Kornimate/medical-research-clean huggingface dataset:
chemotherapy induction and chemoradiotherapy in patients with esophageal carcinoma

Conditions: Esophageal Cancer

Summary: the aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.

patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a low survival prognosis following surgical resection. in studies published to date no positive effect upon overall survival could be demonstrated for preoperative chemotherapy or chemoradiotherapy. however, patients with a complete remission following preoperative therapy show prolonged survival. this study design is based upon decreasing primary tumour and preventing oder delaying micrometastases by means of a chemo induction therapy, increasing r0 resection rates and preventing local recurrence by means of preoperative chemoradiotherapy, increasing the radiosensitivity of tumour cells through treatment combination with cetuximab, surgical resection of the locoregional primary tumour or definitive radiochemotherapy in case the primary tumour is inoperable. the aim of this study is therefore to evaluate the feasibility and safety of a 3-staged therapy approach including an egfr antibody in the treatment of patients with potentially resectable esophageal cancer, as well as the evaluation of objective response rates to this preoperative therapy.

Eligibility criteria:
inclusion criteria: * signed informed consent * histologically confirmed esophageal cancer (squamous cell carcinoma) * measurable, non-metastatic disease (ut1-4) * no previous cancer therapy (chemotherapy, radiotherapy or resection) * life expectancy \> 3 months * age \> 18 years * who status ≤ 2 * negative pregnancy test for women of child-bearing potential, and use of adequate contraception * hematological status: neutrophiles ≥ 1,5x10e9/l, thrombocytes ≥ 100x10e9/l * adequate renal function: serum creatinine ≤ 1,5 x uln * adequate liver function: alkaline phosphatase \< 2,5 x uln, total bilirubin \< 1,5 x uln exclusion criteria: * pregnant or nursing women * women of child-bearing potential without adequate contraception * concomitant anti-tumoral therapy except study mandated procedures * cervical esophageal cancer or diagnosis of metastases * participation in other clinical trials within the last 30 days * history of malignant disease within the last 5 years * peripheral neuropathy (nci ctc ≥ grade 1) * concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions * active infections

Keywords: esophageal cancer pre-operative chemo-immunotherapy radiochemo-immunotherapy egfr radiosensitivity resection
exercise for people with parkinson's disease

Conditions: Parkinson's Disease

Summary: this randomized, controlled exercise intervention with three groups compares two exercise approaches to standard of care. supervised interventions are administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. functional outcomes are measured at the completion of the supervised exercise (4 months) as well as 10 and 16 months.

this randomized, controlled exercise intervention study compares physical therapy interventions for people in early and mid-stages of parkinson's disease. two different approaches to exercise are compared to standard of care. the two exercise programs consist of supervised interventions, administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. the standard of care program consists of a home program in which participants exercise in a group setting once a month with an exercise trainer. functional outcomes are measured at the completion of the supervised exercise at 4 months as well as 10 and 16 months. this study is the first long term exercise study for people with parkinson's disease pd of which we are aware and is the most comprehensive examination of exercise for people with pd to date. results of this study will provide definitive information regarding the best approach to exercise for people in early and mid stages of pd, both in terms of immediate 4 month and long term 16 month effects.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease * hoehn \& yahr stages 1-3.5 exclusion criteria: * cardiovascular contraindications to aerobic exercise * reliance on walker or wheelchair * psychiatric conditions * dbs or other surgeries * any other conditions that would interfere with exercise
study to assess the efficacy, safety and tolerability of akb-9778 ophthalmic solution as and adjunct to latanoprost in patients with ocular hypertension or open angle glaucoma

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Summary: this is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of akb-9778 ophthalmic solution 4.0% administered once (am) or twice (am \& pm) daily when used as an adjunctive therapy to latanoprost ophthalmic solution 0.005% once daily (pm) in subjects with elevated iop due to oag or oht.


