cyrilzakka/clinical-trials huggingface dataset:
Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care

This component of a larger Center of Research Excellence Grant improves treatment for drug abuse by developing effective linkages between specialty drug treatment and primary health care.

This is a longitudinal two-arm quasi-experimental 3-month alternating off/on design over a 30 month period in which, after a random start, the Linkage condition alternately is added to Usual Care in the Chemical Dependency (CD) clinic and then removed. We compare Usual Care to Usual Care plus Linkage. Follow-up interviews will be conducted at 6, 12 and 24 months. The Linkage intervention includes Usual Care plus 1) sessions on activation regarding overall health behaviors and on selecting a Primary Care physician and communicating with him/her, and 2) a linkage phone call (and/or a facilitated email) with the patient, clinician, and Primary Care physician. The intervention aims to place drug abuse problems in the context of overall health and health care and to activate patients to increase involvement in their own health care.

Eligibility Criteria:
Inclusion Criteria:

* Research participants will be adult patients at the Kaiser Permanente San Francisco Chemical Dependency Recovery Program, who have completed 2 weeks of treatment.

Exclusion Criteria:

* Patients with a diagnosis of dementia, mental retardation, or who are actively psychotic or suicidal will be excluded by their clinician.
The Canadian Cohort Obstructive Lung Disease

Abstract Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in Canada. COPD is not just a disease of men, nor is it solely a disease in old age. Women have been underrepresented and early disease has not been studied. Underdiagnosis of COPD remains a significant problem, and it may indicate an unmet healthcare need. This can potentially results not only in a patient been misinformed, but can lead to incorrect management.

Epidemiological research is needed to develop a framework to combat this major health problem, by better characterization of the population of men and women at risk and patients with early disease, by better understanding which factors modifiable through health interventions are related to health perception (health-related quality of life) and disease evolution.

This will be possible through a nationwide study, the Canadian Cohort Obstructive Lung disease (CanCOLD), a prospective longitudinal study. The CanCOLD study is built on the current ongoing prevalence nationwide study, the Canadian Obstructive Lung disease "COLD" study.

The CanCOLD will be the first study to assess prevalence of disease across Canada and its consequence in men and women, and to evaluate a conceptual model of disease severity based on patient's health perception (health-related quality of life). Ultimately, this project will extend to a longitudinal follow up (3 years or beyond) and will allow to have a better understanding of the lifestyle risk factors, not only smoking but also diet, physical activity, and co morbid conditions. This will be a great asset to shift from management of a single risk factor (tobacco control) to total COPD risk management. The results of the study will greatly help to assist decision makers in developing policies to improve the diagnosis, the management of COPD and to optimize health care services use.


Eligibility Criteria:
Inclusion Criteria:

* All the subjects have taken part in the COLD study, a true population based prevalence study. Subjects must have an inclusion criteria of 40 years and older to participate in the COLD study.
The EMINENCE Study - PET/MR Imaging of Head Neck Cancer

Head and neck cancers (HNC) often receive radiotherapy as part of their treatment. However, unacceptable failure rates and severe side effects remain a challenge. The improvements in radiotherapy are closely related to improvements in medical imaging. Functional imaging, where intratumoural characteristics such as tumour oxygenation, metabolism, and blood vessel function can be quantified, offers possibilities to personalize the radiotherapy. In this study we will establish the clinical workflow for PET- and MRI-based radiotherapy in HNC by acquiring images prior to and during radiotherapy to develop new concepts for image-based biologically adaptive radiotherapy, both based on photon-based radiotherapy and also proton therapy, which soon will be available for cancer patients in Norway. The investigators aim to contribute towards further developments of personalised high-precision radiotherapy for HNC patients resulting in improved outcome, reduced side-effects and better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee
* histologically confirmed squamous cell carcinoma in the head neck region (pharynx, larynx, oral cavity or sinonasal area)
* locally advanced disease without sign of dissemination (T3/T4 and/or N1-3, M0) on diagnostic imaging
* scheduled for definitive radiotherapy with curative intent with or without concomitant chemotherapy
* adequate renal function: Creatinine clearance ≥ 60 ml/minute
* lymph node metastasis from cancer of unknown primary of the upper neck (i.e. level II-III) were PET/CT is negative outside the head-neck region can be considered for inclusion at the discretion of the study investigators.

Exclusion Criteria:

* general contraindications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
* serious comorbidity (including previous or othe cancer) that in the opinion of the investigator would compromise the patient's ability to complete the study of interfere with the evaluation of the study objectives (e.g. poorly controlled diabetes mellitus)
* histologically confirmed SCC of same or other origin within the last five years
* patient wants to withdraw for any reason during the study
Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation

The purpose of this study is to comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation.

