Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and effectiveness of asoprisnil in the treatment of uterine fibroids

Conditions: Leiomyoma; Menorrhagia; Metrorrhagia

Summary: the objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

no medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. the objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Eligibility criteria:
inclusion criteria: * premenopausal women * history of regular menstrual cycles (21-42 days) * diagnosis of uterine fibroid(s) * abnormal vaginal bleeding associated with uterine fibroids * otherwise in good health * agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails * negative pregnancy test * agrees to double-barrier method of contraception * pap smear with no evidence of malignancy or pre-malignant changes * endometrial biopsy with no significant histological disorder exclusion criteria: * any abnormal lab or procedure result the study-doctor considers important * severe reaction(s) to or are currently using any hormone therapy * history of osteoporosis or other bone disease * previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months * history of polycystic ovary syndrome or prolactinoma * mri shows significant gynecologic disorder * uterine size \> 25 weeks gestation * hemoglobin \< 8 g/dl at day -1

Keywords: symptomatic uterine fibroids excessive uterine bleeding uterine hemorrhage asoprisnil
blood oxygen level dependent magnetic resonance imaging (bold mri) and fluorothymidine positron emission tomography (flt pet) in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy

Conditions: Locally Advanced Breast Cancer (LABC)

Summary: the objective of this pilot study is to determine the effectiveness of fluorothymidine positron emission tomography (flt pet) and blood oxygen level dependent magnetic resonance imaging (bold mri) in assessing tumour response to neoadjuvant chemotherapy (na ct) in women with locally advanced breast cancer.


Eligibility criteria:
inclusion criteria: * histologic proof of breast cancer (invasive ductal or lobular carcinoma). breast sarcoma and lymphoma are not eligible. * clinical diagnosis of locally advanced breast cancer (stage iib (t3,n0,m0), stage iiia, iiib, or iiic, according to american joint committee on cancer (ajcc) tumour-node-metastasis (tnm) cancer staging), including inflammatory breast cancer. * ability to undergo neoadjuvant chemotherapy. exclusion criteria: * evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests); * previous chemotherapy or hormonal therapy for breast cancer; * significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease); * known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (b-hcg) pregnancy test); * inability to lie supine for imaging with positron emission tomography (pet); * any contraindication to undergoing magnetic resonance imaging (mri) or pet; * currently receiving antabuse; * inability to provide informed consent (e.g. dementia or severe cognitive impairment).

Keywords: locally advanced breast cancer (labc) neoadjuvant chemotherapy fluorothymidine positron emission tomography (flt pet) blood oxygen level dependent magnetic resonance imaging (bold mri) tumor response mastectomy
continues positive airway pressure treatment for patients with dilated cardiomyopathy and obstructive sleep apnea

Conditions: Dilated Cardiomyopathy; Obstructive Sleep Apnea

Summary: the aim of this randomized controlled study is to investigate the effect of continues positive airway pressure (cpap) treatment in patients with dilated cardiomyopathy (dcm) and concomitant obstructive sleep apnea (osa). the primary endpoint is left ventricular function measured by magnetic resonance (improvement of at least 4%) after six months treatment with cpap. the secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality of life.

sleep apnea, either obstructive (osa) and central (csa), occurs in more than half of all patients with heart failure (hf), and is associated with poor prognosis in these individuals. dilated cardiomyopathy (dcm) is the most common type of cardiomyopathy and is defined as the presence of the left ventricle dilatation and left ventricular systolic dysfunction without concurrent valvular or coronary artery disease. its etiology is unclear, but a genetic component is present in at least 25% of cases. in younger individuals, the etiology is more heterogeneous, where a rare type of cardiomyopathy may occur in women in connection with pregnancy, s.c. peripartum cardiomyopathy. other underlying causes include alcohol, drugs, pharmaceuticals, endocrine disorders, systemic diseases and general muscle. these factors account for approximately half the cases of dcm in younger and other half designated as idiopathic (idcm). the relationship between cardiomyopathies and osa is insufficiently studied so far. in a smaller population of 20 individuals with dcm, sleep apnea (osa or csa) had 16, ie 80% of patients. the first-line treatment of osa is continues positive pressure breathing mask (cpap) during sleep in patients with daytime sleepiness. effect of cpap therapy in patients with dcm and osa is completely unknown, because many of them do not report daytime sleepiness. the fact that patients with heart failure and reduced pumping function usually have symptoms of including fatigue, it becomes difficult to distinguish what is fatigue due to heart failure and what is related to sleep apnea. interpretation of the epworth sleepiness scale (ess) is thus difficult and possibly unsure why all patients with dcm and osa will be randomized to treatment with cpap.

Eligibility criteria:
inclusion criteria: patients with newly diagnosed or previously known dcm, treated and followed at cardiology outpatients clinic, stable in their symptoms and functional class at least 2 weeks after the last medicine change. * consent for the study. * ef ≤ 45%. * osa diagnosis (apnea-hypopnea index\> = 15 in the sleep recording below). exclusion criteria: * patients already treated with continues positive airway pressure. * patients with claustrophobia
prediction model for multiple pulmonary nodules

Conditions: Multiple Pulmonary Nodules

Summary: this study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (pkum model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.

it is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (mpns). we have developed a web-based mathematic model (pkum model) by using a multi-centric database from three institutions (peking university people's hospital, haidian section of peking university third hospital, people's hospital affiliated to hebei medical university) to predict the probability of a nodule to be malignant in patients with mpns. this prospectively observational study will recruit patients with mpns between january 2019 and march 2019, allowing radiologists, surgeons, and a predictive model (pkum model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.

Eligibility criteria:
inclusion criteria: * patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic ct scans * patients with at least two nodules resected for pathological evaluation exclusion criteria: * history of malignancy within 5 years * presence of pneumonia or pleural effusion on thoracic ct scans * patients with none or only one nodule resected * patients with initial chemo-radiation therapy

Keywords: multiple pulmonary nodules; predictive model
intermittent theta burst stimulation after acute stroke

Conditions: Ischemic Stroke,

Summary: this pilot sham-controlled study aims to determine the safety and efficacy of repetitive transcranial magnetic stimulation given as a facilitatory intermittent theta burst stimulation (itbs1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute stroke patients.

the patients with first-ever, mri-confirmed monohemispheric ischemic stroke in the middle cerebral artery territory, and nih stroke scale motor arm score 1-2 with recordable active motor thresholds (amt) of the extensor carpi radialis (ecr) between 2-4 weeks after the stroke onset, are randomized into two groups to receive either itbs1200 or sham stimulation over the ipsilesional m1 hand region for 10 daily sessions in 2 weeks. all have standardized medical and intensive rehabilitation treatments. the outcome measures included action research arm test (arat), fugl-meyer test (fmt), amt and motor evoked potentials (meps) of ecr.

Eligibility criteria:
inclusion criteria: * patients with first-ever, subacute (between 2-4 weeks post-stroke), monohemispheric ischemic stroke within the middle cerebral artery (mca) territory, and mild to moderate hand paresis (nihss motor arm score 1-2) are enrolled. exclusion criteria: * age over 75, severe hand paresis without detectable active motor threshold (amt) of the extensor carpi radialis (ecr), seizure history (clinical or eeg abnormalities), psychosis, aphasia, apraxia, concomitant neurological diseases or severe systemic diseases (e.g. sepsis, advanced malignancy, hepatic or renal failure.

Keywords: theta burst stimulation, stroke, motor, plasticity
effects of cpap on visceral fat thickness

Conditions: Obstructive Sleep Apnea

Summary: we hypothesize that patients with untreated osas will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with cpap may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.

this proposed randomized control trial (rct) will compare the effects of therapeutic cpap versus subtherapeutic cpap in patients newly diagnosed with osa with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (imt), lateral pharyngeal wall (lpw) thickness, plasma lipids and adipokines over a treatment period of 3 months. the results of this study will advance our understanding of the relative role of osa and obesity in the pathogenesis of metabolic syndrome (mets) and whether cpap therapy can improve these metabolic dysregulation.

Eligibility criteria:
inclusion criteria: * symptomatic patients with osa of apnea hypopnea index (ahi) \>= 5/hr exclusion criteria: * recent or past history of myocardial infarction/stroke/heart failure, unstable angina, underlying malignancy, * patients with clinical features of any active infection * those who require urgent cpap treatment because of associated respiratory failure or to prevent job loss through excessive daytime sleepiness (eg professional drivers, those handling dangerous machinery) * moderate to severe valvular heart disease, cardiomyopathy, and previous diagnosis of osa and/or previous use of cpap therapy.
comparing the effects of yoga nidra to yoga nidra with pain acceptance intention and motor imagery on pain outcomes

Conditions: Chronic Pain

Summary: yoga nidra is a scripted mind-body intervention (mbi) that uses guided relaxation technique in a reproducible sequence of mechanisms that naturally produce a parasympathetic response. this is a randomized controlled trial in which participants will be randomly assigned to one of three interventions: 1) yoga nidra (yoga nidra script basic), 2) yoga nidra with pain acceptance (yoga nidra acceptance intention), 3) yoga nidra with pain acceptance and explicit motor imagery (yoga nidra acceptance intention and visualization).


