Kornimate/medical-research-clean huggingface dataset:
dose ranging study to compare the efficacy and safety of methotrexate in plaque type psoriasis

Conditions: Psoriasis

Summary: in this study the investigators intend to compare the efficacy and safety of two fixed doses of once weekly oral methotrexate in a prospective randomized double blind manner in patients with severe plaque type psoriasis.


Eligibility criteria:
inclusion criteria: * patients with plaque-type psoriasis having more than 10% body surface area involvement (severe psoriasis).20 * patients of either sex with age between 18-65 years. * females who were postmenopausal or tubectomised or have completed their family size and are willing to maintain contraception 1 month before, during and 1 month after completion/stopping of treatment and negative pregnancy test 2 weeks before starting of treatment and at day 2 or 3 of a normal menstrual cycle. * males who were willing to maintain contraception during and 3 months after completion/stopping of treatment. exclusion criteria: * pregnant or lactating women. * any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness. * significant abnormalities in liver function (serum bilirubin, ast, alt, and alp \>1.5 times the upper limit of normal), viral hepatitis or cirrhosis. * history of excessive alcohol consumption. * severe anemia, leucopenia or thrombocytopenia. * active infectious disease or immune system deficiency including aids. * history of intolerance/hypersensitivity to methotrexate. * history of phototherapy in past 6 months. * patients who had received any systemic treatment for psoriasis in the past 4 weeks and topical treatment in the past 2 weeks. * body mass index (bmi) \> 30 kg/m2.
trial evaluating the efficacy and safety of patiromer in chinese subjects

Conditions: Hyperkalemia; Renal Insufficiency, Chronic

Summary: this is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (part a) followed by an 8-week randomised placebo-controlled withdrawal phase (part b) and a 2-week follow-up period.

in part a, participants who meet all eligibility criteria will initiate patiromer at an oral dose of 8.4 g (1 packet/day). the dose will be adjusted based on the serum potassium (sk+) levels. after the completion of part a, all the participants who meet the eligibility criteria for part b will be randomised to receive patiromer or placebo. participants will start part b with the same dose of patiromer they were receiving at the end part a. however, patiromer dose may be up- or down-titrated based on sk+ levels. the primary objectives of the study are: part a - to evaluate the efficacy of patiromer for the treatment of hyperkalemia in chinese subjects. part b - to evaluate the effect of withdrawing patiromer on sk+ control. to determine if the treatment with patiromer will result in continued use of renin-angiotensin-aldosterone system inhibitor (raasi) medications.

Eligibility criteria:
inclusion criteria: * chinese subjects at least 18 years of age. * chronic kidney disease (ckd) stage 3 and 4. * mean of 2 measurement of serum potassium higher than 5.0 and lower than 6.5 meq/l at baseline. * subjects on any stable dose of at least 1 raasi medication for at least 28 days before day 0/baseline. * if on antihypertensive medication, have a stable dose for 28 days before day 0/baseline. * women of childbearing potential must agree to continue using contraception throughout the study and for 4 weeks after study completion. exclusion criteria: * any level of hyperkalemia at day 0/baseline that, in the opinion of the investigator, requires emergency intervention. * type 1 diabetes or type 2 diabetes mellitus with glycated haemoglobin (hb a1c) higher than 10.0% at screening/part a baseline. * history of acute renal insufficiency in the past 3 months prior to the beginning of the study. * diseases affecting the hearth muscle and heart's ability to pump blood around the body * major surgery including thoracic and cardiac within 3 months prior to the beginning of the study or anticipated need during study participation. * heart or kidney transplant recipient or anticipated need for transplant during study participation * diagnosis or treatment of a malignancy in the past 2 years before day 0/baseline. * use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to day 0/baseline. * pregnant women or breastfeeding.

Keywords: hyperkalemia chronic kidney disease
corticosteroid injection in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: to compare the effectiveness of different dose of ultrasound guided steroid injection in patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in evlauation

this is a prospective, single-blinded randomized controlled study to determine the efficacy of low dose corticosteroid in patient with cts. patient with cts were randomly assigned to group receiving ultrasound guided steroid injection with different dosage of triamcinolone acetonide (shincort) mixed, 1ml 10mg (10mg/ml) or 1ml 40mg (40mg/ml) with 1 ml of 2% lidocaine hydrochloride. the follow up at 6 and 12 weeks includes boston carpal tunnel questionnaire, nerve conductive study and vas pain score.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cts * the diagnosis of cts was confirmed by electrophysiological tests. exclusion criteria: * presence of thenar atrophy * existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic cts such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome * prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery * history of distal radius fracture * pregnancy or lactation * regular use of systemic nsaids ,corticosteroids or diuretics * known allergy to corticosteroids and local anesthetics. * impaired cognitive function
pharmacokinetic study of pyrotinib and docetaxel in combination with trastuzumab in patients with her2 metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus trastuzumab in her2 positive mbc. the secondary objective of the study is to evaluate the safety and efficacy (orr) of pyrotinib and docetaxel plus trastuzumab in her2 positive mbc.


Eligibility criteria:
inclusion criteria: 1. her2 positive recurrent or metastasis breast cancer. 2. eastern cooperative oncology group (ecog) performance status 0 or 1. 3. adequate organ function. 4. signed, written inform consent obtained prior to any study procedure. exclusion criteria: 1. patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis. 2. history of her tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or pertuzumab used in the neo-adjuvant or adjuvant setting. 3. assessed by the investigator to be unable receive systemic chemotherapy. 4. history of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. 5. pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
effects of dexmedetomidine on inflammatory cytokines in patients with aneurysmal subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. the investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.


Eligibility criteria:
inclusion criteria: * aneurysmal subarachnoid hemorrhage * world federation of neurological surgeons (wfns) grade 4-5 (see table below) * surgical intervention with clip or coil * placement of cerebrospinal fluid drain (lumbar or ventricular) * mechanically ventilated at start of infusion exclusion criteria: * hemodynamic instability (sbp \< 100, hr \<60, or on continuous infusion of catecholamines) at screening * heart failure class iii or iv (new york heart association) * renal failure (rifle classification - see table below) * liver failure (serum protein \ 5 mg/dl) * known or suspected brain death * pregnancy * unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery * allergy to dexmedetomidine * prisoners

Keywords: aneurysmal subarachnoid hemorrhage dexmedetomidine cytokines
intervention in the surgical treatment of obesity

Conditions: Obesity, Morbid

Summary: the worldwide prevalence of obesity reaching epidemic levels, and directly associated with several non-communicable chronic diseases, being considered the sixth leading cause of death in the world. in brazil, estimated that one third of the population is overweight. currently, bariatric surgery the fastest and most effective method to control the disease. however, most patients do not follow the postoperative follow-up protocol, causing weight regain. intervention in the literature that goes beyond multidisciplinary and can prevent weight relapse. the develop and apply an interdisciplinary manual, based on the guidelines of the food guide for the brazilian population, as a support in the prophylactic treatment of weight relapse patients and bariatric surgery

the objective of this randomized clinical study is to compare the eating behavior of obese participants who underwent the dietary guide after bariatric surgery treatment. the main questions are: * can an interdisciplinary intervention through a dietary guide promote a change in eating behavior in participants undergoing surgical treatment for obesity? * participants will participate in consultations and receive a food guidance guide and lectures with guidance. * researchers will compare intervention and control groups to see if there will be changes in eating behavior

Eligibility criteria:
inclusion criteria: referred for bariatric surgery having or not comorbidity associated with obesity. exclusion criteria: not signing the informed consent form.

Keywords: obesity bariatric surgery food guide interdisciplinarity
balance training with tens for spastic diplegic cerebral palsy

Conditions: Diplegic Cerebral Palsy

Summary: children with spastic diplegic cerebral palsy (cp) often show motor impairment due to a number of deficits; including poor muscle control, weakness, spasticity and reduced range of motion in the extremities. all these factors affect the ability of children with cp to maintain balance and walk which are the primary rehabilitation concerns of parents and clinicians. the balance trainer provides a safe balance environment and assists with muscle activation of ankle and hip joints, and it is hypothesized that to promote spasticity inhibition, the use of tens may decrease hyper-excitability, modulate reciprocal inhibition, and increase presynaptic inhibition. to the best of the authors' knowledge, the current study is the first research to investigate the effect of using biodex balance training with tens in improving children with spastic diplegia.


Eligibility criteria:
inclusion criteria: * a diagnosis of spastic diplegia cerebral palsy. * age from 10 to 12 years. * spasticity grade 1 and 1+ according to the modified ashworth scale. * level ii motor function according to the growth motor function classification system. * able to understand and follow instructions. * their heights are more than 100 cm and weights are more than 20 kg which are the lower limits of height and weight needed by the biodex stability system. exclusion criteria: * epilepsy. * significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination). * structural or fixed soft tissue deformities of the lower extremities. * neurological or orthopedic surgery in the past 12 months. * botox injection in the lower extremities in the past 6 months. * fracture, sprain, or strain injury of the lower extremities in the past 6 months.
biomarker discovery for novel drug development in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Summary: drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations. this is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have ipf and those who do not. the people who have ipf will be followed for 12 months to collect more biological samples and record clinically relevant information. the goal of this study is to identify new molecular markers that are measurable and reliable in people who have ipf. it is hoped that these markers can be used in future drug studies to significantly speed up the process of finding drugs that help.


Eligibility criteria:
inclusion criteria: * age 35 to 80 years * a diagnosis of ipf by consensus criteria exclusion criteria: * any condition that makes the patient at unacceptable risk for bronchoscopy * the presence of significant co-existing emphysema on hrct * active cigarette smoking (defined as smoking within the last 6 months) * the presence of a significant co-morbidity felt to limit life expectancy to less than 12 months. * active listing for lung transplantation * inability to provide informed consent
chemical ice packs for cooling hyperthermic patients

Conditions: Heat Stroke, Heat Exhaustion

Summary: a common tool to cool people in the pre-hospital setting is the chemical ice pack. these are used by athletic trainers, ems personnel, er staff, and people in the prehosoital setting. the ability of these to cool a person has never been quantified, the efficiency and extent of cooling, as well as location of placement of ice packs is purely anecdotal. the purpose of this study is to determine whether strategically placed chemical ice packs will provide benefit to individuals subjected to heat stress.


Eligibility criteria:
inclusion criteria: * young healthy males \> 18 years old with no active medical problems and able to run 10 km. exclusion criteria: * active medical problems or inability to exercise for 45 minutes in a heated room.
palmoplantar pustular psoriasis efficacy and safety with secukinumab

Conditions: Palmoplantar Pustular Psoriasis

Summary: a one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks


Eligibility criteria:
inclusion criteria: * palmoplantar pustular psoriasis for at least 6 months before randomization * moderate to severe palmoplantar pustular psoriasis as defined at baseline by: * pppasi score of ≥ 12 and * dlqi ≥ 10 * candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by: * topical treatment, and/or * phototherapy, and/or * previous systemic therapy exclusion criteria: * forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis) * drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis * patients not willing to limit uv light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study * ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, uv therapy). washout periods detailed in the protocol have to be adhered to * previous exposure to any biologic drug directly targeting il-17 or il-17 receptor (e.g., secukinumab, ixekizumab, or brodalumab) * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment * active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy * use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer other protocol-defined inclusion/exclusion criteria may apply.

Keywords: palmoplantar, pustular, psoriasis
metformin in step-down regimen versus conventional low dose step-up protocol in patients with pcos undergoing ivf

Conditions: Infertility; PCOS

Summary: because many women with polycystic ovary syndrome (pcos) are very sensitive to the use of gonadotropins, several strategies have been proposed to reduce the risk of ovarian hyperstimulation syndrome (ohss) and multiple pregnancies. the low dose step-up protocol and the step-down protocols in pcos patients have been described in literature. the step-down regimen is designed to achieve the follicle stimulating hormone (fsh) threshold through a loading dose of fsh with a subsequent stepwise reduction as soon as follicular development is observed on ultrasound. on the contrary the step-up regimen is based upon the principle of a stepwise increase in fsh supply to determine the fsh threshold for follicular development. after commencement of gonadotropin administration, if follicle development is not observed on ultrasound after 1 week, an increase in the dose is recommended. once follicle growth is observed, the same fsh dose is maintained until follicular selection is achieved. preliminary studies report that both step-up and step-down regimens achieve similar high rates of monofollicular development. however, the largest study published so far has shown that the step-up regimen is safer in terms of monofollicular development. recent data demonstrate that metformin administration in infertile pcos patients who are at high-risk for ohss reduces the incidence and severity of ohss during gonadotropin ovarian stimulation in a step-down regimen for in vitro fertilization (ivf) programs. the aim of the present study will be to compare the conventional low dose step-up protocol and the combined protocol consisting in metformin and gonadotropin step-down regimen.


