Kornimate/medical-research-clean huggingface dataset:
renin-guided therapeutics in the management of untreated, uncontrolled, or complicated hypertension

Conditions: Hypertension

Summary: plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate in elevating blood pressure and are useful in selecting effective antihypertensive therapy.2,3 the researchers hypothesize that: 1. plasma renin-guided therapeutics will improve systolic and diastolic blood pressure control in patients with untreated hypertension as well as in patients with treatment refractory or resistant hypertension that are managed by clinical hypertension specialists. 2. renin-guided therapeutics will reduce the number of medications required to maintain blood pressure control to \<140/90 mmhg in hypertensive patients receiving 3 or more medications, while under the care of a clinical hypertension specialist. 3. renin-guided therapeutics selection will reduce the total cost of antihypertensive care provided by clinical hypertension specialists.

hypertension affects \~25% of adults. the prevalence of hypertension and related complications is greater among the elderly, obese, and ethnic minorities. unfortunately, hypertension control rates remain in the 25% range and are often significantly lower for the high-risk groups noted.1 since the high-risk groups are growing more rapidly than the general population, the prevalence of hypertension and associated morbidity and mortality will probably increase sharply in the years ahead unless successful strategies are implemented for dramatically improving blood pressure control. direct measurements of plasma renin reflect the relative balance between volume (v) and vasoconstrictor (renin \[r\]) factors underlying the elevated blood pressure in patients with essential hypertension.2 while many antihypertensive medications have effects on both the volume (v) and vasoconstrictor (renin \[r\]) components of elevated blood pressure, one or the other usually predominates

Eligibility criteria:
inclusion criteria: * age, 21 years of age and older * male or female (post-menopausal or effective method of birth control) * bp and treatment criteria noted above * willingness to provide written, informed consent * ability to adhere to study protocol exclusion criteria: * uncontrolled diabetes or hyperlipidemia requiring medication changes * any active disease process requiring new diagnostic and therapeutic plans * any life-threatening illness * history of alcohol or drug abuse in past 5 years * mental illness or personality disorder that interfere with adherence to study protocol * serum creatinine \>2.5 mg/dl unless documented stable for at least one year * dialysis for chronic renal failure, even if creatinine stable for at least one year * intolerance to two or more classes of antihypertensive medications * normal home bp (\<140/90 mmhg at baseline), i.e., office only hypertension.

Keywords: hypertension renin-guided therapeutics
tantrum tamers 2.0: the role of emotion

Conditions: Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Problem Behavior

Summary: this study aims to better understand how to best help parents of young children with problem behavior. problem behaviors vary between and within children, but can include inattention/hyperactivity, tantrums, and/or noncompliance.

if eligible and choose to participate, this study includes: a baseline assessment which will include asking a series of questions about parent, child and family, as well as parent-child observations. if eligible for treatment, sessions occur once per week for approximately 8 to 12 weeks. sessions include new information and lots of practice and discussion about how to make the skills work best for specific families. after finishing treatment a post-assessment (similar to bl) conducted. all of the assessments (i.e., video-and audio-recorded), as well as the sessions with a therapist will be recorded (i.e., video recorded).

Eligibility criteria:
inclusion criteria: * clinically significant child problem behavior exclusion criteria: * current severe symptoms in parent or child that would prohibit participation (e.g., parent current psychotic or substance use disorder)

Keywords: tantrums inattentive noncompliance
genetics and heart health after cancer therapy

Conditions: Breast Cancer; Hereditary Breast/Ovarian Cancer (brca1, Brca2); Heart Diseases; Drug-Induced Cardiomyopathy

Summary: the overall objective of this study is to use patient-centered in vitro and in vivo models to answer the fundamental question of whether or not pathogenic mutations in brca1/2 result in an increased risk of cv disease


Eligibility criteria:
inclusion criteria * ≥18 years of age * initial diagnosis of breast cancer in 2005 or later * documented brca testing (results from a local laboratory are acceptable) showing * confirmation of a germline mutation in brca1 or brca2 that is predicted or suspected to be deleterious or * confirmation that no mutation was detected in brca1 or brca2 * non-carriers will have been treated with an anthracycline-based chemotherapy regimen; carriers may or may not have been treated with an anthracycline-based chemotherapy regimen. * approximately at least 12 months from initiation of adjuvant treatment or neo-adjuvant chemotherapy * able to provide informed consent exclusion criteria * stage iv breast cancer * genetic testing confirming a variant of unknown significance (vus) or benign polymorphism in brca1 or brca2 * v02 testing contraindicated for any reason, including: * myocardial infarction (within past 3 months) * high-risk unstable angina; * high-risk or uncontrolled cardiac arrhythmias; * symptomatic severe aortic stenosis; * uncontrolled symptomatic heart failure; * acute pulmonary embolus or pulmonary infarction; * acute myocarditis or pericarditis; * acute aortic dissection; * coronary revascularization procedure within the past three months; * uncontrolled hypertension, defined as systolic blood pressure ≥ 180mmhg or diastolic blood pressure ≥ 100mmhg; * clinically significant valvular heart disease (severe stenosis or regurgitation); * known aortic aneurysm; or * any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the v02 test * women who are pregnant * any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Keywords: cardio-oncology
effect of kinesio tape application and stretching exercises on calf cramps during pregnancy

Conditions: Calf Cramps During Pregnancy

Summary: the aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy

up to 30% to 50% of pregnant women suffered from leg cramps, especially in the third trimester. almost two-thirds of these women experience leg cramps twice per week and they can occur at any time, particularly at night.in mild and moderate cases, calf cramps may last for seconds, but in severe cases, leg cramps in pregnancy may last for minutes .in many cases calf cramps are very painful , which can affect daily activities, restrict exercise and performance, motive sleep disturbance and reduce the quality of life.non-drug treatments are found to being effective for the treatment of muscle cramps. non-drug treatments such as muscle stretching, physical exercise, avoidance of physical fatigue, massage, relaxation, heat therapy, weight loss, sensory nerve stimulation, ankle splints worn while sleeping, and changes to sleeping and sitting positions.this study has two groups; one recieved kinesio-tape application and stretching exercises and the second one recieved instructions about dealing with cramps with self low sustained stretch

Eligibility criteria:
inclusion criteria: * pregnant women who are suffering from calf cramps. * their age range from 25 to 35 years. * their body mass index range from 25 to 29.9 kg/m2 . exclusion criteria: * skin abnormalities (skin malignancy in the treated area or burned). * history of previous back surgery. * neuromuscular diseases like multiple sclerosis. * sensory disturbances. * evidence of previous vertebral fractures or major spinal structural abnormality, spondylolisthesis or spinal stenosis. * systemic disease of musculoskeletal system. * viscerogenic cause of back pain. * also, women who have eclampsia or pre-eclampsia.

Keywords: kinesio-tape,stretching exercises, calf cramps, pregnants, cramp questionnaire
icu acquired neuromyopathy and diaphragm function

Conditions: Critical Illness Myopathy; Respiratory Paralysis

Summary: critical illness neuromyopathy is a common disease acquired during icu stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation. the main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a mrc score \< 48). the second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; icu stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the medical research council - mrc score).

diaphragm function will be assessed through phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion (expressed in cmh2o). it will be assessed during a spontaneous breathing trial for each patient with a known critical illness neuromyopathy. the diaphragm (thickness and course) will be studied by ultrasound assessment as well. peripheral limbs force will be evaluated by the mrc score. a total of 40 analysable patients will be included. all these measurements will be made at the time of the spontaneous breathing trial (sbt) during the weaning phase. no modification of the clinical practices of the care should be modified by the study. the twitch airway pressure during airway occlusion will be assessed at the begining of the sbt. the other measurements will be performed 30 mn after the sbt if this one will be well tolerated. participants will be followed for the duration of icu stay.

Eligibility criteria:
inclusion criteria: * mrc score \<48 * ready for weaning from mechanical ventilation exclusion criteria: * previous history of neuromyopathy * impossibility to perform a magnetic stimulation * cervical spine injury * bihemispheric or brain stem lesion

Keywords: critical illness neuromyopathy diaphragm dysfunction mechanical ventilation weaning ultrasound
memantine for neuroprotection and cognitive enhancement following traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.

this is a pilot/feasibility study of memantine in severe traumatic brain injury (tbi) persons, employing a randomized, double-blind, placebo-controlled, design. outcome evaluations will occur after 24 weeks of treatment (on medication) and 4 weeks after treatment discontinuation.

