Kornimate/medical-research-clean huggingface dataset:
regulatory post-marketing surveillance of xolair® for chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this study aims to evaluate the safety and effectiveness of xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.

this is a 24-week, prospective, open-label, multi-center, single-arm, observational, post-marketing surveillance study under routine clinical practice and does not impose a therapy, visit, or assessment. the study design was approved by the korean health authority. the purpose of this study is not to answer scientific hypotheses, but to describe the incidences of all potential adverse events (aes), serious adverse events (saes), and unexpected aes not listed in the local label information occurring in korean patients under routine clinical practice following the approved local label information.

Eligibility criteria:
inclusion criteria: 1. adults aged ≥18 years 2. patients with crswnp who are not adequately controlled with conventional therapy (incs) 3. patients prescribed with xolair® as per the locally approved label information. 4. patients who provide written informed consent to participate in the study exclusion criteria: 1. patients who do not provide consent to participate in the study 2. patients participating in other clinical trial 3. contraindications listed in the locally approved label information of xolair® * hypersensitivity to the active ingredient or any other ingredient of xolair® * patients with myocardial infarction or history of myocardial infarction (pre-filled syringes only)

Keywords: chronic rhinosinusitis with nasal polyps crswnp korea nis xolair
platelet rich fibrin in soft tissue healing after implant uncovering

Conditions: Healing Surgical Wounds

Summary: this study represents a prospective, controlled and randomized clinical trial assessing the effects of l-prf on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the apically positioned flap (apf) procedure in the uncovering phase of two-stage implants. a total of 40 patients were recruited and divided into two groups. the implant uncovering procedure in the test group was performed with apf and application of l-prf on the donor area. patients in the control group, on the other hand, were treated with apf alone, leaving the donor area to heal by secondary intention.


Eligibility criteria:
inclusion criteria: * to have at least one implant in the maxilla with a quantity of vestibular keratinized gingiva \< 2 mm * to be in good systemic health * to have a good oral hygiene (fmps and fmbs \< 20%) exclusion criteria: * systemic diseases: coagulation disorders; medications affecting periodontal status in the previous 6 months; pregnancy or lactation; * smoking habits; * peri-implant surgery on the experimental sites.

Keywords: platelet rich fibrin wound healing implant uncovering
the effect of sumatriptan and placebo on cgrp induced headache

Conditions: Migraine

Summary: to develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with acalcitonine gene related peptide (cgrp). if the headache responds to sumatriptan, the model can be used to test new drug candidates.

there remains a great need for more effective anti-migraine drugs with fewer side effects. human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. the investigators' group has shown that calcitonine gene related peptide (cgrp) induce headache/migraine in both healthy volunteers and in patients with migraine without aura (mo). to validate this model, the headache must respond to specific migraine treatment with sumatriptan. hypothesis: cgrp induces a migraine-like headache in both healthy subjects and in mo-patients and induced headache responds to a specific anti migraine drug; sumatriptan. aim: developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility criteria:
inclusion criteria: healthy: healthy subjects of both sexes age 18-60 years weight 45-95 kg. females were requested to use effective contraception. migraine patients: migraine patients who meet ihs criteria for migraine with or without aura of both sexes 18-60 years 45-95 kg. exclusion criteria: healthy: any type of headache (except episodic tension-type headache \< 1 day per week) serious somatic or psychiatric disease pregnancy intake of daily medication (except oral contraceptives). migraine patients: any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week) serious somatic or psychiatric disease pregnancy intake of daily medication (except oral contraceptives) triptan non-responders
assess gastrointestinal blood loss after receiving aspirin or aspirin plus rivaroxaban in healthy adult participants

Conditions: Healthy Volunteer

Summary: the primary objective of the study is to determine whether aspirin alone or aspirin combined with various doses of rivaroxaban causes subclinical gi blood loss as determined by the hemoquant assay. the secondary objective of the study is to evaluate the safety and tolerability of aspirin alone or in combination with rivaroxaban to healthy volunteers.


