cyrilzakka/clinical-trials huggingface dataset:
Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery

The aim of the GLORIA study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. In addition, the investigators also aim to evaluate whether continuous glucose monitoring (CGM) can be used to diagnose gestational diabetes (GDM).

The GLORIA study is a Belgian multicenter prospective cohort study. The investigators aim to recruit 95 pregnant women after bariatric surgery (gastric bypass or sleeve gastrectomy) and as a control group, an age and BMI-matched cohort of 95 pregnant women without bariatric surgery. Participants will be recruited before 12 weeks of pregnancy. To evaluate glucose homeostasis, a masked CGM will be used for 10 days during each trimester in pregnancy and at the time of screening for GDM (at 24-28 weeks). The primary outcome is the mean glycaemia levels and glycaemic variability (SD) measured by CGM in pregnancy. At the different time points, anthropometric measurements (including body composition), food diary, questionnaires and micronutrients will be evaluated. In addition, in collaboration with the lab of Cristina Legido Quigle from the Steno Diabetes Center in Copenhagen, metabolomics will be analyzed. Women with a history of bariatric surgery will receive screening for GDM between 24-28 weeks of pregnancy by performing self- monitoring of blood glucose (SMBG) with a glucometer during one week. In addition to SMBG, women will receive a masked CGM during one week.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days
* for the group with bariatric surgery: history of gastric bypass (RYBG) or sleeve gastrectomy (SG)
* Participants need to speak and understand Flemish, French or English and have e-mail access.

Exclusion Criteria:

* multiple pregnancy
* pregnancy ≥12 weeks
* other types of bariatric surgery than RYBG or SG
* known pregestational diabetes
* a physical or psychological disease likely to interfere with the conduct of the study
* medications known to interfere with glucose metabolism.
Endoscopic Assessment of Polyp Histology

Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts to save costs include endoscopic assessment of polyps with regards to differential diagnoses between adenomas (which have to be removed) and hyperplastic polyps (could be left in place or removed and not examined histologically). Such a concept would only be feasible if endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates - between 80% and 95% - have been reported from reference centers with specific scientific interest. The investigators want to test whether these results a) can be reproduced in the private practice setting performing large-volume screening colonoscopies and b) whether latest generation endoscopes provide benefit in terms of better accuracy.

Patients undergoing screening colonoscopy will be randomized to the use of two different colonoscopes, namely the latest generation (Pentax iScan, Hi Line) versus the previous generation (Classic Line). On withdrawal, all polyps found will be diagnosed according to their pit pattern (classification scheme mit example images provided) and a differential diagnosis made during the live examination. Pit patterns I/II will be classified as hyperplastic polyps, patterns III-V as adenomas (in a subgroup IV and V will be classified as pre-/malignant). All polyps will be photographed from near distance to allow for later blinded review which will be done on patients with only one polyp (to avoid mix-up of polyps) by 3 examiners and 2 independent hospital experts.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing screening colonoscopy

Exclusion Criteria:

* Missing consent
* No screening colonoscopy (diagnostic colonoscopy because of symptoms)
Comorbid Insomnia and Sleep Apnea

Insomnia and OSA coexist in clinical populations, but the prevalence of comorbid insomnia among OSA patients in the community and risk factors remain poorly known. Little is known about the impact of sleep apnea and insomnia on the quality of life and quality of sleep compared to the presence of one of the sleep disorders alone. Our hypothesis is that the co-existence of OSA and insomnia is high in our community. We also hypothesized that the co-existence of OSA and insomnia promotes greater impairment of quality of life and quality of sleep when compared to the presence of OSA or insomnia alone.

Patients referred to polysomnography will be submitted to 6 questionnaires to assess daytime sleepiness (EPWORTH), insomnia severity index (ISI), anxiety and depression assessment (Beck's anxiety and depression inventory), quality of life assessment(WHOQOL- BREF) and sleep quality assessment (Pittsburgh questionnaire) and they will also be submitted to a polysomnography type III.

