Kornimate/medical-research-clean huggingface dataset:
assessment and referral versus exercise in primary prevention of falls: pa healthy steps program

Conditions: Lower Extremity Weakness Distal; Distorted; Balance

Summary: older adults at high risk of falls will complete the pa healthy steps program. this program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. participants will then be randomly assigned to three arms: (i) follow-up only; (ii) falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) healthy steps in motion, a 4-week group exercise program designed to complement healthy steps. all participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.

this falls prevention program is offered in 11 senior housing sites. trained instructors from the research team provide the healthy steps in motion exercise classes. participants provide a signed form indicating physician clearance for participation. falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk. this study is a pilot. the research team is interested in participation and adherence, as well as the primary outcome of falls incidence.

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent 2. willing to be randomized 3. scoring in the lowest tertile on at least one test in the healthy steps lower extremity performance battery 4. age 50+ exclusion criteria: 1. hospice enrollee or life-threatening illness 2. active cancer treatment 3. neurologic disease linked to falls risk, such as parkinson's 4. unable to ambulate indoors 5. high likelihood of moving in next 6 months

Keywords: falls exercise safety injury older adults
open thyroid surgery with pillow versus no pillow for better post-operative outcomes

Conditions: Post-operative Pain

Summary: primary: to compare the post-operative pain in patients with neck extension and without neck extension. secondary: to determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (rln) injury and hypocalcaemia in both groups. hypothesis: patients who undergoing thyroidectomy without neck extension will have less post-operative pain and there are no significant difference of post-operation complications between both groups.

conventional open thyroid surgery is still one of the most common operations performed globally. traditionally, patients who undergoing thyroid surgeries are usually positioned with extended neck by using pillow under shoulder in order to facilitate neck exposure and make the surgery easier. however, the degree of benefit from the extended neck is doubtful and there is little objective evidence that suggest extended neck thyroid surgery offers better outcomes. on the the hand, over-extension of the neck should be avoided because of it is associated with post-operative pain, vomiting, spinal damage and stroke. the objective of the present study is to compare the post-operative pain in patients with neck extension and without neck extension. in addition to that, we also like to determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (rln) injury and hypocalcaemia in both groups. this is a prospective randomized controlled trial, which will be conducted from 1st of march 2012 till 30th september 2012. given that approximately 300 to 400 patients would undergo thyroid surgery in each year, we estimated 180 patients will be recruited and randomly divided into 2 groups (neck extension and no neck extension) before undergoing open thyroid surgery for this trial. visual analogue scale (vas) is used to determine the post-operative pain. primary end point and other peri-operative variables are then analyzed with spss software.

Eligibility criteria:
inclusion criteria: * all patients who will be undergoing thyroid surgery in queen mary hospital and tung wah hospital. * age from 18 till 80 years old. exclusion criteria: * patients with history of bleeding disorder and tendency. * patients with history of cervical spine surgery and disease. * patients with history of rln injury and underlying cause of hypocalcemia. * patient with mental disorder and subnormal intelligence. * pregnant and lactating women. * patients who is having other surgical problem that needed other surgical procedure performed at the same setting.

Keywords: post-operative pain wound bleeding requiring exploration pth rln complication hypocalcaemia complication
a retrospective analysis of incisional hernia repair's postoperative recurrence

Conditions: Incisional Hernia; Recurrent Hernia

Summary: abstract purpose：a retrospective study was conducted among patients with incisional hernia in our hospital to analyse the factors associated with postoperative recurrence of abdominal wall incisional hernia. methods：patients with a diagnosis of incisional hernia obtained from our hospital's electronic medical record system were divided into primary incisional hernia group and recurrent incisional hernia group according to whether or not they had a recurrence after surgery. baseline information on these patients was recorded and statistically analysed after our review.


Eligibility criteria:
inclusion criteria: * inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary; surgical treatment for hernia repair at our hospital; all patients originating from outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of admission; and those with a well-established preoperative examination. exclusion criteria: * exclusion criteria: severe organ dysfunction (asa score of iv, v, vi); unconsciousness and poor cooperation with various preoperative examinations; correction of other types of abdominal hernia by perfect examination after admission; incomplete necessary information.
real-world use of hybrid closed loop in adolescents and young adults 15-25 years of age with type 1 diabetes

Conditions: Type1 Diabetes; Adolescents; Young Adults

Summary: the purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.

type 1 diabetes (t1d) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. however, these complications can be prevented by maintaining correct glycemic control, according to international guidelines. for the past few years, the arrival of new technologies as insulin pump and particularly continuous glucose monitoring (cgm) showed a significant improvement on metabolic control. nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets. at this time, hybrid closed loop, pairing continuous glucose monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.

Eligibility criteria:
inclusion criteria: * patient aged between 15 and 25 years old * type 1 diabetes since at least 1 year at the moment of instauring hcl * at least 3 months of hcl use exclusion criteria: * informed patient that have been opposed for their data collect

Keywords: type 1 diabetes hybrid closed-loop adolescents young adults hba1c tir
pemetrexed and temozolomide in treating patients with relapsed primary central nervous system lymphoma （pcnsl）

Conditions: Central Nervous System Tumors

Summary: in this trial, we will treat relapsed pcnsl with temozolomide, pemetrexed. our objective was to assess our treatment strategies' availability based on response rates, progression-free survival (pfs), median pfs, and toxicity.

the best reported outcomes of pcnsl treatment are high-dose methotrexate-based chemotherapy combined with whole-brain radiation therapy (wbrt). despite aggressive therapy, however, nearly 50% of patients will relapse within 24 months of diagnosis. furthermore, the application of high-dose methotrexate-based regimen is complex, needing be hydrated, alkalified and detoxified, and treatment-related toxicity mortality is severe. in an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 relapsed pcnsl patients who was fail in high-dose methotrexate-based chemotherapy. our objective is to assess our treatment strategies' availability based on response rates, progression-free survival (pfs), median pfs, and toxicity.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary cns lymphoma. * ecog (eastern cooperative oncology group) performance status of 0-1. * positive cerebrospinal fluid (csf) cytology or immunohistochemical diagnosis of csf monoclonality with or without measurable intracranial disease. * measurable (greater than 1 cm in diameter) tumor by ct scan or mri. * progressed during first-line chemotherapy and/or radiotherapy or relapsed after initial successful treatment. * no systemic lymphoma by ct scan of the chest, abdomen, and pelvis with contrast. * no leptomeningeal lymphoma by lumbar puncture for cns cytology/flow cytometry. * no ocular lymphoma by slit lamp examination. * must have adequate organ function as defined by the protocol: adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min; adequate hepatic function: bilirubin level ≤ 1.5 x uln, asat \& alst ≤ 1.5 x uln.adequate bone marrow reserves: neutrophil (anc) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl. * age \>/= 18 and \</= 75 years. * signed written informed consent prior to study entry. exclusion criteria: * patients with human immunodeficiency virus seropositivity and systemic lymphoma manifestation. * serious uncontrolled concurrent illness. * previous brain radiotherapy, systemic chemotherapy. * concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol. * any evidence of prior exposure to hepatitis b virus. * unable to comprehend the study requirements or who are not likely to comply with the study parameters. * pregnant (confirmed by serum or urine β-hcg) or lactating.

Keywords: lymphoma
evaluation of the sensei® laparoscopic tethered gamma probe for 99mtc-nanocolloid sentinel lymph node biopsy in prostate cancer

Conditions: Prostate Cancer

Summary: this study is a prospective, open label, single-arm study to examine the performance and safety of the sensei® laparoscopic tethered gamma probe in patients undergoing 99mtc-nanocolloid slnb for prostate cancer (pca) during rp and eplnd surgery. patients scheduled for rp and eplnd using the standard treatment pathways at each centre will have preoperative 99mtc-nanocolloid imaging. rp and eplnd will be conducted as standard of care, with slnb guided by the sensei® laparoscopic tethered gamma probe carried out after rp and prior to eplnd. the first 2 patients per site (n = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. subsequent patients will be evaluable for the pp population. the primary analysis of diagnostic performance will be performed using the pp population of patients with sln identified on preoperative imaging


