cyrilzakka/clinical-trials huggingface dataset:
Comfort of Patients Under Non Invasive Ventilation According to the Mask

A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. The primary objective is to compare the comfort of the sub-nasal mask with that of a standard naso-oral mask.

Non-invasive ventilation (NIV) is a first-line treatment for many conditions encountered in the ICU. This technique requires training of heath professionals, appropriate equipment, optimisation of ventilator settings and good cooperation from the patient. Indeed, NIV failures lead ton invasive mechanical ventilation, thus increasing morbidity and mortality. These failures are favoured by the patient's poor tolerance to NIV. The success of the treatment depends greatly on the patient's compliance and comfort. The choice of the mask is therefore essential. There are different types of interface, such as the full-face helmet, the face mask, the nasal-oral mask or the nasal mask. The nasal-oral mask rmains the most commonly used interface. Recommendations emphasise the importance of choosing a mask that is the right size and best tolerated by the patient. Despite benefits of NIV, there are a number of potential complications: skin lesions at pressure points, particulaly at the nasal bridge, gastric distension, barotrauma, haemodynamic effects of positive presure ventilation, claustrophobia, anxiety, difficulty in speaking and eating, dry eyes, patient-ventilator asynchrony. Some of these complications depend on the type of mask used. a sub-nasal mask with a skirt that fits the nostrils and a dedicated port for the nasogastric tube has recently been introduced. To our knowledge, this interface has never been compared to commercially avaible nasal-oral masks.

Eligibility Criteria:
Inclusion Criteria:

Indication of NIV, carried out by the physicians in charge of the patient, among the following:

* COPD exacerbation
* Hydrostatic acute pulmonary edema
* Acute Chest Syndrome with Hypercapnia in Sickle Cell Patients
* Post-extubation, planned in a patient at risk or recovering from extubation failure
* Hypoventilation-obesity syndrome

Exclusion Criteria:

Formal contraindication to NIV among:

* Indication for orotracheal intubation at the outset
* Non-cooperative, agitated, opponent of the technique
* Coma
* Respiratory exhaustion
* Shock, severe ventricular arrhythmias, immediate aftermath of cardiac arrest
* Undrained pneumothorax, blowing chest wound
* Upper airway obstruction (except sleep apnea, laryngotracheomalacia)
* Uncontrollable vomiting
* Upper gastrointestinal bleeding
* Measure of protection of justice
* Facial deformity
* Dying or palliative care patient
* Pregnancy
Evaluation of the Effect of Oil Pulling

The objectives of this study were to evaluate the inhibitory effect on plaque and the tooth discoloration associated with agents used in the chemical plaque control of oil pulling in comparison with chlorhexidine-containing mouthwash and water in a four-day plaque regrowth model.

One hundred dentistry students were included in this randomized, parallel-group, placebo-controlled clinical study. In this study, participants were divided into 5 equal groups: Group 1: Gargling with 0.2% chlorhexidine; Group 2: Oil pulling with coconut oil; Group 3: Oil pulling with black cumin oil; Group 4: Oil pulling with terebinth oil; Group 4: Gargling with distilled water. Participants were instructed to refrain from mechanical oral hygiene and rinse only with the allocated mouth rinse during the four-day period. The differences in plaque index, gingival index, and tooth discoloration were evaluated in the study.


Eligibility Criteria:
Inclusion Criteria:

* Without systemic disease,
* Had at least 24 teeth, and
* Without fixed or removable prostheses or orthodontic appliances

Exclusion Criteria:

* Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months
* Individuals with an allergy to any ingredient used in the study
* Smokers
* Pregnant or breastfeeding women
* Individuals with ≥2 mm gingival recession
Efficacy and Periodontal Parameters in Self-ligating Brackets Alone or With Corticotomy vs Conventional Brackets

Patients who have severe crowding on the upper jaw that requires two first premolars extraction will be enrolled in this trial. The different types of brackets, such as self-ligating brackets and conventional brackets, and the various acceleration methods, such as corticotomy, have different effects on the orthodontic treatment time and the periodontal tissues. So, this study will assess and compare the overall leveling and aligning time and the changes in periodontal indices between patients with severe crowding, treating with self-ligating brackets associated with flapless corticotomy versus conventional brackets alone versus self-ligating brackets alone.

There are three groups:

The first group (control group): the patients in this group will be treated using conventional brackets alone.

The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.

The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

The prolonged duration of the treatment period can cause many problems such as caries and periodontal diseases. The oral environment is considered a suitable environment for many germs and microorganisms to grow. Any increase in the percentage of these germs predisposes to the occurrence of dental and periodontal problems.

Several studies have used various procedures and many types of brackets to accelerate dental movement in order to reduce treatment time.

Orthodontic treatment using different devices usually contributes to change the nature of the oral environment and its contents of microorganisms Many bracket systems have been used, such as the conventional brackets and self-ligating brackets. The use of self-ligating brackets has increased significantly in recent years. The absence of wired or elastic elements may cause less accumulation of plaque.

Eligibility Criteria:
Inclusion Criteria:

* Sever crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires extraction of two upper premolars.
* The Little's Index of Irregularity is more than 7 mm.
* Good oral health (plaque Index is less or equal to 1).
* Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0).
* Overbite is between 0-4 mm.
* No skeletal constriction on the upper jaw.
* No congenitally missing or extracted teeth (except for the third molars).

Exclusion Criteria:

* Any systemic diseases affect teeth movement.
* Any congenital syndromes or cleft lip and palate.
* Bad oral health.
* The patient is not committed to periodic follow-up times.
A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)

To determine the safety and tolerability of single oral doses of HPN-100 as a formulation (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy male subjects.

A randomized, open-label, four-treatment, four-period crossover study in which healthy male subjects received a single dose of each of the following four treatments on four separate dosing days, 7 days apart:

* Oral sodium phenylbutyrate (Buphenyl®) equivalent to 3 g/m2 of 4-phenylbutyric acid (PBA) per dose
* Oral GT4P-F mole equivalents to 3 g/m2 of PBA per dose
* Oral GT4P-API mole equivalents to 3 g/m2 of PBA per dose
* Intravenous 10% sodium phenylacetate plus 10% sodium benzoate (Ammonul®) 2.75 g/m2

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

Subjects were required to fulfill the following criteria in order to participate in the study:

* Males aged 18 to 45 years of age
* Ability to provide written, informed consent before any study-related procedures, and ability, in the opinion of the investigator, to comply with all the requirements of the study
* Subjects who were in good health as determined by a medical history, physical examination, serum chemistry, hematology, urinalysis, 12 lead ECG, and vital signs
* Weight within the range of 60-120 kg

Exclusion Criteria:

Subjects who fulfilled any of the following criteria were excluded from the study:

* Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurologic, immunologic, or psychiatric disorder(s), as determined by the investigator
* Clinically significant abnormal laboratory values (as determined by the investigator)
* Significant illness within 14 days prior to screening
* Any disorder that might significantly interfere with the absorption, distribution, metabolism, or excretion of any drug
* Use of any prescription medication within 14 days prior to screening
* Use of dietary supplements, herbal medicines, vitamins, or over-the-counter medication(s) (with the exception of acetaminophen ≤ 500 mg/day) within 10 days prior to first dosing
* Positive drugs of abuse urine test at screening or pre-dose day (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, methadone)
* Positive alcohol breath test at screening or pre-dose day
* Donation or loss of blood (500 ml or more) within 30 days prior to first dosing, or during the study
* Donation or loss of plasma within 7 days prior to first dosing, or during the study
* History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC)
* History of acquired immunodeficiency syndrome (AIDS) or determined HIV positive at screening
* Use of any investigational drug within 12 weeks prior to first dosing
* Known hypersensitivity to sodium phenylbutyrate or similar drugs
* Previous exposure to sodium phenylbutyrate
To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
* High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score \>10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.

Exclusion Criteria:

* Known or suspected secondary hypertension
* Known New York Heart Association (NYHA) functional class IV Heart Failure
* History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
* Clinically significant valvular disease
* Women who are pregnant, intend to become pregnant or are breastfeeding
* Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
* Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
* Other protocol-defined inclusion/exclusion criteria may apply
Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques

The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

Different irrigation delivery systems are introduced to the market aiming to improve root canals disinfection. The conventional endodontic needle is commonly used because of its ease in use and good control of needle depth and irrigant volume. However it carries a higher risk of extruding the solution periapically because of positive pressure used in solution delivery.

Passive ultrasonic irrigation is a noncutting irrigation technique that is done with ultrasonically activated files with continuous or intermittent flow of irrigant. It was shown that it is effective in removing remnants of pulp tissue, dentin debris and planktonic bacteria.

The vibringe (Cavex Holland BV, Haarlem, the Netherlands) is an irrigation device that combines manual delivery and sonic activation of the irrigant.

The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females
* Age between 16-60 years old
* Permanent Mandibular molars with:

  * Non-vital response of pulp tissue
  * Absence of spontaneous pain

Exclusion Criteria:

* Pregnant females
* Patients having significant systemic disorder
* Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours
* Teeth that have:

  * Vital pulp tissues
  * Association with swelling or fistulous tract
  * Acute periapical abscess
  * Greater than grade I mobility
  * Pocket depth greater than 5mm
  * Previous endodontic treatment
Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer

The purpose of this registry is to collect uniform genomics-centered data on patients with nodular thyroid disease and cancer in a prospective fashion. After initial clinical evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation and a needle biopsy of the thyroid (fine needle aspiration (FNA) or core biopsy) as clinically indicated. Biopsy samples will be evaluated cyto-pathologically. A molecular/genomic profiling will be obtained using Thyroseq v2 test. Surgical treatment will be performed as per clinically determined indications. Standard surgical pathology will be processed and reported per the institutional policy and procedures. A molecular/genomic profiling will be obtained using Thyroseq v2 on the surgical specimen. All patients undergoing thyroid nodule work-up may be enrolled. The registry will collect patient demographic and clinical data, cytopathology reports, and surgical pathology reports and slides (if/when a review is required).

This is an open-ended prospective registry. The patients who were diagnosed with thyroid nodules will have a complete clinical and US evaluation. Thyroid nodule biopsy indication and FNA vs core biopsy choices will be made entirely on the clinical grounds, by the managing physicians. Thyroid nodule biopsies may be performed at a participating medical or surgical endocrinology office. Following standard cytologic examination a molecular testing using Thyroseq will be performed.

The biopsy results will be categorized according to Bethesda scoring system. Category I is non-diagnostic FNA and will require a repeat FNA. Category II is benign cytology, categories III, IV and V are the indeterminate group, and category VI is malignant cytology. The FNA analysis of registry patients will be collected under six groups. Thyroseq molecular testing may be deferred if not felt needed following cytology.

1. Cytology(benign) / Thyroseq(-)
2. Cytology(benign) / Thyroseq(+)
3. Cytology(indeterminate) / Thyroseq(-)
4. Cytology(indeterminate) / Thyroseq(+)
5. Cytology(Malignant) / Thyroseq(-)
6. Cytology(Malignant) / Thyroseq(+). Thyroid operation indication and lobectomy vs total thyroidectomy choices will be made entirely on the clinical grounds, by the managing physicians. The routine histopathology will be processed and reported as per the institutional protocols. The molecular testing of the preoperatively biopsied and intraoperatively and postoperatively identified lesions will be performed, as indicated.

The registry is open to all interested physicians involved in thyroid patient care and interested in participating

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for registry enrollment if they are undergoing thyroid nodule work-up.

Exclusion Criteria:

* Patients will not be eligible for registry enrollment if a work-up beyond clinical evaluation is not indicated.
Engaging Patients for Physical Exams During Virtual Care Visits

The goal of this clinical trial is to validate patient-oriented edits to a guided video on self-performed hand examination in participants with no prior hand diagnoses or medical background. The study aims to:

* examine the effect of adding interactive components to an existing orthopedic provider video
* determine if these changes enhance patients' understanding of hand and wrist anatomy as well as carpal tunnel syndrome
* determine if patients are able to use this video to perform an effective physical exam Participants will watch an original physician-oriented training video and a second version (patient-oriented video), which was edited with the input of a patient advisory committee to include interactive elements and a slower speed. The order in which the participants will watch the video will be randomized.

If there is a comparison group: Researchers will compare knowledge scores and general patient preference between the two videos being examined.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Patients who comprehend and speak English
* Patients with carpal tunnel syndrome confirmed on EMG and/or symptoms consistent with carpal tunnel syndrome, including bilateral hand pain, non-traumatic hand pain, and/or numbness/tingling in hand.

Exclusion Criteria:

* Patients under 18 years of age
* Patients who do not speak or comprehend English
* Patients who have cognitive impairments that would be detrimental to understanding of video
* Patients whose symptoms do not match carpal tunnel syndrome
Constraint Induced Movement Therapy (CIMT)- Neuroimaging Predictors of Positive Response to Constraint

CIMT has shown great promise in helping children and adults regain lost function in a disabled limb by forcing its use through an intensive motor training program and constraining the unaffected arm with a cast. However, relatively little is known about the underlying mechanisms of CIMT in hemiplegic CP. This project will use an integrated translation model to explore neuroimaging predictors of a positive clinical response to CIMT.

The primary research objective is to evaluate neuroimaging predictors of a positive response to CIMT in children with hemiplegic CP secondary to a middle cerebral artery territory stroke (MCA). A focus on the MCA territory is chosen as (1) it targets children with significant hand impairment who have the potential to benefit from CIMT, (2) is the most common neuropathological subtype, and (3) allows for enhanced homogeneity for the matching of case and comparison groups. The primary research question is: In children aged 7 to 16 years with hemiplegic CP secondary to an MCA stroke, are there neuroimaging predictors of a positive response to CIMT, a positive response being defined by an improvement in the Assisting Hands Assessment (AHA) one month after CIMT?

Neuroimaging predictor variables include laterality index (LI) of the primary M1 and S1 areas on fMRI, IHI evaluated by resting state fMRI, dissociation of the M1 and S1 for the hemiplegic hand measured by fMRI, size and vascular distribution of the MCA lesion with T2 weighted MRI, and white matter tract abnormality with Diffusion Tensor Imaging (DTI). We hypothesize that a negative LI, a non-dissociated M1 and S1, low IHI, small size of infarction, and large size of the contralateral corticospinal tract will predict a positive response to constraint. An evaluation of the neuroimaging predictor variables on the persistence of a positive response to CIMT at 6 months as measured by the AHA will also be explored. A secondary objective will evaluate change in the neuroimaging variables from baseline to one month post CIMT by comparing children in the case group who have received CIMT and a comparison group who are matched on baseline QUEST scores.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hemiplegic CP secondary to an MCA infarct
* Age between 7 and 16 years
* Ability to co-operate, understand, and follow simple instructions for neuro-imaging outcome measurement: The functional MRI protocol will require some cooperation and the child will need to lie still in a confined place for approximately 45-60 min.
* No previous CIMT within 12-months of study entry or Botulinum toxin upper limb injections within 6-months of study entry.

Exclusion Criteria:

* None
Parkinson's KinetiGraph as Tool for DBS Eligibility Assessment

The purpose of the study is to investigate the feasibility of using the commercially available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of motor fluctuations would support the general neurologists in the referral of PD patients to the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers.

As part of the routine clinical practice, PD patients are referred to the DBS surgical center (clinical site) to optimize their PD treatment and potentially receive a DBS therapy, and the Principal Investigator (PI), a DBS specialist, assesses their DBS eligibility following published expert evaluation criteria and assigns the patient to one of the following two groups (PI assessment):

1. DBS ready, if the patient presents severe motor fluctuations and/or clear dyskinesia history.
2. DBS not-ready, if the patient presents neither severe motor fluctuations, nor clear dyskinesia history.

As part of routine clinical practice, the PKG responsible physician will provide the patient with the PKG to be worn for 6 to 10 days.

Based on the Global Kinetics Corporation (GKC) algorithm applied on the data recorded by the PKG, a GKC representative assigned the patients to one of the above mentioned groups: DBS ready or DBS not-ready.

The primary objective is to evaluate whether the GKC algorithm can differentiate DBS ready from DBS not-ready patients as assessed during the visit at the clinical site by the DBS specialist. The primary endpoint is therefore the percentage of agreement between the PI assessment and the GKC assessment (DBS ready or DBS not-ready) about the DBS eligibility of the PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed with PD.
* Patients are presented to the clinical sites to evaluate DBS candidacy or optimize their PD treatment eventually with DBS therapy.
* Patients are at least 18 years old.
* Patients are able to provide written data release consent as required by Ethics Committee (EC) institutions or local law and regulations.

Exclusion Criteria:

* Patients have restricted movement, e.g. bed bound.
* Patients operate heavy machinery for prolonged periods.
* Patients have serious medical conditions that compromise safety or interfere with mobility in addition to PD (e.g. arthritis and rheumatisms).
* Patients have been already screened by Stimulus or EarlyStimulus questionnaires
* Patients present no response to Levodopa medication or have atypical Parkinsonism.
* Patients have major medical or psychiatric illness other than stable, treated depression or anxiety that may jeopardize the patient's ability to give informed consent, follow study requirements, or that may confound the patient's diagnosis or assessments.
* Patients have major neurological diagnoses other than PD.
* Patients are not capable of following the required clinical instructions