cyrilzakka/clinical-trials huggingface dataset:
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP

This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.

PRIMARY OBJECTIVE:

I. To compare the incidence of desaturation (oxygen saturation \[SpO2\] \< 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula.

SECONDARY OBJECTIVES:

I. To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation).

II. To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support.

III. To evaluate the incidence of adverse events. IV. To evaluate times related to anesthesia and procedure (defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively).

V. To evaluate time from procedure end to anesthesia end. VI. To describe hemodynamics within the two groups (recorded blood pressures, heart rates, oxygen saturations, and end tidal carbon dioxide \[CO2\]).

VII. To evaluate anesthesiologist placing the device (training video viewed, number of practice attempts, years of experience).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo ERCP with LMA Gastro.

ARM II: Patients undergo ERCP with standard nasal cannula.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>= 18 years old) undergoing ERCP

Exclusion Criteria:

* Patients with propofol allergy
* Patients at increased aspiration risk
* Patients with abnormal head/neck pathology preventing LMA Gastro placement
* Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
* Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past
* Esophagectomy patients
* Patients already intubated upon arrival to endoscopy suite
* Patients undergoing endoscopic ultrasound (EUS)
* Patients with body mass index (BMI) \>= 35 kg/m\^2
* Patients with hypoxemia (SpO2 \< 94% on room air or on home oxygen)
* American Society of Anesthesiology (ASA) Physical Status IV-V
Effect of Cough Assist Device in COPD Patients Admitted to Respiratory Intensive Care Unit at Assiut University Hospital

1. To evaluate the effecacy of cough assist device (CAD) in COPD patients admitted in RICU either on invasive or Non-invasive ventilation.
2. To detect any possible complications associated with the use of cough assist device.

Effective cough is a protective mechanism against respiratory tract infections. COPD patients may have impaired cough and a reduction in peak cough flows(PCF) as a result of inspiratory and expiratory muscle weakness, which causes a reduction in the pressure available to drive the cough manoeuver.

Cough augmentation with mechanical Insufflation-Exsufflation (MI-E) has been described as a technique that facilitates airway secretion clearance in COPD patients, thus avoiding hospitalisations and preventing pneumonias and episodes of respiratory failure .

Cough augmentation techniques comprise lung volume recruitment, (also termed air stacking or breaths tacking), mechanically assisted cough using mechanical insufflation-exsufflation (MI-E) device. During lung volume recruitment, the person inhales a volume of gas via the ventilator, or self-inflating resuscitation bag adapted with a one-way valve to facilitate gas holding. The person retains the inhaled volume by closing the glottis, inhales another volume of gas and then again closes the glottis; this process is repeated until maximum insufflation capacity is reached MI-E devices deliver a positive (inflation) and negative pressure (rapid deflation) delivered to the person via an oronasal interface, mouthpiece, or endotracheal or tracheostomy tube. MI-E comprises a pressure -targeted lung insufflation followed by vacuum exsufflation, enabling lung emptying and increasing peak cough flow. Alternation of pressure may be manually or automatically cycled. Pressures of 40 mmHg (insufflation) to 40 mmHg (exsufflation) (54 cmH2O) are usually most effective and best tolerated by the person .

Treatments usually comprise three to five insufflation-exsuflation cycles followed by a short period of rest to avoid hyperventilation. Treatments can be repeated until no further secretions are expectorated. MIE can be performed in isolation or in combination with manually assisted cough .

Few complications associated with MI-E devices as a drop in oxygen levels, barotrauma elevated blood pressure for more than 30 minutes have been reported, most likely due to use of pressures that are much lower than physiological cough pressures and the short duration of application .

Eligibility Criteria:
Inclusion Criteria:

* All COPD patients above 18 years old who admitted to RICU.

Exclusion Criteria:

* • All patients who have: neuromuscular diseases, pulmonary oedema, cardiac arrest, cardiogenic shock, acute myocardial infarction, pneumothorax, pulmonary neoplasm, pulmonary thromboembolism.
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.


Eligibility Criteria:
Inclusion Criteria:

* Is aged 12 to \<18 years.
* Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization.

Exclusion Criteria:

* Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization.
* Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months.
* Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization.
* Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.
* Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study.
* Is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. Cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.
A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions

Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.


