Kornimate/medical-research-clean huggingface dataset:
study evaluating dvs-233 sr to treat vasomotor systems associated with menopause

Conditions: Menopause; Hot Flashes; Sleep Disorders

Summary: the purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (dvs) for treatment of moderate to severe vasomotor symptoms (vms) that are associated with menopause, and also to assess the effects of dvs on sleep parameters and health outcomes indicators.


Eligibility criteria:
inclusion criteria: * generally healthy, postmenopausal women who seek treatment for hot flushes * minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening * body mass index (bmi) less than or equal to 40 kg/m2 other inclusions apply. exclusion criteria: * hypersensitivity to venlafaxine * history of seizure disorder * history of myocardial infarction or unstable angina within 6 months other exclusions apply.

Keywords: menopause
optimal multimodal analgesia in laparoscopic cholecystectomy

Conditions: Cholecystolithiasis

Summary: to test the current standard of care (soc) treatment for laparoscopic cholecystectomy with a group receiving soc + additional perioperative analgesics in terms of postoperative abilities, ponv, pain and discharge time from the pacu

aim of the study: to compare postoperative complaints (ponv, pain, etc) and pacu discharge time between two groups: * a: standard of care (soc)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium * b: soc + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol. primary endpoints: * postoperative abilities over time * discharge time from pacu according to fixed criteria * consumption of analgesics and antiemetics in the pacu secondary endpoints: * degree of nursing requirements at the pacu * general tolerability of the regimes

Eligibility criteria:
inclusion criteria: * elective laparoscopic cholecystectomy * age above 18 years * written informed consent * asa class i-iii exclusion criteria: * planned abdominal cholecystectomy * intraoperative conversion of laparoscopic to laparotomic cholecystectomy * allergy to part of the treatment regimens * previous reactions to opioids (nausea, cognition)
modified capecitabine and oxaliplatin (mcapox) for patients with gi malignancies

Conditions: GI Cancers

Summary: this study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard folfox or capox regimens.


Eligibility criteria:
inclusion criteria: * patient with gi malignancy * provider plans non-curative intent treatment with either capox or folfox (mfolfox6) at standard dosages for \>3 months note: patient is not required to have radiologically measurable disease. note: planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed. exclusion criteria: * patients not meeting standard hematologic parameters for chemotherapy administration as follows: * absolute neutrophil count (anc) ≥ 1500 * platelet count ≥ 100,000 patients not meeting standard liver function parameters for chemotherapy administration as follows: * ast ≤ 5x uln * alt ≤ 5x uln * total bilirubin ≤ 1.5x uln patients not meeting standard renal function parameters for chemotherapy administration as follows: * serum creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml/min note: planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.

Keywords: capecitabine oxaliplatin gi chemotherapy fluoropyrimidine modified schedule
safety, tolerability, and pk of an2728 in adolescents with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to investigate the safety, tolerability, and systemic exposure of an2728 topical ointment, 2%, in subjects with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male or female 12 to 17 years of age, inclusive * clinical diagnosis of atopic dermatitis (according to the criteria of hanifin and rajka) * ad in treatable areas (excludes the scalp and venous access areas) involving ≥10% and ≤35% of the total body surface area(bsa) * investigator's static global assessment (isga) score of 2 or 3 * normal or not clinically significant screening laboratory results * have adequate venous access to permit repeated pk sampling on days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site * willing and able to comply with study instructions and commit to attending all visits * females must use a highly effective method of birth control. * parent/guardian has the ability to understand, agree to and sign the study informed consent form (icf) prior to initiation of any protocol-related procedures; subject has the ability to give assent exclusion criteria: * significant confounding conditions as assessed by study doctor * unstable or actively infected ad * active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation * history or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis) * concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period * treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years * current pregnancy or lactation, or intent to become pregnant during the study * known sensitivity to any of the components of the study drug * participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * participated in a previous an2728 clinical study

Keywords: atopic dermatitis
screening for hepatitis c using a rapid diagnostic orientation test (trod) in patients over 50 years old in the digestive endoscopy department of the europeen hospital marseille

Conditions: Hepatitis C

Summary: chronic viral hepatitis c is a public health problem and several management recommendations are available. according to the french high authority of health, hepatitis c screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated . french government recommendations aim to achieve elimination of hepatitis c virus hcv (as early as 2025) and since april 2018 the european hospital marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital. since 2017, direct-acting antiviral treatments have become available in france to all patients infected with hcv, regardless of the degree of severity of their disease. these treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. as of today, it is estimated that there are still 110,000 people likely to be treated in france. among them, 75,000 are unaware of being hcv positive, people who need to be tested. with one of the largest volumes of digestive endoscopic examinations in france, the european hospital marseille may be a significant source of screening for hepatitis c. our study proposes to evaluate hepatitis c screening in consenting patients hospitalized in the endoscopy department at the european hospital marseille.


Eligibility criteria:
inclusion criteria: * aged ≥ 50 * giving free and informed written consent * being affiliated with or benefiting from a social security scheme exclusion criteria: - patient unable to express consent
virtual reality to reduce delirium

Conditions: Delirium; Cognitive Impairment

Summary: delirium has been long considered as a major contributor to cognitive impairments following a critical illness. currently, both pharmacologic and non-pharmacologic prevention and treatment strategies are used in the intensive care unit, despite these strategies remaining controversial. however, with previous studies showing the feasibility of using virtual reality (vr) within the critical care setting, the investigators propose to use this technology to investigate the effect of 360-degree immersive virtual reality stimulation on the incidence of delirium in the icu. stimulation will be provided for 30 minutes, three times a day, evenly spaced between 7:00 am and 7:00 pm, using a commercially available head-mounted display. the investigators hypothesize that by providing relaxing virtual environments to patients through a head-mounted display and headphones, the incidence of delirium will be lower compared to the control group receiving no vr stimulation. secondary outcomes will include evaluating the movement patterns and intensity between the intervention and control group, and between patients with and without delirium, using inertial measurement units and an under mattress bed sensor. it is hypothesized that it will be possible to detect difference in movement patterns between groups and identify patterns indicating the presence or absence of delirium. secondary objective also include the evaluation of the effect of vr on duration of delirium. here it is hypothesized that the duration of delirium will be shorter in participants receiving the vr stimulation compared to those in the control group. physiological parameters (e.g. heart rate, respiration rate, oxygen saturation, etc.) will also be recorded during the stimulation to further understand what, if any, effect vr has.


Eligibility criteria:
inclusion criteria: * written informed consent (by the patient, relatives, or authorized representative) * no severe visual or auditory impairments (strabismus, macular degeneration, retinopathy) * estimated length of stay \>24 hours * can keep eyes open for at least 30 seconds * german or french speaking exclusion criteria: * known psychotic disorders associated with delusions (e.g. schizophrenia) * recent history of major depression * admission for drug overdose

Keywords: virtual reality delirium intensive care unit critical care movement analysis
seasonal variation of blood cholesterol levels

Conditions: Atherosclerosis; Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to describe and delineate in a prospective study the nature and causes of seasonal variation of blood lipid levels in the general population.

background: significant seasonal variation of blood cholesterol levels has been shown in a number of cross-sectional studies, with important implications for national screening and therapeutic guidelines. however, the phenomenon has not been well studied: little is known about etiology or about seasonal variation of lipid subfractions. design narrative: the investigators assessed the magnitude and timing of the seasonal effect for total cholesterol and the important lipoprotein subfractions (low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoproteins ai and b, and lipoprotein (a)) in both sexes and at different ages. they also identified and quantified the effects of the main factors determining the variation and assessed the seasonal variation of other blood elements thought to play a role in the development of coronary heart disease, including hemostatic factors and antioxidants finally, they explored the implications of the phenomenon for public health policy. baseline and serial measures were repeated quarterly for one year. these included measures of: serum lipids and lipoproteins; antioxidant vitamins; platelets and hemostatic factors; demographic factors; weight, waist-hip ratio, height, body mass index (bmi) and blood pressure; dietary intake; physical activity; light exposure; and psychologic factors. meteorologic data were also collected. data were collected by written questionnaire and by the use of computer-assisted evening telephone interviews (cati), which were used for the collection of dietary, physical activity and individual light-exposure and other lifestyle data. activity and light data were verified in a subset of 80 patients by the use of a monitoring device. analyses included methods to describe the seasonal variation in dietary, physical activity, psychologic, and light exposure data and repeated measures in linear regression models to determine the roles of specific dietary, physical activity, psychologic, and light-exposure related covariates in explaining variability in blood lipids, antioxidant vitamins, and hemostatic factors. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
analysis of respiratory system mechanics and inflammatory response during orthotopic liver transplantation (spplit trial)

Conditions: End Stage Liver Diseases

Summary: during orthotopic liver transplantation (olt), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. in particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. the object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall. we hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. this impairment is associated with the systemic inflammatory response following liver reperfusion.


Eligibility criteria:
inclusion criteria: * orthotopic liver transplantation * valid informed consent exclusion criteria: * age \< 18 yrs

Keywords: orthotopic liver transplantation ischemia reperfusion syndrome cytokines respiratory system elastance lung elastance chest wall elastance shunt dead space acute respiratory failure atelectasis pleural effusion
camel's milk as a safe alternative in cow's milk allergy

Conditions: Cow's Milk Allergy

Summary: by performing a challenge with camel's milk in patients who are allergic to cow's milk, the investigators will examine if camel's milk is a safe alternative for these patients.


Eligibility criteria:
inclusion criteria: * proved cow"s milk allergy exclusion criteria: * pregnant women
interlocking polyetheretherketone implants for orbital floor reconstruction

Conditions: Large Orbital Floor Fracture

Summary: patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically

twenty two patients with large orbital floor fracture will be included in this study. patients will be received, examined and managed at the oral \& maxillofacial surgery department, faculty of dentistry, tanta university. full clinical examination and radiographic examination using multi axial c.t scan for proper diagnosis and treatment planning. dicom files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. after written informed consent from the patient, the surgery will be done under g.a, either infraorbital or transconjunctival incision will be done according to the case. follow up: all patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months \& radiographically for orbital volume immediately and 6 months postoperatively

Eligibility criteria:
inclusion criteria: * patients with large orbital blow out fracture either isolated or combined with other fracture * patients willing for surgical operation and follow up * patients with no contraindications for surgical intervention exclusion criteria: * patients who are not fit for g.a * uncooperative patients

Keywords: orbital reconstruction interlocking peek patient specific implant
neoadjuvant icotinib with chemotherapy for epidermal growth factor receptor(egfr)-mutated resectable lung adenocarcinoma

Conditions: NSCLC; EGF-R Positive Non-Small Cell Lung Cancer

Summary: icotinib is a first-generation inhibitor of egfr-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (nsclc). here we will evaluate neoadjuvant icotinib with chemotherapy prior to surgery, in patients with resectable stage ii-iiib n2 egfr mutation-positive nsclc. the primary endpoint is centrally assessed major pathological response at the time of resection. secondary endpoints include pathological complete response, objective response rate, r0 resection rate at the time of resection, disease-free survival, and overall survival. safety and tolerability will also be assessed.


Eligibility criteria:
key inclusion criteria: * written informed consent * male or female, aged ≥18 years and ≤75 years * histologically or cytologically documented lung adenocarcinoma with completely resectable disease (stage ii-iiib n2, according to the 8th edition of the iaslc staging manual in thoracic oncology) * complete surgical resection of the primary nsclc must be deemed achievable, as assessed by an mdt evaluation * a tumor which harbors either ex19del or l858r egfr-tki-sensitizing mutations, either alone * ecog ps 0/1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing * adequate organ and marrow function as defined by: * hemoglobin: ≥9.0 g/dl * absolute neutrophil count: ≥1.5 × 109/l * platelet count: ≥100 × 109/l * serum bilirubin: ≤1.5 uln * alt and ast: ≤2.5 × uln * creatinine clearance: ≥60 ml/min * life expectancy of 6 months prior to randomization exclusion criteria: * prior treatment with systemic anti-cancer treatment for nsclc, egfr-tki treatment or pre-operative radiotherapy * egfr-tki-sensitizing mutations with t790m * mixed small cell and non-small-cell lung cancer histology * t4 tumors infiltrating the aorta, esophagus and/or heart * bulky n2 disease * candidates for segmentectomies or wedge resections only * medical history of ild, drug-induced ild, radiation pneumonitis which required steroid treatment or any evidence of clinically active ild * severe or uncontrolled systemic diseases/active infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy

Keywords: nsclc, egfr, icotinib
a study to evaluate the safe and effective use of the prefilled safety syringe or the auto-injector for the subcutaneous self-injection of bimekizumab solution by subjects with moderate to severe chronic plaque psoriasis (pso)

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis

Summary: the purpose of the study is to evaluate the ability of subjects with moderate to severe chronic plaque psoriasis (pso) to safely and effectively self-inject bimekizumab at study start and 8 weeks after training in self-injection technique using a prefilled safety syringe or an auto-injector.


Eligibility criteria:
inclusion criteria: * subject fulfills all inclusion criteria for the ps0014 \[nct03598790\] study * subject is considered reliable and capable of adhering to the dv0002 protocol (eg, able to understand and complete questionnaires, willing to self-inject, able to use investigational device according to the instructions for use (ifu), and able to adhere to the visit schedule) according to the judgment of the investigator exclusion criteria: * subjects are not permitted to enroll in dv0002 if any of the ps0014 \[nct03598790\] study exclusion criteria are met

Keywords: bimekizumab pso psoriasis auto-injector
management of non-organic dysphonia in adults.

Conditions: Functional Dysphonia; Resonance Tube Voice Therapy; Smith Accent Method Therapy

Summary: the purpose of this study is to determine the effect of a semi-occluded vocal tract training program, "resonant tube therapy," versus the "traditional smith-accent method" on the quality of voice in patients with non-organic "functional" dysphonia.


Eligibility criteria:
inclusion criteria: * patients diagnosed with non-organic functional dysphonia with or without minimally associated pathological lesions and referred for voice therapy. the diagnosis was based on the results of the routine clinical assessment of cases of voice disorders by a phoniatrician in the voice clinic. * patients 'ages between 15 - 60 years old. * native speakers of arabic. * language comprehension adequate for the task. exclusion criteria: * patients with organic voice disorders. * patients with aphonia or phon asthenia. * females within the week of their menstrual cycle or menstruating at the time of data collection to control for the possible hormonal effects or premenstrual water retention on voice quality. * history of severe respiratory allergies, thyroid pathologies, neuro-motor impairment, hearing impairment, psychiatric problems and physically limiting diseases that might interfere with study completion. * those on any regular medication that might affect voice quality. * speech disorders. * cigarette smoking, alcohol, or drug abuse for the past 5 years. * patients with previous micro laryngeal surgery. * patients with gastrointestinal reflux disease.
acupuncture for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

Conditions: Cholecystitis, Acute; Cholelithiasis; Nausea, Postoperative; Vomiting, Postoperative; Pain, Postoperative

Summary: the purpose is to find out if intraoperative acupuncture performed by needling pc 6 and li4 point bilaterally, and yin tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. the hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.


Eligibility criteria:
inclusion criteria: 1. patient ages 18-64 2. american society of anesthesiology physical status i, ii or iii 3. patients scheduled to undergo laparoscopic cholecystectomy at harris health system ben taub hospital exclusion criteria: 1. scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures 2. renal dysfunction (serum cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications 3. allergy to any of the standard anesthetic agents 4. patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) 5. patient or surgeon refusal
coaching in childhood asthma

Conditions: Asthma

Summary: asthma among low-income, minority children remains a prime example of health disparities that are resistant to change. demonstrations of reductions in disproportionate hospitalizations in controlled trials are limited. we performed a controlled clinical trial of an asthma coach to reduce hospitalizations among low-income, african american children.


Eligibility criteria:
inclusion criteria: * mothers of children with asthma 2-8 years of age and hospitalized for an acute exacerbation, with medicaid insurance, and living in st. louis city exclusion criteria: * other respiratory disease present

Keywords: childhood asthma