bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of ASIMOMMY® Compared to Domperidone and Placebo in Increasing Breastfeeding: Randomized Single-Blind Controlled Trial in Indonesia
Condition: Breastfeeding Mothers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is assess the efficacy of ASIMOMMY® in increasing breast milk
      production in postpartum mothers.
    

Detailed description: 
      Several traditional herbs have been used and is well known since a long time ago by
      Indonesian people to increase the production of breastmilk, such as Katuk leaves (Sauropus
      androgynous Folium), Fenugreek (Trigonella foenum-graceum), and Moringa leaves (Moringa
      oleifera Folium). These plants have been scientifically proven through preclinical and even
      clinical research. However, not many have been further developed as phytopharmaceuticals that
      can be used in formal health services.

      In previous research, ASI MOMMY® capsules have been successfully produced in accordance to
      the traditional method of making good herbal drugs, with each capsule containing extracts of
      Katuk leaf (300 mg), Fenugreek (150 mg), and Moringa leaf (50 mg). This formulation has gone
      through pharmacodynamic activity test, and acute and subactute toxicity test. Research has
      shown that ASI MOMMY® is works actively as a galactogogue and is not toxic, therefore it is
      safe to be given to humans (unpublished),

      No research has been done to test the benefits of ASI MOMMY® in increasinng breastmilk
      production. Therefore, this research is a clinical trial that intends to see the benefits of
      ASI MOMMY® for increasing breastmilk production in postpartum women. This research is a part
      of the previous main research that is still ongoing to this day which aims to develop the
      formulation of ASI MOMMY® as a phytopharmaceutical
    

Intervention name(s): ASIMOMMY®; Domperidon; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ASIMOMMY 500 mg; Domperidone capsule 10 mg; Capsules of placebo 500mg.
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: breastmilk; domperidone; neonates; ASIMOMMY®; Poly Herbal Formulation
Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding
Condition: Postpartum Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their
      infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive
      method postpartum. The investigators will compare the frequency of breastfeeding among women
      receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after
      vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no
      difference in breastfeeding prevalence between the two groups.
    


Intervention name(s): Levonorgestrel-releasing intrauterine system
Intervention type(s): Drug
Intervention description(s): Placement within 48 hours of delivery
Other intervention name(s): Mirena
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases
Condition: Ulcerative Colitis; Crohns Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Mare's milk consumption could improve the well-being in patients with Crohn's disease and
      ulcerative colitis, respectively.
    

Detailed description: 
      Background: Dietetic effects of mare's milk have been reported for a long time and can be
      based on bactericidal and immunological components of mare's milk.

      Objective: Dietetic effects of oral intake of mare's milk in adolescent patients with chronic
      inflammatory bowel diseases were investigated.

      Design: In a randomized, placebo-controlled, double-blind, cross-over intervention study,
      eight Crohn's disease patients and nine ulcerative colitis patients received daily 250 mL
      mare's milk or placebo drink.
    

Intervention name(s): mare´s milk; placebo drink
Intervention type(s): Dietary Supplement; Other
Intervention description(s): oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design); oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mare's milk, Crohn's disease, ulcerative colitis, clinical
A Randomized Comparison Trial Examining the Impact of a Family-based Cooking Workshop
Condition: Diet Habit
Study type: Interventional

Summary: 
      Increasing fruit and vegetable intake is important to health but children's vegetable intake
      remains low. In younger age groups parents act as gatekeepers by providing access,
      availability, persuasion and modelling. This study aimed to enhance parent vegetable serving
      behaviour and child vegetable intake through an 8-week social cognitive theory-based family
      cooking program.
    


Intervention name(s): Mind the Gap: Home Activity Only; Mind the Gap: Home Activity + cooking Workshop
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The primary focus of the home activity program was based on collaborative parent-child cooking activities which the families undertook themselves at home. There were two key tasks: the first was to add one extra vegetable to the evening meal each day, the second was to select, prepare and cook one recipe from the cook book each week.; The main purpose of these workshops was to provide hands-on successful food preparation and cooking experiences for the families and several opportunities to taste new vegetable-based recipes as well as promoting knowledge of cost and healthy eating. Children and their parents were then encouraged to take whatever was learned and apply it at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Family-based intervention
Veteran Primers for CRC Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a prospective, randomized controlled trial that will evaluate the effectiveness of
      primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to
      annual CRC screening. This project is for the purpose of quality improvement and has been
      designated as non-research by the VHA Office of Primary Care, Improvement & Innovation (VHA
      Program Guide 1200.21).
    

Detailed description: 
      Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using
      permuted block randomization (with random block sizes of 4 and 8) to the following
      interventions:

        1. Active arm: Primer

             1. Intervention Type: Other

             2. Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit
                receipt for annual CRC screening

        2. Control arm: No primer a. Intervention Type: No intervention

      Randomization will be stratified within arms by prior screening status (prior screener vs.
      never screener)

      Our primary outcome of interest is the return rate at three months post randomization. Our
      secondary outcome of interest is the return rate at six months post randomization. Enrollment
      in the trial will occur between May 1, 2021 and January 1, 2022.
    

Intervention name(s): Primer
Intervention type(s): Other
Intervention description(s): Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Cancer screening; Behavioral economics; Adherence
Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for
      pediatric participants with advanced solid tumors. This study will have three parts. Part 1
      will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for
      dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination
      with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD)
      found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination
      therapy.
    


Intervention name(s): dalotuzumab; dalotuzumab; ridaforolimus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): For Part 1: dalotuzumab, intravenously (IV) over 60 minutes every three weeks, dose based on participant body surface area (BSA), starting dose of 900 mg/m^2, and escalated for successive cohorts of participants until MTD is found; For Part 2: dalotuzumab IV over 60 minutes every three weeks, dose based on participant BSA, starting at the lowest tolerated dose that met PK target levels in Part 1. For Part 3: dalotuzumab IV over 60 minutes every three weeks, dose based on participant BSA, at the dose level identified for combination therapy in Part 2; For Part 2: ridaforolimus 10 mg enteric coated tablets, orally, on 5 consecutive days each week, dose based on participant BSA, at 1 dose level lower than the MTD or highest dose level used in the companion study MK-8669-056. For Part 3:ridaforolimus 10 mg enteric coated tablets, orally, on 5 consecutive days each week, dose based on participant BSA, at the dose level identified for combination therapy in Part 2
Other intervention name(s): MK-8669
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gynecomastia Extension Study
Condition: Gynecomastia
MeSH terms: Gynecomastia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in
      reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another
      anastrozole study).
    


Intervention name(s): Anastrozole
Intervention type(s): Drug
Other intervention name(s): ZD1033; Arimidex™
Intervention MeSH terms: Anastrozole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gynecomastia; Anastrazole; Arimidex; Pubertal; males; boys
Pulsatile Cupping in Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether pulsatile cupping with a cupping device is
      effective in the treatment of patients with chronic low back pain compared to no cupping or
      to minimal cupping.
    


Intervention name(s): Pulsatile Cupping; Minimal Cupping
Intervention type(s): Device; Device
Intervention description(s): 8 cupping sessions (each 8 minutes) in 4 weeks (-150 to -350 mbar), interval 2 seconds.
Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day); 8 cupping sessions (each 8 minutes) in 4 weeks witth (-60 to -70 mbar). Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day).
Other intervention name(s): HeVaTech PST 30 pulsatile cupping device; HeVaTech PST 30 pulsatile cupping device
Allocation: Randomized
Masking: Single (Participant)
Primary purpose: Treatment
Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      This study aims to evaluate the clinical effect of CO2 laser on enamel resistance to white
      spot lesions formation around orthodontic brackets.

      25 patients needing fixed orthodontic treatment will participate in the study, the CO2 laser
      will be applied in a split mouth design around orthodontic brackets in two contrast quarters
      of mouth in every patient and the other quarters will serve as a control. The white spot
      lesion formation will be monitored around the brackets during the orthodontic treatment after
      four and twelve weeks of irradiation with laser.
    

Detailed description: 
      Prior to enrollment of each subject into the study, they will be examined completely to
      determine the orthodontic treatment plan. The operator will inform them about the aim of the
      study and ask them to provide a written informed consent.

      Before brackets' bonding (T0) the operator will evaluate with intraoral clinical examination
      and take intraoral photographs and evaluate with DIAGNOdent. Then after brackets' placement
      on teeth, the CO2 laser will be applied to the area of enamel about 2 mm of width around
      orthodontic brackets in a split mouth design. To blind the intervention sides on patients the
      control sides will receive nontherapeutic light.

      Then intraoral photographs will be taken and the teeth will be assessed with DIAGNOdent (T1).

      All patients will be trained to brush their teeth with a tooth paste containing 1100 ppm of
      fluoride twice a day. After 4 weeks of irradiation (T2) the patients will be examined for
      white spot lesions formation by clinical examination using Geiger index, photographic
      examination using AutoCAD 2009 evaluating formation and area percentage of white spot
      lesions, and the degree of demineralization will be assessed with DIAGNOdent. The all exams
      will also be done after 12 weeks of irradiation (T3).
    

Intervention name(s): CO2 laser irradiation; Placebo
Intervention type(s): Radiation; Other
Intervention description(s): CO2 laser irradiation will be applied onto the enamel surrounding the orthodontic bracket; No irradiation is going to be applied in the intervention. Just a red light will be used as placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Split mouth design, the mouth will be split into four quadrants. Two quadrants will receive the active treatment, whereas the opposing two quadrants will receive the placebo.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Condition: Hepatitis A Virus
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and
      varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together
      with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose.
      Immunogenicity and safety data will be collected after each dose of vaccine.
    

Detailed description: 
      Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps,
      Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine
      (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.

      Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration
      of Treatment: 2 Doses, 6 months apart.
    

Intervention name(s): Comparator: VAQTA™ (Hepatitis A vaccine); Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): VAQTA™ 0.5 mL injection; ProQuad™ 0.5 mL injection; Prevnar™ 0.5 mL injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A Virus
Oropharynx (OPX) Salivary Biomarker Study
Condition: Healthy
Study type: Observational [Patient Registry]

Summary: 
      The goal of this study is to analyze certain biomarkers to look at the relationship between
      HPV in the saliva, stage at presentation, and a potential self-test compared to saliva of
      non-cancerous participants.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): saliva collection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy non-cancerous participants
      
Biospecimen description: 
      Blood, saliva, and tumor tissue
Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers
Condition: Blood Stem Cell Harvest Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does
      not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are
      therefore called "poor mobilizers". A generally accepted optimum CD34+ PBSC dose for
      allogeneic transplantation is > 4.5 x 106/kg body weight of the recipient. The minimum total
      CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective of
      this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in
      allogeneic stem cell donors with a poor CD34+ cell yield after the first day of peripheral
      blood stem cell collection.
    

Detailed description: 
      In this trial the administration of a single dose of Plerixafor 240 µg/kg body weight of the
      donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1 will be
      provided. The apheresis on day 2 is performed according to standard recommendations.
    

Intervention name(s): Plerixafor
Intervention type(s): Drug
Intervention description(s): Administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1.
Other intervention name(s): Mozobil
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plerixafor; donor; allogeneic peripheral stam cell donation; PBSC; poor donors
Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the
      effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and
      induced sputum inflammatory biomarkers will be evaluated.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Asthma; Ciclesonide; Airway hyperresponsiveness; Sputum; Nitric oxide
ET-01 in Subjects With Lateral Canthal Lines, LCL-207
Condition: Lateral Canthal Lines; Crow's Feet
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Detailed description: 
      This product is being tested for its ability to reduce lateral canthal lines, also known as
      Crow's Feet.
    

Intervention name(s): Vehicle; botulinum toxin, Type A; botulinum toxin, Type A
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vehicle Formulation; botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline; botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Other intervention name(s): ET-01; ET-01
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel dose groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study
Condition: Malignant Neoplasm of the Breast; Acquired Absence of the Breast
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Observational

Summary: 
      The study is a prospective multi-centered cohort study designed to determine the safety and
      efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the
      study is designed to determine if sterility of human acellular dermal matrix results in a
      lower incidence of infection and seroma. The study will determine if gamma radiation, as a
      method of terminally sterilizing human acellular dermal matrix, has a negative impact on
      graft incorporation into the host tissue.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Breast cancer patients who opt for immediate breast reconstruction with tissue expanders
        from clinic.
      
Biospecimen description: 
      A 1 cm square of AlloMax will be harvested from the first 20 patients for histologic
      examination to determine wether or not there is neovascularization and collagen deposition.
Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting
Condition: Heart Disease
MeSH terms: Heart Diseases; Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG)
      tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are
      routinely used in patients undergoing surgery. They are presumed to reduce postoperative
      nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric
      volumes; however, their insertion and use is not however without potentially serious
      complications. Existing literature does not address their efficacy in reducing PONV after
      cardiac surgery. However, current evidence suggests that up to 50% of patients in this group
      suffer significant nausea and vomiting. The objective of this study is to determine whether
      NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.
    


Intervention name(s): Placement of nasogastric tube
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasogastric Tubes; Nausea; Vomiting; Cardiac surgery