Eligibility criteria:
inclusion criteria: * 18-65 years old of age at time of enrollment * severe traumatic brain injury (tbi) * feeding access (e.g., orogastric (og), nasogastric (ng), or percutaneous endoscopic gastrostomy (peg) tube) permitting delivery of memantine or placebo * availability of legally-authorized representative (lar) to provide consent and participate in some study activities (e.g., monitoring for side effects, providing information about the patient) exclusion criteria: * pre-existing history of serious neurological disorder * pre-existing history of serious psychiatric disorder (e.g., schizophrenia) * anticipated poor prognosis, based on the presence of bilaterally fixed and dilated pupils, severe hemodynamic instability, severe elevations in intracranial pressure refractory to interventions, or other factors leading to a determination of a probable non-survivable injury * primarily penetrating mechanism of injury (e.g., gunshot wound to the head) * isolated epidural hematoma with anticipated good prognosis * low probability of participant being compliant or being able to finish study procedures (e.g., present for outcome rating) in the judgment of the investigator * not english speaking (due to inability to complete outcome measure) * medical contraindications to memantine: severe hepatic impairment (defined as albumin \> 15gm/dl, alk phos \> 375 u/l, alt \> 150 u/l, ast \> 120 u/l or bilirubin \> 3mg/dl). moderate-to-severe renal impairment (defined as creatinine clearance \< 60) * pregnancy or breastfeeding

Keywords: traumatic brain injury memantine memory
a study to evaluate the tolerability and efficacy of tamsulosin 0.4mg ocas formulation in patients who are unsatisfied with the treatment of tamsulosin 0.2mg conventional formulation

Conditions: Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Summary: this is an open-label, single-arm, prospective interventional study to assess the tolerability and efficacy of harnalidge® ocas® 0.4 mg in taiwan patients who are unsatisfied with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).

after obtaining informed consent, subjects who meet the inclusion criteria and not violating the exclusion criteria will be enrolled to receive harnalidge® ocas® 0.4 mg for treatment. the interventional period for the study is three months after the first date of enrollment or until the patients are discontinued the treatment of harnalidge® ocas®. all subjects will be instructed to contact the site if a patient's partner becomes pregnant during or within 90 days from the discontinuation of dosing, the investigator should report the information to the sponsor as if it is an sae.

Eligibility criteria:
inclusion criteria: * diagnosed as luts associated with bph * currently taking oral tamsulosin 0.2 mg for at least 4 weeks * unsatisfied with the treatment of tamsulosin 0.2 mg the definition of 'unsatisfaction' is based on patient's satisfaction. investigator will ask patient one question "are you satisfied with your current treatment?" prior to study enrollment * ipss-qol score ≧3 points at baseline exclusion criteria: * subjects who underwent prostatectomy during the period of one year prior to this study * subjects with neurogenic bladder dysfunction, bladder neck sclerosis, urethral stricture, prostatic cancer, cystolithiasis, severe vesical diverticulum, urinary tract infection * subjects with any other complication which may cause voiding dysfunction * subjects with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorders, orthostatic hypotension, or senile dementia * subjects clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial * subjects who are currently participating in any other investigational drug study or who have participated in a study of an investigational drug within 3 months prior to this study

Keywords: tamsulosin, benign prostatic hyperplasia, α1-adrenoceptor antagonists
conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation

Conditions: Infertility

Summary: the purpose of this study is to compare the efficiency of conversion to iui and ivf in patients with a poor ovarian response to stimulation

in 5 to 10% of in vitro fertilization (ivf) cycles, a poor response to ovarian stimulation (defined as less than 4 mature follicles) is noted, even though high doses of exogenous gonadotropins are used. to date, there is no consensus on the ideal management strategy in poor responders. there are three therapeutic options available nowadays: 1. oocyte retrieval is performed and the ivf cycle continued, despite the low number of mature follicles. 2. conversion of the ivf cycle to an intrauterine insemination (iui), on the condition of having at least one patent fallopian tube and good semen parameters. 3. cancelation of the ivf cycle. in everyday practice, it is difficult for the physician to cancel the ivf cycle in the presence of 2, 3 or 4 mature follicles, especially following a lengthy stimulation. if live birth rates were comparable between iui and ivf, conversion to iui would be the better option for poor responders, since it would avoid an invasive procedure (oocyte retrieval) and the associated risk of complications, and is associated with at a lower cost. to our knowledge, no prospective randomized controlled trial comparing ivf to conversion to iui in poor responders has been published to date. the studies published so far have been retrospective and observational, and had several methodological flaws. therefore, we aimed to analyze whether conversion of ivf cycles to iui in poor responders would result in the same live birth rates as oocyte retrievals followed by embryo transfers.

