Kornimate/medical-research-clean huggingface dataset:
a study to evaluate abt-126 for the treatment of cognitive deficits in schizophrenia

Conditions: Schizophrenia

Summary: this is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

this is a phase 2 study designed to evaluate the safety and efficacy of abt-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.

Eligibility criteria:
inclusion criteria: * has a current diagnostic and statistical manual of mental disorders-, 4th edition, text revision (dsm-iv-tr) diagnosis of schizophrenia confirmed by the mini-international neuropsychiatric interview (m.i.n.i.). * is clinically stable while receiving a regimen of one or two allowable antipsychotic medications: lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of positive and negative syndrome scale (panss) no worse than moderate in severity throughout screening period of at least 4 weeks. * has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit. * has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit. * has an identified contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements. exclusion criteria: * in the investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode. * has a positive urine drug screen for cocaine, phencyclidine (pcp), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the screening period. * has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age. * has a clinically significant abnormal electrocardiogram (ecg) at screening visit 1 as determined by the investigator. * has any risk factors for torsades de pointes (tdp)

Keywords: schizophrenia
post-covid-19 epidemic depression assessment in adults in south punjab pakistan

Conditions: Depression, Anxiety

Summary: to assess the depression in adults especially in post covid-19 duration in the rural and urban settings.

this study is designed to assess the prevalence of depression after the general and smart lockdown in various areas. this study includes both genders of any age.

Eligibility criteria:
inclusion criteria:any individual who can respond to the given questionnaire, with or without any ailment will be included in this study - exclusion criteria: unconcious and non-cooperative individuals -

Keywords: depression anxiety epidemiology
open-label treatment in cushing's syndrome

Conditions: Cushing Syndrome; Cushing Disease

Summary: this is a long-term, open-label extension study of levoketoconazole in subjects with endogenous cushing's syndrome.

this is a long-term, ole study of levoketoconazole in subjects with endogenous cs who have completed one or both parent studies or otherwise potentially qualify for this study, as defined in the eligibility criteria.

Eligibility criteria:
inclusion criteria: 1. completed the extended evaluation phase of study cor-2012-01 (i.e. m12) 2. completed the restoration phase of study cor-2017-01 (i.e. res2) note: subjects meeting criteria 1 or 2 above who have had a break in therapy may be eligible only after discussion with the medical monitor. if eligible, such subjects may require re-establishment of the therapeutic dose via titration. all subjects who have had a break in therapy should be discussed with the medical monitor to determine the starting dose of levoketoconazole. prior to resuming treatment with levoketoconazole, other therapies for cushing's syndrome must undergo an appropriate washout period, with minimum durations as follows: * ketoconazole or metyrapone: 2 weeks; * dopamine agonists: bromocriptine (2 weeks), cabergoline (8 weeks); * octreotide acetate lar, lanreotide autogel, pasireotide lar: 12 weeks; * lanreotide sr: 8 weeks; * octreotide acetate (immediate release) or short-acting pasireotide: 1 week; * mifepristone (ru 486, korlym): 4 weeks; * megestrol acetate or medroxyprogesterone acetate (and selected other synthetic progestins): 6 weeks. 3. currently in a named patient program or other expanded access program receiving levoketoconazole 4. were levoketoconazole-naïve prior to entry and received early rescue therapy with open-label levoketoconazole in study cor-2017-01. 5. achieved a clinically meaningful partial response (with reduction of ufc) in study cor-2017-01 at dose level 7 or at a maximally tolerated dose of levoketoconazole but did not meet the randomization criteria for study cor-2017-01 at the end of the dose titration and maintenance phase when randomization was open. 6. were levoketoconazole-naïve prior to entry and were enrolled in study cor-2017-01 in the dose titration and maintenance phase when randomization was closed. (note: such subjects must receive at least 1 dose of levoketoconazole before transitioning to this study.) exclusion criteria: 1. discontinued levoketoconazole while participating in study cor-2012-01 or study cor-2017-01 or a named patient program or other expanded access program, due to safety or tolerability concerns or lack of efficacy. 2. scheduled for surgery for treatment of cs or received surgery for treatment of cs within the 6 weeks prior to screening. 3. treated with mitotane within 6 months prior to enrollment. 4. history of malignancy, including adrenal or pituitary carcinomas (other than low-risk, well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely to require further treatment in the opinion of the treating physician, or squamous cell or basal cell carcinoma of the skin).
clevidipine vs placebo or standard of care for dyspnea and blood pressure control in ahf

