Kornimate/medical-research-clean huggingface dataset:
the efficacy of induction and adjuvant camrelizumab combined with chemoradiation for la-hnscc

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of pd-1 blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.

all participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. after 4\~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: 1. males and females ≥18 years of age. 2. ecog performance status 0 or 1. 3. histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus. 4. stage iii, iva, ivb (according to the 8th ajcc edition); stage iii for hpv positive oropharyngeal disease. 5. inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy. 6. with measurable target lesions by ct or mri. 7. adequate bone marrow function. 8. adequate renal and liver function. 9. pregnancy test (for patients of childbearing potential) negative at screening. 10. signed written informed consent. exclusion criteria: 1. have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation. 2. active autoimmune disease (such as type i diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded). 3. has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment. 4. pregnancy or breast feeding. 5. has a history of psychiatric substance abuse, alcoholism, or drug addiction. 6. prior therapy with a pd-1, anti-pd-ligand 1 (pd-l1) or ctla-4 agent. 7. has received a live vaccine within 4 weeks of planned start of study therapy. 8. has hepatitis b surface antigen (hbsag) positive with hbv dna copy number of ≥1000cps/ml or hepatitis c virus (hcv) antibody positive.

Keywords: camrelizumab locally advanced hnscc chemoradiotherapy
a comparative study of six methods to measure human contrast vision

Conditions: Methods to Measure Contrast Vision

Summary: this study evaluates the relative performance of different methods to measure the human spectral contrast sensitivity function (csf).

the human spectral contrast sensitivity function (csf) is a better way to estimate human vision than letter charts commonly used by ophthalmologists, optometrists and opticians. the current methods used to measure the csf are often unreliable, due to high variability between measurements. this study will compare four (4) new tests with two (2) currently used standard tests. the contrast sensitivity function will be measured using all of the six (6) methods three times (3) in each of the two (2) eyes at two (2) occasions. each subjects csf will be measured 6x3x2x2 = 72 times. in addition, for each of the csf measurements, the time used to measure the csf and number of background variables for the subjects will be recorded. after informed consent is obtained, the subjects will undergo a visual examination. if they match the inclusion criteria they will be included. at that time or at their earliest possible convenience, their csf will be measured using the six methods and some background information will be recorded. the follow-up measurement occasion will occur between 4 to 6 weeks (28 to 42 days) after the first. to facilitate comparison with previous studies, the csf-measurements (in rel. contrast/cycles/degree) will be converted to a log (base 10 logarithm) scale. the unit will thus be log csf (lcsf) \[log\[relative contrast\]/log\[cycles/per degree\]\].

Eligibility criteria:
inclusion criteria: * normal best corrected visual acuity: logmar = 0 * no current or previous eye disease in either eye. * student at uppsala university exclusion criteria: * previous surgery in any eye * inability to follow the test procedure.

Keywords: contrast sensitivity diagnostic techniques, ophthalmological
concurrent chemotherapy based on genetic testing in patients with high-risk salivary gland tumors

Conditions: Salivary Gland Tumors; Head and Neck Cancer

Summary: the role of postoperative concurrent chemotherapy (cct) has not been established for salivary gland tumors (sgts). this prospective study was conducted to evaluate the feasibility and safety of customized cct regimens based on the gene targets of sgts.


Eligibility criteria:
inclusion criteria: 1. pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade 2. pathologic stage t3-4 or n1-3 or t1-2, n0 with a close (≤ 5mm) or microscopically positive surgical margin 3. surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual 4. no evidence of distant metastases 5. no synchronous or concurrent head and neck primary tumors 6. karnofsky score over 60 7. adequate organ function including the following: 1. absolute neutrophil count (anc) \>= 1.5 \* 10\^9/l 2. platelets count \>= 100 \* 10\^9/l 3. hemoglobin \>= 10 g/dl 4. ast and alt \<= 2.5 times institutional upper limit of normal (uln) 5. total bilirubin \<= 1.5 times institutional uln 6. creatinine clearance \>= 50 ml/min 7. serum creatine \<= 1 times uln 8. signed written informed consent exclusion criteria: 1. evidence of distant metastasis 2. prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Keywords: salivary gland tumors head and neck cancer concurrent chemotherapy genetic testing
crizotinib plus pembrolizumab in alk-positive advanced non small cell lung cancer patients

