Kornimate/medical-research-clean huggingface dataset:
the effects of kuvan on functional brain connectivity in individuals with phenylketonuria (pku)

Conditions: Phenylketonuria

Summary: the objective of the study is to determine whether kuvan™ (sapropterin) improves the strength of the functional connectivity between brain regions in individuals with pku.

the proposed study is designed to evaluate the hypothesis that functional connectivity may represent an early marker for neurocognitive improvements related to kuvan treatment. as a first step in the study, 20 patients with pku who are ≥ 6 years of age will receive baseline functional connectivity magnetic resonance imaging (fcmri) evaluations before being treated with kuvan™. response to kuvan™ will be monitored for 4 weeks. at the end of 4 weeks, response to kuvan™ will be reviewed and all 20 patients will receive follow-up fcmri evaluations. fifteen patients with a reduction of ≥ 20% in blood phenylalanine will continue in the study and receive a third fcmri evaluation at the end of 6 months of treatment with kuvan™. for comparison purposes and to control for possible practice effects in repeated testing, a matched control group of 20 healthy individuals without pku will used. all 20 of the control subjects will receive baseline and 4-week fcmri evaluations; fifteen will receive a 6-month evaluation.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent or assent. * willing and able to comply with study procedures. * greater than or equal to 6 years of age. * for phenylketonuria, intention of physician to prescribe sapropterin. * for phenylketonuria, phenylalanine level greater than or equal to 300μmol/l. * for phenylketonuria, negative pregnancy test if of childbearing potential. * for phenylketonuria, willing to use contraception if sexually active. exclusion criteria: * pregnant, breastfeeding, or planning to become pregnant during study. * use of investigational product less than 30 days prior to or during study. * concurrent condition that could interfere with participation or safety. * any condition creating high risk of poor compliance with study. * perceived to be unreliable or unavailable for study. * use of l-dopa, methotrexate, or other drugs that inhibit folate metabolism. * for phenylketonuria, known hypersensitivity to sapropterin or excipients.

Keywords: sapropterin kuvan cognition brain
the usefulness of patients receiving their own letter after an outpatient attendance

Conditions: Heart Diseases; Lung Diseases

Summary: as part of the nhs plan it has been proposed to extend some consultants' usual practices and to send all patients copies of the letters sent to their general practitioners (gps) following outpatient consultations. the current secretary of state for health has further extended this proposal and suggested that patients should have a specific letter to themselves after a hospital consultation. the aim of this study is to send patients both a copy of the letter sent to their gps and a specific letter to themselves and to assess the usefulness and comprehensibility of each.

as part of the nhs plan it has been proposed to extend some consultants' usual practices and to send all patients copies of the letters sent to their general practitioners following outpatient consultations. the current secretary of state for health has further extended this proposal and suggested that patients should have a specific letter to themselves after a hospital consultation. the aim of this study is to send patients both a copy of the letter sent to their gps and a specific letter to themselves and to assess the usefulness and comprehensibility of each. this study will assess the two styles of letter in cardiology and respiratory outpatient clinics staffed by 7 consultants and will involve a group of 15-20 patients from each of the clinics, total number approximately 150 patients. all patients attending the clinics will be given a sheet outlining the study before their consultations. if they are interested in the study, patients will be given a patient information sheet and asked consent to take part. the length of each of the two dictated letters will be recorded. to avoid costs to the nhs, the direct to patient letters will be typed at the study investigators' cost. two copies of each letter, a short explanatory letter and a questionnaire will be sent to the patient and the patient will be asked to circle points in each of the letters which are unclear and return them to the department. at the end of the study the general practitioners will be contacted and asked their views about the two letters.

Eligibility criteria:
inclusion criteria: * all patients attending respiratory/cardiology outpatient clinics exclusion criteria: * patients with reading/language difficulties

Keywords: post consultation letter
a phase 2 study with mip-1404 in men with high-risk pc scheduled for rp and eplnd compared to histopathology

Conditions: Prostate Cancer

Summary: this was a multicenter, multi-reader, open-label, phase 2 study assessing the safety and performance characteristics of mip 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. comparative performance characteristics between mip 1404 imaging and mri were also assessed, as judged by histopathology results.

this is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. patients receive a single iv dose of 99mtc-mip-1404 (study drug) followed by spect/ct scan 3-6 hours after injection. as standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (eplnd) within three weeks of study drug dosing. 99mtc-mip-1404 image data will be evaluated for visible uptake and compared with histopathology.

Eligibility criteria:
inclusion criteria: * male aged 21 years or older. * ability to provide signed informed consent and willingness to comply with protocol requirements. * biopsy confirmed presence of adenocarcinoma of the prostate gland. * at high-risk for metastatic disease by a stage of ct3, ct4, or a total nomogram score of greater than or equal to 130. * scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection. * agree to use an acceptable form of birth control for a period of 7 days after the 99mtc mip-1404 injection. exclusion criteria: * participating would significantly delay the scheduled standard of care therapy. * administered a radioisotope within 5 physical half lives prior to study drug injection. * have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study. * have a contraindication for mr imaging.

Keywords: prostate cancer high-risk prostatectomy surgery newly diagnosed
study of a-interferon with adriamycin, bleomycin, velban, and dacarbazine (abvd) with hodgkin's disease

Conditions: Lymphoma

Summary: this is a clinical research study of interferon (ifn) plus chemotherapy with the standard combination of adriamycin, bleomycin, velban, and dacarbazine (abvd). the treatment will be given to patients with hodgkin's disease. the study will look at whether adding ifn to abvd improves the immune response against hodgkin's disease, and will determine whether the toxicity of abvd is increased by adding ifn.

each treatment cycle will last 2 weeks. on days 1 - 4 of each cycle, patients will be given a shot of ifn under the skin. on day 4, patients will be given abvd through a vein over one-hour. the plan is for patients to receive 12 cycles of treatment. however, patients will leave the study if they have severe side effects or if the cancer grows or spreads. they will also leave if the cancer does not improve after 6 cycles. patient who leave the study will be offered other treatments. a maximum of 35 patients will be treated with that dose. before the first treatment, patient will have a physical exam, blood tests, and a heart scan. within 1 month of starting treatment, patients will have a chest x-ray, ct scans of the abdomen and pelvis, and a gallium scan. during the study, patient will have blood tests every week and a physical exam every 2 weeks. the x-ray, ct scans, and gallium scan will be repeated after cycles 6 and 12. all the drugs in this study are approved by the u.s. food and drug administration and are available by prescription. abvd is a standard treatment for hodgkin's disease; ifn is an investigational treatment for hodgkin's disease. about 35 patients will be enrolled in the study. all treatment will be given in the outpatient clinic at m.d. anderson cancer center.

Eligibility criteria:
inclusion criteria: 1. hodgkin's disease patients who relapse after radiation therapy alone, or in combination with novantrone, oncovin, velban, and prednisone (novp); and previously untreated patients with stage iii and iv who are eligible for standard abvd therapy. 2. must have adequate bone marrow reserve absolute neutrophil count (anc) \> 1,000/ul, platelets \> 100,000 3. left ventricular ejection fraction (lvef) \>/= 50%, serum creatinine \< 2mg/dl, serum bilirubin \< 2mg/dl exclusion criteria: 1. no prior therapy with mustargen oncovin procarbazine prednisone (mopp). 2. no severe pulmonary disease including chronic obstructive pulmonary disease (copd) and asthma.

Keywords: lymphoma hodgkin's disease stage iii and iv adriamycin doxorubicin rubex bleomycin bleomycin sulfate blm dacarbazine dtic-dome interferon-2a interferon-alfa-2a roferon-a velban vinblastine
effect of the postoperative trendelenburg position on chronic subdural hematoma recurrence

Conditions: Chronic Subdural Hematoma; Trendelenburg; Recurrence; Mortality; Prognosis; Clinical Trials

Summary: objective: determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (csh) in patients undergoing surgery. materials and methods: an open-label, randomized, controlled clinical trial was conducted in three hospitals in medellín. patients with csh were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. csh recurrence was measured at 3 months, along with functional outcome (modified rankin scale), adverse events, and comfort (likert scale).

objective: determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (csh) in patients undergoing surgery. materials and methods: an open-label, randomized, controlled clinical trial was conducted in three hospitals in medellín. patients with csh were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. csh recurrence was measured at 3 months, along with functional outcome (modified rankin scale), adverse events, and comfort (likert scale).

Eligibility criteria:
inclusion criteria: * the study included patients aged 18 years or older who required surgical management of symptomatic csh confirmed by ct scan and whose informed consent was given by the patient or responsible family member to participate in the study exclusion criteria: * pregnant or breastfeeding * conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease, * history of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting * simultaneous participation in any other clinical trial.
when is the best moment to remove the urinary catheter after laparoscopic hysterectomy?

Conditions: Urinary Tract Infection; Bladder Retention

Summary: objective: the aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. in addition, we want to investigate patient's experience on this subject. study design: randomized controlled trial, non-inferiority study. study population: women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy. intervention: * group a (treatment group): the patients in this group will have their catheter directly removed in the or after lh. * group b (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).


Eligibility criteria:
inclusion criteria: * older than 18 years * scheduled for lh for benign indication or low-grade malignancy (with or without salpingo-oophorectomy) exclusion criteria: * concomitant procedures such as prolapse surgery, severe endometrioses and/or bowel resection * preoperative known urinary voiding problems (incontinence) * preoperative known urinary tract infection * patients suffering from diseases potentially associated with inability to void (e.g. ms) * a gravid or postpartum hysterectomy
the effect of an exercise program in breast cancer patients with joint pain while taking aromatase inhibitors.

Conditions: Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness

Summary: the objective of this study is to determine if patients taking aromatase inhibitors (ai), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. the overarching objective is to improve patient compliance with the medication and ultimately clinical outcome. in this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and physical therapy (pt) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. patients will be divided into two cohorts. group a will receive ai therapy with a directed exercise program. group b will receive ai therapy without a directed exercise program. data will be collected when both cohorts of patients enroll in the study, at the end of pt for group a and, at the end of 8 weeks for group b. at these time points, both groups will undergo a pt evaluation; have blood drawn for cytokine profiles; answer questions on an ipad that includes: the pain disability index, the phq-4 (psycological health questionaire depression scale, and pain level scale.


Eligibility criteria:
inclusion criteria: * 1. women over age 40 with histological evidence of hormone receptor positive breast cancer. 2. post- menopausal 3. adjuvant ai therapy. 4. significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of ai therapy. 5. currently not in an active directed exercise program (\>60 minutes 2x/wk) exclusion criteria: 1. preexisting ra or fibromyalgia. 2. systemic metastasis 3. ecog performance status of greater than 2. -

Keywords: estrogen receptor positive, aromatase inhibitors, exercise,
do home monitors improve blood pressure control?

Conditions: Hypertension; Diabetes Mellitus

Summary: the purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.


Eligibility criteria:
inclusion criteria: * over 18 years old, * diabetes as defined by hga1c over 6.5%, * uncontrolled blood pressure (sbp \> 130 and or dbp \> 80) exclusion criteria: * pregnancy, * transplanted organ, * mi/chf/cva within 3 months, * dialysis, * arrhythmia, * metastatic cancer, * dementia, * visual or hearing difficulties
individualized plan for improving adherence to portable oxygen therapy in patients with respiratory pathology

Conditions: COPD; ILD; Dyspnea

Summary: pilot study with patients with prescription of portable oxygen therapy, to test the impact on adherence of a patient-centered empowerment program, with contents on the nature of the respiratory pathology, the symptom of dyspnea, the benefits of the therapy, adjustment expectations and beliefs, as well as health habits.

all patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. this care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. the interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). the empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc.

