bioihbjkbjnl/mcl2 huggingface dataset:
Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine if plerixafor can make cells more
      sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to
      as "7+3" that is commonly used in treating acute myeloid leukemia (AML). In this study,
      plerixafor is used with treatments cytarabine and daunorubicin and with and without
      granulocyte-colony stimulating factor (GCSF). Subjects will be monitored to see how well they
      tolerate the use of these drugs together and how well they work to treat the leukemia.

      The purpose of the study is to determine the maximum tolerated dose (MTD) per plerixafor
      dosing schedule (once daily [QD] or twice daily [BID]), and/or recommended phase 2 dose
      (RP2D), by assessing safety and tolerability of plerixafor (Mozobil®) when used in
      combination with cytarabine and daunorubicin, and with and without granulocyte-colony
      stimulating factor (G-CSF)
    


Intervention name(s): Plerixafor
Intervention type(s): Drug
Intervention description(s): 240 mcg/kg/dose and proceeding to escalating dose levels for determination of the single-dose maximum tolerated dose (MTD) provided that there are no unacceptable dose limiting toxicities
Other intervention name(s): AMD3100; Mozobil
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cytarabine,; Daunorubicin,; De Novo,; Acute Myeloid Leukemia,; AML
The Safety and Efficacy of Low and High Carbohydrate Diets
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet)
      with a high carbohydrate diet (conventional USDA diet).
    

Detailed description: 
      Despite the considerable mass appeal of popular diet books, such diet approaches lack data to
      support their efficacy and safety. Despite its widespread use for more than 30 years, the
      Atkins diet has never been evaluated in a large, randomized, controlled trial. This study
      will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a
      high-carbohydrate diet in overweight and obese men and women.

      Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate,
      unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low fat). The
      study will evaluate the effects of each dietary approach on changes in: 1) weight and body
      composition, 2) metabolic and organ function, 3) exercise tolerance. Each participant will be
      enrolled in the study for 2 years.
    

Intervention name(s): Low- Carbohydrate -Atkins Diet; Low Calorie Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Low Carbohydrate Diet; Maintain a low calorie diet
Other intervention name(s): low carb; low cal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss
Study on Fermentable Carbohydrates in Healthy Infants
Condition: Infant; Growth; Nutrition; Healthy
Study type: Interventional

Summary: 
      The purpose of this project is to study the effect of fermentable carbohydrates in the
      nutrition of healthy infants.
    

Detailed description: 
      Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed
      infants, and this has been ascribed to their different flora composition. The purpose of this
      project is to study the effect of fermentable carbohydrates in the nutrition of healthy
      infants. Additionally, other metabolic parameters will be investigated and compared to
      breast-fed infants.
    

Intervention name(s): Fermentable carbohydrates.; Standard infant formula.
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Infant formula enriched with fermentable carbohydrates.; Standard infant formula.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Keywords: Carbohydrates; Infant; Intestine; Faeces; Growth; Diet
Effect of Patient Education in Rheumatic Diseases
Condition: Polyarthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effect of patient education (PE) in patients with
      arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used
      as an element in the treatment of patients with chronic complaints. Our hypothesis is that

      - PE delivered as group education, followed by an individual nurse consultation increases the
      patients wellbeing an ability to cope with the disease.
    

Detailed description: 
      There has been a rather long tradition of PE for patients with arthritis. A recent systematic
      review found that PE had small short-term effects on disability, joint counts, patient global
      assessment, psychological status and depression, but this effect disappeared on the latest
      time of follow up (3-14 months). A recent large British study also failed to show an effect
      on pain, physical functioning, or contact with primary care after 12 months, but found a
      significant effect on anxiety and improved the participants' perceived self efficacy. This
      indicates that the present forms of interventions fails to show a long term effect. One
      possible reason for the lack of long term effect might be that these interventions are given
      to groups only. Patients seem to prefer one-to-one interaction regarding information about
      the disease and its treatment together with emotional aspects, while education in groups are
      preferred for physical training and relational topics.
    

Intervention name(s): Patient education with individual nurse consultations
Intervention type(s): Behavioral
Intervention description(s): 3 group meetings followed by 1-2 individual nurse consultations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Patient education; Nurse consultation; Arthritis; Wellbeing; Coping; Health related quality of life
TOFO Insulin Combination Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objectives:

      To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an
      add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over
      a period of 16 weeks in patients with type 2 diabetes mellitus.

      To assess the safety of tofogliflozin in combination with insulin treatment throughout 52
      weeks.

      Secondary Objectives:

      To assess the effects of tofogliflozin in comparison to placebo on:

        -  Body weight

        -  Fasting plasma glucose (FPG)

        -  Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of
           tofogliflozin.
    

Detailed description: 
      The total study duration from screening for a patient can be approximately up to 1 year,
      including a screening period of 2 weeks, double-blinded placebo controlled treatment period
      of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.
    

