Kornimate/medical-research-clean huggingface dataset:
a dose finding study of krn321(darbepoetin alfa) for the treatment of anemia in subjects with solid tumor

Conditions: Anemia

Summary: to assess the clinical effective dose of krn321 administered with once triweekly schedule.


Eligibility criteria:
inclusion criteria: * patients diagnosed as solid tumor or malignant lymphoma * patients receiving cyclic chemotherapy * written informed consent * hemoglobin concentration below 11 d/dl at enrollment * life expectancy of more than 4 months exclusion criteria: * hemolysis, gastrointestinal bleeding, postoperative bleeding * iron deficiency * megaloblastic anemia * received \> 2 rbc transfusions within 4 weeks before randomization or any rbc transfusion within 2 weeks before randomization * any primary hematological disorder that could cause anemia * prior treatment with krn321 * received erythropoetin therapy within 8 weeks before treatment

Keywords: darbepoetin alfa anemia cancer patients chemotherapy
orbital: open-label primary care study: rosuvastatin based compliance initiatives linked to achievement of ldl goals

Conditions: Primary Hypercholesterolaemia

Summary: 24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. if the subject does not reach the eas ldl-c treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.


Eligibility criteria:
inclusion criteria: * primary hypercholesterolaemia: * statin naïve subjects (ldl-c level \> 3.5 mmol/l) or subjects on an ineffective "start dose" of a lipid-lowering therapy (ldl-c level \> 3.1 mmol/l). * cv risk \> 20%, * history of chd or other established atherosclerotic disease exclusion criteria: * history of severe adverse events with another hmg-coa reductase inhibitor * secondary hypercholesterolaemia; * unstable cardiovascular disease; * uncontrolled diabetes, active liver disease; * severe hepatic or renal impairment; * treatment with cyclosporin.

Keywords: rosuvastatin hypercholesterolaemia cholesterol ldl-c triglyceride plasma lipids compliance
the impact of pharmaceutical care practice on patients in cardiac rehabilitation unit

Conditions: Acute Coronary Syndrome

Summary: this study aims to investigate the role of clinical pharmacist in the development of a pharmaceutical care program for patients with acute coronary syndrome tailored to their specific learning needs and their cultural context, and to verify the program's effects on physiological factors and recurrent symptoms or cardiac events.


Eligibility criteria:
inclusion criteria: 1. are diagnosed with acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft. 2. at 20-79 years of age. 3. has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist. 4. willing to participate in this study. 5. able to be reached by telephone postdischarge. exclusion criteria: 1. patients with cognitive impairment. 2. if they need professional help to take their medication at home. 3. with terminal illness. 4. inability to communicate. 5. severe arrhythmia.

Keywords: pharmaceutical care service, clinical pharmacist cardiac rehabilitation unit acute coronary syndrome patient education and counselling
evaluation of clinical and radiological outcomes in patients undergoing fixation of osteochondral fragments with reasorbable screws in the knee joint

Conditions: Osteochondral Defect; Osteochondritis Dissecans; Osteochondral Fracture; Osteochondral Fracture of Patella

Summary: various techniques for the fixation of unstable osteochondral fragments have been used over the years, each with associated advantages and disadvantages, and differing clinical outcomes. however, the literature on the treatment of this type of injury in the adolescent and young adult population is scarce and involves small case series. failure to treat these injuries can lead to serious consequences such as chronic pain, residual joint stiffness, and the development of early osteoarthritis, necessitating more invasive and burdensome interventions for the national health system, such as prosthetic replacements or osteotomies. due to the lack of real consensus within the scientific community regarding the ideal treatment for these patients and the insufficient medium/long-term follow-up data on the effects of these injuries on articular cartilage in young patients, this study aims to evaluate the clinical and radiological conditions of patients undergoing osteochondral fragment fixation using the same surgical technique (fixation with resorbable screws performed arthroscopically or via open surgery depending on the lesion's location) in order to clarify preventive measures against cartilage degeneration following these injuries, which are very common in adolescence.


