Kornimate/medical-research-clean huggingface dataset:
efficacy of pd-1 inhibitor combination therapy in non-small cell lung cancer patients who have not achieved major pathologic response after neoadjuvant immunotherapy: a multicenter, phase ii clinical trial

Conditions: Non Small Cell Lung Cancer

Summary: exploring the efficacy of pd-1 inhibitor combination therapy strategies for adjuvant therapy in a population that has not achieved major pathological regression after neoadjuvant immunotherapy for non-small cell lung cancer: a multicenter, phase ii clinical study

this study explores the potential resistance problem in patients with low response rates after neoadjuvant icis treatment by addressing their potential resistance problems through an adjuvant immune combination regimen of icis, with the aim of providing a personalized choice of perioperative regimens for patients with early stage ii-iii resectable nsclc, and to reduce the risk of postoperative recurrence and death in patients.

Eligibility criteria:
inclusion criteria: 1. subjects ≥ 18 years of age on the day of signed informed consent, male or female, and willing to follow study procedures; 2. ecog score of 0 \~ 1; 3. patients with resectable clinical stage ii-iiib (n2 only) nsclc prior to neoadjuvant as assessed by the investigator (ajcc 8th ed.) and who are receiving 3 to 4 courses of standard pd-1 monoclonal antibody in combination with chemotherapy (platinum-containing two-agent chemotherapy) as neoadjuvant therapy during the neoadjuvant phase 4. pathological evaluation of tumor for mpr (less than 10% residual tumor cells from the primary tumor) and specific remission rate (1 - residual tumor/primary tumor) 5. subjects must have had complete resection of the nsclc (no residual tumor and all surgical margins negative) 6. histologically or cytologically confirmed squamous or non-squamous nsclc. exclusion criteria: 1. subjects who have undergone segmental lung resection or wedge resection only, and subjects who have not undergone systemic or lobe-specific lymph node dissection; 2. postoperative treatment with off-protocol antitumor therapy (e.g., radiotherapy, chemotherapy, targeted therapy, other immunotherapies, etc.; antitumor herbal therapies require a 2-week washout period); 3. severe grade 3 or higher irae or severe organ damage during neoadjuvant immunotherapy; 4. previous history of allogeneic bone marrow or organ transplantation; 5. previous or current interstitial pneumonitis/lung disease requiring systemic hormone therapy; 6. uncontrolled hypertension (blood pressure ≥150/90 mmhg at rest), with antihypertensive medications maintained at a stable dose for 7 days prior to the first dose of study drug; 7. combination of other malignant tumors within 5 years prior to the first dose of study drug that require active treatment, except for tumors cured in the opinion of the investigator;
benazepril hydrochloride, lisinopril, ramipril, or losartan potassium in treating hypertension in patients with solid tumors

Conditions: Hypertension; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure. purpose: this phase ii trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

primary objectives: i. to determine which drug has the greatest effect on ang-(1-7) levels in cancer patients with hypertension. secondary objectives: i. to determine the effect of these drugs on levels of ang ii, vegf, plgf, and ace in the same patients. outline: patients are randomized to 1 of 4 treatment arms. * arm i: patients receive oral benazepril hydrochloride once daily on days 1-7. * arm ii: patients receive oral lisinopril once daily on days 1-7. * arm iii: patients receive oral ramipril twice daily on days 1-7. * arm iv: patients receive oral losartan potassium once daily on days 1-7. in all arms, treatment continues in the absence of unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed solid tumor malignancy and hypertension, defined as a systolic pressure \> 130 or a diastolic pressure \> 80 * patients cannot be on active chemotherapy or radiation therapy; start of treatment with ace-i or arb must occur at least four weeks after the last dose of chemotherapy or radiation therapy * creatinine \< 2.5 * potassium \< uln * ability to understand and the willingness to sign a written informed consent document * hiv positive patients are eligible to participate in this study exclusion criteria: * patients who are pregnant or nursing due to significant risk to the fetus/infant * patients who are unable to take oral medications * patients who are currently taking an ace-inhibitor or arb
the early high risk period for patients with heart failure

Conditions: Heart Failure, Congestive

Summary: many people with heart failure either die or are admitted to the hospital in the first few months after the condition is diagnosed. the reasons for this are currently unclear- but may be due to worsening heart failure or other medical conditions such as angina, heart attack or sudden electrical problems of the heart. the investigators propose to recruit and follow-up 450 people, with a new diagnosis of heart failure for a minimum of six months in a multi-centre observational study at two hospital sites: the hillingdon (uxbridge) and the conquest (hastings) hospitals. the total study duration will be two years. people will be recruited after a diagnosis of heart failure is made and the study will assess reasons for death or admission to hospital and the psychological impact of the condition on both patients and their carers. this is an observational study and no change will be made to patients' conventional treatment. hypotheses: 1. the high mortality and hospitalisation rate in the early period after diagnosis of heart failure is related to progressive pump failure; or 2. the high mortality in the early period after the diagnosis of heart failure is related to co-morbid events- principally major coronary events such as myocardial infarction or acute coronary syndrome. this research should help to identify ways of improving the outlook for people with newly diagnosed heart failure. the analysis of the data generated by this study will be supervised by a statistician. clinical and demographic data will be described using mean + standard deviation, for continuous variables, and absolute numbers and percentages for categorical variables. group differences will be examined by t-tests for continuous variables and chi-square (x2) test for categorical variables. survival will be reported in terms of kaplan-meier curves with differences analysed by cox proportional hazards.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure exclusion criteria: * under age of 18 years * unable to give consent

Keywords: heart failure, congestive survival patient admission
prolonged intravenous therapy versus early initiation of an oral loop diuretic in decompensated heart failure

Conditions: Heart Failure

Summary: the goal of this clinical study is to compare treatment regimens of loop diuretics in patients with decompensated heart failure. the main aim is to answer if early change from intravenous to oral loop diuretics is safe and effective.


Eligibility criteria:
inclusion criteria: * patient hospitalized due to exacerbation of heart failure symptoms, where ahf is the main cause of hospitalization. to be included in the study, all criteria 1 to 6 must be met: 1. fluid retention features: * described congestion above the lung fields on chest x-ray * rales on chest auscultation * peripheral edema, yielding to pressure occurring within the limbs or the sacral part of the spine * increased pressure in the jugular veins (\>=8 cm h2o) 2. the concentration of natiuretic peptides must be assessed within 24 hours of admission to the hospital and be: ✔ ntpro-bnp \>450 pg/ml for \ 1800 pg/ml for \>75 years 3. exacerbation of heart failure treated with at least 40 mg of furosemide iv. (or 20 mg torasemide equivalent) 4. left ventricular ejection fraction \< 50% (assessed and documented in the last 12 months prior to study entry) 5. age \>= 18 years 6. the study participant gave and signed an informed consent to participate in the study. no medical procedure related to the study was performed prior to giving informed consent. exclusion criteria: * 1. shortness of breath caused by respiratory infection, exacerbation of bronchial asthma, copd 2. body temperature \> 38 c, signs of active infection requiring antibiotic therapy, sepsis, infective endocarditis 3. an episode of acute coronary syndrome, stroke or tia within 6 months before randomization 4. severe valvular disease requiring or in the process of qualifying for repair 5. patients requiring dialysis (in the past, during hospitalization or in the process of qualifying for dialysis) 6. history of alcohol abuse in the last 2 years before randomization 7. pregnancy or breastfeeding 8. active cancer or in remission for less than 5 years

Keywords: diuretic oral intravenous
different feeding in traumatic brain injury patients

Conditions: Traumatic Brain Injury

Summary: this was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. patients enrolled were divided randomly into the observation group with intermittent oro-esophageal tube feeding or the control group with nasogastric tube feeding for enteral nutrition support, respectively. nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

the safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. nasogastric tube feeding has been the mainstream choice in china but with the risk of complications. intermittent oro-esophageal tube feeding is an established modality of enteral nutrition support that can be used with routine treatment. this study reports the clinical outcomes of intermittent oro-esophageal tube feeding vs. nasogastric tube feeding, in patients receiving routine treatment. this was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. patients enrolled were divided randomly into the observation group with intermittent oro-esophageal tube feeding or the control group with nasogastric tube feeding for enteral nutrition support, respectively. nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, meeting the diagnosis of severe traumatic brain injury, confirmed through mri * score of glasgow coma scale (gcs) \<8; * presence of no contraindication for enteral nutrition; * with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications; * informed consent form was obtained from the patients' family members. exclusion criteria: * unable to cooperate in completing treatment and assessment due to personal reasons or other disorders; * complicated with other intracranial lesions, such as stroke; * with severe consciousness disorders caused by other diseases.
cellular immune augmentation in colon and rectal cancer

Conditions: Colon Cancer; Rectal Cancer

Summary: while new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. new strategies for treatment of disseminated colorectal cancer are needed. under this proposal, patients with advanced colorectal cancer will receive granulocyte-macrophage colony-stimulating factor (gm-csf) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. this will be combined with standard chemotherapy and patients will be followed for response and overall survival. detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.


Eligibility criteria:
inclusion criteria: * patient must have: metastatic, disseminated or recurrent colon or rectal cancer * patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) examples include: 5fu or 5fu/leucovorin given once weekly irinotecan (single agent) given once weekly 5fu/leucovorin/irinotecan given once weekly * patient must be able to be taught to administer gm-csf subcutaneously exclusion criteria: * known allergic or other adverse reaction to gm-csf * chemotherapy administration more frequently than bi-weekly * pregnant or lactating women

Keywords: metastatic colon cancer metastatic rectal cancer
study to assess the efficacy, safety, and tolerability of avp-786 for the treatment of intermittent explosive disorder

Conditions: Intermittent Explosive Disorder

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to evaluate avp-786 for the treatment of intermittent explosive disorder (ied).

eligible participants for this study must have a diagnosis of current ied. this is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of current intermittent explosive disorder (ied) according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria, as solicited by the structured clinical interview for dsm-5, clinical trials version * at least 3 ied days (at least 1 ied episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator * score ≥ 12 on the life history of aggression scale at screening * score ≥ 6 on the overt aggression scale - modified total irritability at screening and baseline * score ≥ 4 on the modified clinical global impression of severity for ied at screening and baseline exclusion criteria: * diagnosis of major depressive disorder within 6 months of screening * significant symptoms of a depressive disorder or a patient health questionnaire-9 score ≥ 10 at screening * met only the dsm-5 a2 criterion for ied * lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (dsm-5 criteria) * recurrent ied episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (dsm-5 criteria)

Keywords: intermittent explosive disorder avp-786
the effect of social skills intervention on praxis and social functioning in individuals with schizophrenia

Conditions: Schizophrenia

Summary: this study will be carried out with individuals diagnosed with schizophrenia who continue to community mental health. social skills training will be applied in the study. this study will be conducted to examine the effect of social skills training on praxis and social functionality in individuals with schizophrenia.

this study will be conducted to examine the effect of social skills training on praxis and social functionality in individuals with schizophrenia. test of upper limb apraxia (tulia) will be used for praxis assessment. social functioning assessment scale (sfas) will be used for social functioning assessment. in this study, individuals with schizophrenia will be examined with the model of creativity ability as an occupational therapy model and role playing activities will be determined according to the model. in secondary outcomes, the effect of social skills training on the symptoms of schizophrenia will be examined. therefore scale for the assessment of positive symptoms - saps and scale for the assessment of negative symptoms - sans will be used in the study.

Eligibility criteria:
inclusion criteria: * being an individual with a diagnosis of schizophrenia registered with the community mental health center * volunteering for the study and having written consent exclusion criteria: * be under the age of 18 or over the age of 65 * having a physical disability that limits participation in group activities

Keywords: schizophrenia social skills apraxia, motor social functioning
intralesional injection of sts in treatment of calcinosis

Conditions: Systemic Sclerosis (SSc); Dermatomyositis; Mixed Connective Tissue Disease (MCTD); Calcinosis

Summary: the specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of sts on calcinosis symptoms and lesion size in systemic sclerosis (ssc), mixed connective tissue disease (mctd) and dermatomyositis (dm) patients. injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.

calcinosis is a condition in which calcium builds up in the skin and tissue under the skin. it develops in ∼30% of adult dermatomyositis,18%-49% of systemic sclerosis patients, 25-40% of patients with limited systemic sclerosis. there is no standard treatment recommended by physicians currently. many treatments have been tested, all with limited benefits and without good evidence that any are effective. they are, based only on single cases or small numbers of patients in studies called "case series." but in some cases, these agents may be effective. there are several case series that have shown the effectiveness of injecting a chemical compound called sodium thiosulfate (or "sts") into calcinosis lesions. there was some improvement in terms of pain control, and a decrease in size and resolution of the calcinosis. the aim of our study is to test intralesional sodium thiosulfate (sts) injection for symptoms relief of calcinosis. sts has been approved by the u.s. food and drug administration for certain conditions related to childhood cancers. it has not been approved by the fda to treat calcinosis. the specific aims of this study are to assess change in calcinosis size and quality-of-life measures.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inﬂammatory myopathy * must be over 18 years of age * participants must be competent to give informed consent * participants must have radiographic evidence (xray or ultrasound) of calcinosis. * participants must need symptomatic relief exclusion criteria: • pregnant women will be excluded

Keywords: calcinosis
a two-week open-label pharmacodynamic and pharmacokinetic study of multiple doses of a darifenacin liquid oral suspension in children (2 - 15 years) with neurogenic detrusor overactivity

Conditions: Neurogenic Detrusor Overactivity

Summary: this study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. the results will support a benefit-risk based dosage recommendation for phase iiia clinical trials.


Eligibility criteria:
inclusion criteria: * male and female participants ages 2-15 years * documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline * using clean intermittent catheterization (cic) on a regular basis * participating in a bowel program on a regular basis * able to swallow the study medication in accordance to the protocol * participants and/or parent/guardian able to complete the bladder diary and follow the study procedures exclusion criteria: * treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function * fecal impaction. participants may be included, once this condition has resolved * clinically significant anatomical abnormalities or acquired disorders of the urinary tract * previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet * symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary. * diabetes insipidus * electro stimulation therapy or bladder training within 2 weeks prior to visit 1 and at any time during the study * concomitant diseases, in which the use of darifenacin is contraindicated * history of hypersensitivity to darifenacin or to drugs with similar chemical structures * participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion * female adolescent of child-bearing potential, unless using an acceptable method of contraception * pregnant or nursing (lactating) female adolescents other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pediatric, children, urodynamics, oral suspension, overactive bladder, dose-finding, neurogenic detrusor overactivity, meningomyelocele, spinal cord injury
a research study, looking at how tresiba® works in people with type 2 diabetes in local clinical practice in saudi arabia

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how tresiba® works in real world patients. patients will get tresiba® as prescribed to them by their study doctor. the study will last for about 6 to 8 months. patients will be asked questions about their health and diabetes treatment as part of their normal study doctor's appointment.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * the decision to initiate treatment with commercially available tresiba® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study * male or female, age above or equal to 18 years at the time of signing informed consent * diagnosed with type 2 diabetes and treated with any antihyperglycaemic medication(s), except tresiba®, for at least 26 weeks prior to informed consent and initiation visit (visit 1) * available and documented hba1c value measured within the last 12 weeks prior to initiation of tresiba® treatment exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * hypersensitivity to the active substance or to any of the excipients as specified in the tresiba® local label