Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effectiveness and safety of paliperidone palmitate in subjects with acute schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).

this is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic participants. this study consists of a screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early withdrawal visit. safety evaluations will include adverse events, clinical laboratory tests, concomitant medications, physical examination, and vital signs, which will be monitored throughout the study. the total duration of study participation for each participant will be approximately 13 weeks.

Eligibility criteria:
inclusion criteria: * have a current diagnosis of schizophrenia as defined by diagnostic and statistical manual of mental disorders version iv (dsm-iv) * must be admitted to a hospital within 4 weeks prior to screening experiencing an acute exacerbation of schizophrenia * have a positive and negative syndrome scale (panss) total score of more than or equal to 60 or clinical global impressions - severity (cgi-s) score of more than or equal to 4 (moderately ill) at screening * agree to protocol-defined method of contraception * must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at screening exclusion criteria: * have a primary active dsm-iv axis i diagnosis other than schizophrenia * have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination * have a history of neuroleptic malignant syndrome * participants at risk of suicide * have received clozapine within 1 month prior to screening

Keywords: schizophrenia antipsychotics paliperidone palmitate paliperidone invega sustenna psychotic disorder psychosis
clinical/microbiological impact of a specific antimicrobial stewardship program for nursing homes

Conditions: Human Microbiome; Antibiotic Resistant Infection; Nursing Homes

Summary: background: in nursing homes, excessive and inappropriate use of antimicrobials, adverse events caused by these drugs, and infections by multidrug-resistant bacteria (mdrb) are more frequent than in the general population, posing a serious public health risk. antimicrobial stewardship programs (asp) are a key strategy to improve the use of antibiotics and to fight against bacterial resistance. its usefulness in hospitals has been demonstrated. the centers for disease control and prevention urge the implementation asp in nursing homes, with measures taken from the asp in hospitals, but the available information is so limited that it does not allow specific recommendations to be made for these centers. objectives: to know if an asp with an individual intervention measure, the clinical assessments, is better to an asp with general intervention measures, both designed specifically for nursing homes, and what is the clinical and ecological impact of both, on the baseline situation. methods: a) randomized clinical trial, in parallel groups, for comparison of both asp. b) quasi-experimental study of timeseries for the evaluation of the clinical and ecological impact on the baseline situation. the following indicators will be analyzed: the use of antimicrobials in the centers; the intestinal microbiota diversity of nursing home residents, and the incidence of mdrb and clostridium difficile infections; and the frequency of adverse events caused by antimicrobials and hospital admissions for infections. the study population will be 2.220 residents from 20 public nursing homes.


Eligibility criteria:
inclusion criteria: * public nursing homes under the ownership of the department of equality and social policies of the junta de andalucía exclusion criteria: * nursing homes that are not under the ownership of the department of equality and social policies of the junta de andalucía
study of mdx-1203 in subjects with advanced/recurrent clear cell renal cell carcinoma (ccrcc) or relapsed/refractory b-cell non-hodgkin's lymphoma (b-nhl)

Conditions: Renal Cell Carcinoma; Non-hodgkin's Lymphoma

Summary: the purpose of this study is to determine if mdx-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin's lymphoma.

multicenter, open-label, dose-escalation, multidose study of mdx-1203, a fully human monoclonal antibody drug conjugate targeting the cd70 transmembrane cell-surface protein which is highly expressed in ccrcc and b-nhl. mdx-1203 is composed of a human anti-cd70 monoclonal antibody covalently linked to a prodrug form of a cytotoxic deoxyribonucleic acid (dna) minor-groove binding agent (mgba). the study will consist of 3 periods: screening (up to 28 days), treatment (up to 17 cycles or 2 years), and follow-up (up to 6 months).

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 to 2 * criteria specific to each tumor type: * for clear cell renal cell carcinoma (ccrcc): advanced or recurrent disease. must have failed at least 1 prior systemic therapy * for b-cell non-hodgkin's lymphoma (b-nhl): must have failed at least 1 prior systemic therapy * measurable disease criteria by tumor type: * for ccrcc: at least 1 unidimensional measurable lesion * for b-nhl: at least 1 bidimensionally measurable lesion * prior therapies for advanced/recurrent ccrcc or relapsed/refractory b-nhl or have become intolerant to a systemic therapy * provide archived or fresh tumor tissue for cd70 status. subjects must be cd70+ * provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 b-nhl subjects exclusion criteria: * prior therapy with an anti-cd70 antibody * history of severe hypersensitivity reactions to other monoclonal antibodies * active or untreated central nervous system lymphoma * active infection (viral, bacterial, or fungal) * evidence of bleeding diathesis or coagulopathy * active autoimmune disease requiring immunosuppressive therapy * known current drug or alcohol abuse
an exploratory study of caregiver burden among family caregivers of patients with cancer

Conditions: Caregivers; Cancer

Summary: this study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer.

the goal of this study is to explore caregiver burden and the coping behavior of caregivers of patients with cancer. it has been documented that non-professional caregivers and long-term care providers to patients with cancer receive little preparation, information, or support to perform their vital role. through this study, the investigators will identify the relationship between cognitive dysfunction, resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer. the findings of this study will direct future intervention studies to reduce caregiver burden and improve outcomes for the many individuals caring for family members with cancer.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * self-identified primary caregiver of patients with cancer * co-residence with the patient * providing a minimum of 4 hours of direct care for at least 3 days per week * able to speak, read, and understand english * willing to participate in completion of surveys exclusion criteria: * professional or paid caregivers
vaginal co2 laser and the genitourinary syndrome of menopause

Conditions: Vaginal Atrophy

Summary: this study evaluates the clinical, histopathological, cytological and microbiological efficacy of microablative fractional co2 laser intravaginally administered in postmenopausal women with genitourinary syndrome of menopause. half participants will receive active co2 laser therapy, while the other half will receive placebo co2 laser therapy.


Eligibility criteria:
inclusion criteria: * symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness) * menopause exclusion criteria: * systemic or local hormonal therapy the last 6 months * use of moisturizers or lubricants the last month * active genital infection (i.e herpes, vaginitis) * prolapse stage \>=2 * underlying pathologies that could interfere with the protocol compliance
cardiology prevention in systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: we propose a feasibility study of aggressive cv risk factor management directed by preventive cardiology compared to usual care. we will determine: 1) the efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid imt and plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving cv risk factor target goals. we hypothesize lupus patients randomized to the preventive cardiology program will have less cardiovascular progression over two years than those lupus patients who are given standard care for cardiovascular risk, defined by carotid intima-media thickness and plaque.

we will recruit 30 eligible patients from the lupus center of excellence outpatient clinic. patients will either be randomized into a preventive cardiology program for aggressive treatment, or randomized to usual care (1:1 ratio) in a single-blinded, randomized trial of 24 months duration. in this feasibility trial we hope to identify and refine any limitations in anticipation of designing a larger, randomized intervention study. for both arms of the study, at baseline, 6 month, 12 month, 18 month, and 24 month visits (5 visits in total) all patients will be seen by dr. elliott, principal investigator. visits will include an interview, fasting laboratory tests completion of questionnaires regarding demographics, socioeconomic status, health status, and risk factors (traditional, inflammatory, and lupus-specific). dr. elliott will perform the physical examinations on all patients and complete the lupus-specific disease activity and damage questionnaires. at the baseline visit, 12-month visit, and 24 24-month visits, all patients will have a carotid ultrasound. cohort 1: preventive cardiology program arm: above and beyond the standard care, which is listed below, the patients in this arm will be aggressively treated by the cardiologist. as deemed prudent, the following may be prescribed: antihypertensives, lipid reducing agents, anti-platelets, further cardiac testing, and behavioral modifications. no standard care treatment will be withheld. cohort 2: standard care arm: the pi will send a letter of all testing results to their designated pcp. no standard care treatment will be withheld.

Eligibility criteria:
inclusion criteria: 1. definitive diagnosis of sle 2. \>18 years of age 3. followed by rheumatologists (not the investigator, dr. elliott) at the lupus center of excellence 4. informed consent signed 5. effective form of birth control exclusion criteria: 1. prior cardiovascular disease history (mi, coronary angioplasty, coronary artery bypass graft, abnormal coronary angiography, abnormal nuclear or treadmill stress test) 2. prior evaluation by preventive cardiology 3. active cardiac issues 4. pregnancy, breastfeeding, or anticipating pregnancy in the next 2 years

Keywords: sle lupus cardiovascular imt systemic lupus erythematosus
c1-inhibitor in allergic asthma patients

Conditions: Asthma

Summary: the purpose of this proof-of-concept study is to determine the effect of intestinal microbiota depletion or intravenous administration of c1-inhibitor on inflammation and coagulation after bronchial instillation of house dust mite allergen and lipopolysaccharide in allergic asthma patients

intravenous administration of c1-inhibitor (n=20) or vehicle (n=20). one group of patients (n=20) will receive broad spectrum antibiotics (vancomycin, ciprofloxacin, metronidazole) for 7 days (washout 36 hours before study day). this group will receive the same vehicle as the control group 2 hours prior to challenge. hdm will be administered together with the environmental pollutant lps in a lung subsegment via a bronchoscope (mimicking environmental exposure to hdm); a contralateral lung subsegment will be administered with saline (control side). after 7 hours, bronchoalveolar lavage (bal) fluid will be harvested by a second bronchoscopy. blood samples will be collected before administration of c1-inhibitor or vehicle, and before both bronchoscopies. faeces will be collected prior to antibiotic administration as well as prior to hdm+lps challenge.

Eligibility criteria:
inclusion criteria: * intermittent to mild asthma according to the global initiative for asthma (gina) criteria * allergy for hdm documented by a positive rast and a positive skin prick test. * no clinically significant findings during physical examination and hematological and biochemical screening * at spirometry fev1 more than 70% of predicted value * a pc20 between 0.3 - 9.6 mg/ml (corresponding with increased airway hyperreactivity) * able to communicate well with the investigator and to comply with the requirements of the study * stable asthma without the use of asthma medication 2 weeks prior to the study day. as documented by the juniper's asthma control questionnaire (acq) score \< 1,2. * written informed consent * no current smoking for at least 1 year and less than 10 pack years of smoking history exclusion criteria: * relevant comorbidity, pregnancy and/or recent surgical procedures. * a history of smoking within the last 12 months, or regular consumption of greater than three units of alcohol per day * exacerbation and/ or the use of asthma medication within 2 weeks before start * administration of any investigational drug within 30 days of study initiation * donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation\] * history of venous or arterial thromboembolic disease * history of enhanced bleeding tendency or abnormal clotting test results. * history of serious drug-related reactions, including hypersensitivity * inability to maintain stable without the use of asthma medication 2 weeks before start of the study

Keywords: c1-inhibitor house dust mite complement system
propofol-related euphoria in pain-free gastrointestinal endoscopy patients

Conditions: Propofol; Addictive Behaviors

Summary: to define the prevalence, duration and severity of propofol-associated euphoria in patients undergoing painless gastrointestinal endoscopy and to explore the independent influencing factors by means of a single-center, cross-sectional clinical research study


Eligibility criteria:
inclusion criteria: * proposed to perform painless gi endoscopy, and simple endoscopic maneuvers such as single small polyp clamping, performing hp examination, etc; * gender is not limited; * 18 years old ≤ 80 years old; * asa classification: i-ii; * 18 kg/m2 \&lt;bmi \&lt;30 kg/m2; * informed consent, voluntary participation in the trial, and informed consent signed by the subjects themselves. exclusion criteria: * adjudicated respiratory management difficulties; * history of substance abuse as well as drug use; * participation in a clinical trial of another drug or device within 3 months prior to the screening period * use of therapeutic drugs (e.g., benzodiazepines, opioid analgesics) by the subject within 3 months prior to the screening period for a variety of reasons (e.g., insomnia, pain, etc.) that may have an impact on the outcome of the trial, etc; * allergy or contraindication to the study drug or components thereof; * previous psychiatric or neurological disorders (e.g., schizophrenia, mania, bipolar disorder, psychosis, epilepsy, neuralgia, etc.) and a history of taking medications corresponding to the treatment of the corresponding psychiatric or neurological disorders (e.g., antidepressants, anxiolytics, convulsants, antiepileptic drugs, etc.); * pregnant women; * subjects with severe communication disorders due to severe hearing deterioration; * refusal to participate in this study; * those deemed unsuitable by the investigator.
detection of clinically significant prostate cancer using transperineal targeted biopsy compared to standard transrectal biopsy

Conditions: Prostate Cancer; Magnetic Resonance Imaging; Target Lesion; Fusion Biopsy; Clinically Significant Prostate Cancer; Transperineal

Summary: prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. many biopsies, however, are unnecessary or cannot detect significant prostate cancer (pca). with multi-parametric magnetic resonance imaging (mpmri) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (cspca) while decreasing the detection of non-significant pca.

in men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (psa) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. the hypothesis of this study is that targeted mri/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (cspca) compared with systematic transrectal ultrasound-guided prostate biopsy. patients who fulfill all eligibility criteria and have provided written consent will be randomized to undergo mri followed by biopsies (arm a) or trus transrectal biopsy (arm-b). patients will be randomly assigned to arm a or arm b following a 1:1 simple randomization procedure according to a computer-generated randomization list. the primary end point will be the comparison of detection rates cspca between arm a and arm b. cspca will be defined according to the standards of reporting for mri-targeted biopsy studies (start) criteria for targeted biopsy gleason score ≥ 7 or maximum ccl ≥ 5 mm and the updated epstein criteria for sb (gleason score ≥ 7, psa density ≥ 0.15, gleason score ≥ 2 positive cores, and bilateral cancer). the secondary end points will be (1) comparison of the overall detection rate of pca and cspca between arm a mpmri+ and arm b and (2) comparison of complication rates between arm a mpmri+ and arm b.

Eligibility criteria:
inclusion criteria: 1. males aged 18-75 years old 2. psa \>1 ng/ml but \<15 ng/ml 3. negative dre 4. signed informed consent exclusion criteria: 1. previous prostate biopsy or prostate surgery 2. previous prostate mpmri 3. contraindication to mpmri: patients with pacemakers, defibrillators or other implanted electronic devices 4. patients in the texas department of criminal justice (prisoners) 5. patients with acute urinary symptoms including urinary retention and urinary tract infection

Keywords: prostate cancer magnetic resonance imaging transperineal biopsy target lesion fusion biopsy
glp-1 analogue effects on food cues, stress, motivation for highly palatable foods, and weight

Conditions: Obesity

Summary: to examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.

a randomized, double-blind, placebo-controlled 12-week study with glp-1 analogue (semaglutide) in men and women with obesity (bmi 30-49.9 kg/m2) in a validated laboratory model to identifying processes underlying greater food craving, intake and weight change, in order to test mechanisms by which a glp-1 analogues may exerts significant weight effects in obesity.

Eligibility criteria:
inclusion criteria: * bmi ranging from 30-49.9 kg/m2 * no significant medical problems, including diabetes * no history of hgba1c \<6.5% * english speaking and able to read english and complete study evaluations * able to provide informed written and verbal consent exclusion criteria: * any significant current medical conditions, including neurological, renal, thyroid, cardiovascular, liver, endocrine or immune conditions, including diagnosis of t2dm or t1dm by american diabetes association (ada) criteria * meet current or past dsm-ivr criteria for alcohol dependence or any substance use disorders, including nicotine, or psychiatric disorders, including eating disorders, or use of any psychiatric medications, including anxiolytics, antidepressants, naltrexone or antabuse, anti-smoking medications * current active participation in a weight loss program or weight loss of \>10% of total body weight during the prior 6 months * taking any other anti-obesity medication * history of pancreatitis, medullary thyroid cancer, or men syndrome, or (6) women who are pregnant or lactating, or peri/postmenopausal
time to relapse of iron deficiency anemia after standard treatment with a new intravenous iron (monofer®)

Conditions: Iron Deficiency Anemia

Summary: the purpose of this study is to monitor and quality assure the efficacy and safety of monofer® in a broad patient population when monofer® is used according to the monofer® label (spc) in current practice and where standard routines are being followed.

the total duration of the study is approximately 21 months, which includes a 6 months enrolment period. the number of patient visits depends on the number of monofer® treatment courses needed during the study period. each patient can receive one or more treatment courses during 12 months after informed consent. the last blood test will be taken after the last monofer® treatment course which might occur 13-15 months after informed consent. patients will only attend hospital visits planned as part of their standard treatment and they will receive treatment as a part of standard care and according to the doctor's discretion. study termination will occur once the 12 months observational period has been completed for all patients and the last blood test has been collected from the last monofer® treated patient in the study. each treatment course can consist of one or more monofer® administrations. for each administration of monofer® either intravenous infusion or injection can be used. pre- and post-treatment blood tests according to standard treatment are a part of the monofer® treatment course. data collection: * clinical data management will be performed in accordance with applicable standards and data cleaning procedures. * the collected data will systematically be entered into an ecrf (myedc, biostata). the source of information is the relevant laboratory results obtained from the patient record. * the data will be evaluated by the pharmacosmos a/s medical affairs team. laboratory assessments, i.e. anemia work-up/treatment evaluation, shall be a part of local standard practice. the protocol does not accept any additional samples outside current local standard practice to be taken.

Eligibility criteria:
inclusion criteria: patients with iron deficiency anemia treated on the doctor's discretion with monofer® as standard treatment according to current practice exclusion criteria: none