cyrilzakka/clinical-trials huggingface dataset:
Prebiotic Fiber to Prevent Pathogen Colonization in the ICU

This is a pilot trial testing enteral feeds that are high versus low in prebiotic fiber in 20 critically ill adults. The long-term goal is to determine the efficacy of fiber for the prevention of pathogen colonization/infection in the ICU.

This study will test prebiotic fiber in 20 adults who are receiving broad-spectrum antibiotics in the medical or surgical ICU by open-label randomization of patients to approximately 20 g prebiotic fiber/day including 45% short-chain fructooligosaccharides versus 0 g fiber/day by providing one of two feeds. Per 10 ounces of feed, both the high and low fiber feeds contain identical micronutrients and have 296 kilocalorie (kCal), 19 g protein, 8 g fat, and 39 g carbohydrates. The sole difference is that the fiber-containing feed has 4 g fiber including 45% short-chain fructooligosaccharides per 10 ounces whereas the other feed has 0 g fiber. Randomization will take place at the time the order for enteral feeding is placed. Rather than supplying the feed itself, the investigators will supply a randomized recommendation for a feed type (i.e., high vs low fiber) and the feed will be obtained from the hospital pharmacy in the usual manner. Determination of the feed rate and duration will be decided on the individual patient's needs by the treating ICU team. The primary outcome will be to determine whether high fiber feeds alter the gut microbiome in the face of antibiotics and critical illness, calculated by comparing within-individual microbiome differences from baseline to Day 3 in each intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Medical or surgical ICU patients ≥18 years old at our institution;
* Receiving broad-spectrum antibiotics at the time of enrollment;
* Deemed appropriate for the study by the treating ICU team;
* With capacity to give consent or have an appropriate surrogate;
* Able to undergo assessment within 4 hours of the order for enteral feeds;
* Expected to receive enteral feeds for ≥3 days but not yet receiving them.

Exclusion Criteria:

* Inability to receive enteral feeds;
* Celiac disease or known allergy to fiber;
* Surgery involving the intestinal lumen within 30 days;
* Limited treatment goals (i.e., do-not-resuscitate (DNR), do-not-intubate (DNI), or no escalation of care);
* Lack of capacity to consent and lack of an appropriate legally authorized representative.
A Study of Rituxan in the Treatment of Polyneuropathies Associated With Serum IgM Autoantibodies

Peripheral neuropathies cause weakness and sensory loss that can produce severe disability. Some neuropathies are immune-mediated and associated with antibodies. It has been postulated that Rituxan treatment may reduce the level of antibody production limiting the loss of muscle strength and hence improve activities of daily living. The purpose of this open-label study (all participants get Rituxan and not placebo) is to determine the safety and effectiveness of Rituxan in the treatment of polyneuropathies associated with serum IgM autoantibodies in those who have already been treated with one course of Rituxan. Subjects will be treated on the in-patient Clinical Research Center with Rituxan for two treatments one week a part and then individual treatments every 10 weeks for one year. The effectiveness of Rituxan will be followed by looking for increases in muscle strength and decreases in the serum IgM autoantibodies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of characteristic peripheral neuropathy by appropriate history, physical examination, nerve conduction findings and serum autoantibodies.
* Serum anti-GM1 on anti-MAG antibodies present at high titers in serum, continued by testing in the neuromuscular clinical laboratory at Washington University.
Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma

Hepatocellular carcinoma represents the commonest primary cancer of the liver.serum lactate dehydrogenase is an indirect marker of tumor hypoxia,angioneogenesis and worse prognosis.

Hepatocellular carcinoma (HCC) represents the commonest primary cancer of the liver. Incidence is increasing and HCC has risen to become the 5th commonest malignancy worldwide and the third leading cause of cancer related death, exceeded only by cancers of the lung and stomach. HCC prevalence is higher in sub-Saharan Africa, central and Southeast Asia.Serum lactate dehydrogenase (LDH) levels is an indirect marker of tumor hypoxia, angioneogenesis and worse prognosis. Lactic dehydrogenase (LDH), which is a glycolytic enzyme, composed of four polypeptide chains, each one encoded by separate gene (M and H), exists in various types of human tissue and neoplasms. LDH is a key enzyme in the conversion pyruvate to lactate under anaerobic conditions .Five isoforms of LDH have been identified as a result of the five different combinations of polypeptide subunits.

Hypoxia represents a clinical biological mechanism for treatment resistance in cancer cells via the formation of new blood vessels. Furthermore, a growing body of evidence indicates that hypoxia might actually promote cancer development.

Eligibility Criteria:
Inclusion Criteria:

* patients with Hepatocellular carcinoma diagnosed by biopsy or imaging criteria and alpha feto protein.
* signed informed consent before registration in study
* Eastern Cooperative oncology Groups Performance status between 0 and 2.

Exclusion Criteria:

* Cachexia or poor condition
* pregnant or human chorionic gonadotropin positive
* patient with another liver tumor
* Any previous treatment
Study of the Effect of Capsinoid Supplementation on Brown Adipose Tissue in Obese Adolescents

Among the new strategies being considered for the treatment of obesity and its metabolic complications, the activation of brown adipose tissue (BAT) from white adipose tissue looks promising. Interest in the study of BAT has increased over the last 5-10 years in response to the discovery of functional BAT in humans. The BAT is a tissue specialized in regulating energy expenditure by producing heat through the oxidation of fatty acids contained in the multiple lipid droplets of brown adipocytes. This adipose tissue does not play a storage role, but rather an anti-obesogenic one, thanks to its high metabolic and energetic activity.

In addition to exposure to cold, which is the major physiological inducer of brown adipocytes, it seems that exercise and the intake of "adrenergic" foods can activate the TAB and potentially induce a change from white to brown tissue via the production of adrenalin and myokines. Acute and/or chronic effects of thermogenic food supplements have been reported on BAT activation and energy metabolism. The most conclusive of these involve the capsinoids found in sweet peppers and chillies. Weight loss also improves BAT activation.

The BAT has already been identified in children. A decrease in its volume and activity from childhood to adolescence and during puberty has been reported.

The main objective of this randomized controlled double-blind study is to investigate the effects of capsinoid dietary supplementation on BAT activity in obese adolescents.

Our general working hypothesis is that capsinoid supplementation, combined with dietary management, leads to an increase in BAT activity.


Eligibility Criteria:
Inclusion Criteria:

* member or beneficiary of a health insurance scheme
* aged between 11 and 18
* Body Mass Index Z score corresponding to stage 2 obesity according to the curves of Rolland-Cachera et al., 1991 and an absence of weight loss of more than 5% of the total weight over the last 3 months.
* effective contraception (in pubescent females)

Exclusion Criteria:

* known allergy to capsinoids and/or soya
* inflammatory digestive pathology and/or history of digestive tract surgery
* participation in another study or in a period of exclusion determined by a previous study
* pregnant, parturient or breastfeeding
* The holder(s) of parental authority or the adolescent refuse(s) to sign the authorisation or acceptance form, respectively.
* It proves impossible to provide the adolescent or parental guardian(s) with informed information.
Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty

This study evaluates the pathophysiological effects of a single dose of methylprednisolone administered prior to total knee-arthroplasty surgery. The investigators examine the effect on complement activation.

Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.

The investigators hypothesize that the group receiving methylprednisolone will experience beneficial inhibition of the undesirable parts of the complement activation.

The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.

Anaesthesia and surgery are associated with a dramatic increase in the inflammatory response. The complement system participates in the disposal of products due to inflammatory damage. The complement activation generates proinflammatory mediators which amplifies the tissue damage and the inflammation.

Glucocorticoid administration prior to surgery is thought to effectively reduce the inflammatory response and the activation of the complement system. The effect of glucocorticoids on specific complement markers after surgery is unknown and calls for further investigation.

This study is embedded in a primary study registrated as: NCT02319343

For further details please view the EudraCT registration:

EudraCT nr.: 2014-003395-23

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthrosis
* Undergoing total unilateral knee-arthroplasty surgery
* Speak and understand Danish
* Have given informed consent

Exclusion Criteria:

* Revision, bilateral or uni chamber knee-arthroplasty surgery
* General anaesthesia
* Allergy or intolerance towards Methylprednisolone
* Local or systemic infection
* Permanent systemic treatment with steroids within 30 days preoperatively
* Insulin-dependent diabetes
* Active treatment of ulcer within 3 months preoperatively
* Cancer disease
* Autoimmune disease incl. rheumatoid arthritis
* Pregnant or breast feeding women
* Menopause \<1 year
Twins Born in Guangzhou

The 2-BIG is a twin birth cohort study located in Guangzhou, China.Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental, family and lifestyle exposures on twins from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the twins and their parents.

Twins share the same intrauterine environment and the early family environment. When conducting research of chronic disease etiology, twins cohort can be a good control of bias from age, gender, genetic and early environment. Twin-based designs provide an estimate of the relative contribution of genetic and non-genetic factors to a specific phenotype. Twins study has an advantage of calculating heritability of traits. Since heritability of traits is various from different populations. It is important to establish database to calculate the heritability of traits associated with chronic major diseases in Chinese population. Twins cohort is rare in China at present. Therefore, extensive information including physical characteristics, mental health, and behaviors is collected from both twins and their parents. Longitudinal follow-up and surveillance of common diseases are also to be conducted. The 2-BIG aims to explore epigenetic markers and genes related to health status, as well as gene-environment interactions on diseases, both in intrauterine and childhood stages, especially in Chinese population.

Eligibility Criteria:
Inclusion Criteria:

1. Live twins delivered in Guangzhou Women and Children's Medical Center
2. Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years
3. Baseline information during pregnancy available
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

The purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene HCl. All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo. All study participants will receive raloxifene HCl in the third phase of the study.


Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with osteoporosis
* Must be female, age 55 through 80
* Must be at least 5 years postmenopausal
* Must be free of other severe or chronically disabling conditions
* Must be able to properly use injection device.

Exclusion Criteria:

* Must not have bone diseases other than osteoporosis
* Must not have history of certain cancers
* Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes)
* Must not have treatment with particular medications (warfarin, estrogens, androgens, steroids, calcitonins, fluorides, biphosphonates)
* Must not have known allergy to the study agent or raloxifene HCl
Could Cervical Postural Changes Affect the Long Thoracic Nerve Electromyographic Findings?

This study investigates one of the mechanism factors of neck pain. Cervical lordotic angle alterations affect the tension of serratus anterior muscle. Expected result that the long thoracic nerve can be affected in this situation, and could be observed the functional changes of the nerve with serratus anterior electromyographic findings.

Different methods exist in order to evaluate muscle function. For the neck pain, the most commonly used method by researchers and clinicians are spot radiography and surface electromyography (sEMG). Radiographs can be used for the kyphotic angle or cervical lordotic angle measurements. Parameters that can be studied by EMG are amplitude, timing, conduction velocity, fatigability and characteristic frequencies/patterns.

The long thoracic nerve innervates the serratus anterior muscle. This nerve arises from the anterior rami of three spinal nerve roots: the fifth, sixth, and seventh cervical nerves (C5-C7) The nerve descends through the cervicoaxillary canal behind (posterior to) the brachial plexus and the axillary artery and vein, resting on the outer surface of the serratus anterior. The Serratus anterior electromyography, the needle can be inserted into the muscle superficially to the fourth to sixth rib in the medial or posterior axillary line. The usual nerve latency time is between 2.6-4 ms.

In this study, the results of serratus anterior muscle EMG activity and postural cervical angle alterations (lateral radiography) in patients with chronic mechanical neck pain will be compared with healthy volunteers without neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is \> to 18 years and \<40 yo
* Patient presenting a chronic neck pain (symptoms over 3 months)
* No neurological deficit
* Asymptomatic volunteers (for control group)
* Obtaining the enlightened consent of the patient

Exclusion Criteria:

* Patient having refused to sign his consent
* Patients whose age is \< to 18 years or \>40 yo.
* Patients with neurologic deficits
* Patients presenting history of allergy
* History of cervical spine surgery
* Patient presenting an anticoagulant or salicylated treatment which can not be interrupted.
* Pregnant woman.
* Patient with acute head and neck trauma
* Patient with a contra-indication to radiography.
* Patient with a psychiatric pathology preventing a clinical evaluation.
* Patient with contra-indication (cutaneous or different) to needle electromyography.
* Surgery contra-indication (cardiac failure, respiratory...)
* Patient without health coverage.
Specialized Palliative Telemedicine for Patients with Advanced Cancer

Specialized palliative care (SPC) plays an important role in providing patient-centered care and support to informal caregiver, besides establishing/intensifying/coordinating collaboration with primary and secondary health care sectors (hospital nurse/district nurse and general practitioner/oncologist) to improve care and support for patients and burdened informal caregiver. This study proposes to develop a SPC intervention enriched with a dyadic psychological intervention for patients with advanced cancer and their informal caregiver delivered by telemedicine at home (TeleSPC). It is our hypothesis that the intervention can enhance patient-centered care at home, support their informal caregiver, and improve relations/integration between the SPC teams, oncologic teams, the general practitioners and district nurses.

