Kornimate/medical-research-clean huggingface dataset:
olive oil polyphenols, vitamin d, docosahexaenoic acid (dha) and locomotor function (polivd3)

Conditions: Osteopenia; Sarcopenia

Summary: the present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. among the nutrients that may be of interest for bone and muscle tissues, unsaturated fatty acids and vitamins are the most described. consequently, based on the promising available preliminary data, the present project aims to investigate the possible preventive effect of olive oil polyphenols and eventually the synergistic effects of fatty acids and vitamin d on bone, muscle and adipose tissue, in order to prevent any locomotor dysfunction. volunteers will be supplemented during 9 months. the primary and secondary outcome measures will be performed at baseline, 3 and 9 months.


Eligibility criteria:
inclusion criteria: * caucasian female * within at least 7 years post-menopause * generally healthy as determined by standard medical assessment on physical and mental health * normal weight as determined by bmi (20≤ bmi ≤30) * affiliated to national health insurance * willing to comply with the study procedures * willing to accept use of all nameless data, including publication, and the confidential use and storage of all data * having received both oral and written explanations about the study * having provided her written informed consent exclusion criteria: * intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignancy, chronic malnutrition * osteoporosis (defined by t-score of -2.5 standard deviation (sd) at hip and/or spine) * on therapy with drugs known to interfere with bone and muscle metabolism * taking regular calcium and vitamin d supplements * currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous study• * intense physical activity

Keywords: vitamin d bone loss
limiting adverse birth outcomes in resource-limited settings

Conditions: Birth Outcomes; Labor and Delivery; Respiratory Infection

Summary: the primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in settings where the occurrence of adverse outcomes is high. the investigators will gather detailed laboratory, physiologic, and clinical information, and precisely characterize major adverse diagnoses and outcomes. the resulting high-quality, granular, and generalizable data will be used to develop new algorithms to signal actionable intrapartum diagnoses and prospectively stratify women according to their risk for adverse maternal and neonatal outcomes.

this is a prospective multi-country cohort study of up to 15,000 women admitted to the hospital for delivery or for management of respiratory infection. women will be recruited and screened for study participation at the time of presentation to the hospital. participants will be assessed through hospitalization, labor, delivery, and discharge and at 1- and 6-week postpartum contacts. liveborn infants will be enrolled at birth and followed through 42 days of life. the pilot phase of this protocol will enroll up to 500 women in labor and their newborns and follow them through labor, delivery, and 42 days postpartum.

Eligibility criteria:
inclusion criteria for women enrolled: * maternal age of majority * intrauterine singleton pregnancy * admission to the hospital for any of the following: 1. vaginal delivery 2. cesarean delivery in the presence of signs/symptoms of parturition, elevated blood pressure, or fever 3. management of respiratory infection\* * ability and willingness to provide written informed consent * willingness to adhere to study procedures * willingness to provide locator information for follow-up * inclusion of participants admitted to hospital for management of respiratory infection applicable to zambia site only. exclusion criteria for women enrolled: * admission to the hospital for cesarean delivery in the absence of signs/symptoms of parturition, elevated blood pressure, or fever * any condition (social or medical) that, in the opinion of study staff, would make participation unsafe or not feasible. study staff may note physical, psychological, or social conditions that are not explicitly stated in the eligibility criteria that could make some women poor candidates for study participation.

Keywords: labor and delivery childbirth in limited resource setting
hepatitis b virus reactivation after withdrawal of prophylactic antiviral therapy in lymphoma patients

Conditions: Hepatitis; Hepatitis B; Lymphoma; Hematologic Diseases

Summary: this study is a retrospective analysis to explore the incidence of hepatitis b virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis b virus infection.

all eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. we did not assign specific interventions to the subjects in this study. the primary endpoint of this study is the incidence of hepatitis b virus reactivation after withdrawal of prophylactic antiviral therapy. the secondary endpoints include the incidence of hepatitis flare related to hepatitis b virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.

