bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance
      model with arm assessment pre-surgery followed by ongoing surveillance and targeted
      physiotherapy treatment after breast cancer surgery may improve early detection and
      management of arm morbidity. This study aims to determine the effect of prospective
      surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance
      group compared to control group at 12-months after breast cancer surgery.
    


Intervention name(s): Prospective Surveillance Group; Education Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved.; Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff.
Other intervention name(s): Prospective surveillance for arm morbidity and physiotherapy treatment; Attention Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Surveillance; Physiotherapy; Arm morbidity
Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, five- period, cross-over, randomized, single dose, single centre study
      in healthy subjects. This is the second clinical study for the UD-DPI. This study will
      ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the
      plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of FF
      delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the
      ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three
      dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This
      study is designed to compare the pharmacokinetic profile of various doses and blends of FF
      administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be
      screened 28 days prior to study initiation. During each treatment period, subjects will be at
      study site from evening prior to dosing until completion of the 48 hour post-dose PK sample
      collection on Day 3. Minimum 7 days washout will be between treatments after completion of
      all five treatments and the follow-up visit will be conducted 7-14 days post last dose.
      Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of
      companies.
    


Intervention name(s): FF UD-DPI; FF ELLIPTA DPI
Intervention type(s): Drug; Drug
Intervention description(s): A blister containing a small quantity of powder comprising of a blend of FF (micronised) and excipient(s) will be administered using UD-DPI. It is available in following dosages: 80mcg/Blister (0.8% Blend); 100mcg/Blister (0.8% Blend); 140mcg/Blister (0.8% Blend); 100mcg/Blister (0.6% Blend); A blister strip contained within the ELLIPTA device. Each blister contains a small quantity of powder comprising of a blend of FF and excipient(s) in dose 100mcg/Blister (0.8% Blend)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteer; Asthma; inhaled corticosteroid; UD-DPI; ELLIPTA DPI; Fluticasone furoate
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study is to determine the safety profiles, tolerability,
      pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy
      adult subjects.
    

Detailed description: 
      This will be a randomized, double-blind and placebo-controlled safety study with single oral
      doses of HMS5552 given to healthy volunteers.

      The primary objective is to characterize the safety profiles of HMS5552 following single
      ascending doses (SAD) in healthy adult subjects.

      The secondary objectives include:

        1. To assess the pharmacokinetic profiles of HMS5552 after single dosing

        2. To assess the preliminary pharmacodynamic profiles of HMS5552

      Each study subject will receive a single oral dose of HMS5552. During each dosing, eight
      subjects will be allocated to receive HMS5552 and two subjects will be allocated to receive
      placebo treatment.

      Several doses of HMS5552 will be tested. Dose titration or reduction is determined for each
      cohort based on the safety and pharmacokinetic data obtained from the lower dose cohorts.
    

Intervention name(s): HMS5552; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with
      mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to
      define the optimal dose(s) to be used in future trials.
    


Intervention name(s): AZD3480; Donepezil
Intervention type(s): Drug; Drug
Intervention description(s): 3 oral doses
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dementia; Alzheimer Type; Alzheimer Disease
Donepezil HCl & Cognitive Deficits in Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This 11-week study will examine the safety and effectiveness of the medication donepezil
      (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents
      with Autism Spectrum Disorder.
    

Detailed description: 
      Children with autism spectrum disorder (ASD) often have impaired communication, problems with
      social interaction, and repetitive and stereotyped patterns of behavior. While most research
      has attempted to treat the behavioral deficits commonly associated with ASD, few studies have
      attempted to improve the core features of this disorder. A recent study found that donepezil
      HCl helped to improve speech production, attention span, and ability to express emotions in a
      group of children with autism. This study will provide an opportunity to conduct further
      testing of the effects of donepezil HCl on the cognitive deficits presumed to underlie the
      core features of ASD.

      This study begins at Week 1 with a baseline assessment. Participants are then randomly
      assigned to either donepezil HCl or placebo. Participants will start with either a 5mg/day
      dose of donepezil HCl or placebo followed by a cognitive assessment after 4 weeks on this
      dose. Participants will then have their dose increased to 10mg/day. Another cognitive
      assessment will be given after 4 weeks on this dose.
    

