bioihbjkbjnl/mcl2 huggingface dataset:
Project CHOICE: Efficacy Testing of CHOICE and CHOICE+Normative Feedback Interventions
Condition: Substance-related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will use a pilot test format to examine the efficacy of a brief Motivational
      Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE
      (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance
      abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.
    

Detailed description: 
      This study will use a pilot test format to examine the efficacy of a brief Motivational
      Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE
      (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance
      abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL. The study
      will have two arms: one group will receive the standard CHOICE Motivational Interview (MI)
      while the second group will receive the CHOICE Motivational Interview with a Normative
      Feedback component, called CHOICE+ (CHOICE Plus). The hypothesis is that there will be no
      difference in outcomes between those that receive the standard CHOICE and those that receive
      the CHOICE+ MI.
    

Intervention name(s): Motivational Interview with Normative Feedback; Motivational Interview
Intervention type(s): Behavioral; Behavioral
Intervention description(s): NOrmative Feedback (NF) contrasts and individual's substance use to available norms for one's reference group (i.e., descriptive norms.) Essentially, NF highlights how an individual's behavior is non-normative, which in turn, is thought to lead to reduced substance use.; The Motivational Interview (MI) addresses ambivalence about change. It's effects are mediated by how well counselors evoke change talk, or in-session client utterances about the: need for; commitment to; ability to; or steps needed, to change.
Other intervention name(s): CHOICE + (MI + NF); CHOICE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Motivational Interview, normative feedback, adolescents
Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators are hoping to figure out how youth with type 1 diabetes can best control
      their blood glucose levels after meals, by determining whether accurate carbohydrate dosing
      or the timing of the bolus is more important. There is evidence to suggest that each strategy
      is important for blood glucose control. Unfortunately, for some people, prebolusing is
      difficult, because they may not know how much they are going to eat. To give an exact dose of
      insulin 20 minutes before a meal can be difficult. In this study, the investigators would
      like to show that taking even just part of the insulin bolus 20 minutes before the meal is
      preferable to waiting until mealtime and taking the entire bolus. To do this, the
      investigators will have 24 patients in the study, who will each spend 4 mornings at The
      investigators clinic. The order of the visits will be selected randomly. The visits will
      include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½
      bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the person
      will eat the same meal, but the timing and amount of the bolus will be different. The
      investigators will measure the blood glucose levels with a blood glucose meter, and also with
      a laboratory test called YSI. The investigators will also be measuring the glucose levels
      under the person's skin with a continuous glucose monitor. The investigators will compare the
      area under the curve for the different visits, as well as the glucose levels at different
      points after the meal.
    


Intervention name(s): Bolus timing and dosing
Intervention type(s): Other
Intervention description(s): We will be altering the timing and dosages of the prescribed meal bolus.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparing two treatments for shivering after cesarean delivery for labor dystocia under
      epidural anesthesia.
    

Detailed description: 
      It is a double blinded randomized control trial.

      Study population: parturients undergoing a cesarean delivery for labor dystocia under
      epidural anesthesia experiencing shivering grade III or IV on the standardized shivering
      scale of Crossley and Mahajan

      Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes

      Control group: meperidine 0.35 mg/kg IV in 2 minutes

      Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan
      standardized shivering scale after the administration of the study drug

      Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia,
      maternal satisfaction and a cost-benefit analysis.

      The hypothesis is that dexmedetomidine will act faster, will have a superior response rate
      with less adverse effects.
    

Intervention name(s): Dexmedetomidine Injection; Meperidine Injection
Intervention type(s): Drug; Drug
Intervention description(s): 0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery; 0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Other intervention name(s): precedex; demerol
Intervention MeSH terms: Meperidine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metazym for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)
Condition: Metachromatic Leukodystrophy (MLD)
MeSH terms: Leukodystrophy, Metachromatic
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives: The overall objective is to evaluate the safety, efficacy and pharmacokinetics
      (PK) of rhASA treatment in patients with late infantile MLD.

      Methodology: This is a single center, open-label study of patients with late infantile MLD.
      Twelve patients will be enrolled in this study receiving a total of thirteen intravenous
      infusions of Metazym. One infusion will be given every other week for a period of half a
      year. After the half year the subjects will continue treatment every other week until safety
      data is available. Safety (AE/SAE) will be monitored at every visit during this period.
    

Detailed description: 
      Test product, dose, mode of administration, batch No.: The lowest dose level will be
      evaluated as a single dose of 25 U/kg. The three upper dose levels will be evaluated as
      repeated doses. Patients in each cohort will receive one dose of enzyme every other week for
      a period of eight weeks, a total of five doses. Dosing will be performed as follows: Cohort
      1: 25 U/kg as a single dose - hereafter 50 U/kg; Cohort 2: 100 U/kg; Cohort 3: 200 U/kg.
      Patients receiving the lowest dose as a single dose will receive the next dose level as a
      repeated dose. After twenty six weeks the subjects will continue treatment every other week
      until safety data is available. Safety (AE/SAE) will be monitored at every visit during this
      period. The dose will be adjusted monthly to account for changes in body weight. The infusion
      length will be dependent on the dose. Doses of 25 U/kg, 50 U/kg and 100 U/kg will be diluted
      in 50 ml isotonic sodium chloride and infused over 30 minutes. Infusion of 200 U/kg will be
      administered in the same manner except for an infusion time of 60 minutes.

