Kornimate/medical-research-clean huggingface dataset:
impact of hospital admission on patients with dementia

Conditions: Dementia

Summary: people with dementia have complex medical, social, and psychological needs and can be exacerbated by physical illness and the complex relationships between health care systems, patients and their families or caregivers. they are a vulnerable and fragile population that differs significantly from the population without dementia. therefore, the investigators propose the following objectives: 1. to describe the evolution of dementia patients admitted during the study period in two hospitals in the basque health service-osakidetza and complications associated with such admissions. 2. to compare with a control group (matched by type of pathology, age and sex and adjusting for other clinical variables (severity of dementia ...) the patient's condition before and after admission, in terms of quality of life, dependency, instrumental activities of daily living and severity of dementia. 3. to compare the length of stay, complications, mortality rate, the degree of dependency and quality of life of patients with dementia compared to those without dementia, matched by groups of pathologies, gender and age.


Eligibility criteria:
inclusion criteria: * for the patients with dementia cohort, the inclusion criteria were: (a) being patient aged over 75 years; (b) having been diagnosed with dementia according to the diagnostic and statistical manual for mental disorders-iv (american psychiatric association, 1994) by any of the psychiatrists; (c) having received inpatient treatment by the time of the study in the hospital//with an unplanned medical admission to any medical speciality in the galdakao-usansolo hospital (d) agreeing to participate voluntarily and providing written informed consent. patients with dementia were included if a caregiver agreed to participate voluntarily. caregiver is defined as any person who cares for a needy person in his or her direct environment on a regular basis and more or less as a matter of course. the caregiver is related (family, friend...) to the person receiving care and is not a professional caregiver (shoenmakers et al., 2010). * for the cognitive intact patients cohort, the inclusion criteria were patients without dementia admitted in the hospital by the time of the study, matched with patients with dementia, after controlling for age, gender and types of pathologies. exclusion criteria: * patients with dementia (or caregivers) were excluded if they did not provide inform consent. * the exclusion criteria for patients without dementia were disorders interfering with psychometric assessment, or not given written informed consent.

Keywords: dementia hospital admission mortality health-related quality of life activities of daily living
safety and tolerability of oral opc-34712 as adjunctive therapy in adults with major depressive disorder (the orion trial)

Conditions: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders

Summary: to assess the long-term safety and tolerability of oral opc-34712 (brexpiprazole), given in addition to an fda approved antidepressant (adt) for the treatment of adults with major depressive disorder (mdd)


Eligibility criteria:
inclusion criteria: * male and female outpatients 18-65 years of age eligible subjects from trials 331-10-227, 331-10-228 or 331-12-282: * subjects who completed participation in the double-blind randomization phase (i.e. week 14 visit) in trial 331-10-227, trial 331-10-228, or trial 331-12-282 or * subjects who met criteria for a response, but did not meet criteria for remission at week 14 of either trial eligible subjects from other phase 3, double-blind, brexpiprazole mdd trials: • subjects who completed the last scheduled visit of the prior double-blind randomized phase 3 trial. exclusion criteria: * females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving opc-34712. * subjects with a major protocol violation during the course of their participation in the double-blind randomization phase

Keywords: opc-34712 brexpiprazole major depressive disorder adjunctive treatment
a study of velaglucerase alfa (vpriv) given as standard patient care in young children with gaucher disease

Conditions: Gaucher Disease

Summary: the main aim of this study is to learn if velaglucerase alfa (vpriv) improves growth and symptoms in participants up to 5 years of age with gaucher disease. symptoms will be checked with blood tests. this study is about collecting data available in the participant's medical record as well as data from each participant's ongoing treatment. no study medicines will be provided to participants in this study. the study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. when the participants start the study, they will visit the study clinic every 6 months after their first visit.


Eligibility criteria:
inclusion criteria: * the participant's caregiver is able and willing to provide informed consent. * the participant is male or female younger than or equal to 4 years of age at treatment initiation. * the participant has received and confirmed a current diagnosis of gd type 1 or type 3 (biochemically and/or genetically). * the participant has been receiving intravenous (iv) velaglucerase alfa treatment for gd. * in the opinion of the investigator, the participant's caregiver is capable of understanding and complying with protocol requirements. * the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: * the participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., child, sibling) or may consent under duress. * the participant is judged by the investigator as being ineligible for any other reason.
maternal iodine supplementation and effects on thyroid function and child development

Conditions: Iodine Deficiency; Infant Development

Summary: rationale: in regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of their offspring. however, the potential adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear. inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in iodine deficiency. objective: to determine whether the daily oral administration of 200 µg iodine to pregnant women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid function, pregnancy outcome, birth weight, infant growth and cognitive performance. study design: double-blind randomized controlled multicentre trial. study population: pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be recruited at two research sites, namely st. martha's hospital in bangalore, india and ramathibodi hospital, mahidol university, bangkok, thailand. at each site, 400 women will be recruited. intervention: half of the women will be randomized to iodine treatment (200 µg per day) and the other half to placebo throughout pregnancy. main study parameters/endpoints: differences between group means in indicators of thyroid function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor development.


Eligibility criteria:
inclusion criteria: * age 18-40 years; * gestational age: ≤ 14 weeks (as judged by the date of the last menstrual period); * single pregnancy; * non-lactating; * planned residence in the area for the duration of the study (3 years). exclusion criteria: * tsh levels outside the normal range * history of serious medical conditions such as hiv, hypertension, diabetes, renal, hepatic or cardiovascular disease, thyroid disorders, mental disorders; * use of iodine supplement.

Keywords: iodine deficiency pregnancy thyroid function infant development growth
safety and immunogenicity of a commercially available influenza vaccine (formulation 2006/2007) when administered to subjects 18 years of age or older

Conditions: Influenza

Summary: to evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over


Eligibility criteria:
inclusion criteria: * 18 years of age or older exclusion criteria: * any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (copd) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of * immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) * fever within the past 3 days * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * within the past 12 months have received more than one injection of influenza vaccine * women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)

Keywords: influenza adult elderly vaccine
rezvilutamide in patients with biochemical recurrence after radical prostatectomy for prostate cancer

Conditions: Prostate Cancer; Biochemical Recurrence

Summary: to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(adt) and standard salvage radiation therapy(srt) or rezvilutamide in combination with adt in prostate cancer patients with biochemical recurrence of prostate-specific antigen(psa) persistence after radical prostatectomy(rp).


Eligibility criteria:
main inclusion criteria: 1. age ≥ 40 years, male. 2. patients with histologically-confirmed diagnosis of prostate adenocarcinoma. 3. pathologically node-negative (pn0) or pathologically node cannot be assessed (pnx); 4. patients with psa \< 0.1ng/ml within 8 weeks after radical prostatectomy (rp) and maintained for at least 6 months; 5. biochemical recurrence (two consecutive rises in psa with absolute values \> 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and ct/mri scan); 6. eastern cooperative oncology group (ecog) performance status score of 0 to 1; 7. estimated life expectancy \>10 year; 8. adequate laboratory parameters * absolute neutrophil count (anc) ≥ 1.5 x 10\^9/l * platelet count (plt) ≥ 100 x 10\^9/l * haemoglobin (hb) ≥ 90 g/l * serum creatinine (cr) ≤ 1.5 x upper limit of normal(uln) or creatinine clearance \> 50 ml/min. * total bilirubin (tbil) ≤ 1.5 x uln. * glutamic oxaloacetic transaminase (ast/sgot) or glutamic alanine transaminase (alt/sgpt) levels ≤ 2.5 x uln. * international normalised ratio (inr) ≤1.5, prothrombin time (pt) and activated partial thromboplastin time (aptt)≤1.5 x uln . * left ventricular ejection fraction (lvef) ≥ 50%. 9. patients able to comply with the protocol. arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy. 10. signed informed consent. main exclusion criteria: 1. prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic . 2. postoperative biochemical recurrence with psa \> 2 ng/ml. 3. postoperative pathology containing neuro-endocrine differentiation or small cell features. 4. prior malignancy other than prostate cancer in the past three years. 5. history of any of the following: * seizure or known condition that may pre-dispose to seizure * severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry. * active infection (eg, human immunodeficiency virus \[hiv\] or viral hepatitis) 6. any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Keywords: prostate cancer biochemical recurrence rezvilutamide
an efficacy and safety study of elagolix (nbi-56418) in women with endometriosis

