cyrilzakka/clinical-trials huggingface dataset:
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants

The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

* Healthy male and female participants, aged 18 to 49, as determined by medical history, physical examination, 12 lead electrocardiogram, vital signs, and clinical laboratory evaluations

Key Exclusion Criteria:

* Any significant acute or chronic medical illness; donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only); or blood screen findings positive for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibodies
SPI-1005 for the Treatment of Meniere's Disease (Open Label)

Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.


Eligibility Criteria:
Inclusion Criteria:

* Adult males/females, 18-75 years of age at the time of enrollment.
* Diagnosis of probable or definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
* At least two of three active symptoms (fluctuating hearing; tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease, within 3 months of study enrollment.
* Type A tympanogram at screening.
* Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in both ears.
* Subject is willing and able to provide informed consent and perform study procedures and assessments per protocol.
* Reproductive requirements

Exclusion Criteria:

* Current, or within 60 days prior to study enrollment, use of IV or intratympanic ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
* History of otosclerosis or vestibular schwannoma.
* History of significant middle ear or inner ear surgery in the affected ear.
* Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
* Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
* Current use or within 30 days prior to study enrollment systemic steroids.
* Current use or within 7 days prior to study enrollment intratympanic steroids.
* Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or excipients.
* Female patients who are pregnant or breastfeeding.
* Participation in another investigational drug or device study within 30 days prior to study consent.
* Participant resides more than 100 miles from the study site.
Evaluation of Colecalciferol Substitution in Dialysis Patients

The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system


Eligibility Criteria:
Inclusion Criteria:

1. Serum 25-OH-Vit.D-levels \< 60 ng/ml
2. Age \> 18 years
3. dialysis treatment \> 3 Months
4. signed written informed consent
5. Serum-Calcium-levels \< 2,6 mmol/l within the last 4 weeks
6. Serum-Phosphate-levels \< 7,0 mg/dl within the last 4 weeks
7. Ca x P-Product \< 75 mg2/dl2 within the last 4 weeks

Exclusion Criteria:

1. Serum 25-OH-Vit.-D-levels \> 60 ng/ml
2. concommitant participation in another interventional trial
3. psychiatric disorders preventing from valid informed consent
4. Hyperphosphatemia (\> 7,0 mg/dl) within the last 4 weeks
5. Hypercalcemia (\> 2,6 mmol/l) within the last 4 weeks
6. Ca x P-Product \> 75 mg2/dl2 within the last 4 weeks
7. pregnancy or lactation
8. known malignancy
9. liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels
10. PTH levels \< 50 pg/ml
11. current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels
12. Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C)
13. Immunosuppressant Medication
14. known hematologic disorders, other than renal anemia
15. age below 18 years
16. known anaphylactic reaction against the study medication or other ingredients of the study drug preparation
17. renal calculus
18. Pseudohypoparathyroidism
19. Medication including cardiac glycosides
20. Sarkoidosis
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented or suspected Barrett's esophagus presenting for endoscopy
2. Age \> 18 years
3. Ability to provide written, informed consent

Exclusion Criteria:

1. Presence of erosive esophagitis
2. Inability to obtain biopsies due to anticoagulation, varices, etc.
3. Allergy to fluorescein, pregnancy
4. Presence of an esophageal mass other than small 10mm or less nodules
5. Renal insufficiency
Pharmacokinetics and Safety/Tolerability Profile of CKD-379

A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* 50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2

Exclusion Criteria:

* Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
* Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
* Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery
* Those who are pregnant or breastfeeding
* Those who are deemed inappropriate to participate in clinical trial by investigators
The Use of Bone-borne Guides in Orthognathic Surgery Cases

The present study was conducted to evaluate a new design of the intermediate stent that is used in orthognathic surgery cases requiring Le Fort I osteotomy. The new design relied on referencing the maxillary segment to the zygomatic buttress. The study was carried out as a randomized controlled clinical trial in which 16 patients were enrolled according to the inclusion and exclusion criteria. In control group (n=8) conventional interocclusal splint was used and in study group (n=8) the proposed intermediate stent was used.

Background: Dentofacial deformities have many negative consequences in the form and function of head and neck region. This includes breathing, swallowing, speech and temporomandibular disorders. It is estimated that in about 19% of orthodontic patients, orthognathic surgery is required along with the orthodontic procedure. The introduction of CAD/CAM technology in orthognathic surgery planning has facilitated the procedure and allowed for more predicted results. Aim of this study: The aim of the present study is to propose a new design of the intermediate stent that relates the mobilized maxilla to a fixed anatomical landmark in the skull which would allow for more accurate positioning of the maxilla during orthognathic surgery. Materials and methods: This study was conducted on sixteen patients who have been undergone Le Fort I osteotomy procedure. Eight of them (group A) were treated via a conventional stent while the other eight patients (group B) via a CAD/CAM bone-borne stent. Postoperative patient evaluation was performed by comparing the predicted maxillary position to the resultant position postoperatively. This was done via 3D reconstruction CT scans.

Eligibility Criteria:
Inclusion Criteria:

* Patients with dentofacial deformity requiring Le Fort I osteotomy

Exclusion Criteria:

* Patients with severe asymmetry
The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497

To evaluate the efficacy and safety of CKD-497


Eligibility Criteria:
Inclusion Criteria:

1. 19 ≤ age \< 75
2. Subject with acute upper respiratory infection and acute bronchitis infection
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria:

1. Subject who need antibiotics treatment during the clinical trial
2. Subject suffering from severe respiratory diseases such as pneumonia, asthma, chronic closed lung diseases (COPD), tuberculosis, bronchial enlargement, malignant tumors in the lungs, and chronic bronchitis during screening
3. Subject who cannot participate in a clinical trial based on the PI's judgment
Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit

People with advanced and life-threatening illnesses experience challenges across multiple domains of function including physical, psychological, social, and spiritual. The benefits of non-pharmacological interventions for palliative care patients are well recognized, but are relatively under-utilized. Virtual Reality (VR) therapy may help address these challenges and be a valuable addition to the current therapies used in palliative care.

VR is a computer generated, three-dimensional environment that individuals can explore and interact with using specialized equipment such as a head-mounted display with internal sensors. VR has been increasingly adapted for applications in healthcare, as a simulation for medical training and an intervention tool to impact pain management, stress and anxiety. VR has the potential to improve both physical and psychological symptoms in patients with terminal illnesses.

The current study is a small randomized controlled trial to understand the impact of VR on physical symptoms, psychological symptoms and quality of life in patients at the end of life. Participants will be randomized to a single comparator session, single session of standard VR, or single session of personalized VR. The comparator arm will consist of participants viewing an ordinary two-dimensional video on an iPad such as a peaceful nature scene. The standard VR arm will consist of participants viewing a "bucket list" experience self-selected from a VR library i.e. an experience the participant desires but has never experienced. The personalized VR arm will consist of participants viewing content that is personally meaningful to them. This content will be obtained through either a) family/friends creating a personalized video (e.g. video footage of their summer cottage) or b) the participant will select an experience from the VR library that is personally meaningful (e.g. visiting their honeymoon destination, exploring their childhood hometown, etc.) if option a) is not possible.

Participants will complete self-report questionnaires about their physical and psychological symptoms and quality of life before and after the intervention (two days and seven days post intervention). Participants will also complete a feedback survey to evaluate their satisfaction with the intervention. Surveys will be administered by the research assistant.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to Baycrest PCU
* Capable to consent to the study
* Able to complete the outcome measures through a telephone interview with a research assistant
* Estimated prognosis ≥3 weeks
* At least 2 or more ESAS scores of 4 or greater within the week of the intervention
* English speaking

Exclusion Criteria:

* Intractable nausea/vomiting
* History of seizures or epilepsy
* Vision and/or hearing impairment that cannot be accommodated e.g. pocket talker
* Any abnormalities of the head preventing use of the headset
* Patients who are too unwell to participate based on the opinion of the clinical team
Pilot Dispensing Evaluation of a Plus Power Lens

The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 years of age and no more than 45 years of age.
* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
* The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
* Any cylinder power must be ≤ 0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
* Need any near correction.
Cricoid Pressure Versus Paratracheal Pressure

Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.

Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.

During the laryngoscopy, the modification of the Cormack and Lehane grade before and after the application of the cricoid or paratracheal pressure will be noticed.

concerning the effectiveness of the procedure, a gastric tube will be introduced through the oesophagus during the procedure, under direct vision.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with no criteria of difficult intubation or mask ventilation
* no criteria of full stomach requiring crush induction

Exclusion Criteria:

* Unexpected difficult laryngoscopy or mask ventilation
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia

This is a Phase 2, open-label, multicenter, study to evaluate safety, tolerability and efficacy of SAR442501 in children from birth up to 12 years of age with Achondroplasia.

Up to approximately 275 weeks: 3 weeks Screening + 52 weeks primary treatment period + up to approximately 216 weeks extended treatment period+ 4 weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have ACH with a confirmed mutation in the FGFR3 gene
* Participants and/or parent(s) or legal representative(s) must be willing and able to perform all the study procedures to the best of their physical ability.
* Parent(s) or legal representative(s) capable of giving signed informed consent and participants capable of giving assent when applicable.

Exclusion Criteria:

* Have hypochondroplasia (or the N540K mutation) or short stature condition other than ACH (eg, trisomy 21, pseudochondroplasia)
* Participants have received any dose of medications or investigational product, including human growth hormone, IGF-1, intended to affect participants' stature or body proportions between the completion of OBS16647 and enrollment (Week 0/Day 1/Visit 2).
* Have a history of growth plate closure.
* Long bone fracture within 3 months of enrollment (Week 0/Day 1/Visit 2)
* Current evidence of corneal or retinal disorder/keratopathy.
* Participants have had a previous surgical intervention involving the foramen magnum (Stage 2 only).
* Hyperphosphatemia.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Use of Point-of-care Ultrasound in High Risk Surgical Patients

There is currently a lack of evidence to support the use of perioperative point-of-care ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical patients.

Point-of-care ultrasound is increasingly established as a useful bedside tool when performed by the anesthesiologist for evaluation of cardiopulmonary dysfunction and other emergent situations. However, it remains unclear whether use of perioperative point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical risk patients.

Patients were randomly allocated to two groups. In the point-of-care ultrasound group, treatment was oriented by the findings of point-of-care ultrasound, while in the control group the decisions about the management of patients were made by the experience of the clinical team. The primary outcome measures were hospital mortality and 28-day mortality, and the secondary outcome measures were the complications and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have comprised cardiovascular，respiratory diseases，or other critical illness.

Exclusion Criteria:

* Patients who decline to participate.
Study Evaluating the Benefit of Dry Needling for Patients With Neck Pain

The purpose of this study is to determine whether individuals with neck pain will respond favorably to a program of manual therapy, directed at the cervical and thoracic spine (including thrust manipulation), and exercise, in combination with dry needling, as compared to manual therapy, directed to the cervical and thoracic spine (including thrust manipulation), and an exercise program alone.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-60 years old
2. Primary complaint of neck pain
3. Restricted cervical extension/and or cervical rotation ROM
4. Neck Disability Index \> 20 points

Exclusion Criteria:

1. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
2. Use of blood thinners
3. History of whiplash injury within the past six weeks
4. Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   * Muscle weakness involving a major muscle group of the upper extremity
   * Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
   * Diminished or absent sensation to pinprick in any upper extremity dermatome
6. Prior surgery to the neck or thoracic spine
7. Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 12-months
8. Workers compensation or pending legal action regarding their headaches
9. Insufficient English language skills to complete all questionnaires
10. Inability to comply with treatment and follow-up schedule
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus
* Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening
* BMI= 27-45 kg/m2
* HbA1c value between 7.5% and 11%

Exclusion Criteria:

* Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening
* Patients treated previously with AC2993
* Patients presently treated with insulin