bioihbjkbjnl/mcl2 huggingface dataset:
Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
Condition: Acute Lymphocytic Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome; Non-Hodgkin Lymphoma; Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study hopes to show that specially treated umbilical cord cells, called stem cells, can
      be safely given to a person after they receive chemoradiation therapy or chemotherapy for
      their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells
      that are needed to make the different types of cells in their blood, including their immune
      system cells. These cells must be replaced in order for the blood and immune systems to work
      properly. Some people receive bone marrow transplants or other types of stem cell transplants
      to get the cells they need. CB001 is being developed as an option for people who need bone
      marrow transplants or other types of transplants to replace those cells. It is also being
      developed for people who do not have the option of other types of transplants.
    


Intervention name(s): Expansion of umbilical cord stem cells
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: umbilical cord blood; transplant; ALL; AML; MDS; NHL; CML
Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals
Condition: Gestational Diabetes; Obesity
MeSH terms: Diabetes, Gestational; Overweight
Study type: Interventional

Summary: 
      This is a prospective, randomized, placebo controlled study with three parallel arms
      examining the effects of magnesium supplementation in the second trimester of pregnancy.

      Recent research has shown that supplemental magnesium can have beneficial effects, especially
      in overweight individuals. Not only do many people have a magnesium deficient diet, there is
      also evidence that magnesium can improve blood sugar levels. Due to the growing concern of
      obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal
      growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes.

      In this study, 60 overweight and obese pregnant patients in their first trimester will be
      enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg
      elemental Magnesium), group B will receive dietary counseling about following a magnesium
      rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine
      specimens will be collected at three time points during the pregnancy to analyze changes in
      levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal and
      maternal complications of pregnancy will be noted, including maternal weight gain. At
      delivery, patients will have a placental cord blood specimen and placental biopsy collected
      for gene expression patterns and further analysis.
    


Intervention name(s): Magnesium citrate; Placebo; Dietary modification
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium); Identical appearing placebo with inactive ingredients, two pills once daily.; Nutritionist counseling session and advice on following a magnesium rich diet
Intervention MeSH terms: Magnesium citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight gain in pregnancy; Metabolic and Inflammatory markers
Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals'
      HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and
      0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule
      (0,1,6 months) in 15-25 year old females.
    


Intervention name(s): GSK Biologicals' HPV vaccine 580299
Intervention type(s): Biological
Intervention description(s): Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
Other intervention name(s): Cervarix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV infection; Human Papillomavirus; Cervical cancer; HPV-16; HPV-18; vaccine
GOLO Open-Label Pilot 1
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this open-label pilot study is to evaluate the effect of the commercially
      available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic
      patient population after approximately 3 months.
    

Detailed description: 
      Golo For Life (GFL) is a weight management program that helps people who are overweight or
      obese limit and portion their consumption of conventional foods and make healthier choices in
      their diets. GFL includes a point-based system from the four macronutrient food groups that
      is based on the individual's activity level and body mass. Additionally, GFL includes
      common-sense instructions, motivation and tips supporting compliance and requires a minimum
      of 15 minutes of exercise per day. GFL also includes a dietary supplement containing zinc and
      chromium, essential nutrients that support regulation of blood sugar.

      In case studies from clinician and wellness program use, GFL has shown the ability to reduce
      body weight in both healthy and diabetic people who are overweight or obese. Secondary
      endpoints including measures of blood sugar have been observed to decrease as a result of the
      GFL program.

      While GFL has been developed and used in private clinical practice in both healthy overweight
      and type 2 diabetic people, more systematic research is needed to determine to what extent it
      is able to support healthy weight loss. This open-label pilot study is intended to observe
      the effects of the program in a representative group of subjects with stable type 2 diabetes
      at one outpatient medical practice.

      The objective of this open-label pilot study is to evaluate the effect of the commercially
      available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic
      patient population after approximately 3 months.
    

Intervention name(s): GOLO RELEASE
Intervention type(s): Dietary Supplement
Intervention description(s): GOLO RELEASE plus Diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Social Cognition and Interaction Training for Autism
Condition: Autism; Social Behavior
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and
      following a group based clinical therapy program to determine the effectiveness of the
      therapy approach. The therapy program is aimed at improving social cognitions and skills of
      individuals who find social situations difficult, stressful and/or uncomfortable and with a
      desire to enhance skills required for social interactions.

      Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment
      disorder, who have general difficulty with social interactions.

      Procedures: Participants enrolled in a clinical therapy program for improvement of social
      cognitions and skills will complete eye tracking tasks, several questionnaires and rating
      scales, and a diagnostic interview prior to and following the 8 week therapy program. The
      post treatment assessments will be conducted within a week of the therapy completion and then
      again approximately 2 months after the last therapy session. The entire study duration is
      expected to be approximately 17 weeks. These outcome measures will measure the effectiveness
      of the treatment.
    


Intervention name(s): Social Cognition and Interaction Training for Autism (SCIT-A); Treatment as Usual (TAU)
Intervention type(s): Behavioral; Other
Intervention description(s): The group therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions.; Participants in the treatment as usual (TAU) group will continue to receive other interventions (e.g., individual therapy, job skills coaching) during the Social Skills Clinic. No participants in either group will participate in other group-based interventions concurrently with their participation in this study.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Switching to Potential Reduced Exposure Products in Adult Smokers
Condition: Tobacco Use Disorder; Oral Nicotine Pouch Use; Smoking Behaviors; Harm Reduction; Toxic Effect of Tobacco and Nicotine; Carcinogenesis
MeSH terms: Carcinogenesis; Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study aims to assess the feasibility, acceptability, and the potential harm reduction of
      switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this
      study aims to assess the interest of current smokers in switching to an e-cigarette device
      (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless
      tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of
      30 non-treatment seeking adult smokers to investigate within-person changes in smoking
      behavior as a result of switching to different concentrations of oral nicotine pouch products
      (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of
      tobacco exposure from baseline, this will allow the study to assess the potential for harm
      reduction in switching from cigarettes to oral nicotine pouches.
    


Intervention name(s): ZYN
Intervention type(s): Device
Intervention description(s): 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.
Masking: Single (Participant)
Primary purpose: Other
Effects of Embryogen in RIF Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage
      Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with
      repeated implantation failure (RIF)
    

Detailed description: 
      60 patients with repeated implantation failure were involved.

      RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo
      transfers (fresh and frozen) with 06 top quality embryos or more.

      Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were
      inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of
      GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at ﬁxed
      time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after
      ovum retrieval.

      Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day;
      Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum
      hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was
      performed at gestational weeks 7 and 12.
    

Intervention name(s): GM-CSF
Intervention type(s): Biological
Intervention description(s): 2ng/ml of GM-CSF supplemented into culture media
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GM-CSF, repeated implantation failure
Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.
    


Intervention name(s): Valsartan
Intervention type(s): Drug
Intervention description(s): 80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks
Intervention MeSH terms: Valsartan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; valsartan
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
Condition: Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of
      single dose of F2695 at 75mg on modulation of the cerebral motor network.
    


Intervention name(s): F2695; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate Inflammation Caused by Gingivitis in Adults
Condition: Gingivitis
MeSH terms: Gingivitis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice
    


Intervention name(s): Triclosan/Copolymer/fluoride toothpaste; sodium monofluorophosphate toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily usage; Twice daily usage
Other intervention name(s): Total toothpaste; Colgate cavity protection toothpaste
Intervention MeSH terms: Triclosan; Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic
      profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in
      approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will
      evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when
      administered in combination with Bendamustine/Rituximab following a dose escalation scheme,
      with the objective of defining the dose limiting toxicity and the maximum tolerated dose.
    


Intervention name(s): ABT-199; Rituximab; Bendamustine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-199 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.; Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle.; Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle.
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Maximum Tolerated Dose; Safety; Bendamustine; Non-Hodgkin's Lymphoma; Rituximab; ABT-199; Cancer; Preliminary Efficacy
Early Family-Centered Prevention of Drug Use Risk (Aka Early Steps)
Condition: Substance Use; Conduct Disorder; Depression; Anxiety
MeSH terms: Substance-Related Disorders; Conduct Disorder
Study type: Interventional

Summary: 
      The investigators are testing the efficacy of a family-based preventive intervention, which
      began when the children were age 2, with children at risk for developing significant conduct
      problems. Families who were originally recruited from Women, Infants and Children (WIC) were
      randomly assigned to a family-centered intervention developed by Dishion and colleagues
      (Dishion & Kavanagh, 2003; Dishion & Stormshak, 2006) referred to as an 'ecological approach
      to family intervention and treatment' (EcoFIT). The current study expands the Early Steps
      intervention into the elementary school years beyond what is currently available for a WIC
      service delivery venue, in which children are no longer eligible for services at age 6.

      The investigators are testing the hypothesis that periodic, tailored, and adaptive
      interventions delivered to caregivers at school entry will (a) reduce the probability of
      elevated risk associated with early-onset problem behavior, including the eventual use of
      drugs and other health-risking behaviors; (b) reduce the likelihood of mental health problems
      such as childhood depression, anxiety, conduct problems and co-morbidity; and (c) promote
      children's development of self-regulation, which underlies school readiness, early school
      literacy academic achievement, and positive peer relations.
    

Detailed description: 
      Aims of the current project are:

        1. Refine the intervention model to address the child's adaptation to school and
           development of self-regulatory skills and underlying multiple dimensions of school
           success.

        2. Examine and test the consistency of developmental models of problem behavior, emotional
           adjustment, and normative self-regulation in childhood.

        3. Evaluate the long-term impact of intervention on risk pathways to later drug abuse and
           health-risking behaviors by examining early risk markers, including children's problem
           behavior, poor emotional adjustment, and lack of school readiness.
    

Intervention name(s): Ecological Family Intervention and Treatment (EcoFIT)
Intervention type(s): Other
Intervention description(s): Includes the Family Check-Up (in-person intake, family video observations and Assessment questionnaires used to provide and tailored feedback using motivational interviewing techniques) as well as continued tailored intervention services using the Everyday Parenting Curriculum.
Other intervention name(s): Family Check-Up (FCU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: parenting interventions; Family Check-Up; Early Intervention; Self-Regulation
Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      Influenza is an important public health problem. Organ transplant patients are particularly
      susceptible to severe disease. Also, they shed higher quantities of virus for longer
      durations, leading to greater contagious potential, thereby potentially serving as nodes of
      spread in the community. Therefore, improved strategies to prevent influenza in this
      population is an important public health concern. Standard vaccination is poorly immunogenic
      post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules
      that create a strong local inflammatory response and they attract immune cells to the site of
      injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza
      vaccines containing adjuvants have become available in Canada but have only limited
      information in transplant patients. This randomized trial is designed to assess the
      immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for
      seasonal influenza in a cohort of adult organ transplant recipients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult kidney tranplant recipients
      
Keywords: kidney transplant recipients
Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
Condition: Vision Correction
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the retention rate over a two month
      period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.
    


Intervention name(s): Multifocal Test Contact lens
Intervention type(s): Device
Intervention description(s): Used in a daily wear modality
Other intervention name(s): etafilcon A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
My Health Coach Study
Condition: Health Behavior
Study type: Interventional

Summary: 
      The "My Health Coach Study" seeks to determine if health coaching by a medical assistant can
      help patients have better sleep, a better diet, be more physically active or lose weight,
      according to the recommendation of their health care provider.
    

Detailed description: 
      The aim of the study is to determine whether medical assistants (MAs) can assist primary care
      providers to achieve healthier lifestyles via better sleep, food choices, weight loss and/or
      increased physical activity in their patients. The hypothesis driving this research is that
      health coaching can be done by existing medical support staff to facilitate healthy
      lifestyles in a primary care setting. Coaching can maximize the health of the patient
      population in a cost-effective way if the coaching service is integrated into primary care
      clinics with minimal capital investment at the outset. A major focus will be on behaviors
      associated with weight management since this is the most common health issue in the U.S.
      today. This method, if successful, should be easily adaptable to other health behaviors and
      in most any medical practice that seeks to improve the health of its patient base in a
      cost-effective way.

      In order to achieve a change in health behaviors, and especially weight loss, regular
      follow-up contacts are needed. Previous research has shown health coaching to be effective,
      but this has utilized programs that "add on" to the existing clinic structure. This type of
      coaching model is difficult to sustain. Utilizing existing staff for health coaching is a
      method we propose to more fully integrate this service into primary care clinics.
    

Intervention name(s): health coaching
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: nutrition; physical activity; sleep; weight loss