bioihbjkbjnl/mcl2 huggingface dataset:
R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
Condition: Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation
      PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients
    

Detailed description: 
      Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation
      PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low
      risk profile according to age-adjusted IPI (0 with bulky or 1)
    

Intervention name(s): Treatment plan
Intervention type(s): Drug
Intervention description(s): R-CHOP14 or R-CHOP21 for 6 cycles Restaging after 2, 4, 6 cycles Consolidation therapy with RT (36 Gy) if PET positive (PET after 6 R-CHOP cycles)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLBCL
The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia
Condition: Eating Disorder Symptom and Body Image Dissatisfaction
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The trial is a randomized control trial about the effective of an eating disorders prevention
      programmer for young Saudi women.

      The prevention program is title The Body Project. Participants will be Saudi undergraduates
      from Princess Nourah Bint Abdulrahman University. Sample size is 64 participants. They will
      be divided randomly to two groups, each group has 32 participants. The first group is the
      intervention group where the prevention program will be provided. The second group will be
      the control group where healthy eating education material will be provided. The outcomes will
      be measured with adapted tools to local culture at three points (pre, post and 3 month
      follow-up).
    


Intervention name(s): The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention
Intervention type(s): Other
Intervention description(s): The Body Project is a a selective dissonance-based prevention program that targets women with body image concerns. It has been developed with University and similar populations in mind, making it appropriate to the current research.The Body Project is based on a protocol, and aims to create cognitive dissonance that encourages participants to reduce pursuit of the thin-ideal. It involves the use of a scripted manual, covering four interactive weekly sessions. These involve role play, behavioural, verbal and written exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to evaluate the relative bioavailability of the
      BIIB104 test formulation compared with the reference formulation in healthy Caucasian male
      adult participants in the fasted state and to assess the impact of food on BIIB104
      pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult
      participants.

      The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5
      milligrams (mg) test formulation in the fasted and fed states following single-dose
      administration.
    


Intervention name(s): BIIB104 Reference Formulation; BIIB104 Test Formulation
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children
Condition: Dental Anxiety; Anxiety Disorder; Aromatherapy
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the impact of lavender oil (Lavandula
      angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation)
      among children planned to undergone surgical intervention.
    

Detailed description: 
      Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to
      dental care, especially for children ranges from 3% to 43% in different populations. To the
      best of our knowledge, this is the first study to investigate the use of lavender oil
      inhalation and to assess the correlation of anxiety and vital signs among children during a
      stressful surgical dental intervention. This study design was constructed according to the
      vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil
      inhalation prior to surgical dental interventions would affect vital signs and consequently
      reduce anxiety and perception of pain in children.
    

Intervention name(s): Anxiety scale; Pain scale - 1; Pain scale - 2; Inhalation
Intervention type(s): Other; Other; Other; Behavioral
Intervention description(s): Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.; Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction; Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction; lavender oil inhalation in a separate room for 3 minutes prior to interventions
Other intervention name(s): 100 % pure, high strength lavender oil inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: lavandula; phytotherapy; aromatherapy; dental anxiety; anaesthesia
Study to Evaluate the Efficacy and Safety of Minocycline in Angelman Syndrome
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RANDOMIZED CLINICAL TRIAL, PLACEBO COMPARED TO EVALUATE THE EFFICACY AND SAFETY OF
      MINOCYCLINE IN ANGELMAN SYNDROME (A-MANECE STUDY)
    

Detailed description: 
      STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MINOCYCLINE IN ANGELMAN SYNDROME
    

Intervention name(s): MINOCYCLINE; PLACEBO (for Minocycline)
Intervention type(s): Drug; Drug
Intervention description(s): Pill Minocycline 50 mg capsule; Pill manufactured to mimic Minocycline 50 mg capsule
Other intervention name(s): Commercial name: Aknemin 50; Active substance: MINOCYCLINE; Administration routes: Oral use; Commercial name: NA; Non Active substance:; Administration routes: Oral use
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Angelman Syndrome; EFFICACY; SAFETY; MINOCYCLINE; Pediatrics population; Rare diseases
Host Response to Urinary Tract Infection in Women
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Observational

Summary: 
      This study is being done to identify those elements of the immune response that may
      predispose a woman to recurrent urinary tract infection. We suspect that lesser effectiveness
      of certain components of the host response will lead to recurrent urinary tract infection. We
      will also evaluate the role that the bladder reservoir may play in recurrent urinary tract
      infection.
    

