Kornimate/medical-research-clean huggingface dataset:
yearly strain variation study, 2009/2010

Conditions: Influenza; Seasonal Influenza

Summary: the purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to world heath organization/european union (who/eu) recommendation for the 2009/2010 season for yearly licensing application.


Eligibility criteria:
inclusion criteria: * subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum a only) * subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum b only) * subject has given written informed consent prior to study entry * subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice * subject agrees to keep a daily record of symptoms for the duration of the study * if female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study * subject is willing and able to comply with the requirements of the protocol exclusion criteria: * subject has a history of severe allergic reaction or anaphylaxis * subject has an oral temperature of \>= 37.5°c on the day of vaccination in this study * subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating * subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry * subject has received a seasonal influenza vaccine within 6 months of study entry * subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder * subject has any inherited or acquired immunodeficiency * subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. such treatment includes, but is not limited to, systemic or high dose inhaled (\>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. * subject has a functional or surgical asplenia * subject has a known or suspected problem with alcohol or drug abuse * subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study * if female, subject is pregnant or lactating at the time of study enrollment
longitudinal experimental study on ulntt and cervico-thoracic spine motion patterns relationship

Conditions: Cervicobrachial Neuralgia

Summary: study design: longitudinal experimental study objective: analyze the relationship between upper limb neural tension test (ulntt1) and cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing model based on least square approximation. summary of background data: ulntt1 is a test able to determine cervical nerve roots and brachial plexus displacement within their interface structures. no studies were conducted about ulntt1 and cervico-thoracic spine motion patterns relationship. methods: 12 subjects with ulntt1 asymmetry \> 10° (as group) and 11 subjects with ulntt1 symmetry (s group) at clinical tests will be enrolled for the study. subjects will be analyzed for ulntt1 with an electrogoniometer using two parameters, one operator and one patient-dependent. fine lateral bending cervico-thoracic spine motion patterns will be collected with motion-capturing technique and data will be analyzed with least square approximation tools. subjects with impairments in cervico-thoracic spine mobility will undergo to correction of those with spinal manipulative therapy. ulntt1 and spine mobility will be so re-evaluated with same methods.


Eligibility criteria:
inclusion criteria: * as group: ulntt asymmetry \>10° * s group: ulntt symmetry exclusion criteria: * history of neck, shoulder or arm surgical interventions or major trauma, peripheral neuropathy, mental disturbance, limitation of shoulder, elbow or wrist range of motion, bmi \>25.

Keywords: neurodynamics
safe surveillance of pci under mechanical circulatory support with the saranas early bird bleed monitoring system

Conditions: Coronary Artery Disease

Summary: the objective of this study is to establish the safety of complex high-risk percutaneous coronary intervention (pci) using mechanical circulatory support (mcs) and surveillance with the saranas early bird bleed monitoring system (ebbms).

to demonstrate that patients undergoing complex high-risk pci using mcs and surveillance with the saranas early bird bleed monitoring system will have relative incidence rate reduction of access site related barc type iii or v bleeding. an optimal outcome will show a a reduction in access-site related bleeding rate when using mcs with the saranas ebbms in high-risk pci patients compared to historical incidence rate.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * planned complex high-risk pci using mcs with impella from a femoral access and use of saranas early bird bleed monitoring system * the study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site. exclusion criteria: * absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication * active bleeding * incapacity to access safely femoral artery or femoral vein * significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of mcs * anemia (hgb \<9 g/dl), thrombocytopenia (plt \<50,000 cell/ml), history of bleeding diathesis or coagulopathy, or hypercoagulable states * active infection not controlled with antibiotic therapy * currently pregnant or women of child-bearing potential without documented negative pregnancy test * estimated life expectancy \< 24 hours * patient is in cardiogenic shock at the time of enrollment

Keywords: percutaneous coronary intervention
berberine and cinnamon in management of diabetes

Conditions: Diabetes

Summary: in this randomized clinical trial, patients with diabetes will be randomly assigned to receive either berberine, and cinnamon supplements or placebo for 12 weeks. then the glycemic characteristics will be compared in two groups.