Conditions: Dyspnea; Hypertension; Acute Heart Failure

Summary: the purpose of this study is to evaluate dyspnea improvement and other parameters of efficacy and safety in acute heart failure (ahf) patients receiving an intravenous (iv) infusion of clevidipine in comparison to standard of care (soc) and placebo.

randomization will occur in two stages. stage 1 patients will be randomized in a double-blinded manner in a 1:1 ratio to receive either clevidipine or placebo iv infusion. upon completion of stage 1, stage 2 patients will be randomized in an open-label manner in a 1:1 ratio to receive either clevidipine or standard of care (soc) iv infusion. at the time of randomization, a patient-specific, prespecified systolic blood pressure (sbp) target range will be determined and recorded prior to study drug treatment. up to 500 patients may be enrolled to achieve a total of 100 stage 1 and 300 stage 2 patients with confirmed ahf per protocol. a data safety monitoring board will be utilized periodically throughout the study to monitor the safety of patients. adverse events will be assessed for 7 days post-study randomization or hospital discharge, whichever occurred sooner. serious adverse events (saes) were assessed for 30 days following study randomization.

Eligibility criteria:
inclusion criteria: * age 18 years or older and providing * presentation consistent with ahf as manifest by pulmonary congestion * dyspnea score (sitting) ≥ 50 mm on a 100 mm visual analog scale * in stage 1, baseline sbp ≥130 - 160 mmhg (measured immediately prior to initiation of study drug); in stage 2, baseline sbp ≥ 130 mmhg exclusion criteria: * administration of an iv or oral antihypertensive agent within the previous 2 hours of randomization (short acting oral or sublingual nitrates are permitted) * chest pain and/or electrocardiogram (ecg) with st segment changes consistent with acute coronary syndrome * known or suspected aortic dissection * acute myocardial infarction (ami) within the prior 14 days * dialysis-dependent renal failure * requirement for immediate endotracheal intubation * suspected pregnancy or breast feeding female * intolerance or allergy to calcium channel blockers * allergy to soybean oil or lecithin * known liver failure, cirrhosis or pancreatitis * participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
benefit evaluation of foot reflexology in oncology

Conditions: Lung Cancer and Cancer of Digestive System

Summary: chemotherapy with platinum salts is very emetic. the aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.


Eligibility criteria:
inclusion criteria: * patient with a thoracic or digestive cancer with indication of management with platinum salts-based chemotherapy * good performance status of (ecog 0-2) * more than 18 years old * ability to complete the questionnaires (comprehension oral and written french language) and to carry out the required exercises. * patient affiliated to social security or equivalent * informed consent signed exclusion criteria: * phlebitis * cellar syndrome * weight loss\> 5% in 3 months * uncontrolled pain * patients under morphine and derivatives * brain metastases * patient benefiting from foot reflexology outside the study * patient under guardianship or curatorship or deprived of his rights

Keywords: supportive care cancer foot reflexology nausea vomiting
acute study to collect electrical signals from the heart using a special lead

Conditions: Tachycardia; Ventricular Arrhythmias

Summary: the main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future implantable cardioverter defibrillator (icd) system.


Eligibility criteria:
inclusion criteria: * subject must be undergoing surgical procedure for approved indications for: * cardiothoracic surgery where a midline sternotomy is planned, or * cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or * vt ablation procedure with epicardial access, or * implant of a subcutaneous icd (s-icd®), or implant of a transvenous icd (single or dual chamber) * subject must be willing to provide informed consent * subject must be ≥ 18 years old exclusion criteria: * subject has known hiatus hernia or moderate or worse pectus excavatum * subject had previous pericarditis or prior sternotomy * subject has known significant right ventricle/ right ventricular dilation * subject has hypertrophic cardiomyopathy * subject is pacemaker dependent * subject has known skin irritations due to the covidien multi-function defibrillation electrode * subject is considered to be at high risk for infection(1) * subject has left ventricular ejection fraction \< 20% (most recent available lvef measurement in the last 6 months) * subject has new york heart association class iv * subject has myocardial infarction within the last 6 weeks * subject currently has unstable angina * subject has severe aortic stenosis * subject at high risk of stroke (2) * subject has chronic obstructive pulmonary disease and is oxygen dependent * subject has permanent af and will not be adequately anticoagulated during the asd2 acute testing procedure (3) * subject with an implanted active cardiac or non-cardiac device during the asd2 acute testing procedure (e.g., icd, s-icd®, pacemaker, neuro stimulator) * subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a medtronic study manager * subject has any medical condition that would limit study participation * subject is pregnant, or of childbearing potential and not on a reliable form of birth control. women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the asd2 acute testing procedure * subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.) * subject is legally incompetent 1. screening subjects at high risk for infection will be based on the local investigator judgment decision. 2. subjects who are at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to acc/aha/esc 2006 guidelines for high risk factors for stroke (i.e. exclusion of subjects with previous stroke, tia, or embolism; mitral stenosis; prosthetic heart valve). 3. screening will be based on the local investigator judgment decision.
establish finite element mesh of the numerical models of the thoracic aorta

