cyrilzakka/clinical-trials huggingface dataset:
Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study

Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive disorder. However, fewer than 50% of patients show sufficient response. Therefore, the optimal treatment protocol is worth investigating. Recent studies show that the relationship between stimulation intensity and prefrontal hemodynamic response is not linear but in an inverse U-shape by exploring the hemodynamic changes before and after iTBS. Concurrent transcranial magnetic stimulation (TMS)/functional near-infrared spectroscopy (fNIRS) setup allows the investigators to observe the prefrontal hemodynamic response during stimulation.

The aim of this study is to investigate the effects of different intensities on brain activity during and after the stimulation using fNIRS.

Please refer to the full proposal

Eligibility Criteria:
Inclusion Criteria:

* Right-handed

Exclusion Criteria:

* history of epilepsy, seizures, or convulsions
* current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
* current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
* with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker
A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age 19\~50 years in healthy male volunteers
* BMI is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.

To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 18 years
* Subjects must have provided IRB approved written informed consent
* Subjects must have clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients.
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
Processing Speed as an Objective Measure of Tinnitus

The overall purpose of this research is to assess whether both the "60 second Brain Game" and the "Brain Speed Test" computer-based programs can be used as assessment tools for objectively defining the severity of the functional impact of tinnitus.

This cross-sectional study aims to assess for deficits in brain processing speed and attention (two cognitive domains whose deficits have been implicated in tinnitus) with the use of the "Brain Speed Test".

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 18 and 80.
* Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6-months duration or longer.
* Participants must be able to read, write and speak using the English language.
* Participants must be able to provide informed consent.

Exclusion Criteria:

* Participants with tinnitus related to Workman's Compensation Claim or other litigation-related situations.
* Participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia.
* Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear.
* Participants unable to hear the highest volume of the computer-based objective assessments.
* Any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates.
* Any medical condition the PI determines would compromise the safety of the participant or complicate the interpretation of the study results.
Diagnosing and Targeting Mechanisms of Diuretic Resistance in Heart Failure

Effective diuresis is the primary goal of most acute decompensated heart failure hospitalizations, but diuretic resistance is common and our ability to detect it is limited. Further, there are therapeutically distinct groups of diuretic-resistant patients. These are not easily distinguished using currently available methods, leading to trial-and-error based treatment that promotes lengthy hospitalizations.

The aims of this study are:

1. To develop inexpensive and efficient tools to predict diuretic response
2. To understand the prevalence of therapeutically targetable mechanisms of diuretic resistance using endogenous lithium clearance
3. To develop methodology to differentiate diuretic resistance mechanisms using common/inexpensive laboratory tests
4. To provide proof of concept that mechanistically tailored diuretic therapy can improve natriuresis

This study is a minimal-risk observational open-label single center study with randomization between two standard of care interventions. Approximately 500 patients admitted to the hospital (Yale New Haven Health System) with a clinical diagnosis of heart failure will be enrolled in the overall study.

Patients will undergo sampling of their blood and collection of urine at a minimum of 4 timepoints (called "visits"), or a minimum of 5 in the interventional arm. Patients with a low urine sodium output (\<100 mmol) on Visit 1 will be eligible for 1:1 randomization to either an increased dose of their Visit 1 loop diuretic or addition of IV chlorothiazide to their Visit 1 loop diuretic.

Eligibility Criteria:
For all patients:

Inclusion criteria:

* Age ≥ 18 years
* Clinical diagnosis of ADHF with at least one objective sign of volume overload: rales, edema, elevated JVP, preadmission weight gain
* Current use of bolus IV loop diuretic therapy and projected need by the treating clinician for continued treatment with IV diuretics for at least 3 days with the goal of significant fluid removal (\>1L net fluid loss/day)

Exclusion criteria:

* Inability to perform informed consent or comply with the serial urine collection procedures
* Significant bladder dysfunction or urinary incontinence
* Hematocrit less than 21% or active bleeding

For patients in the interventional arm:

Inclusion criteria:

* Cumulative 6-hour sodium output \< 100 mmol following Visit 1 IV loop diuretic dose
* Visit 1 IV loop diuretic dose ≤ 160 mg of furosemide equivalents
* Serum sodium \> 125 mmol/L
* At least 6 hours since last dose of diuretic

Exclusion criteria:

* Current use or projected future requirement by the treating physician for thiazide diuretics
* Use of high dose mineralocorticoid receptor antagonist therapy (\>50mg of spironolactone or \>100mg of eplerenone) or amiloride
Intracranial Arterial Stenosis and Resin of Cannabis Use

There is an association between intracranial arterial stenosis and ischemic stroke in young adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis in asymptomatic regular resin of cannabis users in comparison with control subjects.


Eligibility Criteria:
Inclusion Criteria:

* regular resin of cannabis users

Exclusion Criteria:

* taking vasoactive medications
* taking other illicit drugs
Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)

Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>= 18 years old
* Scheduled for laparatomy surgery

Exclusion Criteria:

* history of allergies to anaesthetic drugs
* impaired consciousness
* neurocognitive disorder
* psychiatric disorder
* mental disorder
* cerebrovascular disorders
* sick sinus syndrome
* hypoalbuminemia
* massive bleeding
* liver disease
* kidney diseases.
Safety of Phenylephrine for Oral Mucositis Prevention

The purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes
* normal ECG
* normal blood pressure

Exclusion Criteria:

* untreated cardiac disease
* connective tissue disorders
* open sores, wound, ulcerations to oral cavity
* allergy to phenylephrine
* know untreated hypertensin
* abnormal ECG in past 6 months
* taking prescription monoamine oxidase inhibitor (MAOI)
* are pregnant
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use

Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.

Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients.

Eligibility Criteria:
Inclusion criteria:

* Adult ICU patients (aged ≥18) with an expected ICU stay of \>24 hours
* Patients who are (expected to become) agitated within the first 14 days of their ICU admission

Exclusion criteria:

* Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity);
* Neurological patients with an (expected risk of) increased intracranial pressure;
* An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);
* Support with Extracorporeal Membrane Oxygenation (ECMO);
* Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);
* A high risk of physical aggression towards healthcare professionals;
* No consent for long term follow up in the MONITOR-IC study;
* Not able to read or understand the Dutch language and no relatives able to assist;
* Enrolment in other sedation studies.
Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

Prone positioning (PP) is an adjunctive therapy used that has been proven to save lives in sedated patients with confirmed moderate-severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (MV). PP involves placing patients in the prone, i.e. face down position for time periods of up to 16 hours per day. PP promotes lung homogeneity, improves gas exchange and respiratory mechanics permitting reduction of ventilation intensity, and reducing ventilator-induced lung injury (VILI).

Maintaining self-ventilation is associated with increased aeration of dependent lung regions, less need for sedation, improved cardiac filling and removes the risk of VILI, and so is an important therapeutic goal in hypoxic patients. The use of PP in awake self-ventilating patients with COVID-19 induced acute hypoxic respiratory failure (AHRF) and/or ARDS could improve gas exchange and reduce the need for invasive MV, but has not been studied outside of case series.

However, an increase in oxygenation does not necessarily reduce the risk of invasive MV. PP has significant attached risks such as causing pressure sores in patients, PP is uncomfortable for some patients, it increases nursing workload, and if ineffective could hinder the delivery of other (effective) medical care. Hence there is a need to determine if PP of awake patients is effective in reducing the need for invasive MV. This multi-centre, open label, randomized controlled study of COVID-19 induced AHRF/ARDS will determine if PP reduces the need for mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed COVID19 infection
* Bilateral Infiltrates on CXR
* SpO2 \<94% on FiO2 40% by either venturi facemask or high flow nasal cannula
* RR \<40
* Written informed consent

Exclusion Criteria:

* Age \<18
* Uncooperative or likely to be unable to lie on abdomen for 16 hours
* Receiving comfort care only
* Multi-organ failure
* RR\>40
* Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy \>20/40 gestation, severe brain injury).
Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars

Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars


Eligibility Criteria:
Inclusion Criteria:

1. Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
2. Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.

Exclusion Criteria:

1. Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
2. Children are allergic to nickel and resin.
3. Children unable to return for recall visits.
4. Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
5. Children are undergoing orthodontic treatment with fixed or removable appliances.
The Effect of UV-C Enriched Foods on Vitamin D Deficiency

This study is an experimental design study in which demographic characteristics, food consumption, biochemical parameters and anthropometric measurements of individuals with low vitamin D levels before and after consuming UV-enriched foods will be examined.

It was designed to be applied to individuals with low vitamin D levels working in Fatih Sultan Mehmet Training and Research Hospital who meet the research conditions.

n the first phase of the study, demographic information will be recorded by asking demographic information from the people who volunteered to participate in the study and who meet the study criteria by using a questionnaire form and 3-day food consumption record information by face-to-face interview technique; anthropometric measurements of the participants will be taken and baseline blood values will be recorded. At the beginning of the experimental study, individuals will be randomized by computer-assisted randomization into four different groups. Biochemical analyses will be analyzed every two weeks, analyses will be repeated 1 month after the study and the effects of vitamin D enrichment on biochemical parameters will be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Working in the hospital
2. Being between the ages of 18 and 65
3. Not being pregnant or lactating
4. Not taking vitamin D supplements or fish oil in the last 1 month
5. Serum 25(OH)vitamin D value below 30 μg/L
6. No kidney disease, kidney stones, cortisone use, blood thinners
7. Not being in a solarium
8. Not eating fish more than once a week
9. Volunteering to participate in the research

Exclusion Criteria:
Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)

The study is promoted by the Emilia Romagna Region which identified in the Bologna AUSL the coordinating center (Unità Operativa Complessa Laboratorio Unico Metropolitano, LUM, Maggiore Hospital). The medical genetics centers, participating in the technical-scientific coordination group of assessment (resolution No. 1894, 4/11/2019), the family counseling centers and the region prenatal hospital clinics are involved as collaborative experimental centers.

Currently, 14,400 combined tests are carried out in the Emilia Romagna Region every year.

As a result offering the new non-invasive NIPT test, it is estimated that the number of participants in the screening program will increase by up to 20,000/year.

The study will collect data on the women who will access the combined test in the first 9 months of the protocol and join the enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.
* Women able to understand the information, participate in pre-test counseling and provide informed consent.

Exclusion Criteria:

* Women under the age of 18 and/or unable to give informed consent
* pregnancies with more than two twins
* certain evidence of initial twinning, with subsequent disappearance of one of the twins (vanishing twin)
* known maternal chromosome mosaicisms present in the mother and involving the chromosomes subject to investigation
* presence of neoplasia in pregnant women
* previous allogeneic transplantation in pregnant women
* immunotherapy, radiotherapy or hemotransfusion performed in the pregnant woman within the previous 3 months.
A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older

The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).


Eligibility Criteria:
Inclusion Criteria:

* Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
* Participant is medically stable as confirmed by documented medical history, physical examination and vital signs. Participant may have underlying illnesses such as hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are medically controlled. If he/she is on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination
* Participant must have a body mass index (BMI) of less than or equal to (\<=)35.0 kilogram per square meter (kg/m\^2)
* Contraceptive (birth control) use by woman should be consistent with local regulations regarding the acceptable methods of contraception for participant participating in clinical studies
* All females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4 (prior to the second vaccination)

Exclusion Criteria:

* Participant with contraindication to intramuscular (IM) injections and blood draws, for example, bleeding disorders
* Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its excipients
* Participant with abnormal function of the immune system resulting from: a) clinical conditions (for example, autoimmune disease or immunodeficiency); b) chronic or recurrent use of systemic corticosteroids; c) administration of antineoplastic and immunomodulating agents or radiotherapy
* Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated) within the past 1 year or a history of any hematological malignancy
* Participant with history of acute polyneuropathy (for example, Guillain-Barre syndrome)
* Participant who has a history of an underlying clinically significant acute or (uncontrolled) chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments