Kornimate/medical-research-clean huggingface dataset:
study evaluating the clinical and therapeutic management of rheumatoid arthritis in spain

Conditions: Rheumatoid Arthritis

Summary: this is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (ra) in usual clinical practice in spain. two groups of patients will be analyzed: individuals who have had ra for two years or less (the "early ra" group) and individuals who have had ra for more than 2 years and who currently meet the acr criteria for ra (the "established ra" group).


Eligibility criteria:
inclusion criteria: * group 1: early ra : patients with disease lasting 2 years or less, considered by the investigator as an early ra * group 2: established ra: patients with disease lasting more than 2 years who meet the acr criteria for ra exclusion criteria: * patients with any rheumatic disease different from ra * participation in any clinical trial or study in the last 12 months
combination anticancer therapy of paclitaxel and everolimus for relapsed or refractory small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the objective of this phase i study is to determine the maximum tolerated dose (mtd) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history.

small cell lung cancer (sclc) accounts for 15% to 20% of all lung cancer, and more than half of these patients are diagnosed with extensive-stage disease (ed). sclc is a particularly aggressive form of lung cancer with a tendency for rapid tumor growth, early dissemination and high frequency of the metastasis in this study, we evaluate the mtd of everolimus combined with paclitaxel combination chemotherapy in sclc.

Eligibility criteria:
inclusion criteria: 1. patients with histologically or cytologically confirmed small cell lung cancer 2. regarding a limited disease, the disease in a patient, who had concurrent chemoradiation therapy before, is relapsed or progressing, the patient should have received the first line platinum-based anticancer therapy. the disease should be progressing/relapsed during or after the previous treatment. 3. regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed. 4. patient with asymptomatic or treated brain metastasis. 5. patients without current concomitant chemotherapy 6. patients without current concomitant radiotherapy 7. patients who are not receiving chronic treatment with steroids or another immunosuppressive agent. 8. patients with at least one measurable lesion according to the response evaluation criteria in solid tumors (recist). 9. patients aged 18 years or older 10. ecog performance status 0-2 11. adequate organ function as evidenced by the following; absolute neutrophil count \> 1.5 x 109/l; platelets \> 100 x 109/l; hemoglobin \> 9g/dl; -; total bilirubin ≤1.5 unl; ast and/or alt \< 5 unl; creatinine clearance ≥ 50ml/min. 12. patients who signed and dated the informed consent form prior to specific study procedures. 13. patients who can comply with the scheduled follow-up and toxicity management procedure.' exclusion criteria: 1. patients with history of treatment with mtor inhibitors 2. pregnant with gastrointestinal problem impairing absorption of drugs 3. patients who could not use appropriate method of contraception 4. pregnant or feeding patients 5. other medically ill patients 6. severe heart/pulmonary disease 7. dm patients 8. other malignancy except cured skin cancer or uterine cervix carcinoma in situ 9. high cholesterolemia greater than grade 3 10. patients with symptomatic brain metastasis 11. chronic hepatitis or liver cirrhosis (patients with hbsag positive, igm anti-hbc positive or hcv ab positive) 12. patients receiving immunosuppressant

Keywords: relapsed or refractory small cell lung cancer paclitaxel everolimus
hydroxyurea in the treatment of sickle cell disease

Conditions: Sickle Cell Disease

Summary: this is a retrospective cohort study of sickle cell disease (scd) patients attending 32 treatment centers across italy. the aim of this study will be to report the italian experience with the use of hydroxyurea in a large cohort of scd patients and to evaluate the benefits and safety of this intervention for the prevention and management of a wide range of clinical morbidities

the indication for hydroxyurea initiation was 2-3 vaso-occlusive crisis and/or hospitalizations in the last year. the study will analyze demographics (age and gender), origin, genotype, clinical phenotype (vaso-occlusive or hemolytic), transfusion history (including exchange), and folic acid use, average laboratory values up to three years pre-hydroxyurea and for the period post-hydroxyurea therapy including total hemoglobin level, fetal hemoglobin level, hemoglobin s level, white blood count, platelet count, lactate dehydrogenase level, total and direct bilirubin levels, aspartate and alanine aminotransferase levels, and serum creatinine level. the incidence of complications pre- and post-hydroxyurea therapy will be also analyzed including: stroke, silent cerebral infraction, acute chest syndrome, vaso-occlusive crisis, hospitalization, pulmonary hypertension, leg ulcers, bone necrosis, and kidney injury. safety data included adverse events as reported by the treating physician and the incidence of malignancy or death as well as pregnancy incidents and their outcomes will be also pointed out.

