Kornimate/medical-research-clean huggingface dataset:
pert for treatment of exocrine pancreatic insufficiency in patients with unresectable pancreatic cancer

Conditions: Pancreatic Insufficiency; Pancreatic Cancer; Pancreatic Enzyme Abnormality

Summary: does pancreas enzyme replacement (pert) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme replacement therapy in weight loss and quality of life. prevalence of pancreatic exocrine insufficiency (pei) will be determined with fecal elastase-1 test (fe1) in patients with unresectable pancreatic cancer, without evidence of pancreatic duct (pd) or common bile duct (cbd) obstruction based on mri or / and endoscopic ultrasound (eus). patients with pei (fe1 \<200) receive pertzye or placebo in a cross-over fashion, each for 4 weeks. body weight, body mass index (bmi), body composition (bioimpedance), are measured at the time of diagnosis of pei and at 4 and 10 weeks of cross-over treatment. baseline measurement of vitamin d-25, vitamin a, iron (ferritin, total iron binding capacity (tibc), iron), vitamin b12,tissue transglutaminase iga (ttg) with total immunoglobulin a (iga). quality of life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the functional assessment of cancer therapy for patients with liver, bile duct and pancreas cancer (fact-hep) for physical, social, emotional, and functional quality of life.

Eligibility criteria:
inclusion criteria: * patients 18-80 years * underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis) * on established chemotherapy regimen for pancreas cancer, which will be continued over the time of study * fecal elastase-1 test (fe1) less than 200 mcg pancreatic elastase/g stool exclusion criteria: * common bile duct obstruction resulting in obstructive jaundice * celiac disease * crohn's disease * benign pancreatic conditions * bowel obstruction * surgically altered bowel anatomy
the effect of whole body vibration in individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: previous studies reported that whole body vibration has the potential impact on balance and walking abilities in individuals with parkinson's disease; however, the inconsistent treatment protocols and different experimental designs lead to inconclusive results. therefore, the purpose of this study is to investigate the short term and long term effect of whole body vibration on sensorimotor function in individuals with parkinson's disease. the experimental design will be randomized double-blinded controlled trial. sixty individuals with idiopathic parkinson's disease will be randomly assigned to two groups and they are non-random whole body vibration group and conventional therapy group. each participant will receive the treatment about one hour after the administration of medicine. for non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6hz and 3mm respectively. each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest. for the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. each session is 10 minutes in both groups and all participants will receive one and twelve treatment sessions for short-term and long-term effect respectively. outcome measures include proprioceptive sensitivity threshold of upper limb, position sense test of the knee joint, unified parkinson's disease rating scale-motor (updrs motor), functional reach, and time up and go test (tug). specifically, the investigators want to answer the following four questions: 1) is there any difference in proprioceptive sensitivity, motor performance and balance before and after treatment in individuals with parkinson's disease? 2) is there any difference in short-term and long term effect of whole body vibration in individuals with parkinson's disease? 3) is there any difference in treatment effect in individuals with parkinson's disease in taiwan?


Eligibility criteria:
inclusion criteria: * agree to sign the informed consent form. * diagnosed with idiopathic parkinson's disease with hoehn and yahr stage 2\~3 * cognitive impairment (mini-mental state examination \[mmse\] score greater than 24 points * no depression as evaluated by the beck depression inventory * no severe arm injuries or shoulder dislocation which might interfere with proprioceptive function * can perform reaching movement * no diagnosed peripheral nerve disorders or other neurologic conditions * no severe tremor which might interfere with the measurement proprioceptive function exclusion criteria: * diagnosed with other central nervous system diseases, ex: stroke * had surgeries in head or arms * unable to sit for assessment

Keywords: proprioception vibration balance
phase iii trial of cuv1647 in polymorphic light eruption (ple)

Conditions: Polymorphic Light Eruption (PLE)

Summary: the purpose of this study is to determine whether the afamelanotide (cuv1647) formulation is effective in preventing ple episodes or reducing the severity of ple symptoms in patients with a well documented history of the disease. the study also aims to determine whether treatment with afamelanotide (cuv1647) can reduce the use of rescue medication in this group.

polymorphic light eruption (ple) is a prevalent photosensitivity disorder, occurring in up to 20% of the european and us populations and up to 5% of the australian population. the disease is characterised by a rash that is intensely itchy with blisters, bumps and patches presenting on areas of the skin that have been exposed to the sun. there is a lack of effective treatment available for the condition but the most common available forms of therapy include sun avoidance and the use of the use of steroids and/or phototherapy.

Eligibility criteria:
inclusion criteria: * aged 18 - 70 years at inclusion. * well documented history of moderate/severe ple as diagnosed/confirmed by a photodermatologist or photobiologist. newly diagnosed patients with moderate/severe ple can be included if numbers of established patients are limited provided their diagnosis is confirmed by a photodermatologist or photobiologist. * recurrent episodes that occur at least once a year, developing in own country (to exclude patients affected only when traveling to sunnier climates). * have given written informed consent to participate in the study. exclusion criteria: * personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi. * current bowen's disease, basal cell carcinoma, squamous cell carcinoma or other malignant skin lesions. * documented history of other photosensitive conditions. * female who is pregnant (confirmed by positive serum β-hcg pregnancy test prior to baseline) or lactating. * females of child-bearing potential that are not using adequate contraceptive measures.

Keywords: polymorphic light eruption (ple) afamelanotide cuv1647 photoprotection sun poisoning
expressed beliefs about the cause of pain in a paediatric population

Conditions: Chronic Pain; Pediatric ALL; Pain Perception

Summary: the aims of this study are to explore what beliefs children and adolescents manifest about the cause of the pain they describe; to compare whether if there are differences between beliefs by age and by persistence of pain; and to relate explanations of the cause of pain with current scientific evidence to determine if these beliefs are erroneous.

design: mixed (explanatory sequential). the primary endpoint of the study were explanations of the cause of pain recorded by means of an open-ended question. setting: the participants were school-age children attending a charted school in the province of barcelona. participants: of the 345 potential school participants, 306 agreed to participate. 36 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 270.

Eligibility criteria:
inclusion criteria: * to be schooled at the el cim school * to be between 10 and 16 years old (both included) * to have or have had pain in the last month; to be able to read and write in catalan and/or spanish. exclusion criteria: * had an intellectual disability and/or cognitive impairment that interfered with their participation * had not submitted the informed consent form duly completed and signed by their legal guardians
combination chemotherapy in treating patients with recurrent or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i/ii trial to study the effectiveness of combination chemotherapy consisting of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or metastatic colorectal cancer.

objectives: i. determine the response rate and survival of patients with recurrent or metastatic colorectal carcinoma treated with fluorouracil (5-fu), leucovorin calcium, and gemcitabine. ii. evaluate and establish the toxic effect profile of 5-fu, leucovorin calcium, and gemcitabine in these patients. outline: this is a dose escalation study. patients receive intravenous leucovorin calcium for 60 minutes and bolus infusions of fluorouracil (5-fu), followed by gemcitabine infusions, weekly for six weeks followed by 2 weeks of rest. the dosage of gemcitabine is increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities. phase ii proceeds at the maximum tolerated dose (1 dose level below that at which 3 patients experience grade 3-4 toxicities). patients receive a minimum of two courses of treatment to be considered evaluable for response. patients with stable disease, partial, or complete remission may continue therapy for up to six treatment cycles. patients exhibiting disease progression or intolerable toxic effects are removed from the study. projected accrual: a total of 63 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven recurrent or metastatic primary colorectal carcinoma must have measurable disease (evaluable disease acceptable in phase i) patient characteristics: age: not specified performance status: ecog 0-3 life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 platelet count at least 150,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl or 3.0 mg/dl in patients with liver metastases liver enzymes no greater than 3.0 times upper limit of normal (in patients with liver metastases) renal: not specified other: not pregnant or lactating fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: prior chemotherapy for metastatic disease allowed prior treatment with 5-fu allowed prior treatment with irinotecan allowed endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiotherapy (measurable disease must be located outside the prior radiotherapy portal) surgery: not specified other: prior treatment with folinic acid allowed

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer
intra-arterial chemotherapy for the treatment of progressive diffuse intrinsic pontine gliomas (dipg).

Conditions: Diffuse Intrinsic Pontine Glioma (DIPG)

Summary: the goal of this pilot study is to determine if intra-arterial (ia) chemotherapy is safe in the treatment of progressive diffuse intrinsic pontine gliomas (dipg). ia administration of the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing the local delivered dose while minimizing systemic toxicity. it also provides a treatment option for these patients at the time of tumor recurrence.

delivering the chemotherapeutic agent directly to the tumor via the arterial system avoids the complications and adverse events associated with toxicity from systemic chemotherapy.

Eligibility criteria:
inclusion criteria: * pediatric patients of all ages with progressive dipg. * consensus following presentation of the case at the multidisciplinary pediatric neuro-oncology conference, which includes participation of neuro-oncology, neurosurgery, radiation oncology, interventional neuroradiology and neurology. exclusion criteria: * documented hypercoagulable disorders or vasculopathies * inr value more than a grade 1 toxicity by ctcae v 4.0 criteria (\>1 - 1.5 x uln; \>1 - 1.5 times above baseline if on anticoagulation). * aptt value more than a grade 1 toxicity by ctcae v 4.0 criteria (\>uln - 1.5 x uln). * platelets less than 50 x 103/mm3 * absolute neutrophil count less than 500/ mm3 * pregnancy * documented severe allergic reaction to iv iodinated contrast, specifically bronchospasm and anaphylaxis.

