cyrilzakka/clinical-trials huggingface dataset:
Vitamin D and Sexual Health

Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the United States (US): 23% of white women versus. 52% of black women have BV. The investigators hypothesize that inadequate vitamin D contributes to BV development and/or recurrence. Vitamin D is essential to immune function, serving both to stimulate mechanisms associated with pathogen elimination and to regulate immune response. According to nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two recent analyses, low vitamin D was associated with higher BV prevalence in pregnant African-Americans; a third replicated this finding in pregnant African-American and white women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a public sexually transmitted disease (STD) clinic. This small (n=150), two-arm, placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform the development of future large-scale RCT design and implementation.


Eligibility Criteria:
Inclusion Criteria:

* speak English;
* be between 18 and 50 years old, inclusive;
* be pre-menopausal;
* have at least one ovary;
* be positive for bacterial vaginosis

Exclusion Criteria:

* pregnant at enrollment or in the previous 3 months;
* planning to become pregnant in the next six months;
* currently breastfeeding;
* currently be menstruating heavily;
* have a contraindication to oral metronidazole treatment
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)

Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy children aged from 4 to 7 years
* No history of spontaneous pain or swelling
* No signs or symptoms of irreversible pulpits or loss of vitality
* Absence of radicular or priapical lesions.
* Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars.

Exclusion Criteria:

* Children with systemic disease
* Presence of priapical lesions
Effects of Mode of Contraction on Neuromuscular Fatigue

Aging is associated with multiple deteriorations of the neuromuscular system. Given the increase in life expectancy, the investigators can now distinguish old adults (\>60 years old) who conserve their neuromuscular capacities with regular physical activity and very old adults (\>80 years old) who suffer from an inexorable decline, even if the number of octogenarians and their quality of life are progressively increasing. However, the most part of the literature on fatigue and neuromuscular capacity with aging focused on isometric tasks. The results showed a significant decrease in maximal force production capacity and a greater resistance to fatigue for old people compared to the young population. When fatigue is induced trough dynamic contractions, greater fatigability was observed in old adults compared to young adults. Investigations performed on the population aged over 80 years old are rare, showing greater fatigability in octogenarians than old men (aged 60-80 years old) during isometric tasks. The knowledge about the effects of dynamic contractions in this population are limited, and performed uniquely in single leg isokinetic mode. Evaluations that require the use of both legs and higher muscle mass involved in the task (cycloergometer) are needed. Understanding neuromuscular fatigue and fatigability across different exercise modalities is necessary to set adapted physical activity programs aimed to maintain autonomy in older individuals.


Eligibility Criteria:
Inclusion Criteria:

* Belong to a defined age group: young (18 to 35 years old inclusive), old (60 to 80 years old inclusive) and very old (81 to 95 years old inclusive),
* Signed written consent form
* Being affiliated to social security

Exclusion Criteria:

* Pathology or surgery resulting in a locomotor disorder, within 6 months prior to the study,
* Chronic neurological, motor or psychological pathologies
* Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) for the duration of the study.
* Contraindication to magnetic stimulation:
* Cardiac or respiratory insufficiency.
* Cardiac pacemaker.
* Cardiac valve wear and serious cardiovascular diseases.
* Presence of prosthetic material or ferromagnetic foreign bodies in the head.
* Presence of cochlear implants or ocular prosthetic material.
* History of neurosurgical interventions.
* Neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumour, multiple sclerosis, history of stroke or traumatic brain injury).
* History of comitiality, contralateral knee pathology or pathology of the musculoskeletal system.
* Mini Mental State Examination \< 20
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old

The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.

The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.

Guidelines for treatment of acute pyelonephritis in infants and children are different from one country to another. The main question is the incidence of renal scars.

intravenous route (IV) treatment is supposed to give the best results, but no previous study has ever given the incidence of renal scars after PO treatment.

This multicenter, randomised trial is an equivalence study of PO and intravenous route (IV) treatments.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children more than 1 month old and less than 3 years old
* First episode of acute pyelonephritis with gram negative strains
* Fever more than 38.5°C
* Procalcitonin (PCT) value \> 0.5 ng/ml
* Urine obtained by transurethral bladder catheterization, suprapubic aspiration or midstream collection
* Urine exam: more than 100.000 leukocytes and gram negative strains +
* Normal hemodynamic exam
* Normal renal ultrasonography
* Positive DMSA renal scan for pyelonephritis during the first week after diagnosis
* Parental informed consent

Exclusion Criteria:

* Newborn
* Children more than 3 years old
* Past urine infection
* Septic hemodynamic abnormalities
* Obstructive uropathy and any renal ultrasonography abnormalities
* Allergy to cefixime or ceftriaxone
* Antibiotic during the five previous days
* Gastrointestinal abnormalities able to interfere with antibiotic intake or absorption
* Absence of parental consent
* Social familial difficulties
Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5%
* estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2
* The median UACR of the first morning void urine samples is ≥50 mg/g Cr and \<300 mg/g Cr
* Stable blood pressure(diastolic blood pressure (DBP) \<100 mmHg and stable systolic blood pressure (SBP) \<160 mmHg)

Exclusion Criteria:

* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
* A diagnosis of non-diabetic renal disease.
* A following serum potassium level.

  * eGFR of 30-59mL/min/1.73m2; serum potassium level of \<3.5 or \>4.7 mmol/L,
  * eGFR of ≥60mL/min/1.73m2: serum potassium level of \<3.5 or \>5.0 mmol/L
* symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)\<50mmHg and systolic blood pressure(SBP)\<110mmHg)
* QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes
* New York Heart Association (NYHA) Class III or IV heart failure
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.

The objective of this study is to determine the effectiveness of the Focal-Fusion Bx device at finding clinically relevant prostate cancer.

A multiparametric MRI examination will be carried out prior to study enrollment. Probable cancerous regions (regions of interest, ROI) will be identified, and these ROIs will be used as targets during the biopsy.

Three prostate sampling methods will be conducted in the same session on all patients. These include:

i) Focal-Fusion Bx targeted biopsy ii) Cognitive fusion targeted biopsy and iii) Systematic (untargeted) biopsy. Trans-rectal ultrasound (TRUS) imaging will be conducted with BK Flex Focus Ultrasound system (Analogic Corporation, Peabody, MA).

Primary hypothesis: The technique used to acquire the biopsy samples will impact the proportion of clinically relevant cancers by improving the specificity of detecting clinically significant cancers. It is hypothesized that Focal-Fusion Bx biopsies will diagnose more high risk cancers and fewer low-risk cancers than non-targeted systematic biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Adult male subjects up to 80 years of age
* Candidates for fusion biopsy
* Elevated PSA levels
* MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist)
* Subject is willing and able to read, understand and sign the Informed Consent Form document

Exclusion Criteria:

* Previous treatment for prostate cancer
* Any contraindication to a standard TRUS prostate biopsy procedure
* Refusal to sign the Informed Consent document
Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue

Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at the beginning and end of surgery, were analyzed using high performance liquid chromatography.

Some published studies suggest that the dose of 2g does not supply the minimum inhibitory concentration for principal causal agents of surgical site infection.

To determine the concentration of Cefazolin in adipose tissue of patients undergoing bariatric surgery and to evaluate the relationship between concentrations obtained and body mass index (BMI).


Eligibility Criteria:
Inclusion Criteria:

* body mass index greater than 35 and less than 50kg/m2

Exclusion Criteria:

* Hypotension during surgery with use of vasoactive drugs
* renal disfunction (creatinine \>1.5 mg/dL)
A Family Intervention for Delirium Prevention

To address the feasibility of implementing a randomized, educational intervention to prevent delirium, directed at family members of hospitalized older (70 years of age or older) medical in-patients. Specifically rates of recruitment and acceptance rates of such an intervention to family members will be assessed. An estimate of the effect size of this intervention will also be calculated. This is a pilot study. The investigators hypothesize that this intervention will be feasible and agreeable to family members to perform, with acceptance rates exceeding 80%.

In a recent study in Chile, investigators randomized family members of admitted patients to an educational intervention to prevent delirium. Family members actively participated in a non-pharmacological intervention to prevent delirium. This has not been done in a North American environment, with different cultural and climactic factors.

This study will be a randomized controlled trial (pilot study) involving family members. Family members will be randomized to a control group or an educational intervention. The control group will receive a general brochure, outlining general health information published by the Ministry of Health. The intervention group will receive a specific brochure on details around delirium (what it is and how to prevent it), and then a brief educational session comprising a didactic session and to address any questions. This pilot study will examine the feasibility of doing this kind of intervention in a North American environment. The family-based intervention is similar to what was done in the Chilean study. It involves six elements including the educational session. The five other elements include: 1) family being present for extended periods (at least 5 hours if possible); 2) engaging in conversation with study patients for re-orientation to current time and current events; 3) avoiding sensory deprivation (ensuring hearing or visual aids and dentures are available as needed; 4) providing familiar objects to patients; 5) provision of a clock and calendar to the patient. The intervention brochure is similar to what was provided to family members as part of the original Chilean study (kindly provided to the principal investigator, M. Dasgupta, by the lead author of the Chilean study, Dr. F.T. Martinez).

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years or older
* Residing in the community
* Admitted to a general medical unit at the London Health Sciences center, University Campus
* Having a willing and interested English-speaking family member
* Not delirious on admission
* Able to communicate in English

Exclusion Criteria:

* Terminal condition
* Delirious on admission
* Advanced dementia
* Admission to the ICU (or transfer to the ICU within one week of admission)
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment

Exclusion Criteria:

* History of allergy to any vaccine component
* Prior receipt of a varicella or zoster vaccine
* Ability to defend against infection is suppressed by a medical condition or medication
Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder

The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors (SSRIs).

The study consists of two phases, each lasting a total of four weeks (8 weeks total), with visits at the DCRP every 10 days. If the subject is eligible, they will be asked to return two weeks later for a baseline visit, when they will be randomly assigned, like a flip of a coin, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a placebo is a pill that looks like a study drug but contains no active medication). They will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study.

Neither the subject nor the research staff will know which group the subject is in.

All subjects will be asked to take the study medication in the morning, in addition to their ongoing SSRI treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Meet criteria for current Major Depressive Disorder
* Currently taking an SSRI

Exclusion Criteria:

* Pregnant women
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
* Prior course of MTHF augmentation, or intolerance to MTHF at any dose
* Substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
* Have failed more than 2 adequate antidepressant trials during the current Major Depressive Episode
Clinical Feature and Microbiology Characteristics of Empyema in Children

The study is designed to clarify the clinical characteristics and reversion of children with empyema, observe the effect of streptococcus vaccine application on serotype of streptococcus, and to explore the susceptibility factors of streptococcus empyema in children in China.

Empyema is a major complication of bacterial community-acquired pneumonia in children. And studies have shown that although the incidence of community-acquired pneumonia in children has decreased with the application of pneumococcal conjugate vaccine, the incidence of empyema has increased, which raises the difficulty to disease treatment, and aggravates the financial burden on medical care.

Streptococcus is one of the most common pathogens causing children's empyema. In recent years, although more and more researches are reported on children's community- acquired pneumonia or pleural effusion, the clinical studies on streptococcus pneumoniae empyema are rarely mentioned. Therefore, a multicenter observational study is needed to better understand the clinical characteristics and reversion of children with empyema, observe the effect of streptococcus vaccine application on serotype of streptococcus, and explore the susceptibility factors of streptococcus empyema in children in China. The study mentioned above will contribute to optimize the treatment strategy of streptococcus empyema for the future, and reduce the incidence of children's empyema.

The trial will be completed in 3 years with 100 participants taken from hospitals in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases, China.

Eligibility Criteria:
Inclusion Criteria:

* Age between 1 day to 18 years
* Admitted with diagnosis of pneumonia combined with pleural effusion
* The appearance of thoracic fluid or the results of fluid examination conforms to empyema with at least 1 of the following criteria:

  * Thoracentesis is pus.
  * Thoracic fluid smear observation show bacterial-positive.
  * Thoracic fluid culture test show bacterial-positive.
  * Cell counting of thoracic fluid is more than 10x109/L.

Exclusion Criteria:

* Subjects will be excluded if the thoracic fluids are caused by non-infectious factors, such as cardiovascular, connective tissue disease, tumor or trauma, etc.
Promoting Aerobic Training in Multiple Sclerosis

Multiple sclerosis (MS) is a chronic neurological disease characterized by inflammation and degeneration within the central nervous system. Over the course of the disease, most patients with MS successively accumulate inflammatory lesions and axonal damage with an increasing degree of disability. Thus, pharmacological treatment options are currently adopted to limit inflammation and to decrease the relapse rate, or simply to alleviate symptoms. On the other hand, neurorehabilitation aims to maintain and possibly improve the residual capacities of neurological patients in order to preserve personal and social activities, constituting an important part of quality health care for MS patients. However, to date, there is no definite agreement on which specific exercise therapy program can be considered the most successful in improving activities and participation. Several studies suggest that a training based on voluntary movements produces greater improvements than a passive treatment. Aerobic exercise training has been also shown to have significant neurophysiological effects in different populations. Furtherly, sports activity may increase adherence and motivation, especially in a young population such as the MS community. However, feasibility of sports activity has not been investigated yet and, in general, the potential interest of these approaches for MS patients remains to determine.

This study aims at promoting physical activity in people with MS. Specific objectives are: (i) to evaluate the motor behavioral and neural changes induced by aerobic exercise combined with upper limb motor training based on task-oriented exercises; (ii) to assess the feasibility of leisure time physical activity (e.g. water sports activities) largely involving upper limb function.

Participants will receive task-oriented treatment, but only the experimental group will perform also aerobic training in order to evaluate the effect of aerobic exercise. Moreover, the role of sports activities will be preliminary investigated, by promoting the participation of the included patients to local or national events focusing on adapted aerobic sports specifically involving upper limb function (e.g., water sports such as sailing, windsurfing, canoeing). Clinical measures will be performed before and after interventions.


Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis diagnosis according to McDonald criteria
* relapsing-remitting course
* absence of relapses in the last three months
* an Expanded Disability Status Score (EDSS) ≤ 4

Exclusion Criteria:

* steroid-use, psychiatric disorders or severe cognitive impairment
* acute cardio-respiratory diseases
* magnetic resonance imaging contraindications