cyrilzakka/clinical-trials huggingface dataset:
Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents

Nicotine is one of the most widely abused substances in the United States. Nicotine replacement therapy (NRT) is currently an effective treatment for nicotine dependence; however, even with NRT most people fail at quitting smoking after their first attempt. Modafinil is a promising drug that may be useful in treating nicotine dependent individuals. The purpose of this study is to evaluate the safety of the combination of modafinil and NRT in treating nicotine dependent adolescent smokers.

NRT is a critical part of treating nicotine withdrawal symptoms, such as cravings, sleeplessness, poor concentration, and anxiety. The addition of modafinil, a promising pharmacologic agent, may enhance the effectiveness of NRT by further reducing inattention and depressed mood. The purpose of this study is to examine the safety of using both modafinil and NRT in treating nicotine dependent adolescents. In addition, this study will examine the effects of modafinil and NRT, alone and in combination, on alleviating symptoms of inattention and depressed mood.

Participants in this 12-day dose escalation study will be tested under eight different dose conditions. Modafinil and NRT will first be tested alone; participants will be exposed to low doses prior to higher doses of medication. Various modafinil-NRT dose combinations will then be tested. Modafinil will be administered at 5 p.m. each day, and NRT will be self-administered at the start of each day in which a participant must complete lab tests. The following measures will be obtained at study visits occurring before and after the various modafinil-NRT dose combinations: nicotine withdrawal symptoms, medication side effects, activity level, cardiovascular response, and profile of mood states (POMS).

Eligibility Criteria:
Inclusion Criteria:

* Smokes 10 or more cigarettes per day

Exclusion Criteria:

* Current use of any medication for a psychiatric disorder
* Positive drug screen test
* Uses smokeless tobacco
Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-resuscitation With Furosemide Group and Control Group

The impact of early de-resuscitation with furosemide on patients with sepsis-related acute kidney injury using pNGAL as the parameter of acute kidney injury.

Sepsis-related acute kidney injury (SAKI) is a complication leading to morbidity and mortality in septic patients. Some 50% of AKI patients in the Intensive Care Unit (ICU) are sepsis patients, which is the highest cause of death in the ICU. In sepsis, there is systemic inflammation that causes endothelial damage, which manifests in capillary leakage. Fluid accumulation that has occurred since the patient came to the hospital due to a capillary leak in sepsis and is exacerbated by fluid resuscitation has a negative impact on the kidneys. Therefore, the aim of this study was to assess the effectiveness of early de-resuscitation using furosemide on the incidence of AKI in septic patients using pNGAL as a parameter of AKI.

This study used a double-blind, randomized clinical trial design. This study was conducted on septic patients with a cumulative balance of \>1500 mL/day and urine output of 0.8 cc/kg/hour in the ICU of Dr. Cipto Mangunkusumo National Central Public Hospital in the July-December 2023 period. pNGAL levels were checked at the 0th and 48th hours of ICU care. A total of 48 subjects were divided into 2 groups: 24 patients in the treatment group were given a continuous injection of furosemide at 2 mg/hour, and 24 patients in the control group were given a placebo injection at 2 mg/hour. The patient's condition will be followed after the ICU stay for up to 28 days to record the need for renal replacement therapy and death.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis patients with a cumulative balance of \>1500 mL/day and urine output \<0.8 cc/kg/hour.

Exclusion Criteria:

* Has undergone a kidney transplant procedure.
* End-stage chronic kidney failure.
* History of heart valve abnormalities.
* Congenital heart disease.
Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19

Full Title: A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19.

Short Title: PROTECT-Patient study

Aim: Assess the safety and efficacy of COVID-19 convalescent plasma (CCP) as a therapeutic treatment for hospitalised patients with moderate to severe COVID-19

Study Design: Randomised, double-blinded, placebo-controlled, phase III clinical trial

Intervention: Randomised 1:1 to either CCP plus standard of care (SOC) or to SOC plus placebo (200 mL normal saline)

Active Agent: A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.

