bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Cognitive Training in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Schizophrenia is associated with a wide range of symptoms impacting a number of different
      domains, including cognitive impairment. Given the array of cognitive deficits associated
      with schizophrenia and their relationship to daily functioning, numerous research groups have
      examined the impact of cognitive remediation on many aspects of cognition. However, it is
      currently unclear as to which domains of cognition should be targeted to produce the most
      widespread and durable benefits for schizophrenia patients. It may be the case that targeting
      lower-level cognitive processes that are important for higher-level and more complex aspects
      of cognition may produce the most widespread benefits in cognition and everyday functioning.
      Relatively few studies have examined the effects of working memory or processing speed
      training on individuals with schizophrenia, as most studies examine broad-based remediation
      programs. Thus, there is a need for targeted working memory and processing speed training
      studies to better understand the mechanisms of cognitive enhancement through training in
      patients. This study will aim to: 1) investigate near-transfer gains associated with working
      memory and processing speed training in schizophrenia patients, 2) investigate far-transfer
      gains associated with working memory and processing speed training (i.e., gains in other
      neurocognitive domains and social cognition), and 3) investigate real-world gains associated
      with training (i.e., gains in daily functioning). Towards this aim, 81 schizophrenia patients
      will be recruited and randomly assigned to a working memory training group, a processing
      speed training group, or a no training control group. Training will be completed at home for
      30 minutes per day, 5 days per week, for a total of 10 weeks. Neurocognitive, social
      cognitive, and daily functioning measures will be administered both pre- and post-training to
      detect training-related gains.
    


Intervention name(s): Cognitive training
Intervention type(s): Behavioral
Intervention description(s): The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. Participants randomized one of the cognitive training arms will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cognitive Training; Working Memory; Processing Speed
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of the project is to investigate effects of medical exercise therapy (MET) on
      patients with knee osteoarthritis. MET is a common physical therapy intervention, and the
      project aim to strengthen the evidence of this intervention. An experimental cohort design is
      chosen, and 20 participants will be followed for 6 months. Assessments will be clinical
      tests, questionnaires and accelerometer measurements before, during, and after a 3 month
      period of exercise (3 days per week) with a physical therapist. The project will answer if a
      3 month physical therapy intervention using MET causes changes in pain level, function and
      activity level for patients with knee osteoarthritis. In addition, it will investigate
      whether a single global endurance workout for 30 minutes will have an effect on pain level
      for these patients
    


Intervention name(s): Medical Exercise Therapy
Intervention type(s): Behavioral
Intervention description(s): physiotherapy intervention with Medical exercise therapy (MET) during 3 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise Therapy; Musculoskeletal Pain; Knee osteoarthritis; Physical Therapy Modalities
Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety
      of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects
      with mild to moderate essential hypertension
    

Detailed description: 
      Non Probability Sampling
    

Intervention name(s): Olmesartan medoxomil
Intervention type(s): Drug
Intervention description(s): olmesartan medoxomil 20 mg and HCTZ 12.5 mg
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Filipino patients with Uncontrolled Mild to Moderate Essential Hypertension
      
Keywords: Efficacy; Tolerability; Safety; Essential Hypertension
A Study of LY2140023 in Healthy Participants
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the effect of activated charcoal on absorption of LY2140023. The
      study involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth 2
      times during study (once with activated charcoal, once without activated charcoal). This
      study will last approximately 16 days, not including screening. Screening is required within
      28 days prior to study entry.
    


Intervention name(s): LY2140023; Aqueous activated charcoal
Intervention type(s): Drug; Drug
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Prevention of Post Operative Bone Loss in Children
Condition: Osteoporosis; Cerebral Palsy; Spina Bifida; Osteopenia; Osteogenesis Imperfecta
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteogenesis Imperfecta; Cerebral Palsy; Spinal Dysraphism
Study type: Interventional

Summary: 
      Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk
      for low bone density

      Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre
      operatively and studied with DXA scan. After surgery, children will be randomized to receive
      either pamidronate or saline. Repeat DXA scan will determine bone lost after end of
      immobilization or nonweightbearing.
    

