cyrilzakka/clinical-trials huggingface dataset:
Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors

Obesity is a global epidemic and a major contributor to some of the leading causes of death.

Although research on overweight and obesity is constantly increasing, to date, in the Italian panorama, there is a lack of (A) rigorous psychological measurement tools of obesity-related constructs and (B) analysis of the relationships between constructs (and indicators) involved in the development and maintenance of overweight and obesity.

The present study aims to examine the psychometric properties of the main questionnaires for the assessment of eating behaviors in 3 groups of subjects (1) the general population (control group); (2) subjects with obesity without a comorbid diagnosis of an eating disorder; (3) subjects with obesity and a comorbid diagnosis of an eating disorder.

Participants were selected in the main rehabilitation centers for the treatment of obesity and eating disorders (sample of subjects with obesity) and through an online survey (community sample). The survey lasted about 30 minutes and - together with selected demographic and biomedical information - required the completion of the following self-report measures: the Binge Eating Scale (BES); the Modified Yale Food Addiction Scale version 2 (mYFAS 2.0); the Repetitive eating questionnaire (Rep-EAT); the Measure of Eating Compulsivity (MEC); the Addiction-like Eating Behavioural Scale (AEBS); the Three Factor Eating Questionnaire 18 (TFEQ-18); the Eating Disorders Examination Questionnaire-Short Form (EDEQ-SF); the Palatable Eating Motive Scale (PEMS); the Weight Sigma Questionnaire (WSSQ); the Emotional Eating Scale (EES); the Somatic Symptom Scale 8 (SSS8).

Before administration, all questionnaires were first translated from English (their original language) to Italian by two bilingual translators, independently - then back-translated into English by another independent translator whose mother tongue was English to ensure equivalence between the translations. Following, a purposive sample of respondents was asked to fill in the final version of each measure in order to assess its items' comprehensibility.

In order to avoid halo effects, the questionnaires were presented to the subject in random order.

The responders could withdraw the administration at any time, and contact a psychologist independent from the study in case of perceived emotional distress.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2 (clinical sample)
* Diagnosis of an eating disorder (clinical sample)
* age range 18-75 years
* Italian mother tongue
* written and informed consent to participate

Exclusion Criteria:

* visual impairing
* neurological problems
* alcohol/drug abuse
Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants

Randomized crossover clinical trial in which is intended to assess the effect of facilitated tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with normal practice, without facilitated tucking device.

Population(n): 20 newborn When a patient is a possible candidate, consent will be asked their parents. After obtaining informed consent signed by parents, it will be assigned a random group (G1, G2). In the G1, the first weight without facilitated tucking device and the next day with facilitated tucking device will be held. G2 will be done in reverse.

Handling pre phase (T0): at least 20 minutes before vitals heart rate and respiratory rate are taken in five times.

handling phase (T1): 1. the facilitated tucking device is placed. 2. will wait five minutes and weight will be held in the incubator;at the time of leaving it in the incubator the same constants are taken.

post handling phase (T2): the same constants are taken one hour after such manipulation.

Eligibility Criteria:
Inclusion Criteria:

* ≤1500 grams newborns
* a week of life about

Exclusion Criteria:

* Surgery
* Hemodynamic instability requiring vasoactive drugs
* Sedation
* Phototherapy at the time of the procedure
* Congenital anomalies.
A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients

This is a prospective, randomized study of two types of continent ileal neobladder construction in patients undergoing cystectomy for primary bladder cancer. Patients will be randomly assigned to have either a T-pouch or a Studer pouch constructed at the time of their surgery. They will be followed long-term to determine the relative advantages and disadvantages of the two types of diversion. The investigators' hypothesis is that the inclusion of an antireflux mechanism in the T-pouch will result in significantly fewer episodes of symptomatic urinary tract infection, and will have a lower incidence of upper tract dilation and loss of renal function over the long term.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing radical cystectomy for bladder cancer who are considered candidates for a neobladder reconstruction are eligible for enrollment.
* Diagnosed with primary bladder cancer (any histology).
* Scheduled to undergo a radical cystectomy (cystoprostatectomy in men and anterior exenteration in women).
* Felt by the treating physician to be a candidate for an orthotopic neobladder urinary diversion.
* Be competent and willing to sign the informed consent.
* Patients may have received previous radiation therapy or intravesical or systemic chemotherapy. Patients with documented metastatic disease are not excluded as long as they are felt to be candidates for a continent neobladder urinary diversion.

Exclusion Criteria:

* Patients undergoing radical cystectomy for any malignancy other than primary bladder cancer (for example prostate cancer or colon cancer invading the bladder,or a gynecologic malignancy), or non-malignant disease (such as a neurogenic bladder or radiation cystitis).
* Unwilling or unable to sign the informed consent.
* Not eligible for an orthotopic neobladder reconstruction.
* A history of other malignancy (except for stage I cancer treated with curative intent without evidence of recurrence, clinically localized prostate cancer either untreated or treated with prostatectomy or radiation therapy or hormone therapy,or non-melanoma skin cancer) within the previous 5 years.
Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi

The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.

In our R34 pilot trial, the Enhanced Friendship Bench intervention showed strong feasibility, acceptability, fidelity, and preliminary effectiveness to improve perinatal depression and engagement in HIV care. The goal of this proposal is to evaluate the effectiveness of the Enhanced Friendship Bench in a fully powered randomized control trial to improve perinatal depression, HIV care engagement, and infant health outcomes, examine mediators and moderators that help elucidate mechanisms of action, and collect key implementation measures to accelerate the translation of findings into practice.

Eligibility Criteria:
Inclusion Criteria:

* Presenting for antenatal care at one of our 5 recruitment sites
* ≥ 18 years of age
* ≤ 34 weeks gestation
* HIV-positive, based on medical records
* Initiating, re-initiating, or on established ART during index pregnancy
* Elevated depressive symptoms as indicated by a EPDS score ≥10. The EPDS is widely used to assess perinatal mood disorders that has been validated in perinatal populations in Malawi with this cut point to identify probable perinatal depression

Exclusion Criteria:

* Suicidal ideation evaluated as acute risk.
* Other health concerns requiring emergent response.
HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM

This study aims to evaluate the safety and effectiveness of the combination of 30Gy/5fx HSRT and 20Gy/10fx IMRT adjuvant therapy. The total biological effective dose (BED) of the PTV is 72 Gy in a ratio of alpha/beta ratio of 3, which equals to the conventional 60Gy/30fx treatment. This study can provide evidence for future non-inferiority phase III randomized controlled trials. The abbreviated course of radiotherapy can reduce the treatment time by half, benefit patients, and utilize the health resource.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years of age;
2. Karnofsky performance status (KPS) ≥ 60 within 14 days prior to registration;
3. Histopathologically proved diagnosis glioblastoma multiforme;
4. Underwent surgery, gross total resection or subtotal resection;
5. Estimated survival of at least 3 months;
6. Hgb \> 90/gL; absolute neutrophil count (ANC) \> 1.5×109/L, platelets \> 80×109/L; Creatinine \< 1.5 times the upper limit of laboratory normal value; Bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) \< 3 times the upper limit of laboratory normal value;
7. Signed informed consent form;
8. Agreed to participate in the follow-up.

Exclusion Criteria:

1. Prior invasive malignancy unless disease free;
2. Received irradiation or other anti-tumor adjuvant therapies;
3. Brain stem disease or tumor greater than 6 cm in maximum diameter;
4. Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
5. Pregnancy or nursing mothers;
6. Participated in other trials after diagnosis;
7. Influence factors toward oral medications;
8. Patients with CTCAE5.0 grade 3+ bleeding within 4 weeks prior to registration;
9. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \<50%;
10. Long-term unhealed wounds or fractures;
11. History of organ transplantation;
12. Serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment.
Specimen Repository for HIV Immunopathogenesis

Specimen Repository for HIV Immunopathogenesis Studies

The goal is to build a large specimen repository for collaborating scientists to run studies of immunity and HIV-1.

Eligibility Criteria:
Inclusion Criteria:

1. HIV positive (acutely infected, viremic and elite controllers)
2. Signed Informed Consent Form
3. Age at least 18 years old
4. Immune controllers, two types: "Elite suppressors" (HIV-positive with any three consecutive plasma HIV-1 RNA PCR undetectable while off treatment) or "viremic suppressors" (HIV-positive with any three consecutive HIV-1 RNA PCR \<3000 while off treatment).
5. Acutely infected subjects:

Persons identified to have a negative HIV antibody response (ELISA) but positive detection of HIV-1 in the blood (RT-PCR) or individuals who have evidence of a recent (past 30 days) HIV negative result along with a current HIV positive result.

Exclusion Criteria:

1. Uncontrolled bleeding diathesis.
2. Pregnant.
3. Inability to provide informed consent.
The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults

Despite availability of many alternative and conventional weight loss options, the prevalence of obesity increased from 15% in 1993 to 27 in 2015. In 2015, 68% of men and 58% of women in the UK were overweight or obese. Overweight and obesity increase the risk for comorbidities such as hypertension, dyslipidaemia, cardiovascular disease, type 2 diabetes and certain cancers. Hormonal regulation of appetite has been shown to influence body weight and body fat . Gut hormones secreted from the intestine are particularly important both in the regulation of appetite and blood glucose level, and recently the gut hormone Glucagon Like Peptide -1 (GLP-1) has been successfully targeted to treat both type 2 diabetes and obesity. Targeting the gut microbiota has been shown to influence gut hormones, in a way is likely to help treat or prevent obesity and type 2 diabetes. In past decades, considerable attention has been given to investigating the new applications of natural prebiotic polymers on gut microbiota composition. Moreover, recent trend in research indicates a bidirectional communication between the gut microbiota and the central nervous system through the microbiome-gut-brain axis (MGBA).

Therefore an in vivo intervention feeding study is proposed performed with a variety of psychological and nutritional tests aiming to compare io fibrewater with an equivalent placebo control water and also highlight both cognitive function, emotional bias and response to appetite and also metabolic profiles of the gut microbiota.

Study design: A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes.

Participants: 20 participants will be invited to take part in this study. They will be randomly assigned to treatment (n=10) or control (n=10) groups, where they will consume io Fibrewater or Volvic sugar free Lemon \& Lime water for 4 weeks. Both water samples (1 bottle/day) need to be taken with the meals (lunch).

Eligibility Criteria:
* Inclusion criteria

  1. Females and males, aged 18 years to 65 years
  2. BMI ≥25 kg/m2 with any of the following:

     1. IGT (blood glucose level of 7.8-11.0 mmol/L after a 2-hour oral glucose tolerance test (OGTT)), or
     2. IFG (fasting blood glucose level of 5.6-6.9 mmol/L) or
     3. impaired HbA1c (HbA1c level of 5.7%-6.4%)
  3. Not dieting within the last month
  4. not having lost \>5% body weight in the previous year
  5. Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study.
  6. Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice.
  7. Able to eat most everyday foods with no current IBS symptoms.
  8. Habitually consumes three standard meals a day (i.e., breakfast, lunch, and dinner)
* Exclusion criteria Current use of prescribed medication for neuropsychiatric disorders or history of neuropsychiatric disorders
Anodal TDCS and Postural Stability in Subacute Stroke

Stroke patients experience weakening of muscles on the affected side. Damage to the motor cortex and the pyramidal tract due to a stroke leads to a motor control disorders and co-contraction of trunk muscles due to abnormal levels of abdominal muscle tension and voluntary movement.

TDCS is known to modulate motor excitability in humans and motor performance is crucial in postural control. Studies reports that applying anodal TDCS to the ipsilesional motor cortex improved motor functioning in which the Transcranial Direct Current Stimulation may have stimulated preserved areas of the motor cortex to enhance synaptic efficiency along the corticospinal tract.

Anodal TDCS has been shown to have immediate and short-term effects in stroke but its long-term effects in stroke are still unclear. Additionally, the available literature focuses on acute and chronic stages of stroke so we will target subacute stage of stroke. Therefore, this study is designed to investigate the short and long-term effects of Anodal Transcranial Direct Current Stimulation on postural stability in subacute stroke.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* Sub-acute stroke
* Minimum score of 18 on PASS

Exclusion Criteria:

Hearing and Visual loss/ deficit

* Recurrent CVA
* Neurological condition affects the cognition
* Wound at skull
* Presence of shunt and/or metallic implant at cranial region
* Brain tumors
* Musculoskeletal conditions/ surgery in the lower extremities
* Cognitively compromised
Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia

The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.

Up to 106 patients with coronary artery disease undergoing elective coronary artery bypass graft (CABG) surgery will be recruited to undergo this single visit study. In the timeframe shortly after the induction of anaesthesia and prior to the start of surgery, myocardial strain as a marker of cardiac function will be measured by transesophageal echocardiography (TEE). Echocardiography measurements will be acquired at two different oxygen states for each patient. The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen level is investigated first. Thereafter, the study intervention is completed and anaesthesia and surgery will be performed as planned by the treating team. Echocardiography images will be analyzed in a blinded manner for cardiac function and systolic and diastolic strain parameters. The results will help anaesthesiologists to better weigh risks and benefits when selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia as a risk factor for myocardial injury.

Eligibility Criteria:
Inclusion Criteria:

* Elective CABG surgery (with or without other cardiac surgery)
* Ability to give and sign informed consent
* Age \>18 years.

Exclusion Criteria:

* Absolute contraindication for TEE
* Emergency surgery, including but not limited to patients with instable CAD: ST- and Non-ST-elevation myocardial infarction (STEMI, NSTEMI) and instable angina (instable AP)
* Atrial fibrillation or significant arrhythmia
* Pacemaker, CRT, left bundle branch block
* Severe-grade valvular disease
* Pericardial disease
* Previous cardiac or thoracic aortic surgery
* Previous chest radiation therapy or cardiotoxic or bleomycin chemotherapy
* Severe pulmonary hypertension, cor-pulmonale, or right ventricular dysfunction, i.e., where high FIO2 might reduce pulmonary vascular resistance and right ventricular afterload
* Patients where study explanation and informed consent cannot been performed/obtained at the latest on the day before scheduled surgery
* Females of child-bearing potential
Effects of Cognitive Training on Speech Perception

In this study, the investigators are testing whether cognitive training can lead to improvements in speech perception for individuals with hearing loss. Individuals will complete 20 hours of cognitive training that is designed to improve cognitive abilities such as short term memory and attention. The investigators predict that cognitive training that improves the cognitive abilities affected by hearing loss will improve speech perception.


Eligibility Criteria:
Inclusion Criteria:

* Able to come to Dalhousie University, Halifax, Nova Scotia, Canada for study visits
* Adults (50 years or older) with mild to moderate hearing loss
* Access to an internet-connected device that is able to use Flash media, basic computer skills
* Medically stable participants
* Not currently taking medication that may affect brain function (e.g., anti-anxiety medication)
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Participants with neurological conditions such as epilepsy or concussions will be excluded for safety reasons
* Participants who are not native English speakers (materials used in the study are only in English)
* Participants who are unable to provide consent
* Participants with impaired cognition (assessed with the Montreal Cognitive Assessment)
* Participants with high accuracy on the Speech Perception in Noise task at the second study visit (to eliminate participants who may be performing at ceiling level)
Study of AT-527 in Healthy and HCV-Infected Subjects

This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.


Eligibility Criteria:
Inclusion Criteria:

All subjects (healthy and HCV-infected subjects):

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg
* Willing to comply with the study requirements and to provide written informed consent

Additional inclusion criteria for HCV-infected subjects:

* Must have not received prior treatment for HCV infection
* Documented clinical history compatible with chronic HCV infection
* Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.

Exclusion Criteria:

All subjects (healthy and HCV-infected subjects):

* Pregnant or breastfeeding
* Infected with hepatitis B virus or HIV
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Expression of microRNA-133a and microRNA-208b in Acute Myocardial Infarction

Cardiac-enriched micro-RNAs (miRNAs), micro RNA 208b and 133a(MiR-208b, MiR-133a)) corresponds to the health and disorders of the cardiovascular system. An intron of the cardiac myosin heavy chain gene MYH7 encodes miR-208b. It is found on chromosome 14 in humans. Identify new diagnostic biomarkers based on miRNAs, researchers examine the expression of miR-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers cardiac troponine (cTnl) and Creatine kinase-MB (CK-MB).

The 98% of human genes are non-coding RNA, which is further divided into long non-coding RNA (lncRNA, \> 200 bp) and short non-coding RNA (200 bp, including microRNA (miRNA) and circular RNA). More than 2000 human miRNAs have been discovered, and it seems that they regulate around 60% of human genes.Through a number of pathways, miRNAs control the development, re-modelling, and regeneration of the heart as well as endothelial function, vasculo-genesis, and neoangiogenesis. 30% of the genes in the human genome are regulated by about 1000 miRNAs. Endogenous miRNAs are 19-22 nucleotide single-stranded RNA molecules that frequently target the 3' untranslated regions (3'-UTR) of mRNAs to regulate gene expression at the post-transcriptional level in physiological processes, disease development, and conditions like cancer, autoimmune and inflammatory diseases, neuro-degenerative diseases, and cardiovascular diseases. Cardiac-enriched miRNAs, MiR-208 in health and disorders of the cardiovascular system are investigated.

Identify new diagnostic biomarkers based on miRNAs, researchers examine the expression of miR-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers cTnl and CK-MB.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with ST-Elevated Myocardial Infarction will be identified at the Coronary Care Unit at Ain-shams University hospital
2. Acute episode of Myocardial Infarction
3. With No history of previous Myocardial Infarction Treatment

Exclusion Criteria:

1. Patients not diagnosed with ST-Elevated Myocardial Infarction and healthy at the Coronary Care Unit at Ain-shams 2. University hospital
2. Previously Known patients of Myocardial infacrtion
3. Previous medication