Kornimate/medical-research-clean huggingface dataset:
evaluation of the safety of adjunct brexpiprazole in elderly patients with major depressive disorder and an inadequate response to antidepressant treatment

Conditions: Major Depression Disorder

Summary: the purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment


Eligibility criteria:
main inclusion criteria: * • the patient is a man or woman aged ≥65 yrs * the patient has major depressive disorder according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr™). * the patient has an inadequate response to at least one adequate antidepressant treatment in the current major depressive episode (mde). * the patient has had the current mde for ≥8 weeks * the patient is currently treated with a protocol specified adt for at least 6 weeks * the patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator. * montgomery and åsberg depression rating scale (madrs) total score \> 18 at screening and baseline * clinical global impression - severity (cgi-s) total score ≥3 at screening and baseline main exclusion criteria: * • the patient has a clinically significant unstable illness * the patient has newly diagnosed or unstable diabetes * the patient has a mini mental state exam (mmse) score \<24 * the patient has received transcranial magnetic stimulation (tms) and/or electroconvulsive therapy (ect) less than 6 months prior to the screening. * the patient, in the opinion of the investigator or based on columbia-suicide severity rating scale (c-ssrs) suicidal ideation and behaviour rating, is at significant risk of suicide other protocol defined inclusion and exclusion criteria may apply
epidemiology of sepsis in turkish icus.

Conditions: Sepsis; Septic Shock; Severe Sepsis

Summary: the prevalence and mortality of sepsis in turkey is not know at large. turkish society of intensive care medicine, sepsis study group conducted a multi-centre,point prevalence survey to determine the prevalence, causative micro-organisms and outcome of sepsis in turkish icus.


Eligibility criteria:
inclusion criteria:all patients present on or admitted to participating icu on study day. exclusion criteria: * age\<18 years * patients who underwent cardiovascular surgery.

Keywords: sepsis icu point prevalence
trial of exemestane +/- mm-121 in postmenopausal women with locally advanced or metastatic estrogen receptor positive and/or progesterone receptor positive her2 negative breast cancer

Conditions: Her2 Negative Breast Cancer Patients

Summary: to determine whether the combination mm-121 + exemestane in er+ and/or pr+ breast cancer patients is more effective than exemestane alone

the study is a double-blind, randomized phase 2 trial of exemestane +/- mm-121. the trial is designed to demonstrate whether mm-121 + exemestane is more effective than exemestane alone in er+ and/or pr+ and her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (ai)and/or tamoxifen. patients will be treated until radiologic or clinical progression of their disease is documented. local radiologist and/or pi assessment is accepted.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic breast cancer * histologically or cytologically confirmed er+ and/or pgr+ and her2 negative breast cancer * ≥ 18 years of age exclusion criteria: * received prior treatment with exemestane * extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases) * symptomatic cns disease

Keywords: breast cancer her2 negative estrogen receptor positive progesterone receptor positive mm-121 exemestane postmenopausal women
impaired vigilance, and its effects on cognition and behavior

Conditions: Sleep Deprivation; Feeding Behavior

Summary: fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions that were at least five days apart. the first session was a baseline. the sleep intervention took place on the night prior to session 2, where the amount of time in bed was manipulated to be 60-130% of the individual's habitual sleep time. within both sessions, subjective (stanford sleepiness scale, sss) and objective (psychomotor vigilance test, pvt) alertness were measured. during the middle of each session, a 40-minute ad libitum meal opportunity allowed participants to eat from eight different food items. food healthfulness, caloric density, distribution and number of calories were measured and compared to alertness levels.


Eligibility criteria:
inclusion criteria: * age: 18-45 years * bmi: 20-29 kg/m² * eat breakfast at least 5 days per week * wake time occurs between 5\&10am at least 5 days per week * time in bed for sleep between 5\&10 hours at least 5 days per week exclusion criteria: * dietary restrictions that prohibit them from selecting one of the food choices offered in the study (e.g., gluten allergies, diabetes, vegan diet, dairy avoidance, allergies to the respective food choices available), * are currently on a calorie-restricted diet, or * are currently at a weight that is less than 20% of their highest weight within the last three years. * participation in shift work within 7 nights of the experiment * diagnosed as having severe sleep apnea syndrome, narcolepsy or chronic insomnia * diagnosed as having an eating disorder * active serious health condition * regularly taking vigilance-related medication (e.g., adhd prescribed medication) * typically consume more than 600 mg of coffee or more than 10 cigarettes per day
n-acetyl cysteine and clomiphene citrate or metformin and clomiphene citrate for women with cc resistant polycystic ovary syndrome (pcos).

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to compare and determine the efficacy of combined n-acetyl cysteine and clomiphene citrate(cc)with combined metformin and cc in infertile women with polycystic ovary syndrome(pcos)not responding to treatment with clomiphene alone.

in combined nac-cc group group,patients received nac (200 mg per sachet, sedico, egypt) for 5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g orally in three divided doses, 3 sachets per dose). all patients in other group received metformin hcl (cidophage®; chemical industries development, egypt), 500 mg thrice daily for 5-6 weeks from the 1st day of spontaneous or induced menstruation. then after the end of this period, patients in either group received 100 mg cc (clomid®; global napi pharmaceuticals,cairo, egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. with persistent anovulation, it was increased by 50 mg for the next cycle. patients continued treatment for three successive cycles using the same protocol. nac and metformin were stopped only when pregnancy was documented.

Eligibility criteria:
inclusion criteria: * cc resistant pcos exclusion criteria: * congenital adrenal hyperplasia * cushing syndrome * androgen secreting tumors

Keywords: polycystic ovary syndrome clomiphene resistance metformin n-acetyl cysteine
modulation of cognition and brain connectivity by noninvasive brain stimulation in patients with mild cognitive impairment due to alzheimer's disease

Conditions: Mild Cognitive Impairment

Summary: alzheimer's disease (ad) has a detrimental impact on cognitive functions. based on pilot studies results in patients with neurodegenerative brain diseases the investigators aim for promoting the brain plasticity and improving cognition by noninvasive brain stimulation (nibs) in healthy young, healthy aged and subjects with mild cognitive impairment due to ad. mild cognitive impairment (mci) is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. different new brain targets, cognitive tasks and stimulation protocols will be tested and optimized for specific subject groups. design of a functional mri (fmri) - repetitive transcranial magnetic stimulation (rtms) - fmri study will enable us to explore and identify effect of age, presence of the disease and genetic risk factor (apoe4) on repetitive transcranial magnetic stimulation (rtms)-induced changes in cognition and related brain connectivity/activations. the study results will improve our understanding of healthy and pathological brain aging and will provide novel information about the usefulness of nibs in specific subject groups. these results will have an important impact on future non-pharmacological treatment strategies.

intensified intermittent theta-burst stimulation (itbs) protocol will be applied in the mci study group. a two-parallel-group, randomized, placebo controlled design will be used. ten mci subjects will be stimulated in a week-long therapeutical sessions. other ten mci subjects will be stimulated with the same protocol using sham stimulation. the investigators will study the change in subjects immediately after and again at a two-weeks follow-up visit after the end of the last stimulation session.

Eligibility criteria:
inclusion criteria: * amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (albert et al., 2011) exclusion criteria: psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by mri that might present with cognitive decline * a cardio pacemaker or any mri-incompatible metal in the body * epilepsy * any diagnosed psychiatric disorder * alcohol/drug abuse * lack of cooperation * presence of dementia
study of the use of the ingaron in volunteers for the prevention of covid-19

Conditions: COVID-19 Respiratory Infection

Summary: the main purpose of this study is to evaluate the effectiveness of the prophylactic use of ingaron (inn: recombinant interferon gamma human, lyophilisate for solution for intranasal administration 100,000 iu) in the regimen of 3 drops in each nasal passage intranasally every other day for 10 days with a break of 7 days (2 10-day cycles) in volunteers.

distribution between groups is made randomly at the request of the participant. according to the methodology approved by the observational program, the participant must use or not use the investigational drug (depending on the distribution group and their own will) during the 27 days of the prophylaxis course (10 days + 7 days + 10 days). the control group does not receive study therapy.

Eligibility criteria:
inclusion criteria: 1. medical workers and medical personnel working in the "red zone" and in contact with patients infected with covid-19. 2. men and women over 18 years of age. 3. signing an informed consent form for data processing. 4. ability and agreement to complete the questionnaire (part 1) of the participant. 5. no symptoms of a respiratory infection. 6. negative pcr test result for the presence of sars-cov-2 rna according to the biomaterial obtained by nasopharyngeal swab. exclusion criteria: 1. any clinically confirmed or documented history of diseases that may complicate the interpretation of the data being assessed (hiv, cancer, organ transplantation, etc.). 2. any other comorbidities or conditions that, in the opinion of the investigator, may distort the results of the study, limit the rights of the volunteer, or put him at greater risk. 3. contraindications to the use of the investigational medicinal product. 4. individual intolerance to the ingredients that make up the study drug. 5. pregnancy or breastfeeding. 6. the presence of antibodies to sars-cov-2 (igm, igg).

Keywords: covid-19 prevention interferon gamma nasal drops
palliative care for patients with dementia

Conditions: Dementia

Summary: a multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. from inpatient and outpatient settings associated with four hospitals across new york city, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.

the objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. in addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. the trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression. patients randomized to the intervention will be scheduled for an intake visit. this visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, md), depending on patients' needs. visits will combine a combination of video-teleconferencing technology and in person visits. following this visit, and in conjunction with the nurse practitioner and/or md, a care plan will be developed to address areas of clinical need highlighted during the intake visit. patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. patients' cases will be discussed at the weekly idt meeting, as appropriate to the level of clinical need. patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a mount sinai based physician, which acts as an advice line out of hours. these physicians will be able to provide advice to patients and caregivers.

Eligibility criteria:
inclusion criteria: * have advanced dementia, based on global deterioration score (gds)\>6 * impairment in at least one activity of daily living (adl -which is inherent in this level of gds) * at least one hospitalization or ed visit within the last 12 months * a physician who is primarily responsible for their dementia-related care whose clinical outpatient site is associated with one of the four mount sinai sites in manhattan * a family caregiver willing to enroll * a residence in manhattan where they are currently living (not in a long-term care facility) * capacity to consent or a legal representative available to provide consent * fluency in english or spanish, or their legal representative must be fluent in english or spanish * age \>64. exclusion criteria: * does not have a family caregiver to enroll * does not reside in manhattan outside of long-term care facility * does not have fluency in english or spanish doesn't
post operative quality of life after patulous eustachian tube treatment

Conditions: Eustachian Tube Patulous

Summary: patulous eustachian tube (et) is a usually asymptomatic poorly known et pathology. when it becomes so and thus impairs the eardrum (retraction pockets, cholesteatoma) or patients' quality of life (qol), therapeutic management is proposed. the surgical treatment has diversified in recent years but remains dominated by filling spaces around the et (autologous fat and/or septal cartilage grafting). efficiency is traditionally objectivized by dynamic otoscopy, tubomanometry and audiometry, but qol must also be taken into account and its postoperative assesment was the objective of this work. materials and methods this is a unicentric retrospective study conducted from november 2016 to march 2019 on all patients with a disabling patulous et, single or bilateral, managed surgically by autologous fat and/or septal cartilage grafting in investigators ent department. patients for whom a concomitant procedure was performed were excluded from the study. the post-operative qol assessment was performed using the glasgow benefit inventory (gbi), postoperative self-administered questionnaire validated in ent, including a general, physical and social evaluation. predictive factors for qol improvement were investigated among pre-, per- and post-operative clinical data.


Eligibility criteria:
inclusion criteria: * any surgically treateble patient with a unilateral patuluos eustachian tube exclusion criteria: * any patient for whom an other surgical step than the eustachian tube one was needed, * bilateral desease ,cholesteatoma
noninvasive vns to facilitate excitability in motor cortex

Conditions: Stroke; Stroke Sequelae; Motor Activity

Summary: transcranial magnetic stimulation (tms) positively influences motor rehabilitation in stroke recovery. transcutaneous auricular vagus nerve stimulation (tavns) has shown effects on cortical plasticity. we investigate whether combination of tms and tavns is more effective at motor cortex excitability than either modality alone.

the investigators aim to determine the effects of tavns on motor cortex excitability. the hypothesis is that tavns alone (sham rtms + active tavns) will induce increases in motor cortex excitability (post-stimulation compared to baseline). the investigators expect these changes will be of a lesser magnitude than those of tms alone (active rtms + sham tavns) due to the indirect mechanistic approach of tavns. another aim is to determine whether tavns-paired tms is more effective at inducing cortical excitability than tms alone, as it is hypothesized that pairing two forms of neuromodulation (active rtms + active tavns) will increase tms-induced cortical excitability in the motor cortex when compared to single modality approaches (active rtms + sham tavns; sham rtms + active tavns). furthermore, it is expected that this increase is timing sensitive, and the paired approach will induce larger tms-induced cortical excitability compared to unpaired neuromodulation (active tavns + active tavns).

Eligibility criteria:
inclusion criteria: * age 18-80 * endorsing good health exclusion criteria: * no tms-induced motor cortex excitability changes in response to 20hz motor cortex rtms * active psychiatric or neurological disorders * history of cns disease, concussion, overnight hospitalization, or other neurologic sequelae, tumors, seizures, frequent or severe headaches * metal implanted above the neck * currently taking seizure reducing medications * currently taking psychotropic medications * any psychotropic medication taken within 5 half-lives of procedure time * abuse or dependence of drugs (excluding nicotine and caffeine) * currently taking medications that lower the seizure threshold * taking any of the stimulants, thyroid medication, or steroids * implanted devices/ferrous metal of any kind * history of seizure or seizure disorder * inability to determine motor threshold. * pregnant females and children under the age of 18 will be excluded for safety reasons * no vulnerable populations or special classes of subjects will be considered for participation.

Keywords: stroke recovery tms vns motor motor cortex
study of subcutaneous methylnaltrexone (mntx) in the treatment of opioid-induced constipation during rehabilitation after orthopedic procedures

Conditions: Opioid-induced Constipation

Summary: the purpose of this study is to examine the safety and activity of mntx in relieving opioid-induced constipation following orthopedic procedures.

this is a double-blind, randomized, parallel-group, placebo- controlled phase 2 study to evaluate the safety and activity of subcutaneous (sc) mntx versus sc placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. participants will sign an informed consent form and be screened between days 4-10 after their orthopedic procedure. those participants who meet all eligibility requirements will be enrolled in the study. treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. originally, participants were receiving treatment for up to 7 days. then after protocol amendment 1 (12 march 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days".

Eligibility criteria:
inclusion criteria: 1. male and female participants greater than or equal to (\>=) 18 years of age. 2. participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma). 3. participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization. 4. participants must be acutely constipated following their orthopedic procedure. 5. participants must receive all doses of study drug in either hospitals or rehabilitation facilities. 6. participants must sign an informed consent form. 7. females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study. 8. body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds \[lbs\]). exclusion criteria: 1. participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone. 2. participants who received any investigational new drug (experimental) in the previous 30 days. 3. participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose. 4. participants with constipation not attributed to post procedure opioids. 5. participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years. 6. female participants who are pregnant or lactating. 7. participants with a known history of chronic active hepatitis b or hepatitis c virus or human immunodeficiency virus (hiv) infection.
a randomized, double blind, placebo-controlled study to assess the the preemptive benefit of etoricoxib in patients receiving anterior cruciate ligament reconstruction

Conditions: Post-operational Pain

Summary: post surgical pain associated with ligament reconstruction may persist for few days after the surgical procedure. arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain through oral administration. this study will test the safety and efficacy of arcoxia in the management of post-operational pain in patients receive the ligament reconstruction surgery.


Eligibility criteria:
inclusion criteria: 1. men and women age ranged from 16\~35 who have anterior cruciate ligament injury and/or associated injuries are scheduled for acl reconstruction surgery. 2. patient agrees to participate into this study and is willing to sign the patient informed consent form.

Keywords: cox-2; post-operative ; sports injury; surgical pain