cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fasted state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 50, inclusive.
* Body weight ranging from 50 to 100 (kilograms) kg and a body mass index (BMI) ≥18 and ≤34 (kg/m2).
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and electrocardiogram (ECG).
* Females of child-bearing potential must be using an adequate and reliable method of contraception.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any history of or current drug or alcohol abuse for 5 years.
* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of an opioid-containing medication in the past 30 days.
* History of known sensitivity to oxycodone, naltrexone, or related compounds.
* Any history of frequent nausea or emesis regardless of etiology.
* Any history of seizures or head trauma with current sequelae.
* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
* Any significant illness during the 30 days preceding the initial dose in this study.
* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
* Consumption of alcoholic beverages within 48 hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
* Positive results for urine drug screen or alcohol screen at Check-in of each period, and hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb)(unless immunized), anti-hepatitis C antibody (HCV).
* Positive Naloxone hydrochloride (HCl) challenge test.
* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.


Eligibility Criteria:
Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with no previous treatment experience

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Global Postural Re-education Program on Neck Pain in Breast Feeding Females.

The significance of this study is that it will add to the growing body of knowledge that if these techniques yield outcomes in treatment of neck pain in breast feeding mothers. This study will add the beneficial effects to treat the neck pain in breast feeding females.

Nonspecific neck pain is an increasingly frequent musculoskeletal condition affecting 22% to 70% of the population that is more prevalent in women than in men. Some patients will not experience complete resolution of pain and disability which can become a more complex chronic pain syndrome.(2) When symptoms persist for more than 12 weeks, the condition acquires the value of chronicity and is denominated chronic nonspecific neck pain. This is associated with high costs for public health, and is becoming a socio-health problem.

The mechanisms underlying recurrence or persistence of neck pain may be associated with biomechanical, functional, proprioceptive, and postural changes. However, the multidimensional nature of neck pain can involve not only the sensory-motor component, but also psychosocial components, such as anxiety, depression, and fear and catastrophic thoughts in response to pain (kinesiophobia and pain catastrophizing).

In 2018, a study is conducted on the effect of global postural reeducation in patients with chronic nonspecific neck pain and their study suggested that global postural reeducation shows promising results for the improvement of neck pain and disability in patients with chronic neck pain.

In 2016, a randomized controlled trial is conducted on Effectiveness of Global Postural Re-education in Patients With Chronic Nonspecific Neck Pain The result of the study showed that global postural reeducation , when provided in the absence of other intervention, can significantly decrease pain Pain intensity , disability and increases cervical range of motion.

In 2015, a research is conducted to find out the effects in short and long term of global postural reeducation (GPR) on chronic low back pain the result showed that global postural reeducation is effective in the treatment of low back pain and function this study, suggests that postural reeducation was highly effective in managing pain and function due to low back.

Although quite a number of researches have been done regarding more effective treatment of neck pain, there are actually no research in effect of postural re-education is seen in breast feeding females.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-35 Years
* Mothers who have pain score of 4 in NPRS
* Mothers who breast feed their babies
* Post-partum period

Exclusion Criteria:

* Neck pain due to any other comorbidity e.g. Previous history of trauma or fracture, disc prolapse, facet joint stenosis
* Previously kyhoscoliotic mothers
* Females who have C-section
Anabolic Therapy in Postmenopausal Osteoporosis

In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women at high risk of fracture

Exclusion Criteria:

* Prior therapy exclusions

  1. current use or use in the past 12 months of oral bisphosphonates or denosumab
  2. current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
  3. use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
  4. any current or previous use of romosozumab or strontium
  5. current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.

Other exclusions

1. Confirmed serum alkaline greater than 2 times the upper normal limit.
2. Stage 4 or 5 chronic kidney disease (GFR less than 30)
3. Hypercalcemia (Ca greater than 10.5 mg/dL)
4. Hypocalcemia (Ca less than 8.8 mg/dL)
5. Elevated blood PTH (intact PTH greater than 77 pg/mL)
6. Serum 25-OH vitamin D less than 20 ng/mL
7. HCT less than 32%.
8. History of malignancy (except basal cell carcinoma).
9. Significant pulmonary disease
10. History of myocardial infarction or stroke within the preceding year.
11. History of unstable angina or transient ischemic attack in the past year.
12. Current atrial fibrillation.
13. Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
14. Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
15. Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
16. Uncontrolled eczema
17. Congenital or acquired bone disease other than osteoporosis.
18. Known sensitivity to denosumab or any of its excipients.
19. Known sensitivity to romosozumab or any of its excipients.
20. History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.
Emotion Assessment to Study Consciousness in Awakening Patients

After a coma, one important challenge is the detection of awareness with patients with disorders of consciousness. For some patients, the only behavioral manifestation indicative of awareness is an appropriate emotional response. Studies show that the use of a particular conditioning - with delay - appears to be an objective solution to study the conscious perception of an emotion in none-communicating people. Until now, emotions of patients suffering disorder of consciousness (DOC) have been scarcely studied. It has been proved that some awakening patients have vegetative reactions following an emotional stimulus, but the investigator can't confirm whether or not the emotional experience of the patient is conscious.

The investigator's main purpose is to study emotional reactions from patients suffering a disorder of consciousness.

The investigator hypothesize that some patients have preserved reflexes reaction to the emotional stimuli while others could demonstrate a conscious emotional experience.

In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli both in DOC patients and healthy controls; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence. The investigator plan to include patients vegetative patients (n=15); minimally conscious patients (n=15); acquired brain injured patients without conscious disorder (n=15) and healthy participants (n=15).


Eligibility Criteria:
Inclusion Criteria:

For Patients :

* age between 18 and 80
* acquired brain lesion (brain injury, stroke, anoxia) with a delay since the insult superior to 1 month
* level of consciousness assessed with the coma recovery scale revised (CRS-R)
* patient with health insurance
* informed consent signed by the patients or his representative

For Healthy participants:

* age between 18 and 80
* participant able to understand instructions and normal hearing
* patient with health insurance
* informed consent signed

Exclusion Criteria:

For Patients :

* non controlled epilepsy
* dysautonomic crisis
* unstable medical state
* pregnancy or breath feeding for women
* Persons under guardianship, curatorship

For Healthy participants:

* neurological disorder
* pregnancy or breath feeding for women
* Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty
Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride

2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.

In-vivo part:

Each varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application).

In-situ part:

Dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared.

it will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline.

Eligibility Criteria:
Inclusion Criteria:

* Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.
* Males or females.
* Patient's age range 25-50 years.
* Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).
* Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).
* Patients accept the 2-months follow-up period.
* Provide informed consent.

Exclusion Criteria:

* • Patients participating in another dental study that may alter the results of this study.

  * A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).
  * Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.
  * Patients used or applied a desensitizing varnish within the last four weeks.
  * Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.
  * Lack of patient's approval and compliance.
A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand 11C-MK-3168 and the Blocking of the Retention of the Ligand in the Human Brain by JNJ-42165279

The purpose of the study is to measure the uptake, distribution, and clearance of 11C-MK-3168 by Positron Emission Tomography (PET) scan and to model the tissue specific kinetics of 11C-MK-3168 with the appropriate input function in human brain in Part A; to measure blocking of retention of 11C-MK-3168 at the estimated time to maximum plasma concentration after dosing (tmax) following each single oral doses of JNJ-42165279 and model the exposure/enzyme interaction of JNJ-42165279 in Part B; to measure the saturation of enzyme inhibition in the brain at steady state plasma concentrations of JNJ-42165279 (on Day 8) after 7 once-daily doses of JNJ-42165279 by conducting PET studies with 11C-MK-3168 at trough plasma concentrations on Day 2 in Part C.

This is an open-label (both \[participants and investigator\] know what treatment participants will receive) study. This study consists of 3 consecutive parts: A, B, and C. Each part will consist of a screening phase (between 21 to 2 days prior to the study medication), a treatment phase (Part A: 1 day; Part B: 8 days; Part C: 8 days), and the end-of-study/ follow-up visit (within 5 to 7 days after last PET scan). In the treatment phase of the Part A, participants will undergo a baseline PET/computed tomography scan (after administration of 11C-MK-3168 on Day 1); In Part B, participants will undergo a baseline PET scan, followed by 2 post-treatment PET scans after 2 single doses of JNJ-42165279 on Days 1 and 8; in Part C, participants will undergo a baseline PET scan, followed by 2 post-treatment PET scans after 24 hours postdose of JNJ-42165279 on Days 1 and 7. Safety will be evaluated by the assessment of adverse events, vital signs, 12-lead electrocardiogram, clinical laboratory testing, physical examination (including weight and tympanic temperature \[temperature measure in an ear\]), and neurological examination. The total duration of study participation for a participant will be approximately 4 weeks for Part A and approximately 5 weeks for Parts B and C.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kg/m2 inclusive (BMI = weight/height2)
* Non-smoker (not smoked for 3 months prior to screening)
* Agree to use one of the protocol mentioned barrier methods of birth control

Exclusion Criteria:

* Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study
* Clinically significant abnormal laboratory values and abnormal physical and neurological examination at screening
* Any clinically significant Magnetic Resonance Imaging (MRI) abnormalities at screening, as determined by a neuroradiologist, which are relevant for the study
* Allen test (test to assess the arterial blood flow to the hand) indicating abnormal blood supply to the hand
* Has implanted or embedded metal objects, or fragments in the head or body that would present a risk during the MRI scanning procedure
Effects of Anesthesia on Atelectasis

We know that respiratory functions of patients are affected under general anaesthesia. Although there are many underlying causes of ventilation-perfusion mismatch in the airways, the main cause is atelectasis during general anaesthesia.

