cyrilzakka/clinical-trials huggingface dataset:
Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children

Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application

Sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows:

* Group I: children will receive oral health education and nano silver fluoride varnish.
* Group II: children will receive oral health education and tri calcium phosphate varnish.
* Group III: children will receive oral health education

for all children ,Assessment of pH, streptococcus mutants count, lactobacillus count and immunoglobulin A will be assessed at baseline, one day , 3 months and 6 months after application

Eligibility Criteria:
Inclusion Criteria:

Visually impaired children

Exclusion Criteria:

* uncooperative children or children not willing to participate in the study.
* Children with systemic diseases
* Children with bronchial asthma.
* Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months
* History of fluoride treatment in the past 3-4 weeks.
MElanoma Research Lymph Node Prediction Implementation National_001

MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines) elected to undergo sentinel lymph node biopsy per the treating physician's recommendation.
* Male or female, age ≥18 years.

Exclusion Criteria:

* Full primary melanoma pathology report unavailable.
* Documented clinically apparent nodal metastases at diagnosis.
* Distant metastatic disease (M1a,b,c,d) clinically present at primary diagnosis
* Any prior or concurrent primary invasive melanoma mapping to the same draining lymph node basin(s).
* Documented history of another (prior or concurrent) primary invasive melanoma of T1b or greater at any site within the last 5 years.
* Previous surgery in or radiation therapy to the draining lymph node basin(s) of the current primary melanoma.
* Ocular, vulvar, perianal or mucosal melanomas or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.
A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea

The purpose of this study is to estimate the cumulative incidence of all adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESI), among participants who have been administered niraparib as per the approved indications.

This is a long-term prospective, observational post-marketing surveillance study of niraparib in participants with ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more lines of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either: BRCA mutation irrespective of platinum sensitivity; or platinum-sensitive HRD positive. The study will assess the safety and effectiveness of niraparib for its approved indication with real-world setting in South Korea.

The study will enroll approximately 600 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

• Participants With Ovarian Cancer

The multi-center study will be conducted in South Korea. Data collection will be based on routinely scheduled and emergency visits during a 24-month surveillance period or until end of the study whichever occurs first after drug administration. The overall duration of the study will be approximately 6 years.

Eligibility Criteria:
Inclusion Criteria:

1. Monotherapy for the maintenance treatment of adult participants with ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
2. Monotherapy for the maintenance treatment of adult participants with recurrent high-grade serous ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in a complete or partial response to 2 or more lines of platinum-based chemotherapy.
3. Monotherapy treatment of adult participants with recurrent ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens with either a) BRCA mutation (irrespective of platinum sensitivity) or b) platinum-sensitive HRD positive.

Exclusion Criteria:

1. Treated with niraparib outside of the locally approved label in Korea.
2. Niraparib is contraindicated as per product label.
3. Participating in other clinical trials of cancer treatment.
Heat Shock Protein 47 in Thrombosis

The goal of this observational study is to learn if the novel biomarker Heat shock protein 47 (HSP47) can be used as a prognostic marker for vascular disease in people with acute venous thromboembolism (VTE), myocardial infarction (AMI) or ischaemic stroke compared to healthy volunteers. The main questions it aims to answer are:

1. Are platelet levels of HSP47 higher in patients with acute VTE, AMI or stroke, compared to healthy volunteers.
2. Does platelet levels of HSP47 remain elevated in patients with acute thrombotic events compared to healthy volunteers at 3 and 12-months of follow-up.
3. Are platelet levels of HSP47 postively associated with platelet function and negatively associated with fibrinolytic capacity in patients with an acute thrombotic event.

Participants with VTE, AMI or stroke will be giving a blood sample at diagnosis and again after 3 and 12 months of follow-up. Healthy volunteers will be giving a blood sample once.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Informed consent

VTE group:

* Deep vein thrombosis confirmed on ultrasonography OR
* Pulmonary embolism confirmed on computed tomography angiography (CTA)

AMI group:

* ST-segment elevation on electrocardiogram (ECG) AND
* Culprit lesion(s) on coronary angiography

Stroke group:

* Stroke confirmed on magnetic resonance imaging AND
* Atrial fibrillation (Detected on ECG, telemtry or Holter monitoring) AND
* Stroke localisation classic for AFib: cortical, cerebellar, brainstem or subcortical \>1.5 cm in diameter

Healthy group:

- Healthy

Exclusion Criteria:

* \<18 years of age
* no informed consent
* Known haematological disorders
* Active haematological malignancy
* Severe renal insufficiency defined as eGFR \<15 or dialysis

VTE - Pulmonary embolism incidentally detected by CTA conducted for purposes unrelated to pulmonary embolism assessment without concomitant DVT

AMI

* Coronary dissection
* Takotsubo cardiomyopathy

Stroke

- Stroke from other causes, e.g. findings pointing towards large vessel disease

Healthy

* Known acute or chronic disease
* Prior VTE, AMI, stroke or other thromboembolic event
Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839

Primary Objective:

To assess the long-term safety of vatelizumab in MS patients

Secondary Objective:

To assess the long-term efficacy of vatelizumab

The maximum study duration per patient will be 192 weeks, including a Treatment Period of 96 weeks and Post-treatment Safety Follow-up Period of 96 weeks.

Eligibility Criteria:
Inclusion criteria:

Patients who completed the 12-week treatment period in DRI13839.

Exclusion criteria:

* Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient's participation in the long-term extension study.
* Confirmed platelet count below the lower limit of normal at any time during DRI13839.
* Pregnancy or breast-feeding.
* Other protocol defined exclusion criteria may apply.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Doxycycline for Helicobacter Pylori Rescue Treatment

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by doxycycline.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* under 18 or over 80 years old
* history of gastrectomy
* pregnant or lactating women
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test

The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect.

The AcuVid COVID-19 Rapid Antigen Saliva Test performance will be compared to a high sensitivity FDA EUA approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) swab results will be collected from subjects by healthcare providers at CLIA Waived COVID-19 Testing Centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers.

This prospective, observational, study will test up to 300 participants to establish the performance characteristics of the AcuVid test on saliva specimens.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing to sign verbal informed consent form.
* Age ≥12 and parents or legal guardians must consent as required by law.
* Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab sample.
* Participant is willing to provide a self-collected saliva sample.

Exclusion Criteria:

* Participant has previously tested positive for COVID-19 within the past 90 days.
Imaging of Traumatic Brain Injury

This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.

It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.

The goal of this study is to identify advanced magnetic resonance imaging markers that can serve as a prognostic marker in the evaluation and management of traumatic brain injury patients.

Magnetic resonance imaging and cognitive testing (when possible) will be performed in the acute (within 10 days following injury), and recovery stages (about 1 month, about 6 months,and about 18 months). The relationship between the advanced magnetic resonance imaging markers and the clinical condition of the patient will be evaluated at each time point to determine which combination of imaging markers best describe the current clinical status of the patient and which markers best predict a patient's outcome status.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status.
* Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments.

Exclusion Criteria:

* History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease.
* History of Stroke
* History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type.
* History of Brain Tumor
* Status post trauma due to asphyxiation
* Preexisting contraindications for Magnetic Resonance Imaging (MRI)
* Active Duty Military Status
* Police custody or prisoner status
* Pregnant women
Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients

Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications. ultrasound-guided continuous sciatic block (CCBN) is strategy effective and safe to consider in this patients.

This prospective descriptive exploratory cohort study evaluates CCBN as a effective therapeutic tools for patients whit (CLI)

Critical limb ischemia is the final stage of peripheral vascular disease identified by resting pain greater than 2 weeks with ulcers or gangrene in 1 or both extremities. Pain relief is a therapeutic challenge due to its severity, which significantly affects the quality of life, and the comorbidities that occur frequently in these patients, which limits the use of analgesics medications. Regional techniques can play an important role as they are safe and effective in analgesic management . Within these we find the ultrasound guided continuous sciatic block as a strategy to consider in the periods of exacerbation of pain, as a bridge to a palliative or resolutive management.

Prospective descriptive exploratory cohort study.

Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids will be included. A continuous ultrasound-guided sciatic nerve block with longitudinal approach will be performed, with no anti-aggregation or anticoagulation suspension, continuing with an infusion of Bupivacaine 0.1%

The primary outcome will be numerical pain rating scale (NPrs) and secondary outcome Pinprick test, catheter duration, opioid consumption reduction and side effects to it.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids

Exclusion Criteria:

* Under 18 years old
Dairy Products to Your Gut and Brain

The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less. Furthermore, the study aims to explore underlying mechanisms linking the gut and the brain.

In addition, a sub-study will be conducted to explore differences in gut and brain measures between women with daily (reference group) and few (intervention group) weekly bowel movements, respectively, and to explore associations between measures of gut- and brain function.

Participants in the intervention study (n=60) will consume 300g of fermented dairy (yogurt) or non-fermented dairy (milk) daily for 4 weeks. After a washout period of at least 4 weeks, the participants will consume the alternative dairy product (yogurt or milk) for 4 weeks. The participants will collect samples at home and be tested at the institute before and after each condition (yogurt or milk).

Participants in the sub-study (n=40) will not undergo any dairy interventions and they will only take part in the baseline assessments.

Prior to all visits at the institute, the participants are asked to complete some study activities at home, including:

* consumption of sweet corns to estimate whole gut transit time
* collection of fecal- and urine samples
* measurement of methane and hydrogen in breath
* reporting of gastrointestinal symptoms, including stool frequency and Bristol Stool Scale

During all visits at the institute, the participants will undergo tests and measurements, including:

* measurement of methane and hydrogen in fasting breath
* collection of fasting blood samples
* completion of cognitive tests
* recordings of electrophysiological signals of the gut and the brain
* completion of questionnaires assessing mood, quality of life, and physical activity, among others

Eligibility Criteria:
Inclusion Criteria:

* Self-reported defecations every second day or less (intervention study only)
* Willing to consume 300g milk/yogurt on a daily basis (intervention study only)
* Owns a smartphone (iOS 11.0 and later or Android 5.0 and up)
* Understand Danish or English

Exclusion Criteria:

* Current pregnancy or lactation
* Dairy allergy or intolerance
* Prior diagnosis of psychiatric or neurological illness
* Current diagnosis of depression, anxiety, or stress
* Prior diagnosis of metabolic or gastrointestinal disease (e.g., cardiovascular disease, diabetes, chronic constipation or diarrhea, inflammatory bowel diseases (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), cancer, etc.)
* Use of antibiotics within the last month
* Use of peroral corticosteroids (inhalers excepted)
* Use of medications that alter normal bowel function and metabolism (e.g., laxatives, antidiarrheal agents, narcotics, diuretics, anticonvulsants, etc.)
* Use of neuroactive medications (e.g., antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinsonian, etc.)
* Concurrent participation in another trial
* Any condition that makes the project responsible researcher doubt the feasibility of the volunteer´s participation
Protein in Feeding Strategies to Accelerate Muscle Recovery From ACL Reconstruction

Musculoskeletal injury, particularly injuries requiring surgical repair, induce significant muscle atrophy, resulting in diminished physical function. The protein turnover-associated (diminished protein synthesis, elevated protein breakdown, negative net muscle protein balance) etiology of injury and surgical-induced atrophy are, in part, similar to those observed with muscle wasting induced by hyper-catabolic and inflammatory conditions and prolonged periods of skeletal muscle disuse (e.g., cachexia and joint immobilization). Combining dietary strategies to optimize the anabolic properties of beef as a high quality protein source that provides essential amino acids prior to surgery and throughout post-surgery rehabilitation may attenuate muscle atrophy and accelerate the restoration of muscle function. This project will examine the efficacy of habitual consumption of a beef-based higher protein meal pattern and post-physical rehabilitation beef protein supplementation throughout post-surgical rehabilitation intervention on skeletal muscle function in response to anterior cruciate ligament (ACL) repair in healthy, physically active adults.

Stable isotope methodologies, proteomic analysis of muscle protein synthesis, and molecular assessments of skeletal muscle atrophy and remodeling will be assessed to evaluate the effects of increased protein intake, including consumption of a high quality beef-based protein supplement following patient physical therapy sessions on:

1. Skeletal muscle protein fractional synthetic rates during and in recovery from surgery;
2. Inflammatory, proteolytic, and anabolic intramuscular signaling during surgery and their association with skeletal muscle protein synthesis and muscle function;
3. Muscle size and functional recovery;
4. Duration to return to routine exercise, sport, or physical activity.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age
* identified as appropriate for study recruitment by their respective orthopedic surgeon
* undergoing their first anterior cruciate ligament (ACL) repair
* undergo ACL reconstruction under general anesthesia
* body mass indexes (BMIs) within normal to overweight ranges

Exclusion Criteria:

* reporting metabolic or cardiovascular abnormalities, food allergies, gastrointestinal disorders (i.e. lactose intolerance)
* use of nutritional/herbal/sports supplements including anabolic steroids, and tobacco products will be excluded from the study
* BMIs above 29.9
Study on the Effectiveness and Safety of VRT in Patients With Visual Field Defects

The goal of this clinical trial is to learn if visual restoration therapy (VRT) (a type of treatment that aims to improve vision) works to the visual rehabilitation of patients with visual field defects. It will also learn about the safety of VRT. The main questions it aims to answer are:

* Can visual reconstruction therapy help expand the visual field in patients with visual field defects?
* What medical problems do patients with visual field defects experience during the procedure of VRT? Researchers will look at how patients with visual field defects who use a visual aid in combination with VRT and those who use a visual aid only, compare the visual field expansion at three months to see how well visual reconstruction therapy works.

Participants will:

* will undergo a specialized visual function assessment and be provided with a pair of appropriate vision aids.
* Visit the clinic at one month and three months after enrolment for review of visual function and completion of a Chinese-version Low Vision Quality of Life (CLVQOL) questionnaire.
* Participants receiving VRT will additionally undergo 30 minutes of VRT three times per week for 3 months.
* Keep a diary for their symptoms and severity and frequency of occurrence during treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with a clear diagnosis of visual field defects.
2. Participants were between 18 and 80 years of age (including borderline values);
3. Participants have been treated for their primary disease and conditions are stable;
4. Participants are not at significant risk of vision loss in the last three months;
5. Participants do not have planned intraocular surgery during the trial period；
6. Participants can understand the trial protocol and sign informed consent.

Exclusion Criteria:

1. Participants diagnosed as blindness;
2. Participants with a previous history of seizures or other psychiatric disorders;
3. Participants with cognitive impairments;
4. Participant's attention span is less than 30 minutes;
5. Participants had conditions such as significant ptosis or severe dry eye;
6. Participants who were in poor general health or who could not cooperate in completing the study protocol for some reasons such as transport.