Kornimate/medical-research-clean huggingface dataset:
preoperative pain neuroscience education in patients with carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: study design: a double-blind randomized controlled study. background: patients operated on for carpal tunnel release surgery may persist with pain after surgery, which could be modulated by psychosocial factors such as depression, catastrophic thinking and kinesiophobia. objectives: to evaluate the efficacy of a preoperative session in pain neuroscience education combined with postoperative therapeutic exercise in the perception of pain, functionality and psychosocial variables in patients following carpal tunnel release. methods: thirty participants were randomly assigned to the pain neuroscience education group combined with postoperative therapeutic exercise (n = 15) or to the control group with preoperative usual care combined with postoperative therapeutic exercise (n = 15). evaluations included the visual analogue scale (vas), disability of arm, shoulder, and hand questionnaire (quickdash), pain catastrophizing scale (pcs), tampa scale of kinesiophobia (tsk-11) and hospital anxiety and depression scale (hads) . a basal, fourth and twelfth week measurement was made.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * medical diagnosis of carpal tunnel syndrome waiting for surgery * agree to participate in the study. exclusion criteria: * inability to understand instructions, * illiteracy, * previous participation in educational programs regarding pain, * pathology of uncontrolled mental health, * cognitive problems, * previous surgeries in the operated extremity.

Keywords: physical therapy pain disability kinesiophobia.
safety/ feasibility of percutaneous administration of vonapanitase as monotherapy for peripheral artery disease (pad) of the sfa and popliteal arteries

Conditions: Peripheral Artery Disease

Summary: the research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with pad.


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years. 2. clinical diagnosis of pad secondary to atherosclerosis affecting a lower limb. 3. abi \ 1.30 (non-compressible), or radiographic evidence of pad that correlates with clinical symptoms. 4. rutherford category 2-4. 5. screening duplex doppler ultrasound with a sfa or pa lesion with a psvr \>2.4. 6. de novo lesion, not previously treated by angioplasty, atherectomy, or stent. 7. if female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 1 week following study drug administration. acceptable methods of birth control include abstinence, barrier methods with spermicide, implants, injectables, oral contraceptives, intra-uterine device, or a vasectomized partner. 8. ability to understand and comply with the requirements of the entire study and communicate with the study team. 9. ability to provide written informed consent using a document that has been approved by the required institutional review board. exclusion criteria 1. patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g., buerger's disease, vasculitis). 2. total occlusion of the sfa or pa in the index leg. 3. planned surgical or endovascular procedures to the affected leg on the day of or within 28 days of study drug administration. 4. deep vein thrombosis within the past 3 months. 5. known bleeding disorder. 6. presence of any arterial aneurysm in the index leg. 7. known hypercoagulable state (e.g., protein c deficiency, factor v leiden mutation, prothrombin g20210a mutation). 8. platelet count \ 3.0 times the upper limit of normal. 9. arterial systolic bp \>200 mmhg or diastolic bp \>100 mmhg at screening or day of procedure. 10. pregnancy, lactation or plans to become pregnant during the course of the study. 11. presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. 12. malignancy or treatment for malignancy within the previous 12 months with the exception localized basal cell or squamous cell skin cancer, or any cancer in situ. 13. treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent. 14. known allergy to contrast media, iodine, lidocaine, prilocaine, or emla cream (lidocaine 2.5% and prilocaine 2.5%).

Keywords: peripheral artery disease pad vonapanitase claudication superficial femoral artery sfa popliteal artery stenosis elastase chymotrypsin-like elastase 1 cela1 prt-201
comparison of two rehabilitation programs in patients with mild to moderate parkinson's disease.

Conditions: Parkinson's Disease

Summary: parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years. the training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in parkinson's disease. there is indeed in parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. the hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate parkinson's disease. this is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects). the duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.


Eligibility criteria:
inclusion criteria * patient diagnosed with parkinson's disease on ukpdsbb criteria. * hoehn \& yahr stage 2, 3 in "off" state * age ≥18 years * patient who agreed to sign an informed consent to participate in this study. exclusion criteria * patients who cannot or do not wish to follow a motor rehabilitation program for two months with a subsequent follow-up 3 months * intercurrent severe condition jeopardizing the vital or functional prognosis or the ability to participate in rehabilitation sessions. * cognitive dysfunction making effective communication or participation in a rehabilitation program impossible * person not benefiting from french state health insurance * current participation in another research protocol

Keywords: parkinson's disease mild to moderate stage asymmetric motor strengthening rehabilitation
leo19123 cream in the treatment of hand eczema

Conditions: Hand Eczema

Summary: to compare the efficacy and safety of two different dose combinations of leo19123 cream (calcipotriol and leo80122) with leo19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hand eczema with or without atopic etiology/background * investigator.s global assessment of disease severity graded as at least mild at visit 1 * patients should be caucasian males aged from 18 years * attending a hospital outpatient clinic or the private practise of a dermatologist. * following verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out, including activities relating to wash-out periods. exclusion criteria: * systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (inhaled or intranasal steroids for asthma or rhinitis may be used). * puva or uvb therapy on the hands within 4 weeks prior to randomisation. * topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from who groups iii or iv on the hands within 2 weeks prior to randomisation. * other topical therapy on the hands (except for the use of emollient) within 1 week prior to randomisation. * use of other treatment (drug, non-drug) on the hands during the trial except for the use of investigational product and emollient. * concurrent skin diseases on the hands. * current diagnosis of exfoliative dermatitis. * significant clinical infection (impetiginised hand eczema) on the hands, which requires antibiotic treatment. * known or suspected hypersensitivity to component(s) of the investigational product. * positive patch test as defined in protocol * known or suspected severe renal insufficiency or severe hepatic disorders. * patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia. * patients with history of cancer except for basal cell carcinoma. * current participation in any other interventional clinical trial. * patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation. * previously randomised in this study. * patients known or, in the opinion of the investigator, is unlikely to comply with the clinical study protocol (e.g. alcoholism, drug dependency, or psychotic state).
the effect of implementation of bundle for preventing blood culture contamination in neonatal intensive care unit

Conditions: Newborn; Infection

Summary: in this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (nicu).

infections are never as frequent and life-threatening as in the neonatal period. the lack of sepsis-specific findings in the neonatal period, the narrow repertoire of clinical findings in newborns, and the fact that non-infectious clinical conditions frequently encountered in this period have similar findings pose a serious problem for early diagnosis and treatment of neonatal sepsis. another important problem is that early empirical antibiotic treatment without diagnostic confirmation has to be resorted to very frequently in order to avoid morbidity and more importantly mortality with early intervention. this leads to unnecessary and prolonged treatment of newborns with potentially dangerous broad-spectrum antibiotics as well as prolonged hospitalizations and significant costs. the rate of contaminated blood culture in the neonatal period is 2.6-18%. in this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (nicu).

Eligibility criteria:
inclusion criteria: newborns diagnosed with sepsis exclusion criteria: newborns receiving antibiotic treatment

Keywords: blood culture bundle blood culture contamination cost-effectiveness neonatal intensive care unit neonates
oximetry in children for sleep apnea diagnosis

Conditions: Obstructive Sleep Apnea

Summary: video-polygraphy or video-polysomnography (vp(s)g) is the reference exam for the diagnosis of obstructive sleep apnea syndrome (osas) in children as it allows the detection of the respiratory events presented by the child during sleep. this exam requires a one-night hospitalization and several sensors installed on the child's body, sometimes not well-accepted in children. portable oximetry is an easier test to perform, better accepted by the child, and gives the desaturation index that may be used for the diagnosis of osas because most respiratory events are associated with desaturations. the hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(p(s)g) can identify a moderate-severe osas in children.

video-polysomnography (vpsg) with video surveillance and monitoring by a nurse to reposition the sensors if needed during the night is the gold standard exam for the diagnosis of obstructive sleep apnea syndrome (osas) in children. the vpsg gives the obstructive apnea-hypopnea index (oahi), necessary for the diagnosis of osas and to determine its severity. but the vpsg is a rather cumbersome exam, sometimes difficult to perform in children, with several sensors and electrodes to install on a child's body (electroencephalogram (eeg), electromyogram (emg), electrooculogram (eog), nasal cannula, thoracoabdominal belts, pulse oximetry, body position) that is time-consuming for installation and analysis. video-respiratory polygraphy (vpg) is very similar to vpsg but without eeg, eog and emg electrodes. vpg represents an alternative for the diagnosis of osas. however, these sleep examinations, vp(s)g, requires a number of electrodes and sensors to be installed on the child's body and one night of hospitalization. the desaturation index obtained by simple portable oximetry could be used for the diagnosis of osas because most respiratory events are associated with desaturations. portable oximetry is an easier test to perform. it is better accepted by the child because it only requires a finger or toe sensor and could be done on an outpatient basis or in the hospital. the coupling of these 2 examinations, vp(s)g and oximetry, is part of our current routine practice. the hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(p(s)g) can identify an osas in children.

Eligibility criteria:
inclusion criteria: children aged 2 to 18 years suspected of osa who underwent a vp(s)g simultaneously with oximetry during the period june 2017 to june 2022. exclusion criteria: children with non-interpretable recordings

Keywords: sleep child polysomnography polygraphy
laparoscopic surgery for t4 tumor of the colon cancer (lst4c trial)

Conditions: Colonic Neoplasms

Summary: the purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for t4 colon cancer

the investigators previous study indicated that laparoscopic surgery is feasible in t4 colon cancers with comparable clinical and oncologic outcomes. laparoscopy can be considered as an alternative approach for t4 colon cancers with the advantage of faster recovery. however, the clinical value of laparoscopic surgery for t4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. the aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for t4 colon cancer as well as the mortality and the morbidity. the number of patients needed to get a 80% power is 1960. the average number of patients/surgical center is approximately 200 in each of 10 surgical centers. the preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center. the baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed equestionnaire. systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy vs conventional open surgery).

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * histologically confirmed diagnosis of colon carcinoma * ct or mri verified as t4 colon cancer without involvement of other organs * without multiple lesion other than carcinoma in situ * tumor size \< 8 cm * no bowel obstruction * sufficient organ function * no history of gastrointestinal surgery * 18 years of age or older * performance status (ecog) 0, 1 or 2 and life expectancy \> 12 weeks * operable patients exclusion criteria: * • women who are pregnant (confirmed by serum b-hcg in women of reproductive age) or breast feeding * unstable or uncompensated respiratory or cardiac disease * serious active infections * hypersensitivity to capecitabine/fluorouracil or oxaliplatin * stomatitis, ulceration in the mouth or gastrointestinal tract * severe diarrhea * peripheral sensory neuropathy with functional impairment

Keywords: colonic neoplasms laparoscopic surgery t4
effects of a virtual reality intervention on mental health outcomes and academic success in physical therapy students

Conditions: Mental Stress; Anxiety; Depression; Satisfaction

Summary: exploring the impact of a virtual reality program, first resort on graduate physical therapy student wellness and academic success.

this study is exploring the impact of an 8-week virtual reality intervention among graduate physical therapy students. self-report measures of anxiety, depression and stress will be collected pre/post to assess the impact of the virtual reality intervention. purpose: 1. determine if there is an impact of a virtual reality intervention on symptoms of anxiety, depression and stress levels in first year physical therapy doctoral students 2. explore correlations between performance, anxiety, depression, stress and first resort use in first year physical therapy doctoral students 3. explore the feasibility of use of first resort app in first year physical therapy doctoral students

Eligibility criteria:
inclusion criteria: physical therapy students enrolled at a single university in the southern united states during the fall 2024 semester - exclusion criteria: patient health questionnaire-8 score of 15 or more general anxiety disorder-7 score of 15 or more history of seizures history of motion sickness history of epilepsy history of balance impairment history of significant visual history of auditory impairment -
study of acalabrutinib (acp-196) versus ibrutinib in previously treated participants with high risk chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: this study is designed to evaluate progression-free survival (pfs) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * ecog performance status of 0 to 2. * diagnosis of cll. * must have ≥ 1 of the following high-risk prognostic factors: * presence of 17p del by central laboratory. * presence of 11q del by central laboratory. * active disease meeting ≥ 1 of the following iwcll 2008 criteria for requiring treatment * must have received ≥ 1 prior therapies for cll. * meet the following laboratory parameters: * absolute neutrophil count (anc) ≥ 750 cells/μl or ≥ 500 cells/μl in participants with documented bone marrow involvement, and independent of growth factor support 7 days before assessment. * platelet count ≥ 30,000 cells/μl without transfusion support 7 days before assessment. participants with transfusion-dependent thrombocytopenia are excluded. * serum aspartate aminotransferase (ast)/serum glutamic oxaloacetic transaminase (sgot) and alanine aminotransferase (alt)/serum glutamic-pyruvic transaminase (sgpt) ≤ 3.0 x upper limit of normal (uln). * total bilirubin ≤ 1.5 x uln. * estimated creatinine clearance ≥ 30 ml/min. exclusion criteria: * known cns lymphoma or leukemia. * known prolymphocytic leukemia or history of, or currently suspected, richter's syndrome. * uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. * prior exposure to ibrutinib or to a b-cell receptor (bcr) inhibitor or a b-cell lymphoma-2 (bcl-2) inhibitor. * received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug. * prior radio- or toxin-conjugated antibody therapy. * prior allogeneic stem cell or autologous transplant. * major surgery within 4 weeks before first dose of study drug. * prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease \> 3 years before screening and at low risk for recurrence. * significant cardiovascular disease within 6 months of screening. * known history of infection with human immunodeficiency virus (hiv). * history of stroke or intracranial hemorrhage within 6 months before randomization. * history of bleeding diathesis. * requires or receiving anticoagulation with warfarin or equivalent vitamin k antagonists within 7 days of first dose of study drug. * requires treatment with a strong cytochrome p450 3a (cyp3a) inhibitor/inducer.
diet and physical activity on nafld and erytrocyte membrane lipid profile.

Conditions: NAFLD

Summary: this study aims to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index mediterranean diet and of the interaction of both, on nafld score and on the lipid composition of the erythrocyte membrane.

the surveys conducted on the populations of castellana grotte and putignano (bari, italy) evidenced that non-alcoholic fatty liver disease (nafld) reaches a prevalence of 30%, especially among aged and male individuals. being a crucial outcome of several metabolic alterations, it becomes imperative for public health to adopt strategies aimed to control the factors responsible for nafld onset. the objective of this study is to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index mediterranean diet and of the interaction of both, on nafld score and on the lipid composition of the erythrocyte membrane. study participants responding to the inclusion criteria of this trial will be chosen both in the hospital setting and in the general practitioners' clinics. at the enrollement, anthropometric and biochemical variables will be measured, as well as bioimpedenziometric and calorimetric parameters; participants will also undergo fibroscan-cap to measure the outcome and will be asked about their medical history and life-style. subjects will be randomized to the different arms of the trial and be followed-up at the end of the sixth and the twelfth week of enrollement. all data will be statistically analysed by applying the chi-square test and t-test for discrete and continuous variables, respectively. as it deals with the analysis of data repeatedly measured on the same subject, the generalized estimating equation (gee) will be applied to evaluate the effect of the intervention on the outcomes.

Eligibility criteria:
inclusion criteria: * bmi ≥ 25.0 * moderate or severe nafld * 30 \< age \<60 exclusion criteria: * overt cardiovascular disease and revascularization procedures; * stroke; * clinical peripheral artery disease; * type-2 diabetes mellitus (current treatment with insulin or oral hypoglycemic drugs, fasting glucose \>126 mg/dl, or casual glucose \>200 mg/dl); * severe medical condition that may impair the person to participate in a nutritional intervention study; * impossibility to follow mediterranean diet for religious or other reasons.

Keywords: diet physical activity trial lipidomics occidental diseases