cyrilzakka/clinical-trials huggingface dataset:
Cultural Meal and Postprandial Oxidative Stress

This one-year randomized crossover study is proposed to compare the changes of postprandial oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of POS differ with meals from different cultures. Four cultural meals are chosen, namely Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and Northern Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy male or female of Chinese ethnicity with BMI less than 25 kg/m2
* Aged from 18 to 45 years for female to avoid menopausal effect, and 18 to 50 years for male (inclusive)
* Normal glucose tolerance as assessed by fasting HbA1c of \<6% at the screening
* Willing to give consent and follow the study procedures

Exclusion Criteria:

* Lifestyle factors that affect POS as shown by the literature including
* Current smoker
* Physically active as defined by three days or more of 30 minutes \[accumulated over the course of a day\] moderate to vigorous activity weekly in the past three months. Vigorous physical activity is described as causing heavy sweating or a large increase in breathing or heart rate, and moderate as causing light sweating or a slight to moderate increase in breathing or heart rate.
* Regular or current use of vitamin or antioxidant supplements
* Pregnant or lactating
* Concurrent participation in any clinical trial or dietary intervention program
* Adherence to a special diet, allergies or aversions to foods on the study meals
* Use of medications that could affect study outcomes
* With diabetes, hypertension, renal, liver or thyroid dysfunction, any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study
Blood Flow Restriction Training Following Glenoid Labral Repair

The objective of this study is to evaluate the effects of BFR training on patient reported outcome measures and shoulder muscle girth in patients following glenoid labral repair. The investigators hypothesize that participants receiving BFR with rehabilitation will have greater improvements in patient reported outcome measures and shoulder muscle girth than participants who are treated without BFR.

Patients between the ages of 18 and 55 who had a superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair will be screened for participation in this study. Participants will be randomized in a 1:1 ratio to receive standard physical therapy with blood flow restriction training or without blood flow restriction. Participants will receive standard of care rehabilitation for labral repair regardless of group assignment. The length of each physical therapy session will be approximately one hour. The BFR and control group will perform leg press and leg extension exercises prior to shoulder strengthening. The resistance for both groups will be set as 30% of one repetition maximum (1-RM). The goal will be for the participants to perform 4 sets of repetitions sequenced 30, 15, 15, 15 of each exercise, if this is not obtainable then the number of set/repetitions will be decreased. The lower extremity strengthening exercises for this study will be performed by all participants beginning at the first physical therapy visit post-surgery. These exercises will be performed at each physical therapy session for 6 consecutive weeks (approximately 2-3 sessions/week). Standard rehabilitation will continue at the conclusion of the 6-week intervention for all participants.

Eligibility Criteria:
Inclusion Criteria:

* Superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair
* Willing to complete their post-operative rehabilitation at Andrews Institute Physical Therapy

Exclusion Criteria:

* Patients with prior procedures or significant injuries to the same shoulder will be excluded
* Patients with arthroscopic debridement of labral tears alone
* Patients with concomitant rotator cuff repair surgery
* Patients with Workers' Compensation or automobile insurance claim will be excluded.
* Patients who have a medical history involving any of the following medical conditions will be excluded - uncontrolled hypertension, diabetes, autoimmune disorders, rheumatoid or psoriatic arthritis, multiple sclerosis, peripheral vascular disease, peripheral neuropathy, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, blood disorders, disorders requiring immunosuppression, cancer, an ongoing infectious disease, use of steroids, or significant cardiovascular, renal, hepatic or pulmonary disease
Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement

Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The investigators hypothesize that use of a food based prophylactic will decrease incidence of rotavirus infection in young children in south India, prevent intestinal damage and overall result in lower infection rates and better gut function. This trial will evaluate the efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or antibody fragments expressed in yeast or placebo are given daily as a food supplement to children between the ages of 6 and 12 months. The children will followed for one year and rates of rotavirus diarrhoea, antibody responses and gut function will be compared between children receiving antibody fragments or placebo.

The study will be carried out in an urban slum area in Vellore, south India. Children between the ages of 6 and 12 months will be recruited for participation in the study. They will be randomized to receive supplementation with ARP or placebo, and will be followed for a period of one year, with weekly home visits and monitoring of all episodes of diarrhoea. In addition, every two weeks, surveillance stool samples will be collected and tested for rotavirus to identify asymptomatic infections by PCR. All episodes of diarrhoea will be investigated intensively for bacterial, viral and parasitic agents of diarrhoea using both conventional and molecular techniques and all cases will be treated appropriately at the study clinic or referral hospital as required. Monthly anthropometric measurements will be carried out to estimate rates of growth and to identify growth faltering. Blood samples will be taken at 4, 8 and 12 months for estimation of anti-rotavirus IgA and IgG antibodies. Studies on intestinal absorption and permeability will be carried out at recruitment, 6 and 12 months by the lactulose:mannitol test (measured by HPLC detection of sugars). All rotavirus strains obtained will be characterized by genotyping.

Eligibility Criteria:
Inclusion Criteria:

* Healthy child aged 6 to 12 months, families resident in the study area, willing to participate and available for follow up for a period of one year
* Normal birth weight (\> 2.5 kg), child exclusively breast fed for at least four months

Exclusion Criteria:

* Families not available for a follow up period of one year
* Children with any atopic conditions
* Children with gross congenital anomalies including cardiovascular, renal or hepatic disease
* Children with syndromic or serological evidence of HIV infection
THRA_hematologic Variables

Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.


Eligibility Criteria:
Inclusion Criteria:

* avascular necrosis of hip
* total hip replacement arthroplasty

Exclusion Criteria:

* revision operation
* hematologic disease
* anticoagulant medication
* preoperative hemoglobin \< 10 g/dl
* preoperative transfusion of red blood cells
Evaluation of Novel Cardio-Pulmonary Physiological Monitor, the VQm PHM™, for Acute Care Medicine

This is a prospective, observational study to assess agreement of pulmonary health parameters measured by a new non-invasive physiologic monitor, the VQm pulmonary health monitor (PHM)™ with clinical gold standards.

The specific aim of this study is to evaluate the intermittent non-invasive measurements of pulmonary function: pulmonary blood flow (PBF), functional residual capacity (FRC), shunt fraction index (Qsi) and airway dead space measured by the VQm PHM™ compared to known clinical standards. PBF will be compared to continuous and intermittent bolus thermodilution cardiac output as measured through a Swan-Ganz catheter. FRC will be compared to an FRC measurement provided by a standard nitrogen washout method. Qsi will be compared to shunt fraction calculated through mixed venous and arterial blood gas values (VBGs/ABGs). Airway dead space will be compared to an airway dead space measurement provided by a ventilator.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia without the use of inhalation anesthetics
* Surgical procedure that requires pressure-controlled positive pressure ventilation using an endotracheal tube
* Surgical procedure that requires the use of intra-arterial pressure monitoring and/or a Swan-Ganz catheter for the monitoring of continuous cardiac output

Exclusion Criteria:

* Patients who require ventilation tidal volumes less than 250cc
* Age less than 18 years
* Pregnancy
* Prisoners
* Surgical procedure which requires carbon dioxide (CO2) insufflation
* Unable to tolerate a transient increase in inhaled CO2
* Unable to tolerate a transient increase in inhaled nitrous oxide (N2O) or use of N2O is contraindicated
* Patients who require a high fraction of inspired oxygen (FiO2) (\>70%) to maintain a hemoglobin saturation (SpO2\>98%)

Women, minorities or non-English speaking subjects will not be excluded
Use of Ultrasound for Measuring Size of Oral Tongue Cancers

The purpose of this study is to investigate the use intraoral ultrasound for measuring depth of invasion (DOI) in oral tongue squamous cell carcinoma. The DOI's measured on ultrasound and measurements from MRI scans, will be compared to the measurements made from pathological examination of removed specimens.

The investigators will conduct a prospective cohort study to investigate the correlation between DOI measurements from preoperative imaging (MRI and intraoral ultrasound), and final histopathology findings.

All patients with oral tongue cancer histologically verified on biopsy diagnosed in the Capital Region and Zealand Region (population 2.6 mio) are treated at the department of Head and Neck surgery at Copenhagen University Hospital (Rigshospitalet). These patients will be invited to participate in the study before or at their multidisciplinary team (MDT) conference at Rigshospitalet where the final treatment will be decided.

The ultrasound exam is conducted with a bk5000 or bk3000 machine, a "Hockey Stick" X18L5s transducer or a 18L5s Linear transducer.

The transducer will be placed directly on the tongue tumor. The tumor size will be measured, and depth of invasion will be estimated. For later reevaluation of the ultrasound images, a sweep will be performed, and image files and video clips will be stored for documentation.

Patients will primarily be examined in the outpatient clinic, and the measurement will be repeated at the time of surgery when the patient is in general anesthesia. It is, however, at time of the examination outpatient clinic that the information about DOI is most useful in planning the treatment, and therefore this is measurement the investigators will be focusing on.

Each MRI scan will be reviewed by a radiologist and the DOI will be assessed if possible. According to the AJCC Cancer Staging System, 8th edition, "DOI is measured by first finding the 'horizon' of the basement membrane of the adjacent squamous mucosa. A perpendicular 'plumb line' is established from this horizon to the deepest point of tumor invasion" \[AJCC \]

The investigators aim to include 30 Patients in this study. The annual number of patients in our clinic operated for oral tongue carcinoma is around 50, so the investigators aim to include the 30 patients within one year.

Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell carcinoma on the lateral tongue

Exclusion Criteria:

* Patients with tumor elsewhere in the oral cavity
Efficacy and Safety Study of SUNPG1623

This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent
* Subject is ≥ 18 years of age at time of Screening
* Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP
* Subject has a negative evaluation for TB within 4 weeks before initiating IMP
* Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis \[CASPAR\] criteria) with symptoms present for at least 6 months.
* Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.

Exclusion Criteria:

* Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition
* Subject has an active infection or history of infections
* Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease
* Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus
Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis

The purpose of the study is to determine whether vitamin A can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.

Sepsis and necrotizing enterocolitis (NEC) are leading causes of morbidity and mortality in neonates. Studies have shown that early reversal of the signs associated with severe disease is an important prognostic factor during acute illness. Vitamin A deficiency is widespread among children, including neonates, in developing countries. Vitamin A plays an important role in mediating immune responses and in maintaining epithelial integrity. For this reason vitamin A supplementation during the acute phase of neonatal infection could work synergistically with present antibiotic regimens in promoting early reversal of signs associated with adverse outcome and shorten the total duration of clinical illness. The purpose of the proposed hospital-based clinical trial is to evaluate the efficacy of vitamin A supplementation on reducing the morbidity and mortality among neonates hospitalized with sepsis (n=366) and NEC(n=150). Enrolled subjects will be randomized at the time of hospitalization to receive one dose of either 50,000 IU of vitamin A or placebo at enrollment, in addition to standard antibiotic therapy. We will compare the proportion of treatment failures in sepsis patients, the frequency of disease progression and mortality in NEC patients, and the time to clinical recovery and discharge between treatment groups. In addition, the study will determine whether vitamin A reduces pro-inflammatory cytokine levels; elevated host inflammatory cytokines are thought to contribute to the severity of both conditions. If vitamin A is found to be efficacious in the treatment of sepsis and NEC it could present a needed cost-effective approach to decreasing the global morbidity, mortality and the economic cost associated with neonatal sepsis and NEC in the developing world.

Eligibility Criteria:
Inclusion Criteria:

* newborns less than 29 days with clinical sepsis

Exclusion Criteria:

* healthy infants
* major congenital abnormalities
* known inborn error(s) of metabolism
* chronic disorders of other organs (e.g. cholestasis)
* definite or severe NEC (\> stage 2)
* congenital heart disease
* Infants receiving VA supplements
* Infants requiring mechanical ventilation
* Infant is unconscious
Post-Authorization Study Evaluating Safety Of Tigecycline

This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.

Since around 50 patients were included in Spanish centers involved in the Phase III Tygacil clinical development program, and on the basis of the recruitment capacity of the centers within the predefined time window and the number of patients consenting to be enrolled in the study, the total number of patients estimated to be enrolled in the study is 500. With this sample size, it will be possible to obtain precise estimations of the incidence of particular types of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by patients prior to this study entry.
* 18 years of age or older at the screening visit.
* Patients with cIAI or cSSTI.
* Patients who are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections.
* In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol.

Exclusion Criteria:

* Known hypersensibility to tigecycline.
* Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
* Use any investigational drug within four weeks of the screening visit.
* Uncooperative patients or a history of poor compliance.
Ventricular Asynchrony in Cardiac Surgery Patients

The purpose of this study is to:

1. assess the existence of inter-ventricular and intra-ventricular asynchrony in cardiac surgery patients before (PRE) and after cardiopulmonary bypass surgery (POST)
2. investigate whether a modification of usual pacing practices (RA-LV pacing) can achieve inter- and intra-ventricular synchrony and improve heart function, as evaluated by hemodynamic and echocardiographic indexes, when compared with the patient's native rhythm (normal sinus rhythm (SR), or conventional pacing modes


Eligibility Criteria:
Inclusion Criteria:

* scheduled for cardiac surgery, in normal sinus rhythm

Exclusion Criteria:

* atrial fibrillation, abnormal hearth rhythms
Melatonin and Salt on Blood Vessel Function

Increased dietary sodium causes increases in oxidative stress and damages blood vessels. Americans eat more than the recommended amount of sodium. Melatonin is a powerful endogenous antioxidant that has reduced oxidative stress levels in clinical and healthy populations. This study will investigate whether melatonin can attenuate the negative effects of sodium on blood vessels.

Americans consume on average double the recommended amount of sodium established by organizations such as the American Heart Association and the Dietary Guidelines for Americans. Excess dietary sodium damages the inside of our blood vessels in a process known as endothelial dysfunction. This reduces the ability of blood vessels to dilate as much. This type of dysfunction can lead to the development of cardiovascular disease. Animal and human studies have identified one potential mechanism linking high sodium consumption and endothelial dysfunction; that is oxidative stress. Furthermore, high dietary sodium consumption has been shown to increase blood pressure reactivity in animal studies. Melatonin is a powerful endogenous antioxidant that has reduced oxidative stress levels in clinical and healthy populations. Melatonin has been shown to attenuate sympathetic responses, but research is limited. Whether supplementation of melatonin can offset the deleterious effects of a high sodium diet is unknown. Thus, the purpose of this study is to investigate the effect of melatonin supplementation compared to a placebo on markers of oxidative stress and blood vessel function in healthy young adults that consume a 10-day high sodium diet. Our hypotheses are that: 1) melatonin will reduce oxidative stress levels and restore blood vessel function and 2) melatonin will reduce the sympathetic nerve response to high sodium consumption.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normal blood pressure

Exclusion Criteria:

* hypertension
* heart disease
* diabetes
* kidney disease
* renal impairment
* cancer
* obese (BMI ≥30)
* sleep disorder
* use of tobacco products
* pregnant or breastfeeding
* take any medications for the above conditions
* endurance trained athletes
* night shift worker
* melatonin or antioxidant consumption for the previous 3 months
* use of selective serotonin reuptake inhibitors
A Study of RO6926496 in Healthy Volunteers

This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history
* A body mass index between 18 and 30 kg/m2
* Male subjects and their partners of childbearing potential must agree to use 2 methods of contraception, one of which must be a barrier method for the duration of the study

Exclusion Criteria:

* Positive hepatitis B, hepatitis C, or HIV infection
* History of any clinically significant disease or disorder
* Clinically significant abnormalities in laboratory test results
* Participation in an investigational drug or device study within 90 days prior to screening
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* History or presence of clinically significant ECG abnormalities
* Smokers who smoke more than 10 cigarettes daily or equivalent and unable or unwilling not to smoke during the in-clinic period
* Any clinically relevant history of hypersensitivity or allergic reactions
* Any familial history of early onset Alzheimer's disease