cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures

Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction, endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs) have been shown to result in a longer patency times as compared with plastic stents. However, despite improvements in materials and stent design, stent obstruction still occurs in 13% to 44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.

Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction. The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of the bile duct lumen. The procedure has the potential of reducing the rate of stent obstruction after SEMS and also prolonging survival. The safety profile appears to be comparable that of placement of SEMS alone without added complications (\<10%). The aim of the current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in a randomized controlled trial.We hypothesize that the application of EBRFA can reduce recurrent biliary obstruction after SEMS.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old with informed consent
2. Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
3. Inoperability by staging, comorbidities or patient wishes
4. Distal tumors 2cm away from the portal hilum
5. Bilirubin \> 50umol/L at diagnosis

Exclusion Criteria:

1. Periampullary tumours
2. Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria)
3. Presence of main portal vein thrombosis
4. Prior SEMS placement
5. Prior Billroth II or roux-en Y reconstruction
6. History of bleeding disorder or use of anticoagulation
7. Child's B/C cirrhosis
8. Pregnancy
9. Performance status ECOG ≥3 (confined to bed / chair \> 50% waking hours)
10. Presence of other malignancy
11. Presence of gastric outlet obstruction
12. Life expectancy \< 3months
WIReD: Wireless Interstage Remote Device Study

A mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/LAR and the feasibility of the collection of physiologic data related to the use of the Pediarity System. This system includes the Gabi Band and software platform (Gabi Analytics).

After enrollment, parents will be taught by the study team on the use of the Pediarity System which includes the placement of the Gabi Band and the use of the Gabi Wi-Fi monitor application for data transfer. This education by the study team will ensure uniform training and preliminary understanding with teach back on the use of the Gabi band and Gabi Wi-Fi monitoring application. Parents can ask the study team any use and/or technical questions during this time period. All clinical care questions from standard of care monitoring will go to the CHAMP healthcare team. If parents/LARs have a clinical concern from a value on the Pediarity System - they will be referred to use their standard of care pulse oximetry before any clinical intervention and care is recommended by the healthcare team. The study team will not make any healthcare or diagnostic recommendations during the monitoring period based on any Pediarity System data.

The study team will educate parents and LARs on the Pediarity System. This system does not replace any use of their standard of care pulse oximetry and CHAMP videos. Parents may place the Gabi band on their child and use the Pediarity System at any frequency they choose in the home setting for a length of approximately one month at home (to coordinate when they return to the study site for a care visit). Parents can email or Teams call the study team directly (during daytime hours M-F) for any technical questions during this the study period. The study team will evaluate clinical data only at the conclusion of the study period and qualitative feedback from the parents will be gathered.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will be parent-child dyads - pediatric patients who have been diagnosed with congenital, arrhythmic, or acquired heart disease at Children's Mercy Kansas City.
* Age criteria for children: after birth and who are less than two years of age at the time of being approached.
* The child of the parent-child dyad must be planned from the clinical standpoint prior to approach for discharge home with standard of care oxygen saturation/heart rate/pulse oximeter for remote patient monitoring population - and followed with the CHAMP application in the home setting.
* CHAMP App CM IRB 15030113 - Pediatric patients may be followed by the CHAMP Clinical team or enrolled in the CHAMP App Cardiac Study

Exclusion Criteria:

* Over two years of age at the time of being approached for study participation.
* Families that do not speak English or Spanish (languages supported by the devices).
* Families that do not have access to a Wi-Fi network at home.
Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement

The main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.

Background: The Center for Disease Control identified prescription drug abuse as one of the top 5 current health threats in the US. Orthopedic Surgeons rank among the top 3 prescribers of opioid analgesics. Opioids are commonly used following total knee arthroplasty. Peri- operative protocols have been developed to reduce opioid intake however complications related to opioid analgesics remain problematic resulting in increased morbidity and mortality. There is a pressing need for non-narcotic adjuncts that can minimize /eliminate the use of opioids following elective total knee arthroplasty (TKA). Mind-body techniques including mindful medication (MM) have been demonstrated to reduce pain in acute and chronic disease states.

Purpose: To determine whether mindful meditation, in conjunction with standard analgesic protocols, can impact opioid consumption, pain and function following elective primary TKA.

Methods: a prospective, randomized control trial was conducted in patients aged 18-99 with degenerative joint disease of the knee presenting for primary TKA. Controls received standard perioperative analgesia. In additional to standard analgesia, study patients performed Isha-Krya meditation peri-operatively for 2 weeks followed by 4 weeks post operatively. Outcome measures: opioid consumption, time to discontinue opioids, Pain by Visual Analog Score (VAS), Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) Global Health Short Form, Knee injury and Osteoarthritis Outcome Score (KOOS)

Eligibility Criteria:
Inclusion Criteria:

* • Male and female, ages 18-89 years

  * Narcotic naive patients ("Narcotic naïve" for the purpose of this study will be no history of narcotic tolerance prior to surgery, defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
  * Scheduled for primary total knee replacement for osteoarthritis
  * Willing to sign informed consent form

Exclusion Criteria:

* • Surgery to be performed for other disease entities (e.g., inflammatory arthritis, post septic arthritis, posttraumatic arthritis or acute fracture)

  * History of narcotic tolerance prior to surgery (defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
  * Currently taking non-narcotic analgesics other than acetaminophen and non-steroidal anti-inflammatory medications (e.g. Tramadol)
  * History of pain syndromes (e.g., fibromyalgia, complex regional pain syndrome, chronic low back pain)
  * Dementia or other disorder of cognitive function that precludes study consent and/or participation in the MM program
  * In investigator's opinion, unable to complete study tasks over 12-month follow-up period
Evaluation of Esophageal Injuries in Corrosives in Assiut Governorate - Experimental Comparison Between Different Treatments

Esophageal stricture is one of the most common sequelae of caustic injury. Up to 70% of patients with grade IIB and more than 90% of patients with grade III injury are likely to develop esophageal stricture. Stricture formation can be prevented by suppressing fibrosis and scar formation therefore; many agents are explored for treatment on various models in this subject.

In spite of the multiple efforts to educate the public, Caustic ingestion maintains its place as an important public health issue due to the availability of caustic agents and the loose regulatory control on its production. All the cases will be evaluated by detailed history and thorough physical examination and necessary investigations. Patient's sheet will include; name, age, sex, occupation, residence, type of administrated substance, route and mode of exposure, symptoms and sighs (pain , vomiting , diarrhea) and any received treatment.

Eligibility Criteria:
Inclusion Criteria:

-1- All the cases with the primary diagnosis of acute caustic injury will be included in the study.

2- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

* 1- Caustic substance ingested patient with any chronic disease. 2- Patients with history of congenital esophageal stricture. 3- Unable to provide informed consent. 4- Unlikely to return at 8 weeks. 5- Ingestion of substances other than corrosive (co-ingestion).
Care Package for Preventing Pressure Ulcers in ICU Patients

The aim of this study is to evaluate the effectiveness of the care package (CP) developed to prevent pressure injury (PI) in patients in intensive care and to evaluate the effect of the training given to nurses on their knowledge levels and attitudes.

This experimental study was carried out in the anesthesia and reanimation intensive care unit of Düzce Atatürk State Hospital. The part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group. The occurrence rate of PI was compared between the control group and the application group. In the section about nurses, no sample was selected and all 50 nurses working in intensive care were included in the study. Nurses' knowledge and attitudes about PI before and after the training were compared. Data were analyzed using a statistical program.

