cyrilzakka/clinical-trials huggingface dataset:
SENSing Inner BodiLy State: Understanding the Role of Interoception in obEsity

Successfully perceiving the flow of interoceptive cues and integrating them with exteroceptive information are fundamental aspects of countering the body's inherent instability and guaranteeing homeostatic regulation. This process deeply affects cognitive/emotional functioning and general health. Recently, it has been suggested that an important signature underpinning obesity might be an interoceptive dysfunction in perceiving internal body signals and/or integrating them with information from the external environment. There is evidence that interoceptive deficits correlate with Body Mass Index (BMI), but it is still largely unclear how different measures and facets of interoception are related to high BMI and eating behaviour. Within this framework, it is mandatory to understand the role of interoception in obesity at perceptual, cognitive, and emotional levels. One open issue regards the relationships between interoceptive signals and the reactivity to external food cues.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed individuals diagnosed with obesity
* In rehabilitative treatment at the Istituto Auxologico

Exclusion Criteria:

* Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
Promoting Physical Activity Among Older Women Living in Socio-economically Disadvantaged Areas

The aim of the project is pilot an intervention to promote physical activity (PA) among older women.

Participants will be women aged ≥50 years attending an identified community centre situated in a socioeconomically deprived area of Belfast. The intervention consists of education, social support and information on local opportunities for physical activity (PA), based on Social Practice Theory. A stepped wedge design shall be used. The intervention was developed using findings from a literature review, systematic review and interviews with stakeholders. Outcome measures are accelerometer data, self-reported PA, a mental health questionnaire and qualitative interviews.

Participants will be recruited from previously established older women's community groups. The intervention will utilize existing weekly community group sessions. A stepped wedge design, with a delayed intervention, shall be used to allow a randomised controlled trial to be conducted and to control for seasonal weather effects on PA levels. Two community groups from each centre shall be identified. One group from each centre shall receive the intervention from week one for 6 weeks; the second group shall receive the control condition from week one for 6 weeks and then receive the intervention at week 7 for 6 weeks. The intervention will consist of three educational sessions, encouragement to enlist the support of a partner or 'buddy' (e.g. a spouse, partner or friend), an information pack (containing information on the local area, walking routes, points of interest) and the option of weekly telephone contact. At each weekly meeting, participants will be given the opportunity to discuss their progress and share feedback with the rest of the group to gain peer social support. The intervention was developed using findings from a literature review, systematic review and interviews with stakeholders. The intervention is underpinned by constructs from the Social Practice Theory, a model that facilities behaviour change through the three elements of: materials (information on the local area, telephone calls, interactive group sessions), meanings (benefits of increasing PA, improving physical health and mental well-being) and competencies (encouragement to seek social support, knowledge of how to increase PA, knowledge of the local area).

Eligibility Criteria:
Inclusion Criteria:

* Females
* Aged over 50 years
* Member of women's community centres in an area of socioeconomic deprivation

Exclusion Criteria:

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Acetylcholinesterase in Postoperative Delirium

The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The investigators therefore score patients once preoperatively and twice postoperatively with the german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the serum anticholinergic activity (SAA) at corresponding time points.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Elective surgery

Exclusion Criteria:

* Preexisting psychiatric or neurological disease
* No surgery
* Reduced level of consciousness
Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.


Eligibility Criteria:
Inclusion Criteria:

* Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
* Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of study drug
* Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study

Exclusion Criteria:

* Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
* Is pregnant or breastfeeding
* Has previously received either IDX719 or simeprevir
* Has participated in another clinical drug study within 30 days of Screening
AsiDNA (a DNA Repair Inhibitor) Administered IntraVenously in Advanced Solid Tumors

The aim of the study is to assess:

* Part A: the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of AsiDNA in patients with advanced solid tumors.
* Part B: the safety and preliminary efficacy of AsiDNA in combination with Carboplatin with or without Paclitaxel in patients with Advanced solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 months.
* Patient with histologically or cytologically documented advanced/metastatic primary or recurrent solid tumors who failed or are not eligible to standard therapy (Part A) and who are candidate to Carboplatin (Part B1) and to Carboplatin and Paclitaxel (Part B2).
* Part A: Fresh tumor sample from a biopsy
* Part B: A most recent available tumor sample from a biopsy for all patients will be collected for retrospective analysis of 6 genes expression profile for validation of further stratification approach (exploratory purpose).
* Prior anticancer therapies (chemotherapy, radiation therapy, hormonal therapy, immunotherapy, biological therapy) are allowed under conditions
* At least one measurable lesion according to RECIST 1.1; Patient with no measurable lesion can be enrolled, if the tumor evaluation can be properly documented
* Must meet select hematological and biochemical laboratory indices

Part B only:

* Patient must be eligible to Carboplatin (Part B1) and to Carboplatin + weekly Paclitaxel (Part B2).
* Patients must not have received more than 6 prior cycles of platinum-based chemotherapy.

