cyrilzakka/clinical-trials huggingface dataset:
Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer

The purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate, functional outcomes and quality of life.

This study is a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 80 years; (2) Histologically confirmed rectal adenocarcinoma；(3) Performance status (ECOG) 0-2; (4) Undergoing/scheduled for neoadjuvant chemoradiotherapy lasting at least 4 weeks. (5) Fried frailty score ≥2. Patients operated as emergency, pregnant or with comodities constraining physical exercise or causing disturbance of consciousness are excluded.

All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care. All patients were treated with an ERAS protocol. The primary end-point is postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated. The secondary end-points were functional walking capacity, hospital length of stay, nutrition status, patient-reported health related quality of life and immune function markers. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal cancer undergoing/scheduled for neoadjuvant chemoradiotherapy
* Fried Frailty score≥2 (intermediately frail or frail)
* Written consent informed

Exclusion Criteria:

* Co-morbiditie contraindicating physical exercise or causing disturbances of conciousness (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
* Emergent surgery
* ASA grade IV-V
* Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
* Known drug abuse/ alcohol abuse
Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function

The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.

To comprehensively evaluate the effect of an AFO on ambulatory function and loading in hemiplegic gait. This study is addressing important questions regarding the effect of an AFO on gait and introduces technology for quantifiable objective assessment of AFO effectiveness. It will attempt to identify if AFO wear compliance increases community ambulation and walking efficiency bilaterally. Research is needed to fully understand how compliance affects mobility outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 75
* Have sustained a stroke at least 6 months prior to study enrollment
* Use a prescribed custom brace while walking
* Have no history of injury, orthopedic or other medical problem in the normal leg
* Be able to walk independently or with close supervision for 25 feet without a brace or cane
* Wear shoes sizes 5 1/2 - 11 US womens or size 6-13 US mens

Exclusion Criteria:

* Orthopedic problems or history that will interfere with walking or limit the range of motion of legs
* Neurological illness, history, or conditions that my interfere with walking except for stroke
* Psychiatric conditions or history that would interfere with the ability to walk or follow directions
* Serious lung or heart condition that could severely limit the ability to walk
A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).


Eligibility Criteria:
Inclusion Criteria:

Individuals eligible for enrollment into this study are male and female adult patients who:

* Are 18 to 75 years of age
* Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
* Are able to provide written informed consent.

Exclusion Criteria:

Individuals not eligible to be enrolled into the study are those who:

* Have a major medical problem
* Have previously participated in a CORLUX (C-1073, mifepristone) clinical trial
* Have a history of an allergic reaction to CORLUX (C-1073, mifepristone).
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years or older
* Complicated skin and skin structure infection (cSSTI)
* Infection of sufficient severity to warrant hospitalization
* Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy

Exclusion Criteria:

* Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug
* Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
* Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
* Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
* Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
Genetics of Coronary Artery Disease in Alaskan Natives (GOCADAN)

To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native Alaskans who are members of approximately 40 families.

BACKGROUND:

There are many compelling reasons to study heart disease in the Native Alaskans. These Eskimo villages are remote and isolated. The traditional lifestyle is being eroded by mechanization and a westernized diet. There has been relatively little outside genetic influence and they are, like the American Indians of the lower 48 states, beginning to show a marked acceleration in the prevalence of atherosclerosis and coronary artery disease.

DESIGN NARRATIVE:

The study is a family-based, cross sectional study. Recognized and emerging risk factors and prevalent cardiovascular disease are documented in each individual through a standardized interview, physical exam, laboratory measurements, carotid ultrasound, ECG, and a review of centralized medical records. Assays will be made of contemporary samples and serum specimens stored at the Anchorage Center CDC antedating this study (10 to 20 years ago) for specific markers of inflammation and serologic responses. Through a ten-centimorgan genetic map, attempts will be made to find specific genes that relate to cardiovascular disease.

The study uses standard methods to assess risk factors relating to lipid metabolism, hypertension, and diabetes mellitus. Importantly, the study also uses state-of-the-art methods for detection of infectious disease exposure, specifically to C. pneumoniae, cytomegalovirus, and other infectious agents hypothesized to play a role in atherogenesis. A case-control age-matched design is used to analyze the infectious disease burden.

Eligibility Criteria:
No eligibility criteria
Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness

Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. A threshold value of 12% allowed discrimination between responders and nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is already used to measure cardiac output. The primary endpoint of this study is to determine the predictive value of the respiratory variability in aortic blood velocity measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint is to compare maximum velocity and velocity time integral measured by suprasternal and transthoracic view.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* American Society of Anesthesiologists (ASA) score 1 or 2
* General Anesthesia with mechanical ventilation
* General Surgery

Exclusion Criteria:

* Arrhythmia
* Spontaneous breathing activity
* Significant valvular disease
Immunologic Effects of Echinacea

The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 21-65 years old
* If female of child-bearing potential, willing to use contraception to prevent pregnancy
* Speaks and reads English
* No use of any medication (other than multivitamins, essential fatty acids or probiotics)
* Willing to abstain from ingesting edible mushrooms throughout study
* Willing to eat less than 2 garlic cloves per day throughout study

Exclusion Criteria:

* Positive pregnancy test or currently breastfeeding
* History of autoimmune disease
* History of allergic rhinitis
* History of physician diagnosed eczema
* Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus)
* Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A
Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females

Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to premenopausal females and age-matched males. Current exercise guidelines appear inadequate to ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic nitrate supplementation enhances both exercise performance and CVD risk profile in several clinical conditions. However, the effects of this intervention in post-menopausal females is unexplored.

The purpose of this study is to determine whether acute inorganic nitrate supplementation and exercising at different exercise intensities (high vs moderate) improve vascular health in post-menopausal females.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal female, defined as having not had a menstrual cycle for at least 1 year
* Greater than age 45 but less than age 75
* Sedentary (does not exercise regularly)
* No major changes in medication in the last 3 months

Exclusion Criteria:

* Smokers within last 5 years
* Weight unstable (loss/gain of more than 3kg in the past 3 months)
* Any medical condition that prevents the subject from exercising safely
* Hormone replacement therapy (current or within last 3 months)
* Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
* Hysterectomy or oophorectomy
Influence of Non-steroidal Anti-inflammatory Drugs (NSAID) on Muscle Regeneration

The purpose of this study is to determine the influence of non-steroidal anti-inflammatory drugs (NSAIDs) on muscle regeneration.

The investigators' hypothesis is that ingestion of NSAID will delay or impair muscle regeneration.

The model employed to induce muscle damage is electrical stimulation. Muscle biopsies will be examined to follow the response of satellite cells and muscle regeneration. Study participants will be randomly assigned to a placebo or NSAID group in a double-blinded manner.

Eligibility Criteria:
Inclusion Criteria:

* male
* healthy
* does not exercise regularly

Exclusion Criteria:

* displays contraindications for taking NSAID
* well-trained
Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux

Elderly is often associated with social, physiological and psychic changes. However, no study has examined accidental poisoning-induced changes.

The objective of the study is to identify and analyze the various causes of potentially toxic accidental exposure of the elderly to determine preventable causes and propose prevention strategies.

Elderly is often associated with social, physiological and psychic changes. Many studies tried to demonstrate their influence in the genesis of pathological events such as falls or suicide of the elderly but none on the genesis of accidental poisoning.

However, poisoning in this age group is frequent and sometimes severe. In order to improve care of the elderly, it seems necessary to focus on potential toxic accidental exposure.

For this, Poison Control Centre of the University Hospital of Bordeaux has identified the causes over a period of 5 months (from 01 March to 31 July 2017) from calls to the centre.

Eligibility Criteria:
Inclusion Criteria:

* All subjects aged 65 and over,
* Victims of accidental exposure regardless of the agent (drug, household product, plant ...)
* Victims of voluntary exposure (out of suicidal behavior)
* And for which a call (notice, report) to the Poison Control Centre of Bordeaux has been recorded.
* Calling dates between March 1st and July 31st, even if the exhibition is prior to March 1st, 2017).

Exclusion Criteria:

* Suicide
* Calls for inquiries
Xylitol for Caries Prevention in Inner-City Children

The purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.

This is a two group, 30 month randomized controlled clinical trial to assess, in conjunction with other primary preventive modalities, the use of xylitol gummy bears as snack food during school hours to reduce dental caries among children attending Kindergarten at the time of recruitment.

Classrooms in five elementary schools were randomized to receive xylitol gummy bears or the control sugar-free (fiber) gummy bears. All gummy bears were formulated to be similar in size, consistency, color, and sweetness. They were in six bright colors attractive to children, and in strawberry and cherry flavors which are popular among children. Children were encouraged to chew the gummy bears slowly to maximize the xylitol exposure time in the mouth. The children received xylitol or placebo gummy bears throughout the 9 month kindergarten year, 3 times/day within the supervised school environment.

In addition to gummy bears, all participating children received oral health education, tooth brushing and fluoridated toothpaste, topical fluoride varnish treatment, and dental sealants when the first permanent molars have completely erupted. This design allows for the comparison between the current best recommended public heath practices and the addition of the new strategy, xylitol gummy bear snacks. Children were enrolled in kindergarten and followed until the middle of 2nd grade.

Eligibility Criteria:
Inclusion Criteria:

* attending kindergarten in one of the participating schools
* must have parental permission

Exclusion Criteria:

* children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.)
* children with strict dietary restriction (ex. Diabetes)
Feasibility Study of Uterine Transplantation from Living Donors in Terms of Efficacy and Safety in Patients with Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)

In France, one in 4500 women is affected by the MayerRokitantskyKüsterHauser (MRKH) syndrome which is characterized by the absence of uterus at birth. Currently, the only solutions for these patients are:

* Gestational surrogacy, prohibited in France
* Adoption
* Resignation

Uterine transplantation could become a good alternative.

This study is conducted in 10 patients with MRKH type I syndrome, who will be transplanted from a living donor uterus

The aim of the study is to obtain a pregnancy after uterine transplantation from a living donor. Also, this study will assess (anatomically and functionally) the issue of the transplants of a uterus taken from a living donor and the safety of the living donor (functionally and psychologically)

Eligibility Criteria:
Inclusion Criteria:

Graft recipient is a patient with Mayer-Rokitansky-Küster-Hauser Type I Uterine Vaginal Agenesis (without renal, cardiac and bone malformations):

* Being aged between 18 and 38 years old
* In stable couple, with a pregnancy project, favorable psychological evaluation
* No history of cancer and transfusion

The living donor is a woman related to the Graft recipient with

* Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology)
* Absence of uterine surgery, abdomino-pelvic major pathology history

Exclusion Criteria:

Graft recipient:

* Extreme oligo-astheno-spermia and azoospermia in the husband
* History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis

Living donor :

* Known thromboembolic risk factor
* No Compatibility with the recipient (group, rhesus, HLA)
ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome

Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high risk of developing Type 2 Diabetes and cardiovascular disease.

Dietary fibers have been shown to have positive effects on the components of MetS. The investigators have special interest in the combination of two types of fiber (Resistant (RS) starch and Arabinoxylans (AX)) .

Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and markers of inflammation.

The subjects undergo two dietary interventions of 4 weeks duration each: A "Healthy Carbohydrate Diet" with a high content of RS and AX is compared to a "Western Style Diet" with a low content of RS and AX.

Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, dyslipidemia, hypertension and impaired glucose tolerance. Subjects with MetS have high risk of developing Type 2 Diabetes and CVD.

Resistant Starch (RS) and Arabinoxylans (AX) are dietary fibers that have been shown to have positive effects on the components of MetS. The combination of RS and AX has not been tested before .

Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases postprandial lipaemia, improves glucose tolerance, insulin resistance, blood pressure and markers of inflammation.

Design:

A nonblinded randomized cross over study Two dietary interventions of 4 weeks duration each. A healthy carbohydrate Diet with a high content of RS and AX is compared to a Western Style diet with a low content of RS and AX. Between the two interventions, there is a wash out period of 4 weeks.

The primary outcome is postprandial lipaemia estimated by a high fat meal test of 6 hours duration. The test is performed before and after each intervention.

Secondary outcomes are:

* Glucose tolerance and insulin resistance estimated by OGTT
* 24 hours blood pressure
* MRI estimation of liver fat content
* Postprandial changes in genes of adipose tissue

Eligibility Criteria:
Inclusion Criteria: At least 3 out of the 5 following criterions

* Central obesity (Female \>80 cm, Male \>94)
* HDL cholesterol (female \< 1,03 mmol/l, male \< 1,29 mmol/l)
* Blood Pressure (\> 130/85)
* Fasting Blood Glucose \> 5,6 mmol/L

Exclusion Criteria:

* Diabetes
* Gastrointestinal disease
* Anticoagulation treatment
* Serious liver, heart or kidney disease
* Anaemia
* Corticosteroid treatment
* Waist circumference above 130 cm
* Alcohol or drug addiction
* Pregnancy og lactation