Kornimate/medical-research-clean huggingface dataset:
a single session pain psychology class for spine surgery patients

Conditions: Lumbar; Injury

Summary: this project tests the feasibility a single session pain psychology class (trek for surgical success) for patients undergoing spine surgery and compares outcomes in those who engage in the class to a historical group of similar patients undergoing usual care perioperatively. as of january 2020, the class option has been updated to include an online video module platform, to be used for patients unable to attend in person.

the proposed study intends to utilize a psychobehavioral protocol from darnall and colleagues to deliver a single session behavioral medicine for pain intervention for the spine surgery patient entitled "trek (transform, restore, empower, knowledge) for surgical success" (trek for ss). the intervention is based off of the above noted evidence based 2 hour pain psychology class that has been used in the chronic pain population and is also currently being tested in other surgical populations. use of this established and evidenced based treatment for the proposed project enhances the treatment fidelity. the proposed project addresses questions in the literature such as the benefits of this class in an in-person or online format and its adaptability and effectiveness in the spine surgery population. the primary objective of the proposed project is to determine the feasibility of a single session digital behavioral medicine for pain intervention (trek for ss) offered the perioperative period of lumbar spine surgery as measured by patient satisfaction and intervention acceptability ratings and retention rates. in this study the perioperative period is defined as a 8 week window straddling the surgery date. a secondary objective of the study is to gather preliminary data to support the efficacy of trek for ss as measured by relevant post surgical outcomes compared to a group of historical controls who received usual care. should this pilot study demonstrate effectiveness in lumbar spine surgery patients, there is the potential to study larger groups of patients and to integrate the class into the standard of care as a cost-effective intervention for the spine surgery population. additionally, findings from this pilot study could substantiate the need for training in the class protocol across disciplines so that barriers to receiving pain psychology intervention can be minimized.

Eligibility criteria:
inclusion criteria: * adults 18 and older * undergoing lumbar laminectomy with or without fusion exclusion criteria: * none
assess the effectiveness and safety of lipovirtide combined with nucleoside drugs in hiv-infected patients.

Conditions: HIV

Summary: a randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of lipovirtide combined with nucleoside drugs in hiv-infected patients who have not received antiviral treatment before.

multiple sites, randomized, open-label, controlled study design. 64 eligible subjects will be enrolled in this study, and they will be randomly assigned to each group in a 1:1:1:1 proportion, 16 subjects in each group. each site will compete to enroll subjects. the 4 groups are as follows： group a：lipovirtide 10mg+3tc+tdf（lp-80：once a week；3tc+tdf：once daily）； group b：lipovirtide 40mg+3tc+tdf（lp-80：once a week；3tc+tdf：once daily）； group c：lipovirtide 60mg+3tc+tdf（lp-80：once every 2 weeks；3tc+tdf：once daily）； group d：dtg +3tc + tdf（once daily）.

Eligibility criteria:
inclusion criteria: 1. age≥18 years (including the critical value) when signed the informed consent form ,.male or female. 2. untreated, confirmed hiv-1 infected patients; 3. hiv rna viral load≥1000 copies/ml； 4. cd4+ t cell counts≥200 cells/mm3； 5. subjects who have no plans for conception within the 2 weeks prior to screening and 3 months after the end of the trial, and who agree to use effective non-pharmacological contraceptive measures during the trial; 6. sign informed consent prior to the test and fully understand the purpose, nature, methods, and possible adverse reactions, and be willing to participate in the study. exclusion criteria: 1. subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug; 2. subjects with severe opportunistic infections or opportunistic tumors; 3. subjects with confirmed aids or in the acute infection stage; 4. hepatitis b virus surface antigen (hbsag)/hepatitis c virus antibody (hcv-ab) positive; 5. alt and/or ast≥5×uln； 6. alt≥3×uln and total bilirubin≥2×uln (direct bilirubin/total bilirubin\>35%; 7. gfr\<70ml/min/1.73m2 (estimated from creatinine values based on the ckd-epi creatinine 2009 equation), or creatinine ≥uln; 8. subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases; 9. subjects with a pancreatitis disease history ever before; 10. subjects who are pregnant or lactating women; 11. subjects with a history of drug abuse, alcoholism, or substance misuse; 12. any clinical trials in the 3 months prior to the screening of the trial; 13）subjects may not be able to complete this study or other investigators' judgment for other reasons.

