bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several
      studies demonstrating their efficacy, we are conducting this study to look into the efficacy
      and safety of this novel combination of three fibres, in appetite regulation.
    

Detailed description: 
      Appetite regulation plays an important role in determining the food intake, which is a
      complex process influenced by biological, behavioral and environmental stimuli. Satiation
      (intrameal satiety) is defined as the process of feeling full and subsequently stopping food
      consumption during eating, it therefore reduces hunger and limits the energy consumptions
      during meals. On the other hand, satiety or more precisely intermeal satiety, delays the
      onset and possibly reduces the consumption of the next meal. High viscosity and bulking food
      components such as dietary fibre are expected to elicit stronger satiation/satiety than
      macronutrients or clear liquid.

      Due to its unique physicochemical properties, dietary fibre has been recognized as a
      potential ingredient that helps to enhance the sensation of satiety in the upper gut by
      increasing gastric distension and delaying gastric emptying, which subsequently reduces the
      food intake, and eventually leading on to weight loss.

      The investigational product is formulated from IQP-AK-102, a proprietary, patent pending
      combination of three soluble fibres. In-vitro studies showed synergistic properties for the
      fibres in IQP-AK-102. When consumed orally, IQP-AK-102 capsules dissolve in the stomach to
      release the fibres. Once hydrated, the fibres swell to form a thick, viscous and indigestible
      gel structure in the stomach. This physical structure results in increased gastric distension
      and delays the gastric emptying that induces satiety and fullness.

      However the unique composition of IQP-AK-102 had not been evaluated in human clinical
      studies. The objective of this placebo controlled, double blind study was to confirm the
      benefit of IQP-AK-102 in weight loss through promoting satiety and managing appetite. In this
      study, 120 overweight and obese subjects (60 per study arm) were tested to investigate if
      IQP-AK-102 is effective in reducing body weight over a period of 12 weeks.
    

Intervention name(s): IQP-AK-102; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.; The placebo contained microcrystalline cellulose and other excepients. Both active and placebo capsules had identical physical appearance in terms of size, shape, colour and opacity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2
      diabetic patients who had two 24 hour measurements performed within one week with the
      Arteriograph24 equipment.
    

Detailed description: 
      Arteriograph24 is a new monitor for measuring ambulatory blood pressure and additional
      performing brachial cuff based on analysis of a suprasystolic pulse wave.

      The study aim to test the feasibility of ambulatory pulse wave analysis every twenty minute
      (the fraction of missed measurements)and the reprodicility of pulse wave velocity and central
      augmentation index in type 2 diabetic patients. In addition we will explore the relation
      between diurnal variation of brachial blood pressure, central blood pressure and pulse wave
      velocity.

      20 type 2 diabetic patients will have 24h ambulatory blood pressure performed twice with an
      interval of one week.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetes patients recruited from out patient clinic
      
Keywords: pulse wave analysis; pulse wave velocity; Arteriograph24; Ambulatory; diabetes; reproducibility; diurnal variation
A 3 Way Cross-over Study Evaluating the Effects of ADOAIR Twice Daily Plus Tiotropium Bromide Once Daily Compared With the Individual Treatments of Japanese Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects on lung function of a combination of
      ADOAIR 50/250mcg twice daily plus tiotropium bromide 18mcg once daily compared with the
      individual treatments (tiotropium bromide 18mcg once daily alone and ADOAIR 50/250mcg twice
      daily alone) in Japanese subjects with COPD. The study will utilize a three-way cross-over
      design with a 2-week wash-out period between each 4-week consecutive treatment period. The
      aim is to support the rationale for "triple combination" therapy by demonstrating that
      treatment with both ADOAIR and tiotropium can potentially produce improved, clinically
      relevant effects compared with either treatment alone.

      This study will utilize a range of lung function measures in order to fully assess the
      benefits of triple therapy. The primary endpoint will be based on airways conductance
      measured using plethysmography (sGaw measured over 4hours post dose (AUC 0-4hr) on Day 28).
      Secondary endpoints will include lung function measures based on plethysmography and
      spirometry. The lung function measures will be supported by measurement of the use of relief
      salbutamol .
    


Intervention name(s): fluticasone propionate/salmeterol; tiotropium bromide; fluticasone propionate/salmeterol plus tiotropium bromide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250mcg fluticasone + 50 mcg salmeterol, twice daily 4 week treatment in each treatment sequence (crossover design); 18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design); 250mcg fluticasone + 50 mcg salmeterol, twice daily plus 18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design)
Other intervention name(s): ADOAIR is a registered trade mark of the GlaxoSmithKlline group of companies.; ADOAIR is a registered trade mark of the GlaxoSmithKlline group of companies.
Intervention MeSH terms: Fluticasone; Xhance; Bromides; Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons
      in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and
      loss of muscle function. Motor neurons are responsible for sending signals to muscles in our
      bodies to trigger movement. While there are drugs to help relieve symptoms of ALS, there is
      no cure for ALS.

      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means
      that the nervous system may be protected against weakening. It is known that rasagiline has
      possible neuroprotective characteristics, but the effectiveness of rasagiline for patients
      with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's
      disease.

      Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration
      (FDA) and is investigational. Investigational drugs are studied to find out if they are safe
      and effective in the treatment of diseases or conditions.

      By doing this study, researchers hope to learn if rasagiline is safe and slows disease
      progression in patients with ALS.

      Funding Source - FDA OOPD (FDA Orphan Products Division).
    

Detailed description: 
      The study is a phase II, double-blind, placebo-controlled, multicenter study of rasagiline
      2mg/day. Subjects will be assigned to either active agent or placebo (3:1) for twelve months.
      Subjects will undergo outpatient evaluations at screening, baseline, and months 1, 2, 4, 6,
      8, 10 and 12 and telephone assessments at months 3, 5, 7 and 9. There will be a close-out
      phone call 30 days post month 12.
    

Intervention name(s): Rasagiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rasagiline 2mg once a day for 12 months.; Placebo (looks like study drug but has no active ingredients) once a day for 12 months.
Other intervention name(s): Azilect
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children
Condition: Overweight and Obesity; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight
Study type: Interventional

Summary: 
      Nonalcoholic fatty liver disease is a serious health condition in overweight children which
      can lead to heart disease. This project will examine the links between liver health and
      cardiovascular risk factors in overweight and obese children, and will test the effect of a
      long-term after-school exercise program.

      Provision of comprehensive evidence for the benefits of exercise on children's health may
      reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.
    

Detailed description: 
      This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded
      randomized trial of exercise in overweight children ("SMART study," R01 HL087923, P.I. Davis,
      NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular
      health to provide information about the effects of exercise on these conditions.
    

Intervention name(s): Exercise; After-school program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Heart rate monitors worn by each child at each session; Supervised recreational program with token economy
Other intervention name(s): Aerobic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: arterial stiffness
Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder
Condition: Amphetamine Use Disorders
Study type: Interventional

Summary: 
      Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use
      disorder in previous studies, while the evidence-based protocols still required. The aim of
      this research is to develop more applicable rTMS intervention pattern and protocols to reduce
      craving and relapse of methamphetamine-dependent patients.
    

Detailed description: 
      The limbic circuit and executive control circuit are two important frontal-striatal neural
      circuits associated with drug dependence. Previous studies showed increased functional
      activity within the limbic neural circuit (e.g. medial prefrontal cortex (mPFC) and ventral
      striatum) in the presence of a salient cue and decreased activity in the executive control
      circuit (e.g. dorsal prefrontal cortex and dorsal striatum). TMS was used to reverse the
      activities of these two circuits, by using continuous TBS and intermittent TBS, respectively.
      In this study, vmPFC cTBS was conducted to modulating the limbic circuit, while left dlPFC
      iTBS was conducted to modulating the executive control circuit. Combined treatment of vmPFC
      cTBS and left dlPFC iTBS was conducted to modulating two circuits simultaneously. Focused on
      evaluating the efficacy of the interventions and investigate the mechanisms,
      neuropsychological tests, biochemical tests, and electroencephalography will be used to
      investigate the neurobiological mechanism of the methamphetamine use disorder, craving, and
      relapse. The study will be very helpful to develop evidence-based rTMS protocols for
      methamphetamine-dependent patients in clinical practice and decrease harm for both the
      patients and their families.
    

Intervention name(s): sham TBS; real mPFC cTBS; real dlPFC iTBS; real dlPFC iTBS + real mPFC cTBS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Stimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil.; Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.; Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.; Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Amphetamine-type stimulants; prefrontal-striatal circuits; rTMS; individualized therapy; craving; relapse
A Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers
Condition: Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This study is designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following
      the use of nicotine pouches in cigarette smokers who have experience with use of smokeless
      tobacco (SST) [e.g., snus, moist snuff].
    

Detailed description: 
      Potential subjects will complete screening procedures to assess their eligibility within 45
      days prior to enrollment, randomization and confinement.

      Following the Screening Visit, eligible subjects will be scheduled for a Day 1 Check-in visit
      to complete procedures to confirm eligibility. Eligible subjects will be enrolled and begin
      confinement at the clinical site for 10 days and 9 nights. In addition, on Day 1, subjects
      will use at least one nicotine pouch (7 mg nicotine) but no more than 3 pouches to
      familiarize themselves with the investigational product (IP). Subjects will participate in
      separate Test Sessions for plasma nicotine PK assessment, one for each IP. Each Test Session
      will last for approximately 3 hours following the start of the IP use, and will include
      collection of plasma samples for PK assessments prior to, during, and following IP use.

      Safety will be monitored throughout the study by the Principal Investigator (PI) (or
      designee) by assessing adverse events (AEs), vital sign measurements, physical examinations
      (including an oral examination), and clinical laboratory tests. Mandatory physical and oral
      examination will be performed as part of end of study or early termination procedures.

      The clinical site will attempt to contact all subjects who used at least one IP (including
      subjects who terminate the study early) using their standard procedures approximately 7 days
      after the last IP use to determine if any AE has occurred since the last study visit. A
      return visit may be scheduled for follow-up assessments at the discretion of the PI or an
      appropriately qualified designee.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E; Product F; Product G; Product H; Product I
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): A 4mg nicotine pouch product; A 7mg nicotine pouch product; A 7mg nicotine pouch product; A 7mg nicotine pouch product; A 7mg nicotine pouch product; A 7mg nicotine pouch product; A 7mg nicotine pouch product; A 7mg nicotine pouch product; A 7mg nicotine pouch product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
HFCS, Apple Juice, Excess Free Fructose & asthma-the FHS-OS
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Perform an exploratory analysis of association between consumption of high excess free
      fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple
      juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.
    


Intervention name(s): Dietary intakes
Intervention type(s): Other
Intervention description(s): Analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the Framingham Heart Study (Offspring) cohort
Growth Arrest in Focal Dermal Hypoplasia
Condition: Focal Dermal Hypoplasia
MeSH terms: Focal Dermal Hypoplasia
Study type: Observational

Summary: 
      Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by
      mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb
      and eye abnormalities. Short stature and underweight have been noted in the majority of these
      patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect
      that pituitary deficiencies may contribute to poor linear growth. This study will examine the
      nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth
      stunting and low weight that is observed in FDH. The investigators will utilize standard
      clinical tools including a bone age xray, glucagon stimulation test to evaluate growth
      hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal
      markers, food diaries, symptom diaries, and growth charts.
    

Detailed description: 
      Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by
      mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb
      and eye abnormalities. Short stature and underweight have been noted in the majority of these
      patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect
      that pituitary deficiencies may contribute to poor linear growth. This study will examine the
      nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth
      stunting and low weight that is observed in FDH. The investigators will utilize standard
      clinical tools including a bone age xray, glucagon stimulation test to evaluate growth
      hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal
      markers, food diaries, symptom diaries, and growth charts.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with focal dermal hypoplasia
Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to assess how glucagon administered nasally, using a nasal
      dosing delivery device, works in children and adolescents compared with
      commercially-available glucagon given by injection. In addition, the safety and tolerability
      of glucagon given nasally was evaluated.
    

Detailed description: 
      This study was conducted to permit determination of appropriate dose level(s) for pediatric
      use based on the safety observations and results of glucagon and glucose assays.

      Each participant 12 to less than 17 years of age underwent two visits in random order and
      received glucagon nasal powder once and commercially available glucagon (GlucaGen, Novo
      Nordisk) by intramuscular (IM) injection once. Participants 4 to less than 12 years were
      randomly assigned to have either 1 visit with commercially available glucagon (GlucaGen, Novo
      Nordisk) by IM injection OR to have 2 visits with a 2.0 milligram (mg) dose of glucagon nasal
      powder administered during one visit and a 3.0 mg dose of glucagon nasal powder administered
      during the other visit. For those randomized to complete two research dosing visits, the dose
      of glucagon nasal powder given during each visit was masked to the participant and study
      personnel.

      Glucagon was administered after glucose was lowered to <80 mg/dL using insulin if necessary
      on the dosing day. Participants were treated with either glucagon given nasally (either 2.0
      mg or 3.0 mg for participants 4 to less than 12 years of age or 3.0 mg for those 12 to less
      than 17 years of age) or by intramuscular (IM) injection (1 mg for those 55 pounds [lbs] or
      more and 0.5 mg for those weighing less than 55 lbs) in the quadriceps muscle of the leg.

      Blood glucose levels and adverse events were carefully monitored for 90 minutes post-dosing.
      After a wash-out period of 7 days or more, participants 12 to less than 17 years of age
      returned to the clinic and the procedure was repeated with each participant crossed over to
      the other treatment. Participants 4 to less than 12 years assigned to have 2 dosing visits
      returned to clinic for repeated procedures and received alternate dose of nasal glucagon
      (NG). Participants 4 to less than 12 years assigned to a single dosing visit did not return
      for a second dosing visit.
    

Intervention name(s): Nasal Glucagon; Intramuscular Glucagon
Intervention type(s): Drug; Drug
Other intervention name(s): AMG504-1; LY900018; GlucaGen HypoKit
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment