cyrilzakka/clinical-trials huggingface dataset:
Probiotics and Gut Health

This study evaluates the effects of probiotic consumption on inflammatory outcomes and measures of gut health. Participants will be given yogurt with probiotics for one period and yogurt without probiotics for another, with a break in between. These periods will occur in random order.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ to 25 and less than 35 kg/m\^2
* Increased waist circumference (men: ≥ 94 cm, women: ≥ 80 cm)
* At least one of the metabolic syndrome criteria-
* serum triglycerides: ≥ 150 mg/dL
* HDL cholesterol: ≤ 40 mg/dL in men, ≤ 50 mg/dL in women
* blood pressure: ≥ 130 mmHg systolic or ≥ 85 mmHg diastolic
* fasting plasma glucose ≥ 100 mg/dL

Exclusion Criteria:

* allergy to dairy
* smoking and/or use of tobacco products
* systolic blood pressure ≥ 160 mmHg
* diastolic blood pressure \> 100 mmHg
* fasting glucose ≥ 126 mg/dL
* history of myocardial infarction, cardiovascular disease (CVD), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication)
* use of cholesterol or lipid lowering medications
* use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods)
* refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics
* clinical diagnosis of inflammatory bowel disease (IBD) e.g. Chron's disease or ulcerative colitis
* Use of antibiotics within the last 2 months
* excessive alcohol consumption (≥ 14 standard drinks per week)
* regular use of anti-inflammatory medications (e.g. aspirin, ibuprofen)
Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions

Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male subjects aged 20- 30 years old (both ages included).
* BMI within the range 20-25 kg/m2 (both inclusive).
* Height within the range 1.60-1.75 m (both inclusive) for female subjects and 1.70-1.85 m (both inclusive) for male subjects.
* Monophasic contraceptive method (female subjects only)
* Smoking less than 10 cigarettes/day
* Fluid intake habits falling within one of three designated arms

Exclusion Criteria:

* Pregnant woman (as determined by a pregnancy test) or woman planning to become pregnant during the study; breast-feeding woman.
* Any clinically relevant acute or chronic diseases which could interfere with the subjects' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
* Having participated in a clinical study for the renal diseases or having received any treatment related to the kidneys, cardiovascular disease or to hypertension in the last 12 months.
Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.

OBJECTIVES:

* Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
* Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
* Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.

OUTLINE: This is a dose escalation study.

Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection.

Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignancy expressing GD2, including, but not limited to:

  * Medulloblastoma/primitive neuroectodermal tumor of the CNS
  * Malignant glioma
  * Neuroblastoma
  * Retinoblastoma
  * Ependymoma
  * Sarcoma
  * Melanoma
  * Small cell lung carcinoma
  * Other tumor types must have GD2 expression confirmed by immunohistochemical staining
* Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
* Prior measurable human anti-mouse monoclonal antibody titer allowed

PATIENT CHARACTERISTICS:

Age:

* 3 and over

Performance status:

* Not specified

Life expectancy:

* At least 2 months

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 50,000/mm\^3

Hepatic:

* Bilirubin less than 3 mg/dL

Renal:

* Creatinine less than 2 mg/dL
* Blood urea nitrogen less than 30 mg/dL

Other:

* May have active malignancy outside the central nervous system
* No obstructive hydrocephalus
* No CNS grade 3 or 4 toxicity as a consequence of prior treatments
* No life threatening infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior monoclonal antibody treatment allowed

Chemotherapy:

* Prior chemotherapy allowed
* Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy allowed
* At least 6 weeks since prior cranial or spinal irradiation

Surgery:

* Not specified
TORQ Clinical Study

The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.


Eligibility Criteria:
Inclusion Criteria:

* Referred for elective cardiac surgery at St Paul's Hospital
* Expected to live greater than 12 months
* Capable of giving written informed consent
* Willing to participate in follow-up
* Greater than 18 years of age, and of legal age of consent in host country

Exclusion Criteria:

* Patient has had previous median sternotomy, requiring redo sternotomy
* Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique)
* Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)
Inhalation of Sevoflurane Versus Intravenous Midazolam,Ketamine,Propofol For Pediatrics Undergoing Upper GI Endoscopy

In the field of pediatric gastroenterology, upper gastrointestinal endoscopy has established itself as a diagnostic and therapeutic tool. In order to increase patient tolerance during this procedure, deep sedation is essential. Children are at a higher risk of serious adverse effects from procedural sedation; thus, their safety is a primary issue throughout this procedure. Multiple studies have been done to find the ideal method for procedural sedation in terms of ease of administration, quality, safety of sedation and recovery profile, but the consensus seems lacking. In this study we will compare between nasal inhalation of sevoflurane versus intravenous ketamine, midazolam and propofol for pediatrics undergoing upper gastrointestinal endoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. A consent from the parents or 1st degree relative.
2. Both sexes.
3. Pediatric patients aged 1year to 4 years old undergoing
4. elective upper GI endoscopy.
5. ASA class I \&II.
6. BMI between 5th percentile and the 85th percentile (http://www.kidshealth.org).

Exclusion Criteria:

1. Hypersensitivity to drugs included in the study.
2. Difficult airway or known airway problems.
3. Active bleeding from esophageal varices.
4. Respiratory and cardiac problems.
5. Neurological disorders
PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock

This study evaluates PK/PD of an extended-infusion protocol of meropenem, piperacillin-tazobactam and cefepime, in the early phase of septic shock.

Beta Lactams are the keystones of shock septic treatment. Early phase of septic shock is a period of disturbed pharmacokinetics, with augmented renal clearance and distribution volume of hydrophilic drugs as Beta Lactams. Consequently, early phase of septic shock is a period at risk of underdosing Beta Lactam, which could increase the risk of clinical failure an mortality.

Data are available concerning underdosing of MEROPENEM, PIPERACILLIN-TAZOBACTAM and CEFEPIME, when administered in bolus.

No data exist concerning the achievement of a target of 100% of the whole interval above 4 time the superior breakpoint of Pseudomonas Aeruginosa according to EUCAST (European Committee on Antimicrobial Susceptibility Testing), during the 48 first hours of treatment of septic shock, when Beta Lactam are administered in extended infusion.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock
* Meropenem, piperacillin-tazobactam or cefepime started after enrollment

Exclusion Criteria:

* Pregnancy
* Central nervous system infection
* Burns
Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

This prospective pilot study will compare adolescents with restrictive anorexia nervosa who participated for 3 months at olfactory workshops, patients who did not, and healthy patients.The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

The restrictive anorexia nervosa (AN) in adolescents is an eating disorder with decreased desire to eat (wanting) following olfactory stimulation. Oxytocin is an hormone involved in the neuromodulation of eating behavior, but also involved in olfactory perception in schizophrenia patients, and in social cognition in patients with autism. Its plasma level was found low in anorexic patients compared to control subjects.

Because of the similarity in disorders of social cognition between these three diseases, we assume that the desire to eat evoked by olfactory perception varies with the plasma oxytocin levels.

With a prospective pilot study we will compare patients with AN who participated for 3 months at olfactory workshops, AN patients who did not, and healthy patients.

The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

One application of this study will be the use of ocytocyne nasal spray to increase the eating desire and to allow weight regain

Eligibility Criteria:
Inclusion Criteria:

* Medical-Review
* Female or male -Sexe,
* 11 to 18 years
* Anorexia nervosa diagnosed according to the criteria DSM V
* Outpatient care or hospitalization
* Be able to answer the clinicals evaluations questionnaires
* Affiliated to social security
* Consentement of the legal representative and the patient

Exclusion Criteria:

* Somatic comorbidity associated with diabetes, celiac disease, brain tumor
* Intolerance odors, predisposed to develop asthma and / or respiratory allergies Pathologie chronic rhino-sinus
* Hyposmiques or anosmic
* Patients not of an inclusion criteria
Comparison of Proprioception for HTO (High Tibial Osteotomy) and UKA (Unicompartmantal Knee Arthroplasty)

Osteoarthritis of the knee (KOA), a common degenerative joint disease, affects a significant part of the world's population. Although it can hold all the compartments in the knee joint, isolated medial compartment involvement has been reported in about 85% of individuals diagnosed with KOA.

In the management of degenerative medial gonarthrosis; symptomatic relief and provide orthopaedic surgeons with the aim to slow down the progression of Total Knee Arthroplasty (TKA) unikompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) is used. In recent years, HTO and UKA have been preferred more frequently among these surgical methods due to a number of advantages they provide for patients.

As a result of the orthopedic surgeries performed, interventions are made on bone and joint structures and problems may occur in the proprioceptive inputs provided by the body. In UKA, a new joint structure is created by changing the bone structure and removing the tibial plateau, while in HTO, the existing bone structure is preserved and a positional change is created. Thus, while it is expected that the proprioceptive response to be different between the two surgeries, no studies have been found in the literature on this issue. Accordingly, the purpose of this study is to compare the effects of HTO and UKA surgeries applied to individuals diagnosed with medial gonarthrosis on the proprioception of patients and to examine the effects of HTO and UKA surgeries on patients diagnosed with medial gonarthrosis.

H0: There is no difference between the surgical methods applied when the proprioception of patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis is considered.

H1: There is a difference between the surgical methods applied when the proprioception of patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis are considered.

Volunteer participants who have been diagnosed with medial gonarthrosis and have varus deformity and have undergone surgery will be included. The surgical groups will be divided into two categories: HTO and UKA. Evaluations of the participants in terms of proprioception will be made. A voluntary consent form will be obtained from the participants.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery at the age of 50-65
* Performing unilateral UKA or HTO surgery
* Moderate medial knee arthrosis on pre-op X-ray
* Presence of mild varus deformity in the pre-op period
* Should be BMI\<30

Exclusion Criteria:

* Regular exercise at least 3 days a week, 150 minutes, moderate intensity
* Having undergone revision surgery
* The presence of any other orthopedic problems/problems and surgery
* Concomitant of a common rheumatological disease
* Presence of neurological problems/problems
* Having visual and auditory problems at a level that prevents communication
Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes

This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.

The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for more than 12 months
* Current treatment: Basal-bolus insulin regimen for more than three months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal)
* HbA1c (glycosylated haemoglobin A1c) between 7.0 and 11.0%
* Able and willing to maintain consistent physical activity level throughout the entire study period
* Able and willing to maintain consistent eating habits throughout the entire study period

Exclusion Criteria:

* Proliferative retinopathy that has required acute treatment within the last six months
* Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
* Liver, kidney or heart problems as judged by the Investigator
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
The Effects of Progressive Core Stabilization Exercise Training

A study to investigate the effects of 6 week-core stability training on adolescent volleyball players

Aim: The purpose of this study is to reveal effectiveness of 6-week progressive core stabilization exercise training on muscle strength, endurance, and balance in adolescent female volleyball players.

Method: Adolescent female volleyball players will be divided into study and control groups. Both groups will continue their routine ball training (30 times/day, totally 6-week), the SG will also participate in progressive core stabilization exercise training (45 min/session, 3 times/week, totally 6-week). Core muscle endurance (sit-ups test, lateral bridge test and Biering Sorenson Test), isokinetic muscle strength test of gluteus medius (Biodex 3 dynamometer in 1800/s, 2700/s, and 3600/s) and balance (Star Excursion Balance Test) will be evaluated in all players before and after 6-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* female volleyball player aged between 12-14 years
* being trained by the same trainer

Exclusion Criteria:

* having had a lower or upper extremity injury lasting less than 3 months
* having had a back-related operation
* being diagnosed with spondylosis-spondylolisthesis
* having acute low back pain
* lack of family permission or
* not being willingness.
Fall Prevention Study Among Seniors in Bomlo

Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.

Participants randomized to either exercise group or control group. Tests for balance and strength performed by physiotherapist at inclusion, and after three and six months and one year for both groups. Further follow-up and further inclusion of participants had to be terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-85, home-dwellers in Bomlo municipality, capable of following up group-exercize, informed consent.

Exclusion Criteria:

* Serious illness, in need of walking-aid indoors, moderate to severe cognitive impairment
Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection

This study aims to evaluate the efficacy and safety of 14-day quadruple therapy based on fecal molecular antimicrobial susceptibility tests for the first-line eradication of H. pylori infection, thus, providing more evidence to inform the value of fecal antimicrobial susceptibility tests in the first-line treatment of H. pylori infection.

The eradication rate of H. pylori is decreasing year by year due to the occurrence of bacterial resistance, especially clarithromycin, one of the most widely-used antimicrobials against H. pylori. Understanding antibiotic resistance before treatment may be the main determinant of the successful eradication of H. pylori. Nevertheless, due to the invasive examination of sampling, the economy-benefit ratio, and the harsh cultivation conditions, traditional antimicrobial susceptibility test is rarely used before first-line eradication treatment in the real world. As an alternative, faster and simpler molecular methods applied to fecal samples obviate the need for endoscopy and provide the possibility to popularize the antimicrobial susceptibility tests catering to initial treatment. This study aims to explore the efficacy, safety, and economic benefits of the first-line therapy for H. pylori guided by fecal antimicrobial susceptibility tests.

Eligibility Criteria:
Inclusion Criteria:

Participants enrolled should meet the following criteria: (1) Participants aged 18-65 with no history of eradication treatment; (2) diagnosed as H. pylori infection by one or more of the following methodologies: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), the 13C-UBT, and/or fecal antigen; (3) were requested to undergo an endoscopy before the eradication treatment if they have alarm symptoms, a family history of gastric cancer or age over 40 years old without undergoing an endoscopy before; and (4) voluntarily participated in the clinical trial and have signed the informed consent.

Exclusion Criteria:

Potential participants will be screened on the following exclusion criteria: (1) Participants had a history of using antibiotics or bismuth within four weeks or acid inhibitor (including H2 receptor antagonist (H2RA), proton-pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB)) within two weeks before inclusion; (2) had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction; (3) had a history of esophagectomy or gastrectomy; (4) had an allergy to any study drug; (5) were pregnant or breastfeeding; (6) had a history of alcohol abuse or drug addiction; (7) existence of mental illness; or (8) without self-judgment ability.
Evolution of the Profile of Infectious Endocarditis in France in 2008 (EI2008)

Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious (20 % of deaths during hospitalization) disease . Its epidemiological profile was considerably modified these last years.New predisposing factors appeared, due to increasing number of patients wearing valvular prosthetics. The purpose of this study is to realize in 2008 a new observational study on populational basis to describe and analyze the evolution of the epidemiology of IE in France, compared to previous studies conducted in 1991 and 1999.

It is a prospective observational study based on a population of 25 million inhabitants. The cases are recruited over a one year period, from January 1st till December 31st, 2008, in six regions of France (Rhône-Alpes, Paris et Petite Couronne, Lorraine, Franche-Comté, Marne, Languedoc-Roussillon) and in the department of Ille-et-Vilaine. The IE cases are declared by clinicians taking care of the patients, microbiologists and cardiac ultrasonographists.

Eligibility Criteria:
Inclusion Criteria:

* Major Patient
* Supported in one of the participating centers
* The application of diagnostic classification criteria of Duke modified by Li is carried out after collection of all the data at the output of the patient. Will be included in the observatory that patients meeting criteria for definite or possible endocarditis.

  * Affiliated with the French social security regime

Exclusion Criteria:

* Patients not living in one of the studied regions