cyrilzakka/clinical-trials huggingface dataset:
Terbinafine HCl 250 mg Tablet Under Fasting Conditions

The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years or older inclusive with a body mass index (BMI) of 30 or less.
* Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
* Signed and dated informed consent form, which meets all criteria of current FDA regulations
* If female and of child bearing potential subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.

Exclusion Criteria:

* If female, pregnant, lactating or likely to become pregnant during the study.
* History of allergy or sensitivity to terbinafine, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
* Significant history or current evidence of chronic evidence of chronic infectious disease, system disorder ot organ dysfunction.
* Presence of gastrointestinal disease ot history of malabsorption within the last year.
* History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
* Presence of a medical condition requiring regular treatment with prescription drugs.
* Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes. within 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to dosing.
* Drug or alcohol addition requiring treatment in the past 12 months.
* Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
* Positive test results for drug of abuse at screening.
* Tobacco user within 90 days of the first study dose.
* Unable, or unwilling to tolerate multiple venipunctures.
Ankle Instability Using Foot Intensive Rehabilitation

The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients.

Lateral ankle sprains are one of the most common injuries sustained by the general population with the greatest rates in people who are physically active or service members. Approximately 40% of lateral ankle sprain patients develop chronic ankle instability (CAI) characterized by recurrent lateral ankle sprains, repetitive sensations of ankle "giving way", residual ankle sprain symptoms, and self-reported disability. Factors related to the development and progression of CAI has been thoroughly studied. However, few interventions have been developed which have successfully created long term reductions in re-injury rates, physical function, or health-related quality of life. Recent work by our research team has uncovered several novel motor and sensory deficits in the foot in patients with CAI. Deficits in foot function may contribute to the high re-injury rates, deficits in balance and strength, and diminished health-related quality of life commonly experienced by individuals with CAI. The investigators expect the additive effect of FIRE with components of the standard of care (balance training, strength training, and range of motion) will create the synergy needed to reduce future injuries (Aim 1), enhance physical function (Aim 2), and reduce self-reported disability in CAI patients (Aim 3).

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-44.
2. Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months.
3. Participants must answer "yes" to at least 5 questions on the Ankle Instability Instrument.
4. Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI).
5. Confirmed clinical presentation of CAI by a PT, AT, or MD.

Exclusion Criteria:

1. Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months.
2. History of surgery to the lower extremity.
3. Sustained a lower extremity fracture.
4. History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance.
5. Current participation in a formal ankle joint rehabilitation program.
6. Sustained a concussion in the last 12 months.
7. Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity).
To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers

This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Korean or Caucasian volunteers

Exclusion Criteria:

* Individuals with a clinically significant disease or history
* Individuals with a history of a gastrointestinal disorder or surgery
* In the case of all female individuals with childbearing potential, except for those who are surgically sterile
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Children 2-12 months of age presenting to Emergency Department
* Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles
* Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist

Exclusion Criteria:

* Previous history of wheezing
* Known heart or lung disease
* Premature birth defined as birth before 37 weeks gestation
* Immunosuppression or immunodeficiency
* Treatment with corticosteroids in the previous 48 hours
* Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration
* Oxygen saturation \<85% on room air at the time of recruitment
Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer

Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.


Eligibility Criteria:
Inclusion Criteria:

Some of the requirements to be in this study are:

* Patient must be at least 18 years old.
* Patient must have been diagnosed with non-small cell lung cancer.
* Patient must be able to visit the doctor's office once a week.
* Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.

Exclusion Criteria:

Patients cannot participate in this study for any of the following reasons:

* Patient has previously had chemotherapy.
* Patient has previously had thoracic radiation therapy.
* Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
* Female patient is pregnant or breast-feeding.
* Patient is unsuitable to participate in the study in the opinion of the investigator.
* Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery

Using retrospective medical records to analyze the difference between the analysis of the correlation between operation time, blood loss, anesthesia methods, anesthesia medication, and postoperative recovery time

In Orthognathic surgery, facial bones involved in the operation site are more likely to bleed. In order to reduce the amount of bleeding during the operation, intentional hypotensive anesthesia is executed during the operation.

Because the amount of bleeding is controlled within a reasonable range, the surgical field of vision is naturally clear, which can also make the operation go smoothly, shorten the operation time, and increase the postoperative comfort. Therefore, for orthognathic surgery, the maintenance of intraoperative blood pressure is very important. Using inhaled anesthetics can easily achieve deeper anesthesia, but may increase postoperative nausea and vomiting. Generally speaking, these patients will be fixed with steel wires between the upper and lower jaws after the operation. Postoperative nausea and vomiting will increase the risk of aspiration pneumonia, but intravenous anesthesia can reduce postoperative nausea and vomiting.

This research is a retrospective investigation of medical records. The purpose of this study is to understand the differences in the analysis of the correlation between the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery of patients undergoing surgery during orthognathic surgery. In the future, orthognathic surgery (Orthognathic surgery) anesthesia policy and anesthesia target process guidelines can be formulated, and it can help remind medical staff to make an early and appropriate treatment at any time.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing conventional anesthesia surgery and orthognathic surgery.

Exclusion Criteria:

* Exclude the operation time greater than 8 hours.
Effect of TDCS Combined with Intraoral Electrical Stimulation

Objective: To investigate the clinical efficacy of transcranial direct current stimulation (tDCS) combined with intraoral electrical stimulation in patients with dysphagia after pontine infarction. Methods: This prospective study enrolled a total of 90 patients with dysphagia due to pontine infarction from October 2022 to November 2024, and they were divided into three groups according to the treatment method: control group A, control group B, and experimental group C. Control group A was given intraoral induction electrical stimulation, control group B was given transcranial direct current stimulation (tDCS), and experimental group C was given tDCS combined with intraoral induction electrical stimulation. The three groups were compared in terms of efficacy, modified Waffield Drinking Water Test Score (MWST), Penetration-aspiration scale (PAS), Functional Oral Intake Scale (FOIS), Hyoid-Larynx Complex mobility, maximum amplitude of surface electromyography, and swallowing time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dysphagia (able to cooperate with swallowing assessment) and consistent with the criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"\[9\] or pontine infarction by clinical imaging examination;
* Age≥18 years or ≤80 years;
* The modified water swallow test (MWST) score is 3-5\[10\] or the Functional Oral Intake Scale score \<4

Exclusion Criteria:

* Those who are intolerant to electrical stimulation or allergic to auxiliary electrodes;
* Patients with implanted pacemakers, metal stents in the neck, or other reasons that cannot be treated with electrical stimulation;
* Patients who are critically ill or unable to cooperate with the assessment and treatment of patients with dysphagia due to other reasons.
rTMS Treatment in Patients With General Anxiety Disorder

This study will compare the change detected by a standardized rating scale (Hamilton Anxiety Rating Scale) scores in the active treatment group as compared to sham (placebo) group after 6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to improvement of core symptoms in patients with GAD.


Eligibility Criteria:
Inclusion Criteria:

* signed patient informed consent;
* primary GAD diagnosis;
* HARS \>=15;
* male/female 18-65 years;
* without GAD pharmacotherapy at least last 2 weeks or if they are taking GAD medication it must be stable for at least 6 weeks prior to the start of the study and not be changed during the 6 weeks of the study treatment phase.
* Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.

Exclusion Criteria:

* current serious Axis I schizophrenia, bipolar I, MDD;
* other primary Axis I in the opinion of investigator;
* HDRS \>=18;
* metallic implant in cranium except mouth;
* severe/unstable medical conditions;
* ect within last 3 months;
* history epilepsy;
* neurological disorder leading to increased intracranial pressure;
* severe cardiac disorder/intracardiac lines/pacemakers;
* current suicide risk.
Innovation Adoption in Medical Robotic Surgery: Case of Royal Bournemouth Hospital

This research sets to address two key areas. The first is identified by the researcher in academic literature that there is a lack of a comprehensive innovation adoption model in UK National Health System (NHS), specifically for Medical Robotic Surgery. Existing frameworks are mainly developed in the US or in other fields. The second problem was identified by surgeons involved in Robotic Surgery in Royal Bournemouth Hospital (RBH). The project started by offering RBH a deeper understanding of the innovation adoption process, issues and development of an adapted innovation model, however after our initial meeting with the Surgical Director and his team, it was clear that one the main areas RBH was keen for us to investigate, was the communication pathway of all stakeholders involved in robotic surgery adoption. They were concerned that key staff dealing with patients undergoing medical robotic surgery were uninformed about the technology and process which can impact patients' experience and staff communication.

The research will develop a comprehensive innovation adoption model for robotic surgery (and similar medical innovation) in NHS. Currently there are no models adapted to NHS UK structure and requirements. This model will assist the NHS to understand and evaluate any innovation adoption process within the NHS and to avoid future innovation adoption failure.

The case example will Identify the communication pathway and key stakeholders in RBH for the process of Gastrointestinal Robotic Surgery, evaluation of stakeholders' knowledge and needs and further proposing ways to improve adoption and increase knowledge. NHS can use the proposed communication pathway to identify stakeholders that need to be informed, trained and communicated to, in any innovation adoption process within NHS.


Eligibility Criteria:
Inclusion Criteria:

Being involved with conducting Robotic Surgery or caring for patients undergoing Robotic Surgery

Exclusion Criteria:

-

As this study is recruiting staff, and there is no medical intervention, the eligibility criteria is basic.
Community-Acquired Pneumonia - Study on the Initial Treatment With Antibiotics of Lower Respiratory Tract Infections

The purpose of this study is to compare the cost(effectiveness) of three existing antibiotic strategies for patients with community-acquired pneumonia admitted to the hospital, but not the ICU.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to one of the participating hospitals needing treatment for CAP, not being admitted to the ICU are eligible for study inclusion.
* Admission is defined as hospital stay for more than 24 hours.

Exclusion Criteria:

* Patients who are readmitted with CAP within 2 weeks after a previous episode are not eligible.
* Patients with cystic fibrosis are not eligible.
Aspiration of Residual Gastric Contents

The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.

The participants in the study will be randomly assigned (like the flip of a coin) to either have the leftover food in their stomach removed before each feeding, or not have the leftover food removed before each feeding. In addition, when a blood drawn is performed as regular care an extra amount with be taken. A test to determine how much of the hormones gastrin and motilin are contained in the blood will be performed. Stool samples will be collected. Participation could last up to approximately 6 to 8 weeks of age.

Eligibility Criteria:
Inclusion Criteria:

* born at 32 weeks of less of gestational age
* birth weight \</= to 1250 grams
* receiving some enteral feedings by 72 hours of age
* receiving parenteral feedings by 24 hours of age

Exclusion Criteria:

* Congenital or chromosomal abnormalities
* complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities
Intrahospital Transport in Patients With High-flow Nasal Oxygenation: Prospective Observational Study

High-flow nasal oxygen therapy is commonly used in intensive care unit (ICU). Intra-hospital transfer of critical patients is frequent: 1) to perform diagnostic 2) between emergency room or medical wards and ICU. During theses transfers, oxygenation should be continued.

There is high-flow nasal oxygen therapy for transport using an external battery. This mode of operation in transport mode allows about 30-45 min of autonomy.

Intra-hospital transport under high-flow nasal oxygen therapy has been previously described on children.

The objective of this study is to evaluate the occurrence of complications during intra-hospital transports under high-flow nasal oxygen of critical patients.

High-flow nasal oxygen therapy is commonly used in intensive care unit (ICU). Intra-hospital transfer of critical patients is frequent: 1) to perform diagnostic 2) between emergency room or medical wards and ICU. During theses transfers, oxygenation should be continued.

There is high-flow nasal oxygen therapy for transport using an external battery. This mode of operation in transport mode allows about 30-45 min of autonomy.

Intra-hospital transport under high-flow nasal oxygen therapy has been previously described on children.

The objective of this study is to evaluate the occurrence of complications during intra-hospital transports under high-flow nasal oxygen of critical patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with high-flow nasal oxygen therapy before the intra-hospital transport prior to transport
* Requiring an intra-hospital transport (e.g., CT scan, OR, etc.) or inter-departmental transport supervised by the ICU team

Nb: Once the patient is included in the study, any intra-hospital transport under high-flow nasal oxygen therapy will be analyzed until discharge from the intensive care unit and at until D28.

Exclusion Criteria:

* Under 18 years old
* Patient being under guardianship, tutorship or curatorship
* Pregnancy or breastfeeding
* Lack of social security number
* Refusal to participate in the study
Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.

Endovascular treatment is now the first line treatment for the management of intracranial aneurysms. However aneurysm recanalization is an important limitation to this treatment. Several factors seems to be associated with aneurysm recanalization including medical history of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location, modalities of treatment, immediate post-operative occlusion of the aneurysm.

A precise knowledge of factors increasing the risk of aneurysm recanalization is quite important to optimize strategy of treatment and reduce the recanalization rate. No large, prospective, multicenter trial dealing with this question has been published in the literature.

The prevalence of intracranial aneurysms is high (between 2 and 3%). The major risk of an intracranial aneurysm is its rupture leading to intracranial bleeding (subarachnoid, parenchymal and/or intraventricular) associated with mortality and morbidity.

Endovascular treatment is now the first line treatment for both ruptured and unruptured aneurysms. One major limitation of this treatment is aneurysm recanalization observed in approximately 20% of aneurysms and leading to retreatment in approximately 10% of aneurysms.

CARAT trial has shown that the risk of rebleeding after aneurysm coiling is significantly associated with the quality of aneurysm occlusion. The risk of rebleeding is 1.1% in case of complete occlusion, 2.9% when aneurysm occlusion is between 91 and 99%, 5.9% when aneurysm occlusion is between 70 et 90%, and 17.6% when aneurysm occlusion is less than 70%. However it should be outlined that few studies have clearly analyzed the relation between recanalization and rebleeding.

Several factors are probably associated with aneurysm recanalization. Ruptured aneurysms are more prone to aneurysm recanalization than unruptured aneurysm. Age, elevated blood pressure, smoking probably play a role in aneurysm recanalization. Anatomical features are also probably key factors for aneurysm recanalization. Aneurysm and neck sizes are probably important factors for aneurysm recanalization. The role of aneurysm location is more controversial. Therapeutic factors certainly play also an important role, but precise analyses are still missing. The quality of post-operative aneurysm occlusion is probably important for the future evolution of the aneurysm. Surface-modified coils have not demonstrated any efficacy to prevent aneurysm recanalization. The role of adjunctive techniques has also not precisely be evaluated (remodeling, stenting).

Eligibility Criteria:
Inclusion Criteria:

* Patients treated by endovascular approach for intracranial aneurysm(s)
* Patients older than 18 years
* Patients accepting to participate to the study

Exclusion Criteria:

* Patients younger than 18 years
* Patients protected by law
* Patients already treated by endovascular approach for an intracranial aneurysm
* Patients having a brain arteriovenous malformation
* Patients having a fusiform aneurysm
* Patients having a dissecting aneurysm