Kornimate/medical-research-clean huggingface dataset:
sofosbuvir with ribavirin or simeprevir with hcv gt4 egyptian patients

Conditions: Chronic Hepatitis C Virus Infection

Summary: a total of 201 participants with chronic hcv gt4 infection were allocated into two groups. one group participants were treated with sof plus rbv (24 weeks). the second group was treated with sof plus smv (12 weeks).

a total of 201 participants, treatment-naïve and experienced, with chronic hcv gt4 infection were allocated into two groups based on the type of the regimen used. all eligible participants were treated orally with sof plus daily oral weight-based rbv (24 weeks; group 1), or sof plus daily oral smv (12 weeks; group 2).

Eligibility criteria:
inclusion criteria: * participants with plasma hcv rna level \>10,000 iu/l for the two groups. * treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-ifn/rbv therapy. * treatment-experienced patients in group 2 were those who had previously failed treatment with sof/rbv exclusion criteria: * coinfected with hepatitis b virus or human immunodeficiency virus infection, * any cause of liver disease other than hcv gt4 infection; * liver decompensation, * hepatocellular carcinoma, * major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (hba1c \>9) * participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count \<50,000 cells/mm3)

Keywords: egyptian patients hcv gt4 naive ribavirin simeprevir sofosbuvir experinced
reliability and validity of the turkish version of sensory hypersensivity scale

Conditions: Central Sensitisation; Hypersensitivity

Summary: central sensitization (cs) is as increased response to normal or sub-threshold stimuli of central nervous system. patient history and physical examination, quantitative sensory testing(qst), imaging methods, neuroinflammatory marker levels, electrodiagnostic studies and clinical scales can be used in the diagnosis of cs, but there is no standardized method yet. among these methods, clinical scales are preferred because they are practical, inexpensive and do not require experience. the sensory hypersensitivity scale was developed by dixon et al. for investigate the personal hypersensitivity and cs. the aim of this study is to investigate the turkish validity and reliability of the sensory hypersensitivity scale.

the term central sensitization (cs) was first used by wolf in 1988 and was explained as the increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. with the development of cs, a decrease in the pain threshold and an increase in generalized sensitivity occur. there is no method for the diagnosis of cs is accepted as a gold standard. clinical scales and quantitative sensory testing (qst) is used for this purpose widely. in addition, the well-known scale used for the evaluation of cs is the central sensitization inventory (csi), developed for detect cs in chronic pain patients. the use of csi, which is more practical to use, is becoming widespread because qst takes time, is costly and requires experienced practitioners. considering the place of sensory hypersensitivity in the diagnosis of cs and the application difficulties of qst, the sensory hypersensitivity scale was developed in 2016. this scale includes 25 questions in the form of a likert scale and questions the increase in modality-specific (touch, taste, hearing, etc.) sensitivity as well as the general sensitivity increase. especially in chronic pain conditions, there is an increase in the evidence regarding the development of cs day by day, and the need for auxiliary tools in diagnosis is increasing in parallel. in this study, it was planned to show the turkish reliability and validity the sensory hypersensitivity scale.

Eligibility criteria:
inclusion criteria: * have musculoskeletal pain that lasts for at least 3 months * accepting to participate in the study exclusion criteria: * refuse to participate in the study

Keywords: central sensitization chronic pain sensory hypersensitivity sensory hypersensitivity scale central sensitization inventory
trial to determine the therapeutic benefit of an otc cream on dry, itchy skin of adults and children with eczema

Conditions: Atopic Dermatitis

Summary: the objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (otc) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate ad.

approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control). adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. subjects will apply study product as indicated for 7 days to affected areas. subjects will record treatment use in a daily diary and complete questionnaires. a dermatologist will examine and score the eczema and symptoms. skin moisture levels will also be tested.

Eligibility criteria:
inclusion criteria: 1. able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) 2. male or female of any race or ethnicity, ages 12 and older 3. diagnosed as having eczema 4. willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study exclusion criteria: 1. known sensitivity to any investigational product ingredient 2. females who are pregnant , breastfeeding , or planning on becoming pregnant during the study 3. individuals with a history of skin cancer 4. use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema 5. participation in any clinical study within 30 days of visit 1 6. active infection of any type at the start of the study 7. diagnosed as having severe eczema 8. has a compromised immune system 9. individuals with any planned surgeries and/or invasive medical procedures during the course of the study 10. requires greater than 2.0mg/day inhaled or intranasal corticosteroids

Keywords: eczema, itchy skin
clinical evaluation of the one-piece tecnis multifocal intraocular lens (iol)

Conditions: Cataract

Summary: the purpose of this study is to evaluate near vision of the one-piece tecnis multifocal lens (zmb00) vs. the one-piece tecnis monofocal lens (zcb00)and additionally evaluate general postoperative outcomes of the one-piece tecnis multifocal lens.


Eligibility criteria:
inclusion criteria: * bilateral cataracts and otherwise healthy eyes * visual potential of decimal 0.8 in each eye exclusion criteria: * any medications affecting vision * any chronic disease/illness that would affect risk to subject or outcomes of the study * any ocular pathology/abnormalities that may affect visual outcomes or confound study results * desire for monovision
effects of the sglt2-inhibitor empagliflozin on patients with siadh - the sand study

Conditions: SIADH

Summary: syndrome of inappropriate antidiuresis (siadh) is characterized by an imbalance of antidiuretic vasopressin (avp) secretion. the impaired avp regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia. the therapeutic options, aside from treating the underlying disease, depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion. alternative therapeutic options are loop diuretics, administration of oral urea or vasopressin receptor antagonists (vaptans). despite those options, there are a considerable number of patients which do not sufficiently respond, making additional therapy necessary. empagliflozin (jardiance)® is a sodium glucose co-transporter 2 (sglt2)-inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. the sglt2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. the inhibition of sglt2 results in renal excretion of glucose with subsequent osmotic diuresis. this mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in siadh. the aim of this study is to evaluate whether empagliflozin (jardiance)® has an effect on the serum sodium levels of patients with siadh.


Eligibility criteria:
inclusion criteria: - hyponatremia \<130mmol/l due to siadh exclusion criteria: * any treatment for siadh during \>48h before study start * severe illness with icu-admission * treatment with 3% sodium chloride (nacl) solution * uncontrolled hypothyroidism * uncontrolled adrenal insufficiency * severe renal impairment (gfr \<30ml/min), end stage renal disease * severe hepatic impairment (child-pugh class c) * systolic blood pressure \<90mmhg * diabetes mellitus type 1 * acute myocardial infarction or chronic venous insufficiency (cvi) * treatment with sglt2 inhibitor, lithium chloride or urea * recurrent urinary-/genital tract infections * contraindication for lowering blood pressure * severe immunosuppression * pregnancy or breastfeeding * palliative care

Keywords: hyponatremia sglt2 inhibitor
outcome of transcatheter closure of patent ductus arteriosus in pediatric cardiology unit in 3 years duration

Conditions: Patent Ductus Arteriosus (PDA)

Summary: transcatheter closure of patent ductus arteriosus to evaluate the outcome of percutaneous transcatheter closure of patent ductus arteriosus in children


Eligibility criteria:
inclusion criteria: * children with patent ductus arteriosus confirmed by echocardiography * aged from 6 months to 16 years underwent percutaneous transcatheter pda closure at pediatric cardiology unit. exclusion criteria: * children with pda younger than 6 months or older than 16 years and that are not candidate for transcatheter closure .
development of an inclusive adaptive treatment strategy for weight loss in people with prediabetes using a sequential multiple assignment randomized trial

Conditions: Disabilities; Obesity and Overweight; Prediabetes

Summary: this is a sub-study to nct04745572 to include a new cohort of participants with disabilities. this 16-week study will use an experimental approach called the sequential multiple assignment randomized trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. after 4 weeks, participants will be identified as responders (greater than or equal to 2.5% weight loss) or non-responders (less than 2.5% weight loss). responders will continue with their initial randomized group for the remainder of the trial. non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.


Eligibility criteria:
inclusion criteria: * 18-75 years of age * bmi of 27 kg/m2 or greater for ambulatory individuals and 22 kg/m2 for individuals with spinal cord injury. adjustments will be calculated for those with amputations and/or limb indifference * at risk for developing type 2 diabetes (prediabetes) * one or more physical or mobility disabilities * stable medication type and dosage for 3 or more months for medications likely to affect body weight and/or appetite * willing to complete requirements for participation exclusion criteria: * pregnant, planning to become pregnant or breastfeeding * currently taking medication(s) for weight loss * medical history of type 1 or 2 diabetes, using exogenous insulin, using prescription or otc weight loss medications within the past 3 months, current alcohol or drug abuse or dependence, smoker with unstable habits in the past 3 months, pacemaker or other life-threatening medical implant, eating disorder(s)

Keywords: smart diet exercise weight loss disabilities
impact of detecting initial and active caries lesions in primary teeth

Conditions: Dental Caries

Summary: the present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. for this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of sao paulo. the caries detection will be conducted using the international caries detection and assessment system (icdas) and, depending on allocation, an adjunct criterion for caries activity assessment. children will be randomized in two groups according to the caries threshold to be detected: group a (only advanced lesions will be detected and treated, independently of their activity status) and group b (all caries lesions, including initial ones, will be detected and all active lesions will be treated). after this, the treatment plan for each child will be made according to strategies mentioned above. data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. for comparison between groups, multilevel regression analyses will be performed. the primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.


Eligibility criteria:
inclusion criteria: * individuals aged 36 months to 83 months; * should have complete primary dentition; * children must assent to participate and their parents must consent to their participation by signing the consent form. exclusion criteria: * medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child; * children involved in other research that may impact on this study; * families who are expected to move out of the coverage area of study during the first year of enrollment.

Keywords: dental caries primary tooth caries detection
a study of amg 337 in subjects with advanced solid tumors

Conditions: Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors

Summary: first in human, open-label, sequential dose escalation and expansion study of amg 337 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years old * subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor * subjects with primary central nervous system (cns) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up mri shows no new lesions appearing * measurable disease per recist guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study) * eastern cooperative oncology group (ecog) performance status of ≤ 2 * competent to sign and date an institutional review board approved informed consent form * adequate hematologic and renal function as determined by laboratory blood and urine tests exclusion criteria: * men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug. * women who are lactating/breastfeeding or planning to become pregnant during the duration of the study * history of bleeding diathesis * myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (new york heart association \> class ii), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension * a baseline ecg qtc \> 470 ms * active infection requiring (iv) antibiotics within 2 weeks of study enrollment * significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption * known positive test for hiv * known acute or chronic hepatitis b or hepatitis c infection as determined by serologic tests * anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent * major surgery within 30 days of study day 1 * any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

Keywords: solid tumors c-met inhibitor
effects of diffused ylang-ylang essential oil amongst older persons with dementia

Conditions: Dementia; Behavioral and Psychiatric Symptoms of Dementia

Summary: ylang-ylang (cananga odorata) essential oil has been postulated to have calming effect, which may improve bpsd in persons with dementia. this study aims to examine dementia-related behavioural changes using established assessment tools and brain derived neurotropic factor (bdnf) in persons with bpsd.

behavioural and psychological symptoms of dementia (bpsd) refers to the spectrum of non-cognitive and non-neurological symptoms of dementia, such as agitation, psychosis, depression and apathy. ylang-ylang (cananga odorata) essential oil is postulated to have calming effect, which may improve bpsd in persons with dementia. thus, this study aims to examine dementia-related behavioural changes using established assessment tools and brain derived neurotropic factor (bdnf) in persons with bpsd. a pre-post quasi-experimental pilot study will be conducted over a two-month period in nursing homes with persons with dementia. approximately 30 persons with dementia are expected to participate in this study. during the pre-intervention phase, water will be diffused using a diffuser in a common area of the nursing homes. during the intervention phase, ylang-ylang essential oil will be diffused using the identical diffuser over the same common area. both water and essential oil will be diffused twice a day, each for a duration of 20 min during the respective phases. observation and documentation of behavioural symptoms will be taken using validated instruments during the pre- and post-intervention phases. in addition, 10 ml of blood will also be collected at pre and post intervention for biochemical analyses.if ylang-ylang essential oil were found to be beneficial based on the laboratory and observational findings, it can be possibly used as an alternative approach in managing bpsd.

Eligibility criteria:
inclusion criteria: * persons who have been diagnosed with dementia by their physicians and in nursing homes in selangor, malaysia. * persons with dementia who have at least one symptom of bpsd exclusion criteria: * persons with dementia with a comorbid respiratory problem like asthma or chronic obstructive pulmonary disease * persons with dementia who are allergic to fragrance/perfumes * persons with dementia who had a change in their psychotropic or dementia medications in the 30 days before commencement of the study, namely: acetylcholinesterase inhibitors n-methyl-d-aspartate (nmda)-receptor antagonist (memantine), antipsychotics, antidepressants, sedatives, or medications with anticholinergic properties * persons who have been diagnosed with schizophrenia or mental retardation * persons who have no documented behavioral history in the previous three month * persons who are currently hospitalized * persons with dementia who are unwilling to participate or disallowed by caregivers/family members

Keywords: aromatherapy ylang-ylang behavioral and psychological symptoms of dementia dementia
platelet rich fibrin vs hyaloronic acid in management of pain after harvesting a free gingival graft

Conditions: Pain, Postoperative

Summary: comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure . .

- patients of both groups will be subjected to: 1. case history including personal data, medical, surgical history and family history. 2. clinical examination. after local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal extension.. the free gingival graft extended from the mesial line angle upper 5 and distal line angle of upper 6 . the coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival margin. a second horizontal incision will be drawn 8 mm apico coronal . care will be taken to obtain a graft thickness of 1.5 mm. thickness will be measured at the central point of the graft during the surgery by using an endodontic file then the grafts will be positioned, and firmly adapted to the bed, and stabilized with simple periosteal sutures. preparation of platelet rich fibrin:( intervention group) the classic prf protocol was introduced by choukroun \& coworkers. prf requires around 10 ml of blood to be collected from the forearm of patient without anticoagulant in a glass coated plastic tubes. after collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12 minutes. after the completion of cycle, the blood become separated into three distinct layers; platelet poor plasma at the top, prf in the middle and a red blood corpuscular base in the bottom. pliers will be inserted into the tube to gently grab the fibrin clot with attached rbc's. the clot thus obtained will be compressed to form plugs to be placed in the palatal donor site and stabilized by criss cross resorbable suture then covered by periodontal pack control group control group: as the intervention group but the palatal wound will receive a .2% hyaluronic acid gel then covered by periodontal dressing ..

Eligibility criteria:
inclusion criteria for participants: * patients with mucogingival defects scheduled for free gingival graft * age at least 18 years. * not having any systemic disease that could compromise wound healing * no previous periodontal surgery on the experimental sites. exclusion criteria for participants: * systemic diseases that may be a contraindication for any surgeries. * loss of maxillary premolars and molars. * pregnancy or lactation * smoking

Keywords: gingival recession gingival augmentation free gingival graft platelet rich fibrin in wound healing 2 steps free gingival graft hyaluronic acid in wound healing