bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer
Condition: Peptic Ulcer Hemorrhage
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion
      against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic
      endoscopy.
    

Detailed description: 
      We have previously performed a prospective randomized controlled trial on the effect of
      scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent
      bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and
      appropriate therapy performed within 24 hours after initial hemostasis.

      When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion
      after primary endoscopic therapy, we found that there was also a significant reduction in the
      rate of rebleeding, the number of operation performed and the transfusion requirement.

      Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding
      after successful endoscopic hemostasis. A recent cost-effective analysis on various
      strategies showed that selective scheduled second endoscopy strategy was probably the most
      effective and least expensive to prevent recurrent peptic ulcer bleeding.

      We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs
      scheduled second endoscopy on the management of bleeding peptic ulcers.
    

Intervention name(s): Intravenous omeprazole infusion; Scheduled second endoscopy
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Peptic ulcer hemorrhage; Omeprazole; Scheduled second endoscopy
Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
Condition: Preterm Infant; Effect of Drugs; Zinc Deficiency Disease
MeSH terms: Deficiency Diseases; Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Zinc (Zn) is a structural component of human body and is a crucial element for a wide
           variety of cascades that take place in almost all organ systems.

        -  Due to many reasons, preterm infants are generally believed to be naturally in a
           negative Zn balance during the early periods of life.

        -  Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.

        -  There still is a lack of knowledge in the possible relation of Zn deficiency and
           development of NEC and/or feeding intolerance in preterm infants.

        -  Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis
           and found to reduce treatment failure in these high risk population, data in preventing
           infectious diseases in preterm infants is still lacking.
    

Detailed description: 
      Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally
      believed to be in a negative Zn balance in the early period of life. In this study, we aimed
      to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW)
      infants on feeding intolerance and development of mortality and/or morbidities including
      necrotizing enterocolitis (NEC), late-onset sepsis (LOS).

      Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of
      <32 weeks were randomly allocated on the seventh day of life to receive extra amount of
      supplemental zinc along with the enteral feedings or not, besides regular low dose
      supplementation, from enrollment until discharge. Outcome measures were feeding intolerance,
      NEC (stage≥2), LOS and mortality.
    

Intervention name(s): Zinc Sulfate
Intervention type(s): Drug
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 4

Summary: 
      Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but
      the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among
      these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected
      morphine.
    

Detailed description: 
      Forty parturients underwent elective cesarean section under spinal anesthesia were divided
      into two groups of 20 each in this prospective randomized study. Group I received 100 µg of
      intrathecal morphine (ITM) mixed with 12 mg of 0.5% heavy bupivacaine (M100) while group II
      received 200 µg of ITM mixed with 12 mg of 0.5% heavy bupivacaine (M200). Two blood samples
      were taken from each patient for serotonin estimation, preoperatively and 4 hrs later.
      Postoperatively all patients were assessed for pruritus (incidence & severity), visual analog
      scale (VAS), first request of analgesia, and total analgesic dose required within 24 hrs.
    

Intervention name(s): Morphine 100 μg; Morphine 200 μg
Intervention type(s): Drug; Drug
Intervention description(s): Intrathecal injection of morphine100 μg; Intrathecal injection of morphine 200 μg
Other intervention name(s): M100; M200
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: morphine, pruritus, serotonin
Morning Light Treatment at Home to Reduce PTSD Symptoms
Condition: PTSD
Study type: Interventional

Summary: 
      There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive
      retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain
      implicated in PTSD. Thus, a self-administered morning light treatment at home (shifts clock
      earlier and stimulates ipRGCs) may be a potentially efficacious adjunctive strategy for
      reducing PTSD symptoms. This study will test a 4 week daily 1 hour morning light treatment
      (active vs placebo) in individuals with PTSD. Outcome measures include measures of PTSD and
      depression.
    


Intervention name(s): Retimer; Retimer placebo
Intervention type(s): Device; Device
Intervention description(s): The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.; The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients
Condition: Pressure Sores; Intensive Care
MeSH terms: Pressure Ulcer; Critical Illness
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether the addition of omega-3 and antioxidants
      to nutritional support in critically ill patients in the intensive care unit influences the
      immune and anti-inflammatory systems and so improves wound healing.
    

Detailed description: 
      A prospective randomized study to include 40 consecutive patients admitted to the general
      intensive care unit. The control group will receive nutritional support composed of a
      standard formula. The study group will receive nutritional support enriched with fish oil and
      anti-oxidants. The following variables will be assessed in all patients: demographics,
      severity of illness, assessment of bed sores. Blood tests will also be taken for the
      following: CD 8, CD 14, CD 18, CD 11a, CD49c, CD 49d. In addition, blood samples will be
      collected for TNF, IL-1b, IL-6, IL-8, and levels of C-reactive protein. Metabolic parameters
      such as resting energy expenditure, BMI, albumin, prealbumin, levels of zinc, relationship
      between omega 3 and omega 6. Theses test will be performed at time of ICU admission, days 7,
      14 and 28 after admission.

      The outcome: improved repair of pressure sores, together with improvement in objective
      parameters of immunity and inflammation.
    

Intervention name(s): Eicosapentanoic acid, docosahexaenoic acid
Intervention type(s): Dietary Supplement
Intervention description(s): Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid
Other intervention name(s): OXEPA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intensive care; critically ill; fish oil; pressure sores
Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain
Condition: Ankle Sprains
MeSH terms: Emergencies; Sprains and Strains; Ankle Injuries
Study type: Observational

Summary: 
      Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often
      causes pain, a temporary period of disability and can results in recurrence and chronic ankle
      instability. Therefore, an early management and follow up treatment is necessary. Now,
      functional treatment is clinically the treatment strategy of choice for ankle sprain. It is
      based on rest, ice, compression, elevation and can use a functional support (like an ankle
      brace). To evaluate gravity and improve management, a clinical assessment delayed between 4
      and 5 days post injury is necessary.
    


