Kornimate/medical-research-clean huggingface dataset:
chemotherapy, radiotherapy and bevacizumab in patients with unresectable stage iii non-small-cell lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.

the patients on this study will receive treatment in 3 stages of therapy. the first stage is induction therapy. this therapy is 7 weeks long. patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. during induction patients will also receive radiation therapy daily, monday through friday, for 7 weeks (weeks 1-7). this is followed by 2 weeks of rest. during this rest period patients will have scans done to see how their disease has responded to treatment. the next stage of treatment is consolidation therapy. this stage is 10 weeks long. patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. this is followed by 3 weeks rest. during week 19 patients will have scans to see how their disease has responded to treatment. the last stage of treatment is maintenance therapy. patients will receive bevacizumab alone by vein every 3 weeks. treatment will be given every three weeks for up to 9 treatments. (week 45)

Eligibility criteria:
inclusion criteria: * clinically confirmed non-small cell lung cancer stage iiia and selected stage iiib * measurable or evaluable disease * be up and about and able to care for self * adequate kidney, liver and bone marrow function * no prior treatment for this disease * must be able to give written informed consent * must be able to take folic acid, vitamin b12 and dexamethasone as described in the protocol * age 18 years or older exclusion criteria: * stage iv or iiib patients with pleural or pericardial effusions * stage iiib disease with contralateral mediastinal nodes greater than 4cm * squamous cell predominant tumors * pregnant or lactating women * patients with active infections * history of another cancer within the last 5 years with the exception of skin cancer or cervical carcinoma in situ * history of stroke, transient ischemic attacks, or acute mi within the past 6 months or any other serious cardiovascular disease * symptoms of peripheral vascular disease * history of neurological disease * recent history of blood in the sputum or vomitus * non-healing wounds, ulcer or long bone fractures * history of bleeding problems or coagulation problems * history of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months * history of uncontrolled hypertension * chronic use of non-steroidal anti-inflammatory medication not allowed on this study please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
role of nintendo wii in improving negative symptoms and quality of life in chronic schizophrenia

Conditions: Chronic Schizophrenia

Summary: the purpose of this study is to determine whether the use of nintendo wii will help improve negative symptoms of schizophrenia and quality of life of patients with chronic schizophrenia.

the proposed study seeks to determine whether any benefit in daily functioning and quality of life can be gained from using the nintendo wii video game console in chronic mental illness, namely schizophrenia. there is a small research base on the use of the wii console in elderly nursing home residents as a means of increasing mobility, with attendant benefits in areas such as falls, quality of life, and relief of subsyndromal depression. for individuals with schizophrenia, adjunct exercise therapy has been associated with gains in both psychiatric and physical symptoms. however, people with schizophrenia face physical and functional barriers in initiating and continuing organized activity programs. thus, the nintendo wii fit plus interactive fitness video game is being proposed as a novel way of introducing and engaging people with schizophrenia in various forms of physical activity. as the first study to assess the use of the nintendo wii in chronic mental illness, the purpose of this pilot study is to assess the feasibility and the capacity of the nintendo wii in improving the health and functioning of people with severe, chronic schizophrenia. although it is hypothesized that nintendo wii use will lead to gains in these domains, the information gained from this study will be used to determine specific areas of benefit and to assess whether any observed differences in outcome measures are sufficient to warrant a full-scale study. furthermore, this initial study aims to pilot the interview schedule, clarify wording on the questionnaires, ensure that all important areas have been covered by the questionnaires, and determine whether participants are capable of meeting the demands of the study.

Eligibility criteria:
inclusion criteria: * patients diagnosed with schizophrenia defined by the dsm-iv-tr (diagnostic and statistical manual of mental disorders-fourth edition-text revision) * males or females aged 18 years of older * participate in the community high intensity treatment team (chitt) out-patient program * certified by their physician to participate in physical activity exclusion criteria: * history of violence or other risks that may endanger study research assistants during home visits

Keywords: chronic schizophrenia nintendo wii quality of life
a natural history study to evaluate functional and anatomical progression in retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: this study will assess the progression of rp as seen on newer modalities including spectral-domain optical coherence (sd-oct) and macular assessment integrity (maia) microperimetry to evaluate disease status. understanding the natural history of the disease is not only essential to monitoring and comparing patient populations in clinical trials. it is also fundamental in the predevelopment phase in order to optimize the study duration needed to observe a statistically significant outcome. furthermore, since the progression of rp is usually slow, relying on traditional tests can take an unfeasible length of time to observe any meaningful changes and assess therapeutic efficacy for new drugs. therefore, the results of this study will be beneficial in establishing reliable endpoints and outcome measures for future clinical trials. such outcome measures may be able to detect treatment response with more precision. more importantly, investigators may be able to detect changes early enough to prevent irreversible vision loss.


Eligibility criteria:
inclusion criteria: * age 18 years or older * patients diagnosed with retinitis pigmentosa * ability to provide informed consent * ability to authorize use and disclosure of protected health information exclusion criteria: * concomitant ocular pathology that limits central macular function, including but not limited to age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion * if ez width ≤200µm
perinatal thymic dysregulation: characterization of perinatal mood episodes

Conditions: Perinatal Mental Health

Summary: the perinatal period is recognized as a time of heightened psychological vulnerability. this research aims to improve the diagnosis and therapeutic management of mood episodes occurring during this time. it is integrated into routine clinical care and seeks to standardize the evaluation of criteria used to characterize mood episodes, while also exploring relevant contextual factors. traditionally, clinical attention has focused on postnatal depression; however, increasing evidence highlights the presence of hypomanic symptoms-such as distractibility, reduced need for sleep, tachypsychia, and irritability-during the postpartum period. these symptoms may coexist with depressive features, resulting in complex clinical presentations that are often difficult to recognize and manage. consequently, many cases go undiagnosed and untreated. current research has largely concentrated on depressive episodes (perinatal depression), with less emphasis on manic, hypomanic, or mixed episodes indicative of bipolar disorder. a systematic evaluation of hypomanic symptoms occurring alongside depressive symptoms in the postpartum period could refine clinical diagnosis and support more targeted and effective therapeutic interventions.


Eligibility criteria:
inclusion criteria: * women over 18 years old * pregnant or having given birth less than a year ago * first psychiatric consultation for the pregnancy concerned. * good command of the french language. * participant affiliated to the social security system * participant who has given her consent to take part in the study. exclusion criteria: * women who gave birth more than a year ago. * participant under psychiatric care * participant under court protection

Keywords: perinatal mental health perinatal depression perinatal bipolar troubles
brevera™ breast biopsy system data collection study

Conditions: Breast Cancer Female

Summary: the brevera breast biopsy system integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. this post-market clinical trial will be performed to obtain clinical/operational data and feedback on the brevera breast biopsy system.


Eligibility criteria:
inclusion criteria: * female aged 18 years of age or older * subject has at least one breast imaging finding requiring biopsy for which images are available * subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her exclusion criteria: * patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy. * patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.

Keywords: breast biopsy breast biopsy imaging stereotactic imaging
a clinical study of klh-2109 in uterine fibroids patient with menorrhagia

Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)

Summary: multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of klh-2109 to leuprorelin acetate in uterine fibroids patient with menorrhagia


Eligibility criteria:
inclusion criteria: * premenopausal japanese woman diagnosed with uterine fibroids * patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions: * larger than a certain standard * no calcification * not receiving surgical treatment * patients with a normal menstrual cycle * patients diagnosed with menorrhagia exclusion criteria: * patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia) * patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis * patients with undiagnosed abnormal genital bleeding
early amniotic membrane transplantation in bacterial keratitis

Conditions: Keratitis of Both Eyes

Summary: in this study investigators are going to do early amniotic membrane transplantation (amt) for bacterial keratitis.

in this study investigators are going to do amniotic membrane transplantation (amt), early in the first week for bacterial keratitis. investigators are comparing this technique with no amniotic membrane transplantation (namt) in a clinical trial, inform consent is going to be taken, then the enrolment population is added in the study. investigators are going to compare the final scar size, the time to scar formation, perforation rate , early need to penetrating keratoplasty (pkp), risk of vision loss (being no light perception (nlp) between two groups.this trial has been approved by the review board in tehran university of medical sciences.( 487/5671)

Eligibility criteria:
inclusion criteria: bacterial keratitis being in the first week of diagnosis medically undergoing treatment exclusion criteria: thinning limbal extension intraocular extension underlying disease nocardia keratitis

Keywords: keratitis amt bacterial keratitis medication
can enhanced glycemic control in type ii diabetics improve myocardial protection during coronary artery bypass grafting?

Conditions: Type 2 Diabetes

Summary: the investigators have previously demonstrated that the administration of insulin in the form of an infusion with additional sugar and potassium may improve cardiovascular performance and reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing coronary artery surgery. the investigators now seek to demonstrate that similar benefits can be achieved in diabetic patients by administering insulin to maintain as near absolutely normal sugar levels as possible.


Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus patients (as defined by who) * diet, oral hypoglycaemic or insulin therapy * undergoing elective and urgent coronary artery bypass surgery exclusion criteria: * non-diabetics * emergency and redo cabg * \< 18 years * pregnancy * dialysis-dependence * history of cva/tia \< 6 months * heart valve disease requiring surgery * stemi \< 3 months
relationship between succinate dehydrogenase mutations and high-altitude illness

Conditions: Altitude Intolerance; High-Altitude Illness

Summary: this study is is the first step of a full study named chemogene because it explores the genetic determinant of an alteration of the chemoreflex. this reflex determines hyperventilation when the pressure of oxygen falls in the blood. this happens when subjects travel to high-altitude where oxygen levels diminish in the atmosphere. subjects with such an altered chemoreflex are intolerant to altitude and develop pulmonary or cerebral edema associated with a severe headache. in this study we compare subjects tolerant to high altitude (8000 meters)to subjects intolerant to altitude. the chemoreflex is measured i.e. the hyperventilation associated with hypoxia and all subjects are scanned for the genes implicated in the mitochondrial respiratory chain. the idea is that subjects with an impaired oxygen sensing will exhibit an altered chemoreflex and will be intolerant to high-altitude.

subjects are selected at an outpatient clinic specialised in the diagnosis of tolerance to altitude, where the chemoreflex is analyzed during a bicycle exercise performed with a oxygen deprived air simulating a 8000 meters altitude. all subjects will go later to high altitude for trekking usually. the patients are those subjects with an altered chemoreflex who exhibited cerebral edema or pulmonary edema during the trekking. the controls are the subjects with a normal chemoreflex who did not exhibit any trouble during their journey. fourty subjects of each group are included. a blood sample is withdrawn and studied for succinate dehydrogenase genes in a blind fashion. after completing the inclusion the allelic mutations will be compared in the two groups.

Eligibility criteria:
inclusion criteria: * chemoreflex sensitivity measured (normal or pathologic) * journey to high-altitude (well tolerated or with a severe disease such as pulmonary edema or cerebral edema) exclusion criteria: * asthma, * arterial hypertension, * drug treatment

Keywords: altitude anoxemia mitochondria reflex genetic research
a pharmacokinetic study of sevoflurane inhalation in burn icu patients

Conditions: ICU Patients With Indication of Sedation

Summary: comparing a pharmacokinetic model of a short sevoflurane sedation in burn icu patients with control icu patients.

prospective clinical study in icu with sedated ventilated patients with sevoflurane with the anaconda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn icu patients

Eligibility criteria:
inclusion criteria: * adult patients ventilated requiring invasive procedure in icu * stable respiratory and hemodynamic conditions * consent of patients or family * arterial line * burn patients : burn area between 20 and 50% (3rd degree) or non burn patients exclusion criteria: * bmi \<30 * sevoflurane anaphylaxia

Keywords: pharmacokinetics sevoflurane burn sedation
investigation of the perceptual and acoustic voice in trans man

Conditions: Gender Dysphoria; Voice Disorder Due to Transsexualism; Transgender Persons; Hormone Replacement Therapy

Summary: the aim of the study is to follow acoustic and perceptual voice changes in trans men during hormone therapy and to examine the relationship between psychosocial and vocal characteristics and testosterone measured in routine follow-up in accordance with international follow-up guidelines.

