Kornimate/medical-research-clean huggingface dataset:
study on sotrovimab and its impact on the immune response to covid-19 infection in real-life in the uae and bahrain

Conditions: COVID-19

Summary: the united arab emirates (uae), the kingdom of bahrain, kuwait, oman, and qatar have authorised sotrovimab for emergency use. local experience among physicians include recent successful covid-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal antibodies such as sotrovimab in the management of covid-19 and expertise to integrate the latest knowledge into the local or regional covid-19 management guidelines. the aim of this study is to collect local clinical evidence for sotrovimab effect in the real-life setting in the uae and the kingdom of bahrain. overall study population is 20,000 and the duration of the study will be approximately six months from recruitment date.


Eligibility criteria:
inclusion criteria: * adults and paediatric patients (≥ 12 years of age weighing at least 40 kg) * mild-to-moderate covid-19 * positive results of direct sars-cov-2 viral testing * high risk for progression to severe covid-19 exclusion criteria: * patients who are hospitalised due to covid-19 before sotrovimab administration * patients who require oxygen therapy due to covid-19 before sotrovimab administration opatients who received pharmacological treatment including monoclonal antibodies to any components of sars-cov-2 virus within 6 months prior to enrolment into the study in retrospective and prospective arms.

Keywords: sotrovimab
a comparison study of basal bolus therapies together with lispro insulin in type 2 diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ilps) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).


Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 * have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to visit 1 (screening) * hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 11.0% * body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/m\^2 * capable and willing to follow the protocol * give written consent exclusion criteria: * are taking any glucose-lowering agents (other than those listed in the inclusion criteria above) * have a history of severe hypoglycemia in the past 6 months * are pregnant or may become pregnant * women who are breastfeeding * have significant cardiac disease * have significant renal or liver disease * undergoing therapy for a malignancy * contraindications to the study medications * have an irregular sleep/wake cycle * have a serious disease or any condition considered by the investigator to be exclusionary
a trial to learn if different doses of regn7544 are safe in healthy adult participants

Conditions: Healthy Volunteers

Summary: the study is researching an experimental drug called regn7544.the study is focused on healthy adults. the aim of the study is to see how safe and tolerable the study drug is in healthy adults. the study is looking at several other research questions, including: * what side effects may happen from taking the study drug * how much study drug is in your blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. has a body mass index between 18 and 32 kg/m\^2 2. is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ecgs) performed at screening and/or prior to administration of initial dose of study drug, as defined in the protocol 3. has normal blood pressure (bp) and pulse rate readings, as defined in the protocol 4. difference between semi-recumbent systolic blood pressure (sbp) measurements in left and right arm less than 20 mmhg at screening visit key exclusion criteria: 1. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation 2. history, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension (bp \<90/50 mmhg with associated symptoms), symptomatic orthostatic hypotension, postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac arrhythmia 3. presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study 4. was hospitalized (ie, \>24 hours) for any reason within 30 days of screening 5. is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to screening note: other protocol defined inclusion / exclusion criteria apply

Keywords: hypotension and/or hypovolemia
the clinical effects of montelukast in patients with perennial allergic rhinitis (0476-265)

Conditions: Rhinitis, Allergic, Perennial

Summary: the purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing exclusion criteria: * medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
a study to evaluate the blood levels, safety, and tolerability of pf-00734200 in subjects with impaired kidney function and normal kidney function

Conditions: Renal Insufficiency, Chronic

Summary: the purpose of this study is to compare how pf-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. the removal rate of pf-00734200 by hemodialysis will be calculated. the safety and tolerability of pf-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.


Eligibility criteria:
inclusion criteria: 1. subjects must meet one of the following renal function categories normal renal function mild renal impairment moderate renal impairment end stage renal disease requiring chronic hemodialysis 2. body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg 3. subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications exclusion criteria: 1. women who are pregnant, nursing or women of childbearing potential 2. subjects with acute renal disease.
systemic lupus erythematosus exercise program

Conditions: Systemic Lupus Erythematosus

Summary: this pilot study is a randomized controlled trial to assess the effect of an individualized supervised exercise program in patients with systemic lupus erythematosus (sle) compared to treatment-as-usual (tau).

the aim of this study is to evaluate the effect of a 12-week individualized exercise program in subjects with sle in comparison to treatment-as-usual therapy. several previous studies showed that exercise leads to various benefits in treating sle, including enhanced aerobic capacity, reduced symptoms of depression and fatigue. moreover, it has been shown that exercise is well tolerated and does not impair disease activity in sle negatively. here, the effects of an individual internet-based exercise therapy for 12 weeks will be evaluated.

