Kornimate/medical-research-clean huggingface dataset:
tqc2731 clinical trial for the treatment of severe asthma with injection

Conditions: Asthma

Summary: this study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase iii clinical trial designed to evaluate the efficacy and safety of tqc2731 injection (420 mg q4w) in adult subjects with inadequately controlled severe asthma. a total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either tqc2731 (420 mg q4w) or placebo (q4w) via subcutaneous (sc) administration.


Eligibility criteria:
inclusion criteria: * sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial; * age 18 \~ 75 years old, gender is not limited; * documented physician diagnosis of asthma at least 12 months prior to visit 1; * subjects who received high-dose inhaled corticosteroids (ics) in asthma control medications prescribed by their physicians at least 6 months prior to visit 1; * there must be a record of receiving a stable total daily dose of ics at least 3 months prior to visit 1; * there must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; for subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment. * documented at least 2 asthma exacerbations in the 12 months prior to visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed. exclusion criteria: * have a clinically significant lung disease other than asthma； * pre-existing autoimmune disease; * a history of known or suspected immunosuppression, including a history of invasive opportunistic infections; * any disease that has not been determined to be stable by the investigator； * cancer history: patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study. * current smoker or smoking history ≥10 pack-years (former smokers with smoking history \<10 pack-years had quit smoking less than 6 months before interview 1); * other factors determined by the investigator that subjects were not suitable to participate in the study.
detection and inflammatory characterization of deep infection after surgery for locally advanced rectal cancer with microdialysis catheters

Conditions: Locally Advanced Rectal Cancer; Abdominoperineal Resection; Infection

Summary: the intention of the study is to explore metabolic and inflammatory parameters in the pelvis after abdominoperineal resection for locally advanced rectal cancer in patients that have received radiation therapy before surgery.

locally advanced rectal cancers (larc) threaten the normal surgical margins and therefore needs neoadjuvant (chemo-) radiotherapy to down-stage the tumor before surgery. the norwegian radium hospital oslo university hospital is a regional center for treatment of larc in the south-eastern part of norway and treat approximately 80-100 patients in this category annually. about 50 of these patients receive abdominoperineal resection (apr) as the main surgical treatment. a very high rate of deep surgical site infections is reported in the apr group internationally, particularly in the patients that have received chemo-radiotherapy. the knowledge of why these patients have such a high rate of infections is scarce. microdialysis is a technique which enables close to real-time monitoring of the tissues and organs of interest. the investigators want to utilize the microdialysis method to describe and monitor metabolic and inflammatory parameters, after extensive oncological surgery for larc in patients that have undergone chemoradiotherapy before surgery. with the knowledge of how the normal biology is, the investigators hypothesize that infection can be readily detected by the biomarkers retrieved by microdialysis.

Eligibility criteria:
inclusion criteria: * patients with primary rectal adenocarcinoma that have received radiation ≥25 gy to the pelvis. * operation with apr. * have accepted and signed the consent form. exclusion criteria: * apr for other reasons

Keywords: locally advanced rectal cancer deep infection microdialysis surgical site infection
vital values at circadian markers in postoperative patients

Conditions: Postoperative Complications; Circadian Dysrhythmia

Summary: to describe changes in various diurnal patterns in vital values after surgery. these will be analyzed based on whether the patients have complications or no complications.


Eligibility criteria:
inclusion criteria: * admitted for surgery * expected time of surgery was more than 2 hours. * expected post-operative length of stay was more than 2 days. exclusion criteria: * allergy to study materials * patients with a pacemaker * patients that were expected to be unable to cooperate with study procedures (for instance a mini-mental state exam(mmse \< 25)

Keywords: postoperative physiology vital signs
effects of music or hypnotherapy on cancer patients during chemotherapy

Conditions: Breast Neoplasm; Ovary Cancer

Summary: chemotherapies often induce side effects. this study examines whether hypnosis, music therapy versus standard therapy influence these side effects.

primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.

Eligibility criteria:
inclusion criteria: * no previous chemotherapy * compliance of the patient to fill out questionnaires * informed consent and signed forms * histologic secured breast cancer or ovary cancer (residual tumor after surgery equal or less than 0,5 cm) * one of following chemotherapy regime: 4x epirubicin / cyclophosphamid, 12x paclitaxel oder 6x carboplatin / docetaxel / perjeta/ herceptin oder 6x doxorubicin, docetaxel, cyclophosphamid oder 6 x carboplatin / paclitaxel + / - avastin oder 4x epirubicin / cyclophosphamid -\> 12x paclitaxel /herceptin/ perjeta oder 4x epirubicin / cyclophosphamid q21-\>12xcarboplatin, paclitaxel 4 epirubicin / cyclophosphamid q14-\> 12 carboplatin, paclitaxel exclusion criteria: * does not understand the german language * psychosis * not able to sign consent form

Keywords: chemotherapy side effects of chemotherapy
nintendo wii and exercises at rehabilitation of individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: patients with parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. in this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the nintendo wii. 45 patients will be evaluated through the berg balance scale, dynamic gait index, timed up and go and pdq-39, and will then be randomized to receive 16 sessions of exercises or nintendo wii alone or together. after this period the patients will be reassessed to verify the effects of the techniques.

patients with parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. in this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the nintendo wii. 45 patients will be evaluated through the berg equilibrium scale, evaluated by the dynamic gait index and the timed up and go and pdq-39. later patients will be randomized to receive 16 sessions of kinesiotherapy or nintendo wii alone or together, twice a week, for 50 minutes at the neurociencias outpatient clinic of teacher magalhães neto - fuba. after this period the patients will be reassessed to verify the effects of the techniques.

Eligibility criteria:
inclusion criteria: * age between 40 and 80 years, * stage 1 to 3 on the hoehn and yahr scale, * absence of visual or auditory impairment, exclusion criteria: * presence of cognitive alterations according to meem: illiterate 19 points; 1 to 3 years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points * presence of other neurodegenerative diseases, * uncontrolled osteomioarticular or chronic diseases * participation in other rehabilitation programs.

Keywords: parkinson's disease ande video games
clinical performance of two cad-cam fabricated ceramic restoration in teeth affected with mih

Conditions: Molar Incisor Hypomineralization

Summary: this study will be performed to evaluate the clinical performance (plaque accumulation, fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit and discoloration) of two cad/cam fabricated ceramic restorations (zirconia-reinforced lithium silicate glass ceramic and hybrid ceramic) with different preparation designs (modified occlusal veneer and endocrown) for rehabilitation of permanent first molars affected with different severity level of molar incisor hypomineralisation (mih), evaluated at different time periods

clinical evaluation of all restorations will be performed according to: - modified united states public health service (usphs) ryge criteria, at base line (1 week), 3, 6 and 12 months after cementation.

Eligibility criteria:
inclusion criteria:- * patient from 8 to 13 years * permanent first molar tooth affected with different severity levels of mih * ability to physically and psychologically tolerate conventional restorative procedures. exclusion criteria:. * patients have active periodontal diseases. * patient with poor oral hygiene and motivation. * patient with psychiatric problems or unrealistic expectations
study of the outcome of patients with acute myeloblastic leukemia and myelodysplastic syndrome receiving iron chelation therapy after allogeneic hematopoietic stem cell transplantation

Conditions: Myeloid Leukemia; Myelodysplastic Syndromes

Summary: iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-hsct. this multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-hsct in patients with acute myeloid leukemia and myelodysplastic syndrome. the investigators will compare the results obtained in the prospective study to those observed in a historical retrospective cohort of paired patients who did not receive chelation. given our clinical experience and literature results, the investigators will evaluate the exjade chelator. although not demonstrated, the presence of mutations of the hfe gene could play an indirect role on leukemogenesis by promoting overload. it is therefore important to evaluate the status in this patient population.


Eligibility criteria:
inclusion criteria: * adults older than 18 years old * patients with aml or mds in complete remission receiving csh transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning. * patients with iron overload defined by at least one ferritinemia\> 1000 μg / l in the 6th month after csh allograft * creatinine less than 1.5 x uln; alat and asat \<2 x uln * patients giving their informed consent (prior to performing any study procedure) exclusion criteria: * hypersensitivity to the exjade * association with another iron chelator * proteinuria\> 1g / 24h * acute and chronic hepatitis (b and c viruses); hiv * extended corrected qt * history of ocular toxicity related to iron chelation treatment * gastrointestinal abnormal absorption of oral medications * pregnancy and lactation

Keywords: acute myeloid leukaemia myelodysplastic syndrome iron chelation therapy (exjade) allogeneic hematopoietic stem cell transplantation (allo-hsct)
a study for participants with small-cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: part a: this study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer. part b: this study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.


Eligibility criteria:
inclusion criteria: * have histological or cytological evidence of extensive-disease small-cell lung cancer * have the presence of measurable disease as defined by the response evaluation criteria in solid tumors (recist 1.1) * have received at least 1 prior chemotherapy regimen with agents known to provide clinical benefit for small-cell lung cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy * have discontinued all previous therapies for cancer, including chemotherapy, biologic therapy, hormone therapy, or radiotherapy. participants must have recovered from the acute effects of therapy (except alopecia and fatigue) before study enrollment * part a: have a performance status of 0 to 2 on the eastern cooperative oncology group scale * part b: have a performance status of 0 to 1 on the eastern cooperative oncology group scale exclusion criteria: * have received treatment within 28 days of the first dose of ly2523355 with a drug that has not received regulatory approval for any indication * have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung cancer * have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study * part a: have symptomatic, untreated, or uncontrolled central nervous system (cns) metastases. participants with treated cns metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. screening of asymptomatic participants without history of cns metastases is not required * part b: have symptomatic, untreated, or uncontrolled cns metastases or a history of cns metastases. participants who have received prophylactic radiation are not excluded. screening of asymptomatic participants without history of cns metastases is not required
possible effects of supplement therapy with oral phenolics on cluster of differentiation 163 (cd-163) biomarker of patients with age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: in this multi-center study, possible effects of supplement treatment with oral phenolics on plasma cd-163 and progression of dry and wet age-related macular degeneration (amd) via evaluating the cd163 before and after the prescription of this drug will be evaluated in patients with dry type amd and neo vascular age-related macular degeneration (namd). both amd subgroups will be recruited. in terms of evaluation of the effects of phenolics (500 mg caplets/day) on amd progression, patients will be randomized and divided into 2 subgroups i.e. (i) receiving phenolics supplementation; and, (ii) receiving placebo for 1 month. the phenolics/placebo caplets will resemble completely and be encoded at origin; neither the participants nor the researchers will be informed about the codes until the end of the study.


Eligibility criteria:
inclusion criteria: * diagnosis of intermediate to late amd (dry amd and namd ) * age-matched controls without any sign of amd * signed informed consent exclusion criteria: * systemic disease or other eye-related diseases (diabetes, immunologic or inflammatory, active or chronic infectious disease, active malignancy, uveitis, retinal vascular occlusive disease, glaucoma) * systemic therapy with corticosteroids or biological drugs.
study of walk in patients with pelvic fixation

Conditions: Scoliosis

Summary: the purpose of this study is to determine the effect of double end spinal instrumentation from the upper thoracic to the pelvis with sacro-iliac ﬁxation on the gait of ambulating patients with pelvic obliquity 6 month after surgery.

the pelvic fixations were used since many years for these patients. however there are no prospective study investigating the gait evolution before and after a surgical treatment by long spinal instrumentation with pelvic fixation. investigators are planning to analyze the gait, before and 6 months after surgery. investigators will use 2 qualitative criterions with a gait analysis and a walking test, and 1 quantitative criterion with a questionnaire assessing the patient's functional change. investigators will use as surgical treatment a long double end spinal fixation without fusion, investigators use an ilio sacral screw as pelvic anchor on each side. evaluation of changes in gait after pelvic fixation of a long spinal instrumentation will make it possible to extend or, on the contrary, restrict the indications for pelvic fixation surgery in walking patients, who are candidates for pelvic fixation.

Eligibility criteria:
inclusion criteria: * patient under 18 walking or strolling * patient with scoliosis requiring long instrumentation taking pelvis with iliosacral screws exclusion criteria: * patient presenting a predictable pejorative evolution of the walk due to the pathology of the patient within 2 years * patient or parent who has notified their refusal to participate

Keywords: walking analysis spinal surgery scoliosis pelvic fixation
north taiwan stroke center for prevention and treatment

Conditions: Cerebrovascular Accident

Summary: the northern taiwan stroke center for prevention and treatment project is a single medical center, 3-year, multipurpose study. the aims of this study are (1) to set up a multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to establish a systemic stroke prevention / education protocol based on people's awareness of stroke; and (3) to create a better stroke rehabilitation protocol and pathway.there are three components in rehabilitation projects. first, we want to identify potential factors related to functional outcome in patients with stroke before and after stroke center. second, we want to compare the functional outcome in patients who admit to the stroke center as to those admitted to the general ward. third, we want to investigate the effect of electrical stimulation on upper limb function in patient with acute stroke.


Eligibility criteria:
inclusion criteria: * acute stroke * age \> 18 y/o * consult rehabilitation * client or agent can sign a letter of consent exclusion criteria(for rehabilitation protocol): * contraindication of electrical stimulation(pacemaker implant, severe arrhythmia, malignant cancer, wound on stimulation site)

Keywords: cerebrovascular accident stroke center stroke team intensive care of stroke rehabilitation of stroke
metabolic profiling of esketamine treatment in depressive disorder

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is one of the most common psychiatric disorders, characterized by extremely high prevalence, relapse rate and therapeutic resistance. treatment with ketamine and its enantiomer esketamine is the next step towards the successful treatment and understanding of depression that is resistant to treatment with standard antidepressants. the proposed study will include approximately 50 patients with mdd and 50 healthy control subjects of both sexes. using untargeted metabolomic approach, we plan to detect changes in biochemical pathways related to the diagnosis of treatment-resistant mdd and changes related to the mechanism of action of esketamine. the proposed research will contribute to further understanding of the mechanism of action of esketamine in patients with mdd. metabolic changes will be associated with improvements in specific domains of depressive symptoms and symptom severity in subjects with treatment-resistant major depressive disorder.


Eligibility criteria:
inclusion criteria: * for healthy control participants: 18-70 years, both sexes, without psychiatric drugs * for patients: from 18- 70 years, both sexes, failed treatment attempts with at least two antidepressants of the appropriate dose and duration. exclusion criteria: * for patients: treatment with tryptophan, st. john's wort, and/or opioid analgesics in the last month, daily intake of benzodiazepines; * for all participants: presence of psychotic symptoms, alcohol and/or drug addiction, disorder seizures, eating disorder, dementia and other neurodegenerative diseases, epilepsy, intellectual disabilities, severe somatic diseases (including insufficiently controlled arterial hypertension, diabetes and thyroid diseases), active psychotherapeutic treatment (except supportive psychotherapy, which is an integral part of every psychiatric treatment and will be the same in all groups of respondents). participants will be excluded if they follow a weight loss diet or take weight loss medication, are pregnant or breastfeeding.
determining the mechanisms of loss of car t cell persistence

Conditions: Acute Lymphoblastic Leukemia With Failed Remission; Acute Lymphoblastic Leukemia Not Having Achieved Remission; Acute Lymphoblastic Leukemia, Pediatric; Acute Lymphoblastic Leukemia, Adult; Acute Lymphoblastic Leukemia, in Relapse

Summary: a prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (all) patients treated with cd19 chimeric antigen receptor t-cells (car-t cells). the study will examine changes in car-t persistence over time and causal factors.


Eligibility criteria:
inclusion criteria: 1. children and young adults (age 25 years or younger) with relapsed/refractory all who are planned to receive licensed cd19-targeted car-t cell treatment (tisagenlecleucel) 2. written informed consent exclusion criteria: 1. patients receiving an alternate cd19-directed car t-cell product on a clinical trial 2. any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol
correspondence of folate dietary intake and biomarker data

Conditions: Folate Deficiency

Summary: this nhanes analysis compares self-reported dietary folate with serum and red blood cell folate status in u.s. adults.

background: public health concerns of both low and high folate status exist in the u.s. recent publications have questioned the utility of self-reported dietary intake data in research and monitoring. objective: the purpose of this analysis was to examine the relationship between self-reported folate intakes and folate status biomarkers, and to evaluate their usefulness for several types of applications. design: usual dietary intakes of folate were examined using the national cancer institute (nci) method to adjust 2, 24-hour dietary recalls (including dietary supplements) for within-person variation and compared these intakes with serum and red blood cell (rbc) folate among 4,878 non-pregnant, non-lactating participants ≥19y in nhanes 2011-2012, a nationally representative, cross-sectional survey, with respect to consistency across prevalence estimates and rank order comparisons.

Eligibility criteria:
inclusion criteria: * adults, ages 19+ years exclusion criteria: * missing data * non-pregnant * non-lactating

Keywords: nhanes folate folic acid