Kornimate/medical-research-clean huggingface dataset:
oral antihypertensive regimens for management of hypertension in pregnancy

Conditions: Hypertension in Pregnancy; Preeclampsia

Summary: this is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. women presenting with severe hypertension in pregnancy in two hospitals in nagpur, india will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. this trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. the investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.

this is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. women presenting with severe hypertension in pregnancy in two hospitals in nagpur, india will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. this trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. the investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.

Eligibility criteria:
inclusion criteria: * pregnant gestational age \>= 28 weeks * systolic blood pressure \>=160 mm hg or a diastolic blood pressure of \>=110 mm hg measured twice more than 15 minutes apart * able to swallow pills * \>= 18 years exclusion criteria: * indication for emergent cesarean or known fetal anomaly * anti-hypertensive therapy received in the past 12 hours * history of eclampsia or other adverse cns complication (e.g., stroke or pres) in this pregnancy * actively wheezing at time of enrollment or history of asthma complications * known coronary artery disease or type i dm with microvascular complications or signs of heart failure or clinical dissection of the aorta

Keywords: hypertension in pregnancy preeclampsia anti-hypertension labetalol nifedipine methyldopa
a long term study to evaluate the safety and tolerability of cp-690,550 for patients with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: the main objective of this study is to evaluate the long-term safety of cp-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. this is an open label extension study available to patients who participated in one of the qualifying studies with cp-690,550 providing entry criteria is met.

the study terminated on 08mar2016 as it met its objectives of characterizing long term safety and tolerability. the study did not terminate due to safety concerns.

Eligibility criteria:
inclusion criteria: * have participated in qualifying study with cp-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris). exclusion criteria: * non-plaque or drug induced forms of psoriasis; * cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (puva or uvb). * any uncontrolled significant medical condition.

Keywords: chronic severe treatment safety cp-690,55 plaque psoriasis psoriasis vulgaris xeljanz tofacitinib
vertical versus horizontal plicataion in transperienal repair of rectocele

Conditions: Rectocele

Summary: we assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. the present randomized study aimed to evaluate the outcome of tpr with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ods, recurrence of rectocele, postoperative complications and dyspareunia.


Eligibility criteria:
inclusion criteria: * vertical plication of the rectovaginal septum was done exclusion criteria: * patients with ods caused by conditions other than rectocele such as anismus and internal rectal prolapse * patients with slow transit constipation. * patients with recurrent rectocele after previous surgery. * patients with pre-existing fi * patients with associated anorectal pathology.
metronomic oral vinorelbine combination with tislelizumab in egfr/alk-negative advanced nsclc

Conditions: EGFR/ ALK-negative Advanced NSCLC

Summary: to evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in egfr/alk-negative advanced nsclc patients intolerant to first-line standard chemotherapy.

this study is a clinical intervention study. the patients who comfirm the criteria will be treated with tislelizumab plus metronomic oral vinorelbine. the patients will be followed up until the tumor progressed, and the efficacy (pfs, orr, dcr) of tumor therapy were evaluated. drug administration regimen: tislelizumab 200mg intravenous drip once every 3 week3; oral vinorelbine 40mg three times a week for three weeks and q28d for one course.

Eligibility criteria:
inclusion criteria: * has a histologically or cytologically confirmed diagnosis of stage iv (m1a or m1b-american joint committee on cancer \[ajcc\] 8th edition) squamous nsclc or non-squamous nsclc without sensitising egfr or alk alterations. * has measurable disease based on recist 1.1 as determined by the local site investigator/radiology assessment. * has not received prior systemic treatment for metastatic nsclc. * has a life expectancy of at least 3 months. * has fully understood this study and voluntarily signed a written informed consent form. * deemed unsuitable by the investigator for any platinum-doublet chemotherapy due to poor performance status (ecog performance status of 2-3)；\>= 75 years of age；substantial comorbidities; contraindication(s) for any platinum-doublet chemotherapy. exclusion criteria: * histological or cytological confirmation of small cell lung cancer. * has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * has disorders of oral medication.
primary anastomosis versus enterostomy in the surgical treatment of necrotising enterocolitis