Conditions: Heart Diseases

Summary: this study will be using finite element meshes and averaged algorithms to create the numerical thoracic aorta at different ages.

this study will be using finite element meshes and averaged algorithms to create the numerical thoracic aorta at different ages.

Eligibility criteria:
inclusion criteria: * normal thoracic aorta

Keywords: thoracic aorta finite element mesh
serum lipid levels and lp-pla2 in chronic periodontitis

Conditions: Chronic Periodontitis (Disorder)

Summary: to assess the association between periodontal parameters, serum lipid profile and lp-pla2 level in systemically healthy chronic periodontitis subjects and healthy controls.

seventy five participants were divided into 3 groups. the groups consisted of group i- generalized severe chronic periodontitis, group ii- generalized moderate chronic periodontitis and group iii- systemically and periodontally healthy volunteers who served as control. the selected patients were then evaluated for periodontal parameters, lipid profile and lp-pla2.

Eligibility criteria:
inclusion criteria: group i: 1. subjects with age ≥ 35 years. 2. presence of at least 24 teeth, with clinical attachment loss (cal) ≥ 5mm in more than 30% of sites. group ii: 1. subjects with age ≥ 35 years. 2. presence of at least 24 teeth, with clinical attachment loss (cal) between 3-4 mm in more than 30% of sites. group iii: 1. subjects with age ≥ 35 years. 2. healthy and intact periodontium exclusion criteria: 1. presence of any systemic disease or conditions that could affect periodontal tissues. 2. history of periodontal treatment in past 6 months. 3. smoking and alcoholism 4. anomalies of blood and immune system 5. systemic medication or antibiotic treatment for the previous 6 months. 6. pregnant females.

Keywords: chronic periodontitis lipids lp-pla2
vac regimen for aml patients who failed to response to va regimen

Conditions: Acute Myeloid Leukemia

Summary: chidamide in combination with venetoclax and azacitidine (vac) were expected to improve remission rate of patients following to va regimen treatment failure.

venetoclax and azacitidine has become the standard first-line treatment for elderly/unsuitable aml patients who can't tolerate for intense chemotherapy. however, a proportion of patients who were not able to achieve remission after failing to va regimen and then were given the second cycle, and their rate of achieving remission was even lower. chidamide down-regulates the expression of mcl and is expected to improve the remission rate further in combination with va regimen.

Eligibility criteria:
inclusion criteria: patients with aml who are not suitable for intensive chemotherapy according to the who diagnosis: age ≥60 years or age \<60 years but fulfil the following criteria; 1. age 18 to 59 years; 2. eastern cooperative oncology group (ecog) physical status score of 2 or 3; 3. expected survival time ≥3 months; 4. or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (a) presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (b) lung carbon monoxide diffusing capacity (dlco) ≤ 65%, or first forced expiratory volume (fev1) ≤ 65%; (c) moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0 x upper limit of normal (uln); (d) creatinine clearance ≥ 30 ml/min to \< 45 ml/min; 5. not received radiotherapy, treatment regimens other than the va regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment; 6. other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable; 7. ability to understand and willingness to sign the informed consent for this trial; 8. the patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy. exclusion criteria: 1. patients with a history of myeloproliferative neoplasms (mpn), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (cml) with or without bcr-abl1 translocation, and aml or acute promyelocytic leukemia (apl) with bcr-abl1 translocation; 2. patients with flt3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued); 3. patients with less than 50% reduction of blasts after va regimen; 4. patients with active cns involvement; 5. with prior treatment with chidamide; 6. clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage; 7. pregnant or lactating women; 8. participation in any other clinical trial within 3 months prior to vac regimen; 9. with other malignant tumours; 10. with uncontrolled mental disorders; 11. any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.

Keywords: aml venetoclax azacitidine chidamide unfit
effect of hypoxic exposure on blood variables in elite wrestlers

Conditions: Hypoxia

Summary: twelve male wrestlers of the national polish team were observed in the study during the camp. the hypoxia group (n=6) participated in sports training and hypoxic exposure, while the control group (n=6) included wrestlers participating only in sports training. the hypoxic group lived and slept in hypoxic rooms. during the camp, all wrestlers followed the same training schedule and diet. in the blood were determined levels of creatine kinase (ck), c-reactive protein (hscrp) concentration, nitric oxide (no), morphology, reticulocytes, lipid profile, and ferritin. also vascular endothelial growth factor (vegf, vegfr2, and vegfr3), erythropoietin (epo), angiopoietin (ang 1, ang 2), endothelial cell adhesion factor-1 (vcam-1), erythropoietin (epo) and hypoxia-inducible factor 1 (hif-1). body weight composition was determined.

hypoxia exposure applied to professional athletes has attracted attention and scientific debate due to its effects on improving physiological response through cardiovascular and hematological mechanisms. presently, hypoxic training programs are developed to improve exercise performance in athletes, a useful training method for athletes that may improve their performance in future sea-level competitions. 12 males were divided into the hypoxic (h) and control (c) groups. group h was living and sleeping in hypoxic rooms (method live high-train low) for 8-14h/d (fio2≈14%). the implementation of the project was intended to: 1) assess the dynamics of changes in the concentration of pro-inflammatory indicators and hematopoiesis in athletes to variable training loads and hypoxia, 2) explain the usefulness of hypoxic exposure in adaptation to physical exercise, 3) observe the length of the hypoxic cycle necessary to maintain the effect of high-altitude training. in the blood serum the level of basic biochemical indicators of fatigue related to muscle damage, inflammation, and energy deficit, i.e. total creatine kinase (ck) activity, c-reactive protein (hscrp) concentration, nitric oxide (no). moreover, basic hematological indicators: morphology, reticulocytes, lipid profile, and ferritin. also, angiogenesis regulators: vascular endothelial growth factor (vegf) and vegf receptors (vegfr2 and vegfr3), erythropoietin (epo), angiopoietin (ang 1, ang 2), endothelial cell adhesion factor-1 (vcam-1), erythropoietin (epo) and hypoxia-inducible factor 1 (hif-1). body weight composition was determined using a body analyzer. further investigations into hypoxia methods while considering individual capabilities are necessary for gaining deeper insights, into how hypoxia affects blood count and different blood variables among athletes.

Eligibility criteria:
inclusion criteria: * member of national wrestler's teams, and sports camp participant. exclusion criteria: * negative symptoms of hypoxia, and/or injury.

Keywords: hypoxia epo wrestlers hif-1 athletes
pharmacokinetics of posaconazole in allogeneic transplant patients with mucositis

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Summary: the goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.


Eligibility criteria:
inclusion criteria: * patients receiving allogeneic stem cell transplantation - treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections exclusion criteria: * gastroparesis * vomiting or diarrhea within 2 hours after intake of posaconazole * concomitant administration of potent inducers of the enzyme ugt1a4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,... * age under 18 years

Keywords: allogeneic hsct posaconazole prophylaxis mucositis pharmacokinetics
non-inferiority study to compare the efficacy and safety of mylan's insulin glargine with lantus® in type 1 diabetes mellitus patients (instride 1)

Conditions: Type 1 Diabetes

Summary: to test whether mylan's insulin glargine once daily is non-inferior to lantus® once daily (based on change in hba1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.

this trial is a multicenter, open-label, randomized, parallel-group trial in patients with type 1 diabetes mellitus (t1dm) comparing the efficacy and safety of mylan's insulin glargine with that of lantus®.

Eligibility criteria:
inclusion criteria: * patients with an established diagnosis of t1dm per ada 2014 criteria * body mass index (bmi) of 18.5 to 35 kg/m2 at screening (both values inclusive). * glycosylated hemoglobin (hba1c) ≤9.5% at screening. * hemoglobin ≥9.0 g/dl at screening. exclusion criteria: * history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, or history of significant allergic drug reactions. * history of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior. * history of use of a regular immunomodulator therapy in the 1 year prior to screening. * history of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in appendix i), as judged by the investigator. * history of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening. * serological evidence of human immunodeficiency virus (hiv), hepatitis b (hbsag) or hepatitis c (hcvab) antibodies at screening. * history of drug or alcohol dependence or abuse during the 1 year prior to screening.