bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Low Doses of Caffeine on Mood, Physiology and Mental Function
Condition: Healthy
Study type: Interventional

Summary: 
      It is often assumed that levels of caffeine found in 'decaffeinated' beverages are below any
      psychopharmacological threshold. However, recent findings indicate that caffeine doses as low
      as 9 mg may be psychoactive. The effects of caffeine have also been shown up to 6 hours
      post-administration. The study aimed to establish the lowest active dose of caffeine, and to
      ascertain the duration of any effects.
    

Detailed description: 
      The majority of recent caffeine studies have evaluated doses in the range of 75 - 150 mg or 1
      - 2 mg/kg (approximately 130 - 260 ml fresh coffee). Such doses produce well characterised
      effects; including increased 'alertness', and improvements to measures of reaction time and
      sustained attention. A previous study has demonstrated improvements to performance following
      9 mg caffeine, which represents the lowest known psychoactive dose of caffeine. A number of
      these effects, including elevated salivary caffeine levels, were still apparent at 6 hours
      post-caffeine consumption (9). Findings showing effects of 12.5 and 9 mg caffeine are
      important as these are approaching the levels found in decaffeinated beverages, which are
      assumed to have no behavioural or physiological effects. However, despite extensive research
      in this area, the lower threshold for psychoactive effects has not been established. A
      randomised, placebo-controlled, double-blind, balanced crossover study was undertaken. 20
      young men and women (13 female, mean age 20.7 years, standard deviation 2.4) undertook
      computerised assessments of memory and attention and rated subjective mood. Autonomic
      activity and salivary caffeine were co-monitored. Assessment took place at baseline, 1, 3, 6,
      and 9 hours post-administration of placebo, 2.5, 5, and 10 mg caffeine (on separate days)
      administered in 150 ml fruit juice.
    

Intervention name(s): caffeine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Basic Science
Keywords: caffeine; coffee; decaffeinated; cognition; mood; autonomic
Clinical Effects of Temperature Controlled Laminar Airflow (TLA)
Condition: Asthma; Perennial Allergy
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether clean air administered to the breathing
      zone with Temperature controlled Laminar Airflow (TLA) during night is effective in the
      treatment of perennial allergic asthma.
    

Detailed description: 
      Background: Exposure to inhaled allergens is a pathogenetic factor in allergic asthma.
      However, most studies that previously looked at air cleaning devices have shown little or no
      effect on patients with perennial allergic asthma. Aims and objectives: This study aims to
      investigate a novel treatment, TLA, using temperature controlled laminar airflow with a very
      low particle concentration directed to the breathing zone of teenagers and adults with
      allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure
      during the night will have an effect on bronchial inflammation and quality of life. Method:
      Patients are randomized to start with active or placebo treatment for 10 weeks. All patients
      receive both active and placebo treatment with unfiltered air, with a 2-week wash-out period
      in between treatments. Maintenance treatment with inhaled corticosteroids is unaltered during
      the trial period. Health related quality of life (miniAQLQ)is the primary effectiveness
      measure. Exhaled nitric oxide (FeNO) and spirometry are also investigated.
    

Intervention name(s): Temperature controlled Laminar Airflow (Protexo); Placebo TLA
Intervention type(s): Device; Device
Intervention description(s): The intervention is designed to reduce the allergen load in the patients breathing zone by vertically displacing the allergens, originating from the bed and the ambient room environment, with a temperature controlled laminar airflow (TLA) during night sleep. The airflow is filtered through a high efficiency particulate air filter(HEPA), slightly cooled and ''showered'' over the subject. Due to the higher density, the cooled air descends slowly, and displaces the allergens from the breathing zone.; TLA treatment with disabled filtration function
Other intervention name(s): Protexo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Protexo; Asthma; Temperature controlled Laminar Airflow; Perennial allergy; Quality of life; MiniAQLQ; FeNO; FEV1; PEF
Effect of Senobi Versus Buteyko Technique on Functional Performance of Chronic Obstructive Pulmonary Disease Patient.
Condition: Shortness of Breath
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional

Summary: 
      Effect of Senobi breathing exercise versus Buteyko breathing technique on functional
      performance among chronic obstructive pulmonary patient.
    

Detailed description: 
      chronic obstructive pulmonary disease is a chronic inflammatory lung disease that cause
      obstructed airflow from the lungs. Symptoms include Breathing difficulty. cough, mucus
      production and wheezing. Its typically caused by long term exposure to irritating gasses or
      particulate matter, most often from cigarette smoker.

      Emphysema and chronic bronchitis are two most common condition that contribute to chronic
      obstructive pulmonary disease. Chronic obstructive pulmonary disease is progressive disease
      that gets over a time. Clinical trials will be Conducted in Gulab Devi chest hospital in
      Lahore. Through the convenient sampling Technique. Which will be allocated through the random
      sampling two groups are involved group A and group B. In group A check the effect of Senobi
      techniques (stretch the body) and in group B check the effect of Buteyko technique. (Inhale
      the through the nose while mouth is closed) by using 6 mint walk test, Borg scale and quality
      of life questionnaire. Apply the technique to check the effectiveness of dyspnea and quality
      of life of patient The Buteyko technique offers a complementary method of reliving
      respiratory symptoms based on the voluntary control of breathing as well as considering the
      effect of environmental and dietary trigger. Data will be collected by the questionnaire and
      analyzed by using statistical package for the social science SPSS software version 21. The
      Buteyko method made its way to Australia to Europe and the unite states in 1990, it become
      best for the asthma and chronic obstructive pulmonary disease patient. The Senobi stretch
      exercise of the respiratory muscle improve the chest expansion and also improve the chest
      wall mobility in chronic obstructive pulmonary disease patient. Senobi breathing exercise was
      found to be effective for depression and it regulate the sympathetic nerve activity.
    

Intervention name(s): pursed lip breathing
Intervention type(s): Combination Product
Intervention description(s): pursed lip breathing
Other intervention name(s): Senobi technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dyspnea, Quality of life, senobi,and buteyko
Culturally-Adapted Diet for Puerto Rican Adults
Condition: Diabetes Mellitus, Type 2; Obesity; Hypertension; Dyslipidemias; High Triglycerides; High Blood Glucose; Abdominal Obesity
MeSH terms: Obesity; Diabetes Mellitus, Type 2; Dyslipidemias; Obesity, Abdominal; Hypertriglyceridemia; Hyperglycemia
Study type: Interventional

Summary: 
      This pilot project will determine whether a diet culturally-adapted to Puerto Ricans can
      effectively decrease cardiometabolic risk for diabetes. This will help define a
      culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2
      diabetes and obesity outcomes.
    

Detailed description: 
      This pilot intervention will culturally-tailor a diet to the Puerto Rican adult population
      based on staple foods as well as culturally-appropriate strategies to reduce cardiometabolic
      risk factors of type 2 diabetes and obesity. Based on preliminary results from studies in the
      island, investigators will conduct a 4-month, 2-arm intervention among 200 adults (100 per
      arm) ages 25-65 living in Puerto Rico with at least 2 of 5 cardiometabolic risk factors. The
      two arms are: (1) intervention group consisting of culturally-appropriate advice in an
      initial individual session with daily text messages for 2 months (delivery phase); (2)
      control arm of standard general nutritional advice at the initial individual session, and
      text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the
      education and text messages. Investigators will measure changes in cardiometabolic risk
      factors and in eating-behaviors and psychological measures.
    

Intervention name(s): Culturally tailored food and diet advice; Standard healthy eating advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.; Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants
Condition: Biochemical Cobalamin Status; Motor Neurodevelopment
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Premature birth and low birth weight implies insufficient intrauterine growth and fetal
      malnutrition. During the first months of life where the infant is breastfed, the low stores
      aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants
      with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months
      infants with biochemical signs of impaired cobalamin status (i.e.: tHcy > 97.5 percentile for
      cobalamin treated infants, i.e.: tHcy>6.5 µM/L) will be randomised to cobalamin treatment or
      placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo
      treatment according to infant biochemical status and neurodevelopment.

      Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency
      will normalize biochemical status and cause improved motor neurodevelopment.
    


Intervention name(s): Hydroxycobalamin; Sham injection
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection; needle injection without any substance given
Intervention MeSH terms: Hydroxocobalamin; Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Post Marketing Surveillance for ADACEL™ in South Korea
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      This safety surveillance study is being conducted in accordance with Korea Food and Drug
      Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new
      drug".

      The study objective is to assess within 30 days post-administration, the safety of ADACEL™
      administered under the real clinical practice.
    


Intervention name(s): ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Intervention type(s): Biological
Intervention description(s): 0.5 mL, intramuscular (IM)
Other intervention name(s): Adacel™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adacel; Diphtheria; Tetanus; Pertussis
Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)
Condition: Steatoblepharon
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the
      efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid
      steatoblepharon (undereye bags).
    


Intervention name(s): XAF5 (concentration A: 0.1%); XAF5 (concentration B: 0.035%); Matching placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Ascending Dose Study of ALA-1000
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of
      ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single
      ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine
      sublingual films for 7 days.
    

Detailed description: 
      The study will include opioid-dependent subjects who have been receiving stable, orally
      administered buprenorphine for at least 2 weeks or buprenorphine naïve subjects who will be
      stabilized on orally administered buprenorphine for 3 days prior to ALA-1000 administration.

      All subjects will be washed off of oral buprenorphine for 7 days prior to ALA-1000
      administration except Cohort 6 which will receive ALA-1000 administration after 7 days of
      buprenorphine sublingual film dosing.

      The subsequent cohorts will be initiated after safety and PK information from the preceding
      cohorts is available.

      The expected maximum duration of participation for each subject is 192 days approximately,
      consisting of up to a 7-day screening period, up to a 31-day residential phase, and up to a
      154-day nonresidential period.
    

Intervention name(s): ALA-1000; buprenorphine sublingual film
Intervention type(s): Drug; Drug
Intervention description(s): Blood sample for PK analysis are collected before and post single injection of ALA-1000 (Day1) according to the schedule of procedures. Subjects remain in the residential phase through Day21 for safety assessment.; ALA-1000 injection after 7 days of buprenorphine sublingual film dosing. Blood sample for PK analysis are collected before and post sublingual buprenorphine dosing on Day-1
Other intervention name(s): Depot Buprenorphine Formulation
Intervention MeSH terms: Buprenorphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS
Condition: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS); Hematopoietic Stem Cell Transplant (HSCT)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare safety and efficacy of reduced-intensity conditioning
      and myeloablative conditioning regimens prior to HSCT in high-risk AML/MDS pediatric and
      young adult patients. This study investigates the use of two novel conditioning therapies for
      hematopoietic stem cell transplant (HSCT). The primary focus of both the investigators'
      myeloablative and reduced-intensity conditioning regimens is to reduce overall toxicity so
      that pediatric and young adult patients with high-risk AML/MDS with significant pretransplant
      comorbidities who would have been ineligible to proceed to HSCT previously can now receive
      potentially life-saving treatment.
    


Intervention name(s): Reduced-Intensity Conditioning Regimen; Myeloablative Conditioning Regimen
Intervention type(s): Drug; Drug
Intervention description(s): Campath (alemtuzumab) - drug class: monoclonal antibody Droxia (hydroxyurea) - drug class: antimetabolite Fludara (fludarabine) - drug class: antimetabolite Alkeran (melphalan) - drug class: alkylating agent Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent; Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent
Other intervention name(s): Campath, Droxia, Fludara, Alkeran, Thiotepa; Campath, Thiotepa, Fludara, Busulfex
Intervention MeSH terms: Vidarabine; Fludarabine phosphate; Fludarabine; Alemtuzumab; Thiotepa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, pharmacokinetics, and
      pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy
      Japanese non-elderly participants.
    


Intervention name(s): Placebo; TS-142, 10 mg; TS-142, 20 mg; TS-142, 30 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive placebo once daily for 7 consective days; Participants will receive 10 mg of TS-142 once daily for 7 consective days; Participants will receive 20 mg of TS-142 once daily for 7 consective days; Participants will receive 30 mg of TS-142 once daily for 7 consective days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Analysis of CRBSI Rates in Patients With a NexSite™ HD (Hemodialysis) Catheter
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      A U.S. multi-centre post approval registry to analyse the CRBSI rate in patients with the
      NexSite HD Catheter for long term vascular access for hemodialysis.
    

Detailed description: 
      This is a U.S. multi - centre, prospective, non-randomized post approval registry.
      Approximately one hundred and twenty patients will be implanted with a NexSite HD catheter at
      four to eight U.S. sites where hemodialysis catheters are routinely implanted. Each site may
      enrol a maximum of 50 patients. Enrolled patients will be followed from device placement to
      device removal or 180 days post device placement. Patients will be enrolled once only.

      The primary endpoint is CRBSI rate related to the NexSite HD catheter. Determination of
      infection will be decided by the investigator and if necessary adjudicated by the CEC
      (Clinical Events Committee) based on blood culture results, regardless of whether the
      catheter is removed.

      Secondary endpoints for the study are

        -  Successful placement and continued use of the NexSite HD device designed for use in
           patients requiring long term hemodialysis.

        -  Healing of catheter exit site

        -  Tunnel Infections

        -  Exit site infections

        -  Early non-infectious complications associated with CVCs

        -  Late non-infectious complications associated with Central Venous Catheters
    

Intervention name(s): NexSite HD Patients
Intervention type(s): Device
Intervention description(s): Measurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Maintenance Study of Entocort for Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
    

Detailed description: 
      A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a
      Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years,
      Inclusive
    

Intervention name(s): Entocort
Intervention type(s): Drug
Intervention description(s): Entocort capsules, taken orally, 6 mg daily.
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease
Effects of Exercise Training on Patients With Long COVID-19
Condition: Long COVID-19
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome
Study type: Interventional

Summary: 
      Effects of Exercise training on Patients With Long COVID-19, is a single-center, randomized,
      controlled trial designed to evaluate the effects of 4- week aerobic exercise administered to
      patients with long COVID-19 symptoms. The main outcome is cardiopulmonary fitness and long
      COVID-19 symptom improvement. Quality of life, depression, anxiety, insomnia status and
      perceived stress will also be assessed before and after the exercise program.
    

Detailed description: 
      Long COVID-19 symptoms are characterized by systemic deterioration of the entire body,
      leading to significant physiological and functional imbalances. Common symptoms may be
      related to decreased short-term or long-term exercise capacity resulting from organ tissue
      damage, such as myocardial and pulmonary dysfunction. Currently, even vaccines and
      medications cannot effectively address the long-term consequences of COVID-19. Exercise
      training has been proven to improve exercise capacity and quality of life during the recovery
      period for various chronic disease patients.

      A total of 24 patients will be included in the study. Following informed consent and baseline
      testing, the participants will be randomized in a 1:1 fashion to receive a 4-week aerobic
      exercise training or attention control.The main objective is to assess the effects of a
      4-week aerobic exercise training program on cardiopulmonary fitness and long COVID-19 symptom
      improvement. Secondary objectives include: to characterize baseline and intervention-related
      changes in quality of life, depression, anxiety, insomnia status and perceived stress status.
    

Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): Patients randomized to the exercise group will be offered aerobic exercise plan containing 12 sessions over 4 weeks (3 times per week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Long COVID-19; Exercise training; Cardiopulmonary fitness; Symptom improvement