Kornimate/medical-research-clean huggingface dataset:
juanbi pill for rheumatoid arthritis

Conditions: Juanbi Pill; Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether juanbi pill combined with methotrexate are effective in the treatment of active rheumatoid arthritis (ra).

rheumatoid arthritis patients are suffering from painful and swelling of joints as well as joint destruction and functional disability with the duration of disease activity. patients and physician try to find a way to alleviate the swell and tenderness of joints to avoid irreversible joints impairment, for evidence indicating that early aggressive treatment results in greater improvement than therapy initiated later in the disease course. as a complementary and alternative medicine (cam), herbal medicines have the potential to achieve a clinical remission, or push the disease back to low disease activity. in traditional chinese medicine (tcm), rheumatoid arthritis is a bi syndrome and juanbi decotion (notopterygium root, radix angelicae pubescentis, gentiana macrophylla, kadsura pepper stem, mulberry twig, angelica sinensis, ligusticum wallichii, frankincense, radix aucklandiae, shaved cinnamon barka and liquorice ) is a medicine specially for bi syndrome and it has been used in chinese for hundreds of years. juanbi pill is the raw extration of juanbi decotion for the sake of convenience of quality control and storage. although the long term usage of juanbi decotion, there is no high quality evidence about the decotion on rheumatoid arthritis. using a well-designed clinical trial, the investigators will survey the effectiveness of concurrent use of this decotion in relieving disease activity. therefore, the present study is to examine effectiveness and safety of juanbi pill, a compound traditional chinese herbal medicine on rheumatoid arthritis in a randomized, double-blind, placebo-controlled trial. results of this study will provide evidence regarding the value of the juanbi pill as an intervention to lower the disease activity and protect the affected joints from deformity.

Eligibility criteria:
inclusion criteria: * adults with rheumatoid arthritis (score more then 5 of acr (american college of rheumatology) /eular (european league against rheumatism), 2009 ) * moderate-to-severe disease activity (disease activity score for 28-joint counts (das28) of more than 3.2 * an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents * paid employment or unpaid but measurable work (e.g., caring for a family and home) exclusion criteria: * combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al. * abnormal liver and my kidney function * pregnancy or have a plan of pregnancy,breast feeding women * severe chronic or acute disease interfering with therapy attendance * alcohol or substance abuse

Keywords: juanbi pill methotrexate active rheumatoid arthritis
peripartum bacteruria and urinary tract infections (uti)

Conditions: Urinary Tract Infection

Summary: in the last years urinary tract infections (uti) and pyelonephritis have been the most common reason for readmission to our hospital after birth. uti is know to be one of the leading causes of postpartum fever affecting about 3%-8% of all postpartum women. the investigators hypothesize that collecting urine cultures pre- and postnatally may help identify women at risk for developing uti, while treating women with positive cultures could decrease the rehospitalization rate due to postpartum fever. collecting data during delivery may help identify women at risk for this complication.

the study is planned as a randomized controlled study with 500 women in each arm. the study group will have pre and post labor urine cultures taken, and the risk factors during delivery will be documented, while the control group will have no cultures taken, as the common practice prior to the study. women with positive cultures will be contacted by telephone, and antibiotic treatment recommended according to bacteria sensitivity. all women will be contacted by telephone 1 month post partum and data regarding urinary tract symptoms and need for hospitalization, will be collected. the rehospitalization rate will be documented and compared between the two groups. the assumption is that routine urine culture to women in the peripartum period may reduce the uti rate and hospitalization after delivery.

Eligibility criteria:
inclusion criteria: * parturients planned for vaginal delivery exclusion criteria: * parturients receiving antibiotic treatment during delivery or in the week before

Keywords: postpartum period
study of biomarker profiles in asia pacific erb2+/her2 breast cancer patients treated with lapatinib

Conditions: Neoplasms, Metastasis

Summary: the purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbb2 positive breast cancer patients.


Eligibility criteria:
inclusion criteria: 1. her2-positive (defined as either (a) ihc3+ or (b) fish+ in local lab) recurrent / metastatic breast cancer patients who have received treatment with lapatinib-based regimen. these are either new, current or completed cases from any of the following settings: * treated according to physician's clinical judgement in routine practice; or * treated in clinical trials with known allocation to lapatinib-based regimen; or * treated via lapatinib expanded access or named patient programs. these regimens should contain lapatinib as the only anti-her2 agent. 2. exposed to \< 2 lines of trastuzumab-based regimen in the metastatic setting prior to start of lapatinib-based regimen. these regimens should contain trastuzumab as the only anti-her2 agent. 3. patients with an historical tumor biopsy specimen available from their primary breast cancer diagnosis. if this is not available, then at least a specimen should be available anytime during the period before the patient started on any anti-her2 therapy. 4. willing to give written informed consent to release the tumor biopsy specimen with corresponding clinical data. if consent could be waived according to institutional practice (eg. patient already deceased, or patient previously provided blanket consent for institution to utilize tissue/data for research purpose), this is accepted with appropriate supporting documentation. exclusion criteria: 1. patients who have been exposed to other experimental anti-her2 therapy eg. pertuzumab, trastuzumab-dm, neratinib, ertumaxomab, av-412, bibw2992, cudc-101, anti-her2 vaccines. 2. other primary lesions that are not of breast origin.
overcoming addictions: a randomized clinical trial of a web application based on smart recovery