Eligibility criteria:
inclusion criteria: 1. patients undergoing surgical fixation of osteochondral fragment using resorbable screw technique, either arthroscopically or via mini-open procedure depending on the lesion's location, from 01/01/2017, and all new patients eligible for this type of intervention until 31/12/2025. 2. patients aged between 12 and 35 years at the time of the surgical intervention. 3. patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging. 4. patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments. 5. patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma. exclusion criteria: 1. patients with concomitant complex ligamentous injuries or fractures at the time of the intervention; 2. patients who are no longer reachable; 3. women of childbearing age who cannot exclude pregnancy; 4. patients who are unable to provide informed consent or patients who are unwilling to sign the informed consent form.
investigation of the 24 hour forced expiratory flow in 1 second (fev1) profile of a single dose of indacaterol/mometasone delivered via the twisthaler® device in adult patients with persistent asthma

Conditions: Asthma

Summary: this study is designed to provide data about the 24 hours fev1 profile, safety and tolerability of indacaterol/mometasone twisthaler device compared to placebo and using fluticasone/salmeterol as an active control.


Eligibility criteria:
inclusion criteria: * male and female adult patients aged 18-75 years (inclusive), who have signed an informed consent form prior to initiation of any study-related procedure, * patients with persistent asthma, diagnosed according to global initiative for asthma (gina) guidelines (national institute of health, national heart, lung and blood institute, 2006) and who additionally meet the following criteria: * patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the product label, in a stable regimen for the month prior to visit 1. * patients with an fev1 at visit 1 ≥50% of predicted normal. * patients who demonstrate an increase of ≥ 12% and ≥ 200 ml in fev1 over their pre-bronchodilator. exclusion criteria: * pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception. * patients who have used tobacco products within the 6 months period prior to visit 1, or who have a smoking history of greater than 10 pack years. * patients diagnosed with chronic obstructive pulmonary disease (copd) as defined by the gold guidelines (global initiative for chronic obstructive lung disease 2006). * patients with seasonal allergy whose asthma is likely to deteriorate during the study period. * patients who have had an acute asthma attack/exacerbation requiring hospitalization in the 6 months prior to visit 1. * patients who have had an acute asthma attack / exacerbation requiring an emergency room visit within 6 weeks prior to visit 1 or at any time between visit 1 and visit 2. * patients who have had a respiratory tract infection within 4 weeks prior to visit 1 or at any time between visit 1 and visit 2. * patients with a history of long qt interval syndrome or whose qt interval corrected for heart rate (qtc) interval (bazett's) measured at visit 1 or visit 2 is prolonged: \> 450 ms (males) or \> 470 ms (females). * other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma qmf indacaterol mometasone
safety and immunogenicity of purified verocell rabies vaccine pvrv administered intramuscularly and intradermally

Conditions: Rabies

Summary: rabies is fatal disease but preventable with rabies vaccines and immunoglobulins, conventionally involves intramuscular (im) administration of the vaccine. however, switching the intradermal (id) route offers potential advantages in dosing, time and cost without compromising efficacy and safety. therefore, this study aims to compare the safety and immunogenicity of a short-term three-doses intradermal regimen (3d-id) with a conventional five-doses intramuscular regimen (5d-im) of the purified vero cell rabies vaccine (pvrv), administered via both intramuscular (im) and intradermal (id) routes as post-exposure prophylaxis (pep).

rabies vaccines can be used id for pep, according to a who expert committee recommendation. the administration of short-term pep through id (3-doses) offers a safe, immunogenic, dose-sparing, and cost-effective alternative to the conventional protocol (im, 5-dose regimen) while reducing the volume by up to 60 to 80% and vaccination schedules by 3 weeks. this strategy has the potential to reduce the overall requirement and cost of such vaccines, along with minimizing the burden on healthcare professionals and facilities. furthermore, this strategy is more likely to improve vaccination compliance compared to conventional protocol, and will certainly improve treatment outcomes.

Eligibility criteria:
inclusion criteria: * participants aged 2 year or older * both male and female * dog-bite cases only * informed consent form signed by the individual participant and/or their parents or guardian in case of minor age or major trauma exclusion criteria: * subject is participating in any other clinical trial. * pregnant and lactating women * have a plan to donate blood while participating in the study * received any other vaccine except rabies vaccines in last 6 months
study to evaluate the efficacy and safety of adjunctive pimavanserin in major depressive disorder (clarity)

Conditions: Adjunctive Treatment of Major Depressive Disorder

Summary: to assess the efficacy of pimavanserin compared to placebo when given adjunctively to a selective serotonin reuptake inhibitor (ssri)/serotonin-norepinephrine reuptake inhibitor (snri) antidepressant as treatment of patients with major depressive disorder (mdd) and an inadequate response to antidepressant therapy


Eligibility criteria:
inclusion criteria: 1. adult patients, aged 18 years and above 2. a clinical diagnosis of major depressive disorder (mdd) 3. is being treated with one of the following ssri or snri antidepressants as monotherapy: * citalopram * escitalopram * paroxetine * fluoxetine * sertraline * duloxetine * venlafaxine * desvenlafaxine * venlafaxine xr 4. has a history of inadequate response to antidepressant treatments exclusion criteria: 1. patient has a psychotic disorder other than mdd 2. patient has current evidence of a serious and/or unstable neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program 3. patient has a history or symptoms of long qt syndrome patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
efficacy and safety of humira® in patients with psoriatic arthritis in normal medical practice

Conditions: Psoriatic Arthritis

Summary: this study is a documentation of effectiveness and safety of humira in patients with psoriatic arthritis.

psoriatic arthritis participants receiving adalimumab are evaluated in a prospective, non-interventional study (nis) for 2 years. patients receive adalimumab 40 mg every other week (eow), per its label. efficacy and safety parameters are measured routinely at baseline and after 3, 6, 9, 12, 18 and 24 months.

Eligibility criteria:
inclusion: * 18 years of age or older (younger patients may be enrolled at the discretion of physician) * diagnosis of psoriatic arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy * signed/dated informed consent exclusion: -none

Keywords: humira long-term safety and effectiveness psoriatic arthritis
the treatment of initial stage of hip osteonecrosis: the core decompression

Conditions: Hip Necrosis; Hip Injuries

Summary: this retrospective study evaluates 52 cases of avascular necrosis of femoral head (avn) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (prf) and concentrated autologous mesenchymal stromal cells (mscs).

we report 52 cases of avascular necrosis of the hip (avn), operated by decompression of the necrotic area with bone chips allograft, adjuvanted by concentrated autologous mesenchymal stromal cells (mscs) and fibrin platelet rich-plasma (prp). the patients were followed-up at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year. each time a clinical evaluation by harris hip score (hhs) was carried out by the same orthopedic surgeon. radiological controls (pelvis and hip affected) were performed at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year. the primary outcome evaluated was the avoiding or delaying of total hip replacement (thr), while the secondary outcomes were the assessment of any change in clinical performance as measured by harris hip score

Eligibility criteria:
inclusion criteria: - hip avascular necrosis exclusion criteria: * protrusio acetabuli * concentric femoral head migration; * presence of extensive surgery of the reference joint (osteotomies around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular impingement) * presence of excessive deformity (acetabular or femoral head dysplasia; collapse deformity and deformed femoral head sequelae of perthes); * concomitant rheumatic diseases; * bone tumors

Keywords: hip avascular necrosis hip conservative surgery
efficacy of the use of diaries in intensive care units

Conditions: Diary (Blank Journal); Intensive Care Unit; Patient; Family; PICS; Stress; Anxiety; Depression; Quality of Life

Summary: randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an icu in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after icu discharge.

randomized, parallel, open, non-blinded, multicenter clinical trial, with an experimental group (diary) and a control group (usual practice), to compare the effect produced on quality of life by post-traumatic stress and anxiety/depression of patients and relatives, whether or not they have access to a diary during the stay in the unit. three validated scales will be used at three different times. 120 cases per group, carrying out a preliminary pilot test. data analysis according to ibm spss v.24 to describe and compare both groups.

Eligibility criteria:
inclusion criteria: * admitted intensive care unit * sedated and mechanically ventilated for 24hours * signed consent * not language barrier * willingness to attend follow-up visits exclusion criteria: * verbal manifestation of psychiatric, mental or cognitive antecedents * who do not coluntarily agree to participate
efficacy trial of warrior check-up

Conditions: Alcohol Abuse; Alcohol Dependence; Substance Abuse; Substance Dependence

Summary: this study will develop and test a brief telephone-delivered motivational enhancement intervention for substance abusing military personnel who are not currently in treatment. the hypotheses being tested are that this intervention will prompt a willingness to participate voluntarily in a self-appraisal of substance abuse behavior and consequences, self-initiated change or enrollment in a treatment or self-help program, and cessation of abuse of alcohol or other drugs.

the health and well-being of military personnel, and consequently the capacity for optimal functioning of military units, are compromised by the abuse of alcohol and/or other drugs. rates of heavy drinking are higher among military personnel than in the general population and are even higher among recently deployed personnel. while counseling can be effective, most substance abusers do not tend to voluntarily seek treatment. moreover, military personnel encounter more real and perceived barriers to seeking treatment. the substance abuse field is increasingly focusing on developing interventions for those at early stages of readiness to change, i.e., those contemplating but not yet committed to change. a brief, telephone-delivered motivational enhancement intervention (met) called a "check-up," has shown promise in promoting self-initiated behavior change as well as voluntary treatment entry, enhanced retention, and more successful outcomes for substance abuse. adapting the "check-up" for application with military personnel is warranted for three key reasons: (1) it has the potential of overcoming barriers to treatment-seeking, i.e., stigma and apprehension of a negative impact on one's military career; (2) it has the potential of attracting voluntary participation; and (3) protocols for disseminating this low cost intervention for use with deployed military can readily be developed and evaluated.

Eligibility criteria:
inclusion criteria: 1. current abuse or dependence on one or more substances 2. not currently enrolled in a counseling program focusing on substance abuse 3. currently serving in the army or other branch of the military. exclusion criteria: 1. non-fluency in english 2. evidence of psychosis

Keywords: motivational enhancement therapy
efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension

Conditions: Hypertension

Summary: this is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (hctz) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).


Eligibility criteria:
inclusion criteria: * male or female age 18 or older * diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm hg but \< 180 mm hg and mean seated diastolic blood pressure ≥ 90 mm hg and \<110 mm hg) exclusion criteria: * patients with severe hypertension: systolic ≥ 180 mm hg or diastolic ≥ 110 mm hg * history of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.) * history of myocardial infarction, stroke \[e.g. cerebrovascular accident (cva), thrombotic stroke, transient ischemic attack (tia)\], or onset of heart failure within the last 6 months. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypertension high blood pressure blood pressure control blood pressure reduction valsartan
nerve grafting with an allograft during radical prostatectomy - extended follow-up in a prospective randomized trial

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Summary: earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft. the investigators evaluate the use of the implantation of the allogenic nerve graft avance® in patients undergoing non nerve-sparing radical prostatectomy.

in this prospective randomised and single-blind, clinical phase-iv study, 60 patients are randomized into the treatment group and the control group. the follow-up is at least 24 months. the inclusion criteria were localized prostate cancers ct3 and/or gleason score ≥ 7 (a or b) and/or prostate-specific antigen (psa) ≥ 20 ng/ml and furthermore an erectile function with an iief ≥ 21 (iief-6). the operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles. the outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "international index of erectile function" (iief) questionnaire. the limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.

Eligibility criteria:
inclusion criteria: * localized intermediate-risk or high-risk prostate cancer ct3 * gleason score ≥ 7 (3+4 and/or 4+3) and/or * psa ≥ 20 ng/ml * intact preoperative erectile function with an iief ≥ 21 (iief-6). exclusion criteria: * iief \< 21 * operations in the past 6 months which could limit the erectile function * erectile dysfunction in the history or current medication for erectile dysfunction * current involvement in another comparable study.

Keywords: radical prostatectomy erectile function nerve grafting allogenic prostate cancer allogenic nerve graft time required for nerve grafting