bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Sedentary Time in Aging: New Directions
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The investigators are doing a study to learn how to support patients aged 60+ in taking more
      breaks from sitting. The goal of the study is to find out if using commercially available
      devices are helpful in reducing sitting time.
    

Detailed description: 
      To date, no one has tested whether the prompting features of commercially available
      wrist-worn devices (e.g., Jawbone Up) improve breaks from sitting. Single case designs are a
      cost-effective way to conduct a controlled, randomized study that can inform larger
      intervention trials. Because the investigators are interested in ascertaining the effect of a
      very specific intervention on a very specific/single outcome, this study is well-suited to
      this approach.

      The investigators will conduct iterative single case experimental studies using randomization
      tests. This design can help evaluate technologies for behavior change. To increase
      statistical power, the investigators opted to conduct an ABA study design (also termed a
      reversal design) where A is baseline and B is an intervention. Using randomization tests, the
      length of each A and B phase are determined to vary randomly in length prior to the beginning
      of each participant's experiment. The investigators will constrain the total time of each A
      and B phase to last a minimum of 5 days to provide adequate exposure to the A (measurement
      only) and B (intervention) conditions. The maximum total number of days participants will be
      enrolled is 28.
    

Intervention name(s): Sitting time prompt
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sedentary time; Sit-to-stand transitions
Cerebral Changes Following CTS Treated With Guided Plasticity
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with
      unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm
      deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated
      outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome
      questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH).
      Clinically patients were assessed for tactile discrimination and dexterity and nerve
      conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with
      functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline,
      after 90 min of initial treatment, and after 8 weeks.
    


Intervention name(s): EMLA® adjuvant; Sensory training
Intervention type(s): Other; Behavioral
Intervention description(s): cutaneous forearm deafferentation; Sensibility training of the median nerve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Magnetic Resonance Imaging; Somatosensory Cortex; Anesthesia; Hand
Hati Salama (Secure Voucher)
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria
      prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net
      distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to
      electronic vouchers in this program has increased efficiency and the ability to track and
      distribute nets since 2007. Although the program has been successful, to date, electronic
      voucher redemption varies widely across the country and it has not been clearly established
      as to what barriers exist for women who receive electronic vouchers in the program. This
      cluster-randomized trial was designed to examine perceived barriers to electronic voucher
      redemption among pregnant women and to evaluate if educational and personalized text messages
      around electronic voucher redemption and bed net usage will increase electronic voucher
      redemption when directed at pregnant women who receive electronic vouchers in the currently
      existing program.
    


Intervention name(s): Behaviour change communication via text message
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: mHealth; Text message
Feasibility of an Exercise Intervention
Condition: HIV
Study type: Interventional

Summary: 
      The overall purpose of this research is to evaluate the effect of a home-based exercise
      program on physical function and to improve the health and quality of life for the
      HIV-infected older adult community.
    

Detailed description: 
      Subjects are being asked to participate in this study if they are infected with the human
      immunodeficiency virus (HIV), and they are 45 years of age or older.
    

Intervention name(s): HOME-EX
Intervention type(s): Other
Intervention description(s): Motivational Counseling: The first session will be an hour face-to-face interview to establish a rapport with subjects, assess motives and competence. The rest will be 30 min. phone calls to assess week's performance and agree on an action plan for next 2 weeks.
Exercise Intervention: Using the average number of steps for each subject from their baseline assessment, the targeted number of steps the subject needs to walk every day will be calculated. The individualized strength training exercise will target the upper and lower body. If possible, they will be encouraged to progressively increase from their individual baseline sets and repetitions to a maximum of 4 sets of 15 repetitions for each exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Aging; Physical Activity; Physical Function; HIV; Frailty; Autonomous Motivation; Depression
Breast Cancer and Quality of Life
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The study aims to analyse and decode interviews of patient with breast cancer, and then
      established according a multidimensional profile specific to the population and to create a
      questionnaire tha will allow a practical and qualitative evaluation of the quality of life.
    


Intervention name(s): interview
Intervention type(s): Behavioral
Intervention description(s): psychological, emotional, family and social parameters
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patient with breast cancer, diagnosed before aged 45, having a life partner
      
Keywords: breast cancer; everyday issues; couple
Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate whether the pharmacokinetics (body
      concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when
      they are administered together
    


Intervention name(s): Saxagliptin; Dapagliflozin
Intervention type(s): Drug; Drug
Other intervention name(s): Onglyza®; BMS-477118; BMS-512148
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. It is not yet known whether giving fludarabine together with
      cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic
      leukemia.

      PURPOSE: This randomized phase III trial is studying giving fludarabine together with
      cyclophosphamide to see how well it works compared to fludarabine alone in treating patients
      with advanced chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the progression-free survival, as well the overall survival and duration of
           remission in patients with previously untreated, advanced chronic lymphocytic leukemia
           treated with fludarabine with versus without cyclophosphamide.

      Secondary

        -  Compare the incidence of side effects and quality of life of patients treated with these
           drugs.

      OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment
      arms

        -  Arm I: Patients receive fludarabine IV on days 1-5.

        -  Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both
           arms, treatment repeats every 28 days for up to 6 courses in the absence of disease
           progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
    

Intervention name(s): Fludarabine plus Cyclophosphamide; Fludarabine
Intervention type(s): Drug; Drug
Intervention description(s): fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses; fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses
Intervention MeSH terms: Vidarabine; Cyclophosphamide; Fludarabine; Fludarabine phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion
Condition: Bimaxillary Protrusion
Study type: Interventional

Summary: 
      Brief summary: there's a scarcity in literature concerning time needed to retract anterior
      segment following premolars extraction. the purpose of this study is to determine, in
      orthodontic patients with maxillary protrusion, which form of technique of retraction offers
      a faster treatment duration of retraction : en-masse or two step techniques
    

Detailed description: 
      Anterior segment retraction can be done in one of two ways: through En masse or two step
      techniques. Both are viable options, but, ideally, the investigator wanted to retract and
      complete the orthodontic treatment as quickly as possible, in order to decrease the negative
      effects that may occur during treatment. Which of these techniques results in a decreased
      treatment time is still up for debate.
    

Intervention name(s): En masse retraction; Two-Step retraction
Intervention type(s): Procedure; Procedure
Intervention description(s): Retraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw.; Retraction of canine started on a 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: En-masse retraction; two step retraction; friction; retraction time; Dental models
Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery
Condition: Paediatric; Surgery; Analgesia; Anesthesia
Study type: Interventional

Summary: 
      Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining
      effective postoperative analgesia in the paediatric age group is very crucial in terms of
      future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an
      interfascial plane block characterized by its ease of application and low complication rates
      with the introduction of ultrasonography. The aim of this study is to investigate the
      analgesic effects of ESPB in this particular age-group.
    


Intervention name(s): Erector Spinae Plain Block; Intra-Venous Analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.; Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Erector spinae plain block; Ultrasound-guided; Paediatric; Upper abdominal surgery; Analgesia; Anesthesia
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive
      substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in
      patients with Major Depressive Disorder who demonstrate an incomplete response to a
      prospective trial of the same assigned FDA approved ADT
    


Intervention name(s): OPC-34712 + ADT; Placebo + ADT; Placebo + ADT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT); Placebo + FDA Approved Antidepressant (ADT); Placebo + FDA Approved Antidepressant (ADT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment
Safety and Immunogenicity of CJ-50300
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The currently available stock of smallpox vaccine would be insufficient in the face of an
      incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine is urgently
      needed because previous manufacturing methods using calf lymph are no longer acceptable in
      the view of current standards. Recently, CJ corporation in Republic of Korea has developed
      cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5
      cells. The aim of this phase 1 clinical trial were to assess safety, reactogenicity, and
      immunogenicity of CJ-50300.
    


Intervention name(s): cell-culture derived smallpox vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: smallpox, vaccine, immunity
Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study will be to evaluate safety, tolerability and immunogenicity of
      13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations
      in Mexico.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the
      hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in
      subjects with type 1 diabetes.

      The trial is designed as a two-period, crossover trial where the trial participant is
      randomised to one of two treatment periods.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.; Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Continue Entecavir Rollover From China
Condition: Chronic Hepatitis B Virus
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if treatment with entecavir is safe and well
      tolerated in patients who completed dosing in a previous entecavir study in China, but are
      requiring further treatment of their chronic hepatitis B virus infection.
    


Intervention name(s): Entecavir; Entecavir
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started; Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
Other intervention name(s): Baraclude; BMS-200475; Baraclude; BMS-200475
Intervention MeSH terms: Entecavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
Condition: Scar; Nevus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate whether autologous fat grafting is safe and/or
      effective to prevent expanded skin from expansion failure.
    

Detailed description: 
      The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue
      expansion is a widely used technique for the repair of skin defects. Early expansion-related
      complications such as skin thinning, telangiectasia, and striae may result in expansion
      failure and ultimately jeopardize final outcome. In the past years, discontinuation of the
      expansion procedure was the only therapeutic option, when early alarm signs such as
      semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed
      to overcome these complications by therapeutic fat grafting to prevent skin necrosis and
      enable continuation of the expansion procedure.

      Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including
      scars and nevi that required therapeutic intervention due to early complication signs were
      included in this study. Patients were randomly divided into treatment group using autologous
      fat grafting and control group with discontinued expansion and expectant management. The
      treatment group received autologous fat transfer to the expanded skin.
    

Intervention name(s): Fat grafting
Intervention type(s): Procedure
Intervention description(s): In the experimental group, liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fat grafting; Expansion-related complications
PEEP Setting in COVID19-related ARDS
Condition: ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2
MeSH terms: Severe Acute Respiratory Syndrome
Study type: Observational

Summary: 
      The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from
      acute respiratory distress syndrome is still matter of debate. Electrical impedance
      tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an
      optimized ventilation homogeneity.
    

Detailed description: 
      COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical
      ventilation were enrolled. Patients were monitored by an esophageal catheter and a
      32-electrode EIT device. Within 48 hours after the start of mechanical ventilation, different
      levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive
      end-expiratory transpulmonary (PL)/ FiO2 table, and EIT. Respiratory mechanics variables were
      recorded.
    

Intervention name(s): PEEP setting
Intervention type(s): Other
Intervention description(s): PEEP setting according to various methods
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive adult patients under mechanical ventilation following COVID19-ARDS