Kornimate/medical-research-clean huggingface dataset:
study to compare oral pf-06651600, pf-06700841 and placebo in subjects with moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether pf-06651600 and pf-06700841 are effective in treatment of moderate to severe ulcerative colitis.


Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis for greater than/equal to 3 months. * moderate to severe active ulcerative colitis * inadequate response to, loss of response to, or intolerance to at least one conventional therapy for uc. exclusion criteria: * pregnant or breastfeeding * clinical findings suggestive of crohn's disease * history of bowel surgery within 6 months

Keywords: mayo score
efficacy of dark chocolate in achalasia patients

Conditions: Achalasia

Summary: flavanols, present in dark chocolate, were shown to induce nitric oxide synthesis. since nitric oxide facilitates smooth muscle relaxation, it might ease the relaxation of the les (lower esophageal sphincter)as well. the objective of the present study is to evaluate tha efficacy of dark chocolate in improving les relaxation in achalasia patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of "achalasia" * "achalasia" diagnosis during manometry at day 1 of the study. exclusion criteria: * pregnancy * pseudoachalasia * consumption of gi-motility modifiers durin 72 hours preceding the study.

Keywords: achalasia lower esophageal sphincter nitric oxide dark chocolate flavanols
alternative blood pressure measurements in ob patients

Conditions: Obesity; Blood Pressure

Summary: the incidence of obesity has been increasing worldwide. in women with obesity, the anthropometric differences in the distribution of subcutaneous tissue can make accurate measurement of blood pressure difficult. a large upper arm circumference can prevent the use of a brachial artery blood pressure cuff and often prompts the use of alternative methods for blood pressure measurement, including measurements on the wrist or forearm. outside of the obstetric population, there is evidence that if measurement of the blood pressure at the upper arm is not possible then measurement at the wrist can be used. despite this evidence in non-pregnant patients, there is limited evidence in pregnancy regarding the accuracy of blood pressure measurements on the forearm or wrist. accurate measurement of blood pressure is especially important in pregnancy to allow for prompt treatment of severe hypertension and for accurate diagnosis of hypertensive disorders of pregnancy. error in measurement could lead to iatrogenic preterm birth or under treatment of severe hypertension, both which can lead to severe maternal and fetal morbidity and mortality. additionally, it is biologically plausible that an increase in subcutaneous edema and vascular changes in pregnancy could lead to a larger discrepancy in blood pressure measurements between upper arm, forearm and wrist measurements. due to the increasing epidemic of obesity and the increasing need for accurate alternative blood pressure measurements the investigators propose a prospective observational study of pregnant women ≥18 years old admitted to labor and delivery for any indication or seen for prenatal care in obgyn clinic. a total of 20 women in each bmi class (normal, overweight (25-29.9), class 1 (30-34.9), class 2 (35-39.9), class 3 (\>40) will be enrolled (100 total). participation will include a total of 9 blood pressure measurements, biometric measurements on the patient's upper arm, forearm, and wrist and a brief questionnaire. the investigators hypothesize that there will be a discrepancy between blood pressure measurements on the upper arm and forearm or wrist.


Eligibility criteria:
inclusion criteria: * \>=18 years old * prenatal care at study hospital * english speaking exclusion criteria: * age \<18 * active upper extremity dvt * inability to measure blood pressure on arm * unable to give consent
the cia score: a learner's tool

Conditions: Anesthesia, Local

Summary: the goal of this project is to use a previously described scoring system - the cia system - as a teaching tool to help learners assess the bleeding risk of peripheral nerve blocks. we will teach the cia system to residents, then they will complete a survey in which they apply the system to various peripheral nerve blocks. we hypothesize that the cia system will allow learners to reach the same consensus about bleeding risk as expert opinions.

prior survey of stanford and palo alto va regional anesthesiologists showed diverging assessments of whether various blocks are considered superficial or deep. investigators hope to have a simple systematic approach to "scoring" regional anesthesia procedures which can be used as a basis for discussion and comparison of regional expert's opinions. a scoring system using three categories of consideration to classify any regional procedure is proposed. the following three categories, critical, intervention, and assess (cia) can be used to analyze any procedure to determine bleeding risk. a score of 0 or 1, was given to each parameter depending on whether it was absent or present. a total score can be range from 0 to 3. from this, the risk can be categorized based on the total score as low-risk (0), intermediate-risk (1) or high-risk (2 or 3).

Eligibility criteria:
inclusion criteria: * regional anesthesiologist and interested staff from stanford exclusion criteria: * non-regional anesthesiologists and non-interested staff at stanford

Keywords: regional anesthesia peripheral nerve block acute pain medicine
deep venous thrombosis screening in the icu by nurses

Conditions: Deep Venous Thrombosis

Summary: despite of preventive measures, the incidence of deep venous thrombosis (dvt) in icu patients is estimated to range from 5-31%. while clinical diagnostics is unreliable, ultrasound compression test (uct) has proven to be a highly sensitive and specific modality for the recognition of lower extremity dvt. delegating this competence to icu nurses can increase uct availability and enable preventive dvt screening. therefore, the investigators decided to conduct a clinical study to evaluate the sensitivity and specificity of uct performed by general icu nurse in icu patients compared to an investigation by icu physician certified in ultrasound. prior to the study, each nurse-investigator participating in the study undergo one-hour training in uct and examine 5 patients under supervision. then, icu patients without known dvt will be investigated by uct in the femoral and popliteal region of both lower extremities by trained general icu nurse-investigators. on the same day, the examination will be repeated by an icu physician-investigator. the results of the examinations of each patient will be blinded to each other for both investigators until both tests are performed. the sensitivity and specificity of the test performed by general nurse will be calculated in comparison with the examination by a specialist.


Eligibility criteria:
inclusion criteria: * all icu patients without known deep venous thrombosis, hospitalised more than 72 hours exclusion criteria: * contraindication of compression ultrasound testing * end-of-life decision regimen of care

Keywords: compression ultrasound testing nurse
healthcare transition of adolescents with chronic health conditions

Conditions: Transition; Diabetes; Kidney Diseases; Liver Diseases; Inflammatory Bowel Diseases; Rheumatic Diseases; Congenital Heart Disease; Neurologic Disorder

Summary: at least 12% of children have a chronic disease that requires regular medical follow-up after patients reach legal maturity. this international study aims to provide prospective evidence for improving health and wellbeing outcomes in this population. the primary hypothesis is that transition readiness will be more strongly associated with adherence to follow-up, fewer emergency visits and continued education than disease severity or chronological age. the secondary hypothesis is that positive experiences of care will be associated with lower levels of anxiety. positive care experiences and low anxiety will predict better health-related quality of life during the transition period. a cohort of 504 young patients will be followed for three years. patients have been recruited from pediatric hospitals 0-12 months prior to the transfer of care and follow-up will be completed after the patients have been followed for two years in adult healthcare.


Eligibility criteria:
inclusion criteria: * adolescents with a chronic medical condition (duration at least 6 months prior to recruitment) * attend care and/or follow-up at either the new children's hospital in helsinki, finland or the royal children's hospital in melbourne, australia in one or more of the following disciplines: endocrinology, gastroenterology, cardiology, rheumatology, neurology, pediatric surgery, nephrology and solid organ transplantation. * care to be transferred to adult services within 0-12 months following recruitment exclusion criteria: * lack of fluency in study languages (finnish, swedish and english) * cognitive limitations that inhibit responding to questionnaires

Keywords: adolescent
long-term follow-up of conservative and surgical treatment results of patients with lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment. patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.

patients between 40-85 years old who are hospitalized and treated with the diagnosis of lss in physical medicine and rehabilitation, orthopedics and neurosurgery clinics will be included in the study. the diagnosis of lss will be made by mr and / or ct and neurogenic claudication history. total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment, and the duration of the study is considered to be 24 months. patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment. clinical evaluation will be done by the same physician. in patients with spinal stenosis, pain (movement, rest, night) vas, functional status walking distance and ilbdi (istanbul waist pain disability index) inquiry form, nottingham extended life profile will be used.

