Kornimate/medical-research-clean huggingface dataset:
arcadiusxp l post market clinical follow-up

Conditions: Degenerative Disc Disease

Summary: the purpose of this study is to collect clinical and radiological mid-term (2 years) data on the arcadiusxp l® lumbar stand-alone cage in a post-market clinical follow-up study (pmcf) limited to 32 patients.


Eligibility criteria:
inclusion criteria: * all indications as given by the instructions for use * patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from l4 to s1 * age 18 - 60 * at least 6 months of unsuccessful treatment including conservative measures * non-sequestrated and subligamentous prolapse exclusion criteria: * all contraindications, which are listed in the instructions for use. * existing pregnancy, planned or occurring during study period * patients with a higher degree of segmental degeneration in other than the segment to be operated * body- mass-index (bmi) \> 30 * systemic or local infection * increased risk of osteoporosis according to assessment by the score evaluation * bone metabolism disorders * chemotherapy or radiotherapy (ongoing or planned) * participation in another clinical trial * scheduled for spinal litigation * other serious conditions that hinder the participation in the study * nanogel® filling of the cage, prior to implantation was not done
quadratus lumborum block versus fascia iliaca block for hip arthroplasty

Conditions: Post Operative Pain

Summary: quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. in a cadaveric study, the spread of local anesthetic in the anterior approach of ql block (ql3) was reported to cover nerve roots from t10 to l3. thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection. this study aims to compare ql3 block and suprainguinal fascia iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects.

a randomized, controlled, double blinded, trial will be conducted in cairo university hospital. written informed consent will be obtained from all participants. randomization will be achieved using a computer-generated sequence. concealment will be achieved using opaque envelopes. patients scheduled for hip replacement surgeries under subarachnoid block (sab). e.g. hip hemiarthroplasty, total hip arthroplasty. on arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg iv). monitoring will include electrocardiography, non-invasive arterial blood pressure, and pulse oximetry. before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups: qlb group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (anterior qlb or qlb iii) fib group (n=17): this group will receive suprainguinal fascia iliaca block to achieve double blinding, patients will receive the block with 30 ml bupivacaine (0.25%) by the anesthetist. another doctor not involved in the block procedure will evaluate the patients postoperative. after finishing the block \& assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room. postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours. if the visual analogue scale (vas) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting vas at \<3 with maximum total 24-hours morphine 10 mg.

Eligibility criteria:
inclusion criteria: * patients scheduled for hip replacement surgeries under subarachnoid block (sab). e.g. hip hemiarthroplasty, total hip arthroplasty. exclusion criteria: * coagulopathy, infection at the injection site,. * allergy to local anesthetics. * severe cardiopulmonary disease (≥asa iv),. * diabetic or other neuropathies. * patients receiving opioids for chronic analgesic therapy. * contraindication to spinal anesthesia. * inability to comprehend visual analogue scale (vas).
feasibility and efficacy of a brief mindfulness-based intervention smoking intervention via the internet

Conditions: Substance Use; Smoking Reduction

Summary: the current study will examine both the feasibility and efficacy of a single session, web-based mindfulness-based intervention for smoking cessation. the study will explore (1) participants' subjective experiences of the intervention, (2) cravings and negative affect both before and after the intervention, and (3) changes in tobacco use one week and one month following the initial intervention. further, the study will examine how often participants utilize the intervention between the initial study and follow-up periods.


Eligibility criteria:
inclusion criteria: * daily smoker * has a desire to quit or reduce smoking. * is not currently involved in another smoking reduction or cessation program. exclusion criteria: -

Keywords: smoking reduction
effects of mulligan's technique in subjects with shoulder impingement syndrome

Conditions: Shoulder Impingement Syndrome

Summary: participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist. after, participants will be attended 72 hours after data recording of the baseline measures (range of motion with a goniometer, pressure pain threshold with a algometer, and peak force with a dynamometer) for four sessions per week with 24 hours of interval between sessions. at each experimental week session, each participant will receive one of the two treatment conditions (mwm or sham) and then will repeats the assessment. in the following week, there will be a crossover condition of each individual and 24 hours after the last treatment session, the examiner will do the last assessment.