Keywords: lipovirtide hiv nucleoside drugs
c-patrol - non-interventional study (nis) to collect clinical and patient reported outcome data in an olaparib treated brcam+ psr ovarian cancer population

Conditions: Ovarian Cancer, Hereditary Ovarian Cancer Syndrome

Summary: the main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with brcam+ (breast cancer gene(s) mutation positive) platinum sensitive relapsed (psr) ovarian cancer in german hospitals and outpatient practices treated with olaparib.


Eligibility criteria:
inclusion criteria: * signed written informed consent * women aged ≥ 18 years * patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. patients must be currently in response to platinum-based chemotherapy. for the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course. * documented brca mutations (germline and/or somatic mutation in brca1 (breast cancer gene 1) and/or brca2 (breast cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) * patients should be in line with the specifications mentioned in the german lynparza (olaparib) smpc (summary product characteristics) for hard capsules or tablets. * patients are able to read and understand german, english, turkish or arabic exclusion criteria: * known hypersensitivity to olaparib or any of the excipients of the drug * patients who have started olaparib monotherapy for more than 14 days before giving their informed consent * pregnancy or breast feeding

Keywords: ovarian cancer, fallopian tube cancer, primary peritoneal cancer, brca1 gene, brca2 gene
target engagement for oxytocin: dose ranging study

Conditions: Schizophrenia Spectrum

Summary: this study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two proposed measures of target engagement in brain. the targets are (1) the suppression of a particular wave form (mu) on the electroencephalogram (eeg) while subjects observe a socially relevant form of motion and (2) pupil dilation will subjects identify faces showing different emotions.

subjects with schizophrenia spectrum disorders will be randomly assigned to one of 8 doses of oxytocin. after screening and informed consent subjects will receive either their assigned dose or a placebo. thirty minutes following the drug administration patients will be evaluated on the eeg and pupillometry tasks followed by two tests that evaluate social salience. one week later subjects will have a second challenge in the alternative (drug or placebo) condition.

Eligibility criteria:
inclusion criteria: * schizophrenia, schizoaffective disorder, delusional disorder * able to cooperate with study procedures exclusion criteria: * serious medical condition or substance use * pregnancy

Keywords: psychosis schizophrenia oxytocin
dysmenorrhea of emotional freedom techniques (eft) and its effect on perceived stress level

Conditions: Dysmenorrhea Primary; Stress; Emotional Freedom

Summary: the aim of the study is to determine the effect of eft application on the level of dysmenorrhea and stress perception in women with dysmenorrhea. for this purpose, eft will be applied to women with dysmenorrhea with high stress perception assigned to the experimental and control groups, and their stress perceptions and dysmenorrhea levels will be re-evaluated after the application. perceived stress scale (pss) and visual analog scale (vas) will be used in the research.

application of the experimental group the women in the experimental group will be informed about the function, click points and application of eft through a written material. the eft application will be explained practically by a certified researcher and the application steps will be followed. women who underwent eft will be contacted again within a week or two and asked how they feel and feedback will be received about whether the problem or problems during the first meeting still bother them. by asking women to show how they feel on the sue scale, the eft application will be repeated until the woman expresses positive emotions on the sue scale. the number of eft applications will be decided according to the woman's condition. after the eft application is completed, the woman will be re-evaluated with vas and pss in the 1st and 2nd months. it will be recorded and reported as perceived stress when assessing the eft practitioner researcher's certification is s.e.m. it is a certificate with a total scope of 50 hours, including face-to-face training, issued by the academy considering international education standards and criteria. the training was given by a trainer with a trainer certificate on eft. the researcher, who has a nationally and internationally valid certificate, has prepared a guideline in parallel with the training he has received, received expert opinions on the guideline and will carry out its pilot application. application of the control group a meeting will be held with the women in the control group at the beginning of the research and information will be given about the study. the researcher will open a whatsapp group for the women in the control group and follow them to eliminate their lack of information. throughout the research, women in the control group will continue their routine coping habits regarding dysmenorrhea and perceived stress levels, and this group, like the experimental group, will be re-evaluated with vas and pss in the 1st and 2nd months of the research.

Eligibility criteria:
inclusion criteria: * must be between 18-49 years old and single, * must be literate and willing to participate in the study, * there should be no wounds, scars or infections in the area where eft will be applied. * the perceived stress level must be high and they must be experiencing dysmenorrhea exclusion criteria: * there should be no change in menstrual cycle in the last six months, * there must be no communication problems or illnesses that may prevent work.
novel biomarkers in chronic airway diseases

Conditions: Asthma; COPD

Summary: the purpose of this study is: * to define the differences of bio-chemical phenotypes in chronic airway inflammatory diseases. * to identify novel biomarkers in chronic airway inflammatory diseases as a screening, diagnostic, or monitoring marker.


Eligibility criteria:
inclusion criteria: * \> 18 years olds * both sexes * asthma or copd was diagnosed according to the criteria of the american thoracic society, gina, gold guideline * acute exacerbation was defined by the criteria of the american thoracic society, gina, gold guideline * for stable disease, none of the subjects had received inhaled or oral corticosteroids or any other anti-inflammatory drugs, had an exacerbation history in the previous 6 months
phase ii study of the trifunctional antibody catumaxomab administered intra- and postoperatively in patients with ovarian cancer

Conditions: Ovarian Cancer; Epithelial Ovarian Cancer

Summary: primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

an open label, multi-center, single-arm, phase ii study according to fleming´s one-stage design. the surgical procedure on day 0 will be performed according to ago state of the art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. the discharge visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the end of study visit on day 30. catumaxomab is a trifunctional antibody targeting epcam on tumor cells and cd3 on t cells. trifunctional antibodies represent a new concept for targeted anticancer therapy. this new antibody class has the capability to redirect t cells and accessory cells (e.g. macrophages, dendritic cells \[dcs\] and natural killer \[nk\] cells) to the tumor site. according to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent form before any protocol-specific screening procedures * patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (figo ia(g2-g3) - iv) * karnofsky index \> or equal 70 * female at an age of 18 years or older * negative pregnancy test exclusion criteria: * exposure to prior cancer therapy specific for ovarian cancer * previos treatment with non-humanized mouse or rat monoclonal antibodies * known / suspected hypersensitivity to catumaxomab or similar antibodies * second malignangcy within the last 5 years * presence of constant immunosuppressive therapy * presence of symptomatic heart failure or occlusive arterial diseases * inadequate renal or hepatic function * presence of any acute or chronic systemic infection

Keywords: ovarian cancer catumaxomab phase ii intraoperative adjuvant trifunctional antibody
procalcitonin ratio's impact on the decision upon on-demand relaparotomy in septic peritonitis

Conditions: Secondary Peritonitis After Intestinal Perforation

Summary: procalcitonin (pct) serum levels are monitored in patients with secondary peritonitis after initial operative focus elimination to investigate the pct ratio's impact on decision-making for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic peritonitis.


Eligibility criteria:
inclusion criteria: * age \>18 years * necessity for operative intervention to eliminate an infectious peritoneal / abdominal focus after organ perforation * abdominal sepsis according to the american college of chest physicians/society of critical care medicine consensus conference definition exclusion criteria: * pregnancy * immunosuppressive medication

Keywords: on-demand relaparotomy pct procalcitonin peritonitis sepsis focus index
mk-8527 single-dose trial in hiv-1 infected participants (mk-8527-004)

Conditions: Human Immunodeficiency Virus

Summary: this is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of mk-8527 in antiretroviral therapy (art)-naïve participants living with human immunodeficiency virus type 1 (hiv-1) infection. the primary hypothesis is that, at a dose that is safe and generally well tolerated, mk-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma hiv-1 ribonucleic acid (rna) of ≥1.0 log10 copies/ml. a total of 4 arms was initially planned but arm d was never initiated as the primary objectives were achieved following completion of arms a to c.


