Kornimate/medical-research-clean huggingface dataset:
initiation of exogenous female sex hormones and airway responsiveness to methacholine - a prospective cohort study

Conditions: Asthma

Summary: the project aims to investigate the effect of female sex hormone treatment (both contraceptive treatment and hormone therapy during menopause) on bronchial hyperreactivity in adult women. the study is a prospective cohort study involving 300 women, examining airway responsiveness before and after the initiation of hormone treatment, whether as hormone therapy in menopause or contraceptive treatment. participants will be recruited from general practitioners in the capital region of denmark. lung function, bronchial hyperreactivity, airway inflammation, and body composition will be assessed before and after hormone treatment. blood samples will also be collected and stored for later analysis of inflammation markers. the study will include women aged 18 to 75 who are about to begin hormone treatment.


Eligibility criteria:
inclusion criteria: * women aged 18 to 75 years * planning to initiate hrt/hc within next 30 days exclusion criteria: * gynecological, endocrinological or other disease affecting the ovarian cycle * fev1 \< 60% of expected or \< 1.5l * current hormonal medication * pregnancy
safety, tolerability and efficacy of evolocumab (amg 145) in children with inherited elevated low-density lipoprotein cholesterol (familial hypercholesterolemia)

Conditions: Familial Hypercholesterolemia

Summary: the main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (sc) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.


Eligibility criteria:
inclusion criteria: heterozygous familial hypercholesterolemia (hefh): -completed study 20120123 (nct02392559) while still on assigned investigational product and did not experience a treatment-related serious adverse event homozygous familial hypercholesterolemia (hofh): * male or female, ≥ 10 to ≤ 17 years of age at time of enrollment * diagnosis of hofh * on a low-fat diet and receiving background lipid-lowering therapy * lipid-lowering therapy unchanged for ≥ 4 weeks prior to ldl-c screening; fibrates must be stable for at least 6 weeks prior to screening. * fasting ldl-c at screening ≥ 130 mg/dl (3.4 mmol/l) * fasting triglycerides ≤ 400 mg/dl (4.5 mmol/l) exclusion criteria: -currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s); except study 20120123 hofh: * moderate to severe renal dysfunction * active liver disease or hepatic dysfunction, * creatine kinase \> 3 times the upper limit of normal (uln) at screening

Keywords: hypercholesterolemia elevated cholesterol high cholesterol pcsk9 mutations severe familial hypercholesterolemia evolocumab repatha heterozygous familial hypercholesterolemia homozygous familial hypercholesterolemia pediatric paediatric
dorado - fixed doses of darusentan as compared to placebo in resistant hypertension

Conditions: Hypertension

Summary: this is a research study of a new experimental drug called darusentan. darusentan is not currently approved by the u.s. food and drug administration (fda) for use in the united states, which means that a doctor cannot prescribe this drug. the purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more antihypertensive drugs, including a diuretic.


Eligibility criteria:
inclusion criteria: * subjects who are competent to provide written consent * aged 35 to 80 years * subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg * all other subjects must have a mean systolic blood pressure ≥140 mmhg * receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic * female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile) exclusion criteria: * average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg * serum alt or ast \>2 x the upper limit of the normal range (uln) * subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (cva) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia * implanted pacemakers or implanted cardioverter defibrillator (icd) * symptomatic congestive heart failure requiring treatment * hemodynamically significant valvular heart disease * type i diabetes mellitus * hemodialysis or peritoneal dialysis; or history of renal transplant * diagnosis or recurrence of malignancy within the past 3 years * sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90% * subjects who perform alternating shift or night work * subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to screening
to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses azd8848 in healthy subjects

Conditions: Safety,; Tolerability,; Healthy Subjects

Summary: this study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of azd8848 in healthy subjects.

a phase 1, single centre, double-blind, randomised, placebo-controlled, study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics after administration of multiple ascending (mad) once weekly inhaled doses of azd8848 in healthy subjects

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture * women must be of non-childbearing potential or must have been stable on a highly effective contraceptive for at least 3 months prior to screening and be willing to continue on the chosen contraceptive with additonal use of condom until 3 months postdose * male subjects should be willing to use barrier contraception ie, condoms, from the first day of investigational product administration until 3 months after the last administration of investigational product * have a body mass index (bmi) between 18 and 32 kg/m2 and weigh at least 50 kg and no more than 110 kg * women must have a negative pregnancy test at screening and on admission to the study centre, must have a date of last menstruation, must not be lactating or must be of non-childbearing potential exclusion criteria: * abnormal vital signs, after 10 minutes supine rest, defined as any of the following: sbp \>140 mmhg, diastolic blood pressure (dbp) \>90 mmhg, heart rate \ 85 beats per minute * history of asthma or allergic rhinitis * prolonged qtcf \>450 ms or shortened qtcf \<340 ms or family history of long qt syndrome * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class as azd8848 - any clinically significant abnormalities in clinical chemistry.

Keywords: safety, tolerability, phase i, pharmacokinetic, pharmacodynamic, inhaled
envafolimab plus chemoradiotherapy for locally advanced npc, a prospective, single armed phase ii trial.

