Kornimate/medical-research-clean huggingface dataset:
spinal cord stimulation for intractable mononeuropathy

Conditions: Mononeuropathies; Spinal Cord Stimulation

Summary: rationale: for patients with mononeuropathy, literature has shown that spinal cord stimulation (scs) is an effective therapy for patients who are therapy-resistant to more conventional treatments. however, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. before conducting a large randomized controlled trial (rct) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. we will assess the effects of scs in patients with mononeuropathy measured according to the "initiative on methods, measurement, and pain assessment in clinical trials" (immpact) guidelines, and assess the stimulation paradigm preferences in these patients. objective: to perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done. study design: mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the erasmus medical centre. study population: 12 patients suffering from intractable peripheral mononeuropathic pain. intervention: participants who receive a spinal cord stimulator must fill in immpact guideline questionnaires and undergo several measurement procedures after receiving scs implantation. the effect of various scs paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months. main study parameters/endpoints: effect of 6 months of individually optimized scs in patients with mononeuropathy according to the immpact guidelines.


Eligibility criteria:
inclusion criteria: * suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (emg) * symptoms refractory to conventional medical management for at least 6 months according to treating physician * 18 years or older * pain score on numeric rating scale (nrs) of at least 5 (average pain intensity in week prior to assessment) * stable or absent concomitant analgesics exclusion criteria: * mononeuropathy located in the head or torso * mononeuropathy by avulsion at the plexus brachialis * life expectancy \<1 year * anticoagulant drug therapy or disturbed coagulation * immune-compromised patients * pregnancy * lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s) * patients with psychological factors or addiction that require treatment
a study of sndx-5613 in combination with intensive chemotherapy in participants with acute myeloid leukemias

Conditions: Acute Myeloid Leukemias

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of sndx-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (aml) harboring alterations in kmt2a, npm1, or nup98 genes.

the dose escalation portion of this study will identify the maximum tolerated dose, or if different, the recommended phase 2 dose of sndx-5613 to be used in combination with intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in participants with newly diagnosed aml harboring alterations in kmt2a, npm1, or nup98 genes. in the dose expansion portion of the study, safety and preliminary efficacy of sndx-5613 may be explored in expansion cohorts at tolerated dose levels. in both dose escalation and dose expansion, the treatment period will consist of an induction phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include hematopoietic stem cell transplant for participants who are transplant eligible and have an available donor), and a maintenance monotherapy phase with sndx-5613. the cycle duration will be 28 days.

Eligibility criteria:
inclusion criteria: * established, pathologically confirmed diagnosis of aml by world health organization 2022 criteria. * previously untreated aml and eligible to receive intensive chemotherapy. * kmt2ar, npm1c, or nup98r mutations identified by local laboratory prior to the first dose of sndx-5613. * eastern cooperative oncology group performance status ≤2 and ≤1 if \>65 years old . * adequate liver, kidney, and cardiac function. exclusion criteria: * diagnosis of acute promyelocytic leukemia. * clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms). * fridericia's corrected qt interval (qtcf) \>450 milliseconds (average of triplicate), diagnosis or suspicion of long qt syndrome or family history of long qt syndrome. * any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion. * cirrhosis with a child-pugh score of b or c. * any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (new york heart association classification class ≥ii), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack. * hepatitis b, hepatitis c, or hiv-positive with detectable viral load. * documented active, uncontrolled infection. * uncontrolled disseminated intravascular coagulation. * lactating/breast feeding or pregnant. * use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy. * use of strong cyp3a4 inducers or inhibitors (except for itraconazole, ketoconazole, posaconazole, or voriconazole).

Keywords: sndx-5613 lysine-specific methyltransferase 2a kmt2a/mll nucleophosmin 1 npm1 nucleoporin 98 nup98 aml
shock wave therapy for lateral hip pain, caused by tendon pathology

Conditions: Tendinopathy

Summary: the aim of this randomized controlled study is to investigate if focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.


