Kornimate/medical-research-clean huggingface dataset:
improving quality of life in early parkinson's disease

Conditions: Parkinson Disease; Depression

Summary: the study will examine 30 patients between ages 50-80, newly diagnosed with early-stage parkinson's disease. patients will be randomized to receive either citalopram or carbidopa-levodopa. the investigators' primary outcome measure will be change in quality of life over a prospective period of 6 months. secondary outcome measures will include change in mood state and motor symptoms, as well as comparison of improvement between two treatments. primary investigators would also like to collect quantitative electroencephalogram (qeeg) recordings, which is a reading of brain activity as an additional interest of this study. primary investigators will assess the qeeg recordings for electrophysiological findings before and after interventions.


Eligibility criteria:
inclusion criteria: * patients aged 50-80 years of age presenting with diagnoses of early stage parkinson's disease (updrs part iii score \<20) without a previous treatment trial of either antidepressants or levodopa and able to provide consent. * screened positive with depressive symptoms suggestive of an underlying mild to moderate major depressive episode on the phq-9 (scores 10-20). exclusion criteria: * currently taking an antidepressant (ssri, snri, tca, maoi), antipsychotic, or dopaminergic parkinson medication, or in the last 8 months. * tremor with a updrs-part iii score of 3 or more. * currently participating in another clinical trial, which might directly influence findings of this study. * inability to provide informed consent. * dementia as defined by montreal cognitive assessment (moca) score of \<24 and/or clinical evidence of dementia. * a lifetime diagnosis of another mental disorder including bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, moderate and severe alcohol use disorder as per chart review or patient self-report. * high risk of suicide (e.g. active suicidal ideation and/or current/recent intent or plan) as per self-report or relevant item on the phq-9. * non-correctable clinically significant sensory impairment. * unstable medical illnesses including delirium, uncontrolled diabetes mellitus, hypertension, and hyperlipidemia or cerebrovascular or cardiovascular risk factors that are not under medical management, including qtc\>480 on electrocardiogram.

Keywords: de novo parkinson disease depression quality of life updrs
ibrutinib for the treatment of aiha in patients with cll/sll or cll-like mbl

Conditions: Autoimmune Hemolytic Anemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Monoclonal B-Cell Lymphocytosis CLL-Type

Summary: this is a multicenter, single arm, phase ii study aimed at evaluating ibrutinib therapy for the treatment of aiha in patients with cll/sll or cll-like mbl.

this is a multicenter, phase ii study to assess the efficacy of ibrutinib for the treatment of aiha in adult patients with cll/sll or cll-like mbl. patients will receive ibrutinib 420 mg/day po for up to 12 cycles of 28 days in the absence of cll progression or unacceptable toxicity. every patient will be followed-up for 1 year after the completion of study treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cll/small lymphocytic lymphoma (sll) or cll-like monoclonal b-cell lymphocytosis (mbl) according to iwcll guidelines. 2. patients \>18 years old 3. active aiha (waiha or cad) that i) is relapsed after previous treatment with corticosteroids (with or without rituximab), or ii) is steroid-resistant (failure to obtain hematologic response within 3 weeks on at least 1 mg/kg predniso(lo)ne), or iii) is steroid-dependent (need to continue on predniso(lo)ne at a dose of \>10 mg/day to maintain a response). aiha is defined as: anemia (hemoglobin ≤10 g/dl; or hemoglobin \>10 g/dl dependent on transfusions to maintain this level of hemoglobin) and laboratory evidence of hemolysis (presence of 3 of 4 markers: increased reticulocyte count, increased indirect bilirubin, increased lactate dehydrogenase, decreased haptoglobin) and positive dat (either igg dat, c3 dat or both). 4. eligibility of patients with dat-negative active aiha should be confirmed by the principal investigator and co-principal investigator for the trial. 5. signed written informed consent according to ich/eu/gcp and national local laws. exclusion criteria: 1. contraindication to ibrutinib therapy as per treating physician's discretion. 2. contraindication to ibrutinib therapy as per ibrutinib data sheet (severe hepatic impairment, known allergy to the drug or to one of the excipients, concomitant treatment with warfarin or other vitamin k antagonists). 3. previous exposure to ibrutinib as cll-directed therapy. 4. other cll/sll- or aiha-directed treatment at the time of enrollment in the study, other than corticosteroids. 5. female patients who are currently in pregnancy or are willing to be pregnant or are lactating.
additive homeopathy in cancer patients

Conditions: Malignant Tumors

Summary: the investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. the investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment. the null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. in addition the investigators evaluate survival time.

the eortc-qlq-c30, sf-36 as well as a vas scale for subjective well-being will be filled out by the patients.

