cyrilzakka/clinical-trials huggingface dataset:
Response to Diaphragmatic Pacing in Subjects With Pompe Disease

The purpose of this study is to determine the effect of diaphragm pacing on respiratory function in subjects with Pompe disease by evaluating the duration and pattern of spontaneous respiratory function versus paced ventilation respiratory function in patients with Pompe disease who have received the NeuDx Diaphragm pacer (DPS).

Subjects with Pompe disease who are scheduled to receive a NeuRx Diaphragm pacer (DPS) will be invited to participate in this study. The following tests will be performed during participation in the study:

1. Forced expiratory tests
2. Maximal Inspiratory Pressure (MIP)
3. Resting Breathing Pattern
4. Phrenic Nerve Function Evaluation with EMG
5. Severe Respiratory Insufficiency Questionnaire
6. Magnetic stimulation
7. Diaphragm conditioning consisting of:

   1. The external stimulator settings
   2. The duration of diaphragm stimulation
   3. Off-ventilator spontaneous breathing (SB)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Pompe disease as defined by mutational analysis, GAA enzyme activity assay in blood spot, and/or fibroblast culture less than 40% of control value
* Medically and functionally eligible for NeuRx DPS implantation, as determined by a clinical surgical evaluation. The surgeon will determine eligibility through pulmonary function tests, ability to stimulate your diaphragm, and arterial blood gas levels. Eligibility may also be determined by your response to traditional respiratory strengthening exercises without a pacemaker.
* History of mechanical ventilation dependence (six or more hours of invasive or non-invasive mechanical ventilation support daily for at least 21 days in duration

Exclusion Criteria:

* Current participation in another treatment study (other than enzyme replacement therapy) directed at improving diaphragm function
* Unable to complete pulmonary function testing
Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older.
* Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.
* Normal lip, nose, eyelid, and cheek sensation.
* Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.
* Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
* Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
* Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Exclusion Criteria:

* Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).
* Inadequately controlled active thyroid disease of any type.
* Frequent nose bleeds (≥ 5 per month).
* Having received dental care requiring a local anesthetic within the last 24 hours.
* History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
* History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
* Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
* Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
* Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.
* Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
* History of congenital or idiopathic methemoglobinemia
Quantitative Measurement of ARI

A crucial step at end of debonding is to evaluate the site of bond failure. An accurate assessment of the site of bond failure will allow the clinician to select an optimum method for adhesive remnant removal from the enamel surface.

The aim of this study is to do a randomized clinical trial to measure adhesive remanent index quantitively after debonding with wing and base method of debonding

After informed consent data would be collected from patients who are undergoing debonding of orthodontic brackets after comprehensive orthodontic treatment of at least 2 years. Only the cases which have no loose anterior upper and lower brackets for the last 6 months would be randomly allocated to one of the two sides in each arch for debonding with a specific technique. A protocol of block randomization would be followed for this study. Debonding of brackets would be done either by wing or base method in a split fashion after removal of orthodontic wires. The patient would be explained that both methods are conventional used and are safe for debonding. After debonding each bracket the patient would be asked for the level of pain he felt during the debonding of that specific bracket. The patient will explain the pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain. After debonding a digital microscope (Supereyes) would be used along with plastic tubing for taking the adhesive remanent pictures intraorally from the labial surface of teeth. The plastic tubing would have a calibrated scale attached to it. For each new patient, a new tubing or disinfected tubing would be used. The available data would be measured extra orally on a computer-based software (ImageJ). Variable like age, gender, oral hygiene, ARI, side of adhesive flush, and pain would be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* All the patients undergoing comprehensive orthodontic treatment by fixed orthodontics
* No reporting of bracket failure in the last 6 months.
* Same company metal brackets used.
* Same adhesive used with same bonding protcol

Exclusion Criteria:

* Syndromic patient
* An episode of bracket failure in the last six months
* Short-term orthodontic treatment
Fosamprenavir Expanded Access

This open-label study will enable HIV-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in Switzerland.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected subjects.
* Subjects must belong to one of the following populations:

  1. Subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs.
  2. Subjects who already receive amprenavir (Agenerase®)
  3. Subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.
EVALUATİON of the EFFECTS of RİBOSE CROSS-LİNKED THİCK COLLAGEN MEMBRANES WİTH CONNECTİVE TİSSUE GRAFTS on SOFT TİSSUE and POST-OPERATİVE PATİENT COMFORT İN AREAS WİTH PERİ-IMPLANT SOFT TİSSUE DEFECTS

Aim:Methods to increase peri-implant mucosa thickness (PIMT) in cases of soft tissue deficiency are important to maintain peri-implant health and aesthetics. The aim of this study was to compare the effect of ribose cross-linked thick collagen membrane (RCCM) compared to subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant.