Intervention name(s): Donepezil HCl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.; Placebo used in placed of Donepezil HCL
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Home-based vs. Supervised Exercise for People With Claudication
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a home-based exercise rehabilitation
      program compared to a supervised exercise program on intermittent claudication (leg pain or
      discomfort) and ambulatory function.
    

Detailed description: 
      This study seeks to 1) compare the changes in ambulatory function, vascular function, and
      health-related quality of life in patients limited by intermittent claudication following a
      home-based exercise rehabilitation program, a supervised exercise program, and a light
      resistance training exercise program; and 2) determine whether changes in walking efficiency,
      calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and
      supervised exercise rehabilitation improve ambulatory function.

      We hypothesize that a home-based exercise program utilizing new physical activity monitoring
      technology that can accurately quantify exercise adherence as well as the intensity,
      duration, and volume of exercise sessions will result in similar changes in ambulatory
      function, vascular function, and health-related quality of life compared to a standard,
      supervised exercise program. Further, both the home-based and supervised exercise
      rehabilitation programs will result in greater changes in ambulatory function, vascular
      function, and health-related quality of life than a light resistance training exercise
      program. Finally, we hypothesize that the changes in walking efficiency, calf muscle
      circulation, and calf muscle oxygen will each be predictive of improved ambulation following
      the home-based exercise program as well as the supervised exercise program.

      The 3-month program will consist of walking 3 times per week, with progressive increases in
      duration and intensity. The two walking exercise programs will be matched on the estimated
      caloric expenditure during the training sessions. Patients in the control group will perform
      light resistance training without any walking exercise.
    

Intervention name(s): Walking Exercise; Control--Resistance Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three times per week for 3 months; Three times per week for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: aging; gait; musculoskeletal disorder therapy; peripheral blood vessel disorder; muscle function; muscle strength; quality of life
Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)
Condition: Delirium
MeSH terms: Delirium
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to evaluate the efficacy and safety of suvorexant (MK-4305) for
      reducing the incidence of delirium in Japanese participants who are at high risk of delirium.
      The primary hypothesis is that suvorexant reduces the proportion of participants with
      delirium compared with placebo as assessed by the diagnostic and statistical manual of mental
      disorders 5th edition (DSM-5) criteria.
    


Intervention name(s): Suvorexant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Suvorexant administered at a dose of 15 mg QD via oral tablet; Suvorexant-matching placebo administered QD via oral tablet
Other intervention name(s): MK-4305
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

        -  To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in
           healthy male subjects.

        -  To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy
           male subjects.

        -  To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy
           male subjects.

        -  To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and
           esomeprazole in healthy male subjects.
    


Intervention name(s): CJ-12420; Esomeprazole 40mg
Intervention type(s): Drug; Drug
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics
Common Engagement Strategies (Common Factors) for Childhood Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This trial examines the effectiveness of training pediatric primary care providers (nurse
      practitioners, doctors) to use of strategies that enhance family/youth empowerment and
      engagement during office visits for children with mild to moderate problems with anxiety.
      Children coming for routine care at one clinic are screened for anxiety symptoms and seen by
      either a specially trained provider or one of the clinic's other regular staff members.
    

Detailed description: 
      Children who are thought to have mild to moderate anxiety will, via their parents, be offered
      the opportunity to receive treatment from their pediatric primary care provider. Providers
      will either use their existing anxiety approaches or will use those approaches combined with
      extra communication skills designed to promote patient and parent engagement in care.
      Children will be seen for up to 4 30-minute visits at 2 week intervals, with a follow-up
      telephone call 3 months later to asses the impact of treatment. Children with more severe
      anxiety (or those whose parents so desire) will be referred for specialized mental health
      care.
    

Intervention name(s): Common factors engagement training for provider; Standard pediatric advice for childhood anxiety
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Primary care providers have received brief training in communication skills designed to promote family engagement in care including understanding of treatment and empowerment.; Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Tunnel Access for Lateral Alveolar Ridge Augmentation
Condition: Bone Loss; Implant Site Injury
Study type: Interventional

Summary: 
      Minimally invasive procedures with the tunnel technique have been suggested to decrease
      patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge
      augmentation tunnel technique, crestal incision and the release of the connective tissue are
      avoided in order to enhance the blood supply of the flap. This approach preserves the blood
      circulation and does not damage the periosteum The purpose of this study is to evaluate the
      clinical outcome of a minimally invasive technique for maxillofacial horizontal bone
      augmentation .

      performed by using a collagen dermal matrix, deproteinized bovine bone and hyaluronic acid.

