Kornimate/medical-research-clean huggingface dataset:
a confirmatory safety and efficacy study of bbi-4000 in subjects with axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: this study is being conducted to assess the safety and efficacy of 3 concentrations of bbi-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.

this is a multicenter, randomized, double blind, vehicle-controlled study to evaluate the safety and efficacy of 3 concentrations of topically applied bbi-4000 in subjects with axillary hyperhidrosis. safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.

Eligibility criteria:
inclusion criteria: * male or female subject ≥ 18 years of age. * diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) hdsm-ax of 3 - 4, (c) hdss of 3 or 4 and (d) a minimum gsp of 50 mg is each axilla with a combined total of at least 150 mg. * the ability to understand and follow all study-related procedures including study drug administration. * sexually active female of childbearing potential (focbp)\* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product. exclusion criteria: * in the investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s). * prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis. * anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration. * use of potent inhibitors of cytochrome p450 cyp3a and cyp2d6. * use of any cholinergic drug (e.g. bethanechol) within 30 days. * known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.). * subjects with unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, bph, neurological or psychiatric conditions, sjögren's or sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion. * subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation. * subject is pregnant, lactating or is planning to become pregnant during the study. * history or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.

Keywords: sweat gland disease sweating underarm
a study to assess tolerability, safety, pharmacokinetics and effect of azp2006 in patients with psp

Conditions: Progressive Supranuclear Palsy

Summary: a phase 2 study to assess tolerability, safety, pharmacokinetics and effect of azp2006 at different doses versus placebo on cerebrospinal fluid biomarkers in 36 patients with progressive supranuclear palsy. the patient study duration is 29 weeks including a washout period.

this is a randomized, double blind, placebo controlled, parallel group study comparing 2 doses of azp2006 (60 mg once daily \[qd\] during the 12-week treatment period or 80 mg for 10 days followed by 50 mg qd) with placebo in 36 men and women aged ≥40 years and ≤80 years and diagnosed with probable or possible psp according to movement disorder society psp (mds-psp) criteria. patients were assessed for eligibility at baseline. eligible patients were randomized on day -1 in a 1:1:1 ratio into one of the following 3 study intervention groups based on a randomization scheme with blocks stratified by center using an interactive web response system (iwrs): 1. 60 mg azp2006/day during the 12-week treatment period; 2. 80 mg azp2006/day for 10 days followed by 50 mg azp2006/day; 3. placebo.

Eligibility criteria:
inclusion criteria: * male and female patients with probable or possible psp * patients must be stable with their medication for at least 30 days prior to the inclusion visit. exclusion criteria: * any history of clinically significant head trauma or cerebrovascular disease or recent history of substance abuse or alcohol abuse and deemed to be clinically significant by the investigator. * history of deep brain stimulator (dbs) surgery other than sham surgery for dbs clinical study.
optic nerve sheath diameter in urologic surgery

Conditions: Urological Manifestations; Anesthesia

Summary: the investigators aimed to determine intracranial pressure changes during spinal and general anesthesia by using optic nerve sheath diameter and near infrared spectrometer in urologic surgery patients in lithotomy position. also the investigators plan to evaluate to measure intrathoracic pressure effects to intracranial pressure.

the patients will be divided into 2 groups as those who underwent general anesthesia and spinal anesthesia.both groups at the specified times. (the patient is supine for both groups before the start of the anesthesia procedure.) position t0, for group g, t1g 2 minutes after intubation, t1s 2 minutes after spinal anesthesia for group s, two t2, lithotomy 5 minutes after the lithotomy position for the group lithotomy to t3 30 minutes after the t4, t5 in pacu ) 60 minutes after optic nerve sheath diameter (osc) values and lung assessment (lus), cerebral cerebral palsy with near-infrared spectroscopy (nirs) oxygenation, mean arterial pressure, peripheral oxygen saturation, serum sodium, arterial carbon dioxide values and heart rate values will be recorded and significant statistical differences will be evaluated.

Eligibility criteria:
inclusion criteria: * asa 1-2-3, patients * over 18 years of age who will undergo urological surgery exclusion criteria: * existing disease that causes an increase in intracranial pressure * patients with optic nerve pathology, * ophthalmologic diseases

Keywords: optic nerve sheath diameter lithotomy position near infrared spectrometer
mechanisms of dupilumab in aerd

Conditions: Aspirin-exacerbated Respiratory Disease

Summary: aspirin-exacerbated respiratory disease (aerd), although uncommon in the general population, is an important phenotype of severe asthma and nasal polyposis where it occurs in 15% of severe asthmatics, and up to 30% of those with nasal polyposis. an important therapy for aerd is aspirin therapy after desensitization (adat). this is an inexpensive and proven therapy to improve the burden of sinus disease in aerd. aspirin desensitization is the mechanism by which tolerance is induced in aerd patients. this is a 1-2 day outpatient procedure whereby increasing doses of aspirin are administered and the patients invariably experience some degree of hypersensitivity reactions. it is important to understand the effect of medications on the aspirin desensitization. it is known that the leukotriene modifier medications decrease the severity of the reactions in aerd. other treatments such as antihistamines and the biologic agent omalizumab might have an effect on either blocking or blunting reactivity in aerd during desensitization. dupilumab is a new respiratory biologic approved for atopic dermatitis, eosinophilic asthma and nasal polyposis. as such, it is well situated to be used for many aerd patients whose disease cannot be well controlled. the effect of dupilumab on the aspirin desensitization process and reaction is unknown and is the topic of this investigation. the primary objective is to determine the effect of dupilumab on reactions during aspirin challenge/desensitization.


Eligibility criteria:
inclusion criteria: * subjects \>18 years old with aspirin-exacerbated respiratory disease this is diagnosed via either a positive oral aspirin or intranasal ketorolac challenge or a history of at least two stereotypical hypersensitivity reactions to aspirin leading to nasal-ocular symptom and/or asthmatic symptoms. * current treatment with dupilumab at standard asthma/nasal polyposis dosing of 300mg subcutaneously every 2 weeks for a minimum of 12 weeks. * all subjects will be required to have a known history of nasal polyposis either via imaging, endoscopy, or nasal examination exclusion criteria: * history of gastrointestinal reactions (severe abdominal pain with or without vomiting) during nsaid triggered events * unstable asthma or history of severe reactions during previous desensitization attempts * inability to take montelukast pretreatment * history of gastrointestinal bleeding or bleeding disorder * pregnancy * previous use of any other respiratory biologic in the past 3 months (omalizumab, tezepelumab, mepolizumab, reslizumab, benralizumab) * need for systemic corticosteroids to stabilize asthma prior to challenge * time from sinus surgery \<1 month.
effect of post traumatic stress disorder on parenting

Conditions: Post Traumatic Stress Disorder

Summary: ptsd affects a wide variety of symptoms, some of which have been shown to disrupt family relationships. this study will examine some of the effects on parenting, from the perspective of the parent with ptsd.


Eligibility criteria:
inclusion criteria: * ptsd (pss\>15) children under age 18 exclusion criteria: * non ptsd (pss\<15) children under age 18

Keywords: ptsd, parenting
follow up trial for keppra (levetiracetam) as monotherapy in patients with newly diagnosed epilepsy coming from n01175 (nct00175903).

Conditions: Epilepsy

Summary: for ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial n01175 (nct00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in europe. to continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.


Eligibility criteria:
inclusion criteria: * male/female adult subjects (≥ 16 or 18 years) * diagnosis of epilepsy (all types of seizures may be included) * subjects who completed n01175 (nct00175903) trial and benefited from levetiracetam monotherapy other inclusion criteria may apply exclusion criteria: * subjects withdrawn from n01175 (nct00175903) trial for any reason * subjects who received treatment other than levetiracetam in n01175 (nct00175903) trial * subject requiring add-on antiepileptic treatment * subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment * sexually active woman with childbearing potential who is not using a medically accepted birth control method

Keywords: newly diagnosed epilepsy levetiracetam keppra n01175 (nct00175903)
ultrasound imaging of the larynx and diaphragm during niv and cough assist

Conditions: Healthy Persons

Summary: the study examines if diagnostic ultrasound imaging of larynx and diaphragm can be as accurate as transnasal fiberoptic laryngoscopy in visualizing the larynx during niv and mechanically assisted cough interventions.

transnasal fiberoptic laryngoscopy (tfl) is gold standard for visualising the larynx. tfl has been used to visualize the laryngeal response patterns during non-invasive therapeutic interventions, as during mechanically assisted cough in patients with amyotrophic lateral sclerosis. the examinations revealed that the larynx adducted during the application of positive pressures, which restricted the airflow and reduced the efficacy of the treatment. the higher treatment pressures resulted in ineffective interventions as a result of the adducted vocal cords obstructing flow. this knowledge has changed the treatment approach for patients with possible upper airway instability by individualizing the treatment pressures and flow due to laryngeal responses. tfl may cause slight discomfort when placing the laryngoscope. diagnostic ultrasound is non-invasive easily applicable technique that has gained increasing popularity in diagnosing cardiopulmonary and laryngeal conditions during the recent times. the aim of the study is to investigate whether the diagnostic ultrasound of the larynx can be as accurate as tfl during mechanically assisted cough and non-invasive ventilation (niv). the present study will include healthy participants. hypothesis is that diagnostic ultrasound of larynx can provide clinical valuable information of the laryngeal response patterns during mechanically assisted cough and niv. the aims of the study are: * to evaluate the feasibility of diagnostic ultrasound imaging of the larynx, and to compare to the gold standard of tfl used during ongoing niv and mechanically assisted cough in healthy subjects. * to evaluate the feasibility of ultrasound imaging if the diaphragm during ongoing niv and mechanically assisted cough in healthy subjects.

Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * history of laryngospasm or pneumothorax

Keywords: transnasal fiberoptic laryngoscopy diagnostic ultrasound cough assist noninvasive ventilation
infected elders in the emergency department: outcomes and processes of care

Conditions: Sepsis

Summary: the purpose of this study is to determine factors which predict a complicated hospital course and then to develop from these findings an emergency department guideline to assist in knowing who is at highest risk of elderly patients with infection presenting for care.

the study is looking at how closely physicians adhere to treatment guidelines in caring for elderly patients, and then to determine if there are differences in elderly patient disease symptoms that result in a failure to use guidelines. if this is known, physicians can then be aware of these differences and provide appropriate care.

Eligibility criteria:
inclusion criteria: * age 65 or older * blood cultures ordered in the emergency department * admitted to the hospital from the emergency department exclusion criteria: * age less than 65 * prisoners * patient unable to provide consent and no legally authorized representative available * non-english speaking * ed visit or admission in the last 7 days for the same condition * primary evaluation by the trauma team

Keywords: geriatric sepsis outcome assessment(healthcare)
effect of insoles in patients with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic; Foot Orthoses; Musculoskeletal Pain

Summary: demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with sle and podiatric involvement.


Eligibility criteria:
inclusion criteria: * 18 years or more. * medical diagnosis of les. * foot involvement. exclusion criteria: * treatment with foot orthoses. * les with acute symptomatic flare. * ulcers. * skin involvement. * neurological problems. * cognitive deterioration. * need for walking assistance. * refused to change footwear to use the foot orthoses.

Keywords: lupus erythematosus, systemic foot orthoses foot pain
fusion ultrasound imaging of the thyroid gland with i-124 pet. evaluation of nodule allocation.

Conditions: Thyroid Nodule; Thyroid Diseases; Thyroid Goitre

Summary: regular thyroid diagnostics versus augmented thyroid work-up with additional i-124 pet/us fusion for metabolic-sonographic nodule allocation in patients with benign thyroid diseases


Eligibility criteria:
inclusion criteria: * patients with thyroidal nodules, * euthyroidism * uptake \>0,5% on tc-99m-pertechnetate- scintigraphy exclusion criteria: * thyroid medications in the last 6 months * iodine exposition in the last 6 months * thyroid surgery or radioiodine therapy

Keywords: fusion hybrid imaging mapping iodine ultrasound
investigating the effect of using myopia prediction algorithm on myopia children

Conditions: Refractive Errors

Summary: in this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm

we propose to enroll myopia children aged 8-10 in china. children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group a use myopia prediction algorithm to predict myopia development, while in group b, the participants do not use myopia prediction algorithm to predict myopia development. the visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups

Eligibility criteria:
inclusion criteria: * children aged 8-10 * has the record of eye refraction examined in the past year, ser\<-0.5d * current bcva≥0.8, ser\<-0.5d, astigmatism less than 1.50 d, anisometropia less than 1.50 d * written informed consents provided exclusion criteria: * definitive diagnosis of other diseases except for refractive error * previous eye surgery * previous usage of orthokeratology lenses and atropine * unwilling to participate in this trial
radiofrequency interstitial tissue ablation in treating patients with localized renal cell carcinoma (kidney cancer)

Conditions: Kidney Cancer

Summary: rationale: radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature. purpose: this phase ii trial is studying radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma (kidney cancer).

objectives: primary * evaluate the efficacy of radiofrequency interstitial tissue ablation in terms of tumor destruction or slowed tumor growth rate in patients with localized renal cell carcinoma. secondary * assess the toxicity of this treatment regimen in these patients. outline: patients undergo percutaneous radiofrequency interstitial tumor ablation (rfa). patients are offered laparoscopy-assisted percutaneous rfa in the operating room if their tumors are not safely accessible. intra-operative ultrasound is used to confirm probe placement and to monitor treatment delivery. if the target temperature or impedance are not reached, treatment is repeated no more than twice. no more than 5 tumors are treated per kidney. all patients are followed at 2 to 3 months, 6 months, and then at 1 year. patients with tumors greater than 2 cm in diameter are followed every 6 months for up to 5 years. patients whose tumors become greater than 3 cm are recommended for surgery and removed from study if surgery is performed. projected accrual: a total of 63 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * localized renal cell carcinoma, meeting both of the following criteria: * enlarging renal tumors on imaging studies over a minimum of 12 months * tumor size between 0.5-4.0 cm in diameter at time of treatment patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * creatinine less than 2.0 mg/dl or * creatinine clearance greater than 60 ml/min other: * not pregnant * negative pregnancy test prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specifed radiotherapy * not specified surgery * not specified

Keywords: stage i renal cell cancer stage ii renal cell cancer
efficacy and safety of glycopyrronium/formoterol fumarate fixed-dose combination relative to umeclidinium/vilanterol fixed-dose combination over 24 weeks in patients with moderate to very severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease COPD

Summary: this is a phase iiib randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of glycopyrronium/formoterol fumarate (gff) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to umeclidinium/vilanterol (uv) 62.5/25 μg fixed-dose combination 1 inhalation once daily in patients with moderate to very severe copd.


Eligibility criteria:
inclusion criteria: * age 40-95 years at screening * current or former smoker with a history of at least 10 pack-years of cigarette smoking * current clinical diagnosis of copd, with copd symptoms \> 1 year prior to screening, as defined by gold criteria or other current guidelines * copd severity defined by fev1/fvc ratio \<0.70 and fev1 \<80% of predicted normal value at screening and at randomisation * copd treatment with rescue medication only, or stable dose of maintenance monotherapy (lama, laba or ics), or stable dose of double maintenance therapy (lama/laba or ics/laba), for one month prior to screening * copd assessment test (cat) score ≥10 at randomisation * documentation of a chest x-ray (as per local practice) or computed tomography (ct) within 6 months prior to screening, with no clinically significant pulmonary abnormalities other than related to copd exclusion criteria: * respiratory disease other than copd, including: * current diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * other respiratory disorders and conditions as listed in the protocol * severe copd exacerbation (resulting in hospitalisation) not resolved within 8 weeks prior to screening, or moderate exacerbation not resolved within 4 weeks, or during screening * pneumonia or lower respiratory tract infection that required antibiotics within 8 weeks prior to screening, or during screening. * significant diseases or conditions other than copd which may put the patient at risk, or influence the results of the study or the patient's ability to participate, including cardiac disease, advanced renal disease, and cancer that has not been in complete remission for at least 5 years. * patients who have needed additions or alterations to their usual maintenance therapy for copd due to worsening symptoms within 1 month prior to and during screening * treatment with depot corticosteroids within 6 weeks, or other systemic corticosteroids within 4 weeks, prior to screening. (patients maintained on an equivalent of 5 mg prednisone per day for at least 3 months prior to screening are allowed.)

Keywords: copd