cyrilzakka/clinical-trials huggingface dataset:
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release tablet.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained.
* The subject can read, speak, and write in English.
* The subject is a man or woman 18 through 45 years of age, with a body mass index (BMI) of 20.0 to 30.0 kg/m2, inclusive.
* The subject is in good health as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, urinalysis, and serology.
* Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, be using an acceptable method of contraception, and agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
* The subject has a negative alcohol test and urine drug screen (UDS).
* The subject must be willing and able to comply with study restrictions and to remain at the study center for the required duration of each study drug period during the study.

Exclusion Criteria:

* The subject has any clinically significant uncontrolled medical conditions (treated or untreated).
* The subject has a clinically significant deviation from normal in ECG or physical examination findings, as determined by the investigator or the medical monitor.
* The subject has habitually consumed, within the past 2 years, more than 21 units of alcohol per week, or has a history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision (DSM-IV-TR, American Psychiatric Association 2000). NOTE: A unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine, or 8 ounces of beer.
* The subject is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
* The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal (GI) surgery; a history of appendectomy is allowed).
* The subject has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.
* The subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, their related compounds, or to any metabolites, or naltrexone, or any compound listed as being present in a study formulation.
* Other exclusion criteria apply.
Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.

This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Adult or child ages ≥5 years;
* Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;
* Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and
* Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria:

* instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.
Systematic Efficacy Replication Study of Conjoint Behavioral Consultation in Elementary Schools

The purpose of this project is to conduct an impact evaluation of the Conjoint Behavioral Consulting (CBC) intervention under real-world conditions as an IES Efficacy Replication trial. CBC is a family-school partnership intervention proven efficacious for children with serious emotional and behavior problems. The investigation will conduct a systematic efficacy replication of CBC to identify important process and context variables in need of attention prior to a CBC effectiveness study. School-based specialists (SBSs) will implement CBC and will be responsible for working directly with parents and teachers who have a student with or at risk for severe emotional disturbance, with more implementation support (i.e., non-routine conditions) than would be expected under routine conditions to ensure adequate fidelity of implementation. The research questions examine the impact of CBC, when implemented by SBSs, on student, parent, and teacher outcomes, as well its effect on mediational pathways. In addition, the research team will gather stakeholder feedback in focus groups to provide information about factors that stakeholders perceive as impeding or promoting CBC adoption, implementation, and sustainability.

Sixty schools will be recruited for this impact evaluation (20 from Madison Metropolitan School District, and 40 from Milwaukee Public Schools). The population for this evaluation will consist of the 12 children from grades k-4 in each participating school who demonstrate the highest levels of behavioral and/or emotional difficulties in school, based on teacher ratings on the BASC3-BESS screening (and whose families consent to participate in the evaluation). The total population for this evaluation will include 720 students. Baseline will take place at the beginning of the intervention school year, outcome 1 at the end of the intervention school year, and outcome 2 at the end of the subsequent school year. At all three timepoints, the research team will gather parent questionnaires (covering competence in problem solving, parenting strategies, parent-teacher relationships, and their child's social and behavioral functioning), teacher questionnaires in relation to each study child (covering the parent-teacher relationship, teacher competence in problem solving, and the student's social and behavioral functioning), direct observations of teacher and student behavior in the classroom, and student records related to discipline.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in kindergarten, Grade 1, Grade 2, Grade 3, or Grade 4 at recruitment
* Among the 12 students with the highest risk score on the Behavioral and Emotional Screening System 3 Behavioral and Emotional Screening System (BASC3-BESS) in the above grade span in their school (among those with parental consent for screening).

Exclusion Criteria: None
A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation

The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m\^2)
* A total body weight of more than (\>) 50 Kg
* Nonsmoker or ex-smoker for at least 3 months before screening
* Participants of non-childbearing potential

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
Functional Brain Imaging of Pain Phenotype and Genotype

This study has two purposes: first, to locate and identify the "brain activation" (the areas of the brain) which respond to pain; and second, to look at how brain activation is influenced by a person's genetics (the traits they inherited from their parents). A Magnetic Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an x-ray, but based on different scientific principles) that will be used to determine which areas are active. The hypothesis is that the variation in brain activity between people can be partially explained by genetic differences. This study consists of an two pain tasks applied during a one time visit to the MRI suite. There are no followup visits.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50
* Right-handed
* Male or female
* Healthy individuals not taking any medication.