Eligibility criteria:
inclusion criteria: * adult patients (over 18 years old) with prescription of portable oxygen therapy by the pneumology service of the sant joan de dèu hospital in manresa. exclusion criteria: * psychophysical inability to carry out questionnaires or refusal to answer them. * severe displacement problems.
opiate sparing protocol randomized controlled trial in open distal radius fracture repair

Conditions: Distal Radius Fracture

Summary: a comparison of oral morphine equivalents between an opiate sparing cohort and an opiate based cohort following open reduction internal fixation of a distal radius fracture.

recently, the opioid epidemic has been the center of focus for healthcare providers and governmental agencies due to rising rates of opioid abuse, opioid-related fatalities, and overall economic burden of treating the opioid epidemic. the prescribing patterns of opioid pain medications have fallen under scrutiny and healthcare providers have sought alternative pain management strategies that have limited opioid pain medication use. as orthopaedic surgeons account for 7.7% of all dispensed opioid prescriptions within the united states, surgeons have investigated multimodal pain management strategies to assess effectiveness in controlling postoperative pain as well as limiting opioid use and opioid related complications. the literature documents the safety and effectiveness of non-steroid anti-inflammatory drugs (nsaid) and acetaminophen in soft tissue hand procedures and distal radius fracture plating. currently, there remains no clear consensus on the ideal pain management strategy following open reduction internal fixation (orif) of distal radius fractures and the vast majority of strategies are based on opiate-driven protocols. this study will investigate the effectiveness of an opiate sparing protocol following open reduction and internal fixation (orif) of distal radius fractures on opiate consumption as measured by oral morphine equivalents at the 2, 6 and 12 week postoperative time point through collection of pill counts. secondary outcomes are pain scores, patient satisfaction, and safety reporting (complications, reoperations, and readmissions) during the 12-week episode-of-care. this study will document the safety and effectiveness of an opiate sparing, multimodal pain management protocol in properly selected patients undergoing orif of distal radius fractures. following written consent documentation, subjects will be randomized to either the opiate sparing cohort or the opiate based cohort at a 1:1 randomization. no blinding will occur as part of the study.

Eligibility criteria:
inclusion criteria: * open reduction internal fixation surgery at campbell clinic surgery center * body mass index less than or equal to 45 * fluent in verbal and written english exclusion criteria: * known sensitivity to medications in either protocol * renal disease by medical history * concomitant ipsilateral upper extremity injury or condition other than wrist * chronic pain syndrome * consumption of ten consecutive day so opioid use in the previous 90 days * worker's compensation * women who are pregnant, planning to become pregnant, or are breastfeeding * takes either angiotensin-converting enzyme inhibitor or angiotensin ii receptor blockers for hypertension
in-patient study with gsk716155 in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this study is a placebo-controlled study in patients with type 2 diabetes mellitus to assess safety and tolerability parameters, the levels of gsk716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. assessments include ecgs, vital signs, repeat blood sampling and monitoring of any side effects.


Eligibility criteria:
inclusion criteria: * subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months. * must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea. * subjects must be willing to wash-out of these medications for 14 days prior to the start of the study. * subjects must have a bmii between 25 and 40 kg/m² and weigh at leas 50kg. * women must be of non-childbearing potential. exclusion criteria: * laboratory values that meet certain criteria (for example, total cholesterol \> 240 mg/dl). * clinically significant hepatic enzyme elevation. * fasting plasma glucose greater than 240mg/dl. * positive test result for hepatitis b surface antigen, positive hepatitis c or hiv. * any major illness other than diabetes. * previous use of insulin as treatment for diabetes. * significant renal disease as defined by screening lab tests. * history of drug or other allergy, which in the opinion of the investigator contradicts subject participation. * smoking or use of nicotine-containing products within the previous 6 months. * history of alcohol or drug abuse. * unwilling to abstain from alcohol during the study. * unwilling to abstain from caffeine- or xanthine-containing products during the study. * use of st. john's wort during the study. * has donated 500 nl or more blood within 56 days of dosing or plans to donate blood in the month following study participation. * previously received any glp-1 mimetic that has moe than 70% sequence homology to glp-1.

Keywords: gsk716155 albiglutide pharmacodynamics pharmacokinetics