Kornimate/medical-research-clean huggingface dataset:
the safety and efficacy of sublingual/oral immunotherapy for the treatment of milk protein allergy

Conditions: Milk Allergy

Summary: the purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.


Eligibility criteria:
inclusion criteria: * are age 6 to 21 years * provide signed informed consent (by parent or legal guardian if the subject is a minor), and informed assent if applicable * have a history of symptomatic reactivity to cow's milk (i.e. eczema, urticaria, upper or lower respiratory symptoms, gi disturbances, other rash or oral symptoms) * have a positive skin prick test (defined as wheal 3 mm ≥ negative control) and cow's milk- immunoglobulin e (ige) \> 0.35 kilo immunoglobulin units (kiu)/l * have a positive ofc to cow's milk at a cumulative dose of less than 184 milligrams of cow's milk intact protein (2,400 mg total milk protein). * are using appropriate birth control if subject is female and of child bearing age. * have self-injectable epinephrine (ie. epipen® or epipen jr.®) available at home exclusion criteria: * have a history of severe anaphylaxis defined as hypoxia (cyanosis or spo2 ≤ 92% at any stage), hypotension, confusion, collapse, loss of consciousness; or incontinence * have a history of intubation related to asthma * tolerate more than 184 milligrams of intact cow's milk protein at initial ofc * are pregnant or lactating * have a viral upper respiratory infection (uri) or gastroenteritis within 7 days of ofc (ofc needs to be rescheduled) * have pulmonary function tests \<80% of predicted (fev1) or clinical history consistent with more than moderate persistent asthma * are currently taking greater than medium dose inhaled corticosteroid (\>400 mcg/day fluticasone or fluticasone equivalent if ≤ 12 years old or \> 600 mcg/day if \> 12 years old) * are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges * have used systemic corticosteroids within 4 weeks prior to baseline visit * are receiving omalizumab, beta-blocker, angiotensin converting enzyome (ace) inhibitor or tricyclic antidepressant therapy * have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes) * have participated in any interventional study for treatment of a food allergy in the past 12 months * have a severe reaction at initial dbpcfc, defined as either: life-threatening anaphylaxis, or reaction requiring hospitalization

Keywords: food allergy oral immunotherapy immunoglobulin e
adequacy assessment of bronchoscopic biopsy samples using a novel instrument

Conditions: Lung Cancer; Lung Diseases

Summary: the goal of this study is to learn whether the ruby robotics system enables pathologists to determine whether a bronchoscopic biopsy sample is adequate for diagnosis. the main question it aims to answer is: - are pathologists' evaluations of ruby digital images concordant with their evaluations of manually created rapid on-site evaluation slides?


Eligibility criteria:
inclusion criteria: * the subject will undergo a planned, non-emergent transbronchial lung and/or thoracic lymph node biopsy. exclusion criteria: -

Keywords: lung biopsy bronchoscopy
erector spinae plan block (espb) with dexmedetomidine and dexamethasone in lumbar spine fusion

Conditions: Lumbar Degenerative Disease

Summary: this study wants to understand if using a pre-operative anesthetic injection could contribute to better pain relief after the surgery. this injection is referred to as an erector spinae plane block (espb, or "block" for short). in the past, blocks have been commonly used to alleviate different types of pain, including pain following lumbar spine surgery, but our investigators are curious to study if adding two additional commonly used drugs could improve pain relief following surgery when used together. this possibility for improvement in pain management is important for our doctors to study because they want to find ways to reduce the amount of pain medication required after surgery. we try to assess if one treatment is better than the other by looking into the amount of pain medication used immediately after the surgery (up to five times within the first 2 days; this is usually done by reviewing progress notes) and by asking patients if they can share with us their pain experienced at different times during their stay at the hospital and at 2-weeks after their procedure.

regional anesthetic techniques, including interfascial plane blocks, have demonstrated success in postoperative pain control and improved patient satisfaction. erector spinae plane blocks (espb) are a relatively new regional anesthetic modality, which have shown potential for perioperative pain control in lumbar spinal surgery. this study aims to investigate whether adding dexmedetomidine and dexamethasone as adjuncts to bupivacaine in espb improves analgesia and reduces opioid usage in lumbar spinal fusion patients receiving multimodal pain regimens. it will also assess the impact of these adjuncts on postoperative nausea and vomiting (ponv) and anti-emetic medication requirements. the study employs a randomized, double-blind design, with participants divided into two groups: espb without adjuvants (group a) and espb with dexmedetomidine and dexamethasone (group b). primary outcomes include opioid consumption at 24 hours postoperatively, while secondary outcomes involve opioid consumption at various time points and visual analog scale (vas) pain scores. the results of this investigation will provide valuable insights into the efficacy of espb with adjuncts in postoperative pain management in lumbar spinal fusion patients.