Intervention name(s): TOFOGLIFLOZIN CSG452; insulin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:tablet Route of administration: oral
Other intervention name(s): Apleway; Deberza
Intervention MeSH terms: 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prevention of Iron Deficiency in Breastfed Infants
Condition: Iron Deficiency; Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      With early screening and appropriate iron supplementation, iron deficiency in the first year
      of life can be prevented in breastfed infants.
    

Detailed description: 
      Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive
      iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All
      infants will receive iron-fortified cereal starting at 4 months of age.
    

Intervention name(s): Fer-in-Sol; control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal; No dietary supplements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: iron deficiency; anemia
Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Evaluation of the predictive value of serum levels of adipocytokines and primary phase
      reactant for recurrent atrial fibrillation (RAF) after catheter ablation in 26 patients had
      persistent and 91 patients had paroxysmal AF. During 12-m follow-up, 41 patients had RAF
      (35%). Patients had RAF were significantly older, had significantly higher BMI, lower
      ejection fraction and wider maximal left atrial diameter (LAD). Serum hs-CRP, IL-6, TNF-α,
      visfatin, and adiponectin levels were significantly higher in patients developed. Elevated
      serum levels of TNF-α, visfatin and adiponectin are a significant positive predictors for
      RAF.
    

Detailed description: 
      Objectives: Estimation of serum levels of visfatin, adiponectin, tumor necrosis factor-α
      (TNF-α), interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) in patients
      had atrial fibrillation (AF) resistant to medical treatment and assigned to catheter ablation
      (CA) to evaluate these biomarkers as predictors for recurrent AF (RAF).

      Patients & Methods: 117 patients; 26 patients had persistent and 91 patients had paroxysmal
      AF underwent had clinical and echographic evaluations and gave blood samples for ELISA
      estimation of serum levels of studied cytokines. CA was performed through isolation of all
      pulmonary veins according to the stepwise procedure of ablation. Patients were re-evaluated
      every three months till 12-m follow-up for post-procedural RAF.
    

Intervention name(s): Measuring Serum bio-markers
Intervention type(s): Diagnostic Test
Intervention description(s): ELISA Estimation of Serum visfatin and tumor necrosis factor-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Renal Transplant Injury and the Renin-Angiotensin System in Kids (RETASK)
Condition: Renal Transplant; Renin-Angiotensin System; Rejection Acute Renal; Rejection Chronic Renal; Rejection of Renal Transplant
Study type: Observational

Summary: 
      In pediatric kidney transplant patients, rejection, medication toxicity and ischemia cause
      early and chronic renal allograft injury, which reduces graft lifespan and patient survival.
      Early detection of injury would facilitate prevention and treatment. The gold standard
      surveillance biopsy has limitations including delayed discovery of injury. No noninvasive
      test identifies graft injury before it is clinically apparent. This project's goal is to
      develop a novel early marker of subclinical graft injury to facilitate prompt recognition and
      treatment.
    

Detailed description: 
      Kidney damage activates the traditional renin-angiotensin (Ang) system (RAS), characterized
      by Ang-converting enzyme (ACE)/Ang II/Ang II type 1 receptor. The Ang-converting enzyme 2
      (ACE2)/Ang-(1-7)/Mas pathway counteracts this damage. The balance, or ratio, between levels
      of the ACE/Ang II and ACE2/Ang-(1-7) pathways may be clinically important because Ang-(1-7)
      counteracts Ang II-mediated injury. An increase in ACE and Ang II expression and a decrease
      in ACE2 and Ang-(1-7) expression on tubular cells may promote renal injury. Tubular damage
      may increase urinary loss of protective ACE2 and Ang-(1-7), propagating renal damage by
      allowing ACE and Ang II to stimulate inflammation and fibrosis unopposed. The investigators
      hypothesis is that a shift in the urinary ACE-to-ACE2 and Ang II-to-Ang-(1-7) ratios towards
      ACE2 and Ang-(1-7) predicts acute graft injury diagnosed on renal biopsy and predicts chronic
      graft damage on renal biopsy.
    

Intervention name(s): Renal Transplantation
Intervention type(s): Procedure
Intervention description(s): Kidney transplantation and biomarkers that can identify injury after transplant.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is an observational study with a convenience sample of patients recruited from Lucile
        Packard Children's Hospital kidney transplant evaluation clinic.
      
Biospecimen description: 
      De-identified urine and plasma specimens.
    
Keywords: Pediatric Renal Transplant; Renal Allograft; Angiotensin II; Angiotensin-(1-7); ACE; ACE2
Appetite-Related Brain Activity in Women With Anorexia Nervosa
Condition: Eating Disorders; Anorexia Nervosa
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Observational

Summary: 
      This study will use functional magnetic resonance imaging to compare appetite-related brain
      activity in women with anorexia nervosa before and after receiving treatment for the
      disorder.
    

Detailed description: 
      Anorexia nervosa (AN) is a serious eating disorder that is characterized by an extreme loss
      of appetite. People with AN view themselves as overweight and cannot bring themselves to eat,
      even though most are dangerously thin. Functional magnetic resonance imaging (fMRI) is a
      technique that can be used to determine which parts of the brain are activated by physical
      stimuli. When a certain stimulus is introduced, blood flow to the corresponding area of the
      brain increases. This increase in blood flow is depicted on the fMRI scan. A person with AN
      may have different responses to food when evaluated prior to treatment versus after
      treatment. This study will use fMRI to compare appetite-related brain activity in women with
      AN before and after receiving treatment for the disorder.

