Kornimate/medical-research-clean huggingface dataset:
comparison of mobilization and ozone therapy in impingement syndrome

Conditions: Impingement Syndrome

Summary: studies investigating the efficacy of the mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. the aim of this study was to compare the effectiveness of mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. ozone therapy will be practiced to study group. mulligan mobilization will be practiced to control group. pain, range of motion and function will be assessed before and after treatment.

the subacromial bursa and rotator cuff muscles are compressed between the acromion and the proximal humerus. if the subacromial surface volume decreases, degeneration and tears of the soft structures may occur during forward extension and rotation. studies investigating the efficacy of the mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. the aim of this study was to compare the effectiveness of mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. ozone therapy will be practiced to study group. inject 10 ml of ozone gas (o2-o3) at a concentration of 10 µg/ml 3 times at one week intervals. all injections will be performed by the same experienced specialist doctor. mulligan mobilization will be practiced to control group. mobilizations will be performed once a week for 3 consecutive weeks. the first one is a seated position with the patient's arm in approximately 90° abduction. the patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand. pain, range of motion and function will be assessed before and after treatment.

Eligibility criteria:
inclusion criteria: * patients aged 8-65 years * patients with shoulder impingement syndrome exclusion criteria: * shoulder surgery * history of scoliosis * infection * cardiac pacemaker * recent myocardial infarction * malignancy

Keywords: impingement syndrome ozone therapy mulligan mobilization
women's health project for women wanting to lose weight

Conditions: Obesity

Summary: the prevalence of obesity has steadily increased in the united states. this can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. the medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. we hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.

none needed

Eligibility criteria:
inclusion criteria: * any woman between the ages of 18 and 70 who is interested in counseling for weight loss * the body mass index (bmi) must be over 25 (overweight category) and below 40 (morbidly obese) exclusion criteria: * women who cannot reasonably expect to commit the time needed for 6 visits, two lab draws, and completion of three one week sleep logs * women who have had recent hospitalization or major surgery and cannot participate in a self directed exercise program * women with significant cardiac or respiratory disease and cannot participate in a self directed exercise program

Keywords: obesity weight loss sleep hygiene diet exercise
toripalimab with neoadjuvant chemotherapy for locally advanced esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this is a single-institution, single arm trial of toripalimab with neoadjuvant carboplatin and paclitaxel for locally advanced esophageal squamous cell carcinoma (escc).the primary study hypothesis is that the patients who received toripalimab combined with carboplatin and paclitaxel will increase complete pathologic response rate.

enrolled patinets will receive two cycles of toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), paclitaxel(135 mg/m2) and carboplatin(auc 5) administered as an intravenous infusion per 3 weeks. giving the drugs on the first day of each cycle.

Eligibility criteria:
inclusion criteria: * 1.histologically confirmed escc; * 2.clinical stage t1-2n2-3m0 or t3n1-3m0 or t4n0-3m0(ajcc 8 tnm classification); * 3.have a performance status of 0 or 1 on the ecog performance scale; * 4.the important organs functions meet the following requirements:the absolute neutrophil count(anc) ≥1.5×109/l; the platelet count ≥100×109/l; hemoglobin ≥90g/l; bilirubin is less than or equal to 1.5 times uln, alt and ast less than or equal 2.5 times uiln; creatinine clearance rate(ccr) ≥50ml/min; the thyroid function is normal; * 5.expected survival time is greater than or equal to 3 months; * 6.female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; * 7.female subjects of childbearing potential must be willing to use an adequate method of contraception - contraception, for the course of the study through 90 days after the last dose of study medication; * 8.be willing and able to provide written informed consent/assent for the trial. exclusion criteria: * 1.has any active autoimmune disease or a history of autoimmune disease; * 2.the patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy; * 3.the patient had active infection, fever of unknown cause ≥38.5℃ within 7 days before the medication, or white blood cell count at baseline \>15×109/l; * 4.the patient had previously received other anti-pd-1 antibody therapy or other immunotherapy targeting pd-1 / pd-l1,or received chemoradiotherapy; * 5.have a history of mental illness or psychiatric substance abuse; * 6.patients who had participated in clinical trials of other drugs within 4 weeks; * 7.patients with a serious risk to treating patients' safety or a concomitant disease that affects the completion of the study according to the researchers judgment; * 8.senior or uncontrolled virus injection: hiv, tp, hepatitis virus; * 9.other patients whom the medical practitioner considers inappropriate for inclusion.

Keywords: esophageal squamous cell carcinoma toripalimab neoadjuvant treatment chemotherapy
tips in fundal variceal bleeding (the tfb study)

Conditions: Portal Hypertension; Bleeding Gastric Varices

Summary: in the last years, important advances have been done in the treatment and prevention of fundal variceal bleeding in patients with cirrhosis. experts agree that the combination of pharmacological and endoscopic therapy (with tissue adhesives) should be the first line therapy in the acute bleeding episode from isolated gastric varices (igv1) or type 2 gastroesophageal varices (gov2) varices; whereas transjugular intrahepatic portosystemic shunt (tips) is considered a rescue therapy. tips has been shown to effectively prevent variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy and/or liver failure. in this sense, a recent randomized controlled trial (rct) in esophageal variceal bleeding showed that an early tips, performed during the first 72h after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. moreover, survival was also significantly increased as well as other portal-hypertension related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, etc). the present study is directed at comparing the outcome of patients with acute bleeding from fundal varices (igv1 or gov2) treated by standard therapy (vasoactive drugs + endoscopic injection of tissue adhesives) with or without early tips (performed during the first 1-5 days after admission). main end-point will be survival free of variceal rebleeding at 1 year from inclusion.


Eligibility criteria:
inclusion criteria: patients developing acute variceal bleeding from gov2 and/or igv1 defined according to baveno ii criteria, admitted in the hospital and receiving standard combined medical therapy (somatostatin 3 mg/12h continuous iv infusion or terlipressin, 2mg/4h iv + endoscopic injection of tissue adhesives as per center protocol). exclusion criteria: * hepatocarcinoma without therapeutic options (according to milan criteria). * portal or mesenteric vein thrombosis avoiding the performance of tips. * acute alcoholic hepatitis. * platelet count \< 20.000/mm3. * previous treatment with portosystemic shunt. * pregnancy. * previous inclusion in the current study. * terminal liver disease (bilirrubin \> 10 mg/dl and/or prothrombin index \< 30%); or other fatal non-liver diseases. * denied informed consent.

Keywords: bleeding gastric varices transjugular intrahepatic portosystemic shunt (tips) injection of adhesives
virtual mom power with high-adversity mothers and children (mphamc)

Conditions: Psychopathology

Summary: this study is a randomized controlled confirmatory efficacy trial of virtual mom power (mp), a group-based, relationship-focused multifamily preventive intervention.

this study is a randomized controlled confirmatory efficacy trial of virtual mom power (mp), a group-based, relationship-focused multifamily intervention with previously demonstrated effectiveness improving maternal mental health and parenting stress in randomized controlled trials. vmp targets 5 core components: 1) enhancing social support; 2) attachment-based parenting education; 3) self-care, including affect regulation; 4) guided parent-child interactions, and 5) connecting to care. eligible and enrolled participants will be randomized to receive the 10 week group-based intervention or 10 weeks of informational mailings; both groups will receive individual home-based sessions. outcomes include maternal social support, psychopathology, sensitive parenting, child psychopathology, two-generational biobehavioral self-regulation targets (respiratory sinus arrhythmia), parent and child emotion and behavior regulation, and dyadic behavioral and physiological synchrony. assessments will occur at intake, post, and 6 months following the group.

Eligibility criteria:
inclusion criteria: * enrollment status in one of the following services: supplemental nutrition assistance program (snap), family independence temporary assistance program (fitap), medicaid, special supplemental nutrition program for women, infants, and children (wic), or head start * maternal age of at least 18 years * mother is primary caregiver of child * mother speaks english * child age is between 3-5 years * family resides within 8 parish new orleans metro area exclusion criteria: * mother is not biological mother * diagnosis of a heart condition in the mother or the child * presence of a pacemaker in the mother or the child * child diagnosis of autism or global developmental delay * active maternal substance use * active maternal psychosis

Keywords: biobehavioral regulation respiratory sinus arrhythmia parenting behavior
mindfulness based intervention (mbi) on the quality of life and non-motor symptoms (nms) of persons with pd

Conditions: Parkinson's Disease

Summary: scientific abstract: the investigators propose a study to examine the impact of a mindfulness based intervention (mbi) on the quality of life and non-motor symptoms (nms) of persons with parkinson's disease (pd). nms add significantly to the disease burden and negatively impact the quality of life in pd (1,2). in a previous study the investigators confirmed the high prevalence of nms in pd patients with either early- or late-onset of disease (3). despite currently available treatments, pd leads to worsening disability and there remains a need for new approaches. a mindfulness based intervention may provide an important adjuvant therapy in the treatment of pd in relation to nms and quality of life. a minimum of 100 patients will be randomly assigned to the mbi or 'treatment as usual' (tau) groups. clinical assessments (motor and non-motor scores) will be performed in both groups. the tau group will be offered mbi after completion of the study. to the best of our knowledge, this is the first large scale study using mbi in this indication.

the investigators propose a study to examine the impact of a mindfulness based intervention (mbi) on the quality of life and non-motor symptoms (nms) of persons with parkinson's disease (pd). nms add significantly to the disease burden and negatively impact the quality of life in pd (1,2). in a previous study the investigators confirmed the high prevalence of nms in pd patients with either early- or late-onset of disease (3). despite currently available treatments, pd leads to worsening disability and there remains a need for new approaches. a mindfulness based intervention may provide an important adjuvant therapy in the treatment of pd in relation to nms and quality of life. a minimum of 100 patients will be randomly assigned to the mbi or 'treatment as usual' (tau) groups. clinical assessments (motor and non-motor scores) will be performed in both groups. the tau group will be offered mbi after completion of the study. to the best of our knowledge, this is the first large scale study using mbi in this indication.

Eligibility criteria:
inclusion criteria: * diagnosis of pd according to the uk brain bank criteria; * patients in hoehn \& yahr stage 1-3; * lack of features suggestive of atypical parkinsonism; * no history of neuroleptics or other drugs that induce parkinsonism in the last 60 days; * currently optimally treated with medication and unlikely to be requiring anti-pd medication adjustments in the next 4 months; * on a stable dose of all medications for 30 days; * lack of cognitive dysfunction as based on the moca (score ≥ 26). exclusion criteria: * cognitive dysfunction based on the moca (score \< 26); * patients with hoehn \& yahr stage 4 and above when in 'on' stage; * unstable, major psychiatric or life threatening concomitant disease.

Keywords: parkinson's disease
evaluation of efficacy and tolerance of cladribine in symptomatic pulmonary langerhans cell histiocytosis

Conditions: Langerhans Cell Histiocytosis of Lung

Summary: ecla is a phase ii, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5 days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary langerhans cell histiocytosis and impairment of lung function patients.

ecla is a phase ii, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5 days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary langerhans cell histiocytosis and impairment of lung function patients.

Eligibility criteria:
inclusion criteria: * age 16 to 55 yr * histologically proven pulmonary langerhans cell histiocytosis ( patients with presumptive diagnosis whose lung function precludes lung biopsy may be included after revision of their medical record at the national reference center for langerhans cell histiocytosis) * symptomatic pulmonary langerhans cell histiocytosis (nyha dyspnea class ≥2) with: * irreversible airflow obstruction (fev1/fvc\<70%) with postbronchodilator fev1 comprised between 30 and 70% of predicted * and/or decrease ≥15% in fev1, fvc or dlco as compared to baselines values in the year preceding the inclusion * signed written informed consent exclusion criteria: * women at childbearing age without adequate contraception or wishing breastfeeding * male without adequate contraception during the study * dyspnea due to severe pulmonary arterial hypertension (pap≥35mmhg) confirmed by cardiac right catheterism * previous malignancy * current infectious disease * renal failure * liver failure * severe alteration of lung * hematologic disease unrelated to langerhans cell histiocytosis * epilepsy * hepatic, spleen or hematology involvement by langerhans cell histiocytosis * pneumothorax within a month previously to inclusion * previous treatment with cladribine * contra indication to the use of cladribine * previous myelosuppressive treatment * simultaneous participation to another interventional clinical trial
a study of ly3127804 in participants with covid-19

Conditions: COVID-19; Pneumonia

Summary: a randomized, double-blind, placebo-controlled, clinical trial of ly3127804 in participants who are hospitalized with pneumonia and presumed or confirmed covid-19.


Eligibility criteria:
inclusion criteria: * are hospitalized with pneumonia, and presumed or confirmed covid-19 * are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed) exclusion criteria: * female participants must not be pregnant and/or lactating * have acute respiratory distress syndrome (ards) or will require immediate intermittent mandatory ventilation (imv), or are ineligible for imv * have any concurrent serious medical condition (for example dialysis) or concomitant medication that would preclude participation in the study * are moribund irrespective of the provision of treatments * have a known history or show evidence of human immunodeficiency virus (hiv) and/or hepatitis * have recently undergone major surgery or central venous access device placement * have a significant bleeding disorder or active vasculitis * have experienced a thromboembolic event * have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia * have a serious, nonhealing wound, peptic ulcer, or bone fracture * have liver cirrhosis * have a known sensitivity to monoclonal antibodies (mabs) or other therapeutic proteins * have a history of hypertensive crisis or hypertensive encephalopathy or current, poorly controlled hypertension

Keywords: corona virus disease 19 (covid-19) 2019 novel coronavirus (2019 n-cov) severe acute respiratory syndrome (sars) pulmonary disease sars-cov-2
dynamic changes in circulating tumour cells protein expression

Conditions: Recurrence Free Survival

Summary: this multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. patients were selectedm( at hospital san giovanni and celio in rome) according to ctcs results ( ctcs-guided managment performed at university magna graecia) or managed by the treating clinician according to standard pathological criteria (standard management). the participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (t3 or t4).

the investigators enroll patients with histologically confirmed advanced stage (t3 or t4, n1/2, m0/1) colorectal adenocarcinoma with molecular analysis on ras mutant status. the participants are enrolled within 3 weeks at the time of progression disease (pd) from any line of therapy. blood samples were collected from each participant after obtaining informed consent. permission to perform ctcs analysis from blood was obtained from the regional ethical committee (no.2013/34) and the study is conducted in accordance with the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance-status score of 0 to 2 (scores range from 0 to 5, with higher numbers reflecting greater disability) , * medically able to receive chemotherapy. exclusion criteria: * evidence of infective disease before enrollment , * a history of another primary cancer within the previous 3 years, * the presence of synchronous primary colorectal cancer.
cesarean section study

Conditions: Diarrhea; Atopic Dermatitis

Summary: effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by cesarean section. exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures * healthy newborns * born by cesarean section * singleton birth * age at enrollment in the study \< 24h * birth weight ≥ 2500g and ≤ 4300g * gestational age ≥ 37 weeks and ≤ 42 weeks exclusion criteria: * congenital diseases or malformations that may inhibit growth * prenatal and/or postnatal diseases * parents are expected to have difficulty complying with the feeding regime * planned re-admittance to the hospital in the first 14 days of life * antibiotic treatment at the time of enrollment in the study

Keywords: cesarean section, probiotic, formula fed, gut microbiota
montelukast in children with wheezing

Conditions: Wheezing

Summary: in this study children with recurrent wheezing (\>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. they will undergo lung function evaluation by rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with montelukast 4 mg/day. symptom dairies will be filled by parents during the study period.

patients aged less than 2 years with recurrent wheezing. at visit 1 patients with symptoms will be enrolled and the study explained. they will return home with bronchodilator therapy. within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. skin prick test will be evaluated at that time. at visit 3 after 1 week of the run-in period they will start therapy with montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries. the final visit will be after four weeks with re-evaluation of the lung function

Eligibility criteria:
inclusion criteria: * age between 6-24 months * patients with recurrent wheezing (at least 2 episodes in the last 6 months) * patients with symptoms at enrollment exclusion criteria: * chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission

Keywords: wheezing children montelukast bronchodilators lung function rint
balneotherapy in primary fibromyalgia

Conditions: Fibromyalgia, Primary

Summary: balneotherapy (bt) is recommended as non-pharmacological treatment for fibromyalgia syndrome (fs). bt efficacy is based on beneficial properties of both mud bath and stay in a spa environment. the main aim of this multicentric prospective longitudinal cohort study is to evaluate bt effectiveness in patients withfs. all fs patients with a stable treatment in the past month and a fibromyalgia impact questionnaire (fiq) score ≥39 will be enrolled after providing written informed consent. patients will be divided into two groups based on whether or not bt is added to usual therapy: bt group and control group. each patients will be assessed at baseline, after 15 and 45 days in bt group and at baseline and after 15 days in control group with an assessment of pain by visual analogue scale, fiq, short-form health survey, state-trait anxiety inventory (stai) and center for epidemiologic studies depression scale (ces-d). collected data will provide a new insight of bt role and the removal of daily stress in fs management


Eligibility criteria:
inclusion criteria: * diagnosis of primary fs according to the 2010 american college of rheumatology (acr) criteria; * pharmacological and non pharmacological treatment stable for at least 3 months; * fiq-total score ≥ 39 exclusion criteria: * secondary fs; * primary fs patients actually enrolled in other clinical trials; * patients who had receveid a cycle of bt or of mud-bath in the previous 6 months; * patients treated with intra-articular steroid injections of any joints in the previous 3 months; * pregnancy or breastfeeding; * cognitive or psychiatric disorders and history of substance abuse; * absolute and relative contraindications to bt

Keywords: balneotherapy