Placebo: A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines

Sample Size: 600

Study Population: Consenting adult inpatients with moderate to severe COVID-19, not requiring invasive ventilation, who are admitted to a participating public or private sector hospital and who are not enrolled in another COVID-19 treatment trial.

Settings: Participating public and private sector hospitals in South Africa

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed SARS-CoV-2 by positive RT-PCR on any respiratory sample;
* Age ≥ 18 years;
* Require hospital admission for COVID-19 pneumonia as defined by the presence of pulmonary infiltrates on chest x-ray;
* Moderate to severe Covid-19 disease, defined as: SpO2 ≤ 93% on room air; plus requiring non-invasive oxygen therapy (WHO R\&D BOSCI 4 or 5
* Signed informed consent;
* Pregnant women will be allowed to participate.

Exclusion Criteria:

* Current participation in another therapeutic clinical trial for COVID-19;
* Invasive mechanical ventilation;
* Expected survival \< 24 hours based on clinical assessment (however, the study does not exclude critically ill patients who are not, due to resource limitations, candidates for critical care admission and/or mechanical ventilation);
* Known hypersensitivity to immunoglobulin or any components of the formulation;
Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions

Retrospective chart review to determine the presence of rhabdomyolysis among patients admitted to CHMCA from 1997-2007 with Jimsonweed ingestions and to define possible risk factors predisposing patients to the developement of Jimsonweed-associated rhabdomyolysis.


Eligibility Criteria:
Inclusion Criteria:

* admitted to CHMCA between 1/1/1997 to 12/31/2007 with a qualifying ICD-9 diagnosis code for rhabdomyolysis, myoglobinuria, and hemoglobinuria (728.88, 791.2, 791.3)or other ICD-9 codes identified during the study
* between the ages of 0-21 years at diagnosis

Exclusion Criteria:

* rhabdomyolysis or serum CK concentrations not actually documented
* patient admitted to the burn center
* patient \> 21 years of age
A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.

Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR.

The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.

GEHC has decided not to provide this detail.

Eligibility Criteria:
Inclusion Criteria:

* Study Subjects must be adults with confirmed or suspected Renal Artery stenosis.
* The subject must have been referred for Digital Subtraction Angiography.

Exclusion Criteria:

* The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product.
* The subject is lactating.
* The subject is pregnant as defined by a serum or urine β-HCG pregnancy test obtained within 24 hours before investigational product administration.
* The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less than 24 hours after the investigational product administration.
* The subject has received or is scheduled to receive X-ray contrast medium within 7 days prior to or less than 24 hours after administration of investigational product.
* The subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration.
* The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months.
* The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed within 4 weeks prior to investigational product administration.
* The subject has a stent in the renal arteries.
* The subject has had a kidney transplantation.
* The subject has a serum creatinine value of \>3.5 mg/dL (309.4 µmol/L).
* The subject has previously been included in this study.
* The subject has a contra-indication for MRI according to accepted clinical guidelines.
Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices contain direct connectivity functionality which will be compared in terms of streamed Audio quality, streaming stability and Usability preferences of all available functions and features. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* willingness to wear Receiver in the canal hearing aids
* Informed Consent as documented by signature
* owning an iPhone 6 or higher

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems
* Central hearing disorders
A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects

This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese subject aged 18-45 years (both inclusive)
* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the investigator
* Body mass index 19.0-24.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
* Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
* Smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per
A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Atopic dermatitis of 850-1700cm2
* In good health

Criteria for exclusion:

* Co-morbid conditions
* Hepatic dysfunction
* Clinical infection
* Immunocompromised status
* Clinically significant illness
* Use of immunomodulating treatment
* Medications related to respiratory system or to heart rhythm
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS). Study participants will be randomly assigned to receive either LDN or placebo for a period of several weeks. During this period participants will be asked to attend either in-person or virtual study visits and complete questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Upper and/or lower extremity CRPS
* On stable treatment for 1 month
* CRPS for at least 1 year
* Meet the Budapest criteria for CRPS at time of the study.

Exclusion Criteria:

* Any known allergy to naltrexone or naloxone
* Use of prescription opioid analgesics or illegal opioid use
* Current or planned pregnancy.
Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot

The goal of this study is to develop and test a mobile web application to optimize early stimulant medication treatment for children receiving care for Attention/Deficit Hyperactivity Disorder (ADHD) in a publicly-funded mental health clinic.

In other words, the study will find out whether it is feasible and acceptable for parents to receive reminders for clinic visits and ADHD medication and enter daily ratings of their child's ADHD symptoms and medication side effects into a smart phone. It will also examine whether it is feasible and acceptable for doctors to use this information summarized on a tablet (iPad) screen during a medication follow-up visit. If the parent consents, the study will also examine whether it is feasible and acceptable for the child's teacher to enter their ratings of ADHD symptoms twice a week using a link on their email. This information will also be included in the doctor's iPad screen. If this technology is found to be promising, then a larger study will be done to examine if medication treatment is safer, more consistent, and more effective using this technology compared to usual care. This is important because the technology may remove the burden on parents and teachers to report ADHD symptoms and medication side effects using paper forms, and for doctors to record this information in the medical record. In total, there will be 12 parent/ child dyads, 6 clinicians and up to 12 teachers enrolled. Each parent/child dyad will be videotaped for up to 3 visits with the clinician (n=36 videotaped sessions). The study time period is from the first visit that ADHD medication is prescribed to the time of the third follow-up medication visit. We anticipate that the follow-up visits will be every 1-2 weeks during this early phase of stimulant medication treatment. Thus, the study time period for each parent/child dyad will be between 4-8 weeks. We anticipate that data collection will occur between August 19, 2013 and June 31, 2014.

Eligibility Criteria:
Inclusion Criteria:

* parent's and child's primary language is English or Spanish
* child is between 5-11 years
* child received a clinical diagnosis of ADHD
* child is receiving stimulant medication for the first time
* child does not take any other medication on a regular basis (like every day)

Exclusion Criteria:

* any chronic medical condition that requires on-going medication management
* prescription of combined psychotropic medication
* moderate-severe developmental delays, mental retardation or autism
COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE

General objective:

To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users.

Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed.

Patients will be randomly assigned to one of two treatments:

1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment
2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment


Eligibility Criteria:
Inclusion Criteria:

1. - Having a first psychotic episode. DSM-IV-TR diagnosis of a psychotic disorder (i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, bipolar disorder, atypical psychosis, brief psychotic disorder, or major depressive disorder with psychotic symptoms).
2. - Being a regular cannabis user according DSM-IV
3. -Being in remission from the first psychotic episode (not exceeding 5 years).

Exclusion Criteria:

1. Presenting organic brain pathology.
2. Presenting mental retardation according to DSM-IV criteria.
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients

The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab

Exclusion Criteria:

* parent or patient refusal
* use of narcotic medications prior to procedure
Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life

Regular physical activity promotes physical and mental well-being in the general population. Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or because of deficiencies related to the disease, or even on the advice of their caregivers in order to save their functional abilities. Time for leisure activity could be almost 20% lower in MS patients compared to healthy controls, and this situation is likely to aggravate the functional symptoms of multiple sclerosis.

The literature described the benefit of physical activity for MS patients according to protocols and varied assessments. Evaluations were indeed concern very analytical elements of metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account the performance of components or fatigue and quality of life. Due to the multiplicity of RE protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the double issue was the profit earned by an RE program and of this benefit by level of severity of MS. The main objective of our study was an evaluation of the effects on fatigue and quality of life of a retraining program to effort suitable for levels of impairment and patients with MS activity limitations. The secondary objective was checking a performance improvement of the patients in this adapted program.


Eligibility Criteria:
Inclusion Criteria:

* Patients necessarily declare fatigue perceived as annoying in everyday life.
* Basic electrocardiogram should be absolutely normal.
* Patients should subject themselves to regular participation in the RE program

Exclusion Criteria:

* In the previous month the inclusion or during the RE, the MS patients should not have presented thrust nor undergone intravenous chemotherapy, or have been in care center.
* Free of cognitive impairment.