Exclusion Criteria:

* Pregnancy
* Diagnosed with any treated or untreated medical or neurological conditions
* Using any prescription drugs, including antidepressants, pain medications, sedative medications, blood pressure medications, seizure medications, or antipsychotics. Oral contraceptives are permitted
* Using any over-the-counter medications including aspirin, Tylenol, or herbal supplements
* Using any illicit substances
* Contraindications to magnetic resonance imaging.
Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders

This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders.

Using air polishing with sodium bicarbonate powders with grain size 65 µm provides efficacy in the removal of dental stains but it can cause gingival trauma if used towards the gingiva. Since having big size particles is uncomfortable, the current recommendation according to literature is to use a smaller grain size (40 µm) that results in more patient comfort. However, the efficacy of small grain size on stain removal has not been studied adequately. This study aimed to compare the stain removal efficacy between sodium bicarbonate powders with grain size 65 µm and 40 µm and also to evaluate patient's acceptance after treatment and operator's opinion after using both air polishing powders.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects who aged over 18 years old.
2. Subjects who have healthy periodontal health or gingivitis.
3. At least 3 upper teeth (anterior, premolar and molar) are presented on both side (right \& left side), which will be refer as index teeth, that did not present with any gingival recession, cervical abrasion and/or abfraction, caries, restoration or orthodontic appliance.
4. Intrinsic stain is not present.
5. Index teeth are presented with extrinsic stain with individual Lobene score scored 2 or above.

Exclusion Criteria:

1. Pregnancy or current breastfeeding mother.
2. Allergy to sodium bicarbonate or the aroma of the powder
Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

This study is a single-center, randomized, controlled prospective study. Those patients with repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are enrolled in the study. To determine the effect of vaginal progesterone on the clinical pregnancy outcomes of RIF patients.

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the vaginal progesterone added group (test group). Group B was the regular FET group (control group).

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 20 and 40 years old;
2. BMI: 18-28 kg/m2；
3. Consistent with the diagnosis of repeated implantation failure of unknown reasons, the previous embryo transfer situation meets one of the following:

   Total embryos transferred ≥ 4 high-quality cleavage-stage embryos; ≥ 2 blastocysts; ≥ 2 high quality cleavage-stage embryos +≥ 1 blastocysts;
4. At least 1 high-quality embryo remained for embryo transfer;
5. Volunteer to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions);
2. Adverse pregnancy history (stillbirth, fetal malformation, etc.);
3. Severe paternal factors: need for TESA or PESA;
4. PGT;
5. Failure of embryo implantation due to any definite reason, including but not limited to: endometrial adhesion (moderate to severe), thin endometrium (\<7 mm before transformation), endometritis, endometriosis (medium or severe), adenomyosis, untreated hydrosalpinx, hysteromyoma (submucosal fibroids, non submucosal fibroids \> 4.0 cm and/or endometrial compression), reproductive malformation, serious immune disease, serious coagulation function abnormality;
6. Chromosome abnormality of either spouse;
7. Those with contraindications to pregnancy or assisted reproductive technology.
A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.

Eligibility Criteria:
Inclusion Criteria

1. Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
2. Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
3. Patients who provide informed consent

Exclusion Criteria

1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
2. Prior participation in a perampanel clinical study
3. Hypersensitivity to perampanel
Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy

The goal of this study is to gather feedback on a potential program that collects and shares real-world information to help create products and services to support people who have substance use disorders.


Eligibility Criteria:
Inclusion Criteria:

* U.S. resident
* Speaks, read, and understands English
* Adults ≥ 21 years of age
* Self-reported substance use disorder or at risk for substance use disorder as defined by cannabis use, tobacco use, illegal drug use, or prescription medication use for nonmedical reasons on at least 2-3 times in the past year
* Self-reports at least one of the following health-related social needs as assessed by American Academy of Family Physicians Social Needs

Screening Tool:

* Housing instability
* Non-reliable transportation
* Food insecurity
* Utility needs
* Personal safety
* Willingness and availability to participate in a recorded online interview (Phase 1A participants)

Exclusion Criteria:

* Participation in Phase 1A (among Phase 1B participants), to be assessed using participation history
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.

This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.

Eligibility Criteria:
Inclusion Criteria:

* A signed written Informed Consent
* Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
* If subjects are receiving anti-arrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply
* One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
* In good physical health
* 18 years of age or older
* Agree to comply with follow-up visits and evaluation

Exclusion Criteria:

* Prior typical atrial flutter ablation treatment
* Pregnancy
* Atypical flutter or scar flutter (non isthmus dependent)
* Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
* A recent myocardial infarction within 3 months of the intended procedure date
* Permanent coronary sinus pacing lead
* Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve
* Evidence of intra-cardiac thrombus or a history of clotting disorders
* Participation in another investigational study
* Cardiac surgery within 1 month prior to the intended procedure date
* Allergy or contraindication to Heparin
Trial on Innovative Technologies in Colonoscopy

The trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination.

* Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band imaging (NBI) will be used for innovative colonoscopies
* Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used for conventional colonoscopies Endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. All endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological lesions will be performed to establish final diagnosis. The main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.

A total of 600 consecutive patients undergoing screening unsedated colonoscopy will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions acc. to Sano and Kudo classification. Endoscopic biopsy will be taken from all lesion and endoscopic diagnosis will be compared with final histological diagnosis. Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, coecal intubation rate and pain intensity (VAS scale) will be established. This study will help to establish whether new technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* no previous abdominal surgery
* no colonoscopy during last 10 years

Exclusion Criteria:

* age \< 40 and \> 65 years
* large bowel resection in history
* colonoscopy performed during last 10 years
* contraindications for general anaesthesia
* ASA \> IV
* pregnancy
* confirmed neoplastic disease
* cirrhosis (Child B or C) or ascites
* immunosuppressive therapy or steroids intake
* malabsorption syndrome
Safety Evaluation of Dexmedetomidine for EBUS-TBNA

Lung cancer is the second most commonly diagnosed primary neoplasia in Canada accounting for 22 865 new cases in 2007. Recent randomized trials have shown a significantly better diagnostic yield and fewer unnecessary thoracotomies with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) when compared to conventional TBNA for various clinical conditions including peripheral pulmonary lesions and sarcoidosis. EBUS-TBNA are now routinely performed in our institution for staging of pulmonary and mediastinal cancer. EBUS-TBNA are performed under monitored anesthesia care (MAC) in the endoscopy suite at the Centre de soins ambulatoires of the Hôpital Maisonneuve-Rosemont.

Remifentanil, used in combined regime or as single agent proved to be effective and safe for MAC. Nonetheless, anesthesiologists are still confronted to the respiratory depression profile of remifentanil and other commonly used agents. An analysis of the ASA Closed Claims demonstrated that respiratory depression remains a significant drawback during MAC in remote locations. Furthermore, patients with coexisting pulmonary diseases scheduled for EBUS-TBNA are at increased risk of such complications.

The investigators hypothesize that compared to the use of remifentanil-based MAC protocol, the use of dexmedetomidine-based MAC protocol for EBUS-TBNA will result in a lower incidence of major respiratory and hemodynamic adverse events (bradypnea, apnea, oxygen desaturation, hypotension, hypertension, bradycardia and tachycardia) with equivalent overall procedure conditions.

See above

Eligibility Criteria:
Inclusion Criteria:

* Subjects with planned EBUS-TBNA under conscious sedation.
* Age 18-75 years old.
* American Society of Anesthesiologists class I-III.
* The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.

Exclusion Criteria:

* Subjects allergic to any of the study drugs.
* BMI \> 34 kg/m2.
* Severe renal or hepatic failure.
* Pregnancy.
* Emergent procedure.
* Heart failure NYHA \> III.
* Systolic blood pressure \< 90 mmHg.
* Advanced heart block (unless patient has a pacemaker).
* Unstable angina and/or myocardial infarction within past 6 weeks.
* FEV1 ≤ 0.8 L.
* Oxygen-dependent patient.
* Use of α2-adrenoreceptor agonist or antagonist within 14 days.