      Duration of treatment: Half a year (26 weeks)
    

Intervention name(s): rhASA - Dose Level 1; rhASA - Dose Level 2; rhASA - Dose Level 3
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intravenous infusion 25 U/kg as a single dose - hereafter 50 U/kg every other week for 26 weeks; Intravenous infusion 100 U/kg every other week for 26 weeks; Intravenous infusion 200 U/kg every other week for 26 weeks
Other intervention name(s): HGT-1111; metazym; HGT-1111; metazym; HGT-1111; metazym
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rhASA; MLD; Metazym
Acalabrutinib Study in Indian Patients With Chronic Lymphocytic Leukaemia & Relapsed and Refractory Mantle Cell Lymphoma
Condition: Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is plan to assess the safety and efficacy of Acalabrutinib in Indian patients with
      chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL)
    

Detailed description: 
      A prospective, multi-centre, phase IV clinical trial of Acalabrutinib capsules in Indian
      adult patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle
      cell lymphoma (MCL). As per recommendation from Indian health authority, the current phase-IV
      study is planned with the aim to assess the safety and efficacy profile of Acalabrutinib in
      Indian patients with CLL/SLL, and patients with MCL who have received at least one prior
      therapy. The data obtained from the study will help to understand the safety and efficacy
      profile of Acalabrutinib in Indian patients. Patients will be monitored throughout the study
      period for Adverse Events of Acalabrutinib
    

Intervention name(s): Acalabrutinib capsule
Intervention type(s): Drug
Intervention description(s): The recommended dose of Acalabrutinib is 100 mg given per oral (PO) twice daily
Other intervention name(s): Calquence®
Intervention MeSH terms: Acalabrutinib
Intervention model: Single Group Assignment
Intervention model description: A Prospective, Multicentre, Phase-IV study and Clinical trials with a single arm.
Masking: None (Open Label)
Primary purpose: Treatment
Female Patient Preferences Regarding Physician Gender
Condition: Female Patient Preference
Study type: Observational

Summary: 
      This is a cross sectional survey study to describe female patient preferences when choosing
      their OB/GYN and other providers.
    

Detailed description: 
      The American College of Obstetricians and Gynecologists (ACOG) published that as of 2009,
      79.7% of the Obstetrics and Gynecology residents were female. Given the striking decline in
      male providers selecting OB/GYN in more recent years, it is critical to characterize patient
      preferences in the current environment.

      Nevertheless, it is not clear that females have strong preferences regarding gender. We hope
      to better understand the influence of bias on physician gender in present day.

      The purpose of this study is to describe female population preference based on physician
      gender and specialty.

      The study will be conducted on an online platform distributed across the United States by the
      aid of SurveyMonkey® .
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female population residing in the USA
Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo
      for the treatment of spasticity in subjects with multiple sclerosis (MS).
    


Intervention name(s): Arbaclofen placarbil 15 mg BID; Placebo; Arbaclofen placarbil 30 mg BID; Arbaclofen placarbil 45 mg BID
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): arbaclofen placarbil 15 mg BID; Placebo for arbaclofen placarbil 15, 30 and 45 mg BID; arbaclofen placarbil 30 mg BID; arbaclofen placarbil 45 mg BID
Other intervention name(s): XP19986 SR4; Sugar Pill; XP19986 SR4; XP19986 SR4
Intervention MeSH terms: Arbaclofen placarbil; Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Levetiracetam for the Treatment of Alcohol Dependence and Anxiety
Condition: Alcoholism; Generalized Anxiety Disorder; Panic Disorder; Social Phobia; Anxiety Disorders
MeSH terms: Alcoholism; Anxiety Disorders; Panic Disorder; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if levetiracetam is effective in treating alcohol
      dependence in patients with anxiety symptoms. The researchers hypothesize that individuals
      are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and
      sleep disturbance symptoms that accompany reduction in alcohol use.
    

Detailed description: 
      Alcohol dependence is frequently associated with anxiety disorders. Treatment studies of
      individuals suffering from both alcohol dependence and anxiety have been limited.
      Anti-seizure medications have been used for the treatment of alcohol withdrawal for three
      decades. More recently, anti-seizure medications have been shown to reduce drinking and
      promote abstinence, and reduce drinking in abstinent alcoholics. Levetiracetam is a newer
      anti-seizure medication, with a structure different than that of other anti-seizure
      medications, that is safe and generally well tolerated. The Food and Drug Administration
      (FDA) has approved levetiracetam for use with other anti-seizure medications in the treatment
      of epilepsy in adults. The metabolism of levetiracetam is less complicated than older
      anti-seizure medications, which makes it easier to use and better tolerated, and it is not
      likely to interact with other medicines. Levetiracetam has been shown to prevent anxiety
      during sedative withdrawal, which is similar to alcohol withdrawal, in a laboratory study
      using mice. Levetiracetam also had anti-anxiety effects in laboratory study using mice. Given
      that other anti-seizure medications have been shown to be helpful in treating alcohol
      dependence, that levetiracetam is not likely to have interactions with other medications, and
      that in animals levetiracetam appeared to be helpful for treating a condition similar to
      alcohol dependence and anxiety, we believe it should be studied for the treatment of alcohol
      dependent patients with anxiety disorders.
    

