Kornimate/medical-research-clean huggingface dataset:
a clinical study to evaluate the safety and effectiveness of novabel bioabsorbable steroid-releasing stent for the chronic sinusitis

Conditions: Chronic Sinusitis

Summary: the goal of this clinical trial is to learn about the safety and effectiveness of novabel bioabsorbable steroid-releasing stent in chronic sinusitis. the main questions it aims to answer are: * the safety of this device for the chronic sinusitis * the effectiveness of this device for the chronic sinusitis participants will be implanted bioabsorbable steroid-releasing stents after fess surgery. participants will be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and 360 days after procedure. researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.


Eligibility criteria:
inclusion criteria: * diagnose with crs based on chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018), who were scheduled to undergo primary or revision bilateral ess. * have evidence of bilateral sinus based on computed tomographic (ct) scan (lund-mackay \[l-m\] score of \<=3 on each side). * can understand the purpose of this study and will to join and finish all the follow up according to the study. sign the icf. exclusion criteria: 1. know history of allergy or intolerance to corticosteroids or mometasone furoate. 2. the subject has a known allergic reaction or contraindication to the device material and its degradation products (l-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid). 3. clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors. 4. clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis. 5. glaucoma, ocular hypertension, posterior subcapsular cataracts. 6. known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease. 7. clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 360 day follow-up period. 8. current ess including frontal sinus surgery is aborted for any reason. 9. pregnant or lactating female 10. investigator determination that the potential study subject is unable to comply with study procedures and/or follow-up, or provided informed consent. 11. currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.

Keywords: bioabsorbable steroid-releasing stent
tislelizumab combined with neoadjuvant radiotherapy and chemotherapy for resectable esophageal squamous cell carcinoma.

Conditions: Advanced Esophageal Squamous Cell Cancer

Summary: this study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. the tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. this study will provide valuable information for further prospective clinical trials of neoadjuvant anti-pd-1 and other immunotherapy in esophageal cancer patients.


Eligibility criteria:
inclusion criteria: 1. age 18-75 2. histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( ct1-2n+/ ct3-4an0-3m0) 3. eastern cooperative oncology group (ecog) status 0-1 4. signed written informed consent prior to the implementation of any trial-related rocedures 5. adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy absolute neutrophil count ≥ 1,500 х109/l thrombocytes ≥ 100 х 109/l hemoglobin ≥ 90 mg/l creatinine ≤ 1.5 x uln or creatinine clearance (calculated using the cockcroft-gault formula) ≥40 ml/min alanine aminotransferase (alt) and aspartate aminotransferase (ast) \> 2.5 x upper limit of normal (uln) alkaline phosphatase (alp) \> 5 x uln bilirubin \> 1.5 х uln exclusion criteria: 1. patients diagnosed with any other malignant tumor 2. patients at risk for tracheoesophageal fistula or aortoesophageal fistula 3. have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor 4. insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding 5. have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment 6. patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction 7. a history of interstitial lung disease or non-infectious pneumonia 8. active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years 9. known history of human immunodeficiency virus (hiv) infection (i.e., positive for hiv 1/2 antibody) and various viral hepatitis infections 10. patients who have received allogeneic stem cell or solid organ transplantation 11. women during pregnancy or lactation
computerized cognitive training in middle-aged adults with generalized anxiety disorder: a pilot study

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.


Eligibility criteria:
inclusion criteria: * 45-59 yrs of age * no neurological or psychiatric illness, dementia, or loss of consciousness \> 5 mins * nongamers (i.e., report \<1 hour of video/cognitive training games/week over last 2 yrs) * proficient in english (reading and writing) * computer meets technology requirements (i.e. windows: windows 7 or above using internet explorer 11 or edge, mozilla firefox 41 and above, google chrome 48 and above; mac os: mac os x v10.8 and above using safari 10 and above, mozilla firefox 42 and above, google chrome 48 and above; android app: android 6 or higher version; ios app: ios 10 or higher version * meet clinical dx criteria for generalized anxiety disorder. exclusion criteria: * unable to provide informed consent * unable to undergo randomization * telephone interview for cognitive status-modified (tics) score \<33, 2) * other sleep disorder (i.e., sleep apnea, periodic limb movement disorder-plmd, narcolepsy, rem sleep behavior disorder) * severe untreated psychiatric comorbidity that renders randomization unethical * psychotropic, anxiolytic medications or other medications(e.g., beta-blockers) that alter mood or sleep * uncorrected visual/auditory impairments * participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.

Keywords: anxiety middle-aged sleep cognition older adults
retrospective observational study on the epidemiological characteristics of influenza patients

Conditions: Influenza

Summary: seasonal influenza outbreaks contribute to the saturation of emergency services. better knowledge of the epidemiology and clinical presentation of this pathology would optimize the organization of emergency reception services and provide better care for patients, disseminate educational elements to the population more appropriate as well as optimal recommendations for health professionals.


Eligibility criteria:
inclusion criteria: * major subject ((≥18 years old) * subject who consulted the emergency department of the adult emergencies of the strasbourg university hospitals between september 2018 and march 2019 * subject for which the flu smear is positive * subject not expressing opposition to the use of his data for research purposes exclusion criteria: * subject having expressed his opposition to participating in the study * subject for which the flu smear is negative * subject under the protection of justice * subject under guardianship or curators

Keywords: influenza grippe emergency services influenza, human
doripenem in the treatment of complicated lower urinary tract infection or pyelonephritis

Conditions: Urinary Tract Infections; Pyelonephritis

Summary: the purpose of this study is to assess the microbiological cure rate of doripenem in the treatment of patients with complicated urinary tract infection or pyelonephritis. the study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.

doripenem is an antibiotic medication not yet approved by the us fda. this is a phase 3, multi-center, prospective, open-label, single-arm study of doripenem in the treatment of complicated lower urinary tract infection or pyelonephritis in adults. patients are hospitalized, but subsequently, patients may treated as outpatient or through home-based therapy at the discretion of the investigators. conventional laboratory data will be collected from patients at specified times throughout the study. the primary endpoint is microbiological response measured at test of cure visit. the patients will receive doripenem with duration of therapy up to 10 days.

Eligibility criteria:
inclusion criteria: * diagnosis of complicated lower urinary tract infection or pyelonephritis exclusion criteria: * women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control * history of moderate or severe hypersensitivity reactions to antibiotic medications

Keywords: complicated urinary tract infections pyelonephritis
endocrine and nutritional assessment in b thalassemia major

Conditions: Thalassemia

Summary: b thalassemia patients developed short stature and low weight in spite no evident endocrine abnormalities. one hypothesis is that they developed some degree of malnutrition,then the purpose of this study is to assess the nutritional status before nutritional intervention and after one year. siblings of the patients will serve as a control group. bmi, lipid and endocrine profile and leptin levels will be analysed in the study group only.

the nutritionist will advice the patients about calories requirement and intake, balance diet and follow up the patients during the study period of one year. no special medicaments or drug therapy will be provided as part of the study protocol

Eligibility criteria:
inclusion criteria: * all patients above age 5 ys treated in the clinic.

Keywords: thalassemia nutrition endocrine bmi
study of quizartinib in japanese patients with newly diagnosed acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: this is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy.


Eligibility criteria:
inclusion criteria: * no prior treatment for aml (including quizartinib) * ecog (eastern cooperative oncology group) performance status of 0 to 2 exclusion criteria: * diagnosis of acute promyelocytic leukemia * active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy.

Keywords: aml phase 1 hematology malignancy newly diagnosed
synergistic effects of aerobic exercise and cognitive training on cognition in stroke patients with cognitive decline

Conditions: Stroke Patients With Cognitive Decline

Summary: the purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. the investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.


Eligibility criteria:
inclusion criteria: 1. ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment 2. age range from 20 to 90 years 3. mmse score ≥ 19 4. moca\<26 5. self- or informant-reported memory or cognitive complaints or cdr scale ≤ 0.5 6. able to follow the study instruction 7. adequate cardiopulmonary function to perform aerobic exercise 8. able to walk with or without assistive devices exclusion criteria: 1. unstable medical history (e.g., recent myocardial infarction) that might limit participation 2. concomitant with other neurological disorders (e.g., parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis) 3. current participation in another interventional trial
effect of itopride, on symptoms of functional dyspepsia, such as indigestion, bloating, inability to finish a meal

Conditions: Dyspepsia

Summary: itopride is a new compound that is already marketed in japan and in some countries of eastern europe under the name of ganaton. it is used to treat symptoms of functional dyspepsia. patients suffering from this condition have difficulties digesting food. they feel full after eating a few bites; they feel bloated and their stomachs hurt. the goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

the study lasts approximately 10 weeks. patients may either receive the real itopride, or a sugar pill called placebo. they have equal chances of receiving either treatment. after having completed this study, patients may be eligible to continue treatment for a longer period. at that point, all patients receive itopride. patients need to come to the clinic for evaluations 4 times during the trial. various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Eligibility criteria:
inclusion criteria: * patients suffering from functional dyspepsia according to rome ii criteria * 18-65 years old * absence of, or infrequent heartburn (one episode per week or less) * helicobacter pylori (h. pylori) negative * normal upper endoscopy

Keywords: functional dyspepsia abdominal symptom relief fullness bloating indigestion
electro-acupuncture and transcorneal electrical stimulation (tes) for retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: measures of vision in rp patients receiving promising therapy using transcorneal electrical stimulation.

retinitis pigmentosa (rp) is a slowly progressive retinal degeneration for which there is no proven treatment. patients are interested in trying alternative therapies to try to reduce their vision loss, but only limited research evidence exists to support their use and potential benefit. the goal of this research project is to gain a better understanding of possible changes in ocular and retinal blood flow and measures of vision in rp patients receiving two promising therapies, electroacupuncture and transcorneal electrical stimulation. we are currently only doing transcorneal electrical stimulation.

Eligibility criteria:
inclusion criteria: * age 18+ * diagnosis of retinitis pigmentosa (rp) * best-corrected visual acuity better than 20/400 in at least one eye * more than 20% loss of goldmann visual field area (iii4e test target) in at least one eye * able and willing to participate in all study visits for a \~4-6 month period * provide informed consent exclusion criteria: * very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests * vision loss due to ocular diseases other than rp, cystoid macular edema, or cataracts * schedules do not permit participation in all study visits * previous acupuncture or tes treatment for rp * inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment) * dementia; long or short-term memory loss * unable to read or speak english * smoking, excessive alcohol, or illegal drug use * receiving current psychiatric care (i.e. unstable emotional and mental health status) * history of excessive bleeding * reduced general health and/or systemic medications that may diminish the potential response to the electroacupuncture treatments * implanted cardiac pacemaker * pregnancy

Keywords: retinitis pigmentosa acupuncture electroacupuncture transcorneal electrical stimulation microcurrent
second-line therapy versus supportive care for pretreated advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (agc), and because randomly allocating patients to treatments that do not accord with their preferences may influence trial validity, the investigators employed a patient preference randomized trial design to compare the efficacy of second-line chemotherapy and best supportive care.

fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in agc patients because it has shown superiority in terms of response rate and time to disease progression compared with 5-fu monotherapy and other combinations in phase iii trials. despite the lack of evidence for benefit associated with administering salvage chemotherapy, it is a common practice to offer further chemotherapy for agc patients after first-line failure. for patients who failed after fluoropyrimidine and platinum, taxanes (paclitaxel or docetaxel) and irinotecan have been evaluated extensively in the second-line setting. currently, there is no evidence that slc in patients with agc will result in substantial prolongation of survival and there is potential for toxicity from the treatment.

