bioihbjkbjnl/mcl2 huggingface dataset:
LATCH: Lactation Advice Thru Texting Can Help
Condition: Breastfeeding Support
Study type: Interventional

Summary: 
      The purpose of this study is to find out if a two-way texting platform to be used as an
      adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among
      women enrolled in the WIC program in Connecticut. The hypothesis of the study is that
      providing additional information and support through text messaging starting in pregnancy and
      continuing after the birth of the child will increase exclusive breastfeeding rates during
      the first six months of life.
    


Intervention name(s): LATCH Intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Breastfeeding; Breastfeeding peer counseling; Exclusive breastfeeding; Formula supplementation; Mobile health; WIC program
Suspension Syndrome
Condition: Circulatory Collapse; Circulatory Failure; Syncope, Vasovagal, Neurally-Mediated; Orthostatic Hypotension
MeSH terms: Syncope; Hypotension, Orthostatic; Syncope, Vasovagal; Hypotension; Shock
Study type: Interventional

Summary: 
      Suspension syndrome refers to a potentially life-threatening condition that can occur in
      unconscious persons after prolonged suspension in a harness. To date, our understanding of
      the pathophysiology and appropriate treatment is based primarily on case reports and expert
      opinion. The main pathophysiological hypothesis implicates blood pooling in the lower
      extremity and lack of return via muscle pumping. However, a recent French study could not
      support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in
      the pathophysiology of suspension syndrome. The aim of this study is to better understand the
      pathophysiological basis of suspension syndrome and to develop practical recommendations for
      prevention and treatment.
    


Intervention name(s): Suspension in a harness; Climbing
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device
Condition: Malocclusion; Orthodontic Appliance Complication
MeSH terms: Malocclusion
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Thermoplastic devices are used in orthodontic treatment and consists of a series of nearly
      invisible, removable aligners. However, every device used in the mouth can change the buccal
      flora and increase the number of bacterias. This is a risk factor for enamel
      demineralization. The treatment can vary in time of use per day. The patient under
      orthodontic treatment has to use the device for 22 hour each day. When the period of
      retention comes, it is reduced to 8 hours. The investigators want to know if the
      concentration of bacterias in saliva and dental plaque will increase, and if the material can
      cause damage on gingiva.
    

Detailed description: 
      The orthodontic thermoplastic devices became more affordable and with simple techniques, due
      to the technological advancement. The main advantage of this appliance is that it is nearly
      invisible, seen that patients do not want to show braces. Others reasons for searching this
      kind of treatment is because it is removable. While eating, brushing the teeth or even in a
      important social event, there is the facility to remove the appliance. In the other hand this
      appliance, according to the american board association, does not finish the treatment as well
      as the conventional braces. Another problem is that every device placed in the mouth is more
      plaque retentive, increasing the risk of enamel demineralization. Also, this device disrupts
      the normal flow of the saliva, preventing the buffering. This study will analyse the amount
      of streptococcus mutans and lactobacillus in the saliva and in the biofilm of the teeth and
      of the appliance, seeded in culture medium. Another point, is check the prognosis of the
      gingival health owing to the contact with the device during the hole treatment.
    

Intervention name(s): hours of use (Essix); collect saliva; collect biofilm; collect epithelium
Intervention type(s): Device; Other; Other; Other
Intervention description(s): the patient will use de thermoplastic device during the night or during all day; the patient spit during 30 seconds in a small bottle; a sterile swab is rubbed at the buccal surface of the upper teeth; a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
Other intervention name(s): retainer use; aligner use; saliva; biofilm; epithelium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Removable Orthodontic Appliance;; malocclusion; Streptococcus mutans; Lactobacillus; Epithelium
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin
      acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet
      after single oral administration in healthy subjects.
    

Detailed description: 
      This study is two-ways crossover design. The subjects will receive a dose of four 600 mg
      LipoCol Forte Capsules or 20 mg Mevacor Tablet in fasted state in the morning. There is a
      minimum of a 6-days washout period before crossover of treatments.

      Each subject will be admitted before administration of the investigational product in each
      period. Study responsible personnel will give the subjects a single tablet or four capsules
      in fasted state in the morning. The blood samples will be drawn prior to the dosing, and
      0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.

      Observations will be conducted up to 12 hours after the dosing. If no particular health
      abnormalities are observed in each period, the subjects will be discharged on 12 hours after
      the dosing.
    

Intervention name(s): LipoCol Forte capsules; Lovastatin Tablet
Intervention type(s): Drug; Drug
Intervention description(s): The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.; The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Red yeast rice; lovastatin; Pharmacokinetics
Satiating Effects of Isolated Soy Proteins
Condition: Weight Management
Study type: Interventional

Summary: 
      Proteins are known to be more satiating than the other macronutrients; however, the type and
      amount of protein needed to induce a significant effect on satiety (fullness between meals)
      is sometimes difficult to determine. In this study, 2 differentially processed isolated soy
      proteins will be tested for satiety using subjective visual analogue scales. The amount of
      food consumed following intake of the isolated soy proteins will be measured 3 hours after
      consuming the proteins. The hypothesis is that differentially processed isolated soy proteins
      will show unique satiety responses.
    


Intervention name(s): Dry-Blended Beverage
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity, isolated soy protein, satiety, food intake
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma
Condition: Breast Cancer; Kidney Cancer; Lymphoma; Melanoma; Multiple Myeloma; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Melanoma; Multiple Myeloma; Neoplasms, Plasma Cell; Kidney Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth
      of cancer.

      PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in
      treating patients with stage IV solid tumors, lymphoma, or myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV
           solid tumors, lymphoma, or myeloma.

        -  Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous
           injection in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment
      continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

      Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
      of 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): recombinant interferon alpha-1b; IFN
Intervention type(s): Biological; Drug
Intervention description(s): interferon; IFN daily
Other intervention name(s): Interferon; Interferon
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon-alfa-1b
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV melanoma; unspecified adult solid tumor, protocol specific
Impact of Teeth Brushing in Ventilated COVID-19 Patients.
Condition: Microbial Colonization; COVID-19 Respiratory Infection; Dysbiosis; VAP - Ventilator Associated Pneumonia; HAI
MeSH terms: Infections; Communicable Diseases; COVID-19; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Dysbiosis
Study type: Interventional

Summary: 
      The aims of this study were:

        1. Observation of dynamics in oral microbiota and its association with the incidence of
           HAIs and VAP in mechanically ventilated COVID-19 patients in an ICU setting

        2. Evaluation of the incidence of HAIs and VAP and their association with oral
           bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting

        3. Assessment of impact of different oral hygienic procedures on oral microbiota, the
           incidence of HAI and patients' safety in mechanically ventilated COVID-19 patients in an
           ICU setting approaches to oral care in an ICU setting

      Intervention of oral hygienic procedures implemented in study:

      Patients were divided into 2 groups depending on the oral care procedure:

        1. Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess
           fluid)

        2. Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing,
           suction of excess fluid)
    


Intervention name(s): Oral Procedure
Intervention type(s): Procedure
Intervention description(s): Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were divided into 2 groups depending on the oral care procedure:
Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)
Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid) The procedures were performed twice daily in each patient. The detailed information on these procedures is included in the Appendix 1. The allocation protocol was based on patients' location in the ward. Each room was assigned with one type procedure (standard- even number or extended - uneven number of room), that was permanent during the study period.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: oral microbiota; healthcare-associated infection
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable
      liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression
      regimen to a modified release tacrolimus based immunosuppression regimen.
    

Detailed description: 
      A one arm study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in
      stable liver transplant patients converted from a tacrolimus (Prograf®) based
      immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
    

Intervention name(s): tacrolimus modified release (MR); tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Advagraf,; FK506E,; MR4,; FKMR,; Astagraf XL; Prograf,; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pharmacokinetics; Therapy; Immunosuppression; Drugs, Investigational; Adult
Clinical Trial of Chidamide Combined With CHOP in Peripheral T-cell Lymphoma Patients
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this dose-escalation study is to assess the safety and tolerability of
      treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients
      with newly diagnosed peripheral T-cell lymphoma.
    

Detailed description: 
      The purpose of this study is to assess the tolerability and safety include adverse events,
      vital signs, laboratory tests, etc., of a range of doses of chidamide combined with CHOP in
      peripheral T-cell lymphoma patients, and to determine the dose limit toxicity and the maximum
      tolerable dose.
    

Intervention name(s): Chidamide; cyclophosphamide; adriacin; vincristine; prednisone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle.; On Day 1, cyclophosphamide is given in a 20-minute intravenous (IV) infusion at 750 mg/m^2 in 5 minutes after chidamide administration; On Day 1, Adriacin is given in a 20-minute IV infusion at 50 mg/m^2 soon after cyclophosphamide administration.; On Day 1, vincristine is given in IV infusion at 1.4 mg/m^2 after adriacin administration.; On Day 1 to 5, prednisone is given orally at 100 mg once a day
Other intervention name(s): CS055; CTX; ADR; VCR; PED
Intervention MeSH terms: Prednisone; Cyclophosphamide; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peripheral T-cell lymphoma; PTCL; chidamide; CHOP; phase Ib
Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Outcomes from the investigators' recent investigation suggested that a high dosage of
      challenging physical therapy exercises can result in clinically improvements in the postural
      balance and walking speed of individuals with MS.

      This investigation will evaluate mobility and postural balance improvements in individuals
      with MS who participate in a therapeutic protocol consisting of activity based exercises, and
      in individuals with MS that participate in challenging physical therapy protocol.
    

Detailed description: 
      Background: Outcomes from the investigators' recent exploratory investigation suggested that
      a high dosage of challenging physical therapy exercises can result in clinically relevant
      improvements in the postural balance and walking speed of individuals with MS.

      Objective: The investigators anticipated that the promising results were due to the novel
      challenging postural balance and mobility exercises. The purpose of this investigation was to
      test this notion by evaluating the mobility and postural balance improvements that could be
      achieved in a cohort of individuals with MS who participated in a therapeutic protocol that
      consisted of activity based exercises, and a cohort of individuals with MS that participated
      in the challenging physical therapy protocol.
    

Intervention name(s): Therapeutic Challenge Program; Therapeutic Exercise Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Therapeutic Challenge Program will consist of a 5 minute warm-up, 20 minutes of challenging balance training, and 20 minutes of challenging treadmill and overground walking.; The Therapeutic Exercise Program will consist of 15 minutes of strength training and flexibility exercises, 15 minutes of balance exercises, and 15 minutes of treadmill walking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more
      effective for advanced or metastatic soft tissue sarcoma.

      PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of
      doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the progression free survival rate in patients with advanced or
      metastatic soft tissue sarcoma treated with either of two different regimens of ifosfamide or
      doxorubicin. II. Assess the toxic effects of these therapies and response rate in these
      patients.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized into one of 3 arms
      (continuous ifosfamide, ifosfamide daily for 3 days, or doxorubicin). Patients are stratified
      by performance status (0 vs 1), liver involvement (no vs yes), histological type
      (leiomyosarcoma vs synovial sarcoma vs other), and histological grade (1 vs 2 vs 3). Arm I:
      Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks. Arm II:
      Patients receive ifosfamide by intravenous infusion for 4 hours on days 1, 2, and 3 every
      three weeks. Arm III: Patients receive ifosfamide by intravenous infusion for 72 hours every
      3 weeks. Patients are assessed after every 2 courses of therapy. Each course of therapy
      consists of 3 weeks of treatment. Patients may receive a maximum of 6 courses of therapy in
      the absence of toxicity and disease progression. Patients are followed every 12 weeks for
      survival.

      PROJECTED ACCRUAL: A total of 780 patients (260 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): doxorubicin hydrochloride; ifosfamide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Ifosfamide
Allocation: Randomized
Primary purpose: Treatment
Keywords: adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; recurrent adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult rhabdomyosarcoma; stage IV uterine sarcoma; recurrent uterine sarcoma; stage IV adult soft tissue sarcoma
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant
      administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody
      response to the diphtheria antigen after a three-dose primary vaccination course.
    

Detailed description: 
      Randomized study with five groups to receive one of the following vaccination regimens:

      One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the
      two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV
    

Intervention name(s): Tritanrix™-HepB; Rotarix™; Zilbrix™; Triple Antigen™; Engerix™-B; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Drug
Intervention description(s): GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.; GSK Biologicals' live attenuated human rotavirus vaccine; GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine; Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.; GSK Biologicals' hepatitis B vaccine; Placebo for the Rotarix™ vaccine
Other intervention name(s): DTPw-HBV; HRV vaccine; DTPw-HBV Kft; DTPwcsl vaccine; HBV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Pertussis; Prophylaxis; Hepatitis B diseases; Tetanus