Kornimate/medical-research-clean huggingface dataset:
aiming for remission in rheumatoid arthritis (ra) - the arctic trial

Conditions: Rheumatoid Arthritis

Summary: the ultimate goal of treatment in early rheumatoid arthritis (ra) is remission, i.e. an absence of signs and symptoms of the disease. however, the optimal way of reaching this goal is not known. ultrasonography (us) is an imaging modality which application is rapidly growing. it has a number of advantages over other advanced imaging techniques such as magnetic resonance imaging (mri), including low cost, good accessibility, and ability to scan many joints in a short period of time. however, the additional benefit of using this modality in terms of patient outcomes has not been demonstrated. thus, clarification is needed if the use of us leads to better care for ra patients. this study will assess if the use of a treatment strategy incorporating information from ultrasonography assessment will allow for better outcomes of patients with ra, than a strategy based on clinical and laboratory assessments alone.


Eligibility criteria:
inclusion criteria (all): * male or non-pregnant, non-nursing female * \> 18 years of age and \< 75 years of age * patients classified as having ra (according to new acr/eular criteria) * disease duration less than 2 years (defined as time from 1st joint swelling) * the treating rheumatologist decides the patient requires treatment with a disease modifying anti-rheumatic drug (dmard) * the patient has taken no prior dmard * patients able and willing to give written informed consent and comply with the requirements of the study protocol exclusion criteria (any): * abnormal renal function (serum creatinine \> 142 µmol/l in female and \> 168 µmol/l in male) * abnormal liver function, active or recent hepatitis, cirrhosis * major co-morbidities like severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease and/or severe respiratory diseases. * leukopenia and/or thrombocytopenia * inadequate birth control conception, pregnancy, and/or breastfeeding * indications of active tuberculosis * psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible

Keywords: rheumatoid arthritis ultrasonography remission imaging remission tight control treat to target
methotrexate polyglutamates as a marker of clinical response and toxicity in the treatment of psoriasis

Conditions: Psoriasis Chronic; Injury of Liver

Summary: methotrexate (mtx) is widely prescribed to treat inflammatory conditions including psoriasis, where it is the recommended first-line systemic therapy in moderate-to-severe disease. approximately 40% of patients with psoriasis have a sub-optimal response to mtx and a significant number experience side effects that may include deranged liver enzymes. there is currently no validated test to predict how patients with psoriasis will respond to mtx, in terms of disease outcome and/or toxicity, or to guide dose escalation in this group.

data for this study is drawn from the bstop (biomarkers of systemic treatment outcomes in psoriasis) cohort. this is a multi-centre, prospective, cohort study to establish clinically relevant biomarkers and pharmacogenetic markers of systemic treatment outcomes in patients with severe psoriasis.

Eligibility criteria:
inclusion criteria: * patients with psoriasis * taking oral or subcutaneous methotrexate * measurement of methotrexate polyglutamates on at least one occasion during therapy. * patients who have given written informed consent exclusion criteria: * unable to consent * not taking methotrexate

Keywords: psoriasis methotrexate methotrexate polyglutamates injury of liver
study of motor control mechanisms in dbs-implanted parkinson's disease patients

Conditions: Parkinson Disease

Summary: akinesia is one of the most prominent symptom in parkinson's disease (pd) patients. it typically consists in a inability to initiate voluntary movement, and it affects patients' quality of life. this study aims at exploring the influence of deep brain stimulation (dbs) in the quality of motor control, and particularly of voluntary movement initiation, and its neural correlates. they will be evaluated using behavioral and motor tasks together with transcranial magnetic stimulation (tms) and electrophysiology (emg and eeg).


Eligibility criteria:
inclusion criteria: * pd patients that are monitored for the tuning of their dbs stimulator by grenoble's hospital. * pd patients that are hospitalized for the tuning routine 12 months after the surgical implantation. * good tolerance following temporary stops of the dbs stimulator * affiliated to a social security system * mental abilities sufficient for performing the behavioral tasks (mmse score \>= 24, tested less than 6 months ago) exclusion criteria: * patients that are concerned by articles l1121-5, l1121-6, l1121-7 and l1121-8 of french code de la santé publique, * history of psychiatric or neurological illness other than pd * patients that are currently excluded from an other clinical trial * contraindications for tms practice * inability to stay seated without pain for two hours * pregnancy
a phase i/ii study of ixo with bevacizumab in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(fu)/leucovorin (lv) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mcrc). the oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-fu/lv in metastatic colorectal cancer. a phase i dose-escalation study established dose limiting toxicity (dlt), maximum tolerated dose (mtd) and recommended phase ii doses (rpiid) of irinotecan, oxaliplatin and capecitabine. this phase i /ii study is to determine dose-limiting toxicities (dlts), maximum tolerated dose (mtd), phase ii recommended dose (rd) of ixo and bevacizumab combination and safety at the rd in an expanded cohort.


Eligibility criteria:
inclusion criteria: * histologically documented adenocarcinoma of the colon or rectum. * advanced and/or metastatic disease, incurable with standard therapy. * unresectable advanced and/or metastatic unidimensionally measurable disease (recist scale). * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * age: over 18 years. * adequate haematological, renal and hepatic functions * patient consent must be obtained according to local reb requirements. * patients must be accessible for treatment and follow up. exclusion criteria: * previous or concurrent malignancies * pregnant or lactating women. women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration. * concurrent treatment with other experimental drugs or anticancer therapy. * previous chemotherapy for advanced and/or metastatic disease. * previous adjuvant therapy with irinotecan or oxaliplatin. * previous full dose curative pelvic radiation therapy. * patients with documented brain metastases. * serious illness or medical condition. * gilbert's disease * use of enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine
sensory analysis and taste modulation of ketone esters

Conditions: Flavor Perception in Normal, Healthy Adults

Summary: ketone ester (ke) drinks are sold commercially in the usa and elsewhere (the fda has accepted a gras (generally regarded as safe) notification on the kes we propose to study). ke drinks can have beneficial effects on metabolism. unfortunately, ke drinks have a strongly unpleasant flavor which can trigger rejection. the current study will generate data to help inform ke drink formulations with improved flavor. first stage, trained subjects will rate the intensity of various sensation qualities (e.g., bitter, sour, metallic, and astringent) from ke drinks to help understand the nature of the unpleasant flavor and the particular sensory systems involved (e.g., taste vs. smell). then, subjects will taste ke drinks with and without various flavor modifiers. subjects will be healthy adults (aged 21-45) without known food allergies.


Eligibility criteria:
inclusion criteria: 1. good general health (self report) 2. men and women 3. age from 21 to 45 exclusion criteria: 1. current (or within the last four weeks) acute illness, such as cold or flu 2. currently active allergies 3. regular use of medication (over the counter or prescription), except for birth control. 4. any history of food allergy or sensitivity (particularly to ke drinks or msg). any history of sensitivity to 6-propylthiouracil (bitter compound frequently used to assess individual differences in sensitivity to bitterness). 5. pregnant, nursing, or trying to become pregnant during the study (pregnancy can affect flavor perception) 6. chronic illness (any ongoing condition that is serious or required medical monitoring), including kidney problems, liver problems, cardiovascular problems (e.g., heart disease or high blood pressure), diabetes, hiv infection, or other ongoing illness). diabetes or other metabolic issues could be important for safety as well as quality of data. 7. history of taste problems (absent or abnormal sense of taste) 8. weigh less than 100 pounds (45.4 kilograms). this is to help ensure that the amount of ke drink consumed remains below the single serving in the gras (generally regarded as safe) notice which the fda has accepted.
electrocardiogram clinical validation study

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to confirm the software's ability to create a lead-1 electrocardiogram (ecg) that is clinically equivalent to a reference device. also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (sinus rhythm or atrial fibrillation) using a single lead ecg.


Eligibility criteria:
inclusion criteria: * individuals who are 22 years of age and older * able to read, understand, and provide written informed consent * willing and able to participate in the study procedures as described in the consent * have a wrist circumference that fits within the band * able to communicate effectively with and follow instructions from the study staff * for subjects enrolled into the af population, subjects must have a known diagnosis of af and be in af at the time of screening exclusion criteria: * physical disability that precludes safe and adequate testing * mental impairment resulting in limited ability to cooperate * subjects with a pacemaker or implantable cardioverter-defibrillator (icd) * acute myocardial infarction (mi) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, increases the risk to the subject or renders data uninterpretable * acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening * stroke or transient ischemic attack within 90 days of screening * subjects taking rhythm control drugs * symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis on both wrists or over electrode attachment sites * known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ecg) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices * a history of abnormal life-threatening rhythms as determined by the investigator * significant tremor that prevents subject from being able to hold still * pregnant women: women who are pregnant at the time of study participation * for subjects enrolled into the sinus rhythm population, they must not have any diagnosis of af
laser acupuncture against nausea in children

Conditions: Nausea; Vomiting; Cancer

Summary: to investigate whether nonthermal low level laser acupuncture has beneficial effects on nausea and vomiting in children receiving highly emetogenic chemotherapy for a malignant solid tumor. in a previous crossover study comparing needle acupuncture to no intervention in an otherwise similar setting we found beneficial effects, but this trial was not even single-blinded and therefore the results are questionable. the hypothesis is that active laser acupuncture is more effective than placebo laser acupuncture concerning episodes of retching/vomiting (primary outcome measure) and rescue antiemetic medication (secondary outcome measure) with a fix standard antiemetic medication


Eligibility criteria:
inclusion criteria: * age 0-17, * highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages) exclusion criteria: * age older than 17 years, * participation in another clinical trial on supportive care

Keywords: cinv chemotherapy induced nausea and vomiting (cinv)
efficiency of two dimensional high definition vs three dimensional endoscopic systems in transanal endoscopic surgery

Conditions: Rectal Adenoma

Summary: introduction: the usual surgical technique for large adenomatous tumors and rectal cancer is anterior resection of the rectum or abdominoperineal resection. these techniques are associated with high mortality and morbidity and with genitourinary dysfunctions. to solve these problems, transanal endoscopic microsurgery (tem) was designed. through its 3-d vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge. it is associated with minimal morbidity and has few repercussions for anal continence. the use of 2-d high definition cameras and screens obtains images of a similar quality to 3-d images. this means that from the surgical point of view the procedure known as teo (transanal endoscopic operation) seems as practicable as classic tem. main aim: to assess the effectiveness of 2-d high definition vision systems (teo) versus conventional 3-d (tem) in endoscopic surgery of rectal tumors, with respect to surgical facility, postoperative morbidity, quality of the surgical specimens, and cost. design: prospective, controlled, randomized study of the efficacy of the use of 2-d high definition endoscopic systems versus 3-d (tem) in transanal endoscopic surgery. disease studied: rectal adenomas and adenocarcinomas "in situ" suitable for local surgery. main variable evaluated: cost per procedure assuming similar surgical efficacy and equal postoperative morbidity. study population and total number of patients: patients diagnosed with rectal tumor treated with curative intent (rectal adenomas and adenocarcinomas "in situ"). the total sample calculated for the trial was 36 patients, 18 in each group (teo and tem). timing and expected finish date: after approval by the ceic, the expected date for the inclusion of the first patient was august 2010. the study is expected to last 18-24 months.


Eligibility criteria:
inclusion criteria: * patients of either sex older than 18 years * rectal tumor identified as rectal adenoma by multifocal biopsy using colonoscopy, with endorectal ultrasound and magnetic resonance imaging findings of non-invasive tumor. * size of the tumor between 2 and 6 cm in maximum diameter. * tumor location, lower edge at least 2 cm from the anal verge, and upper edge at least 15 cm from the anal verge. * asa score more than iii. * intervention was performed under general anesthesia exclusion criteria: * invasive adenocarcinoma shown in the final pathology study. "in situ" or intraepithelial adenocarcinomas are not excluded . * pregnant patients * patients with liver cirrhosis or blood dyscrasia. * patients who can not be administered under general anesthesia. * patients on antiplatelet or anticoagulation therapy who have not been properly prepared for surgery. * presence of two or more transanal endoscopic excisions in the same procedure. * informed consent not signed.

Keywords: transanal endoscopic microsurgery transanal endoscopic operations rectal adenomas transanal endoscopic surgery rectal adenocarcinomas "in situ"
effect of empowerment-based interventions on self-efficacy and self-care capacity among adults with sickle cell disease

Conditions: Self-Efficacy; Self-Care

Summary: this study aimed to to investigate the effect of empowerment-based interventions (ebi) on self-efficacy and self-care capacity among adults with sickle cell disease (scd). the hypotheses of this study were: adults with scd who receive ebi exhibit higher self-efficacy, self- management capacity and hrqol than those who do not.

a pre-test-post-test control group experimental study was conducted at two randomly selected health centers in bahrain using a cluster sampling technique. a sample of 68 out of 122 adults with scd was randomly assigned to two groups. the ebi was implemented through structured small-group discussion sessions, individualized consultations, and follow-up sessions. individualized consultations for self-management were done by adopting the 5a model (assess, advise, agree, assist, and arrange). weekly communication was done to check the patient's progress, and both groups were re-evaluated for self-efficacy and self-care capacity after one month.

