bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Colonoscopy is considered by many the preferred mode of screening for colorectal cancer
      (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate
      bowel preparation.

      For bowel preparation, effective, well-tolerated and safe methods should be applied.

      Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of
      direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate
      solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned
      the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel
      preparation
    

Detailed description: 
      For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate
      solution (OSS) in split method for bowel preparation
    

Intervention name(s): HAPREP®; SUCLEAR®
Intervention type(s): Drug; Drug
Intervention description(s): Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc)
: : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]; Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]
Other intervention name(s): 2L polyethylene glycol with ascorbic acidl PEG-Asc; oral sulfate solution; OSS,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: polyethylene glycol with ascorbic acid; oral sulfate solution; bowel preparation
The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative
      kidney for transplantation and are at the risk of post transplantation rejection more than
      other transplanted patients. We evaluated the effect of simvastatin on PRA and post
      transplant outcome of these sensitized patients. We also performed a descriptive study.
    

Detailed description: 
      The presence of panel reactive antibodies (PRAs) in the sera of renal transplant candidates
      is associated with hyperacute or delayed humoral immune responses against the graft after
      transplantation .

      In addition, these sensitized patients wait for a long time to find a cross-match negative
      kidney for renal transplantation . As a result, some modalities have been used for
      desensitization including plasmapheresis and intravenous immunoglobulin (IVIG) in combination
      with immunosuppressive drugs .

      However, recently, the use of statins such as simvastatin, pravastatin and etc. has been
      proposed to be safer and more effective for desensitization .
    

Intervention name(s): simvastatin
Intervention type(s): Drug
Intervention description(s): 20 mg simvastatin daily
Intervention MeSH terms: Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal transplant; panel reactive antibody; sensitization; simvastatin; immunological
Late Onset Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The purpose of this trial is to study the effects of different combinations of antiemetics on
      the incidence of late onset postoperative nausea and vomiting.
    

Detailed description: 
      The authors will study the effect of many antiemetics on the occurrence of nausea and
      vomiting following strabismus surgery in pediatrics.
    

Intervention name(s): Placebo; Ondansetron, Dexamethasone; Midazolam, dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Saline; Use of ondansetron and dexamethasone as combined antiemetics; use of midazolam and dexamethasone as combined antiemetic
Other intervention name(s): saline; Zofran; Midazolam
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Midazolam; Ondansetron; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Postoperative nausea and vomiting; Pediatric; Strabismus; Late onset postoperative nausea and vomiting
A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic
      therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions
      (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The
      efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).
    


Intervention name(s): Infliximab
Intervention type(s): Biological
Intervention description(s): Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Other intervention name(s): Remicade, SCH 215596
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia
Condition: Osteopenia/Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score
      below pharmacologic treatment indication have limited treatment options in the prevention of
      osteoporosis/treatment of osteopenia. Further, there is a concern about long-term side
      effects of bisphosphonate treatment among young postmenopausal women, and hormone replacement
      therapy has been controversial. In a pilot study 20 microgram Calcifediol Hy.D improved
      several muscle related function in this target population within 4 months of treatment, which
      can help to prevent falls and associated bone fractures. Thus the main aim of this study is
      to test whether Calcifediol Hy.D at a daily dose of 20 μg / day improves muscle function
      (lower extremity test battery) compared with (1) placebo and compared with (2) 3200 Vitamin
      D3 IU per day, at 3 and 6 month follow-up. As a secondary and exploratory objective of this
      study, the investigators will compare the beforementioned doses on muscle strength and the
      quality of the bones, beside muscle mass, body composition and systolic and diastolic blood
      pressure measurements.
    


Intervention name(s): Calcifediol; Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): One capsule orally of Calcifediol (20 µg) per day with a meal for a duration of 6 months; One capsule orally of Cholecalciferol (3200 IU) per day with a meal for a duration of 6 months; One capsule orally of a Placebo capsule per day with a meal for a duration of 6 months
Other intervention name(s): 25-hydroxyvitamin D (Hy.D); Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcifediol; Hydroxycholecalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Local Anesthetic Treatment of Oral Pain in Patients With Mucositis
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 2

Summary: 
      Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and
      painful adverse effect caused by the radio therapy and/or chemo therapy patients with head
      and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the
      current treatment with opioids is not sufficient and can cause adverse effects.

      Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce
      the oral pain caused by mucositis compared with the current standard treatment.
    


