Kornimate/medical-research-clean huggingface dataset:
preemptive acetaminophen for postoperative pain control following minimally invasive hysterectomy

Conditions: Post Operative Pain

Summary: this study is investigating whether administration of acetaminophen the day before surgery improves post operative pain following minimally invasive hysterectomy. patients will receive either acetaminophen or placebo to take twice per day the day prior to their scheduled surgery. the morning of surgery all participants will receive oral acetaminophen at least 30 minutes prior to surgery. the investigators will examine whether there is a difference in post operative pain between the two groups.


Eligibility criteria:
inclusion criteria: * undergoing minimally invasive hysterectomy for benign indications exclusion criteria: * acetaminophen allergy * liver disease * kidney disease * consume \>3 alcoholic beverages per day * weigh \<50 kilograms * report daily opiate use * contraindication to acetaminophen * used acetaminophen within 24 hours of surgery * undergoing a concomitant pelvic reconstructive procedure
this is a safety and tolerability study evaluating a new treatment for subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a long term extension study to evaluate safety and tolerability of subjects who complete study m10-985 which is evaluating a new treatment for subjects with mild to moderate alzheimer's disease.

this is a phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of abt-126 in subjects who complete dosing through week 24 of study m10-985. up to 410 subjects may participate at approximately 30 sites in several countries.

Eligibility criteria:
inclusion criteria: - the subject and caregiver must voluntarily sign and date an informed consent. if the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. - the subject was randomized into study m10-985 and completed dosing through week 24 in that study. - with the exception of a diagnosis of mild to moderate ad and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead ecg. - if male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. however, if the male subject's partner has been postmenopausal for at least 2 years or is surgically sterile, then use of a barrier method of birth control is not required. - the subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study. - the subject and caregiver must have sufficient visual, hearing and graphomotor skills to complete the study procedures. exclusion criteria: - experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ecg measurements in study m10-985 that indicates the subject could become medically unstable during the current study. - the subject is currently taking or is expected to be prescribed any excluded medications (including acetylcholinesterase inhibitors or memantine), without the approval of abbott medical monitor. - the subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals. - the subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial. - the subject developed any significant medical or psychiatric condition that, in the opinion of the investigator, renders the subject an unsuitable candidate to participate in this study. - for any other reason the investigator considers the subject to be an unsuitable candidate to receive abt-126 or to participate in this study.
effects of obesity on rectus femoris muscle thickness, sarcopenia, gait and balance in women

Conditions: Sarcopenic Obesity; Sarcopenia; Obesity

Summary: research; it is a planned, non-invasive, controlled study in obese female volunteers and non-obese female volunteers. the population of the study consists of voluntarily non-obese women and obese women. sarcopenia assets of individuals will be measured with the sarc-f questionnaire, and then muscle strength, muscle mass and physical performance tests will be measured. then, rectus femoris muscle thickness will be measured with usg, and then walking and balance will be measured with zebris.


Eligibility criteria:
inclusion criteria: * being over 18 years old and female * volunteering and accepting to participate in the study * bmi 30-39.9 kg/m2 in obese women (experimental group) * bmi 18-27.9 kg/m2 in non-obese women (control group) * not having cardiorespiratory, neurological, orthopedic and metabolic disorders exclusion criteria: * being under 18 years old and male * having a bmi of 40.0 kg/m2 and above in obese women (experimental group) * bmi 28.0 kg/m2 and above in non-obese women (control group) * having cardiorespiratory, neurological, orthopedic and metabolic disorders
study comparing 3 new formulations of premarin® 0.625 mg/mpa 2.5 mg with a reference formulation

Conditions: Menopause

Summary: the purpose of this trial is to determine the equivalence of 3 new formulations of a premarin®/medroxyprogesterone acetate (mpa) combination tablet to the currently marketed dosage form (prempro® \[tm\]). this study will be performed in healthy postmenopausal women. each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.


