Kornimate/medical-research-clean huggingface dataset:
a study to evaluate shr-1210 in combination with apatinib as first-line therapy in patients with advanced hcc

Conditions: Locally Advanced or Metastatic and Unresectable HCC

Summary: this is a randomized, open-label, international, multi-center, phase iii trial to evaluate the efficacy and safety of shr-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced hcc.


Eligibility criteria:
inclusion criteria: * histopathologically or cytologically confirmed advanced hcc * no previous systematic treatment for hcc * have at least one measurable lesion (in accordance with recist v1.1) * bclc stage b or c, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy * ecog-ps score 0 or 1 * child-pugh class: grade a * life expectancy of at least 12 weeks * subjects with hbv infection: hbv dna\<500 iu/ml or \< 2500 copy/ml, and have received anti-hbv therapy for at least 14 days prior to enrollment in the study * subjects with hcv-rna(+) must receive antiviral therapy * adequate organ function exclusion criteria: * known hepatocholangiocarcinoma, sarcomatoid hcc, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except hcc within 5 years or simultaneously * moderate-to-severe ascites with clinical symptoms * history of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage * abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * known genetic or acquired hemorrhage or thrombotic tendency * thrombosis or thromboembolic event within 6 months prior to the start of study treatment * cardiac clinical symptom or disease that is not well controlled * hypertension that can not be well controlled through antihypertensive drugs * factors to affect oral administration * history of hepatic encephalopathy * previous or current presence of metastasis to central nervous system * hiv infection * combined hepatitis b and hepatitis c co-infection * be ready for or previously received organ or allogenic bone marrow transplantation * interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity * active known, or suspected autoimmune disease * subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment * use of potent cyp3a4 inducers or inhibitors within 2 weeks prior to the signature of icf * known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug * severe infection within 4 weeks prior to the start of study treatment * palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment * treatment of other investigational product(s) within 28 days prior to the start of study treatment
a study of duloxetine (ly248686) in japanese children and adolescents with depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of japanese children and adolescents with depressive disorder.


Eligibility criteria:
inclusion criteria: * participants diagnosed with major depressive disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) with the mini international neuropsychiatric interview for children and adolescents (mini-kid) ver.7.0.2. * participants whose incipient age of depression was ≥7 years old. * total score of cdrs-r is ≥40 and cgi-s score is ≥4 at both screening and baseline. exclusion criteria: * have remarkable response to psycho-education (defined as \>30% decrease in the total score of cdrs-r between screening and baseline). * have a current or previous diagnosis (dsm-5) of the following as judged by the investigator: * neurodevelopmental disorders * schizophrenia spectrum and other psychotic disorders * bipolar and related disorders * trauma and stressor-related disorders * disruptive · impulse control · and conduct disorders * have a current diagnosis (dsm-5) of the following as judged by the investigator: * obsessive-compulsive and related disorders * anorexia nervosa, bulimia nervosa, binge-eating disorder * sleep-wake disorders * neurocognitive disorders * disruptive mood dysregulation disorder * have personality disorders, in the judgement of the investigator.
proprio spine measurement tool

Conditions: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Spinal Curvatures; Spinal Osteochondrosis; Spinal Osteophytosis; Spinal Stenosis; Spondylitis; Spondylosis

Summary: this study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. the study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries. objectives primary: to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively. secondary: to determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes. hypothesis the application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.

patient reported outcomes data will be collected on two separate forms- the oswestry disability index (odi) and the sf-36. the odi has been widely used since its development in 1980 and has been viewed as effective for measuring disability in daily living associated with low back pain4. the sf-36 is the most used patient reported outcomes measure used both generically as well as specifically for low back pain, and it consists of both a mental as well as physical assessment5. study data will be compared to historical literature data. the intraoperative spinal measurement system to be used is the paradigm tm system by proprio. patients will fill out odi and sf-36 and will have a postoperative standing long x-ray or eos at regular follow-up intervals (typically 6w, 3m, 6m, 12m, 24m).

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or older at the time of surgery * type of surgery: consecutively scheduled patients where the measurement system will be used who will have thoracolumbosacral posterior spine surgery that includes spinal instrumentation and fusion and that consent to the study exclusion criteria: * patients treated for traumatic injury (penetrating injuries, etc.) * incarcerated persons * pregnant females * any patient current in another trial for a new implant or technique * non-spine related surgeries: patients who had surgeries for reasons other than spine-related conditions (even if they incidentally involved the spine) * patients having additional surgery occurring concurrently with spine surgery * patients ineligible for surgery

Keywords: spine surgery proprio spine measurement adults posterior spine surgery spine fusion thoracic spine surgery lumbar spine surgery sacral spine surgery
sustainable and efficient platform trial of new therapeutic development for early breast cancer

Conditions: Breast Cancer

Summary: randomized phase ii trial targeting early-stage breast cancer (stage ii-iii) applicable to preoperative chemotherapy (nac), comparing standard treatment with multiple experimental treatments.

this randomized phase ii trial targets early-stage breast cancer (stage ii-iii) with preoperative chemotherapy (nac). it compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. patients are classified by subtype and randomized between standard and experimental treatments. the trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor dna (ctdna) evaluation for precise efficacy and prognosis prediction.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed invasive breast carcinoma 2. stage ii or iii 3. ecog performance status of 0 or 1 4. age 18-80 exclusion criteria: 1. continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants. 2. history or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings. 3. infection requiring systemic treatment. 4. active double cancer (however, the following are not excluded: (1) completely resected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage i, carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2) gastrointestinal cancer that has been curatively resected by esd or emr, (3) other cancers that have not recurred for more than 5 years).
the long term follow-up results of the direct nipple ureteroneocystostomy technique

Conditions: Vesicoureteral Reflux; Nipple Ureteroneocystostomy

Summary: to evaluate the long term follow-up results of the direct nipple ureteroneocystostomy technique.


Eligibility criteria:
inclusion criteria: * megaureter. * ligated ureter during surgery. exclusion criteria: * neurogenic bladder * surgical wound infection

Keywords: nipple technique ureter vesicoureteral reflux
efficacy study of a standardized pollen extract preparation (cernilton) to treat inflammatory chronic prostatitis-chronic pelvic pain syndrome (cp-cpps)

Conditions: Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Summary: in this placebo controlled study the safety and efficacy of cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. the purpose of this study is to determine whether cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.

we conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of cernilton, a standardized pollen extract, in men with inflammatory cp-cpps (national institutes of health (nih) type iiia). participants were randomized to cernilton or placebo for 12 weeks and were evaluated using the national institutes of health chronic prostatitis symptom index (nih-cpsi) individual domains and total score, the number of leukocytes in post prostatic massage urine, the international prostate symptom score (ipss) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.

Eligibility criteria:
inclusion criteria: * men between 18 and 65 years * symptoms of pelvic pain for at least 3 months during the 6 months before study entry * a score in the pain domain of the german validated version of the nih chronic prostatitis symptom index (nih-cpsi) of 7 or higher * leukocytes of 10 or more in post prostate massage urine exclusion criteria: * urinary tract infection * acute bacterial or chronic bacterial prostatitis * history of urethritis with discharge 4 weeks prior to study entry * a history of epididymitis or sexually transmitted disease * residual urine volume of more than 50 ml due to bladder outlet obstruction * indication for or history of prostate surgery including prostate biopsy * treatment with phytotherapeutic agents * alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks prior to study entry * treatment with agents influencing intraprostatic hormone metabolism 6 months prior to study entry

Keywords: chronic prostatitis symptom index male inflammatory cp-cpps cernilton pelvic pain symptoms
safety and efficacy study of at-101 in combination with docetaxel and prednisone in men with hrpc

Conditions: Prostate Cancer

Summary: this is an open-label, multicenter phase i/ii study to evaluate the safety and efficacy of at-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,


Eligibility criteria:
inclusion criteria: 1. rising prostate specific antigen (psa) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist therapy. 2. patients must have metastatic disease by bone scan, computed tomography (ct) scan, or magnetic resonance imaging (mri). 3. ecog performance status 0 or 1 4. adequate hematologic function 5. adequate liver and renal function 6. able to swallow and retain oral medication. 7. patients enrolled into cohort b must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising psa, progression of disease per recist, or \>2 new lesions on bone scan. 8. patients enrolled into cohort b must have received at least two cycles of docetaxel. minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule. 9. at least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide. exclusion criteria: 1. patients enrolled into cohort a must not have received prior chemotherapy for hrpc. 2. known history of or clinical evidence of central nervous system (cns) metastases. 3. active secondary malignancy or history of other malignancy within the last 5 years. 4. prior history of radiation therapy to \> 25% of the bone marrow 5. peripheral neuropathy of \> grade 2 6. uncontrolled concurrent illness 7. failure to recover fully, as judged by the investigator, from prior surgical procedures. 8. concurrent anti-cancer therapy other than docetaxel and prednisone. 9. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh therapies are acceptable to maintain castrate levels of testosterone)

Keywords: at-101 at101 cancer hormone refractory prostate docetaxel prednisone
objective randomised blinded investigation with optimal medical therapy of angioplasty in stable angina

Conditions: Stable Angina

Summary: in this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. after the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

the investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (pci) and optimal medical therapy (omt) versus a sham procedure and omt. two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. baseline investigation of functional capacity and myocardial ischaemic burden will be performed. this will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to pci or a sham procedure. follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.

Eligibility criteria:
inclusion criteria: * stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation exclusion criteria: * acute coronary syndrome * previous coronary artery bypass graft surgery * left main stem disease * contraindications to pci or drug-eluting stent (des) implantation * heavily calcified or tortuous vessels * chronic total occlusion in target vessel * life expectancy \<2yr * pregnancy * age \ 85yr * angiographic stenosis ≥ 50% in non-target vessel * inability to consent

Keywords: stable angina percutaneous coronary intervention optimal medical therapy sham-control
the impact of total body skin examination on skin cancer detection

Conditions: Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Merkel Cell Carcinoma; Skin Cancer

Summary: this will be a study where all patients will undergo a two-step procedure: step 1 - physicians examine the problem area of skin only and record result. step 2 - physicians perform tbse and record result. eventual lesions suggestive of melanoma and non-melanoma skin cancers will be recorded after step 1 or step 2 examination and will be finally biopsied and histopathologically diagnosed. exceptions to biopsy may include patients with multiple non-melanoma skin cancers (e.g. actinic keratoses or basal cell carcinomas). each center will be provided with an electronic data sheet for patients record, or alternatively, with a paper record form. endpoints of the study are new parameters concerning the standard of care for skin cancer screening. we expect to conclude that tbse enables clinicians discovering an increased number of skin cancers thus resulting in earlier detection.

clinicans performed a two-step examination for skin cancer, with clinical examination of individual lesions was aided by the use of dermoscopy, as needed. in the first step, physicians performed inspection of problem areas and uncovered areas only, and lesions suggestive of melanoma or non-melanoma skin cancer were noted. in the second step, tbse was performed. following both examinations, lesions suggestive of melanoma or non-melanoma skin cancer were excised or biopsied. histopathologic diagnosis was recorded for each of the biopsied or excised lesions. statistical analysis: we calculated absolute risks as the proportion of individuals with the target disease divided by all individuals at risk. the number needed to examine was calculated by dividing the individuals at risk by the numbers of individuals with the target disease. confidence intervals for proportions were calculated using standard formulas based on the binomial distribution. chi square tests were used for comparison of proportions. continuous variables are presented as mean and standard deviation (sd) unless otherwise specified. for univariate and multivariate analyses we used odds ratios derived from logistic regression to estimate relative risks and their confidence intervals. all p-values reported are 2-tailed. statistical significance is defined as p \<0.05. statistical analysis was performed using spss software, version 16.0 (spss, chicago, ill, us).

