bioihbjkbjnl/mcl2 huggingface dataset:
Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency
Condition: Alpha-1 Antitrypsin Deficiency (AATD); Pi*ZZ, Pi*SZ, Pi*Null, Another Rare Phenotype/Genotype Known to be Associated With Either Low or Functionally Impaired AAT Including F or I Mutations; Emphysema or COPD
MeSH terms: Alpha 1-Antitrypsin Deficiency; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multicenter, double-blind, randomized (1:1), placebo-controlled, 12-week,
      proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic
      effect of oral administration of alvelestat (MPH966) in subjects with confirmed AATD defined
      as Pi*ZZ, Pi*SZ, Pi*null, or another rare phenotype/genotype known to be associated with
      either low (serum AAT level <11 μM or <57.2 mg/dL) or functionally impaired AAT including "F"
      or "I" mutations.
    

Detailed description: 
      Alpha-1 antitrypsin deficiency (AATD) is the most common genetic cause of chronic obstructive
      pulmonary disease (COPD) and early-onset emphysema. AATD is characterized by low AAT levels;
      leading to excessive neutrophil elastase (NE) mediated lung destruction. Current treatment
      requires the periodic infusion of pooled AAT derived from human plasma, but this therapeutic
      approach (termed augmentation) does not definitively slow the rate of emphysema
      progressionlung function decline and is very expensive. In addition, it is not clear that the
      currently recommended dose for augmentation fully controls lung inflammation and destruction.
      Alvelestat (MPH966, formerly AZD9668) is a potent, selective, and reversible, oral inhibitor
      of human NE. Suppression of NE is expected to reduce lung damage and may slow disease
      progression. This study is to establish proof of clinical concept by investigating the
      mechanistic effect and safety of alvelestat (MPH966) in patients with AATD.
    

Intervention name(s): Alvelestat (MPH966); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.; Placebo is a pill or tablet that does not contain any study drug.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized (1:1), placebo-controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Implant Driver Facilitated Micro-osteo Perforation on the Rate of Tooth Movement.
Condition: Tooth Movement Techniques
Study type: Interventional

Summary: 
      we have conducted a split-mouth randomized clinical trial to study effects of implant induced
      micro-osteoperforations on the rate of tooth movement during canine retraction.
    

Detailed description: 
      The experimental group will receive implant driver facilitated microosteoperforation on one
      side of the mouth( according to split mouth design) decided by random allocation.

      After 3 months of extraction of upper first premolar ( according to planned orthodontic
      treatment), 3 microosteoperforation will be done with implant in an implant driver distal to
      canine. Surgical procedure will be done in local anesthesia, no flap will be raised. Alginate
      impressions will be taken before the procedure and 28 days after canine retraction has
      started, to measure the difference between rate of canine retraction on both sides.
      Measurement was done by a digital vernier caliper,
    

Intervention name(s): implant driver facilitated micro-osteoperforations
Intervention type(s): Procedure
Intervention description(s): 3 micro-osteoperforations(in a vertical pattern) are done on the randomly allocated experimental side , distal to canine under local anesthesia. the other side of the mouth is used as a control.
alginate impression is taken before the intervention .
Other intervention name(s): micro-osteoperforations by any other means.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: micro-osteoperforations, tooth movement, implant driver
Ischemic Preconditioning and Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to determine the impact of 7 days of daily ischemic preconditioning
      (IPC) on vascular function and insulin sensitivity in Type 2 Diabetes Mellitus.
    

Detailed description: 
      Occlusion (cuff inflation to a pressure that reduces blood flow) using a blood pressure cuff
      on the upper arm for 5 mins followed by recovery (cuff deflation so blood flows normally
      gain), is known as ischemic preconditioning (IPC). An intervention consisting of 4 cycles of
      5 min arm occlusion followed by 5 min periods of recovery on a daily basis can improve blood
      vessel function. This is a simple and easily applicable intervention that immediately
      improves the blood vessels capacity to deliver blood to an organ (e.g. heart or the muscle).
      However, it is currently unknown if a daily IPC can improve blood vessel function in patients
      with type 2 diabetes mellitus (T2DM) and if it will aid in improving blood glucose control.
      Therefore, the purpose of this study is to investigate if daily IPC for 7 days can improve
      blood vessel function and blood glucose control in T2DM.

