Kornimate/medical-research-clean huggingface dataset:
safety of ruconest in 2-13 year old hereditary angioedema (hae) patients

Conditions: Hereditary Angioedema

Summary: this open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of ruconest at a dose of 50 u/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.

this study was an open-label, phase 2, non-comparative, multinational, multicenter clinical study in pediatric patients from 2 up to and including 13 years of age, with a confirmed diagnosis of hae. patients were eligible for treatment with recombinant human c1-inhibitor (rhc1inh) if they presented to the clinic within 5 hours of onset with an acute attack of at least moderate severity without signs of spontaneous regression. patients received rhc1inh at a dose of 50 u/kg body weight up to a maximum of 4200 u. the reconstituted solution was administered as a slow intravenous (iv) injection over approximately 5 minutes. the patients remained in hospital and were closely monitored in the study center for at least 4 hours after study medication administration.

Eligibility criteria:
inclusion criteria: * from 2 up to and including 13 years of age * clinical and laboratory confirmed diagnosis of hae (baseline c1inh activity \<50% of normal) * signed written informed consent form (icf)(parental permission) signed by the legal guardian(s) * clinical symptoms of an acute hae attack * onset of eligible symptoms within 5 hours from the moment at which medical evaluation to determine eligibility has occurred * attack severity moderate or greater, as rated by the investigator exclusion criteria: * a diagnosis of acquired c1inh deficiency (aae) * a medical history of allergy to rabbits or rabbit-derived products or positive anti-rabbit epithelium (dander) immunoglobuline e (ige) test

Keywords: hereditary angioedema hae angioedema recombinant c1 inhibitor rhc1inh pediatrics
adapt-altering diet for african american populations to treat hypertension

Conditions: Hypertension

Summary: the purpose of the study is to develop a culturally appropriate dash intervention and test the effectiveness of the intervention lower blood pressure in a group of african american participants at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage i).

the effectiveness of the dietary approaches to stop hypertension (dash) diet has shown to have limited impact on blood pressure control among african americans, which might be explained by inappropriate adaptation to african american culture and tradition. therefore, the adequate adaptation of the dash diet would result in blood pressure control among african-americans. using the nominal group technique as a part of the formative assessment, this project proposes to identify key cultural variables that impact dietary patterns for african americans. based on those results, a modified behavioral intervention will be developed and tested in african americans with pre-hypertension or stage i hypertension. primary outcomes will include change in systolic and diastolic blood pressure at six months. it is expected that this project will contribute an additional tool for physicians, patients and health care systems to improve hypertension control amongst african americans. the specific aims for this dietary intervention are: (1) to develop a modified dash dietary pattern that is culturally appropriate for african-americans by using principals of formative analysis and (2) to conduct a randomized, controlled trial to determine the effectiveness of the modified dash dietary pattern in reducing blood pressure for a cohort of african-americans with pre-hypertension or stage i hypertension to a usual care control group.

Eligibility criteria:
inclusion criteria: * baseline sbp 120-159 mmhg and dbp 80-95 mmhg * age 25 or older as of the initial screening visit * willing and able to participate fully in all aspects of the intervention * not on rigid diet * provide informed consent * bmi 18.5-45 kg/m2 exclusion criteria: * regular use of anti-hypertensive drugs or other drugs that raise or lower bp (any in previous three months) * current use of insulin or oral hypoglycemic agents * use of oral corticosteroids \>5 days/month on average * current use of medications for treatment of psychosis or manic-depressive illness * use of oral breathing medications other than inhalers \> 5 days/month on average * use of weight-loss medications in previous 3 months

Keywords: blood pressure dash diet
mobile health interventions to prevent heart disease after hypertensive disorders of pregnancy

Conditions: Hypertension in Pregnancy; Pre-Eclampsia; Eclampsia; Gestational Hypertension

Summary: the purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (hdp).

the purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (hdp). all participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. if randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. if randomized to the control arm, the participant will receive care as usual.