Eligibility criteria:
key inclusion criteria: 1. has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive 2. is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ecgs) performed during screening 3. is in good health based on laboratory safety testing obtained at the screening visit 4. willing and able to abstain from alcohol use for the duration of the study key exclusion criteria: 1. history of anemia, abnormal bleeding (including vaginal bleeding or excessive menstrual periods), previous diagnosis of bleeding diathesis, or blood clots as defined in the protocol 2. history, in the last year, of any bleeding gi lesions such as peptic ulcer, hemorrhoids or anal fissure, or a positive fecal occult blood test performed either during screening or on day 1 3. presence of irregular stool patterns, constipation, or frequent diarrhea that, in the opinion of the investigator, may interfere with stool collections required by the protocol 4. inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc. 5. hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal 6. pt and aptt values above the upper limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal 7. platelet count below the lower limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal 8. history of clinically significant respiratory, hepatic, renal, gi, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation. history of any atherosclerotic cardiovascular disease 9. presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study 10. has received a covid-19 vaccination within 1 week of day 1 of the study or for which the planned covid-19 vaccinations would not be completed 1 week prior to day 1 of the study. note: other protocol defined inclusion / exclusion criteria apply.

Keywords: no gastrointestinal (gi) disease no risk factors for bleeding direct oral anticoagulant (doac) fecal occult blood testing (fobt)
a study to evaluate itca 650 for the treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: phase 3 study to examine whether treatment with itca-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing hba1c in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * hba1c between 7.5% - 10% * on diet \& exercise, metformin (met), sulfonylurea (su) or thiazolidinedione (tzd) alone or in combination or combined (su + tzd) or in combination with met + su, met + tzd, met + tzd + su * bmi between 25 \& 45 kg/m2 exclusion criteria: * taking dpp-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months * history of pancreatitis
effectiveness of kinesio tape in morning stiffness and functional capacity in patients with rheumatoid arthritis.

Conditions: Wrist Morning Stiffness

Summary: the purpose of this study is to determine how the applications of kinesio tape affect the morning stiffness in patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis according to the criteria of the american rheumatism association with a minimum of 6 months evolution from diagnosis. * these subjects must have morning stiffness daily in the wrist joint of a member or bilateral at least a month. exclusion criteria: * subjects in postoperative affecting the mobility of joints to study phase. * subjects with sensory deficits or other inflammatory arthropathies. * subjects who are or come in a state of emergence of the hand or wrist joints during the investigation. * subjects who change their usual treatment (medication or other therapies) two months before the study or during the study. * we exclude subjects who present some kind of allergy to kinesio-tape in which case it will be removed immediately.
structural changes of subcutaneous tissue by ultrasonographies in patients after treatment with pnkcelulitis® program

Conditions: Cellulite

Summary: exploratory, prospective, uncontrolled and single-blinded pilot study, with clinical and ultrasound assessments of cutaneous cellulite before and after treatment with a specific multidisciplinary programme following dietary guidelines, physical exercise and the application of a cosmetic cream.

females older than 18, with normal weight ranges in addition to the presence of cutaneous non-infectious cellulite (edematous-fibrosclerotic panniculopathy), were recruited for the study and to undergo treatment with the multidisciplinary programme. all patients were treated with the specific multidisciplinary programme for cellulite (pnkcelulitis®). this programme consists of three phases or processes: the restructuring, drainage and toning processes, each of which combines diet, physical exercise and the application of an anti-cellulite cream that combines active lipolytic and vasodilator agents (cellulite gel k-line®). patient's clinical assessment follow-up was performed by the prescribing doctor for the multidisciplinary treatment and was done in four visits: baseline (before starting treatment) and at the end of each of the phases (restructuring, drainage and toning). anthropometric data were recorded at each visit and a bioelectric impedance test to assess body composition (amount of fat mass and muscle mass). the clinical evaluation of the degree of cellulite was made according to the nürnberger-muller classification scale. cutaneous ultrasound was performed by an expert dermatologist in the dermatology outpatient clinic of the hospital and subsequently assessed blinded. two skin scans were done for each patient, one before starting the treatment and another at the end. the objective data collected on each ultrasound were total skin thickness, thickness of the dermis and hipodermis, the area of the indentations of the subcutaneous cellular tissue in the dermis and changes in the echogenicity of the dermis blinded and independently assessed by two researchers, comparing ultrasounds before and after treatment.

Eligibility criteria:
inclusion criteria: * females older than 18 years * normal weight ranges * presence of cutaneous non-infectious cellulite (edematous-fibrosclerotic panniculopathy) * women who are going to begin treatment with the multidisciplinary programme exclusion criteria: * pregnant or lactating females * contraindications of a ketogenic diet

Keywords: cellulite cutaneous ultrasound pnkcelulitis® program
a study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of pf-06882961 in chinese adults with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this is a phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult chinese participants with t2dm who are receiving metformin as background antihyperglycemic medication.


Eligibility criteria:
inclusion criteria: * patients with t2dm who are taking metformin monotherapy as their only antihyperglycemic treatment * hba1c greater than or equal to 7% and less than or equal to 10.5% * total body weight \>50 kg (110 lb) with bmi of 22.5 to 45.4 kg/m\^2 exclusion criteria: * any condition possibly affecting drug absorption * diagnosis of type 1 diabetes mellitus or secondary forms of diabetes * history of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening * any malignancy not considered cured * personal or family history of mtc or men2, or participants with suspected mtc * acute pancreatitis or history of chronic pancreatitis * acute gallbladder disease * known history of hiv, hepatitis b, hepatitis c or syphilis, or positive testing of them * supine blood pressure greater than or equal to 160 mmhg (systolic) or greater than or equal to 100 mmhg (diastolic) * clinically relevant ecg abnormalities * positive urine drug test * clinical relevant laboratory tests abnormalities
pressure-sensing mattresses and mechanical ventilation weaning in neonatal

Conditions: Bronchopulmonary Dysplasia

Summary: this study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.

background： traditional physiological measurement methods often require subjects to remain immobile or have various devices attached to their bodies, causing discomfort, especially unsuitable for neonatal care. however, with the development of electronic technologies, these methods have improved. ballistocardiography (bcg) presents a possible solution for monitoring neonates' physiological signals. bcg is a non-invasive and non-contact instrument that measures the body's reactive motion pressure changes caused by cardiac contraction. these sensors do not require direct attachment, allowing for long-term physiological signal measurement without disturbing the subject. methods： the study will be conducted in the neonatal intensive care unit on the seventh floor of fu jen catholic university hospital, with an expected enrollment of 60 participants. the subjects will be grouped and stratified based on weight and the use of invasive respiratory support. during the hospitalization, daily output of ventilator data and physiological monitor data will be collected and analyzed for correlation. effect： this trial is expected to confirm the application of bcg in the neonatal population, demonstrate its correlation with current conventional physiological monitors, and assess its applicability in low-weight preterm infants. additionally, the study will investigate whether continuous bcg monitoring during hospitalization can predict the possibility of bronchopulmonary dysplasia.

Eligibility criteria:
inclusion criteria: * using invasive ventilation support with flow sensors or non-invasive ventilation support * the legal representative signs the informed consent form exclusion criteria: * refusal to participate in the study

Keywords: newborn ballistocardiograph pressure sensor unobtrusive sensing
istart: a campus & community initiative for services in tec-health

Conditions: Substance Use; Binge Drinking; Marijuana Use; Alcohol Drinking; Prescription Opioid Misuse; Illicit Drug Use

Summary: the istart intervention is a 30-day substance prevention web-app whereby students complete five weekly interactive modules using a smart device or computer. each module is approximately 15 minutes long, and focuses on a select substance: (i) alcohol, (ii) marijuana, (iii) nicotine, (iv) prescription drugs, and (v) illicit drugs. the modules are based on key theoretical constructs, behavior change strategies, and practical module components: attitudes (knowledge), perceived susceptibility (risk perceptions), subjective norms (normative re-education), and self-efficacy (refusal skills). this intervention will be evaluated via a time series design using a sample of 600 students randomly assigned to either the intervention, comparison, or control condition at a public institution in southern california.


Eligibility criteria:
inclusion criteria: * current cal state northridge (csun) matriculated students * age 18-30 exclusion criteria: * not currently a csun student * not 18-30 years of age * identified as having an alcohol or substance use disorder (aud or sud) as determined by the brief dsm-5 screener

Keywords: web-app module mhealth
comparison of single i̇ncision laparoscopic cholecystectomy versus laparoscopic cholecystectomy

Conditions: Laparoscopic Surgical Procedures

Summary: the aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between single incision laparoscopic cholecystectomy (silc) and conventional laparoscopic cholecystectomy (clc).twenty eight patients underwent silc and 30 underwent lc.fifty-eight patients were included the study and divided into two groups. the results of the questionnaires were statistically compared.

recently, single incision laparoscopic cholecystectomy (silc) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. this study was conducted with fifty eight patients between january 2011 and march 2013 in turkey. fifty-eight patients were included the study and divided into two groups. quality-of-life measures was evaluated by the euroqol eq-5d questionnaire.cosmesis and body image were evaluated with the body image questionnaire. all statistical analyses were performed by ibm statistics 21.0 and ms-excel 2007. a value of p\<0.05 was accepted as statistically significant.

Eligibility criteria:
inclusion criteria: * the patients who were scheduled for elective cholecystectomy were included in the study exclusion criteria: * pregnancy * acute cholecystitis * asa 3-4 (american society of anesthesiologists) * history of bile duct stone migration * biller pancreatitis * upper laparatomy * any ventral hernia repair * chronic systemic disease or * with allergic attitude to any agent

Keywords: single i̇ncision laparoscopic surgery conventional laparoscopic surgery
the outreach and prevention at alcohol venues in east africa study (opal-east africa- aim 1)

Conditions: HIV/AIDS

Summary: this study will test innovative interventions to increase uptake and use of biomedical hiv prevention options by engaging women and men at drinking venues in rural kenya and uganda in care, while gaining insights into the facilitators, barriers, and cost-effectiveness of these approaches.

\[background\] alcohol use is a common risk factor for both hiv prevention uptake and retention in sub-saharan africa (ssa). interventions that promote biomedical hiv prevention (prep and pep) among persons with heavy alcohol use and their sexual partners are urgently needed. alcohol-serving drinking venues play an important role as sites of hiv transmission in ssa and are ideal sites to engage women and men at increased risk of hiv in biomedical prevention services. \[overview\] the investigators have developed a mobilization strategy of integrating hiv testing within multi-disease screening to recruit \>2,000 people from drinking venues in kenya and uganda. the investigators now need to determine whether multi-disease mobilization can promote uptake of hiv prevention for adults at drinking venues in the context of new biomedical prevention options. the project will rigorously test innovative interventions in kenya and uganda to increase uptake of biomedical hiv prevention, and assess facilitators, barriers, and cost-effectiveness of these approaches. specific aims: * compare the effectiveness of two mobilization strategies to increase uptake of biomedical hiv prevention among adults at drinking venues. * determine the cost-effectiveness of interventions that increase biomedical hiv prevention uptake among adults at high-risk for hiv who attend drinking venues. the proposed research will address the critical intersection of alcohol use and hiv risk in ssa, by promoting reach and uptake of biomedical hiv prevention and exploring associated facilitators and barriers.

Eligibility criteria:
participant inclusion criteria: * adult (≥18 years) * patron or worker at a drinking venue within the study community exclusion criteria: * age \<18 years * previous participation in the study (may only participate once) * inability to consent (including gross inebriation)

Keywords: drinking venues biomedical hiv prevention uganda kenya
compassionate use study of two dose levels of thalidomide in adults with hiv wasting syndrome

Conditions: HIV Infections; HIV Wasting Syndrome

Summary: to allow patients with hiv-associated wasting to receive thalidomide treatment at 1 of 2 doses. to gain safety and efficacy data from a broader base of patients with hiv-associated wasting in order to support celgene's pivotal placebo-controlled study.

patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. patients failing the low dose will be eligible to increase the dose to the higher dose. treatment may continue indefinitely. after 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiretroviral therapy. * prophylaxis or treatment for opportunistic infection. patients must have: hiv-associated wasting. prior medication: allowed: * prior enrollment on celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.

Keywords: acquired immunodeficiency syndrome cachexia thalidomide
comparison of the efficiency of game-based exercise program and trunk stabilization exercise training in adolescent playing archery

Conditions: Athlete; Itch

Summary: the aim of our study is to investigate the effects of a game-based exercise (exergame) program and trunk stabilization exercise training on shooting performance, reaction time, trunk muscle endurance and balance in adolescents playing archery. while the importance of the effect of trunk stabilization on shooting performance is mentioned in individuals practicing archery, it is emphasized that trunk stabilization training increases sportive performance and protects against injuries in individuals interested in sports for the upper extremity. however, no study is found that directly compared game-based exercise programs and trunk stabilization exercise training in adolescents who play archery. therefore, two different training programs will be given to the adolescents playing archery at the archers foundation sports club in istanbul, and shooting performance, reaction time, trunk muscle endurance, and balance levels will be evaluated before and after the training.


Eligibility criteria:
inclusion criteria: * archers who have been practicing archery for at least 1 year * roller or olympic archers exclusion criteria: * archers with a history of musculoskeletal injuries causing physical limitation in the last 6 months. * archers who did not volunteer to participate in the study. * archers with any visual and hearing disabilities.

Keywords: archery trunk balance exergame core stability