Eligibility criteria:
inclusion criteria: * treatment-naive patients with lymphoma * patients with a history of previous exposure to hepatitis b virus (hbv): hbsag or hepatitis b core antibody (anti-hbc) positive exclusion criteria: * hbsag and hbcab negative

Keywords: hepatitis hepatitis b lymphoma hematologic diseases
effect of vitamin d therapy in autism spectrum disorder

Conditions: Effect of Drug

Summary: the aim of this work is to study the adjuvant effect of vitamin d supplementation on inflammatory marker (il4) and habilitation outcome in children with autism spectrum disorder in order to evaluate its efficiency as a treatment option based on correction of immune dysfunction.

vitamin d is one of environmental factors potentially modulating brain development and functioning. vitamin d3 deﬁciency during pregnancy and early childhood is suggested to be one of several risk factors for development of asd in genetically predisposed individuals (cies´lin´ska et al., 2017). many studies e.g (eyles et al., 2013; grant and sole, 2009; noriega and savelkoul, 2014) suggested that vitamin d has an important role as a neuroactive steroid, which can affect neuronal differentiation, axonal connectivity and brain structure and function. vitamin d has been increasingly recognized for its immunomodulatory role and has been implicated in the pathogenesis of autoimmune disorders. also it has numerous and dynamic effects on the immune system, ranging from altering t cell responses and regulating cytokine pathways (kocˇovská et al., 2017). so from this point of view, this study will be conducted to show adjuvant effect of vitamin d supplementation on asd children at clinical level and inflammatory marker (il4).

Eligibility criteria:
inclusion criteria: 1. delayed language development due to asd. 2. good nutritional status (normal weight and height using growth charts, no anemia and no clinical evidence of vitamin deficiency). 3. normal hearing and vision. exclusion criteria: 1. history of vitamin d supplementation, drugs modulating immune system as steroid and drug formula containing vitamin d as cod liver oil. 2. known chronic disease. 3. known neurological disorders or psychiatric disorders. 4. known autoimmune or gastrointestinal disorders.
manual diaphragmatic release on ventilatory functions in elderly diabetic women

Conditions: Diabetes; Elderly

Summary: evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women.

sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at mansoura university hospitals in egypt, with referrals from endocrinologists. patients were randomly assigned into two groups. the study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. at baseline and poststudy, the following outcomes are assessed: 1. ventilatory functions (forced vital capacity and forced expiratory volume in the first second). 2. functional capacity using modified bruce treadmill incremental exercise test (maximal oxygen consumption estimation).

Eligibility criteria:
inclusion criteria: * type 2 diabetic for more than 5 years. * well controlled diabetes with glycated hemoglobin≤7%. * normal to mild ventilatory functions impairment. * their ages ranges from 65 to 70 years old. * their body mass index are less than 30 kg/m2. exclusion criteria: * other types of diabetes. * patients with any other chronic chest diseases . * cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension). * smokers. * rheumatoid arthritis. * musculoskeletal/ neurological limitations to exercise.
running title: ppar-γ, rxr-α, and vdr expressions in periodontitis

Conditions: Periodontitis

Summary: objective: the present study aimed to determine the expressions of nuclear receptors ppar (peroxisome proliferative activator receptor)-γ, rxr (retinoid x receptor)-α, and vitamin d receptor (vdr) in healthy volunteers and periodontitis patients with different grade involvement. methods: group-1; healthy individuals, group-2; periodontitis patients-stage 3 grade b, (h-gradeb), group-3; periodontitis patients-stage 3 grade c, (d-gradec). clinical parameters as plaque index (pi), gingival index (gi) and clinical attachment levels (cal) were measured. fibroblast and inflammatory cells, ppar-γ, rxr-α, and vdr levels were determined in histological slides.


Eligibility criteria:
inclusion criteria: * systemic health * no drug use * no previous periodontal treatment within six months * no tobacco use exclusion criteria: * pregnant or lactating women * patients used antibiotics in the last 6 months

Keywords: periodontitis, ppar-γ, rxr-α, vdr
effectiveness of combined levetiracetam and midazolam in generalized convulsive status epilepticus in children

Conditions: Status Epilepticus; Generalized Convulsive Status Epilepticus; Status Epilepticus, Generalized; Status Epilepticus, Generalized Convulsive

Summary: generalized status epilepticus is a common pediatric neurological emergency with significant mortality and morbidity. benzodiazepines remain the first anticonvulsive line but benzo-diazepines don't control seizures in about 30% of cases. gcse may be more rapidly stopped and controlled through combining another drug with benzodiazepines such as levetiracetam, acting by different pathways. this study aims to evaluate the effectiveness of combined levetiracetam and midazolam in treatment of generalized convulsive status epilepticus in children.

generalized convulsive status epilepticus (gcse) is a common pediatric neurological emergency with an annual incidence of up to 73 episodes per 100,000 children and is associated with mortality in 2.7% of cases and overall morbidity in 10% - 20% of cases, including hemodynamic instability and long-term neurological impairments. the management of gcse in children starts with emergency measures (stabilization phase) with monitoring and laboratory testing in the first 5 minutes. benzodiazepines are used as first-line anticonvulsants for gcse that persists for more than 5 minutes. however, studies have shown that benzo-diazepines don't control gcse in about 30% of patients. gcse may be more rapidly stopped and controlled through combining another drug with benzodiazepines, acting by different pathways. levetiracetam is a recent broad-spectrum antiepileptic drug with a relatively high safety profile. the effectiveness of intravenous levetiracetam has been demonstrated as a second-line anticonvulsant in gcse. in this study, we aim to evaluate the effectiveness and safety of levetiracetam plus midazolam versus midazolam alone as first-line therapy of gcse in children.