Eligibility criteria:
inclusion criteria: * positive ana-titer (≥ 1:80) or anti-dsdna (≥ 200 iu/ml) or highly avid-dsdna autoantibody (≥ 30 iu/ml) * stable immunosuppressive therapy more than 30 days before beginning of the study with steroid (0-20 mg/day) or other immunosuppressive medication like hydroxchloroquin, chloroquin, azathioprin, methotrexat, mycophenolatmofetil, cyclosporin, belimumab, rituximab exclusion criteria: * pregnancy, active lupus nephritits, physical activity more than two times a week

Keywords: exercise aerobic training anaerobic training internet-based exercise program
the effects of brown rice compared to white rice on postprandial changes in il-6 and mda levels in sedentary workers

Conditions: Sedentary Employees; Postprandial Oxidation and inﬂammation

Summary: the goal of this clinical trial is to learn if brown rice and white rice affect oxidative stress and inflammation in office workers who don't exercise much. the main question it aims to answer is: does eating brown rice change mda and il-6 levels differently than eating white rice in people who don't exercise much? participants will: be interviewed to collect personal data, medical history, lifestyle habits, and dietary patterns. be measured to calculate body mass index (bmi). be interviewed to complete a questionnaire to assess their physical activity level in the past week. be interviewed to record all food and beverages consumed in the past 24 hours. blood samples will be drawn twice, before and after consuming the research meal. be provided with a research meal consisting of rice (either brown or white), scrambled eggs, and tofu stew that must be finished within 15 to 20 minutes.


Eligibility criteria:
inclusion criteria: * healthy administrative employees, * age 21-59 years, * normal body mass index (18.5-22.9 kg/m2), * low physical activity (≤600 mets minutes/week), * assign for informed consent exclusion criteria: * being pregnant/breastfed/menopause, * consumption of herbal medicines and/or supplements within 24 hours before data collection, * having history of dm, cvd, cancer, and autoimmune disease, * being vegan, * smoking/alcohol drinking, * allergic to research food's ingredients

Keywords: brown rice white rice interleukin-6 malondialdehyde sedentary inflammation oxidative stress postprandial
sensorimotor training using whole body vibration exercise to reduce chemotherapy-induced peripheral neuropathy

Conditions: Breast Neoplasm, Exercise

Summary: cipn is induced by neurotoxic chemotherapeutic agents and manifests with sensory and/or motor deficits. it is associated with significant disability and poor recovery. common symptoms include pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control and insecure gait. the purpose of the study is to compare effects of sensory vibrations training to conventional aerobic and strenght exercise on neurophatic symptoms related to chemotherapy treatment.

aim: to (a) compare the effects of wbv exercise compared to regular cardiovascular and resistance exercise (car) on the primary outcome of (a) cipn symptoms and secondary outcomes of (b) balance, physical function, and quality of life. based on previous pilot study findings, we hypothesize that wbv exercise compared to car will reduce relevant symptoms to a larger degree, such as the loss of peripheral deep sensitivity, pain, weakened or absent reflexes and loss of balance control (aim a) and that patients will experience an improvement in physical function and quality of life (aim b). the study employs a prospective, multicenter, two-armed, randomized controlled design. study participants will be informed about the study procedure and sign a written informed consent. patients will then be assigned randomly either to the wbv group or the car group. patients allocated to the wbv group receive a defined wbv exercise program twice a week in addition to their usual treatment. patients in conventional aerobic and resistance exercise (car) group will receive a defined exercise program twice a week in addition to their usual treatment.

Eligibility criteria:
inclusion criteria: * patients with breast cancer, aged 18-80 years, * eastern cooperative oncology group (ecog) performance status of 0-2, * completed chemotherapy in the past 3 months. experiencing symptoms of cipn exclusion criteria: * pre-existing neuropathy of other cause (eg, diabetes), * given contraindications for wbv including instable bone metastases and severe cardiovascular disease.
the effect of phrenic nerve blockade on acute and chronic shoulder pain in patients for lobectomy and pneumonectomy

Conditions: Postoperative Pain

Summary: the purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.


Eligibility criteria:
inclusion criteria: 1. patients planned for elective lobectomy or pneumonectomy 2. 18 years or more on the day of the operation 3. danish skills appropriate for fulfilling preoperative questionnaires exclusion criteria: 1. known contralateral paresis of the phrenic nerve 2. allergy to ropivacaine or sodium chloride 3. preoperative ipsilateral shoulder pain 4. infection or eczema on the intervention site. clinical decision 5. dementia or similar cerebral condition that makes the subject unable to perform a nrs-score of pain. determined by clinical evaluation 6. pregnancy 7. acute porphyria

Keywords: postoperative pain acute postoperative pain chronic postoperative pain shoulder pain thoracotomy thoracoscopy
database retrieval for the comprehensive shoulder

Conditions: Osteoarthritis of the Shoulder; Avascular Necrosis; Rheumatoid Arthritis; Prior Failed Revision; Correction of Functional Deformity; Fracture of Proximal End of Humerus; Cuff Tear Arthropathy

Summary: this study is a retrieval of database information regarding survivorship of the comprehensive shoulder system family of products. the primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.

the comprehensive shoulder system has been cleared by the fda via premarket notifications. no experimental or investigational surgical techniques or devices will be used in this study. all devices and products will be used in accordance with their instructions for use and/or approved labeling. the aim of the comprehensive shoulder system is to improve shoulder function and reduce pain. one site will be used for this database retrieval. the number of patients involved will depend upon the size of the comprehensive database available at acromion, llc.

Eligibility criteria:
inclusion criteria: * must have one of the following indications: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * rheumatoid arthritis * revision where other devices or treatments have failed. * correction of functional deformity. * fractures of the proximal humerus, where other methods of treatment are deemed inadequate. * difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. * need to obtain pain relief and improve function * ability and willingness of the patient to follow instructions, including control of weight and activity level * a good nutritional state of the patient * the patient must have reached full skeletal maturity exclusion criteria: * absolute contraindications include infection, sepsis, and osteomyelitis. * uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * osteoporosis. * metabolic disorders which may impair bone formation. * osteomalacia. * distant foci of infections which may spread to the implant site. * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Keywords: total shoulder arthroplasty medical device performance safety shoulder prosthesis
efficacy of pregabalin on chronic cough

Conditions: Cough

Summary: the purpose of this study is to determine if pregabalin, a medication used for the treatment of seizures and chronic pain, can be used to effectively treat people who suffer from non-asthmatic chronic cough (cough lasting over 8 weeks).

a significant number of patients have an impaired quality of life due to chronic cough that fails to respond to therapeutic efforts. research suggests that patients with chronic cough may have an oversensitive cough reflex. reflexes are involuntary responses to nerve stimulation. since standard cough medicines may not be helpful for treating the oversensitive cough reflex, treatment with neurologically acting agents has been investigated. existing work in treatment of cough of unknown etiology has focused on the use of gabapentin, a compound that acts neurologically that is used in the treatment of epilepsy and pain. a similar drug, pregabalin, may be a superior medication for this indication. pregabalin is rapidly absorbed with peak blood concentrations within 1 hour, has an approximate bioavailability of 90%, and is 3 to 10 times more potent than gabapentin and has no known pharmacokinetic drug interactions.

Eligibility criteria:
inclusion criteria: * diagnosis of non-asthmatic chronic cough defined as a cough experienced for a period of at least 8 weeks * negative methacholine challenge (within past year) * chest x-ray with absence of gross abnormality that could justify the cough or be a cause for the cough (within past 6 months) * male or female 18 years or older * willing and able to limit to 1 or less alcohol beverage per day (example: 360 ml of beer or 330 ml of cooler or 120 ml of wine) exclusion criteria: * concurrent use of gabapentin or pregabalin for other indications (seizure disorder, chronic pain) * history of allergy / intolerance or adverse effect with gabapentin or pregabalin. * concurrent use of central nervous system depressants (i.e. opioids or benzodiazepines) * not able to limit daily alcohol intake as recommended in the inclusion criteria * creatinine clearance \< 60ml/min within past three months * current smoker or has been quit less than 8 weeks * symptoms of post nasal drip * history of gastroesophageal reflux. only participants with untreated gastroesophageal reflux disease (gerd) or less than 8 weeks of therapy will be excluded. * symptoms of upper airway cough syndrome * ace inhibitor use * allergy to citric acid * pregnant or nursing women * history of angioedema or congestive heart failure

Keywords: chronic cough cough hypersensitivity lyrica pregabalin cough reflex sensitivity
evaluation of dental implant placement in the sloped alveolar ridge

Conditions: Atrophy of Edentulous Alveolar Ridge

Summary: the aim of this study was to investigate the therapeutic effect of sloped dental implants. it can reduce the need of osteoectomy, reduce discomfort of procedures, and is easier for maintenance.

20 osseospeed ™ profile ev and 20 osseospeed ™ ev groups will be randomly implanted into the oblique edentulous ridges of subjects, and the treatment response will be monitored for 3 years. the implantation area will be randomly divided into two groups, one group was treated with osseospeed ™ profile ev (sloped group) and the other group was treated with osseospeed ™ ev (control group). the same patient had the same implant as the same quadrant. the patient will be followed up regularly for follow-up, followed by clinical attachment level, probing depth, bleeding on probing, keratinized gingival width (keratinized gingiva), mobility (mobility) and other clinical indicators of the measurement, regular dental radiography, gingival crevicular fluid (gcf) collection and bone integration measurement. after six months of implantation, prosthesis will delivered and loaded functionally, and regular follow-up will be arranged. in each time of follow-up, examination will be carried out with regards to periodontal pocket depth, clinical attachment height, periodontal bleeding index, keratinized gingival width, and other clinical indicators of the measurement, at the end of the experiment, that is, after three years, and then a dental root film irradiation, gcf collection and osseointegration measurement.

Eligibility criteria:
20-80 years old with appropriate oral cleaning ability; the computer tomography shows \> 1 mm buccolingual discrepancy of alveolar ridge height; no generalized periodontitis, or had history of periodontitis but has been completed treatment; no major systemic infection or major systemic illness; not taken antibiotics in the past two weeks not pregnant or breastfeeding

Keywords: dental implant edentulous ridge
method of levels for people using community crisis services

Conditions: Individuals Presenting to Crisis Services

Summary: a mental health crisis is when someone is so distressed they need urgent help from services; often because they behave in ways that poses risk to themselves or others. crisis teams offer care in the community to support people at home rather than in hospital. current psychological interventions offered by crisis teams tend to be short-term and mainly involve providing information about the difficulties people are experiencing and help them to develop skills, such people as problem solving. this can be useful, however providing more intensive psychological support has been much more difficult within crisis settings, as teams must use limited resources to focus on managing risk. a therapy, called method of levels (mol), designed to be flexible, may be helpful to add to treatment offered by crisis services in the community. mol aims to help people hold their attention on a problem long enough to view it in different ways, so that they might think of new solutions. this works by helping a person to regain a sense of control in their life and feel less distressed. mol is useful for working with lots of different issues, since therapy does not only focus on one type of problem. people also get to choose what is discussed in therapy and session structure. research has shown mol can be useful for people in crisis in places such as inpatient settings. so far, no research has been conducted within the community for people in crisis. this study aims to examine if mol can be delivered within a crisis service in a way that is helpful and acceptable to people. to do this, the investigators will offer mol to a small number of people presenting to crisis teams and collect information on whether people take up the therapy, and their experience of receiving it.


Eligibility criteria:
inclusion criteria: 1. adults, aged over 18 years. 2. meet criteria for crisis services and currently working with the crisis team 3. able to provide informed consent (no queries regarding capacity) 4. willing to engage in psychological therapy. 5. ability to speak english fluently enough to provide informed consent and engage in therapy. exclusion criteria: 1. inability to provide informed consent. 2. inability to speak english fluently enough to engage in therapy: as mol is a therapy that relies on mobilising attention, the use of interpreters during therapy for non-english speakers may serve to alter the participants attention differently. this may confound results; as this is a preliminary case series, it would not be appropriate to include non-english speakers. 3. problems of an organic nature, or a learning disability that might affect cognitive functioning. 4. substance misuse as primary presenting problem.