Eligibility criteria:
inclusion 1. healthy postmenopausal women aged 35 to 70. 2. body mass index of 18 to 35 kg/m2, weight must be at least 50 kg. 3. nonsmoker or smoker of fewer than 10 cigarettes/day. exclusion 1. history or presence of hypertension (\>139 mm hg systolic or \>89 mm hg diastolic). can take up to 2 antihypertensive medications to keep blood pressure under control. 2. history within 1 year of study day 1 of alcohol or drug abuse. 3. use of any investigational drug within 30 days before study day 1.

Keywords: premarin®
humidified culture and live birth after icsi

Conditions: Infertility

Summary: humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after icsi compared with a dry incubator. whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. this rct is to examine the effect of dry and humidified culture on live birth rates after icsi.


Eligibility criteria:
inclusion criteria: * women undergoing a first or second icsi attempts * primary or secondary infertility with a bmi of \< 31 kg/m2 * duration of infertility of ≥ 18 months and normal baseline ultrasonography * 18 to 40 years of age * tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors * tubal factors exclusion criteria: * surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia * thin endometrium * uterine anomaly and adhesion * adenomyosis * submucous myoma * endometriosis * severe medical condition
effect of amitriptyline and trifluoperazine on patients with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. it will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. the main questions it aims to answer are: does drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? what medical problems do participants have when taking drug amitriptyline and trifluoperazine? researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only. participants will: take drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. a third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. after that all three groups will be kept only on standard first line treatment for an additional 4 weeks. they will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point likert scale at baseline, week 4, 8, and 12. additionally, patient reported adverse events will be documented.


Eligibility criteria:
inclusion criteria: * age 18 years or more * patients with fd diagnosed according to rome iv criteria * patients who are willing to sign informed written consent exclusion criteria: * structural lesion in endoscopy and positive h. pylori status * history of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease * major medical and psychiatric disorders * previous history gastrointestinal surgery * any patient with ongoing treatment with antidepressants or antipsychotics * any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine * patients for whom amitriptyline and trifluoperazine are contraindicated * elderly patients\> 60 years * pregnancy and breastfeeding

Keywords: functional dyspepsia amitriptyline trifluoperazine
meal-based exposure and response prevention in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: patients with anorexia nervosa (an), a serious psychiatric disorder, exhibit restricted dietary intake and endorse fear of consuming calorie-dense foods, which in turn drives weight loss. premorbid anxious personality traits and comorbid anxiety disorders are common in patients with an. although intensive behavioral treatment programs can achieve weight restoration in a majority of adults with an, relapse rates are high. predictors of relapse include elevated state anxiety and low dietary variety, including lower intake of fat, after discharge, which suggests that relapse following weight restoration may be related to inadequate fear extinction to high energy density (ed) foods during treatment and consequent resumption of restrictive eating patterns. despite evidence of anxiety's role in the onset and maintenance of restricted eating behavior, utilizing exposure and response prevention (ex-rp) and meal-based interventions to reduce food-related fears is understudied. ex-rp is the gold standard of treatment for obsessive compulsive disorder (ocd). this proposal aims to test the efficacy of an adjunct meal-based ex-rp intervention to reduce food-related fears during intensive behavioral weight restoration in hospitalized patients with an in comparison to a control treatment, motivational interviewing. the investigators will assess changes in a) self-reported anxiety regarding consumption of high-ed foods, b) physiological (skin conductance and heart rate variability) responses to imagined consumption of food items elicited utilizing a visual food cue task, and c) caloric intake of a challenging test meal pre- and post-treatment. a secondary aim is to assess the relationship of early treatment response to ex-rp, operationalized as a reduction in self-reported anxiety within the first three weeks of treatment, and end-of-treatment as well as six-month post-discharge outcomes. helping patients tolerate food-related anxiety and increase dietary variety across meal contexts may augment treatment effectiveness in adult patients during intensive treatment for an and has potential to decrease relapse rates.


Eligibility criteria:
inclusion criteria: * meets diagnostic and statistical manual of mental disorders (dsm) -5 criteria for an or other specified feeding and eating disorder. * body mass index (bmi) \> 14.0 kg/m2 and \< 20.0 kg/m2 * age \> 12 years, \< 66 years * fluency in the english language exclusion criteria: * diagnosis of schizophrenia, schizophreniform disorder, bipolar illness (type i) with active psychotic symptoms * history of traumatic brain injury with current impairment in functioning * current use of benzodiazepines, as these medications may alter psychophysiological assessment * allergy to dairy products or chocolate contained in the test meal
long-term vascular, functional and morphological changes in glaucoma and ocular hypertensive patients

Conditions: Glaucoma; Ocular Hypertension

Summary: this is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects. the aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.

this is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects. the aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes. secondary aims of the study are: * evaluating the effect of age on functional, morphological and vascular changes and their relationship, * evaluating the effect of myopia on functional, morphological and vascular changes and their relationship, * evaluating clinical and demographic factors associated with glaucoma onset and progression, * evaluating the effects of vascular, functional and morphological changes on quality of life during the study patients will undergo bcva assessment, biomicroscopy, iop measurement, cct measurement, gonioscopy, visual field test, optic nerve head and macula oct scan, oct angiography scan, fundoscopy, every 6 months (for glaucoma and ocular hypertensive patients) and every 12 months (for healthy subjects). the study lasts 3 years. four italian glaucoma center will partecipate in this study, in addition to the promoter. four hundred patients and 100 healthy subjects will be involved.

Eligibility criteria:
inclusion criteria: * diagnosis of primary glaucoma (open or closed angle) or secondary glaucoma (pseudoexfoliative or pigmentary) defined by the presence of a glaucomatous defect of the optic nerve and/or a perimetric glaucomatous defect as defined by the european guidelines * diagnosis of ocular hypertension (defined by the presence of intraocular pressure values≥22 mmhg, optic nerve and visual field examination within normal limits) * no optic nerve disease and iop\<21mmhg for healthy subjects * age\>18 years * able to read and sing the informed consent form exclusion criteria: 1. bcva \<5/10 2. previous eye surgery, except glaucoma surgery or removal of cataracts performed more than 6 months prior to enrollment 3. other pathologies that can cause alterations of the optic nerve or visual field defects 4. presence of maculopathies 5. inability to perform visual field tests 6. opacity of the dioptric media such that it is not possible to perform reliable oct and octa of acceptable quality

Keywords: glaucoma ocular hypertension vascular changes morphological changes functional changes
precise robotically implanted brain-computer interface

Conditions: Tetraplegia/Tetraparesis; Quadriplegia; Cervical Spinal Cord Injury; Amyotrophic Lateral Sclerosis; Quadriplegia/Tetraplegia; Tetraplegic; Paralysis

Summary: the prime study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the neuralink n1 implant and r1 robot device designs in participants with tetraparesis or tetraplegia. the n1 implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the r1 robot, a robotic electrode thread inserter.


Eligibility criteria:
inclusion criteria: * severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (als) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below * life expectancy ≥ 12 months. * ability to communicate in english * presence of a stable caregiver exclusion criteria * moderate to high risk for serious perioperative adverse events * active implanted devices * morbid obesity (body mass index \> 40) * history of poorly controlled seizures or epilepsy * history of poorly controlled diabetes * requires magnetic resonance imaging (mri) for any ongoing medical conditions * acquired or hereditary immunosuppression * use of smoking tobacco or other tobacco products * psychiatric or psychological disorder * brain mri demonstrating hemorrhage, tumor, distorted or adverse anatomy. * any condition which, in the opinion of the investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

Keywords: spinal cord injury, als, brain computer interface, bci
amino acid loss during continuous renal replacement therapy

Conditions: Renal Insufficiency; Kidney Failure

Summary: the goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. the main questions it aims to answer are: what amount of amino acids is lost over the duration of continuous renal replacement therapy? how do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy? amino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. in addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.

in order to quantify the amount of amino acids lost via the continuous renal replacement (crrt) machine, it is warranted to measure amino acid concentrations in the blood and effluent over the entire treatment period. to this end, 20 intensive care patients will be examined throughout the entire duration of crrt as part of this exploratory non-interventional study. additionally, 10 intensive care patients without renal replacement therapy will be enrolled. in the crrt-group amino acid loss through the effluent will be measured at different time points. amino acid plasma concentrations will be determined in both groups. amino acid urine concentration, nitrogen balance, as well as blood urea nitrogen, creatinine and albumin in the plasma will be measured as secondary outcome parameters. additionally, observations regarding nutritional status and mobility (indirect calorimetry, bioimpedance analysis, ultrasound muscle and adipose tissue thickness, strength and mobility scoring) will be analyzed as exploratory secondary outcomes. duration of crrt, length of intensive care and hospital stay as well as mortality will be monitored. high-performance liquid chromatography fluorescence as well as liquid chromatography-mass spectrometry will be performed to measure amino acid concentrations in plasma, effluent and urine. to answer the primary research question, change in amino acid plasma concentrations and effluent loss between treatment start and day 4 of continuous renal replacement therapy will be analysed using a two-sided wilcoxon signed rank test.

Eligibility criteria:
inclusion criteria: * postoperative icu patients * age ≥ 18 years * patients on enteral or/and parenteral nutrition given according to internal standard operating procedure a) crrt group: - crrt treatment planned; all types of crrt (continuous veno-venous hemodialysis (cvvhd), continuous veno-venous hemodiafiltration (cvvhdf), continuous veno-venous hemofiltration (cvvh)) b)non-crrt group: * no current or previous (\<30 days) continuous or intermittent rrt * no chronic kidney disease stage g3-g5 exclusion criteria: * preoperative intensive care patients * patients with liver cirrhosis stage 1-3 according to the child-pugh classification * patients with acute liver failure

Keywords: amino acid continuous renal replacement therapy effluent loss
adding specialist palliative care to transplantation pilot trial

Conditions: End Stage Liver DIsease

Summary: specialist palliative care has been shown to be beneficial for patients experiencing serious illness, but has not been studied for patients being evaluated for liver transplantation. the investigators hope in the future to design a multi-center trial of a specialist palliative care intervention to measure the effects of specialist palliative care for patients undergoing liver transplant evaluation. this project represents a pilot to gather needed information to design such a future study.


Eligibility criteria:
inclusion criteria: * adult patients (age 18 years or greater) undergoing evaluation for liver transplantation at vanderbilt university medical center exclusion criteria: 1. patient does not speak english fluently 2. patient lacks a telephone 3. patient is a prisoner 4. patient is deaf 5. patient currently receives specialist palliative care 6. patient is not a resident of tennessee
novel pulmonary function measures for diagnosis of bronchiolitis obliterans syndrome following hematopoietic stem-cell transplantation in children

Conditions: Bronchiolitis Obliterans Syndrome

Summary: in this study, we will study 129xe-mri and lci as tools for diagnosis of bos in pediatric patients who have received hematopoietic stem cell transplantation (hsct) and have been identified as eligible for this study. participants will be required to have vital signs collected, complete breathing tests and complete an mri. the mri will require participants to perform breath holds in the mri scanner with xenon gas while being coached by a research assistant.


Eligibility criteria:
inclusion criteria: * male and female participants aged 6 -17.9 years old. * received hsct treatment at least 6 months prior to enrollment in study. * participants should have an fev1%pred value greater than 40%. * participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent. * participant must be able to perform a breath hold for 16s. * participant meets mri screening criteria exclusion criteria: * participant has had a cold or respiratory infection in the last four weeks. * participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%. * participant is unable to perform spirometry or plethysmography maneuvers. * participant is pregnant or lactating.

Keywords: stem cell transplantation xenon mri lung
can a self-guided mobile phone application program improve wellbeing in university students

Conditions: Perfectionism; Shame; Depression, Anxiety; Stress; Self-Compassion

Summary: this study seeks to evaluate and compare the effectiveness of a mobile phone application-based intervention in improving wellbeing in young adults. 400 university students are randomized into 1 of 4 intervention types. pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.


Eligibility criteria:
inclusion criteria: * access to a mobile phone with the following requirements: iphone 8 and above, or android 5.2+ (display greater than 5 inches) * have scores of greater than or equal to 29 on the 'concerns over mistakes' subscale on the fmps exclusion criteria: * participants who do not meet the inclusion criteria * currently pregnant * undergoing psychological treatment or counselling * have any change in psychotropic medication within twelve weeks before starting intervention