Materials and Methods:In our study, single implant sites in 20 systemically healthy patients were included. 10 patients were operated simultaneously with the implant operation and 10 patients were operated simultaneously with the implant operation. Before the operation, PIMT and peri-implant mucosa width (PIMW) were measured. Visual analog scale (VAS) and oral health impact profile-14 (OHIP-14) scores were recorded on post operative days 1, 3 and 7. At 1 and 3 months, VAS and OHIP-14 measurements were repeated.

Keywords:Connective tissue graft, Collagen membrane, Soft tissue, Peri-implant mucosa thickness, Peri-implant mucosa width.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy
* The edentulous space for which implant treatment is planned to be single tooth size and molar tooth site
* Those with soft tissue deficiency in the horizontal aspect in the site where implant treatment is planned
* Age between 18-60 years
* Does not have a condition that may cause a bleeding disorder
* No nausea-vomiting reflex
* Patients with good oral hygiene

Exclusion Criteria:

* Patients with systemic disorders (diabetes, hypertension, radiotherapy/ chemotherapy, etc.)
* Patients who have insufficient horizontal alveolar bone in the site where implant treatment is planned and who may lead to bone dehiscence after implant placement
* Patients with collagen allergy
* Those taking any medication that may affect wound healing
* Those with bleeding disorders
* Smokers who smoke more than 10 cigarettes a day
* Poor oral hygiene
* Those with vomiting-nausea reflex
* Allergic to anti-inflammatory drugs
* Patients with pregnancy/breastfeeding status.
Penpal Loneliness Project

The purpose of this research is to study whether sending letters helps reduce loneliness for either the facility resident or the teenager.

Hypothesis: Our hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness

Aims, purpose, or objectives:

Our objective is to reduce loneliness and increase quality of life for patients residing in residential care facilities and for high school students.

Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):

In response to the Covid pandemic, to protect their residents, residential care facilities have implemented restrictions limiting visitors as well as social activities. Anecdoctally this has negative impacted the quality of life of those residents, increasing their loneliness. Previous studies have shown positive impact of intergenerational programs including penpal programs.

Eligibility Criteria:
Inclusion Criteria:

* Care facility residents with capacity to make decisions:
* Measured via their most recent cognitive assessment;
* Subjectively measured via nursing staff.
* High school students will be invited via recommendation of their instructors and school administrative staff:
* Parental permission will be required.

Exclusion Criteria:

* Care facility residents that have significant cognitive impairment.
* Residents who lack decision-making capacity.
Cervical Foley Plus Vaginal Misoprostol for Labor Induction

The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.

More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* vertex presentation
* unfavorable cervix(Bishop's score less than or equal to 6)
* greater than 24 weeks gestation

Exclusion Criteria:

* fetal malpresentation
* multifetal gestation
* spontaneous labor
* more than 5 uterine contractions in 10 minutes
* contraindication to prostaglandins
* non-reassuring fetal heart rate tracing
* intrauterine growth restriction
* anomalous fetus
* fetal demise
* previous cesarean delivery or other significant uterine surgery
Wellness Achieved Through Changing Habits (The WATCH Study)

The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.

Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention.

The intervention will include 15 sessions over 6 months.

A post-treatment visit will occur.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent girls between ages 14-19 with overweight or obesity above the 85th percentile for sex and age as determined by CDC growth charts

Exclusion Criteria:

* Known pregnancy or plans to become pregnant in the next 2 years
* Any condition prohibiting physical activity
* A diagnosis of cardiovascular disease or diabetes
* Have active cancer or cancer requiring treatment in the past 2 years
* Have active or chronic infections (e.g., HIV or TB)
* Have active kidney disease or lung disease
* An eating disorder or substance abuse disorder
* Having begun a course of or changed the dosage of any medications known to affect appetite or body composition within the previous 3 months
* Weight loss greater than or equal to 5% in the previous 6 months
* If they do not follow the study plan
Leber Congenital Amaurosis Inherited Blindness of Gene Therapy Trial(LIGHT)

The purpose of the study is to determine whether HG004 as gene therapy is safe and effective for the treatment of Leber Congenital Amaurosis caused by mutationsin RPE65 gene.


Eligibility Criteria:
Inclusion Criteria:

* Male or females between 8 and 50 years of age at the time of signing theinformed consent form.
* Willing to adhere to protocol as evidenced by written informed consent orparental permission and subject assent.
* Clinical confirmed diagnosis of Leber congenital amaurosis (LCA) andmolecular diagnosis of LCA due to RPE65 mutations.
* Ability to perform tests of visual and retinal function.
* Visual acuity of ≤ 20/160 or visual field less than 20 degrees in the eye to beinjected.
* Acceptable hematology, clinical chemistry, and urine laboratory parameters.

Exclusion Criteria:

* OCT examination determined that the outer nuclear layer was not visible inthe planned injection area (Bleb) in the study eye.
* Presence of epiretinal membrane by OCT.
* Complicating systemic diseases or clinically significant abnormal baselinelaboratory values.
* Complicating systemic diseases would include those in which the diseaseitself, or the treatment for the disease, can alter ocular function.
* Prior ocular surgery within six months.
* Prior gene therapy or oligonucleotide therapy treatments.
* Any other condition that would not allow the potential subject to completefollow-up examinations during the study and would, in the opinion of theinvestigator, make the potential subject unsuitable for the study.
Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial

Exclusion Criteria:

* Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator
Function Following Thumb MP Fusion and IP Fusion

This study is to determine function following simulated thumb metacarpophalangeal (MP) and thumb interphalangeal (IP) joint fusion. The investigators want to determine the functional limitation created by MP and IP joint fusion. 20-30 volunteers will be fitted for custom molded orthoplast splints immobilizing either the MP or IP joint. The volunteers will then be taken through multiple tests including lateral pinch strength, tip pinch, grip strength, grooved pegboard test time, and Jebson Taylor test. Each patient will be tested without a splint, with their MP joint immobilized and with their IP joint immobilized. The results of this study can be used for patient education before surgery in order to help them make informed decisions as well as manage expectations. It can also serve as a decision aid in pinch restoration in the context of ulnar nerve palsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a healthy volunteer
* Patient is willing and able to review and sign a study informed consent form

Exclusion Criteria:

* Any subject who does not want to voluntarily participate.
Assessment of Diagnostic Adequacy of AI-assisted Point-of-Care Echocardiography Among Anesthesiology Trainees

This pilot study serves to assess the diagnostic adequacy of Artificial Intelligence (AI)-guided point-of-care. Focused echocardiography examinations will be obtained by Anesthesiology trainees and assessed by an expert Cardiologist Echocardiographer. AI-guided echocardiography examinations will be compared to each other. AI-guided and non-AI-guided echocardiography examinations will also be compared.

This pilot study will involve Post-Graduate Year 2 Anesthesiology trainees on rotation in the Loma Linda University Medical Center operating rooms. Prior to participation, the trainees will give written informed consent to participate in the study and complete a baseline questionnaire to collect information regarding prior education in point-of-care echocardiography and the number of those examinations personally performed prior to study participation. All subjects will watch a brief training video about the AI guidance platform and participate in a hands on training session to familiarize themselves with AI guidance.

When adult patients having anesthesia for procedures present with a clinical indication for peri-anesthesia point-of-care echocardiography examination, the assigned trainee will use the AI-guided system to obtain a standardized point-of-care focused cardiac examination. Subjects will be completing 11 total examinations, 10 using AI guidance, 1 without.

Images of the examination will be assessed by an expert Cardiologist Echocardiographer that is blinded to the resident involved to measure diagnostic adequacy.

A final non-AI-guided echocardiogram examination will be completed by the resident to measure and compare the time and adequacy of the images to the AI-guided examination images.

Eligibility Criteria:
Inclusion Criteria:

* Loma Linda University resident in Anesthesiology
* Post-Graduate Year 2

Exclusion Criteria:

* Residents not a part of a Loma Linda University residency program
* Residents not a part of an Anesthesiology residency program
* Loma Linda University Anesthesiology Post-Graduate Year 1 Residents
* Loma Linda University Anesthesiology Post-Graduate Year 3 Residents
* Loma Linda University Anesthesiology Post-Graduate Year 4 Residents
Triathlon Tritanium Knee Outcomes Study

The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.

Cases are to be enrolled at five to ten centers. The same center may be included in both arms. Conversely, a center may choose to participate in only a single arm. The enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the number of participating centers. Although a goal is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the enrollment goal, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) or Ethics Committee (EC) approval. Non-compliance of a study center may result in termination of the center's participation in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female age 18-75 years at time of study device implantation.
3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has a Body Mass Index (BMI) \> 40.
2. Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
3. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
4. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
5. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
6. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
7. Patient is diagnosed with lumbar radicular pain.
8. Patient has a known sensitivity to device materials.
9. Patient is a prisoner.