Conditions: Necrotizing Enterocolitis

Summary: necrotizing enterocolitis (nec) is a devastating disease that affects the intestine of premature infants and is the most common surgical emergency in newborns. it is estimated that up to 10% of premature babies can suffer from this condition. despite aggressive medical treatment, surgical intervention is necessary in up half of the cases for bowel necrosis or perforation and these often represent the more severe form of the disease. the advances in neonatal intensive care and surgical knowledge have resulted in improved survival rate in recent years. for nec patients with severe disease (i.e.) those with intestinal perforation or gangrenous bowel not responding to medical therapy, surgery with resection of diseased segments is the treatment of choice. traditional surgical approach would be to resect the diseased bowel segment with formation of enterostomy. however, in a few advanced centres, primary anastomosis after the resection of diseased bowel segment is practised. retrospective reports of the primary anastomosis approach have shown that this is also a viable option with no increased rate of peri-operative morbidity. it also has the advantage of avoiding a second operation for enterostomy closure. nonetheless, prospective studies comparing the two approaches are lacking. the proposed study will fill up the following knowledge gap on what the best surgical option for nec at laparotomy is. the findings will help guide our practice for nec patients in the future in order to provide them with the best possible and evidence-based care. in this study, the investigators hypothesize that neonates with major nec undergoing primary anastomosis after surgical resection is not inferior to neonates who have enterostomy, in terms of peri-operative morbidities. aim of the study is to compare the short term and medium term outcomes of nec patients requiring surgical intervention who either receive primary anastomosis or enterostomy creation.


Eligibility criteria:
inclusion criteria: * all neonates with confirmed nec and require surgical intervention will be included exclusion criteria: 1. neonates found to have nec totalis and deemed unsalvageable; 2. neonates found to have multiple sites of gangrenous bowels which require more than two anastomoses; 3. neonates found to be extremely unstable cardiovascularly intra-operatively and can only withstand excision of gangrenous bowels, but will not allow anastomosis or stoma creation; 4. parents who do not agree to participate in the study 5. neonates found to have pathology other than nec after recruitment (either on intraoperative findings or pathological findings on surgical specimens).

Keywords: necrotizing enterocolitis neonatal surgery primary anastomosis enterostomy
metabolic effects of plant-based diet

Conditions: Healthy Diet; Fatty Liver; Insulin Resistance; Metabolic Syndrome; Healthy Lifestyle; Healthy Nutrition

Summary: the purpose of this study is to assess the metabolic effects of plant based diet on healthy young adults.

an internet announcement will be made and 60 participants who meet the eligibility requirements will be randomly selected. after being informed about study, all participants (60 omnivores) giving written informed consent will be assigned to the vegan and vegetarian groups of the study according to their preferences, while 20 participants will continue to be omnivores as the control group. at week 0 and 24, blood samples, urine samples, proton density fat fraction mri evaluations and body composition analyze will be completed.

Eligibility criteria:
inclusion criteria: 1. being 18-40 years old, 2. bmi is 18-30 kg/m2, 3. having no chronic diseases, 4. not smoking exclusion criteria: 1. having chronic disease, 2. being older than 40 years old or younger than 18 years old, 3. smoking, 4. alcoholism or drinking more than 140 gr/week of alcohol,

Keywords: plant-based metabolic fatty-liver
act for mental health in neurological disorders

Conditions: Neurological Disorders; Mental Health; Executive Function (Cognition); Depression/Anxiety; Stress; Brain Injury; Post-COVID

Summary: the goal of this clinical trial is to examine the efficacy of this manual for mental health in people with mixed neurological disorders, including post-covid. these conditions are often associated with cognitive impairment, which may hamper the effects of psychoterapy. executive functioning and especially the ability to abstract thinking may be useful for individuals using acceptance and commitment therapy. therefore, the main questions research questions are: * is this intervention effective in improving mental health? * do executive functions predict the extent of social participation and mental health at the end of therapy? participants will take part in 8 weekly group therapy sessions of 100 minutes each.