Atelectasis occurs in almost all patients receiving general anaesthesia. The main cause of atelectasis is the loss of muscle tone during general anaesthesia. Postoperative atelectasis was described in the last century. It is defined as the closure of the alveoli due to a decrease in inspiratory force and collapse of the lung and the resulting loss of aeration.

Inhalation anaesthetics have been shown to cause hypoxic pulmonary vasoconstriction in studies. However, not all inhalation anaesthetics affect the airways in the same way.

In patients who will undergo surgical procedures under different general anaesthesia maintenance methods, conditions that disrupt the ventilation-perfusion balance in the lung peroperatively can be diagnosed and monitored early, easily and inexpensively by lung ultrasonography.

Lung ultrasound is a noninvasive, reliable, reliable, radiation-free imaging method that provides instantaneous imaging at the bedside. Lung ultrasound score is a scoring system that provides scoring of the loss of ventilation in the lung. For this purpose, it was aimed to divide both lung tissues into 12 areas and to give a score between 0 and 3 points and to show the severity of the loss of aeration according to the resulting total score.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old ASA I-II Surgical procedure time between 2 hours and 5 hours in supine position Patients who will undergo rhinoplasty, septorhinoplasty operation Patients whose consent was obtained with an informed consent form

Exclusion Criteria:

* Those with a history of malignant hyperthermia,
* People with alcohol or drug addiction,
* Presence of dementia or confusion,
* Uncooperative patients,
* Those with respiratory disease,
* Those with coronary artery disease, congestive heart failure,
* Patients with unstable blood pressure,
* Significant anaemia, liver or kidney disease,
* Women during pregnancy or lactation,
* Allergy to anaesthetic agents,
* Body mass index (BMI) \>30 kg/m2,
* Those with sepsis or bacterial infection, Body temperature below 35°C and above 38°C at control value
Effects of Peppermint Oil in Cardiometabolic Outcomes

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Previous non-randomized interventions have shown that oral peppermint may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Between 18 \& 65 years
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to peppermint
* Habitual consumption of peppermint
* Not regularly taking medication or antioxidant supplements
Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach

This research protocol is comparing the effectiveness of surgical excision to the "wait and see" approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.

Different treatments have been proposed for the management of oral leukoplakia (OL) in order to prevent oral squamous cell carcinoma onset. However, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset.

A recent RCT compared surgical treatment with "wait and see approach" care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias.

The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or reducing the onset of potential oral squamous cell carcinoma, with a follow-up of 5 years. This study will be the first RCT comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.

Eligibility Criteria:
Inclusion Criteria:

* OL diagnosis should be confirmed by incisional diagnostic biopsy and subsequent histopathological analysis
* Subjects' age: 18 years or older
* Lesions' size: 3 cm maximum longitudinal size of the single lesion
* Lesions's location: oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries.
* Ability to understand and to sign a written informed consent document

Exclusion Criteria:

* Previous oral cancer
* Head and neck radiotherapy
* Subjects under the age of 18
* Subjects affected by PVL (proliferative verrucous leukoplakia)
* High-risk of surgical damages to anatomical structures such as nerves, salivary ducts and/or arteries
The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery

Background: There is scarce literature investigating how patients dispose of unused opioid supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General has identified research on the prevention of opioid use disorder area as well as research on the management of pain as a "Surgeon General Priority" that needs urgent investigation.

Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days of delivery.

Methods: This is a prospective single arm interventional pilot study.


Eligibility Criteria:
Inclusion criteria:

* Age 18+ at time of enrollment, per ERM
* Delivered ≥26.0 weeks, per ERM
* Status post low transverse cesarean delivery, per ERM
* Physically located on labor \& delivery and is postpartum day #1 or #2 at time of enrollment, per ERM
* Opioid prescription has been sent (per ERM) or will be sent (per obstetric team).

Exclusion criteria:

* Positive urine toxicology anytime in pregnancy for non-prescription opioids, fentanyl, amphetamines, benzodiazepines, cannabinoids, LSD, or cocaine, per ERM.
* Buprenorphine or methadone Rx, per ERM
* Patient preferred communication language not English, per ERM
* Documented history, per ERM:

  * Cannabinoid use disorder
  * Hypnotic use disorder
  * Opioid use disorder
  * Stimulant use disorder
  * Fibromyalgia
  * Sickle cell anemia
  * Lumbar disc herniation
  * Multiple sclerosis
  * Trigeminal neuralgia
  * Active cancer
  * Complex regional pain syndrome
  * Systemic lupus erythematosus
  * Rheumatoid arthritis