Eligibility criteria:
inclusion criteria: * generalized convulsive status epilepticus, which is clinically defined at the time of presentation as continuous, generalized, tonic-clonic seizure activity or ≥ 2 generalized tonic-clonic seizures without recovery of consciousness for more than 5 minutes. exclusion criteria: * failure to obtain informed consent. * prior therapy with any anticonvulsant for the presenting episode of generalized convulsive status epilepticus. * epileptic patients on levetiracetam therapy. * known allergy or contraindications to any of the study drugs. * end-stage kidney disease. * severe liver disease. * cardiac diseases. * hypoglycemia or hyperglycemia. * inborn errors of metabolism. * known mood/behavioral disorder. * failure to obtain intravenous access in the first 5 minutes. * cessation of seizures during the stabilization phase (0 - 5 minutes). * traumatic brain injury

Keywords: status epilepticus convulsions children seizures benzodiazepines midazolam levetiracetam
clinical study of cd7 car-t cells for relapsed/refractory autoimmune diseases

Conditions: Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria

Summary: the primary objective was to evaluate the safety of cd7 car-t cells for the treatment of subjects with relapsed/refractory aid. cd7 car-t cells were infused in a single infusion in subjects who were screened after signing an informed consent form and undergoing single nucleus cell collection and pretreatment, and blood was collected before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations.

subjects who meet the inclusion/exclusion criteria will be entered into 3 groups in sequential order for a single dose. the dose-escalation study utilizes a "3+3" design, i.e., 3-6 subjects in each group will complete a single dose. after the last subject in each dose group completes a dose-limiting toxicity (dlt) assessment window of 28 days after the single dose, enrollment in the next dose group can begin. when 1 dlt occurs in 3 subjects in a dose group, 3 additional subjects are required in the same dose group (up to 6 subjects in that dose group have completed dlt assessment): if no dlt occurs in the 3 additional subjects, continue the dose escalation; if 1 of the 3 additional subjects develops a dlt, stop the dose escalation; if \>1 of the 3 additional subjects dlt occurs, the dose escalation is stopped and a one-dose reduction is required to continue enrolling 3 more subjects for dlt assessment.

Eligibility criteria:
inclusion criteria: - diagnosed relapsing/refractory systemic sclerosis that has failed treatment with at least two immunosuppressive and/or biologic agents. bone marrow and coagulation function, liver and kidney function, cardiopulmonary function are satisfied no serious mental disorders exclusion criteria: - malignancy other than aid disease within 5 years prior to screening hepatitis b surface antigen (hbsag) positive, aids, syphilis and other virus positive persons severe heart disease
postoperative subtenons anesthesia for postoperative pain in pediatric strabismus surgery

Conditions: Strabismus

Summary: the purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.


Eligibility criteria:
inclusion criteria: * age 1 year to \< 8 years * undergoing strabismus surgery under general anesthesia * no previous surgery on muscle to be operated * no known allergy to lidocaine or bupivacaine * investigator willing to inject subtenons ns or preservative-free bupivacaine 0.75% by cannula into all surgical wounds and willing to administer topical lidocaine 3.5% ophthalmic gel or hypromellose 0.3% gel (genteal severe dry eye relief) to all surgical wounds at the end of strabismus surgery.
studying pain and symptom distress in patients with advanced colon cancer, rectal cancer, pancreatic cancer, or liver cancer

Conditions: Colorectal Cancer; Depression; Fatigue; Liver Cancer; Pain; Pancreatic Cancer

Summary: rationale: studying a patient's understanding of his or her illness, pain, symptoms, and quality-of-life may help the study of advanced cancer and may help patients live more comfortably. purpose: this clinical trial is studying pain and symptom distress in patients with advanced colon cancer, rectal cancer, pancreatic cancer, or liver cancer.