Intervention name(s): Bupivacaine; Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg bupivacaine lozenge; Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin
Intervention MeSH terms: Acetaminophen; Lidocaine; Morphine; Gabapentin; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anesthetics, Local; Bupivacaine; Lozenge; Administration, Topical
Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of
      patients not responding to other antipsychotics will respond to clozapine. However, the use
      of clozapine is restricted due to the risk of agranulocytosis and consequently the need for
      mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in
      patients home and analyze WBC and granulocytes by a single capillary blood drop. This study
      aims to investigate whether this new procedure increases the acceptability of clozapine
    


Intervention name(s): Venous blod sample; CHEMPAQ
Intervention type(s): Device; Device
Intervention description(s): Regular venous blood sample withdrawn from the laboratory; Capillary blood sample analyzed by CHEMPAQ
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with clozapine
      
Keywords: Clozapine; hematological monitoring; CHEMPAQ; Granulocytes; WBC
Prevention of Postpartum Depression in Low-Income Women
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine whether a prevention program reduces the incidence of postpartum
      depression in pregnant women who receive public assistance and are at risk for postpartum
      depression.
    

Detailed description: 
      The impact of major depression in the postpartum period is profound, with considerable
      emotional pain for the new mother as well as disturbances in infant development.
      Unfortunately, few preventive interventions have been developed or systematically tested to
      reduce the risk of postpartum depression. An area of even greater neglect is the development
      of such an intervention for financially disadvantaged women who are at high risk for
      postpartum depression and for the disturbances associated with postpartum depression. This
      study will develop a psychosocial intervention for financially disadvantaged pregnant women
      at risk for postpartum depression.

      Participants are randomly assigned to receive either the "Life at Home with a New Baby"
      intervention or care as usual. Women who receive the intervention join a counseling group in
      which information about mother-baby relationships is shared. This information is reinforced
      with a follow-up "booster" session after the infant is born. Participants are assessed at
      baseline, after the booster session (for the intervention condition) or after 2 weeks
      postdelivery (for the care as usual condition), and at 3 months postpartum. Depression levels
      and social adjustment are measured at baseline and 2 weeks after delivery. Functional status
      is also measured. A self-report questionnaire is completed by the mothers to measure parental
      distress, parent/child dysfunctional behavior, and difficult child interactions. At 3 months
      postpartum, a brief standardized interview is used to assess the presence of a depressive
      disorder.
    

Intervention name(s): Survival Skills for Moms with New Babies
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Food Choices in Healthy Weight Women
Condition: Addictive Behavior; Food Preferences; Food Habits; Healthy; Habituation
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      This study will examine differences in habituation to foods high in sugar and fat content
      versus those that are not, in normal weight women.
    

Detailed description: 
      Participants will complete two experimental sessions, in which habituation to chocolate cake
      and dried apricots will be measured, with each session measuring habituation rate to one
      food. Upon arrival to the session, participants will write down what they have consumed and
      the minutes of physical activity they have engaged in during the previous 24 hours.
      Participants will rate their feelings of hunger and fullness using a 100mm VAS. They will
      also rank their liking of the food being used in the session using a 100mm VAS. Participants
      will be given a peanut butter flavored granola bar, containing 190 kcal, and be instructed to
      consume all of the bar.

      Next, participants will complete a computer generated task to measure habituation to a food
      (chocolate cake or apricots). The computer task will be programmed at a variable interval of
      120 ± 42 seconds (VI-120) reinforcement schedule, so that participants will be rewarded one
      point for the first response made after approximately 120s have passed. The computer task
      consists of two squares, one that flashes red every time a mouse button is pressed and
      another square that flashes green when a point is earned. The habituation phase will be 24
      minutes, divided into 12, 2-minute trials, during which participants can earn points towards
      access to 75 kcal portions of the food that is being measured. Participants will receive the
      food immediately after each point is earned to consume and can continue to play the computer
      task while eating. Participants will be instructed that when they no longer want to earn
      access to the food they can go to another table and engage in the activities provided (i.e.,
      reading magazines). After the computer task, participants will rate their feeling of hunger,
      fullness, and liking of the food. During the computer task the number of consecutive
      two-minute time blocks before responding ceases, as well as the overall pattern of
      responding, will be measured.
    

