Kornimate/medical-research-clean huggingface dataset:
a study to evaluate sage-217 for prevention of relapse in adult participants with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a study with an open-label (ol) phase followed by a randomized, double-blind (db), placebo-controlled phase to assess efficacy and safety of sage-217 on relapse prevention in adults with major depressive disorder (mdd).

this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: 1. participant had a diagnosis of mdd as diagnosed by structured clinical interview for diagnostic and dsm-5 clinical trial version (scid-5-ct), with symptoms that had been present for at least a 4-week period. 2. participant had at least 1 prior major depressive episode (mde) in the 5 years prior to screening (not including the current episode). 3. participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including cognitive behavioral therapy for insomnia \[cbt-i\]) until after study completion. exclusion criteria: 1. participant had attempted suicide associated with the current episode of mdd. 2. participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. massachusetts general hospital antidepressant treatment response questionnaire (mgh atrq) was used for this purpose. 3. participant had a positive pregnancy test at screening or on day 1 prior to dosing.

Keywords: mdd sage-217
macintosh blade size during laryngoscopy for endotracheal intubation. a prospective observational study.

Conditions: Endotracheal Intubation

Summary: endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal macintosh blade size remains unknown to date.

endotracheal intubation is an extremely frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital). apart from special cases of foreseen difficult programmed intubation, direct laryngoscopy remains the most frequently used technique. it requires the use of a handle (short or long), which serves as a light source on which is adapted a macintosh curved blade, metallic or plastic, single or multiple use. the choice of blade size is based on the experience of the physician. most often, in adult settings, size 3 or 4 blades are used. the very spartan literature on the subject and the current recommendations do not provide any information on the choice of blade size. we therefore wish to evaluate these practices in terms of success of the first laryngoscopy, cormack-lehane and pogo (percentage of glottic opening visualized) scores, the need to use an alternative technique or a second operator. the results will be analyzed with regard as a function and experience of the person performing the laryngoscopy, as well as the setting (urgent or scheduled). these data are usually collected during the performance of an endotracheal intubation whatever the circumstances: operating room, intensive care unit and emergency department (in-hospital) and in the samu-smur (pre-hospiatl medical service) at clermont-ferrand university hospital.

Eligibility criteria:
inclusion criteria: * patients must be admitted in an operative room, an intensive care unit (icu) or an emergency department and require mechanical ventilation through an orotracheal tube. * adult (age ≥ 18 years) * subjects must be covered by public health insurance * written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency. exclusion criteria: * anticipated difficult intubation requiring videolaryngoscopy * nasotracheal intubation * refusal of study participation or to pursue the study by the patient * absence of coverage by the french statutory healthcare insurance system * protected person

Keywords: intubation macintosh blade laryngoscopie operative room intensive care unit emergency department
aging and family outcomes in supportive care of advanced cancer patients

Conditions: Aging; Neoplasms

Summary: the diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. this grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.

we are testing a coping and communication support (ccs) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. this randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the louis stokes cleveland vamc and metrohealth medical center. recruitment and randomization are based on patient's diagnosis and age. the patient had to have been diagnosed with a stage iv cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). patients are stratified by age group and then randomized to usual care or ccs intervention. family care-givers are randomized along with the patient. trained clinical nurse specialists with advanced training in mental health serve as ccs practitioners. they are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. the primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the ccs intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.

Eligibility criteria:
inclusion criteria: * patients diagnosed within 1 year with advanced cancer (stage iv), aged 40 years or older. * patients must be cognitively intact at time of enrollment. * patient need not have family care-giver to be enrolled, but if there is one, fcg is enrolled with the patient. fcg need not be 40 years of age. exclusion criteria: - less than stage iv cancer, stage iv cancer diagnosed over 1 year previously or younger than 40 years of age.