Eligibility criteria:
inclusion criteria: * chronic pain in the neck, low back, shoulder, hip, elbow, knee, wrist, or ankle that has lasted for over three months * pain intensity rated as 3/10 or higher in the past 24 hours (0=no pain, 10=worst pain imaginable) exclusion criteria: * non-english speaking * systemic medical conditions that affect sensation (such as uncontrolled diabetes) * history of surgery or fracture within the past six months * any blood clotting disorders (such as hemophilia) * any contraindication to the application of ice (blood pressure \&gt; 140/90 mmhg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise) * exceed pressure and heat sensory thresholds * unable to access internet or email * pregnant

Keywords: chronic pain meditation
effect of remote ischemia preconditioning on myocardial injury in patients undergoing heart valve surgery

Conditions: Heart Valve Diseases

Summary: remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. however, no data was reported on heart valve disease surgery. rheumatic heart disease is one of the major heart diseases requiring surgery in china. thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.


Eligibility criteria:
inclusion criteria: * all heart valve diseases needing heart valve surgery. exclusion criteria: * all four limbs existed ischemic condition

Keywords: rheumatic heart disease degenerated heart valve disease heart valve prolapse
regorafenib alone or in combined with transcatheter arterial chemoembolization in treatment of advanced hepatocellular carcinoma after first line targeted therapy

Conditions: Hepatocellular Carcinoma; Transcatheter Arterial ChEmoembolization; Regorafenib

Summary: . 1 clarify the difference in efficacy of regofinib combined with tace compared with second-line treatment of advanced liver cancer; 2. to evaluate the safety and prognostic imaging factors of regorofenib in advanced second-line therapy; 3, to explore whether it is necessary to increase the treatment of tace in the second-line treatment of advanced hcc.


Eligibility criteria:
inclusion criteria: ( - ) after pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) cnlc ⅲa patients with intrahepatic recurrence before (including a); ( - ) previous failure of first-line systemic treatment; ( - ) age: 18-75 years old; ( - ) child-pugh 7 points; ( - ) ecog ps grade 0-2; ( - ) at least one measurable lesion in the liver. exclusion criteria: ( - ) known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; ( - ) previous (within 5 years) or concurrent other incurable malignant tumors; ( - ) having received local treatment, systemic chemotherapy, radiotherapy other than tace during the first-line systemic treatment; ( - ) during the second-line systemic treatment, i also received local treatment, systemic chemotherapy, radiotherapy other than tace; ( - ) serious uncontrollable systemic and other systemic diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) allergy to any drug included in the study; ( - ) pregnant or lactating women;
a study of oral pf-01913539 in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease; Dementia; Dimebon; Investigational Drug

Summary: the purpose of this study is to demonstrate the safety and efficacy of pf-01913539 in the treatment of patients with mild-to-moderate alzheimer's disease. it is a 6-month study enrolling 651 patients in japan, hong kong, korea, and republic of china. all patients completing the 6-month study will be eligible to receive pf-01913539 in an open-label extension trial (b1451031).


Eligibility criteria:
inclusion criteria: * mild-to-moderate alzheimer's disease * mmse score 10-24 inclusive exclusion criteria: * administration of anti-dementia drugs including cholinesterase-inhibitors or nmda receptor antagonists within 90 days * complication of other causes of dementia

Keywords: alzheimer's disease clinical trial memory loss investigational drug neurodegenerative disease dementia
effectiveness and safety of sodium bicarbonate pleural lavage in the treatment of complex pleural effusion

Conditions: Complicated Pleural Effusion/ Empyema

Summary: the goal of this clinical trial is to evaluate the safety and efficacy of sodium bicarbonate pleural lavage in treating complex pleural effusion in adult. the main questions it aims to answer are: will sodium bicarbonate pleural lavage reduce the failure rate of medical treatment (referral rate for surgery) for complicated pleural effusion？ can sodium bicarbonate pleural lavage accelerating the rehabilitation of patients with complicated pleural effusion？ will sodium bicarbonate pleural lavage improve the prognosis of patients with complicated pleural effusion? participants will will undergo catheter placement for continuous drainage of pleural effusion. once at least 200 ml of pleural effusion has been drained: group a: participants will receive a daily intrapleural injection of 200 ml of saline in 7 days; group b: participants will receive a daily intrapleural injection of 200 ml of 2.5% sodium bicarbonate in 7 days.

for patients with ultrasound evidence of pleural effusion loculations or drainage tube obstruction, intrapleural administration of urokinase may be performed at the discretion of the treating physician to ensure effective drainage.

Eligibility criteria:
inclusion criteria: * hospitalized patients aged 18 to 80 years, inclusive. * patients fulfilling any one of the following three criteria for complicated pleural effusion: a. pleural fluid ph \ 1000 iu/l; c. positive pleural fluid culture or smear for pathogens. * pleural effusion volume exceeding 300 ml, as determined by ct imaging using the formula d\^2 \* l (where d represents the maximum depth and l the maximum length), and for whom pleural effusion drainage is clinically indicated according to established guidelines or criteria. exclusion criteria: * patients with known allergies to sodium bicarbonate or normal saline. * patients with severe coagulation disorders. * patients with severe heart or kidney failure. * pregnant or lactating women. * patients with pleural effusion caused by hospital-acquired interference, tuberculosis, fungal infections, or non-infectious causes. * patients unable to tolerate intrapleural administration. * patients with chronic lung diseases that may affect antibiotic efficacy, such as uncontrolled chronic obstructive pulmonary disease (copd gold e group), bronchiectasis, or immunodeficiency. * patients who have experienced shock, major bleeding, trauma, or pulmonary surgery within the past 5 days. * patients with a history of lung or pleural surgery on the side of the pleural effusion. * patients who have recently had chest tubes placed due to pneumothorax, surgery, or pleural effusion. * patients currently enrolled in another drug or device clinical trial. * patients with poor compliance or difficulty in follow-up, or those with an expected survival of less than 3 months due to conditions other than pleural effusion.
effect on cognitive function of a treatment with aripiprazole

Conditions: Schizophrenia

Summary: to evaluate the effectiveness of aripiprazole after 12 weeks of therapy for schizophrenic patients.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia * score of 2-6 in the cgi-s scale at basline * ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment exclusion criteria: * women of child bearing potential * women pregnant or breast feeding * patients with a score of 0,-1 or 7 * substance use
comparison of gastrointestinal motility in healthy children and children with constipation

Conditions: Constipation; Childhood Acute Lymphoblastic Leukemia; Neurofibromatosis 1; Chronic Constipation With Overflow

Summary: to gain a better understanding of the underlying dysmotility in constipation in children, we will use a novel minimal invasive method called 3d transit. we will examine four groups of children aged 7 to 17 years: healthy children, chronically constipated children (rom iv criteria), children with neurofibromatosis type 1 and finally children receiving chemotherapy (vincristin) for acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria applicable to all participants: • children between 7-17 years of age where permission is granted for the participation by habitable parents with custody of the child. in case of joint custody, permission must be obtained from both parents. inclusion criteria applicable only to healthy participants: • gastrointestinal healthy children without chronic constipation inclusion criteria applicable only to constipated participants: • chronic constipation defined by rom iv criteria, which is a diagnostic score for chronic constipation inclusion criteria applicable only to children in vincristine treatment: • children with cancer in treatment with vincristine inclusion criteria applicable only to patients with nf1: • diagnosis of nf1 with gastrointestinal symptoms exclusion criteria: * children with parents who are unable to understand the given particpant's information * children with known dysregulated metabolic disease * previously major intra-abdominal surgery * cns surgery * other treatment-requiring gastrointestinal disorder * systemic steroid treatment within the last week * children with difficulty swallowing * children with known gastrointestinal obstruction or perforation * acute infections * diagnosed malabsorption including bile acid malabsorption * menarche in girls
clinical evaluation of the infinity deep brain stimulation system

Conditions: Parkinson Disease

Summary: the purpose of this post-market study is to characterize the clinical performance of the infinity deep brain stimulation (dbs) system, including the implantable pulse generator (ipg), directional dbs leads, extensions, ipad clinician programmer, ipod patient controller and related system components. participants in the progress study are not assigned to interventional therapy groups. participants in the progress study are followed in an observational format as they receive omnidirectional and then directional dbs programming that is part of routine medical care. data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.


Eligibility criteria:
inclusion criteria: * subject is able to provide informed consent; * subject is diagnosed with parkinson's disease (pd) and has been recommended to receive an infinity dbs system with a bilateral dbs implant in the subthalamic nucleus (stn), or has received an implant of an infinity system with bilateral lead implants in the stn; * subject must be available for follow-up visits. exclusion criteria: * subject is not a surgical candidate; * in the investigator's opinion, the subject is unable to tolerate multiple programming sessions within a single setting; * subject is unable to comply with the follow-up schedule.

Keywords: sjm-cip-10061 progress infinity dbs parkinson disease updrs