Kornimate/medical-research-clean huggingface dataset:
effect of maternal smoking on neonatal lung function

Conditions: Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease

Summary: to determine factors, including maternal cigarette smoking and acute respiratory illness, influencing infant lung function at birth and up to five years of age.

background: over the past four decades, a significant research effort has been devoted to the understanding of the epidemiology and pathophysiology of chronic obstructive airways disease (copd) in adult life. epidemiologic studies uniformly have identified cigarette smoking as the predominant risk factor for the occurrence of copd. other factors such as socioeconomic status, environmental pollution, occupational exposures, and inherent genetic susceptibility have been observed to have very limited roles as risk factors. a number of studies have suggested that postnatal maternal cigarette smoking has a measurable effect on lung function in children. one longitudinal analysis of this problem in children 5-19 years of ages identified significant effects on the growth of fev1 and forced expiratory flow between the 25th and 75th percent volume points (fef25-75) of the volume-time curve. these investigators, however, pointed out that the effects which they observed could have resulted from the in utero consequences of maternal smoking during pregnancy and/or from exposure to factors such as severe respiratory illnesses which have been documented to occur with increased frequency early in infancy and were not measured by the study. design narrative: pregnant women were identified during the first trimester and followed monthly. assessments were made of their smoking habits, urinary cotinine measurements, general medical condition, and status of pregnancy. within two weeks of birth the infants were evaluated with partial forced expiratory flow-volume curves and measurement of passive respiratory system compliance and resistance. measurements were repeated at intervals until age five. babies were also observed regularly for respiratory illness experience, passive exposure to cigarette smoke, and general respiratory health. the study helped to elucidate: the effect of maternal cigarette smoking on lung function at birth and development of function at five years; the effects of postnatal factors on lung development; the extent to which the reported increased frequency of respiratory illness in infants of smoking mothers resulted from in utero exposure to tobacco smoke products or postnatal passive smoking. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
internal compartment knee osteoarthritis: odra (orthosis distraction and rotation for osteoarthritis) made-to-measure hinged knee brace versus usual care.

Conditions: Knee Osteoarthritis

Summary: this is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups: * 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months. * 60 patients in the "odra" group: these patients will wear the odra brace for 12 months in addition to their usual care. they will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down. the distribution of patients in the groups will be randomized. for this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * knee osteoarthritis (defined according to american college of reumatology criteria): * radiological stage ii, iii or iv according to the kellgren and lawrence (kl) classification documented by a radiological examination in the previous 12 months. * predominantly affecting the internal compartment (internal kl stage greater than external kl stage) and symptomatic with a pain visual analogue scale \> 40/100 on the target side (side with the most symptomatic disease) * patients who have provided written consent * patients able to understand simple instructions, to read, write, and to give informed consent * patients with national health insurance cover exclusion criteria: * severe venous insufficiency in the lower limbs * history of deep venous thrombosis in the lower limbs * inflammatory flare of knee osteoarthritis (synovial effusion) on the target side * person over 18 under guardianship or unable to provide consent * pregnant or breast-feeding women
effect study of clinical outcomes of traditional chinese medicine to advanced gastric cancer by propensity score

Conditions: Gastric Adenocarcinoma

Summary: the researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.

the purpose of this project is to further evaluate the role of traditional chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study. the patients who suffer from advanced gastric cancer often have a very short time survival . their total survival time is only 4.3 months after the best supportive care. at present palliative chemotherapy is still the main method for advanced gastric cancer . in recent years, the results of international multi center phase iii clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time. in china, the clinical curative effect of traditional chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. some reports with large samples of clinical research show that the traditional chinese medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer. real world study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. the observational study of registry (registry study in clinical practice) is particularly widely used. clinical practice of traditional chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. there must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in china.

Eligibility criteria:
inclusion criteria: * gastric adenocarcinoma without operation or recurrence after operation or metastasis * diagnosed within three months * kps score≥60 * expected survival time was above 3 months * hb ≥80g/l 、wbc≥4.0×109/l、 n ≥2.0×109/l 、pla ≥80×109/l * normal function with heart 、kidney and liver exclusion criteria: * not gastric adenocarcinoma * simultaneous diagnosis with other malignant tumor * participate in clinical trials of new drugs not listed in china * combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications
neuronal inertia in propofol anesthesia

Conditions: General Anesthesia; Propofol Pharmacodynamics; Propofol Target Controlled Infusion; Loss of Consciousness and Recovery of Consciousness; Propofol Plasma Concentration

Summary: loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. this eventual difference between dose response curves for loss of consciousness (loc) and for recovery of consciousness (roc) beyond hysteresis has received the name of neuronal inertia. we performed a volunteer-study comparing loc and roc curves during a slow, steady-sate, stepped target controlled infusion of propofol. our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between loc and roc, demonstrating the existence of neuronal inertia.

loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. this eventual difference between dose response curves for loss of consciousness (loc) and for recovery of consciousness (roc) beyond hysteresis has received the name of neuronal inertia. we performed a volunteer-study comparing loc and roc curves, during a slow, steady-sate, stepped target controlled infusion of propofol using schnider's pharmacologic model. our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between loc and roc, demonstrating the existence of neuronal inertia.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists status i or ii age \>18 years fasted at least 8 hours bmi\<30 exclusion criteria: * any known adverse reaction to propofol administration soy or egg-protein allergy psychotropic use (illegal of medically indicated)

Keywords: neuronal inertia loss of consciousness propofol pharmacodynamics bispectral index anesthesia, general/pharmacology
the efficacy of botulinum toxin in disabling multiple sclerosis (ms) tremor

Conditions: Multiple Sclerosis; Tremor

Summary: the incidence of tremor in multiple sclerosis (ms) has been estimated to affect up to 2/3rds of patients. over half of the tremors involve the upper limb and frequently lead to further disability. medical treatment of ms tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. the investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to botulinum toxin injection therapy. aims: 1. the investigators aim to determine the efficacy of commonly used doses of botox on the patients with symptomatic unilateral or bilateral arm tremor due to ms; and any side effects associated with this treatment.


Eligibility criteria:
inclusion criteria: * relapsing-remitting ms or secondary progressive ms according to the mc donald criteria * age 18-80 years of age * competent to understand and sign informed consent * presence of symptomatic head and/or limb tremor exclusion criteria: * treatment with botulinum toxin type a of any brand within the 4 months prior to enrollment * a known contraindication to botox injection * pregnancy
a phase ii study in patients with moderate to severe ards due to covid-19

Conditions: Covid19

Summary: this is a phase ii multi-center, double-blind, placebo-controlled, randomized study in patients with moderate to severe lung injury due to covid-19 or other potential viral and bacterial pathogens.

this is a phase ii multi-center, double-blind, placebo-controlled, randomized study in patients with moderate to severe lung injury due to covid-19 or other potential viral and bacterial pathogens. the study will enroll up to 40 patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (lrs) plus standard treatment. on the treatment (day 0) cohort 1 will receive a single iv dose of hmscs cohort 2 will receive lactated ringer's solution. a second dose of mscs or lrs will be given to cohort 1 or cohort 2, respectively on day 3 after the first dose. patients who discontinue the study before month 1 for reasons other than adverse events will be replaced.

Eligibility criteria:
inclusion criteria: * laboratory-confirmed diagnosis of covid-19 \<= 14 days prior to randomization * the presence of moderate to severe acute respiratory distress syndrome (ards) as defined by the berlin definition: 1. bilateral chest radiograph infiltrates. 2. pao2:fio2 ratio of less than 200. 3. absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema) * absence of moribund state that would indicate imminent demise and poor chance of survival. exclusion criteria: * females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with a positive pregnancy test on screening day will be excluded. * breastfeeding mothers * patients on ecmo * receiving concurrent treatment with an investigational agent in a clinical trial. * exception: use of covid-19 convalescent plasma is permitted. * more than 72hrs on mechanical ventilation before randomization * receiving concurrent investigational vaccine
comparison of clinical results of two cementless femoral stem

Conditions: Osteoarthritis, Hip

Summary: in the present study, two types of cementless femoral stem- uts stem and utf-reduced stem- were utilized in total hip arthroplasty. due to the design for proximal femur fixation, both femoral stems could prevent stress shielding around the implant, further preventing osteolysis. the difference between both femoral stems is the length, in which uts stem is 20% shorter than utf-reduced stem. the clinical outcomes of both femoral stems will be compared. both femoral stems are expected to have equally good radiologic outcome and clinical performance.

total hip arthroplasty (tha) is a common orthopedic procedure aimed at improving joint function and alleviating pain in patients with hip joint degeneration. however, the phenomenon of stress shielding-whereby the mechanical properties of the prosthesis lead to reduced load transmission to the surrounding bone-can compromise long-term outcomes. in particular, uncemented tha designs are susceptible to stress shielding, potentially resulting in bone resorption and implant loosening. to address this challenge, the study focuses on optimizing femoral stem fixation within the proximal femur in two specific stem designs: the uts and the utf reduced stem. these stems are strategically designed to enhance load transfer while minimizing stress shielding effects. a total of 60 patients who are undergoing total hip arthroplasty at linkou chang gung memorial hospital will be recruited, including 30 patients in the "uts" group and 30 patients in the "utf-reduced" group.the clinical assessments including success rate of prosthesis, numerical rating scale (nrs) for pain, harris hip score (hhs), medical outcome study short form-36 (sf-36) and : dual-energy x-ray absorptiometry (dexa) scanning for bone mineral density monitoring.

Eligibility criteria:
inclusion criteria: 1. patients who receive total hip arthroplasty with either a uts femoral stem or a utf-reduced femoral stem after june, 2020 2. patients who have not received total hip arthroplasty in the past exclusion criteria: 1. patients who are unable or unwilling to return for follow-up 2. patients who suffer from mental disorders

Keywords: total hip arthroplasty total hip replacement femoral stem
double-blind, placebo-controlled study of two doses of epa-e in patients with non alcoholic steatohepatitis (nash)

Conditions: Steatohepatitis

Summary: this is a controlled study to determine the effectiveness and safety of ethyl icosapentate (epa-e) in the treatment of adult patients with non-alcoholic steatohepatitis (nash).

this is a phase ii, double-blinded, placebo-controlled study to investigate the safety, efficacy, and pharmacokinetic profile of two doses of epa-e in adult subjects with nash. subjects are required to have a liver biopsy with proven nash in the 6 month period prior to screening. up to 70 subjects will be enrolled into each treatment arm in a 1:1:1 ratio, for a total of 210 subjects. subjects will be stratified at randomization by presence or absence of diabetes. duration of treatment is 12 months.

Eligibility criteria:
inclusion criteria: * diagnosis of definite nash * patients with diabetes taking stable doses of anti-diabetic agents are eligible * no significant concomitant medical illness exclusion criteria: * diagnosis of cirrhosis. * serum alt \> 300 u/l * use of drugs associated with steatohepatitis * use of the following anit-nash agents: 1. vitamin e \> 60 iu per day 2. omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (pufa)-containing supplements \> 200 mg per day 3. thiazolidinediones (e.g. pioglitazone) * use of non-stable doses of the following anti-nash agents: hmgcoa reductase inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (udca), taurine, betaine, n-acetylcysteine, s-adenosylmethionine (sam-e), milk thistle, anti-tnf therapies, or probiotics. * other liver disease

Keywords: omega-3 fatty acids alanine transaminase triglycerides lipids epa ethyl-epa ethyl icosapentate non alcoholic steatohepatitis non alcoholic fatty liver disease fatty acids
phase 2 study of duvelisib in previously treated patients with chronic lymphocytic leukemia /small lymphocytic lymphoma

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is a multi-center, single-arm, open-label, phase 2 study of duvelisib, an orally bioavailable dual inhibitor of pi3k-δ,γ, in patients with cll/sll who have previously been treated with ibrutinib or another bruton's tyrosine kinase inhibitor (btki) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age. 2. diagnosis of cll or sll. 3. received at least one prior anti-cancer therapy for cll or sll. 4. previous exposure to btki and meet at least one of the criteria below: 1. progressive disease (pd) while receiving or within 6 months after completing btki therapy. 2. discontinued a btki therapy due to btki treatment- related intolerance. 5. measurable disease with a lymph node or tumor mass \> 1.5 cm in at least one dimension. 6. eastern cooperative oncology group (ecog) performance status ≤ 2. 7. resolution of toxicities due to prior btki therapy to acceptable level. 8. willingness of male and female patients to use medically acceptable methods of birth control. 9. willing and able to participate in all required study evaluations and procedures. exclusion criteria: 1. richter's transformation or prolymphocytic leukemia 2. uncontrolled autoimmune hemolytic anemia or thrombocytopenia 3. received prior transplant 4. experienced pd or serious adverse events on a prior phosphoinositide-3-kinase (pi3k) inhibitor 5. known central nervous system involvement by cll/sll

Keywords: leukemia lymphoma refractory relapse
randomized controlled double blind trial of short vs long acting dihydrocodeine in chronic non-malignant pain

Conditions: Pain

Summary: we wish to compare the effect of long acting vs short acting opioids in chronic non-malignant pain. the study opioid is dihydrocodeine continus and dihydrocodeine 30 mg tablets. we measure pain relief, health related quality of life, sleep, breakthrough pain and depression with validated questionnaires to compare the two treatment arms. hypothesis: the pain relief will be better and more stable with long acting opioids. quality of sleep, breakthrough pain and quality of life will also be improved with long acting dihydrocodeine.


Eligibility criteria:
inclusion criteria: * chronic pain * use 5-10 p.forte every day for the last two weeks * 18-75 years. exclusion criteria: * cancer * hepatic failure * severe mental disorders * history of known substance abuse.

Keywords: dihydrocodeine opioids, long acting opioids, short acting chronic pain non-malignant pain
efficacy of lipid-containing artificial tears in the treatment of dry eye

Conditions: Dry Eye Disease; Dry Eye; Dry Eye, Evaporative

Summary: this clinical study involves patients with dry eye disease (ded) who are visiting an ophthalmology outpatient clinic. eligible participants must have an ocular surface disease index (osdi) score ≥14 and \<50, and at least one positive diagnostic test: tear break-up time (tbut) \<7 seconds, schirmer i test \<10 mm/5 min, or positive corneal staining based on the oxford grading scale. at baseline, tear film thickness will be measured using pentacam imaging. participants will then receive proluxx eye spray, applied four times daily for 28 days. after this treatment period, a follow-up examination with all baseline assessments will be repeated.

this clinical trial aims to evaluate the effects of proluxx artificial tear spray in patients diagnosed with dry eye disease (ded). participants are recruited from an ophthalmology outpatient clinic and must have had symptoms of ded for at least 3 months. inclusion criteria include an ocular surface disease index (osdi) score between 14 and 50 and at least one positive diagnostic test: tear break-up time (tbut) \<7 seconds, schirmer i test (≤10 mm/5 min), or positive corneal staining based on the oxford grading scheme. in addition, participants must not have used artificial tears for at least two weeks prior to enrollment, even if they were previously on such therapy. exclusion criteria include the use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months. the goal of the study is to classify patients based on ded subtype: hyposecretory, evaporative, or mixed. the study will analyze clinical parameters at baseline, including osdi score, tbut, schirmer test, oxford staining, cptft (central precorneal tear film thickness) measured by pentacam, bcva (best corrected visual acuity), intraocular pressure (iop), and risk factors. participants will use proluxx artificial tear spray four times daily for 28 days. after the treatment period, all baseline assessments will be repeated. the study will compare clinical findings from day 0 and day 28 to assess changes in ocular surface health and tear film quality following therapy.

Eligibility criteria:
inclusion criteria: * ocular surface disease index (osdi) score between 14 and 50 and at least one positive diagnostic test: tear break-up time (tbut) \<7 seconds, schirmer i test (≤10 mm/5 min), or positive corneal staining based on the oxford grading scheme. in addition, participants must not have used artificial tears for at least two weeks prior to enrollment, even if they were previously on such therapy exclusion criteria: * use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months

Keywords: dry eye artificial tears