Keywords: aging behavioral research quality of life end of life family relations supportive care advanced care bereavement
capecitabine/erlotinib followed of gemcitabine versus gemcitabine/erlotinib followed of capecitabine

Conditions: Pancreatic Cancer

Summary: this crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. the study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. it is the first trial of its kind to incorporate second-line treatment into the study design. patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. the trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * histologically proven pancreatic cancer stage iii or iv (t1-3 n1m0 or t1 3n0 1m1) * no option for resection with curative intent * at least one measurable or not measurable lesion (according to recist) * no previous chemotherapy or other systemic tumor therapy * no previous radiation * performance-status 0-2 according to who/ecog * life expectancy of at least 3 months * adequate kidney-, liver- and bone marrow function, defined as * absolute neutrophil count \* 1,5 x 109/l * hemoglobin \* 8 g/dl * thrombocytes \* 100 x 109/l * bilirubin \* 2 x upper norm (with liver mets \< 5-fold) * serum creatinine \* 1,25 x upper norm * creatinine clearance \> 30 ml/min (cockroft/gault) * transaminases \* 2,5 x upper norm (with liver mets \< 5-fold) * possibility of regular long-term follow-up * negative pregnancy test in women at childbearing age * all patients must have signed an informed consent before study entry. exclusion criteria: * known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri * clinically unstable cns-metastases * known hypersensitivity against study medication * severe impairment of renal function (creatinine clearance \< 30 ml/min) * severe impairment of liver function (bilirubin \> 2,0 x above upper norm, transaminases \> 2,5 x upper norm, or with known liver metastasis \>5 x upper norm) * clinically relevant disease of the cardiovascular system or other vital organs * known polyneuropathy * known dpd-deficiency (screening not required) * simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin * pregnancy, lactation or lack of reliable contraception in women at childbearing age * mental disease, drug- or alcohol abuse * participation in another clinical trial within the last 4 weeks * all other diseases which may prevent adequate participation in the trial * indication of lack of compliance with study regulations

Keywords: capecitabine gemcitabine erlotinib pancreatic cancer advanced
the effect of education based on roy adaptation model for infertile individuals on adaptation and coping with stress

Conditions: Health Education

Summary: psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health. it appears that learning adaptation strategies in infertile couples is concurrent with health promotion. in addition to medical treatments, it is aimed to add training to be given in accordance with the roy adaptation model, to adapt to the process and infertility, and to control stress in infertile individuals in the management of the process. the study was planned to examine the effect of education based on the roy adaptation model for infertile individuals on adaptation and coping with stress.


Eligibility criteria:
inclusion criteria: * 18-45age difference primary infertility exclusion criteria: - secondery infertility
study of single agent perifosine for recurrent pediatric solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to test whether perifosine- a drug that inhibits the protein akt, and has had some success in the treatment of adult cancers- is safe and effective in treating cancer. the investigators want to find out what effects, good and/or bad, it has on the patient and the cancer. the investigators are testing different dose schedules of perifosine and the patient will be asked to partake in one of the dose schedules.


Eligibility criteria:
inclusion criteria: * any solid tumor that failed standard therapy. * patient must have evidence for tumor by ct, mri, pet scan, mibg scan, serum markers, or tissue sampling. * age ≤ 21 years. * karnofsky/lansky performance status ≥ 50% (karnofsky score for age\> 16 years and lansky score for age ≤ 16 years) * anc≥ 1000 at least 24 hours off gcsf * platelets ≥ 75k at least one week off platelet transfusions * hg≥ 8g/dl at least one week off prbc transfusion * ast ≤ 3 x the upper limit of normal * alt ≤ 3 x the upper limit of normal * total bilirubin ≤ 2.0 mg/dl * serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear gfr ≥ 70 ml/min/1.73 m2. * ≥ 3 weeks since last non-nitrosourea chemotherapy * ≥ 6 weeks since last nitrosoureas * ≥ 4 weeks since last rt * patients must agree to practice adequate contraception. females of childbearing potential must have a negative b-hcg pregnancy test documented within 14 days prior to drug initiation. females must not be breast feeding. * patients must be able to swallow tablets whole exclusion criteria: * pregnancy * patients must not have active infection or serious intercurrent medical illness. * hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions. hiv testing not required. * patients must not be taking eiaeds. if patients were previously eiaeds that have been discontinued, patients must have been off the agent for at least 2 weeks prior to registration.

