Kornimate/medical-research-clean huggingface dataset:
innovative biomarkers in de novo parkinson's disease

Conditions: Parkinson's Disease; Healthy Controls Group - Age and Sex-matched

Summary: this study aims at identifying potential new and innovative biomarkers in de novo parkinson's disease patients. new finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.

the investigators will use 4 different approaches in parallel: 1. detailed clinical evaluation using the current available validated clinical scales and the dopamine transporter (dat) spect imaging; 2. anatomical and perfusional brain evaluation using functional mri; 3. cortical brain mapping and transcranial magnetic stimulation assessment using a robotized approach; 4. emotional responses study using a novel paradigm. these 4 modalities will be assessed at baseline, 1 year and 2 years follow-up. the investigators will integrate these 4 analysis using a mathematical paradigm in order to define specific phenotype of disease and disease progression.

Eligibility criteria:
inclusion criteria: * parkinson's disease * asymmetric bradykinesia and/or resting tremor and rigidity since less than 2.5 years ; * hoehn \& yahr ≤ 2/5 ; * montreal cognitive assessment ≥ 26/30 ; exclusion criteria: * treatment for parkinson's disease (except selegiline and rasagiline) * severe visual/retinal pathology revealed during ophthalmological assessment * hyper-sensibility to gadolinium * renal failure * specific mri contraindication * specific tms contraindication

Keywords: biomarkers magnetic resonance imaging (mri) neuropsychology transcranial magnetic stimulation (tms)
mrd-directed therapy for low-risk and intermediate-risk aml.

Conditions: Acute Myeloid Leukemia; Minimal Residual Disease

Summary: acute myeloid leukemia(aml) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-sct. however, these patients may eventually relapse in some cases. our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate aml. to further verify the results, we conducted a prospective multi-center study. the purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (mrd) analysis to determine whether a mrd-directed therapy for low and intermediate aml patients has positive results in terms of overall survival.


Eligibility criteria:
inclusion criteria: low-risk and intermediate-risk aml subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. exclusion criteria: any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) patients with any conditions not suitable for the trial (investigators' decision)

Keywords: mrd acute myeloid leukemia
spyral gemini pilot study

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases; Chronic Kidney Diseases; Diabetes Mellitus

Summary: the purpose of the spyral gemini pilot study is to evaluate that multi-organ denervation with the gemini system is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.

this study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (mdn) and provide preliminary efficacy data in two parallel single arm cohorts: * gemini pilot off med: mdn for hypertension off anti-hypertensive meds and, * gemini pilot on med: mdn for hypertension and high cardiovascular risk on anti-hypertensive meds there is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).

Eligibility criteria:
inclusion criteria: all subjects (both cohorts): 1. ≥18 and ≤80 years of age. 2. diagnosed with htn and has a baseline office sbp ≥150 mmhg and \<180 mmhg and an office dbp ≥ 90 mmhg. 3. 24-hour average sbp ≥140 mmhg and \<170 mmhg measured by abpm at baseline. exclusion criteria: 1. individual lacks appropriate renal artery or common hepatic artery anatomy. 2. prior renal or hepatic denervation. 3. prior stroke or transient ischemic attack (tia). 4. documented type 1 diabetes or use of insulin or sulfonylureas within 6 months. 5. secondary cause of hypertension. 6. documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement. 7. estimated glomerular filtration rate (egfr) of \<40 8. pregnant, nursing or planning to become pregnant during the study. 9. primary pulmonary arterial hypertension. 10. history or evidence of active / suspected chronic liver or biliary disease. 11. current or chronic pancreatitis.

Keywords: renal insufficiency chronic disease disease attributes pathologic processes kidney diseases hypertension cardiovascular diseases vascular diseases denervation renal denervation hepatic denervation
freeride study, freeway paclitaxel coated balloon catheter to treat peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: the primary objective of this prospective, randomized, controlled, multicentre, open study is to investigate the inhibition of restenosis by the paclitaxel-eluting percutaneous transluminal angioplasty (pta) balloon freeway versus pta alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (sfa) or popliteal arteries.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female (\> 18 years of age) with symptomatic ischemia, requiring treatment of sfa or pi segment ( 2-5 of rutherford classification) * single and/or multiple de novo occluded, stenotic or reoccluded, restenotic lesion(s) of \> 70% , ≤ 15 cm in total length and vessel diameter ≥ 4mm and ≤ 7mm (by visual estimation). * patient provides a signed informed consent and complies with the follow up visits * successful wire crossing of lesion * at least one patent (less than 50% stenosis) tibioperoneal run-off vessel exclusion criteria: * gastrointestinal bleeding or coagulopathy contraindicating use of anti-platelet therapy * known intolerance contraindications to study medications and contrast agents, non-controllable with medication. * patient actively participating in another device or drug study * history of hemorrhagic stroke within 3 months * previous or planned surgical or intervention procedure within 30 days of index procedure * significant untreated inflow disease or no normal arterial segment proximal of lesion in which duplex ultrasound velocity ratios can be measured * acute or sub-acute thrombus in target vessel * use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon) * patients with in-stent restenosis or prior surgery of the target lesion * patients with abdominal aortic, iliaca or popliteal aneurysm (aaa) with ≥ 4cm diameter
safety and pharmacokinetics of single intravenous doses of peginesatide in healthy volunteers

Conditions: Anemia; Chronic Kidney Disease; Chronic Renal Failure; Cancer

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics (pk), and minimum pharmacologically active dose of peginesatide in healthy volunteers.

this was a phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. in each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. planned peginesatide dose levels were to escalate by cohort. the study was conducted at a single clinical center.

Eligibility criteria:
main eligibility criteria: * participant is a healthy male, age ≥ 18 years and ≤ 40 years, with body mass index (bmi) ≥ 18 and ≤ 30 kilograms per squared meter (kg/m\^2), and weight ≥ 50 and ≤ 95 kilograms (kg) * participant has hemoglobin of ≤ 16 grams per deciliter (g/dl) at the time of study entry * participant has normal iron stores

Keywords: anemia chronic kidney disease ckd chronic renal failure crf erythropoietin epo erythropoiesis stimulating agent esa hematide™ hemoglobin hb hgb omontys peginesatide red blood cell red blood cell production
online relapse prevention study

Conditions: Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Anorexia Nervosa, Atypical; Other Specified Feeding or Eating Disorder

Summary: the purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ed) treatment: an imaginal exposure therapy and a writing and thinking intervention. the second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ed outcomes (e.g., ed symptoms, fears). the investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ed outcomes. the investigators also plan to test if baseline differences in fear conditioning relate to change in ed outcomes across treatment.


Eligibility criteria:
inclusion criteria: * over the age of 18 * discharged from intensive treatment within the last four months (inpatient, residential, partial hospital/day program, intensive outpatient program) * currently meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa exclusion criteria: * high and active suicidality, psychosis, mania, or medical compromised status will be excluded, as these comorbidities would make it difficult to complete study procedures * under the age of 18 * does not meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa. * discharged from intensive treatment more than four months ago

Keywords: relapse prevention treatment eating disorder symptoms therapy
holmium: yag versus cold knife internal urethrotomy in management of short urethral strictures

Conditions: Urethral Stricture, Male

Summary: urethral stricture disease is defined as narrowing of the urethral lumen because of fibrosis, which occurs in urethral mucosa and surrounding tissues. the etiology could be congenital, iatrogenic, infectious, or idiopathic. several techniques are currently available for minimally invasive treatment of urethral strictures, including cold-knife incision, electrocautery, and various types of laser incisions. an incision with the cold knife does not cause any thermal effect on surrounding tissues but should create a mechanical injury that may lead to recurrence in long term. an incision with the electrocautery should cause a significant thermal effect on healthy surrounding tissues resulting in recurrent strictures during follow-up. laser treatment modalities have gained popularity in the last two decades. the aim of this trial is to evaluate the safety and efficacy of endo-urethrotomy with holmium laser and cold knife endo-urethrotomy