Eligibility criteria:
inclusion criteria: * consecutive, unselected adult (18 years or more) patients with any skin disorders. skin disorder must be localized on a limited body area and should not require total body skin examination (tbse) to be diagnosed and/or treated. exclusion criteria: * patients who ask for or need tbse as the main reason for consultation. a patient must be also excluded if a significant part of the body should be undressed for diagnosis and/or treatment (i.e. if the shirt or trousers should be removed for diagnosis and/or treatment, then the patient must be excluded). * patients under the age of 18 years. * patients who do not agree to get tbse.
safety and efficacy evaluation of the mosaic ultra device

Conditions: Skin Texture Disorder; Photoaging; Wrinkle; Scar; Stretch Mark; Acne Vulgaris; Hair Loss

Summary: evaluate the safety and efficacy of the mosaic ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss.


Eligibility criteria:
inclusion criteria: * non-smoking, male or female * age 18 - 60 years old * understands and accepts the obligation not to undergo any other procedures in the areas to be treated. * participants who are willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. * optional - participants who are willing to undergo biopsies. exclusion criteria: * previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure * a study participant must not be pregnant or have been pregnant in the last 3 months * a recent history of smoking (6 months) * presence of an active skin disease or condition that may affect wound healing (ie. diabetes myelitis; connective tissue disease; radiation therapy; or chemotherapy) * seizure disorder caused by bright light * a history of thrombophlebitis * a history of acute infections * a history of heart failure * cancer, malignant disease, skin pathology, condition, or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during, or after treatments * received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin e, or anti-inflammatories within 2 weeks prior to treatment * intolerance or allergy to medications that could be prescribed before or after the procedure (eg, antibiotics, anesthesia) * a history of keloids * a history or evidence of poor wound healing * a history of coagulative disorder or current use of anticoagulant drugs within 2 weeks of study participation * use of steroids within 2 weeks of study treatments * patients with implanted pacemaker or defibrillator, or metal pins, or prosthetic joints within 4 cm of treatment area * history of psychoneurosis and/or a history of alcohol or drug abuse
a comparison between sonoguided injection corticosteroid and hyaluronic acid injection in treatment of trigger finger

Conditions: Trigger Finger

Summary: the study is to compare the effect between steroid injection and hyaluronic acid in treatment trigger finger. using sonoguided injection technique achieves more accurate injection location and therapeutic effect. we hypothesize hyaluronic acid has both lubricant and anti-inflammation effect in treatment of trigger finger, and can provide better outcome and lower adverse effect than steroid injection.

this is a prospective, randomized, double-blinded controlled study. patients with the diagnosis of trigger finger will be recruited and enrolled from taipei veteran general hospital pm\&r outpatient clinic. subjects will be randomized into two groups; hyaluronic acid and triamcinolone acetonide injections, both via ultrasound-guided with one injection only.we hypothesize that through the anti-inflammatory property of the hyaluronate acid, the treatment effects will be as effective as the traditionally used steroid injections with equal or even lower recurrence rate for treatment of trigger finger. we expect that injections of hyaluronate into tendon sheath could become a new treatment option for trigger finger.

Eligibility criteria:
inclusion criteria: * patients with trigger digits and patients * without previous treatment of the trigger digit exclusion criteria: * patients with prior treatment of the trigger digit (eg, splinting, injection, or therapy), * patients less than * 20 years old, * patients with allergy or contraindication to hyaluronic acid, * patients with trigger digits due to rheumatoid arthritis, * and patients with infection at the site of injection.

Keywords: hyaluronic acid, trigger finger