Kornimate/medical-research-clean huggingface dataset:
pros in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated with pregabalin

Conditions: Low-Back Pain

Summary: the purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

rational and background : the care for low back pain associated with neuropathic pain is a problem often encountered in daily outpatient. and the care effectiveness has been frequently evaluated by the patients directly, because the pain would be felt by patients themselves. on the view of those, we decided to investigate the clinical treatment outcome of pregabalin or other analgesics medication for relief of pain and improvement of sleep interference and qols by patient-reported outcomes. research question and objectives : to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice. study design: this is an 8-week, multicenter prospective observational study. subjects who have chronic low back pain patients with accompanying lower limb pain (with a neuropathic component) and meet all other entry criteria are enrolled at baseline in the duration of study. the analgesic treatment is determined by the clinical judgment of the physician in charge of patient management. this therapeutic choice is not related to the decision to take part in the study. all enrolled subjects will be received with analgesic treatment. the study requires 3 visits at least, baseline/enrollment visit, week 4 visit and week 8 visit (or discontinuation).

Eligibility criteria:
inclusion criteria: 1. subject who received the enough study information and signed informed consent form. 2. subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle. 3. subject is male or female patient ≥18 years old. 4. subject who has complained low back pain for 3 months or more before visit 1. 5. subject who is refractory to prior analgesics for 3 months and more. 6. subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic. 7. subject whose pain numeric rating scale(nrs) ≥ 5 at baseline (based on recall over the past week) exclusion criteria: 1. subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason. 2. subject who has been already treated by pregabalin

Keywords: low-back pain neuropathic pain pregabalin
effectiveness and tolerability of an oral nutritional supplement (preop booster) given before surgery

Conditions: Rectal Tumors

Summary: the aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (preop booster), given to rectal tumour patients prior to low anterior resection.


Eligibility criteria:
inclusion criteria: * rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (apr) * preoperative radiotherapy (5x5 gy) or chemoradiation * loop ileostoma or colostoma; exclusion criteria: * severe malnutrition * severe renal insufficiency * diabetes mellitus i or ii * concomitant thyroid medication * corticosteroids * diuretic medication and antihypertensive medication * known or suspected allergy to any component of the investigational product(s)

Keywords: enteral nutritional regimen prior to surgery
maternal risk factors for autism spectrum disorders: a case-control approach

Conditions: Autism; Autism Spectrum Disorder; Autistic Disorder; Pregnancy Related; Diet, Healthy; Diet; Deficiency; Folate Deficiency; Folic Acid Deficiency; Folic Acid Overdose

Summary: new research suggests that about 1 in 8 children may be diagnosed with an autism spectrum disorder (asd) in the united states. this could be due to several reasons which remain unknown. this study invites mothers who have given birth to children in the united states to share their experiences with diet and supplementation during pregnancy. the purpose of this study is to understand the role of a mother's diet, social standing, and supplementation with folate or folic acid may have on her child's future development of autism. comparisons will be made between mothers of children who have a child with an official asd diagnosis from a clinician to mothers of children without an asd diagnosis. findings from this study can be used to help identify risk factors for asd risk.

autism spectrum disorders (asd) are a broad range of conditions characterized by social skills, repetitive behaviors, speech, and nonverbal communication challenges. current prevalence estimates assert that 2.3% of children aged eight years or older live with an asd, an increase from 1.5% in 2012. estimates suggest that 1 in 44 children will be diagnosed with asd. a child diagnosed on the spectrum faces several challenges and may require support from a caregiver, possibly across the lifespan. asd etiology remains elusive, but research suggests there may be a link to genetic, environmental, and dietary risk factors while in-utero. further evidence suggests a folate/folic acid link during the peri-conceptual period. prior folate/folic acid studies suggest a u-shaped relationship between maternal multivitamin supplementation. high maternal plasma folate and b12 levels are associated with the risk of asd. this study aims to apply a case-control approach to understand the role of folate/folic over- or under-supplementation, maternal sociodemographics, and diet during pregnancy on asd risk.

Eligibility criteria:
inclusion criteria: * mothers 18 years or older with a child aged 3-12 years who have an official asd diagnosis from a clinician * mothers 18 years or older of children aged 3-12 years who do not have an asd diagnosis so comparisons can be made between groups exclusion criteria: * mothers outside of the united states * mothers less than 18 years of age * mothers who have not given birth to their child or who used a surrogate

Keywords: diet maternal diet autism pregnancy perinatal folate folic acid
a pilot study to evaluate an intervention for gestational weight gain

Conditions: Pregnancy Related; Weight Gain; Maternal

Summary: the purpose of this study is to enable the investigator to conduct proof of concept work related to the feasibility, acceptability, initial efficacy and mechanisms of action (focusing on maternal and infant modifiable factors) for a novel self-management intervention for pregnant women.

this proposed study aims to adapt intervention to address excessive gestational weight gain and psychosocial functioning among a socioeconomically and racially diverse sample of pregnant women .additionally, data on behavioral mechanisms associated with self-regulatory capacity, such as impulsive control and the ability to delay rewards, that may be linked to self-regulation during pregnancy are needed to support future interventions. in this study, the investigators will develop and adapt an intervention (self-management around the reproductive transition; smart) that addresses maternal weight, stress, and mood, and document the feasibility, acceptability and initial efficacy of the smart intervention.

Eligibility criteria:
inclusion criteria: * at least 14 years of age * less than 16 weeks gestation * english speaking * singleton pregnancy * receiving care at magee-womens hospital, latterman family health or other upmc practices that provide obstetric care exclusion criteria: * preexisting diabetes * use of medications known to affect weight * enrolled in current weight management programming * history of weight loss surgery * women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate care
trigen sureshot™ distal targeting system study

Conditions: Femoral Shaft Fracture

Summary: the objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the trigen sureshot distal targeting system versus standard nailing instrumentation.

the trigen sureshot™ distal targeting system was designed to be an intraoperative image-guided localization system to aid with drill positioning for screws during intramedullary nailing distal interlocking. it is hypothesized that this system will aid in identification of the distal holes leading to reduced exposure to radiation. the sureshot system provides information to the surgeon that is used to place surgical instruments utilizing electromagnetic tracking data obtained intraoperatively. it is indicated for long bone fractures treated with intramedullary nailing in which the use of stereotactic surgery may be appropriate. the hypothesis is that using the trigen sureshot™ distal targeting system will allow accurate distal locking while effectively decreasing the amount of radiation exposure compared to the standard instrumentation process.

Eligibility criteria:
inclusion criteria * unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate. * subject is between 18-80 years of age. * subject is skeletally mature * subject is of legal age and capable of providing legal consent. * subject is suitable for current intramedullary nailing procedure * subject willing to accept randomization either to the trigen sureshot distal targeting system or trigen standard instrumentation. exclusion criteria * femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate. * fracture with vascular injury (gustilo type iiic) requiring repair * open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement). * fracture of the metaphyseal distal femur with intraarticular comminution * known pathological fracture * subject is a prisoner * operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures * subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator. * contralateral femoral shaft fracture
the alteration of hdl protein composition in patients with coronary heart disease before and after statins treatment

Conditions: Coronary Heart Disease

Summary: the protein composition of hdl is complicated. the investigators have identified 40 distinct proteins associated with hdl by proteomics technology, and these proteins have been confirmed to be related to the function of anti-inflammation, anti-oxidation, improvement of endothelial function, inhibition of thrombosis and so on. and the investigators also found that the levels of some proteins in hdl changed in patients with coronary heart disease, compared with the healthy control group. so, this study is to conduct in the two following aspects: enlarge the sample size to verify the preliminary results to find new research ideas of pathogenesis and biomarkers for coronary heart disease; and study the changes of hdl protein composition in patients with coronary heart disease before and after statins treatment using proteomics technology in order to find the mechanism of statins pleiotropic effects and indicators for evaluating the treatment effectiveness.


Eligibility criteria:
inclusion criteria: angiographic evidence of coronary artery disease, and no lipid-lowering therapy in the past 2 weeks for treatment group; exclusion criteria: * use of potent lipid-lowering therapy for more than 2 weeks; myocardial infarction or percutaneous coronary intervention in the past 6 months; severe congestive heart failure, valvular heart disease and other non-coronary heart disease cardiovascular disease; liver or renal dysfunction; connective tissue disease; infection, malignancy; and other conditions that physicians considered inappropriate to the study.
treatment for symptomatic peripheral neuropathy in patients with diabetes

Conditions: Diabetic Neuropathies; Diabetes Mellitus, Insulin-Dependent; Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of this protocol is to determine if an investigational drug known as ly333531 is effective in treating nerve malfunction in diabetes.


Eligibility criteria:
inclusion criteria: * patients must have type i or type ii diabetes mellitus. * have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months. * has a hba1c less than or equal to 12%. patients with hba1c greater than 9% must be insulin therapy. * must be 18 years or older. * be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study. exclusion criteria: * history of significant liver problems. * have poor kidney function. * drink an excess of alcohol or abuse drugs. * have recently participated or currently participating in a medical study in which you receive an experimental drug. * are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.
a comparison of the control of asthma provided by symbicort® turbuhaler® versus symbicort® turbuhaler® plus pulmicort® turbuhaler® plus terbutaline turbuhaler®

Conditions: Asthma

Summary: the purpose of this study is to determine if a flexible dose of symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of symbicort with additional glucocorticosteroids added.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma for at least 6 months * prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one exclusion criteria: * respiratory infection affecting asthma within 30 days prior to study * intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study * any significant disease or disorder that may jeopardize the safety of the patient
gastroprotected superoxide dismutase in combination with uvb vs placebo and uvb for treating vitiligo.

Conditions: Vitiligo

Summary: the role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. the objective of the study is to compare the association of glisodin (a gastro-protected superoxide dismutase) and nb-uvb to nb-uvb and placebo for treating vitiligo. adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included. the main criteria of evaluation will be the ves score at 6 months compared to baseline in both groups.


Eligibility criteria:
inclusion criteria: * vitiligo * vitiligo, sod, uvb * non-segmental vitiligo with bsa\>5% exclusion criteria: * criteria of non-inclusion * segmental or mixed vitiligo * pregnancy * vitiligo lesions localized only on hands and feet * immuno-suppressive drugs * corticosteroids * photosensitive drugs * photodermatosis * personal history of skin cancer * allergy to gluten
study to evaluate the safety and preliminary efficacy of idct, a treatment for symptomatic lumbar intervertebral disc degeneration

Conditions: Degenerative Disc Disease

Summary: the purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of idct (discogenic cells + sodium hyaluronate vehicle) and two controls (saline, sodium hyaluronate vehicle) in subjects with chronic low back pain due to degenerative disc disease (ddd) at one lumbar level from l3 to s1.

this is a phase i, first-in-human, randomized, double-blind, vehicle and placebo-controlled, parallel-group, multi-center study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (\>6 months) and unresponsive to conservative therapy for at least 3 months. the study will compare single intradiscal injections of high and low dose idct with two control groups (saline, sodium hyaluronate). 8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 52, week 72 and week 104. the subject will be assessed for safety and efficacy utilizing vas and odi questionnaires alongside radiographic evaluations. the study will have a 1 year follow-up and a 1 year extension period (total 2 years).

Eligibility criteria:
inclusion criteria: the subject must have: 1. diagnosis of early to moderate degenerative disc disease (ddd), modified pfirrmann grade 3-7. 2. chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care. 3. low-back pain of 40 to 90 mm on the vas and odi score of 30 to 90. exclusion criteria: the subject is excluded if he/she has: 1. symptomatic involvement of more than one lumbar disc. 2. other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc. 3. fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc. 4. evidence of dynamic instability on lumbar flexion-extension radiographs. 5. grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or type iii modic changes around the target disc. 6. clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology. 7. clinical suspicion of facet pain as primary pain generator. 8. subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection. 9. patients who are deemed unsuitable for clinical study participation by the investigator.

Keywords: lumbar disc degeneration low back pain intervertebral disc degeneration
palliative morphine with or without concurrent modafinil

Conditions: Cancer; Pain Palliation; Excessive Sleepiness

Summary: oral morphine is often utilized as a convenient and effective method of achieving palliation of pain in the terminally ill cancer patients. however, at effective doses, a majority of patients do experience an undue amount of excessive sleepiness. given the generally low expected survival periods among this patient population, the fact that morphine causes the patient to spend a significant period of remaining life in sleep, is often unacceptable for the patients and their families. given the proven benefits of modafinil in conditions characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the investigators designed a prospective placebo controlled randomized trial by the addition of modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after randomization.


Eligibility criteria:
inclusion criteria: * diagnosed and confirmed malignancy * able to orally consume tablets * blood pressure: systolic \<144mmhg; diastolic \<92mmhg * normal blood sugar * no active systemic infections * consenting * oral morphine being consumed as a part of terminal symptom palliation exclusion criteria: * candidates receiving oral morphine for temporary pain management, such as being potential candidates for radical curative approaches in the future * poor performance status (karnofsky performance status score \<50) * prior history of hypertension, diabetes, tuberculosis, epilepsy * prior history of psychiatric and neurological illness

Keywords: morphine palliation cancer hospice sleepiness modafinil
study to evaluate the effectiveness of abc+3tc +efv in once-daily regimens versus klt in twice-daily regimens in naive hiv patients

Conditions: HIV Infections

Summary: to evaluate the therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.

the efficacy of the highly active antiretroviral treatment (haart) has been demonstrated in several clinical trials. even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice. adherence to haart treatment is critical to obtain lasting viral suppression. thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication. it has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves. the combination of abacavir 600 mg + lamivudine 300 mg qd in a single tablet is a novel dosage that may help increase treatment adherence.

Eligibility criteria:
inclusion criteria: 1. age\> 18 years. 2. hiv-1 infected patients. 3. naive to antiretroviral treatment. 4. candidate patient for initiating antiretroviral treatment\*. 5. subject able to follow the treatment period. 6. signature of the informed consent. 7. women may not be fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use two contraceptive methods during the study, one of them at least being a barrier method. exclusion criteria: 1. hepatic tests \> 5 times above normality. 2. pregnancy or breastfeeding. 3. treatment for opportunistic infections or neoplasms associated with the stable hiv over the last 6 weeks. 4. suspected or documented resistance to any of the investigational drugs. 5. known allergic hypersensitivity to any of the investigational drugs or any similar drug. 6. subjects with abusive consumption of alcohol or illegal drugs. 7. patients participating in another clinical trial. 8. terminal renal disease.

Keywords: simplification therapy efficacy safety virological effectiveness immunological effectiveness hiv
accuracy of pulse oximeters with profound hypoxia

Conditions: Hypoxemia

Summary: the goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. the study is designed in accordance with iso 80601- 2-61,2ed:2017-12 \& 2018-02.


Eligibility criteria:
inclusion criteria: - exclusion criteria: pregnancy -

Keywords: hypoxia pulse oximetry