Kornimate/medical-research-clean huggingface dataset:
bilateral ultrasound guided esp block versus tap block on post-operative analgesia after total abdominal hysterectomy

Conditions: Post-operative Analgesia

Summary: * abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. narcotics are often required during patient recovery but can result in adverse side effects. transversus abdominis plane block(tap block) is a regional anesthetic technique that is found to be effective as post-operative analgesia after total abdominal hysterectomy. recently, erector spinae plane block(esp)block is found to be safe, and simple regional anesthetic technique that decrease total opioid consumption in patient undergoing breast, or abdominal surgery. * the aim is to compare the efficacy of bilateral erector spinae plane block, and bilateral transversus abdominis plane block on postoperative analgesia in patients after abdominal hysterectomy under general anesthesia, and their need for opioid. hypothesis * null hypothesis (h0): no difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia. * alternative hypothesis (h1): there are difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.

sample size: assuming that mean±sd of reduced pain scores in erector spinae plane block is 4.7±3.7 versus 2.5±1 in transversus abdominis plane block.so, the total sample size is 48 cases (24 in each group) using open source statistics for public health (open epi) with confidence interval 95% and power of test is 80%. d) method of sample collection: forty eight female patients will be divided into two groups by a computer-generated randomization table: group (es) (n=24): will receive bilateral ultrasound guided erector spinae plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) at the level of t9. group (ta) (n=24): will receive bilateral ultrasound guided transversus abdominis plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000).

Eligibility criteria:
inclusion criteria: * female patient. * patient acceptance. * age (40-60) years old. * american society of anaesthesiologist (asa) i / ii * elective total abdominal hysterectomy under general anesthesia. * patient with body mass index (bmi) (25-35kg/m²) exclusion criteria: * patient refusal. * local infection at site of puncture. * altered mental status. * history of allergy to study drugs ( bupivacaine, morphine). * patients with chronic pain. * patients with severe hepatic or kidney impairment. * patients having a history of hematological disorders, including coagulation abnormality.
the impact of aquatic therapy on walking, balance functions, and quality of life in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of the study is to contribute to the rehabilitation program by comparing the effects of traditional rehabilitation methods and aquatherapy given in addition to these methods in patients with cerebral palsy. if the superiority of the rehabilitation program including aquatherapy is demonstrated, evidence will be provided for its more widespread use.

the participants will be divided into two groups as the study group and the control group. the study group will receive an aquatherapy rehabilitation program in addition to the conventional rehabilitation program, while the control group will only receive the conventional rehabilitation program.

Eligibility criteria:
inclusion criteria: 1. having a diagnosis of hemiplegic type or diplegic type cerebral palsy 2. being between the ages of 3 and 16 3. being at gmfcs levels i, ii, and iii 4. having sufficient cognitive abilities such as understanding simple instructions, following them, and performing requested tasks 5. parents and patients aged ≥ 9 agreeing to participate in the research exclusion criteria: 1. experiencing uncontrolled seizures 2. having serious learning difficulties, behavioral problems, skin lesions, visual and/or hearing impairments that could affect function and participation 3. active infection 4. incontinence

Keywords: aquatic therapy rehabiltation
emerald - assessment of comorbidities & atrial arrhythmia burden in dual-chamber paced patients

Conditions: Atrial Arrhythmia

Summary: the purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.

the study will focus on the number of patients moving to persistent atrial fibrillation as a function of cumulative %vp (\ 40%), in a general dual-chamber pacemaker population through a 2 year follow-up (n=2188). the same endpoint will be analyzed in sub populations (sinus node disease and avb) at 4 years follow up (n=4290).

Eligibility criteria:
inclusion criteria: - patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion. exclusion criteria: * contraindicated for cardiac pacing, according to the esc and acc/aha/hrs guidelines * permanent or persistent atrial tachyarrhythmia

Keywords: reply symphony atrial arrhythmias v pacing evaluate the incidence and evolution over-time of co-morbidities
energy intake and exercise timing

Conditions: Pediatric Obesity

Summary: the aim of the present study is to compare the effect of an exercise performed 180 or 30 minutes before lunch on the energy intake of adolescents with obesity.

the present study will compare the nutritional response to the realisation of an acute exercise 180 or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 180 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. their ad libitum energy intake will be assessed during lunch as well as at dinner time. appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria:
inclusion criteria: * - bmi percentile \> 97th percentile according to the french curves. * ages 12-16 years old * signed consent form * being registered in the national social security system * no contraindication to physical activity exclusion criteria: * previous surgical interventions that is considered as non-compatible with the study. * diabetes * weight loss during the last 6 months * cardiovascular disease or risks

Keywords: appetite control obesity adolescents exercise timing
efficacy, safety, pk, pd, and ada of eculizumab in chinese adults with nmosd

Conditions: NMOSD; Neuromyelitis Optica Spectrum Disorders

Summary: the primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of eculizumab in chinese adults with neuromyelitis optica spectrum disorders (nmosd).