Detailed description: 
      Children at risk for post operative bone loss will be studied with preoperative DXA scan of
      spine and distal femora

      Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D

      Following surgery of hip(s) or lower extremities, randomization into treatment with low dose
      IV pamidronate (one dose) v placebo group

      Repeat DXA scan after end of immobilization or non-weightbearing
    

Intervention name(s): pamidronate; saline
Intervention type(s): Drug; Other
Intervention description(s): The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children < 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume.; receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
Other intervention name(s): Aredia; normal saline
Intervention MeSH terms: Pamidronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pediatric osteoporosis; pediatric osteopenia; pamidronate; post operative osteopenia
Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve
      the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone
      sensitive breast cancer patients, subsequent to 2-3 years tamoxifen
    


Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention description(s): 1 mg once daily oral dose
Other intervention name(s): ARIMIDEX; ZD1033
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hormone Sensitive Primary Breast Cancer; Adjuvant Treatment; Aromatase Inhibitor
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes
Condition: Periorbital Wrinkles
Study type: Interventional

Summary: 
      The purpose of this study is to look at how safe and effective the Ulthera ultrasound system
      is at reducing the appearance of wrinkles when used with subjects who have wrinkles around
      the eyes.
    

Detailed description: 
      The purpose of this prospective, multi-center, single treatment, clinical trial is to
      evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment
      of periorbital wrinkles and rhytids.
    

Intervention name(s): Ulthera™ System
Intervention type(s): Device
Intervention description(s): ultrasound treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      This project evaluates the use of different types of proteins from various food sources after
      an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have
      low muscle mass). Specifically, researchers want to:

        -  Examine the efficiency of protein intake after exercise on muscle mass and physical
           abilities;

        -  Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL
           cholesterol, total cholesterol and triglycerides);

        -  Examine the impact of exercise and proteins on liver enzymes;

        -  Examine the impact of exercise and proteins on a hormone that controls hunger;

        -  Evaluate the program's impact on the ability of the body to produce energy.

      All participants are exercising (resistance training) and ingest one of the 3 different
      sources of proteins, immediately after training:

        -  Milk proteins (from milk beverage)

        -  Essential amino acids (added to a soya beverage)

        -  No protein (rice beverage - control group)

      Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical
      function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins
      and EAA will be both superior to control group.

      This would represent an interesting finding since milk is more accessible, palatable and
      cheaper than essential amino acids commercial mix.
    


Intervention name(s): Resistance training
Intervention type(s): Other
Intervention description(s): All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sarcopenia; Physical capacity; Muscle force; Muscle quality; Milk proteins; Essential amino acids; Proteins; Resistance training; Exercise
The Effects of CPAP Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in OSA
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder
      associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate.
      A causal relationship between OSA and systemic hypertension as well as peripheral endothelial
      dysfunction was shown, and there is accumulating evidence from physiologic and observational
      studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal
      consequences of OSA. However, there are no data from randomised controlled trials proving a
      causal relationship between OSA and impaired cerebral vascular reactivity (CVR). The aim of
      this randomised controlled trial is to study the effects of a short-term CPAP withdrawal, and
      thus returning OSA, on daytime CVR and brain oxygenation to establish whether there is a
      causal relationship between OSA and cerebral vascular damage.
    


Intervention name(s): Continuous positive airway pressure device
Intervention type(s): Device
Intervention description(s): (ResMed Spirit S8)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Continuous Positive Airway Pressure; Stroke; Cerebrovascular reactivity; Brain oxygenation
Bioequivalence of Telmisartan Film-coated Tablet Compared With the Conventional Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the
      conventional 40 mg telmisartan tablet
    


Intervention name(s): Telmisartan film coated tablet; Telmisartan conventional tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide
Condition: Adult Disease
Study type: Observational

Summary: 
      The purpose of this study is to investigate the time-related intracuff pressure and volume
      change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.
    

Detailed description: 
      Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal
      and distal conical cuff designed to secure a patient's airway during either spontaneous
      breathing or controlled ventilation. Application of this device with the use of N2O may be
      related to the ischemic change of the oropharyngeal mucosa. The objective of this study was
      to investigate the time-related intracuff pressure and volume change (which reflects the
      pharyngeal pressure) of the LT during anesthesia with N2O.

      Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and
      isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were
      recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure
      followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was
      deflated to the initial intracuff pressure and the volume of deflated air and postoperative
      airway complications were recorded.
    

Intervention name(s): laryngeal tube (VBM Medizintechnik)
Intervention type(s): Device
Intervention description(s): laryngeal tube number 4
Other intervention name(s): The laryngeal tube (VBM Medizintechnik, Sulz, Germany)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with general anesthesia
      
Keywords: intracuff pressure; laryngeal tube; nitrous oxide
Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145
      in healthy volunteers as a single agent and in combination with plerixafor.
    

Detailed description: 
      The study consists of up to four parts: Part A, to investigate the safety and tolerability of
      MGTA-145; Part B, to investigate the safety and tolerability of MGTA-145 when administered in
      combination with plerixafor; Part C, to investigate the safety and tolerability of two
      sequential days of dosing MGTA-145 in combination with plerixafor; and Part D, to investigate
      the safety, tolerability, and measure by apheresis, the total number of CD34+ cells mobilized
      after a dose of MGTA-145 administered in combination with plerixafor.
    

Intervention name(s): MGTA-145; plerixafor; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): MGTA-145 will be given in various doses intravenously; 240 µg/kg subcutaneously; Placebo will be given in various doses intravenously
Other intervention name(s): Mozobil
Intervention MeSH terms: Plerixafor
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether there is a drug interaction between
      GSK1349572 and the HIV protease inhibitors Tipranavir/Ritonavir (TPV/RTV).
    

Detailed description: 
      The construction of a new antiretroviral regimen with GSK1349572 in raltegravir-resistant
      subjects will likely require less commonly used agents such as tipranavir and enfuvirtide.
      Ritonavir-boosted tipranavir (TPV/RTV) has been shown to induce drug metabolizing enzymes and
      lead to decreased exposure of some antiretrovirals thus necessitating a drug interaction
      study with GSK1349572 as GSK1349572 is eliminated primarily by metabolism.

      This is a single-center, single sequence, open-label, three-period study, in adult male and
      female healthy subjects. Approximately 18 subjects will receive GSK1349572 50mg QD for 5 days
      (Treatment A). Subjects will then be administered TPV/RTV 500/200mg BID for 7 days (Treatment
      B) followed by the combination of GSK1349572 50mg QD and TPV/RTV 500/200mg for 5 days
      (Treatment C). There will be no washout periods between treatments. Safety evaluations will
      be collected during each treatment period. Serial PK samples for GSK1349572 will be collected
      and compared between Treatment A and C. A follow-up visit will occur 7-14 days after the last
      dose of study drug.

      The study will be conducted at one centre in the US with healthy adult male and female
      subjects.

      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship.
    

Intervention name(s): GSK1349572
Intervention type(s): Drug
Intervention description(s): GSK1349572 QD x 5 days
TPV/RTV 500/200mg BID x 7 days
GSK1349572 50mg QD and TPV/RTV 500/200mg BID x 5 days
Other intervention name(s): TPV/RTV 500/200mg BID x 7 days; GSK1349572 QD x 5 days; GSK1349572 50mg QD and TPV/RTV 500/200mg BID x 5 days
Intervention MeSH terms: Dolutegravir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteer; pharmacokinetics; HIV, GSK1349572, tipranavir, ritonavir, drug interaction
A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease
Condition: Behcet Disease
MeSH terms: Behcet Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of infliximab in induction regimen by
      assessing the mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD)
      score of 20 or more in participants with active intestinal Behcet's disease who are
      refractory to conventional therapies.
    

Detailed description: 
      This is an open-label (all participants know the identity of the intervention), single arm,
      multicenter (when more than one hospital or medical school team work on a medical research
      study) study of Infliximab in participant with Moderate-to-Severe Refractory Intestinal
      Behcet's Disease. The study consists of 3 Phases: Screening Phase (4 weeks), induction Phase
      for 8 weeks, and maintenance Phase for 24 weeks extending from Week 0 (baseline), and a
      safety Follow up visit (Week 36 or approximately 6 weeks after the last administration of
      study drug). The duration of participation in the study for each participant is approximately
      40 weeks. The mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD)
      score of 20 or more will be evaluated primarily. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): Participants will receive infliximab 5 milligram per kilogram (mg/kg) infusion at Week 0, Week 2, and Week 6 for the induction phase. Participants who complete the induction phase will continuously receive 5 mg/kg infliximab infusion every 8 weeks up to week 32 in the maintenance phase.
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behcet Disease; Infliximab; Adult participants