Eligibility criteria:
inclusion criteria: * delivery at northwestern memorial hospital (prentice women's hospital) * live birth at any gestational age * pregnancy complicated by new-onset hdp (pre-eclampsia, eclampsia, or gestational hypertension) exclusion criteria: * hellp syndrome * history of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease) * current omron remote patient monitoring or noom user * bmi\<18.5 kg/m2 at enrollment * inadequate gestational weight gain or gestational weight loss

Keywords: digital health echocardiogram blood pressure
efficacy and safety of panobinostat (lbh589) in patients with refractory de novo or secondary acute myelogenous leukemia (aml)

Conditions: Refractory Leukemia; Acute Myelogenous Leukemia

Summary: this study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary aml.


Eligibility criteria:
inclusion criteria: * written informed consent prior to study-specific screening procedures * life expectancy of ≥ 60 days * eastern cooperative group (ecog) performance status ≤ 2 * refractory aml with confirmed initial diagnosis of de novo aml (excluding apl) - or- refractory aml with confirmed initial diagnosis of aml (excluding apl) secondary to ahd or mds with either condition precedent to aml (mds/ahd) * negative serum pregnancy test (within 7 days of first dose) * negative urine pregnancy test immediately prior to first dose exclusion criteria: * known hiv * psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up * concurrent use of medications that might prolong the qt interval or of inducing torsade de pointes * female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug. * male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment * patient unable to swallow capsules * patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat other protocol-defined inclusion/exclusion criteria may apply

Keywords: acute myeloid leukemia aml relapsed acute myeloid leukemia refractory aml refractory de novo aml refractory secondary aml secondary aml aml following myelodysplastic syndrome (mds) aml following antecedent hematological disorder (ahd) aml resistant to therapy
role of antimicrobial peptides in host defense against vaccinia virus

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. recent studies have demonstrated that the skin of people with ad my have decreased antimicrobial peptide (amp) expression. the purpose of this study is to compare smallpox virus replication and the number of amps and other antiviral molecules in people with ad, as compared to those seen in people with psoriasis or asthma, or healthy individuals.

ad is a chronic inflammatory skin disease characterized by frequent viral skin infections. recent studies have found that components in the skin of people with ad may block amp expression. amps are responsible for preventing infection from viruses. the purpose of this study is to examine smallpox virus replication and amp expression in the skin of patients with ad as well as identify other antiviral molecules involved in immune response. these findings will be compared with those of people with psoriasis or asthma, or healthy individuals. this study will consist of one study visit at which skin and blood samples will be taken.

Eligibility criteria:
inclusion criteria for participants with ad: * 2 years of age or older * history of active or inactive ad or eczema herpeticum, as defined by the advn standardized diagnostic criteria * parent or guardian willing to provide informed consent, if applicable * male or female of any race and ethnicity inclusion criteria for participants with asthma or psoriasis, and for non-atopic controls: * 18 years or older * history of psoriasis or history of asthma not requiring systemic medications * parent or guardian willing to provide informed consent, if applicable * male or female of any race and ethnicity exclusion criteria: * oral corticosteroids or any systemic immunosuppressive or immunomodulatory medication within 28 days prior to study entry * immunotherapy within 3 months prior to study entry * history of bleeding disorder * aspirin, oral antihistamines, oral antibiotics, oral cyclosporine, or topical medications within 7 days of screening visit including, but not restricted to, protopic, elidel, topical corticosteroids, and topical antibiotics * anxiolytic agents and antidepressants within 2 days of screening visit * diabetic requiring medication * autoimmune or immunodeficiency * active fungal, bacterial, or viral infections within 7 days prior to study entry * active systemic cancer. participants with uncomplicated nonmelanoma skin cancer are not excluded. * theophylline or leukotriene antagonists within 24 hours of screening visit * received any vaccination within 30 days prior to study entry * known lidocaine allergy * previously vaccinated for smallpox * pregnant or breastfeeding
mk0991 in combination with standard antifungal agent(s) for the treatment of salvage invasive aspergillosis (0991-037)

Conditions: Aspergillosis

Summary: invasive aspergillosis is a type of fungal infection typically identified in very sick patients (for example, patients with cancer or who have had a bone marrow or organ transplant). this study will seek to enroll patients (16 years of age or older) with invasive aspergillosis infections (involving organs or deep tissues) who are failing or could not tolerate standard antifungal therapy. your doctor will make this determination based upon specific study criteria. patients that fulfill all study criteria will be treated daily with both the investigational drug and another antifungal agent. the choice of the other agent is up to your doctor. this investigational drug is approved for the treatment of invasive aspergillosis by itself. the safety and efficacy of this investigational drug, in combination with other agents is not known.

the duration of treatment is 12 months.

Eligibility criteria:
* patients must meet a specific definition of probable or definite invasive aspergillosis and be considered to have failed or be intolerant of standard antifungal therapy. * the patient must be at least 16 years old and if a woman of childbearing potential, must have a negative serum or urine pregnancy test sensitive to 25 iu hcg prior to enrollment.

Keywords: definite or probable invasive aspergillosis either refractory or intolerant to prior antifungal treatment.
a study evaluating efficacy and safety of cro-sbt in the treatment of gonorrhea

Conditions: Gonorrhea

Summary: this is a phaseiv, multicenter, open-label，single arm study which will be performed to evaluate efficacy and safety of ceftriaxone sodium and sulbactam sodium for injection for the treatment of uncomplicated urogenital infection caused by neisseria gonorrhoeae in adolescent and adult subjects.

in this study, adults will be administered as one 3g iv dose at the study site,children under 12 will be administered as one 75mg/kg iv dose . approximately 100 subjects will be recruited to receive study treatment. the duration of the study will be approximately 14 days.

Eligibility criteria:
inclusion criteria: * subjects must be \>=6 or ≦80 years of age at the time of signing the informed consent,both gender * subjects having clinical suspicion of a urogenital gonococcal infection with or without gonococcal infection according to the laboratory test results of symptoms, physical symptoms, gonococcus smear, culture, etc. * subjects having clinical suspicion of a gonococcal infection must have both of the following risk factors:once used three generations of cephalosporin invalid, and sensitive to this product (including gonorrhea urethritis, cervicitis, proctitis, pharyngitis). * male and female subject must agree to use contraception (male condoms) during intercourse from the baseline visit through completion of the toc visit. exclusion criteria: * subject has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation * subject has received any cephalosporinl therapy for the treatment of a gonococcal infection * pregnant or lactating women, or women subject of childbearing age who were unwilling or unable to use acceptable methods of contraception throughout the study period. * famale subject who were positive for pregnancy tests at the time of inclusion or before the start of study drug use. * subject has risk of potentially serious drug interactions * subject has major diseases such as cardiovascular disease, hepatorenal disease and mental disease, or other factors, the researcher should not participate in the study according to comprehensive judgment * subject has a known history of alcohol or drug abuse * subject has a known any complicated or systemic gonorrhea infection, such as pelvic inflammatory disease, arthritis, endocarditis
tai chi easy in treating cancer survivors with peripheral sensory neuropathy

Conditions: Cancer Survivor; Peripheral Sensory Neuropathy

Summary: this pilot clinical trial studies how well tai chi easy works in treating cancer survivors with peripheral sensory neuropathy. tai chi easy is a simple and repetitive form of exercise that consists of movements with meditation and may improve peripheral neuropathy symptoms among cancer survivors.

primary objectives: i. examine effects of tai chi easy (tceasy) exercise intervention on peripheral sensory neuropathy of cancer survivors who have chemotherapy compared with an educational control (ec) intervention. outline: patients are randomized to 1 of 2 groups. group i (tai chi easy): patients attend tai chi easy class for 60 minutes once a week for 6 weeks. patients also receive a dvd and exercise manual of tai chi easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks. group ii (educational control): patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks. after completion of study, patients are followed up at 2 months.

Eligibility criteria:
inclusion criteria: * 1 month - 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy * self-report of \>= 4 on the peripheral neuropathy question exclusion criteria: * recurrence of cancer or other active cancer * severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator) * uncontrolled diabetes, untreated hypothyroidism
clinical trial to compare the solifenacin/tamsulosin combination therapy with tamsulosin monotherapy for luts due to bph

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Summary: clinical trial to compare the efficacy and safety of solifenacin/tamsulosin combination therapy with tamsulosin monotherapy for lower urinary tract symptoms due to benign prostatic hyperplasia


Eligibility criteria:
inclusion criteria: * over 45 years * benign prostate hyperplasia diagnosed by 20 ml \< trus * lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form exclusion criteria: * subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years * subjects who have acute urinary retention within 12 weeks before screening * subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening * subjects who have hypersensitivity to investigational product * subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum * subjects who have myasthenia gravis, narrow angle glaucoma * subjects who have hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * sbp \> 180 mmhg or dbp \> 100 mmhg * hba1c \> 9.0 % * subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.
transdermal testosterone gel/effect on erection quality as measured by dir

Conditions: Hypogonadism

Summary: low testosterone may be responsible for "soft" erections in men. the purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the "hardness" of a man's erection.


Eligibility criteria:
inclusion criteria: * testosterone \<350 ng/dl, * 21-59 years of age, * bmi \<30 exclusion criteria: * those with carcinoma of the breast or known or suspected carcinoma of the prostate or with known hypersensitivity to any of the ingredients in androgel. * men will be excluded if they have unstable angina, hypertension, diabetes, heart failure, or coronary artery disease. * men will agree to discontinue use of current testosterone replacement, as well as viagra or any other pde5 inhibitors for 30 days.

Keywords: hypogonadism low testosterone level gonadal deficiency
comparison of minisling suburethral sling and laparoscopic buch colposuspension

Conditions: Genuine Stress Incontinence

Summary: when the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (sui), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. the aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine sui.

when the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (sui), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. the aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine sui. investigators planned to measure patients' kings health questionary and prolapse quality of life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.

Eligibility criteria:
inclusion criteria: 1. to be between the ages of 18-80 2. isolated genuine stress incontinence or accompanying pelvic organ prolapse 3. having accepted surgery for stress urinary incontinence - exclusion criteria: * 1. previously undergo pelvic organ prolapse surgery 2. having a chronic lung disease such as asthma or chronic obstructive pulmonary disease (copd) 3. having juvenile diabetes mellitus 4. history of gynecological cancer 5. mesh allergy

Keywords: genuine stress incontinence minisling laparoscopic burch
hernia belt in laparoscopic inguinal hernia repair

Conditions: Hernia, Inguinal; Recurrence; Seroma Following Procedure; Pain, Postoperative; Quality of Life

Summary: in this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,vas), health-related quality of life (36-item short-form health survey, sf-36). follow up by physical examination, ultrasonography and telephone.

some scholars believe that the use of hernia belts to compress the inguinal region reduces postoperative complications. according to the international guidelines for the management of inguinal hernia in adults (2018) interpretation, the incidence of seroma after inguinal hernia repair ranges from 0.5% to 2.2%. however,there is no consensus among different research organizations and clinical staff on the use of hernia belts after laparoscopic inguinal hernia repair. in this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,vas), health-related quality of life (36-item short-form health survey, sf-36). follow up by physical examination, ultrasonography and telephone.

Eligibility criteria:
inclusion criteria: 1. 18 years or order. 2. primary unilateral oblique inguinal hernia, direct hernia, femoral hernia. 3. qualified for laparoscopic transabdominal preperitoneal approach(tapp) or totally extraperitoneal(tep). 4. eligible to tolerate general anesthesia. exclusion criteria: 1. incarcerated hernia, recurrent hernia and other types of hernia. 2. patients presenting for obvious contraindications to surgery. 3. need for an open inguinal hernia repair. 4. difficult to follow-up or communication. 5. patients who are unable to give informed consent.

Keywords: laparoscopic inguinal hernia repair hernia belt hernia recurrence seroma following procedure pain, postoperative quality of life