cyrilzakka/clinical-trials huggingface dataset:
Decision Making Deficit and DNA Methylation in Opioid Receptor Genes Among Community Heroin Addicts

Heroin addiction has emerged as a serious problem with tremendous impacts on the addicts and the society. Since the introduction of opioids substitutive treatment in 2006, more than 30,000 heroin addicts had received treatment, and nearly 12,000 continued on treatment currently. However, an unknown proportion of patients hidden in community remained un-treatment. To motivate the community heroin addicts is thus a challenging task.

It is suggested that decision making deficit is core feature which determine outcomes and treatment motivations in patients with addiction disorders. Recently, the state-of-the-art development of epigenetics uncover that environmental modification, via altering level of DNA methylation and gene expression will influence on neurocognitive functioning.

Via respondent-driven sampling, this study aims to recruit a representative sample targeting at the hard-to-reach community heroin addicts. The goal of this study is to identify the clinical feature as well as decision making-related neurocognitive deficit in these patients. Moreover, the investigators will explore the interplay of clinical features, DNA methylation and gene expressions on opioids receptor genes. The findings will help to clarify the clinical characteristics of community heroin addicts, to uncover the links between DNA methylation and clinical features of heroin addiction and to develop modifiable treatment targets in the future.


Eligibility Criteria:
Inclusion Criteria:

* 1) 20 to 65 of age; 2) meeting DSM-IV criteria of opioids dependence

Exclusion Criteria:

-
The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 1

The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.

The proposed study will assess the sensitivity of a wearable device to measure the respiratory signals in COPD patients, who have previously experienced hospitalisation due to exacerbation of their COPD. Participation in the study involves wearing a small sensor. The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy.

Eligibility Criteria:
Inclusion Criteria:

* Any person aged 18 years or over.
* Current diagnosis of COPD.
* Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'.
* Be able to give written consent.
* Able to understand written and spoken English.

Exclusion Criteria:

* Inability to give written informed consent.
* Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
* Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders).
* Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ).
* Based on their medical record if there is any social violence/substance misuse.
* Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
* Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
* Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months.
* Pregnancy
* Patients already involved in an ongoing research study.
* Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life.
* Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons.
* Known allergy to surgical adhesive tape.
* On long-term oxygen therapy.
* Acute exacerbation of COPD within 6 weeks prior to inclusion.
A School-based Education Programme to Reduce Salt Intake in Children and Their Families

The study is to test whether an education programme targeted at school children can lower salt intake in children and their families. In this study, the investigators will educate children on how to reduce salt intake, and the investigators will empower children by asking them to deliver the salt reduction message home to their families, particularly children need to persuade the person who does the cooking for the whole family to cut down on the amount of salt used during food preparations. The study will involve children aged about 11 years, and their parents and grandparents in Northern China.


Eligibility Criteria:
Children

Inclusion Criteria:

* All children in Grade 5 of primary schools (age about 11 years) are eligible for the study.

Exclusion Criteria:

* Children who do not have lunch or dinner at their own home will be excluded.

Adult family members:

Inclusion Criteria:

* For each participating child, we will recruit two adult family members. All adult family members who share the same meals with the child are eligible for the study.

Exclusion Criteria:

* If more than two adults in one family agree to take part in the study, we will select two of them (i.e. one male and one female) in the order of grandparents, parents, uncles and aunties.
Treatment Drop-out and Missed Appointments Among Adults With ADHD

The investigators knowledge of factors associated with treatment drop-out and missed appointments among adults with Attention-Deficit/Hyperactivity Disorder (ADHD) within a naturalistic, clinical setting is very limited. Drop-out rates among adult ADHD patients in randomised controlled trials (RCT´s) have been reported to be 26.6% - 50%, and similar rates are reported in two naturalistic studies of medication adherence.

Based on proposed hypotheses that past behaviour patterns are more predictive of current behaviours of treatment drop-out and missed appointments than are sociodemographic and clinical characteristics, the aim of the present study is to examine the associations of 1) sociodemographic variables, 2) clinical variables, 3) risk-taking behaviour 4) educational and occupational instability and 5) behaviours during primary/lower secondary school with treatment drop-out and number of missed appointments.

The target group of the study consists of all patients who initiates assessment at the adult ADHD Clinic at Regional Psychiatric Services West, Herning, Central Denmark Region in the period from September 1, 2010 to September 1, 2011. The patients are referred to this Clinic from general practitioners and specialised psychiatric authorities. The investigators study is designed as an observational, cohort study in which the patients are offered medical and non-manualised psychosocial treatment as it is usually offered in this tertiary ADHD Clinic from which the data are collected.

Data regarding sociodemography, clinical symptoms and impairments, risk-taking behaviour, educational and occupational instability and behaviours during primary/lower secondary school are collected using a semistructured protocol.

In the investigators study the investigators define treatment drop-out as premature termination of ongoing treatment, without any prior clinical or agreed resolution. No standardized definition of treatment drop-out is used through out the literature of adherence to treatment among patients in the psychiatric care system.


Eligibility Criteria:
Inclusion Criteria:

* Referred to the ADHD Clinic and initiating assessment between September 1, 2010 and September 1, 2011

Exclusion Criteria:

* No ADHD diagnosis as assessed by the ADHD Clinic
Effect of EITC on Biological Markers of Aging, Health and Mortality

Paycheck Plus (PP) is a randomized controlled experiment (RCT) that explores the health and longevity effects associated with increasing the Earned Income Tax Credit (EITC). EITC is a national program that provides tax credits to low-income, disproportionately minority workers who file taxes. EITC is politically popular, having received bipartisan support. The EITC, along with state supplemental programs, have 7 million American families out of poverty. The investigators' preliminary data analyses show that the EITC has had large population health impacts, reversing declines in self rated health and survival among the poorest Americans.

Poverty disproportionately impacts minority and rural populations and is very strongly correlated with poor health over the life cycle, and has been hypothesized to lead to a shorter, less healthy aging process. Poverty is associated with a greater burden of disease than smoking and obesity combined and accounts for the bulk of health disparities by race. It is widely believed that an antipoverty policy, such as Earned Income Tax Credit (EITC), could improve healthy aging among working-age low-income adults over the life cycle. It does so by increasing material hardship and psychological stress, two risk factors that are strongly correlated with biological markers of premature aging (e.g., shorter telomeres, higher cholesterol levels, and higher blood pressure).

Eligibility Criteria:
Inclusion Criteria:

1. a US resident
2. Filed taxes
3. Earned \<$30,000 in the previous year
4. Aged 21-64
5. Have a Social Security number

Exclusion Criteria:

1. Eligible for Supplemental Security Income or Social Security Disability Insurance
2. Married
3. Have dependent children
Effect of Caffeine on Heart Rate Variability in Newborns

The aim of this study was to evaluate the impact of caffeine treatment, given either orally or intravenously, on heart rate variability in newborns. In addition, the investigators sought for a potential association between caffeine treatment and vital functions.

At Neonatal Department of University Medical Centre Ljubljana caffeine is used to treat neonatal apnoea. It has known affects on central nervous and cardiovascular systems, but little is known about the impact of caffeine intake on heart rate variability (HRV) in newborns.

In this study, the investigators performed measurements on one sample of 25 newborns with apnoea who had been admitted to the Neonatal Department of University Medical Centre Ljubljana and treated with caffeine citrate. The treatment regimen consisted of caffeine citrate of a loading dose of 20 mg/kg of body mass, followed by a daily maintenance dose of 5 mg/kg after 24 hours. The investigators measured parameters of HRV in two situations: while the treatment with caffeine citrate was ongoing and after the treatment was withdrawn. The newborns served as controls. Electrical activity of the heart was measured with a Holter ECG while the newborn was sleeping in supine position, first without a bed tilt and afterwards with a 30° head-up tilt. Simultaneously was evaluated the alertness of the newborn and measured their physiological variables (the breathing frequency, the heart rate, the arterial oxygen saturation, and the body temperature).

All parents were given their written consent for their child to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* newborns with apnoea treated with caffeine citrate
* newborns whose parents have signed the informed consent form

Exclusion Criteria:

* severe perinatal hypoxia
* infection
* liver or renal insufficiency
* neurological disorders
* congenital anomalies
Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study

A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.

10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment

BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy.

surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice.

10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 60 years old
* BCC was determined with tissue diagnosis in the lower extremity
* One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use.

Exclusion Criteria:

* Patient unable to read, understand and sign the consent form
Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome

The aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .

Although mechanical ventilation is life-sustaining for patients with ARDS, it can perpetuate lung injury. A number of recent advances have greatly improved in the mechanical ventilation strategies and treatment for acute respiratory distress syndrome (ARDS), however, Mortality remains high, even with the use of low tidal volume and adequate positive end expiratory pressure(PEEP). Numerous experimental showed that the BILEVEL-APRV mode used in animal ARDS model can improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the dosage for sedative drugs.

The aim of this single-center, prospective, randomized, controlled, open study is to compare the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .

Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory distress syndrome,according to the Berlin definition of ARDS, - The receipt of endotracheal mechanical ventilation for a period was no longer than 48 hours
* A ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen(FiO2) was less than 250.

Exclusion Criteria:

* Pregnancy
* The expected duration of mechanical ventilation was less than 48 hours
* Intracranial hypertension (suspected or confirmed)
* Neuromuscular disorders that are known to prolong the need for mechanical ventilation
* Known or suspected chronic obstructive pulmonary disease(COPD)
* Preexisting conditions with an expected 6-month mortality exceeding 50%
* Pneumothorax (drained or not)at enrollment
* Treatment with extracorporeal support (ECMO) at enrollment
* There was a lack of commitment to life support.
Neck Fat Accumulation and Its Relationship to Cardiovascular Risk and Metabolic Syndrome

Accumulation of fat in the neck using tape measures has been linked to increased cardiovascular risk. The investigators' hypothesis is that detailed measures of neck fat using computed tomography will show that specific fat compartments in the neck contribute differently to cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* no history of malignancy at the time of image acquisition
* fasting glucose measured immediately prior to PET/CT

Exclusion Criteria:

* history of neck cancer, radiation therapy, and/or surgery
A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System

This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.

Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.

* Demographics and Medical History
* Pre \& Post-Operative Data including Range of Motion
* Surgical Data
* Survivorship (phone/email or last known visit)
* Patient Reported Outcomes (phone/email single time point visit)

  * Patient Satisfaction
  * KOOS Jr.

Eligibility Criteria:
Inclusion Criteria:

1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
2. Over 18 Years of age

Exclusion Criteria:

1. BMI \> 40
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.

Eligibility Criteria:
Inclusion Criteria:

* urinary incontinence
* failed urinary incontinence (UI) treatments

Exclusion Criteria:

- does not meet inclusion criteria, gender and age limit
A Preoperative Cognitive Behavioural Therapy Program Based on Self-determination Theory for Bariatric Surgery Candidates

The objective of this study is to evaluate the impact of a pre-surgical intervention program based on Cognitive and Behavioural Emotional Therapies, on the degree of dietary restriction of patients who are candidates for bariatric surgery in order to increase the long-term effectiveness of this kind of surgery


Eligibility Criteria:
Inclusion Criteria:

* Patient starting a preparation for bariatric surgery in the endocrinology department at St Philibert Hospital
* 18 ≤Age≤60 years
* Patient meeting the criteria of the High Authority of Health (HAS) for the agreement of a bariatric treatment
* Patient affiliated to the social security
* Patient giving informed consent

Exclusion Criteria:

* Low level of comprehension of French
* Pregnant women
* Patient under guardianship or curatorship.
Kids Safe and Smokefree (KiSS)

The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.

Child secondhand smoke exposure (SHSe) is a significant public health problem that has been linked to asthma, acute respiratory illnesses, otitis, and SIDS, and is associated with increased risk of cancers, cardiovascular disease, and behavior problems. This project will test the effectiveness of a comprehensive multilevel intervention to reduce young children's SHSe in minority and medically underserved communities known to have the highest SHSe-related morbidity and mortality risk. First, we will provide a clinic-level quality improvement (CQI) intervention to improve the care of pediatric patients with SHSe in four pediatric clinics in North and West Philadelphia. We will then randomize eligible parents visiting the CQI clinics into either a home-level behavioral counseling intervention (CQI+BC) or a home-level attention control intervention (CQI+A). In addition to clinic-level intervention, CQI+BC provides personalized, behavioral counseling with intensive skills training and support where SHSe occurs (in the home), as well as systems navigation to facilitate access to and effective use of reimbursable nicotine replacement therapy and smoking cessation medication. Participants will complete assessments at pre-treatment, 3-month end of treatment, and 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* English-speaking
* parent or legal guardian of child under 11 years old who lives with him/her
* daily smoker

Exclusion Criteria:

* non-nicotine drug dependence
* psychiatric disturbance (bipolar, schizophrenia, psychosis)
* pregnant
* inadequate health literacy