Kornimate/medical-research-clean huggingface dataset:
efficacy analysis of neoadjuvant treatment in lung cancer using low-dose nivolumab combined with chemotherapy

Conditions: Lung Cancer, Nonsmall Cell; Non-Small Cell Lung Cancer NSCLC

Summary: the primary objective of this study is to assess the major pathological response (mpr) rate and pathologic complete response (pcr) rate in stage ib-iiia non-small cell lung cancer (nsclc) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.


Eligibility criteria:
inclusion criteria: * able to provide a signed informed consent form (icf), indicating agreement to comply with the requirements and restrictions in the icf and protocol. * male or female, aged 18 years or older. * diagnosed with non-small cell lung cancer (nsclc) with clinical staging ib, ii, or iiia. * receiving treatment at hospital de base. * eastern cooperative oncology group (ecog) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose. * tumor sample meets the following requirements: * negative for egfr gene expression. * negative for alk and ros1 protein expression. * pd-l1 protein expression documented and assessable. * tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (ir, cm, and hn) following a multidisciplinary review. * adequate organ and bone marrow function as defined below: * hemoglobin: ≥ 9.0 g/dl\* * absolute neutrophil count: ≥ 1.5 × 10\^9 /l\* * platelet count: ≥ 100 × 10\^9 /l\* * \*note: granulocyte colony-stimulating factor (g-csf), platelet transfusions, and blood transfusions are not permitted to meet these values. * serum bilirubin: ≤ 1.5 × upper limit of normal (uln), except for participants with confirmed gilbert syndrome, who may be included upon physician consultation. * alt and ast: ≤ 2.5 × uln. * creatinine clearance: ≥ 50 ml/min (calculated using the cockcroft and gault formula). * life expectancy greater than six months prior to randomization. exclusion criteria: * refusal to sign the informed consent form (icf). * nsclc clinical stages ia, iiib n3, iiic, iva, and ivb. * tumors with t4 invasion of the aorta, esophagus, and/or heart; or presence of bulky n2 disease. * tumor deemed unresectable. * prior systemic anticancer therapy for nsclc, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs. * history of another primary malignancy, with exceptions for: * malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (ip) and with a low risk of recurrence. * adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease. * adequately treated carcinoma in situ with no evidence of disease. * incomplete basic medical information in the electronic medical record. * positive for egfr gene expression. * positive for alk protein expression. * no available data on pd-l1 protein expression. * positive for ros1 protein expression. * pregnant or breastfeeding at the time of enrollment.

Keywords: low dose immunotherapy neoadjuvant immunotherapy non-small-cell-lung-cancer
quantifying patient-specific changes in neuromuscular control in cerebral palsy

Conditions: Cerebral Palsy

Summary: impaired neuromuscular control hinders movement for individuals with cerebral palsy and other neurological disorders. in this research, the investigators are developing new tools to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of the most common treatments, orthopaedic surgery. the results from this research will empower clinicians to identify patient-specific factors that contribute to impaired movement and improve treatment and quality of life.

the long-term goals of this research are to quantify patient-specific changes in neuromuscular control in order to optimize treatment planning and improve mobility for individuals with cerebral palsy (cp). as a first step, the aims of this proposal are to evaluate neuromuscular control before and after one of the most common treatments for individuals with cp, orthopaedic surgery. the investigators will evaluate if patient-specific measures of neuromuscular control, based upon the framework of muscle synergies, can predict improvements in walking ability after surgery. further, investigators will determine whether neuromuscular control changes after surgery and if these changes contribute to improvements in movement. to achieve these goal the investigators will implement and test new tools to quantify neuromuscular control which integrate clinical gait analysis and two computational techniques: synergy analysis and dynamic musculoskeletal simulation. this research will provide the foundation to use measures of altered neuromuscular control to inform treatment planning, develop alternative treatments, and improve mobility in cp and other neurologic disorders.

Eligibility criteria:
inclusion criteria: * diplegic cerebral palsy * mild or moderate impairment, gross motor function classification system (gmfcs) levels i-iii * will receive follow-up care and physical therapy within the gillette children's specialty healthcare system exclusion criteria: * botulinum toxin injections, baclofen, or other similar treatments in the 3 months prior to pre-operative gait analysis
comparison between treatment with yellow micropulse laser and green conventional laser in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: macular edema is the most important cause of visual impairment in diabetic patients. intravitreal injections of antivegf (vascular endothelial growth factor) agents and laser treatment are two effective therapies for stabilising visual acuity. however, antivegf therapy is very expensive and potentially needs to to be repeated for all patients life. laser treatment, according to modified etdrs (early treatment diabetic retinopathy study), produces retinal burns with possible negative consequences such as alterations in the visual fields. with micropulse treatment modality laser energy is delivered in short pulses ("micropulses") rather than as a continuous wave. in this way the amount of energy delivered to the retina and retinal pigment epithelium (rpe) is significantly reduced. this finer control of the photothermal effects should avoid any retinal and rpe damage. at the same time, according to several published reports, the efficacy of treatment appears to be equivalent to conventional laser therapy. previous studies investigated the effects of 810nm micropulse laser therapy. recently, this treatment modality has been made available also with 577nm wavelength, which corresponds to the maximum absorption level for blood. aim of this study is to assess the safety and efficacy of 577nm micropulse laser treatment compared to conventional modified etdrs laser therapy.


Eligibility criteria:
inclusion criteria: * written informed consent prior to study entry * male or female patients \>= 18 years of age * patients with diagnosis of diabetes type 1 or 2 and clinically significant macular edema * visual impairment due to clinically significant diabetic macular edema * best-corrected visual acuity included between 21 and 74 etdrs letters * central retinal thickness greater than 320 micron (spectralis sd-oct, heidelberg engineering, germany) * leakage and/or micro aneurysm in fluorescein angiography images within the area of retinal thickening * hba1c ≤10% with well-controlled blood pressure and renal function exclusion criteria: -

Keywords: edema diabetic laser treatment
efficacy of manual therapy to improve quality of life and decrease pain in subjects with endometriosis

Conditions: Endometriosis; Pelvic Pain; Dysmenorrhea

Summary: this study will compare subjects with a history of pelvic or menstrual pain diagnosed with endometriosis treated at clear passage with untreated control subjects. the treatment group will be a retrospective chart review; the control subject group will be a prospective questionnaire based study. the study will assess the changes in pain experienced by subjects treated with manual therapy at clear passage to untreated subjects with endometriosis.

this study has two segments the first is a chart and outcome assessment of patients treated at clear passage (cp) with a diagnosis of endometriosis. these patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. the second segment is a prospective observational, online questionnaire based study of female subjects with a diagnosis of endometriosis not treated at cp. data on the impact of quality of life (qol) over time of subjects not treated at cp will be assessed using the same questionnaire used as standard of care in the clinic twice, 30 days apart. this will be accomplished using online forms with subjects able to complete the questionnaires with ease via the internet. the data obtained from the untreated subjects will allow for reporting of overall impact on qol in this population, as well as provide a control group for assessment of improvement for manual therapy interventions for patients with endometriosis.

Eligibility criteria:
inclusion criteria: * diagnosis of endometriosis * experience either pain with menstruation or other pelvic pain * able to complete the questionnaires online exclusion criteria: * currently pregnant * cancer diagnosis * prior chemotherapy or radiation treatment(s) * prior treatment at clear passage

Keywords: endometriosis pelvic pain dysmenorrhea
efficacy and safety of fosaprepitant in preventing chemotherapy-induced vomiting in children treated with medium and high emetic chemotherapeutic drugs

Conditions: Chemotherapy Induced Nausea and Vomiting Pediatric Cancer Patients

Summary: this study was a prospective, randomized, double-blind, parallel controlled clinical trial. the children who met the inclusion criteria and were treated with medium and high emetic chemotherapy drugs were randomly included in the experimental group (forsapitan group) and the control group (placebo group) in the ratio of 1 ∶ 1. the children in the experimental group were infused with fosapitan, dexamethasone and granisetron before chemotherapy, and then continued to be infused with granisetron and dexamethasone until 48 hours after the end of chemotherapy. the antiemetic regimen of children in the control group was placebo instead of fosapitan, and the others were the same as those in the experimental group. in this study, cnnc antiemetic scale and pediatric scale proposed by dupuis were used to evaluate the vomiting data. the primary end point was the proportion of children who achieved complete remission (cr) in the delayed period (within 24-120 hours after the start of chemotherapy); the secondary end points were the cr rate in the acute phase (within 24 hours after the first chemotherapy administration) and the overall phase. the antiemetic efficacy and adverse reactions of the two groups were observed and analyzed.