Eligibility criteria:
inclusion criteria: * participants with diagnosis of nmosd as defined by the 2015 international consensus diagnostic criteria * anti-aqp4 antibody positive * at least 1 attack or relapse in the last 12 months prior to the screening period * edss score ≤ 7 * if a participant enters the study receiving ist(s) for relapse prevention, the participant must be on a stable maintenance dose of ist(s) as follows, prior to screening and must remain on that dose for the duration of the study, unless the participant experiences a relapse * female participants of childbearing potential must have a negative pregnancy test (serum hcg at screening * male participants are eligible to participate if they agree to the following during the study intervention treatment period and for at least 5 months after the last dose of study intervention: * refrain from donating fresh unwashed semen. plus, either, * be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. or * must agree to use barrier as detailed below: * agree to use a male condom when having sexual intercourse with a wocbp who is not currently pregnant. exclusion criteria: * pregnant, breastfeeding, or intending to conceive during the course of the study * prior history of n meningitidis infection or unresolved meningococcal disease * any systemic bacterial or other infection which is clinically significant in the opinion of the investigator and has not been treated with appropriate antibiotics * presence of fever ≥ 38 c within 7 days prior to study intervention administration on day 1 * hypersensitivity to murine proteins or to one of the excipients of study intervention * use of rituximab, inebilizumab, or other b cell-depleting therapy within 6 months prior to day 1 and during the study * use of mitoxantrone or satralizumab within 3 months prior to screening and during the study * use of ivig within 3 weeks prior to screening * if a participant enters the study receiving oral corticosteroid(s) with or without other ists, the daily corticosteroid dose must be no more than prednisone 20 mg/day (or equivalent) prior to screening and the participant must remain on that dose for the duration of the study or until the participant experiences a relapse (specific medications listed in section 6.9.1 may be allowed) * has previously received treatment with c5 inhibitors * participation in any other investigational drug study or exposure to an investigational drug or device within 5 half-lives of treatment (if known) or 30 days, which is longer, before the first dose administration

Keywords: nmosd neuromyelitis optica spectrum disorders eculizumab anti-aqp4
accelerated rtms for the reduction of nicotine craving

Conditions: Nicotine Use Disorder; Nicotine Dependence

Summary: the purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rtms) can reduce craving for cigarettes in smokers. rtms uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.


Eligibility criteria:
inclusion criteria: * outpatient adults aged 18-70 * cigarette smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled co reading of \>10ppm day of visit. * ability to provide informed consent exclusion criteria * current treatment with varenicline or bupropion * currently making a smoking quit attempt (not currently smoking). * current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer. * current episode of major depression determined by mini interview. * current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by mini. * current daily consumption of alcohol or current alcohol use disorder. * current substance use disorder except for nicotine or cannabis use disorder. * currently pregnant or lactating. * contraindications to rtms including history of seizure, metal implanted above the neck, pacemaker or any brain lesion. * unstable medical conditions * suicidal ideation or history of suicide attempt within the last six months. * inability or unwillingness of subject or legal guardian/representative to give informed consent

Keywords: tms rtms transcranial magnetic stimulation smoking nicotine
ultrasound-assisted treatment of inoperable pancreatic cancer

Conditions: Pancreatic Adenocarcinoma

Summary: the investigators primary aim is to increase chemotherapeutic drug uptake in inoperable tumours the specific sub-objectives of the studies are: * to quantify tumour sizes and relate it to the patient survival over time, dependent of treatment method. * to evaluate and compare the toxic effects and safety of gemcitabine in combination with us contrast agent under sonication with gemcitabine alone. * develop and validate new ultrasound perfusion algorithms based on burst- replenishment for diagnosis and monitoring of therapy. * to quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points. * to assess plasma and tissue concentrations of gemcitabine, its main metabolites and endogenous nucleotides in those patients where surgical resection can be performed on standard clinical indications.

the primary outcome is monitor for toxicity effect for the combination therapy.