trans men who have completed the evaluation and follow-up procedure and decided to use sex hormones will be included in the study. participants will be followed for 8 doses of sex hormone use. acoustic and perceptual changes in voice will be monitored at baseline (before hormone use), 4th dose, and 8th dose. the relationship between testosterone and psychosocial and vocal characteristics will be examined. at the baseline of the study, participants will be evaluated with videolaryngostroboscopy (vls). as a result of vls, perceptual and acoustic voice evaluation will be made to the participants who are determined to have healthy vocal folds. during routine psychiatric visits, participants will be asked to fill in self-report scales. endocrinological routine evaluations will be applied to the participants and the data of these routine evaluations will be used in the study. all of these evaluations (perceptual and acoustic voice evaluation, endocrinological and psychiatric evaluations) will be repeated at the 4. and 8. doses of the hormone therapy, except for the vls evaluation. ibm spss statistics 26.0 and microsoft excel 365 programs will be used for statistical analysis. the number of participants to be included in the study was calculated using the g power 3.1 program. in the analysis, the number of participants was determined as 28 (g power=0.80, α =0.05). the normal distribution of the data will be examined by visual and analytical methods (shapiro-wilk test, kolmogorov-smirnov test).the analysis of each variable measured at three time points will be evaluated using anova if the assumptions of parametric tests are met, and using the friedman test if the assumptions of parametric tests are not met. when the parametric conditions are met paired t test will be used to compare the measurement values, and when the parametric conditions are not met, the wilcoxon signed-rank test will be used. multiple regression analysis will be used to determine the factors affecting the person's own perception of voince. finally, statistical significance level was accepted as p\<0.05.

Eligibility criteria:
inclusion criteria: * being diagnosed with "gender dysphoria" according to dsm 5 * having decided to start hormone therapy exclusion criteria: * diagnosis of vocal fold lesion in videolaryngostroboscopy evaluation * having previously received voice therapy or undergone voice surgery * having a systematic/or neurological disorder that may affect voice quality * having had hormone therapy or still on hormone therapy

Keywords: trans man voice, hormon therapy
a study to test efficacy, safety, and pharmacokinetics of certolizumab pegol in children and adolescents with moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol


Eligibility criteria:
inclusion criteria: * participant must be 6 to 17 years, inclusive, at the time of signing informed consent/assent * participant has been diagnosed with active crohn's disease (cd) as confirmed by endoscopic examination with/without histological confirmation ≤12 weeks before the screening visit * participant has moderately to severely active disease despite current treatment * participant has an inadequate response or intolerance to conventional therapy * participants are certolizumab pegol (czp) and adalimumab (ada) naïve exclusion criteria: * participant has had an extensive colonic resection, subtotal or total colectomy, diagnosis of short bowel syndrome or a history of \>3 small bowel resections * participant has had a primary failure (ie, lack of response within the first 12 weeks of treatment) to any anti-tumor necrosis factor-α agent for treatment of crohn's disease

Keywords: certolizumab pegol cimzia phase 3 crohn's disease pediatric kids ohana cd
gls-1200 topical nasal spray to prevent sars-cov-2 infection (covid-19)

Conditions: SARS-CoV 2; Infection

Summary: this clinical trial will evaluate the safety, tolerability and effectiveness of topical gls-1200 nasal spray to reduce the incidence of confirmed, symptomatic sars-cov-2 infection.

this phase ii randomized, placebo-controlled, double-blind study will assess whether topical gls-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of confirmed sars-cov-2 infection. subjects will be randomized to either the gls-1200 or placebo group in a 2:1 ratio with a target enrollment of 225 subjects. subjects will self-administer study drug three times daily for 4 weeks.

Eligibility criteria:
inclusion criteria: * age 18 or older * able to provide informed consent * able and willing to comply with study procedures * able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential through to the end of treatment exclusion criteria: * know allergy to quinine, quinidine, or mefloquine * confirmed prior positive test for sars-cov-2 * treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir * pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding or plans to become pregnant during the course of the study

Keywords: covid-19
fatigue reduction in chronic kidney disease (ckd)

Conditions: Chronic Kidney Diseases; Fatigue

Summary: in this pilot trial, investigators will pilot test a cognitive behavioral intervention for acceptability and proof of concept for a larger future trial to be submitted for federal funding. this is a one-group design with qualitative and quantitative data collection integrated into the intervention.


Eligibility criteria:
inclusion criteria: * interest in participating in a fatigue study * age ≥18 years old * estimated glomerular filtration rate (egfr) 15-44 ml/min/1.73 m2 * ability and willingness to provide informed consent * ability to speak english * ability to walk * ability to join remote study sessions via webex exclusion criteria: * current involvement in an activity/exercise program * high likelihood of a kidney transplant within 6 months (assessed via the medical record) * any safety concerns about increased walking (assessed via the medical record)