bioihbjkbjnl/mcl2 huggingface dataset:
A Study to See How BIIB122 Works in the Human Body, and to Evaluate it's Safety, and Tolerability in Healthy Adult Japanese, Chinese, and Caucasian Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be looking at an investigational drug, BIIB122, in healthy adult Japanese,
      Chinese, and Caucasian participants. The main goal of the study is to compare the drug level
      achieved in the body, between the different ethnic groups, after single and multiple doses of
      BIIB122. Researchers also want to see if single and multiple doses of BIIB122 are safe and if
      healthy participants can tolerate given doses of BIIB122.
    


Intervention name(s): BIIB122
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm.
Other intervention name(s): DNL151
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy
Condition: Masseter Muscle Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric
      hypertrophy compared with placebo
    


Intervention name(s): Meditoxin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Meditoxin (Botulinum toxin type A); Placebo (Normal saline)
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
NDT on Fall Risk in Cerebral Palsied Children
Condition: Cerebral Palsy, Spastic; Falling
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      Children with spastic cerebral palsy experience falls due to weakness in balance skills and
      abnormalities in gait parameters. It is necessary to improve the quality of life of these
      children by reducing the frequency of falling. Aim of this study was to investigate the
      effect of Neurodevelopmental Treatment on the risk of falling and balance and to contribute
      to the literature on this subject. Cases were randomized into study and control groups. At
      the beginning of the study, the balance skills of all the cases with spastic cerebral palsy
      were measured with the Pediatric Balance Scale, and the gait parameters and fall risks were
      measured with the LEGSys Temporospatial Gait Analysis Device. Then, an 8-week, case-specific,
      neurodevelopmental therapy program with intensive gait and balance training was applied to
      the study group in a 45-minute single session, 2 days a week. The control group received 8
      weeks of conventional physiotherapy. At the end of the treatment process, the evaluations
      were repeated with the same methods.
    


Intervention name(s): Neurodevelopmental Therapy (NDT); Conventional Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): In the treatment program; vestibular and proprioceptive training on the balance board; dynamic balance training in sitting with eyes open and closed, kneeling upright and standing; balance exercises in front of the mirror; standing on one leg with eyes open and closed to increase proprioceptive input; vestibular and proprioceptive training on exercise balls of the appropriate size; balance training on the trampoline; footpad sensory stimulation with different materials; weight-bearing training in sitting, crawling, kneeling and standing positions; functional reaching and throwing-holding exercises in different positions; multitasking pieces of training; gait exercises in various ways and training for climbing and descending stairs appropriate to the child's situation (assisted, unaided, symmetrical, reciprocal) took place.; Classical physiotherapy applications for balance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ADME Study of [14C]ICP-022 in Healthy Males
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the absorption, the metabolic pathways and the
      excretion of ICP-022 in healthy male adult participants after administration of a single oral
      dose of 150 mg of 14C ICP-022.
    


Intervention name(s): [14C]ICP-022
Intervention type(s): Drug
Intervention description(s): 150mg suspension containing 100μCi of [14C]ICP-022
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Observational

Summary: 
      In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED)
      with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron
      Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral
      Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less
      vomiting within 15 minutes of administration than those receiving Ondansetron OS.
    

Detailed description: 
      Vomiting related to viral gastroenteritis is the most common presentation to the Alberta
      Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was
      implemented to improve the care and flow of patients with vomiting and/or diarrhea through
      the department. Administration of an antiemetic, Ondansetron, is an integral part of
      improving the hydration status of children managed by the pathway. However it is not know
      whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who
      have active vomiting. The investigators aim to show that children receiving Oral
      Disintegrating Tablets have less vomiting immediately after medication administration than
      children receiving Oral Solution. By demonstrating this improved tolerability the
      investigators will provide health care providers the stimulus for implementing Ondansetron
      Oral Disintegrating Tablets into their practice for children with active vomiting.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Alberta Children's Hospital Emergency department, all patients presenting with acute
        gastroenteritis
Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A new, more specific skin test to detect tuberculosis has been developed by Statens Serum
      Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a
      positive test result will show as redness and/or induration at the injection site, while a
      negative test will leave no reactions.

      The aim of this study is to address if the size of induration and the sensitivity of C-Tb is
      influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to
      evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.
    

Detailed description: 
      The TESEC-07 trial is a GCP double blind randomised controlled phase II/III trial
      investigating if concomitant injections of the diagnostic agents C-Tb and 2 T.U Tuberculin
      PPD RT 23 SSI affect the induration responses in combination with a safety assessment of
      C-Tb. TESEC-07 is a multi-centre trial and will be conducted in South Africa in patients
      recently diagnosed with TB comprising 360 HIV negative and 90 HIV positive adults allocated
      to 3 trial groups.