Eligibility Criteria:
Inclusion Criteria:

* - 18 years of age or older,
* No development of pressure ulcers in any part of the body,
* Patients expected to stay in the clinic for at least 72 hours or more
* patients with a braden score below 15 points
* Obtaining written consent from the first-degree relatives of patients whose written consent is obtained, patients who are unconscious and unable to give consent

Exclusion Criteria:

* - 18 years of age or younger,
* BY in any part of the body,
* BBYRDS score more than 15
* Failure to give written consent by himself/herself or his/her 1st degree relative
* Exitus, discharge, change of department and the patient's wish to leave the study before completing the number of days determined during the data collection phase
Promoting Cervical Cancer Screening for Emergency Department Patients

The purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. Cervical cancer screening is an important part of cervical cancer prevention. The study team will determine if the patient is currently up-to-date with cervical cancer screening recommendations. If the patient is not up-to-date, then they will be randomly assigned to one of two interventions. One intervention consists only of referral to a women's health care provider to obtain cervical cancer screening. The other intervention consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* Registered patient in the Emergency Department of the University of Rochester Medical Center
* Women
* Age 21 - 65

Exclusion Criteria:

* Past hysterectomy with cervical removal
* Known infection with HIV (screening recommendations for women with HIV differ from the general population)
* Non-English speaking
* Inability to consent
* Lack of text-capable mobile phone and/or inability to use text function
Evaluation of Trigeminal Nerve Blockade

Cleft palate repair requires high doses of opioids for pain control postop. An alternative approach is placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve \& covering the entire midface. Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve may provide effective analgesia for cleft lip repair, improving time to oral intake, pain control and time to hospital discharge.

Cleft palate is a common congenital anomaly for which surgical repair is indicated during early childhood. The surgical repair of cleft palate is very painful, and generally requires high doses of opioids for adequate pain control, placing children at risk for post-operative respiratory depression and airway obstruction. An alternative approach to post-operative analgesia for cleft palate repair is the placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve and covering the entire mid-face. This randomized, double-blinded study will investigate the utility of maxillary nerve blockade in controlling post-operative pain, decreasing opioid requirements, improving post-operative oral food and drink intake, and decreasing hospital length-of-stay after cleft palate repair.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting for palatoplasty for cleft palate only.
* Parent/guardian consents to participate
* Normal oral food and water intake before surgery
* No underlying chronic pain condition

Exclusion Criteria:

* Parent/guardian refuses to consent
* Patient requires revision surgery on the palate
* Patient requires surgery in addition to palatoplasty, including, but not limited to pharyngeal flap or soft palate lengthening procedures.
* Any underlying chronic pain condition
* Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
* Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
* History of Pierre Robin sequence
* Planned or anticipated need for any type of artificial airway post-op
MRI-based Artificial Intelligence Software (NNS-SOT) for Onset Time Estimation in Lesion With Acute Ischemic Stroke

This study evaluates the efficacy of investigational device named Stroke Onset Time Artificial Intelligence(AI) (Model name:NNS-SOT). Using the investigational device, analyze the image and the onset time of occurrence of acute ischemic stroke lesion on the brain image (4.5 hours or more from the onset of symptoms) and evaluate the efficacy of correctly estimating the onset time.

This clinical trial software medical device (Model name: NNS-SOT) is developed based on artificial intelligence algorithms.

Through clinical validation, it will be easier to determine whether the golden hour (4.5 hours) has elapsed at the time of cerebral infarction in the medical field. It can be used for estimation of the onset time of occurrence in acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Brain imaging in patients with acute ischemic stroke aged 20 years and older
* Brain imaging of ischemic stroke manifestation lesion confirmed by medical staff in brain MR image
* Brain imaging taken within 24 hours of ischemic stroke symptoms
* Brain imaging including Magnetic Resonance(MR) images (DWI and FLAIR)
* Patients with clearly recorded onset time of acute ischemic stroke symptoms

Exclusion Criteria:

* Brain imaging used in NNS-SOT development process
* Brain imaging with noise (Artifact)
* Brain images damaged in data
Drug Order for Rapid Sequence Intubation

This is a randomized, blinded trial comparing the order of drug administration for rapid sequence intubation in the Emergency Department.

Based on data (excluding outliers) from protocol 16-4146, the intubation time with the paralytic and sedative first administered is 86 s, and 93 s, respectively, with a standard deviation of approximately 25-30 s. Using these assumptions, 470 patients (235 per group) will need to be enrolled to detect an 7 s absolute difference between groups with 80% power.

Because a greater difference is anticipated in those who receive rocuronium rather than succinylcholine (because succinylcholine takes action faster), goal enrollment is 470 patients who receive rocuronium as the paralytic who are intubated successfully on the first attempt. The total enrollment will be higher, accounting for those who receive succinylcholine and those who are not successful on the first attempt. The data for those who receive succinylcholine first will be reported and is planned to be used to determine the feasibility of a future trial.

The primary group of analysis will be those receiving rocuronium, because this medication acts somewhat slower than succinylcholine. Patients who receive either drug will be analyzed, but it is pre-specified that the group of interest are those receiving rocuronium.

The primary outcome, first intubation attempt duration, and apnea duration will be measured only in those with a successful first attempt because these timing events will be confounded by attempt failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order.

The remainder of the outcomes will be measured in all enrolled subjects in an intention to treat analysis.

An analysis for patients by RSI drug order actually received, regardless of treatment allocation, will also be presented.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be undergoing orotracheal intubation in the Emergency Department
* The patient must be receiving both a sedative and paralytic immediately prior to intubation (i.e. undergoing rapid sequence intubation).
* The patient must be presumed to be 18 years of age or older at the time of enrollment.

Exclusion Criteria:

* Prisoner or in custody
* Known or suspected to be pregnant, based on the opinion of the attending physician.
* Intubation performed by a physician assistant (this is rarely done in our ED; each physician assistant intubates less than twice per year, so the intubation outcomes would hinge more on their experience rather than drug order).
Stem Cell Transplantation for Hurler

The purpose of this study is to determine the safety and engraftment of donor hematopoietic cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming) cell transplant for Hurler syndrome, Maroteaux Lamy syndrome, Mannosidosis, or I-cell disease.

Prior to transplantation, subjects will receive Busulfan intravenously (IV) via the Hickman line four times daily for 4 days, Cyclophosphamide intravenously via the Hickman line once a day for 4 days, and Anti-Thymocyte Globulin IV via the Hickman line twice daily for three days before the transplant. These three drugs are being given to subjects to help the new marrow "take" and grow.

On the day of transplantation, the donor's hematopoietic cells will be transfused via central venous catheter.

After hematopoietic cell transplant, subjects will then receive two drugs, cyclosporin and either methylprednisolone or Mycophenolate Mofetil (MMF). Cyclosporin and methylprednisolone or MMF are given to help prevent the complication of graft-versus-host disease and to decrease the chance that the new donor cells will be rejected.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Mucopolysaccharidosis, type I (e.g., Hurler syndrome), Maroteaux-Lamy syndrome (MPS VI), Alpha Mannosidosis, or mucolipidosis type II (I-cell disease) who have an HLA-identical or mismatched (at 1 antigen) related marrow, PBSC, or cord blood donor.
* Patients with Mucopolysaccharidosis, type I, Maroteaux-Lamy syndrome (MPS VI), Alpha Mannosidosis, or mucolipidosis type II (I-cell disease) who have an HLA-identical or HLA-1 antigen mismatched unrelated marrow, PBSC, or HLA-0-2 antigen mismatched umbilical cord blood donor.
* Patients with MPS type I, Maroteaux Lamy Syndrome (MPS VI), or mucolipidosis type II (I-cell disease) will have a mental developmental index within two standard deviations of the normal mean, as best as can be determined using Bayley scales of infant development or other standardized testing, recognizing that these may be affected by speech and/or hearing impairment.
* Adequate organ function:
* Cardiac: ejection fraction \>40%; no decompensated congestive heart failure or uncontrolled arrhythmia
* Renal: serum creatinine \<2.0 mg/dl
* Hepatic: total bilirubin \<3x Upper limits of normal transaminases \< 5.0 x Upper limits of normal
* Signed consent.

Exclusion Criteria:

* Presence of major organ dysfunction (see above)
* Pregnancy
* Evidence of HIV infection or known HIV positive serology
* Patients or parents are psychologically incapable of undergoing BMT with associated strict isolation or documented history of medical non-compliance
* Patients \>50 kg may be at risk for having cell doses below the goal of ≥ 10 x 106 CD 34 cells/kg and therefore will not be eligible to receive unrelated PBSCs.