cyrilzakka/clinical-trials huggingface dataset:
Effects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and Intensity

A sample of 60 children is randomly assigned to an intervention and a control condition. The intervention group receives 15 sessions of child-focused treatment with play training to enhance play persistence and intensity. The control group receives the same amount of placebo play sessions. The intervention group receives subsequently 15 sessions of parent training. All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD. Main hypothesis are a stronger reduction of ADHD symptoms of the child in different settings in the intervention than in the control group. Play-persistence and -intensity should also increase more in the intervention group. An additional effect of a subsequent parent training shall furthermore be tested.


Eligibility Criteria:
Inclusion Criteria: Diagnosis of ADHD or combinde ADHD/ ODD, age 3 to 6, 5 Items regarding play behavior on DSM-IV symptom checklist above 95th percentile, parents motivation to provide 15 to 30 weekly sessions

Exclusion Criteria: Autism Spectrum Disorder, IQ below 80, massive actual impairment, that requests sudden in-patient treatment, school entry in less than 2 months
Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas

The purpose of this study is to determine the safety profile and the maximum dose of Debio 1143 (AT-406) that can be given to humans. This study is also designed to measure how much Debio 1143 (AT-406) gets into the blood stream (pharmacokinetics), and how Debio 1143 (AT-406) interacts with proteins related to cancer that the drug is targeted to affect (pharmacodynamics).

Ascenta Therapeutics, Inc. is conducting a clinical trial of the compound Debio 1143 (AT-406), a small molecule second mitochondria-derived activator of caspase C (Smac) mimetic. In vivo and in vitro studies have demonstrated that Debio 1143 (AT-406) induces cell death in several tumor models by inhibiting XIAP (X linked IAP), cIAP-1 (cellular IAP-1) and cIAP-2 (cellular IAP-2), thus releasing initiator and effector caspases to promote apoptosis. This protocol is a Phase I, dose-escalation, open-label, multi-center study conducted in patients with advanced solid tumors and lymphomas to evaluate the safety, tolerability and pharmacology of Debio 1143 (AT-406) in humans when administered orally.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumor or lymphoma;
* Locally advanced or metastatic disease for which no life prolonging therapy is available and no standard therapy is judged appropriate by the investigator;
* Eastern Cooperative Oncology Group Performance Status ≤ 1;
* Adequate hematologic function as indicated by, ANC ≥ 1,500/mm3, Hgb \>9.0 g/dL, platelet count ≥ 100,000/mm3
* Adequate renal and liver function as indicated by serum creatinine ≤ 1.0 x ULN or creatinine clearance of \> 60 cc/min, serum albumin ≥ 3.0 gm/dL, total bilirubin \< 1.0 x ULN, AST and ALT ≤ 2.5 x ULN ; Alkaline phosphatase ≤2.5 x ULN
* Negative Hepatitis B and Hepatitis C testing;
* QTc interval ≤450ms.

Exclusion Criteria:

* Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. Patients who have received prior radiotherapy must have discontinued steroids for 14 days prior to study entry and be clinically stable;
* Not recovered to ≤ Grade 1 toxicity from prior radiotherapy or chemotherapy agents;
* Use or requirement for use of aspirin or aspirin containing products with \>81 mg of aspirin per day;
* History of gastrointestinal bleeding within 1 year;
* History of diabetes mellitus requiring treatment with oral agents or insulin;
* Active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation;
* Known or suspected Wilson's Disease, or other conditions that affect copper accumulation or regulation;
* Prior treatment with IAP inhibitors.
Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction

This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs, chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..

Most of mortality from advanced chronic liver disease (ACLD) is mediated by so- called specific complications of end-stage liver disease (ESLD); one of the most important is infection (25-30%). Infection is responsible for considerable proportion of ESLD-related mortality. Important in pathogenesis of infections in ESLD is CAIDS (cirrhosis - associated immune dysfunction syndrome), recently re-named to CAID (Cirrhosis-Associated Immune Deficit). TRANSFER FACTOR (TF) is supposed to act at several points in CAID - cascade. This gave rise to hypothesis, that TF could be of benefit in AD/ACLF.

Characteristics of TF It has been shown that transmission fo T-Lymphocyte reactivity is transmissible not only by T-cells alone, but also by hommogenate of peripheral white blood cells. Later it became clear that for the transmission of cellular immunity is responsible dialysable fraction of T-lymphocytes homogenate (with small molecular weight of 10 kDa; consists of amino acids, small peptides, nucleotides etc). This homogenate was named Transfer - factor (TF). One dose of lyophilized drug contains: Leucocyti dialysatum 200 x 10 6 (contains various IFNs, ILs, chemokines, endorfins, heat shock protein etc)

* stimulates T H 1 response
* induces production of IL-1, IL-2
* activates chemotaxis of immunocompetent cells
* increases fagocytic activity
* activates antigen-presentation by APCs

The aim of this study is to assess the efficacy of transfer factor in decreasing rate and/or severity of infections in ACLF.

Eligibility Criteria:
Inclusion Criteria:

* admission to hospital at participating liver units or ICUs or internal medicine wards with acute decompensation (AD) of advanced chronic liver disease or acute-on-chronic liver failure according to CLIF - C criteria
* ability to provide informed consent,

Exclusion Criteria:

* disapproval
* lymphoproliferative disorders
* liver transplantation in the past
* pregnancy
* suspected. chronic infection in risk locations
* CNS
* peritoneum
* Known virus-related immune deficiency
* malignancy
* severe heart failure (NYHA \>= III)
* severe lung disease (COPD, GOLD\>3)
Dose Range Finding Study of Bimagrumab in Sarcopenia

The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* Low muscle mass as confirmed by DXA;
* Low gait speed \<0.8 m/s
* SPPB score less than or equal to 9;
* Weigh at least 35 kg;
* Adequate dietary intake;

Exclusion Criteria:

* A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management);
* Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing, toileting).
* Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening;
* Any underlying muscle disease including active myopathy or muscular dytrophy;
* Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (e.g. dilated cardiomyopathy);
* Type I diabetes or uncontrolled Type 2 diabetes;
* Chronic kidney disease \[estimated glomerular filtration rate (GFR) \< 30 mL/min\];
* History of confirmed chronic obstructive pulmonary disease with a severity grade \> 2 on the Medical Research Council Dyspnea Scale;
* Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids \>10 mg/d prednisone equivalent;
* Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis);
* Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening;
* Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine cervix);
* Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc).
Effects of a School-based Intervention to Increase the Water Consumption in Elementary School Children

The purpose of this controlled intervention study is to evaluate the effectiveness of a school-based intervention aiming at increasing the water consumption in elementary school children. The intervention schools received refillable water bottles and drying racks for all school children as well as educational material. The focus of the intervention is the promotion of drinking tap water.

This pilot project, called "H2NOE-Wasserschulen" (Water Schools in Lower Austria), aims to increase the water consumption of school children in elementary schools, to raise awareness of water drinking in children, parents and school teachers and to promote water drinking in Lower Austria in general.

By increasing the consumption of water, the consumption of sugar-sweetened beverages may decrease and in the long run may have a positive impact on children's body weight and tooth status.

All intervention schools receive refillable water bottles for each school child and drying racks for each classroom. Furthermore, in each school an information session for all school teachers is held and the teachers receive prepared educational material. The control schools do not receive the water bottles nor the educational material.

For the study, the investigators recruited 22 intervention schools and 32 control schools. Outcomes will be measured by paper and pencil questionnaires of school children at third grade of participating elementary schools in Lower Austria and with online questionnaires of teachers at baseline, at the end of the intervention (after one school year/June 2019) and at the one-year follow-up (after two school years/June 2020).

For process evaluation outcomes, the investigators will carry out focus group discussions with a subsample of school children and teachers and include questions in the respective questionnaires for school children, teachers and school headmasters. Parents will have the possibility to give feedback online.

Eligibility Criteria:
For the intervention schools:

Inclusion criteria:

* elementary school in Niederösterreich (Upper Austria, a province of Austria)
* no juice provided with the school milk programme

For the school children taking part in the survey:

Inclusion criteria:

* school children in third class of elementary school (at baseline)
* written declaration of consent by a parent/guardian
The Results of Oxford Unicompartmental Knee Arthroplasty in Patients With and Without Preoperative Genu Recurvatum

The purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Specifically, this study compare the number of occurrences of postoperative genu recurvatum and the postoperative hyperextension angles among the patients. Additionally, the knee scores, the pain scores, and the functional scores for the two groups of patients are compared.

Materials and methods: This study prospectively followed 104 patients (114 knees) who had been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up. The patients were divided into two groups: those without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores, and the functional scores were recorded and compared between two groups..

The patients in both groups were applied with cemented Oxford unicompartmental knee arthroplasty with the same surgeon. The all patients were performed surgery with minimally invasive surgery technique. The gender, site, range of motion, alignment of prosthesis, operative time, blood loss, and posterior slope of tibial component also were recorded and compared between two groups. The incidence of postoperative genu recurvatum, gender, and site were computed using Fisher's exact test. The hyperextension angle, knee score, pain score, functional score,range of motion, alignment of prosthesis, posterior slope of tibial component, operative time, and blood loss were compared with student t-test.

Eligibility Criteria:
Inclusion Criteria:

* The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20°

Exclusion Criteria:

* patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.
Children Born Preterm: Sustainable Health Monitoring

Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.


Eligibility Criteria:
Inclusion Criteria:

* Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region
* Acquisition of the informed consent

Exclusion Criteria:

* Residing outside Tuscany region
68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

After completion of study, patients are followed up within 3-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill criteria for initial staging or restaging as outlined below:

  * Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (\> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:

    * Surgery
    * External radiation therapy (RT)
    * Other focal therapies
    * Systemic medical treatment
    * Watchful waiting
  * Assessment for subsequent treatment strategy (restaging), any of the following:

    * Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:

      * Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
      * Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
    * Patients with known prostate cancer who undergo restaging because of new symptoms
    * Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
    * Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
    * Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
* Capability to provide written informed consent
* Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
* Inability to provide written informed consent
Improving Pain Management in Hospitalized Cancer Patients. A Before-after Cluster Phase II Trial

The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in improving the quality of pain management in hospitalised cancer patients. This is a before-after cluster phase II study performed in medicine, oncology and respiratory disease hospital wards. The Pac-IFicO programme is a complex interventions with multiple components. The primary end-point of the study is the proportion of cancer patients with severe pain.

Cancer-related pain continues to be a major healthcare issue worldwide. Despite the availability of effective analgesic drugs, published guidelines and educational programs for Health Care Professionals the symptom is still under-diagnosed and its treatment is not appropriate in many patients.

The objective of the study is to evaluate the efficacy of the Pac-IFicO programme in improving the quality of pain management in hospitalised cancer patients.

This is a before-after cluster phase II study. After the before assessment, the Pac-IFicO programme will be implemented in ten medicine, oncology and respiratory disease hospital wards. The same assessment will be repeated after the completion of the intervention.

The Pac-IFicO programme is a complex interventions with multiple components. It includes focus group with ward professionals for identifying possible local obstacles to optimal pain control, informative material for the patients, an educational programs performed through guides from the wards, and an organisational intervention to the ward.

The primary end-point of the study is the proportion of cancer patients with severe pain. Secondary end-points include opioids administered in the wards, knowledge in pain management, quality of pain management. We plan to recruit about 500 cancer patients from ten hospital wards. This sample size should be sufficient, after appropriate statistical adjustments for clustering, to detect an absolute decrease in the proportion of cancer patients with severe pain (the primary end-point) from 20% to 9%.

Eligibility Criteria:
Inclusion criteria

WARD LEVEL

1. consent from the head of the ward to participate to the study;
2. ward classified as oncology, medicine, respiratory disease ward according to the regional classification of hospitals;
3. number of beds: ≥20 ;
4. number of ordinary admissions with primary or secondary diagnosis of tumour (ICD-IX 140-239) \>180 per year;
5. yearly average stay in hospital between 4 and 19 days;
6. punctual prevalence of patients with primary or secondary diagnosis of tumour (ICD-IX 140-239) ≥ 8 patients.

STAFF LEVEL

1. affiliation to the ward;
2. informed consent to participate to the study.

PATIENT LEVEL

1. ordinarily admitted in the ward for at least 24 hours;
2. age ≥ 18 years
3. able to fill in the questionnaire according the profession judgment;
4. informed consent to participate to the study.

Exclusion criteria

WARD LEVEL

1. the ward had received or is receiving quality improvement programme of staff education for improve pain control.

PATIENT LEVEL

1. patient already assessed in one of the previous assessments.
Glucose and Insulin Responses to Test Foods

In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male \& half female, and half normal weight (BMI \> 19.0 and \< 25.0) and half overweight but not obese (BMI \> 25.0 and \< 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include:
* Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose \< 5.6 mmol/L (100 mg/dL) AND plasma glucose levels \< 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit)
* Systolic blood pressure 100-150 mmHg inclusive
* Diastolic blood pressure 60-90 mmHg inclusive
* Resting heart rate 50-90 beats/min inclusive after 3 minute rest
* Able to refrain from eating legumes and drinking alcohol the day before each test session
* Fasting triglycerides \< 2.0 mmol/L (178 mg/dL)
* Fasting HDL cholesterol \> 0.9 mmol/L (35 mg/dL) for males and \> 1.1mmol/L (42 mg/dL) for females
* Fasting LDL cholesterol \< 5.0 mmol/L (193 mg/dL)
* AST and ALT \< 120% of upper limit of normal (ULN)
* hsCRP \< 10 mg/L
* Urea and creatinine \< 150% ULN

Exclusion Criteria:

* failure to meet any one of the inclusion criteria
* age less than 18 or over 45 years
* known history or AIDS, hepatitis, diabetes or a heart condition
* participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
* participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines.
* Food allergies of any kind
* General anaesthesia in the month prior to inclusion.
* Smokers