This is a pilot randomized controlled trial in an open-label fashion, which proposes to develop a SPC intervention enriched with a dyadic psychological intervention (needs-based therapeutic framework based on existential-phenomenological therapy) for patients with advanced cancer and their informal caregiver delivered by telemedicine (video consultation) at home. The primary aim is to investigate the intervention effects on the patients' health-related quality of life (HRQoL). The secondary aims will be to analyze the intervention effects on number of hospitalizations, days spent at home, hospital admissions, survival, dyadic coping between patients and informal caregiver, staff satisfaction with the intervention and caregiver burden in patients' informal caregiver.

Eligibility Criteria:
Patient inclusion criteria:

* adults (at least 18 years old)
* solid organ cancer
* no longer receives curativ treatment
* provide written informed consent
* are able to speak and understand Danish Language
* are cognitively able to participate in the study
* have at least one symptom or problem with score ≥ 3 at the EORTC QLQ-C30

Patient exclusion criteria:

* primary brain cancer or central nervous system metastases
* a prognosis of less than six months
* incapable of cooperating in the trial
* already receive SPC

Informal caregiver inclusion criteria:

* adults (at least 18 years old)
* indicated by the patient as the closest informal caregiver
* able to speak and understand danish langues
* provide written informed consent

Informal caregiver exclusion criteria:

- refuse to participate in the study
Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery

compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery

Functional endoscopic sinus surgery is a well-established therapeutic option for intractable CRS and other indications. Functional endoscopic sinus surgery is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid leakage and the duration of surgery increase. Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications.

Dexmedetomidine is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes dexmedetomidine primarily sedative and anxiolytic.The elimination half-life of dexmedetomidine (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration.

Intranasal Dexmedetomidine is convenient, effective, and noninvasive and also has useful analgesic and sedative effects in surgical procedures. Cheung's research has shown that intranasal Dexmedetomidine 1 and 1.5 micro/kg in surgical procedures produced significant sedation and less postoperative pain. Several previous research were determined the effect of intranasal dexmedetomidine in several clinical evaluations

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent Functional Endoscopic Sinus Surgery
* American Society of Anesthesiologists (ASA) physical status classification I or II

Exclusion Criteria:

* Patients with a body mass index \> 30 kg/m2 existing or recent significant disease
* contraindications to the use of dexmedetomidine
* history or presence of a significant disease significant cardiovascular disease risk factors
* significant coronary artery disease or any known genetic predisposition
* history of any kind of drug allergy
* drug abuse
* psychological or other emotional problems
* special diet or lifestyle
* clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening
* known systemic disease requiring the use of anticoagulants, patients with a history of previous Functional Endoscopic Sinus Surgery
Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer

The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* advanced cancer with no effective treatment
* Karnofsky performance status no less than 70
* adequated organ function
* informed consent

Exclusion Criteria:

* allergic to chlorogenic acid
* persistent toxicities from previous treatment (no less than grade 2)
Adherence to Different Exercise Interventions

Only 50% of sedentary adults that start an exercise training program adhere to the program after 6 months. Exercise variety may improve adherence. The goal of this study is to examine different exercise interventions that include a variety of exercise on adherence.

Regular exercise, in the form of walking 150 minutes per week, is widely regarded as having many health and fitness benefits. Despite these well-known benefits, adherence to exercise interventions is extremely low. When sedentary adults start an exercise training program only 50% adhere to the program and meet the national recommendations of 150 minutes per week. A possible explanation of the low adherence is that most adults only walk for exercise, and that providing a variety of exercise may increase adherence. Preliminary observational data show that a variety of exercise may increase weekly exercise expenditure compared to other interventions. The overall objective of this study is to investigate the feasibility, adherence, and acceptability of different exercise interventions including 1) walk intervention, 2) variety intervention, and 3) progressive intervention (see below for description).

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* Sedentary (\<1 hour per week of exercise)
* BMI 18.5 to 40 kg/m2

Exclusion Criteria:

* Adults with diagnosed cardiovascular, diabetes, renal, or any other metabolic disease determined by Health and Fitness History questionnaire.
* Any other disability, ailment, or physical characteristics that may hinder the ability to participate in regular exercise determined by Health and Fitness History questionnaire.
* Participating in other studies that would interfere with their ability to safely complete the exercise protocols.
* Pregnant or trying to become pregnant, and peri-menopausal or post-menopausal women.
* History of smoking within the last 6 months
* Any other vulnerable population (children \<18, pregnant women, prisoners, etc.)