Eligibility criteria:
inclusion criteria: * aged 75 year or younger * advanced gastric cancer * ecog performance status 0 or 1 * previous failure after chemotherapy with fluoropyrimidine and platinum * adequate major organ functions exclusion criteria: * severe concurrent illness and/or active infection * previously treated with taxanes and irinotecan * active cns metastases * pregnant or lactating women * who have not recovered from prior treatments

Keywords: failed after previous chemotherapy
long-term effect of soy consumption on cardio-renal indices and crp in type 2diabetes with nephropathy

Conditions: Kidney Transplantation

Summary: we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy consumption on lipid profiles, renal-function indices and crp level among type 2 diabetic patients with nephropathy.

background: several short-term trials on the effect of soy consumption on cardiovascular risks are available, but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy. objectives: to determine the effects of long-term soy consumption on cardiovascular risks, c-reactive protein and kidney-function indices among type 2 diabetic patients with nephropathy. design: this longitudinal randomized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy (18 men and 23 women). twenty patients in soy protein group consumed a diet containing 0.8 g protein/kg body weight (35% animal proteins, 35% textured soy protein, and 30% vegetable proteins) and 21 patients in control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins for 4-years.

Eligibility criteria:
inclusion criteria: * type 2 diabetes with nephrophaty exclusion criteria: * dialysis * transplantation

Keywords: soy diabetes nephropathy
effect of psycho-educational program and relaxation training on resilience among women with breast cancer

Conditions: Women With Breast Cancer

Summary: aim: to evaluate the effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer. design: randomized controlled trials used a pretest and posttest design to determine the effect of psychoeducational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer presenting to breast clinics in assiut, egypt. the women were randomly allocated to the intervention group and control group. method: data collection took place at the outpatient clinic at the assiut university in south egypt cancer institute. the study involved a total of 100 participants diagnosed with breast cancer recruited using a purposive sampling method, who were categorized into two groups, each comprising 50 women. group 1 received a psychoeducational program and relaxation training, while group 2 received only routine care without the psychoeducational program. inclusion criteria were age ranging from 20 to 60 years, consent to research participation, and nonmetastatic breast cancer diagnosis. the investigators excluded failing to engage regularly in the psychoeducational program, suffering from a significant illness other than breast cancer, having a history of persistent psychological illnesses, and using psychiatric medications.

breast cancer is the most frequent kind of cancer among women in developed as well as developing nations, and it is the leading malignancy among females in egypt

Eligibility criteria:
inclusion criteria: * age ranging from 20 to 60 years * consent to research participation * nonmetastatic breast cancer diagnosis exclusion criteria: * failing to engage regularly in the psychoeducational programme * suffering from a significant illness other than breast cancer * having a history of persistent psychological illnesses * using psychiatric medications.

Keywords: self-esteem psychological distress breast cancer
patients with chronic obstructive pulmonary disease at altitude - effect of nocturnal oxygen on breathing and sleep

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung disease.

patients with moderate to severe chronic obstructive pulmonary disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). outcomes will be assessed at low altitude (zurich, 490 m, baseline), and during 2 study periods of 2 nights each spent at moderate altitude (st. moritz salastrains, 2048 m) separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m).

Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease (copd), gold grade 2-3 * residents at low altitude (\<800 m) exclusion criteria: * unstable condition, copd exacerbation * mild (gold 1) or very severe copd (gold 4) * requirement for oxygen therapy at low altitude residence * hypoventilation * pulmonary hypertension * more than mild or unstable cardiovascular disease * use of drugs that affect respiratory center drive * internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test. * previous intolerance to moderate altitude (\<2600m). * exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study. * pregnant or nursing patients

Keywords: airway disease bronchitis emphysema lung
study to assess the efficacy and safety of sitagliptin in recently diagnosed, naive type 2 diabetics with inadequate glycemic control on diet and exercise (0431-158)

Conditions: Diabetes Mellitus

Summary: after 24 weeks of treatment evaluate the efficacy and security.


Eligibility criteria:
inclusion criteria: * patients being treated with metformin * patients with hba1c between 6.5 % and 12.0%. * type 2 dm