Eligibility criteria:
key inclusion criteria: * diagnosis of oag or oht in each eye (oag in one eye and oht in the fellow eye is acceptable) * must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the screening visit; may be taking one additional iop lowering eyedrop * iop of ≥ 18 mmhg and ≤ 27 mmhg in one eye or both eyes at screening visit * following 4 week washout period, iop ≥ 24 mmhg and \< 36 mmhg at 08:00 hour and iop ≥ 22 mmhg and \< 36 mmhg in both eyes at 10:00, 12:00 and 16:00 hours. key exclusion criteria: * clinically significant ocular disease which might interfere with interpretation of the study efficacy endpoints or with safety assessments * pseudoexfoliation or pigment dispersion component glaucoma * history of angle closure glaucoma, or narrow angles or with evidence of peripheral anterior synechiae (pas) ≥ 180 degrees by gonioscopy within 6 months prior to screening * intraocular pressure ≥ 36 mmhg * cup/disc ratio of \> 0.8 in either eye * severe visual field defect or significant defect (sensitivity of ≤ 10db) within 10 degrees of fixation in either eye
measurement of hormonal concentration in chylothorax fluid in infants with congenital chylothorax

Conditions: Congenital Chylothorax

Summary: late onset hypothyroidism was found in infant with congenital hypothyroidism. the hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. in this study hormonal concentration will be measured in the chyle as well as hormonal serum level.

late onset hypothyroidism was found in infant with congenital hypothyroidism. the hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. in this study hormonal concentration will be measured in the chyle as well as hormonal serum level.

Eligibility criteria:
inclusion criteria: * infants with congenital chylothorax requiring thorax drain exclusion criteria: * none
multiparametric high-resolution ultrasound of the breast

Conditions: Breast Cancer

Summary: despite advances in mammographic technique, mammography is limited in the detection and diagnosis of breast lesions with respect to sensitivity and specificity. in recent decades, ultrasound has become an essential adjunct to mammography for the further characterization of mammographically detected or palpable lesions or in the diagnosis of patients with dense breasts. however, in spite of defined morphological criteria for the differentiation of benign from malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and specificity. on the one hand, benign lesions may have one or more malignant characteristics and thus require a biopsy. on the other hand, malignant lesions can also show benign characteristics and thus make an accurate assessment difficult. to overcome these limitations, newer sonographic methods have been developed. these include elastography, color and power doppler imaging, contrast enhanced imaging and 3d sonography. the application of elastography is based on the fact that cancer has a higher stiffness than healthy breast parenchyma. in addition, cancers are characterized by neoangiogenesis and thus generally show an increased vascularization in color and power doppler. the detection of neoangiogenesis can be improved by the application of contrast agents. the latter provides both morphological and functional information about tumors, through the study of the contrast agent kinetics. finally, 3d sonography allows for tumors to be examined in a third, coronal plane. this way, the interaction between the tumor and the surrounding healthy tissue can be better appreciated. the objective of this study is the evaluation of suspicious (classified as bi-rads 4 and 5) breast lesions by using high-resolution sonography, including elastography, color/power doppler, contrast agent application and 3d sonography. both morphological and functional information can thus be obtained. the primary hypothesis of this study is that this multiparametric approach will improve the detection and characterization of breast lesions.


Eligibility criteria:
inclusion criteria: * clinical, mammographic, mr-tomographic and/or ultrasonographic verification of a suspicious breast lesion (birads 4 and 5) * age \> 18 years * written informed consent * histopathological verification of the lesions either by core biopsy or by surgical excision exclusion criteria: * unstable or non-compliant patients * pregnant or lactating patients or patients with suspected pregnancy * known contraindication to the intravenous administration of us contrast agents * acute or chronic renal insufficiency * pre- or post-transplant patients

Keywords: ultrasound elastography doppler ultrasound contrast enhanced ultrasound three-dimensional ultrasound
effect of regorafenib on digoxin and rosuvastatin in patients with advanced solid malignant tumors.

Conditions: Neoplasms

Summary: evaluate the effect of regorafenib on the pharmacokinetics of digoxin (p-gp substrate : p-glycoprotein) and rosuvastatin (bcrp substrate: breast cancer resistant protein) by comparing their area under time curve (auc(0-24)) and maximum drug concentration (cmax) on day -7 and cycle 1 or cycle 2 day 15 of regorafenib in cancer patients


Eligibility criteria:
* inclusion criteria: * the following criteria apply to all patients starting the study treatment: * patients with histologically confirmed, locally advanced or metastatic solid tumors refractory to standard therapy or in whom regorafenib is considered a standard treatment. * male or female caucasian patients \>/= 18 years of age * women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. * life expectancy of at leat 12 weeks * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate bone marrow and liver function * estimated creatinine clearance (clcr) ≥ 30 ml/min as calculated using the cockroft-gault (c-g) equation. * thyroid stimulating hormone(tsh) within normal ranges. * the following inclusion criteria apply to group a (digoxin + regorafenib) patients only: * potassium, magnesium and calcium blood levels within normal range according to the local laboratory. * the following inclusion criteria apply to group b (rosuvastatin + regorafenib) patients only: * signed genetic informed consent. patients must be able to understand and willing to sign the written informed consent intended to screen for bcrp and oatp1b1 polymorphisms. * exclusion criteria: * for all patients * major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication. * non-healing wound, skin ulcer, or bone fracture. * ongoing or active infection. * other anticancer treatment. * patients unable to swallow oral medications * for group a (digoxin + regorafenib): * family history of sudden cardiac death. * for group b (rosuvastatin + regorafenib): * patients with porphyria. * patients with intestinal or urinary obstructions.