      Participants in this study will undergo two fMRI scans. Participants with AN will have one
      scan before entering the "weight gain phase" of treatment for AN and another scan upon
      completion of treatment. Healthy volunteers will undergo scans during a similar time frame.
      Participants will not be allowed to eat from midnight on the night before the scan until
      after the fMRI procedure, but they may drink water. During the scan, participants will be
      shown various objects and real foods; they will also be asked to touch the objects and food
      with their eyes closed. Each visit will last approximately 45 minutes. Ear protectors will be
      provided to reduce scanner noise.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with AN between 18 and 45 years of age hospitalized for treatment of anorexia
        nervosa.
      
Keywords: Eating Disorders; Anorexia Nervosa
Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      Mechanical debridement is the traditional method for the treatment of peri-implant mucositis
      and its success depends on the patient's correct oral hygiene. It is believed that probiotics
      may help by their ability to modulate the oral biofilm, resulting in anti-inflammatory and
      anti-bacterial plaque action. The aim of this study is to evaluate the adjuvant effect of the
      probiotic Limosilactobacillus reuteri in the mechanical treatment of peri-implant mucositis.
      This study aims to include 32 subjects with implant-supported total rehabilitation and
      peri-implant mucositis, divided into test and control groups, equally subjected to
      professional mechanical debridement, with the administration of a daily GUM® PerioBalance®
      lozenge for 30 days added to the test group. Plaque Index, Bleeding Index and probing pocket
      depth are evaluated before the intervention (baseline) and at 6 and 10 weeks later.
    


Intervention name(s): Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
Intervention type(s): Dietary Supplement
Intervention description(s): Non-surgical professional mechanical debridement and probiotic supplement Limosilactobacillus reuteri Prodentis® (combining L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 strains)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two-group parallel design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: probiotic; Limosilactobacillus reuteri; dental implant; peri-implant mucositis; total rehabilitation; mechanical therapy; nonsurgical treatment
Gong's Mobilization and Sustained Natural Apophyseal Glide in Office Workers With Cervical Spine Overload
Condition: Cervical Spine Sprain
Study type: Interventional

Summary: 
      Neck pain is a frequent and disabling complaint in the general population. One of the most
      common causes of neck pain is mechanical dysfunction of the cervical spine. Although diverse
      methods have been proposed for increasing cervical range of motion (ROM), joint mobilization
      has been confirmed as effective in several studies. Typically, joint mobilization methods for
      increasing cervical ROM include spinal manipulative therapy, the activator and diversified
      techniques. There are different mobilization techniques for neck pain, and mulligan's
      technique is one of them. It has two techniques Sustain Natural Apophyseal Glides (snags) and
      Natural Apophyseal Glides (nags). Gong's mobilization technique helps to heal physical pain
      as well as distract the mind from stress. In this study, the effectiveness of gong's
      mobilization and Sustained Natural Apophyseal Glides (snags) will be compared in office
      workers who have problems with cervical posture and range of motion (ROM) in order to examine
      the effects of gong's mobilization on cervical pain and cervical ROM. Twenty office workers
      with problems of cervical posture, pain and ROM is divided into a gong's mobilization group
      (n=10) and a Snags group (n=10). Gong's mobilization and nags will be administered three
      times a week for four weeks to each respective group and then changes in cervical posture,
      pain and cervical ROM will be evaluated.
    


Intervention name(s): Gong's mobilization; SNAG
Intervention type(s): Other; Other
Intervention description(s): Ten patients will be treated with Gong's mobilization.; : Ten patients will be treated with SNAGs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mobilization,; cervical spine overload,; Gong's mobilization,; SNAGs
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, inpatient, open label pharmacodynamic study to determine the effect
      of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for
      4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low
      sodium and high potassium diet.
    

Detailed description: 
      This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will
      be screened to achieve 20 subjects completing the study. Subjects will be randomized to
      receive ZS 5 g or 10 g (1:1) once daily (qd) in conjunction with breakfast and will be
      continued with a standard diet during the ZS treatment period.
    

Intervention name(s): Sodium Zirconium Cyclosilicate (ZS)
Intervention type(s): Drug
Intervention description(s): Sodium zirconium cyclosilicate (ZS) is a non-absorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for sodium and hydrogen ions in the gastrointestinal tract after oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Chinese Subjects, Pharmacodynamic Study
GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2; Non-Insulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to compare the safety, blood concentrations, and effects of GSK189075,
      GW869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes.
    


Intervention name(s): GSK189075 oral tablets; GW869682 oral tablets
Intervention type(s): Drug; Drug
Other intervention name(s): GSK189075 oral tablets
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes; sodium dependent glucose transporter; SGLT2; GSK189075; GSK189074; SGLT1; GW869683