Eligibility criteria:
inclusion criteria: * patients with inoperable pancreatic cancer (icd-10 c25.0-3) at the department of surgical gastroenterology of haukeland university hospital, who have volunteered to participate exclusion criteria: * patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug). * patient has severe chronic obstructive pulmonary disease or severe chronic asthma. * patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry. * patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study. * patient has a known history of hepatitis b, hepatitis c or hiv infection. * patient requires dialysis or has severely impaired renal function, defined as a serum creatinine \> 180 mmol/l at the screening visit. * patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/l and/or a protrombin time inr \> 2.3 (or aptt \> 6 seconds above the upper limit of normal) at the screening visit. * patient is pregnant or is breast-feeding. * patient is allergic to or intolerant of gemcitabine * patient is allergic to or intolerant of sonovue® bracco ultrasound contrast agent * any reason why, in the opinion of the investigator, the patient should not participate.

Keywords: pancreatic cancer adenocarcinoma ultrasound ceus
gene therapy clinical study in adult pku

Conditions: Phenylketonurias; PAH Deficiency

Summary: this is a phase 1/2, open-label, randomized, concurrently-controlled, dose escalation study to evaluate the safety and efficacy of hmi-102 in adult pku subjects with pah deficiency. participants will receive a single administration of hmi-102 and will be followed for safety and efficacy for 1 year.

part 1 of this study will evaluate the safety and efficacy of hmi-102 gene therapy in adult subjects with pku due to pah deficiency. subjects will receive a single dose of hmi-102 administered intravenously. up to 3 dose levels of hmi-102 may be investigated in this study. at a given dose level, a minimum of 2 subjects will be enrolled and dosed. dosing of the first two subjects will be staggered. following evaluation of data from the first 2 subjects in a cohort, a decision can be made to either escalate to the next dose level or expand the cohort at the selected dose level. additional doses may be added by hmi to investigate intermediate or higher doses. in part 2 dose expansion, evaluation of up to 2 dose levels is planned. subjects will be randomized to receive hmi-102 or a concurrent delayed treatment control arm. subjects in the delayed treatment control will be eligible to receive hmi-102 after 28 weeks.

Eligibility criteria:
key inclusion criteria: * adults 18-55 years of age at the time of informed consent * diagnosis of phenylketonuria (pku) due to pah deficiency * two plasma phe values with a concentration of ≥ 600 μmol/l drawn at least 72 hours apart during the screening period and at least one historical value ≥ 600 μmol/l in the preceding 24 months. * subject has the ability and willingness to maintain their baseline diet, whether phe-restricted or unrestricted for the duration of the trial, unless otherwise directed key exclusion criteria: * subjects with pku that is not due to pah deficiency * presence of anti-aavhsc15 neutralizing antibodies * alt \> uln and ast \> uln * alkaline phosphatase \> uln. * total bilirubin \> uln, direct bilirubin \> uln * serum creatinine \>1.5x uln * international normalized ratio (inr) \> 1.2 * hematology values outside of the normal range (hemoglobin \<11.0 g/dl for males or \<10.0 g/dl for females; white blood cells (wbc) \<3,000/μl; absolute neutrophils \<1500/μl; platelets \<100,000/μl) * hemoglobin a1c \>6.5% or fasting glucose \>126 mg/dl * any clinically significant abnormal laboratory result at screening, in the opinion of the investigator * contraindication to corticosteroid use or conditions that could worsen in the presence of corticosteroids, as assessed and determined by the investigator * previously received gene therapy for the treatment of any condition.

Keywords: pku phenylketonuria pah deficiency hyperphenylalaninemia phenylalanine adeno associated virus aavhsc15
effects of arzoxifene on bone mass and the uterus

Conditions: Postmenopausal Bone Loss

Summary: the purposes of this study are to determine: * the effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women. * the effects of arzoxifene on the uterus (womb) in postmenopausal women. * the effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density. * the effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk. * the safety of arzoxifene and any side effects that might be associated with its use.