      This randomised control trial consists of 3 visits to Liverpool John Moores University;
      before intervention, immediately following intervention, and 8 days following the end of the
      intervention. Participants will be trained to apply the IPC device and then perform it at
      home daily for 7 days.
    

Intervention name(s): Ischemic Preconditioning
Intervention type(s): Other
Intervention description(s): Ischemic preconditioning (IPC) refers to cycles of 5 minutes of upper arm cuff inflation with 5 minute periods of cuff deflations, repeated 4 times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Quetiapine in Specific Phobia
Condition: Specific Phobia
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that quetiapine XR has anxiolytic properties. The study aims to
      investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety
      disorders. Therefore, in a proof-of-concept design patients with simple phobia will be
      selected to investigate specific anxiolytic and antipanic activity during acute anxiety.
      Moreover, in a combined fMRI/visual stimulus presentation paradigm activity of fear-network
      associated brain structures such as the amygdala will be investigated under treatment with
      quetiapine XR or placebo. Additionally, genetic factors potentially mediating anxiolytic
      properties of quetiapine will be studied.
    


Intervention name(s): Quetiapine XR; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 100 mg single-dose Quetiapine XR; Placebo
Other intervention name(s): - Seroquel XR; - Seroquel Prolong; - ATC-Code: N05A H04; no other name
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: specific phobia; simple phobia; anxiety disorder
EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The general objective of this project is to investigate the possible efficacy of a training
      based on proprioceptive and visual feedback carried out with the GRAIL (Motekforce Link)
      virtual reality environment on postural control and balance skills of school-aged children
      with clinical diagnosis of ASD.
    


Intervention name(s): exergames with GRAIL virtual immersive reality environment
Intervention type(s): Device
Intervention description(s): The participants will perform exergames on GRAIL immersive virtual reality to improve balance (e.g. load shifts, exercises with adaptations to motor perturbations). GRAIL can provide proprioceptive and visual feedback to participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor abilities
Influence of Priming on Goal-directed and Cue-dependent Behavior
Condition: Eating Behavior; Habits
Study type: Interventional

Summary: 
      The current proposal aims to investigate implicit and explicit priming paradigms for changing
      cue-dependent and goal-directed nutritional behavior.
    

Detailed description: 
      Food choice and intake is a daily and throughout normal subject. However, for more and more
      people eating habits and the question of food choice are of increasing interest and in
      several cases even a problem. The prevalence of obesity has tripled in the last decades and
      it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail
      on the long run, also because people fall back into former unhealthy eating habits. Various
      factors influence our daily food choice, not all of which are apparent to ourselves. Thus,
      food choice might be goal-directed and therefore conscious and reflective, yet in other
      circumstances the choice to eat something specific might be based on cue dependent processes
      which are automatic and thus difficult to control. Since a change in eating-behavior and
      long-lasting weight loss is most problematic to achieve, the current proposal aims to
      investigate implicit and explicit priming paradigms for changing cue-dependent and
      goal-directed nutritional behavior.
    

