Kornimate/medical-research-clean huggingface dataset:
telmisartan/amlodipine (80/10) vs. telmisartan/amlodipine (40/10) vs. amlodipine10 in resistant hypertension

Conditions: Hypertension

Summary: the primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (t40/a10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (t80/a10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (a10) in patients who fail to respond to six weeks treatment with a10.


Eligibility criteria:
inclusion criteria: * diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (dbp) \>= 95 mmhg if on existing antihypertensive treatment or seated dbp \>= 100 mmhg if treatment-naïve). * failure to respond to six weeks treatment with amlodipine 10mg. (failure to respond defined as seated dbp \>= 90 mmhg.) * able to stop any current antihypertensive therapy without unacceptable risk to the patient. * willing and able to provide written informed consent. exclusion criteria: * pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential). * known or suspected secondary hypertension. * mean seated systolic blood pressure (sbp) \>=200 mmhg and/or mean seated dbp \>= 120 mmhg during run-in treatment or mean seated sbp \>= 180 mmhg and/or mean seated dbp \>= 120 mmhg at the randomisation visit or at any time during randomised treatment. * any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant. * clinically relevant hyperkalaemia. * uncorrected volume or sodium depletion. * primary aldosteronism. * hereditary fructose or lactose intolerance. * symptomatic congestive heart failure. * patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or arbs. * history of drug or alcohol dependency within the six months prior to signing consent. * concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent. * hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve. * known allergic hypersensitivity to any component of the formulations under investigation. (includes known hypersensitivity to telmisartan or other arbs or amlodipine or other dihydropyridine ccbs.) * non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period. * current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period. * chronic administration of any medication known to affect blood pressure, other than the trial medication. * any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
caries transmission prevention in alaska native infants

Conditions: Dental Caries

Summary: the purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between alaska native mothers to their infants.

alaska native children are disproportionately affected by early childhood caries, compared to all u.s children. dental care needs for adults and children in rural alaska far exceed the acute care and prevention resources available. as a result, there is a high level of dental morbidity present among adults that likely contributes to early transmission of mutans streptococci (ms) from adult caregivers to infants in the household. furthermore, the cultural practice of pre-mastication of solid food for infant feeding amplifies the transmission of oral secretions from adult to child. the prevention of early ms acquisition and subsequent caries in infants and toddlers requires efforts starting at birth. since alaska natives are a rural population at high risk for caries, interruption of vertical transmission of ms using a combination of improved oral hygiene practices, and topical antimicrobials and bacteriostatic agents may be an ideal prevention strategy for childhood caries. chlorhexidine and xylitol are two agents that have been shown to reduce dental decay and ms counts. the specific aim of this proposal is to conduct a community based, randomized blinded trial to determine if the serial use of chlorhexidine and xylitol will reduce the vertical transmission of caries between alaska native mothers and infants. we hypothesize that a two week period of twice-daily chlorhexidine mouthwash use prior to delivery, followed by a subsequent two year period of maternal xylitol gum use, will lead to a significant reduction in the age-specific prevalence of early childhood caries at 12 and 24 months of age among the offspring of mothers in the intervention group, compared to control group mothers. we also hypothesize that, compared to controls, mothers and children in the intervention group will have significant reductions in oral ms counts at each follow-up interval. if proven successful, this intervention could have a significant impact on the prevalence of caries among young alaska native children and other population groups at high risk for childhood caries.

Eligibility criteria:
* primiparous or multiparous pregnant alaska native mothers of all ages * in the last month of pregnancy * reside in the health service delivery area of the native health corporation, in one of the communities with the highest birth counts from 2002 * eligible for obstetric care from the health corporation * plan to give birth to their infant in a specified city of alaska
a study to evaluate the efficacy and safety of tegoprazan in gerd patients with nighttime heartburn

Conditions: Gastroesophageal Reflux Disease

Summary: this study aims to compare the nighttime heartburn improvement effect of tegoprazan 50mg and esomeprazole 40mg(or 20mg) in patients with gerd.

this is a multi-center, double-blind, randomized, active-controlled phase 4 study. subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).

Eligibility criteria:
inclusion criteria: 1. subjects aged between 19 and 75 years 2. subjects who have erosive reflux disease or non-erosive reflux disease exclusion criteria: 1. unable to undergo upper gi endoscopy 2. symptoms of primary or secondary esophageal movement disorders 3. subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)
a prospective study of natural history and clinical outcomes for basilar invagination

Conditions: Basilar Invagination

Summary: a prospective study of natural history and clinical outcomes for basilar invagination

since basilar invagination was reported, its pathogenesis has been considered both primary and secondary. surgical treatment methods emerged in an endless stream, and a hundred schools of thought contend. however, the link between the symptoms and imaging has not been studied in detail. we prospectively enrolled patients with basilar depression, and then explored the natural history of the disease and the clinical outcomes of early intervention.

Eligibility criteria:
inclusion criteria: 1. bi discovered by the patient not incidentally; 2. patients with depression of the skull base caused by congenital skeletal developmental malformations and symptoms; 3. the patient was initially treated in our center, and the interval between onset and treatment was at least 1 month or no treatment; 4. the imaging diagnosis of bi meets the standard (3-5mm higher than the chamberlain's line) exclusion criteria: 1. secondary bi caused by trauma, pathological factors such as rheumatoid arthritis, hyperparathyroidism, osteogenesis imperfecta, rickets, osteomalacia, spinal cord tumors, tuberculosis, inflammation of adjacent structures, and simple aad, odontoid body deformity, etc. 2. spinal vascular disease, intervertebral disc herniation, tethered spinal cord disease and other diseases that may cause symptoms. 3. patients with incomplete imaging data or symptomatic data.
study of the effects of chinese herbal medicine on chronic urticaria

Conditions: Chronic Urticaria

Summary: urticaria is a common dermatology disease. urticaria affects nearly 25% of the population at some time in their lives. recurrent skin itch, insomnia, daily activities limitation greatly affect the quality of life. some patient with chronic urticaria who had poor response to antihistamine may need second line medication. in united states, up to 54% chronic urticarial patient use oral corticosteroid to control. however, long-term use of oral steroids still needs to consider the impact of its side effects. therefore, patients may seek for alternative medicine as an adjuvant therapy. it is still lack large-scale clinical trials in traditional chinese medicine research of chronic urticarial. the aim of this study is to conduct a double-blind, randomized clinical trial to analyze the effectiveness of chinese medicine in chronic urticaria and its possible mechanisms.

traditional chinese medicine has been used widely in taiwan for several diseases, such as allergic rhinitis, atopic dermatitis. for urticaria,certain antipruritic chinese herbal medicine, such and xiao-feng-san (xfs), qing-shang-fang-fen-tang (qsfft), have been commonly used in clinical practice, yet no clinical trials have been done to prove the effectiveness. in this study, a double-blinded, randomized, placebo control trial is designed and total 100 chronic urticaria patients will be enrolled. all subjects will be divided into chinese herbal medicine (chm) and placebo control groups, in 1:1 allocation ratio. chm group will receive capsule of mixture of xfs and qsfft, 4gm four times a day, total 16 gm in a single day; while control group will receive placebo capsule with similar look, smell, and taste with same scheme. total 1 month treatment course with 1 month follow-up study course will be done. changes in symptom severity is the primary outcome, while improvement in sleep disturbance, and serologic marker evolution are the secondary outcome.

Eligibility criteria:
inclusion criteria: * diagnosed as idiopathic urticaria at least 6 weeks * ages from 18 to 75 years * symptom severity must be above 10 points (uas7 scoring) * will to complete questionnaires and take medicine as schedule in this study * volunteer for study enrollment and sign inform consent exclusion criteria: * other dermatological diseases related to skin pruritus, judged by clinician * systemic diseases, such as cancer, renal diseases, liver diseases, autoimmune diseases, and acute infectious diseases. judged by clinician * using oral/injected steroid, leukotriene inhibitors, immuno-suppressant, or other chinese herbal medicine during one month before enrollment * abnormal hemogram, liver or renal function tests in laboratory examination * women who are pregnant or are planned to conceive

Keywords: chinese herbal medicine urticaria antipruritics phase iii clinical trial
covidisc: rapid diagnostic tests on nasopharyngeal swabs for the detection of covid-19

Conditions: COVID-19; SARS-CoV-2

Summary: the covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (rt-pcr) on a nasopharyngeal sample taken by swab. this technique is expensive (54€) and its production time is several hours. alternative methods are in progress, including, rapid diagnostic tests. the mems microfluids and nanostructures (mmn) laboratory, in partnership with the institut chimie biologie innovation (cbi) (paris, 75005), have developed a portable test "covidisc", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (rt-lamp). the "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic rt-pcr (sensitivity of 7 copies per μl, specificity 100%). the objective of this study is to validate the in vitro diagnostic medical device, covidisc, with the standard nasopharyngeal rt-pcr test.

all outpatients and hospitalized patients (intensive care unit, internal medicine service and emergency service) will be proposed to participate to the study after assessment of eligibility criteria by the investigator. the investigator will collect a written consent of the patient or from the support person or a familiar if, the patient is not in condition to consent. patient's participation will be notified in his medical record. after inclusion of patient, the nurse will collect general and clinical data and 2 nasopharyngeal swabs will be taken. one sample to test the prototype of the rt-lamp and the second one to carry out the classic rt-pcr. the results will be collected and compared in a second step.

Eligibility criteria:
inclusion criteria: * patients undergoing nasopharyngeal sars cov2 rt-pcr testing exclusion criteria: * \< 18 years old * having signed a written informed consent form, * affiliation to the social security system.
effect of tumor base size in bladder cancer

Conditions: Bladder Cancer

Summary: investigators aim to investigate the effect of the size of the base of the tumor in contact with the bladder mucosa on recurrence and progression in non-muscle invasive bladder tumors.

between march 2021 and september 2023, 130 patients who applied to our clinic with complaints of hematuria, dysuria, and suprapubic pain, and who were diagnosed with bladder tumor by imaging methods and underwent tur-mt were included in the study. the groups were compared in terms of age, gender, smoking, asa, comorbidities, bmi and the number of tumors, size, stage as intraoperative and postoperative data. patients with tumor base size \<2 cm were classified as group 1, while with tumor base size ≥2 cm were classified as group 2. kaplan meier survival analysis without recurrence and without progression were performed after comparing the groups in terms of recurrence and progression.

Eligibility criteria:
inclusion criteria: * bladder tumor exclusion criteria: * invasive bladder tumor
self transcranial direct current stimulation and mindfulness-based meditation for pain in older adults with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tdcs and mindfulness-based meditation for pain in older adults with knee osteoarthritis (oa).


Eligibility criteria:
inclusion criteria: * self-reported unilateral or bilateral knee oa pain, according to american college of rheumatology criteria. according to american college of rheumatology criteria, participants should meet at least 3 of 6 criteria, including age \> 50 years, stiffness \< 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth. * have had knee oa pain in the past 3 months with an average of at least 30 on a 100 numeric rating scale (nrs) for pain * can speak and read english * have a device with internet access that can be used for secure video conferencing for real-time remote supervision * have no plan to change medication regimens for pain throughout the trial * are able to travel to the coordinating center * are willing and able to provide written informed consent prior to enrollment exclusion criteria: * participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following * history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation * serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm hg), heart failure, or history of acute myocardial infarction * alcohol/substance abuse * cognitive impairment * pregnancy or lactation * hospitalization within the preceding year for psychiatric illness
a study of melphalan in people with lymphoma getting an autologous hematopoietic cell transplant

Conditions: Lymphoma; Lymphoma, B-Cell; Lymphoma, T-Cell; Lymphoma, Hodgkin; Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to find out whether it is practical to use a newer way to calculate melphalan dose given (called population pk model) in beam chemotherapy before ahct. standard dose is fixed for everybody and is calculated using height and weight. the population pk model, tested in this study, uses information based on people who have previously received melphalan and aims to calculate an optimal dose separately for each person. study researchers think that the dose calculated using the population pk model may still be effective but have less side effects than the standard melphalan dose.


Eligibility criteria:
inclusion criteria: * age18 - 79 years old * diagnosed with any type of lymphoma \[hodgkin, non-hodgkin (b- or t-cell)\] and planned for beam-ahct * kps \> 70 * cardiac ejection fraction of \> 45% * hemoglobin-adjusted diffusing capacity of carbon monoxide (dlco) of ≥45% * creatinine clearance of ≥ 40 ml/min * completion of most recent systemic therapy within 12 weeks of enrollment * complete or partial response to systemic chemotherapy by iwg working group criteria. * total bilirubin \< 2.0 mg/dl in the absence of suspected gilbert's disease (if gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dl), and ast \& alt \< 2.5 uln. * minimum stem cell dose of 2 x 10\*6 cd34+ cells/kg exclusion criteria: * disease progression by iwg working group since last therapy * pregnant or lactating females * contraindication to ce melphalan or any of the required supportive treatments, including hypersensitivity to g-csf or pegfilgrastim * any known allergy or allergic reactions to captisol * any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial

Keywords: pharmacokinetics carmustine etoposide melphalan cytarabine 22-086
respiratory muscle function, dyspnea, exercise capacity and quality of life in severe covid19 patients

Conditions: Covid19

Summary: further knowledge regarding sequelae in severe covid-19 patients who have required icu admission for invasive mechanical ventilation is still needed. available evidence suggests ongoing respiratory impairment and impact in quality of life.

purpose: to evaluate post-icu clinical outcomes in severe covid-19 icu survivors. design: a prospective observational study conducted in public hospital in madrid, spain. methods: participants: patients diagnosed with severe covid-19 who have survived icu admission for invasive mechanical ventilation and have been discharged from hospital. intervention: patients will be invited to attend follow-up visits at the hospital for assessments 3 months and 6 months after icu discharge. outcome measures: tests of respiratory muscles function will include ultrasonography of the diaphragm muscle to measure diaphragm thickness (dt), diaphragm thickening ratio (tr) and diaphragm excursion (de); respiratory muscle strength measurement to obtain maximal inspiratory pressure (mip), maximal expiratory pressure (mep) and maximal sniff nasal inspiratory pressure (snip); functional exercise capacity will be assessed with the six minutes walk test (6mwt); dyspnea and health-related quality of life will be evaluated with the modified medical research council scale (mmrc scale) and the saint george's respiratory questionnaire (sgrq). data on participants' demographics and clinical data will also be collected. statistical analysis: descriptive statistics will be used to summarise data. spearman's correlation coefficients will be used to explore associations between variables. conclusions and significance of the research: understanding post-icu clinical outcomes in patients with severe covid-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes

Eligibility criteria:
inclusion criteria: * ⋧18 years old, * subjects diagnosed with covid-19 confirmed by positive sars-cov-2 pcr testing who require admission to icu for invasive mechanical ventilation * invasive ventilation \> 24 hours. exclusion criteria: * pre-existing cognitive impairment, * communication/language barrier * any concurrent physical or mental health condition/ impairment that prevents subjects from taking part in evaluations or providing informed consent * loss of independent walking ability (with or without walking aids) prior to hospitalisation defined by a score of ≤2 on the mobility item of the modified barthel index, * pregnancy, * any injuries/surgery that requires medical bed rest.

Keywords: covid19 diaphragm ultrasound respiratory muscle strength dyspnea exercise capacity quality of life post-icu outcomes
preoperative ultrasound guided thoracic erector spinae plane block versus costoclavicular block for shoulder arthroscopy

Conditions: Preoperative; Ultrasound; Thoracic Erector Spinae Plane Block; Costoclavicular Block; Shoulder Arthroscopy

Summary: this study was conducted to compare the perioperative analgesic effect of ultrasound guided high thoracic erector spinae plane block versus ultrasound guided costoclavicular block for shoulder arthroscopy

shoulder surgery is one of the most common orthopedic surgical procedures that causes severe pain . pain management in such patients is very important because pain relief allows early mobilization, effective postoperative rehabilitation, and shorter hospitalization stays. several regional anesthesia techniques have been used for pain management following shoulder surgery. interscalene brachial plexus block (isb) is the gold standard analgesic technique for shoulder procedures, but this method can lead to some serious complications, such as hemidiaphragmatic paralysis (hdp), horner's syndrome, and hoarseness. the costoclavicular block (ccb) was introduced as infraclavicular approach, first described in 2015 , targets the brachial plexus in the costoclavicular space where its three cords are tightly clustered together lateral to the axillary artery and more superficially than with the classical approach of infraclavicular fossa . recently, garcia-vittoria et al have suggested that the costoclavicular space could also serve as a retrograde channel to supraclavicular brachial plexus blocks, so if local anesthetic (la) injected in the costoclavicular space can reliably reach the supraclavicular brachial plexus enabling reliable anesthesia including anesthesia to the suprascapular nerve during shoulder surgery, one could achieve analgesic parity with small-volume supraclavicular block (and isb) while retaining the 0% incidence of hdp seen with infraclavicular blocks. erector spinae plane block (espb) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016 (. it is an interfascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site

Eligibility criteria:
inclusion criteria: * 90 patients admitted for elective unilateral shoulder arthroscopy. * aged (21 - 65) years. * american society of anesthesiologists (asa) physical activity i, ii exclusion criteria: * patient refusal. * patient with neurological deficit. * patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant and antiplatelets drugs). * uncooperative patient. * infection at the block injection site. * patients with history of allergy to local anaesthetics