Eligibility criteria:
inclusion criteria: * duration of lateral hip pain of six weeks or longer, * normal passive hip range of movement (rom), * sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter exclusion criteria: * general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area), * history of rheumatologic disease, * previous fractures or surgery in the affected limb, * full thickness tear of the gluteal tendons, * osteoarthritis of the hip (with rom limitation), * clinical signs of lumbar radiculopathy, * corticosteroid injections or other conservative therapies (except pharmacological pain treatments) since the onset of the current pain episode.

Keywords: shock waves greater trochanteric pain syndrome
effect of crrt duration on solute removal

Conditions: AKI; Sepsis

Summary: the only fda approved treatment for acute kidney injury(aki) for patients is dialysis-also known as renal replacement therapy(rrt). continuous rrt(crrt) is the preferred method in the icu. patients receiving crrt with aki will be recruited to the study where blood and effluent will be collect prior to crrt initiation and day 1,2,and 3 following. metabolites will be assessed to determine solute removal, and also to identify the time at which solute removal has reached steady state. this will help determine the best duration of crrt.

acute kidney injury (aki) occurs in 30-50% of hospitalized patients admitted to the intensive care unit (icu). dialysis - also known as renal replacement therapy (rrt) - is the only fda approved treatment for aki and continuous rrt (crrt) is generally the preferred method of rrt in the icu. the in-hospital mortality of patients with aki requiring dialysis in the icu is over 50% which is much greater than other serious illnesses.unfortunately, the quality of care delivered to patients with aki receiving crrt is poor due to practice variability and lack of quality indicators to assess crrt performance. since one of the fundamental purposes of crrt is to remove the build-up of metabolites that accumulate during aki, accurate methods to assess solute clearance would be especially valuable. indeed, development of methods to assess solute clearance during crrt has been identified as a research priority. although changes in plasma creatinine has been suggested as a potential quality indicator of solute removal during crrt, no study has assessed how reductions of plasma creatinine over time compare to the reductions of other plasma metabolites. thus, the duration of crrt necessary to achieve adequate solute removal is unknown - in fact, there is not yet even an agreed-upon working definition of what adequate solute removal during crrt should be. the investigators propose to conduct a prospective, single center study of 112 crrt patients to determine the effect of crrt duration on solute removal in order to identify the time at which solute removal has reached steady state. to assess solute removal, 102 metabolites will be determined in the plasma and effluent via untargeted ultra high pressure liquid chromatography coupled to mass spectrometry (uhplc-ms). metabolites will be assessed on plasma collected immediately prior to crrt initiation, and on plasma and effluent collected on days 1, 2, and 3 post-crrt initiation. steady state is defined as the time point at which a plasma metabolite is not significantly reduced during crrt - as assessed over a 24 hour time period. based on preliminary data, the investigators hypothesize that \>90% of metabolites will reach steady state by day 2 of crrt, and that \>95% of metabolites will reach steady state by day 3 of crrt.

Eligibility criteria:
inclusion criteria: * all adult patients being initiated on crrt at university of colorado hospital (uch) will be considered for enrollment. exclusion criteria: * vulnerable populations such as children, pregnant women, and prisoners will be excluded.
duration of androgen blockade combined with pelvic irradiation in prostate cancers

Conditions: Prostate Cancer

Summary: the objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the european organization for research of the treatment of cancer (eortc protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone (lhrh) agonist, all for three years, combined with pelvic and prostate irradiation; this arm is currently considered to be a standard for high-risk prostate cancers. the proposed study intends to challenge the duration of hormonal therapy and verify whether the five-year outcomes in favour of combined treatment in regard to survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal therapy that is half as long, namely 18 months, with the possibility of hormone salvage therapy in the event of biochemical and/or clinical failure (local, regional, or distant); this applies to both arms. the proposed study will compare survival in the two groups and evaluate in each one the total duration of initial hormonal therapy, followed by initial hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal therapy until hormonal therapy resistance, and the side effects of this hormonal therapy, with everything being related to an assessment of the quality of life of these patients.


Eligibility criteria:
inclusion criteria: * to have at least one of the following three risk factors: * tumour classified t3 or t4 * gleason score 8-10 * prostate-specific antigen (psa) level \> 20 * performance status score of 0-1. * patients must sign a consent form before the start of the study. * no evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography \[cat\] scan, magnetic resonance imaging \[mri\], lymphography) or surgical staging or negative pelvic node dissection. * no distant metastasis. these patients must all have a negative bone scan 12 weeks prior to randomization. * hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected. * patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years. * the patient must be available for treatments and follow-up visits. * treatments must start in the three weeks following randomization. exclusion criteria: * severe medical or psychiatric problems that could compromise study compliance. * chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase \> 1.5 times the upper normal limit.

Keywords: stage t3 t4 psa > 20 gleason score > 7
diagnostic value of procalcitonin in patients with acute appendicitis

Conditions: Appendicitis

Summary: the values of laboratory examinations which are useful for the diagnoses of acute appendicitis are white blood cell count (wbc), c-reactive protein (crp) and erythrocyte blood sedimentation rate (esr). another laboratory value which has recently received considerable attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (pct). in recent studies it has been clearly shown that pct is one of the most important biochemical indicators which closely correlates with the severity of inflammatory host response to microbial infections. aim of this open, prospective study is therefore to investigate if pct has an accurate diagnostic value for the diagnosis of acute appendicitis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of appendicitis exclusion criteria: * antibiotic therapy * infection at other body sites * age \< 14 years * appendectomy in the medical history

Keywords: diagnostic appendicitis procalcitonin
transfusion effects in myelodysplastic patients: limiting exposure

Conditions: Myelodysplastic Syndromes

Summary: the goal of this study was to compare a restrictive rbc transfusion policy (a hb transfusion trigger: 7.2 gr/dl) with a more liberal rbc transfusion policy (a hb transfusion trigger: 9.6 gr/dl) on physical fatigue.

the goal of this study was to compare a restrictive rbc transfusion policy (a hb transfusion trigger of 7.2 gr/dl) with a more liberal rbc transfusion policy (a hb transfusion trigger of 9.6 gr/dl) on physical fatigue.

Eligibility criteria:
inclusion criteria: * diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction. * refractory anaemia (ra): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: \< 5% blasts, ringed sideroblasts ≤ 15% of the erythroid cells * refractory anaemia with ringed sideroblasts (rars): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: \ 15% of the erythroid cells * refractory anaemia with excess blasts (raeb): blood: \< 5% blasts, ≤ 1 x 109 monocytes; bone marrow: blasts ≥ 5 -≤ 20% * chronic myelomonocytic leukaemia (cmml): blood: \>1 x 109/l monocytes, \<5% blasts; bone marrow: blasts \< 20%, increase of the monocytic component * erythrocyte transfusion need * working knowledge of the national language * written consent for participating this study (informed consent) exclusion criteria: * candidate for bone marrow- or organ transplantation * medication: growth factors (gm-csf), or epo * patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks * refractory anaemia with excess blasts in transformation (raeb-t): blood: ≥ 5% blasts or auer rods; bone marrow: or blasts \> 20 - \< 30% or auer rods * pregnancy at the moment of inclusion * patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia * patients with aids or a severe congenital or acquired (e.g. iatrogenic) immunological disorder * severe active infections at the moment of inclusion * severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion

Keywords: mds, fatigue, rbc transfusion
six week study of experimental mouth rinses: effect on gingivitis and plaque

Conditions: Gingivitis; Plaque

Summary: the purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.


Eligibility criteria:
inclusion criteria: * adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect) * a minimum of 20 gradable teeth including 4 molars with scorable facial and lingual surfaces. teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count * a mean gingival index greater than or equal to (\>=) 1.95 per the modified gingival index at baseline (for those in the randomized treatment group) * a mean gingival index less than or equals to (\<=) 0.75 per the modified gingival index at baseline (for those in the healthy reference group) * a mean plaque index \>= 1.95 per the 6 site turesky modification of the quigley-hein plaque index at baseline (for those in randomized treatment groups) * greater than or equal to 10 percent (%) bleeding sites at baseline (for those in randomized treatment groups) exclusion criteria: * history of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye * dental prophylaxis within four weeks prior to screening/baseline 1 visit * more than three sites that have periodontal pockets depths measuring 5mm or greater in depth * teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group) * history of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures * use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin a, immunostimulants/ immunomodulators during the study or within the one month prior to the baseline 1 exam. intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
the efficacy of botulinum toxin vs. corticosteroid for the treatment of refractory plantar fasciitis

Conditions: Plantar Fasciitis

Summary: this single-blinded, randomized-controlled trial compares the efficacy of ultrasound-guided onabotulinumtoxina (btx-a) injections to the flexor digitorum brevis with current standard of care corticosteroid injections to the plantar fascia for the treatment of refractory plantar fasciitis in patients that have failed six weeks of non-operative treatment.

treatment of plantar fasciitis is not well described in the current literature, often making management difficult for both providers and patients. recent literature has suggested potential use of onabotulinumtoxin a (btx-a) as an effective treatment to reduce pain and allow patients to return to their previous level of functional activity. the study will consist of veteran patients at the george e wahlen department of veteran's affairs (slc va) in salt lake city, ut. this pilot study aims to randomize patients with plantar fasciitis into current standard of care treatment with corticosteroid injection into the plantar fascia and experimental treatment with btx-a injection into the flexor digitorum brevis cohorts. we predict that those who receive btx-a injections will report better outcomes on the numeric pain rating scale (nprs) as well as the foot and ankle ability measure (faam) when compared to those receiving corticosteroid. the results of this study could aid in providing evidence towards more reliable and beneficial treatment of plantar fasciitis.

Eligibility criteria:
inclusion criteria: 1. diagnosed increased pain when pressure applied at the medial calcaneal tubercle 2. x-ray negative for calcaneal fractures or tumors 3. patient with plantar fasciitis who have failed 6 weeks of non-operative treatment exclusion criteria: 1. prior botulinum toxin injections in the plantar fascia 2. any botulinum toxin injections in the past 3 months 3. cortisone injection in the plantar fascia in the previous 3 months 4. previous surgery on the plantar fascia 5. active workers compensation claim for plantar fasciitis 6. active infection or fever 7. botox or steroid allergy 8. pregnancy 9. current other treatment specific to the plantar fascia or intent to undergo during the trial

Keywords: onabotulinumtoxina botulinum toxin a plantar fasciitis corticosteroid
plethysmographic perfusion index and fluid responsiveness

Conditions: Fluid Responsiveness

Summary: the objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care.

in patients with acute circulatory failure, it is recommended to assess fluid responsiveness. fluid responsiveness is defined by an increase in cardiac output of 10 to 15% after fluid loading. the assessment of fluid responsiveness usually needs cardiac output monitoring (or stroke volume). however, in limited resource settings or during the initial management of patients with acute circulatory failure, cardiac output measurement is usually unavailable. the perfusion index (pi) is derived from the plethysmographic signal of the pulse oximeter and represents the ratio between the ratio of pulsatile on non-pulsatile light absorbance of the plethysmography signal. the pi is influenced by vascular and stroke volume. the investigators hypothesized that the peripheral index could track the changes in cardiac output induced by fluid loading and therefore detect fluid responsiveness. adult patients with acute circulatory failure in whom physicians want to test the fluid responsiveness will be included. at baseline, the pi will be recorded. an initial echocardiography will be performed to measure the left ventricular outflow tract velocity time integral (a surrogate of stroke volume). a fluid loading with 500 ml of 0.9% saline or ringer lactate will be performed. after fluid administration, the velocity time integral and the pi will be collected. fluid-responsive patients are defined by a 15% increase in velocity time integral. the investigators will analyze the ability of the pi to detect fluid responsiveness.

Eligibility criteria:
inclusion criteria: patients aged 18 and older with acute circulatory failure (acf). exclusion criteria: * low echogenicity: the inability to perform echocardiographic measurements according to established recommendations. * absence of the plethysmographic signal.

Keywords: acute circulatory failure fluid responsiveness perfusion index left ventricular outflow velocity time-integral echocardiography