Conditions: Alcoholism

Summary: the objective of this research project is to develop, evaluate, and disseminate an internet-based (web) application for smart recovery: overcoming addictions (oa). oa will be based on the four point cognitive-behavioral program for smart recovery (www.smartrecovery.org). the goal of the oa program is to help users learn cognitive and behavioral skills to abstain from drinking, drug use, and problem gambling. the investigators will evaluate the effectiveness of the oa web application for heavy drinkers in a randomized clinical trial (rct) with follow-ups at 3- and 6-months. the study design has three conditions: 1) participation in face-to-face smart recovery meetings alone; 2) use of the oa web application as a stand-alone intervention; and 3) combining the oa web application with participation in face-to-face smart recovery meetings. study hypotheses: 1. all three groups will reduce their alcohol consumption, drug use (if any), and alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month post-baseline assessments. 2. the oa only group (experimental group 1) will show a greater reductions in drinking, drug use (if any), and alcohol/drug-related problems relative to the face-to-face only (control) group. 3. the oa + face-to-face group (experimental group 2) will have better outcomes on drinking and drug use variables compared to the control group.


Eligibility criteria:
inclusion criteria: 1. minimum age 18. 2. positive response to quantity/frequency screening questions regarding heavy drinking in the previous 90 days. 3. an alcohol use disorders identification test (audit) score of 8+. 4. is a new member of smart recovery(i.e., just joining or joined within the last 4 weeks). 5. has a computer at home with internet access. 6. has a primary focus on abstaining from drinking. exclusion criteria: 1. court mandated 1st time dwi offenders. 2. current diagnosis of drug dependence or consider themselves to be drug dependent. 3. current evidence of uncontrolled psychosis or bipolar disorder. 4. evidence of significant cognitive impairment from brain dysfunction. 5. english reading level below the 8th grade. 6. unwilling or unable to be available for 3 and 6 month post-baseline assessments. 7. unwilling or unable to provide one significant other (so) for corroboration of participant's self-report of drinking and drug use (if any).

Keywords: alcohol dependence intervention internet delivered intervention alcohol dependence treatment internet delivered treatment
a study of vemurafenib in participants with metastatic melanoma

Conditions: Malignant Melanoma

Summary: this multi-center study evaluates the safety and efficacy of vemurafenib in participants with braf v600 mutation-positive, surgically incurable, and unresectable stage iiic or iv (american joint committee on cancer \[ajcc\]) metastatic melanoma.


Eligibility criteria:
inclusion criteria: * participants with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage iiic or stage iv; ajcc) with braf v 600 mutation determined by cobas 4800 braf mutation test. unresectable stage iiic disease must have had confirmation from a surgical oncologist * participants with either measurable or non-measurable disease according to response evaluation criteria in solid tumours (recist) version 1.1 * participants may or may not have received prior systemic therapy for metastatic melanoma * eastern cooperative oncology group (ecog) performance status between 0 to 2 * adequate hematologic, renal and liver function exclusion criteria: * evidence of symptomatic central nervous system (cns) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib * previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix * concurrent administration of any anti-cancer therapies other than those administered in the study * clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug * refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
systemic effects of epidural methylprednisolone injection on glucose tolerance in diabetic patients

Conditions: Diabetes; Healthy

Summary: several studies have shown that in diabetic patients, the glycemic profile was disturbed after intra-articular injection of corticosteroids. little is known about the impact of epidural injection in such patients. the goal of this study was double, at first comparing the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate methylprednisolone either intra-articular or epidural, secondly to compare the amount of systemic diffusion of the drug the after both procedures.


Eligibility criteria:
inclusion criteria: * diabetes stable for more than ten days * no contraindication for steroids * lumbar stenosis * articular pain exclusion criteria: * unstable diabetes * renal insufficiency

Keywords: methylprednisolone intra articular infiltration glycemia epidural infiltration diabetes
satiating effects of isolated soy proteins

Conditions: Weight Management

Summary: proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. in this study, 2 differentially processed isolated soy proteins will be tested for satiety using subjective visual analogue scales. the amount of food consumed following intake of the isolated soy proteins will be measured 3 hours after consuming the proteins. the hypothesis is that differentially processed isolated soy proteins will show unique satiety responses.


Eligibility criteria:
inclusion criteria: * bmi between 20 and 30 kg/m2 * age between 18-65y * unrestrained eater (score\<12) * regularly consume 3 meals per day * moderate exercise (eg running, aerobics classes, other sports activities) of no more than 7 hours per week exclusion criteria: * use of drugs that influence carbohydrate or lipid metabolism (eg. hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication, and anti-diabetic medication) * presence of any significant disease (eg gastrointestinal diseases, diabetes, a cvd event less than 12 weeks from study entry, current hepatic disease, etc) * use of special dietary treatments within 4 weeks of study (eg weight loss diet, extremely high or low carbohydrate/protein/fat diet, use of meal replacements more than once a day) * use of supplements within 1 week of study (does not include vitamin supplements or supplements which are routinely taken and were initiated 4 weeks before the study and which will be continued during the study period) * restrained eater (score\>12) * weight change (absolute body weight change of ≥ 10%) within the previous 6 weeks * alcohol intake \>2 drinks/day * food allergies of any kind * swallowing difficulties * exercising more than 7 hours per week

Keywords: obesity, isolated soy protein, satiety, food intake
anti-cd3 & anti-cd7 ricin a immunotoxin-combination for acute graft versus host disease

Conditions: Acute Graft Versus Host Disease

Summary: in this study, a combination of two t-cell directed antibodies both conjugated to a cell-killing toxin will be evaluated. previous in vitro studies have demonstrated that this so-called immunotoxin-combination (it-combination) acts synergistically in eliminating t cells. in a subsequent clinical pilot-study, the it-combination has generated encouraging results when applied as third line therapy. extensive biological and clinical responses could be noted in the absence of severe acute toxicities. building on this experience, the current study aims at evaluating the characteristics of the it-combination when administered in an earlier phase of the disease, i.e. as second line instead of as third line therapy.

"the experimental design is a non-controlled multicentric fixed-dose phase i/ii study. a total of 12 evaluable patients will be enrolled in 4 transplant centers throughout the netherlands, in a 9 to 12 months period. the treatment consists of a standard dose of 4 infusions it-combination (4 mg/m2), given 48-hours apart over a 4-hour period. the intended follow-up period is 12 months. the patient will also be asked to participate in additional research aiming at determining the presence and evolution of biomarkers suggestive for the extent to which the it-combination 'resets the t-cell compartment, induces clinical tolerance, and/or enhances the risk of over-immunosuppression."

Eligibility criteria:
inclusion criteria: * patients suffering from severe acute gvhd (grade ii-iv) progressing after 3 days, or non-improving after 5 days, of prednisolone at 2 mg/kg a day. * age ≥ 18 years. * patients or their guardians should have given written informed consent using forms approved by the institutional review board. exclusion criteria: * patients receiving concomitant investigational therapeutics/prophylaxis for acute gvhd at the time of enrollment. * patients with histological signs/symptoms suggestive of chronic gvhd. * patients requiring mechanical ventilation, requiring vasopressor support, requiring hemodialysis, having serum creatinine \> 266 μmol/l (\> 3 mg/dl), or having a serum albumin level of 20 g/l or less. * patients having uncontrolled bacterial, viral or fungal infections at the start of therapy. * patients with current evidence of active intrapulmonary disease. * patients with known hypersensitivity to any of the components of the study drug (murine mab or rta). * patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study.

Keywords: acute gvhd immunotoxin anti-cd3 anti-cd7 ricin a
transperineal laser ablation treatment (tpla) for prostate cancer (pca) registry

Conditions: Prostate Cancer

Summary: rationale: transperineal laser ablation (tpla) treatment for prostate cancer (pca) is a minimal invasive focal therapy technique studied worldwide to determine its efficacy. in pilot studies it has shown to be a safe and feasible technique and it has potential to preserve continence and potency over current standard radical therapies. however, (long-term) treatment outcomes of tpla for pca remain largely unknown. the aim of this international retrospective registry is to collect and combine data on patients treated tpla for pca in order to provide data on safety, feasibility, functional and oncological outcomes. objective: to assess safety and feasibility of tpla for pca, to assess functional and oncological outcomes of tpla for pca and to determine baseline patient characteristics in a multicentre cohort. study design: this is an international, retrospective observational registry in which data is recorded of patients who have been treated with tpla for pca. study population: male patients treated with tpla for pca. main study parameters/endpoints: the primary endpoint of this registry is oncological outcomes of tpla for pca. secondary endpoints are safety, feasibility and functional outcomes of tpla for pca.


Eligibility criteria:
inclusion criteria: * male, histological-confirmed disease of localized prostate cancer, tpla treatment for pca is performed exclusion criteria: * age \< 18 years

Keywords: laser ablation minimal invasive focal therapy
diagnostic accuracy of magnetic resonance cholangiopancreatography in patients with obstructive jaundice

Conditions: Obstructive Jaundice

Summary: evaluate the diagnostic accuracy of magnetic resonance cholangiopancreatography (mrcp) compared with ultrasound and computed tomography (ct) in patients with obstructive jaundice taking findings of ercp/ ptc and histopathology as gold standard.

mrcp as a diagnostic role to determine the presence and severity of biliary and pancreatic ductal dilatation. it can also detect the length of the stricture as well as the exact cause and location of the obstructing lesion in comparison to other modalities.

Eligibility criteria:
inclusion criteria: adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests. exclusion criteria: patients with non-obstructive (prehepatic/hepatic) cause of jaundice. patients having contraindications to perform mri (patients with any electrically, magnetically or mechanically activated implants, pacemaker, cochlear implants or any metallic orthopedic implants and claustrophobic patients).
chuvashia inappropriate prescribing study

Conditions: Multimorbidity, Cardiovascular Diseases

Summary: this is a cross-sectional study based on an outpatient registry. all medical therapy will be registered in order to assess inappropriate prescribing's, in accordance with the criteria prompt and beers, also in accordance with the officially approved instructions for the use of this medicinal product.


Eligibility criteria:
inclusion criteria: * age \> 50 years old, multimorbidity, signed patients' informed consent exclusion criteria: * age \< 50 years, presence of mental illnesses, oncological diseases detected less than 5 years ago, acute cardiovascular pathology within 6 months prior to inclusion.

Keywords: multimorbidity self-medication drugs over-the-counter (otc) drugs prescription drugs adherence inappropriate prescribing
effects of post-isometric relaxation technique vs soft tissue mobilization in leg spin bowlers

Conditions: Sports Physical Therapy

Summary: effects of post-isometric relaxation technique versus cross friction soft tissue mobilization in leg spin bowlers with rotator cuff strain

the existing body of research on pakistani cyclists lacks comprehensive investigation into the role of sciatic nerve flossing and active release technique, creating a noticeable gap in understanding the impact of such techniques on the performance, improving flexibility, and overall physical well-being of these athletes. given the unique physical demands of cyclists and the potential benefits associated with lower limb muscle strength, a focused exploration in this area is crucial to inform training strategies, enhance athletic performance, and contribute to the holistic development of pakistani cyclists. to determine the comparative impact of sciatic nerve flossing and active release technique on pain, flexibility, and functionality in the lower limbs of cyclists with sciatica.

Eligibility criteria:
inclusion criteria: * age 16-30 years * symptomatic male bowlers (leg spinners) * pain from at least 2 months * playing regularly from at least 1 year. * difference of rom as compared to contralateral extremity. exclusion criteria: * prior history of shoulder surgery * shoulder symptoms requiring medical treatment. * cricketers not involved in any other sports.

Keywords: cross friction soft tissue mobilization, spin bowlers
brighter bites & university of texas physicians produce rx extension: evaluating the effectiveness of a prospective clinical nutrition study with produce prescriptions

Conditions: Obesity, Childhood

Summary: the purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child).


Eligibility criteria:
inclusion criteria: * must be a patient at university of texas physicians greens clinic or university of texas physicians pediatric primary care in houston, texas * bmi\>85th percentile * reside within a 10-mile radius of a brighter bites school * medicaid recipients or low-income uninsured * parents must be able to read and write in english or spanish to complete surveys exclusion criteria: * currently participating in brighter bites * a family member/sibling currently participating in brighter bites * child is currently attending a school that offers brighter bites
angelman syndrome natural history study

Conditions: Angelman Syndrome

Summary: the goal of this study is to conduct a prospective, longitudinal natural history study of children and adults with angelman syndrome using investigator-observed and parent-reported outcome measures to obtain data that will be useful for future clinical trials.

the overall goal is to increase our understanding of the long-term natural history of angelman syndrome and obtain angelman-specific norms for outcome measures that can be used in clinical trials, ultimately improving the care of individuals with angelman syndrome.

Eligibility criteria:
inclusion criteria: * molecular diagnosis of angelman syndrome exclusion criteria: * presence of another condition, unrelated to angelman syndrome, that affects neurodevelopment

Keywords: angelman syndrome