mental health issues, especially depression, anxiety, and stress, are common in people with neurological disorders and post-covid but often neglected and hence, remain untreated. acceptance and commitment therapy (act) is a promising approach to assist people in adapting to their conditions by improving "psychological flexibility". a previous study translated an adapted group psychotherapy manual for stroke survivors into german and demonstrated its feasibility. this pilot study also gave first indications on the manual's efficacy in reducing symptoms of anxiety, depression, and stress. the aim of this study is to investigate the efficacy of this act-based group therapy. people with neurological disorders may have impairments in executive functions, which can affect the psychotherapeutic process. since act often uses metaphors and imagery, executive functions, particularly the ability to abstract, could influence the efficacy of the therapy and are therefore being investigated in this study. the program includes 8 weekly sessions with a session length of 100 minutes.

Eligibility criteria:
inclusion criteria: * value above a cut-off of the dass-21 subscales (depression \> 10, anxiety \> 6, and stress \> 10) * sufficient cognition and language ability (clinical rating) * sufficient therapy motivation (clinical rating) exclusion criteria: * behavioral disorders (e.g., high irritability or apathy in clinical rating) * other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability) * simultaneous psychotherapy or neuropsychological therapy

Keywords: acceptance and commitment therapy (act) group therapy neurological disorders brain injury anxiety stress depression executive functioning abstraction ability post-covid
use of metformin to reduce cardiac toxicity in breast cancer

Conditions: Breast Cancer; Breast Tumors

Summary: the goal of this study is to determine if co-administration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left ventricle ejection fraction (lvef).

this is a randomized, open-label, phase ii design pilot study in patients with breast cancer requiring neoadjuvant or adjuvant chemotherapy. eligible patients will be equally randomized to either receive metformin plus standard of care therapy or standard of care therapy alone. patients receiving metformin will continue drug until the doxorubicin-containing cycles are complete, unless unacceptable toxicity occurs or the patient decides to withdraw from the study. both arms of the study will undergo echocardiograms with contrast at baseline, upon completion of doxorubicin-containing cycles (within 28 days of completion), and at the one-year and seven-year time points. additionally biomarker labs will be obtained to explore if there is a correlation between change in cardiac activity and the activity of metformin. if willing, all enrolled patients will provide a sample of whole blood for further exploratory analysis. symptoms reported during the study will be correlated with know single nucleotide polymorphisms (snps) found during an exploratory genomic analysis.

Eligibility criteria:
inclusion criteria: * breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin * complete metabolic panel demonstrating adequate organ functions as defined by the following: aspartate transaminase (ast) less than 2.5 times upper limit of normal (uln); alanine transaminase (alt) less than 2.5 times uln; alkaline phosphatase less than 2.5 times uln; serum creatinine less than 1.5 mg/dl; serum bilirubin less than uln * eastern cooperative oncology group (ecog) performance status of 0 or 1 * age greater than or equal to 21 years exclusion criteria: * known diabetes * history of cardiac arrhythmias or symptomatic cardiac disease * currently taking antiarrhythmic medications, beta-blockers, or other rate controlling cardiac medications * currently taking metformin and/or sulfonylureas * known hypersensitivity or intolerance to metformin * baseline ejection fraction of less than 50% measured by echocardiogram * known hypersensitivity to contrast used during echocardiogram * risk factors associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more alcoholic beverages per day) * pregnant or breast feeding

Keywords: breast cancer doxorubicin metformin cardiotoxicity ejection fraction lvef
the effect of obesego! towards adolescent obesity

Conditions: Adolescent Behavioral Change

Summary: adolescents nowadays is having most of their times other than school hours spending on screen by playing games, watching the movies and surfing the internet. thus, it was suggested that internet-based interventions have the potential for establishing healthy dietary style and physical activity that may persist in adulthood and reduce the risk of chronic disease. preventing adolescent obesity requires an attitude of willingness by adolescents to implement healthy behaviors. by providing the health related activities in website, it would help the adolescents to spend time on screen by having something which can benefit them and improve their knowledge and attitudes.

this study done in improving the health promotion in malaysia. it will be an evidenced in creating the most effective way in creating the awareness among adolescent. by having an effective health promotion it will help in reducing the prevalence of obesity and improving health among adolescents hence will reducing the comorbidities among adulthood.

