bioihbjkbjnl/mcl2 huggingface dataset:
Milk Proteins and Micronutrient Supplementation in Obese Children
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Milk proteins and micronutrients could be beneficial in the prevention and treatment of
      obesity.

      The objective was to evaluate a supplement with milk proteins and multivitamins and minerals
      with nutrition education on anthropometry, body composition, micronutrient status, blood
      pressure, lipid profile, systemic inflammation, leptin and insulin resistance in obese
      children at baseline and after 6 months.
    

Detailed description: 
      Obese children were selected in elementary schools from 5 rural communities of the State of
      Querétaro. One hundred fifty two obese children (Z-score >2 standard deviations) aged 6-11y
      were randomly assigned to receive one of two treatments: 1) 237mL/day of milk proteins and
      multiple micronutrients supplement (MPMS) plus Nutrition Education (NE) program or 2) NE
      alone for 24 weeks.

      Children in both groups were evaluated at baseline and 6 months after treatment initiated. At
      both times the following variables were evaluated:

      Visit 1 (Screening): Mothers and parents received oral and written information regarding all
      aspects of the study. Informed consent, medical history, demographic information, weight and
      height were obtained.

      Visit 2 (Clinical Laboratory testing): A blood preasure and sample was taken by an
      specialist. Blood test included Glucose, total cholesterol, triglycerides, HDL cholesterol
      and LDL cholesterol, Tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6) and
      interleukin-10 (IL-10), C reactive protein, insulin and leptin.

      Visit 3 (Nutrition Clinic at UAQ): body composition was determined by DEXA. The NE were given
      at Nutrition Clinic and school to the children's parents each week.
    

Intervention name(s): Supplement with micronutrients; Nutrition education
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Obese children were divided in 2 groups. A group received the supplement plus nutrition education and other group was a control, only received nutrition education.; Group received nutrition education program during 6 months
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group received only nutrition education and treated group received nutrition education plus a supplement with milk protein and micronutrients.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: micronutrients; obesity; school-age children; milk proteins
Sheffield Physical Activity Booster Trial
Condition: Public Health
Study type: Interventional

Summary: 
      Adults that increase their physical activity can improve their health, and reduce future
      risks to health, but long-term changes are difficult to sustain. This study assesses whether
      it is worth providing further support, 3 months after giving initial advice, to those who
      have managed to do more physical activity. All participants will initially be given an
      interactive DVD. A researcher from Sheffield Hallam University will provide two telephone
      follow ups at one month intervals to assess physical activity levels. Only those that have
      increased their physical activity at this point will remain in the study. These participants
      will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of
      a two telephone calls one month apart to discuss physical activity and usage of the DVD. A
      "full booster" consists of a face-to-face meeting with the facilitator at the same intervals.
      The purpose of these booster sessions is to help the individual to maintain their increase in
      physical activity. The investigators will measure the differences in physical activity,
      quality of life and costs, associated with the booster interventions, 3 months and 9 months
      from randomisation. The research will be carried out in 20 of the most deprived
      neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high
      levels of economic deprivation, low levels of physical activity, poorer health and shorter
      life expectancy. Participants will be recruited through general practices and community
      groups, as well as by postal invitation to ensure the participation of minority ethnic groups
      and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a
      range of facilities and activities to promote physical activity and variations in access to
      these between neighbourhoods will make it possible to examine whether the effectiveness of
      the intervention is modified by access to community facilities.
    


Intervention name(s): Mini Booster; Full Booster
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Two telephone-based physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation; Two face-to-face physical activity consultations, delivered in a motivational interviewing style, at one month and two months from randomisation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Humans; Middle Aged; Behavior Therapy; Directive Counseling; Health Behavior; Interview, Psychological; Motivation; Exercise; Physical Fitness; Self Efficacy; Life Style; Health Promotion; Health Knowledge, Attitudes, Practice; Body Mass Index; Monitoring, Ambulatory; Walking
Ultrasound Paravertebral Block in Breast Surgery.
Condition: Breast Cancer
Study type: Observational

Summary: 
      The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral
      block with single shot is a safe and reliable anesthetic technique in breast surgery.
    

Detailed description: 
      General anaesthesia is currently the conventional technique used for breast surgery. Thoracic
      Paravertebral block (PVB) has been used with multiple injection.

      We compared a single injection thoracic PVB with general anaesthesia (GA) in 20 consenting
      patients, scheduled for unilateral breast surgery.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient candidate for minor breast surgery.
      
Keywords: Ultrasound-guided paravertebral block; regional anesthesia; breast surgery
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
Condition: Marijuana Use; Pregnancy
MeSH terms: Marijuana Abuse; Marijuana Use
Study type: Interventional

Summary: 
      Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal
      exposure to marijuana can have lasting negative effects. However, current answers to this
      problem are failing to reach most women who use marijuana while pregnant. This project will
      develop and begin testing two technology-based, highly practical interventions that could
      reduce the number of children who are prenatally exposed to marijuana.
    