objectives: * to describe illness perception as indicated in the five domains of the common sense model (i.e., identity, cause, time line, consequences, controllability) and their relationship to symptom distress in patients with colon, rectal, pancreatic, or liver (i.e., hepatocellular carcinoma) cancer. * to describe pain and other symptoms and their relationship to overall symptom distress in these patients. * to describe overall quality of life (qol) and its specific summary scales in these patients. * to explore the relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and qol in these patients. outline: patients undergo an empirical examination of illness perceptions as predictors of disease, specifically from the five domains in the common sense model. patients undergo an assessment of the relationship between influencing characteristics (i.e., sociodemographic), symptoms, and behavioral factors (i.e., illness perceptions, overall symptom distress, and quality of life). patients complete questionnaires to evaluate demographics by the sociodemographic, disease, and health status tool; illness perception by the illness perception questionnaire-revised (ipq-r); symptoms and symptom distress by the memorial symptom assessment scale (msas) and brief pain inventory; and quality of life by the sf-12. patients also undergo a medical chart review and self-report on sociodemographic characteristics.

Eligibility criteria:
disease characteristics: * histologically confirmed colon, rectal, pancreatic, or liver (i.e., hepatocellular carcinoma) cancer * stage iii or iv colon, rectal, or pancreatic cancer * child-pugh class b or c hepatocellular carcinoma patient characteristics: * able to read english * able to provide written informed consent and complete questionnaire packet prior concurrent therapy: * any treatment modality (e.g., chemotherapy, radiotherapy, surgery) allowed

Keywords: pain depression fatigue stage iii colon cancer stage iv colon cancer recurrent colon cancer stage iii rectal cancer stage iv rectal cancer recurrent rectal cancer stage iii pancreatic cancer stage iv pancreatic cancer recurrent pancreatic cancer adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer
a study to assess the safety and efficacy of oral lpcn 1154a in women with severe ppd

Conditions: Depression, Postpartum; Depression, Post-Partum; Postpartum Depression (PPD); Post-Natal Depression; Peripartum Depression; Postnatal Depression

Summary: the purpose of this research study is to test the study drug, lpcn 1154a, as a possible treatment for postpartum depression (ppd). the trial aims to determine: * if lpcn 1154a reduces depressive symptoms in subjects with severe ppd * how well lpcn 1154a is tolerated and what side effects it may cause * if lpcn 1154a reduces anxiety symptoms in subjects with severe ppd


Eligibility criteria:
key inclusion criteria: * are female between 15 and 45 years of age, inclusive; * have had a depressive episode that began no earlier than third trimester and later than the first 4 week following delivery * are \< 12 months postpartum at screening * hamilton depression rating scale (ham-d) 17-item score indicative of severe depression key exclusion criteria: * have a history of bipolar disorder, schizophrenia or schizoaffective disorder * are currently experiencing active psychosis per investigator assessment * have a history of suicidal behavior within 1 year * have a history of seizure within 6 months of screening
the effect of remote ischemic preconditioning on elective percutaneous coronary intervention in diabetic nephropathy

Conditions: Contrast Induced Acute Kidney Injury

Summary: contrast-induced acute kidney injury (ci-aki) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. when remote ischemic preconditioning is applied before percutaneous coronary intervention (pci), the kidneys can be protected against ischemia-reperfusion injury and subsequently ci-aki. in this randomised controlled trial, diabetic nephropathy patients undergoing pci as part of their assessment and treatment of cardiovascular disease are randomized to receive ripc or control sham preconditioning.

contrast-induced acute kidney injury (ci-aki) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. diabetes with pre-existing renal disease can increase the risk of ci-aki. remote ischemic preconditioning (ripc) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. these brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. in a recent pilot study, using ripc prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that ripc significantly reduced the incidence of ci-aki (er et al circulation. 2012;126(3),296). we hypothesized that ripc would be protective as an adjunctive therapy in reducing the incidence of ci-aki in diabetics with pre-existing ckd. this prospective study was performed to evaluate the efficacy of ripc for the prevention of ci-aki among diabetic nephropathy patients undergoing percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: * informed written consent * all of the following: * known diagnosis of type 2 diabetes * nstemi, unstable or stable angina * patients undergoing elective coronary angiography and/or percutaneous coronary intervention * egfr \ 300 mg/dl exclusion criteria: * stemi * decompensated heart failure in the preceding 6 months * patients with underlying end stage renal disease on maintenance dialysis * recent (in the last 3 months) cerebrovascular disease * chronic liver disease * chronic obstructive pulmonary disease * gastrointestinal bleeding * acute or chronic infection or malignancy