Keywords: diffuse intrinsic pontine glioma (dipg) intra-arterial chemotherapy angiography
trial with bronchipret and sinupret to evaluate acceleration of mucociliary clearance (mcc)

Conditions: Current Smokers

Summary: proof of concept: superiority of bronchipret or sinupret to placebo in respect to mucociliary clearance


Eligibility criteria:
inclusion criteria: 1. volunteers who have given their signed declaration of consent and have signed the data protection declaration 2. male or female volunteers 25 - 40 years 3. current smokers (5-20 cigarettes per day since 5 years at least) 4. ability to taste sweetness of saccharin 5. perception of sweetness within 30 minutes after placement of saccharin behind nasal valve exclusion criteria: 1. ciliary dyskinesia 2. cystic fibrosis 3. copd/emphysema 4. asthma 5. chronic rhinosinusitis 6. acute respiratory tract infection within the last 6 weeks prior to enrolment 7. septal or sinus surgery 8. symptomatic allergic rhinitis 9. known allergic rhinitis 10. treatment with not-permitted previous or concomitant therapy 11. history of snuff consumption for longer than 1 month or intranasal consumption of recreational drugs such as cocaine or heroin for longer than 1 month 12. any disease or condition that might affect the safety of the subject during the trial, according to the investigator's judgement
shock wave versus vacuum assisted closure on chronic diabetic foot ulcer

Conditions: Chronic Diabetic Foot Ulcer

Summary: this study will be a randomized, open-label, pretest post-test with two study groups.

the randomization procedure will be performed by a simple drawing of lots (a or b) which determined whether participants would receive shock wave therapy ( group a) or vacuum-assisted closure therapy (group b). patients in both groups will receive the same medical treatment and nursing care.

Eligibility criteria:
inclusion criteria: all patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence. exclusion criteria: patients with acute cellulitis, osteomyelitis, or gangrene anywhere in the affected extremity. patients with renal, hepatic, neurological, or malignant diseases. patients with severe protein malnutrition (serum albumin \< 2.0 g/dl) or severe anemia (hgb \< 7.0 g/dl). patients with an ankle-brachial index \< 0.7, absence of the dorsalis pedis or posterior tibial artery pulse. patients who had debridement; pregnancy. patients who refused to join the study, or to sign the written consent.

Keywords: shock wave therapy vacuum-assisted closure chronic diabetic foot ulcer
colecalciferol as an add-on treatment to subcutaneously-administered interferon-beta-1b for treatment of multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: this is a one-year multi-centre, double blind, placebo controlled, randomized trial investigating oral vitamin d3 (colecalciferol) as an add-on treatment to interferon-beta-1b for multiple sclerosis (ms). not less than one month after initiation of therapy with interferon beta 1b, ms patients will be randomised to once weekly treatment with peroral colecalciferol capsules (dekristol®, swiss-caps, switzerland) containing 0.5 mg of vitamin d3, or to once weekly peroral treatment with matching placebo. the hypothesis is that vitamin d suppresses clinical and mri activity of ms.

the patients will be examined clinically at baseline and at 6, and 12 months. laboratory assessments will be performed at screening and 1, 2, 3, 6, 9 and 12 months after baseline. mri will be performed (t1-weighted and t2-weighted) at randomization and 12 months thereafter. sample size is 80 patients: two groups with 40 patients in each group. the primary statistical analyses will be based on the intent-to-treat (itt) population which consist of all randomized patients who have started study medication. the primary efficacy variable mri t2 bod will be analyzed using ancova with mri t2 bod at baseline as covariate. the incidence (with corresponding 95% confidence interval) of hypercalcaemia (mild, moderate and severe), laboratory abnormalities, dose adjustments, and significant adverse events will be calculated. the vitamin d status (proportion of patients with p-pth \ 85 nmol/l) at 6 and 12 months will be analyzed using logistic regression.

Eligibility criteria:
inclusion criteria: * rrms edss 0-5 * betaferon used for at lest one month with positive mxa-response exclusion criteria: * hypercalcaemia * kidney stones * uncontrolled hypertension * hypothyreosis * peanut allergy * severe depression * sarcoidosis * use of other imd than interferon-beta

Keywords: ms vitamin d environment
does use of topical lidocaine in egd reduce amount of iv midazolam and fentanyl required and shorten recovery time

Conditions: Dysphagia; GERD; Abdominal Pain

Summary: patients will be randomized to a placebo or study group who will receive topical lidocaine prior to egd. amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.

the study will be a double blinded randomized placebo controlled trial patients between 18 and 89 years old who are scheduled for egd may be eligible to enroll in the study. potential subjects will be sought through referral by their treating attending and fellow gastroenterologist, who will be apprised of the inclusion and exclusion criteria. patients possibly meeting inclusive and exclusive criteria will be approached and discussed the study further with the investigators. those expressing a desire to participate in the study will be given written informed consent prior to participation. the investigators will enroll patients into the study with a goal of at least 53 patients in each group which is the number of patients our statistician recommended to appropriately power our study. patients who consent to enroll in the study will be randomized into 2 groups. group 1: swish and swallow 10ml of 2% lidocaine solution group 2: swish and swallow 10ml of 0.45% sodium chloride solution the patients will then undergo endoscopy for the indication identified in their clinic appointment. following the procedure, patients will be taken to the recovery area and recovered per clinic protocol. the endoscopist will complete a satisfaction questionnaire. the day following the procedure a nurse will call to check for post-operative complications per clinic protocol. the day following, an investigator will also call to perform a patient satisfaction survey..

Eligibility criteria:
inclusion criteria: * egd alone performed by staff gastroenterologist as an outpatient * between the age of 18 and 89 * not requiring anesthesia support or use of medications other than fentanyl and midazolam exclusion criteria: * prior history of head and neck surgery * known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine * patients having interventions other than polypectomy performed * pregnant or breast feeding females * patients with severe liver impairment * known hypersensitivity to benzodiazepine or fentanyl

Keywords: egd topical lidocaine recovery time intravenous sedation
inflammation and metabolic acidosis at birth (again: autophagy acidosis newborn)

Conditions: Neonatal Encephalopathy; Cell Damage; Metabolic Acidosis; Inflammation

Summary: protection of brain development is a major aim in the neonatal intensive care unit. neonatal encephalopathy (ne) occurs in 1.8 to 7.7 infants per 1000 births. over the last six years, several randomized control trials have demonstrated that therapeutic hypothermia reduces the rate of death or disability at 18 months of age among infants who survived. however, the neurodevelopmental outcome in milder ne not treated with hypothermia remains unclear. a multicenter prospective observational study will be conducted to determine biological changes of mild neonatal encephalopathy who are not recruited for therapeutic hypothermia .

it is a prospective observational multicenter study on 50 newborns with mild neonatal encephalopathy and metabolic acidosis at birth not qualified for therapeutic hypothermia compared to healthy controls. infants with metabolic acidosis at birth and evidence of mild encephalopathy graded according to sarnat\&sarnat neurological evaluation will be recruited to evaluate plasma concentration of melatonin and levels of autophagy, mitophagy and inflammation. plasmatic changes will be compared to: * healthy control * infants with isolated metabolic acidosis at birth and normal neurological evaluation.

Eligibility criteria:
inclusion criteria: * gestational age \> 35 weeks and weight \> 1800 gr * apgar score \ 12 mmol/l or ph \< 7,0 at initial blood gas analyses * evidence of mild encephalopathy graded according to sarnat\&sarnat neurological evaluation * normal amplitude integrated electroencephalography exclusion criteria: * suspected inborn errors of metabolism * major chromosomal congenital defects

Keywords: mild neonatal encephalopathy birth asphyxia metabolic acidosis autophagy mitophagy inflammation
echotip acucore post-market clinical study

Conditions: Adenocarcinoma; Neuroendocrine Tumors; Hepatocellular Carcinoma; Cholangiocarcinoma; Malignant Lymphoma; Metastasis; Chronic Pancreatitis; Autoimmune Pancreatitis

Summary: the purpose of collecting this data is to continue to learn more about the echotip acucore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the echotip acucore.


Eligibility criteria:
inclusion criteria: * patient has been referred for an endoscopic ultrasound (eus) fine needle biopsy procedure * the echotip acucore device is the first eus biopsy needle used in the procedure. exclusion criteria: * patient's age is less than 18 years * patient is unable or unwilling to sign and date the informed consent. if irb approves a waiver of consent, this exclusion criterion is not applicable. * patient is simultaneously participating in another pre-market investigational drug or pre-market investigational device study involving an eus fine needle biopsy procedure and for which the patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment in this study. * inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)

Keywords: fine needle biopsy (fnb) core biopsy endoscopic ultrasonography-guided fine-needle biopsy (eus-fnb) tissue diagnosis histology endoscopic ultrasound interventional eus pancreas