cyrilzakka/clinical-trials huggingface dataset:
Probiotic Toothpaste to Assess Microbial Colonization

The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults

This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18.

Participants will be randomly assigned to one of 2 groups for brushing teeth with a probiotic toothpaste containing two different doses of Streptococcus salivarius M18 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility Criteria:
Inclusion Criteria:

* In general good health
* Practise good oral hygiene

Exclusion Criteria:-

* Have a history of autoimmune disease or are immunocompromised.
* Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
* History of allergy (e.g. dairy).
Concussion Prevention in Female Soccer Athletes

The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.

This study will investigate the effectiveness of this device in high school athletes playing a non-helmeted sport such as soccer. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. This study will focus on the use and effectiveness of the device solely in females, as male football and hockey players have previously been investigated. All participants will be outfitted with an adhesive patch-like accelerometer (which will be placed behind the ear (Xpatch-X2 Biosystems http://www.x2biosystems.com/x2_x_patch/) which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined via differences in longitudinal brain imaging and functional testing following competitive soccer participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. At each of these time points participants will also undergo various neurocognitive assessments

Eligibility Criteria:
Inclusion Criteria:

* Female
* Normal healthy volunteer
* Able to provide written consent
* Must be 14 years or older and a participant on a high school soccer team

Exclusion Criteria:

* Unable to provide written consent
* History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
* Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
* Glaucoma (Narrow Angle or Normal Tension)
* Hydrocephalus
* Recent penetrating brain trauma (within 6 months)
* Known carotid hypersensitivity
* Known increased intracranial pressure
* Central vein thrombosis
* Any known airway obstruction
* Any known seizure disorder
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.

To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks)
* Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen
* Plasma HIV RNA level \> 1000 and \< 30,000 copies/mL on two occasions
* Genotypically documented M184V variant of HIV RT
* Clinically stable HIV status with no AIDS-defining events
* CD4 \> 200 cells/mm3
* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
* All women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of b-HCG) within 72 hours prior to the start of study medication
* No active opportunistic infection requiring treatment
* Subject must be able to provide written informed consent
* Baseline laboratory values measured within 28 days of initiating study drug as follows:
* HGB≥9.0g/dl or HCT≥27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks
* Absolute neutrophil count≥1000 cells/mm(\^3) (in the absence of on-going G-CSF therapy
* Platelet count ≥75,000/mm(\^3)
* AST \<7.0 times the upper limit of normal
* ALT ,7.0 times the upper limit of normal
* Serum creatinine \<1.1 times the upper limit of normal

Exclusion Criteria

* Evidence of active HBV infection as demonstrated by HBsAg positivity
* Hepatitis C co-infection
* Concurrent systemic antiviral treatment
* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
* Alcohol abuse
* Pregnancy or breast-feeding
* Inability to tolerate oral medication
* AST \> 7.0 times the upper limit of normal
* ALT \> 7.0 times the upper limit of normal
* Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
* Use of any other drug or substance with anti-HBV activity
Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects

Once a day oral administration with DCCR is the optimal dosing regimen

POPULATION The population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dL and ≤ 1500 mg/dL at the Screening Visit.

Number of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.

Eligibility Criteria:
Inclusion Criteria:

Basic requirements

1. Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing
2. Body mass index (BMI) between 22 and 35 kg/m2

   Specific laboratory test results
3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL
4. Fasting glucose ≤ 110 mg/dL
5. HbA1c ≤ 6.0 %

Exclusion Criteria:

Medications: recent, current, anticipated

1. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
2. Thiazide diuretics within 2 weeks prior to Screening Visit

   History of allergic reaction or significant intolerance to:
3. Diazoxide
4. Thiazides
5. Sulfonamides

   Lifestyle changes
6. Subjects intending to change exercise habits, and/or quit smoking

   Specific diagnoses, medical conditions and history
7. Known type I or III hyperlipidemia
8. Known type 1 DM
9. Known type 2 DM
10. Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator

    Specific laboratory test results
11. Any relevant biochemical abnormality interfering with the assessments of the investigational drug
Immediate Effects of the HVLA Talocrural Distraction Technique in Soccer Players

This clinical trial aims to evaluate the effect of a high-speed, low-amplitude physiotherapy technique at the ankle level, when performed on amateur soccer players.

In this randomized, single-blind, cross-sectional and prospective clinical trial, the effect on ankle mobility and changes in plantar pressure centers obtained after performing a high-velocity, low-amplitude physiotherapy technique in amateur soccers will be assessed.

Two intervention groups are used; in one of them this treatment will be applied in a real way, and in the other one a simulation will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Men over 18 years old
* Men that played or have played soccer as an amateur or professional on a regular basis
* No previous musculoskeletal history that would contraindicate HLVA techniques (recent fractures, osteosynthesis material placed in the joint, infections...)

Exclusion Criteria:

* Subjects under 18 years old
* Subjects who have suffered musculoskeletal pathology in the lower limb that contraindicates manipulation or who have a medical diagnosis of chronic ankle instability
* Subjects who suffer neurological or cognitive alterations that prevent the understanding of questionnaires or physical tests; and those who have not signed the informed consent documents
Antibiotics in Infancy--Risk Factor for Childhood Asthma

To examine possible relationships between antibiotic use, as determined by prescriptions filled, and asthma in children ages 6 to 7.

BACKGROUND:

Morbidity and mortality from childhood asthma have been increasing in all developed countries over the past three decades, including in the United States. Numerous theories have been advanced to explain this asthma epidemic, but no single theory has held up to careful scrutiny. Recent international studies have suggested a relatively strong causal relationship between increased risk of childhood asthma and exposure to antibiotics during childhood, especially during the first year of life. The increased asthma risk was seen whether antibiotics were used to treat respiratory or non-respiratory infections. While these previous studies are suggestive, there are significant methodologic concerns about each study. A major concern with most of the studies is their reliance on retrospective recall of antibiotic exposure data from parents years after the exposure. The study relied on prospective data from the Childhood Asthma Study.

DESIGN NARRATIVE:

Data were used from the prospective, NIH-funded study of the relationship between early environmental exposures and the development of asthma in a birth cohort of children followed to an average 6.7 years of age. At 6.7 years, 482 (58%) of the original 833 children were clinically examined as part of this Childhood Asthma Study (CAS). In addition to clinical histories, the 6- to 7- year clinical examination included skin tests, IgE antibody tests, pulmonary function tests and methacholine challenge. At entry all of the CAS children were within the Health Alliance Plan (HAP) HMO. The study was based on combining the CAS data set with pharmacy data extracted from the HAP data archives. This allowed an examination of possible relationships between antibiotic use, as determined by prescriptions filled, and asthma at 6 to 7 years of age. While not strictly a prospective study, these methods avoided many of the potential sources of bias found in previous studies. The study was also able to evaluate any relationships between antibiotic exposure and asthma for confounding by other risk factors such as bedroom allergen levels, pet ownership, cigarette smoke exposure, and parental history of asthma or allergy.

Eligibility Criteria:
No eligibility criteria
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to.

The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 to 55 years
* A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)
* Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods
* A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above
* Positive double-blind, placebo-controlled food challenge (DBPCFC) to one of the relevant foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)

Exclusion Criteria:

* Clinically significant laboratory abnormalities at screening.
* Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.
* Poorly controlled or severe asthma/wheezing at screening
* History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation.
* Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening.
* Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.
* Past or current history of eosinophilic gastrointestinal disease within three years of screening.
* Past or current history of cancer, or currently being investigated for possible cancer.
* Past or current history of any food immunotherapy (e.g., oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening.
* Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening.
* Inability to discontinue antihistamines for minimum wash-out periods required for skin prick tests (SPTs) or oral food challenges (OFCs).
* Pregnant or breastfeeding, or intending to become pregnant during the study
* Evidence of clinically significant chronic disease.
Chinese Health Investigation of Nurse Aging

A follow-up intervention for the climacteric symptoms of nurses in Peking

As we all know,hormone replacement therapy (HRT) is the main therapy to climacteric symptoms.But HRT has also some disadvantages including breast cancer,cardiovascular disease and so on, especially long period of HRT. It makes us to find the non-hormone therapy. So we want to investigate the exercise on the effect of climacteric symptoms.Doing exercise is helpful for avoiding and treating many disease,including climacteric symptoms.In our previous research,we found that playing exercise can treat moderate climacteric symptoms.

Eligibility Criteria:
Inclusion Criteria:

* they are nurse ,aged40-55, lived in peking ,who are among perimenopausal women.

Exclusion Criteria:

-
Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Hepatocellular carcinoma (HCC) occurs in 90% of cirrhosis primary liver cancers. In France, 8,500 new cases of HCC occur each year, and about 8,000 deaths per year are related to this cancer. The 5-year survival rate is 10%, one of the lowest survival rates of all cancer types. HCC raises a number of major challenges: HCC is discovered at a curable stage in only 25% of cases, reflecting the marked delay in the diagnosis of early stages. The state of knowledge about HCC is well behind that of other cancers (no biomarker, complex carcinogenesis, influence of the aetiology, poorly valorised data, etc.). Rapid technological progress requires large-scale studies to evaluate new diagnostic and therapeutic modalities.

The CHIEF project constitutes a common basis knowledge for research project using prospectively collected data in patients with HCC, regardless of the cause and stage of the cancer.

This project is a Multicentre longitudinal observational study of patients with HCC with prospective data collection on inclusion and patient follow-up. Constitution of a biological resources collection. 5,000 patients will be included over 2 years with a follow-up of patients of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* New cases of HCC
* suspected case of HCC regardless of the cause, stage, treatment
* Known HCC: drug treatment for recurrence or progression

Exclusion Criteria:

* Associated serious condition threatening life in the short term (with the exception of liver disease itself)
* So-called vulnerable populations: minors, persons under guardianship or temporary guardianship, or person deprived of their liberty by an administrative or judicial decision
Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

The study examines the effect of two diets on fasting and post fat load lipoproteins of subjects with type 2 diabetes with moderate hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female,
* 18 - 75 years of age
* Type 2 diabetes
* Fasting triglycerides 300 -800mg/dL
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.


Eligibility Criteria:
Inclusion Criteria:

1. Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug.
2. Disease Assessments performed within 30 days prior to first dose of maintenance study drug.
3. Written informed consent in accordance with federal, local, and institutional guidelines
4. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of maintenance study drug.
5. Subjects must agree to adhere to the study visit schedule and other study requirements and receive outpatient treatment and laboratory monitoring at the institution that administers the drug.

Exclusion Criteria:

1. Administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug.
2. Pregnant or lactating females
3. Diagnosis of a new malignancy of a different tumor type.
PEMF vs Laser for Stress Urinary Incontinence

Stress urinary incontinence, or involuntary urine leakage during activities like coughing, laughing, or exercise, is a common condition that impacts quality of life for many women. Pelvic floor muscle training is often used to treat stress incontinence, but additional therapies may enhance outcomes. This randomized controlled trial will compare two physical therapy modalities, pulsed electromagnetic field (PEMF) therapy versus laser acupuncture, along with pelvic floor training for improving stress urinary incontinence in 60 adult women. The study will evaluate their effects on pelvic floor muscle strength, severity of urine leakage, and quality of life. We hypothesize that PEMF and laser acupuncture will both improve stress incontinence, but PEMF will be more effective based on greater pelvic floor stimulation. The study aims to provide evidence on these physical therapy options so that optimized treatment plans can be developed for women with stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Adult females aged 18-65 years with stress urinary incontinence
* Able to comply with study procedures and schedule

Exclusion Criteria:

* Prior pelvic floor surgery
* Pregnancy
* Active urinary tract infection
* Pelvic organ prolapse \>Stage 2
* Neurologic disorder affecting urinary function
The Effects of Fragility Fracture Integrated Rehabilitation Management

• To determine the effects of Fragility Fracture Integrated Rehabilitation Management approach in geriatric hip fracture patients (post surgical)

This refers to Fragility Fracture Integrated Rehabilitation Management and will include following comprehensive rehabilitation program including rehab specialist, physiotherapist, occupational therapist and rehab nurse.

Eligibility Criteria:
Inclusion Criteria:

1. Patients above 55 years of age, who underwent hip fracture management NIRM Pakistan due to hip fracture
2. Patient diagnosed with femur neck, intertrochanteric fracture, and sub-trochanteric fracture
3. Patient who got bipolar hemiarthroplasty, total hip replacement arthroplasty, reduction and internal fixation

Exclusion Criteria:

1. Patients who underwent surgery for a cause other than a hip fracture (infection, arthritis, loosening, avascular necrosis)
2. Patients who underwent surgery because of femur shaft fracture, acetabular fracture, periprosthetic fracture pathologic fracture by tumor
3. Isolated fracture of the greater or lesser tuberosity
4. Multiple fracture
5. Revision operation
6. Patients who do not agree to participate in clinical trials
Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:

This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.

Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2

Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)

Eligibility Criteria:
Inclusion Criteria:

1. Age: From 4 to 6 years
2. Caries in primary molars within enamel / dentin without pulp disease

Exclusion Criteria:

1. Presence of signs and symptoms of necrosis
2. Root caries
3. Spontaneous pain