bioihbjkbjnl/mcl2 huggingface dataset:
Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to empirically test a series of medications to: 1) determine
      each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective
      dose range for each medication. In this study, amantadine is tested."
    

Detailed description: 
      16-week participation plus a 2 weekk lead-in period. Participants are assigned randomly to
      placebo or amantadine. Participants attend group meeting 3 times/week
    

Intervention name(s): Amantadine
Intervention type(s): Drug
Intervention MeSH terms: Amantadine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Amantadine; Cocaine; Pharmacotherapy; Outpatient
Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients
      aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin
      diseases.
    

Detailed description: 
      This is a multi-center, open-labelled study to confirm the safety as main objective, and
      consisting of minimum 1-week screening period and 2-week treatment period. The subjects who
      meet the inclusion criteria are to be placed on one of the following two regimens according
      to their ages at the start of treatment period: once daily administration of levocetirizine
      at a dose of 1.25 mg (in the morning) to infants aged between 6 months and 1 year old
      (younger age group), and twice daily administration of levocetirizine at a dose of 1.25 mg
      (in the morning, in the evening before sleep) to infants aged between 1 year and 2 years old
      (older age group).
    

Intervention name(s): Levocetirizine; Levocetirizine
Intervention type(s): Drug; Drug
Intervention description(s): Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered once daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning to infants aged between 6 months and 1 year old; Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered twice daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning and evening before sleep to infants aged between 1 year and 2 years old
Intervention MeSH terms: Cetirizine; Levocetirizine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Pediatric; Pruritus; Levocetirizine
Islet Cell Transplantation Alone and CD34+ Enriched Bone Marrow Cell Infusion in Patients With Diabetes Mellitus: Steroid-Free Regimen
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of islet cell transplantation in Type 1 diabetics is to provide those affected with
      constant normal blood glucose levels, thereby reducing or eliminating altogether the need for
      injected insulin. This normalization may prevent or slow progression of diabetic
      complications, result in a healthier lifestyle, and lead to a better quality of life.

      Participants who meet the inclusion criteria will undergo an extensive screening process
      which typically includes a series of blood tests, EKG, chest x-rays, and a psychological
      evaluation, among others. Those who are eligible for and chose to participate in the trial
      will receive an islet cell transplant and bone marrow infusion from the same donor, together
      with following immunosuppressive medications: tacrolimus, sirolimus, daclizumab and
      infliximab. Because the bone marrow infusion may successfully prevent the transplanted islet
      cells from rejecting, some participants may be able to stop taking the immunosuppressive
      medications after a year.

      The islet cell transplant is done under local anesthesia in a special procedure radiology
      room. Several days after the islet cell transplant, the participant is admitted to the
      hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion
      procedure.

      All participants will need to be seen at the Diabetes Research Institute after the transplant
      for follow-up testing and post-islet cell transplant care.
    


Intervention name(s): Islet Cell Transplantation
Intervention type(s): Procedure
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I Diabetes Mellitus; Immunosuppression; Islet Cell Transplant; Percutaneous Transhepatic Portal
A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of
      aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with
      schizophrenia.
    


Intervention name(s): aripiprazole IM depot; aripiprazole tablets
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.; Aripiprazole tablets 10 mg once daily in the morning for 14 days.
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of the Novel "Step Up Your Game" Program on Men's Lacrosse
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      For the purpose of this pilot study, the investigators hypothesize that the use of the Step
      Up Your Game protocol will result in statistically significant improvements in health and
      athletic performance. The key to this is the coordination of resources from a supervising
      physician, physical therapist, trainer, dietitian, coach, competitor, role model,
      psychologist, and spiritual leader. Notably, Step Up Your Game provides resources which would
      allow patients to find or be their own physical therapist, trainer, dietitian, coach,
      competitor, role model, psychologist, and spiritual leader. The role of the supervising
      physician, however, is meant for a qualified professional, who follows the osteopathic
      approach to medicine, in which the body is treated as an integrated whole, while also working
      to prevent and treat injuries. Though not limited solely to osteopathic physicians, it is
      critical to take into account every health aim and injury in the context of the athlete and
      how these affect all aspects of participants lives.
    


Intervention name(s): Counseling; Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Counseling on healthy behaviors with in person meetings.; Counseling on healthy behaviors with emails.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to test the idea that a controlled release formulation of CE-224,535 may allow
      for less frequent dosing and exposure to lower levels of drug than an immediate release
      formulation.
    


Intervention name(s): suspension IR; CR 1; CR 2; CR 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg IR suspension once daily for one day; 50 mg shorter release CR once daily for one day; 50 mg medium release CR once daily for one day; longer release SR formulation once daily for one day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation
The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment
Condition: HIV Positive; Opioid Dependence; Opioid Agonist Treatment; HIV Infections
MeSH terms: HIV Seropositivity; Opioid-Related Disorders
Study type: Observational

Summary: 
      HIV drug resistance presents a significant public heath problem. This proposal is designed to
      explore the association between ongoing illicit drug use and the prevalence of HIV drug
      resistance among HIV+ opioid dependent patients receiving opioid agonist treatment with the
      following hypotheses:

        1. Hypothesis 1: The prevalence of HIV drug resistance will range between 10% and 30%.

        2. Hypothesis 2: Patients with evidence of ongoing illicit drug use will be more likely to
           have HIV drug resistance.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV+, opioid dependent
      
Keywords: HIV; resistance; opioid dependence
Impact of CES1 Genotype on Metabolism of Methylphenidate
Condition: Carboxylesterase 1 (CES1) Genotype; CES1 Activity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether differences in the gene coding for the
      liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of
      methylphenidate, a CES1 dependent drug.
    


Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): 10 mg as a single dose followed by one blood sample 3 hours post-dose
Other intervention name(s): Ritalin
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared
      with fenofibrate
    


Intervention name(s): placebo; fenofibrate/omega; fenofibrate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insulin resistance
Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol
      transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of
      cholesterol.
    


Intervention name(s): Niaspan; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Niaspan™; Placebo
Other intervention name(s): NIASPAN™
Intervention MeSH terms: Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Psychological and Behavioral Intervention for Post-Bariatric Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The study is designed to test a pilot intervention for bariatric patients who are starting to
      regain weight after the 1st year post-surgery. Dialectical Behavior Therapy (DBT), an
      empirically supported therapy for Borderline Personality Disorder, has also successfully been
      applied to patients with substance use and binge eating problems. The purpose of this study
      is to develop and test a group intervention based on DBT and cognitive behavioral therapy
      (CBT) techniques for patients engaging in these maladaptive behaviors after surgery with
      co-occuring weight gain.
    

Detailed description: 
      Weight regain post bariatric surgery may be due to anatomical, physiological, or
      psychological and behavioral factors. One potential psychological and behavioral contributor
      to poor weight loss outcome following bariatric surgery may be low distress tolerance,
      characterized by emotional reactivity to stressors and lack of appropriate emotional
      regulation, and using eating, drinking, or other substances to improve mood. Recent research
      indicates that a subset of patients post-surgery experience challenges with subjective
      bulimic episodes, graze eating, and alcohol misuse; evidence for poorer excess weight loss
      (EWL) outcomes is associated with graze eating and uncontrolled eating behavior. This
      submission is for a pilot project designed to examine the impact of participation in a
      dialectical behavior therapy (DBT) plus cognitive behavioral therapy intervention delivered
      post-surgery on weight, psychological, and behavioral outcomes after Roux-en-Y gastric bypass
      surgery (RYGB) for patients experiencing weight regain relapse with co-occuring disordered
      eating or substance misuse behaviors.
    

Intervention name(s): Behavioral intervention for regain after bariatric surgery
Intervention type(s): Behavioral
Intervention description(s): 6 week intervention targeting dietary behavioral adherence, stress management, and distress tolerance skills to prevent weight regain
Other intervention name(s): CBT-DBT intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: bariatric; obesity; post-surgery; intervention
D-0120 Safety and PK/PD Study in China
Condition: Hyperuricemia or Gout
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      It is a randomized, double-blind, placebo-controlled, multiple-administration, multiple-dose,
      dose-escalating, phase Ib/IIa clinical study to evaluate the safety, tolerability, PK and PD
      of D-0120 in healthy subjects and hyperuricemia patients (gout or asymptomatic) in China.
    


Intervention name(s): D-0120
Intervention type(s): Drug
Intervention description(s): D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This project is a national, open label, multicenter, randomized split-mouth study in patients
      from 18 to 70 years of age to compare the efficacy and acceptability of lidocaine gel
      compared to injection anesthesia with articaine (infiltration anesthesia for the upper jaw
      and infiltration or nerve block anesthesia for the lower jaw). It is planned that about 90
      patients with a proven moderate periodontitis will be enrolled in 5 German study centers.

      Dynexan Mundgel® (lidocaine hydrochloride) is a topical anesthetic gel containing lidocaine
      that is commercially available as an anesthetic for temporary, symptomatic treatment of pain
      at the oral mucosa, gingiva and lips. The gold standard for scaling and root planing (SRP) is
      still the use of injection anesthesia. This raises the question what kind of anesthesia
      patients would prefer if they had a free choice.

