Kornimate/medical-research-clean huggingface dataset:
a study of tocilizumab and methotrexate in combination or as monotherapy in treatment-naïve patients with early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. anticipated time on study treatment is 2 years, and target sample size is 300.

multi-center, randomized, double-blind, placebo-controlled (double placebo) three-arm parallel group, comparative study. patients were randomized in a 1:1:1 ratio to one of the following treatments: * tcz 8 milligram (mg)/kilogram (kg) + mtx (group i: tcz+mtx) * tcz 8 mg/kg + placebomtx (group ii: tcz+placebo) * mtx + placebotcz (group iii: mtx+placebo) randomization was stratified by participating center and baseline disease activity score, scoring 28 joints (das28) level (\<5.1 vs. ≥5.1). patients were evaluated every 4 weeks and at each visit a decision on dosage changes was made based on efficacy parameters (das28) and occurrence of adverse events (aes). patients received mtx/placebomtx in climbing dosages. hydroxychloroquine (hcq) was added when remission was not reached with the maximum tolerable dosage (mtd) of mtx/placebomtx. if after 12 additional weeks remission was not reached, hcq was stopped and replaced by standard of care therapy (in group i) or placebo therapy was replaced by the corresponding verum resulting in tcz+mtx combination therapy (in groups ii and iii). in case remission was reached, mtx/placebomtx and tcz/placebotcz had to be decreased. patients were followed for a maximum of 24 months

Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * early rheumatoid arthritis (disease symptoms \<1 year) according to acr criteria * disease activity das28 \>2.6 * body weight \</=110kg, bmi \</=36 exclusion criteria: * rheumatic autoimmune disease other than ra * current inflammatory joint disease other than ra * previous treatment with any dmard or biologic drug used in the treatment of ra * intra-articular, parenteral or oral glucocorticoids used for the arthritis

Keywords: treat-to-target, tight control, strategy study, tcz, mtx
effects of bobath technique versus task oriented training on gross motor function in cerebral palsy children

Conditions: Cerebral Palsy

Summary: cerebral palsy is the most familiar motor disorder of childhood. consistent with the results of recent scientific researches bobath approach in physical restoration of youngsters with cerebral palsy promotes formation of motor skills. improvement in mobility has been primary goal in treatment of cp. there are only a few studies available within the efficacy of "task-oriented training" to improve gross motor function in cp child. hence, this comparative study is undertaken to gauge the effect of task-oriented training verses neurodevelopmental training on gross motor function in cerebral palsy child. objective of this study is to find out the effects of bobath technique and task training on gross motor function in cerebral palsy children. a convenient sample of cerebral palsy children fulfilling inclusion and exclusion criteria, from physiotherapy opd of allied \& dhq hospitals of faisalabad will be considered. informed consent will be taken from all patient's caregivers. patients will be divided into two groups through chit draw randomization. age of children will be 3 years to 10 years without discrimination of gender. group a will receive bobath training and group b will receive task training. data will be collected through gross motor function measure (gmfm-88). data analyses using spss version 25 as a statistical tool.


Eligibility criteria:
inclusion criteria: male and female patient age 3- 10 years. diagnosed with cp by a specialist. children with cp gmfcs level i-ii. types of cerebral palsy (spastic diplegic, quadriplegic, hemiplegic,) without severe abnormalities cognitive ability should be sufficient that he/she follow simple verbal commands and instructions during training exclusion criteria: patient with fixed contracture patient receiving treatment that affects motor function such as botulinum injection and orthopedic surgery -
effectiveness of a hydrophobic dressing for microorganisms' colonization and infection control of vascular ulcers

Conditions: Venous Leg Ulcer; Bacterial Infections; Chronic Ulcer of Skin of Lower Limb Nos

Summary: this study will determine the effectiveness of cutimed® hydrophobic dressings against aquacel® silver dressings in bacterial colonization of vascular ulcers.

chronic wounds with torpid evolution are a real challenge for health services today. in the case of venous ulcers, it is estimated that more than 80% of these wounds may be colonized or infected by bacteria, which is associated with its chronification by delaying the healing process. the most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. in addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments. in this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as cutimed®.

Eligibility criteria:
inclusion criteria: adult patients with chronic venous vascular ulcer located in lower limbs with signs of critical colonization, according to the criteria of lazareth and moore, which imply the presence of at least 3 of the following five: 1. severe pain during dressing change 2. perilesional edema. 3. local edema. 4. unpleasant smell. 5. abundant pus 6. microbial colonization higher than 100000 cfus exclusion criteria: * patients younger than 18 years old. * venous ulcer with signs of infection which requires antibiotic therapy * venous ulcers that do not meet lazareth and moore criteria * arterial ulcers. * patients with type i or type ii diabetes. * patients with immunosuppression of any etiology or in immunosuppressive treatment or with nsaids. * patients with rheumatoid arthritis in the acute phase. * patients with dermatitis prior to the appearance of the ulcer. * patients with neuropathy or lack of sensitivity of any etiology. * patients who, for local or systemic clinical reasons, will need to initiate antibiotic therapy.

Keywords: venous ulcer leg injuries bacterial infections
effect of local endometrial injury on pregnancy outcomes during ovulation induction cycles

Conditions: Asymptomatic Diseases

Summary: the aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.

patients will be randomized using a list of computer generated random sample into two groups: group 1: couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate. group 2: couples who will undergo ovulation induction with clomiphene citrate. the drug chosen for ovulation induction in both groups will be clomephine citrate. timing and technique of endometrial sampling: timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. technique: this will be done using the pipelle method (williams et al., 2008). the procedure is as follows: 1. vaginal speculum to expose the uterine cervix then sterilization by saline. 2. the piston positioned at the extreme distal end of the sheath then the pipelle is inserted gently through the cervical canal into the cavity of the uterus. 3. while holding the sheath in position with one hand, the other hand rapidly pulls the piston firmly and without interruption. 4. a negative pressure within the sheath will draw the tissue into the curette opening at the distal end of the sheath and captures the separated tissue within its lumen.

Eligibility criteria:
inclusion criteria: 1. male partner should have a normal semen count and motility according to world health organization criteria (murray et al., 2012). 2. primary, secondary or unexplained infertility for at least one year. 3. failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles. 4. age varies from 20-35 years with at least one year of infertility. 5. body mass index between 19-30 kg/m2. 6. day 2 serum fsh\< 12 iu/ml. 7. normal uterine cavity on hystrosalpingography. 8. at least one patent tube of normal appearance on hsg. 9. no previous attempts of intrauterine insemination (iui) or in vitro fertilization (ivf). exclusion criteria: 1. infertility due to tubal factor or male factor. 2. intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope. 3. hypogonadotrophic hypogonadism.
clinical response and toxicity of hypo-fractionated chemoradiotherapy in cervix cancer

Conditions: Cervix Uteri Cancer

Summary: uterine cervix cancer can be treated definitively with concurrent chemoradiation (external beam radiotherapy and chemotherapy) followed by high dose rate brachytherapy. treatment duration can be shortened by increasing the dose per fraction of treatment which can reduce costs and patient exposure. the aim of our study is to determine the non-inferiority of hypofractionated radiotherapy compared with conventional treatment.

in this study we aim to determine if clinical response and toxicity of radiotherapy hypofractionation is non-inferior to the conventional treatment. we will enroll 60 eligible patients with cervical cancer stage ib to iiic and randomly allocate them into the intervention (hypofractionation) group or the control (standard) groups. the patients in the intervention group will receive external beam radiotherapy(ebrt) to a total dose of 40 gy in 15 fractions within 3 weeks concurrently with weekly chemotherapy with cisplatin 40mg/m2 (total of 3 cycles). whereas, the control group will receive ebrt to a total dose of 45 gy in 25 fractions within 5 weeks concurrently with weekly chemotherapy with cisplatin 40mg/m2 (total of 5 cycles). all patients from both groups will undergo high dose rate brachytherapy one week after completion of ebrt to a total dose of 28 gy per 4 weekly sessions. patients will be evaluated regarding early and late toxicities as described by common terminology criteria for adverse events (ctcae) version 5.0 at the completion of brachytherapy, and at 3 months, 6 months, and 3 years from completion of treatment. also, clinical response will be evaluated through dynamic contrast enhanced pelvic mri 3 months, 1 year, and 3 years after completion of brachytherapy.

Eligibility criteria:
inclusion criteria: * pathology of squamous cell carcinoma (scc), adenocarcinoma, adenosquamous carcinoma of uterine cervix- international federation of gynecology and obstetrics (figo) stage ib, iia, iib, iiia, iiib (due to hydronephrosis without creatinine clearance compromise), iiic1 (if less than 3 lymph nodes with size less than 3cm, and without involvement of common iliac chain)- patient eligible for definitive chemoradiotherapy followed by brachytherapy exclusion criteria: * creatinine clearance less than 30ml/min, any histology other than the above, requirement of paraaortic lymph node irradiation, inflammatory bowel disease, connective tissue disorders, previous pelvic radiotherapy, figo stage ia or iv, eastern cooperative oncology group (ecog) performance status greater than 2, history of previous hysterectomy

Keywords: hypofractionation chemoradiation brachytherapy
study of beta2-microglobulin removal by standard versus new high cut-off haemodialysis membrane

Conditions: Renal Dialysis

Summary: the purpose of this study is to determine whether a novel haemodialysis membrane, compared with the standard dialysis membrane, will increase the removal of beta2-microglobulin in chronic dialysis patients.

despite advances in treatment of kidney diseases, morbidity and mortality of chronic dialysis patients remains unsatisfactory. standard haemodialysis membranes remove middle-sized molecule solutes poorly such as beta2-microglobulin, which has a pathogenic role in dialysis-related amyloidosis. pre-dialysis beta2-microglobulin concentration has been shown to be independently predictive of mortality. a new polyamide haemodialysis membrane has been developed with increased pore size to increase the removal of middle-sized uraemic toxins such as beta2-microglobulin. this study aims to evaluate the effectiveness of the new membrane in beta2-microglobulin removal compared with standard haemodialysis membrane in dialysis patients and the degree of increased loss of albumin as a potential limiting factor of its use.

Eligibility criteria:
inclusion criteria: * chronic haemodialysis patients for more than 2 years * urine output \<100 ml per day * 3 haemodialysis sessions per week * permanent arteriovenous dialysis access exclusion criteria: * serum albumin \<25 g/l

Keywords: beta 2 microglobulin haemodialysis albumin
prospective study evaluating the use of prospect to reduce insomnia in patients with early stage breast cancer

Conditions: Breast Cancer; Insomnia

Summary: women with early stage breast cancer may experience difficulty falling asleep or staying asleep. if this occurs for more than 4 weeks, these participants may have chronic insomnia. chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of medications for sleep and an overall decrease in quality of life. the investigators have developed an internet-based website that is designed to help people manage symptoms typically experienced by breast cancer survivors, including insomnia, fatigue, pain and overall poor quality of life. the investigators want to learn whether this type of treatment can reduce chronic insomnia and improve the way subjects feel using both questionnaires and a special form of a wrist watch. this information may help the investigators better manage sleep difficulties in subjects who experience these symptoms after diagnosis of their breast cancer.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of insomnia as identified through the screening insomnia severity index score \>14 2. insomnia present for \> 30 days per patient report 3. female gender 4. histologically proven stage 0-iii invasive carcinoma of the breast a. patient's must have completed primary surgical resection at least 2 weeks prior to enrollment, radiation at least 2 weeks prior to enrollment and/or cytotoxic chemotherapy at least 6 weeks prior to enrollment in the study 5. ecog performance status 0-2 6. ability to operate the accelerometer (actiwatch spectrum pro) 7. the patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent document exclusion criteria: 1. subjects who do not have access to the internet to use the internet-based module, prospect 2. initiation of hormone therapy \<4 weeks prior to enrollment in the study 3. initiation of sleep aids, including over-the-counter or prescription medications taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for \< 4 weeks prior to enrollment in the study 4. use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy 5. history of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), parkinson's disease and cancer involving the bone 6. second or third shift workers or others with non-traditional sleep schedules 7. serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation

Keywords: insomnia quality of life cognitive behavioral therapy
indoor daylight photo dynamic therapy for actinic keratosis

Conditions: Actinic Keratosis

Summary: the purpose of this study is to understand better if indoor daylight photo dynamic therapy (pdt) can provide effective lesion clearing versus conventional red lamp light therapy.

subjects who enroll into this research study, their participation in this study will last up to 6 months. they will be asked to return to the clinic 3-4 times. subjects will be randomized into one of two study arms: arm 1 - indoor daylight pdt therapy arm 2 - fda approved standard light therapy treatment

Eligibility criteria:
inclusion criteria: * all patients with actinic keratosis appearing at the dermatology clinic for pdt treatment. * age ≥ 18 years older. exclusion criteria: * pregnant women or women who are breast-feeding. * any patients with a condition that makes them not suitable for clinical pdt.
fetal heart rate variability and fetal growth restriction

Conditions: Fetal Growth Retardation

Summary: there is growing evidence in the field of fetal heart rate variability revealing the fetal neurological state. furthermore, fetal heart rate variability has shown potential as fetal surveillance in fetal growth restriction. this study aim to investigate the association between fetal heart rate variability and doppler flow changes in growth restricted fetuses.


