cyrilzakka/clinical-trials huggingface dataset:
Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study

Critically ill infants and children who are mechanically ventilated are often given large doses of opiates and benzodiazepines to provide analgesia-sedation. These drugs significantly cause tolerance and dependence, depresses the drive to breathe, and thus prolongs the need for mechanical ventilation and the associated complications. We propose IV CLON could be used as effectively as DEX.

All critically ill mechanically ventilated infants and children receive intravenous analgesic-sedatives which often include opiates and benzodiazepines (BENZO). Undesirable side effects from these drugs include respiratory depression, tolerance and dependence. Alpha 2-adrenergic receptor agonists, dexmedetomidine (DEX) and clonidine (CLON) have excellent sedative-analgesics effects, do not cause respiratory depression and are opiate/BENZO sparing. While both are efficacious in providing sedation, several factors have led to a substantial increase in the use of the newer drug DEX over the more established drug CLON in adults, children and infants. However, studies to guide therapy and dosing for infants and children are lacking. While these infants and children do require less opiate/BENZO therapy and fewer days on mechanical ventilation, they quickly develop tolerance to and have significant withdrawal from DEX. This necessitates protracted weaning of DEX and longer length of stay in the pediatric intensive care unit (PICU) since DEX can only be administered as a continuous intravenous (IV) infusion. CLON, on the other hand, has a longer half-life and has formulations that allow for continuous or intermittent IV and oral administration. Dr. Gauda has an approved IND to use the epidural formulation of CLON intravenously in infants and children. The purpose of this pilot study is to determine the effective IV dosing scheme of CLON that can be safely used as an adjunct to analgesic-sedation management for infants and children in the PICU. It will include a total of 24 infants and children with 4 CLON and DEX exposed in each age stratum: 0-3, 4-6, and 7-12 months. We hypothesize that IV CLON can achieve optimal sedation and reduce the need for opiate/BENZO therapy in critically ill infants and children who would otherwise receive DEX, and thus, reduce the length of stay in the PICU. Data from this study will be used to inform a larger randomized trial and will directly benefit infants and children in Baltimore who are critically ill. Funds are requested to cover the cost of the CLON drug levels and the investigational pharmacy.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children age: 0-12 months
* Intubated and mechanically ventilated in the JHH PICU
* Meet criteria for starting dexmedetomidine (per PICU protocol)

Exclusion Criteria:

* Postoperative from complex congenital heart disease
* Asphyxia
* Traumatic Brain Injury
* Major Chromosomal anomaly (Trisomy 13, 18)
* Any infant or child who is receiving ECMO therapy
* If death is considered imminent
Botswana Study of UC-781 Vaginal Microbicide

This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.

45 women and 45 men, all healthy and sexually active, 21-45 years old, without HIV infection, will be enrolled in Francistown and Gaborone, Botswana. Volunteers will be randomized to receive either 0.1% or 0.25% UC-781 carbomer gel or placebo gel (3 arms. Women will be instructed to apply gel intravaginally, morning and evening, and prior to sex (always with male condom use) for 14 consecutive days. Men will be instructed to apply gel topically for 14 consecutive nights, before bed, allow to dry overnight, and wash it off in the morning. Additionally instructed never to use gel during sex but always to use condoms. Volunteers will be seen weekly for evaluation of symptoms, laboratory toxicities, genital exam findings (with colposcopy for women, and plasma drug levels. Acceptability will be assessed in focus groups in the month after completing gel use.

Eligibility Criteria:
Inclusion Criteria:

* 21-45 years old
* citizen of Botswana
* willing to use condoms for 14 days
* PAP smear (normal, inflammation, ASCUS)
* regular menses or amenorrhea
* lives within 1 hour of a study clinic
* pass comprehension test
* provide written informed consent

Exclusion Criteria:

* genital mucosal disruption at screening
* genital surgery within past 8 weeks
* pregnant within past 8 weeks
* currently breastfeeding
* prior hysterectomy
* plans to move within 2 months
* ALT, AST, total bilirubin, or creatinine Grade 2 or above
* Prothrombin or partial thromboplastin time Grade 2 or above
* In other drug/vaccine safety trial
* Has more than one sexual partner in past month
* Unwilling/unsure they can have sex at least twice weekly for 2 weeks
* Any other condition that investigator believes will interfere with the evaluation of study objectives
QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety

The purpose of this study is to determine the treatment effect of QL1203 in combination with mFOLFOX6 compared to Placebo in combination with mFOLFOX6 as first line therapy for metastatic colorectal cancer.

The study is a randomized, double-blind, Placebo-controlled, multi-center Phase III study. It is planned to enroll 590 patients with previously untreated wild-type RAS metastatic colorectal cancer. Subjects are randomized into the QL1203 combined with Oxaliplatin/5-fluorouracil/ Leucovorin or Placebo combined with Oxaliplatin/5-fluorouracil/ Leucovorin treatment group by a ratio of 2:1.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as metastatic colorectal adenocarcinoma and is not suitable for local treatment such as radical resection, radiotherapy, radiofrequency and so on.
* Man or woman at least 18 years old.
* At least one measurable lesion can be evaluated according to Response Evaluation Criteria In Solid Tumors 1.1（RECIST1.1） criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status should be 0-1 before randomization.
* The level of organ function must meet the requirements before randomization.
* Prior to randomization, the damage caused by other treatments had recovered to \< grade 2 (CTCAE version 4.03).

Exclusion Criteria:

* Prior systemic or local chemotherapy for colorectal cancer，except in the following cases: the interval between the last dose of neoadjuvant or adjuvant therapy and recurrence\> 6 months。
* Prior epithelial growth factor receptor(EGFR)-targeted drugs for colorectal cancer.
* Presence of central nervous system (CNS) metastases before the informed consent was signed, except for those who had stabilized CNS metastases for more than 4 weeks and had no symptoms after treatment.
* History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment.
* History of interstitial lung disease.
* Existing intestinal obstruction before randomization, active inflammatory bowel disease.
* Patients with non-healing abdominal fistula and gastrointestinal perforation before randomization.
* There were severe active infections or uncontrollable infections that required systemic treatment and could not be enrolled at the decision of the investigator within 14 days before randomization.
Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters

The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.

Patients with voiding dysfunction and chronic urinary retention are taught the technique Clean Intermittent Self Catheterisation (CISC) by specialist Nurse Continence Advisors.

For several decades, patients have been taught to catheterise using a "clean" technique where they rinse their catheter under tap water and store the catheter in a sterile solution (e.g. Milton). The catheter is re-used for up to one week. The risk of urinary tract infection (UTI) was known to be minimal (and certainly much less than having a permanent indwelling catheter).

Recently, the Therapeutics Goods Administration has issued a guideline that CISC catheters should be "single-use items" but no data to support this guideline appears to have been collected.

The aim of this project is to assess the incidence of urinary tract infection (UTI) when comparing single-use catheters with re-use of catheters for CISC, and to determine the cost differences between the two methods.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* CISC \> 2/day
* No current symptomatic UTI
* Willing to change catheter use method

Exclusion Criteria:

* Symptomatic Urinary Tract infection despite treatment
* \<18 years old
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine

To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects 19-65 years of age inclusive
* Subjects with hypertension as defined 100 mmHg ≤ SBP\<140 mmHg and 65 mmHg ≤ DBP \< 90 mmHg after more than 5 minutes in the supine position
* Written informed consent
* Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subjects with acute or chronic disease within 4 weeks of study initiation.
* Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
* Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors
* Subjects with clinically significant abnormalities on laboratory tests
* Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position
* Subjects with abnormal QTc interval(≥440ms)
* Subjects with color-blindness or weakness
* Subejcts with alcohol, drug or caffeine abuse
* Diet known to alter drug absorption, distribution, metabolism or elimination processes
* Subjects who participated in other clinical studies within 2 months before an administration
* Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
Video Game Play to Alleviate Adolescent Anxiety

Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. At least two lines of research have been explored in the past years in this area. First, studies have tested the anxiolytic effects of casual video games, hypothesizing that, through the induction of flow, these games can effectively distract individuals from anxiety-related thoughts and feelings. Second, the bidirectional link between poor attentional control and higher anxiety has led to the design of novel interventions aiming to improve attentional control such as working memory training studies. Importantly, action video games, classified as a distinct gaming genre, have been shown to enhance attentional control. In this study, we aim to compare the effects of action video game play and casual game play to a no-training group, assessing their potential to alleviate anxiety when delivered entirely online. The goal of this three- arms randomized controlled trial is to evaluate the feasibility of a 6-week video game training intervention to reduce adolescent anxiety-related symptoms. We will also examine the efficacy of the proposed treatment when entirely deployed at adolescents' home.


Eligibility Criteria:
Inclusion Criteria:

1. Age 12-14 years
2. High-anxious score from the 41 items SCARED-Parent version (i.e. total score equal or above 17)
3. Access to a computer (at least Windows 7 or Mac OSX) at home and a reliable internet connection

Exclusion Criteria:

1. DSM diagnoses of Bipolar, Psychosis, Autism Spectrum Disorder, present or past.
2. Neurological injury (i.e. head injury)
3. Currently enrolled in another cognitive training intervention
Intravascular Stents Fracture Effects

The goal of the study is to evaluate long term durability and hemodynamic effect of implanted stents in the aortic arch and in pulmonary artery branches.

Patients who underwent trans-catheter implantation of balloon expanded stents in the aortic arch and in branch pulmonary arteries will be evaluated by physical examination with blood pressure values measurement of upper and lower limbs.

Echo-Doppler cardiography will be performed for flow velocity analysis. Zoomed fluoroscopy will be performed and recorded in two orthogonal views to evaluate stent integrity or stent fracture.

It is our intention to include 20 patients in this study from our follow-up clinic.

Eligibility Criteria:
Inclusion Criteria:

-patients who underwent stent implantation for coarctation of the aorta and for branch pulmonary artery stenosis

Exclusion Criteria:

-Pregnancy
Lidocaine to Prevent Cough and Hemodynamic Changes in Tracheal Extubation

Coughing during tracheal extubation can be associated to adverse effects like tachycardia, arterial hypertension (AHT), increase of intracranial pressure (ICP) and intraocular pressure (IOP), and the dehiscence of surgical wounds. In ophthalmic, head and neck, and abdominal surgery, and in several other neurosurgical interventions it is vital to prevent these effects. The incidence of laryngeal irritation due to orotracheal intubation hinders patient comfort in the immediate postoperative (POP) period and no pharmacological intervention has been yet proven to prevent it.

At the end of the surgical procedure, the depth of the anesthetic plane decreases with the concomitant suspension of the anesthetic agents. However, the patient still requires ventilatory support through the endotracheal tube (EDT). The physical stimulation of the trachea created by this foreign body leads to the activation of the sympathetic nervous system, expressed in AHT, tachycardia, and ICP. To tolerate the EDT and prevent these effects, different maneuvers have been tested such as extubating the patient in a deep anesthetic plane or administering intravenous (IV) narcotics with the entailed complications: airway (AW) obstruction and hypercapnia, and the aspiration of an unprotected AW. Progress has been made with the introduction of ultrashort acting opioids, with significant statistical results. Moreover, beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors and dexmedetomidine have been used to decrease the hemodynamic impact associated to tracheal extubation. The use of both IV and intratracheal lidocaine in doses ranging from 1 mg/kg to 3 mg/kg, has been studied with controversial results.

In view of the above, and as lidocaine is the most commonly used low-cost drug in all operating rooms with a good safety profile when used at low doses, the purpose of this study is twofold: to assess its effects at reducing coughing and to evaluate its hemodynamic impact when administering IV 1 mg/kg prior to extubation. Then, the efficiency of reducing the incidence of sore throats after the immediate POP shall be investigated.


Eligibility Criteria:
Inclusion criteria:

* American Society of Anesthesiologists Risk I \& II.
* Age 18-65 years.
* Scheduled for: cholecystectomy, hernioplasty or laparoscopic gynecological surgery, under balanced general anesthesia (GA) and orotracheal intubation (OTI).

Exclusion criteria:

* Local anesthetic (LA) allergy.
* Presence of predictors of potentially difficult intubation (DI) according to criteria defined by the American Society of Anesthesiologists.
* Upper airway inflammatory symptoms during the previous week.
* Chronic kidney disease with clearance lower than 60 ml/m using the Modification of Diet in Renal Disease (MDRD) equation.
* Child-Pugh B-C liver disease.
* Treated with ACEinhibitors and/or BB.
* Second and third grade atrioventricular block.
* Symptomatic bradycardia.
* Tachyarrhythmias.
* Left bundle branch block (LBBB).
Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants

Alport syndrome (AS) is the second most common monogenic cause of end-stage renal failure (ESRF). AS is caused by variants in the COL4A3, COL4A4, and COL4A5 genes, which encode for the a3, a4, and a5 chains of type IV collagen. This trial is a prospective, randomized, controlled and multicenter trial. Mainly to assess the safety and efficacy of ramipril in Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 30-50 Years;
2. Sex: All;
3. Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5; hematuria or microalbuminuria; eGFR\>90 mL/min/1.73m2;
4. Patients with microscopic hematuria only;
5. Patients with microscopic hematuria and microalbuminuria: 30-300mg/24h or urine albumin/creatinine: 30-300mg/g;
6. No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment.

Exclusion Criteria:

1. With primary or secondary kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephropathy, benign renal arterioles, etc.;
2. Patients with a history of angioedema;
3. Hypovolemia or hypotension (systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 60mmHg);
4. Pregnant and lactating women;
5. Patients with bilateral renal artery stenosis or unilateral renal artery stenosis with solitary kidney;
6. Hyperkalemia, blood potassium\>5.5mmol/L;
7. Severe aortic stenosis, severe mitral stenosis;
8. Treatment of drug allergy;
9. Hypertension or other diseases that may require treatment with angiotensin-converting enzyme inhibitors;
10. Disagree to participate in this research.
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions

The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.

This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence study under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, non-smoking (for at least 6 months) male or female volunteers, 18 - 55 years of age.
* Weighed at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
* Medically healthy subjects with clinically normal laboratory profiles, vital signs, and ECG.
* Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study, or using one of the following acceptable birth control methods:

  1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
  2. Intrauterine device (IUD) in place for at least 3 months.
  3. Barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
  4. Surgical sterilization of the partner (vasectomy for 6 months minimum).
  5. Hormonal contraceptives for at least 3 months prior to the first dose of the study.
* Gave voluntary written informed consent to participate in the study.

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:

  1. Alcoholism or drug abuse within the past 2 years;
  2. Hypersensitivity or idiosyncratic reaction to pantoprazole, omeprazole, or any other substituted benzimidazole proton-pump. inhibitors.
* Females who were pregnant or lactating.
* History of tobacco use or use of products containing nicotine (i.e., smoking cessation aids such as nicotine gum or patches) within the 6 months prior to the first dose.
* Subjects who tested positive at screening for human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen screen (HbsAg), or hepatitis C antibody screen (HCV).
* Treatment with any known enzyme-altering drugs (barbiturates, phenothiazines, cimetidine, etc.) within 30 days prior to the first dose.
* Difficulty in swallowing medication or any gastrointestinal disease that would affect the drug absorption.
* Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who, through completion of the study, would have donated in excess of:

  * 500 mL of blood in 14 days;
  * 1500 mL of blood in 180 days;
  * 2500 mL of blood in one years.
* Subjects who participated in another clinical trial with 28 days prior to the first dose.
Effect of Magnesium on Dose of Rocuronium for Deep Neuromuscular Blockade

It is well known that magnesium enhances the effect of neuromuscular blocking agents such as rocuronium. However, it is not known how much magnesium can reduce neuromuscular blocking agents in maintaining deep neuromuscular blockade. Through this study, the investigators will quantitatively analyze the rocuronium saving effect of magnesium.

It is well known that magnesium potentiate the effect of neuromuscular blocking agents. It prolonged the duration of rocuronium and reduces the onset time of rocuronium. Magnesium acts on motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, the quantitative rocuronium saving effect of magnesium is not clear. This study's hypothesis is that magnesium would reduce the amount of rocuronium. And the investigators want to evaluate how much magnesium can reduce the amount of rocuronium. Secondary outcome is the effects of magnesium on recovery time, postoperative pain, nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo elective robot assisted radical prostatectomy, between 20 and 80 years with a American Society of Anesthesiologists physical status classification of I or II

Exclusion Criteria:

* Conduction abnormalities in preoperative EKG such as Atrioventricular block, sinus pause
* Glomerular filtration rate \<60ml/min/1.73m2
* Allergy to rocuronium, sugammadex, magnesium
* Medications that interfered with muscle activity
* Neuromuscular disease
* Hypermagnesemia