Eligibility criteria:
inclusion criteria: * is in good health other than hiv-1 infection * is documented hiv-1 positive * is art-naïve, which is defined as not having received any marketed antiretroviral agent for treatment of hiv-1 infection (prior use of an art for prep or investigational therapy is permitted if the last dose was ≥30 days prior to study drug administration) * is willing to receive no other art for the monitoring period of this study exclusion criteria: * has a history of clinically significant endocrine, gi, cardiovascular, hematological, hepatic, immunological (outside of hiv-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit * has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
cysteine-lowering treatment with mesna

Conditions: Obesity; Drug Effect

Summary: the primary objective of this study is to determine the efficacy of the drug mesna® (uromitexan) in healthy participants with overweight or obesity with respect to change in plasma concentrations of total cysteine, following single ascending doses of oral mesna.

in both animal experiments and human studies, cysteine in the blood is strongly associated with obesity. in rodents, changes in cysteine induced by dietary means are accompanied by changes in fat mass. in this phase i, single ascending dose study the investigators will determine the effects of mesna in healthy volunteers with overweight and obesity with focus on its effects on plasma total cysteine concentrations. the aim of this dose-finding clinical trial is to determine the lowest single oral mesna dose that will lower plasma total cysteine concentrations by 30% using pharmacokinetic (pk)/ pharmacodynamic (pd) modelling. the investigators will further evaluate the effect of mesna on plasma cysteine fractions and related metabolites, urinary cysteine excretion, safety and adverse drug reactions, and plasma biomarkers.

Eligibility criteria:
inclusion criteria: * bmi between bmi 27-40 kg/m2 * age between 18-55 years * male * healthy as determined by medical evaluation, medical history, physical examination, 12-lead ecg, and laboratory tests exclusion criteria: * presence of chronic disease * chronic drug use * past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing * veganism * strenuous physical activity ≥3 times every week * smoking

Keywords: cysteine phase 1 mesna
acute intermittent porphyria related abnormalities in cardiovascular system

Conditions: Porphyrias, Hepatic

Summary: this study aims to assess the changes in the cardiovascular system in patients with acute intermittent porphyria (aip).

porphyrias are heterogeneous group of the disorders of heme biosynthesis. acute intermittent porphyria (aip) is the most common acute hepatic porphyria, caused by the mutations in the gene encoding hydroxymethylbilane synthase. clinical symptoms i.e. abdominal pain, nausea, vomiting, paresis or paralysis, coma and/or mental abnormalities may be induced by many porphyrinogenic factors, such as drugs, alcohol, starvation or stress. the symptoms are often accompanied by tachycardia and elevated blood pressure. due to the non-specific clinical picture, aip is often diagnosed too late and causes a threat to the patients' lives. there is a scarcity of data regarding the changes in cardiovascular system in patients with aip. the aim of this study is to assess the structure and function of heart in patients with this disease. the prevalence of hypertension, cardiac arrhythmias and selected cardiovascular risk factors in patients with aip will also be evaluated. this is a case-control study with prospective observation of the subgroup of patients examined during the exacerbations of aip. specific goals: * assessment of the cardiac morphology and function, * assessment of the concentrations of markers of myocardial injury (troponin t) and heart failure (nt-probnp), * assessment of the prevalence of cardiac arrhythmias and electrocardiographic abnormalities, * assessment of the blood pressure profiles, * assessment of selected cardiovascular risk factors, * assessment of quality of life, * assessment of clinical and biochemical factors associated with the pathological findings in patients with aip.

Eligibility criteria:
inclusion criteria: * acute intermittent porphyria (aip), * age 18-65 years, * at least one hospitalization due to exacerbation of aip. exclusion criteria: * previous myocardial infarction, * heart failure of established (other than porphyria) etiology, * severe heart valve disease, * congenital heart defects, * history of myocarditis, * pacemaker, * hyperthyroidism / hypothyroidism (except for adequate thyroid hormone replacement therapy), * chronic advanced lung diseases, * lack of consent to participate in the study.

Keywords: acute intermittent porphyria myocardial injury heart failure hypertension cardiac arrhythmia cardiovascular risk factors lipid profile quality of life