cyrilzakka/clinical-trials huggingface dataset:
Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients

This study aims to assess the impact of a group intervention combining self-hypnosis and self-care techniques on prostate patients' well-being. More specifically, the investigators want to investigate the effects of that intervention on sleep, fatigue and emotional distress of the patients.


Eligibility Criteria:
Inclusion Criteria:

* 18-years-old,
* ability to read, write and speak French
* prostate cancer diagnosis
* treatment with surgery and/or radiotherapy.

Exclusion Criteria:

* metastases
* cancer recurrence at the moment of inclusion
* major cognitive or psychiatric disorder.
Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.

The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was \< 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads \> 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.

This monocentre, observational study will include pregnant women whom HBV-DNA is \> 105 IU/mL. HBV MTCT rates will be evaluated, according to the level of HBV-DNA in the women during the last three months of pregnancy and at childbirth (between 105 and 108 IU/mL, or \> 108 IU/mL), and according to the clinical practices of serovaccination in the participating center. The evaluation will be based on the rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth. The rate of detectable HBV-DNA will be also evaluated in infants at the same date.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* whom HBs Ag +
* whom HBV-DNA \>105 IU/mL

Exclusion Criteria:

* Women who have to be treated for HBV hepatitis, (AST/ALT \>2 ULN without any explanation, liver biopsy performed before pregnancy showing hepatitis requiring initiation of treatment)
Nutrition for Trauma Community Survey

The survey will help investigators learn everything about how people view and respond to trauma from a holistic perspective through body (nutrition), mind (mental health rejuvenation and renewal), and spirit (faith-based) lens. Researchers aim to evaluate if such practices will be effective in helping participants with significant life challenges due to trauma, negative life events, or extremely stressful events will recover from these types of lifestyles. The responses will be used to shape the integrative protocols that the investigators develop for professionals involved with trauma clients. This can help increase recovery rates and lead to productive lives.

What is the purpose of this study?

The study is being done to answer the following question:

Can lack of body-mind-spirit practices heighten psychological trauma and is lack of these practices increased in this population?

The survey will help the investigators learn everything about how people view and respond to trauma from a holistic perspective through body (nutrition), mind (mental health rejuvenation and renewal), and spirit (faith-based) lens. Researchers aim to evaluate if such practices will be effective in helping participants with significant life challenges due to trauma, negative life events, or extremely stressful events will recover from these types of lifestyles. The responses will be used to shape the integrative protocols that the investigators develop for professionals involved with trauma clients. This can help increase recovery rates and lead to productive lives.

What is required? This survey will ask questions related to demographics, past traumatic events, levels of stress, dietary habits, self-care practices, and beliefs surrounding holistic wellness.

Eligibility Criteria:
Inclusion Criteria:

* Any one not listed in exclusion criteria that is over 18 years of age

Exclusion Criteria:

* Must not be a prisoner
* Must not be pregnant
* Must not be under 18 years old
PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(\< 65 years old).


Eligibility Criteria:
Inclusion Criteria:

* A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
* All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.

Exclusion Criteria:

* Clinical or biochemical evidence of hepatic decompensation.
* Advanced cirrhosis identified by large esophageal varices (F2 or F3).
* History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
* Hemoglobin level \< 11.5g/L, white blood cell count \< 3×10９/Ｌ，and platelet count \< 50×10９/Ｌ.
* Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
* Excessive active alcohol consumption \> 60 g/day or drug abuse.
* Severe psychiatric disease.
* Antiviral or corticosteroid therapy within 12 months prior to the enrollment.
Effects of PIOMI on Oral Feeding of the Premature Infants

Randomized controlled clinical trial aimed at evaluating the effects of the "Premature infant oral motor intervention" method on the oral feeding skills of the premature infants.

Numerous evidences emerge from the literature review on the usefulness of the PIOMI method to improve food skills in the premature infant. The goal of this study is to evaluate the effects of the PIOMI method by adding the gustatory stimulation to the original protocol.

Eligibility Criteria:
Inclusion Criteria:

* gestational age at birth between 25-33 weeks;
* clinical stability;
* possible presence of nasogastric or oro-gastric tube;
* non-invasive respiratory support (oxygen, high flows)

Exclusion Criteria:

* gestational age \<25 weeks or\> 33 weeks
* absence of clinical stability
* invasive respiratory support (CPAP)
* previous surgical interventions
* ongoing infections
* congenital and / or chromosomal diseases
* brain, metabolic, cardiac, gastrointestinal diseases
* presence of bronchopulmonary dysplasia
Remote Monitoring of Cardiac Mechanics in Heart Failure Patients

Heart failure is a severe heart disease, where the heart's ability to pump blood is unsatisfactory. The consequence is a high risk of hospitalization and death. Heart failure is treated with medicine which relieves symptoms and slows down the disease progression. This medical treatment needs routine adjustment, but in many cases, this adjustment is not done timely, which results in life treating conditions where the patients need acute hospitalization. Remote health monitoring of HF patients has the potential to ensure timely adjustment. However, only sensors placed inside the blood vessels of the lung, have been shown effective. The disadvantage is that the placement of the sensor requires surgery. This makes the method costly and poses a risk for the patient. The aim of the current project is to develop a small intelligent patch, which can measure the heart's function from the outside of the body. The method will be low-cost, simple to use and will not pose a risk to the patient.

The goal of this observational study is to gather data from heart failure participants, and to investigate whether it is possible to detect early alterations in heart failure based on this data. The main goals are

* Investigate whether parameters extracted from the measured data provide information regarding heart failure alterations
* Investigate if it is possible to detect alterations at early stages

The gathered data will be measured from a little sensor placed on sternum measuring acceleration (seismocardiography (SCG)) and electrocardiography (ECG) to provide an impression of the heart\&amp;amp;#39;s mechanical function and electrical function, respectively. This data from the sensor will be analyzed with respect to other parameters obtained from, among others, echocardiography, total blood volume, changes in medical therapy, and hospitalization.

The included heart failure participants should be in the age group 18-90 years and in New York Heart Association Functional Classification (NYHA) class II or higher. Participants will wear the sensor to measure the participant\&amp;amp;#39;s cardiac mechanics and electronics simultaneously. The participants will:

* wear the sensor for a period of 30 days from discharge or visit to heart failure clinic. The sensor will measure SCG and ECG for a short period (less than 30 seconds) once every hour,
* fill out questionnaires at first and last day of the study
* undergo echocardiography at first day and last day of the study
* not change everyday life because of the sensor

Eligibility Criteria:
Inclusion Criteria:

* NYHA Class II or higher
* 18-90 years old

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids, or other drugs
* Mechanical heart valves
* In dialysis
* Not possible to obtain clinical echocardiography of sufficient quality
* Lack of ability to coorperate
Safety and Efficacy of MP-214 in Patients With Schizophrenia

The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Portion Size Strategies for Management of Body Weight

The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. A randomized controlled trial will test two approaches to managing portion sizes: one that gives individuals skills and tools to help them make appropriate portion choices, and another that focuses on consumption of pre-portioned foods in order to limit exposure to large portions in the personal food environment. A third group will receive a basic nutritional program to promote weight loss.

The second aim of the research is to determine the effects of the programs on knowledge and consumption of appropriate portions, as assessed by innovative assessment methods and multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual factors that may influence the response to the portion-control interventions, such as psychosocial indicators, blood biomarkers, and measures of adherence to the interventions. The expected outcome of the project is that it will lead to the development of specific, evidence-based strategies to help control portion sizes in order to manage weight.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 28 to 45 kg/m squared
* Able to safely engage in physical activity (walking)
* Able to attend regular instructional sessions at University Park, Pennsylvania

Exclusion Criteria:

* have a medical condition diagnosed by a physician that precludes participation
* report symptoms indicative of depression or disordered eating
* report serious food allergies or intolerance
* current or planned participation in a weight-loss program
* pregnant or lactating or planning to become pregnant in the next 18 months
High Sensitive C-reactive Protein to Albumin Ratio in Acute Coronary Syndrome

assess the use of hs- C-reactive protein to albumin ratio (hs-CAR) in prediction of in-hospital short-term major adverse cardiac events (MACEs) in acute coronary syndrome (ACS) patients

Observational study conducted at coronary care unit(CCU) in sohag university hospital It included patients with ACS diagnosed according to AHA/ACCF guidelines (according to symptoms, ECG findings and serum troponin levels), who had admitted to the CCU.

Venous blood samples were instantly collected on admission to the hospital. hs-CRP , serum albumin level were measured.

hs-CAR is calculated and the patients divided into two groups: Group A ( patients with high hs-CAR) and group B ( patients with low hs-CAR) In-hospital MACE was regarded as the end point of our study. It was defined as acute heart failure, cardiogenic shock, reinfarction, all-cause death, serious arrhythmia and cardiac death

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 Year or older presented by ACS not candidet for primary percutaneus coronary intervention ( PCI ) .

Exclusion Criteria:

* • Patients aged \< 18 years old

  * Patients who have eGFR \<60 ml/kg /m2
  * Patients who have malignancies
  * Patients who have chronic heart failure (NYHA class \>II)
  * Pateints who have chronic liver disease
  * Patients who have nephrotic syndrome
  * Patients who have acute cerebrovascular stroke
  * Pregnant women
  * Patients who have recent infection
Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program

N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. After the training, participants and trainers were asked to provide feedback regarding the valuation of and the changes due to the training.


Eligibility Criteria:
Inclusion Criteria:

* Borderline diagnosis in mothers
* Infants between 6 months and 6 years
* Mothers and their children must be in regular contact with each other

Exclusion Criteria:

* Acute child endangerment
* Maternal acute suicidality
Safety and Reliability of Artificial Intelligence Driven Symptom Assessment in Children and Adolescentes

Digital health technologies (DHT) are increasingly developed to support healthcare systems around the world. However, they are frequently lacking evidence-based medicine and medical validation. There is considerable need in the western countries to allocate healthcare resources accurately and give the population detailed and reliable health information enabling to take greater responsibility for their health. Intelligent patient flow management system (IPFM, product name Klinik Frontline) is developed to meet these needs. In practice, IPFM is used for decision support in the triaging and diagnostic processes as well as automatizing the management of inflow of the patients. The core of the IPFM is a clinical artificial intelligence (AI), which utilizes a comprehensive medical database of clinical correlations generated by medical doctors.

The study population of this research consists of patients from the Paediatric Emergency Clinic of Turku University Hospital (TUH). Data will be gathered during 6 months of piloting, after which the results will be analysed. Anticipated number of patients to the study is minimum of 500 patients, with objective to be 1 000. When attending to the hospital, patients or their guardians will report their demographics, background information and symptoms using structured IPFM online form. Results obtained from IPFM are blinded from the healthcare professional and IPFM does not affect professional's clinical decision making. The data obtained from IPFM online form and clinical data from the emergency department and TUH will be analysed after the data collection. The main aim of the research is to validate the use of IPFM by evaluating the association of IPFM output with 1) urgency and severity of the conditions; and 2) actual diagnoses diagnosed by medical doctors. The main hypotheses of the research are that 1) IPFM is safe and sensitive in evaluating the urgency of the conditions of arriving patients at the emergency department and that 2) IPFM has sufficient correlation of differential diagnosis with actual diagnosis made by medical doctor.


Eligibility Criteria:
Inclusion Criteria:

* all patients at the emergency department with acute symptoms

Exclusion Criteria:

* Emergency situation
Transfemoral Transcatheter Aortic Valve Implementation At Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients with Prohibitive Surgical Risk.

Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by expert operator team, in patients with prohibitive surgical risk. For the pilot phase, 20 patients will be enrolled. For whole study, all consecutive patients undergoing TAVI in center without CS on site will be enrolled to reach a number of about 200 patients.


Eligibility Criteria:
Inclusion Criteria:

* Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient \> 40 mmHg or jet velocity \> 4.0 m/s aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2)
* Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class \> = II
* Age \>= 75 years old
* Patients with prohibitive risk established in the Heart Team and defined on the basis of the following clinica instrument criteria according with the Varc-2 consensus.
* High surgical risk (%, logES\>20%, EuroSCORE II \> 9 and STS score \> 8%)
* Porcelain aorta (heavy circumferential calcification or severe atheromatous plaques that do not allow clamping.
* Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities, complications form to previous surgery, evidence of severe radiotion damege, history of multiple recurrent pleural effusions causing internal adhesions.
* Fragilty (slowness, weakness, exhaustion, wasting and malnutrition, poor endurance and inactivity, loss of independence, BMI \< 20 Kg/m2 and or weight loss 5 kg/year, serum albumin \< 3,5 g/dl, cognitive impairment or dementia)
* Severe liver disease/cirrosis
* Presence of a patent graft of an internal mammary artery crossing mildline and/or adherent to posterior table of sternum
* Severe pulmoary hypertension
* Severe right ventricular dysfunction
* Transfemoral access allowed
* Signature of informed consent

Exclusion Criteria:

* Tavi in case of aortic valve bioprosthesis (TAVI valve-in valve)
* controindication to femoral access
* Bicuspid aortic valve
* Instrumental characteristics, evaluated by angioTC, associated with an increased risk of major complications: severe left ventricle outflow tract or sub annular calcification, condition associated with an increased risk of rupture of the valve ring, presence of complex aortic plaques correlated with the possibility of dissection, valvular ring-coronary ostia distance \< 10 mm associated with a high probability of coronary obstruction, severe aortic root dilatation or out of range aortic annulus diameters for TAVI are not complatible for safe valve implatation.
To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation.

Liquid Based Cytology is a method of preparing samples for examination in cytopathology.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Conventional cytology is gold standard for biliopancreatic malignancy examination. This method is operator depended and have high inter observer variation . On site evaluation increases the sensitivity of conventional cytology but requires the presence of pathologist at the time of sampling . Our study will compare LBC with conventional cytology ,If found to be non inferior will be great help in centre were on site evaluation cannot be carried out . It will further reduce the interobserver variation


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients (or guardian) undergoing EUS guided sampling of suspected pancreato-biliary tumors

Exclusion Criteria:

* Patients on anti-platelet agents(including aspirin).
* Patients with deranged coagulation parameters, defined by platelet counts \<75,000/mm3 and/or INR \>1.8
Mood and Diabetes Empowerment & Improvement Training

In this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income Latino diabetics. The investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.

The Phase I pilot recruited older Latinos from Dr. Mangione's previous study (who agreed to participate in future research) and 10 participants from a community settings. Those with low mood and poor glycemic control were offered a 12-week intervention combining cognitive behavioral therapy mood management techniques and diabetes self-care into one seamless intervention. Drs. Mangione and Miranda supervised and reviewed (through audiotapes) well-trained health educators conducting the intervention sessions. The study manuals were modified following this Phase I pilot intervention.

The final intervention manual was tested in a randomized trial in Phase II, compared the Mood and Diabetes Empowerment and Improvement Training intervention with enhanced care as usual (providing participants with a letter regarding their mood and hemoglobin (Hb)A1c with recommendations for improving care for their provider). The target population was low-income Latinos with depression and poor glycemic control. Both mood and diabetes outcomes are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Latino men and women age 50 and older
* Must speak English or Spanish
* Hb A1c greater than or equal to 8%
* Currently not taking medication for depression
* A score of 5 or greater on the Geriatric Depression Scale (GDS)

Exclusion Criteria:

* Persons who are legally blind, dialysis dependent, diagnosed with dementia, and/or with hemiparesis from a cerebral vascular accident
* Do not have sufficient hearing or cognitive function