bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of N-acetylcysteine Versus Placebo for the Treatment of Metamphetamine Withdrawal Symptoms
Condition: Methamphetamine Dependence in Remission
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Up to date, no approved medications are available for the treatment of methamphetamine
      addiction. Recently, N-acetylcysteine is recently being studied for methamphetamine
      withdrawal.

      N-acetylcysteine, is a drug that has been long used as a mucolytic. Recent studies
      investigate the use of N-acetylcysteine in cocaine and withdrawal symptoms by its effect on
      restoring glutamate homeostasis in nucleus accumbens. Up to date, there has been 2 pilot
      study investigating the efficacy of N-acetylcysteine for methamphetamine dependence.

      The present study is aimed to confirm the efficacy and safety of N-acetylcysteine in the
      treatment of methamphetamine withdrawal symptoms.
    

Detailed description: 
      Methamphetamine is a stimulant commonly abused worldwide. Methamphetamine can produce a rapid
      pleasurable rush caused by release of dopamine, nor-ephinephrine and serotonin. It produces
      euphoria, a heightened level of alertness and increased level of alertness and increased
      energy. Long-term regular meth use can lead to severe tooth decay, infection, weight loss,
      malnutrition, kidney damage, liver damage, respiratory issues, paranoia, violent behaviour,
      psychosis, severe anxiety and depression.

      Studies suggested that withdrawal symptoms in methamphetamine dependent patients were due to
      the state of hypodopaminergic activities.

      Up to date, no approved medications are available for the treatment of methamphetamine
      addiction. Recently, N-acetylcysteine is recently being studied for methamphetamine
      withdrawal.

      N-acetylcysteine, is a drug that has been long used as a mucolytic. Up to date, there has
      been 2 pilot study investigating the efficacy of N-acetylcysteine for methamphetamine
      dependence. The present study is aimed to confirm the efficacy and safety of N-acetylcysteine
      in the treatment of methamphetamine withdrawal symptoms.
    

Intervention name(s): N-acetyl cysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eligible patients will be randomised to receive N-acetylcysteine or placebo; Matching Placebo
Other intervention name(s): Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, parallel, 4 week-treatment of N-acetylcysteine versus matching placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methamphetamine; N-acetylcysteine; substance abuse
Mepo for Eosinophilic Esophagitis (EoE) Study
Condition: EoE; Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine
      whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and
      decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic
      esophagitis (EoE) after an initial 3 month treatment course, and will also assess the impact
      of an additional 3 months of treatment.
    

Detailed description: 
      This is a multi-center, randomized, double blind, parallel-arm, placebo controlled trial of
      mepolizumab. After the first 3 month blinded phase, there will be a second 3 month blinded
      phase where all patients receive active medication, but the dose will be lower in the
      subjects initially randomized to the placebo arm.

      In the first arm, subjects will receive mepolizumab 300 mg SQ monthly for 3 months. In the
      second arm, subjects will receive a placebo SQ injection monthly for 3 months. Both groups
      will have the injection administered under direct observation in a Clinical & Translational
      Research Center (CTRC) or other clinic to ensure proper administration and compliance. Each
      visit will also provide an opportunity for symptom questionnaires to be completed and for
      blood samples to be drawn. After 3 months (the time point where the primary outcome is
      assessed), all subjects initially randomized to active treatment will continue with
      mepolizumab dosing 300 mg SQ monthly, and will remain blinded. All subjects initially
      randomized to placebo will receive mepolizumab 100mg SQ monthly, and will remain blinded. Of
      note, no dietary changes, changes in baseline Proton Pump Inhibitor (PPI) medication dose,
      changes in inhaled or intranasal steroid doses, or administration or oral, topical/swallowed,
      or systemic steroids will be allowed during the study period. Subjects will undergo endoscopy
      after the first blinded phase (at 3 months) and after the second blinded phase (after 6
      months).
    

Intervention name(s): Mepolizumab 300 mg; Mepolizumab 100 mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Mepolizumab 300 mg subcutaneous injection; Mepolizumab 100 mg subcutaneous injection; Saline subcutaneous injection
Other intervention name(s): Nucala; Nucala; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The nitric oxide supplementation product, Neo40 Daily®, provides a dietary source of No2-.
      The product also allows for robust No2-reduction to NO from the extremely potent
      nitrite-reducing capacity of the polyphenols found in Hawthorne berry.(Bartsch et al., 1993)
      Neo40 Daily® is a unique product since it provides the dietary source of No2-, as well as the
      rate limiting No2- reduction activity.
    

Detailed description: 
      Neo40 Daily® facilitates both endothelial dependent and independent NO production. The acute
      effects of Neo40 Daily® have been demonstrated in hypertensive patients.(Zand et al., 2011)
      Within 30 minutes following a single dose of the Neo40 Daily®, a significant reduction in
      systolic/diastolic BP and vascular compliance was observed, as well as, 4 hours following
      treatment, a significant improvement in endothelial function was seen. Furthermore, it has
      been used in longer term clinical trials to show elevated plasma levels of No3• and No2·,
      indicating an increase in systemically available NO, and lower levels of triglycerides in an
      older population with cardiovascular risk factors.(Zand et al., 2011) This pilot study also
      demonstrated a trend towards reduced BP and improved quality of life among its
      prehypertensive participates (Biswas et al., 2015). This current clinical trial aims to
      expand on this pilot study and examine the effect of NO supplementation on a pre- and mildly
      hypertensive populations with endothelial dysfunction as measured by EndoPAr® and asymmetric
      dimethyl L-arginine (ADMA). In a double blinded placebo controlled parallel arm study, we
      will further investigate the effect of Neo40 Daily® on 40 pre- and mildly hypertensive
      subjects with regards to changes in blood pressure, endothelial dysfunction and other markers
      of NO availability and CVD risk.
    

Intervention name(s): NEO40 Daily
Intervention type(s): Dietary Supplement
Intervention description(s): Per Capsule: N5-carbamoylornithine 100 mg, crataegus laevigata 100 mg, L-ascorbic acid 50 mg, vitamin B-12 0.05 mg, vitamin C 50 mg.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase II, randomized,double-blind, placebo-controlled 2 arm parallel
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of ASP0892 after
      intradermal (ID) injection in adolescent participants with peanut allergy.
    


Intervention name(s): ASP0892; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intradermal; Intradermal; normal saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ASP0892; Peanut Allergy
T3AI-Pain After Breast Surgery
Condition: Pain; Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol
      #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to
      test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients
      undergoing outpatient breast surgery.
    

Detailed description: 
      Block randomization will be used to randomize patients to one of two combinations. Group A
      will receive capsules containing 650 mg Acetaminophen plus 400 mg Ibuprofen. Group B will
      receive capsules containing 600 mg Acetaminophen, 15 mg caffeine and 60 mg codeine. Capsules
      are placed in identical dossettes containing a seven day supply. Patients are instructed to
      start taking their medications post-op and continue until they are pain free. All
      participants are given a series of blank Visual Analogue scales and Likert scales and
      instructed to record their level of pain intensity and pain relief four times per day for the
      entire week. Peri-operative pain management will be standardized. Patients will not receive
      pre-operative analgesics. Intra-operative analgesia will be intravenous opioids as selected
      by anaesthesiology. No local/regional anaesthesia will be used. Intravenous ketorolac will
      not be allowed for trial participants. All patients will receive intravenous opioid and
      anti-emetic if required in PACU. Any patients with peri-operative complications or other
      problems requiring admission or alternative analgesics will be excluded.
    

Intervention name(s): acetaminophen plus codeine; acetaminophen plus ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): capsules four times daily until pain free or for a maximum of seven days; capsules four times daily until pain free or for a maximum of seven days
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Randomized controlled trial; Clinical trial; Breast tumor surgery; Outpatient surgery; Analgesia; Outpatient analgesia; Post surgical analgesia; ≥ 18 and ≤ 70 years of age; Elective outpatient breast surgery for:; lumpectomy/quadrantectomy +/- Sentinel Lymph Node Biopsy; lumpectomy/quadrantectomy with Axillary Node Dissection; simple mastectomy +/- Sentinel Lymph Node Biopsy; Modified Radical mastectomy
Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to evaluate the safe and effective use of the
      single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon
      beta-1a) in participants with multiple sclerosis (MS).
    

Detailed description: 
      The Main Study was a 4-week treatment period which consisted of 1 Avonex manual injection
      using a prefilled syringe, followed by 3 Avonex injections using the single-use autoinjector.
      The Extension Study was designed to provide continuation of treatment with the Avonex
      single-use autoinjector to eligible participants who completed the Main Study for up to an
      additional 12 weeks, and to obtain additional safety and preference data for the Avonex
      single-use autoinjector.

      Participants were enrolled under the initial study protocol (Initial Subject Subset); the
      study was subsequently suspended. Changes were made to the protocol (including modifications
      to the autoinjector needle), and additional participants were enrolled (Main Subject Subset).
    

Intervention name(s): single-use autoinjector with a prefilled liquid Avonex syringe; Avonex prefilled syringe via manual IM injection; BG9418 (interferon beta-1a)
Intervention type(s): Device; Device; Drug
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
Condition: Diabetes; Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will
      assess the use of the medication metformin to improve quality of life, exercise capacity, and
      improved outcomes in heart failure patients with pre-DM or early DM (type II).

      If the patient participates in this study, the patient will receive the drug metformin for
      approximately 3 months. During the study the patient will undergo comprehensive testing which
      includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The
      patient must be 18 years old to participate.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month for a duration of 3 months.
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; Diabetes; Pre-diabetes; Early type II diabetes; Metformin; Pharmacotherapy with metformin for prevention of DM in HF patients with pre-diabetes (pre-DM) and glycemic control in HF patients with early type II DM
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
Condition: Stroke; Gait, Hemiplegic
MeSH terms: Stroke; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      This study aims to evaluate the safety and usability of a motorized mobility assistance
      exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static
      and dynamic rehabilitation sessions with the intention to evaluate the safety and usability
      of the device in the studied population. The protocol has been focused on defining how the
      device can be used appropriately in this population in a safe manner by rehabilitation
      specialists.The study also aims to assess the safety of clinicians implementing the
      intervention, as well as possible benefits derived from the use of the device. As a secondary
      outcome, efficacy measurements will be collected.
    


Intervention name(s): Physical Rehabilitation with MAK exoskeleton
Intervention type(s): Device
Intervention description(s): The participants will assist to 9 physical rehabilitation sessions with the MAK exoskeleton. During these sessions, different movements and therapies will be conducted using the studied device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exoskeleton; robotic device; gait assistance
The Role of Mitochondrial Respiration in the Cardioprotective Capacity of IPC in Diabetic and Non-diabetic Patients
Condition: Reperfusion Injuries, Myocardial
MeSH terms: Reperfusion Injury; Myocardial Reperfusion Injury
Study type: Interventional

Summary: 
      The overall aim of this study is to examine the role of mitochondrial respiration in human
      diabetic tissue before and after ischemia. Furthermore we will examine the ability of
      ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic
      performance of both non-diabetic and diabetic fibers after ischemia. To increase our
      understanding on the metabolic changes during ischemia in both non-diabetic and diabetic
      tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic
      mitochondrial respiration.
    

Detailed description: 
      20 diabetic and 20 non-diabetic patients undergoing elective CABG surgery or other heart
      surgery where extracorporal circulation is used will be included in the study. The patiens
      will not be given any treatment prior to the operation. During the cardiac surgery a small
      sample of the heart is routinely removed when the patient is connection to the heart-lung
      machine. From this tissue sample it is possible to isolate muscle trabeculae which will be
      used in an atrial strip model and randomized to one of four types of treatment.
      Simultaneously with the isolation of the trabeculae, a fifth trabecular will be used to
      assess mitochondrial respiration at baseline. Group 1 will serve as a sham control, group 2
      will serve as ischemic control and receive an extended period of hypoxia, Group 3 will be
      treated with ischemic preconditioning, where short periods of non lethal lack of oxygen will
      be given directly to the tissue (after removal from the patient) prior to the extended period
      of hypoxia, Group 4 will receive dimethyl malonate prior to the prolonged hypoxia.
    

Intervention name(s): Dimethyl Malonate; Ischemic preconditioning; Ischemia reperfusion; Sham
Intervention type(s): Drug; Biological; Other; Other
Intervention description(s): Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.; Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.; Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.; Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
Other intervention name(s): Dimethyl Malonate; PubChem Substance ID 24848281
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of
      combination of rosuvastatin and CS-866 and DWJ1276 alone.
    


Intervention name(s): Cresto; Olmetec; DWJ1276
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, rosuvastatin 20mg; tablet, olmesartan medoxomil(CS-866) 40mg; tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg
Intervention MeSH terms: Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal
      women.
    

Detailed description: 
      The objective of the study is to characterize the pharmacokinetics of progesterone in
      post-menopausal women after the insertion of a vaginal ring containing 2.0 g of progesterone.
      Progesterone is slowly released from the ring within 90 days (sustained-release). Study
      participants will use the vaginal ring for a period of 91 days (13 weeks).

      Progesterone blood concentrations will be determined during the use of the vaginal ring and
      after removal of the vaginal ring after a period of use of 13 weeks. In subgroups of
      participants, progesterone blood concentrations will also be determined after removal of the
      ring for a period of 2 hours or 4 hours on Day 28 of use. A study participant has completed
      the study when the final evaluation takes place, which is 7-15 days after removal of the
      vaginal ring on Day 91.

      The safety of the progesterone vaginal ring will be assessed based on the adverse events
      reported.
    

Intervention name(s): Progesterone vaginal ring
Intervention type(s): Drug
Intervention description(s): Vaginal ring with 2.0 g progesterone (sustained-release over 90-days)
Other intervention name(s): Progering (Trade Mark)
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single site, open-label, randomized, single-dose, with three groups.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Progesterone; Vaginal ring
The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter
Condition: Radial Artery Injury Prevetion
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Compare the effect of periradial injection of papaverine versus nitroglycerine on radial
      artery diamter before cannulation of it in cardiac surgery.
    

Detailed description: 
      we want in this study to facilitate radial artery canulation and decrease the number of
      attemps of puncture which may lead to disappearance of the pulse.

      The aim of this study is to compare the effect of adding papaverine to local anesthetic
      xylocaine versus adding nitroglycerine to it on the diameter and palpability of radial artery
      and if perioperative spasm will decrease significantly with one of these methods.
    

Intervention name(s): papaverine; nitroglycerine; xlyocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound; periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound; periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
Intervention MeSH terms: Nitroglycerin; Papaverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science