Intervention name(s): health mindest; palatability mindset
Intervention type(s): Behavioral; Behavioral
Intervention description(s): groups be confronted with health aspects of food items; groups be confronted with palatability aspects of food items
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite
      identification of [14C]TAS-303 following oral single dose
    


Intervention name(s): TAS-303, [14C]TAS-303
Intervention type(s): Drug
Intervention description(s): oral administration on day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intensive Outpatient Treatment for Suicidal Veterans
Condition: Suicidality
MeSH terms: Suicidal Ideation
Study type: Interventional

Summary: 
      This investigation is a feasibility study conducted in a VA outpatient treatment setting. The
      study is designed to test the feasibility of implementing a novel way of working with
      suicidal patients, the Collaborative Assessment and Management of Suicidality (CAMS). The
      primary purpose of the proposed project is to determine if it is possible to train clinicians
      working in the Mental Health Clinic at the Denver VA Medical Center (VAMC) to utilize this
      therapeutic framework. This project is extremely timely in relation to expectations of future
      increased clinical demands among potentially high-risk Operation Enduring Freedom/Operation
      Iraqi Freedom (OEF/OIF) veterans who may become suicidal in the years to come.
    


Intervention name(s): CAMS
Intervention type(s): Behavioral
Intervention description(s): First, as discussed above, suicidality is the focus of treatment rather than one of many symptoms being treated. Second is the emphasis on patient and therapist collaborating on treatment rather than the therapist dictating how therapy progresses. Beyond those two basic tenets, each therapist is free to utilize their current clinical skills to conduct psychotherapy.
Keywords: suicide; veterans; assessment; CAMS
Non-routine Use of Antibiotics (Amoxi-light)
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Observational

Summary: 
      To evaluate, in routine operational settings of treatment of uncomplicated Severe Acute
      Malnutrition (SAM) in children aged 6-59 months, the risk of nutritional recovery and
      hospitalization with non-routine use of amoxicillin compared to the risk achieved with
      systematic use of antibiotics.
    

Detailed description: 
      Upon admission, all children will receive nutritional treatment and standard medical care in
      accordance with the nutritional guidelines of the national protocol, with the exception of
      the routine distribution of antibiotics. Antibiotics will be provided at admission and during
      follow-up only if clinically justified. The results of the program (ie, nutritional recovery,
      hospitalization, death and abandonment) will be monitored in all children aged 6 to 59 months
      admitted for outpatient therapy in 2 outpatient treatment sites in the Madarounfa health
      district in Niger.

      To ensure that the children included in the study receive appropriate care, the study will
      ask the children's leaders to return to the clinic for medical surveillance in the event of a
      clinical complication. Program staff will facilitate appropriate management, including
      prescription of antibiotics if clinically justified, and transfer to hospital of all children
      in need of close supervision and / or comprehensive medical management.
    

Intervention name(s): Standard medical care
Intervention type(s): Other
Intervention description(s): All children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics.
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All children from 6 to 59 months admitted directly for the treatment of uncomplicated
        SAM(MUAC <115 mm or PTZ <-3 and / or presence of nutritional edema grade + or + + and
        moderate or good appetite with no medical complications) in the 2 CRENAS chosen as study
        sites during the inclusion period of the study. A "direct admission" is defined as an
        admission without reference from CRENI (intensive nutritional recovery and education
        centres) to CRENAS. Readmission cases, that is, children admitted to the nutritional
        program in the last 3 months, and references from the Center for Ambulatory Nutritional
        Recovery for Moderates (CRENAM) remain eligible for inclusion of the study without
        prejudice and without notation at the previous admission.
Nasal Pillows vs. Nasal Masks at High CPAP Pressure
Condition: OSA
Study type: Interventional

Summary: 
      The aim of this evaluation is to test:

        1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks

        2. Patient mask type preferences at high pressures
    


Intervention name(s): Nasal mask; Pillows mask
Intervention type(s): Device; Device
Intervention description(s): Nasal mask (Mirage Activa, Micro, FX); Nasal pillows mask (Swift FX)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The reason for this study is to see if insulin glargine is safe in participants with type 2
      diabetes mellitus (T2DM) in India.
    