Eligibility criteria:
inclusion criteria: * medically optimized patients undergoing 1-3 level lumbar fusion surgery for treatment of degenerative lumbar spinal pathologies * aged 18 years or older * english-speaking patients exclusion criteria: * patients with surgical indications for infection, malignancy, or trauma * women who are pregnancy or breastfeeding * patients with respiratory compromise * patients who are smokers * patients with allergies to local anesthetics, and/or opioid medications

Keywords: analgesia espb erector spinae plane block dexmedetomidine dexamethasone bupivacaine randomized blinded postoperative opioid ponv nausea vomitting fusion
microbiome changes in travelers to tropical destinations

Conditions: Intestinal Diseases

Summary: the human gut contain a wide range of microorganisms creating the gut microbiome. the microbiome has great impact on metabolic and immunologic processes and responses. travelers who travel to tropical destinations where the intestinal infection risk is high are prone to microbiome changes. during the current study the travelers will give feces specimen before and after the travel and their microbiome will be analyzed.

individual differences in the microorganisms variety are affected by external factors such as food, age, geographic location, medication consumption, host genetics and exposure to microorganisms in early stages of life. during the current study the geographic location affect will be tested by comparing the microorganism environment before and after traveling to tropical destinations.

Eligibility criteria:
inclusion criteria: * travelers who intended to travel to tropical areas * good general health exclusion criteria: * medication consumption * background diseases
impact on carriage, acute otitis media, immuno & safety of gsk biologicals' pneumococcal conjugate vaccine 1024850a

Conditions: Infections, Streptococcal; Streptococcus Pneumoniae

Summary: the aim of this study is to assess the effectiveness of gsk biologicals' pneumococcal conjugate vaccine (gsk1024850a) in preventing invasive disease caused by s. pneumoniae or h. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. these data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442. the study will also assess the immune response to the gsk1024850a vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

the protocol posting has been updated with regards to the outcome measures following protocol amendment 4, 12 august 2011.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study. * male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination. * written informed consent obtained from parent(s) or from the guardian(s) of the subject. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period. * previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. if a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, hiv infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, csf fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program. * previous vaccination against hepatitis b virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period. * previous vaccination against hepatitis a virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period. * known severe hypersensitivity to any component of the study vaccines, including neomycin. * any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

Keywords: streptococcus pneumoniae acute otitis media pneumococcal conjugate vaccine nasopharyngeal carriage haemophilus influenzae immunogenicity invasive disease
effect of nigella sativa seed extract on the blood pressure of elderly with hypertension

Conditions: Hypertension

Summary: despite of the development of new anti hypertensive agents, hypertension in elderly is still a big health problem. nigella sativa seed extract, derived from a small plant originating in middle east which can be found abundantly in asia, has shown small antihypertensive effect in adult. diuretic effect of nigella sativa is thought to be the main mechanism for the effect but as it also shows anti-inflammatory and vasodilatory activity which are important contributors in arterial stiffness, the main pathogenesis of hypertension in elderly, thus it has a superior potential benefit for this population. we will conduct a randomized, double blind, placebo-controlled trial to prove the effect of nigella sativa seed extract in elderly patients with hypertension. our hypothesis is 300 mg nigella sativa seed extract twice daily will have anti-hypertensive effect in the blood pressure of elderly with hypertension.

the study will be conducted in geriatric outpatient clinic of cipto mangunkusumo national hospital, jakarta, indonesia. eligibility criteria are men and women over 60 years old and available to participate in the study for 4 weeks with blood pressure higher than 140/90. exclusion criteria are renal disease, hepatic failure, dementia and orthostatic hypotension and malignant hypertension. outcome measures are systolic and diastolic blood pressure after 4 weeks administration of 300 mg nigella sativa seed extract twice daily.

