Kornimate/medical-research-clean huggingface dataset:
paves benchmarking pilot study of daily disposable contact lenses

Conditions: Refractive Errors

Summary: the study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (sihydd) to three (3) benchmark soft daily disposable lenses (dd) and, subsequently, of a new-to-market hydrogel spherical daily disposable (hyddd) soft contact lens to three (3) other hydrogel daily disposable lenses. . the primary outcome variables for this study are subjective comfort and lens preference.

the objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon b with tangible coating daily disposable soft contact lens (sihydd) to three (3) benchmark soft daily disposable lenses (dd) and, subsequently, of a new-to-market hydrogel etafilcon a with tangible coating spherical daily disposable (hyddd) soft contact lens to three (3) other hydrogel daily disposable lenses. . the primary outcome variables for this study are subjective comfort and lens preference.

Eligibility criteria:
inclusion criteria: * healthy full-time wearers of spherical daily disposable contact lenses * vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 ds and from -1.00 to -7.00 ds * visual acuity corrected to at least 20/30 with spherical contact lens exclusion criteria: * participating in another clinical trial * vision not correctable to 20/30 with lens powers listed above

Keywords: contact lens
regional blocks of gynecological surgeries

Conditions: Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia

Summary: this study will be conducted on 273 patients of asa grade i and ii aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse patients will be divided into three equal groups; group a control group for conventional epidural technique(n=91), group b for dural puncture epidural with 27g pencil point whitacre spinal needle (n=91) and group c for dural puncture epidural with 25g pencil point whitacre spinal needle(n=91). randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.


Eligibility criteria:
inclusion criteria: * asa i and ii * height(150-170 cm) exclusion criteria: * patient refusal * hypersensitivity to local anesthetic drugs * bleeding disorders and coagulopathy(platelets count less than 80000,inr less than 1.5 or therapeutic dose of anticoagulant).

Keywords: neuraxial technique, epidural technique, dural puncture epidural technique, gynecologic disease
estimate the effect of lersivirine on the pharmacokinetics of s- and r-methadone

Conditions: Healthy Volunteers

Summary: the objective of this study is to estimate the effect of lersivirine on the pharmacokinetics of r-methadone and s-methadone and to investigate the safety and tolerability of lersivirine when co-administered with methadone. symptoms of methadone withdrawal will also be assessed.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history except drug abuse), full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs). * receiving stable methadone maintenance treatment for at least 3 months (dose range 50-150 mg qd). exclusion criteria: * subjects on therapy for hepatitis b and/or hepatitis c; evidence of impaired liver function (ie, ast and/or alt greater than 3 times the upper limit of normal, total bilirubin \>1.5 times the upper limit of normal, albumin \<3.5 g/dl). * 12-lead ecg demonstrating qtc \>450 msec for males and qtc \>470 msec for females or any other clinically significant abnormalities at screening.

Keywords: drug interaction pharmacokinetics lersivirine methadone
effectiveness of telerehabilitation interventions in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system of unknown etiology. the most common clinical signs and symptoms are motor dysfunction, fatigue, spasticity, impaired mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 66% of people with ms have impaired upper extremity function. as a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. as a result of this influence, there is a decrease in the functional independence of people, quality of life, and participation in activities in the community. exercise training represents an existing behavioral treatment approach to safely manage many functional, symptomatic, and quality-of-life outcomes in ms. telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies." telerehabilitation has proven to be useful for people with ms by increasing physical activity and reducing fatigue. in the studies, telerehabilitation and face-to-face rehabilitation services were compared, and stated that they had similar results. at the same time, it was stated that telerehabilitation provides people with gains in terms of time and cost. in addition to all these, the researchers emphasized the benefits they received from telerehabilitation from the people's statements. therefore, the results of this study, which will be performed on ms patients, will enable the evaluation of telerehabilitation strategies from the patient's point of view. the participants was included in the study titled 'investigation of the effects of the synchronized telerehabilitation-based upper extremity training program on hand-arm function, pain, fatigue, quality of life, and participation in people with multiple sclerosis (clinicaltrials.gov identifier: nct05073731)' will be included in this study. questionnaires that will enable individuals to evaluate their telerehabilitation service will be administered once. physicians and physiotherapists will make evaluations.


Eligibility criteria:
inclusion criteria: * having a definitive diagnosis of ms according to the 2017 mcdonald criteria * being over 18 years old * volunteering to participate in the study * to have received exercise training based on synchronous or asynchronous telerehabilitation exclusion criteria: * having a neurological disease other than ms * having an ms attack 30 days before or during the study * cognitive disability at a level that hinders assessment and treatment.

Keywords: multiple sclerosis upper extremity telerehabilitation patient perspective
the effect of metacognition-based, manualized intervention on fear of cancer recurrence

Conditions: Fear of Cancer Recurrence

Summary: the primary aim of this study is to assess the effect of conquerfear, a metacognition-based manualized intervention on fear of cancer recurrence, using the randomized controlled trial approach, among chinese patients newly diagnosed with curable cancer. this study aims to (1) test the direct effect of conquerfear intervention on fear of cancer recurrence and on maladaptive metacognition, and (2) to test the indirect effect of conquerfear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

a randomized controlled trial will be conducted to test the effect of a metacognition-based manualized intervention on fear of cancer recurrence among chinese breast, gynecologic and colorectal cancer patients with high levels of fear of cancer recurrence. the aims are to test: 1. the direct effect of conquerfear intervention on fear of cancer recurrence, 2. the direct effect of conquerfear intervention on maladaptive metacognition 3. the indirect effect of conquerfear intervention on fear of cancer recurrence through its effect on maladaptive metacognition. primary hypothesis: 1. participants in the conquerfear intervention will show a greater reduction in fear of cancer recurrence compared to participants in the control group 2. participants in the conquerfear intervention will show a greater reduction in maladaptive metacognition than the control participants 3. there will be an indirect effect of conquerfear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.

Eligibility criteria:
inclusion criteria: 1. cantonese- or mandarin-speaking chinese patients recently diagnosed with non-metastatic breast cancer, gynecologic cancer, or colorectal cancer 2. had surgery as a primary treatment 3. have had completed hospital-based adjuvant treatments including radiotherapy and chemotherapy within the past 18 months 4. with the cut-off scored ≥ 13 on severity, the subscale of fear of cancer inventory 5. are able to read and write chinese 6. are over the age of 18 years exclusion criteria: 1. non-chinese ethnicity 2. patients diagnosed with metastatic cancer 3. with a current diagnosis of depression or psychosis 4. currently receiving psychological treatment 5. with language difficulties or intellectual disability.

Keywords: fear of cancer recurrence metacognition cancer survivorship psychooncology breast cancer colorectal cancer gynecologic cancer
effect of using barrier devices for intubation in covid-19 patients

Conditions: Intubation, Intratracheal; COVID-19

Summary: the aim of this study is to compare the impact of using the aerosol box and transparent sheet as an adjunct to conventional personal protective equipment on endotracheal intubation of covid-19 patients. the effect of the head of the bed elevation will also be evaluated during the mentioned simulated scenarios.

this is a randomized, prospective, manikin simulation study. emergency medicine specialists will be participated in the study. participants will be randomly assigned into 6 groups with a 1:1:1:1:1:1 allocation following simple randomization procedures by a program generating online random numbers. 13 participants will be recruited to the study. operators who will intubate the manikin will use following methods: (1) conventional personal protective equipment (ppe) with placing the manikin in the supine position. (2) aerosol box as an adjunct to ppe with placing the manikin in the supine position. (3) transparent sheet as an adjunct to ppe with placing the manikin in the supine position. (4) conventional personal protective equipment (ppe) with placing the manikin in the 30 degree the head of the bed elevated position. (5) aerosol box as an adjunct to ppe with placing the manikin in the 30 degree the head of the bed elevated position. (6) transparent sheet as an adjunct to ppe with placing the manikin in the 30 degree the head of the bed elevated position.

Eligibility criteria:
inclusion criteria: * participants who want to participate the study exclusion criteria: * participants who do not want to participate the study

Keywords: aerosol box covid-19 intubation personal protective equipment barrier device
contrast-enhanced diffusion-weighted mri to detect liver metastases in patients with pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. the current standard of diagnostic workup with contrast-enhanced ct (cect) has a poor sensitivity (38-76%) for the detection of liver metastases. as more sophisticated and expensive treatment options emerge, better staging of pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate treatment strategy. new imaging modalities are available, but their value in staging of pancreatic cancer has not been evaluated yet. therefore prospective imaging studies are necessary. the main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted mri (ce-dw-mri) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and follow up imaging. the study is an international, multicenter prospective cohort study (inclusion of patients until 138 patients with liver metastases are included, with a total maximum of 465 patients). patients with pancreatic cancer will undergo additional ce-dw-mri within two weeks from the cect. cect and ce-dw-mri will be read independently by two radiologists. suspected liver lesions on cect and/or ce-dw-mri will be biopsied to obtain histopathology as reference standard. for liver lesions without histopathologic proof of metastases a paired follow-up cect and ce-dw-mri serve as a composite reference standard. pancreatic resection will be pursued in patients without proven liver or distant metastases. patients with locally advanced or metastatic disease will be offered palliative treatment. follow up cect and ce-dw-mri will be performed in all patients at 3, 6, and 12 months.


Eligibility criteria:
inclusion criteria: * 18 years and older * clinical suspicion of pancreatic cancer * written (signed and dated) informed consent exclusion criteria: * previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, ablation therapy) * concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. subjects with prior malignancies must be disease-free for at least 5 years * contra-indications to undergo ct (due to e.g. extreme claustrophobia, untreatable contrast allergy, renal function impairment) * contra-indications to undergo mri (due to e.g. claustrophobia, untreatable contrast allergy, or not mri compatible medical devices) * insufficient command of the dutch language to be able to understand the patient information or fill in the questionnaires * pregnancy

Keywords: liver metastases diffusion weighted mri
satiating diet, appetite control and body weight loss in individuals with obesity

Conditions: Weight Loss; Weight Maintenance; Appetite Control

Summary: the objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. this is an 18-month, randomized, controlled, parallel weight loss \[phase 1 (p1): 6 months\] and maintenance trial \[phase 2 (p2): 12 months\] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (p1) followed by a continuation of this intervention (p2); (2) conventional restrictive intervention (-500 kcal/d) (p1) followed by a non-restrictive satiating intervention (p2); (3) control group that follows minimal healthy guidelines (p1) followed by recommended weight maintenance strategies (p2). all groups will be controlled for physical activity and sleep patterns. the non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). measurements at baseline (week 0), after p1 and p2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. follow-ups will be done by a dietitian every 2 weeks during p1 and once a month during p2.


Eligibility criteria:
inclusion criteria: * individuals with a bmi ≥30 and \<40 kg/m2 * aged between 18-50 years * waist circumference \>102 cm in men and \>88 cm in women. exclusion criteria: * taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids) * being treated with insulin for type 2 diabetes * large body weight fluctuations (\>4 kg over last two months) * characterized by high restraint behaviour (score \>12, measured with the tfeq) * history of an eating disorder (e.g. binge eating disorder) using the ede questionnaire * performing \>150 min of moderate-vigorous intensity physical activity/week * use of nutritional supplements (multivitamins, calcium, protein, fibre); 8) smoking, drugs or alcohol (\>2 drinks/d) * consumption of \>5 cups of coffee/d * (pre)menopausal or pregnant women * diagnosis of chronic diseases, acute infections or gastric problems (e.g. ulcers) * food allergies/intolerances to ingredients/foods in the satiating intervention * having a pacemaker (for fmri) * taking sedatives or sleeping pills * symptoms of depression (\>20 on the bdi).
disease management in asthma or chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Asthma

Summary: the purpose of this study is to determine whether disease management program is effective in preventing acute exacerbations in patients with unstable chronic obstructive pulmonary disease (copd) or asthma.

the aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (copd) or asthma. the intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the jerusalem and the lowland district of maccabi health services in israel. the main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease. secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.

Eligibility criteria:
inclusion criteria: 1. men and women 2. 40 years or older 3. having unstable copd or asthma exclusion criteria: 1. significant lv dysfunction 2. other severe chronic morbidity compromising short-term survival 3. significant cognitive impairment or psychiatric disease 4. bedridden 5. homeless or no telephone connection

Keywords: chronic obstructive pulmonary disease (copd) asthma
impact of allo-hsct on bone remodeling: evolution of bone mineral density and architecture measured by bone densitometry

Conditions: Myeloid Leukemia, Acute

Summary: evaluation of variation of mineral density and bone microarchitecture after allogeneic hscts transplant in hematologic malignancies. comparison with the general population.

allo-hscts performed for the treatment of hematologic malignancies has been increasing in recent years. there is therefore a growing interest in the quality of life of these patients and in particular for the bone complications of the transplant. indeed, it was found a high incidence of osteoporosis / osteopenia in this population associated with an increased risk of osteoporotic fracture from 6 to 9 times compared to the general population. this study will evaluate the variation of mineral density and bone microarchitecture parameters by bone densitometry with measurement of trabecular bone score and fracturing risk before and after allogeneic hscts transplant, at predefined times. it's also evaluating pain scale, fracture incidence and bone remodeling markers.

Eligibility criteria:
inclusion criteria: * cytological diagnosis of acute myeloid leukemia (aml) with indication for a first-line allo-hscts transplant * patient affiliated to the social security system * for women of childbearing age, use of reliable contraception throughout the study in accordance with the cpr of the drugs used. * the patient must be able to comply with study visits and per protocol procedures * patient who has been informed of the study and has signed his informed consent exclusion criteria: * person under guardianship or curatorship, or unable to understand the purpose of the study. * hematologic malignancies other than aml * history of neoplasia with bone involvement (sarcoma, multiple myeloma, metastasis...) and/or any solid cancer less than 5 years old * history of fracture of the femoral neck prior to the diagnosis of hematologic malignancies * known bone involvement related to aml at diagnosis * primary or secondary osteoporosis known to the diagnosis of hematologic malignancies * corticotherapy \> 3 months at a dose \> 7.5mg/day prior to the diagnosis of hematological disease * autograft or anterior allograft * pathologies influencing bone metabolism: known inflammatory rheumatism (rheumatoid arthritis, ...), primary hyperparathyroidism, chronic renal failure (gfr \< or = at 30ml / min / 1.73m2) * pregnant or lactating woman

Keywords: allo-hscts transplant osteoporosis
20-valent pneumococcal conjugate vaccine safety and immunogenicity study of a 4-dose series in healthy infants

Conditions: Pneumococcal Disease

Summary: 20-valent pneumococcal conjugate vaccine safety and immunogenicity study of a 4-dose series in healthy infants


Eligibility criteria:
inclusion criteria: * male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent. * healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. exclusion criteria: * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) * major known congenital malformation or serious chronic disorder * other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results * previous receipt of \>1 dose of hepatitis b vaccine; or receipt of a single hepatitis b vaccine dose administered at \>30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation