cyrilzakka/clinical-trials huggingface dataset:
In-situ Evaluation of Anti-caries Technology

Three toothpastes will be compared, two toothpastes in each subject, to establish whether changes in the depth or area of an artificially created area of tooth decay is the same for each toothpaste.

Objective is to evaluate the demineralization and remineralization effects of two experimental fluoride containing dentrifices on enamel and root surface lesions compared with a control dentrifice.

Study is a partially randomized, 3-period cross over study involving 30 subjects who need a full-coverage crown on a posterior tooth. Each subject will use each of the study dentrifices over 3 months according to a randomization scheme. Subjects will brush daily with the assigned dentrifice unsupervised. Subjects will each have two provisonal crowns for use during the study. These crowns will contain three hard tooth tissue sections located at interproximal sites. The three tooth tissue slabs will consist of an artificial enamel caries lesion, an artificial root caries lesion, and a sound root. After removal, the tooth slabs will be evaluated using polarized light and photomicrographs for changes in area and depth of lesions.

Eligibility Criteria:
Inclusion Criteria:

* generally good physical health
* at least 18 years old
* needs a full crown on a mandibular first or second molar tooth
* tooth brushing frequency of twice daily or more
* agrees not to participate in other clinical study for duration of this study
* agrees to delay any elective dentistry, including dental prophylaxis, until study complete

Exclusion Criteria:

* any condition requiring antibiotic premedication before a dental procedure
* active treatment for cancer or seizure disorder
* diseases or conditions that could interfere with subject safely completing the study
* currently taking antibiotics or anti-cholinergic medications
* currently using extensive daily fluoride therapy
* gross, visible caries
* chronic use of chlorhexidine within 3 months of baseline
* use of systemic antibiotics within 7 days of baseline
* severe periodontal disease
* use of any fluoride rinses or gels one month prior to study initiation
* pregnancy, the intention to become pregnant
* presence of orthodontic bands or removable retainers
A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.

Participants will be given imvotamab through a vein (i.e., intravenously).

This is a Phase 1b, open-label study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active, refractory, moderate-severe Idiopathic Inflammatory Myopathies. Approximately 5-10 participants will be assigned.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years at the time of signing ICF
* Diagnosis of probable or definite IIM according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for IIM with subgroup classification of either DM, polymyositis (PM), anti-synthetase syndrome, or immune-mediated necrotizing myositis (IMNM).
* Active IIM despite treatment with corticosteroids and at least 1 immunosuppressive or immunomodulatory standard-of-care agent determined at the discretion of the investigator after at least 3 months of treatment.
* If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30 mg/day of prednisone for at least 4 weeks prior to first study treatment

Key Exclusion Criteria:

* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
* Receipt of an investigational therapy less than 12 weeks or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study.
* Has inclusion body myositis or myositis-associated with other connective tissue disease.
Patient Journey in Hospital With Heart Failure in Turkish Population

The purpose of this study is to compose a national database of the etiologies, clinical and demographic characteristics, using diagnostic tests, precipitating and risk factors, management of from intensive care unit or coronary care unit to hospital discharge, length of stay in the intensive care unit and hospital, in-hospital mortality and discharge medications of hospitalized acute heart failure patients in Turkish population.

The etiologies, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted in hospital with acute heart failure in Turkish population will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years olds
* Clinical diagnosis of acute heart failure
* Admitted to the participating hospitals

Exclusion Criteria:

* Patients \<18 years old
* Patients with acute heart failure who are discharged from the emergency room without admission.
* Failure to obtain informed consent
Current Use in Intensive Care Units by Intensivists of Antihypertensive Drugs

Multicenter, prospective and observational study of practices and impacts of the use of antihypertensive therapies in intensive medicine and intensive care

Multicenter, prospective observational cohort study on 200 patients, by doctor's questionnaire on the prescription of antihypertensive drugs in intensive care, follow-up over 72 hours of the prescription.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Admitted to an intensive care unit
* Patient having presented a state of circulatory shock, defined by the need for continuous administration of a vasopressive amine for at least one hour, among: Noradrenaline, Adrenaline
* In whom the introduction of drug treatment for antihypertensive purposes is decided

Exclusion Criteria:

* Patient admitted to intensive care for a hypertensive emergency (hypertensive surge or malignant arterial hypertension leading to organ dysfunction
* Patient who has already received at least one anti-hypertensive drug during his stay in intensive care
* Cerebro-injured patient, proven or suspected cerebral edema, head trauma \<1 month, decrease in cerebral perfusion measured
* Proven or suspected active bleeding
* Patient refusal of participation
Effects of Progressive Elastic Band Resistance Training

Abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity and impairment. The aim of this study was to investigate whether progressive elastic band resistance training can improve physical motor performance and regional body composition in adults with PWS.

Six participants were enrolled in this pilot study. Following 24 weeks of progressive elastic band resistance exercise training, significant reduction was observed in their body weight, BMI, and regional extremities fat mass and percentage. Regarding the functional performances, there were also significant improvements in their hand grip strength, 3 meter timed up and go, 30 seconds sit to stand, and 2-min step up tests, as early as the 8th week of training. Balance function achieved significant improvements after 16 weeks of training.

Eligibility Criteria:
Inclusion Criteria:

* PWS individuals who can cooperate with motor performances

Exclusion Criteria:

* arthritis, fracture, or severe musculoskeletal deformities that would interfere with exercise training or motor performance
* severe cognitive impairment or parents who cannot read nor write.
Family Disclosure in Cascade Testing

Prospective cohort study to evaluate the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members. A pre and post test will be administered to consented patients before and after genetic counseling .

This will be a prospective cohort study to evaluate 1) the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members, 2) utility of the communication tool, and 3) the impact of a patient focused information sheet on the knowledge of genetic testing in women who attend the women's oncology clinic. Genetic counseling is recommended for all women with a diagnosis of ovarian cancer, most patients with pre-menopausal diagnosis of breast cancer, and in younger women with uterine or other gynecologic malignancies. Women with a diagnosis of breast or gynecologic cancer who elect to undergo genetic testing will be approached to participate in this study. If they consent, they will be provided with two information handouts (FORCE sharing worksheets) and family letter template. Participants will complete a baseline knowledge survey prior to receipt of these materials. At a second visit, they will complete the knowledge survey again. Knowledge surveys will be scored and pre and post test scores will be compared with a paired t-test. Feasibility will be assessed by tracking the number of patients approached to participate, the number who sign consents, and the number who complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Diagnosis of breast or gynecologic cancer
* Undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic

Exclusion Criteria:

* Not receiving treatment at UVA
* Not English literate
* Unable to provide consent
* Known pregnancy (self-reported)
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack

When a patient has a heart attack, a blockage occurs in a coronary artery that delivers oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs. IGF-1 is also available as a drug called mecasermin. In this study, heart attack patients will be given either a dose of mecasermin or a placebo (inactive treatment) after their coronary artery has been opened by a stent. The purpose of the study will be to evaluate the safety of the therapy and to test if the therapy will prevent or lessen heart failure by evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight weeks after the heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75
* Presents within 2-12 hours of at least 30 minutes of myocardial ischemic pain
* ECG evidence of myocardial infarction
* Undergoing percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction
* Left ventricular ejection fraction during PCI of 40% or less
* TIMI flow grade 3 in the infarct-related artery following reperfusion and stenting

Exclusion Criteria:

* History of prior myocardial infarction
* Prior history of heart failure, left ventricular dysfunction or cardiomyopathy
* Active or suspected neoplasia
* Known impaired liver function
* Cardiogenic shock
* Estimated glomerular filtration rate \< 45 ml/min/1.73m2
* History of hypoglycaemia requiring hospitalisation
* History of primary insulin-like growth factor-1 deficiency or growth hormone disorders
* Contraindication to cardiac magnetic resonance imaging
* Pregnancy or nursing mothers
* Known allergy to study drug or any of its inactive ingredients
* Treatment with another investigational agent within 30 days of enrolment
* Subjects unable or unwilling to comply with follow-up requirements of study
* Subjects unable to provide written informed consent
A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic Stroke

This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Radiologic assessment confirming an acute middle cerebral artery ischemic stroke
* Index stroke occurred within the past 3-4 days
* Inpatient males and females
* Severe hemiparesis or hemiplegia defined by FMMS score less than or equal to (\</=) 35
* Sufficient speech, vision and hearing to participate in study evaluations

Exclusion Criteria:

* NIHSS greater than (\>) 20
* Severe aphasia that prevents a participant from following directions in rehabilitation
* Significant deficit from prior strokes or pre-existing motor deficit
* History of epilepsy, neurosurgery, severe head trauma or central nervous system infections that have residual symptomatology or have required treatment in the last 12 months
* Known or suspected clinical seizure post-index stroke
* History of pre-existing dementia or use of medications for dementia
* History of clinically significant pre-existing psychiatric conditions within 12 months prior to stroke
* Due to undergo carotid surgery within the next 4 months
* Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 6 times the half-life (whichever is longer)
* Clinically relevant medical conditions that would likely interfere with the study conduct and scheduled assessments
* Contraindication to magnetic resonance imaging (MRI) or conditions which render interpretation of MRI difficult
Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be H. pylori-positive patients at baseline (Visit 1)
2. Participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (Visit 1).

   However, if a history of ulcers is confirmed by the medical interview or previous medical record, Participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study.
3. Outpatient (including inpatient for examination)

Exclusion Criteria:

1. Participants who have received H.pylori eradication treatment
2. Participants who have either acute upper gastrointestinal bleeding, gastric ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], duodenal ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML) on endoscopic examination at baseline (Visit 1).

   However, participants with gastric erosion or duodenal erosion may be included in the study.
3. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
4. Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
6. Participants with hepatic or renal impairment receiving treatment with colchicines
7. Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents
8. Participants with infectious mononucleosis
9. Participants with an organic disease of the brain or spinal cord
Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar

Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser treatment.

In acne scar treatment, ablational laser would be superior to nonablative laser treatment. Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* moderate acne scar

Exclusion Criteria:

* taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin
* anyone who received acne scar procedures within 6 months
* underlying diabetes mellitus, keloid, or malignancy
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older (including 18 years); male or female
* Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay.
* Bilateral lung infection confirmed by imaging.
* Severe disease that meets one of the following conditions: (i) At rest, finger blood oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; (ii) Requiring non-invasive or invasive mechanical ventilation; OR (iii) Requiring high flow oxygen ≥ 15L/min
* Hospitalized for no more than 5 calendar days at the time of screening

Exclusion Criteria:

* Any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment.
* Chronic obstructive pulmonary disease (COPD) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (Part 1 only).
* Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis.
* Cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV.
* Blood system disorders or routine blood analysis test abnormalities: Hemoglobin \< 8 g/dL; Absolute neutrophil count (ANC) \<1500 × 109/L; Platelets \< 50 × 109/L.
* Dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs.
* Subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing
* Subjects that require ECMO.
* Pregnant or breastfeeding females.
Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes

Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Males and females at least 18 years of age
* Personal history of allergic disorders including but not limited to allergic conjunctivitis, allergic rhinitis, contact dermatitis and other eczema, and asthma
* Diagnosis of allergic conjunctivitis
* Presence of any of the following signs including conjunctival redness and papillae, chemosis, red edematous eyelids, reduced tear clearance, reduced TBUT, vital staining, stringy discharge, and/or symptoms including ocular itching, burning and tearing, runny nose or itchy throat

Exclusion Criteria:

* Active ocular or systemic infection
* History of ocular infection within past 6 months
* Presence of punctal plugs
* Recent ocular surgery within past 6 months
* Current use of chemotherapeutic agents
* Presence of ocular trauma
* Inability to give informed consent
* Women who are pregnant, nursing or lactating
PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism. Intermittent pneumatic compression combined with elastic stockings have been shown to be superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism in patients with ICH because the use of anticoagulants may cause an enlargement of the hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization) will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke onset.


Eligibility Criteria:
Inclusion Criteria:

* Intracranial spontaneous hemorrhage on brain CT scan
* Intracranial hemorrhage during treatment with oral anticoagulants
* Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for cerebellar hemorrhage).

Exclusion Criteria:

* cerebral hemorrhage due to intracranial vascular malformation
* rebleeding on CT scan after 72 hours from stroke (before randomization)