Eligibility criteria:
inclusion criteria: * singleton pregnant women with estimated fetal weight below 2 standard deviations (2sd) of mean for gestational age corresponding to minus 22%. fetal weight assessed by doppler ultrasound. exclusion criteria: * fetal malformations
programmed intermittent bolus during continuous interscalene nerve block for shoulder arthroplasty

Conditions: Shoulder Arthroplasty; Shoulder Osteoarthritis; Pain Management

Summary: a new infusion strategy named the 'programmed intermittent bolus' (pib) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. the pib technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. however, it is not known if the pib technique gives any benefits during a continuous nerve block in other settings. the aim of this randomized controlled trial (rct) is to elucidate if pib is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.

local anesthetics are often given in a continuous fashion to block specific nerves after an operation for pain control. a new infusion strategy named the 'programmed intermittent bolus' (pib) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. the pib technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. however, it is not known if the pib technique gives any benefits during a continuous nerve block in other settings. the aim of this randomized controlled trial (rct) is to elucidate if pib is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.

Eligibility criteria:
inclusion criteria: * adult patients * american society of anesthesiologists (asa) physical status i to iii exclusion criteria: * body mass index (bmi) \> 40 * not able to communicate in english * unable to obtain consent * infection over site of placement * severe respiratory disease * cognitive or psychiatric history that would make it difficult to assess pain score * complex regional pain syndrome * chronic pain condition such as fibromyalgia, neuropathic pain * preoperative opioid use greater than the equivalent of morphine 50 mg po daily * allergy to any of the study drug * coagulopathy
thoracic outlet syndrome: case reports and analysis with ultrasound imaging

Conditions: Thoracic Outlet Syndrome

Summary: thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases under the pectoralis minor muscle in the infraclavicular region of the shoulder. the hypothesis is that ultrasound imaging can be used to visualize brachial plexus compression and distortion of the pectoralis muscle during arm activity, such as abduction, and that normal subjects will not demonstrate any plexus compression or muscle distortion.

four patients with thoracic outlet syndrome (tos) underwent clinical exam and nerve testing to prove that they had tos and no other nerve abnormality. they subsequently had ultrasound imaging of the shoulder (infraclavicular region) at rest and during arm abduction stress testing. two control subjects had similar clinical exams and nerve testing to prove they did not have tos, and then underwent similar ultrasound stress testing. the tos patients demonstrated brachial plexus compression and pectoralis minor muscle distortion during the stress tests, and the normal subjects showed no plexus compression or muscle distortion.

Eligibility criteria:
inclusion criteria: thoracic outlet patients must have: * symptoms consistent with thoracic outlet syndrome, and * no electrical testing abnormality, and * positive arm abduction stress tests. normal subjects must have: * no upper limb symptoms, or * normal nerve testing, and * negative arm abduction stress test exclusion criteria: thoracic outlet patients excluded if they have: * nerve test abnormalities, or * negative arm abduction stress test normals excluded if they have: * abnormalities on nerve testing, or * positive arm abduction stress tests

Keywords: thoracic outlet syndrome brachial plexopathy ultrasonography
irf-pai functional outcomes data(with fim instrument variables)

Conditions: Heart and Blood Disease; Muscle, Bone and Cartilage Disease; Nervous System Diseases; Skin and Connective Tissue Disease; Wounds and Injuries

Summary: irf-pai functional outcomes data, including fim instrument variables

united states irf functional outcomes, medical and socio-demographic data for years 2002-2015

Eligibility criteria:
inclusion criteria: * admission to an inpatient rehabilitation facility exclusion criteria: * admission to acute, snf setting, etc.
meibomian gland dysfunction management

Conditions: Contact Lens Discomfort; Meibomian Gland Dysfunction

Summary: the purpose of this study is to compare electronic debridement of the eyelid margin (blephex) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to meibomian gland dysfunction.


Eligibility criteria:
inclusion criteria: * habitual contact lens wearers whose contact lens wear time has reduced due to mgd will be preferentially considered for this study. subjects who currently cannot wear contact lenses due to mgd may be considered on a case-by-case basis. exclusion criteria: * subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation. * subjects who have active ocular infections will be excluded from participation.