Eligibility criteria:
inclusion criteria: * students aged of 16 years old (adolescents) in secondary school in kuala lumpur who have bmi of more than 25 kg/m2, have one guardian or parent who willing to join the study and having access to internet at home were then selected to join this study exclusion criteria: * those who are having existing medical condition and having weight loss more than 2 kg in last two months
pharmacokinetics and pharmacodynamics of caspofungin (cancidas ®) and drug tolerance of fungi to patients with an invasive fungal infection in the intensive care unit

Conditions: Invasive Fungal Infection

Summary: to investigate pharmacokinetics(pk) and pharmacodynamics(pd) of caspofungin in icu patients after received a loading dose of 70mg followed by 50mg (35mg if child-pugh score is 7-9), 40 patients will be recruited. blood samplings for pk analysis will be collected on day 4 in this study. caspofungin plasma concentrations are measured by using solid phase extraction and reverse phase high-performance liquid chromatography. safety analyses will be taken daily during the treatment of caspofungin. tests for drug tolerance of fungi and efficacy assessment (clinical and mycological responses) will be taken every 3 days by clinical and mycological tests.


Eligibility criteria:
inclusion criteria: * patient is admitted to icu with apache-ii score more than 15 * subject is 18 years old and older on the day of the first dosing * subject with evidence of proven or probable ifi defined by modified criteria of european organization for research and treatment of cancer(eortc) exclusion criteria: * patient is known to be hypersensitive to caspofungin * patient's child-pugh score is more than 9 * patient is prone to discontinue treatment result from lack of cost * patient or their guardian refuse to sign a informed consent form * patient concurrently receiving efavirenz, nevirapine, rifampin, systemic dexamethasone, phenytoin, carbamazepine, phenobarbital, or cyclosporine and other agents have influence on pk parameters of caspofungin * patient is treated with caspofungin within 24 hours
post-marketing surveillance (pms) to observe the safety and effectiveness of lyrica cr extended release tablets

Conditions: Peripheral Neuropathic Pain

Summary: this is an open-label, non-comparative, non-interventional, prospective, and multi-center pms study to observe safety and effectiveness of lyrica cr (82.5mg, 165mg, 330mg) in korean subjects under the actual condition of use. pms is an obligation to k-mfds.


Eligibility criteria:
\[inclusion criteria\] to be eligible to enter this study, the subject will have to meet the following inclusion criteria: 1. korean patients who have been administered lyrica cr for the first time according to the current local labeling (indication, dosage and administration). 2. subjects who have consented to participate in this study by signing the data privacy statement. \[exclusion criteria\] patients meeting any of the following criteria will not be included in the study: 1. patients who have deviated from local labeling (indication, dosage and administration) in taking this drug 2. renal impairment patients with clcr less than 30 ml/min or who are undergoing hemodialysis. 3. patients who have hypersensitivity to the active substance (pregabalin) or to any of the excipients. 4. other patients who are decided to be not prescribed by the investigator under the routine medical practice, considering the balance the overall risk and benefit, for example, patients have suicidal behavior and ideation, or have any risk of these, and/or patients who are in pregnancy or lactation, etc.
electromagnetic stimulation of the phrenic nerve in critically ill mechanically ventilated patients (stimit-ii)

Conditions: Muscle Weakness; Critical Illness; Mechanical Ventilation Complication

Summary: ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. a non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible. in this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill icu patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.

during the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (vidd). the damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. recently, a correlation between diaphragmatic atrophy and mortality could be established. induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat vidd. a possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established. in this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill icu patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.

Eligibility criteria:
inclusion criteria: * patients between 18 and 60 years old, hospitalized in icu * mechanical ventilation \< 36 h * prone to stay ventilated \> 72 h exclusion criteria: * known neurological condition affecting motor neuron or muscle (e.g. als) * known paralysis of the phrenic nerve * proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord * conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity) * not able to read and understand the national language german * patients with implanted cardiac support systems (pacemaker, implanted defibrillator) * patients with implanted medical pumps * pregnant patients * patients with skin lesions, infections or strictures in throat/neck area * patients with metallic implants

Keywords: vidd icuaw muscle weakness weaning