Eligibility criteria:
inclusion criteria: * age 30-70 years * diagnosed type-2 diabetes mellitus (based on american diabetes association criteria) exclusion criteria: * patients with an allergy to berberine /cinamon * lactation, pregnancy * patients with any malignancy * patients with unrelated chronic illness * patients with cardiac, liver or respiratory failure

Keywords: diabetes berberine cinnamon
pilot study exploring the use of hyperbaric oxygen in autologous peripheral blood stem cell transplantation

Conditions: Multiple Myeloma; Hodgkin's Disease; Non-Hodgkin's Lymphoma

Summary: by doing this study, researchers hope to learn the following: * the safety of hyperbaric oxygen administration in the setting of the autologous transplant * the effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment

the post stem cell transplant complications of neutropenic fever and mucositis, related to the chemotherapy and/or radiation on hematopoietic tissue administered prior to peripheral blood stem cell transplant, are reversible upon neutrophil count recovery. the investigators will investigate the use of hyperbaric oxygen as an intervention to shorten neutropenia post-high-dose chemotherapy and autologous peripheral blood stem cell transplant. the idea of using hyperbaric oxygen therapy in autologous stem cell transplantation is based on the investigators pre-clinical work that supported the use of hyperbaric oxygen to improve umbilical cord blood (cluster of differentiation 34) cd34+ stem cell transplantation.

Eligibility criteria:
inclusion criteria: * voluntary written informed consent * subjects with multiple myeloma (mm), hodgkin's disease (hd), and non-hodgkins lymphoma (nhl) who are eligible for high-dose chemotherapy and autologous pbsc transplant. subjects should be enrolled within 30 days of transplant. * subjects must be \>/= 18 yrs old and \</= 70 yrs old * karnofsky performance status of \>/= 70% * adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. minimum criteria include: * alt (alanine aminotransferase), ast (aspartate aminotransferase): \< 4x iuln (institutional upper limit of normal) * total bilirubin: \</= 2.0 mg/dl * creatinine: \</= 2.0 mg/dl * ef (ejection fraction) measured by 2d-echo or muga (multiple gated acquisition) scan of \>/= 45% * fev1 (forced expiratory volume), fvc (forced vital capacity) and dlcd(diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin) * women of child-bearing potential and men with partners of child-bearing potential must use adequate contraception prior to study entry and up to 30 days following treatment. exclusion criteria: * pregnant or breast feeding * severe chronic obstructive pulmonary disease requiring oxygen supplementation * history of spontaneous pneumothorax * active ear/sinus infection * claustrophobia * history of sinus or ear surgery, excluding myringotomy or ear tubes * history of seizures

Keywords: peripheral blood stem cell (pbsc) transplant hyperbaric oxygen lymphoma myeloma
follow-up of chronic hepatitis b patients with comorbid nonalcoholic fatty liver disease

Conditions: Chronic Hepatitis B; Nonalcoholic Fatty Liver Disease

Summary: the purpose of this study is to determine the disease progression in chb/nafld compared with chb and nafld including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * liver biopsy proved chb and/or nafld at baseline; * chinese * follow-up duration\>12 months exclusion criteria: * other liver diseases; * secondary causes of hepatic steatosis; * alcohol abuse; * liver cirrhosis, cirrhosis related complications or hcc at baseline; * malignancy; * history of liver transplantation
efficacy of osimertinib in patients with lung cancer

Conditions: Advanced Non-Small Cell Lung Cancer

Summary: this is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. this study does not intend to intervene the current medical practice of the recruited patients.


Eligibility criteria:
inclusion criteria: * patients must be ≥18 years. * provision of fully informed consent prior to any study specific procedures. * advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology. * according to the recist 1.1 standard, the patient must have at least one measurable lesion. exclusion criteria: * none
sleeping for two: trial for cbt for insomnia in pregnancy

Conditions: Insomnia; Sleep Disturbance

Summary: cognitive-behavioural therapy for insomnia (cbt-i) has been shown to be an effective treatment for insomnia in multiple populations, including women during pregnancy and postpartum. this randomized-controlled trial will compare the efficacy of cbt-i for pregnant women with insomnia to a treatment as usual group.

