Kornimate/medical-research-clean huggingface dataset:
effects of diacutaneous fibrolysis on flexibility and active neuromuscular response

Conditions: Hamstring Contractures

Summary: diacutaneous fibrolysis is a physiotherapeutic instrumental technique, used to treat musculoskeletal conditions causing pain and/or movement restriction. it is applied by means of metallic hooks, ending in a spatula with beveled edges, that seems to allow a better pressure distribution on the skin and a deeper and more precise application, compared to the manual approach. recent studies indicate positive responses regrading pain intensity decrease in sports people suffering anterior knee pain, improving range of motion in subacromial impingement syndrome, improving sensory conductivity in symptomatic patients with carpal tunnel syndrome, decreased pain in patients with chronic epicondialgia or improveing function athletes with anterior knee pain. however, the specific action mechanism, have not been investigated in depth yet. there are no studies evaluating its effects on posterior muscular chain of lower extremity in athletes, where fd effects on neuromuscular response could be more evident due to the overload involved on this area. the aim of this study is to evaluate the immediate, and after 30 minutes, effects of a single diacutaneous fibrolysis session on flexibility, strength and neuromuscular activity on hamstring in athletes. a randomized controlled trial with blind evaluator. randomization will be done between lower extremities of each subject (random.org). regardless of its own dominance, diacutaneous fibrolysis will be applied to de following muscles and intermuscular septums: gluteus maixmus, biceps femoris and semitendinosus to de lower experimental limb. the other extremity will not be treat (control limb). sample recruitment. athletes from uic university community, who compete officially or institutionally, whether they are federated or recorded in a sport official register where the predominant activity focuses on the lower train (athletics, cycling, football, rugby...). procedure. the anthropometric data will be collected at the beginning of the study. each outcome assessment will be performed by a blinded evaluator at the baseline, immediately after the technique application and 30 minutes after.


Eligibility criteria:
inclusion criteria: * athletes * \<160º in the passive knee extension test * participants must sign and have informed consent. exclusion criteria: * poor skin * trophic condition * taking anticoagulants * inflammatory process * recent musculoskeletal lower limb injury (\< 6 month)

Keywords: diacutaneous fibrolysis physiotherapy neuromuscular response
cbt for insomnia with anxiety and depression

Conditions: Insomnia

Summary: objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia. hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.

the purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (study group) and cbt-i intervention group (control group). the study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. the related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years, male and female 2. meet the diagnostic criteria of dsm-5 for insomnia, the pittsburgh sleep quality index (psqi) scale total score ≥10 3. may be accompanied by depression symptoms, but currently does not meet any depression disorders diagnostic criteria,14≤hamd-17≤23 4. may be accompanied by anxiety symptoms, but currently does not meet any anxiety disorders diagnostic criteria ,14≤hama≤29 5. have sufficient education and understanding to complete this study to be examined and evaluated 6. voluntary participation in this clinical trial and signature of informed consent. exclusion criteria: 1. dsm-5 other sleep problems, such as apnea syndrome, restless leg syndrome 2. women who are pregnant, nursing or planning to become pregnant during the study 3. insomnia caused by alcohol or substance abuse 4. severe cognitive problems 5. patients who were previously or currently diagnosed as bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stress related disorders, separation disorders, eating disorders 6. patients with history of epilepsy or other serious somatic diseases 7. persons receiving mect treatment for nearly one month 8. excluding those who have received systemic psychotherapy for more than 3 months in a row 9. the researchers believe that it is not suitable to participate in this clinical study.
pet on surgery for loco-regionally recurrent colorectal cancer

Conditions: PET-driven Surgery; Loco-regional Recurrent Colorectal Cancer

Summary: the influence of positron-emission-tomography (pet) on the surgical treatment of loco-regionally recurrent colorectal cancer (lrrcrc) remains obscure and deserves further investigation.

loco-regionally recurrent colorectal cancer (lrrcrc) occurs in 4.0-11.5% of patients following treatment of primary colorectal cancer with curative intent, and can be categorized as peri-anastomotic, mesenteric/paracolic (nodal), retroperitoneal and peritoneal.1-4 in contrast to distant recurrences (e.g. liver, lung or bone metastasis), lrrcrcs is a less recognized clinical entity, although it is generally accepted that surgical resection remains the major treatment modality to provide the long-term survival for such patients.5-7 however, the value of resection for lrrcrc is obscure, given the role of surgical resection in treating lrrcrc has received comparatively little attention with a scant literature to draw upon when making treatment recommendations and no available consensus statements.8,9 moreover, in clinical practice, it has been recognized that more than 50% of patients with recurrent colorectal cancer brought to the operating room for attempted curative surgery were unable to undergo the planned operation because more extensive disease than anticipated was discovered at laparotomy. therefore, it has been suggested that a formal multidisciplinary team (mdt) discussion based on more precise diagnostic armamentariums be mandatory for more accurate evaluation of tumor burden and would allow curative surgery to be offered to a better-selected group of patients with recurrent colorectal malignancy10-14. remarkably, positron-emission-tomography (pet) scans are now being widely used for the surveillance of patients having undergone curative resection for the primary colorectal cancer . whole-body pet scanning in the patient with recurrent colorectal cancer has been reported to be more sensitive and accurate than computed-tomography (ct) and magnetic-resonance-imaging (mri). moreover, pet is purported to be capable of differentiating among recurrent malignancy, scar, fibrosis, and necrosis, thus preventing the patients from futile surgery.15 with the above-mentioned reasons in mind, we then conducted this retrospective study to look at the efficacy of pet scan for directing surgery in patients with lrrcrc. we hypothesized that with the better diagnostic sensitivity and specificity, as compared to the conventional imaging methods (ct/mri) in detecting recurrences of colorectal cancer, pet can positively affect the surgical decision-making and thus improve the treatment outcomes for patients with lrrcrcs.

Eligibility criteria:
inclusion criteria: i. patients with primary colorectal cancers undergoing r0 resection ii. patients with final histopathologic reports documenting the pathologic tumor-node-metastasis (ptnm) stage i, ii, or iii exclusion criteria: i. patients with ptnm stage iv primary colorectal cancer ii. patients with r1/2 resection
the role of the human microbiome in patients after pancreatic resection.

Conditions: Pancreas Cancer; Pancreas Neoplasm; Pancreas Adenocarcinoma; Periampullary Cancer; Periampullary Carcinoma; Microbial Colonization

Summary: the goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles. to identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients.

rationale: resection is the only potentially curative option for pancreatic and periampullary cancer, a complex procedure with a high risk of complications of 30% to 73%. research shows the presence of altered bacterial populations within fecal, pancreatic fluid, bile and jejunal samples of patients after pancreatic resection compared to healthy samples. moreover, specific gut microbial composition in the pre- and postoperative period were associated with a higher risk of developing complications after pancreatic resection in small studies. further research on a larger scale is necessary to validate these findings and to evaluate targeted microbiome modifications to improve outcomes in patients after pancreatic resection. objective: the primary objective of this study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal microbiome profiles. study design: prospective observational cohort study. study population: 200 adult patients with resectable pancreatic or periampullary presumed (pre)malignancy. main study parameters/endpoints: the primary endpoint is a composite of postoperative complications including pancreatic fistula, bleeding, gastroenterostomy-, bile- or chyle leakage, delayed gastric emptying, cholangitis, sepsis and organ failure. nature and extent of the burden and risks associated with participation, benefit and group relatedness: all participants will be offered the standard of care. in addition, rectal swabs, faeces, salivary, bile, blood and tumor samples will be collected at different time points perioperatively. participating in this study carries no additional risks.

Eligibility criteria:
inclusion criteria: * adult patient with a resectable, borderline resectable or locally advanced pancreatic and periampullary presumed (pre)malignancy. * the intention of the treatment must be curative including surgery and (neo-)adjuvant chemotherapy. * willing and able to adhere to the study procedures described in this protocol and to grant the study team access to the electronic patient file and other data that are required to answer the research questions described in this protocol. exclusion criteria: * inability to provide adequate informed consent (e.g. language barrier, illiteracy)
study comparing high-dose flu vaccine to standard vaccine in cancer patients less than 65 receiving chemotherapy

Conditions: Cancer; Influenza Viral Infections

Summary: the safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. this study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.


Eligibility criteria:
inclusion criteria: 1. 18 years old to less than 65 years old 2. subjects with malignancy must be receiving chemotherapy 3. medically stable 4. able to understand and willingness to sign a written informed consent 5. able to comply with study procedures 6. life expectancy of more than 3 months 7. adequate organ function: * anc \>1000/mm3 * platelet \>100,000/ul * creatinine \<2 mg/dl * ast and alt \<3 times the uln exclusion criteria: 1. allergy to eggs 2. prior allergy to influenza vaccine 3. history of guillain-barre syndrome 4. current febrile illness 5. other immunosuppressive disease (recipients of solid organ transplant, uncontrolled hiv) 6. autologous or allogenic stem cell transplant with in a year 7. current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)

Keywords: influenza vaccine oncology chemotherapy
clinical investigation of the bi flex m multifocal iol

Conditions: Cataract

Summary: during cataract surgery an artificial lens is implanted in the eye. these artificial lenses are called intraocular lenses (iols) and there are many different types of iol designs. iols are of fixed focus and so unless a multifocal iol is used you would need to wear spectacles for viewing near objects. this study has been designed to look at how well a multifocal iol corrects distance and near vision in comparison with a conventional monofocal iol. both types of iols are commercially available and are commonly implanted. using new non-invasive methods we hope to be able to better judge the visual performance of these iols. in addition the study will involve imaging and examining the iols to determine the prevalence of any post-operative complications.


Eligibility criteria:
inclusion criteria: * age related cataract patients requiring cataract surgery with phacoemulsification. * patients requiring primary iol implantation * patients with a potential corrected visual acuity of 20/40 or better on clinical assessment * patients with normal anterior segments apart from cataracts * subjects with clear intraocular media other than cataract exclusion criteria: * preexisting pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. this includes the following: * microphthalmia * corneal decompensation or endothelial insufficiency * pseudo exfoliation * high myopia * pars planitis * patient with greater than 1 dioptre of preoperative corneal astigmatism * subjects who are expected to require retinal laser treatment * previous intraocular and/or corneal surgery * history of uveitis, glaucoma, proliferative diabetic retinopathy, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better * operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location * subjects using a systemic medication that is known to cause ocular side effects * subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days * subjects who have only one eye with potentially good vision * patients who are not willing to cooperate for the follow up period * visual eccentricity of greater than 0.7mm * pregnant women * patients where it is not possible to take informed consent

Keywords: lenses intraocular
safer births - reducing perinatal mortality

Conditions: Fetal Heart Rate Abnormalities; Respiratory Depression; Birth Asphyxia; Neonatal Resuscitation

Summary: safer births is a research and development collaboration to establish new knowledge and new innovative products to better equip and increase competence of health workers for safer births and increased newborn survival worldwide. the main objectives are: to randomize different devices for fetal heart rate assessments. to assess if a novel newborn resuscitation monitor will facilitate newborn resuscitation in a low-resource setting. to determine bag mask ventilation treatment and devices beneficial for neonatal outcome.


Eligibility criteria:
inclusion criteria: * randomizing fetal heart rate assessment: singleton delivery, term gestation age, cephalic presentation, fetal heart rate normal, cervical dilatation ≤7cm, consent to participate * randomizing bag mask ventilation: infants in need of positive pressure ventilation, consent to participate exclusion criteria: * randomizing fetal heart rate assessment: placenta abruption/praevia, ruptured uterus, morbid obesity

Keywords: fetal hypoxia birth asphyxia neonatal resuscitation
ibis: italian burden of illness on schizophrenia & bipolar disorder

Conditions: Schizophrenia; Bipolar Disorder

Summary: multicentre, retrospective observational cohort study based on lhu administrative databases aimed to described the pharmacoutilization of antipsychotics in patients affected by schizophrenia and bipolar disorder, the resource consumption and medication adherence. a sub analysis will be performed for those patients switching from quetiapine ir to quetiapine xr and comparing the periods before and after the switch.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or bd (appendix for icd9-10 codes) or an antipsychotic prescription during the period 1/1/2009-30/06/2010 * patients must be assisted in the lhu for the year before the enrollment ( period 1/1/2009-30/06/2010) until 31/12/2010 or death date if earlier

Keywords: schizophrenia bipolar disorder
whole milk compared with skimmed milk and effect on lipids

Conditions: Atherosclerosis

Summary: the aim of the project is to investigate the effects in humans of a daily intake of whole milk compared to skimmed milk primarily and secondarily respectively on: * blood lipids: total-, ldl-, and hdl-cholesterol and triglycerides * risk markers of diabetes type 2: plasma glucose and insulin

this study will be a randomized controlled 2 x 3 weeks crossover intervention study with no wash-out period, as the lipids in the blood are known to adjust after 2 weeks. the effects of a diet containing 0.5 l of whole milk (17.5 g of milk fat/day) will be compared with a diet containing 0.5 l of skimmed milk (1.5 g of milk fat/day). blinding is not possible since the appearance of the test foods cannot be concealed. the study subjects will receive the two test foods in random order, decided by draw of lots. blood samples will be drawn on the first day of the period and in the end of the period for each 3 week-periods.

Eligibility criteria:
inclusion criteria: * all subjects must give their informed consent in writing, after having received oral and written information about the study * age: 20-70 y * bmi: 18.5 - 30 kg/m2 * healthy men and women (with no known diseases) exclusion criteria: * current or previous cardiovascular disease, high blood pressure or cholesterol * diabetes mellitus or other severe chronic disease, including severe allergies * lactose intolerant or milk allergy * use of dietary supplements two month prior to and during the intervention blood donations 1 month prior to and during the intervention * known or suspected abuse of alcohol, drugs or medication * pregnant or are planning pregnancy during the study period * extreme physical activity level (more than 10 hours tough physical activity pr. week) * participation in other research studies * inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
efficacy and safety of pasireotide long acting release (lar) versus octreotide lar or lanreotide autogel (atg) in patients with inadequately controlled acromegaly

Conditions: Acromegaly

Summary: this study will evaluate the efficacy and safety of pasireotide lar 40 and 60 mg versus octreotide lar or lanreotide atg in patients with inadequately controlled acromegaly.


Eligibility criteria:
inclusion criteria: 1. patients with written informed consent prior to any study related activity 2. patients who had inadequately controlled acromegaly as defined by a mean gh concentration of a 5-point profile over a 2-hour period \> 2.5 µg/l and sex- and age-adjusted igf-1 \> 1.3 x upper limit of normal (uln) 3. patients who had been treated with maximum indicated doses of octreotide lar or lanreotide atg for at least 6 months prior to visit 1 (screening). the maximum indicated dose for octreotide lar was 30mg and for lanreotide atg iwas120 mg 4. patients who had a diagnosis of pituitary micro- or macro adenoma. patients could have been previously submitted to surgery 5. patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension exclusion criteria: 1. patients who had received pasireotide (som 230) prior to enrolment 2. concomitant treatment with growth hormone receptor (ghr)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). such patients must have been treated with octreotide lar 30 mg or lanreotide atg 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy. 3. patients who had compression of the optic chiasm causing acute clinically significant visual field defects 4. patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression 5. patients who had received pituitary irradiation within 10 years prior to visit 1 (screening). 6. patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening). 7. patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Keywords: acromegaly hormone disorder growth hormone insulin like growth factor-1 pituitary tumor pasireotide som230
non-dispensing study to check prescription equivalence of two daily disposable toric contact lens types

Conditions: Astigmatism

Summary: the purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.


Eligibility criteria:
inclusion criteria: 1. the subject must be between 18 and 40 years old. 2. the subject must have normal eyes. 3. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 4. the subject must read and sign the statement of informed consent and be provided a copy of the form. 5. the subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 ds in each eye. 6. the subject must manifest -1.25 to -2.00 d of refractive astigmatism in each eye. 7. the subject's refractive cylinder axis must be 180 +/- 30 in each eye. 8. the subject must be an adapted wearer of soft toric contact lenses in both eyes. 9. the subject's best visual acuity (bva) must be better than or equal to 20/25 in each eye. 10. subjects must already possess a wearable pair of spectacles. - exclusion criteria: 1. ocular or systemic allergies or disease that may interfere with contact lens wear. 2. systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear. 3. clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. 4. clinically significant tarsal abnormalities that might interfere with contact lens wear. 5. any ocular infection. 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. pregnancy or lactation 8. any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., hiv). 9. diabetes 10. strabismus -