Eligibility criteria:
inclusion criteria: * sickle cell disease affected patients * 2-3 vaso-occlusive crisis and/or hospitalizations in the last year exclusion criteria * none

Keywords: sickle cell disease hydroxyurea
clean intermittant self catheterisation: a trial comparing single use vs reuse of nelaton catheters

Conditions: Urinary Retention

Summary: the purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.

patients with voiding dysfunction and chronic urinary retention are taught the technique clean intermittent self catheterisation (cisc) by specialist nurse continence advisors. for several decades, patients have been taught to catheterise using a "clean" technique where they rinse their catheter under tap water and store the catheter in a sterile solution (e.g. milton). the catheter is re-used for up to one week. the risk of urinary tract infection (uti) was known to be minimal (and certainly much less than having a permanent indwelling catheter). recently, the therapeutics goods administration has issued a guideline that cisc catheters should be "single-use items" but no data to support this guideline appears to have been collected. the aim of this project is to assess the incidence of urinary tract infection (uti) when comparing single-use catheters with re-use of catheters for cisc, and to determine the cost differences between the two methods.

Eligibility criteria:
inclusion criteria: * over 18 years old * cisc \> 2/day * no current symptomatic uti * willing to change catheter use method exclusion criteria: * symptomatic urinary tract infection despite treatment * \<18 years old

Keywords: urinary retention cisc single use re use
outcomes in bone marrow aplasia.

Conditions: Aplastic Anemia Idiopathic

Summary: bone marrow aplasia, also known as aplastic anemia (aa) is a potentially fatal bone marrow failure syndrome characterized by a paucity of hematopoietic stem cells (hscs) and progenitor cells with varying degrees of cytopenia and fatty infiltration of the bone marrow space. underlying mechanisms include immune-mediated attack, telomere defects, and inherent hsc compartment insufficiency. these events may occur individually or in concert, mostly involving effector t cells historical treatment has included the use of high-dose chemotherapy and allogeneic stem cell transplantation as well as lymphotoxic immunosuppressive therapy (ist) thrombopoietin (tpo) regulates platelet production, maturation, and release through binding of c-mpl on megakaryocytes.

eltrombopag (e-pag) is an oral synthetic small-molecule, noncompetitive, tpo agonist that initially was approved by the us food and drug administration (fda) for the treatment of chronic immune thrombocytopenic purpura. single-agent activity of e-pag was demonstrated in at least 1 lineage in 40 to 45% of patients with aa that was refractory to ist, leading to its approval by the fda in this setting (5). eltrombopag evades cytokines blockade of c-mpl signaling and activates the c-mpl receptor by interacting with the transmembrane receptor domain, resulting in a conformational change without competing with tpo. regarding aa, it is possible that eltrombopag promotes dna repair in hematopoietic stem cells and progenitor cells. however, aa may appear to evolve to other hematologic diseases, most notably paroxysmal nocturnal hemoglobinuria and myelodysplastic syndrome, even to acute myeloid leukemia, and about 15% of patients evolve to myelodysplastic syndrome, acute myeloid leukemia or both after immunosuppressive therapy. therefore, it is unclear but alarming that the use of eltrombopag exacerbates the clone evolution (6). eltrombopag and cyclosporin was active as front-line treatment of severe aplastic anaemia, with no unexpected safety concerns. this approach might be beneficial where horse-atg is not available or not tolerated.

Eligibility criteria:
inclusion criteria: - age \> 18. newely diagnosed bone marrow aplasia eastern cooperative oncology group (ecog) performance status of 0-2. patients started csa plus eltrombopag therapy normal cardiac, hepatic \& renal functions exclusion criteria: hypersensitivity or contraindications to eltrombopag. cardiovascular, pulmonary, hepatic, or renal diseases. history of malignancy. pregnant, breastfeeding. inherited bone marrow aplasia. secondry bone marrow aplasia previous thromboembolic events. previous malignancies either solid or hematologic. -
cord blood 25(oh)-vitamin d level in preterm infants and associated morbidities

Conditions: Respiratory Distress Syndrome

Summary: experimental and observational studies have shown that vitamin d deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. the aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin d (25 (oh) d) concentrations and the subsequent risk of morbidities including rds, pda, nec, bpd and rop in preterm infants.

it was shown that vitamin d play important role in the pathogenesis of long term morbidities of newborn. experimental and observational studies have shown that vitamin d deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. the aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin d (25 (oh) d) concentrations and the subsequent risk of morbidities including rds, pda, nec, bpd and rop in preterm infants.

Eligibility criteria:
inclusion criteria: * infants \<32 weeks of gestational age exclusion criteria: * infants with major congenital abnormality * infants \>32 weeks of gestational age

Keywords: vitamin d, respiratory distress syndrome, sepsis, preterm
micropulse transscleral diode laser cyclophotocoagulation (mp-tscpc) as a treatment modality for glaucoma patients

Conditions: Glaucoma

Summary: the study objective was to evaluate the efﬁcacy and safety of transscleral cyclophotocoagulation (tscpc) using micropulse diode laser treatment in patients with various types of glaucoma.

evaluation of the efﬁcacy and safety of a new form of transscleral cyclophotocoagulation (tscpc) using micropulse diode laser treatment in patients with various types of glaucoma. in this study, 810 nm infrared diode laser radiation in the micro- pulse mode was used in conjunction with a g probe (iridex medical instruments, mountain view, ca, usa). the laser settings ranged from 2000- 2500 mw of 810 nm infrared diode laser set on micro- pulse mode, delivered over 100-200 seconds (envelope of micropulses) depending on severity of the case and other patient factors. with duty cycle 31.3% (this translates to 0.5 ms "on" time and 1.1 ms "off" time), which allows the tissue to cool down between laser shots, thus greatly reducing thermal damage.

Eligibility criteria:
inclusion criteria: * patients previously diagnosed with glaucoma if they had uncontrolled intraocular pressure despite maximal tolerated medical therapy. * patients who are unable to maintain compliance with the prescribed topical medications. * patients who need filtering glaucoma surgery for controlling intraocular pressure but are not generally fit for the surgery. * patients who refused incisional procedures like subscleral trabeculectomy. exclusion criteria: * patients who were unable to give informed consent. * patients who had undergone previous conventional transscleral diode laser cyclophotocoagulation (tscpc). * patients with signiﬁcant scleral thinning deﬁned as thinning of more than one clock hour noticed on scleral transillumination. * patients with ongoing ocular infection or inflammation.

Keywords: glaucoma micropulse laser
efficacy of kinesiology tape on neck disability

Conditions: Pain; Myofascial Pain Syndrome; Trigger Point Pain, Myofascial

Summary: sixty participants with nonspecific neck pain were randomly assigned to either the kinesiotaping (n=30) or exercise (n=30) group. at the beginning, at the 2nd week and at the 1st month, activity and rest pain with visual analog scale, cervical lateral flexion and rotation with goniometer, neck disability scale and trapezius thickness, trigger point volume, trigger point diameter, trigger point area (with ultrasonograpic imaging) will be evaluated. after the initial evaluation of the patients in the kinesiotaping group, 'i' strip kinesiotape will be applied with the space correction technique for the upper trapezius muscle, for a total of 4 sessions, 2 days a week, and the patients will be included in the 1-month home exercise program. patients will be evaluated at the start of treatment, week 2, and month. patients in the control group will only be included in the 1-month home exercise program. patients will be evaluated at the start of treatment, week 2, and month 1. the participants inclusion criteria were; age between 18 and 65 years, symptom duration of at least 3 months. the exclusion criteria were as follows: (1) a diagnosis of cervical radiculopathy or myelopathy, (2) a history of acute neck injury or cervical surgery (3) diagnosis of psychiatric disorders (4) recent trigger-point injection or participation in a physical treatment program witin the last 6 monhts (5) any allergies to the tape and (6) having already received treatment with kinesio-taping.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * symptom duration of at least 3 months exclusion criteria: * a diagnosis of cervical radiculopathy or myelopathy * a history of acute neck injury or cervical surgery * diagnosis of psychiatric disorders * recent trigger-point injection or participation in a physical treatment program witin the last 6 monhts * any allergies to the tape and * having already received treatment with kinesio-taping.
safety and efficacy of xmab18087 ± pembrolizumab in advanced merkel cell carcinoma or extensive-stage small cell lung cancer

Conditions: Merkel Cell Carcinoma; Small Cell Lung Cancer

Summary: this is a phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess pk and immunogenicity of xmab18087 monotherapy and in combination with pembrolizumab in participants with metastatic merkel cell (mcc) or locoregional mcc that has recurred after locoregional therapy with surgery and/or radiation therapy, and mab18087 monotherapy in participants with extensive-stage small cell lung cancer (sclc) that has progressed after standard therapies. this study was terminated by the sponsor. no participants enrolled in part b.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * adult participants ≥ 18 years * disease measurable by recist 1.1 criteria using either computed tomography (ct) or magnetic resonance imaging (mri) scan * eastern cooperative oncology group (ecog) performance status of 0 or 1 * all participants must have adequate archival tumor sample (slides or archival formalin-fixed paraffin-embedded \[ffpe\] block\[s\] containing tumor that has not been previously irradiated * female participants of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after completion of study. success), or sexual abstinence * fertile male participants must be willing to practice a highly effective method of birth control for the duration of the study and continuing for 4 weeks after the last dose of xmab18087 or pembrolizumab (when applicable * able and willing to complete the entire study according to the study schedule additional inclusion criteria for part a and part b cohorts: • histologically or cytologically confirmed metastatic mcc or locoregional mcc that has recurred following standard locoregional therapy with surgery and/or radiation therapy. additional inclusion criteria for part a cohorts: • participants must have progressed on or been ineligible for treatment with anti-pd1 or anti-pdl1 therapy. additional inclusion criteria for part b cohorts: • participants must be eligible to receive pembrolizumab as standard of care. additional inclusion criteria for part c cohorts: • histologically or cytologically confirmed extensive-stage sclc that has progressed following standard therapies exclusion criteria: additional exclusion criteria for part b cohorts: xmab18087 in combination with pembrolizumab * prior treatment with therapeutics directed at anti-programmed cell death 1 (anti-pd1) or anti-programmed cell death ligand 1 (anti-pdl1) * have severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients

Keywords: mcc sclc
study to assess the effect of 24 weeks of treatment with vildagliptin in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to placebo on insulin sensitivity in patients with type 2 diabetes mellitus (t2dm) treated with metformin, assessed as glucose rd (rate of glucose disposal) during a hyperinsulinemic euglycemic clamp.


Eligibility criteria:
inclusion criteria: 1. age in the range of 18-70 years. 2. patients with t2dm, diagnosed at least 6 months prior to visit 1, who have received metformin for at least 3 months and have been on a stable dose of at least 1000mg daily for a minimum of 4 weeks prior to visit 1. 3. hba1c ≤ 7.6% at visit 1. 4. body mass index (bmi) in the range of 22-38kg/m2 inclusive at visit 1. exclusion criteria: 1. pregnant or nursing (lactating) women. 2. patients with cardiac pacemakers or with metallic implants incompatible with magnetic resonance methodology. 3. congestive heart failure requiring pharmacologic treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetes mellitus vildagliptin
aquatic and land exercises for chronic low back pain

Conditions: Chronic Low Back Pain (non-specific, Uncomplicated)

Summary: this study aims to learn about the effects of aquatic and land exercises on managing chronic low back pain in adults aged 18-65. the participants engage in a 12-week supervised land and water-based exercise program. the main questions this study aims to answer are: * how effective are aquatic exercises on low back pain, functional disability, kinesiophobia, sleep quality, and overall quality of life? * is aquatic therapy more effective than land exercises for treating lbp or vice versa?


Eligibility criteria:
inclusion criteria: * age between 18 and 65 * both genders * literate in the english language to understand instructions/ to complete a self-report questionnaire. * having non-specific chronic low back pain (≥12 weeks) * patient willingness to be a part of any randomly selected treatment groups. exclusion criteria: * pregnant females * if they had low back pain as the result of diagnosis of severe osteoporosis, spinal bone disorders such as spondylosis and spondylolisthesis, fractures, lumbar spine stenosis, lower limb joint replacement surgery, hip orthosis, ankylosing spondylitis, rheumatoid arthritis, infective or inflammatory disease, compression of the radial nerve, meningitis, arthrosis, lumbar region tumours, leg length discrepancy, previous back surgery. * uncontrolled hypertension, severe postural hypotension, any heart disease like left heart failure or exercise-induced angina. medical illnesses without a medical managing plan in place, e.g., uncontrolled epilepsy, diabetes mellitus. neurologic deficit, open wounds, current or recurrent radiation treatment. * patients with severe depression and psychosis * people who are already participating in an individually-prescribed exercise programme for lbp. aquatic exercises /pool specific: * individuals with hydrophobia/ water-related anxiety, or inability to adapt to an aquatic environment. * allergy to chlorine, severe limiting airway disease * faecal or urinary incontinence, diarrhoea, and vomiting. * weight more than the emergency evacuation manual handling risk assessment.

Keywords: chronic low back pain aquatic therapy hydrotherapy water-based exercise exercise intervention land exercise quality of life rehabilitation research functional disability
smartwatch and external holter monitoring to detect atrial fibrillation in patients with cryptogenic stroke

Conditions: Paroxysmal Atrial Fibrillation; Cryptogenic Stroke

Summary: stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (af) being one of the most important. prolonged ambulatory cardiac monitoring is recommended for detecting occult af. currently, there are non-invasive monitoring devices such as the textile holter that have proven to be useful for monitoring for up to 30 days but not longer. another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.

the primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult af than monitoring for 30 days. the secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of af. to evaluate the usability and adherence to the use of smartwatches in patients with stroke. detect predictors that can help detect long-term occult af. determine the profile of vascular events in each group. detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.

Eligibility criteria:
inclusion criteria: * age greater to or equal to 55 years * patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram * patients with acute cortical infarction with the presence of intracranial occlusion (preferably) * modified rankin scale (mrs) lower to 4 exclusion criteria: * diagnosis of lacunar infarction or transient ischemic attack (tia) * diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal pfo, post-ami, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic) * use of pacemakers * circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center) * unwillingness to the use of cardiac monitoring wearable devices * not understanding study procedures

Keywords: wearable electronic devices