Eligibility criteria:
inclusion criteria: * history of shoulder pain of \>1-week duration, localized at the proximal anterolateral shoulder region consistent to shoulder impingement syndrome (sis); * at least 1 positive impingement test (jobe's test, neer's test, hawkins-kennedy's test) associated with painful range of motion during arm elevation; or pain during external rotation with the arm in 90 degrees of elevation in the coronal plane. exclusion criteria: * fibromyalgia (based on self-report),pregnancy, a history of onset of symptoms because of traumatic injury, other histories of shoulder injury, torn tendons, ligamentous laxity based on positive sulcus test and apprehension test, numbness or tingling in the upper extremity, previous shoulder or neck surgery, systemic illnesses, body mass index \> 28kg/m2, corticosteroid injection 3 months before evaluation, physical therapy 3 months before evaluation.

Keywords: shoulder impingement syndrome mulligan's mobilization with movement physical therapy
effects of respiratory-gated transcutaneous vagal nerve stimulation in major depression (phase 1)

Conditions: Major Depressive Disorder

Summary: this study will evaluate the short term effects of respiratory-gated transcutaneous vagus nerve stimulation on the regulation of cardiovagal activity, depressive symptomatology and immune function in subjects with major depression and determine the optimal stimulation frequency for this population.

this study will compare the acute effects of respiratory-gated transcutaneous vagus nerve stimulation (tvns) at different stimulation frequencies and sham stimulation during five sessions within a 2 week period. heart rate variability (hrv) point process adaptive filtering estimation algorithms will be used to evaluate changes in cardiac autonomic physiology in subjects with major depression in response to tvns. the effects of tvns on cardiovagal regulation will be evaluated at rest and in response to an emotion reactivity task. depression rating scales (beck's depression inventory) will be used to evaluate short term effects of tvns on depressive symptoms in these subjects. in addition, the study will evaluate the acute effects of the stimulation on serum levels of pro-inflammatory cytokines. the stimulation frequency that produces the greatest regulatory effects on depressive symptoms and physiological variables in this population will be used in a second longitudinal phase of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of recurrent major depressive disorder with a current active depressive episode * currently not taking psychiatric medications or on a stable therapeutic dose of psychiatric medication for at least 30 days prior to entering the study exclusion criteria: * history of cardio-, cerebro-, or peripheral vascular disease, diabetes mellitus, morbid obesity (bmi \> 40 kg/m2), kidney or liver failure, history of unexplained fainting spells * any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar disorders, severe personality disorders) * any chronic condition affecting movement, speech and/or ability to read or follow written instructions * substance use disorder, either mild, moderate, or severe within the past 12 months (excludes nicotine) * history of suicide attempt within the last year or current active suicidal ideation * history of a clinically defined neurological disorder including, but not limited to: any condition likely to be associated with increased intracranial pressure; space occupying brain lesion; history of cerebrovascular accident; transient ischemic attack within two years; cerebral aneurysm; dementia; parkinson's disease; huntington's chorea; or multiple sclerosis. * pregnant or nursing * metallic implants or devices contraindicating tvns

Keywords: transcutaneous vagus nerve stimulation cardiac autonomic function depressive symptomatology
combined haploidentical and umbilical cord blood allogeneic stem cell transplantation in patients with acute leukemia

Conditions: Acute Leukemia

Summary: allogeneic stem cell transplantation (allo-hsct) is the effective and even the only treatment option for acute leukemia. the haplo-hematopoietic stem cell transplantation(haplo-hsct) and "giac" protocol have crossed hla barrier and helped more patients find donors. however, the engraftment failure and incidence of graft-versus-host disease(gvhd) limit the prognosis of patients who receive the haplo-hsct. it is believed that combined haploidentical and umbilical cord blood allogeneic stem cell transplantation improved hematopoietic reconstitution and reduced the incidence of gvhd, there is still no consensus about the efficacy and safety of this kind of therapy. this prospective, randomized and controlled study is to investigate the efficacy and safety of combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

this prospective, randomized and controlled study is to investigate the efficacy and safety of combined haploidentical and umbilical cord blood allogeneic stem cell transplantation. investigators will recruit 116 patients with acute leukemia, with 58 of them entering the haplo-hsct group and receiving haploidentical hematopoietic stem cell transplantation, while the other 58 entering the combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group and receiving haploidentical and umbilical cord blood allogeneic stem cell transplantation at the same day. then primary outcomes including overall survival and disease free survival, as well secondary outcomes such as cumulative relapse incidence and cumulative incidence of engraftment will be measured during 12 months after the intervention being finished.

Eligibility criteria:
inclusion criteria: * ages 16-65 years inclusive. * diagnosed as acute leukemia, planning to receive haplo-hsct * eastern cooperative oncology group (ecog) performance status 0-2 * presence of an available haploidentical donor * signing written informed consent and agreeing with taking designated umbilical cord blood exclusion criteria: * uncontrolled infections less than 4 weeks prior to enrollment * secondary malignancy * psychiatric illness that would limit compliance with study requirements * impairment of heart, hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study * allergic to blood products * other causes which are not suitable for the trial in investigator's consideration

Keywords: acute leukemia haplo-hematopoietic stem cell transplantation (haplo-hsct) umbilical cord blood stem cell transplantation (ucbt)
modelling tau distribution from dti with generative adversarial network for alzheimer's disease diagnosis

Conditions: Alzheimer's Disease Diagnosis

Summary: the most significant impact of this project is to propose for the first time a novel generative adversarial network (gan), as one kind of deep learning architecture, to automatically generate synthetic pet images reflecting tau deposition, from brain dti images. if successful, this framework will become the most state-of-the-art approach to simulate the stereotypical pattern of intracerebral tau accumulation and distribution in vivo. synthetic tau-pet images via dti, possessing overwhelming superiority in radiation-free, non-invasiveness and cost-effectiveness, will potentially serve as one of alternative modalities of pet in detecting tau-load and probably outperform pet on accessibility, generalizability, and availability in future, making it much more attractive in clinical application. a big conceptual shift may occur preferring a fire-new tau-pet simulated via dti. the dti data-driven deep learning framework to be created in this project will constitute an accurate, robust, clinically applicable and explainable tool to efficiently categorize the subjects into tau-burden positive and tau-burden negative cases, which will undoubtedly contribute to both clinical and research activities.


Eligibility criteria:
inclusion criteria: * with the age of 55 years and above * with brain mri taken within ±6 months from the date of clinically confirmed diagnosis of ad, mci or normal cognition. exclusion criteria: * ad with mixed dementia * non-ad dementia * history of severe traumatic brain injury, severe depression, stroke, brain tumors, and incident major systemic illness

Keywords: generative adversarial network tau diffusion tensor imaging
prevalence of dental caries in patients with dental crowding

Conditions: Caries

Summary: dental crowding causes limited access for the toothbrush, and the natural cleansing effect of the teeth by the tongue and saliva is also limited. this malposition allows for prolonged food accumulation, bacterial and plaque retention, which are important factors for the initiation and progression of dental caries.

dental crowding causes limited access for the toothbrush, and the natural cleansing effect of the teeth by the tongue and saliva is also limited. this malposition allows for prolonged food accumulation, bacterial and plaque retention, which are important factors for the initiation and progression of dental caries . according to the world health organization, the main dental problems should be subjected to periodic epidemiological surveys. knowledge of a population's epidemiological situation is vital for planning and providing prevention and treatment services . however, only few studies investigated the correlation between caries and crowding.yet, their findings were inconsistent and still contradictory. previous systematic review concluded that there is no reliable evidence regarding the association between dental caries and crowding and further studies with adequate sample size are required. another systematic review found an association between caries and crowding but only in the adolescent group . as caries is a preventable disease, improving the understanding of this possible association would be beneficial for dental practitioners, public health policy makers and the general population as it will help in the application of medical model. this cross-sectional study can detect one of predictors of dental caries early as crowding so the dentists can prohibit future carious lesions \& help in caries prevention through orthodontic treatment \& proper oral hygiene measures.

Eligibility criteria:
inclusion criteria: * young adults range from 12-30 years. * females or males. * anterior dental crowding. exclusion criteria: * patients undergoing orthodontic treatment. * patients who have any missing anterior teeth. * patients who have any physical or mental disabilities.
safety & effectiveness evaluation of seraph 100 in treatment of pts with covid-19

Conditions: COVID-19

Summary: safety and effectiveness evaluation of seraph 100 microbind affinity blood filter (seraph 100) in the treatment of patients with covid-19

this is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the exthera medical seraph 100 microbind affinity blood filter in the treatment of patients with confirmed sars-cov-2 infection. the clinical investigation will be conducted at 3 centers in germany and at 2 centers in spain. subjects will be randomized to the treatment group (seraph 100 + standard of care) versus control group (standard of care only). subjects will be followed for 28 days. for viral quantification, study-related serum samples are done immediately before the initial treatment with seraph 100 starts in the treatment group or immediately after randomization into the control group. additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.

Eligibility criteria:
inclusion criteria: 1. subjects with confirmed sars-cov-2 infection 2. be ≥ 18 years old and ≤90 years old 3. acute respiratory distress syndrome assessed by a modified sequential organ failure assessment score of at least 2 points 4. at least one additional organ dysfunction assessed by a modified sequential organ failure assessment score of at least 1 point 5. written or electronic consent of the subjects who are legally competent and have the capacity to give consent exclusion criteria: 1. subject is currently participating in another clinical investigation 2. pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 3. presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 4. have child-pugh class c cirrhosis 5. have platelet count \<30.000/ul 6. contraindications for heparin sodium for injection 7. subjects demonstrating any contraindication for this treatment as described in the ifu 8. subjects with known allergy of polyethylene and copolyester 9. subjects with hospital-acquired sars-cov-2 infections 10. subject is held in an institution by court or official order 11. subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary

Keywords: covid-19
urine, dna and clinical information collection from patients with alport nephropathy.

Conditions: Alport Nephropathy

Summary: this biomarker study is a follow-up to cplatfrm2201. the goal of cbasichr0005 is to collect another urine sample, interval clinical information, and an optional dna sample from as many of the original 80 patients as possible. this new information will transform the data obtained in platfrm2201 from a cross-section to a temporal profile, which will (a) further enable the identification of biomarkers predictive of faster progression, and (b) satisfy the fda's recommendation to perform "natural history studies" in rare diseases.


Eligibility criteria:
inclusion criteria: • able to communicate well with the investigator, to understand and comply with the requirements of the study and able to provide written informed consent (parent or legal guardian for pediatric and adolescent subjects), which must be obtained before any assessment is performed. alport subject-specific inclusion criteria: * participation in cplatfrm2201 * physically able to provide a single first-morning urine sample of at least 30 ml (one ounce). alport patients who have initiated dialysis therapy since participation in cplatfrm2201 are exempt from this criterion and may still participate in this study. healthy volunteer-specific inclusion criteria: • male and female volunteers (may include healthy siblings of alport patients) aged 5 to 15 years. exclusion criteria: alport subject-specific exclusion criteria: • none healthy volunteer-specific exclusion criteria: * use of investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. * known history of one of more of (a) hematuria (gross or microscopic), (b)audiological deficits, (c) fixed (non-orthostatic) proteinuria, or (d) reduced renal filtration function with serum creatinine (cr) above the upper limit of the normal age-specific reference range, on at least 2 prior occasions (serum cr need not be measured specifically for eligibility). * any other clinically significant underlying medical conditions as judged by the pi.
study of sapacitabine in acute myeloid leukemia (aml) or myelodysplastic syndromes (mds)

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes

Summary: this is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated acute myeloid leukemia (aml) or concomitantly with venetoclax in previously treated aml or mds

this is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated aml (part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory aml or mds (part 2). treatment will be administered on an outpatient basis. one treatment cycle is 4 weeks.

Eligibility criteria:
inclusion criteria: * newly diagnosed aml based on who classification (part 1) or previously treated aml or mds (part 2) * age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (part 1); age 18 years or older (part 2) * ecog performance status 0-2 * adequate renal function * adequate liver function * able to swallow capsules * ability to understand and willingness to sign the informed consent form exclusion criteria: * aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement * known central nervous system (cns) involvement by leukemia * uncontrolled intercurrent illness including * known hypersensitivity to decitabine (part 1) or venetoclax (part 2) * known to be hiv-positive

Keywords: sapacitabine decitabine venetoclax elderly aml mds refractory relapsed untreated