Eligibility criteria:
inclusion criteria: * female * 45 to 60 years of age, inclusive * at least 2 years since last menstrual cycle * intact uterus (womb). exclusion criteria: * existing fracture of the spine. * bone disorders, other than low bone mass * history of cancer in the last 5 years. also, any history, at any time, of breast cancer or cancer of the lining of the uterus. * abnormal or unexplained vaginal bleeding.
improving the quality of life of elderly individuals living in nursing homes

Conditions: Elderly People

Summary: the development of physical activity (pa) and exercise habits improves strength, flexibility, balance and coordination, activities such as walking, sleep quality and cognitive status in elderly people and supports their participation in social life. the aim of the study is to examine the effects of web-based brain breaks® (bb) video exercises (study group-wg) and posture and balance exercises (control group-cg) on the general physical condition, sleep quality and life satisfaction of elderly individuals. we expect this situation to improve the healthy lifestyle behaviors of elderly individuals. this study, planned to be conducted in two nursing homes, was planned as evaluation-bb physical activity/posture and balance exercises-evaluation-1 month follow-up. participants' sociodemographic characteristics, blood pressure, pulse, respiration, height, weight, muscle strength and flexibility, walking performance, posture, sleep and quality of life and life satisfaction will be evaluated. after the first evaluation, 2-3 bb video exercises will be applied to the study group (total n = 140 videos, t = 3-4 min) and posture and balance exercises (t = 20 min) to the control group, two days a week for 8 weeks, for a total of 16 sessions. during the follow-up period, physical activity habits will be questioned through weekly telephone calls (n = 4). all statistical analyzes will be performed in spss 26.0 program, and p value \<0.05 will be considered statistically significant. differences within and between groups and relationships between data and factors affecting these data will be examined.


Eligibility criteria:
inclusion criteria: * being 65 years or older, * there is no health problem determined by the doctor that prevents physical activity, * volunteering to participate in the study. exclusion criteria: * having a serious life-threatening chronic disease or dementia, * having chronic or acute pain that prevents you from continuing to work, * having uncontrolled hypotension/hypertension, cardiovascular problems, metabolic and chronic diseases

Keywords: brain breaks® (bb) videos physical activity quality of life walking health lifestyle
a study of oral oteseconazole for the treatment of patients with recurrent vaginal candidiasis (yeast infection)

Conditions: Recurrent Vulvovaginal Candidiasis

Summary: recurrent vulvovaginal candidiasis (rvvc), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vvc in the past 12 months. several properties of oteseconazole (vt-1161) suggest that it might be a safer and more effective treatment for rvvc than other oral anti-fungal medicines. this study will evaluate the effectiveness and safety of oteseconazole (vt-1161) for the treatment of rvvc and consists of 2 parts. the first part of the study is a 2-week period for the treatment of the patient's current vvc episode with 3 150mg doses of fluconazole. the 2nd part consists of 12 weeks, when the patient will take either oteseconazole (vt-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period. in addition, at participating sites, an amendment to the study allows us patients who complete the initial 48 weeks without experiencing a confirmed rvvc episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (vt-1161). this study is identical to vmt-vt-1161-cl-012 (nct03561701).


Eligibility criteria:
key inclusion criteria: * 3 or more episodes of acute vvc in the past 12 months * positive koh or gram stain * total vulvovaginal signs and symptoms score of ≥3 at screening visit * total vulvovaginal signs and symptoms score of \<3 at baseline visit * must be able to swallow pills key exclusion criteria: * presence or a history of another vaginal or vulvar condition(s) * evidence of major organ system disease * history of cervical cancer * poorly controlled diabetes mellitus * pregnant * recent use of topical or systemic antifungal or antibacterial drugs * recent use of immunosuppressive or systemic corticosteroid therapies
massage technique for pain, anxiety and delirium in sah patients

Conditions: Subarachnoid Hemorrhage; Anxiety; Pain; Delirium; Sleep

Summary: this research study seeks to explore the effects of massage techniques on pain and anxiety relief among patients with subarachnoid hemorrhages in the icu setting in comparison to subarachnoid hemorrhagic patients using standard medical therapy. in addition, our aim is to decrease the overall medication use to treat pain and anxiety, and to determine the impact of massage on sleep duration, quality, and breathing. our goal is to improve and promote comfort during the icu stay as well as decrease the need for narcotic medication usage.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of aneurysmal subarachnoid hemorrhage exclusion criteria: * upper extremity deep vein thrombus * active alcohol or drug withdrawal