Kornimate/medical-research-clean huggingface dataset:
altitude, exercise and glucose metabolism in pre-diabetic men

Conditions: Diabetes

Summary: concentric (ce) and eccentric (ee) exercises may differently affect glucose metabolism which may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500 - 2500 m) or high (2500 - 3500 m) altitudes. however, data on the effects of glucose metabolism due to ce and ee in hypoxia are scarce but would be of utmost importance considering the increasing number of persons suffering from impaired glucose tolerance or diabetes and the unique opportunities provided by the mountainous regions of the alps to perform ce (e.g. uphill hiking) and ee (downhill hiking, downhill skiing) at altitude between 1500 - 3500 m. metabolic responses to exercise may be largely mediated by interleukin 6 (il-6), which is predominantly derived from the contracting limbs and may support the maintenance of metabolic homeostasis during exercise. in addition, il-6 is elevated with acute and chronic altitude exposure at least partly mediated via adrenergic stimulation. thus, the type of exercise as well as hypoxia may contribute to il-6 elevations and differences in serum il-6 concentrations might help to explain distinctions between responses of glucose metabolism to ce and ee at low and moderate to high altitude. 32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (ee) or uphill (ce) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions at moderate to high altitude (2000 - 2500 m). between normoxic and hypoxic condition will be a break of approximately 12 month. measurements of glucose metabolism, il-6 plasma concentration will be performed pre, mid (day 5) and post intervention. moreover anthropometric, strength and exercise capacity characteristics will be performed pre and post intervention. we hypothesize that ee in hypoxia is more effective in the modulation of glycemic control in pre-diabetic men than ce in hypoxia as well as ee and ce in normoxia. it is suggested that effects on glucose metabolism are associated with changes in plasma il-6 concentrations. ee in hypoxia is expected to result in a more persistent rise of plasma il-6 concentration than ce in hypoxia and in normoxia and to a more pronounced rise in plasma il-6 than ee in normoxia.

not desired.

Eligibility criteria:
inclusion criteria: * pre-diabetes * male * age 50-65 years exclusion criteria: * smoking * bmi \> 30 kg/m2 * diseases not compatible with intervention

Keywords: glucose tolerance, hypoxia, myokines, exercise
efficacy and safety study of qlm3003 ointment in participants with mild or moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: it is a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 clinical trial to evaluate the efficacy of qlm3003 ointment at week 8 based on the primary endpoint (easi 75) and key secondary endpoint (iga-ts).in patients with mild to moderate atopic dermatitis. a total of 360 patients with mild to moderate atopic dermatitis are planned to be included and randomized at a ratio of 1:1:1 to receive 1.5% qlm3003 ointment、2% qlm3003 ointment and placebo, twice a day.


Eligibility criteria:
inclusion criteria: * male or female, 18-75 years old * the diagnosis of atopic dermatitis (ad) during screening meets the hanifin⁃rajka standard, and the history of ad/ eczema ≥1 year before screening. all of the following conditions must be met during the screening and baseline periods:number of participants with iga score of "2" or "3".ad involving the head and neck (scalp excluded), trunk, and extremities, with a total affected bsa of 3-20% (inclusive) exclusion criteria: * subjects with comorbidities or other conditions that may interfere with the assessment of the investigational drug or the study disease, as determined by the investigator to be ineligible for participation * patients whose current ad disease status was assessed by the investigators to be unstable (spontaneous improvement or rapid deterioration) were not eligible to participate in the study. * patients who have received a marketed or investigational biologic for the treatment of ad, such as dupilumab, within 3 months before baseline or within 5 half-lives of the drug (whichever was longer). * patients who had received systemic or topical jak inhibitor therapy, including but not limited to tofacitinib, ruxolitinib, upadacitinib, baricitinib, abrocitinib, ivarmacitinib, and gecacitinib, within 4 weeks before baseline or within 5 half-lives of the drug (whichever was longer).
a phase iib study to determine the efficacy and safety of the study drug in patients with severe sepsis

Conditions: Sepsis

Summary: the purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. patients entered into this study will be randomly assigned to one of two treatment groups. patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins. the study drug is an investigational drug that is still in development. it has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. patient participation in this study will last for about one month.


Eligibility criteria:
inclusion criteria: patients must * show evidence of acute infection * meet specified time windows * be 18 years of age or older exclusion criteria: patients must not * have low white blood cell count * have undergone certain organ transplants * be hiv positive * be pregnant or breast feeding * have severe underlying medical problems

Keywords: sepsis, spla2 inhibitor
safety and immune response of novartis menacwy-crm conjugate vaccine when given to healthy toddlers

Conditions: Meningococcal Infections

Summary: safety immune response of novartis menacwy-crm conjugate vaccine when given to healthy toddlers


Eligibility criteria:
inclusion criteria: * who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent; * who have received complete primary vaccination with recommended licensed vaccines; * who are available for all visits and telephone calls scheduled for the study; exclusion criteria: * whose parent or legal guardian is unwilling or unable to give written informed assent consent * who had a previous or suspected disease caused by n. meningitidis; * who had previous or suspected infection with measles, mumps, rubella, varicella, and/or herpes zoster; * who had household contact with and/or intimate exposure to an individual with culture-proven n. meningitidis infection within 60 days prior to enrollment; * who had household contact with and/or intimate exposure to an individual with measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment; * who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * who have previously received any measles, mumps, rubella or varicella vaccine either alone or in any combination; * who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study; * who have any serious acute, chronic or progressive disease such as, cancer, diabetes, heart failure, malnutrition, epilepsy, hiv/aids, guillain barre syndrome * who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of the vaccine, * who have a known or suspected impairment/alteration of immune function, either congenital or acquired * who have down's syndrome or other known cytogenic disorders; bleeding diathesis

Keywords: vaccine toddlers healthy meningitis meningococcal measles mumps rubella varicella prevention of meningococcal disease types acwy
effects of epidural labor analgesia with esketamine on the incidence of postpartum depression in parturients

Conditions: Postpartum Depression

Summary: postpartum depression is a common psychological abnormality during the puerperium, which seriously affects maternal and neonatal health. esketamine, the s-enantiomer of ketamine, is twice as potent as ketamine and can be safely used for cesarean section and labor analgesia. however, it is not clear whether esketamine used for epidural labor analgesia can significantly reduce the incidence of postpartum depression. this study intends to explore the incidence of maternal prenatal depression and to investigate the effect of esketamine for epidural labor analgesia on postpartum depression and maternal and neonatal outcomes in parturients with prenatal depression through a multi-center, large-scale and high-quality clinical trail, in order to provide a clinical basis and theoretical basis for the application of esketamine used for epidural labor analgesia in postpartum depression and further reduce the incidence of postpartum depression, promote maternal and infant health, and ensure maternal and infant safety .

the study include women who meet the inclusion criteria for antenatal epds score ≥10 for labour analgesia while signing informed consent. the women will be randomized into two groups, one for esketamine group and the other for the control group. follow-up visits will be conducted at 1 day, 7 days and 42 days after delivery. the primary endpoint of the study was the incidence (mini-6.0 for diagnosis of postnatal depression) and severity of maternal depression at day 42 postpartum. the secondary endpoints of the study are maternal epds scores at 7 and 42 days postpartum; pain scores and impact at 1, 7 and 42 days postpartum; breastfeeding at 1, 7 and 42 days postpartum; length of postpartum stay; maternal complications at 42 days postpartum and neonatal illnesses at 42 days postpartum.

Eligibility criteria:
inclusion criteria: * full-term pregnancy; antenatal depressive state (epds score ≥10 and non-depressive diagnosis by a psychiatrist); epidural labor analgesia； signed informed consent. exclusion criteria: * pre-existing history of definite psychiatric disorders (depression, schizophrenia, etc.) or communication disorders；presence of severe preoperative pregnancy complications (e.g., severe preeclampsia, placental implantation, hellp syndrome, placenta praevia, placenta abruptio)；asa classification ≥ grade iii；contraindications to ketamine/s-ketamine (e.g., intractable, refractory hypertension, severe cardiovascular disease \[cardiac function class ≥ iii\], hyperthyroidism); refusal to participate in the study.

Keywords: esketamine epidural labor analgesia postpartum depression
efficacy and safety of omalizumab in adults (18-70 years) with moderate to severe chronic urticaria

Conditions: Chronic Urticaria

Summary: this study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit ige against thyroperoxidase.


Eligibility criteria:
inclusion criteria: * males or females from 18-70 years of age * body weight ≥ 20 kg and ≤ 150 kg and with a total serum ige level ≥ 30 iu/ml and ≤ 700 iu/ml * specific serum ige anti-tpo level ≥ 8.0 iu/ml, documented within 3 months prior to randomization or time of pre-screening * diagnosis of moderate to severe chronic urticaria * subject's current episode of chronic urticaria according to the european academy of allergology and clinical immunology/global allergy and asthma european network/european dermatology forum (eaaci/ga2len/edf) guideline at the time of screening * current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer * urticaria activity score (uas) ≥ 0 at any of the 7 days of the first section of the screening period * uas7 ≥ 10 at the time of randomization exclusion criteria: * females of child-bearing potential or breast feeding * present or past medical conditions that could have interfered with the study results * randomized into any other omalizumab study or who had received omalizumab * received investigational drugs within 30 days of enrollment

Keywords: chronic urticaria, omalizumab, thyroperoxidase, ige
american-australian-african trial with dronedarone in patients with atrial fibrillation or atrial flutter for the maintenance of sinus rhythm

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: to assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (af/afl). to assess the efficacy of dronedarone versus placebo on ventricular rate control in case of af/afl recurrence. to assess the efficacy of dronedarone versus placebo on af/afl-related symptoms.

this is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase iii study. to be eligible, patients must be in normal sinus rhythm at randomisation and must have an ecg-documented history of recent af/afl reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion.

Eligibility criteria:
inclusion criteria: * patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomisation and with at least one ecg-documented af/afl episode in the last 3 months. exclusion criteria: * main criteria (non-exhaustive list, see protocol for details): women of childbearing potential without adequate birth control, pregnant women, breastfeeding women, congestive heart failure nyha class iii or iv, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.

Keywords: atrial fibrillation atrial flutter arrhythmia anti-arrhythmia agents
a study to evaluate clear skin effect on quality of life in patients with plaque psoriasis.

Conditions: Plaque Psoriasis

Summary: study of effects of secukinumab 300 mg s.c. on quality of life (qol) in psoriasis in patients with or without prior exposure to systemic therapy.


Eligibility criteria:
inclusion criteria: * men or women aged at least 18 years at time of screening. * moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to screening and candidate for systemic therapy. * other protocol defined inclusion criteria may apply. please refer to the protocol. exclusion criteria: * forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at screening. * patients with previous treatment with any agent targeting interleukin (il)-17 directly or il-17 receptor a (e.g. secukinumab, ixekizumab, or brodalumab). * pregnant or nursing (lactating) women * women of child-bearing potential unless they use effective contraception

Keywords: secukinumab ain457 moderate to severe plaque psoriasis immune-mediated systemic disease scaly patches papules plaques itching
ultrasonography as a single tool for guided percutaneous transhepatic biliary drainage in obstructive jaundice

Conditions: Obstructive Jaundice

Summary: obstructive jaundice may be of malignant and benign etiologies. carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (cbd) constitute the majority of malignant causes. most of the patients with malignant obstructive jaundice are already advanced and inoperable by the time they are diagnosed, hence carry bad prognosis with palliation being the only option left. obstruction needs to be drained even in such cases for reducing pain, cholangitis, anorexia and pruritus as well as to reduce the serum bilirubin levels in certain cases to initiate chemo or intrabiliary brachytherapy. over the years, palliation has evolved with the introduction of newer methods and improvisation of existing techniques. recent palliative measures prolong longevity and improve the quality of life, hence increasing the acceptance to such procedures; methods of biliary drainage include: a. surgical bypass b. minimally invasive procedures; endoscopic retrograde (ercp) (cholangiopancreatography (ercp), and percutaneous transhepatic biliary drainage (ptbd). ercp as well as ptbd are well-established and effective means for biliary drainage as palliative treatment in unresectable cases. with the current modern technique in experienced hands, percutaneous transhepatic biliary drainage (ptbd) equals endoscopic retrograde cholangio pancreatography (ercp) regarding technical success and complications. in addition, there is a reduction in immediate procedure-related mortality with proven survival benefit. moreover, it is the only immediate lifesaving procedure in cholangitis and sepsis.


Eligibility criteria:
inclusion criteria: * any adult patients with malignant obstructive jaundice will included in this study exclusion criteria: * patients with bleeding diathesis. * patients with associating comorbidities. * patients with insufficient intrahepatic biliary dilatation \< 0.5 cm or with extensive tumor infiltrates.
preventing systemic inflammation after cardiac surgery with alkaline phosphatase

Conditions: Systemic Inflammation; Cardiopulmonary-bypass

Summary: study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (cpb) as defined by the akin criteria.

after cardiac surgery under cardiopulmonary bypass (cpb) patients often show impairments of the immune system. compared to placebo, cpb patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury (aki), late extubation, gastrointestinal or neurological complications within 7 days and aki within 90 days.

Eligibility criteria:
inclusion criteria: * undergoing cardiac surgery with planned cardiopulmonary bypass * additive euroscore ii ≥ 3 or at least 3 surgical cardiac interventions are planned * ability to provide informed consent (not incapacitated) exclusion criteria: * already on renal replacement therapy * patients with chronic kidney disease defined as estimated glomerular filtration rate \[egfr\] \ 3 \] * patients who are pregnant or lactating * concurrent enrollment in another clinical trial * known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan * patients with ongoing infections or current use of steroids * patients with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g. tevar)

Keywords: side-effects heart-lung machine alkaline phosphatase
the effect of palatal brushing on denture stomatitis

Conditions: Denture Stomatitis

Summary: palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers. however, there is no previous clinical trial testing this effect. therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa. after an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes). tested hypotheses: * there is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing. * there is no difference in the number of colony forming unit (cfu) of candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.


Eligibility criteria:
inclusion criteria: * good general health. * completely edentulous maxilla. * currently wearing complete upper dentures. * a clinical diagnosis of denture stomatitis. exclusion criteria: * conditions known to promote candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy. * use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study. * previous palatal brushing habit. * changing of the existing prosthesis during the trial.

Keywords: denture stomatitis denture plaque oral candidiasis oral hygiene
orthostatic hypotension and diabetes mellitus

Conditions: Orthostatic Hypotension; Diabetes Mellitus Type 2

Summary: rationale: orthostatic hypotension increases with age and is associated with increased vascular and all-cause mortality. the prevalence of orthostatic hypotension is also increased in diabetic subjects. in order to prevent related adverse events and vascular mortality it is of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic subjects. objective: to examine the prevalence of orthostatic hypotension and associated adverse events in type 2 diabetic elderly subjects. study design: cross-sectional observational study. study population: elderly type 2 diabetic subjects (70 years and older).


Eligibility criteria:
inclusion criteria: * diabetes mellitus * age (70 years and older) exclusion criteria: * known autonomic dysfunction * neurodegenerative diseases * current malignancy * living in a nursing-home * irregular pulse

Keywords: diabetes mellitus elderly orthostatic hypotension
d-mph in the treatment of fatigue and neurobehavioral function related to chemotherapy in adult cancer patients

Conditions: Fatigue; Neoplasms

Summary: to evaluate the efficacy of dexmethylphenidate (d-mph) in the treatment of chemotherapy-related fatigue in adult cancer subjects.


Eligibility criteria:
* diagnosis of cancer, excluding primary or metastatic brain tumors. * treated with a minimum of four cycles of a cytotoxic chemotherapy, the last chemotherapy treatment must have been completed at least 2 months prior to study entry. * physical/neurological examination consistent with the absence of a focal neurological deficit * women of childbearing potential (wcbp) must have a negative serum or urine pregnancy test. in addition, sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner). * subjects must be able to adhere to the protocol requirements. * subjects must understand and voluntarily sign an informed consent document. * subjects must be a native english speaker or fluent in english, and have at least an eighth grade education.

Keywords: neurobehavioral function chemobrain chemo brain fatigue memory loss exhausted trouble concentrating
effect of apidra compared to humalog in decreasing post-prandial hyperglycemia

Conditions: Type 1 Diabetes

Summary: this study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.

this is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of glulisine (apidra) insulin and lispro (humalog) insulin in a real-world setting. children participating in the florida camp for children and youth with diabetes will be randomized to receive either glulisine or apidra to cover carbohydrates after meals. the difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes * children and youth attending florida diabetes camp in deland, fl exclusion criteria: * only campers participating in sessions i and ii are eligible to participate

Keywords: post-prandial hyperglycemia