Intervention name(s): levetiracetam
Intervention type(s): Drug
Intervention description(s): Levetiracetam 1500 mg BID
Other intervention name(s): keppra
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance-induced anxiety disorder
Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes Patients
Condition: Diabetes Mellitus Type 2; Diastolic Dysfunction; Cardiac MRI; Myocardial Perfusion
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective
      in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac
      MRI. Secondary if the treatment has any effect on the perfusion of the heart on a
      cardiac-MRI.
    

Detailed description: 
      Aim: To test if treatment with liraglutide a GLP-1 analogue in 18 weeks improves diastolic
      performance in type 2 diabetes (DM2) patients with diastolic dysfunction, compared to
      placebo. Furthermore, analyzing cardiac MRI indices of fibrosis and the effect on myocardial
      perfusion.

      The investigators find that especially diastolic dysfunction is of interest, because it is
      highly overrepresented in DM2 patients and no treatment exists. Glucagon-like peptide 1
      analogue could be a possible treatment agent, by increasing the energy level in the
      myocardium. No previous study has tested the effect of treatment with a glucagon-like peptide
      1 analogue on diastolic dysfunction.

      Design: A randomised double-blinded placebo-controlled clinical trial. Sample size: 40
      patients, 20 in each group. The superior inter-study reproducibility results in considerably
      lower calculated sample sizes (reductions of 55% to 93%) required by cardiac MR compared with
      echocardiography to show clinically relevant changes. Power calculations show that only 30
      patients are needed form our primary outcome, to allow for dropouts the investigators have
      chosen to include 40 patients.

      Intervention: After randomization, patients will be treated with placebo or liraglutide (up
      to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks. A cardiac MRI scan and
      an echocardiography will be preformed at baseline and after 18 weeks.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Infrared-LED During Physical Training for Rehabilitation, Physical Performance and Body Aesthetics
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators hypothesis is that the infrared-LED illumination during treadmill training
      can enhance physical performance in postmenopausal women. The basis for such a hypothesis is
      based on the fact that the light therapy during the intense metabolic stage caused by
      exercise may be more efficient.
    

Detailed description: 
      Phototherapy improves cellular activation via absorption of photons by chromophores present
      in the protein components of the mitochondrial respiratory chain - mainly NADH dehydrogenases
      and cytochrome C oxidase, which leads to increased electron transport, production of ATP, and
      tissue regeneration (skin, muscle, bone, and nerves). Moreover, phototherapy stimulates the
      anti-inflammatory effect with analgesia and vasodilatation. Regarding body aesthetics,
      phototherapy increases microcirculation, lymphatic drainage, as well as collagen synthesis
      for the treatment of cellulite. The objective of this study was to develop and evaluate the
      effects of a new clinical procedure: infrared radiation originated from LEDs associated with
      treadmill training in postmenopausal women. LED arrays were developed for an irradiation of a
      large area, such as hip and quadriceps muscles, main actuators during stance and swing
      phases. These body parts are furthermore areas where there is incidence of osteoporosis,
      mainly at the femur, localized fat deposits, and cellulite. Infrared radiation (850 nm) was
      selected because this spectral range shows better skin penetration compared to red interval.
    

Intervention name(s): Photon stimulation by light-emitting diodes (LEDs); Treadmill training
Intervention type(s): Device; Other
Intervention description(s): Treadmill training with the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate. The average power and power density on the skin were 100 mW and 39 mW/cm2, respectively. The treatment time was 45 min bilaterally in both thighs. These parameters led to an approximate fluence of 108 J/cm2.; Treadmill training without the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infrared LED; Treadmill Training; Strength Muscle; Fatigue Muscle; Aerobic Capacity; Cellulite; Osteoporosis
Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Acute Substudy)
Condition: Obesity, Abdominal
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen
      participants with a large waist circumference participating in three OGTTs.
    

Detailed description: 
      The study is a acute, double-blinded, randomized, controlled intervention in 15 subjects with
      abdominal obesity at high risk of developing T2D. Initially, a blood sample is obtained
      (t=-15 min) and at time point 0, the participants will ingest a capsule containing either 6
      or 12mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g
      glucose solution. In the following 2 hours blood samples are collected at time points 15, 30,
      60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose,
      insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject
      will undergo the same set-up again, however now with the different dosage of cafestol or
      placebo. The process is repeated for three weeks until every subject has undergone both
      interventions and the placebo.
    

Intervention name(s): Cafestol 12 mg; Placebo; Cafestol 6 mg
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Capsule with 12 mg cafestol; Placebo capsule without cafestol; Capsule with 6 mg cafestol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment