cyrilzakka/clinical-trials huggingface dataset:
ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches.

To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing.

Eligibility Criteria:
Inclusion Criteria:

Subject must meet all of the following criteria to be eligible for treatment in the Study:

1. The subject must be equal or greater than 18 years old.
2. The subject must be scheduled for the surgical placement of a synthetic (i.e., PTFE/Dacron) vascular graft or patch for large vessel repair/arterial reconstruction/hemodialysis access/arteriotomy.
3. The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
4. The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
5. The subject or guardian must provide written informed consent using a form that is reviewed and approved by the IRB.

Exclusion Criteria:

Subjects will be excluded from the Study if any of the following criteria are met:

1. The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions.
3. The subject is currently enrolled in this, or another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period. Note: Extended follow-up trials for products that were investigational but are currently commercially available are not considered investigational trials.
Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
* Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
* Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
* Males and Females, ages 20 years or older, inclusive

Exclusion Criteria:

* Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
* Other concomitant malignancies (with some exceptions per protocol)
* Any active autoimmune disease or history of known or suspected autoimmune disease
* History of uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply
Intranasal Midazolam in Children as a Pre-Operative Sedative

The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.

Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) surgical procedure requiring mask anesthesia
2. American Society of Anesthesiologists (ASA) Class 1 or 2
3. Parent willing and able to provide written informed consent
4. Parent willing and able to complete the OBD VAS

Exclusion Criteria:

1. ASA Class 3 or greater
2. History of allergy to midazolam or xylocaine
3. Presence of acute respiratory infection at time of surgery
4. Parent unwilling or unable to provide informed consent
5. Parent unwilling or unable to complete the OBD VAS
Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to date, the only therapeutic option is liver transplantation. The study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS according to the ERS task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration of the study is 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Presence of HPS
* Age ≥ 18 years

Exclusion Criteria:

* Intracardiac shunting
* Pregnancy
* Known hypersensitivity to bosentan
* Use of glyburide
* Use of cyclosporin A
* Elevation of aminotransferase level of \> 3 times the upper limit of normal
* Use of rifampicin
* Females of childbearing potential without use of adequate contraception
* Systolic blood pressure \< 85 mmHg
* Clinical relevant anemia
* HIV-infection
Baclofen for Children With Rumination Syndrome

The goal of this clinical trial is to learn about baclofen in pediatric patients with rumination syndrome. The main question it aims to answer is whether baclofen is effective in treating children with rumination syndrome. Participants will be asked to take baclofen or placebo for 4 weeks and fill out surveys regarding symptoms.

Rumination syndrome is a functional gastrointestinal disorder characterized by effortless, repetitive regurgitation of recently ingested meal. The objective of this study is to evaluate the efficacy of baclofen, a GABA-b agonist, in children with rumination syndrome. The investigators hypothesize that children with rumination syndrome who are treated with baclofen in addition to standard behavioral treatment will have greater clinical improvement compared to those who receive placebo.

After enrollment into the study, participants will be randomized into one of two parallel groups in a 1:1 ratio: (a) baclofen or (b) placebo control. The research team will be blinded to randomization. Participants will subsequently meet with investigational pharmacist and receive four-week supply of either baclofen 0.5 mg/kg/day up to 15 mg divided three times a day or matching placebo three times a day in liquid formulation. At baseline, the research team will collect information on demographics, medical, and surgical history, relevant diagnostic testing, and relevant past treatments (including working with a psychologist). Patients/families will complete a baseline questionnaire (rumination severity questions, PedsQL, route of nutrition, medications) and then the patient will start taking study drug or placebo in addition to their usual care as determined by the patient's primary gastroenterologist. Participants/families will complete follow-up questionnaires at week 1, week 2, week 4, and then week 8. The questionnaires will be filled out by the patient or guardian electronically via REDCap. The research team will closely monitor for side effects. In addition to asking about any side effects at follow-up timepoints, the research team will also emphasize that families should contact the team using the research team phone number with any instances of suspected side effects even before the next follow-up timepoint. After the 4-week drug or placebo period, participants are free to start or continue baclofen, or use other treatment modalities, as determined by their primary GI team.

Eligibility Criteria:
Inclusion Criteria:

* Children 4-18 years of age who meets Rome IV diagnostic criteria for rumination syndrome and are see at NCH GI clinic

Exclusion Criteria:

* Patients who have contraindications to baclofen due to medical history and/or current medications
* Patients who are non- English speaking
* Patients who are pregnant
Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial

Patients will undergo a split-mouth protocol which includes:

a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure.

A study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge.

Primary objective: To evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.

Secondary objectives:

* Evaluate the functional limitation in opening the mouth (trismus) 7 days after surgery.
* Evaluate if there is a reduced intake of analgesic drugs in the 7 days following the operation.
* Evaluate the perceived quality of life in the 7 days following the intervention.

Patients will undergo a split-mouth protocol which includes:

a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure.

A study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge.

Primary objective: To evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.

Secondary objectives:

* Evaluate the functional limitation in opening the mouth (trismus) 7 days after surgery.
* Evaluate if there is a reduced intake of analgesic drugs in the 7 days following the operation.
* Evaluate the perceived quality of life in the 7 days following the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Lower third molars included
* Pell-Gregory Class II-B
* Absence of systemic diseases

Exclusion Criteria:

* Hyperthyroidism;
* G6PHD (glucose 6 phosphate dehydrogenase) deficiency;
* Anemia
* Myasthenia
* Pregnancy and breastfeeding
* Allergy to ozone
* Local infections
Advanced Cooking Education Full Scale Study

The aim of this study is to assess the impact of an in-person multi-component Advanced Cooking Education (ACE) 4-H after school program. The ACE Program consists of mindfulness, nutrition education, cooking labs, and professional development activities.

The ACE program is conducted with 7th and 8th grade students attending New York City (NYC) Title I middle schools. Participants attend weekly sessions (2hour) after school to participate in mindfulness, nutrition lessons, and professional development activities. On another day in the week, students participate in cooking labs at their own time at their homes. The investigators hypothesize that after the program, adolescents' diet quality, cooking-related skills, stress levels will be improved compared to prior of the program.

Eligibility Criteria:
Inclusion Criteria:

* 7th and 8th grade students attending Title I funded schools in New York City
* Caregivers of the 7th and 8th grade students attending Title I funded schools in New York City

Exclusion Criteria:

* Do not speak/understand English
* Those who have previously participated in the Virtual ACE program (Feasibility Study), or In-Person ACE Pilot Study
Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections.

This is a single center, prospective, 2-arm randomized, non-blinded study. A total of 100 participants will be assigned to the Silverlon arm and 100 to the AQUACEL AG arm.

The number of procedures to implant CIED has risen in recent years. With this rise has also brought a rise in post-procedure infections. Infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. Wound coverage with appropriate dressings is one aspect that needs to be studied in CIED implant patients. Silverlon and AQUACEL AG are two options of dressings available for these patients. This study will look to see if one of the two is a better option for post-operative CIED implant patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital
* Able to give informed consent

Exclusion Criteria:

* Patients who are already on antibiotics for another reasons
* Immunocompromised patients such as those on immunosuppressant's and HIV positive patients
* Patients who are post device explant for lead infection
* Patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components
Visual Performance of Center Distance Daily Disposable Multifocal Lenses

The purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between Visioneering Technologies, Inc. NaturalVue Multifocal and CooperVivion MiSight.


Eligibility Criteria:
Inclusion Criteria:

* Participants must satisfy the following conditions for inclusion in the trial:

  * Be between 9 and 30 years of age
  * Sign written Informed Consent/Assent.
  * Spherical Equivalent glasses prescription: -0.50 to -7.00 diopters (D), Astigmatism: ≤ -0.75D, Anisometropia: ≤ 1.00D
  * 20/20 vision in each eye
  * Existing contact lens wearer
  * An eye exam in last 9 months, normal stereoacuity on prior chart (or test if not available)
  * No known ocular disease - anterior or posterior (posterior determined by history/chart)
  * Have an acceptable or optimal fit with test lenses and be willing to wear these lenses as directed for the duration of the study.
  * On examination, have ocular findings considered to be within normal limits.
  * Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria:

* Any of the following will exclude a participant from this trial:

  * Current hard lens wearers
  * Using eye medication contraindicating lens wear such as daily use of artificial tears.
  * Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  * History of corneal refractive surgery
  * Currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial.
  * Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  * Allergy or sensitivity to any product used in this trial.
  * Pre-existing ocular condition that would contraindicate lens wear.
  * Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by wearing contact lenses.
  * Lazy eye (Strabismus or amblyopia)
  * Pupil size \< 3.00 mm in either eye in dim light (measured at approximately 10 cd/m2 )
An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types

This is an open label study designed to evaluate the biodistribution and imaging characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a solid tumor of a type likely or known to either overexpress wild-type Epidermal Growth Factor Receptor (EGFR) or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, Non-small Cell Lung Carcinoma (NSCLC), and colorectal carcinoma).
* Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
* Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
* Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
* Subject must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with at least 1 extrahepatic 2 cm lesion.

Exclusion Criteria:

* Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 14 days prior to the first dose of ABT-806i.
* Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806i.
* Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
* Subject has had major surgery within 21 days prior to the first dose of ABT-806i.
* Subject has a clinically significant uncontrolled condition(s) including but not limited to the following:

  * Active uncontrolled infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris or cardiac arrhythmia
  * Psychiatric illness/social situation that would limit compliance with the study requirements
Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe glabellar wrinkles (frown lines)

Exclusion Criteria:

* Previous treatment with botulinum toxin therapy of any serotype
* Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
* Mid-facial or periorbital treatment with non-permanent soft tissue fillers
* Subjects planning a facial cosmetic procedure or visible scars
* Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* History of facial nerve palsy
* A planned extended absence during the study
A Study of Implantation of Retinal Pigment Epithelium in Subjects with Acute Wet Age Related Macular Degeneration

Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss

Phase 1, open-label, safety and feasibility study of implantation of PF-05206388 (human embryonic stem cell derived retinal pigment epithelium) in subjects with wet age related macular degeneration and rapid vision loss

Eligibility Criteria:
Inclusion Criteria:

* Male and /or post-menopausal female subjects aged 60 years or above.
* Diagnosis of wet Age-related Macular Degeneration (AMD) plus rapid recent vision decline
* An informed consent document signed and dated by the subject or a legal representative.

Exclusion Criteria:

* Pregnant females; breastfeeding females; and females of childbearing potential.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Current or previous significant other ocular disease in the study eye, as determined by the investigator.
V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone

Fingertip is a complex structure that is responsible for the fine function of the fingers and the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious condition that if untreated properly could lead to significant functional disability and disuse of the injured finger. Up to date, defining the best treatment option for this injury remains controversial. Hand surgeons are divided between proponents of flap coverage and conservative treatment, driven by beliefs, training programs and financial aspects. After recently reviewing the literature for the current best evidence and fundamentals of conservative treatment, Krauss and Lalandei in their recent review of the literature, pointed out to the necessity for implementing controlled trials to compare both ways of treatment.

The purpose of this study is to determine the efficacy and the results of occlusive dressing in treating fingertip injuries in comparison to flaps with much concern to certain factors that are closely related to our locality including patient compliance for regular follow up , functional outcome , time to return to work and its socioeconomical impact and cosmetic results .

Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.

Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks

Eligibility Criteria:
Inclusion Criteria:

* a. Inclusion criteria:

  1. Age Adults 12 - 60 years
  2. Diagnosis of fingertip injury with exposed bone (Allen type 2, 3 or 4) in any finger.
  3. Informed consent obtained by the patient.

Exclusion Criteria:

* · Old or complicated fingertip injuries.

  * Non-exposed bone fingertip injury (Allen type1).
  * Patients with severe debilitating disease.