It will be calculated the frequency of insomnia, OSA and the comorbidity between insomnia and OSA in the sample. It will be analysed correlations between the insomnia severity index, apnea and hypopnea index, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck's anxiety and depression inventory) and Pittsburgh sleep quality scale. Insomnia severity index scores, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck anxiety and depression inventory) and Pittsburgh sleep quality scale will be compared according to the presence and absence of OSA and the presence and absence of insomnia and the presence of the comorbidity insomnia and OSA.


Eligibility Criteria:
Inclusion Criteria:

-Individuals who will participate in the task force for the diagnosis of sleep apnea promoted by the State Department of Health in an agreement signed with the Heart Institute

Exclusion Criteria:

* individuals under 18 years old
Bioavailability and Vascular Effects of Apple Polyphenols

The main purpose of this study is to determine the oral bioavailability of flavanols (polyphenolic compounds) from apple granules and an apple extract delivered in a water based beverage at two different doses. We will also investigate the effects of apple flavanols on nitric oxide production.

This study is a randomized four phase crossover trial investigating the bioavailability of apple flavanols and the effects on nitric oxide products, a surrogate marker for changes in endothelial function. Each test phase will comprise a 3 day period of intervention which will be identical in nature (except for the test product consumed) and separated by a minimum of 1 week. On days 1-3 of each test phase volunteers will consume a low flavanol diet. After consumption of the test product on the morning of day 2, blood and urine samples will be collected at regular intervals for the next 24h.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 45-70 years

Exclusion Criteria:

* Smokers (or have quit smoking less than 1 year ago)
* Regular prescribed medication (excluding some eye and skin medication that is judged not to affect study outcome)
* Non-prescribed medication that may affect the study data, e.g. aspirin. The use of non prescribed medications will be assessed on an individual basis.
* Dietary supplements or herbal remedies which may affect the study data unless the volunteer is willing to discontinue them for 1 month prior to starting study. (Please note that some supplements may not affect the study and this will be assessed on an individual basis).
* Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
* Diabetics
* Known cardiovascular disease
* Asthmatics (unless no medication taken for 1 year)
* Lactose Intolerance
* Pregnancy or have been pregnant within the last 12 months
* Parallel participation in another research project which involves dietary intervention
* Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 mls.
* Has donated or intends to donate blood within 16 weeks prior to or during the study period.
* Depressed or elevated blood pressure measurements (\<90/50 or 95/55 if symptomatic or \>160/100)
* Any person related to or living with any member of the study team
* Results of the clinical screening which indicate or are judged by the HNU Medical Advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which could affect the study data.
* Alcohol consumption \> approximately 20 g alcohol/day (2.5 units/day)
* BMI \<19.5 or \> 35
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.


Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women with chronic HIV-1 infection
* Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
* Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)
* Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
* Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
* Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort

Exclusion Criteria:

* Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
* HIV-2 infection
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 7 x ULN
* Alkaline Phosphatase \> 5 x ULN
* Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)
Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions

To verify the efficacy of a group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and to compare its effects to a known skills training approach and a control group. Our primary hypotheses were that CBT would do better than the control group at all points in time, and better than the skills training approach, though only at follow-ups

The study's protocol has the following objectives: to verify the efficacy of a group CBT approach; to compare the effects of CBT to those of the symptom management module and to a control group on psychotic symptoms and subjective experiences (e.g., depression, anxiety, self-esteem, social support, insight, and coping); and to assess what the effects are related to, via measuring client variables, therapist variables, and intervention variables that might explain the results. This study follows a randomized controlled trial design where participants are randomly assigned to one of the three groups at each recruiting wave. Both treatment modalities hold the same number of group meetings as well as similar formats, lengths of treatment and operational structures, each operationalized in detailed manuals. Interviewers are blind to group allocation. Symptoms, both psychotic and otherwise, depression, self-esteem, social adaptation, anxiety, insight, social support, and coping are all measured before the beginning of treatment, three months follow-up, nine-months follow-up, and 15-months follow-up

Eligibility Criteria:
Inclusion Criteria:

1) less than two years since their first consultation in psychiatry for psychotic symptoms, 2) a DSM-IV diagnosis in the schizophrenia spectrum (or a psychotic episode suggesting a non-mood related psychosis), 3) ability to read and write in English, 4) aged between 18 and 35, 5) no organic disorder, and 6) consenting to participate

Exclusion Criteria:

-
The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome

Ozone (O2-O3) has been used as a supportive therapy in various musculoskeletal diseases such as lumbosacral disc herniation, knee osteoarthritis, meniscus injury, shoulder pathologies.The aim of this study is to investigate the effectiveness of ozone (O2-O3) injection applied to the trigger point in the treatment of myofascial pain syndrome.

The study was designed as a prospective, randomized, controlled trial. Fourty six people who met the inclusion criteria will randomized into two groups of 23 people. The first group will be designated as ozone therapy group and patients in the second group will be designated as the lidocaine injection group. Patients will be evaluated with visuel analog scale (10cm-VAS), Neck Disability Index (NDI), Pain Score (PS) and neck lateral flexion measurement before and after treatment at 4 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with myofascial pain syndrome according to the criteria defined by Simons et al.
* aged between18-65
* having typical myofascial pain symptoms for at least 3 months

Exclusion Criteria:

* presence of cervical radiculopathy, cervical myelopathy, severe dyscal or bony degeneration
* presence of a history of neck trauma or surgery in the last year
* presence of trigger point injection for myofascial pain syndrome treatment in the last 3 months
* presence of cognitive impairment, malignant hypertension, G6PDH (Glucose 6- Phosphate Dehydrogenase) deficiency, Graves' disease, chronic recurrent pancreatitis attack, severe thrombocytopenia (platelet value \<50,000 / microliter), cerebrovascular disease in which bleeding is active
* presence of systemic diseases such as fibromyalgia, inflammatory diseases such as rheumatoid arthritis, polyneuropathy, coagulopathy.
* presence of pregnancy and breastfeeding
Accelerated Resolution Therapy for Early Maladaptive Grief

The purpose study is to test the effects of accelerated resolution therapy (ART) on pre-loss grief and prolonged grief disorder among older adult family caregivers (FCGs). Additionally, to better understand predictors of response to ART, and cognitive processes that occur among grieving individuals following ART.

Accelerated Resolution Therapy (ART) is an evidence-based treatment for post-traumatic distress in civilians and veterans that may be useful in alleviating maladaptive grief prior to bereavement and could prevent prolonged grief disorder following bereavement. Researchers are proposing to test the efficacy of ART, a low-risk, brief therapy with a strong theoretical rationale for treatment success in maladaptive grief and supported by the promising results of a recently completed preliminary trial. Additional aims of the study are to examine changes in cognitive appraisal and integration of loss following ART using a mixed methods approach and to evaluate personal, social, and psychological factors predictors of response.

During the proposed double blinded, randomized, controlled two arm clinical trial, older adult family caregivers will receive either ART or an educational program that is matched for time and attention. Each participant will receive four sessions of either the ART intervention or the control intervention. Data collection will occur at screening/enrollment (T1), at the end of the 4-session intervention period (T2) and at 6-months (T3) and 13-months post bereavement (T4). A subgroup of 20 participants randomly assigned to ART will participate in semi-structured interviews to enhance understanding of cognitive appraisal and integration of loss.

This trial will provide critical information on the efficacy of the ART intervention as a potential first-line treatment option for pre-loss grief and preventative option for prolonged grief disorder, and contribute new information about characteristics of individuals most likely to benefit from ART.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of immediate family member who has a life expectancy of less than 12 months
* Score of 30 or higher on the PG-12-R, indicating clinically significant pre-loss grief
* Denial of suicidal ideation or intent, with no evidence of psychotic behavior.

Exclusion Criteria:

* Since becoming a family caregiver (FCG), they have engaged in another trauma based psychotherapeutic regimen (EMDR, prolonged exposure therapy, trauma focused cognitive behavioral therapy) that could influence response to accelerated resolution therapy (ART).
* Self-reported or clinically assessed major psychiatric disorder (e.g., bipolar disorder, schizophrenia).
* Score of \> 2 on the adapted CAGE questionnaire indicating alcohol /drug dependence.
* Cognitive impairment (SPMSQ \> 4 errors).
Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation

The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.

90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.

Eligibility Criteria:
Inclusion Criteria:

* Children =/\> 10 years of age
* Undergoing elective diagnostic colonoscopy
* ASA score class 1-3.

Exclusion Criteria:

* Children younger than 10 years of age
* Known epilepsy under treatment
* ASA score class 4 or more
* Interventional colonoscopy (e.g.polypectomy)
Physiology of Weakness in Movement Disorders

This study will compare electroencephalograph (EEG) recordings in healthy volunteers and in people with movement disorders to examine brain activity associated with the weakness. EEG records the electrical activity of the brain ("brain waves").

Healthy volunteers and patients with arm or leg weakness who are between 18 and 80 years of age may be eligible for this study. Healthy subjects are screened with a medical history, physical and neurological examinations, and a questionnaire. They must be right-handed and never have had a neurological disease or head trauma.

All participants have an EEG. An elastic cap with electrodes is placed on the subject's scalp to record the brain's electrical activity. During the EEG, subjects are required to resist against a force with their arm, elbow, shoulder or leg for as long as they can. Several recordings are done with short breaks between them.

Objective

Give way weakness is a symptom often associated with psychogenic etiology, but its neurophysiological basis is poorly understood. Our objective in this study is to identify the cerebral mechanism of give way weakness.

Study population

We will study 6 patients with give way weakness and 6 healthy volunteers all age 18 years old or older.

Design

In this study, patients will try to resist against the examiner's force and subsequently give way. Electroencephalography (EEG) will be recorded while this maneuver is performed repeatedly.

Outcome measures

Movement-related cortical potential (MRCP) analysis will be performed on the data and its amplitude (in volts) and latency (in seconds) in each individual patient will be described in contrast to the data obtained from healthy volunteers.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Both patients and healthy volunteers will be between age 18 and 80.
* Patients will be evaluated in the Human Motor Control Clinic at NINDS.
* The definite diagnosis of the disease may not be completely established at the time of recording.
* Patients have clear and reproducible symptoms of give way weakness of either upper or lower extremities.
* Patients have to be able to resist against the examiner for at least two seconds before giving way.
* Healthy volunteers are right handed adults without history of neurological disease or severe head trauma.

EXCLUSION CRITERIA:

* Subjects (patients or volunteers) who cannot understand the instructions and consent forms of the protocol will be excluded.
* Subjects who cannot follow the instruction during the entire recording for whatever reason will be excluded.
* Patients with a documented organic central nervous system lesion may be excluded from the study. This will be discussed in detail for each individual subject at the Human Motor Control Clinic.
Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study 1-Survey

Despite widespread and growing popularity of complementary and alternative medicine (CAM) in the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical effectiveness, safety and cost- effectiveness. With previous funding support from NCCAM, the Harvard Medical School (HMS) Osher Research Center established and trained a multidisciplinary integrative team of CAM and conventional providers to work collaboratively to provide state-of-the-art "integrative care" in a coordinated and individualized fashion. The Osher Integrative Care Center (OCC) was opened in fall 2007, physically located within the Ambulatory Care Center of the Brigham and Women's Hospital (BWH) at 850 Boylston Street in Chestnut Hill, MA. The focus of this survey study is to characterize the decision-making process of both patients and conventional providers with respect to communication about and referral to an integrative care team in an academic hospital outpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* New patient coming into Osher Clinical Center for any medical reason.
* Physician affiliated with any of included division/department (see above).

Exclusion Criteria:

* Patient has been seen at Osher Clinical Center within past 3 months for any reason.