Detailed description: 
      There are at present no evidence-based interventions for marijuana use during pregnancy,
      despite its being by far the most commonly used illicit drug during pregnancy (particularly
      among African-American women), and despite growing evidence that it may have a range of
      long-term cognitive and neurobehavioral consequences. This R34 clinical trial planning grant
      therefore proposes the development and preliminary validation of two high- reach and mutually
      compatible technology-based interventions for marijuana use during pregnancy. The first, a
      theory-based, synchronous, and highly interactive computer-delivered brief intervention, will
      be based on an emerging knowledge base regarding key elements of efficacious
      technology-delivered interventions. The second intervention, a series of tailored text
      messages, will build on the rich literature regarding key tailoring elements. These
      interventions will be developed and refined with input from pregnant women who report active
      use of marijuana, as well as from health care providers. They will subsequently be
      tested-alone and in combination-in a pilot randomized trial involving 80 women actively using
      marijuana during pregnancy. This Stage I pilot work would set the stage for a confirmatory
      Stage II trial. It would also produce the first high-reach brief interventions for marijuana
      use during pregnancy. If effective, these approaches could have a substantial population
      impact on marijuana use among pregnant women, with potential for lifelong improved outcomes
      for both mother and child.
    

Intervention name(s): eSBIRT; Tailored texting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.; Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Computerized Brief Intervention
An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Glycemic Control Using Hybrid-closed Loop vs. Advanced Hybrid Closed-loop in Young Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Closed-loop systems are becoming an integral part of diabetes management. These systems were
      uniformly proven to improve glycemic control, reduce hyperglycemia and hypoglycemia while
      modestly reducing HbA1c levels and improving quality of life. While overnight control is
      close to optimal under closed loop control, postprandial hyperglycemia during daytime remains
      a challenge. The advanced hybrid closed loop system was designed with an improved auto-basal
      control and additional auto-bolus module that delivers correction boluses automatically. In
      addition, this system was developed to improve user experience by significantly reducing the
      amount of alarms and exits from Auto Mode. Therefore, this system might have an advance in
      treating hyperglycemia over the hybrid closed loop that controls glucose levels by modulation
      of insulin basal rate only. Therefore, we propose the current study that will compare 6 weeks
      glycemic control using hybrid closed loop versus advanced hybrid closed loop that add
      correction boluses among young children and adolescents.

      The objective of this study is to evaluate and compare the safety and efficacy of 6 weeks
      glucose control using Hybrid Closed Loop (HCL-670G) compared to Advanced Hybrid Closed Loop
      System (AHCL- 670G) in young subjects with sub-optimally controlled type 1 diabetes. A total
      of 28 subjects (age 7-14 years) will be enrolled at two investigational centers.

      At the end of the cross-over study participants will be offered with an extension period,
      during which they will be offered to use their preferred closed-loop system for another 3
      months
    


Intervention name(s): Medtronic Minimed 670G 3.0 HCL; Medtronic Minimed 670G 4.0 AHCL
Intervention type(s): Device; Device
Intervention description(s): Hybrid closed loop system; Advanced hybrid closed loop system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hybrid Closed Loop; Closed Loop; Artificial Pancreas
Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective was to estimate the proportion of participants with detectable
      talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after
      administration of talimogene laherparepvec within the first 3 cycles.
    


Intervention name(s): Talimogene laherparepvec
Intervention type(s): Drug
Intervention description(s): Talimogene laherparepvec will be administered by intralesion injection at an initial dose of up to 4.0 mL of 10^6 PFU/mL. The second and subsequent doses will will be up to 4.0 mL 10^8 PFU/mL. The second dose should be administered 21 days from the initial dose. All subsequent doses should be given every 14 days.
Other intervention name(s): IMLYGIC®; OncoVEX^GM-CSF
Intervention MeSH terms: Talimogene laherparepvec
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Parents as Friendship Coaches for Children With ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      Many children with Attention-Deficit/Hyperactivity Disorder (ADHD) have problems with making
      and keeping friends. The current study compared the efficacy of two 10-week behavioral
      interventions for improving the friendships of children with this disorder. Participants were
      children ages 6-11 with ADHD and their families, who were experiencing friendship problems.
      Outcome measures assessed friendship quality and friendship behaviors at baseline
      (pre-treatment), post-treatment, and 8-month follow-up.
    


Intervention name(s): Parental Friendship Coaching; Coping with ADHD through Relationships and Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In this condition, therapists instructed parents in ways to coach their children to display better friendship behaviors using skills teaching, role play, active practice, and homework. This is a 10 week group intervention.; In this condition, the therapist provided parents with psychoeducation about ADHD and friendship difficulties, and encouraged them to apply this information to their child and to support one another with tips about how to address these problems. This is a 10 week group intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to one of two interventions: Parental Friendship Coaching (PFC) or Coping with ADHD through Relationships and Education (CARE)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: friendship
Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative
      bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU
      combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE
      alone; REF).

      The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when
      administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product
      Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic
      parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.
    

Detailed description: 
      This study will enrol healthy subjects. It is considered that study results are more
      discriminative in healthy subjects than in rhinitis patients as there are no interferences by
      varying rhinitis symptoms and respective differences in the status of the nasal mucosa
      regarding the 3 study periods.

      The time schedule for plasma sampling (pre-dose and 15, 30 min, 1, 1½, 2, 2½, 3, 4, 6, 8, 12,
      24, 48, 72, 96, and 120 h p.a.; time refer to the end of the second spray into the second
      nostril of each administration) is derived from previous bioavailability study on the
      marketed product Astelin® Nasal Spray assuming a mean tmax of 2 to 3 h p.a. and a mean t1/2
      of 22 h [L7]. Sampling times are expected to cover an AUC0-tlast above 80% of the total AUC
      of azelastine hydrochloride (bioanalytical detection method with a LLOQ of 2 pg/mL).
    

Intervention name(s): Azelastine, Fluticasone; Azelastine mono; Azelastine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray; REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies); COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product)
Other intervention name(s): MP29-02; Azelastine; Astelin®
Intervention MeSH terms: Fluticasone; Azelastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IFM 99-02 Thalidomide in Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Principal objective is to evaluate the impact of Thalidomide to prolong the duration of
      response after autologous transplantation for myeloma
    


Intervention name(s): Thalidomide; Biphosphonates
Intervention type(s): Drug; Drug
Intervention description(s): Per os thalidomide; Biphosphonates
Intervention MeSH terms: Diphosphonates; Thalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myeloma; Autologous transplantation; Maintenance therapy; Thalidomide
The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT
Condition: HIV Infections; Cytopenias
MeSH terms: HIV Infections; Anemia
Study type: Interventional

Summary: 
      To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS
      patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.
      Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.
    


Intervention name(s): Epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Masking: Double
Primary purpose: Treatment
Keywords: Recombinant Proteins; Injections, Subcutaneous; Erythropoietin; Acquired Immunodeficiency Syndrome; Anemia; Zidovudine
The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation
Condition: Cerebral Palsy
MeSH terms: Hip Dislocation; Cerebral Palsy
Study type: Interventional

Summary: 
      Single Blinded, Randomized-control tiral, Multicenter clinical trial
    


Intervention name(s): Hip protection orthosis
Intervention type(s): Device
Intervention description(s): Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Comparison of Nutrition Risk Screens
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      This research study will compare two different screens for nutrition risk in patients who are
      in the hospital. We will be comparing the ThedaCare Nutrition Risk Screen to see if it is as
      good and consistent as the standard NRS 2002 Nutrition Risk Screen.
    

Detailed description: 
      This research study comparing the ThedaCare screen against the NRS 2002 screen will validate
      the accuracy and reliability of the ThedaCare Screen and the timeliness of nutrition
      intervention of patients with a diagnosis of malnutrition. Early nutrition intervention will
      positively affect the patient's clinical complication, LOS, and readmission.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Hospitalized patients that can consent
      
Keywords: Hospital Nutrition screens
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to estimate the effect of hepatic impairment on the plasma PK of
      PF-07321332/ritonavir. Findings from this study will be used to develop dosing
      recommendations so that the dose and/or dosing interval may be adjusted appropriately in the
      presence of hepatic impairment.
    


Intervention name(s): PF-07321332; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; PK Boosting agent
Intervention MeSH terms: Ritonavir; Nirmatrelvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COVID-19; SARS-CoV-2
Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an
      HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected
      adults in the United States.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity of an HIV vaccine
      (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the
      United States.

      Participants will be randomly assigned to one of three groups. Participants in Group 1 will
      receive 300 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6.
      Participants in Group 2 will receive 100 mcg of gp145 C.6980 and aluminum hydroxide adjuvant
      on Day 0 and Months 2 and 6. Participants in Group 3 will receive placebo on Day 0 and Months
      2 and 6.

      Study visits will occur at Day 0 (study entry), Weeks 1 and 2, and Months 2, 2.5, 6, 6.25,
      6.5, 9, and 12. Visits may include physical examinations, blood and urine collection, HIV
      testing, risk reduction counseling, and questionnaires.
    

Intervention name(s): gp145 C.6980 Vaccine; Placebo; Aluminum Hydroxide Adjuvant
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered by intramuscular injection in the deltoid.; Sodium Chloride for Injection, 0.9%; Administered by intramuscular injection in the deltoid.; Administered by intramuscular injection in the deltoid.
Other intervention name(s): HIV Env gp145 C.6980; recombinant oligomeric gp145 clade C Env protein; Aluminum Hydroxide Suspension
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention