Kornimate/medical-research-clean huggingface dataset:
faecal microbiota transplantation after allogeneic stem cell transplantation

Conditions: Acute Leukemia in Remission; Myelodysplastic Syndromes; Myeloproliferative Syndrome; Hodgkin Lymphoma; Lymphoma, Non-Hodgkin; Myeloma; Chronic Lymphocytic Leukemia

Summary: the aim of this study is to assess the fecal microbiota transplantation (fmt) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-hsct) complications and particularly graft versus host disease (gvhd). the hypothesis of this study is that allogeneic fmt may improve outcomes of these patients.

the tmf-allo study is a prospective, open-label, multi-center, parallel, randomized phase ii clinical trial comparing a group patients with fmt and a control group of patients without fmt. the main objective of this study is to assess the effect of allogeneic fmt versus no treatment on graft-versus-host disease and relapse-free survival (grfs) at one year in adult patients treating with myelo-ablative allo-hsct for haematologic malignancy. the secondary objectives are to evaluate : * overall survival, progression-free survival at 1 and 2 years, * the haematological evolution, * the evolution of infections, * the tolerance and safety of the tmf carried out in post-transplant, * the evolution of the composition and diversity of the microbiota in allograft patients receiving tmf or not.

Eligibility criteria:
inclusion criteria: * patient aged 18 or over * men and women * patients affiliated with a social-security organization * patients undergoing a myelo-ablative allo-hsct for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood) * signed and dated informed consent exclusion criteria: * status of tumor progression at the time of allo-hsct * inability to understand the protocol (linguistic barrier, cognitive difficulties) * medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma) * presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis) * fecal incontinence * participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of gvhd, or studying the effectiveness of a fmt in another indication. * pregnant women * patient under guardianship, curatorship or protection of justice

Keywords: allogeneic hematopoietic stem cell transplantation hematologic malignancies graft versus host disease intestinal microbiota intestinal dysbiosis fecal microbiota transplantation
a study of apremilast use and effectiveness in patients with psoriatic arthritis in the netherlands

Conditions: Arthritis, Psoriatic

Summary: this is a multicenter, prospective, non-interventional, observational single arm study. 100 patients will be recruited in the netherlands over a one year period. in all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. treatment will be according to routine clinical practice and based on recommendations as per the summary of product characteristics (spc) of apremilast (otezla®). each patient will be followed up for a maximum of 24 months.

the objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (psa).

Eligibility criteria:
inclusion criter * patients ≥ 18 years of age who understand and voluntarily sign an informed consent form. * patients starting treatment with apremilast for psoriatic arthritis. exclusion criteria: * refusal to participate in the study. * language barrier for completing the questionnaires. * women who are pregnant or breast-feeding. * hypersensitivity to the active substance or to any of the excipients. * prior exposure to apremilast * initiation of apremilast treatment by a dermatologist for psoriasis

Keywords: psoriatic arthritis apremilast cc-10004
single breath counting test for acute respiratory failure in emergency department

Conditions: Acute Respiratory Failure

Summary: the purpose of the study is to determine whether sbct is a useful tool for diagnosing the main form of failure respiratory acute and to define the sbct limit associated with insufficiency respiratory in this population, the requirement for niv or invasive ventilation. furthermore, the correlation with the most common scores and indices used in the emergency room will be studied, such as: hacor, mew, rems score, ros, curb-65, qsofa, severity index of pneumonia, gwtg hf, lung ultrasound score, single breath count

single breath counting test (sbct) is the measurement of how far an individual can count in a normal speaking voice after a maximal effort inspiration. previous work has demonstrated that sbct has good correlation with the gold standard measures of pulmonary function test, peak expiratory flow rate and forced expiratory volume in the first second. the easy of the sbct makes this test appealing for rapid assessment of respiratory status overall in patients admitted for acute respiratory failure and we hypothesized that it will be valuable, replicable and fast tools for bedside assessment of respiratory function in emergency department. the purpose of the study is to determine whether sbct is a useful tool for diagnosis of the major form of acute respiratory failure and to define the cut-off limit of sbct associated to respiratory failure in this population, requirement of niv or invasive ventilation. moreover, it will be studied the correlation with the most common scores and indexes used in emergency department like: hacor, mew, rems score, ros, curb-65, qsofa, pneumonia severity index, gwtg-hf, lung ultrasound score, single breath counting test

Eligibility criteria:
inclusion criteria: * any acute respiratory failure * sao2 \<92% on air room at ed admission exclusion criteria: * age \< 18 yo * patients already in niv and hcfn in ed * home-oxygen or home-niv therapy * spo2 \< 80% * severe dyspnea * unable to speak complete sentences * uncooperative patients * hemodynamic instability \< 90 mmhg or vasopressor requirement at admission * st elevation-miocardial infarction * tracheo -stomized or -tomized patients * end of life

Keywords: single breath counting test acute respiratory failure
peer-led brief alcohol intervention for college student drinkers in spain

Conditions: Peer Group; Motivational Interviewing; Cognitive Behavioral Therapy; Alcohol Drinking in College

Summary: a pilot randomized controlled trial was carried out. fifty nursing students were randomly assigned either a 50-minute brief motivational intervention with individual feedback or a treatment-as-usual control condition. the intervention was delivered by undergraduate peer counsellors trained in brief alcohol screening and intervention for college students. primary outcomes for testing efficacy were alcohol use and alcohol-related consequences.

aims: to assess the potential efficacy and the feasibility of a peer-led brief alcohol intervention aimed to reduce the alcohol consumption in spanish heavy nursing student drinkers. methods: a pilot randomized controlled trial was carried out. fifty nursing students were randomly assigned either a 50-minute brief motivational enhancement intervention with individual feedback (n=23) or a treatment-as-usual control condition (n=27). both motivational interviewing and personalized feedback were delivered by undergraduate peer counsellors trained in brief alcohol screening and intervention for college students (basics). participants were assessed during their pledge year of university with a one-month follow-up. primary outcomes for testing efficacy were alcohol use (quantity, heavy-drinking episodes, and peak blood alcohol concentration), and alcohol-related consequences. quantitative data were analyzed using the u-mann-whitney and wilcoxon test. content analysis was used for measuring the feasibility of the program.

Eligibility criteria:
inclusion criteria: * first year university students of nursing degree, between 18 and 20 years old. * students of first access to the university. * having had at least one episode of heavy drinking or binge drinking in the past month. exclusion criteria: * students who have started or previously studied other university degrees or a higher degree. * university students who do not consume alcohol or, if they do consume alcohol, have not had binge drinking in the last month.

Keywords: brief interventions motivational interviewing peer counsellors college students alcohol counsellor behavior
an efficacy and safety study of alirocumab in children and adolescents with heterozygous familial hypercholesterolemia

Conditions: Hypercholesterolaemia

Summary: primary objective: to evaluate the efficacy of alirocumab administered every 2 weeks (q2w) and every 4 weeks (q4w) versus placebo after 24 weeks of double-blind (db) treatment on low-density lipoprotein cholesterol (ldl-c) levels in participants with heterozygous familial hypercholesterolemia (hefh) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (lmts) or a stable dose of non-statin lmts in case of intolerance to statins. secondary objectives: * to evaluate the efficacy of alirocumab versus placebo on ldl-c levels. * to evaluate the effects of alirocumab versus placebo on other lipid parameters. * to evaluate the safety and tolerability of alirocumab in comparison with placebo. * to evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. * to evaluate the development of anti-alirocumab antibodies.

the study duration was approximately up to 110 weeks (run-in period \[if needed\]: up to 4 weeks \[+2 days\], screening period: up to 2 weeks \[+5 days\], double-blind treatment period: 24 weeks, open label (ol) treatment period: 80 weeks).

Eligibility criteria:
inclusion criteria: * children and adolescent male and female participants 8 to 17 years of age at the time of signed informed consent. * participants with diagnosis of hefh through genotyping or clinical criteria. * participants treated with optimal dose of statin +/- other lmt(s) or non-statin lmt(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling. * participants with calculated ldl-c greater than or equal to 130 mg/dl (\>=3.37 mmol/l) at the screening visit except for participants who have previously participated in the dfi14223 (nct02890992) study. * a signed informed consent indicating parental permission with or without participant assent. exclusion criteria: * participant with body weight \< 25 kg. * participants aged of 8 to 9 years not at tanner stage 1 and participants aged of 10 to 17 years not at least at tanner stage 2 in their development. * participants with secondary hyperlipidemia. * diagnosis of homozygous familial hypercholesterolemia. * participant who had received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study. * participants with uncontrolled type 1 or type 2 diabetes mellitus. * participants with known uncontrolled thyroid disease. * participants with uncontrolled hypertension. * fasting triglycerides greater than (\>) 350 mg/dl (3.95 mmol/l). * severe renal impairment (ie, estimated glomerular filtration rate \<30 ml/min/1.73 m\^2). * alanine aminotransferase or aspartate aminotransferase \>2\*upper limit of normal (uln). * creatinine phosphokinase (cpk) \>3\*uln. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
clinical cohort study of knee arthroplasty assisted by digital technology

Conditions: Knee Osteoarthritis

Summary: through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. the intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional tka were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to tka were explored, providing references for clinical diagnosis and follow-up research.

through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. the preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional tka we summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.

Eligibility criteria:
inclusion criteria: * a. primary knee osteoarthritis; * b. unilateral primary knee replacement; * c. surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide exclusion criteria: * a. a history of renal insufficiency (cr \> 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of vte or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy; * b. those who do not accept this test for any reason and refuse to sign the informed consent.

Keywords: total knee arthroplasty knee osteoarthritis computer navigation robotic system patient-spercific instrumentation
nurtured heart parenting intervention for child behavioural problems

Conditions: Parent-Child Relations; Child Behavior Problem

Summary: behavioural problems are prevalent in children, yet the consequences can be significant for the child, family and wider society. effective intervention is paramount in reducing the impact of childhood behavioural problems. the nurtured heart approach (nha; glasser \& easley, 2016) is an atheoretical parenting intervention which aims to reduce childhood behavioural problems. although used in clinical practice, there is little empirical research on the effectiveness of the nha. the aims of the study were to examine whether the nha reduced parent-reported child behavioural problems, reduced negative parenting practices, and increased parental reflective functioning. the study used a multiple baseline single case design. parents of children with behavioural problems were recruited from camhs waiting lists. the nha was delivered in a guided self-help format, using the transforming the intense child workbook (glasser, 2016) and weekly phone calls. data collection involved psychometric measures of parent-reported child behavioural problems, parenting practices and parental reflecting functioning. measures were repeated throughout baseline and intervention phases. a follow-up four weeks after the intervention included final measure administration and a change interview. the data were graphed and visually analysed. supplementary analysis included reliable and clinically significant change, tau-u and percentage exceeding the median. framework analysis was used to analyse the change interview.


Eligibility criteria:
inclusion criteria: participants will be parents/carers of children who have been referred to national health service (nhs) children's services for behavioural problems. participants will be recruited from waiting lists of nhs children's services at the two research sites in the east midlands. inclusion criteria: * the referred child is aged between three and eleven years old. * the referred child is on a waiting list for an nhs children's service at the two research sites. * the referred child's behavioural problems are one of the primary reasons for referral to the nhs service. * the parent/carer identifies the referred child's behaviour as problematic. exclusion criteria: * the referred child has a diagnosis of developmental delay or learning disability. * the family is current receiving active multi-agency involvement (e.g. social care, police or youth offending in addition to nhs services). * the parent/carer is aged under 18. * the parent/carer is unable to read or speak english fluently.

Keywords: child behavioural problems parent training nurtured heart approach guided self-help single case design
ribose and sport performance

Conditions: Sports

Summary: investigate the acute effect of ribose supplementation on performance and recovery in athletes.


Eligibility criteria:
inclusion criteria: * men and women * training volume \> 7hrs/week * vo2 max \> 40 and 45 mg/kg/min (for women and men respectively) * otherwise healthy individuals exclusion criteria: * pregnant or breastfeeding women * individuals with endocrine disorders, hypercholesterolemia, cardiovascular diseases, gut diseases, cancer, anemia, hypoglycemia * medication for lipids, diabetes, hypertension, inflammation, autoimmune diseases, mood disorders * excessive alcohol consumption (more than two drinks by day for men, one for women), smoking, drug use, supplements or natural products consumption during the study

Keywords: peak vo2 consumption 3km time trial fatigue perception lactate time to complete
multi-omics study of early-stage lung cancer with distinct phenotypes

Conditions: Lung Cancer Associated with Cystic Airspaces; Multiple Primary Lung Cancers; Non-Small Cell Lung Cancer

Summary: the goal of this observational study is to investigate the multi-omics characterization early-stage lung cancer exhibiting distinct phenotypes including lung cancer associated with cystic airspaces, multiple primary lung cancers, and so on. the main questions it aims to answer are: * what are the differences in pathogenesis of non-small cell lung cancer with different phenotypes explored by multi-omics? * whether differential genes lead to potential prognostic models and therapeutic targets? participants will be followed up after surgery to answer prognosis: whether they have recurred, and the time to recurrence.


Eligibility criteria:
cohort 1: multi-omics study in early-stage synchronous multiple primary lung cancer inclusion criteria: 1. male or female patients:18-75 years old; 2. ecog score:0-1; 3. histopathologically confirmed tnm stage i-ii nsclc; 4. considered multiple or solitary primary lung cancer by clinical criteria (martini-melamed criteria and accp criteria); 5. good compliance, family members agree to cooperate to receive survival follow-up; 6. understand and voluntarily sign the informed consent. exclusion criteria: 1. a history of previous or co-existing malignant tumors; 2. systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment; 3. refusal to participate in the study. cohort 2: multi-omics study of lung cancer associated with cystic airspaces inclusion criteria: 1. male or female patients:18-75 years old; 2. ecog score:0-1; 3. histopathologically confirmed tnm stage i-ii nsclc; 4. ct findings show solitary or multiple nodules with cystic airspaces. exclusion criteria: 1. a history of previous or co-existing malignant tumors; 2. systemic anti-tumor therapies, including chemotherapy, radiotherapy, or targeted therapies (such as monoclonal antibodies, small-molecule tyrosine kinase inhibitors, among others), were administered prior to enrollment; 3. refusal to participate in the study.
prolonged smoking cessation using prescription step care

Conditions: Tobacco Dependence

Summary: smoking is the number one preventable cause of morbidity and mortality in this nation. unfortunately, more than 50% of those who quit following a smoking cessation intervention typically relapse within two weeks, with approximately 80% relapsing within six months. therefore, tobacco use can be conceptualized as a chronic condition. as with many chronic medical problems, tobacco use interventions may benefit from a step care approach to treatment. a total of 400 adult smokers will be enrolled in the study. participants will be randomly assigned to one of two treatment conditions consisting of: 1) a state of the art smoking cessation intervention + recycling or: 2) a state of the art smoking cessation intervention + step care. long term smoking cessation will be assessed by self-report, exhaled carbon monoxide levels, and salivary cotinine. the primary endpoint of the study will be smoking abstinence rates at two-year follow-up. it is predicted that long-term cessation rates will be significantly higher in the step care condition than for those assigned to the recycling group.

a common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. despite a high degree of interest in applying the step care model to smoking cessation (abrams et al., 1996; hughes, 1994), little empirical work has been conducted utilizing this treatment approach. the purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. with that introduction, we propose the following specific aims: aim 1: to enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings; aim 2: to randomize these participants to: 1) state of the art smoking cessation + recycling or 2) state of the art smoking cessation + step care; and aim 3: to evaluate the long-term (24 months post-randomization) relative success of the interventions. it is predicted that long-term cessation rates will be significantly higher in the step care condition.

Eligibility criteria:
cigarette smokers who are 18 years of age or older, who self-report smoking at least 10 cigarettes each day, and who are willing to accept random assignment are eligible to participate. potential participants must agree to commit to the study for at least 24 months, be screened and agree to potentially participate in more intensive interventions to help them stop smoking, and agree to not seek other treatment for smoking cessation during the treatment phase of the study.
pashos project: advanced platform for sleep apnea syndrome assessment

Conditions: Sleep Apnea Syndrome

Summary: the purpose of this study is to develop and validate a work-model in primary health care for identifying patients with sleep apnea syndrome, based on clinical variables and an ambulatory monitoring study.


Eligibility criteria:
inclusion criteria: * patients between 18 to 75 years. exclusion criteria: * cognitive impairment or psycho-physical deterioration that impede to perform ambulatory monitoring study. * worsened or unstable cardiovascular or cerebrovascular disease. * chronic insomnia (\<5h sleep / day). * relevant respiratory comorbidity that could interfere with arterial saturation measurements, as moderate to severe chronic obstructive pulmonary disease. * neuromuscular disease. * refusal to participate in the study.

Keywords: sleep apnea syndrome primary health care