Kornimate/medical-research-clean huggingface dataset:
an assessment of the occurrence of hormone deficiency in patients with empty sella

Conditions: Empty Sella

Summary: the goal of this prospective study is to analyse the hormonal components in the blood of patients that were diagnosed with empty sella. hereby we only take the hormones into consideration that are produced by the pituitary gland and/or are influenced by it due to positive/negative feedback. these are gh, acth, tsh, fsh, lh, prl, oxytocine, adh but also igf-1, estradiol, testosteron, f4 and cortisol. the purpose is to see if abnormalities of the blook levels can be explained by the absence/shrinking of the pituitary gland. during this study, there will be a blood draw twice. the reason is to avoid wrong positive and negative results. together with the second blood draw, there will be an insuline tolerance test in all patients. mri will only be done if the last taken image is more than two years old or if the mri was not taken with main focus on the pituitary gland.


Eligibility criteria:
inclusion criteria: * patients that were diagnosed with an (partial) empty sella detected by mri or ct of the brain have been included in this study. whenever the mri or ct scan was performed more than two years ago, a new mri scan was required. exclusion criteria: * children (patients less than 18 years) and patients with earlier diagnosed carcinomas of the brain as well as patients with secondary empty sella (antecedents of radiation, pharmacological treatment of pituitary adenomas, traumatic head injury and surgery of the pituitary gland as well as the central nervous system) were not included.
postextubation management in patients at risk for extubation failure

Conditions: Ventilatory Failure

Summary: at the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (bipap; oxygen via face mask) and heated high flow nasal cannula oxygen (hfnc; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.

it is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (mv). liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from mv is particularly challenging. evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. however, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients. the purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating bipap with hfnc over 24 hours following extubation. bipap and hfnc are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.

Eligibility criteria:
inclusion criteria: * documented high-risk factors of interest \[congestive heart failure (chf), chronic obstructive pulmonary disease (copd), and/or positive fluid balance\] * the modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/l) * patient must successfully complete spontaneous breathing trial and be determined eligible for extubation * only primary extubations will be included exclusion criteria: * undergoing terminal extubation or placed on comfort care * home ventilator use * any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of bipap or hfnc)
clinical outcomes of eus-guided biliary drainage using partially or fully covered metallic stents

Conditions: Cholestasis, Extrahepatic

Summary: although endoscopic retrograde cholangiopancreatography (ercp) is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ercp may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., roux-en-y anastomosis), or complex hilar biliary strictures. in such cases, percutaneous transhepatic biliary drainage (ptbd) is an useful alternative. however, ptbd had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (qol) of terminally ill patients. since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of eus-guided biliary drainage (eus-bd) suggested that it was a feasible and effective alternative in patients with failed conventional ercp stenting. the potential benefits of eus-bd include one-stage procedure in ercp unit, and internal drainage for avoiding long-term external drainage in cases where external ptbd drainage catheters cannot be internalized, thus significantly improving the qol of terminally ill patients, and possibly lower morbidity than ptbd or surgery. up to date, only a few case series of eus-bd with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.

we investigated the efficacy and safety of eus-bd using partially covered (hybrid) metallic stent with a dedicated introducer for eus-bd, or fully covered antimigration metallic stents in malignant biliary obstruction after failed conventional ercp as a prospective multicenter study.

Eligibility criteria:
inclusion criteria: * malignant biliary obstruction * inoperable state * age \> 18 yrs * failed primary ercp exclusion criteria: * uncontrolled coagulopathy * refuse to this study enrollment

Keywords: endoscopic ultrasonography biliary drainage metal stent
pre-pilot: problem adaptation therapy in caregivers

Conditions: Caregiver Burden

Summary: the proposed pre-pilot project seeks to adapt an evidence-based psychosocial intervention-pain adaptation therapy (path)-that employs emotion regulation, behavioral activation, and problem-solving skills training, that will be augmented with a caregiver (cg) education component, for use by cgs of individuals with alzheimer's disease and related dementias (adrd).

the study team will conduct an uncontrolled pre-pilot test of an adapted path-care intervention with family cgs of persons with adrd (target n=15). following the informed consent process, screening, and enrollment, participants will complete a baseline assessment, 8 path-care sessions with short feedback interviews, tablet-based exercises, and a post-intervention assessment. primary objective(s): to adapt the existing path intervention as a tool to mitigate negative emotions and stress experienced by informal cgs of individuals with adrd, by employing an evidence-based user-center design protocol and obtaining additional suggestions for program refinement through an uncontrolled usability study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * english speaking * informal caregiver of an individual with adrd diagnosis * lives with or near the care recipient * provides at least 10 hours of care per week to a person with adrd * has provided care to a person with adrd for 6 months or more, prior to enrollment * cognitively intact (score of ≥ 26 on adjusted moca-blind) * score of ≥ 12 on the negative affect scale of positive and negative affect schedule or at least one significant negative emotion (score of ≥ 3) exclusion criteria: * age ≤ 18 * non-english speaking * paid caregiver * care recipient does not have adrd diagnosis * provides care for less than 10 hours per week * has provided care for less than 6 months, prior to enrollment * care recipient is currently enrolled in hospice * meets criteria for severe major depression (montgomery asberg depression rating scale ≥ 30) that may require hospitalization * significant cognitive impairment (score of \< 26 on adjusted moca-blind) * score of \< 12 on the negative affect scale of positive and negative affect schedule or no significant negative emotion

Keywords: caregiver
sitosterolemia extension study (0653-004)(completed)

Conditions: Lipid Metabolism, Inborn Errors; Heart Disease

Summary: this is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. this study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

the duration of treatment is 52 weeks.

Eligibility criteria:
inclusion criteria: * patients with elevated sitosterol levels while taking current medication exclusion criteria: * patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Keywords: homozygous sitosterolemia
safety, tolerability and pharmacokinetics of bea 2180 br in healthy male volunteers

Conditions: Healthy

Summary: evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of bea 2180 br; additional exploration of metabolism following inhalation


Eligibility criteria:
inclusion criteria: 1. healthy male based upon a complete medical history, including the physical examination, regarding vital signs (bp, pr), 12 lead ecg measurement, and clinical laboratory tests. there is no finding deviating from normal and of clinical relevance. there is no evidence of a clinically relevant concomitant disease. 2. age ≥21 and ≤50 years 3. bmi ≥18.5 and \<29.9 kg/m2 (body mass index) 4. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and the local legislation. exclusion criteria: 1. any finding of the medical examination (including blood pressure (bp), pulse rate (pr), and ecg measurements) deviating from normal and of clinical relevance 2. evidence of a clinically relevant concomitant disease 3. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 5. history of relevant orthostatic hypotension, fainting spells or blackouts 6. chronic or relevant acute infections 7. history of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator 8. intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation 9. use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study 10. participation in another trial with an investigational drug within 2 months prior to randomisation 11. smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day) 12. inability to refrain from smoking on trial days as judged by the investigator 13. alcohol abuse (regularly more than 40 g alcohol per day for men) 14. drug abuse 15. blood donation (more than 100 ml blood within 4 weeks prior to randomisation or during the trial) 16. excessive physical activities within 1 week prior to randomisation or during the trial 17. any laboratory value outside the reference range that is of clinical relevance 18. inability to comply with dietary regimen of the study centre the following exclusion criteria are specific for this study due to the known class side effect profile of anticholinergic drugs: 19. hypersensitivity to tiotropium and/or related drugs of these classes 20. history of narrow-angle glaucoma 21. history of prostatic hyperplasia 22. history of bladder-neck obstruction
a study of subject satisfaction with botox® cosmetic treatment in facial rhytides

Conditions: Facial Rhytides

Summary: this is a safety and efficacy study of botox® in subjects with facial rhytides (glabellar lines and crow's feet lines).


Eligibility criteria:
inclusion criteria: * glabellar lines and crow's feet lines * no prior use of botulinum toxin therapy of any serotype for any reason exclusion criteria: * previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers * planning a facial cosmetic procedure during the study period * diagnosis of myasthenia gravis, eaton-lambert syndrome, and/or amyotrophic lateral sclerosis * anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
amantadine and functional improvement following abi measured by mri tractography; a pilot study

Conditions: Acquired Brain Injury; Coma; Persistent Vegetative State; Minimally Conscious State; Traumatic Brain Injury

Summary: this is a pilot study. the objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or ras) pre and post treatment on mri tractography. mri findings will be correlated with the disability rating scale (drs) score. the information gathered from this study will be used to formulate a larger clinical trial.

primary aim: to determine the size of the ras tracts as measured by mri tractography. specifically, the investigators will be measuring the fiber tracts that project through the posterior thalamus. the ras is involved in mediating arousal and consciousness. the size of fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days. it is hypothesized that treatment will result in an increase in the size of these fiber tracts. as a pilot study, the investigators will be determining the feasibility of recruiting and retaining patients in this type of study. this will allow the clarification and understanding of the technical standards for mri tractography related to the assessment of the reticular activating system. secondary aim: to determine and monitor changes in function following acquired brain injury as measured by the disability rating scale (drs) score. the drs score will be obtained prior to initiating treatment and at termination of the study. it is hypothesized that treatment with amantadine in addition to standard medical treatment, will be associated with an improvement in function.

Eligibility criteria:
inclusion criteria: * age 18 years - 65 years * nonpenetrating acquired brain injury (abi) * persistent vegetative or minimally conscious state (as indicated by drs score greater than 11) * consent from substitute decision maker exclusion criteria: * contraindication to mri (such as metal in the body, pacemaker, implanted nerve stimulator) * anticipated neurosurgical intervention * medical instability including uncontrolled hypertension, fever, or infection * seizure disorder prior to acquired brain injury or uncontrolled seizures subsequent to acquired brain injury * parkinson's disease * history of heart failure or pre-existing peripheral oedema * history of eczematoid dermatitis * history of angle-closure glaucoma * history of neuroleptic malignant syndrome * current treatment with amantadine * impairment related to other neurologic disease other than abi * allergy to amantadine * pregnancy or lactation * impairment of renal function (creatinine clearance less than 60ml/min)

Keywords: amantadine tractography mri coma abi tbi traumatic brain injury acquired brain injury
healthy lifestyle in adults with attention deficit hyperactivity disorder

Conditions: ADHD; Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to understand the relationship between adhd and the overall health of someone with adhd. people who have adhd have trouble paying attention, concentrating, organizing, and planning. they may have trouble in school, at work, and at home. the investigators are interested in finding out whether these difficulties have had any influence in the past, current, or future health problems of someone with adhd. about 100 people with adhd and 100 people without adhd will take part in this research study, all through massachusetts general hospital (mgh).


Eligibility criteria:
inclusion criteria: adhd subjects 1. signed written informed consent to participate in the study. 2. age: 18 - 60 (inclusive). 3. current diagnosis of dsm-iv adhd by structured interview. late age of onset acceptable for participation provided adhd symptoms meet full criteria currently. control subjects 1. signed written informed consent to participate in the study. 2. age: 18 - 60 (inclusive). 3. subjects must have \<3 symptoms in each domain (inattention and hyperactive/impulsive) and \<5 total symptoms in both domains on the dsm-ivadhd module of the structured interview. exclusion criteria: 1. diagnosis of any psychotic disorder or autism. 2. mental impairment as evidenced by a full scale i.q. less than 80. 3. major sensorimotor handicaps such as deafness or blindness. 4. subject currently taking antipsychotic medication or mood stabilizers. 5. inadequate command of the english language.

Keywords: adhd health healthy lifestyle
far infrared radiation treatment for prostate cancer

Conditions: Prostatic Neoplasms

Summary: a study to determine the use of far infrared radiation for the treatment of prostate cancer.

our initial assessment indicates that electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to cure a number of diseases, including prostate cancer.

Eligibility criteria:
inclusion criteria: * persons with prostate, bladder or testicular cancer. exclusion criteria: * none

Keywords: tumors or cancer of the prostate cancer of prostate cancer of the prostate neoplasms, prostate neoplasms, prostatic prostate cancer prostate neoplasms prostatic cancer
tedizolid phosphate (tr-701 fa, mk-1986) vs linezolid for the treatment of nosocomial pneumonia (mk-1986-002)

Conditions: Pneumonia

Summary: this is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global phase 3 study of tedizolid phosphate (tr-701 fa) 200 mg intravenous (iv) once daily for 7 days versus linezolid (zyvox®, zyvoxid®, etc) 600 mg iv every 12 hours for 10 days for the treatment of ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (habp) or ventilator-associated bacterial pneumonia (vabp), collectively referred to as ventilated nosocomial pneumonia (vnp). participants with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm. the primary objective is to determine the noninferiority (ni) in all-cause mortality (acm) within 28 days after randomization of iv tedizolid phosphate compared with iv linezolid in the intent to treat (itt) analysis set (ni is declared when the lower bound of the 95% ci \> -10).


Eligibility criteria:
inclusion criteria: * requires iv antibiotic therapy with diagnosis of ventilated nosocomial pneumonia * gram-positive bacteria on respiratory gram stain exclusion criteria: * pneumonia of community, viral, fungal or parasitic etiology * structural lung abnormalities * immunosuppression * previous antibiotics for \> 24 hours * expected survival of \< 72 hours
augmentation cystoplasty using an autologous neo-bladder

Conditions: Neurogenic Bladder

Summary: subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled. the hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

subjects with neurogenic bladder secondary to spina bifida (myelodysplasia) that is refractory to medical treatment and require augmentation cystoplasty will be enrolled. the hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance.

Eligibility criteria:
inclusion criteria: * subjects with neurogenic bladders secondary to myleodysplasia exclusion criteria: * prior augment procedures * recent urologic surgery * requires concomitant urologic intervention
the clinical study of atorvastatin and dexamethasone on treatment for chronic subdural hematoma in the patients with coagulation disorders

Conditions: Chronic Subdural Hematoma

Summary: to evaluate efficacy and safety of oral atorvastatin and dexamethasone on conservative treatment for chronic subdural hematoma (csdh) patients with coagulation disorders

study design: two-arm,evaluator-blinded study subjects: csdh patients with coagulation disorders（conservative treatment is adopted） sample size: 60 cases, 30 in atorvastatin and dexamethasone-treated group, 30 in atorvastatin-treated group.

Eligibility criteria:
inclusion criteria: 1. age ≥18 and\<90years old, both gender; 2. long-term antiplatelet and anticoagulant drugs cause coagulation disorders; 3. ct scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (mri scan is warranted if diagnosis is difficult); 4. the midline shift to less than 1 cm; 5. attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. conservative treatment is adopted; 6. patients have never undergo surgery on the hematoma; 7. patient fully understood the nature of the study, and voluntarily participates and signs informed consent. exclusion criteria: 1. allergic to the statin and dexamethasone or its ingredients; 2. hematoma caused by tumors, blood and other known comorbidities; 3. abnormal liver function; 4. uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study; 5. patients have been on oral statin treatment in the past four weeks; 6. patients have been on oral steroids treatment for a long time; 7. diagnosed diabetes patients with poorly controlled blood glucose 8. participate in clinical trials in the past four weeks; 9. pregnant or breastfeeding; 10. failure of completing the trial by poor compliance; 11. for any reason, the researchers believe that the case is not suitable for inclusion.

Keywords: atorvastatin atorvastatin and dexamethasone chronic subdural hematoma conservative treatment