cyrilzakka/clinical-trials huggingface dataset:
Esophageal Fully Covered Metal Stents in Caustic Strictures Study

The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Also to collect data in support of a hypothesis required to prospectively document the safety and effectiveness of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) compared to repeated Bougie Dilation for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Eligibility Criteria:
Inclusion Criteria:

1. Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
2. Availability of patient history pertaining to weight prior to and at completion of SECSER.
3. Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
4. Single esophageal stricture or multiple esophageal stricture over a length \< 6 cm.
5. Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator.
6. Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
7. Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
8. Unable to pass a standard endoscope (approximately 9.8 mm diameter).
9. Age 18 years or older.
10. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Stricture within 2 cm of the upper esophageal sphincter.
2. Concomitant Esophageal ulcerations.
3. Prior esophageal stent placements.
4. Concurrent gastric and/or duodenal obstruction.
5. Patients with prior full or partial gastrectomy.
6. Sensitivity to any components of the stent or delivery system.
7. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
8. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established.

Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.

This randomized controlled trial of consenting women undergoing induction of labor with combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal misoprostol route of administration.

This project will include 216 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with misoprostol. Following admission, women will be randomized into either vaginal or buccal misoprostol.

Women will be randomized with equal probability to the intervention group using block randomization stratified by party.

Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The remainder of labor management will be at the discretion of each woman's obstetric provider.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* full term (≥37 weeks) gestations determined by routine obstetrical guidelines
* singleton gestation in cephalic presentation
* Both nulliparous and multiparous women
* Intact membranes
* Cervical dilation ≤2cm

Exclusion Criteria:

* Any contraindication to a vaginal delivery or to misoprostol
* fetal demise
* Multifetal gestation
* prior uterine surgery, previous cesarean section
* Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods
* women with HIV, and women with medical conditions requiring an assisted second stage
* Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction \<10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction \<5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies

As described in previous research (Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(6):1357-1364)
Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.

Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.

Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.

Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.

Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.

Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.

Follow up of subjects was 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
* Identifiable CEJ on all teeth
* Age ≥ 18
* Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
* No past surgical treatment history of affected area.
* Gingival thickness ≥ 0,8 mm for recession areas.
* Sufficient palatal donor tissue for connective tissue harvesting.

Exclusion Criteria:

* Smoking
* Pregnancy or lactation
* Systematic diseases that may affect outcomes of periodontal therapy
* Self-reported antibiotic medication within three months
* Occlusal trauma in treatment site
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers

The primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. The secondary objectives are to assess the pharmacokinetics (PK) of glyburide and blood glucose and serum insulin pharmacodynamic (PD) responses to glyburide.

This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.

Eligibility Criteria:
Inclusion Criteria:

1. A healthy male or a healthy nonpregnant, nonlactating female.
2. Capable of understanding and complying with the protocol and has signed the informed consent form before the Screening procedures begin.
3. Have a body mass index of between 18.0 and 30.0 kg/m², inclusive.
4. A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening laboratory studies and urinalysis.
5. A negative urine or saliva test for selected substances of abuse and cotinine.

Exclusion Criteria:

1. Clinically significant history of hypoglycemia as assessed by the investigator.
2. History of seizure disorder, even if currently not receiving anticonvulsant medications.
3. History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs.
4. Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme testing at screening.
5. Be an active smoker or user of other forms of tobacco. Former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on Study Day 1.
6. A history or clinical manifestations of significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders (a history of mild depression, currently not receiving therapy, is acceptable).
7. Use any prescription medication within 14 days prior to randomization, or nonprescription drugs within 7 days. Exceptions may be made by the medical monitor on a case-by-case basis.
8. Received another investigational drug within 30 days prior to randomization.
9. A positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus (HIV) antibody test at screening. If the HIV test is positive, the subject will be informed privately and referred for additional counseling.
Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery

For patients requiring the heart valve replacement surgery, heart function is injured in different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular system has important clinical meanings. Etomidate has slight effect on the cardiovascular system, often used in the induction of anesthesia, however target controlled infusion etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe the application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~75 years old
2. Selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery
3. Received heart surgery for the first time
4. New York Heart Association(NYHA) II\~III
5. Written informed consent -

Exclusion Criteria:

1. Emergency surgery
2. Anticipated survival time \<1 yrs
3. Serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection
4. Prolonged use of hormone or history of adrenal suppression disease
5. Severe mediastinal fiber thickening or fibrous adhesions
6. Allergy to experimental drug or other contraindications
7. Occurred or expected occurring of difficulty airway
8. Sure or suspected narcotic analgesics abuse
9. History of neuro-muscular disease
10. Mental instability or metal disease
11. Pregnancy or brest-feeding
12. Participated other clinical trial past 30 days
13. Malignant hyperthermia
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

Management of animal induced occupational asthma is mainly avoidance, but this is not feasible for many occupations. Treatment with avoidance and conventional treatment is also not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and may be effective at reducing symptoms and disease progression in the animal handlers population.


Eligibility Criteria:
Inclusion Criteria:

1. ages 18-65
2. occupation that involves close contact with animals
3. stable dose of ICS for 30 days
4. Skin test positive to one or more animals
5. evidence of asthma on spirometry
6. demonstrate PEFR variability-

Exclusion Criteria:

1. on allergen immunotherapy
2. on prohibited medications
3. unstable asthma
4. recent URI
5. known hypersensitivity to omalizumab-
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)

To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its potential to improve hospital efficiency and patient outcomes. The investigators compare the addition of IV acetaminophen versus placebo on postoperative anesthesia care unit recovery times, inpatient hospital length of stay (LOS), postoperative pain scores, consumption of opiates as rescue agents and side effects among patients undergoing robotic-assisted laparoscopic prostatectomy (RALP).

Although IV acetaminophen has been studied in urologic surgery, it has not been studied specifically in prostatectomies, and therefore there are no outcomes or cost-effectiveness data currently available. In addition, the current trend is to perform prostatectomy with a robot-assisted laparoscopic technique to help minimize incision size, blood loss, postoperative pain, and speed up patient recovery. Current literature only includes the use of opioids in the perioperative setting for robot-assisted prostatectomy to treat pain, but only a small trial used oral acetaminophen as a measure for analgesia in RALP. In addition to the decreasing use of opioids in perioperative pain management, emphasis has been placed on reducing costs of healthcare. A major contributor to this issue is hospital length of stay (LOS) and there has been increased pressure on healthcare providers to decrease overall LOS. Several factors may contribute to hospital LOS, including hospital acquired infections, surgical recovery, wound care, other surgical and anesthesia-related complications, and importantly, inadequate pain control.

In this study we examine the impact of adding IV acetaminophen to the multimodal analgesic regimen for robotic-assisted laparoscopic prostatectomy (RALP). Our hypothesis is that the addition of IV acetaminophen can improve postoperative recovery time, inpatient LOS, postoperative pain scores, and opioid consumption.

This study specifically addresses pharmacoeconomics of IV acetaminophen. The goal is to understand its potential to improve hospital efficiency and patient outcomes. The study compares the impact of the addition of IV acetaminophen versus a placebo on postoperative anesthesia care unit recovery times, inpatient LOS, postoperative pain scores, consumption of opiates as rescue agents and side effects in patients undergoing RALP.

The study is a 2-arm, double-blind, randomized, placebo controlled trial comparing IV acetaminophen to a control (IV placebo). All patients in this study were scheduled to undergo RALP.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robotic-assisted laparoscopic prostatectomy
* ≥18 years old males
* American Society of Anesthesiologists class 1-4

Exclusion Criteria:

* Chronic opiate use
* Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
* Allergy/hypersensitivity to acetaminophen
* Patients with baseline dementia
* Chronic diathesis
* Chronic kidney disease
Use of Wharton Jelly in Diabetic Nephropathy

Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of patients with Diabetic Nephropathy

Mesenchymal stem cells (MSCs) are to be isolated from Umbilical cord Wharton's Jelly obtained after normal full term delivery.

Samples will be tested for any bacterial or fungal growth as well as endotoxin and mycoplasma. The specific markers for MSCs identification will be analyzed by flow cytometry.

Cell suspension will then be injected in the renal parenchyma of patients diagnosed with diabetic nephropathy.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent.
* Type 2 diabetes mellitus (DM) for ≥ 3 years.
* Estimated GFR (eGFR) 15-45 ml/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation on 2 or more consecutive measurements at least 30 days apart within the past 6 months, confirmed by isotope kidney scan.
* Urine protein-to-creatinine ratio (UPCR) ≥ 500 mg/mmol (in spot urine or in 24 hour urine collection) confirmed twice over a period of 6 months.
* Ultrasonographic kidney measurements ≥ 10 cm (for both kidneys).

Exclusion Criteria:

* Patients with uncontrolled hyper or hypo tension; (systolic pressure \>160, \<100: diastolic pressure \< 60, \>100) on two different occasions.
* Poor diabetic control: Hemoglobin A1c (HbA1c) \> 10%.
* New use of hypoglycemic, antihypertensive and/or lipid lowering agent within the past 6 months.
* Increase in the dose of anti-hypertensive and/or hypoglycemic agent of the previous dose within the past 3 months.
* Current fasting total cholesterol \>300 mg/dl.
* Current fasting total triglycerides \>400 mg/dl.
* History of any cardiovascular events in the past 6 months.
* Pregnancy or lactating.
* Positive screening test for infectious diseases as per baseline work up.
* History of kidney transplant
* Systemic autoimmune disease.
* Receiving immunosuppressant medications.
* Patients with glomerulonephritis or any non-DM related kidney disease.
* Patients with any coagulation disorder.
A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain

The purpose of this study is to evaluate the safety and effectiveness of prolonged release tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among Filipino patients.

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes). The study will enroll approximately 100 patients who will be taking prolonged release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patient will be based on the accepted clinical practice in the Philippines. Patients will be monitored at baseline (Day 1) and throughout the 84-day treatment period of prolonged release tapentadol hydrochloride (every 7 days for the first two weeks, and thereafter every 28 days for the next three months) for effectiveness with the help of short form Brief Pain Inventory (BPI) questionnaire. Safety evaluations will include assessment of adverse events, clinical laboratory tests, and co-morbid conditions. The total study will be conducted for 3 years and the duration of treatment will be for 84 days.

Eligibility Criteria:
Inclusion Criteria:

* Filipino patients with moderate to severe non-cancer pain with an onset of 12 weeks or less from the baseline visit and pain requires Schedule 2 opioid treatment as per assessment of the prescribing physician
* Patients who able to independently communicate pain characteristics, understand and complete self administered questionnaires
* Medically stable on the basis of routine physical examination, medical history, and vital signs at the time of baseline visit

Exclusion Criteria:

* Refuse to protocol-defined use of effective contraception
* Pregnant and lactating women
* Patients with severe renal and hepatic impairment, significant respiratory depression, acute or severe bronchial asthma or hypercapnia, and having or suspected paralytic ileus
* Patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs or receiving other mu-opioid receptor agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, and sedatives
* Patients who are receiving Monoamine oxidase (MAO) inhibitors or who have taken them within the last 14 days
* Patients with documented history of increased intracranial pressure, impaired consciousness, coma and seizure
Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

To assess potential link between unrecognized myocardial inflammation (myocarditis) and premature ventricular contractions (PVCs) associated with and without reduced Left ventricular ejection fraction (LVEF) through comprehensive diagnostic work up.

Hypothesized that occult inflammation is clinically under-recognized in patients with symptomatic PVCs with and without Left ventricular (LV) dysfunction and can be a potential link between the 2 conditions. Aimed to evaluate the incidence of underlying inflammation using the Positron emission tomography (PET) scan in patients presenting with symptomatic PVCs enrolled retrospectively in the MAVERIC registry.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age with mono-morphic or polymorphic PVC burden of ≥5000 in 24 hours.
* Non-sustained VT was defined as ≥3 more consecutive beats lasting \<30 seconds

Exclusion Criteria:

* History of myocardial infarction,
* Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or CT angiography,
* History of revascularization,
* Significant symptomatic atrial arrhythmias associated with LV dysfunction,
* Severe valvular disease,
* Cardiomyopathy attributed to toxins such as alcohol and illicit drugs,
* History of cardiac arrest,
* History of channelopathies or inherited arrhythmias.