Key Exclusion Criteria:

* Patient with symptomatic/active central nervous system (CNS) metastases
* Other tumor location necessitating an urgent therapeutic intervention
* Patient with uncontrolled disease-related metabolic disorder
* Patient presenting the following abnormal laboratory values at screening:

  1. hematuria \> 1+ on dipstick,
  2. proteinuria \> 1+ on dipstick
* Patient with uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or IV, uncontrolled hypertension, unstable heart disease
* Patient with significant ECG abnormalities defined as any cardiac dysrhythmia (\> grade 2)
* Patient with significant chronic liver disease or active HBV or HCV infection
* Patients with HIV infection or an active infection requiring specific anti-infective therapy
* Participation in another clinical trial with any investigational drug within 28 days prior to first study drug administration.
Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula

The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into their corresponding long chain polyunsaturated fatty acids was studied.

Preterm infants were randomized in a double-blind fashion to one of three formulas containing different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A control group received human milk. Blood samples were collected at study entry and 14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks visually evoked potentials were recorded.


Eligibility Criteria:
Inclusion Criteria:

* preterm birth
* birth weight between 1000 and 2200 g
* more than 80 % of energy intake from infant formula or human milk at enrollment

Exclusion Criteria:

* apparent genetic, gastrointestinal or metabolic disorders
* artificial ventilation or oxygen supply \> 30% at the time of enrollment
* administration of parenteral fat emulsion (\> 1 g/kg/day for more than seven days) before or after study entry
Risk Indicators of Sarcoidosis Evolution-Unified Protocol

The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.

The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit.

Primary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis.

Secondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period.

The investigators will measure two types of blood markers to achieve this goal:

* Clinically available blood markers that are available in most clinical labs
* Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs

Eligibility Criteria:
Inclusion Criteria:

1. Adults with a diagnosis of sarcoidosis over the age of 18
2. Case definition: we will follow the 1999 statement on sarcoidosis published by the American Thoracic Society for diagnosis which includes tissue biopsy confirmation and exclusion of alternative diagnoses including beryllium sensitization/chronic beryllium disease, mycobacterial, viral, and/or fungal infection

Exclusion Criteria:

1. Inability to tolerate study procedures as determined by the investigator
2. Pregnant or breastfeeding
3. Concurrent medical diagnoses that would influence the expression of biomarkers will be considered an exclusion criterion. This includes diseases such as common variable immunodeficiency, HIV infection, or autoimmune diseases
4. Concurrent interstitial lung diseases such as hypersensitivity pneumonitis or idiopathic pulmonary fibrosis
5. Hematocrit (Packed Cell Volume) \< 25%
Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage

Transcranial Doppler ultrasound (TCD) monitoring and CT-scanner perfusion are useful but imperfect tools to identify vasospasm and allow intervention to avoid infarction.

Permanent monitoring of cerebral tissue oximetry (rSO2) by NIRS, a noninvasive method could allow better vasospasm detection.

This study will evaluate diagnostic accuracy of cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools.

Delayed vasospasm is a serious complication of aneurismal subarachnoid haemorhage (SAH) significantly influencing morbidity and mortality. Mostly observed between days 4 and 10 after aneurismal rupture, its incidence is higher in cases of severe SAH. Vasospasm strongly affects prognisis generating delayed cerebral ischemia.

Clinical deterioration (focal neurological deficit) is the best way to detect severe vasospasm. Unfortunately, most of severe SAH are intubated and sedated prohibiting neurological evaluation. In these frequent situations, Transcranial Doppler (TCD), clinical and biological monitoring, CT-scanner (angio-CT and Perfusion-CT), MRI and cerebral angiography are routinely used to detect vasospasm. Yet, these tools have imperfect sensitivity and specificty delaying diagnosis and treatment.

Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). This technology demonstrated ability to measure cerebral oxygenation and has previously been reported to monitor carotid and pediatric surgery. To date a few studies also reported NIRS monitoring feasability in post-SAH vasospasm. Our aim is here to evaluate NIRS monitoring for the diagnosis of vasospasm in severe SAH.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age ≥ 18 years
* HSA of aneurysmal etiology less than 4 days before inclusion diagnosed by clinical presentation and emergency imaging
* HSA "severe" defined according to the WFNS ≥ III
* Intubated-ventilated patient or any other reason preventing a contributing neurological examination
* Affiliate or beneficiary of a social security scheme
* Free, informed and written consent signed by the representative

Exclusion Criteria:

* Age \<18 years
* Significant vasospasm as soon as the detection was detected on the initial imaging
* Possible Neurological Surveillance
* Intra-parenchymal frontal haematoma limiting the quality of measurement, diagnosed on imaging (Less than 25mm deep from the skin)
* Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics
* Adhesive allergy to measuring patches
* Patient under guardianship or safeguard of justice
* Refusal of legal representative
Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines

This project aims to test the hypothesis that oral consumption of a specific strain of the probiotic bacterium Lactobacillus fermentum (trademarked PCC®) is able to significantly enhance the immune response to a vaccine for influenza.


Eligibility Criteria:
Inclusion Criteria:

* Persons must be adult men and women aged 18-49 years (have not reached 50th birthday).
* Persons must be able and willing to provide informed consent.
* Persons must be willing to receive the influenza vaccine (Fluvax®) given as an intramuscular injection.
* Persons must be willing to consume one gelatin capsule per day containing either probiotic bacteria or placebo (inactive substance) for the duration (42 days) of the study.
* Persons must be willing to provide blood specimens, each of 10 ml, collected by venepuncture.
* Persons must be willing to notify study personnel of a range of health effects by questionnaire.

Exclusion Criteria:

* Any health condition for which the influenza vaccine is not recommended including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency diseases (including HIV infection) or on-going immunosuppressive therapy.
* Currently pregnant; nursing mothers; or planning a pregnancy within one month of vaccination.
* Allergy to latex, egg, or egg protein, or the antibiotics neomycin or polymyxin.
* A prior serious reaction to a vaccine, or have had Guillain-Barre syndrome.
* Received an influenza vaccine in the past.
* Received any other vaccine within one month prior to enrolment
* Are participating in another research study involving any study medication
Decision Support Intervention of Minor Cancer Patients and Their Parents

The purpose of this stuidy are: (1) to explore the information needs of parents having children with cancer when making treatment decisions; (2) to develop a Taiwan version of the Control Preferences Scale for decision support aids; (3) to implement and evaluate the effectiveness of involving minor cancer patients and their parents in treatment decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria for Parents:

  1. Age over 20 years.
  2. Child under 20 years old, diagnosed with cancer by a doctor.
  3. their child know her/his cancer diagnosis.
  4. Agree to have the child participate in family meeting and have ability to communicate in Mandarin or Taiwanese.
* Inclusion Criteria for Minors:

  1. Aged between 7 and 20 years, diagnosed with pediatrtic cancer.
  2. Aware of their cancer diagnosis.
  3. Able to express their thoughts to the researcher in Mandarin or Taiwanese.
  4. Both the minor and their legal guardian consent to participate in the study.

Exclusion Criteria:

1. Diagnosed with depression, and/or anxiety, and/or other mental disorders.
2. Legal guardian is unwilling to inform the minor of their diagnosis.
3. Minor is unwilling to share their thoughts with their parents.
Quantitative COVID-19 SARS-CoV-2 Antibody Pre and Post Cardiopulmonary Bypass

This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

During CPB the patients' blood volume is removed from the body and sent through the CPB machine. CPB consists of a pump (to keep blood moving) and oxygenator (to oxygenate blood). The oxygenator or CPB circuitry may effect antibody levels. In addition, patients on CPB experience hemodilution from blood transfusion and priming volume from the CPB circuit. Hemodilution may effect antibody levels.

Prior to CPB, during standard of care lab drawn from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for pre-CPB quantitative antibody testing.

On morning of postoperative day 1, during standard of care lab draw from standard of care arterial catheter, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing.

On morning of postoperative day 5, during standard of care lab draw, 0.5ml of plasma will be sent to the TJUH microbiology lab for Roche Elecsys Anti-SARS-CoV-2 immunoassay for post-CPB quantitative antibody testing. If patient is discharged from the hospital prior to postoperative day #5, this immunoassay will be omitted.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of FDA approved or Emergency Use Authorization Covid vaccine.

Exclusion Criteria:

* Age \< 18.
* Patients with indeterminant history of vaccination schedule.
Health and QoL in Oncological Patients: Management of Bone Pathology in Italian Citbl Population

Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to provide the Informed consent to participate to the study
* Women aged 18-75 years
* Patients having breast cancer, with no phenotype restrictions
* Patients in natural and stable menopause
* Patients having secondary amenorrhea, that arose after the initiation of oncologic treatment, since at least 12 months or 6 months with FSH\> 40 U/I

Exclusion Criteria:

* Patients with advanced cancer and/or bone metastases and/or visceral metastases
* Patients with severe renal insufficiency and/or in dialysis and patients affected by severe endocrine disorders
Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis

This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

In patients with necrotizing pancreatitis, there has been a recent shift away from surgical debridement (surgical necrosectomy) towards minimally invasive endoscopic treatment. Endoscopic management involves the creation of a fistula (tract) between the gastric or duodenal wall and the necrotic collection, under the guidance of endoscopic ultrasound (EUS) with subsequent placement of a stent. In addition, performing endoscopic necrosectomy, which involves extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.

However to date, there are currently scant data on the optimal timing of endoscopic necrosectomy. The aim of this randomized trial is therefore to compare the clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for necrotizing pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or over
2. Symptomatic necrotic collection (that is suspected or confirmed to be infected), diagnosed on MRI or CT abdomen/pelvis (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall)
3. Necrotic collection of any size with extent to necrosis of ≥ 33% and any number of loculations, located within the pancreatic/peri-pancreatic space
4. Necrotic collection visualized on EUS and amenable to EUS-guided drainage

Exclusion Criteria:

1. Age \< 18 years
2. Females who are pregnant
3. Necrotic collection that is not amenable for EUS-guided drainage
4. Irreversible coagulopathy (defined as INR \>1.5, thrombocytopenia with platelet count \< 50,000/mL)
5. Use of anticoagulants that cannot be discontinued for the procedure
6. Unable to obtain consent for the procedure from either the patient or LAR