Eligibility criteria:
inclusion criteria: * male subjects who are ≥ 18 years of age with histologically proven prostate cancer; and who have signed an informed consent form prior to any study related activity • subjects who are scheduled for radical prostatectomy with eplnd. exclusion criteria: * subjects who have received prior prostate cancer treatment or prior pelvic surgery; * subjects who have an existing medical condition that would compromise their participation in the study; * subjects with a history of hypersensitivity to 99mtc-nanocolloid or any excipients; * subjects who are unable to give voluntary, written informed consent to participate in this study; * subjects who are unable to understand this study and are not willing to complete all the study assessments.
platelet activation markers in pediatric cardiac surgery

Conditions: Coronary Disease

Summary: in this study the focus will be on correlating the levels of platelet activation markers (proteins that are released when blood cells are activated)to the duration of cardiopulmonary bypass, temperature during cardiopulmonary bypass and the weight of the patient.

this research is being done because we would like to learn more about platelet dysfunction in children undergoing cardiopulmonary bypass. it has been an established fact that cardiopulmonary bypass causes dysfunction in platelets. activation of platelets during cardiopulmonary bypass is implicated as being a major factor in causing platelet dysfunction. for all participants, approximately 3.15 ml of blood will be collected in special tubes called ctad tubes, before and after cardiopulmonary bypass (6.30ml in total). this amount of blood draw is well within the guidelines of nih (national institute of health). enzyme-linked immunosorbent assay (elisa) will be performed using this plasma to make quantitative assessment of platelet factor 4 and transforming growth factor beta.

Eligibility criteria:
inclusion criteria: * patients scheduled to have surgery involving cardiopulmonary bypass for congenital cardiac abnormalities. * age: newborn to 7 years * gender: male and female exclusion criteria: * emergency surgery * weight less than 3 kg * age greater than 7 years * patients with low platelet counts (\<100,000) * patients on medications that are known to interfere with platelet function such as prostacyclins, non-steroidal anti-inflammatory drugs, plavix. patients whose parents not willing to give consent

Keywords: pediatric cardiopulmonary bypass surgery cardiac surgery platelet platelet activation markers platelet factor4 transforming growth factor beta
establishment of a model for predicting the prognosis of hbv-related decompensated liver cirrhosis based on rfh-npt

Conditions: Liver Cirrhosis; Malnutrition

Summary: for all countries, chronic liver disease and liver cirrhosis is one of the important disease burdens. malnutrition is an important complication of liver cirrhosis, which always runs through the course of liver cirrhosis. according to a lot of scientific research evidence, as the consensus of experts all over the world, malnutrition in patients with liver cirrhosis is closely related to poor outcome. therefore, early and accurate identification of the risk of malnutrition is very important to improve the prognosis of patients with liver cirrhosis. the purpose of this study was to study the relationship between malnutrition-related indexes and prognosis in patients with liver cirrhosis. 2000 patients with liver cirrhosis were prospectively included, laboratory indexes related to malnutrition and other evaluation indexes were recorded, and long-term follow-up was made to observe the short-term and long-term prognosis of patients with liver cirrhosis. at the same time, a prognostic prediction model was established based on multivariate cox regression, and a series of in-depth studies and verification were carried out on this basis.

malnutrition is one of the most common complications associated with liver cirrhosis, which is more likely to occur in patients with decompensated liver cirrhosis. malnutrition will further lead to muscle loss, that is, the occurrence of myomyositis, which is an important cause of adverse outcome in patients with liver cirrhosis. it is associated with increased risk of death, portal hypertension-related complications, increased infection rates and longer hospital stays. at the same time, liver cirrhosis with portal hypertension leads to esophageal and gastric varices and intestinal mucosal edema, which affects the function of the digestive system and poses a greater challenge to the nutritional maintenance of patients with liver cirrhosis. therefore, timely nutritional assessment and early intervention decision-making on admission is an important aspect of clinical management of patients with liver cirrhosis. for the screening of malnutrition in patients with liver cirrhosis, the commonly used screening tools are mst, must, nrs-2002, rfh-npt and so on. for the screened high-risk population, further specific nutritional assessment is needed, there are four main types. the first is a diet-related assessment conducted by a professional dietitian. the second is the body composition analysis represented by muscle mass, such as bioelectrical impedance analysis (bia), ct, ultrasound and so on. the third is the functional evaluation, of which the more common are five-meter walking speed and grip strength test. the fourth is part of the comprehensive evaluation tools, represented by sga and rfh-sga.

Eligibility criteria:
inclusion criteria: * hospitalized patients with liver cirrhosis exclusion criteria: * patients who refuse the follow-up of outpatient department

Keywords: prediction malnutrition cirrhosis prognosis
owlet band observational study: observe the use of a new pregnancy tracker for expecting mothers

Conditions: Pregnancy; Anxiety; Stress

Summary: this is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.

the owlet band is a wellness product (similar to a fitbit), it is not designed to be a "medical device". the study involves women age 18 and older who are currently pregnant, at least 24 weeks' gestation or later, and who live in the usa. up to 8,000 pregnant women are expected to participate in the study. this study will involve review of owlet band data and participant responses to questionnaires throughout the study. the purpose of this research is to observe if using the new owlet band and the associated iphone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.

Eligibility criteria:
inclusion criteria: * must be at least 24 weeks pregnant with a singleton pregnancy * must be at least 18 years of age * must currently live in the united states * must have a compatible smartphone (apple ios version 13 or above) * able to read and understand english in order to provide informed consent and follow study instructions exclusion criteria: * na

Keywords: owlet pregnancy digital health wellness
a phase ii clinical study of hrs-1893 in non-obstructive hypertrophic cardiomyopathy

Conditions: Non-obstructive Hypertrophic Cardiomyopathy

Summary: this study mainly evaluated the safety and tolerability of hrs-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.


Eligibility criteria:
inclusion criteria: 1. age 18\~85 years old (including boundary value), male or female. 2. body mass index \< 35 kg/m2. 3. understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing. 4. female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study. 5. female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements. exclusion criteria: 1. known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy. 2. paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening. 3. history of syncope or sustained ventricular tachycardia within 6 months prior to screening. 4. those who have participated in the clinical trial of any drug or medical device within 3 months before screening. 5. other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
an observational study on teriflunomide-exposed pregnancies

Conditions: Multiple Sclerosis

Summary: primary objective: to evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies. secondary objective: to evaluate the potential effect of teriflunomide-exposure on other adverse pregnancy outcomes including any potential pattern of minor birth defects, spontaneous abortion, stillbirth, preterm delivery, small for gestational age at birth and at 1 year follow-up.

the total study duration per participant is approximately up to 2 years. * this is a prospective, observational study (no intervention), ie, patient registry. * the statistical analysis for the cohort study describe baseline characteristics in all three cohorts, and then will compare pregnancy outcomes in cohort 1 to cohort 2 and secondarily to cohort 3. * for the "registry" group, without comparisons, only descriptive statistics of pregnancy outcomes will be summarized.

Eligibility criteria:
inclusion criteria : * pregnant women who have provided an oral and/or written consent to enroll no later than 20 completed weeks from last menstrual period (lmp). * pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants (up to 1 year post birth). * pregnant women with a diagnosis of ms and teriflunomide exposure during pregnancy (cohort 1). * pregnant women with ms but not exposed teriflunomide during pregnancy (cohort 2). * healthy pregnant women who do not have a known diagnosis of ms and have no known exposure to a known human teratogen during pregnancy (cohort 3). exclusion criteria: * pregnant women who come in first contact with the project after prenatal diagnosis of a major structural defect (cohort 1, 2, 3). this does not apply to the "registry" group. * pregnant women who first come in contact with the project after 20 completed weeks' gestation (cohort 1, 2, 3). this does not apply to the "registry" group. * pregnant women who had previously enrolled in the study for a previous pregnancy (only 1 pregnancy, per woman, maybe registered) (cohort 1, 2, 3). this does not apply to the "registry" group. * retrospectively reported cases (cohort 1, 2, 3). this does not apply to the "registry" group. * pregnant women with exposures to teriflunomide commencing after the 12th week post-lmp (cohort 1). this does not apply to the "registry" group. * pregnant women who had previously been treated with teriflunomide if they had received any dose of the drug within 2 years prior to the index pregnancy and do not have documented blood levels below 0.02 mcg/ml prior to pregnancy (cohort 2). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.