Intubation with the double-lumen endotracheal tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as GlideScope(R) videolaryngoscope, had been developed for facilitating airway management, the larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of different bending type of DLT in tracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists physical status I-III
2. more than 18 years of age
3. Receiving thoracic surgery with double-lumen endobronchial tube

Exclusion Criteria:

1. risk of regurgitation and pulmonary aspiration
2. history of gastroesophageal reflux
3. pregnancy
4. scheduled tracheostomy and postoperative prolonged ventilation in ICU
5. limited neck extension (\< 35°)
6. a thyromental distance less than 7 cm
7. a sternomental distance less than 12.5 cm with the head fully extended
8. mouth can not open
Clinical Application of Non-invasive PGT-A

The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A.

Background Chromosome abnormality is a leading cause of implantation failure and miscarriage. Chromosome abnormality increases with age, resulting in reduced pregnancy rate. Nowadays, preimplantation genetic testing for aneuploidies (PGT-A) could be used for detection of aneuploidy. However, PGT-A needs embryo biopsy which is invasive and may cause embryo damage. It was found that cell free DNA could be isolated from culture media. The cell free DNA from culture media also could be used to detect embryo ploidy, called non-invasive PGT-A.

Objective The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A. Another aim of this study is to check the concordance rate between non-invasive PGT-A and PGT-A.

Methods The prospective cohort study will be performed at the reproductive medical center of Kaohsiung Veterans General Hospital, in Kaohsiung, Taiwan. Participants who plan to receive an IVF cycle and preimplantation genetic testing for aneuploidies will be enrolled in this study. The investigators will divide the participants into 3 groups: (1) combined non-invasive PGT-A and PGT-A; (2) PGT-A; (3) non-invasive PGT-A. Basal characteristics, infertility history, ovarian reserve and embryo development of the three groups will be recorded. The samples will be detected ploidy by using next generation sequencing (NGS). Then, the investigators will choose embryo to transfer according to the embryo ploidy and follow the pregnancy outcomes after embryo transfer.

Outcome

1. Concordance rate between non-invasive PGT-A and PGT-A
2. The relationship between morphological grade and ploidy of non-invasive PGT-A
3. IVF outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A

Eligibility Criteria:
Inclusion Criteria:

* Infertile women who undergo IVF with PGT
* BMI:18\~30 kg/m2

Exclusion Criteria:

* Primary ovarian insufficiency
* Congenital uterine anomaly
* Severe male infertility (azoospermia)
* One of the couples with chromosome abnormality
* Malignancy
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery

The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 18 years of age
* Planned laparotomy by the gynecologic oncology service at the sponsor institution.

Exclusion Criteria:

* Individuals who have a contraindication to thoracic epidural analgesia
* Individuals with a coagulation disorder
* Individuals with an infection at the site of epidural placement
* Individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions
* Individuals with spinal pathology: abnormal spine anatomy, surgical fusion, or spinal column lesions
* Individuals who have a contraindication to liposomal bupivacaine
* Individuals with a known allergic reaction to liposomal bupivacaine
* Individuals with Childs-Pugh Class B or C liver disease
* Individuals who have a history of long-term opioid use for chronic pain, defined as use of opioid pain medications for ≥4 weeks prior to surgery.
Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery

Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.


Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery patient undergoing cardiopulmonary bypass
* signed informed consent

Exclusion Criteria:

* pregnant or breast feeding women
* Age \<18 years
* pulmonary disease with an oxygenation index \<300mmHg
* liver disease (\>Child B)
* HIV-Infection
* Therapy with corticosteroids
* Condition after transplantation
* preexisting infection before operation
The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases

This study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the MOH area, Ragama and measure the effectiveness of the programme.

Sri Lanka as a developing nation needs to identify feasible and cost effective measures to face the epidemic of NonCommunicable Diseases(NCDs) in the future. Experiences gained over many years in the developed countries can be of great value in planning and implementing NCD prevention and control activities in the developing countries Results from many studies have emphasized the fact that merely providing risk reduction measures for clinically high-risk people in health service settings would have only a limited impact in the whole country. On the other hand, if the population as a whole were to be targeted, even a modest risk factor and healthy lifestyle change would potentially have a huge public impact.This study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the MOH area, Ragama and measure the effectiveness of the programme. Outcome measures are process indicators, as measured by change in the dietary patterns, alcohol and tobacco consumption and physical activity. Short term outcome indicators would be blood pressure and anthropometric measurements. The long term outcome indicators such as morbidity and mortality due to NCD will not be measured as this will be a short term study.

Eligibility Criteria:
Inclusion Criteria:

* adults between 25-60 years

Exclusion Criteria:

* adults with psychiatric disorders
Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern

Obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide. Treatment options for obesity include lifestyle modification, pharmacotherapy and bariatric surgery. Bariatric surgery is a highly effective treatment for obesity and results in rapid and sustained weight loss. Also, it significantly alters gut microbiota composition and function. A very low-calorie diet (VLCD) is a rapid weight loss program which calorie intake is severely restricted (\< 800 kcal/day). It has been shown to be very effective to induce rapid weight loss and result in comorbidities resolution similar to bariatric surgery. Therefore, this study was aimed to study the effects of 12-week VLCD compare to bariatric surgery (Laparoscopic Roux-en-Y gastric bypass (LRYGB) or Laparoscopic Sleeve Gastrectomy (LSG)) on weight loss, body composition, gut microbiota pattern and other metabolic parameters.

The study will include obese patients (body mass index; BMI ≥ 37.5 kg/m2 or BMI ≥ 32.5 kg/m2 with comorbidities), aged 15-65 years at Ramathibodi Hospital, Thailand. The VLCD group will received total diet replacement for 12 weeks and the bariatric surgery group will undergo LRYGB or LSG. Study participants in both groups will be matched according to their age, sex, body mass index (BMI) and diabetic status. Body weight reduction and body composition, gut microbiota pattern, liver stiffness and steatosis, glycemic and other metabolic parameters (glucose, insulin, c-peptide, lipid profile, liver function test, kidney function test, complete blood count, electrolyte blood test, thyroid function tests, serum ketone and adiponectin), health-related quality of life, depression score and twenty-four-hour diet recall and physical activity will be assessed at baseline and at month 1, 3, 6, 9 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Aged 15-65 years
* Male or female
* Body mass index ≥ 32.5 kg/m2 with obesity related co-morbidity
* Body mass index ≥ 37.5 kg/m2 with or without an obesity related co-morbidity

Exclusion Criteria:

* End stage disease such as cancer, cirrhosis Child-Pugh C, critical/acute illness
* Type 1 diabetes mellitus
* Recent eGFR \< 30 ml/min/1.73 m2
* Weight loss ≥ 5% in the previous 3 months
* Use of antibiotics in the previous 1 month
* Use of probiotic or prebiotic supplement in form of tablet or sachet in the previous 14 days
* Current treatment with anti-obesity drugs
* Pregnancy or breast feeding
* Substance abuse
* Uncontrolled psychiatric disorder and eating order
* History of allergy to any components in meal replacement product or whey protein product
* Unable to give informed consent
Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer

This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.

This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer.

Standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.

In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.

We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age \> or equal to 30 years
* High risk (\>20% lifetime risk)
* Has a bilateral mammogram within the last 7 months
* Has had a same day high risk screening MRI

Exclusion Criteria:

* Participants who have a known allergy or contraindication to iodinated contrast.
* Participants who have a known allergy to food or medications.
* Participants who have renal insufficiency or failure.
* Participants who are pregnant or breastfeeding.
* Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
Effect of Zinc Supplementation on Serum Zinc Level in Nursing Home Elderly

Background: Zinc supplementation has the potential to improve serum zinc levels and immunity of zinc deficient nursing home elderly.

Objective: To determine the effect of zinc supplementation of 30mg/d for 3 months on serum zinc levels and T-cell mediated function of zinc deficient nursing home elderly.

Design: This is a randomized, double-blind, placebo-controlled study. Outcome measures included change in serum zinc levels and various T-cell mediated immune factors between baseline and month 3.

Hypotheses: The investigators hypothesize that zinc supplementation of 30mg/d for 3 months will improve serum zinc levels as well as various T-cell mediated immune factors in zinc deficient nursing home elderly.

Four hundred and forty-two medical charts were screened from three participating nursing homes; 53 nursing home elderly were eligible and therefore were screened for low serum zinc levels (\<70µg/dL). Of these, 31 (58%) had low serum zinc levels. Participants were randomized into either the placebo (N=16) or the zinc supplemented (N=15) group. Six participants did not complete the study for various reasons including refusal to take study capsules, and advice from their physicians; one participant in the zinc group experienced nausea on two consecutive days following ingestion of the zinc capsule at the beginning of the study. A total of 25 participants completed the study with 13 and 12 receiving the placebo and zinc capsules, respectively, over a period of three months

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥65 years of age.
2. More than 6 months life expectancy, in the judgment of their study physician.
3. Willing to be randomized to one of the treatment groups.
4. Able to swallow pills.
5. Not currently on antibiotics.
6. Subjects consuming DRI levels of supplements and willing to replace their supplement with our control supplement.
7. Supplements of calcium, vitamin D, and iron will be permitted.
8. Willing to receive influenza vaccine.

Exclusion Criteria:

1. Anticipated transfer or discharge within three months of enrollment.
2. Bed- or room-bound continuously for the last three months.
3. Presence of lung neoplastic diseases or other active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs (including no more than 10 mg/day of prednisone).
4. Naso-gastric or other tube feeding.
5. Long-term intravenous or urethral catheters (30 days).
6. Presence of tracheostomy or chronically ventilator-dependent.
7. Consuming supplements containing more than the DRI level of nutrients known to affect the immune response, i.e. vitamins E, C, B6, selenium, zinc, or β -carotene and unwilling to stop.
8. Chronic prophylactic antibiotic treatment (low percent of subjects meeting other inclusion criteria). 9) Protein energy malnutrition defined as albumin \< 3.0 g/dl and BMI \<18 kg/m2.