Eligibility criteria:
inclusion criteria: * patients who accepted being included and signed the consent forms. * age ≥18 years et \<43 years. * ivf cycle with and without intra cytoplasmic sperm injection (icsi): * "conventional" agonist (long and short) or antagonist protocol, using urinary or recombinant gonadotropins. * having only 2, 3 or 4 mature follicles (≥14 mm) on ovulation trigger day. exclusion criteria: * confirmed bilateral tubal occlusion * non-french speaking patients * partners with severe oligoasthenoteratospermia (oats) (\<5 millions motile spermatozoa in the ejaculate) * suboptimal stimulation protocols: * protocols ≤ 150 iu of daily gonadotropins * mild stimulation protocols * natural and modified natural cycle protocols * women under legal guardianship * women with no health or social security coverage * women participating in other interventional trials

Keywords: in vitro fertilization intra-uterine insemination poor responders
anxiety treatment inspired by dialectical behavior therapy (dbt)

Conditions: Treatment Resistant Anxiety Disorders

Summary: the main interest in this study is to investigate if it is possible to use strategies from dialectical behavior therapy (dbt) to increase effectiveness of ordinary cognitive behavioral therapy (cbt) for patients with anxiety disorders. for the patients included in this study, previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment).


Eligibility criteria:
inclusion criteria: * currently diagnosed with an anxiety disorder. to be included, the level of anxiety in a critical situation should be high and of a more acute type, unlike the lower more generalized anxiety in for example generalized anxiety disorder. * previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment). exclusion criteria: * severe depression. * psychotic disorder. * a documented neuropsychiatric diagnosis.

Keywords: dialectical behavior therapy cognitive behavioral therapy emotion regulation emotion dysregulation anxiety disorders skills training
safinamide as add-on therapy in patients with early idiopathic parkinson's disease treated with a stable dose of a single dopamine agonist (12 month extension)

Conditions: Parkinson's Disease

Summary: to determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic parkinson's disease who are currently receiving a stable dose of a single dopamine (da) agonist.

the study will consist of 12 months of double-blind treatment. patients will continue to take the original treatment administered in study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).

Eligibility criteria:
inclusion criteria: 1. the patient completed 24 weeks of treatment in study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at weeks 12 and 24 (visits 6 and 8) as part of the retrieved dropout (rdo) population. 2. the patient was compliant with taking study medication in study 015. 3. the patient is willing to participate in the study and signed an approved informed consent form. exclusion criteria: 1. the patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study. 2. the patient has shown clinically significant deterioration during participation in study 015. 3. the patient discontinued study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at weeks 12 and 24 (visits 6 and 8) in study 015.

Keywords: parkinson's disease
neoadjuvant fluzoparib combined with camrelizumab in germline brca-mutated her2-negative breast cancer

Conditions: Germline BRCA-mutated HER2-negative Breast Cancer

Summary: this study is an open-label, single-arm, multicenter clinical study. 94 patients with germline brca-mutated her2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline brca-mutated her2-negative early breast cancer。


Eligibility criteria:
inclusion criteria: * women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer * histopathologically confirmed early or locally advanced her2-negative invasive breast cancer as defined by the asco/cap guidelines while meeting the following conditions: her2 negative: ihc 0/1 + or ihc2 + but ish negative; tumor stage: ii-iii; primary tumor size: ≥ 1 cm nodal status: n0-3 * ecog score 0 \~ 1; * centrally confirmed brca1 or brca2 germline mutation; * at least one measurable lesion according to recist 1.1 * eligible level of organ function exclusion criteria: * patients with metastatic breast cancer or bilateral breast cancer; * patients with inflammatory breast cancer; * participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy or tumor embolization; * previously received pd-1/pd-l1 antibody, ctla-4 antibody, or other therapies against pd-1/pd-l1 inhibitors; * previously received parp inhibitors; * human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome (aids); active hepatitis or combined hepatitis b and c co-infection; autoimmune hepatitis; * confirmed history of heart failure or systolic dysfunction (lvef \< 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication * female patients who are pregnant or lactating * history of definite neurological or psychiatric disorders, including epilepsy or dementia * presence of interstitial lung disease, pneumonitis, or uncontrolled systemic disease (eg, diabetes mellitus, pulmonary fibrosis, acute pneumonitis, etc.)