bioihbjkbjnl/mcl2 huggingface dataset:
D-Cycloserine to Enhance Extinction to Alcohol Cues
Condition: Alcohol Use Disorders.
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form
      of dysregulated learning and are influenced by classical conditioning. This is based on
      numerous studies indicating that conditioned contextual cues influence craving for alcohol
      consumption. As a result, there has been considerable interest in extinction-based treatments
      for AUDs (i.e., treatments that focus on extinguishing the associations between alcohol cues
      and motivation to drink), referred to as cue exposure treatment To date, extinction-based
      treatment for AUDs has resulted in disappointing outcomes in clinical trials and there is
      considerable interest in improving this form of treatment. One novel strategy is the use of
      pharmacological adjuncts to enhance extinction. Medications that maximize extinction may
      minimize subsequent reactions to alcohol cues and, in turn, subsequent clinical outcomes.
      This study is examining whether the medication d-cycloserine (DCS) can enhance extinction to
      alcohol cues. Recent basic research has revealed that DCS enhances extinction to fear cues
      and several lines of evidence suggest that DCS may also enhance extinction to alcohol cues.
      Therefore, DCS may serve as a useful pharmacological adjunct to extinction-based treatment
      for AUDs. Our primary aim is to examine whether, compared to placebo, DCS (50 mg) will
      enhance extinction to alcohol cues under controlled laboratory conditions in
      treatment-seeking individuals with alcohol use disorders. We hypothesize that DCS will
      generate greater extinction compared to placebo during the subsequent extinction session as
      measured by attenuated craving in response to alcohol cues. Furthermore, we hypothesize that
      DCS will generate greater extinction compared to placebo at follow-up assessments. This study
      is a proof-of-concept test of whether DCS can reduce reactions to alcohol cues under
      controlled laboratory conditions. It is a preliminary study using a subclinical number of
      extinction sessions and medication administrations to establish whether or not DCS improves
      extinction in the laboratory. If proof-of-concept is supported, it will suggest that a
      clinical trial is warranted. A clinical sample and clinical context are used to maximize the
      potential generalizability from this exploratory study.
    


Intervention name(s): d-cycloserine.
Intervention type(s): Drug
Intervention description(s): 50 mg administered on two occasions.
Other intervention name(s): Seromycin.
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Alcohol; Cues; Extinction; D-Cycloserine
To Evaluate the Safety, Tolerability and to Compare the Pharmacokinetic Profile of ATX-101
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this trial are to evaluate the safety and tolerability of ATX-101
      injections and to compare the pharmacokinetic profile of ATX-101 administered into
      subcutaneous fat in the submental area and abdomen.
    


Intervention name(s): ATX-101
Intervention type(s): Drug
Intervention description(s): 2 mg/cm2 ATX-101
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled
      pilot study is to study feasibility and collect preliminary clinical data related to the
      safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the
      GammaCore device for the prevention of chronic migraine, and to support the development and
      approval of a larger pivotal study.
    


Intervention name(s): GammaCore Active Device; GammaCore Sham Device
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; chronic migraine; migraine; non invasive; gammacore
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants
Condition: Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to perform mass balance following a single oral dose
      of [14C]CCX168 in healthy adult male participants.
    


Intervention name(s): [14C]CCX168
Intervention type(s): Drug
Intervention description(s): Administered orally.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vasculitis; Complement; C5aR; Vascular diseases; Cardiovascular diseases; Systemic lupus erythematosus
Bioequivalence of Two Commercial Amoxicillin Suspensions
Condition: Bioequivalence of Amoxicillin
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the
      bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian
      volunteers.
    

Detailed description: 
      Under fasting condition, 25 volunteers (13 males and 12 females) were included in this
      randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study.
      Blood samples were collected at pre-dose (0h) and 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8 and
      12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2,
      Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations
      for both formulations in each subject.
    

Intervention name(s): amoxicillin
Intervention type(s): Drug
Intervention description(s): Comparison of pharmacokinetics of both formulations
Other intervention name(s): Amoxil; Amoxi-Ped
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Bioequivalence; Amoxicillin; Human
Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
Condition: Gastroenteritis; Vomiting; Diarrhea; Dehydration
MeSH terms: Gastroenteritis; Dehydration; Emergencies; Vomiting; Diarrhea
Study type: Interventional

Summary: 
      The objectives of the study were to determine whether ondansetron treatment would reduce:

        -  the amount of vomiting in the emergency department;

        -  the need for intravenous rehydration; and

        -  the need for hospitalization.
    

Detailed description: 
      Background:

      Vomiting may limit the success of oral rehydration in children with gastroenteritis and
      dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from
      gastroenteritis, emergency department revisits may increase.