Conditions: ALK-positive Advanced NSCLC

Summary: the purpose of this study has 2 phases, a dose finding phase will determine the maximum tolerated dose . the dose expansion phase will explore the safety, tolerability, and anti-tumor activity of the combination.

the patients will be screened for up to 28 days before they start treatment to determine if they meet eligibility criteria. the screening procedures will include physical examination, blood work and radiological scans. in the dose finding phase, patients who meet eligibility criteria will receive crizotinib at the dose level assigned that will be taken on daily basis and pembrolizumab 200 mg intravenous infusion every 3 weeks. once a crizotinib dose level is decided, the dose expansion cohort will start enrolling patients who meet eligibility criteria. all patients will be followed up every three weeks. blood samples will be drawn to test for safety and tumor activities and radiological scans will be performed on certain timepoints to determine the antitumor activities. there will be a quality of life questionnaire administered at certain time points during the study. the study will have a quality assurance plan that addresses data validation and registry procedures. there is a plan to visit the investigator site for routine monitoring and auditing. the team will conduct source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems). the study will also include a statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives of this study, as specified in the study protocol or statistical plan.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proved diagnosis of locally advanced recurrent or metastatic non-squamous nsclc that is not suitable for local curative treatment. * alk-positive nsclc as determined by a test that is approved or validated for use as a companion diagnostic test. * no prior systemic therapy for metastatic disease. * adjuvant chemotherapy more than 12 months prior to study enrollment. * measurable disease as per recist 1.1 * ecog ps 0 or 1. exclusion criteria: * prior exposure to alk receptor tyrosine kinase inhibitor, anti-pd1, anti-pdl1 or any drug targeting t-cell checkpoint pathways. * known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment. * active autoimmune disease that has required systemic treatment in the past 3 months. * history of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease.

Keywords: crizotinib pembrolizumab alk-positive nsclc lung cancer alk-translocated nsclc non small cell lung cancer
effects of a home based walking program using rhythmic auditory stimulation in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Ambulation Difficulty

Summary: rhythmic auditory stimulation (ras) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking. the purpose of this study is to compare the effect on walking performance of a home based walking program (hbwp) with rhythmic auditory stimulation (ras), to that of a hbwp without ras, or to ras without walking exercise. a second part of this study will assess the effects of rhythmic auditory stimulation (ras) on brain activity in patients with multiple sclerosis while performing mental imagery of walking.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. diagnosis of ms per mc donald criteria 3. ambulation index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support) 4. spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment. exclusion criteria: 1. neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment; 2. treatment for an ms exacerbation in the past 30 days; 3. severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure); 4. severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely 5. contraindication to mri such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc. 6. pregnancy.

Keywords: ms ambulation
ymca diabetes prevention program for the treatment of nonalcoholic fatty liver disease (nafld)

Conditions: Weight Loss; NAFLD; Liver Diseases

Summary: this study is for men and women have been diagnosed with non-alcoholic fatty liver disease (nafld) and will consequently participate in the ymca's diabetes prevention program.

this study is for men and women who participate in the ymca's diabetes prevention program (ymca's dpp) and have been diagnosed with non-alcoholic fatty liver disease (nafld). there will be no administration of study drug. the purpose of this study is to see if participation in the ymca's dpp will result in weight loss and improvement in the liver in patients with fatty liver disease. eligible participants will visit weill cornell medical college's gastroenterology and hepatology clinic to review their medical history, physical examination, complete a survey, and conduct imaging tests (fibroscan, ultrasound, dexa scan) for their baseline visit. blood will be collected as part of standard practice. an additional blood sample will be collected for storage. subjects will complete 9 out of 16 weekly sessions. the ymca's program will be conducted at weill cornell medical college gastroenterology and hepatology division. participants will be in the ymca program for about 1 year and an additional 1 year in the long-term follow-up for data collection. participants will be compensated for their time. key eligibility criteria: 1. men and women over 18 years of age. 2. diagnosed with non-alcoholic fatty liver disease. 3. detailed eligibility reviewed when contacting the study team.

Eligibility criteria:
inclusion criteria: 1. age ≥18 2. must provide signed written informed consent and agree to comply with the study protocol 3. bmi \>25 kg/m² 4. hepatic steatosis by imaging or histology 5. baseline fibroscan cap score \> 238 db/m 6. alt \>19iu/ml in females, alt \>30iu/ml in males exclusion criteria: 1. unclear etiology of liver disease 2. competing etiologies for hepatic steatosis 3. co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to: * positive hepatitis b surface antigen * positive hepatitis c virus rna * suspicion of drug-induced liver disease * alcoholic liver disease * autoimmune hepatitis * wilson's disease * hemochromatosis * primary biliary cholangitis or primary sclerosing cholangitis 4. known or suspected hepatocellular carcinoma 5. current or recent history (\ 30g of alcohol per day. for women, it is defined as \>20g of alcohol per day. 6. compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). nash patients with fibrosis stage = 4 according to the nash crn fibrosis staging system are excluded. 7. pregnant females 8. mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain 9. inability to perform fibroscan and/or invalid study
healthy eating, activity and reduction of teen stress

Conditions: Overweight and Obesity; Overweight Adolescents; Emotional Stress; Stress, Psychological; Eating Behavior

Summary: the goal of this study is to develop and pilot test a telehealth behavioral weight control intervention for adolescents from a low-income background that combines facets of mindfulness training with behavioral weight control. we aim to examine biological (e.g., weight) and behavioral (e.g., emotional eating, mindfulness) changes as a result of a 12-session mindfulness-based weight control intervention compared to a 12-session standard behavioral weight control intervention.

the overarching aim of this study is to pilot and refine a novel mindfulness-based weight control (mbwc) intervention to improve weight management outcomes among adolescents (ages 13-18) who are overweight or obese and from a low-income background. first, we will pilot (open-trial) the mbwc intervention, with a focus on decreasing emotional eating, in an adolescent population. second, we will conduct a randomized controlled trial of the 12-week mbwc intervention vs. a 12-week standard behavioral weight control intervention among adolescents who are overweight or obese and compare outcomes of the mbwc and control interventions. all components of this telehealth intervention will be delivered via hipaa-compliant videoconferencing software. we are interested in examining change in biological and behavioral variables (e.g., body mass index normed for age and biological sex; perceived stress; eating and activity patterns; psychological function related to weight management) post-intervention and at three-month follow-up. treatment satisfaction/treatment acceptability will be evaluated at the end of treatment.

Eligibility criteria:
inclusion criteria: 1. 13-18 years old 2. bmi in the overweight or obese range (≥ 85th%ile for age and sex) 3. speak english exclusion criteria: 1. use of medications that have recently resulted in a change in eating or weight 2. cognitive impairment/developmental delay such that study procedures would be inappropriate 3. major psychiatric disorder (e.g. clinically severe depression, psychosis, anorexia nervosa, bulimia nervosa) 4. current participation in a weight loss program 5. pregnant or breastfeeding 6. medical condition known to impact weight or that would otherwise prevent participation

Keywords: emotional eating low-income mindfulness adolescent obesity weight management stress pediatric
drug use investigation for avolve(bph)

Conditions: Prostatic Hyperplasia

Summary: the study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of japanese subjects with benign prostatic hyperplasia (bph) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.


Eligibility criteria:
inclusion criteria: * must be male subjects * use dutasteride capsules for the first time exclusion criteria: * subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor * subjects with severe hepatic function disorder * dutasteride capsules shall not be used to female or child
multimodality treatment including curative resection of advanced nsclc

Conditions: Advanced Non-small-cell Lung Cancer

Summary: this study retrospectively evaluates clinical parameters and outcome of patients with advanced stage non-small cell lung cancer treated with neoadjuvant therapy followed by curative-intent surgery at the divison of thoracic surgery at the medical university of vienna

this study will be undertaken as a retrospective cohort study at devision of thoracic surgery, medical university of vienna. all patients with non-small-cell lung cancer, who received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention at the devision of thoracic surgery, medical university, will be included. the aim of this study is to evaluate peri- and postoperative clinical parameters and short- and long-term outcomes in patients.

Eligibility criteria:
inclusion criteria: * patients with advanced nsclc and multimodality treatment including curative-intent resection exclusion criteria: * patients with early stage nsclc * patients with advanced nsclc without multimodality treatment * patients without curative resection
arimidex bone mass index and oral bisphosphonates

Conditions: Breast Cancer; Bone Density

Summary: to investigate the management of bone health in postmenopausal women with early breast cancer (bca) scheduled to receive anastrozole. postmenopausal women with hormone receptor-positive early bca are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. patients (pts) with a bone mineral density (bmd) t-score \<-2.0 for either spine or hip are designated higher-risk (h) for fracture and receive anastrozole 1 mg/day plus risedronate orally. moderate-risk (m) pts (t-score \<-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (a+r) or anastrozole alone. pts with t-scores -1.0 at both spine and hip were designated lower-risk (l) and receive anastrozole alone. all pts receive calcium and vitamin d. lumbar spine and total hip bmd are assessed at baseline, 12, and 24 months.


Eligibility criteria:
inclusion criteria: * postmenopausal women * er and or pgr positive breast cancer * completed surgery and =/- chemotherapy exclusion criteria: * metastases * history of fractures * hrt or serms * liver or kidney disfunction

Keywords: arimidex bone mineral density bisphosphonates aromatase inhibitors
study looking at longitudinal changes in fatigue and health status in rheumatoid arthritis (ra) patients treated with subcutaneous anti-tnf-α therapy

Conditions: Rheumatoid Arthritis

Summary: people affected by rheumatoid arthritis are often suffering from fatigue and decreased qol. in this study we are measuring the impact of sc biologics on these parameters.

observational prospective study purely descriptive

Eligibility criteria:
inclusion criteria: patients who: * are active ra patients (as judged by treating md) * are 18 years of age or older at time of consent * are scheduled by their rheumatologist to initiate sc anti-tnf-α therapy + mtx exclusion criteria: use of biologics (or any experimental drug) in the last 3 months before initiation of sc anti-tnf-α therapy. participation in other clinical or observational trials
assess safety & efficacy of wc3055 in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of wc3055 compared with placebo for the treatment of subjects with luts secondary to bph.


Eligibility criteria:
inclusion criteria: * history of luts for ≥6 months secondary to bph * total ipss (international prostate symptom score) ≥ 13 at screening exclusion criteria: -
helicobacter rescue therapy with vonorazon and amoxicillin dual therapy versus bismuth-containing quadruple therapy

Conditions: Gastritis Dyspepsia Helicobacter Pylori Infection Gastric Cancer Peptic Ulcer

Summary: this study aims at evaluating efficacy and safety of vonorazon and amoxicillin dual therapy versus bismuth-containing quadruple therapy(bismuth#esomeprazole#tetracycline and furazolidone) in h. pylori rescue therapy. it is hypothesized that vonorazon and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple therapy. patients with confirmed failure of h. pylori eradication will be randomized to one of the treatments described above. at week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

the study will include three phases: screening, treatment and follow-up. screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. one of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations. treatment: subjects are randomly assigned to treatment and will be treated for 14 days. a randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 14 and 16. follow-up: includes one visits. approximately 28 days after the end of treatment. eradication of h. pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.

Eligibility criteria:
inclusion criteria: * 1. age between 18\~70, both gender. 2. patients who had failed h.pylori eradication therapies . 3. women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. exclusion criteria: * 1. patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with h. pylori. 2. contraindications to study drugs. 3. substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. 4. constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(ppi) within 2 weeks before the \[13c\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening). 5. pregnant or lactating women. 6. underwent upper gastrointestinal surgery. 7. dysphagia. 8. evidence of bleeding or iron efficiency anemia. 9. a history of malignancy. 10. drug or alcohol abuse history in the past 1 year. 11. systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12. mental disorder. 13. enrolled in other clinical trials in the past 3 months. 14. refuse to sign informed consent.