Eligibility criteria:
inclusion criteria: * adult patients with scd f * receiving treatment from primary health care facilities * able to read and write * having the chance to attend the educational sessions . exclusion criteria: * a history of mental illness .

Keywords: sickle cell disease self-efficacy self-management activities of daily living
d-dimer levels in pregnant with covid-19

Conditions: COVID-19; D-dimer

Summary: d-dimer measurements act as a global indicator of coagulation and activation of fibrinolytic systems. an optimal cut-off value for d-dimer and its effect on prognosis has not yet been assessed to predict mortality in admission. therefore, studies comparing d-dimer values of covid-19 patients and healthy pregnant women are needed. our study gives us the opportunity to make this comparison.


Eligibility criteria:
inclusion criteria: * pregnant women with covid-19 exclusion criteria: - having a chronic disease that raises d-dimer levels

Keywords: pregnancy covid-19 d-dimer
a study to learn about how loss of liver function affects the blood levels of the study medicine called pf-07817883.

Conditions: COVID-19

Summary: the purpose of the study is to learn about the safety of pf-07817883 and how pf-07817883 is processed in the body of adult participants. these participants will have different degrees of loss of liver function. participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. this study is seeking participants who: * are male or female of 18- 75 years of age * either have different amounts of damage to liver function or for one of the groups, no damage * willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days about, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). in group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4. if participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. if they seem to be eligible for the study, participants will be admitted to a clinic research unit (cru) at least 12 hours before dosing. on day 1, participants will receive a single dose of study medicine (day 1). a series of blood samples will be collected before and after dosing. participants will be discharged from the cru on day 6. a follow-up phone call (on cru visit, if needed), will occur 28-35 days after dosing. the whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.


Eligibility criteria:
inclusion criteria: * (hi cohorts only): stable hi that meets criteria for class a or b of the child-pugh classification; * (all cohorts): bmi of 17.5 to 38.0 kg/m2 exclusion criteria: * any condition possibly affecting drug absorption additional exclusion criteria for hi cohorts only * limited predicted life expectancy * hepatic dysfunction secondary to acute ongoing hepatocellular process. * signs of clinically active grade 2, 3 or 4 hepatic encephalopathy. * severe ascites and/or pleural effusion * history of kidney, liver, or heart transplantation. * persistent severe, uncontrolled hypertension.

Keywords: hepatic impairment covid-19
effectiveness of cognitive processing therapy in pregnant women with a history of pregnancy loss/complication

Conditions: Post-traumatic Stress Disorder; Stress Disorders; Anxiety; Depression

Summary: the purpose of this study is to examine the effects of experiencing a previous pregnancy loss or complication on current physiological and emotional aspects of a current pregnancy.

this study will assess the effectiveness of cognitive processing therapy (cpt) or cognitive behavioral therapy (cbt) among women who are experiencing symptoms of post-traumatic stress disorder (ptsd) and/or anxiety relating to a previous pregnancy loss or complication. lastly, this study includes an option to participate in a procedure whereas startle response will be measured using the eyeblink reflex twice during pregnancy and once in the postpartum period. startle response is examined using a standard acoustic startle procedure whereby heart rate, skin temperature and eye blinking reflex are measured.

Eligibility criteria:
inclusion criteria: * meet dsm-iv (diagnostic and statistical manual of mental disorders) criteria for full ptsd or partial ptsd. * clinician administered ptsd scale (caps) score of ≥18. * gestational age at the time of presentation is between 8 and 30 weeks. * history of at least one of the following: previous pregnancy loss or losses, voluntary termination due to fetal anomaly, obstetrical complication including childbirth, premature birth (\<32 weeks), unexpected neonatal complication, emergency c-section, neonatal death within 28 days of delivery. * fluency in spoken and written english. exclusion criteria: * presence of any lifetime or comorbid dsm-iv axis i psychotic disorder (including bipolar disorder and mdd (major depressive disorder) with psychotic features and excepting psychosis nos (not otherwise specified) related to sensory hallucinations, i.e. reexperiencing symptoms). * presence of any comorbid axis i or axis ii (as determined using the scid-ii (structured clinical interview for dsm-iv)) disorder, which would require immediate treatment or renders the subject clinically unsuitable for this rtc (randomized clinical trial). * history of ptsd due to a non-pregnancy related traumatic event. * presence of a known abnormality in the present fetus. * presence of a serious medical or neurological illness. * starting a new psychotropic agent within the previous 3 months. * assessed to require a new psychotropic medication at the screening appointment or an adjustment in current dose of psychotropic medication.

Keywords: cognitive processing therapy (cpt)