cyrilzakka/clinical-trials huggingface dataset:
Effect of Probiotic on Oral Health of Children

The aim of the randomized, double-blind clinical trial with placebo is to answer the clinical question , or in children with diagnosed childhood early caries the use of L.salivarius and cranberry contained in NutroPharma lozenges will reduce new carious lesions and reduce the titre of the carcinogenic bacteria Streptococcus mutans, compared to the control group in which the placebo will be administered? The main end point will be to reduce the titre of cariogenic bacteria.

Probiotic bacteria are used in the prevention and treatment of gastrointestinal diseases and infections, including the treatment of oral diseases. Probiotic bacteria can be found in saliva, plaque and adhering directly to the mucous membrane. They compete with cariogenic bacteria and pathogens of periodontal disease. Increased interest in probiotics means that attempts are being made to find new solutions regarding the methods of their administration. The use of probiotic bacteria brings beneficial health effects. Lactobacillus salivarius is a strain isolated from human milk. It is inactive (heat treatment) and therefore does not produce metabolites that can promote the formation of carious lesions in the mouth by lowering the mouth potential of hydrogen.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy children aged 3-6;
* recognized caries of early childhood, dmf\> 1,
* lack of active caries and inflammation of the mouth
* colony forming unit CFU \> 105 / ml Streptococcus mutans
* a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.

Exclusion Criteria:

* chronic diseases and chronically taken medicines in the past,
* planned change of residence during the year,
* age below 3 and above 6 years,
* healthy teeth, dmf = 0,
* colony forming unit CFU \<105 / ml Streptococcus mutans
* Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations
* no toothpaste with fluoride
* using xylitol
* lack of written consent of parents / legal guardians for participation in research.
Intra-operative Pancreatoscopy in Patients With IPMN

To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.

The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection

Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment
2. Diameter of pancreatic main duct \>5mm on pre-operative MRI or CT
3. Written informed consent from patient to participate in the study, including compliance with study procedures

Exclusion Criteria:

1. Contraindication for pancreatoscopy
2. Age: less than 18 years
3. Pregnant women, evaluated per local clinical standard
Combining Behavioral Treatment With Agonist Maintenance - 1

The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.


Eligibility Criteria:
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Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea

The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.


Eligibility Criteria:
Inclusion Criteria:

1. Based upon scoring at the study site, the 3-month 'device on' PSG has a 50% reduction in AHI compared to the 1-week 'device off' PSG AHI OR the 3-month 'device on' PSG AHI \<10
2. Used the Provent device at least 4 hours for at least 5/7 nights per week on average during months 1 and 2 of the three month C009 study
3. The study physician and investigator believe that continued Provent use does not represent a significant safety risk for the patient
4. Patient understands and is willing and able to comply with study requirements

Exclusion Criteria:

1. The patient must continue to not meet all of the exclusion criteria of protocol C009
Relationship Between Foot-ankle Characteristics and Lumbopelvic Control, Balance and Physical Performance

It has been shown that foot and ankle postural disorders can alter the biomechanic of lower extremity and pelvis. This situation can affects balance, postural control and phsical performance of individual adversely. However, it is unknown whether the muscles that control lumbopelvic are affected or not affected. The aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.

A healthy load distribution at the foot depends on the ability of the foot to fulfill both the task of stabilization and mobilization. Studies related foot movement disorders usually focus on subtalar joint. The reason for this is that subtalar joint transmits the rotations which in leg to the foot. One of the deformities affecting the foot and subtalar joint is pes planus. Kosashvili et al. have shown that grade 2 and 3 pes planus can affect the lower limb biomechanical alignment, resulting in an increase in perceived pain associated with the knee, hip and pelvic region. Problems related to foot and ankle can affect the balance of individuals as well as affect the pelvic region. Sung et al. have shown that the postural stability and balance of individuals with pes planus are worse than those without pes planus. Studies showing that foot-ankle postural disorders negatively affect physical fitness and motor performance of individuals are also present. Akaras et al. have stated that the increase in pronation in the hindfoot affects individuals' leap and agility performance negatively. It has shown that leg-related problems can affect upper. However, there is no objective study of ultrasonographic imaging of core muscles in foot-ankle problems. The aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate.
* Be between the ages of 18 and 25
* Being a normal weighted individual with a body mass index from 18.5 to 24.9

Exclusion Criteria:

* Presence of any systemic, locomotive or foot related problem
* Undergone any surgical operation related to the foot
* To have loss of sense, diabetic or peripheral neuropathy
* The presence of any problem with the spine (back pain, scoliosis, past surgeons)
* Presence of any neurological problem
Evaluation of the Impact of a Digital Tool MEDIASCREEN of Preventive Information for Patients on the Knowledge of the Risk of Pressure Sores Acquired During a Hospitalization

The study focuses on the impact of a digital MEDIASCREEN tool on the knowledge, technical know-how and behavioural skills in terms of pressure sores of patients. In addition, the cognitive impact of this type of tool will also be studied in our study population (self-esteem and feeling of personal effectiveness). The objective is to compare the impact of a digital MEDIASCREEN information tool with information tool compared to the usual paper-based prevention materials on knowledge of the risk of hospital-acquired pressure sores.


Eligibility Criteria:
Inclusion Criteria:

* Patient in complete hospitalization in Physical Medicine and Rehabilitation
* Patient affiliated to a social security system
* Patient presenting a low to high risk of pressure ulcer inferior or equal to or equal to 16 on the Norton scale
* Patient having signed his consent

Exclusion Criteria:

* Difficulty understanding and is unable to give free and informed consent
* Pregnant women
* Person deprived of liberty by a judicial or administrative administrative decision
* Major under legal protection by a judicial or administrative decision.
* Person in an emergency situation unable to give their informed consent
The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.

The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.

Prospective, randomized, blinded study-dividing patients into one of two groups: fenoldopam or placebo. The infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.Study time period will be approximately six weeks from the date of surgery. Specifically, the following pre- and post operative laboratory results will be recorded if available: . Basic metabolic panel - pre-op, post op days 1, 2, 3, 4, and 6 weeks

* Serum osmolality, urine osmolality, urine sodium - pre-op, post op days 1, 3
* Glomerular filtration rate - pre-op, post op days 1, 3, and 6 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a solitary kidney and present for a partial nephrectomy
* Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney

Exclusion Criteria:

* History of current renal disease beyond the diagnosis of renal malignancy
* Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty
* History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected
* A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics
Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers

Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* 18 to 55 years of age
* Broca index \>= -20% and \<= +20%
* Written informed consent according to Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs, which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration of during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men

This study is a prospective double blind randomized controlled trial to investigate the effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation in idiopathic oligospermic men .Include patients will take the medicine and placebo in different two case and control groups for 3 month and semen parameters and other variants at the start and end of study.

This is a randomized, double blind; placebo-controlled clinical trial has been started from july 2016 and will continue to july 2016 in Royan institute. The eligible patients who fulfilled the study criteria will be included in the trial.

Study protocol and assays All the patients will have a complete history evaluation and physical examination by the attending urologist who is blinded to the study and enter the study according to inclusion criteria.. semen analysis and hormonal laboratory tests \[Testosterone, Luteinizing hormone (LH) Follicle stimulating hormone(FSH)\] will done in same lab at start of study and 3 month after. Intervention time is 3 month for each patient. semen analysis wil be done according to who laboratory manual for the examination and processing of human semen 5th edition and hormonal tests (LH,FSH,Testosterone) with Elisa method (with score of International Unit). DNA Defragmentation will evaluate with Sperm Chromatin Structure Assay(SCSA) method. semen parameters which will evaluate is the number of normal and abnormal shape sperms, velocity of sperms, volume and viscosity of semen at start and end of the study. medicine and placebo prescribe in 500mg capsules for 3month. red and white Bahman is an effective medicine in male infertility treatment In Iranian Traditional Medicine. at the end of study main aim of the study is evaluation effect of combination of Red and White Bahman retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic . Red Bahman and White bahman ,nutrition ,placebo, smoking and Testosterone,LH,FSH,Concentration,number,sha-pe,of sperm before and after the study is variables of study.

Eligibility Criteria:
Inclusion Criteria:

1. all idiopathic oligospermic patient in range of 20 to 45 years old
2. sperm count under 15 million /ml 3;No history of taking chemical or herbal medicine effective on sperm genesis in last 3 month( like Hormonal drug ,antidepressant ,anti hypertension,cimetidine, cyproteron, sulphasalazine, flutamide, spironolactone, estrogen,opium 4:No history of Varicocele and Obstructive disease 5:;No leukocytospermia

Exclusion Criteria:

Taking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm reducing and increasing agent); 2. ; Increasing BMI \> 30 3. Leukocytospermia 4. varicocele
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18-64 years (both inclusive) at the time of signing informed consent
* Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to study interventions or related products
* Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening
* Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
* History of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response

A research study to measure the effect on CD4 counts of adding to current anti-retroviral regimen raltegravir with or without hyper-immune bovine colostrum.

The primary objective of this study is to measure the effect on CD4+ T cell outcome as measured by the mean time weighted CD4+ T cell count change over 24 weeks of two interventions: (I) cART intensification with raltegravir and (II) cART combined with hyper-immune bovine colostrum in HIV-1 infected individuals who have failed to achieve a CD4+ T cell count greater than 350 cells/µL despite persistent HIV plasma viraemia below 50 copies/mL on cART.

Eligible patients will be randomised to one of four arms. I. Raltegravir + hyper-immune bovine colostrum placebo II. Raltegravir placebo + hyper-immune bovine colostrum III. Raltegravir + hyper-immune bovine colostrum IV. Raltegravir placebo + hyper-immune bovine colostrum placebo

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* Age \>18 years
* Signed informed consent
* Receiving combination ART (cART) for at least 12 months with a stable cART regimen for a minimum of 6 months. A formulation change or modification of dosage schedule is acceptable (for example ritonavir - boosted lopinavir capsules for tablets, abacavir (ABC) or tenofovir (TDF) and lamivudine (3TC) or emtricitabine (FTC) as single agents for ABC/3TC or TDF/FTC fixed dose combinations)
* Two consecutive plasma HIV RNA viral load measurements \<50 (or \<400 copies/mL depending upon lowest level of detection of the local assay) in the 9 months preceding the screening visit. A single isolated HIV RNA viral load \>50 (or \>400) copies/mL will not exclude the patient provided the viral load result \>50 (or 400) copies/mL on therapy follows a previous result \<50 (or 400) copies/mL, and there is a follow-up result \<50 copies/mL at least one week following the \>50 (or 400) copies/mL reading in the absence of a change to any component of the ART regimen.
* CD4+ T cell count \<350 cells/µL throughout the 6 months preceding the screening visit with \<50 cells/µL increase in the last 12 months

Exclusion Criteria:

* Receiving a cART regimen containing an integrase inhibitor
* Anticipated change of cART in the 24 weeks following randomisation
* Participating in study with an investigational compound or device within 30 days of signing informed consent
* Use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. Patients using inhaled or nasal steroids are not excluded
* Pregnant or breastfeeding woman
* Cow's milk allergy
* Concurrent treatment with phenobarbitol, phenytoin or rifampicin.
* A known cause of impaired CD4+ T cell gain: for example, patients with splenomegaly or individuals whose current cART regimen contains both tenofovir and didanosine
Effect of Cardiac Preconditioning Upon the Inotrope Score

preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support

Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ;pharmacologic or Physical) Pharmacological pc may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc ) Ischemic pc includes local ;remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs The liberated mediators have favorable effects not only upon the myocardium But ;it extend to protect other organs against inflammatory activation ;ischemia reperfusion injury Inotropic score IS is already an evident predictor of postoperative cardiac mobidity and mortality

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* valve replacement surgery
* ASA grade 2 or 3

Exclusion Criteria:

* emergency surgery
* - poor general conditions
* impaired hepatic or renal function
* peripheral vascular disease
* patient refusal
Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects

This clinical trial aims to investigate the efficacy of freeze-dried bovine hydroxyapatite/secretome composite application for the management of long bone defects and other bone healing disorders in the lower extremities.

The gold standard for treating bone defect conditions is autologous bone graft (autograft). Autograft promotes bone healing due to its osteoconductive (serving as a foundation that facilitates bone growth), osteoinductive (stimulates progenitor cells), and osteogenesis (acting as a precursor of osteoblasts and osteoclasts) properties. However, donor site morbidity and persisting pain following harvest remains a major problem. Hence, we attempt to investigate the efficacy of other bone substitutes, i.e., bovine hydroxyapatite/secretome composite, to treat long bone defects and other bone healing disorders in the lower extremities.

Bovine hydroxyapatite (BHA) is a xenograft (animal-derived graft) with osteoconductive properties. Simultaneously, the secretome of the mesenchymal stem cells contains cytokines, chemokines, and growth factors, which possess osteoinductive properties. Thus, we hypothesize that the combination (composite) of BHA/secretome (in the form of freeze-dried (FD) BHA/secretome composite) will promote bone healing ability that is equal to autografts while eliminating donor-site morbidity in the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with bone defects (less than 5 cm) in the diaphysis of the long bones of the lower extremities due to trauma and other bone healing disorders
* No history of comorbid diseases
* Willing to be involved in the clinical trial

Exclusion Criteria:

* Patients with bone defects or impaired bone healing caused by tumors, infections, and metabolic diseases
* Suffered from multiple fractures and multitrauma patients
* Loss to follow-up