      Methods:

      The investigators conducted a prospective, double-blind randomized trial at a pediatric
      emergency department in 214 dehydrated children, aged 6 months to 10 years with
      gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They
      were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or
      placebo. Oral rehydration was administered according to a standard protocol. The primary
      outcome was the proportion of children who vomited during oral rehydration therapy. The
      secondary outcomes were the mean number of episodes of vomiting, and the proportion of
      children treated with intravenous rehydration or hospitalized.
    

Intervention name(s): Ondansetron Oral Disintegrating Tablet
Intervention type(s): Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This study is a non-confirmatory post-marketing observational study to explore and describe
      the effectiveness of adalimumab on rheumatoid arthritis (RA) treatment course and participant
      satisfaction over time in context with utilization of a patient support program (PSP). The
      core elements of the PSP were call centers (in and outbound)/hotlines, nursing services,
      starter packs, provision of educational materials (print and digital) regarding RA and
      adalimumab, and injection guides. Other elements of the PSP, which varied between countries,
      included (but were not limited to) refill reminders, email contacts, support groups, and
      newsletters.
    

Detailed description: 
      The main objectives of the study are to examine the effectiveness of adalimumab treatment
      with respect to PSPs by means of Health Assessment Questionnaire Disability Index (HAQ-DI),
      Disease Activity Score (DAS28) results, and European League Against Rheumatism (EULAR)
      response criteria, as well as to evaluate the contribution of PSP to disease control,
      treatment continuation over time, participant's satisfaction, and PSP utilization.

      The primary endpoint is the percentage of participants achieving a minimal clinically
      important difference (MCID) in HAQ-DI at Week 78. (MCID is improvement of at least 0.22 in
      HAQ-DI compared to Baseline). Secondary endpoints include the percentage of participants
      achieving MCID in HAQ-DI at Weeks 12, 24, 36, 52, 64 and other effectiveness parameters,
      including: changes in DAS28, Simplified Disease Activity Index (SDAI), Clinical Disease
      Activity Index (CDAI), ACR 20/50/70 and EULAR moderate and good responses. Other secondary
      endpoints include health outcomes assessments including HAQ-DI, Work Productivity and
      Activity Impairment (WPAI), Compliance Questionnaire Rheumatology (CQR), and Treatment
      Satisfaction Questionnaire for Medication (TSQM) scores, expectation regarding PSP and health
      management via Patient Activation Measure (PAM-13), change in participant perceptions as
      measured by the Beliefs about Medicines Questionnaire (BMQ), and satisfaction with PSP as
      measured by PSP satisfaction assessment.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Representative disease population selected from rheumatology clinics in the countries
        selected.
      
Keywords: Rheumatoid Arthritis; Patient Support Program; adalimumab
A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
Condition: Bone Mineral Density
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a
      28-day OC regimen on bone mineral density (BMD) in adolescent females.
    

Detailed description: 
      Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not
      seeking hormonal contraception who meet eligibility criteria will serve as a control group.
      Duration of the study for each study participant will be approximately 13 months.
    

Intervention name(s): 91-day Levonorgestrel Oral Contraceptive; 28-day Levonorgestrel Oral Contraceptive
Intervention type(s): Drug; Drug
Intervention description(s): Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
Take 1 tablet daily; Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Other intervention name(s): levonorgestrel/ethinyl estradiol; DR-105; Seasonique®; levonorgestrel/ethinyl estradiol; Lessina®
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Bone Mineral Density; Oral Contraceptive
Immunoregulation of Periodontal Disease
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Our design is to test in hospital practice a selection of immune parameters that could assess
      the pathophysiology and progression of periodontal lesions.
    

Detailed description: 
      These parameters will be measured in 25 healthy volunteers and 25 moderate-to severe
      periodontal disese patients. Phagocytes will be tested phenotypically and functionally, both
      ex vivo and in vitro.
    

Intervention name(s): Blood sampling; Blood sampling
Intervention type(s): Other; Other
Intervention description(s): Analysis of the PNN, analysis of the monocytes; Analysis of the PNN, analysis of the monocytes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants
Condition: Cerebral Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Healthy (non-injured) and concussed college-aged participants will complete two testing
      sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a
      progressive exercise session to establish symptom exacerbation or maximal exercise capacity.
      Individuals randomized to the control group will receive no intervention between sessions,
      while individuals randomized to the intervention group will complete 30 minutes of stationary
      bike exercise at least 3 days/week.
    

Detailed description: 
      Healthy and concussed participants will be randomized to ACTIVE training (intervention) or
      control (no intervention) groups. Participants, regardless of group assignment, will receive
      clinical symptom, balance, and cognitive evaluations as well as a progressive exercise
      assessment at study outset. Concussed participants will enroll into the study within three
      days of injury and study participation will termination following 24 consecutive hours with
      no reported concussive symptoms. Healthy participants will have arbitrary start dates and
      will terminate the study 10-14 days later to approximate the general length of concussion
      recovery and, therefore, make the time between session in the healthy and concussed cohorts
      as equivalent as possible. Participants in the intervention group will complete stationary
      cycle ergometer workouts for 30 mins at least 3 days per week between testing sessions.
      Healthy participants will complete six ACTIVE training sessions, while concussed participants
      will complete ACTIVE training at least three days per week until asymptomatic. Concussed
      control participants will follow physician guidelines for rest and activity, while healthy
      control participants will be asked to follow their typical routines for rest and activity.
      Participants will repeat the identical testing session assessments prior to study
      termination.
    

Intervention name(s): ACTIVE Training
Intervention type(s): Other
Intervention description(s): Participants will be asked to complete aerobic exercise on a stationary bike during 30-minute sessions. Intensity will progress under a standard procedure for healthy participants (60-80% of VO2max) and as tolerated by concussed participants (starting at 60% of symptom exacerbation).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concussion; Exercise
Emotion and Attention in Alzheimer's Disease (ATEMMA)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The main purpose of this study is to investigate the existence of emotional attention
      impairments in Alzheimer's Disease, in correlation with amygdala and attention networks
      alterations. To this end, functional and structural neuroimaging will be used. A face
      expression recognition task, along with eyetracking, will be used to assess emotional
      attention impairments.
    


Intervention name(s): Facial expression recognition task
Intervention type(s): Behavioral
Intervention description(s): We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: attention; emotion; eye movements; amygdala
Abilify as an Adjunctive Treatment for Refractory Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical
      antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI)
      antidepressant treatment for depressed outpatients who are not responding fully to SSRI
      treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of
      treatment with Aripiprazole and SSRI medication.
    

Detailed description: 
      This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical
      antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI)
      antidepressant treatment for depressed outpatients who are not responding fully to SSRI
      treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule
      and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of
      depressive symptoms, overall functioning, social functioning, and side effects will be
      completed. It is hypothesized that patients' functioning will improve after 12 weeks of
      treatment with Aripiprazole and SSRI medication.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Depression; Unipolar Depression; Treatment Resistant Depression; Adjunctive treatment
The Effects of Stress Reduction on Surgical Wound Healing
Condition: Wound Healing; Stress; Surgery
MeSH terms: Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether a stress reduction intervention prior to
      surgery can improve wound healing and recovery.The investigators hypothesise that patients
      who receive a psychological stress reduction intervention prior to surgery will report lower
      stress and higher perceived control, have lower stress hormones, better wound healing and
      better self-reported recovery than patients who receive standard care alone.
    

Detailed description: 
      In previous prospective research, psychological stress has been shown to slow the healing of
      small superficial wounds and impair surgical healing. We will investigate whether a
      psychological intervention to reduce stress can improve surgical healing.

      Ninety patients undergoing elective laparoscopic cholecystectomy will be randomised to
      receive either standard care or a brief pre-surgical psychological intervention plus standard
      care. Patients will complete a pre-surgical questionnaire to assess stress, anxiety,
      depression, illness perceptions and current health, at least 3 days prior to surgery. Then
      the intervention will be delivered. A second questionnaire on the morning of surgery will
      reassess stress, anxiety and illness perceptions to see whether the intervention has reduced
      stress and increased control perceptions. Plasma catecholamines and salivary cortisol will be
      tested to assess the effectiveness of the intervention in reducing stress-related hormones
      and to investigate their role in wound healing. During surgery 2 small expanded
      polytetrafluroethylene tubes will be inserted in the wound, which will be removed after 7
      days. Wound healing will be assessed by hydroxyproline and total protein deposition in the
      tubes, as well as by the presence of wound infection. Patients' post-surgical recovery,
      including pain and fatigue, will also be assessed. If this brief psychological intervention
      can improve wound healing and aid recovery, it would provide a simple strategy to improve
      outcomes in surgery.
    

Intervention name(s): Stress reduction intervention
Intervention type(s): Behavioral
Intervention description(s): In addition to standard care, patients in the intervention group will receive a one-hour individually delivered programme administered once by a psychologist at least 3 days prior to surgery. This session aims to reduce stress and involves teaching relaxation and guided imagery exercises. Patients are provided a CD (or audiotape)of the relaxation instructions to take home and practice once a day.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychology; Laparoscopy; Cholecystectomy; Psychoneuroimmunology; Wound healing; Preparation for surgery; Stress reduction; Stress; Relaxation
A Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study examines the efficacy of two computer-based training systems to teach children
      with ADHD to attend more effectively.
    


Intervention name(s): Computer attention training systems for children with ADHD
Intervention type(s): Behavioral
Intervention description(s): Computer attention training systems for children with ADHD, one with and one without EEG-biofeedback, were delivered via approximately 20 sessions to the participants
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: EEG-biofeedback; neurofeedback; computer attention training systems; ADHD; ADD; child; children