cyrilzakka/clinical-trials huggingface dataset:
Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members

The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.

As secondary objectives, the study aims to:

* Describe the sociodemographic and clinical characteristics of post bariatric surgery patients.
* Assess changes in quality of life of the post-surgery patients.
* Explain changes of post-surgery in eating behavior and activity varied according to gender
* Explain changes of post-surgery in eating behavior and activity varied according to socio-economic conditions
* Explain changes of post-surgery in eating behavior and activity varied according to inter-generational relation
* Have a overview on the surgery as a turning point in the life of patients
* Estimate the relevant message of cares given to patients, in order to better adjust medical intervention, in conjunction with patients and their family members.

This is a prospective observational study. It will be performed in two university hospitals: CHU Ambroise Paré at Boulogne-Billancourt city and CHU Pitié Salpétrière at Paris, in nutrition department and metabolic surgery department. The study will involve collaboration of a team of social researchers.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Eligible to undergo bariatric surgery
* Post bariatric surgery follow-up visits will take place in the nutrition department
* Living together with family member (children aged 11-17 years, parents, spouse, cohabitee or partner in civil union)
* Informed consent signed

Exclusion Criteria:

* Higher-order cognitive disorders
* Language difficulties in understanding
* Living alone or living without any family member
Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer

RATIONALE: Certain psychological and social factors may increase the risk of developing chronic pain after surgery. Evaluating these factors over time in patients who have undergone surgery for breast cancer may help doctors plan treatment and improve patients' quality of life.

PURPOSE: This clinical trial is studying the psychological and social factors that may increase the risk of developing chronic pain after surgery in women with breast cancer .

OBJECTIVES:

Primary

* Determine the psychological and sociological factors that predispose post-mastectomy pain syndrome after surgery in women with resectable breast cancer.

Secondary

* Determine the psychological and sociological factors that predispose post-surgical pain in these patients.
* Evaluate emotional distress over time in these patients.
* Evaluate the acute and chronic pain over time in these patients.

OUTLINE: This is a multicenter study.

Patients complete multiple questionnaires, including Hospital Anxiety and Depression Scale (HAD), Maudsley Personality Inventory (MPI), PCS, and QLQ-C30, to evaluate psychological variables (alexithymia, neurosis, repression of negative emotions, solicitude, dramatization, emotional distress) and quality of life.

Post-mastectomy chronic pain (PMCP) syndrome is measured immediately after surgery and at 24 hours, day 6, and 5 months post-surgery.

A subgroup of patients (20 with PMCP and 20 without PMCP) are followed at months 5 and 6 months post-surgery for medication use, pathological problems, morbid events, family history, and environmental factors.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Mastectomy or lumpectomy, including axillary lymph node dissection, planned
* Analgesic fixed (or ordered) the morning of surgery

  * No stage III analgesic planned
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* WHO performance status 0-2
* Other prior malignancy allowed
* No American Society of Anesthesiologists' class IV
* No contraindication or drug addiction
* No uncontrolled conditions, including any of the following:

  * Diabetes
  * Thyroid disease
  * Neuropsychiatric disease
  * Infection
  * Insufficient coronary function
  * NYHA class III-IV heart disease

PRIOR CONCURRENT THERAPY:

* No recent major surgery
* No participation in another medical or surgical clinical trial in the past 30 days
* Prior breast surgery for a benign lesion or malignant lesion allowed
Study of Hepatitis C Virus (HCV) Viral Kinetics in HIV/HCV and HCV Patients

The purpose of this study is to evaluate what happens to hepatitis C virus in response to treatment with pegylated interferon and ribavirin in patients with HCV compared to those with HIV and HCV.

This research is being done to help us identify how the composition of HCV changes with interferon in different populations. We will examine how quickly HCV is cleared from your body and what factors may influence that clearance. This information may help us find better treatments for HCV.

All patients who participate in this study will have frequent blood drawn in order to measure how quickly HCV virus declines. Pegylated interferon and ribavirin are not provided by the study, but will be obtained as part of standard of care treatment for hepatitis C. Participants must be willing to spend 48 hours in the hospital for frequent blood draws. They will be compensated for their time.

All patients must be HCV genotype 1. All patients must have a liver biopsy prior to enrollment into study. (This is not provided by the study).

HIV-infected patients must have a CD4 cell count\>300. If HIV-infected and on antiretroviral therapy for HIV, they must be on a stable regimen for 12 weeks. The HIV regimen can not include didanosine (Videx).

Eligibility Criteria:
Inclusion Criteria:

1. HCV infection, as documented by the presence of circulating levels of HCV RNA by any RT-PCR or bDNA assay performed by a laboratory with a CLIA certification or its equivalent within 52 weeks prior to study entry.
2. HCV RNA \>1000 IU/ml.
3. Documented genotype 1 performed by any CLIA certified lab.
4. Men and women age 18 to 65 years.
5. Ability and willingness of subject or legal guardian/representative to give written informed consent.
6. Female study volunteers of reproductive potential must be willing to use two methods of birth control in order to prevent pregnancy while on IFN/RBV.

For HIV infected patients:

1. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
2. CD4+ cell count ³ 300 cells/mm3 within the prior 12 weeks at a CLIA certified lab or its equivalent.
3. Subject may be HAART naïve, but if on HAART should be on a stable regimen for 12 weeks The HAART regimen cannot include didanosine (Videx). Interaction with ribavirin and didanosine has led to fatal hyperlactatemia in a few patients.

Exclusion Criteria:

1. Unwilling to be admitted for 48 hours for serial blood draws for virology studies.
2. Hepatitis B surface antigen (HBsAg) positivity.
3. Prior IFN -based therapy.

Additional Exclusion for HIV-infected:

1. Current symptomatic HIV disease (i.e., AIDS-defining illnesses).
2. HAART regimen that contains Videx (Didanosine). Subject may previously have been on didanosine but if on a new HAART regimen should be on the regimen for 12 weeks.
Quality of Life and Surgical Late Effects of Melanoma Treatment

Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.

The aim of the PhD-study is to evaluate, in a large cohort of Danish melanoma patients:

1. Health-related quality of life assessing psychological, physical and social well-being
2. Physical long term side effects (lymphoedema, scarring and neuropathic pain)
3. Lymphoedema assessed by clinical examination and DXA scans

Eligibility Criteria:
Inclusion Criteria:

* AJCC stage IB-III cutaneous melanoma patients
* At least one year follow-up after melanoma surgery

Exclusion Criteria:

* Pregnancy
* Bilateral axilla or groin melanoma surgery
An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease

The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe Alzheimer's Disease.

This study was terminated on May 7, 2010 due to modification of the dimebon development plan, following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Eligibility Criteria:
Inclusion Criteria:

* Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon study

Exclusion Criteria:

* Any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock

The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized controlled trial compare efficacy between the balanced salt solution and chloride rich solution.

Eligibility Criteria:
Inclusion Criteria:

* children younger than 18 year old who has severe sepsis or septic shock
* inform consent

Exclusion Criteria:

* children who had shock from other aetiologies
* end stage disease or severe congenital anomaly
* refuse to inform consent
Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients

Drama Therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing.

This study will evaluate the effectiveness of a specific version of drama therapy for the treatment of patients suffering from both mental illness (such as depression, bipolar disorder, schizophrenia, etc.) and one or more substance use disorders. The study will also assess participants feelings and thoughts about the drama therapy intervention (such as whether or not they enjoyed it and if/how they found it helpful).

The drama therapy intervention will consist of one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with at least one primary psychiatric disorder, and
* Diagnosed with at least one substance use disorder
* Both disorders active (i.e., meeting DSM-V criteria for each disorder (i.e., with ongoing psychiatric symptoms and ongoing substance use)
* Enrolled in the Addiction Psychiatry Treatment Program (APTP) at Boston Medical Center (i.e., scheduled for follow-up appointments with therapist and/or psychiatrist in APTP).
* Currently taking medications and those not currently taking medications

Exclusion Criteria:

* Incarcerated persons
* Pregnant women
* Inability to understand and/or sign informed consent form
Metabolic Determinants Of Resting Energy Expenditure Among Mechanically Ventilated Critically Ill Patients

Currently there are no study related to Indirect Calorimetry (IC) has been done among hospitalised Malaysian ICU adult patients with its racial mix. The aim of this study is to perform a cross-sectional study in Malaysian critically ill patients to determine metabolic determinants that might influence resting energy expenditure (REE) and to develop predictive equation for the estimation of energy requirement using the regression based approach to increase the accuracy in calorie prescriptions. In addition, expected outcome of this study is to determine which equations have clinical usefulness among Malaysian adult critically ill patients and hope to introduce into routine clinical practice in the future if IC is not available.

Nutrition provision in the clinical setting relies heavily on the accurate estimation of energy and protein requirements. This can be done in a quick and inexpensive manner via the use of predictive equations. Some of the most popularly used predictive equations such as the Harris-Benedict equation and the Mifflin-St. Jeor equation have been widely applied within the clinical setting to estimate energy requirements among mechanically ventilated critically ill patients. However, these existing equations were not specially developed for a population with disease, as the equations were derived from a pool of healthy Caucasian adults. In addition, most of the equations for critically ill patients such as the Penn State equation, Faisy equation and Raurich Equation developed and validated among Caucasian in western country and not among Asian population. Therefore, their accuracy in predicting energy requirement is questionable when applied within Malaysian mechanically ventilated critically ill patients with its racial mix.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged over 18 years old
2. Critically ill patients with mechanically ventilated
3. Expected to have an ICU stay of more than 5 days
4. Patients had implemented for continuous enteral or parenteral nutrition support.

Exclusion Criteria:

1. Requirement for inspired oxygen content (FiO2) greater than 0.6
2. Patients on high frequency ventilation
3. Patients with chest tubes that leak air
4. Patients with incompetent tracheal cuff
5. Patients inhaled nitric oxide therapy
6. Patients receiving intermittent hemodialysis and continuous renal replacement therapy (CRRT) during IC measurement
7. Patients with pregnancy
8. Patients with burn injury
9. Patients infected with human immunodeficiency virus (HIV)
10. Patients with severe liver disease (Child-Pugh score C)
11. Patients with post open heart surgery
12. Patients with paraplegia and quadriplegia
MRI Study of Tic Remission in Tourette Syndrome

Doctors provide a ray of hope to children and their parents with the knowledge that, for most patients, symptoms of Tourette syndrome improve by the time they are young adults. The investigators do not know why some improve and others do not. This study is designed to help answer that question. The investigators will use magnetic resonance imaging (MRI) techniques to test whether individuals who experience improvement of their Tourette's (tic remission) have more mature brain connections than those who do not.

One of the most interesting aspects of Tourette syndrome is a virtual remission of tics by early adulthood in about half of patients. Information is needed to clarify the mechanism of tic remission in order to guide development of better treatments for this disabling condition. For this cross-sectional study, 10 individuals with tic remission and 10 individuals with persistent Tourette syndrome are being recruited for a one-time study visit. 10 neurologically normal (non-TS) controls have also been recruited to obtain control neuroimaging data. All participants will complete a study questionnaire and a 60-minute MRI procedure. Sequences used to compare the groups will be volumetric, diffusion tensor, resting state functional connectivity MRI and MR spectroscopy. Our primary hypothesis is that the pattern of functional connectivity in individuals with tic remission will be more mature than that of those with persistent tics. Secondary hypotheses tested will explore whether the other modalities can be used to differentiate tic remission from persistent TS.

Eligibility Criteria:
Inclusion Criteria:

All subjects: males aged 18-35 with history of Tourette syndrome and at least moderately disabling tics during childhood.

Persistent Tourette's subjects: history of disabling tics during childhood but no longer taking tic suppressing drugs.

Tic remission subjects: no longer experiencing any disability (even social discomfort) from tics. Must have had sustained improvement of tics for at least 3 years.

Normal controls: no longer recruiting.

Exclusion Criteria:

Tourette's subjects still taking tic suppressing drugs are excluded. Also excluded are any patients with a condition (such as a pacemaker, recent tattoo, implantable metal device, or claustrophobia) that could make the MRI examination unsafe.
Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points

This is a prospective, single- center, randomized (1:1) clinical trial comparing the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.

The proposal presents the magnesium sulphate (MgSO4) as a possible injection treatment for TrPs. The MgSO4 prevents the release of pre-synaptic acetylcholine from neuromuscular and sympathetic junctions that could explain the ability of the MgSO4 to relax the muscle and reduce pain Specific aim: evaluate the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.

Hypothesis: the injection of masseter muscle trigger points with magnesium sulphate is more effective than saline injection in pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of myofascial pain with a referral, based on the DC/TMD criteria
* the presence of one or more trigger points in the unilateral or bilateral masseter muscle
* no history of any invasive procedures in the related masseter muscle.

Exclusion Criteria:

* Factors that can cause pain in the orofacial region other than MTPs (decayed tooth, TMJ internal disorder).
* Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
* pregnancy and lactation.
Treatment of Lead-Exposed Children Trial

The Treatment of Lead-Exposed Children (TLC) clinical trial compared the effect of lead chelation with succimer to placebo therapy. TLC was a randomized, double-blind, placebo-controlled clinical trial with sites in Cincinnati and Columbus, Ohio, Philadelphia, Pennsylvania, Baltimore, Maryland and Newark, New Jersey. The study was designed to test outcomes in IQ, neuropsychological function, behavior, physical growth and blood pressure three years after initiation of treatment. Enrollment was conducted between 1994 and 1997, with completion of the initial three-year follow-up in 2000.

At TLC enrollment, the children were between 12 and 33 months of age with baseline blood lead levels (PbB) between 20 and 44 microg/dl. Of 1,854 referred children who were screened for eligibility, 780 were randomized to the active drug (oral succimer) and placebo groups, stratified by clinical center, body surface area, blood lead level and language spoken at home; only the New Jersey Clinical Center enrolled Spanish-speaking participants. Up to three 26-day courses of succimer or placebo therapy were administered depending on response to treatment in those who were given the active drug. Eighty-nine percent of children had finished treatment by six months, with all children finishing by 13 months after randomization. Residential lead clean-up and nutritional supplementation with multivitamins and minerals were provided to all study children, irrespective of treatment group. Children were followed for three years, with regular physical exams, psychological and developmental testing, and measurement of lead concentration in venous blood. Treatment and follow up are closed for this trial; it is open for scientific analysis and report writing only.

Although succimer lowered blood lead levels much more effectively than placebo, there was no difference between the two groups on any of the psychological tests at three years post randomization, when most children were about five years old. Follow up of TLC children continued into school age. At age seven, 647 of 780 subjects remained in the study. Children were tested at age seven and again at seven and a half on standardized neuropsychological batteries that tap cognition, behavior, learning and memory, attention, and neuromotor skills. While chelation therapy with succimer had lowered average blood lead levels for approximately six months, it resulted in no benefit in cognitive, behavioral and neuromotor endpoints when measured at school ages in these children. These additional follow-up data confirm our previous finding that the TLC regimen of chelation therapy is not associated with neurodevelopmental benefits in children with blood lead levels between 20 and 44 microg/dL.

Eligibility Criteria:
* INCLUSION CRITERIA:

The study population will reflect the population known to be at greatest risk to lead exposure, i.e., low income, urban, African-American children.

EXCLUSION CRITERIA:

Linguistic minorities will be excluded in all centers except Newark, where Hispanic children make up a sizable portion of the population and will be included.