urethral stricture disease (usd) is the narrowing of the urethra from scar tissue, related to genitourinary tract infections, inflammatory skin conditions, traumatic urethral injury, pelvic radiation, and urinary tract instrumentation. it has an estimated prevalence rate of 0.6%.1-3 usd is a common and challenging problem for urologists. multiple treatment modalities are available for the management of urethral strictures depending on the site and length of stricture, this includes simple urethral dilatation, urethral stenting, endoscopic visual internal urethrotomy (viu), or open reconstruction. since 1974, sachse's internal urethrotomy has been considered the treatment of choice for usd which is fast and simple to carry out and is associated with a short recovery time. the success rates are 33%-60%. bulow et al in 1979 introduced the laser for internal urethrotomy. the obvious dominance of ho: yag are clear vision, less bleeding, precise incision and ablation of scar tissue, and short hospital admission, however, most literature assessing the adequacy of the laser in contrast to cold-knife urethrotomy show no difference in final results. the aim of this trial is to assess the efficacy, safety, complications, and results of holmium laser urethrotomy and cold knife internal urethrotomy for urethral stricture.

Eligibility criteria:
inclusion criteria: * men with urethral stricture above the age of eighteen were included in our trial. the length of the urethral stricture was less than 1.5 cm. exclusion criteria: * patient with complete urethral stricture with a suprapubic catheter in place. * patients whom internal urethrotomy is not applicable like multiple urethral strictures or balanitis xerotica obliterans.
amino acid profiling of spent culture medium

Conditions: Infertility

Summary: the purpose of this study is to develop an algorithm for embryo selection based on amino acid profiling (aap) of spent culture medium. development of the algorithm will be based on the ongoing implantation rate of the individual embryos transferred. as evaluated by ultrasound scan in gestational week 7.

ivf/icsi treatment has permitted many thousands of couples to conceive worldwide yet is limited by low success rates (in uk, approx. 25% live birth rate/treatment cycle for women up to 42 years of age; hfea annual report, 2006) and a confounding high multiple birth rate (23%) due to the transfer of more than a single pre-implantation embryo. multiple births are associated with prematurity, increased neonatal and maternal mortality and child handicap as well as being a major burden for health care systems. these problems have been highlighted in the data published by the hfea (2009), which has called for "a professionally-led, coordinated national strategy to reduce the number of multiple births". this challenge could be met if single embryos of known developmental competence could be selected for transfer, thereby making the embryo selection process even more crucial. however, current non-invasive embryo selection criteria using light microscope analysis have limited predictive value for ongoing pregnancy.

Eligibility criteria:
inclusion criteria: * minimum 4 x 2pn´s on day 1 post insemination * subjects undergoing ivf or icsi treatment with a maximum of 2 embryos transferred * both partners should be capable of understanding the study to which they are consenting * females \> 18 and ≤ 40 years of age * regular menstrual cycle 21-35 days (both inclusive) * women treated with a standard drug protocol exclusion criteria: * the couple has previously participated in the dk005 study * use of assisted hatching * indication for tesa or pesa * any medical conditions or genetic disorders prohibiting ivf/icsi or interfering with the interpretation of results of the study (including pre- implantation genetic diagnostics). * use of any investigational drug within 30 days before oocyte retrieval * any severe chronic disease of relevance for reproductive function. * oocyte donation patients (donor or recipient).

Keywords: art ivf icsi embryo selection
a study of prexasertib (ly2606368) in platinum-resistant or refractory recurrent ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.


Eligibility criteria:
inclusion criteria: * women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer. * cohorts 1 to 3: have platinum-resistant disease and have documented test results assessing alterations in the brca1 and brca2 genes prior to receiving study treatment. * cohort 1: are brca negative and have received 3 or more prior lines of therapy. * cohort 2: are brca negative and have received less than 3 prior lines of therapy. * cohort 3: are brca positive and have previously received a parp. * cohort 4: have primary platinum refractory disease. * have adequate organ function. * must be able and willing to undergo mandatory tumor biopsy. exclusion criteria: * cohorts 1-3: have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel. * have known central nervous system malignancy or metastasis. * have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients. * have at least one of the following: * history of abdominal fistula or gastrointestinal perforation * intra-abdominal abscess within last 3 months prior to the first dose of study drug * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug * have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis a, b, or c (screening is not required). * have a serious cardiac condition. * have a history of prior radiotherapy to the whole pelvis. * have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids. * have known factors that may increase the risk of infection while on study drug treatment. these may include, but are not limited to, an indwelling peritoneal catheter or open wounds. catheters for vascular access are permitted.

Keywords: dna damage repair replication stress
the role of bleeding at implant placement

Conditions: Bleeding; Angiogenesis; Peri-Implantitis

Summary: angiogenesis is inherently associated to bone formation and healing. during implant osseointegration, a successive and successful angiogenic processes has to occur to promote bone formation. in 1969, branemark et al. demonstrated that direct contact between bone and titanium implant surface was possible, defining osseointegration as "the direct, structural, and functional contact between live bone and the surface of a functionally loaded implant". consequently, the need of an empirical measurement appeared. with the introduction of resonance frequency analysis (rfa), it is now possible to measure the degree of implant stability at any time during the course of implant treatment and loading. in this way, changes in implant stability can be monitored over the time and it is likely possible to find implants at risk of failure before they become loose. the rationale of this study is to analyse how important a good vascularization is for the future bone formation around dental implants.


Eligibility criteria:
inclusion criteria: * males or females american society of anesthesiologists classification (asa) i or ii, between 18 to 80 years of age * patient in good general health as documented by self-assessment. * patients needing implant rehabilitation in the upper or lower jaw. * patients must be committed to the study and must be willing to sign the informed consent. exclusion criteria: * any systemic medical condition that could interfere with the surgical procedure or planned treatment. * immunosuppression, diabetes, anticoagulation or antiaggregatory medication. * current pregnancy or breast feeding/ lactating at the time of recruitment. * radiotherapy or chemotherapy in head and neck area. * intravenous and oral bisphosphonate therapy. * patients smoking \>20 cigarettes a day. * unwillingness to return for the follow-up examination. * conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations. local exclusion criteria: * immediate implant placement after tooth extraction. * risk of extra bleeding due to inflammatory or infectious processes near the zone of implantation.

Keywords: dental implants
a study of the effects of roactemra/actemra on vaccination in patients with rheumatoid arthritis on background methotrexate (visara)

Conditions: Rheumatoid Arthritis

Summary: this randomized, parallel-group, open-label study will evaluate the effect of actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-tnf) therapies.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 to \< 65 years of age * rheumatoid arthritis (ra) of \> 6 months duration at baseline (american college of rheumatology criteria) * willing to receive immunization with pneumococcal polysaccharide and tetanus toxoid adsorbed vaccines * previous immunization with pneumococcal polysaccharide must have occurred ≥ 3 years of baseline, with tetanus containing vaccine ≥ 5 years * methotrexate therapy for at least 8 weeks prior to baseline at stable dose of 7.5-25 mg/week (oral or parenteral) * other disease-modifying antirheumatic drugs (dmards) must be withdrawn before baseline * oral corticosteroids must be at stable dose of \< 10 mg/day prednisone or equivalent * body weight ≤ 150 kg at screening exclusion criteria: * major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 8 weeks after baseline * history of or current inflammatory joint disease or rheumatic autoimmune disease other than ra * pre-existing central nervous system demyelinating or seizure disorders * active current or history of recurrent bacterial, viral fungal, mycobacterial and other infections * any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to baseline or oral antibiotics within 2 weeks prior to baseline * active tuberculosis requiring treatment within 3 years prior to baseline * primary or secondary immunodeficiency (history or currently active) * intra-articular or parenteral corticosteroids within 4 weeks prior to baseline * previous treatment with roactemra/actemra