Intervention name(s): CAKE; APRICOTS
Intervention type(s): Other; Other
Intervention description(s): For the CAKE condition, participants will play a computer task to earn points for cake that they can consume.; For the APRICOTS condition, participants will play a computer task to earn points for apricots that they can consume.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery
Condition: Valvular Heart Disease; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Heart Diseases; Heart Valve Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to compare three different regimens for volume replacement during
      cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).

      Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators
      hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even
      less expensive and as safe alternative has to be shown.
    


Intervention name(s): volume replacement; Humanalbumin 5%; volume replacement
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Hydroxyethylstarch up to 50mL/kg/24 hrs; Humanalbumin 5% up to 50 mL/kg/24 hours; up 10 50mL/kg/24 hours
Other intervention name(s): Voluven; HES 130/0.4; Humanalbumin 5% Baxter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hydroxyethylstarch; Humanalbumin; Ringer Lactate; patients undergoing cardiac surgery
Regional TAP Block for Bariatric Patients
Condition: Bariatric Surgery; Transverse Abdominal Plane Regional Blocks
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese
      patients (BMI >35) undergoing laparoscopic bariatric surgery for weight loss will
      significantly reduce opioid use in the recovery room
    


Intervention name(s): Transverse abdominal plane block; Ropivacaine
Intervention type(s): Procedure; Drug
Intervention description(s): Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.; Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
Other intervention name(s): TAP
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to investigate the safety and tolerability of BI 690517
      in healthy male subjects following oral administration of multiple rising doses over 14 days
      (MRD part).

      Secondary objectives for the MRD part are the exploration of PK (Pharmacokinetic(s)),
      including dose proportionality, as well as investigation of linearity and PD
      (Pharmacodynamic(s)) of BI 690517 after multiple dosing.

      For the FE (food effect) part, the secondary objective is to investigate the relative
      bioavailability of BI 690517 under fasted conditions (Reference, R) compared to BI 690517
      (single dose) after a high fat high caloric breakfast (Test, T).
    


Intervention name(s): BI 690517; Placebo; BI 690517 (Reference); BI 690517
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily; once daily; Fasting; Non- fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Can Singing Kangaroo Improve Outcome of Preterm Infants
Condition: Neurocognitive Dysfunction; Language Development
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      To assess whether a musical intervention (maternal/paternal singing) during the skin-to-skin
      sessions (Kangaroo care) would improve the language development of the preterm infant.
      Infants will be randomized to singing or silence during the Kangaroo care from the age
      corresponding to 30th gestational week until term age (40 gestational weeks).
    

Detailed description: 
      The outcomes are:

      a 2- (3-)year neurodevelopmental follow up

      - Bayley Scales of Infant and Toddler Development, Third Edition (in Finnish in Finland and
      in Swedish in Sweden)

      At the age corresponding to term (40 gestational weeks)

        -  Auditory event related potentials (AERPs) in electroencephalography (EEG), in Helsinki
           cohort

        -  Auditory event related magnetic fields in magnetoencephalgraphy (MEG) in Karolinska
           cohort

        -  Parental stress with The State Trait Anxiety Inventory (STAI)
    

Intervention name(s): Singing
Intervention type(s): Behavioral
Intervention description(s): Infant-directed singing and singing of self-invented songs, especially songs emerging from the interaction with the infant, are especially encouraged. The families will receive audio material of children's songs, lullabies, and lyrics of the lullabies to support them if they feel unable to accomplish the task otherwise.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Kangaroo care; MEG; AERP; preterm infant
Pilot Study on the Tolerability of Dietary Dried Plum
Condition: Healthy; Elderly
Study type: Interventional

Summary: 
      Dried plums (Prunus domestica L.) have traditionally been recognized for their health
      benefits related to conditions such as constipation, irregular menstrual cycles and mouth
      sores. This dried fruit provides high levels of fiber, vitamins and minerals. Dried plum has
      also been shown in animal studies to have beneficial effects on bone and can prevent the loss
      of bone caused by low hormone levels such as occurs after surgical removal of the ovaries. We
      also have shown that dried plum can prevent the loss of bone associated with aging in mice.
      Very few therapies for osteoporosis actually reverse bone loss and improve bone strength. The
      potential therapeutic value of dried plum in men and women with hormone deficiency or
      age-related osteoporosis is clear.
    


Intervention name(s): dried plum powder
Intervention type(s): Dietary Supplement
Intervention description(s): subjects will have 25% of their diet substituted by dried plum powder
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy older people