Eligibility criteria:
inclusion criteria: * men and women more than 60 years old * systolic blood pressure 140 mm hg and or diastolic blood pressure 90 mmhg * available during study duration (4 weeks) exclusion criteria: * renal failure * hepatic failure * dementia * orthostatic hypotension * malignant hypertension

Keywords: nigella sativa seed extract hypertension elderly
impact of [11c]-methionine pet/mri in the detection of pituitary adenomas secreting acth and causing cushing's disease

Conditions: Cushing's Disease

Summary: cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive acth secretion. this results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. the etiological diagnosis is based on magnetic resonance imaging (mri). however, pituitary mri revealed a pituitary tumor in only 60% of patients. the diagnostic procedure is complicated by the existence of extra pituitary tumors responsible for acth ectopic secretion. this rare etiology imposes, in the absence of typical pituitary image, the realization of catheterization of the lower petrosal sinuses. treatment of cushing's disease is based on transsphenoidal surgical management, even in the absence of a formal mri image, if pituitary origin is confirmed by the catheterization. although pituitary surgery without identified target is part of french recommendations, this surgery is associated with a high risk of failure and morbidity. optimization of the management of patients' with cushing's disease thus requires the improvement of the diagnostic methods. hypothesis of our study is that \[11c\] met mri-pet may be performed as a first-line mri for suspected cushing's disease and may limit indications for catheterization of lower petrosal sinuses. its localizing value should also make it possible to improve the surgical results with a better identification of the adenoma


Eligibility criteria:
inclusion criteria: * aged 18 years old or over * patient with a diagnosed cushing's disease according to the french "protocole national de diagnostic et de soins (pnds)" * patient who underwent a mri pituitary for diagnostic purposes * patient who have undergone catheterization of the lower petrosal sinuses (if mri does not detect pituitary adenoma) and have a result in favor of a central secretion of acth * patient having an indication of surgical excision of the adenoma * patient with a micro-adenoma (less than 1 cm in diameter) if the tumor is visualized on mri * patient for which informed and written consent to participate has been obtained. exclusion criteria: * - patient participating in another study * patient with a pituitary macro-adenoma with visual impairment * patient with acth-dependent cushing's syndrome secondary to ectopic acth secretion * patient with recurrence and / or history of pituitary adenoma excision * patient with a contraindication to pituitary surgery or general anesthesia * pregnant woman, breastfeeding or old enough to have children but without effective recognized contraception * contra-indication to the realization of an mri: permanently fixed metal parts (pacemaker, cerebral clip, cephalic end piercing, cochlear implant, pin or screw for recent bone fracture, dental equipment, metal splinters), claustrophobia

Keywords: : cushing's disease, [11c]-methionine pet/mri, sensitivity
clinical trial to explore the papilocare gel efficacy to repair the cervico-vaginal mucosa with lesions caused by hpv

Conditions: Human Papilloma Virus Infection; Human Papilloma Virus; Cervix Lesion

Summary: phase ii, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel papilocare in the repair of the cervico-vaginal mucosa with lesions caused by hpv. all the patients included in the study will be randomized (1:1:1).

phase ii, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel papilocare in the repair of the cervico-vaginal mucosa with lesions caused by hpv. all the patients included in the study will be randomized (1:1:1) to arm a (papilocare schedule a), arm b (papilocare schedule b) and arm c (usual clinical practice -without treatment-). selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. patients will visit the site into a total of 5 visits throughout the study.

Eligibility criteria:
inclusion criteria: 1. woman between the ages of 30 and 65 (both included). 2. able to read and understand the patient information sheet and the informed consent form. 3. accept participation in the study and sign the informed consent form. 4. cytological result of asc-us or lsil or ag-us, with matching colposcopic image, maximum 3 months before the screening visit. 5. positive hpv by pcr performed at the screening visit (or positive available at most 3 months prior to the baseline visit). 6. is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations throughout it. exclusion criteria: 1. clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants. 2. non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit). 3. to had been vaccinated against hpv. 4. other symptomatic vulvovaginal infections. 5. surgical cervical excision in the last year or total hysterectomy. 6. previous history of gynecological cancer. 7. participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the study. 8. any planned surgery that prevents the correct compliance with the protocol. 9. use of vaginal contraceptives or other vaginal hormonal treatments. 10. contraindications for papilocare gel use or known allergies to any of its components. 11. women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.

Keywords: hpv
thalidomide and cyclophosphamide in treating children with recurrent or refractory childhood cancers

Conditions: Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: thalidomide may kill tumor cells by stopping the growth of new blood vessels to the tumor. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining thalidomide with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining thalidomide and cyclophosphamide in treating children who have recurrent or refractory childhood cancers.

objectives: i. determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies. outline: patients receive oral thalidomide 4 times daily. cyclophosphamide is administered iv over 1 hour once every 4 weeks, beginning on the same day as thalidomide. treatment continues in the absence of unacceptable toxicity or disease progression. tumor response is assessed every 3 months. projected accrual: a total of 45-80 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically or cytologically proven pediatric malignancy, except when there is appearance consistent with brainstem tumor on mri, a tumor marker positive for germ cell tumor, or ophthalmologic diagnosis of intraocular retinoblastoma failed conventional treatment or conventional therapy is not available measurable disease by mri, ct scan, biochemical tumor markers, cytology, or bone marrow examination patient characteristics: age: not specified performance status: lansky 60-100% or karnofsky 60-100% life expectancy: at least 6 weeks hematopoietic: absolute neutrophil count at least 750/mm3 (between 300-750/mm3, if due to bone marrow infiltration by malignancy) platelet count at least 75,000/mm3 (between 20,000-75,000/mm3, if due to bone marrow infiltration by malignancy) hepatic: bilirubin less than 2.0 mg/dl alt less than 3 times upper limit of normal (uln) renal: creatinine less than 2 times uln or creatinine clearance at least 70 ml/min neurologic: no peripheral neuropathy grade 3 or 4 no seizure disorder in patients without cns malignancies other: not pregnant or nursing negative pregnancy tests during study and for 1 month after final dose of thalidomide fertile patients must use effective contraception during and for at least 1 month after study prior concurrent therapy: see disease characteristics no limit on the number of prior agents or regimens received biologic therapy: prior bone marrow transplantation allowed chemotherapy: recovered from prior chemotherapy no prior thalidomide endocrine therapy: not specified radiotherapy: not specified surgery: at least 4 weeks since prior major surgery (2 weeks for minor surgery, excluding central venous catheter placement procedures)

Keywords: unspecified childhood solid tumor, protocol specific
collection of specimens for study of inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: this study will collect tissue specimens to be used for research on inflammatory bowel disease. the tissues will be used to explore why people get inflammatory bowel disease and to try to develop new treatments based on the study results. tissue from patients with ibd will be compared with that from patients who do not have the disease patients who undergo bowel surgery for inflammatory bowel disease (ibd) or another bowel disorder may be eligible for this study. patients with ibd must be at least 4 years of age; those with another disorder must be 18 years of age or older. participants undergo bowel surgery for their disease. some of the intestinal tissue removed during the surgery that is not needed for medical care, such as for pathological examination, is provided to researchers for study under this protocol. in addition, patients with ibd provide a blood sample for genetic testing. several genetic variations, or mutations, may increase the risk of developing ibd; blood samples from patients may help identify these variations.

our ongoing natural history studies of the etiology and immune abnormalities of the group of diseases known collectively as the inflammatory bowel diseases require access to clinical samples of intestinal tissue as well as blood samples for genotyping. this protocol provides a mechanism for procurement of intestinal samples obtained at the time of medically-indicated surgical procedures from patients with ibd or some other non-ibd diagnosis (to act as a control group). in addition it allows for the procurement of blood for dna preparation as more ibd susceptibility genes are discovered and we further our work on association of genetic polymorphisms/mutations with the phenotype and immune abnormalities observed in our ibd patients.

Eligibility criteria:
* inclusion criteria for subjects with inflammatory bowel disease: 1. presence of idiopathic inflammatory bowel disease as established by prior endoscopic, histologic, and/or radiographic findings. 2. ability to give consent or have legally authorized person give consent and agree to sample storage. exclusion criteria for subjects with inflammatory bowel disease: 1. less than 4 years old. inclusion criteria for subjects without inflammatory bowel disease: 1. absence of idiopathic inflammatory bowel disease as established by tests that exclude these diagnoses. 2. ability to give consent and agree to sample storage. exclusion criteria for subjects without inflammatory bowel disease: 1. less than 18 years of age.

Keywords: surgery intestinal resection blood sample