 participants are equally and randomly divided into two groups i.e. group a and group b. group a recieves the mulligan mobilization with movement (mwm) and group b receives the maitland's patellar mobilizations. outcomes are recorded at 0 weeks and at end of 2 weeks. outcome measure used for pain is numeric pain rating scale (nprs), for knee rom is goniometery and for knee function is lower extremity function scale (lefs). pre and post intervention reading of all 3 measures will then be compared and data will be analysed

Eligibility criteria:
inclusion criteria: * referred patients from rehabilitation, orthopedic and rheumatology department * both males and females of age 18-40 years * having pain from at least 2 months. * pain score ≥ 3 on nprs. * pain on palpation of medial or lateral patellar facet. (12, 13) * retro patellar pain in at least two of the following activities: * ascending , descending stairs * hopping / jumping * prolonged sitting with flexed knees * kneeling and squatting * patellar tilt test * exclusion crieteria: * positive tests/findings on physical examination for knee menisci, ligaments and bursa. * chondromalacia patellae * individuals with instability of tibiofemoral joint * lower extremity surgery * rheumatoid arthritis, other connective tissue disorders and congenital deformities.
study of the scandinavian total ankle replacement (star) for the treatment of bilateral degenerative ankle disease

Conditions: Osteoarthritis; Post-Traumatic Arthritis; Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety of the s.t.a.r. device for patients with bilateral disease.

the specific objectives are to show that the safety data of the s.t.a.r. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. the bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.

Eligibility criteria:
inclusion criteria: * moderate or severe pain, loss of mobility and function of the ankle * primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis * at least six months of conservative treatment for severe ankle conditions * bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention * willing and able to give informed consent exclusion criteria: * patients who have not reached skeletal maturity * active or prior deep infection in the ankle joint or adjacent bones * prior arthrodesis at the involved site * history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol * obesity (weight greater than 250 lbs) * history of current or prior drug abuse or alcoholism * any physical condition precluding major surgery * prior surgery and/or injury that has adversely affected the ankle bone stock * severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone * insufficient ligament support

Keywords: ankle replacement end-stage arthritis of the ankle degenerative ankle disease
study to evaluate changes in cognitive function in patients treated with pcsk9 inhibitors

Conditions: Cognitive Function; Hypercholesterolemia; Quality of Life

Summary: the main objective will be to evaluate the changes in the cognitive function in naive patients treated with pcsk9 inhibitors (alirocumab and evolocumab) by using the montreal cognitive assesment questionnaire (moca). the secondary objectives will be: 1) to evaluate the levels of ldl-cholesterol changes from the beginning to the end of the study 2) to evaluate changes in quality of life among the euroqol eq-5d-3l questionnaire (it will also be associated to the cognitive function) 3) assesment of direct costs in medications and outpatients consultations related with the health procedures.


Eligibility criteria:
inclusion criteria: * patients 18 years old or over * to start with the first funded dose of pcsk9 inhibitors ( ldl \> 100 mg/dl) * maximum dose or statin intolerance exclusion criteria: * diagnosis of any disease related with cognitive deterioration

Keywords: cognitive function hypercholesterolemia quality of life pharmacoeconomics pcsk9 inhibitors alirocumab evolocumab
effects of an apple derived fibre supplement on constipation

Conditions: Constipation; Functional Gastrointestinal Disorders

Summary: we will conduct a 2 months clinical intervention in which a 20 g appled derived fibre supplement will be compared with a placebo without fibre. the main outcome will be the reduction in the gastrointestinal system rating scale

participants with constipation and mild gastrointestinal symptoms will be invited to participate. those with alarming symptoms such as gastrointestinal bleeding or weight loss, those using laxatives or medications with anticholinergic actions will be excluded from the study at baseline, participants will be weighed and interrogated about their gastrointestinal symptoms using the "gastrointestinal symptom rating scale" their type of stools using the bristol visual stool scale the number of complete spontaneous bowel movements per week afterwards, they will be randomized, balancing by age, gender and body mass index to receive in a doubly blind fashion a 20 g/day powder with apple derived fiber a similarly looking placebo powder the intervention will last 8 weeks. every two weeks, participants will be cited to provide a new supply of the product, retrieve the used vials and be interrogated using the same tools as baseline. at the end of the intervention, participants will be weighed again

Eligibility criteria:
inclusion criteria: * presence of constipation or functional gastrointestinal symptoms exclusion criteria: having serious cardiovascular, kidney or hepatic diseases * gastrointestinal bleeding weight loss use of laxatives use of medications with anticholinergic actions

Keywords: constipation dyspepsia
ketoconazole, dexamethasone, and hydrocortisone in treating patients with prostate cancer that did not respond to androgen-deprivation therapy

Conditions: Prostate Cancer

Summary: rationale: studying samples of blood in the laboratory from patients with cancer receiving ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about how these drugs are used by the body. purpose: this randomized clinical trial is studying how ketoconazole, dexamethasone, and hydrocortisone act in the body of patients with prostate cancer that did not respond to androgen-deprivation therapy.

objectives: * to evaluate the pharmacokinetics of oral dexamethasone with and without oral ketoconazole in patients with androgen-independent prostate cancer. * to compare the pharmacokinetics of oral hydrocortisone with and without oral ketoconazole in these patients. outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral dexamethasone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral hydrocortisone twice daily on days 29-42. * arm ii: patients receive oral hydrocortisone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral dexamethasone twice daily on days 29-42. in both arms, patients may receive ketoconazole and hydrocortisone as standard salvage therapy off study. in both arms, patients undergo blood sample collection on days 1, 14, 29, and 42 for pharmacokinetic studies.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of prostate cancer * must have failed standard androgen-deprivation therapy * evidence of rising psa patient characteristics: * ecog performance status 0-2 * creatinine ≤ 2.0 mg/dl * ast and alt \< 4 times upper limit of normal * bilirubin \< 2.0 mg/dl * no active congestive heart failure * no allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole * no active infection * no uncontrolled glaucoma * no active peptic ulcer disease * no uncontrolled diabetes mellitus * fertile patients must use effective contraception during and for 3 months after completion of study therapy prior concurrent therapy: * more than 2 weeks since prior and no concurrent drugs known to interact with study treatment

Keywords: recurrent prostate cancer
evaluation of prep-30: a demonstration project of pre-exposure prophylaxis for msm and other high-risk group clients at the thai red cross anonymous clinic

Conditions: HIV Prevention

Summary: prep-30 is a demonstration project to assess the feasibility of providing oral prep to msm and other individuals at-risk for hiv in bangkok, thailand as a service that is funded entirely through user fees. tenofovir disoproxil fumarate/emtricitabine prep is provided part of a combined hiv prevention program that includes risk-reduction counseling, regular hiv testing, and the provision of condoms and lubricants. prep-30 is implemented at the thai red cross aids research centre, at the site of the largest hiv counseling and testing center in thailand.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. hiv test negative 3. creatinine clearance \> 60 ml/min 4. no contraindication or allergy to prep medications (tdf/ftc) 5. at least one risk factor for hiv infection within the previous 6 months: * sex partner known to be hiv positive * works as commercial sex worker * use of pep for sexual exposure * injection drug use * any sti (syphilis, gonorrhea, chlamydia) * \> 5 sex partners * inconsistent condom use with high-risk partners, including msm, idu * msm: any insertive or receptive anal sex without condom * women: any sex without condom with high-risk male partner (msm, idu, multiple female partners) * heterosexual men: any sex without condom with high-risk female partner (commercial sex worker, idu, multiple male partners) exclusion criteria: -
teh effect of subgingival irrigation wif ketorolac and chlorhexidine in patients wif chronic periodontist

Conditions: Chronic Periodontitis

Summary: in this study, 40 patients with a history of mild- periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period then, scaling \& root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (balanced block randomization) with four blocks according to the visit time. to group a, oral chlorohexidine and to b group, the drug ketorolac was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months.

in this study, 40 patients with a history of mild- periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period then, scaling \& root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (balanced block randomization) with four blocks according to the visit time. to group a, oral chlorohexidine (ghol darou-tehran) and to b group, the drug ketorolac (exir-boroujerd) was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months. pl, bi, pd were evaluated in the study sessions. at the end of the clinical change, a multiple measure anova test was used to compare the preceding and follow-up sessions in both groups, considering the intervention method as between subject comparison and measured at the time of measurement as a repeated factor.

Eligibility criteria:
inclusion criteria: 40 patients with periodontitis chronic and has a 2 molar symmetrically in the lower jaw pockets of the periodontal depth of at least 5 mm and cal 1-2 mm in at least one of the surfaces of the teeth, were selected exclusion criteria: 1. systemic disease 2. pregnancy or breastfeeding 3. allergy drug used 4. smoking 5. medication 6. not willing to consent to participate in the study 7-trismus 8-the type of disease periodontal (aggressive) 9. history of periodontal treatment in the previous 6 months 10-orthodontic treatment