Eligibility criteria:
inclusion criteria: 1. to be between 40-85 years old 2. defining neurogenic claudication in patient anamnesis 3. diagnosis of lumbar stenosis in mr and / or ct imaging 4. the duration of the symptom should be at least 4 weeks 5. other causes of low back pain have been ruled out exclusion criteria: 1. having had lumbar surgery before 2. physical therapy for lumbar spinal stenosis less than 3 months ago 3. any lumbar injection has been applied before 4. patients with inflammatory low back pain 5. patients with spinal stenosis due to spondylolysis and / or spondylolisthesis 6. patients with a history of trauma and suspected vertebral fracture

Keywords: lumbar spinal stenosis rehabilitation surgery exercise
xpert mtb/rif, a new tool for the diagnosis of pulmonary tuberculosis in two municipalities in brazil

Conditions: Tuberculosis

Summary: diagnosis of tuberculosis (tb) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. a new test (xpert mtb/rif) based on a rapid technique, named polymerase chain reaction (pcr), detects tb in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat tb. the test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. the aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.

the main study consisted of a group-randomized pragmatic trial following a stepped-wedge design. the genexpert machines will be installed in laboratories of the basic health units in rio de janeiro and manaus, two cities with a high burden of the disease in brazil. doctors will prescribe routine tests in the clinics. when sputum specimens arrive in the laboratory, instead of performing smears, the xpert mtb/rif will be performed during the intervention period. if positive, a sputum smear will also be performed. the intervention period will be preceded by an observation period during which routine will be kept unchanged, i.e., only smears will be performed. the observation period will serve as a comparator (control). the investigators will then see how many more cases were detected during the intervention period, and in particular, how many smear-negative cases were detected, compared to the observation period. a total of 35,000 specimens are expected to be tested with the new technology in 14 laboratories. laboratories, not individuals, will be randomized.

Eligibility criteria:
inclusion criteria: laboratories -and not subjects - will be randomized. all laboratories will start doing smears, when indicated by randomization, they will switch to xpert mtb/rif. there are no inclusion or exclusion criteria for the labs. sputum specimens from non-diagnostic (follow up) patients, second samples for diagnostic tests, insufficient volume/visible blood specimens will be excluded from the xpert testing.

Keywords: diagnosis polymerase chain reaction sputum smear stepped-wedge design cost-effectiveness xpert mtb/rif
use of tolvaptan to reduce urinary supersaturation: a pilot proof of principle study

Conditions: Nephrolithiasis, Calcium Oxalate; Nephrolithiasis, Calcium Phosphate

Summary: in this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 am and 15 mg at 4 pm). this relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function (see below). the twice-daily (8 am and 4 pm) regimen is designed to produce a maximal avp inhibition on waking with a gradual fall-off of effect during the night. to this end, a higher dose is used in the morning, with a lower dose in the afternoon.


Eligibility criteria:
inclusion criteria: * history of calcium oxalate or calcium phosphate stone. * good renal function exclusion criteria: * history of hypo-or hypernatremia. * history of hypotension or orthostatic dizziness. * clinical history of congestive heart failure.

Keywords: calcium oxalate calcium phosphate kidney stone
seroquel for frequent, heavy drinkers

Conditions: Alcoholism

Summary: the purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.

this trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.

Eligibility criteria:
inclusion criteria: 1. male and females, 18-70 years old. 2. meets dsm-iv criteria for current diagnoses of alcohol dependence, determined by the mini/scid-iv {first, 1996 #34}. 3. meets the drinking criteria, measured by tlfb and the addiction severity index {mclellan, 1992 #37}: 4. three consecutive days of abstinence from alcohol immediately before randomization 5. lives a commutable distance from the trc and agrees to attend all research visits including follow-up visits. 6. speaks, understands, and prints in english. exclusion criteria: 1. has evidence of dependence on a substance other than alcohol (except nicotine and marijuana). 2. tests positive on the urine drug screen during the screening weeks (one retest allowed). subjects whose urine drug screen tests positive for benzodiazepines will be allowed to randomize, at the discretion of the pi, if they are known to be physician-prescribed for detox purposes. 3. has hepatocellular disease indicated by elevations of sgpt (alt) and sgot (ast) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (\>1.3), with associated elevations of ast and alt above normal limits. 4. meets diagnostic criteria for a current unstable or serious psychiatric or medical illness. has serious heart, lung, kidney, immune system, gi tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease. 5. has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication. 6. tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the patient is of child-bearing potential, meaning has not had a hysterectomy or is in menopause, meaning 50 or over and has not had a menstrual cycle in 12 months. 7. has known hypersensitivity to antipsychotics. 8. has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization. 9. a history of seizure disorder. 10. the presence of cataracts.
individualized pneumoperitoneum pressure in colorectal laparoscopic surgery

Conditions: Individualized Pneumoperitoneum Pressure

Summary: optimizing all factors that increase the intra-abdominal volume and performing an individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15 mmhg).

in the context of multimodal rehabilitation in colorectal laparoscopic surgery (fast track or eras (enhance recovery after surgery)) multiple strategies have been introduced that have managed to improve patient recovery, decrease postoperative complications, decrease hospital days and decrease the overall costs per process. the possibility of performing individualized colorectal laparoscopic surgery with the minimum insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and this would allow us to reduce the impact of surgery on the patient, decrease perioperative morbidity and improve patient recovery. in our study, abdominal compliance, pv0 and maximal pv were determined during the initial performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of intra-abdominal pressure (iap) insufflation was stablished with evaluation by the surgeons, until reaching the minimal insufflation iap in which optimal surgical conditions are maintained.

Eligibility criteria:
inclusion criteria: * over 18 years of age * asa i-iii (american society of anesthesiologists physical status classification) * signed informed consent * absence of cognitive deficit exclusion criteria: * urgent surgery * pregnancy or breastfeeding * immune disorder * advanced renal, hepatic or cardiopulmonary disease * negative to participate in the study * under 18 years * inability to give consent * associated neuromuscular disorders * allergy to rocuronium/sugammadex * contraindication for use of rocuronium/sugammadex

Keywords: pneumoperitoneum pressure laparoscopic pressure intra-abdominal insufflation intra-abdominal pressures abdominal compliance
prognostic indicators for radiation-induced breast fibrosis

Conditions: Breast Cancer

Summary: to study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product lpa in the blood plasma.

to study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product lpa in the blood plasma. autotaxin and lpa cause fibrosis in other situation, but they have not been tested in radiation-induced fibrosis. we will determine if the duration and magnitude of the autotaxin and lpa responses are prognostic for the 15-28% of patients who will develop fibrosis. this fibrosis will be detected by ultrasound and a novel application of elastography, which should provide much earlier and quantifiable fibrotic changes compared to conventional physical examination.

Eligibility criteria:
inclusion criteria: 1. female participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf 2. age 40 and above. 3. treatment with breast conserving surgery. 4. intended adjuvant whole breast radiotherapy dose to a dose of 40-42.5 gy in 15-16 fractions. 5. luminal a subtype as determined by clinipathologic factors (er/pr positive, her-2 negative, low ki-67 or low oncotypedx recurrence score exclusion criteria: 1. women who have smoked within the last 5 years 2. patients requiring adjuvant chemotherapy. 3. requirement for regional nodal radiotherapy. 4. requirement for tumour bed boost. 5. breast implants 6. patients to be treated with partial breast irradiation. 7. uncontrolled intercurrent illness or active infection. 8. patients who have previously received chemotherapy. 9. patients who have previously received chemotherapy.
corellation of mutations, tils and age in breast cancer

Conditions: Breast Cancer

Summary: age may pertain to different tumor genotype characteristics which may interfere with treatment efficacy and prognosis. the investigators investigated the distribution and prognostic effect of mutations (mut) and tumor infiltrating lymphocyte (tils) in young and elderly early breast cancer patients (pts).


Eligibility criteria:
inclusion criteria: * women with early breast cancer \ 65 years old exclusion criteria: * na
clinical study to evaluate the efficacy, safety, and tolerability of act-128800 in patients with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study will assess the efficacy, safety, and tolerability of act-128800 in patients with relapsing-remitting multiple sclerosis.


Eligibility criteria:
inclusion criteria: * adult males and females * diagnosis of rrms as defined by the revised (2005) mcdonald diagnostic criteria for multiple sclerosis (ms). * signed inform consent prior to initiation of any study-mandated procedure. exclusion criteria: * a diagnosis of ms categorized as primary progressive or secondary progressive or progressive relapsing. * patients currently treated for an autoimmune disorder other than ms. * contraindications for mri. * ongoing bacterial, viral, or fungal infection. * history or presence of malignancy. additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.