Kornimate/medical-research-clean huggingface dataset:
evaluation of the effectiveness of paricalcitol versus cinacalcet with low-dose vitamin d

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Hemodialysis

Summary: evaluates the effectiveness of on-label paricalcitol versus cinacalcet with low-dose vitamin d.

during a 4-week washout period, participants stopped taking cinacalcet or other vitamin d receptor activators (vdras). (participants who were naive to cinacalcet or vdras did not have to wash out). at randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i.e., iv at sites in the us and russia and oral at sites in europe). supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as \>= 10.5 mg/dl). the evaluation period was from weeks 21 to 28.

Eligibility criteria:
inclusion criteria 1. male or female patients \>= 18 years old. 2. patient was diagnosed with stage 5 chronic kidney disease (ckd) and had been receiving intravenous (iv) or oral vitamin d receptor activators (vdras) or cinacalcet during the 8 weeks prior to the screening period or naïve patients who had not received vdra or cinacalcet within 8 weeks of screening. 3. patient was on maintenance hd (hemodialysis) 3 times weekly (tiw) for at least 3 months prior to screening and was expected to remain on hd for the duration of the study. 4. for entry into the pre-treatment washout period (for patients who were not naïve to vdras and cinacalcet), the patient had to have screening laboratory values of: * ipth level 130 to 700 pg/ml * serum total alkaline phosphatase level \>= 40 u/l * calcium level \<= 10.0 mg/dl (2.49 mmol/l) * calcium-phosphorus product (caxp) \<= 75 mg2/dl2 (us) and \<= 70 mg2/dl2 (non-us) exclusion criteria 1. patient had a history of parathyroidectomy. 2. patient had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator. 3. use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome p450 (including grapefruit and/or grapefruit juice) 3a (cyp3a) or drugs metabolized by cytochrome p450 2d6 (cyp2d6) (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants) within 2 weeks prior to study drug administration. commonly used beta blockers such as metoprolol and carvedilol are allowed but are metabolized by cyp2d6; thus, an adjustment to a lower dose may have been required. 4. patient was known to be human immunodeficiency (hiv) positive.

Keywords: zemplar paricalcitol impact shpt hemodialysis chronic kidney disease stage 5
frame, external support for lower limb autologous grafts

Conditions: Peripheral Arterial Disease; Peripheral Artery Disease

Summary: 30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein. subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.


Eligibility criteria:
inclusion criteria: 1. patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein. 2. rutherford classification 3-6 3. adequate revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass. 4. patient is able and willing to give their informed written consent. 5. patient is able and willing to comply with study follow up requirements. 6. patient is ≥ 18 years of age exclusion criteria: 1. patients indicated for endovascular treatment 2. prior surgical bypass procedure in ipsilateral lower limb. 3. active ulcer/infection/gangrene at the intended distal anastomosis site. 4. severe vein varicosity 5. saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm. 6. spliced vein technique 7. in-situ vein technique 8. pedal/plantar distal anastomosis 9. planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure. 10. patients with history of hypercoagulable conditions. 11. patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency. 12. concomitant life-threatening disease likely to limit life expectancy to less than 2 years. 13. contraindication to recommended study medications 14. participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Keywords: saphenous vein graft pad peripheral bypass surgery external support
dual channel rehabilitation technology promotes rapid recovery of upper limbs after stroke

Conditions: Stroke; Upper Extremity Dysfunction; Transcranial Direct Current Stimulation; Image, Body

Summary: the injury and remodeling mechanism about upper extremity motor network after stroke is not clear. there are few studies on the motor network covering cortex, white matter and blood perfusion at the time. some studies have shown that metal imagery activates the cortex through active mental simulation. our previous study has shown that passive application of transcranial direct current stimulation causes subthreshold polarization and promotes the effective integration of residual brain high-level network. this study proposes a hypothesis: transcranial direct current stimulation + motor imagery combines active and passive neuromodulation techniques to produce dual channel effect, which can synergistically excite motor cortex, remodel the motor network and optimize cerebral perfusion. the research contents include clarify the effect of transcranial direct current stimulation + motor imagery neuromodulation therapy through comprehensive randomized controlled trial study; present the process of brain injury and secondary neural plasticity through the motor network construction, functional connectivity strength and cerebral perfusion with blood oxygen level dependent, diffusion tensor imaging and arterial spin labeling multimodal magnetic resonance technology; calculate the correlation between motor score and brain functional network, extract the key nodes that can promote the motor network remodeling. the research results are expected to provide preliminary theoretical foundations for further research on the injury and remodeling mechanism about upper extremity motor network after stroke.