Eligibility criteria:
inclusion criteria: * pcos * infertility * high responders exclusion criteria: * poor responders * major medical conditions
evaluation of sacral neuromodulation (snm) in the treatment of active ulcerative colitis (primicistim)

Conditions: Active Ulcerative Colitis

Summary: efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.

neuromodulation is a validated option for the treatment of fecal incontinence. safety of this original approach has been confirmed by several studies. new indications for this minimally-invasive procedure are actually under evaluation particularly in the fields of irritable bowel syndrome and chronic constipation with promising results. its mechanism of action remains partially unknown and the target of neuromodulation is not limited to the anal sphincter but the whole colonic motility seems to be influenced by this therapeutic approach. moreover, recent experimental studies have shown that neuromodulation was able to reinforce the intestinal epithelial barrier involved in the pathophysiology of ulcerative colitis. subsequently, preliminary results in human have shown improvement of inflammation in patients suffering from inflammatory bowel diseases. in fact, despite recent improvement in medical therapies in inflammatory bowel diseases and particularly in ulcerative colitis, several patients are suffering from disabling chronic active disease. in those cases of refractory diseases, the only alternative treatment is a pan-proctocolectomy and ileal pouch surgery. this approach is a curative option, but leads to a significant morbidity and frequent functional disorders in the long-term follow-up (permanent stoma in 7 to 10% of the cases). moreover, in limited distal disease (left colon and rectum) the surgical option seems to be unadapted and many patients remain symptomatic and suffer chronic active disease. the aim of this study will be to assess in a prospective pilot study the efficacy of ulcerative colitis in inducing the remission of chronic active ulcerative colitis limited to the left side of the colon and improving the quality of life of the patients.

Eligibility criteria:
inclusion criteria: * active ulcerative colitis diagnosed on criteria lennard jones (31) for at least 1 year * \> 18 yo * e1 - e2 disease or extended to transverse colon but not beyond the hepatic flexure (endoscopic pictures) * resistant to medical treatment: active after introduction for at least 8 weeks of maintenance treatment (immunosuppressive or anti-tnf) * activity score \>5 and endoscopic score \>2 * absence of bacterial infection in progress (clostridium difficile) * affiliated with a social protection scheme and had signed an informed consent exclusion criteria: * severe forms requiring hospitalization an intravenous treatment or immediate surgery * infectious colitis or proctitis * prednisone\> 20 mg / d * contraindications to the use of neuromodulator * corticosteroid therapy by intravenous route * pregnant women * major trust
twelve step based self-help groups for substance related disorders

Conditions: Substance Use Disorders

Summary: the twelve step groups are the most available and widespread self-help groups for patients with alcohol or drug related disorders. in a public health perspective, self-help groups (shgs) may be considered as a supplement to professional treatment and provide aftercare soon as professional treatment has ended. there is a need to investigate if u.s. findings and procedures concerning referrals from the health services to twelve step groups (tsgs) can be replicated and accommodated to a cultural setting which is unfamiliar with these groups. there is also a particular need in the norwegian treatment system to develop alternative treatment strategies for patients undergoing detoxification to improve their chances of long-term recovery, due to deficient formal follow-up alternatives. we plan to carry out a rct-study. one hundred and sixty patients entering a detoxification treatment center (addiction unit, sørlandet hospital, kristiansand, norway) will be assigned to two different groups: one given standard information about tsgs (brief advice) and one given intensive referral (motivational sessions and contact with tsg volunteers). a follow up assessment is planned at 6 months to determine whether intensive referral results in more tsg attendance, and if this mediates less substance use and better functioning outcomes. this study introduces a new concept in the norwegian health care system and relies on a systematic cooperation with user organizations (shgs) and user volunteers. thus the study focuses strongly on user resources.


Eligibility criteria:
inclusion criteria: * patients with alcohol and substance use disorders treated on a detox ward exclusion criteria: * severe psychiatric comorbidity * patients on opioid replacement therapy * those who have appointment with other inpatient treatment at intake (and will be transferred to such treatment)

Keywords: substance use disorders self-help groups twelve step groups