Intervention name(s): Insulin Glargine
Intervention type(s): Drug
Intervention description(s): Administered SC
Other intervention name(s): LY2963016; Basaglar
Intervention MeSH terms: Insulin Glargine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Assess the Safety and Efficacy of Topical Salbutamol in Healthy Volunteers.
Condition: Scarring
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre, double-blind, placebo (vehicle) controlled, randomised, dose
      escalation trial. Three concentrations of topical salbutamol gel will be compared, in a
      group-wise fashion, with a placebo administration at one incision site on each arm of the
      trial subjects. Each participant will be allocated to only one dosing group. The treatments
      will be paired anatomically so that for each pair of sites, one closed incision site will
      receive the active substance, while the other will receive placebo.
    


Intervention name(s): Incision; Active gel; Placebo gel
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): A skin incision will be made on the medial aspect of the upper arm.; The incision site on one arm will be dosed with the active gel.; The incision site on the other arm will be dosed with placebo gel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects
Condition: Pain Management
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      This study looks at the effect of combined breathing-controlled electrical stimulation
      (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after
      spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of
      combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the
      study in a population of healthy volunteers. Note that this study will also enroll spinal
      cord injury patients, brain injury patients, and amputation patients and that this study as
      applied to these other populations will be covered in separate ClinicalTrials.gov records.
    


Intervention name(s): BreEStim; tDCS active; tDCS sham
Intervention type(s): Device; Device; Device
Intervention description(s): BreEStim will applied for 10 to 20 minutes.; tDCS will be applied for 20 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated
      dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFL.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Treatment duration: 6 weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of a Decision Aid Regarding Natural Health Products for Menopausal Symptoms
Condition: Decision Making; Choice Behavior; Decision Support Techniques; Decision Aids
Study type: Interventional

Summary: 
      The aim of this study is to assess the impact of a patient decision aid regarding natural
      health products for menopausal symptoms on decisional conflict, knowledge and persistence for
      an option of women aged 45-64 years old. We are expecting a decrease in decisional conflict
      and an improvement on knowledge level. We are also expecting an intention to use the decision
      aid in the future and to discuss with the physician or pharmacist about the use, or the
      intention to use natural health products.
    

Detailed description: 
      Health decision making is a process known to be difficult, specially in uncertainty context.
      Because of a lack of evidence, natural health products field remains uncertain. Decision aids
      (or decision support interventions) have been elaborated in the past for several health
      decisions and previous studies showed that they seem to be effective on reducing decisional
      conflict. Following a needs assessment with 40 women and 15 key informants, we developed a
      decision aid tool specific to the context of natural health products for menopause. In this
      study, we will assess its impact on decisional conflict, knowledge, persistence for an
      option, intention to use for a future decision in the same area, and intention to disclose
      use of natural health products to health professionals.

      Comparison: An existing general information brochure on menopause compared to a decision aid
      tool that we developed based on the Ottawa Decision Support Framework.
    

Intervention name(s): Decision aid
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: Decision making; Decision support; Decisional conflict; Menopause; Natural health products; Herbs; Complementary medicine; Complementary therapies
The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      Wheat germ is a by-product of the wheat-milling industry with high nutritional value and
      therefore could be used as a raw source for the preparation of food products such as bread,
      cookies, muffins, etc.

      The aim of this study is to assess the effects of ingesting wheat breads supplemented with
      wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic
      response in healthy human volunteers.
    

Detailed description: 
      This is a crossover, double blinded, placebo controlled randomized trial. The study will
      compare the effect of consumption of wheat breads with or without wheat germ on healthy
      individuals, during 2 intake periods of 4 weeks each and 5 weeks washout before crossover.

      The study will focus on the effects of wheat breads supplemented with wheat germ on
      gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy
      human volunteers.
    

Intervention name(s): wheat bread with wheat germ; wheat bread without wheat germ
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gastrointestinal Discomfort; Wheat germ; Constipation; Glycaemic Index; Blood Cholesterol Level; Glycaemic Response; Cholesterol; PAC-SYM; Gut Microbiota