Kornimate/medical-research-clean huggingface dataset:
a study to compare the effectiveness and safety of ibi310 combined with sintilimab versus sorafenib in the first-line treatment of advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: this is a randomized, open-label, controlled, multicenter phase iii study to evaluate the effectiveness and safety of ibi310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic hcc who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.


Eligibility criteria:
inclusion criteria: 1. histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria; 2. ecog performance status score of 0 or 1 point; 3. no systemic antitumor treatment for hepatocellular carcinoma before the first administration; 4. barcelona clinic liver cancer stage c, or stage b not suitable for radical surgery and/or local treatment; 5. at least 1 measurable lesion according to recist v1.1); 6. child-pugh:≤6 7. adequate organ and bone marrow function. exclusion criteria: 1. with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. 2. have a history of hepatic encephalopathy or have a history of liver transplantation. 3. with clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion. 4. central nervous system (cns) metastasis. 5. uncontrolled high blood pressure, systolic blood pressure \>140mmhg or diastolic blood pressure \>90mmhg after optimal medical treatment. 6. local treatment for liver lesions within 4 weeks.
mechanical insufflation -exsufflation in children with nmd and weak cough

Conditions: Neuromuscular Diseases in Children

Summary: neuromuscular diseases (nmd) in children are severe, possibly life-threatening orphan conditions. the children are vulnerable and often subject to rapid deterioration of pulmonary function due to impaired ability to clear airway secretions. the use of mechanical cough augmentation with insufflation-exsufflation (mie) is a strategy to treat and prevent. possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established. the project aim to improve the quality of the treatment with mie in children with nmd and weak cough. on the basis of a bench study a clinical trial aims to examine the most effective mie settings when used in stable state and when respiratory tract infections are present.

on the basis of a prevalence study and a bench study different settings will be studied in children with nmd and weak cough to examine if settings derived from the lung model, are optimal to increase the peak cough flow (pcf) and comfort measured by visual analogue scale (vas) in children with nmd and weak cough.

Eligibility criteria:
inclusion criteria: * diagnosed neuromuscular disease \< 18 years * established use (\> 3mnd) of mi-e. * reduced pcf * pcf \ 12 years) * \< 5th percentiles for pcf 16 (when 4 - 12 years) * clinical indication (difficulty to clear secretions, audible weak cough, history of pneumonia or frequent or prolonged respiratory tract infections). exclusion criteria: * age \< 6 mnd * obstructive lung disease (hyperinflation or emphysema on x-ray.
sarcopenia in children

Conditions: Sarcopenia; Juvenile Idiopathic Arthritis

Summary: juvenile idiopathic arthritis (aji), is a frequent inflammatory disease in children, characterized by pain, arthritis, and deformities. chronic inflammation leads to physical inactivity and can be associated with muscle weakness around affected joints, low bone strength, and mass(3). to our knowledge, no study has focused on the prevalence of sarcopenia in jia and the data on the muscle disorder are lacking. the purpose of the present study is to detect sarcopenia and identify associated factors in children with jia


Eligibility criteria:
inclusion criteria: * children with juvenile idiopathic arthritis fulfilling the ilar criteria exclusion criteria: * we excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.
oxford unicompartmental knee arthroplasty with and without navigational unit

Conditions: Knee Arthritis

Summary: the purpose of this study is to determine whether a computer navigational unit can improve operating time and consistency during knee arthroplasty when compared to knee arthroplasty without a computer navigational unit.

the ability to use a computerized navigational unit during knee arthroplasty can be a major benefit to surgeons that perform a small amount of knee arthroplasties. navigational assistance can decrease surgery and anesthesia time as well as decreasing variation in posterior tibial slope and improved range of motion.

Eligibility criteria:
inclusion criteria for the oxford knee * symptomatic unicompartmental knee arthritis major surgery * failed non operative treatment modalities * willing and able to give informed consent * skeletal maturity exclusion criteria for the oxford knee * medical conditions that preclude general or spinal anesthetic * ipsilateral knee avascular necrosis * severe osteoporosis or osteopenia * neuromuscular impairment * ipsilateral knee infection patient day surgery criteria * medically stable: an asa category of 1 or 2 * close proximity to the hospital surgery performed for at least 36 hours * good support system in place- someone able to stay with the patient for at least 36 hours immediately post-op. * hemovac to be removed prior to discharge * access to von or other home care hospital approved services * pain buster for pain control for 24 to 36 hours

Keywords: eligible for unicompartmental knee arthritis
a new pelvic osteotomy method for open reduction

Conditions: Developmental Dysplasia of the Hip

Summary: developmental dysplasia of the hip (ddh) was one of the most common hip disorders disease in children. pemberton osteotomy (po) was one of the most widely used by the pediatric orthopedic surgeons. in our clinical work, the investigators found some defect the operation procedure. when the surgeons were not familiar to the po, it may injured the triradiate cartilage or easily be absorbable of the distal iliac. here, the investigators found a new pelvic osteotomy just from the inner "l shaped" iliac osteotomy (ilso) to treat ddh. this approach was in a visible part of the sciatic notch and not presumed to be in the ischium, completely out of sight. comparing to the po method, the investigators' operation method was easy to master and had less complications.


Eligibility criteria:
inclusion criteria: * over two years old * open reduction and acetabular osteotomy * diagnosed as developmental dysplasia of the hip exclusion criteria: * a previous history of ddh surgery * teratologic dislocations * cerebral palsy * other spastic or neuromuscular disease
a prospective analysis of failures of oral implants

Conditions: Dental Implant Failure; Periodontal Bone Loss

Summary: the purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the folktandvården specialistklinik in malmö (spårvägsgatan 12, 214 27, malmö).

the treatment begins with screening against inclusion and exclusion criteria. the patients will then be informed of the design of the study through the reading of the form for patient information and the informed consent in swedish and verbally. all dental implants to be inserted will be included in the study. some surgical, implant, loading, prosthetic variables of the study will be decided according to the surgeon's criteria and patient's decisions. data will be collected in specific forms, and will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and complications. besides descriptive statistics, kaplan-meier analysis will be used to estimate implant survival/failure rates (an estimator for estimating the survival function from lifetime data), and multivariate cox proportional hazards models will be used to identify prognostic variables.

Eligibility criteria:
inclusion criteria: * patients with a minimum age of 18 years; * patients having read, understood, and signed the form for patient information and the informed consent. exclusion criteria: * age less than 18 years; * general contraindications for implant surgery; * subjects with an untreated systemic disease. a complete medical report will permit the disqualification of subjects with an untreated systemic disease. patients with a systemic disease such as diabetes or hypertension will not be excluded, as long as these pathologies were treated and stabilized within normal biologic parameters.

Keywords: dental implants periodontal bone loss implant-supported dental prosthesis dental prosthesis failure
questioning patients about adverse medical events

Conditions: Benign Prostatic Hyperplasia

Summary: this trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects.

214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplasia were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. two methods of ascertainment were open ended questions, and 1 was a checklist. patients were blinded to group assignment, but investigators were aware (single blind). all patients had taken placebo for one month, but had been told it was a study drug (single blind).

Eligibility criteria:
inclusion criteria: * male, age \> 49, american urological association symptom index \> 8 * max urine flow rate \> 4 and \< 15 exclusion criteria: * prior prostate cancer or surgery * use of medications that affect urination * severe concomitant illness

Keywords: adverse events clinical trial methodology
dasatinib (bms-354825) in subjects with myeloid blast phase chronic myeloid leukemia resistant to or intolerant of imatinib mesylate

Conditions: Chronic Myeloid Leukemia; Blast Crisis

Summary: the purpose of this study is to see what effect an investigational drug (bms-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (cml) and who are either resistant to or intolerant of imatinib mesylate. another purpose of the study is to see what side effects this drug may have on subjects.


Eligibility criteria:
inclusion criteria: * subjects with myeloid blast phase chronic myeloid leukemia * subjects who are either resistant or intolerant of imatinib mesylate exclusion criteria: * subjects who are eligible and willing to undergo transplantation * serious uncontrolled medical disorder or active infection * uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc * subjects receiving medications that may affect heart rhythm * other malignancy/cancer other than cml * history of significant bleeding disorder unrelated to cml * pregnant or breastfeeding women (subjects must avoid becoming pregnant) * subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days * subject is receiving medications that affect platelet function or an anticoagulant

Keywords: myeloid blast phase chronic myeloid leukemia (cml)
dna typing of hla-dr/dq alleles in taiwan chinese with rheumatic heart disease

Conditions: Rheumatic Heart Disease

Summary: the current study was designed to determine whether the hla-drb1, dqa1, dqb1 alleles are associated with the risk and the pattern of valve damage of rhd.


Eligibility criteria:
inclusion criteria: * 1.patients with rheumatic mitral stenosis 2.chinese han ethnicity exclusion criteria: -

Keywords: rheumatic heart disease, hla, genetics, taiwan
sensory morbidity following breast surgery

Conditions: Breast Cancer

Summary: the goal of the study is measure breast sensations after breast surgery. the results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.


Eligibility criteria:
inclusion criteria: * the samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment. * patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction * patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy * patients who have undergone mastectomy alone * patients at least 21 years of age * patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry exclusion criteria: * patients who have had any of the following: * delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or * patients who have a pre-surgical history of complex regional pain syndrome * patients who have had radiation therapy * patients who have had a local recurrence * patients who do not speak the english language (validated translations of key questionnaires are not available).

Keywords: plastic surgery reconstruction
strength, aging, and memory in prostate cancer

Conditions: Prostate Neoplasm; Prostate Cancer

Summary: the objective of this study is to compare changes in neurocognitive function across a 12-month period between three groups: (1) men treated with androgen deprivation therapy (adt) for prostate cancer (pca); (2) men under active surveillance for pca; and (3) men without a history of cancer.

aim 1: this study will examine differences in neurocognitive function (cognitive performance, brain structural integrity) from baseline (within 30 days of adt initiation or 90 days of diagnosis) to 6- and 12-month follow-up. aim 2: examine group differences in components of frailty (e.g., lean mass, muscle strength, physical function, fatigue, physical activity) from baseline to 6- and 12-month follow-up. men will be recruited for this study if they are (1) recently diagnosed with pca and scheduled to receive 6-months or more of adt (adt+ group, n=20), (2) recently diagnosed with pca and under active surveillance (adt- group, n=20), or (3) healthy men without a history of cancer (pca- group, n=20). eligible men (n=60) will be scheduled for two or three testing appointments at each testing timepoint. to assess aim 1, participants will complete measures at baseline (m0), 6-month follow-up (m6), and 12-month follow-up (m12). aim 1 measures include: neurocognitive tasks, functional magnetic resonance imaging (optional; n=10 adt+ and n=10 adt- only), and questionnaires. to assess aim 2, outcomes indicated as components of frailty syndrome will be measured, including: dual-energy x-ray absorptiometry (e.g., appendicular lean mass), upper and lower body dynamometry, physical function and functional capacity, questionnaires (i.e., fatigue surveys), and physical activity monitoring (i.e., accelerometry). findings from this study will build upon the scientific framework for the potential frailty pathway of cancer-associated cognitive decline in pca patients in order to develop future evidence-based interventions to manage cognitive impairment in men diagnosed with pca.

Eligibility criteria:
inclusion criteria: * telephone interview of cognitive status (tics-m) performance above impaired range (≥21) group-specific criteria: * first time, primary diagnosis of prostate cancer (adt+ and adt-) * diagnosed within past 30 days (adt-) * scheduled to receive ≥ 6-months androgen deprivation therapy and have not received \>30 days of androgen deprivation therapy (adt+) * men without a history of cancer who are within one year of age of adt+ participants (pca-) exclusion criteria: * second cancer diagnosis (excluding non-invasive skin cancers) * history of stroke, transient ischemic attack, neurological disorder, or brain surgery involving tissue removal * unable to walk without assistance * unwilling to complete study requirements * body weight greater than 300 pounds (dxa requirement) * moderate-intensity physical activity ≥ 150 minutes per week * upper and lower body strength training ≥ 2 days per week * unable to read in english
the visual plasticity during adversity and prosperity in infants with congenital cataracts

Conditions: Cataract

Summary: phenotypic plasticity is the ability of individuals to change their phenotypic status when exposed to environmental variations. however, whether the plastic changes show differential susceptibility in adversity and prosperity is debated and the specific pattern of plasticity remains elusive. here the investigators address this question by tracking the phenotypes (functional, structural, physical, and attachment traits) in two groups of infants before and after visual deprivation: one group experienced a short duration of complete deprivation (extreme adversity) and the other group experienced a long durations of partial deprivation (watered-down adversity).


Eligibility criteria:
inclusion criteria: * diagnosis with dense or non-dense nuclear congenital cataract exclusion criteria: * no metabolic diseases, mental retardation or central nervous diseases * had no history of inherited diseases

Keywords: phenotypic plasticity adversity prosperity
fenugreek wraps in osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: this randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive only usual care. efficacy will be measured using questionnaire on pain, disability,function, quality of life and pressure pain sensitivity.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee, kellgren lawrence stadium 2-3 * at least 50% of days with complaints in past 3 months * initial pain intensity \>45mm on a 100mm visual analoge scale exclusion criteria: * systemic medication with corticoids or immunosuppressive drugs * systemic medication with chondroitinsulfate or glucosamine * secondary arthrosis * operation on the knee within the past 12 months * injection within 4 weeks (cortisone) or 6 months prior (hyaluronic acid) * severe comorbidities (tumor, psychiatric disorders etc.) * participation in other studies, regarding gonarthrosis * asthma * pregnancy, breastfeeding
clinical study to evaluate the efficacy and safety of aliskiren alone and in combination with hydrochlorothiazide in patients with essential hypertension.

Conditions: Hypertension

Summary: to demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (hctz)


Eligibility criteria:
inclusion criteria * patients with essential hypertension * patients who are eligible and able to participate in the study exclusion criteria * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident other protocol-defined exclusion criteria may apply.

Keywords: hypertension, aliskiren, blood pressure, hydrochlorothiazide (hctz).
clinical study of double-endoscopic combined with minimally invasive treatment for early gastric cancer at clinical stage t1b

Conditions: Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

Summary: for patients diagnosed with early gastric cancer involving submucosal invasion, super-esd indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced ct was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① to investigate the safety, feasibility, and efficacy of local resection for patients meeting super-esd criteria; ② to offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.


Eligibility criteria:
inclusion criteria: 1. age 18-70 years old; 2. endoscopic pathological diagnosis: adenocarcinoma; 3. enhanced abdominal ct combined with endoscopic ultrasound clinical staging: t1bn0-1m0. 4. has not received other treatment; 5. no other serious comorbidities; 6. agree to participate in the study and sign the informed consent form. exclusion criteria: 1. pregnant or breastfeeding women 2. history of previous abdominal surgery 3. history of other previous malignancies 4. can patients with severe heart, lung, brain diseases tolerate surgical treatment
a safety study of lenalidomide in previously untreated adult multiple myeloma patients who are not eligible for transplant

Conditions: Multiple Myeloma

Summary: this post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. the objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. treatment in both cohorts will be done according to standard care. the study will gather risk factor information at baseline and throughout follow-up. any cardiovascular event occurring will be assessed by an independent committee. other safety endpoints will be collected through standard procedures. observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. during follow up the incidence of second primary malignancies (spm) and overall survival will be assessed.


Eligibility criteria:
inclusion criteria: 1. must have understood and voluntarily signed the informed consent form (icf) 2. age ≥ 18 years at the time of signing the icf 3. newly diagnosed with multiple myeloma 4. must not be eligible for transplant 5. will be treated with a first-line lenalidomide-containing or nonlenalidomide-containing regimen, or currently is being treated with a first-line regimen and has received less than 2 cycles. exclusion criteria: 1. prior treatment for monoclonal gammopathy of undetermined significance (mgus) or smoldering myeloma with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line multiple myeloma (mm) therapy. 2. prior treatment with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line mm therapy through clinical trial participation or patient access program 3. two or more complete cycles of first-line therapy or any agent considered to be a firstline mm therapy for newly diagnosed multiple myeloma (ndmm) treatment before study enrollment 4. refusal to participate in the revlimid transplant noneligible (tne) newly diagnosed multiple myeloma (ndmm) post-authorization safety study (pass) or current participation in the treatment phase of an interventional clinical trial.

Keywords: multiple myeloma non transplant eligible revlimid pass non-interventional lenalidomide