Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of lenvatinib combined with vic-1911 for the treatment of advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: this study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and vic-1911 in patients with advanced liver cancer.

this study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and vic-1911 in patients with advanced liver cancer. purpose of the study: to observe and determine the safety and efficacy of lenvatinib combined with vic-1911 in the treatment of patients with advanced liver cancer. sample size: according to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase. study subjects: patients with advanced hcc

Eligibility criteria:
inclusion criteria: * gender unrestricted, age 18-75 years; * hcc conforms to aasld or easl clinical diagnostic standards; * hcc barcelona clinic liver cancer (bclc) staging is c, with at least one measurable tumor in the liver (longest diameter ≥1cm); * liver function child-pugh class a or class b with a score of 7; * ecog score of 0-1; * platelet count ≥60×10\^9/l, pt time prolongation ≤6 seconds. exclusion criteria: * irreversible coagulation dysfunction, with obvious bleeding tendency; * patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication; * patients with unstable or active ulcers, gastrointestinal bleeding; * patients with untreated heart disease or poorly controlled hypertension as judged by the researcher; * severe dysfunction of important organs, such as severe cardiopulmonary dysfunction; * patients with hepatic encephalopathy or refractory ascites requiring treatment; * human immunodeficiency virus (hiv) infection; * active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection (activity defined as viral load \> 20000 iu/ml), or hbv, hcv positive patients who refuse to accept standardized antiviral treatment; * inability to swallow oral medication. * gastrointestinal diseases that may affect the absorption or tolerance of the study medication. * history of corneal epithelial cysts or other causes of blurred vision, or medical abnormalities found in ophthalmic screening. * known allergy to vic-1911 or its components. * within 4 weeks before the study, radiotherapy or interventional therapy for the disease under study was performed; * other concurrent antitumor treatments; * the researcher assesses that the patient cannot or is unwilling to comply with the requirements of the study protocol.
effectiveness of 3% boric acid in 70% alcohol versus 1% clotrimazole solution in otomycosis patients

Conditions: Otomycosis

Summary: otomycosis is a superficial fungal infection of the external ear canal. patients should be treated with cleaning fungal debris combined with topical antifungal agent. there is wide range of topical antifungal agents. however, there is still no consensus of the most effective topical antifungal agents in treatment otomycosis is still lacking. according to thai national list of essential medicines for topical antifugal agents are: * acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol) * boric acid (3% in isopropyl alcohol) * gentian violet * clotrimazole ear drop. but from literature review, there is no comparative study between boric acid and clotrimazole solution before. objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.

the hypothesis has been formulated by h0 and ha. h0 = 1% clotrimazole solution has clinical effectiveness not different from 3% boric acid in 70% alcohol for the treatment of otomycosis. ha = 1% clotrimazole solution has more clinical effectiveness than 3% boric acid in 70% alcohol for the treatment of otomycosis. inclusion criteria: * symptomatic otomycosis, age more than 7 year. * microscopic finding revealed fungus * koh smear positive for fungus exclusion criteria: * pregnancy * tympanic membrane perforation and post mastoid surgery * co-infection of ear e.g. severe otitis externa,severe myringitis which are needed other medication. * previous using topical antibiotic / steroid within 2weeks. * during usage of systemic antifungal drug * allergic to 3% boric acid in 70% alcohol or 1% clotrimazole solution. pico model: p= otomycosis patient i= 1%clotrimazole ear drop c= 3% boric acid o= result of treatment as cure

Eligibility criteria:
inclusion criteria: * symptomatic otomycosis, age more than 7 year. * microscopic finding revealed fungus * koh smear positive for fungus exclusion criteria: * pregnancy * tympanic membrane perforation and post mastoid surgery * co-infection of ear e.g. severe otitis externa, severe myringitis which are needed other medications * previous using topical antibiotic / steroid within 2weeks. * during usage of systemic antifungal drug * allergic to 3% boric acid in70% alcohol or 1% clotrimazole solution. * those who can not come to follow up after one week of the treatment

Keywords: otomycosis 3% boric acid 1% clotrimazole ear drop
relationship between rheumatoid arthritis severity and cognition in the elderly: the role of nociplastic pain

Conditions: Rheumatoid Arthritis; Rheumatic Diseases; Rheumatoid Polyarthritis

Summary: this study aims to determine if nociplastic pain mediates the relationship between rheumatoid arthritis (ra) severity and cognitive impairment in geriatric patients 100 patients aged 65-90 years with long-standing ra and assess their disease severity, cognition, and pain sensitization will be recruited. expectations that patients with more severe ra will have worse cognitive function, and that this relationship will be mediated by higher levels of nociplastic pain.


Eligibility criteria:
inclusion criteria: * age 65-90 years * diagnosed with ra for 10-30 years * meet acr/eular 2010 criteria exclusion criteria: * other inflammatory arthritides * dementia * severe depression * recent corticosteroid or immunosuppressant use
association of genes to resistance to weight loss in obese patients

Conditions: Obesity; Metabolic Syndrome; Dyslipidemia

Summary: the overall goal of this study is to determine whether variations in the perilipin, and several other, genes would be a useful tool for physicians who are caring for morbidly obese patients to guide therapy. the main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin gene and several other obesity-related genes are associated with resistance to weight loss for obese individuals on energy restricted diets, potentially playing a role in the development of obesity related complications.

the primary goal of this study is to investigate the association of perilipin gene polymorphisms, with obese subjects who are "resistant" to weight loss in a defined program. the secondary goal of this study is to investigate if additional candidate obesity genes that have previously been associated with obesity or energy metabolism show association with resistance to weight loss in subjects on an energy restricted diet. additionally, we would like to investigate if any metabolic syndrome parameters, such as dyslipidemia or abnormal fasting glucose are associated with perilipin or variations in other obesity-related genes.

Eligibility criteria:
inclusion criteria: * caucasian * competent patients interested in gastric bypass surgery * patients who are eligible for gastric bypass surgery based on nih criteria: * male or female * 21 - 70 years old, inclusive * body mass index (bmi) \> 40 with 2 co-morbid conditions such as sleep apnea, hypertension, or type 2 diabetes * bmi \> 45 with no co-morbid conditions exclusion criteria: * patients not interested in gastric bypass surgery * patients who do not qualify for surgery based on medical contraindications * patients with severe psychological contraindications * patients not willing to be compliant with pre-post surgical recommendations * patients younger than 21 years of age * patients older than 70 years of age * patients who do not qualify for surgery based on insurance constraints i.e., insurance guidelines for bypass surgery * patients who are pregnant * hispanic, black, asian races * abnormal thyroid function

Keywords: obesity genes polymorphisms weight loss haplotype diplotype
study of ras(on) inhibitor combinations in patients with advanced ras-mutated nsclc

Conditions: Non-Small Cell Lung Cancer, NSCLC; KRAS, NRAS, HRAS-mutated NSCLC; KRAS G12C-mutated Solid Tumors, Lung Cancer; Lung Cancer Stage IV, Advanced Solid Tumor, Cancer; RAS G12D-mutated NSCLC

Summary: the purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary antitumor activity of novel ras(on) inhibitors combined with standard(s) of care (soc) or with each other. the first three subprotocols include the following: subprotocol a: rmc-6291 +/- rmc-6236 + soc subprotocol b: rmc-6236 + soc subprotocol c: rmc-9805 +/- rmc-6236 + soc

the platform study design allows combinations of ras(on) inhibitors with other anticancer agents to be evaluated in patients with ras-mutated solid tumors with a focus on nsclc. this is an open-label platform phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary antitumor activity of novel ras(on) inhibitors combined with standard of care (soc), and to define the recommended phase 2 dose and schedule (rp2ds). enrollment of patients with kras or ras mutations will be specified in each subprotocol. subprotocol a is an open-label, multicenter, phase 1b/2 study of rmc-6291, with or without rmc-6236, in combination with pembrolizumab, with or without chemotherapy, in patients with kras g12c-mutated advanced solid tumors. subprotocol b is an open-label, multicenter, phase1b/2 study of rmc-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with ras-mutated non-small cell lung cancer (nsclc) subprotocol c is an open-label, multicenter, phase1b/2 study of rmc-9805 with or without rmc-6236, in combination with other anticancer agents, in patients with ras g12d-mutated non-small cell lung cancer (nsclc) each subprotocol consists of two parts: part 1 - dose exploration and part 2 - dose expansion.

Eligibility criteria:
inclusion criteria: all patients (unless otherwise noted): * ≥ 18 years of age * ecog ps is 0 to 1 * adequate organ function as outlined by the study * received prior standard therapy appropriate for tumor type and stage * must have pathologically documented, locally advanced or metastatic kras g12c-mutated solid tumor malignancy (not amenable to curative surgery) (subprotocol a) * must have pathologically documented, locally advanced or metastatic ras-mutated nsclc (subprotocol b) * must have pathologically documented, locally advanced or metastatic ras g12d-mutated nsclc (subprotocol c) exclusion criteria: all patients: * primary central nervous system (cns) tumors * impaired gastrointestinal (gi) function that may significantly alter the absorption of rmc drugs * major surgery \< 28 days of first dose * active or history of interstitial lung disease (ild) or pneumonitis requiring steroids other inclusion/exclusion criteria may apply.

Keywords: nsclc kras g12c ras mutation kras g12x non-small cell lung cancer lung cancer lung cancer stage iv advanced solid tumor cancer ras g12d
effect of nifedipine gits in patients with mild-to-moderate primary hypertension

Conditions: Hypertension

Summary: this is a multi-center, open-label, observational study. the aim of this study is to evaluate the efficacy of nifedipine gits on lowering blood pressure in chinese adults with mild-to-moderate hypertension.

the primary aim of the study is to evaluate the efficacy of nifedipine gastrointestinal therapeutic system (gits) on lowering blood pressure in chinese adults with mild-to-moderate hypertension. the secondary aim of the study is to evaluate the efficacy of nifedipine gits on lowering blood pressure in hypertensive patients with different urinary sodium levels. based on sample size estimation, the plan is to recruit 700 patients from 16 centers. at baseline, patients'demographic characters, disease history and anthropometric indices will be collected, laboratory tests will be performed for blood routine examination, urinalysis, renal function, hepatic function, urinary sodium and 24-hour urinary sodium. all eligible patients will be assigned to a treatment of nifedipine gits and followed up for 8 weeks. at 0 day, 2,weeks, 4 weeks and 8 weeks of the study, seated blood pressure, vital signs, medication and adverse events were collected. at the end of the study, 24-hour ambulatory blood pressure monitoring (abpm) will be performed for all participants.

Eligibility criteria:
inclusion criteria: * a seated systolic bp (sbp) ≥140 mmhg and \<180 mmhg and/or a seated diastolic bp (dbp) ≥90 mmhg and \<110 mmhg; * an age ≥18 and ≤75 years; * those who had not taken any bp-lowering medications in 1 month before the study. exclusion criteria: * a seated systolic bp (sbp) ≥180 mmhg and/or a seated diastolic bp ≥110 mmhg; * secondary hypertension; * diagnosed heart failure or stroke; * any of alanine aminotransferase (alt) or aspartate aminotransferase (ast) was above 1.5 times of it's normal value upper limit, serum creatinine \>177 µmmol/l (2mg/dl), or liver cirrhosis; * subjects with carotid stenosis or systolic murmur * subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months; * subjects who were within lactation period, pregnant, or planning to become pregnant during the study; * hypersensitive to nifedipine gits or with sae; * subjects who are participating in other clinical trials; * considered not fit for the study due to other reasons according to the researchers (such as malignant tumor, psyche or nervous system dysfunction, or special diseases).
effectiveness of a parent-mediated intervention with pact on children with asd

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a neuro-developmental disorders. there are different types of interventions. among these interventions early start denver model (esdm) and preschool autism communication therapy (pact) have proved efficacy at short and long term. pact is the therapy with the highest evidences when parents delivered the intervention themselves.

in pact, parents are guided, generally in face to face, by a professional to improve the synchrony and communication with their children with asd. then, it is recommended to the parents to practice the therapy daily at home. in france, this type of early intervention is poorly developed and is only accessible in specialized centers located in large urban centers. guiding parents by videoconferencing could make this intervention accessible to families in undeserved areas. the objective of this study is to evaluate the effectiveness of a pact intervention delivered by parents and guided by videoconferencing, on the autism in their children with asd, aged 18 to 36 months at the inclusion. this is a mixed (quantitative and qualitative), multicenter, controlled, randomized, open-label study, comparing a group of children receiving usual care and one of whose parents is trained and accompanied by videoconferencing to developmental techniques as described in the pact, to a group of children benefiting only from the usual care provided by the community. the primary endpoint was the severity of autism measured with the ados-2 (2012 autism diagnostic observation schedule) severity score (css) at 12 months. a total of 212 children will be included in the study (106 / group).

Eligibility criteria:
inclusion criteria: child with autism spectrum disorder * symptoms in autism with a severity superior to 4 as measure by ados-2 * positive adi (autism diagnostic interview) * diagnostic done by a multidisciplinary team * nonverbal iq above 12 months having health assurance exclusion criteria: for the child * child with a twin brother or sister with asd or having a brother or sister already included in this study * epilepsy requiring medication * severe hearing or visual impairment * identification of a genetic anomaly causes participation in the intervention or validity of the data (determined by the principal investigator on a case-by-case basis) for the parents * severe hearing or visual impairment * severe psychiatric disorder * unstable somatic disorders preventing intervention * lack of internet access * parent not available for regular follow-up * opposition of one parent to the child's participation in a study * already receiving pact therapy or any other intensive intervention (e.g. denver)

Keywords: interventions early start denver model (esdm) preschool autism communication therapy (pact)
eﬀects of reparel™ knee sleeve on knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the goals of treating knee osteoarthritis (oa) is to improve or maintain quality of life, mobility and function, pain relief, and improve inﬂammation. the diﬀerent treatment options for knee oa have been extensively studied and implemented, but the optimum treatment is still undecided. there is a belief that anti-inﬂammatory sleeve technology may be beneﬁcial in treating knee oa. the purpose of this study is to determine the clinical eﬀects of reparel™ knee sleeve regarding mobility, functionality, and pain outcomes in managing knee oa.

standard knee compression sleeves have been described throughout literature to provide beneﬁts in pain and functional outcomes through support of the ligamentous structures. bracing is both an eﬀective and economical treatment for osteoarthritis and serves as a crucial option in the treatment of knee oa to aid in both delaying surgery and as options for young patients, or patients that are not ideal surgical candidates. although knee sleeves are commonly utilized treatment modalities, there is a signiﬁcant paucity of literature on the eﬀects of thermo-active braces in the treatment of knee oa. this investigation will examine this non-operative treatment modality and study it eﬀect for the treatment of knee oa specifically by investigating the reparel knee sleeve. the reparel knee sleeve is a class i medical device (510(k) exempt) and used in general sports medicine practice for the alleviation of knee pain. the authors expect that the reparel thermos-active knee sleeve will have a signiﬁcant eﬀect on pain relief from knee oa.

Eligibility criteria:
inclusion criteria: * osteoarthritis visible on knee radiograph * patient opting for non-surgical treatment * no corticosteroid knee injection for 90 days prior to consent * no corticosteroid knee injection for 90 days following consent exclusion criteria: * bilateral symptomatic knee osteoarthritis * prior surgery on the knee of interest * hardware present on the knee of interest * gross instability detected on physical exam * malignancy in the knee of question
impact of an exercise program for children aged 4 to 6 years with bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia; Healthy

Summary: the purpose of this study is to determine the effects of a physical activity program for children with bronchopulmonary dysplasia.

primary objectives is: to compare exercise tolerance and aerobic capacity between healthy children with bronchopulmonary dysplasia children only bronchopulmonary dysplasia children will realise the physical activity program. secondary objectives are: to analyse lung function and to evaluate flexibility.

Eligibility criteria:
bronchopulmonary dysplasia children inclusion criteria: * age between 4 to 6 years old * bronchopulmonary dysplasia diagnostic * ex-prematurity * accept to participate. exclusion criteria: * congenital malformations * neuromuscular disorders * gait alterations * difficulties for communication and understanding * wheezing or pulmonary disease two weeks before to start the program * hemodynamic changes (heart rate \> 130bpm, systolic blood pressure \> 130bpm, diastolic blood pressure \> 80bpm). * heart and/or lung transplantation. healthy children criteria: inclusion criteria: * age between 4 to 6 years old. exclusion criteria: * antecedents of pulmonary or cardiac chronic disease * congenital malformations * neuromuscular disorders * gait alterations * difficulties for communication and understanding * wheezing or pulmonary disease two weeks before to start the program * hemodynamic changes (heart rate \> 130bpm, systolic blood pressure \> 130bpm, diastolic blood pressure \> 80bpm). * heart and/or lung transplantation.
fecal microbiota transplantation (fmt) in the treatment of pouchitis

Conditions: Pouchitis; Ulcerative Colitis

Summary: the aim of our study is to investigate the efficacy and safety of fecal microbiota transplantation (fmt) in the treatment of antibiotic dependent chronic pouchitis. this is a double-blinded randomized placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested donor and 13 patients in the control group receive their own feces.

pouchitis is the most common long term complication among patients with ulcerative colitis who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis (ipaa). the etiology of pouchitis remains unclear. there is significant clinical evidence implicating bacteria in the pathogenesis. it has been shown that fecal microbiota transplantation (fmt) is an effective treatment for recurrent clostridium difficile -infection. case reports have also shown promising results of fmt in patients with inflammatory bowel disease. currently there is no established effective treatment for chronic antibiotic dependent or refractory pouchitis. the aim of our study is to investigate the efficacy and safety of fecal transplantation in the treatment of chronic pouchitis instead of antibiotic therapy. another aim is to evaluate phylogenetic analysis of the fecal microbiota trying to find microorganisms contributing to good results in fecal transplantation in ipaa patients. patients receive fmts on weeks 0 and 4. antibiotic treatment has been stopped 36 hours before the first fmt.

Eligibility criteria:
inclusion criteria: * status post of restorative proctocolectomy with ileal pouch-anal anastomosis (ipaa) for ulcerative colitis * pouchitis diagnosed by the symptoms and by endoscopy including histology within 6 months prior to fmt * need of frequent or continuous use of antibiotics or probiotics because of the chronic pouchitis * availability of consecutive fecal samples during one year * compliance to attend fmt and control pouchoscopy after 52 weeks exclusion criteria: * unable to provide informed consent * use of immunosuppressive or biological medication * use of corticosteroids * acute pouchitis * pregnancy

Keywords: fmt