Keywords: regorafenib probe substrates pharmacokinetics cancer safety advanced solid malignant tumors
the outcome of subthalamic deep brain stimulation in advanced parkinson's disease and morphometry

Conditions: Parkinson Disease

Summary: the research will evaluate possible clinical and individual brain topographic features affecting the outcome in subthalamic deep brain stimulation (dbs) with patients with parkinson's disease (pd). the patient cohort consists 35 pd patients treated with subthalamic dbs in 2020-2022. the clinical features (such as age, disease duration, response to levodopa in the levodopa challenge test) will be evaluated retrospectively from the medical records and brain topographic features from the preoperative 3 tesla brain imaging.

subthalamic deep brain stimulation (stn-dbs) is known to enhance motor function in advanced parkinson's disease and to enable a significant reduction of the use of anti-parkinsonian medication. a levodopa challenge test is considered as a good predictor of dbs outcome, as well as disease duration. there are heterogenous findings on the age effect on dbs outcome. in recent years, the effect of stn's connectivity with other brain areas on dbs outcome have drawn more attention. the study aim was to evaluate, alongside the clinical predictors, the effect of the patients' individual brain topography on dbs outcome. the medical records of 35 patients with pd was used to analyze dbs outcome measured with the following scales: unified parkinson's disease questionnaire, use of anti-parkinsonian medication (ledd), abnormal involuntary movement scale, beck depression inventory, parkinson's disease questionnaire 39, non-motor symptoms questionnaire. the 3 tesla preoperative brain mri images were analyzed with matlab for morphometric differences.

Eligibility criteria:
inclusion criteria: * advanced parkinson's disease and subthalamic deep brain stimulation treatment. the dbs screening and operation done in helsinki university hospital (hus) exclusion criteria: * patients with parkinson's disease and not treated with subthalamic dbs in hus
stablishment of prevention and treatment system for intestinal dysfunction

Conditions: Bowel Dysfunction

Summary: dysfunction and intestinal endocrine dysfunction. this project will use genomics, metabonomics, microbiome and other omics techniques to study the clinical pathway of cid integrated therapy.


Eligibility criteria:
inclusion criteria: * the patients with chronic bowel dysfunction exclusion criteria: * past severe underlying diseases of the respiratory system and cardiovascular system, * allergy to treatment-related drugs, * pregnancy, * accept cid surgery.
optimal lesion preparation with non-compliant balloons before implantation of bioresorbable scaffolds

Conditions: Coronary Artery Disease; Angina, Unstable; Angina, Stable

Summary: study aim : to compare a novel strategy of lesion preparation with noncompliant balloons before implantation of bvs. hypothesis: predilatation with non-compliant balloons could facilitate optimal deployment of bvs. by achieving good scaffold apposition a need for post-dilatation could be significantly reduced. this is expected to result in better short- and long-term outcomes.

study design: following pre-dilatation a bvs will be implanted and optical coherence tomography (oct) will be performed in all patients. after oct post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. final oct will be performed in all patients. 1:1 randomization of two strategies before the implantation of bioresorbable scaffolds: * opn strategy (study group): pre-dilatation with opn® nc (non-compliant) super high pressure ptca (percutaneous transluminal coronary angioplasty) balloons * standard strategy (control group): pre-dilatation with a standard (compliant) balloon enrolment: randomization of 50 patients * 25 in the opn strategy (study group) * 25 in the standard strategy (control group)

Eligibility criteria:
inclusion criteria: * age \> 18 years. * able and willing to give informed consent. * willing to comply with specified follow-up evaluations. * clinical manifestation of coronary artery disease: stable angina, unstable angina or non-st-elevation myocardial infarction. * de novo lesion. * angiographic diameter stenosis \> 70 % and/or fractional flow reserve \<0.80. * vessel diameter between 2.5 and 4.0 mm. * one- or two vessel disease (defined as diameter stenosis \> 70 % in vessels with a diameter \> 2.5 mm). * up to two lesions in one or two vessels can be treated. exclusion criteria: patient characteristics * pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure. * patient with contraindication for 12 months of dual antiplatelet therapy. * st-elevation myocardial infarction. * any contraindication to the implantation of bvs. lesion characteristics * visible thrombus in coronary angiography * chronic total occlusion