Conditions: Locally Advanced Nasopharyngeal Carcinoma; Envafolimab; Induction Chemotherapy; PD-L1

Summary: patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. all the patients will get 3 cycles of gp+ envafolimab for the induction chemotherapy. after that, the patients will receive concurrent chemoradiotherapy. radiotherapy will be given by imrt, under the dose of gtvnx 68-70gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of ddp+envafolimab as concurrent chemotherapy. then patients would receive envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . we aim to evaluate the three years progression free survival of these patients by the combination of envafolimab with curative chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * ecog 0-1 * histologically confirmed non-keratinizing carcinoma (who type ii or iii) of nasal pharynx * stage iii-iva （ajcc/uicc 8th ）, untreated npc patients * ne≥ 1.5×10e9/l, hgb ≥ 100g/l and plt ≥100×10e9/l * alt≤ 1.5 upper limit of normal (uln), ast≤ 1.5uln and bilirubin ≤ 1.5uln * creatinine\<1.5×uln exclusion criteria: * recurrent or metastatic npc patients * histologically confirmed keratinizing carcinoma (who type i) of nasal pharynx * already received radiation or chemotherapy * pregnant or lactating women, or women of childbearing age without birth control * hiv (+) * had other cancers before * used immune checkpoint inhibitor(ctla-4、pd-1、pd-l1 etc.) before * complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose * with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included) * use of massive dose of glucocorticoids within 4 weeks before enrollment * laboratory test values do not meet relevant standards within 7 days before enrollment * significantly lower functions of heart, liver, lung, kidney and bone marrow * serious or uncontrolled medical diseases or infections * participating other clinical trial in the same time * hbsag (+) and hbv dna \>1×10e3 copiers /ml * hcv (+) unless hcv rna pcr(-) * with any other treatment contraindications
the effect of microneedling with low energy laser in androgenic alopecia patients.

Conditions: Dermatologic Disease

Summary: androgenetic alopecia is the most common type of hair loss in men, and affects approximately 50 percent of caucasian men by age 50. the condition is characterized by the progressive loss of terminal hairs on the scalp in a characteristic distribution. the anterior scalp, mid scalp, temporal scalp, and vertex of the scalp are typical sites of involvement. "male balding" and "male pattern hair loss" are additional terms used to refer to this condition. the aim of this study is to investigate the effect of microneedling in androgenic alopecia


Eligibility criteria:
inclusion criteria: - androgenic alopecia patients exclusion criteria: * infection, immune disorder, other dermatosis in treating areas
multifidus plane block versus caudal block for hypospadias

Conditions: Hypospadias; Caudal Block

Summary: this study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia

peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. the usage of regional anesthesia in association with general anesthesia (ga) is a simple intraoperative way that reduces (ga) requirements and side effects. recently, paraspinal fascial plane block, the sacral multifidus plane block (mpb), was used successfully in infants. the study has been designed to determine the effect of mpb versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.

Eligibility criteria:
inclusion criteria: * ⦁ children aged (1 -7) years old. * all patients will be of asa classification i, ii physical status exclusion criteria: * ⦁ parents refusing to participate are excluded from the trial. * children who had spinal anomalies, altered mental status. * a history of developmental delay. * blood diseases: coagulopathy or anaemia. * infection at the site of injection. * drug allergy.

Keywords: hypospadias caudal block
the effect of diluted sodium hypochlorite solution and moisturizers on skin barrier function in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the goal is this study is to investigate the effects of dilute bleach on the skin of subjects with atopic dermatitis and those with healthy skin. the second goal is to evaluate the effects of different moisturizers on the skin barrier of subjects with and without atopic dermatitis. the investigators hypothesize that the bleach bath will increase the skin ph, decrease the skin hydration, and increase skin water loss in all study subjects. secondly, the investigators hypothesize that moisturizers with the lowest ph and the highest water to oil ratio will result in improved skin barrier function. furthermore, the investigators believe there will be a greater improvement in patients with atopic dermatitis.

the study has two main parts. subjects in both groups will have one forearm in a dilute bleach bath and the other arm in a water bath for 10 minutes. the change in skin will be measured using different painless devices. the second part of the study involves application of 4 various moisturizers. the change in skin will be measured over a period of time using the non-invasive devices.

Eligibility criteria:
inclusion criteria: * age 8 years to 65 years * has been diagnosed with atopic dermatitis by a board-certified dermatologist at uc davis * subject/parents/legal guardians able to read and comprehend the study procedure and consent forms. exclusion criteria: * those who are pregnant, prisoners, or cognitively impaired * those who do not fit the inclusion criteria

Keywords: atopic dermatitis
a study to asses the effect of mk0663 in the treatment of patients with postoperative dental pain (0663-092)

Conditions: Postoperative Dental Pain

Summary: the purpose of this study is to compare the pain relieving effect of different doses of mk0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. pain intensity and relief will be measured by the total pain relief score (topar) and patient evaluation.