      Collagen matrix is inserted into a sub-periosteal tunnel using microsurgical instruments.
      Deproteinized bovine bone in a hyaluronic acid carrier are placed and inserted repeatedly
      into the pocket and absorbable suture is used to close the vertical incision.
    

Detailed description: 
      Tunnel bone regeneration achieves treatment objectives using the least invasive surgical
      approach.The goal is to increase patient satisfaction, decrease post-operative discomfort and
      morbidity.Preservation of the integrity of the periosteum is a determining factor in reducing
      postoperative pain and improving wound vascularization.

      The present study value the clinical results of a subperiosteal minimally invasive ridge
      horizontal augmentation technique.

      The technique includes the use of a laparoscopic approach to deliver hyaluronic
      acid,xenograft and a dermal matrix into a subperiosteal pouch.
    

Intervention name(s): bone and soft tissue augmentation
Intervention type(s): Procedure
Intervention description(s): A vertical full-thickness incision in the mesial aspect of the defect ridge.Microsurgery instruments is subsequently use to carefully elevate the full thickness of the mucosa.
Extreme caution must be exercised during these maneuvers to avoid tissue perforation and to maintain the integrity of the periosteum.An dermal matrix is place into the tunnel.A pouch is create between the bone and the membrane and the mixed bone chips and hyaluronic acid are inserted into the tunnel until the desirable ridge dimensions are obtained. Primary closure of the vertical incisions was achieved with single interrupted sutures.
Other intervention name(s): Bone regeneration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo
Condition: Psychological Distress
Study type: Interventional
Phase: Phase 1

Summary: 
      The main research question of the study is whether a family-based, life-skills focused
      psychosocial intervention is effective in reducing psychological distress and stigma and
      improving inter-personal relations and functioning among war-affected children in the
      Democratic Republic of Congo.
    


Intervention name(s): Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention
Intervention type(s): Behavioral
Intervention description(s): A 12-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: community-based; war-affected; psychosocial support; family-focused; psychological distress; adolescents; Democratic Republic of Congo; family functioning; community functioning; daily functioning
A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
Condition: Age-related Volume Deficit in the Mid-face
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA®
      XC injectable gel using cannula in participants seeking correction of age-related volume
      deficit in the mid-face.
    


Intervention name(s): JUVÉDERM VOLUMA® XC injectable gel with cannula; JUVÉDERM VOLUMA® XC injectable gel with needle
Intervention type(s): Device; Device
Intervention description(s): Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.; Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The proposed study will compare a well defined and integrated yoga practice (postures/breath
      control/meditation) to a conventional exercise program in reducing hypertension. The expected
      outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial
      stress, and the autonomic system in individuals with pre- and Stage I hypertension. The
      information gained in this study will have a positive impact by providing critical
      preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial
      on the effects of yoga on individuals with hypertension.
    


Intervention name(s): Yogic practice; Conventional Exercise
Intervention type(s): Other; Other
Intervention description(s): breathing, meditation, physical postures; Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Yoga, Hypertension; Blood Pressure; Autonomic Nervous system
N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Condition: Traumatic Brain Injury (TBI); Hazardous and Harmful Alcohol Use
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the project is to improve the care of Veterans with mild traumatic brain injury
      (mTBI) and unhealthy alcohol use.
    

Detailed description: 
      This is a pilot controlled clinical trial that aims to assess the efficacy of
      N-acetylcysteine (NAC) to reduce alcohol use and improve brain injury symptoms in Veterans
      with mTBI who consume alcohol at hazardous or harmful levels.
    

Intervention name(s): Medical Management Counseling; N-acetylcysteine; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Brief alcohol counseling; Experimental supplement; Placebo comparator
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TBI; hazardous and harmful alcohol use; Veterans; co-occurring disorders; pharmacotherapy