Kornimate/medical-research-clean huggingface dataset:
to evaluate the efficacy and safety on blood pressure in patients with hypertension diagnosed congestive heart failure

Conditions: Hypertension; Congestive Heart Failure

Summary: to compare and evaluate the efficacy and safety of candemore tab. versus atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure

this is an open label, randomized, active drug comparative, parallel group, multi-center, phase iv study. patients receive candemore tablet or atacand tablet. initial dose is 4mg/day or 8mg/day. every 2 weeks, patients take double dose if patients blood pressure is measured sbp ≥ 100mmhg and dbp \> 60mmhg. maximum dose is 16mg/day.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * age 20 years or older * patient with congestive heart failure, taking treatment medicine and nyha grade ii\~iii * patient with hypertension, taking treatment medicine or sbp ≥ 140mmhg or dbp ≥ 90mmhg at the screening visit exclusion criteria: * known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease) * blood creatinine level ≥ 2.5mg/dl * blood potassium level \> 5.5meq/l * blood sgot, sgpt level ≥ maximum normal range x3 or patient with sever hepatic dysfunction, cholestasis * pregnant or breast-feeding * premenopausal women not using adequate contraception * patient has history about hypersensitivity or taboo of investigational product * patient with lactose intolerance or lapp lactase deficiency or glucode-galactose malabsorption * administration of other study drugs within 1 month prior to screening * history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months * in investigator's judgement

Keywords: candemore atacand candesartan cilexetil primary hypertension congestive hypertension
the effect of group-based lifestyle medicine intervention and cbt on depressive symptoms

Conditions: Depression

Summary: the objective of this randomized controlled trial is to evaluate and compare the efficacy of group-based lifestyle medicine intervention and cognitive-behavioral therapy for depression (cbt-d) for chinese adults with depressive symptoms. prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). around 40 eligible participants aged between 18 to 65 with depression (patient health questionnaire-9 \[phq-9\] ≥ 10) will be randomly assigned to the lifestyle medicine group (lm group), or the cbt-d group in a ratio of 1:1. participants in both groups will receive interventions either through lifestyle medicine intervention or cbt-d group therapy for 6 consecutive weeks. the outcomes of interest will include depressive, anxiety, and insomnia symptoms, quality of life, functional impairment, and health-promoting behaviours at baseline (week 0), immediate (week 7) and 3-month post-intervention assessments (week 19). treatment credibility and acceptability will be collected before and immediately after treatment.


Eligibility criteria:
inclusion criteria: 1. chinese adults reside in hong kong; 2. aged between 18 to 65 years; 3. have a patient health questionnaire-9 (phq-9) score ≥ 10, indicating at least moderate level of depressive symptoms; 4. able to read and understand chinese/cantonese and are fluent in cantonese; 5. willing to provide informed consent and comply with the trial protocol. exclusion criteria: 1. received psychotherapy for depression in the past 6 months; 2. a change in psychotropic drugs that target depression within 2 weeks before the baseline assessment; 3. a phq-9 question 9 score higher than 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided); 4. currently participating in another intervention study that may potentially improve mental health; 5. self-disclosure of any psychiatric, medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise is not recommended by physicians); 6. pregnancy; 7. hospitalization.

Keywords: depression lifestyle medicine cognitive-behavioral therapy for depression randomised controlled trial
titanium nitride oxide coated stents and paclitaxel eluting stents for acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: coronary-stent implantation is commonly performed for treatment of acute myocardial infarction (mi). drug eluting stents (des) among selected patients have been shown to reduce target lesion revascularization (tlr) after percutaneous coronary intervention (pci). however, there is no studies comparing titanium-nitride-oxide (titanox) coated stent with paclitaxel-eluting stent (pes) in acute mi.

study design and patient population the titax ami (titanium-nitride-oxide coated stents versus paclitaxel-eluting stents in acute myocardial infarction) trial is a prospective, randomized and a multicenter trial conducted from december 2005 to november 2006 in six finnish hospitals. the study was conducted according to the declaration of helsinki and written informed consent was obtained from all patients. this protocol was approved by the ethics committees of the coordinating centre satakunta central hospital and the participating hospitals. patients \> 18 years of age presenting with acute mi (nstemi or stemi) were eligible for this trial. exclusion criteria included unprotected left main disease, ostial or restenotic lesions, contraindication to aspirin, clopidogrel or heparins, life expectancy of less than 12 months and if a stent longer than 28 mm was needed. according to the trial protocol, randomization was performed after visualization of the culprit lesion or a totally occluded infarct-related vessel during coronary angiography. using sealed envelopes, patients were randomly assigned to the groups in a 1:1 ratio in each participating center.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age presenting with acute mi (nstemi or stemi) were eligible for this trial. * wtitten informed consent exclusion criteria: * restenosis * unprotected left main disease * ostial lesion * contraindication to asa, heparins, thienopyridines * life expectancy \< 12 months * stent length needed \> 28 mm

Keywords: titanium paclitaxel stent myocardial infarction angioplasty pci
assessment of the safety and efficacy of weighted wearable blankets in healthy infants during sleep

Conditions: Sleep

Summary: the goal of this clinical trial is to assess the risk of an infant overheating and/or experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in male/female infant healthy volunteers, 0-12 months of age. the main questions it aims to answer are: primary objective: to pilot an investigation on the impact of weighted wearable blankets on vital signs and infant movement in healthy infants during nap polysomnogram. secondary objective: to investigate the efficacy of weighted wearable blankets on sleep patterns in healthy infants during overnight sleep.

to date, there is no evaluation of the safety or efficacy of weighted wearable blankets on healthy infants during overnight use in the peer-reviewed scientific literature. these are the conditions in which these products are used by consumers, with infants sleeping unobserved throughout the night. given the rising popularity in the use of weighted wearable blankets in infants and the risk speculated, a study of the potential impact of weighted wearable blankets on infant vital signs is warranted. study design: direct observational pilot study of the safety of weighted wearable blankets on a minimum (10) healthy infants aged 0-12 months with nap polysomnogram. participants will be placed in a weighted wearable blanket, in accordance with their age/weight/height, by their parent or caregiver under the supervision of a member of the study team. after being put to sleep on their back, the participant will remain in the weighted wearable blanket until completion of the nap polysomnogram. there are stopping parameters (outlined elsewhere) that will be used for this study. if any of the stopping parameters are met, the weighted blanket will be opened to assess if the weighted blanket is responsible for the change. if determined yes, the weighted blanket will be removed and the nap polysomnogram will be terminated.

Eligibility criteria:
inclusion criteria: * ability of parent, caregiver or legal guardian/representative to understand a written informed consent document and choose to participate in the study * 0-12 months of age * weight greater than or equal to 8 pounds * gestational age 37 weeks or greater * health status: healthy infant without underlying cardiac, neurological, or pulmonary disorders * infant is naive to a weighted wearable blanket exclusion criteria: * health status: medical diagnosis associated with underlying cardiac, neurological, or pulmonary disorder * weight \< 8 pounds * gestational age \< 37 weeks * gestational use of marijuana, alcohol, or illicit drugs * home environment: use of cigarettes, vaping, e-cigarettes, or marijuana * infant is not naive to a weighted wearable blanket

Keywords: sleep healthy infant
effect of scalp nerve block on the recovery quality of parkinson's patients after deep brain stimulation

Conditions: Parkinson Disease

Summary: patients diagnosed with parkinson's disease (pd) undergoing deep brain stimulation (dbs) have a higher risk of perioperative complications and postoperative pain will affect quality of recovery (qor) resulting in longer hospitalization time and higher hospital costs. scalp nerve block (snb) combined with intercostal nerve block (icnb)can alleviate postoperative pain while effect of them on postoperative recovery quality of patients diagnosed with pd was unclear. therefore, the investigators conducted a randomized controlled trails to provide a novel method for enhanced recovery and early prevention and treatment of acute pain after dbs surgery.


Eligibility criteria:
inclusion criteria: * patients with pd who receive elective deep brain stimulation (dbs) surgery * aged ≥ 18 * american society of anesthesiologists (asa) physical status of i-iii * able to communicate normally exclusion criteria: * allergy to local anesthetics * pre-existing infection at block site * severe coagulopathy * pre-existing neuropathic pain condition * previous history of dbs surgery * unwilling to provide informed consent or poor compliance
comparison of the cognitive and behavioral effects of eslicarbazepine acetate and carbamazepine in healthy adults

Conditions: Epilepsy

Summary: double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of eslicarbazepine acetate and carbamazepine in healthy volunteers.

this study is a double-blind, randomized, two period crossover design. the study consists of 6 visits over a 21 week period. forty six (46) normal healthy subjects will be treated with both eslicarbazepine acetate (esl, 800 mg/day) and carbamazepine (cbz, 800mg/day) for 6 weeks and 3 days each (maintenance 4 weeks and taper 3 days). each antiepileptic drug (aed) treatment period will be followed by a four day taper and washout period off aed for the remainder of the month. cognitive and behavioral testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization aed maintenance period, and after the final washout period.

Eligibility criteria:
inclusion criteria: 1. healthy adults between the ages of 18 and 55 years old. 2. male or female exclusion criteria: 1. presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy. 2. presence or history of drug or alcohol abuse. 3. the use of concomitant medications, which are known to affect esl or carbamazepine or the use of any concomitant medications that may alter cognitive function (see section vii.e for a partial list). 4. use of oral contraceptive hormones or other medications that could be affected by esl or carbamazepine. 5. prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds. 6. prior participation in studies involving anticonvulsant medications. 7. subjects who have received any investigational drug within the previous thirty days. 8. subjects with iq \< 70 as determined by the peabody picture vocabulary test. 9. presence of hla b\*1502 in subjects of asian descent; this will be obtained at screening in subjects of asian descent.

Keywords: eslicarbazepine carbamazepine cognition
study of ca-008 (vocacapsaicin) in total knee arthroplasty

Conditions: Postsurgical Pain

Summary: this is a two-part, phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of ca-008 (vocacapsaicin) vs. placebo injected/instilled during an elective tka.

this is a phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating, in a pilot stage of the study, up to 3 ascending dose level cohorts each evaluating a single dose of ca-008 vs. placebo injected/instilled during an elective tka. up to 54 subjects will be randomized in the pilot stage. during the optional second stage of the study, subjects will be randomized to one of either 2 or 3 ca-008 dose levels (to be determined) or placebo. the sponsor made the decision not to proceed with the second stage.

Eligibility criteria:
key inclusion criteria: 1. plan to undergo an elective primary unilateral total knee arthroplasty (tka or knee replacement), without collateral procedure or additional surgeries. 2. be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a bmi ≤ 36 kg/m2 and american society of anesthesiology (asa) physical class 1, 2 or 3 at the time of randomization. 3. males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children. 4. be willing and able to sign the informed consent form (icf) 5. be willing and able to complete study procedures and pain scales and to communicate meaningfully in english. be able and willing to return for outpatient follow up visits as required. key exclusion criteria: 1. in the opinion of the investigator, 1. have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period. 2. have active skin disease or other clinically significant abnormality at the anticipated site of surgery that could interfere with the planned surgery. 2. have a known allergy to chili peppers, capsaicin or the components of ca-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone. 3. have significant medical, neuropsychiatric or other condition. 4. the following are considered disallowed medications: 1. tolerant to opioids as defined 2. capsaicin-containing products or foods. 3. central nervous system active agent as an analgesic adjunct medication 4. antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection 5. parenteral or oral corticosteroids. 6. antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study. 5. have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.
tongue mobility in patients with ankyloglossia following frenectomy

Conditions: Ankyloglossia

Summary: this study aimed to evaluate the improvement in tongue mobility in patients with ankyloglossia (tongue-tie) following frenectomy. ankyloglossia restricts tongue movement, potentially causing issues with speech, swallowing, and dental malocclusion.


Eligibility criteria:
inclusion criteria: * (1) at least four years of age, (2) report a limitation in tongue mobility at least at the moderate class (class ii) according to kotlow criteria and did not response to tongue lengthening exercise. exclusion criteria: * patients who have limited mouth openings that interfere with tongue mobility measurements and patients who have bad compliances due to mental problems or uncooperative children were excluded.
msot for assessment of intestinal transit time in lactose intolerance patients

Conditions: Lactose Intolerance

Summary: the study aims to investigate gastrointestinal transit using multispectral optoacoustic tomography (msot) in a prospective diagnostic study involving patients suspected of primary or secondary lactose intolerance. these patients exhibit varying clinical symptoms and different results from the hydrogen breath test (h2 breath test). lactose intolerance is caused by a deficiency in the enzyme lactase, which is responsible for breaking down lactose into glucose and galactose. without this breakdown, lactose is fermented by colon bacteria, leading to symptoms such as bloating and diarrhea. the prevalence of lactose intolerance is increasing, especially among children, and the current diagnostic gold standard is the hydrogen breath test, which, while specific, has limitations in sensitivity. msot could fill this diagnostic gap by non-invasively measuring intestinal transit time and providing a more objective assessment of the condition. the study will compare msot results with h2 breath test outcomes, particularly focusing on patients with varying disease durations and activity levels. additionally, participants are offered an optional mri examination, which can be used to measure intestinal motility. this helps to further quantify the results of the msot examination and discover new findings regarding the extent of the disease. msot could improve the sensitivity of lactose intolerance diagnosis, differentiate it from other conditions, and offer insights into disease management over time.


Eligibility criteria:
inclusion criteria: * written informed consent of the subject * written informed consent of the subject\&#39;s legal guardian * suspicion or diagnosis of lactose intolerance * age 6 to 18 years general exclusion criteria: * pregnancy * breastfeeding mothers * tattoo in the examination area * subcutaneous fat tissue over 3 cm * known hypersensitivity to icg, sodium iodide, or iodine * hyperthyroidism, focal or diffuse thyroid autonomy * recent treatment for thyroid function assessment involving radioactive iodine (within two weeks before or after the study) * impaired renal function * use of the following medications: beta-blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite mri exclusion criteria: * general contraindications for mri examinations (e.g., electrical implants such as pacemakers or infusion pumps, etc.) * severe claustrophobia

Keywords: msot lactose intolerance pediatric icg gastrointestinal transit
study of alto-101 in patients with schizophrenia

Conditions: Schizophrenia; Cognitive Impairment

Summary: this is a phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of alto-101t versus placebo in change in electroencephalogram (eeg) cognitive processing markers and measures of cognition. additional goals are to assess pharmacokinetic (pk), safety, and tolerability of the recently developed alto-101t transdermal delivery system (tds) formulation in a patient population.


Eligibility criteria:
inclusion criteria: * schizophrenia diagnosis for at least one year * cognitive impairment * stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at visit 2 * positive and negative syndrome scale (panss) score: items p1, p3-p6 ≤ 5 and item p2 and p7 ≤ 4 during screening * have a body mass index (bmi) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive) * willing to comply with all study assessments and procedures exclusion criteria: * evidence of unstable medical condition * acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months * diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability * current episode of major depressive disorder (mdd) * use of mood stabilizer, clozapine, and/or daily benzodiazepine * current moderate or severe substance use disorder
prediction of recovery in patients with neck pain

Conditions: Neck Pain; Chronic Neck Pain; Cervical Radiculopathy

Summary: this prognostic prediction model will be a reference for the health care professionals in clinical decision making and subsequent outcomes in dealing with patients having sub-acute and chronic neck pain, as well as, it will be a guide regarding therapeutic management and patients' education. although various studies have evaluated the prognostic factors for individual neck pain conditions or treatment, to author knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively. therefore, this study is aimed to create a prediction model suggesting the recovery time for neck pain.

neck pain is a highly prevalent condition that leads to considerable pain, disability, and economic cost. it not only constitutes a major personal burden but also affects families, the health system and the economic structure of countries. neck pain is described as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage" in the neck region, which starts at the superior nuchal line and continues down to the level of the scapular spine. acute, sub-acute and chronic neck pain is defined as neck pain with full-time sick-listing for 0 - 21 days (3 weeks), 22 - 84 days (4-12 weeks) and more than 12 weeks, respectively. a number of studies have explored prognostic factors for neck pain. most frequently reported prognostic factors are age, gender, pain severity, a history of neck pain, concomitant low back pain, duration of pain, occupation, previous trauma, and degenerative changes on x-ray. physiotherapy interventions for chronic neck pain showing the strongest support for an effect on pain are strength and endurance training. two of the most widely used treatment strategies for the management of neck pain is exercise therapy (et) and manual therapy (mt). et is defined as a regimen or plan of physical activities designed and prescribed for any therapeutic goals, which includes strength exercises, stabilization exercises and endurance exercises. mt may is defined as "the use of hands to apply a force with therapeutic intent. various studies have evaluated the prognostic factors for individual neck pain conditions or treatment. but the author knowledge, no such prognostic model is available yet that predict the recovery in patients of sub-acute and chronic neck pain when managed conservatively.

Eligibility criteria:
inclusion criteria: * subacute and chronic neck pain. * patients with neck pain with a score of 4-10 on the numeric pain rating scale. exclusion criteria: * acute neck pain. * neck pain due to fracture, tumour, infection or metabolic bone disease. * history of cervical spine injury or surgery. * patients presented with disc herniation. * cervical instability

Keywords: prediction model neck pain recovery chronic sub acute