        -  A within group paired comparison of 0.1 μg/0.1 mL C-Tb and PPD RT 23 in 150 TB patients.
           The C-Tb and PPD RT 23 agents are given concomitantly to each volunteer in the RIGHT AND
           LEFT forearms according to a randomisation scheme.

        -  A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT
           or LEFT forearm.

        -  A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to
           either RIGHT or LEFT forearm.
    

Intervention name(s): C-Tb; Tuberculin PPD RT 23 SSI; C-Tb / Tuberculin PPD RT 23 SSI
Intervention type(s): Biological; Biological; Biological
Intervention description(s): C-Tb is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme; Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme; The C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery
Condition: Maternal-Fetal Relations
Study type: Interventional
Phase: Phase 2

Summary: 
      A newborn's recognition and preference for their mother's voice occurs early in life, very
      likely during fetal development. Maternal voice stimuli undergo a unique form of cerebral
      processing that lends support for the existence of neurophysiologic mechanisms that reflect a
      child's preference for his/her mother's voice. This study aims to evaluate and compare the
      effect t of maternal sound listening in children undergoing cardiac surgery on stress
      response and physiological parameters.
    

Detailed description: 
      Children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be
      randomized into two equal groups (30 in each group) (control group and maternal sound group);
      in control group patients listened to a blank CD, while in maternal sound group patients
      listened to a recorded CD where the mother singing the most popular songs their children like
      or telling a story to their children. Baseline stress markers (blood glucose and plasma
      cortisol) sampled the morning before scheduled operation. A interview with the patients and
      their parents before operation to collect the questionnaire regarding patient's
      characteristic (age, sex, weight and height), patient's clinical data (medical diagnosis and
      American Society of Anesthesiologists physical status) and haemodynamic data (blood pressure,
      heart rate, oxygen saturation on room air, temperature). In addition, the researcher
      interviewed with the mothers to record on one CD their voice while they are singing the most
      popular songs their children like or telling a story to their children to help them to sleep
      to be used during intra-operative period in maternal sound group.
    

Intervention name(s): Control group; Maternal sound group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients in the control group listened to a blank CD connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit; The recorded maternal voice (while they are singing the most popular songs their children like or telling a story to help their children to sleep) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiac Surgery; Maternal sound; Cortisol; Blood sugar; Stress
Comparison of Rice Based-meal on Functional Constipation in Young Korean Women
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of rice based-meal on functional
      constipation in young Korean women.
    

Detailed description: 
      Studies comparing and evaluating the effects of a rice-based diet and a wheat-based diet on
      bowel movements are insufficient. In summary, efficient measures are needed to help
      individuals consume enough dietary fiber from natural sources in daily life to improve their
      bowel movements, rather than to consume a fiber supplements separated or synthesized from a
      particular natural food. In this study, investigators compare and evaluate the effects and
      safety of eating rice-based diets (brown rice-based and white rice-based) and a wheat-based
      diet in terms of bowel health and bowel movements among young women with functional
      constipation.
    

Intervention name(s): Experimental Diet
Intervention type(s): Other
Intervention description(s): Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Functional constipation; Brown rice based-meal; Polished rice based-meal; Wheat based-meal
Phase 2, Double-blind, Randomized, Controlled Multi-center Clinical Trial of the Safety and Efficacy of Transplanted Fetal Porcine Cells in Patients With Parkinson's Disease.
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the differences in safety and efficacy between
      Parkinson's disease patients who either received transplantation of fetal porcine cells or
      placebo treatment.
    


Intervention name(s): Fetal porcine cells, Neurocell-PD
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Comparing Paroxetine and Duloxetine on Cardiovascular Measures
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This double-blind placebo-controlled trial is designed to test and to compare the
      cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients
      with depressive symptoms.
    

Detailed description: 
      This double-blind placebo-controlled study will test the hypothesis that greater reduction in
      heart rate variability will be associated with duloxetine than paroxetine in outpatients with
      major depressive disorder. We will also examine the relationship between changes in heart
      rate variability to the magnitude of serotonin and norepinephrine transporter occupancy
      produced by each drug.
    

Intervention name(s): paroxetine versus duloxetine
Intervention type(s): Drug
Intervention MeSH terms: Duloxetine Hydrochloride; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Micro-osteoperforations on the Rate of Canine Retraction
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      the study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of
      tooth movement, as evaluated by its effect on the rate of canine retraction.
    

Detailed description: 
      Ten adult patients requiring maxillary first premolars' extraction were enrolled in this
      split-mouth randomized controlled clinical trial.

      Micro-osteoperforations were randomly assigned to one side of the maxillary arch at the
      canine-premolar region, and the contralateral side served as the control.

      Mini-screws were used for anchorage reinforcement, and canine retraction was performed using
      nickel-titanium closed coil springs, delivering a force of 150 grams per side.

      The primary outcome was the measurement of canine retraction rate throughout the study period
      from digital dental models obtained every 3 weeks.

      The secondary outcome was the detection of possible canine tipping during retraction.
    

Intervention name(s): Micro-osteoperforations (MOPs); Conventional canine retraction
Intervention type(s): Other; Other
Intervention description(s): MOPs included shallow perforations of the buccal cortical plate surrounding the tooth that requires orthodontic tooth movement, with no flap reflection was performed using a surgical bur using the special calibrated device called PROPEL; using nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: split-mouth
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans
Condition: White Spot Lesion of Tooth; Long Term Adverse Effects; Caries, Dental; Orthodontic Appliance Complication
MeSH terms: Dental Caries; Long Term Adverse Effects
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Orthodontic appliance causes increase in plaque accumulation, especially around brackets,
      wires and attachments. Advances in orthodontics in recent time have led to improved quality
      of appliance and treatment procedures ultimately resulting in improvised standard of patient
      care.

      These bacteria metabolize different kind of carbohydrates accumulated around orthodontic
      appliances and create acidic environment in the oral cavity leading to enamel
      demineralization around the brackets and white spot lesions.

      This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and
      chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are
      not using them.
    

Detailed description: 
      INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where
      plaque gets accumulated, especially around brackets, bands, wires, and other attachments;
      this facilitates the development of white spot lesions. Probiotics act by competitively
      inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while
      Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental
      plaque around orthodontic appliances. AIM & OBJECTIVE - The objectives of the study is to
      evaluate and compare the effects of the topical application of probiotic toothpaste and
      chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic
      patients hence improving the oral micro-flora of oral cavity by competitive inhibition of
      Streptococcus Mutans in plaque present around brackets.

      MATERIAL & METHOD - The study consists of thirty randomly selected orthodontic patients
      undergoing fixed appliance treatment. The patients were divided into three groups - Control
      Group (Group 1), Probiotic Toothpaste Group (Group 2) & Chlorhexidine Mouthwash Group (Group
      3). Samples were collected at two times interval: before the study began (Phase 1) and after
      thirty days (Phase 2).
    

Intervention name(s): Probiotic Toothpaste; Dr. Reddy's Clohex; Control Group
Intervention type(s): Drug; Drug; Other
Intervention description(s): G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria; 0.20% Chlorhexidine Mouthwash; No Probiotic toothpaste & Chlorhexidine Mouthwash
Other intervention name(s): G.D Probiotic Toothpaste; Chlorhexidine Mouthwash
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: White Spot Lesion; Probiotics; Chlorhexidine; Streptococcus Mutans; Fixed Orthodontic Treatment
Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Condition: Prolymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Prolymphocytic
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and
      mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing
      the cells or by stopping them from dividing. Giving more than one drug (combination
      chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can
      block cancer growth in different ways. Some block the ability of cancer cells to grow and
      spread. Others can find cancer cells and help kill them or carry cancer-killing substances to
      them. Combination chemotherapy followed by alemtuzumab may be effective in treating chronic
      lymphocytic leukemia and prolymphocytic leukemia.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by
      alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or
      prolymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the number of severe adverse events and life-threatening infections in
           patients with T-cell chronic lymphocytic leukemia or T-cell prolymphocytic leukemia
           treated with induction chemotherapy comprising fludarabine, cyclophosphamide, and
           mitoxantrone hydrochloride followed by consolidation therapy comprising alemtuzumab.

        -  Determine the remission rate in patients treated with this regimen.

      Secondary

        -  Determine the overall and progression-free survival of patients treated with this
           regimen.

        -  Determine the quality of remission in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive induction chemotherapy comprising fludarabine IV and cyclophosphamide IV for
      3 days and mitoxantrone hydrochloride IV on 1 day. Treatment repeats every 28 days for up to
      4 courses. Patients then receive consolidation therapy comprising alemtuzumab IV 3 times in
      week 1 and then weekly for up to 11 weeks.

      PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.
    

Intervention name(s): alemtuzumab; cyclophosphamide; fludarabine phosphate; mitoxantrone hydrochloride
Intervention type(s): Biological; Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mitoxantrone; Alemtuzumab
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prolymphocytic leukemia; refractory chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; T-cell large granular lymphocyte leukemia