Detailed description: 
      Procedures subjects will undergo once they have read and signed the consent are:

      Questions about their medical and sexual history and current symptoms of urinary tract
      infection. They will be asked to provide a clean catch urine sample. We will collect
      periurethral, vaginal and rectal swabs. Blood will collected. They will be given a diary to
      take home and record all episodes of sexual intercourse, contraceptive use, vaginal and
      urinary symptoms and medication use.

      They will be given standard treatment for the current urinary tract infection. Follow-up
      visits will be scheduled 2 weeks,one month,two month and three month after initial visit.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 18-49 with symptoms of a urinary tract infection for fewer than 7
        days
      
Biospecimen description: 
      whole blood,serum, urine
    
Keywords: Current symptoms of urinary tract infection
Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fed Condition
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE
      products by measurement of Plasma concentrations of Erythromycylamine and calculation of the
      bioequivalence parameters from those measurements followed by ANOVA and 90% confidence
      interval statistical evaluation.
    

Detailed description: 
      An open-label, randomized, two-treatments, two-periods, two-sequences, crossover
      bioequivalence pilot study with a washout period of at least 14 days between doses. Healthy,
      mixed skin Arab & Mediterranean Subjects ages between 18 and 50 years, body-mass index 18.5
      to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers (smokers of
      not more than 10 cigarettes per day).
    

Intervention name(s): DYNABAC 250 MG ENTERIC COATED TABLET; DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dirithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fed condition
Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Despite continued research on effective interventions, obesity remains a major public health
      issue in the United States. Current treatments, including behavioral weight management
      programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited
      reach, reducing the ability of these treatments to address the population-wide scope of the
      obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and
      provide targeted feedback offer promise to help larger groups of individuals to lose weight.
      Despite the commercial popularity of these products, however, little research has been
      conducted to evaluate their impact on excess body weight or to determine how they should
      ideally be implemented. Two key questions need to be addressed. First, is use of
      self-monitoring technology sufficient to produce weight loss, or must this technology be
      combined with interventionist contact? Second, how cost-effective is a technology-based
      intervention, with and without interventionist contact? The current study is small
      prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to
      a technology only condition (TECH) and a technology plus interventionist support condition
      (TECH+INT). All participants will all be given basic weight management information knowledge
      and randomized to one of three conditions. Participants in the self-guided self-monitoring
      condition (SC) will receive traditional paper self-monitoring logs, a standard body weight
      scale, and a pedometer and calorie book; participants in the technology-based condition
      (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and
      will track caloric intake via an associated website; and participants in the interventionist
      contact condition (TECH+INT) will receive the same technology as in the TECH condition,
      combined with weekly interventionist contact delivered via telephone. We will compare the
      impact of each condition on weight loss and investigate preliminary cost-effectiveness.
    


Intervention name(s): Self-monitoring skills; Technology; Interventionist Contact
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Weight Loss; Self-monitoring; Food Records; Self-weighing; Technology
Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Acute exposure to diesel exhaust under normal city conditions leads to a worsening of
      symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent
      on the exposure dose and on the background severity of asthma.

      The worsening asthma is accompanied by increased oxidative stress and inflammation in the
      lungs.
    

Detailed description: 
      The investigators will recruit 60 nonsmoking asthmatics of mild and of moderate severity.
      They will be exposed to Oxford St. or to Hyde Park for 2 hours each, at a walking pace. Real
      time exposure to PM2.5, carbon monoxide and nitrogen dioxide will be made each time. Health
      outcome measurements will be made before and after exposure to each street. Statistical
      analyses will be made to examine the effect of diesel exposure on changes in health outcome
      measures.
    

Intervention name(s): Oxford street; Hyde park
Intervention type(s): Other; Other
Intervention description(s): 2 h walk around Oxford street; 2 h walk around Hyde park
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exposure to Oxford Street; Exposure to Hyde Park
Ion Prostate Irradiation
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and feasibility of primary
      hypofractionated irradiation of the prostate with carbon ions or protons using the raster
      scan technique.
    

Detailed description: 
      as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP,
      Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to establish
      the safety and feasibility of primary hypofractionated irradiation of the prostate with
      protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202.

      http://www.ncbi.nlm.nih.gov/pubmed/24641841
    

Intervention name(s): radiation
Intervention type(s): Procedure
Intervention description(s): radiation with protons or carbon ions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate; IPI; hypofractionation; carbon ions; proton
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
Condition: Chronic Cor Pulmonale
MeSH terms: Pulmonary Heart Disease
Study type: Interventional

Summary: 
      This study evaluates the effect of external diaphragmatic pacemaker on the patients with
      chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker,
      while the other half will receive routine therapy.
    

Detailed description: 
      Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the
      indicators include: respiratory muscle force, diaphragmatic degree of excursion and
      thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of
      life, pulmonary function,NT-proBNP,PaO2 and PaCO2.
    

Intervention name(s): external diaphragmatic pacemaker group
Intervention type(s): Device
Intervention description(s): 9 counts per minute, with stimulate frequency 40 Hz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Resveratrol and Serum Apo A-I
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Although much effort has been done to lower LDL-cholesterol concentrations, there is still a
      substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD
      is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that
      elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite
      many initiatives, no new widely applicable intervention strategies with proven efficacy have
      been developed.

      Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower
      risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert
      a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has
      been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to
      elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human
      intervention studies.
    


Intervention name(s): Resveratrol capsules
Intervention type(s): Dietary Supplement
Intervention description(s): 2 x 75 mg resveratrol each day, for 4 weeks
Other intervention name(s): Resveratrol will be provided as resVida®
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Resveratrol; FMD; PWV; HDL-cholesterol; Macrovasculature; Microvasculature
Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of two
      medications--clonidine and methylphenidate--alone or in combination to treat attention
      deficit hyperactivity disorder in children ages 4 through 6.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) is a disease characterized by one or more
      symptoms of hyperactivity, impulsivity, or inattention that interfere with school, home,
      work, or social settings. ADHD does not have clear physical signs that can be seen in an
      x-ray or a lab test. The disorder only can be identified by looking for certain behaviors,
      which vary from person to person.

      This trial will compare the benefits and side effects of two medications--clonidine and
      methylphenidate (MPH)--used alone or in combination to treat ADHD in children. MPH is
      approved by the Food and Drug Administration (FDA) for the treatment of ADHD symptoms in
      children, and clonidine is FDA-approved for the treatment of hypertension in adults.
      Stimulant medications such as MPH are known to safely and effectively treat many ADHD
      symptoms. Such medicines, however, do not cure the condition or improve all ADHD symptoms,
      and the long-term effectiveness of these medications is not well-known.

      In this study, participants will be randomly selected to receive one of four treatments: 1)
      clonidine; 2) MPH; 3) clonidine and MPH; or 4) a placebo (an inactive substance).
      Participation in the study is about 16 weeks, and includes a baseline screening and 5
      evaluation visits to assess attention, hyperactivity, overall improvement and general
      functioning, medication side effects, blood pressure, pulse, and weight.
    

Intervention name(s): clonidine; methylphenidate; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Clonidine is FDA-approved for the treatment of hypertension in adults; Methylphenidate is known to safely and effectively treat many ADHD symptoms.; inactive substance
Other intervention name(s): MPH
Intervention MeSH terms: Clonidine; Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attention deficit hyperactivity disorder; ADHD; clonidine; methylphenidate; MPH
Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
Condition: Cesarean Section; Infection; Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine
      vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three
      groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and
      vaginal washing with saline alone.
    

Detailed description: 
      This is a prospective trial of vaginal preparation (or vaginal cleansing/washing) on late
      preterm and term pregnancies admitted to Labor & Delivery unit for cesarean delivery with
      three arms. Randomization allocation would be performed in 1:1:1 fashion for vaginal
      preparation with chlorhexidine-alcohol, povidine-iodine, and saline washes. A saline wash
      group is included to determine if the act of cleansing the vagina with a sponge alone reduces
      bacterial colony counts.
    

Intervention name(s): Chlorhexidine-alcohol; Povidine-iodine; Sterile saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.; Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.; Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.
Other intervention name(s): Chlorohexidine Gluconate (CHG); Betadine; Sodium chloride 0.9%
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vaginal preparation; antisepsis; C-section