Eligibility criteria:
inclusion criteria: * first stroke with upper limb motor dysfunction * no rapid natural recovery in the last week * greater than 1 month since stroke onset * pass the motor imagery test exclusion criteria: * severe cognitive disorder * severe spasm or joint contracture * mental implants in vivo * do not sign the informed consent
ait-082 phase 1b study

Conditions: Memory Disorders

Summary: ait-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. preclinical studies in animals have shown that ait-082 improves memory in aged animals and in animals with neurological deficits. this study was a double-blind placebo-controlled safety study that was designed to study whether ait-082 may delay age-related mental decline. eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of ait-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests.


Eligibility criteria:

Keywords: memory mild cognitive impairment nerve growth factors
effect of dual-wave insulin bolus on postprandial glycaemia

Conditions: Type1 Diabetes

Summary: a study was conducted in adolescents with type 1 diabetes (t1d) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition. participants were asked to consume 10 different combinations of meal and bolus type.

the nutritional recommendations of children and adolescents with t1d should be similar to those of healthy people in order to achieve the desirable growth. not only the carbohydrates' intake is underlined according to special guidelines by canadian diabetes association, american diabetes association and international society for paediatric and adolescent diabetes but also proteins and fats are suggested to be taken into consideration in the management of t1d. in order to reach the desirable euglycemic control, children and adolescents can use multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii). by using the csii the insulin can be administrated in three different patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus. dual wave insulin bolus (d/wb) is suggested as the most suitable option based on the effects that is having after meals with different content of carbohydrates, fats and proteins. the aim of this study was to evaluate the impact of different types of d/wb on ppg after 3 given meals, in adolescents with t1d on csii. in order to achieve that, 3 different meals were designed and combined with alternative types of boluses, d/wb and square wave insulin bolus (s/wb).

Eligibility criteria:
inclusion criteria: * duration of t1d \>3 years, csii therapy for at least 1 year, good to moderate glycaemic control, as evidenced by hba1c levels \<8.5% (69 mmol/mol). exclusion criteria: * subjects with eating disorders, food allergy, celiac disease and known diabetic complications

Keywords: type 1 diabetes dual-wave bolus postprandial euglycaemia
a phase i study of rose12 alone and in combination with other anti-tumor agents in patients with solid tumors

Conditions: Solid Tumor

Summary: this is a phase ia/ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of rose12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. the study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.


Eligibility criteria:
inclusion criteria: * age \>= 18 years at time of signing informed consent form (icf) * eastern cooperative oncology group (ecog) ps of 0 or 1 * adequate hematologic and end-organ function * life expectancy \>= 12 weeks * patients with histologic documentation of locally advanced, or metastatic solid tumor * \[dose-escalation parts and biopsy parts\]refractory or resistant to standard therapies or standard therapies are not available * \[dose-escalation parts and expansion part\] patients with confirmed availability of fresh tumor or representative tumor specimens * \[biopsy parts\] patients with accessible lesion(s) exclusion criteria: * clinically significant cardiovascular or liver disease * treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug * any history of an immune-mediated grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase). * all imaes from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline. * adverse events from prior anti-cancer therapy that have not resolved to grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy * primary central nervous system (cns) malignancy, untreated cns metastases requiring any anti-tumor treatment, or active cns metastases * uncontrolled tumor-related pain * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * active or history of clinically significant autoimmune disease * history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. \[expansion part\] * prior treatment with investigational product which has moa of treg depletion * malignancies other than disease under study within 5 years prior to cycle 1 day 1
restoration of disc height reduces chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (lbp), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased lbp.


Eligibility criteria:
inclusion criteria: * at least 18 years of age; * consented for the 6 weeks treatment protocol; * presented with discogenic low back pain of at least 3 out of 10; and * current ct scan not older than 2 months. exclusion criteria: * metastatic cancer; * previous spinal fusion or placement of stabilization hardware; * instrumentation or artificial discs; * neurologic motor deficits, bladder, or sexual dysfunction; * alcohol or drug abuse; or * litigation for a health-related claim (in process or pending for workers' compensation or personal injury). limitations of the spinal decompression system also led to the exclusion of patients with extremes of height (\ 203 cm) and body weight (\> 136 kg).
herb-partitioned moxibustion plus lifestyle modification treatment for simple obesity

Conditions: Obesity

Summary: this study is designed as a three-dummy randomised controlled trial to evaluate the efficacy and safety of herb-partitioned moxibustion plus lifestyle modification treatment in patients with simple obesity.

this study will be a multicenter, randomized, controlled trial conducted from november, 2018 to november, 2019 that includes 108 participants who have simple obesity and meet the eligibility criteria. the participants will be randomly divided into 3 treatment groups: heat application group, medicated plaster group, or herb-partitioned moxibustion group. each treatment will last 4 weeks. the primary outcomes will be the clinical effectiveness.the secondary outcome measures include participants'obesity-related indicators, the iwqol-lite scale, and the syndrome score of traditional chinese medicine. adverse events will be recorded during the intervention period.

Eligibility criteria:
inclusion criteria: participants meeting all of the following criteria will be considered for inclusion: 1. diagnosed as having simple obesity according to the diagnostic criteria; 2. aged between 18 and 45 years old; 3. waistline: male≥ 95 cm, women≥85 cm; 4. being able to fully understand and voluntarily sign informed consent. exclusion criteria: participants will be excluded if they have 1. presence of endocrine disorders such as: polycystic ovary syndrome; cushing's syndrome; uncorrected thyroid disease. 2. presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases. 3. pregnant or lactating state, women who plan to become pregnant within 4 weeks. 4. history of bulimia, anorexia, or any other eating disorders. 5. use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite. 6. history of surgical weight loss, postoperative adhesions. 7. history of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months. 8. presence of local skin rupture, allergy and scar constitution. 9. unable to cooperate with the research caused by other diseases or reasons.

Keywords: herb-partitioned moxibustion simple obesity a randomized controlled trial effectiveness
modulatory effects of multichannel tdcs during prolonged experimental pain

Conditions: Prolonged Pain; Neuroplasticity; Brain Modulation

Summary: corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (seps) is often altered in acute and chronic pain. topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor excitability in the primary motor cortex (m1). recent studies (by fischer et al 2017) indicated that multifocal transcranial direct current stimulation (tdcs) administered to brain regions linked to the resting state motor network (network-tdcs) could enhance corticomotor excitability in healthy participants compared to single site m1-tdcs. it remains unknown whether network-tdcs has also the potential to modulate the inhibitory effects on motor cortex excitability, pain sensitivity, descending pain control and seps associated with prolonged pain

to date, pain modulation to m1 rs-network tdcs during 8% capsaicin induced pain has not been assessed (mylius, borckardt and lefaucheur, 2012). further, it is unknown how multichannel tdcs acts on tonic cutaneous pain for approximately 24 hours. the main objective of these projects are to study and characterize quantitatively the effects of multichannel tdcs in the development of prolonged pain. it is hypothesized that multichannel tdcs of left m1 resting-state network will reduce the severity of experimentally prolonged pain over the m. first dorsal interosseous (fdi), will increase descending pain control, might possibly increase pain thresholds and simultaneously will modulate the peak-to-peak amplitude of seps to electrical painful stimulation. further, it is hypothesized that descending pain modulation of m1 tdcs will be related to interference with the suppression of cortical excitability

Eligibility criteria:
inclusion criteria: -right-handed healthy men and women in the age 21-50 years who speak and understand english exclusion criteria: * lack of ability to cooperate * history of chronic pain or current acute pain * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * present and previous neurologic, musculoskeletal or mental illnesses * chili allergies (subproject 1 and 2) * current use of medications that may affect the trial * previous experience with rtms and tdcs * contraindications to rtms application (history of epilepsy, metal implants in head or jaw, etc.) * failure to pass the questionnaire for tdcs * failure to pass the "tass questionnaire" (tass = transcranial magnetic stimulation adult safety screen) (rossi et al., 2001)
femoral neck fracture between 45 and 64 years : internal fixation versus arthroplasty

Conditions: Femoral Neck Fractures

Summary: the therapeutic choice for femoral neck fracture is conventionally made between conservative treatment and total hip arthroplasty. this choice for patients aged between 45 and 64 years old remains a controversial subject. the aim of our work was to describe the current situation in the management of femoral neck fractures in these patients and to evaluate the results of the two options

our study was retrospective descriptive including patients aged between 45 and 64 years operated between january 2015 and december 2022 for femoral neck fracture. the patients will be divided into two groups: the internal fixation group and the arthroplasty group . epidemiological, clinical and radiological data as well as therapeutic results and postoperative complications will be analysed.

Eligibility criteria:
inclusion criteria: * femoral neck fracture between 45 and 64 years
efficacy and safety of metformin versus empagliflozin on chronic kidney disease progression

Conditions: Renal Insufficiency, Chronic

Summary: this randomized controlled trial aims at evaluating the efficacy and safety of the antidiabetics metformin versus empagliflozin on chronic kidney disease (ckd) progression in patients with ckd stages 2 or/and 3.


Eligibility criteria:
inclusion criteria: * patients with mild or/and moderate chronic kidney disease (stages 2 or/and 3, estimated glomerular filtration rate (egfr) between 30-89 ml/min/1.73 m2) at the time of the baseline visit. * patients with and without type 2 diabetes. * patients with or without proteinuria. * age: ≥ 18 years. exclusion criteria: * type 1 diabetes. * patients with egfr ˂30 ml/min/1.73 m2. * patients with known hepatic cell failure. * decompensated heart requiring acute management. * active malignancy. * planned coronary or surgical interventions. * known hypersensitivity to study medications. * chronic inflammation, trauma, or infection. * pregnant or lactating women. * patients already on metformin or a sodium-glucose cotransporter-2 (sglt2) inhibitor. * any of the study treatments labeled contraindications.

Keywords: metformin empagliflozin chronic kidney disease
detection of single nucleotide polymorphism (snp) rs2235371 of irf6 gene in egyptian patients with non-syndromic cleft lip and palate

Conditions: Cleft Lip and Cleft Palate

Summary: the aim of this work is to study the relation between snp rs2235371 of irf 6 gene and non-syndromic cleft lip and palate in egyptian patients in a prospective study

infants born with facial deformities, such as cleft lip and palate (cl/p), often face lifelong challenges, including communication issues, aesthetic concerns, and difficulty with swallowing, which impact both health and social behavior. without treatment, these conditions require specialized care and lead to higher rates of morbidity and mortality. surgeries, including speech and dental interventions, can help manage these conditions from early childhood . cl/p is one of the most common craniofacial birth defects, affecting populations worldwide, with asian populations experiencing the highest prevalence at 1/500 live births. cleft palate (cp) results from incomplete closure of the palate shelves in early prenatal development. depending on severity, it may range from a minor fissure to a full gap between the mouth and nasal cavity, necessitating surgical repair. cl/p is categorized as syndromic or non-syndromic, with the latter resulting from failure of palatal fusion between 4-12 weeks of embryogenesis, influenced by factors such as single-gene mutations, chromosomal abnormalities, and environmental interactions. key genetic mutations linked to cl/p include those in the irf6, pvrl1, tp63, fgfr1, and tbx22 genes, with irf6 snps being particularly significant . family history increases risk, while gene-environment interactions, maternal drug use, non-gestational diabetes, and vitamin deficiencies contribute further. a multidisciplinary approach is essential for managing cl/p, supporting children's functional and aesthetic outcomes from birth through adulthood.

Eligibility criteria:
inclusion criteria: * patients with non-syndromic cleft lip or cleft lip and palate. exclusion criteria: * patients with syndromic clp.