sleep disturbances are common during pregnancy and typically worsen as pregnancy progresses.treating antenatal insomnia with pharmacotherapy effectively improves sleep quality and confers a protective benefit against the onset of postpartum depression; however, data suggests that pregnant women are reluctant to take prescribed medications due to perception of risk. a large body of research has demonstrated that cbt-i has short-term efficacy equivalent to medication, while long-term results suggest that it outperforms medication. despite the literature showing cognitive behavioural therapy for insomnia (cbt-i) to be effective in a variety of populations including postpartum women, and the demonstrated harmful consequences of sleep disturbances in late pregnancy, there have been few pilot studies examining the effectiveness of cbt-i in pregnancy, which was conducted by our group. results suggested that cbt-i was effective and acceptable in reducing both objective and subjective indices of sleep quality and quantity of insomnia. these results are encouraging, and warrant larger investigations into the efficacy of cbt-i in pregnancy. research question and objectives: the current proposal is an extension of a pilot study into a randomized design of in-person cbt-i compared to a treatment as usual (tau) control for the treatment of insomnia experienced in pregnancy. the primary aim of the current project is to evaluate the impact of a 5-week in-person cbt-i versus a control group in reducing symptoms of insomnia (assessed subjectively by self-report and objectively with actigraphy) experienced in pregnancy. the investigators hypothesize that participants who receive a 5-week program cbt-i (versus tau) will report fewer insomnia symptoms and have improved objectively assessed sleep as measured post-treatment.

Eligibility criteria:
inclusion criteria: * at or over the age of 18 * between 12 and 28 weeks pregnant * are able to read, write and speak in english * have a diagnosis of insomnia according to the dsm-v criteria. exclusion criteria: * experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome \[rls\], sleep-disordered breathing \[sdb\] * having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia) * active suicidal ideation * currently taking prescribed medications for sleep problems * smoking, drinking alcohol or drug abuse during pregnancy * being pregnant with multiples * diagnosis of chronic pain.
effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain

Conditions: Pelvic Pain; Chronic Pain

Summary: the aim of study is to find out the effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain.


Eligibility criteria:
inclusion criteria: * women with chronic pelvic pain of \>6 months' duration and the cause of their pain is unknown * cpp was located within the true pelvis (between and below the anterior iliac crests) * average score of at least 4 out of 10 (0-10) on a numeric rating scale * moderate to severe pain on pelvic pain impact questionnaire exclusion criteria: * history of cancer * pregnancy at the time of inclusion * known pelvic pathology (eg, endometriosis, ovarian cyst, fibroid \>3cm) * intraabdominal and pelvic surgery within the last six months * chronic or recurrent gastro-intestinal disease including irritable bowel syndrome * received any physiotherapy treatment within the previous month

Keywords: pelvic pain female exercise
efficacy and safety of shen que (rn8) moxibustion in unexpected por

Conditions: Infertility

Summary: moxibustion of shen que (rn8) can increase the number of embryos available for transfer, thus improving pregnancy outcomes in women of advanced reproductive age who experience unexpected poor ovarian response.

according to the traditional chinese medicine (tcm) theory, shen que (rn8) is the place where the vitality converges under the navel, and is closely connected with the vitality generated by the kidney qi. therefore, stimulating shen que may stimulate the essence stored in the kidney, and improve the fertility of "五七" (≥ 35 years old) women. shen que moxibustion has been shown to improve ovarian functional reserve in patients with ovarian insufficiency in previous studies. nevertheless, studies on shen que moxibustion in advanced women with unexpected poor ovarian response (por) who undergo ivf-et are very limited. consequently, we designed this randomized controlled trial to validate the hypothesis that shen que moxibustion improves reproductive outcomes in unexpected por women.

Eligibility criteria:
inclusion criteria: * ≥35 years old with normal pre-stimulation ovarian reserve parameters (antral follicle count (afc) ≥ 5 or anti-mullerian hormone (amh) ≥1.2 ng/ml) and with an expected poor ovarian response (fewer than 4 oocytes) after standard ovarian stimulation. exclusion criteria: * individuals with a body mass index (bmi) ≥ 35 kg/m2 * those using the natural cycle or mild stimulation for ivf/intracytoplasmic sperm injection (icsi) treatment * those with a history of unilateral oophorectomy or recurrent pregnancy loss, defined as two or more spontaneous abortions * acceptors of donated oocytes or performed either in vitro maturation (ivm) or blastocyst biopsy for preimplantation genetic diagnosis (pgd) or preimplantation genetic testing for aneuploidies (pgt-a) * those previously diagnosed with congenital (e.g., mediastinal uterus and double uterus) or acquired (e.g., submucosal myoma and adenomyosis) uterine abnormalities * patients with extremely advanced age ( ≥ 45 years old) * presence of a non-surgically treated hydrosalpinx or endometrial polyp and an ovarian endometriosis cyst requiring surgery, during ovarian stimulation

Keywords: shen que (rn8) moxibustion in vitro fertilization and embryo transfer (ivf-et) poor ovarian response (por) poseidon criteria
the perioperative value of platelet counts in predicting outcome after liver transplantation

Conditions: Complication; Death

Summary: recent experimental and clinical studies have shown that platelets play a critical role in liver ischemia and regeneration. thrombocytopenia, a frequent and potentially serious condition in liver transplantation (lt) recipients, was shown to be associated with postoperative morbidity and mortality after partial hepatectomy. the investigators aim at evaluating whether postoperative low platelet counts are indicators of short- and long-term outcomes after liver transplantation.


Eligibility criteria:
inclusion criteria: * age \>18 years old * end stage liver disease * cadaveric-donor liver transplantation exclusion criteria: * age \<18 years old * pregnancy * living-related liver transplantation

Keywords: complications mortality liver transplantation platelet count survival
physical performance levels and social participation in elderly living in urban and rural areas

Conditions: Eldrely

Summary: purpose: this study aims to investigate the effect of physical performance levels of elderly living in rural and urban areas on social participation, social functioning, and quality of life. method: a total of 418 volunteer elderly aged 65 and over living in rural (42.3%) and urban (57.7%) areas participated in this study. the mini-mental state examination, short physical performance battery, the world health organization quality of life scale for older adults, leisure time subscale of the social functioning scale and the community integration questionnaire were applied to participants.


Eligibility criteria:
inclusion criteria: * individuals over the age of 65 years who received a score of ≥24 from the mini-mental state examination were included in the study exclusion criteria: * elderly who were unable to communicate verbally, were unable to move independently, had undergone any operations in the last 6 months, had been diagnosed with cancer, or had severe vision loss, stroke, parkinson's disease, multiple sclerosis, or other neurological diseases were excluded from the study
randomized trial of psychotherapy for persistently depressed primary care patients

Conditions: Major Depression

Summary: this is a pilot study. the purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients.


Eligibility criteria:
inclusion criteria: * current mdd or mdd within the past year or current dysthymia * phq-9 \> 10 * have been prescribed an antidepressant medication (by their pcp) at least 8 weeks before pre-treatment timepoint * are able to speak, read, and understand english sufficiently well to complete study procedures * are between the ages of 18 and 70 exclusion criteria: * presence of significant suicidal ideation or risk * history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year; * history of antisocial personality disorder or borderline personality disorder; * currently in psychotherapy or have received counseling more frequently than once per month in the past year.

Keywords: major depression primary care
relationship and central mechanism between diabetes and cognitive impairment based on simultaneous eeg-fmri approach and peripheral neuropathology biomarkers assay

Conditions: Type 2 Diabetes; Alzheimer Disease; Cognitive Impairment

Summary: this is a cross-sectional and longitudinal study to investigate the relationship and central mechanism between type 2 diabetes and cognitive impairment based on the simultaneous eeg-fmri approach and peripheral neuropathology biomarkers assay.

little is known about the high risks of cognitive impairment and alzheimer's disease (ad) in people with type 2 diabetes. the goal of this study is to characterize brain imaging biomarkers of preclinical ad and related cognitive impairment in people with type 2 diabetes using the simultaneous eeg-fmri approach and peripheral neuropathology biomarkers assay. we will recruit 400 patients with type 2 diabetes in the outpatient and inpatient departments. each subject will undergo simultaneous eeg-fmri scan, classical multimodal mri scan, cognitive assessments and peripheral neuropathology biomarkers assay at the baseline. this study will qualify gray matter volume, cortical thickness, gray matter and white matter microstructure, cerebral blood flow, spectrum changes, as well as resting state and dynamic functional network connectivity from the imaging examination. study duration was 3 years with a follow-up every 12 months. cognitive assessments and imaging scan will be conducted in each follow-up visits. at the end of the study, all of the assessments will be performed again for all recruited subjects.

Eligibility criteria:
inclusion criteria: * aged 40-75 years * right handedness * possessed over 6-year education * provision of informed consent prior to any study specific procedures exclusion criteria: * control participants would be excluded if they had a fasting blood glucose level \>7.0 mmol/l; glucose level\> 7.8 mmol/l after oral glucose tolerance test (ogtt); hba1c\>5.7% * control participants would be excluded if they had a montreal cognitive assessment (moca, beijing edition) score of \< 26 * history of other dementia-related neurological or psychiatric disorders, including psychotic developmental disorders, mania, depression, and schizophrenia * central neural system diseases, including traumatic brain injury, intracranial hemorrhage, and acute cerebral infarction * acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hypoglycemic coma * complicated with severe impairment of liver, kidney or heart function * metal implants, unable to complete the mr scanning * pregnant or lactating women