Kornimate/medical-research-clean huggingface dataset:
evaluation of new markers in type 3 angioedema

Conditions: Angio Edema

Summary: angioedema is a common condition, with multiple etiologies. type 3 angioedema is caused by an increase in kininogenase activity responsible for an increased production of bradykinin. in some cases, it may be associated with clotting factor 12 mutations. however, other genetic abnormalities remain to be identified. clinically, this angioedema type 3 is similar to types 1 and 2. the patient's vital prognosis is good if the diagnosis is made and if they have access to the appropriate treatment. otherwise a significant morbidity is associated with it, hence the importance of being able to define a diagnostic marker. videocapillaroscopy might be able to highlight abnormalities in the microcirculation of patients with a clinical display of angioedema. the purpose of this study is to highlight markers allowing to make an early diagnosis of angioedema. functional analysis of factor xii in patients with symptoms of angioedema may be an interesting marker for diagnosis. microcirculation abnormalities will also be evaluated by videocapillaroscopy, which may be another indicator of the disease.


Eligibility criteria:
inclusion criteria: * population of patients treated within the chu brugmann hospital for an angioedema (and control group of healthy individuals) exclusion criteria: * none
value of tomosynthesis in breast lesion characterization and breast cancer staging

Conditions: Breast Cancer

Summary: study rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. mri is considered as the most sensible exam for this staging. however it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. by contrast, tomosynthesis is performed during the same time than mammography and has a good specificity. although this modality is very promising, it has not been assessed in a population of consecutive patients. study objectives: to compare the diagnostic performance of preoperative bilateral combo mode (mg+tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.


Eligibility criteria:
inclusion criteria: * women at least 40 years old * subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, us, or mri) exclusion criteria: * subjects with brca mutation or at high genetic risk * subjects who have breast implants * personal history of breast cancer * subjects who are pregnant or who think they may be pregnant * subjects who are breast-feeding * subjects who are unable or unwilling to tolerate study constraints * subjects unable or unwilling to undergo informed consent * subject with no rights from the national health insurance programme

Keywords: tomosynthesis mammography breast cancer
rhinocort aqua versus placebo and fluticasone propionate

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of this study is to compare once daily treatment with rhinocort against placebo and fluticasone propionate at reliving the nasal symptoms of seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * at least a 2 year documented history of seasonal allergic rhinitis * who, in the opinion of the investigator, * is a candidate for treatment with nasal steroids based on a history of either * a)inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or * b) prior successful treatment with nasal steroids. * a positive response to a skin prick test at visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study. exclusion criteria: * primary or secondary adrenal insufficiency * nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator. * a diagnosis of asthma requiring treatment as specifies in the protocol.

Keywords: seasonal allergic rhinitis nasal symptoms congestion rhinorrhea sneeze budesonide rhinocort aqua fluticasone propionate flonase
a study of real-world use of ixazomib citrate in people with multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: in this study, people with mm will be treated with ixazomib citrate according to their clinic's standard practice. the main aim of the study is to check for side effects from ixazomib citrate.

this is a non-interventional, prospective, observational post-marketing surveillance study of ixazomib citrate in participants with mm. the study will assess the safety and effectiveness of ixazomib citrate for its approved indications in a clinical practice setting under real-world conditions. the study will enroll approximately 165 participants. the data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-crfs). all participants will be enrolled in a single observational group: • participants with mm the study will be conducted in south korea. the overall duration of the study will be approximately 6 years and 11 months. data will be collected over and up to a 6 months-surveillance period (per participant) once enrolled.

Eligibility criteria:
inclusion criteria: 1. participants with mm. 2. participants who are prescribed and initiate ixazomib citrate for the treatment of mm according to the ixazomib citrate south korean product label. exclusion criteria: 1. participants treated with ixazomib citrate outside of the locally approved label in south korea. 2. participants for which ixazomib citrate is contraindicated as per product label.

Keywords: drug therapy
pain phenotypes in patients with fibromyalgia syndrome

Conditions: Fibromyalgia, Primary; Fibromyalgia; Chronic Pain Syndrome; Pain, Neuropathic; Nociceptive Pain; Central Sensitisation

Summary: fibromyalgia syndrome (fms); is a complex syndrome characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions and psychiatric disorders. it has been stated that there is an urgent need for studies examining the clinicimetric and psychometric properties of the pain phenotype criteria in terms of patients receiving the most appropriate treatment, clinicians deciding on the appropriate treatment, and contributing to the research of scientists. despite all this, no study has yet been found that describes the pain phenotypes in fibromyalgia syndrome and how different types of pain affect patients. the primary aim of this study is to determine the chronic pain phenotypes in individuals with fms. the secondary aim of this study to determine the inter-rater and intra-rater reliability of the algorithm used in the determination of pain phenotypes and to assessment the clinical effects of different pain phenotypes on individuals with fms in terms of pain severity, disease severity, quality of life and catastrophe.


Eligibility criteria:
inclusion criteria: * being diagnosed with fibromyalgia syndrome according to the criteria of the american rheumatology association , * not receiving active treatment related to physiotherapy, * volunteering to participate in the study exclusion criteria: * diagnosed endocrine, neuromuscular, infectious and inflammatory diseases, * severe mental and psychological disorders, using psychological drugs (ssris and snris) * illiterate * problems with hearing and vision
the effect of acupressure on pain, nausea-vomiting, and mental well-being in oncology patients

Conditions: Pain; Nausea With Vomiting Chemotherapy-Induced; Mental Health Wellness 1

Summary: the goal of this clinical trial is to compare the effect of self acupressure and acupressure applied by therapists on pain, nausea-vomiting, and mental well-being in oncology patients. for this purpose, 93 individuals with stage 1-stage 3 cancer will be included in the study. the main questions it aims to answer are: • is acupressure effective on pain, nausea-vomiting and mental well-being in oncology patients? is there a difference in the effectiveness of self-acupressure and acupressure applied by therapist on pain, nausea-vomiting and mental well-being? the participants will be included in the study as three groups, namely the self-acupressure group, the acupressure group applied by the therapist, and the control group. self-acupressure participants will self-administer acupressure. in the acupressure group, which will be applied by the therapist, acupressure will be applied to the participants by researchers who have acupressure certificate. in the control group, acupressure etc. no additional application will be made. visual analog scale, nausea-vomiting and retching index, and mental well-being scales will be applied to all groups at the beginning of the study and three days after the study.

large intestine meridian 4th point (hegu/li4), pericardium meridian/neiguan (p6) point and yintang (ex-hn 3) point will be used for acupressure application in the research.

Eligibility criteria:
inclusion criteria: * ≥18 years * cancer patients without distant metastases in stage-1, stage-2 and stage-3 who have received at least one course of chemotherapy * pain degree 4 and above (will be evaluated with a visual analog scale) * nausea-vomiting degree of 4 and above (will be evaluated with a visual analog scale) * receiving standard antiemetic and standard analgesic treatment (all patients included in the study should receive similar treatment.) * no previous acupressure experience * absence of any wound or lesion in the area where acupressure will be applied. * not using a different complementary approach during the collection of research data * those who signed the informed consent form/written consent form * patients without any psychiatric diagnosis will be included in the study. exclusion criteria: * \< 18 years old * those who have not received chemotherapy before * pain grade below 4 (will be evaluated with a visual analog scale) * nausea-vomiting degree below 4 (will be evaluated with a visual analog scale) * receiving different antiemetic and analgesic treatments * previous acupressure experience * any wound or lesion in the area where acupressure will be applied * using a complementary approach other than acupressure at the time research data was collected * those who did not sign the informed consent form/written consent form * patients with any psychiatric diagnosis will not be included in the study.

Keywords: chemotherapy pain nausea-vomiting mental well-being acupressure
open-label extension of edg-5506 in participants with becker muscular dystrophy

Conditions: Becker Muscular Dystrophy

Summary: edg-5506-203 mesa is an open-label extension study to assess the long-term effect of sevasemten (edg-5506) on safety, biomarkers, and functional measures in adults and adolescents with becker muscular dystrophy

this is an open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of sevasemten. edg-5506-203 mesa will provide continued access to sevasemten treatment to participants with becker muscular dystrophy who were previously enrolled in edg-5506-002 arch, completed edg-5506-201 canyon and grand canyon, or completed edg-5506-202 dune.

Eligibility criteria:
key inclusion criteria: 1. males with a diagnosis of bmd and participation in edg-5506-002 arch, edg-5506-201 canyon and grand canyon, or edg-5506-202 dune. participants are eligible if they complete the respective prior study visits as follows: * edg-5506-002 arch: complete the final study visit 27 \[month 24\]; or, completion of the et visit prior to visit 27 \[month 24\] * edg-5506-201 canyon and grand canyon: complete the final study visit (cohorts 1, 2, 4, and 5: visit 12 \[month 12\]; cohort 6: visit 11 \[month 18\]) * edg-5506-202 dune: complete at least 36 weeks of open-label treatment (visit 14 \[week 52\]) key exclusion criteria: 1. any clinically significant changes during or following participation in edg-5506-002, edg-5506-201, or edg-5506-202 that would affect the potential safety of the participant to receive sevasemten. 2. receiving moderate or strong cytochrome p450 cyp3a4 inhibitors or inducers. 3. receipt of an investigational drug other than sevasemten within 30 days or 5 half-lives (whichever is longer) of dosing in the present study. 3. receipt of oral corticosteroids for the treatment of bmd in the previous 6 months.

Keywords: becker muscular dystrophy
combined effects of bioactive compounds in lipid profile

Conditions: Hyperlipidemia; Low-density-lipoprotein-type; Elevated Triglycerides

Summary: the aim of this study is to demonstrate whether, along with dietary recommendations, armolipid plus ® can improve the profile of patients with elevated plasma ldl-c acting as a change of lifestyle therapy (tlc) according to the definition of adult treatment panel iii (atp iii)

recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme q10 (armolipid plus ®, rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (ldl-c) plasma. taking into account the potential effect of armolipid plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.

Eligibility criteria:
inclusion criteria: * adult patients \> 18 years old * ldl-c plasma levels ≥130 mg/dl and ≤ 189 mg/dl * patients not requiring lipid-lowering drug treatment according to atpiii guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline. * signed and dated informed consent before any study specific procedure. exclusion criteria: * patients on drug therapy to reduce ldl-c, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline). * history of cardiovascular disease, stroke or intermittent claudication. * diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dl). * having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days. * plasma levels of triglycerides \> 350 mg/dl * diagnosis of familial hypercholesterolemia

Keywords: hyperlipidemia metabolic syndrome yeast red berberine policosanol astaxanthin
validation of strasbourg environmental exposure chamber alyatec in mite allergic subjects with asthma

Conditions: Allergic Asthma; Allergy to House Dust; Allergy

Summary: this is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, during allergen exposures in the alyatec environmental exposure chamber (eec). the study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne house dust mite allergen in alyatec eec.


Eligibility criteria:
inclusion criteria: * subjects having signed the informed consent * subjects affiliated to a social security scheme * positive metacholine test * fev1 value \> 70% of theoretical fev1 value * asthma control test (act) ≥ 20/25 in 4 weeks prior to eec exposure group a: * mild allergic asthma to hdm (gina 1 or 2) with associated rhinitis and/or conjunctivitis. * positive skin prick-test to dpt and df (wheal diameter \>5 mm compared to the negative control) * specific immunoglobulin e (ige) for dpt and df \> 0.7 ku/l group b: * mild allergic asthma (gina 1 or 2) not sensitized to hdm with associated rhinitis and/or conjunctivitis. * negative skin prick-test and specific ige for dpt and df. * positive skin prick-test and specific ige for another allergen. exclusion criteria: * uncontrolled asthma * asthma control test (act) \< 20/25 in 4 weeks prior to eec exposure * use of oral corticosteroids in the 4 weeks preceding inclusion in the study * use of biotherapy in the 4 months preceding inclusion in the study * existence of a severe obstructive syndrome with fev1 \<70% of the theoretical value * obstruction triggered by spirometric evaluations * hospitalization for asthma or exacerbation in the last 4 weeks * history of acute severe asthma requiring hospitalization in intensive care or intubation * desensitization to dust mite allergens in the last 5 years * sensitization to allergens in the indoor environment (cat allergens or molds) with obvious exposure to these allergens * active tobacco: plus 10 cigarettes / day and tobacco history of +10 pa * uncontrolled systemic arterial hypertension * recent myocardial infarction (\<3 months) * recent stroke (\<3 months) * known arterial aneurysm * epilepsy under treatment * progressive tumor pathology * chronic renal pathology * hypersensitivity to one of the excipients used * subjects who participated in another clinical study in the three months prior to inclusion

Keywords: allergy asthma house dust mite
fragmin for the treatment of acute vte in pediatric cancer patients

Conditions: Venous Thromboembolism

Summary: three month treatment of acute vte with fragmin in pediatric cancer patients

primary study objectives include are to determine the pharmacodynamic (pd) profiles for treatment doses of dalteparin in pediatric subjects of different ages with cancer and venous thromboembolism (vte), using anti-xa (xa) levels and a population pd analysis methodology, and to determine the median dose required to achieve therapeutic anti- xa levels (0.5 to 1.0 international units \[iu\]/ml) based on subject age and weight.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: vte
clinical trial of pirfenidone in adult patients with neurofibromatosis 1

Conditions: Neurofibromatosis

Summary: the study is a phase ii, open label trial of oral pirfenidone in 24 adult patients with neurofibromatosis type 1. pirfenidone is a new, broad-spectrum anti-fibrotic drug, with proven in vitro and in vivo negative effects on fibroblast growth and collagen matrix synthesis. human studies indicate promising therapeutic effects in arresting and reversing fibrosis in a variety of different conditions, where the excessive formation of fibrous tissue is a major pathogenic mechanism. since the fibrous tissue is a significant component of neurofibroma, reduction of fibrosis could diminish tumor progression and lead to tumor shrinkage. therefore, pirfenidone is an excellent candidate for the treatment of plexiform neurofibromas and surgically unresectable tumors in patients with nf1.

specific aims of this study are: 1. to evaluate efficacy of pirfenidone in nf1 patients with disfiguring or disabling plexiform neurofibroma (pn) and spinal neurofibromas (sn) 2. to determine the acute, subacute and chronic toxicity of pirfenidone in patients with nf1.

Eligibility criteria:
inclusion criteria: * diagnosis of neurofibromatosis type i, based on clinical criteria (nih consensus development conference, 1988). tumors will not be confirmed histologically, since the biopsy could cause a change in tumor growth and such interfere with effect of pirfenidone treatment. * male or female patients * age 18 years old * all patients should be mentally capable of signing the consent form or should have a legal guardian to provide consent * patients who are experiencing symptoms from neurofibromatous lesions and who refuse surgery or are not good surgical candidates, such as those with plexiform neurofibroma who are experiencing significant discomfort, disfigurement or nerve compression or * presence of multiple spinal neurofibromas in which the surgical removal would carry a major risk for spinal cord damage. exclusion criteria: * tumors for which surgical removal could lead to permanent (or long-term) relief of symptoms * patients with open skin lesions and patients for whom surgery is being contemplated or who had surgery less than 4 weeks from starting treatment * patients for whom biopsy is warranted for suspected malignancies * individuals younger than 18 years * pregnant and lactating women * inability to have mr imaging (e.g. claustrophobia, pacemaker or allergy to contrast dye, if administration is needed for neurofibroma imaging)

Keywords: nf1 plexiform neurofibroma
parental affect in dental procedures

Conditions: Behavior; Dental Anxiety

Summary: background: to evaluate the effect of the anxiety of a parent accompanying a child on the child's anxiety during treatment. methods: parents of 160 patients (4-8 years old) were divided into two groups anxious and non-anxious. each groups had separated two randomized subgroups that with/without parents accompanied their children. at the first visit, participating children were examined while the behavior of the child during the examination was evaluated by a single pediatric dentist according to their heart rates measured by a portable pulse oximeter and the data were recorded (objective data).forty-two children with a score of 1 and 4 on the frankel scale were excluded. after the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment. patients were recalled after one week for the treatment visit. both groups were evaluated using the basic behavior technique. compomer fillings were performed on children with infiltration anesthesia. the children's heart rates were measured by a portable pulse oximeter during treatment. finally, the children were asked to express how they felt about the treatment by pointing out one of the faces on the wong-baker faces scale (subjective data). the children also rated the experience on the frankel scale administered by the same operator.


Eligibility criteria:
inclusion criteria: * mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study exclusion criteria: * children with a score of 1 and 4 on the frankel scale were excluded.

Keywords: behaviour dental anxiety parental presence
comparison of osteoporosis disease management strategies (0000-039)

Conditions: Osteoporosis

Summary: the purpose of this study is to assess the impact of disease management interventions on bone mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at high risk for osteoporosis.


Eligibility criteria:
inclusion criteria: * members of the harvard pilgrim health plan exclusion criteria: * individuals who are not members of the harvard pilgrim health plan