Eligibility criteria:
inclusion criteria: * informed consent * clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (nsclc) iiib, iiic, iv. exclusion criteria: * sensitizing mutation of the egfr gene or translocation of the alk gene * refusal to sign informed consent * pregnancy * hematological, hepatic, or renal pathology * coronary heart disease * history of secondary tumor * major surgery within 4 weeks prior to study entry * active infection and symptomatic peripheral neuropathy * central nervous system metastases unless the metastases were treated and stable * active autoimmune disease * use of systemic immunosuppressive treatment * use of systemic treatment during the previous 2 years * active interstitial lung disease, or a history of pneumonitis for which glucocorticoids were prescribed * previous systemic therapy for metastatic disease or previous irradiation * use of any complementary and/or alternative therapy, including homeopathy other than the research treatment during the trial

Keywords: cancer additive homeopathy patients with advanced malignant tumors
knee joint icing and knee-extension strength

Conditions: Arthroplasty

Summary: with this study the investigators wish to (1) investigate the acute effect of knee joint icing on knee-extension strength shortly after total knee arthroplasty (tka); and (2) investigate the acute effect of knee joint icing on knee pain, knee joint circumference and functional performance shortly after tka.

as knee joint icing had no acute effect on knee-extension strength in the present study, prolonged icing may have an effect on one or more of the parameters, and further studies are needed to determine the potential beneficial effects of cooling after tka.

Eligibility criteria:
inclusion criteria: * primary unilateral total knee arthroplasty exclusion criteria: * inability to speak and understand danish * inability to perform the measurements due to other diseases

Keywords: knee joint icing knee-extension strength
the impact of anesthesia on high- grade glioma patients

Conditions: Anesthesia, Outcome, High-grade Glioma

Summary: although bench data and retrospective studies have provided a promising picture of the possible influence of anesthetic technique on the risk of tumor progression and patients mortality, current evidence from rcts is inadequate to show whether the type of anesthetics might influence tumor progression and patient survival.there are many thousands of patients with a cancer diagnosis undergoing surgery every year, and in the context of biological plausibility, it should lead to the urgent undertaking of rcts to further evaluate the association between the anesthetic management and patient outcome.

although bench data and retrospective studies have provided a promising picture of the possible influence of anesthetic technique on the risk of tumor progression and patient mortality, current evidence from rcts is inadequate to show whether the type of anesthetics might influence the outcome of the patients.there are many thousands of patients with a cancer diagnosis undergoing surgery every year, and in the context of biological plausibility, it should lead to the urgent undertaking of rcts to further evaluate the association between the anesthetic management and patient outcome.

Eligibility criteria:
inclusion criteria: 1)magnetic radiology imaging diagnosis of supratentorial high-grade glioma; 2) patients undergoing tumor resection under selective general anesthesia; 3) age 18-80 years old; 4) preoperative kps \< 80; 5) with written informed consent by patients or their relatives. exclusion criteria: 1) history of other operations before; 2) patients with recurrence and metastasis of gliomas or with malignant tumors of other organs; 3) emergency operation; 4) critical condition (asa grade ≥ v before operation, appendix 1, severe liver and kidney dysfunction; 5) patients with mental illness, severe dementia, language disorder, coma, and end-stage disease, etc.; 6) pregnant or breastfeeding women; 7) allergic to study drugs;8) patients who need electrophysiological monitoring during operation. 9) patients receiving reoperation with different anesthesia methods will be removed and the patients with the same anesthesia method will be continued to observe; 10) postoperative pathological result is not high-grade glioma.
multicenter study evaluating certolizumab pegol compared to placebo in subjects with axspa without x-ray evidence of as

Conditions: Axial Spondyloarthritis; Nonradiographic Axial Spondyloarthritis; Nr-axSpA

Summary: patients with active axial spondyloarthritis without x-ray evidence of ankylosing spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (czp) 200 mg every two weeks or placebo. the primary objective is to demonstrate the efficacy of czp in these patients.


Eligibility criteria:
inclusion criteria: * at least 18 years old at the start of screening visit * a documented diagnosis of adult-onset axial spondyloarthritis (axspa) and meet the assessment of spondyloarthritis international society (asas) criteria for axspa * subjects must have had back pain for at least 12 months before screening * no sacroiliitis defined by modified new york (mny) criteria on sacroiliac (si) x-rays * active disease at screening as defined by * bath ankylosing spondylitis disease activity index (basdai) score \>= 4 * spinal pain \>= 4 on a 0 to 10 numerical rating scale (nrs) * inadequate response to, have a contraindication to, or have been intolerant to at least 2 nonsteroidal anti-inflammatory drugs (nsaids) exclusion criteria: * diagnosis of as or any other inflammatory arthritis * prior treatment with any experimental biological agents for treatment of axial spondyloarthritis (spa) * exposure to more than 1 tumor necrosis factor (tnf)-antagonist or primary failure to tnf antagonist therapy * history of or current chronic or recurrent infections * subjects with known tuberculosis (tb) infection, at high risk of acquiring tb infection, or latent tuberculosis (ltb) * recent live vaccination * concurrent malignancy or a history of malignancy * class iii or iv congestive heart failure - new york heart association (nyha) * demyelinating disease of the central nervous system * female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product * subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Keywords: axial spondyloarthritis axspa ankylosing spondylitis anti tnf-alpha certolizumab pegol nr-axspa non-radiographic spondylarthropathies arthritis spinal diseases immunosuppressive agents
parecoxib in total knee arthroplasty

Conditions: Pain, Postoperative; Pain, Acute; Analgesia; Analgesic Nephropathy; Analgesic Adverse Reaction; Knee Osteoarthritis

Summary: early mobilization and rehabilitation can be difficult after total knee arthroplasty (tka) due to a high incidence of moderate to severe postoperative pain. non-steroidal anti-inflammatory drugs (nsaids) are important to multimodal analgesic protocols. parecoxib is an nsaid that selectively inhibits the enzyme cyclooxygenase-2 (cox-2). clinical trials have shown that it does not alter platelet function or gastric mucosa. a recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group. this randomized study will compare the effectiveness of adding a cox-2 inhibitor in the pain management of patients undergoing tka as part of a multimodal analgesia regimen. the morphine consumption was selected as the primary outcome. the study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.


Eligibility criteria:
inclusion criteria: asa i - iii bmi 20 - 35 (kg/m2) exclusion criteria: * adults who are not capable of giving their own consent * pre-existing neuropathy (assessed in the history and physical examination) * coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50) * renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl) * hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (ggt ≥ 50 u/lt) * allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib * pregnancy * chronic pain syndromes that require the use of opioids at home * known history of sulfa allergy * history of ischemic heart disease * history of chronic gastritis or peptic ulcer
the oxidative stress, inflammatory markers, and metabolomics response to exercise in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise.

chronic obstructive pulmonary disease (copd), one of the major causes of morbidity and mortality, is a preventable and curable disease characterized by irreversible airflow limitation. the progressive lung involvement, systemic inflammation, respiratory and peripheral muscle dysfunction, loss of muscle mass, and the dysfunction of the remaining muscles occur in copd. muscle dysfunction, which is defined as loss of strength or loss of endurance characteristics in muscles, is a comorbidity associated with poor outcomes such as frequent hospitalization and decreased survival, as well as adversely affecting exercise capacity and quality of life. exercise increases mitochondrial activity and requires antioxidant defense to achieve cellular redox regulation. the effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. oxidative stress, inflammatory markers, and metabolic responses to different acute exercise modalities in copd patients need to be examined and clarified. therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise. detection of biomolecules that change with acute exercise may also contribute to the identification of exercise-related pathways.

Eligibility criteria:
inclusion criteria: * diagnosis of copd (clinically stable) * being 40-80 years of age * able and willing to complete the informed consent process. exclusion criteria: * to have severe neuromuscular, musculoskeletal and rheumatic problems * unable to cooperate
remote magnetic versus manual navigation-guided ablation for non-outflow tract premature ventricular contractions: a prospective, randomized, controlled trial

Conditions: Premature Ventricular Contraction

Summary: this prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.


Eligibility criteria:
inclusion criteria: 1. non-outflow tract pvcs 2. holter\>10,000/24h or pvcs load\>10% 3. the first ablation procedure 4. failure of at least one aad to treat pvcs before ablation exclusion criteria: 1. pvc ablation history 2. hf with nyha iv 3. 3 months prior to ami or pci 4. cardiac thrombosi 5. hyperthyroidism 6. pregnancy
immune response in patients who have undergone vaccine therapy for stage iii or stage iv breast cancer that overexpresses her2

Conditions: Breast Cancer

Summary: rationale: studying the immune response to a vaccine made from her2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses her2. purpose: this clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage iii or stage iv breast cancer that overexpresses her2.

objectives: primary * determine whether immunologic memory to the her-2/neu (her2) intracellular domain (icd) protein has been generated by active immunization with a her2 icd plasmid-based vaccine by assessing the delayed-type hypersensitivity response to her2 icd peptides 6 months after vaccination in patients with her2-overexpressing stage iii or iv breast cancer. secondary * characterize the memory t-cell population and quantitate memory precursor frequency at 3, 6, and 12 months after active immunization using intracellular cytokine staining. outline: this is an open-label study. patients receive her2 intracellular domain (icd) protein mixture intradermally and sterile water injected intradermally (as a negative control) at 6 months post-vaccination with pngvl3-hicd vaccine. vital signs and injection site will be monitored prior to skin test and at 60 minutes post-test. patients return 48-72 hours after skin test for delayed-type hypersensitivity (dth) measurements. the injection site is biopsied and examined by immunohistochemistry for infiltrating t-cell and antigen-presenting cell populations. blood is drawn at 3, 6, and 12 months post-vaccination for assessment of immune memory response. blood draws are coordinated with parent study. blood samples are examined by flow cytometry for the presence of memory markers including l-selectin, cd45 isoforms, cytokines, and ccr7. projected accrual: a total of 56 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of stage iii/iv breast cancer * completed chemotherapy * receiving trastuzumab (herceptin®) monotherapy * successful completion of her-2/neu (her2) intracellular domain (icd) plasmid-based vaccine trial (protocol 01-9773-d06: "a phase i safety and efficacy trial of a dna plasmid based vaccine encoding the her-2/neu intracellular domain in subjects with her-2/neu-overexpressing tumors") within the past 3 months * hormone receptor status not specified patient characteristics: * male or female (male patients are not excluded) * menopausal status not specified * zubrod performance status 0 * unable to bear children (female patients) prior concurrent therapy: * see disease characteristics * no cytoreductive chemotherapy within the past 30 days * no cytotoxic treatment and/or systemic corticosteroids within the past month * concurrent local radiotherapy or hormonal therapy allowed

Keywords: stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer male breast cancer
prevention of gastric ulcers

Conditions: NSAID Associated Gastric Ulcers

Summary: nonsteroidal anti-inflammatory drugs (nsaids) are often associated with gastric ulcers. this study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk.


Eligibility criteria:
inclusion criteria: 1. no gastric or duodenal ulcer on baseline endoscopy. 2. a clinical diagnosis of a chronic condition that requires daily nsaid treatment for at least 6 months. 3. other inclusion criteria, as defined in the protocol. exclusion criteria: 1. history of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer. 2. history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. 3. other criteria, as defined in the protocol.

Keywords: nsaid, nexium, esomeprazole, gastric ulcers
usability study of the focus touch™ conception system: semen collection

Conditions: Infertility

Summary: this is a human factors usability study designed to validated usability by obtaining feedback in a home use environment regarding ease of use of the focus touch™ conception system conceptacle (when used to collect semen) and the instructions for use. the investigators will collect data to demonstrate that the usability requirements of the conception system as collection device, as determined by usability specification: focus touch conception system, er-000001 have been met. the ability of the device to be used during sexual intercourse without discomfort or injury to the female participant's vaginal/cervical tissues shall also be taken into account. participating couples will be asked to use the focus touch™ conception system conceptacle (in condom form), using the instructions for use, to collect semen during sexual intercourse in a home use environment. this study will involve sexual intercourse between monogamous, heterosexual couples who are trying to conceive or are on a non-vaginal birth control with which they do not normally use condoms. participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. contact information shall be collected, but participants will only be contacted if they fail to return the questionnaire within the requested timeframe.


Eligibility criteria:
inclusion criteria: * heterosexual, monogamous couples, of any race or ethnicity, who are sexually active * 20 - 50 years of age * signed informed consent * past experience with using condoms * trying to conceive or using a non-vaginal birth control with which they do not normally use a condom. exclusion criteria: * vaginal tract medical interventions with the last three (3) month * vaginal prolapse * full hysterectomy

Keywords: cervical cap insemination collection condom instructions for use safety during intercourse acceptability of the cervical cap with condom sheath slip break ease of conversion adequate sample collection