Eligibility criteria:
inclusion criteria: * children aged 2-12 years at the time of study entry with documented cancer scheduled to receive mec or hec (more than 30% emetogenic potential) with karnofsky score of 60 or more (for patients aged greater than 10 years) or lansky play performance score of 60 or more (for patients aged 10 years or less) predicted life expectancy of at least 3 months; and written informed consent provided by parent or guardian exclusion criteria: * vomiting 24 hours before treatment day 1 known history of qt prolongation or allergic reaction to any of the study drugs symptomatic primary or metastatic cns malignancy causing nausea or vomiting patients who received radiation therapy to the abdomen or pelvis in the week before treatment; active infection or any uncontrolled concurrent illness except for malignancy abnormal laboratory values at screening (peripheral absolute neutrophil count \ 5 times of the upper limit of normal for age, bilirubin or serum creatinine \>1.5 times of the upper limit of normal for age) initiation of systemic corticosteroids within 72 hours before study drug administration or as part of the chemotherapy regimen; benzodiazepines or opioids initiated within 48 hours before treatment, except for single doses of triazolam, temazepam, or midazolam use of antiemetics within 48 hours of treatment use of cyp3a4 substrates or inhibitors within 7 days or cyp3a4 inducers within 30 days of treatment

Keywords: fosaprepitant chemotherapy-induced nausea and vomiting pediatric patients emetogenic chemotherapy
photodynamic therapy for cholangiocarcinoma

Conditions: Cholangiocarcinoma Non-resectable

Summary: comparison of the bile duct patency with photodynamic therapy (pdt) and regular endoscopic retrograde cholangiopancreatography(ercp) stents in unresectable cholangiocarcinoma.

cholangiocarcinoma is a malignant tumor originating from the bile duct epithelium, accounting for about 70% of the malignant tumors of the bile duct system. patients have no obvious clinical symptoms in the early stage. after late diagnosis, the effective treatment is surgical resection and \& or liver transplantation, and chemotherapy is only used as adjuvant or palliative treatment. some types of cholangiocarcinomas, such as hilar cholangiocarcinomas, are difficult to achieve radical resection due to their anatomical location, early invasions and are prone to recurrence with a poor long-term efficacy after surgery. therefore, the comprehensive treatment of cholangiocarcinoma by multiple means urgently needs to be explored. in recent years, photodynamic therapy (pdt), as a new local treatment method, has attracted increasing attention. this study investigates the bile duct patency and effectiveness of photodynamic therapy compare with ordinary ercp treatment for cholangiocarcinoma including the median survival, overall survival, and other indicators of side effects.

Eligibility criteria:
inclusion criteria: * ercp cholangiocarcinoma（the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery）; exclusion criteria: * proximal cholangiocarcinoma (bismuth type ⅲ-ⅳ, or intra-hepatic cholangiocarcinoma); * patients with karnofsky performance scale (kps) score≤70； * expected survival≤3months； * patients with porphyria； * coagulation dysfunction (inr\> 1.5) and low peripheral blood platelet count(\<50×10\^9 / l) or using anti-coagulation drugs； * bilirubin could not be reduced to less than 100mmol/l within 1 month after drainage； * patients have intrahepatic metastasis or distant metastasis； * patients with no pathological diagnosis； * known to allergic to study drug(porphyrin drugs) or other similar and related compounds； * other photosensitizers have been used within 4 weeks prior； * metal biliary stents were placed previously； * patients with contraindications to ercp； * patients with hiv infection； * pregnant, parturient, or breastfeeding women； * patients complicated with other malignant tumors； * patients with severe liver function damage； * patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate pdt； * patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects； * patients with other contraindications for photodynamic therapy.

Keywords: ercp pdt cholangiocarcinoma bile duct drainage stent
dose-range finding study of bf2.649 effect on patients with obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnoea; Excessive Daytime Sleepiness

Summary: prospective, multicenter, double-blind, phase ii, randomized, dose-response study in 5 parallel groups (dose-range).

obstructive sleep apnea (osa) is a relatively common condition and is estimated to affect 2 to 4% of middle-aged adults the study medication bf2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine h3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness eds is characterized by daytime somnolence and sudden sleep episodes. this problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs. the primary endpoint of this study will be measured by the change in the well-validated epworth sleepiness scale (ess). the ess is a simple self-administered 8-item questionnaire. the outcome is to get an impression about the level of the daytime sleepiness in several real-life situations. in this study, each patient will be treated during 2 weeks, and randomly assigned to one the 5 arms (bf2.649 at one of the 4 possible dosages or placebo). the patient will then attend a end-of-treatment visit, in order to assess the particularly the ess score.

Eligibility criteria:
main inclusion criteria: * patient with osa (treated or not with ncpap) and still complaining of eds * epworth sleepiness scale score \> or = to 11 main exclusion criteria: * patient suffering from chronic severe insomnia in accordance with the international classification of sleep disorders, but without osa

Keywords: sleep disorder obstructive sleep apnoea excessive daytime sleepiness
dietary restriction to prevent cardiotoxicity in breast cancer patients

Conditions: Cardiotoxicity; Breast Cancer

Summary: the goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. the main question it aims to answer is: what are the effects of a short-term diet with 30% caloric and 70% protein restriction (pcr) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer. researchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin t (hstnt) levels- will be different between these two groups.


Eligibility criteria:
inclusion criteria: * women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant atc-based chemotherapy and of intent to start anticancer treatment; * age between 18 and 75 years; * written informed consent; * body mass index ≥ 19. exclusion criteria: * allergic to any of the ingredients of the diet; * known history of cardiac dysfunction; * severe morbidity with the inability to receive anticancer treatment. * participation in another clinical trial with an intervention arm (database and/or biobank studies excluded); * pregnant women * previous treatment with anthracycline * estrogen receptor positive status

Keywords: dietary restriction diet anthracyclines high sensitivity troponin t hstnt oxidative stress breast cancer cardiotoxicity
radiofrquency ablation combined with cytokine-induced killer cells for the patients with cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: the purpose of this study is to determine whether combining of radiofrequency ablation (rfa) and cytokine-induced killer cells (cik) transfusion can prolong survival of patients with cholangiocarcinoma.

the primary objective is to evaluate whether rfa followed by cik transfusion can prolong survival of patients with cholangiocarcinoma.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed cholangiocarcinoma * primary lesions (cholangiocarcinoma) are not resected * serum bilirubin level of 2.0 mg/dl or less. * performance status of 0 or 1. * expected survival of 1 year or more. * informed consent from the patient. exclusion criteria: * with extrahepatic metastases * with other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.

Keywords: radiofrequency ablation cytokine-induced killer cells cholangiocarcinoma
pain, discomfort, and functional impairments during rapid and slow maxillary expansion

Conditions: Maxillary Constriction

Summary: this study will assess and compare the levels of pain, discomfort, and functional impairments between rapid and slow maxillary expansion in treating skeletal maxillary constriction in the early adolescence period (i.e. between 12 and 16 years). the study sample will consist of 32 patients who suffer from a skeletal posterior crossbite. the sample will be allocated randomly into two groups: rme group and sme group. the patients will be asked to fill out the attached questionnaires at three assessment times.

skeletal maxillary constriction is a popular orthodontic malocclusion that can be seen at any age. the maxillary expansion is the most important treatment choice of this skeletal problem in the upper jaw. there are many types of maxillary expansion regarding the force amount and the number of expansion times: slow maxillary expansion (sme) rapid maxillary expansion (rme), and semi-rapid maxillary expansion (srme). practitioners are conscious that complaints submitted by children and adolescents during the active phase of expansion, such as pain, discomfort and oral ulcers are common symptoms. this trial of two parallel groups will compare the pain, discomfort and functional impairments accompanying the rapid and slow maxillary expansion in early adolescent patients. rme group: a bonded modified hyrax palatal expander will be applied. sme group: a removable palatal expansion appliance with a midline screw will be applied. to assess the pain, discomfort and functional impairments, patients will be asked to fill out questionnaires of six questions: 1) what is the degree of pain/discomfort you have experienced?; 2) do you have difficulty in mastication?; 3) do you have difficulty in swallowing?; 4) do you have a sense of tension or pressure in soft tissue?; 5) do you have swelling in soft tissue?; and 6) how easy is the treatment procedure?.

Eligibility criteria:
inclusion criteria: 1. patients in the early permanent dentition 2. chronological age between 12 and 16 years 3. the presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift) 4. skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically 5. dental and skeletal class i and ii malocclusion 6. normal and mild vertical growth pattern 7. the presence of upper first premolars and molars 8. no general problems 9. good oral health 10. no previous orthodontic treatment. exclusion criteria: 1. presence of periodontal diseases 2. presence of general diseases, syndromes or cleft lip and palate 3. patients with previous orthodontic treatment 4. patients with severe horizontal growth pattern

Keywords: posterior crossbite rapid maxillary expansion slow maxillary expansion pain discomfort