      For this study Ultracaine® D-S 1:200,000 (articaine hydrochloride/epinephrine hydrochloride)
      was selected as the injectable comparator drug because it is the most frequently used
      anesthetic drug for infiltration and nerve-block anesthesia in Germany at present.
    


Intervention name(s): Lidocaine Hydrochloride 1% Gel; Articaine hydrochloride/epinephrine (adrenaline) hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Cylinder vials with 1.7 g gel containing 34 mg lidocaine (1 g gel contains 20 mg lidocaine) will be used. Application of the gel into the periodontal pockets or the sulcus according to summary of product characteristics (SmPC). A total dose of 40 mg lidocaine should not be exceeded.; Cylinder vials with 1.7 ml solution for injection containing 68 mg articaine and 0.0102 mg epinephrine (1 ml contains 40 mg articaine and 0.006 mg epinephrine) will be used. Infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw with articaine solution for injection according to SmPC. Adults can be treated with up to 7 mg articaine per kg of body weight per treatment session.
Other intervention name(s): Dynexan Mundgel®; Ultracain® D-S 1:200,000
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Carticaine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The randomization determines if a subject will be assigned to receive either lidocaine gel or articaine injection anesthesia as the first anesthesia during SRP Treatment of the right upper and lower jaw. The second anesthesia during SRP at visit 2 will be carried out with the remaining anesthetic on the left side of the upper and lower jaw.
Masking: None (Open Label)
Primary purpose: Other
Keywords: scaling and root planing; topical anesthesia
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
Condition: Complicated Infection; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, 3-part study designed to investigate the safety and
      tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when
      both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single
      administration, and following multiple administrations of ATM-AVI in healthy male and female
      (females of nonchildbearing potential) volunteers both young and elderly.
    

Detailed description: 
      A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to
      Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and
      Avibactam given Alone and in Combination (ATM-AVI)
    

Intervention name(s): Avibactam (AVI); Aztreonam (ATM); combination of Aztreonam - Avibactam (ATM-AVI); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PART A: AVI IV infusion; PART A: ATM IV infusion; PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.; PART A, PART B, PART C: matching placebo IV infusions
Intervention MeSH terms: Aztreonam; Avibactam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase I, Safety, tolerability, healthy.
The Effect of Dehydration on Intestinal Permeability
Condition: Dehydration; Indomethacin
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      In this study, the effect of dehydration by sauna exposure on the intestinal permeability in
      20 healthy subjects is investigated. Participants attend three visits: 1) Sauna visit (to
      achieve 3% dehydration), 2) Positive control visit (intake of indomethacin which is known to
      increase intestinal permeability), 3) Negative control visit. At all visits, saliva samples,
      blood samples, faecal samples, saliva samples are collected and the multi-sugar permeability
      test is performed. In this test, participants drink a sugar solution and then urine collect
      urine for 5 and 24 h. The ratio of the sugars detected in the urine by liquid
      chromatography/mass spectometry is a reflection of the intestinal permeability. Saliva
      samples are collected for assessment of cortisol, a stress marker. Blood and faecal samples
      are collected for assessment of markers of intestinal barrier function and inflammation.
    


Intervention name(s): Dehydration by sauna exposure; Indomethacin
Intervention type(s): Other; Drug
Intervention description(s): Participants repeatedly undergo sauna exposures until they loose 3% of their body weight.; Participants take indomethacin in tablet form the evening before and the morning of the visit to induce intestinal permeability
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)
Condition: Erector Spina Plan Block; Preemptive Analgesia; Thoracotomy; Nociception Level Index(NoL)
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The patients who will participate in the study will be determined and informed according to
      the inclusion and exclusion criteria, and the patients who signed the informed consent form
      will be included in the study.52 patients who will undergo elective thoracotomy surgery will
      be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane
      block.

      Intraoperative pain status of the patients will be determined by the "Nociception Level
      Index" device and analgesia will be provided with fentanyl. The primary aim of the study is
      to compare the intraoperative opioid consumption of two groups with plan block at different
      times.

      In the postoperative period, patient-controlled analgesia device will be given to both groups
      for rescue analgesia. The opioid consumption of the patients will be controlled in this way
      in the postoperative period and their pain status will be determined. The secondary aim of
      the study is to examine the effect of plan block application time on the postoperative
      period.
    


Intervention name(s): Erector Spina Plan Block
Intervention type(s): Procedure
Intervention description(s): Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: preemptive analgesia; erector spina plan block; nociception level (NoL) index; thoracotomy; opioid consumption