Eligibility Criteria:
Inclusion Criteria:

1. Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator)
2. Patients with PHN must have had pain \>3 months after rash healing
3. Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration
6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration
7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration
8. Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)
9. Had never received an analgesic regimen that contained lidocaine or gabapentin

Exclusion Criteria:

1. Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study
2. Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine
3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 20-90 years old.
* New York Heart Association (NYHA) class III-IV heart failure
* Followed by the Congestive Heart Failure (CHF) clinic in Nazareth
* Left ventricular ejection fraction \<35%
* Requiring treatment with \>40mg/day of furosemide\* orally or with repeated bolus or intravenous infusion of furosemide\* (\*or equivalent bumetanide or torasemide).

Exclusion Criteria:

* Pregnancy
* Subjects who have received a heart transplant.
* Subjects who are unable or unwilling to follow the study requirements.
* Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
* Patients with skin breakdown in areas on the chest where device and electrode placement is required
Ketamine Compared to Propofol for Pediatric GI Endoscopy

Elective outpatient endoscopy for children can be safely performed under general anesthesia with either propofol (1) or ketamine (2) infusions. Both infusions have an advantage over general anesthesia with volatile agents because they do not require intubation. The goal of both infusions is to have the patient breath spontaneously without reacting to the endoscopy which is a noxious stimulus. Patient movement, stridor and vomiting are can interrupt the procedure and increase overall OR time. Propofol also carries the added risk of causing apnea. This side effect is not commonly seen with Ketamine. Our hypothesis is that Ketamine's profile makes it a superior drug to Propofol for elective outpatient endoscopy because of reduced profound intra-operative interruptions and faster recovery time. We plan a study of pediatric patients ages 1 to 10 years old undergoing elective outpatient endoscopy. The patients will be randomized to receiving either a Ketamine or Propofol infusion, and the intra-operative interruptions will be documented by the anesthesiologist. The Post Anesthetic Care Unit (PACU) time to recovery will be monitored and recorded by a third party.


Eligibility Criteria:
Inclusion Criteria:

* Age 1-10
* Endoscopy with sedation scheduled

Exclusion Criteria:

* A history of chronic respiratory disease
* Upper respiratory infection
* Developmental delays
* Dysrhythmias
* Increased intercranial pressure
* Any sedatives or narcotics up to 6 weeks prior to procedure.
Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents

The aim of this study is to investigate the effectiveness of a computer-based Cognitive Behavioral Therapy (CCBT) and online stress management program for adolescents, and identify the characteristics of depressed adolescents that participate in the programs.


Eligibility Criteria:
Inclusion Criteria:

* adolescents that scored above the threshold for mild depression (PHQ, CES-D)

Exclusion Criteria:

* adolescents with severe depression/neuropsychiatric conditions
A Development Plan of in Vitro Diagnostics of Immuno Magnetic Reduction Assay - A Rapid Etection Kit of Enterobacteraceae in Blood or Blood Culture

This plan is to develop blood culture or to measure diagnostics of Immuno Magnetic Reduction assay in the first stage.


Eligibility Criteria:
Inclusion Criteria:

* emergency cases
* blood culture of positive and negative cases which storage in 4℃ every day

Exclusion Criteria:

* not emergency cases of blood culture
A Clinical Trial to Prevent New Onset Diabetes After Transplantation

Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in decreasing the incidence of NODAT among de novo kidney transplant patients with manifested post-transplant hyperglycemia during the first week after transplantation.

Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress related to the surgery and use of higher doses of immunosuppressive medications, and leads to lower incidence of NODAT at 1 and 2 years.

Specific Aim 2: To determine the improvement in overall glycemic control with the early initiation of insulin therapy.

Hypothesis 2: Early initiation of insulin therapy results in greater overall control of glycemia compared to standard care of dietary counseling, life-style modification, oral hypoglycemic agents and/or insulin as needed at 1 year.

Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to the early initiation of insulin therapy at one year post-transplantation.

Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of post-transplant hyperglycemia and preserves better beta-cell function at 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (\> 18 years) with end stage renal disease (ESRD) undergoing kidney transplantation;
2. Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate mofetil and corticosteroids;
3. Capable to understand the study protocol and to give informed consent;

Exclusion Criteria:

1. Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;
Prospective Observational Study of the Power PICC Family of Devices and Accessories

Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.

Single-arm, post-market, observational, prospective study to asses the safety and performance of the Power PICC Power PICC family of devices and its accessories in a real-world setting. The study will only enroll patients that need a Power PICC catheter as part of their medical care. Patients will be followed from insertion through removal, or up to 180 days (whichever comes first). Data collected will be gathered from the patient's medical chart.

Eligibility Criteria:
Inclusion Criteria:

* Any patient, regardless of age or gender, for which the investigator has decided that one of the PowerPICC study devices for either short-or long-term venous access should be inserted as standard of care
* Expected to be available for observation through the duration of PICC therapy (including outpatient therapy, if applicable)
* Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)

Exclusion Criteria:

* Presence of any device-related infection, bacteremia, or septicemia is known or suspected
* Body size is insufficient to accommodate the size of implanted device
* Known or suspected to be allergic to materials contained in the device
* History of irradiation of prospective insertion site
* Previous episode(s) of venous thrombosis or vascular surgical procedures at the prospective placement site
* Local tissue factors which would prevent proper device stabilization and/or access
Community-based Venues for Delivery of Healthcare Services: Proof of Concept Pilot

The investigators propose to offer a package of evidence-based health services to women in two hair salons in the Umlazi township of Durban. Based on community feedback in previous survey and qualitative work, the package has been designed to include daily PrEP, family planning/contraceptives, and STI screening. Interested salon clients at intervention salons will elect which services to use. An additional salon will serve as control, offering no health services to clients. Surveys will be conducted in both salon groups. Attendance at follow-up visits for monitoring and medication refill will be encouraged using text message reminders, WhatsApp support groups, and lottery-based incentives for free salon services. Recruitment in intervention salons will conclude when 100 clients uptake PrEP, not inclusive of clients who enroll at intervention salons who accept other services through the study. Approximately 250 participants will be recruited in control salons. The study team anticipates an overall total enrollment of 500.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years or older
* English or Zulu speaking
* Able and willing to consent

Exclusion Criteria:

* Symptoms of acute HIV viral syndrome
* Known pregnancy at baseline
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* successful completion of Bonviva study BM16549, with at least 75% compliance;
* ambulatory.

Exclusion Criteria:

* malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
* breast cancer diagnosed within the previous 22 years.
Conversational IT for Better, Safer Pediatric Primary Care

Interactive telephony technologies offer a potentially highly effective, patient-centered communication modality by guiding parents at home through interactive discussions that can gather information and actively reinforce recommendations and treatments. Interactive telephony systems are particularly well suited for use in vulnerable populations since access to the telephone is nearly universal, and the system does not rely on reading printed text. The investigators propose to develop and evaluate an integrated patient-centered health information system, the Personal Health Partner (PHP). The PHP will use fully automated, interactive, conversations to gather personal health data and counsel parents before scheduled visits, exchange that data with the child's primary care clinician via the electronic health record (EHR), and offer personalized follow-up assessment and counseling after visits. The information technology-based approach to be evaluated in this project will link parents and children outside the clinical setting with their primary care center and will offer comprehensive assessments AND counseling to reinforce and support parental behavior change.

A large gap exists between what is recommended for effective primary care of children and what actually takes place in pediatric primary care settings, especially in the areas of preventive care. Furthermore, although medication management (safety and effectiveness) issues have emerged as an important factor for children, little is known about how medication is actually used by families at home.

With growing use of the electronic health record (EHR) come new opportunities to link patient-centered information with clinical health information systems. Linkage of these systems has the potential to inform and activate parents, provide much richer data to drive decision support at the point-of-care, and to provide ongoing support for long-term behavior change following primary care visits. The use of conversational technologies as the foundation for the project offers a number of unique advantages especially the support of lower-literacy populations and near-universal access. Systems like the Personal Health Partner (PHP) represent a model for the future of ambulatory care and the sustainable, affordable delivery of higher quality and safer care by primary care clinicians in the future.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children will be enrolled in the study if they meet a set of eligibility criteria which includes:

  1. Age 0 - 11 years old
  2. A primary care patient at Boston Medical Center
  3. An English speaking child and parent.

Exclusion Criteria:

* Children will be considered ineligible for the study if they plan to move away from the Boston area in less than 3 months, or are participating in another primary care research project with content that overlaps the content within this study. Currently, there are no studies being conducted that would lead to exclusion.