Eligibility criteria:
inclusion criteria: * patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw * patients must be experiencing moderate to severe pain following the dental procedure exclusion criteria: * previous molar extraction within the past 45 days * personal or family history of an inherited bleeding disorder * uncontrolled high blood pressure

Keywords: postoperative dental pain
acupuncture as a supplemental treatment for bipolar depression

Conditions: Bipolar Disorder

Summary: the purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of bipolar depression.

patients receive 8 weeks (12 sessions) of acupuncture treatment plus stable medication. patients are randomly assigned to receive either acupuncture designed to relieve symptoms of depression or acupuncture designed to relieve some other legitimate physical condition. a comparison group of patients who take medication but do not receive acupuncture is assessed to evaluate the effectiveness of medication alone. patients participate in clinical assessment each week, which includes visiting with a psychiatrist and completing symptom rating scales.

Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for bipolar i disorder or bipolar ii disorder * demonstrate symptoms of depression as determined by a minimum score of 25 on the inventory for depressive symptoms-clinician rated scale * have taken stable psychoactive medications for at least 30 days prior to study entry

Keywords: mood disorder acupuncture
comparison of two mesh/fixation concepts for laparoscopic ventral and incisional hernia repair

Conditions: Hernia, Abdominal; Hernia,Ventral

Summary: this is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. it has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.


Eligibility criteria:
inclusion criteria: * informed consent form (icf) signed by the patient or his/her legal representative * primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair * recurrence after former abdominal hernia repair with mesh * recurrence after suture abdominal hernia repair can be included exclusion criteria: * no written informed consent * patient under 18 years old * emergency surgery (incarcerated hernia) * patients with expected life time shorter than one year for example due to generalised malignancy * bmi exceeding 40.0kg/m² * contaminated surgical fields * patients on immunosuppression, steroid therapy, constant pain therapy

Keywords: laparoscopic hernia repair ventral hernia incisional hernia ipom
commissural closure to treat severe mitral regurgitation: standing the test of time.

Conditions: Degenerative Mitral Valve Disease

Summary: mitral regurgitation (mr) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. however, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. a commissural mr can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. however, long term outcomes of mitral valve repair (mvr) for isolated commissural flail or prolapse remain poor defined. in san raffaele hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). the investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. with this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.


Eligibility criteria:
inclusion criteria: * adult patients; * patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin; * patients operated on with median sternotomy or left minithoracotomy; * patients in whom the commissural mr has been treated with commissural closure and annuloplasty; * patients operated on at the cardiac surgery department of san raffaele hospital from january 1997 to december 2007. exclusion criteria: * patients underwent a mitral valve replacement
the effects of zataria multiflora boiss (shirazi's thyme) on nonalcoholic fatty liver disease

Conditions: Fatty Liver; Fatty Liver, Nonalcoholic

Summary: the aim of this study is to evaluate the effects and safety of a dietary supplement, zataria multiflora boiss (shirazi's thyme) in the treatment of non alcoholic fatty liver disease (nafld).

in a randomized double-blind placebo-controlled clinical trial shirazi's thyme is compared with placebo. investigators select randomly 90 patients with nafld by inclusion criteria. investigators measure anthropometric and laboratory parameters including fasting blood sugar, insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. patients are divided into two equal groups. intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg of shirazi thyme powder daily for 90 days. placebo group in addition to the same recommendations for diet and exercise, receives placebo capsules twice daily.

Eligibility criteria:
inclusion criteria: * age: 20-65 years * body mass index: 18-35 kg/m2 * serum alt level: \>45 u/lit. in males, \>29 u/lit. in females * grade \>=1 fatty liver in liver sonography exclusion criteria: * pregnancy and lactation * acute or chronic liver failure * acute or chronic renal failure * autoimmune or viral hepatitis * wilson's disease * diabetes mellitus * alcoholism * malignancy * hypothyroidism or hyperthyroidism * drug used in last three months: ocp, metformin, vitamin e, ursodeoxycholic acid, glucocorticoids, thiazolidenediones. * history of allergic reactions to thyme

Keywords: thymus plant multiflotriol [supplementary concept] zataria multiflora complementary therapies herbal medicine medicine, traditional
a collaborative palliative and oncology care model for patients with acute myeloid leukemia and myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia

Summary: this research study is evaluating the impact a collaborative palliative care and oncology team will have on the quality of life, symptoms, mood, and end of life outcomes of patients with acute myeloid leukemia (aml) and myelodysplastic syndrome (mds). palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

the main purpose of this study is to compare two types of care - standard leukemia oncology care and standard leukemia oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients and families with aml and mds undergoing treatment. the investigators aim to find out whether introducing patients and families undergoing aml and mds treatment to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during their hospitalizations for their leukemia care as well as enhance the quality of patients' end of life care.

Eligibility criteria:
inclusion criteria: * hospitalized patients with high-risk aml, defined as: * newly diagnosed patients with aml ≥ 60 years of age * newly diagnosed aml with antecedent hematologic disorder * newly diagnosed therapy-related aml * relapsed aml * primary refractory aml exclusion criteria: * patients already receiving palliative care * major psychiatric illness or comorbid conditions prohibiting compliance with study procedures. * a diagnosis of acute promyelocytic leukemia (apml)

Keywords: leukemia acute myeloid leukemia