Keywords: coronary artery disease opn nc angina stable unstable
comparing of the pharmacokinetic, safety and immunogenicity of hs-20090-2 injection and prolia® in healthy adults

Conditions: Postmenopausal Osteoporosis

Summary: a randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of hs-20090-2 60mg#1ml#and prolia® in healthy adults.

this is a phase i, single center, randomized, single-blind and parallel group clinical trial .the primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of hs-20090-2 or prolia® in healthy volunteers.the secondary objectives are to assess the clinical safety and immunogenicity similarity of single subcutaneously injection of hs-20090-2 or prolia® in healthy volunteers.

Eligibility criteria:
inclusion criteria: 1. sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements; 2. healthy males, aged ≥18 years or ≤50 years old(including the boundary value); 3. agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered; 4. clinical laboratory examination, chest x-ray, abdominal b-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance. exclusion criteria: 1. occurred or suffering from osteomyelitis or onj (mandibular necrosis) previously; the dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed; 2. serum calcium levels are outside the normal range of the laboratory. 3. subject has positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result viral hepatitis (including hepatitis b and hepatitis c), or positive hiv antibodies, or positive test for syphilis. 4. the subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer). 5. prior use of medications within 12 months before and during the study. this includes medications such as, but not limited to: bisphosphonates fluoride calcitonin strontium parathyroid hormone or derivatives supplemental vitamin d (\>1000 iu/day) glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) anabolic steroids calcitriol diuretics

Keywords: osteoporosis，postmenopausal
evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ibi362 in overweight or obesity subjects

Conditions: Overweight or Obesity

Summary: this trial is conducted in china. the aim of this trial is to investigate safety, tolerability, pk and pd for multiple doses of ibi362 in overweight or obese male and female subjects.


Eligibility criteria:
inclusion criteria: 1. have stable body weight for the past 12 weeks prior to screening 2. have a body mass index (bmi) ≥24 kilograms per meter squared (kg/m²) with complication, or bmi≥28 kg/m²,inclusive at screening 3. willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff exclusion criteria: 1. have a diagnosis of type 2 diabetes 2. have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening 3. previous treatment with a glp-1 (glucagon-like peptide 1) receptor agonists or gcg(glucagon)receptor agonists before. 4. surgical treatment for obesity 5. past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times unr (upper normal range), triglycerides above 500 mg/dl 6. have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study 7. unwilling to comply with smoking and alcohol restrictions during the study
inspires hearing health trial - innovative psychological intervention to reduce stigma in hearing health trial

Conditions: Hearing Loss

Summary: background: reminding people they are moral adaptable human beings ("self-affirming") reduces the perceived stigma associated with wearing hearing aids and increases actual hearing aid use. the proposed study aims to reduce stigma in a representative sample of people aged over 60 from the general population who may or may not already be wearing hearing aids and improve multiple hearing health outcomes (e.g., attending screening, device use). methods/design: double-blinded randomized controlled trial in which a representative sample of people aged over 60 from the general population will be asked to complete surveys about hearing stigma, hearing loss and multiple hearing health outcomes. participants randomized to the control group will only complete the survey; participants in the intervention group will be asked to affirm their values. six months later, all participants will complete the same survey to assess outcomes. discussion: the proposed research will lead to a brief psychological intervention to reduce stigma in relation to hearing loss/aids.

according to self-affirmation theory, defensiveness arises because people are motivated to defend their global sense of self-worth, which in the present case is threatened by perceptions of hearing aids/loss. however, if a person's self-image can be bolstered (affirmed) in a domain that is important to them, thereby preserving self-integrity, the individual should be less likely to process the threatening (i.e., stigmatizing in the present context) information defensively. accumulated empirical evidence demonstrates that affirming the self: (a) reduces public stigma, (b) reduces self-stigma, and (c) causes meaningful changes in behaviour. following a pilot-feasibility trial showing that self-affirming caused significant reductions in first-time hearing aid users' anxieties about ageing and increased their hearing aid use by almost 2 hours/day.

Eligibility criteria:
inclusion criteria: * uk-based adults * aged 60+ exclusion criteria: * adults younger than 60 years * not uk-based