Kornimate/medical-research-clean huggingface dataset:
study of choroid plexus cauterization in patients with hydrocephalus

Conditions: Hydrocephalus

Summary: the purpose of this study is to determine whether endoscopic choroid plexus coagulation is safe in adult patients with communicating hydrocephalus and risk factors for complications from the standard surgical treatment. it may also help determine whether the endoscopic choroid plexus coagulation is effective in treating your communicating hydrocephalus. the investigators hope that this research will allow us to place fewer shunts in patients with conditions similar to yours, avoiding complications.


Eligibility criteria:
inclusion criteria: * adult patients (age 18 or older) with communicating hydrocephalus, who have risk factors for complications following shunt surgery. risk factors include loculated hydrocephalus (i.e., imaging evidence that the ventricles of the brain do not communicate with each other, in the setting of known communicating hydrocephalus); prior episodes of ventriculitis and/or shunt infection; subdural hematoma associated with shunt placement; inability to place a distal catheter in the peritoneal cavity due to scarring or prior infection; and multiple prior episodes of shunt failure. * in patients with communicating hydrocephalus who have significantly increased lateral and third ventricular size and normal fourth ventricular size, an endoscopic third ventriculostomy will be performed in conjunction with the choroid plexus cauterization, provided that communicating hydrocephalus is thought to be present, based on either the history (for example, past meningitis or other infectious or inflammatory disease, or history of communicating hydrocephalus without disproportion of the ventricles in the past; or imaging findings, such as patency of the foramina of magendie and luschka). exclusion criteria: * exclusion criteria include patients who have non-communicating hydrocephalus; patients who are undergoing emergency surgery because of rapid decline in neurologic condition; and patients with medical conditions such as coagulopathy or severe cardiac conditions, that preclude neurosurgical intervention. * in the case of adults unable to consent, informed consent will be obtained from appointed health care proxies. minors, pregnant women, and prisoners will be excluded from the study.
5-ala patch-pdt of actinic keratosis on the upper extremities

Conditions: Actinic Keratoses

Summary: this study evaluates the potential usefulness of photodynamic therapy with pd p 506 a in patients with actinic keratosis on the upper extremities for the first time.

patients will receive a second pd p 506 a-pdt on all ak lesions 1-2 weeks after the first pdt.

Eligibility criteria:
inclusion criteria: * written informed consent has been signed prior to or at screening visit * caucasian male and female patients * age ≥ 18 years * diagnosis of actinic keratosis (ak) with at least three locally separated lesions located on the upper extremities * selected ak study lesions have clearly defined margins and are mild to severe (grades i to iii): * mild grade (i): slight palpability, better felt than seen * moderate grade (ii): moderately thick ak, easily felt * severe grade (iii): very thick and/or obvious ak * skin sun sensitivity type i to iv according to fitzpatrick exclusion criteria: * pdt non-responder * pre-treatment of the ak lesions eligible for study procedures with pharmaceuticals approved for the treatment of ak during the 4 weeks preceding pdt (e.g. antineoplastic topical formulations as e.g. metvix®, ameluz®, luxerm®, solaraze®, aldara®, picato®, actikerall®, 5-fu or vitamin a acid containing formulations) * pre-treatment of the ak lesions eligible for study procedures during the 2 weeks preceding pdt with keratolytic agents e.g. tca, urea or salicylic acid containing formulations * pre-treatment with hypericin during the 2 weeks preceding pdt * treatment with systemic retinoids during the 3 months preceding pdt * treatment with cytostatics or radiation during the 3 months preceding pdt * female patients of childbearing potential (a female is considered of childbearing potential unless she has had tubal ligation, hysterectomy or has been postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months.) * patients with clinically relevant suppression of the immune system * diagnosis of porphyria * known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematosus or pemphigus erythematosus * concomitant use of medicinal products with known phototoxic or photoallergic potential such as hypericin, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines * skin diseases that might interfere with response evaluation of study pdt * skin sun sensitivity type v or vi according to fitzpatrick * known intolerance to one or more of the ingredients of the study medication * dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent * simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion * suspected lack of compliance

Keywords: actinic keratosis on the upper extremities
a study to evaluate the effectiveness of jnj 40929837 for the treatment of asthma using a bronchial allergen challenge model

Conditions: Asthma

Summary: the purpose of this study is to evaluate the allergen-induced late asthmatic response (lar), as measured by maximal percent fall in forced expiratory volume in 1 second, in participants with stable mild atopic asthma after treatment with jnj 40929837 as compared to placebo.

this is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither the physician nor participant will know which of the treatments a participant is receiving, but can access the information in case of an emergency), and crossover (method used to switch participants from one treatment arm to another in a clinical study) study. approximately 18 participants will participate in the study. the study will consist of screening phase (30 days before the administration of study drug), treatment phase, and follow-up phase (2 weeks after the end of the last treatment period). participants will be randomly assigned to receive jnj 40929837, placebo, and montelukast. each participant will receive all the 3 treatments (7 days per treatment) and each treatment will be separated by 14 days of wash-out period (no treatment). safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be evaluated throughout the study. the maximum study duration for a participant will be approximately 51 days.

Eligibility criteria:
inclusion criteria: - generally healthy - have mild atopic asthma requiring no other treatment besides occasional short-acting beta-2-agonists - have allergen-induced early asthmatic response of at least a 20 percent reduction in forced expiratory volume in 1 second (fev1) and late asthmatic response of at least a 15 percent reduction in fev1 during bronchial allergen challenge performed at screening - females who are post menopausal, surgically sterilized, or practicing a highly effective method of birth control - have an fev1 at screening visit at least 75 percent of the predicted value - have a history of asthma symptoms during exposure to indoor or outdoor allergens and a positive prick skin test done at the study site to dust mite, mixed grass pollen, or cat dander exclusion criteria: - worsening of asthma or a respiratory tract infection within 6 weeks - hiv or hepatitis b or c positive - receipt of an investigational drug or use of an investigational medical device within the last month - use of tobacco products of any kind currently or within 6 months - have clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram at screening as deemed appropriate by the investigator

Keywords: asthma mild asthma singulair jnj 40929837 montelukast
csii pilot in adolescents with type 2 diabetes

Conditions: Diabetes

Summary: this feasibility pilot is intended to understand whether adolescents with type 2 diabetes (2dm) can be transitioned to a continuous subcutaneous insulin injection (csii) and if so, assess whether csii is a feasible treatment modality and improves quality of life (qol) in adolescents with t2dm over 3 month period.


Eligibility criteria:
inclusion criteria: * adolescents with type 2 diabetes mellitus between the ages of 12- 23 years, who have had t2dm for at least 6 month duration, and who have had a hba1c \> 8% in the preceding 3 months prior to enrollment into the study. as a diabetes is a chronic disease the aap (american academy of pediatrics; 2002) definition of a "pediatric patient "is from birth until 21 years old. there are patients in the diabetes program that we sometimes follow for 2-3 years beyond this age of 21 years and therefore would like to offer this study until the age of 23 years. this will give opportunity to our patients to be recruited if they would choose to participate in the study. * confirmed t2dm as defined by american diabetes association i.e. fpg \> 126 mg/dl or blood sugar \> 200 mg/dl on a 2 hr, 75 g ogtt or random blood sugar \>200 mg/dl. pubertal, tanner stage \>1 * subjects must be willing to comply with study protocol requirements * females must have a negative pregnancy test within 72 hours prior to the start of the study and on every subsequent study visit. if on any visit their pregnancy test is positive they will be asked to not continue in the study. if the adolescent is using contraception such as birth control pills they will be allowed to continue using them during the study as this should not affect glucose levels. once a female is confirmed to be pregnant we will take the insulin pump and restart insulin injection regimen that they were before the start of the study. we will also make an aptt with "high risk obstretics" and encourage the adolescent to check their blood sugars at least 4-6 times per day. * the patient must be on insulin to qualify for the study. the adolescents could be on oral hypoglycemic agent in addition to insulin to be included in the study. exclusion criteria: * chart review of adolescents with t2dm will be done to confirm absence of glutamic acid decarboxylase, islet cell or insulin autoantibodies or secondary causes of diabetes * other significant major organ system illness * females who are pregnant at their initial assessment. we will be testing female participants on every visit with a urine pregnancy test and if they are found to pregnant we will ask them to stop using their pump and go back to using insulin injections. * significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse and uncontrolled major depression. * all adolescents who have signs of renal insufficiency (creatinine clearance based on schwartz equation \>0.55 for females and males 0.7 ages 13-18 years) (13). serum creatinine will be available on the metabolic profile. subjects with elevated crcl will be excluded from the study.

Keywords: adolescents insulin t2dm
pediatric research on improving speed, memory and attention

Conditions: Brain Tumors

Summary: introduction: the aim of this study is to investigate the efficacy of neurofeedback (nfb) to improve attention, memory and processing speed in children treated for a brain tumour (bt). in the netherlands every year approximately 100 children are diagnosed with a bt. nowadays over 65% of these children have a 5-year survival. treatment for a bt consists of neurosurgery and / or local or craniospinal radiation and / or adjuvant chemotherapy. neurotoxicity caused by radiotherapy and / or chemotherapy (especially methotrexate) is a major cause of neurocognitive decline in childhood brain tumour survivors (cbts). approach: studies have shown that nfb has the capacity to improve the brain systems mediating selective attention and response inhibition in children with attention deficit/hyperactive disorder (adhd). the effectiveness is reported as comparable to methylphenidate (ritalin) without side effects of medication. cbts exhibit symptoms comparable to those of children with adhd and positive response to methylphenidate has been found in cbts. however, nfb has not been used as an intervention in cbts yet. the effectiveness of nfb in children treated for a bt will be investigated in a randomized controlled trial. the intervention group of 30 patients will receive approximately 30 sessions of nfb; the control group will receive 30 session of placebo neurofeedback. neuropsychological tests will be used to evaluate pre- and post-nfb intervention as well as at a 6-month follow-up. relevance: if nfb proofs to be effective for cbts this will be a great improvement for their (neuro-) psychological functioning and quality of life, without the disadvantage of the side effects of medication. the implementation of this intervention might increase cognitive and social functioning and thus facilitate integration of these children in society during childhood and school carrier as well as in adult life.


Eligibility criteria:
inclusion criteria: * being treated for a brain tumour before the age of 16 years * age between 8-18 years at time of enrolment * off treatment at least two years * problems on attention, or memory or speed processing as reported by parents in screening test * being able to speak and understand the dutch language exclusion criteria: * premorbid ad/hd * mental or physical condition that make the neuropsychological assessment impossible to finish

Keywords: childhood brain tumour survivors
sustainable weight loss study: nutrition support tools and weight loss among obese people

Conditions: Obesity

Summary: the purpose of this research study is to determine the effectiveness of nutrition tools to support weight loss among obese individuals. all participation will be based online and there will be no in-person visits. participants will be given nutrition support tools for 6 months. participants will be asked to report their weight and diet at the start of the study, and every month for 6 months during the study period. participants will additionally be asked to report weight and diet at 12 months, 18 months, and 24 months after the start of the study. total study duration will be 2 years.

obesity is a major public health burden. weight loss among obese participants may improve future health outcomes and financial burden to the healthcare system and employers. the effect of personalized meal planning and online food purchasing and delivery on weight loss and management is unknown. design: this trial is an online, three-arm randomized trial to compare a meal planning and telenutrition tool, a meal planning tool only, and myplate optimization. participants will be assigned to randomly assigned in a 1:1:1 ratio to one of the three groups. participants will follow the intervention for 6 months after randomization and will be followed for an additional 1.5 years after randomization. participants will report dietary behavior and weight at baseline and each month of the intervention (6 months), 12 months, 18 months, and 24 months. population approximately 300 participants will be enrolled and randomized (100 per arm). participants will be adults living in new york state who are obese (at least a bmi of 30 kg/m2). outcomes primary outcome: weight change after 6 months other outcomes: waist circumference; blood pressure, dietary changes, cooking, meal planning, and eating out frequencies

Eligibility criteria:
inclusion criteria: bmi ≥ 30 kg/m2 male or female 18 or older non-institutionalized able and willing to provide informed consent willing to change diet for 3 months has access to a scale to weigh themselves lives in ny state exclusion criteria: refuse or are unable to provide informed consent to participate in the study undergoing active cancer treatment has type 1 or 2 diabetes stage 3+ ckd or kidney failure are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months report of congestive heart failure diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) current or former zipongo users

Keywords: weight loss digital nutrition healthy eating food purchasing meal planning obese online myplate
evaluation of 68ga-fapi-46 and 18f-fdg pet/ct imaging for detecting recurrent tumor lesions in patients of ovarian cancer

Conditions: Ovarian Cancer

Summary: a prospective cohort imaging study in a single institution to evaluate 68ga- fapi-46 and 18f-fdg pet/ct imaging for detecting recurrent tumor lesions in patients of ovarian cancer with ca125 elevation from complete response after therapy

ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. serum cancer antigen 125 (ca125) is widely used in ovarian cancer. an elevation in ca125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18f-fdg pet/ct can modify management in approximately half of these patients. however. 18f-fdg pet/ct may yield false negative results. 68ga-fapi-46 pet/ct shows potential here. this study is to assess the diagnostic performances of 68ga-fapi-46 and 18f-fdg pet/ct for ovarian cancer recurrence in patients with ca125 elevation from complete response after therapy.

Eligibility criteria:
inclusion criteria: * pathologically proven ovarian cancer with complete response after therapy * age between 30 and 80 * elevation of serum ca125 value above the normal range (\>35 u/ml) or doubling of serum ca125 value within the normal range * ecog performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed * willing to enter this prospective study with signed informed consent form exclusion criteria: * patients with history of other malignancy * patients who are pregnant or lactating * patients with fasting fingerstick glucose level higher than 200 mg/dl * known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68ga-fapi-46 or 18f-fdg imaging studies * patients who are incapable of lying still for 30 minutes to receive the pet/ct scan as assessed by investigators

Keywords: 68ga-fapi-46 18f-fdg ca-125
efficacy, tolerability and safety study in rheumatoid arthritis (0812-008)

Conditions: Arthritis, Rheumatoid

Summary: to demonstrate the clinical effectiveness of mk0812 in the treatment of arthritis.


Eligibility criteria:
inclusion criteria: * patient has had diagnosis of ra made at least 6 months prior to study start and was greater than 16 years of age when diagnosed * patient has active ra with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints * excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests exclusion criteria: * patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis * patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure * female patient is pregnant or breast-feeding
remote postconditioning in patients with acute myocardial infarction treated by primary percutaneous coronary intervention (pci)

Conditions: Myocardial Reperfusion Injury; Myocardial Ischemia; Myocardial Infarction

Summary: background: experimental studies suggest that remote limb ischaemic postconditioning (rempostcon) can reduce infarct size in pigs. initial clinical applications support the beneficial role of rempostcon in preserving endothelial function during upper limb ischemia in healthy volunteers and in patients with stable coronary artery disease. aim of the study: to evaluate the feasibility, safety and efficacy of rempostcon in the setting of stemi and primary pci (ppci) and to investigate potential circulating mediators of its effects. patients and methods: patients who undergo ppci for anterior stemi within 6 hours since the onset of symptoms are randomly assigned to receive either rempostcon + ppci or ppci alone in a single-blind fashion. all patients receive therapy according to the current international guidelines. three cycles of ischemia-reperfusion are provided to the lower limb inflating a cuff to 200 mmhg. each cycle consists of 5' of ischaemia, followed by 5' of reperfusion. rempostcon is started at the time of angioplasty in the infarct related artery. primary endpoint is the area under the curve (auc) of creatinine kinase - mb (ck - mb). cardiac magnetic resonance (cmr) is performed early before discharge and 4 months after the event, if there are no contraindications.


Eligibility criteria:
inclusion criteria: * age \>= 18 yrs and age =\< 80 yrs * stemi definition * pain to door time \< 6 hrs * killip class 1 - 2 - 3 * initial timi flow 0 - 1 in the anterior descending artery * signed informed consent exclusion criteria: * pregnancy * cardiogenic shock * initial timi flow 2 - 3 in the anterior descending artery * history of prior mi in the past 6 months * history of prior cabg * history of peripheral vascular disease iii - iv grade * history of abdominal aortic aneurysm \> 5 cm * severe coronaropathy that could condition further revascularization before the end of the study * other relevant medical or surgical conditions that can influence prognosis at 4 months

Keywords: remote postconditioning myocardial reperfusion injury myocardial infarction primary pci