Conditions: Endometriosis, Pain

Summary: this study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

this is a phase ii, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (qd); 250 mg elagolix qd or placebo qd. following 12 weeks of dosing, participants will continue in the study for an additional 12 weeks; participants randomized to elagolix will continue to receive their assigned dose and participants randomized to placebo will be re-randomized to receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. six weeks after the last dose of study drug at the end of week 24, a follow-up visit will be performed (end of week 30).

Eligibility criteria:
inclusion criteria: * be female, aged 18 to 49 years, inclusive * have moderate to severe pelvic pain due to endometriosis * have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms * have regular menstrual cycle * have a body mass index (bmi) of 18 to 36 kg/m², inclusive * agree to use two forms of non-hormonal contraception during the study exclusion criteria: * are currently receiving gonadotropin-releasing hormone (gnrh) agonist or gnrh antagonist or have received any of these agents within 6 months of the start of screening * are currently receiving subcutaneous medroxyprogesterone acetate (dmpa-sc) or intramuscular medroxyprogesterone acetate (dmpa-im) or have received any of these agents within 3 months of the start of screening * are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month * have had surgery for endometriosis within the last month * have had a hysterectomy or bilateral oophorectomy * are using systemic steroids on a chronic or regular basis within 3 months * have uterine fibroids ≥ 3 cm in diameter * have pelvic pain that is not caused by endometriosis * have unstable medical condition or chronic disease * have been pregnant within the last six months * currently breast feeding

Keywords: bone mineral density pelvic pain estradiol nbi-56418
autologous immune cell therapy in combination with lhrh-a in patients with mcrpc

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: study of autologous immune cell therapy in combination with the luteinizing hormone releasing hormone agonists (lhrh-a) in patients with metastatic castration-resistant prostate cancer

autologous dendritic cells (dc) are known to activate other immune cells, such as central memory t cells (tcm cells), that are able to mount an attack against cancer cells. the purpose of this study is to evaluate the feasibility, safety and efficacy of patients' own immune cells combined with the luteinizing hormone releasing hormone agonists (lhrh-a) for treatment of metastatic castration-resistant prostate cancer.

Eligibility criteria:
inclusion criteria: * males age ≥ 18 years； * subjects who understand and sign the consent form for this study； * metastatic， castrate resistant, histologically confirmed prostate cancer； * psa\> 5ng / ml； * serum testosterone ≤ 17nmol / l (50ng / dl)； * expected survival time of at least 24 months； * eastern cooperative oncology group (ecog) performance status of 0 or 1； * subjects did not receive chemotherapy, radiation therapy, surgery and other treatment within 4 weeks； exclusion criteria: * the subject has an allergic history of medicine or food； * the patient with more serious heart disease, including but not limited to myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia； * hb \<9.0 g / 100ml, wbc \<3 ×10\^9/ l, ly \<1.0 x10\^9/ l, platelet \<100,000 / mm3； * patients with immune disease or auto-immune disease (such as multiple sclerosis, systemic lupus erythematosus，rheumatoid arthritis and inflammatory bowel disease, vitiligo )； * the subject has uncontrolled or hard-to-control diseases of liver, or kidney system； * patient with visceral metastases, pathological fractures, spinal cord compression symptoms； * severe pain associated with bone metastases (vas score ≧ 4 points)； * patient has received immunotherapy (including but not limited to pd-1 / pdl-1, etc.)； * patient with irregular hemorrhagic disease； * subject is hiv, hepatitis b virus, hepatitis c virus, treponema pallidum infection； * subject has uncontrollable seizures, or because of mental loss of self-knowledge and so on； * the subject has an history of other malignant tumor； * the patient had drug abuse, drug abuse, and long history of alcoholism in the 12 years prior to this trial； * the subject has participated in any other clinical trial in the 3 months prior to this trial； * the subject has any other unsuitable or adverse condition to be determined by the investigator.

Keywords: central memory t cell metastatic castration-resistant prostate cancer
affective responses in neurological rehabilitation

Conditions: Neurological Incidents; Stroke; Traumatic Brain Injury

Summary: using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. both before and after the treatments, a self-report mood survey scale (mss) was used to assess the effects on the treatment on distinct affective states. the subscales of the mss were tested for pre-post changes and different effects between treatments with non-parametric tests.


Eligibility criteria:
inclusion criteria: * voluntary participation * neurological incident exclusion criteria: * lack of communication ability * interference of consciousness * inability to speak german language
comparison between two analgesic methods for pain relief following surgical abortion

Conditions: Pain

Summary: to compare between the efficacy of paracetamol iv vs. lornoxicam iv in pain relief following surgical abortion. the medication will be given at the time of the procedure. following the abortion, pain level will be evaluated.

patients with medical indication for surgical abortion during first trimester will be divided to two groups. the study groups, the surgeons and the nurses will be blinded to one of the treatment arms. pain will be evaluated at fixed intervals following the abortion. comparison in pain levels between the study groups will be analysed.

Eligibility criteria:
inclusion criteria: * elective surgical abortion for first trimester pregnancy exclusion criteria: * chronic pelvic pain * fibromyalgia * pelvic inflammatory disease * chronic renal failure, liver disease, peptic ulcer * cervical stenosis

Keywords: pain abortion paracetamol lornoxicam
weekly antepartum testing in women with bmi 30-40 and neonatal outcomes

Conditions: Obesity Complicating Childbirth

Summary: the purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (bmi) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. the investigators will also assess the differences in maternal and neonatal outcomes between the groups.

over the last decade, the prevalence of obesity has dramatically increased in women in reproductive age. it is well known that obesity has been associated with increased risk of antenatal complications, maternal and perinatal morbidity, including higher risk of stillbirth. studies including obese women without other antepartum comorbidities have shown that up to 11% of pregnancies are complicated with fluid and fetal growth abnormalities. according to american college of obstetricians and gynecologists (acog) guidelines, antepartum surveillance has not been proven to improve pregnancy outcomes in such cases and no specific recommendations for antepartum surveillance in obese women have been established.

Eligibility criteria:
inclusion criteria: * women at or over 18 years of age * singleton pregnancy with no major fetal anomalies * pregnancies and gestational age will be well dated * obese with bmi 30-40kg/m2 exclusion criteria: * women with any complications at time of randomization that would require antenatal testing in the third trimester as per acog guidelines including: hypertension, systemic lupus erythematosus, chronic renal disease, antiphospholipid syndromes, hyperthyroidism poorly controlled, hemoglobinopathies, cyanotic heart disease, gestational hypertension, pre-eclampsia, gestational diabetes medication controlled, oligohydramnios, intrauterine growth restriction before randomization, isoimmunization, history of fetal demise * women with indication for weekly testing as per local protocol

Keywords: pregnant pregnancy ultrasound antepartum testing neonatal outcome antenatal complications
the accuracy of automated audiometry application on smart phone to screen hearing loss

Conditions: Hearing Loss

Summary: the purpose of study is to determine the diagnostic value of hearing test program on smart phone for detected patients who has hearing loss.


Eligibility criteria:
inclusion criteria: * patient who underwent hearing test in our otologic clinic exclusion criteria: * age below 15 year * patients who cannot following command