Keywords: pediatric solid tumors pediatric solid tumors 08-091
does covi̇d-19 m-rna vaccine affect fertility and over reserve ?

Conditions: COVID-19 Virus Infection; Ovarian Function Insufficiency; Fertility Disorders; Vaccine Adverse Reaction

Summary: women's ovarian reserve and fertility were compared before and after 2 doses of vaccination

our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and fertılıty of women are affected by the vaccıne.women who applied to the vaccination outpatient clinic for the first dose of vaccine were included in the study.those who have never been vaccinated and have not had covid 19 infection were included in the study.antı ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve today. ovarian reserve tests including amh were checked and their fertility was questioned and their information was recorded. the same tests were repeated after the volunteers received 2 doses of vaccine. ın the power analysis, it was calculated that 104 volunteers should be included in the study.the study will be terminated when 104 volunteers are reached.

Eligibility criteria:
inclusion criteria: * between 18-45 years old * have ever had a covid vaccine * not be infected with covid 19 exclusion criteria: * pregnancy * diagnosis of any kind of cancer * oral contraceptive usage * endometrioma * pcos * menopause * menstrual irregularity * premature ovarian insufficiency

Keywords: ovarian reserve covid-19 vaccine
transspinal direct current stimulation on functional mobility in post-stroke patients

Conditions: Stroke

Summary: the aim of this clinical trial is to investigate the effects of transspinal direct current stimulation on the functional mobility of post-stroke patients. the main question it aims to answer is: is transspinal direct current stimulation able to improve functional mobility in post-stroke patients? the researchers will compare transspinal direct current stimulation associated with gait training with sham transspinal direct current stimulation associated with gait training. to verify the effects of stimulation on the functional mobility of post-stroke patients. participants: * they will be assessed before starting the care, after the care has been completed, 15 and 30 days after the care has been completed. * they will take part in 10 sessions of transspinal direct current stimulation associated with gait training.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ischemic or hemorrhagic stroke, provided by a neurologist. * age group greater than or equal to 18 years, of both sexes. * any stage of the disease. * presence of lower limb sensorimotor disorder related to the stroke * absence of cognitive impairment verified through the mini mental state examination (score ≥ 18 for illiterate individuals and ≥ 24 for educated individuals) modified for the brazilian population. exclusion criteria: * with other neurological injuries * with vestibular, visual, cardiovascular or osteomyoarticular disorders of the lower limb that may affect the performance of the proposed tests * who have a pacemaker or metallic implants in their spine
bipolar proteomic assay validation study

Conditions: Major Depressive Disorder, Bipolar I and Bipolar II

Summary: the purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate bdi, bdii, and mdd in people seeking treatment for a depressive episode.

this is a hypothesis-driven confirmatory study to validate the diagnostic signature (model) for distinguishing bdi from mdd that also aims to optimize the models to discriminate bdii from mdd and bdi. a binary classification model, using linear discriminant analysis and based on 13 a priori-defined proteomic markers will aim to distinguish bdi from mdd. an alternative binary classification model based on multiple logistic regression and using 10 a priori -defined proteomic markers will aim for the same result. to improve the predictive performance of the signatures, items from self-report mood rating scales and treatment-emergent changes in proteomic markers will be analyzed. in addition, the study will examine if baseline or early treatment-emergent changes in proteomic markers predict treatment response.

Eligibility criteria:
inclusion criteria: * diagnosed with bdi, bdii, or mdd, confirmed with the structured clinical interview for dsm-5 (scid). * currently depressed for ≥4 weeks and ≤104 weeks, without psychotic features, * madrs score ≥ 20 (consistent with at least moderately-severe depression) * ymrs score ≤ 8 (consistent with the absence of hypomanic symptoms) exclusion criteria: * at high risk for suicide, defined as a score ≥4 on item 10 of the madrs * current depression has psychotic features, diagnosed with the scid * meeting criteria for severe alcohol, cannabis, or thc use disorders, as defined by dsm-5 and confirmed by the scid, in the past 3 months, or meeting criteria for other substance use disorders of any severity (eg. cocaine use disorder). for substances other than alcohol, cannabis, and opioids, a positive drug screen at both the screening and baseline visits is also exclusionary. caffeine and nicotine use disorders of any severity will not be exclusionary. * diagnosis of borderline personality disorder, diagnosed with the zanarini rating scale for borderline personality disorder. * medical conditions with neurological sequelae (eg. stroke, brain cancer, multiple sclerosis, loss of consciousness \> 30 min, hiv) * severe chronic pain, at the discretion of the investigator * receiving treatment with high-potency immune-modulating medications, such as corticosteroids, chemotherapy, monoclonal antibodies, or disease-modifying agents for arthritis, multiple sclerosis * any acute unstable medical illness (at the discretion of the site investigator) * in mdd patients: strong risk factors for bipolarity, including 1) short (1-3 day) mood elevations not meeting dsm-5 time criteria for hypomania; 2) a family history of bdi or bdii in a first-degree relative; and 3) a history of antidepressant-induced symptoms suggestive of bipolarity, particularly antidepressant-induced hypo/mania.
carbon dioxide infusion:clinical and histological appraisal in chronic wounds

Conditions: Wounds

Summary: carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and subcutaneous. increase in the concentration of carbon dioxide decreases ph activating local nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor and basic fibroblast growth factor. carbon dioxide infusion restores the blood flow in chronic wounds of the lower limbs.

ten patients with chronic wounds caused by venous insufficiency at both lower limbs were distributed into groups. group i was composed by wounds in the right lower limb that received carbon dioxide and group ii by wounds in the left lower limb that not received carbon dioxide, both related to the same patient. carbon dioxide infusion was performed with the needle pointed toward the granulation tissue, 5cm distant from each one at intervals of 4 days. biopsies were collected from the wounds before carbon dioxide infusion and after the 3rd, 5th and 10th application. statistical analysis of the data was performed using wilcoxon's test and friedman's variance analysis and multiple comparisons test.

Eligibility criteria:
inclusion criteria: * chronic wounds caused by venous insufficiency exclusion criteria: * other diseases of the lower limbs

Keywords: carbon dioxide infusion dilatation of peripheral blood vessels capillaries macrophags fibroblasts improvement granulation tissue in chronic wounds
surveillance study to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in romania

Conditions: Infections, Rotavirus

Summary: the purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children \< 5 years of age in romania.

the study consist of a main study and a health economics study main study: the study will focus on three different groups of patients: * subjects who are hospitalised for acute gastroenteritis. * subjects who visit an emergency room for acute gastroenteritis. * subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation. health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire

Eligibility criteria:
inclusion criteria: * a male or female child aged \< 5 years at the time of admission. a child becomes ineligible on the day of her/his fifth birthday. * a subject, who during the study period: * is hospitalised for acute gastroenteritis or * visits an emergency room for acute gastroenteritis or * has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation exclusion criteria: not applicable

Keywords: gastroenteritis hospital surveillance rotavirus gastroenteritis
mid-term evaluation of metamorphopsia in epiretinal membrane surgery

Conditions: Epiretinal Membrane; Cataract Senile

Summary: this study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. all 30 patients recruited underwent complete ocular examination, visual acuity measurement with etdrs, metamorphopsia assessment with m-charts and metamorphometry® and foveal thickness evaluation by sd-oct preoperatively, at 30, 90, 180 days postoperatively.


Eligibility criteria:
inclusion criteria: * age \> 55 years * visual acuity ≤ 20/40 * idiopathic epiretinal membrane * cataract * amsler test positive for metamorphopsia. exclusion criteria: * previous ocular interventions * other ocular diseases.

Keywords: metamorphopsia epiretinal membrane vitrectomy