Intervention name(s): questionnaires
Intervention type(s): Other
Intervention description(s): 6 weeks after the trauma,during the call, an oral questionnaire will be proposed to collect data on patients' management since they have left the emergency department.
After the call, socio-demographic characteristics, trauma mechanism, medics management will be extracted from the patient's medical records
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who consulted at Tourcoing emergency department for an ankle sprain
      
Keywords: inversion trauma; Ankle sprain; physical examination; therapy; recurrence
Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents
Condition: Pregnancy; Sexually Transmitted Infections; Automobile Accidents
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to measure the effects of an interactive video on adolescent
      risky behaviors and outcomes, with one video intended to reduce teen pregnancies and the
      other intended to reduce automobile accidents.
    

Detailed description: 
      Motor vehicle crashes cause one-third of teenage deaths and many serious injuries. Teen
      drivers ages 16 to 19 are four times more likely than older drivers to crash. Death and
      injuries could be reduced with a change in behaviors that include improved visual and
      attention skills while driving, more seat belt use, appropriate speed control, and not
      combining drinking or texting with driving. Sexually transmitted infections (STIs) and
      unplanned pregnancies are particularly common among adolescents. The U.S. adolescent
      birthrate is by far the highest among industrialized nations. These problems can be decreased
      by less sexual activity and better protection.

      This study uses a randomized controlled trial to measure how well interactive video
      interventions can reduce these common risks to adolescents. Adolescent females will be
      invited to participate if they are currently seeking care at a participating clinic. They
      will answer survey questions about their driving and sexual behaviors, and then a computer
      will determine whether they will be given a video about driving or a video about sexual
      behavior. Participants will have unlimited access to their video, which they can watch at
      their clinic or from any Internet-enabled computer, and will be followed for 6 months.
    

Intervention name(s): Seventeen Days; Driving Skills for Life
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interactive video includes highlighting salience of active choices in sexual decision making, modeling different responses to sexual situations, cognitive rehearsal of preventive behaviors, and information about hormonal and non-hormonal contraception; Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pregnancy prevention, condom use, self efficacy
Relative Bioavailability of Different Formulations of BI 671800 in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the oral bioavailability and rate of absorption of two different formulations of
      BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without
      EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA
      formulations were further investigated concerning food effect and one of the two BI 671800
      HEA formulations identified by interim pharmacokinetic analysis was further investigated
      concerning dose proportionality with 50 mg.
    


Intervention name(s): BI 671800 HEA, 200 mg tablets; BI 671800 HEA EC, 200 mg tablets; BI 671800 HEA, 50 mg tablets; BI 671800 ED, 100 mg capsules; Standard meal
Intervention type(s): Drug; Drug; Drug; Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of treatment with
      sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the
      sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability
      data.

      In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed
      to monitor the degree and the duration of action in a single use of Flumazenil.
    


Intervention name(s): Flumazenil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration; Placebo - only excipients with no API
Other intervention name(s): Romzicon,; Anexate®,; BRN 4763661,; Flumazenilo (Spanish),; Flumazenilum (Latin),; Flumazepil; Lanexat®,; Mazicon®,; Ro 151788,; Ro-15-1788,; Romazicon®,; UNII-40P7XK9392
Intervention MeSH terms: Flumazenil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Regular Consumption of High Phytate Reduces Inhibitory Effect of Phytate on Iron Absorption
Condition: Iron Bioavailability
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether regular consumption of phytate dampens
      its negative effect on nonheme iron absorption.
    

Detailed description: 
      Phytate is one of the main inhibitors of nonheme iron absorption. High phytate consumption is
      of concern in developing countries because of the high prevalence of iron and zinc deficiency
      in these countries. In this study, we investigated the effect of habitual consumption of a
      high phytate diet on the inhibitory effect of phytate on nonheme iron absorption. Thirty-two
      non-anemic female subjects with ferritin ≤ 30µg/L were randomized into two groups, after
      matching for ferritin concentration. Each group consumed either high or low phytate foods
      that were provided for 8 wk. Iron bioavailability from a high phytate test meal was measured
      using area under the curve (AUC) for serum iron at baseline and after the intervention.
    

Intervention name(s): High phytate intake; Low phytate intake
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Iron bioavailability; phytate; serum iron curve; hepcidin; iron status
Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility and effectiveness of
      Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with
      Obsessive-Compulsive Disorder (OCD).
    

Detailed description: 
      The primary objective of this study is to investigate if Internet-delivered Cognitive
      Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with
      Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16
      participants. The treatment duration is 12 weeks. The primary outcome measure is the
      Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be
      followed up 3 months after treatment.
    

Intervention name(s): Internet-delivered Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): The treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets
      on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an
      extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered
      naltrexone 4.8 mg.
    

Detailed description: 
      Bioavailability
    

Intervention name(s): ALO-02 (Oxycodone Naltrexone); ALO-02 (Oxycodone Naltrexone); ALO-02 (Oxycodone Naltrexone)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of ALO-02 capsule under fasting condition; single dose of ALO-02 capsule under fed condition; ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Food effect; bioavailability; oxycodone; sequestered Naltrexone; management of moderate to severe pain
Battlefield Acupuncture for Low Back Pain
Condition: Low Back Pain; Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of Battlefield Acupuncture (BFA) on
      outcomes for pain, sleep, and physical activity level in an active duty military sample with
      subacute or chronic lower back pain (LBP). BFA is a form of auricular acupuncture (AA) that
      has been implemented in many Department of Defense (DoD)/Veterans Affairs (VA) medical
      settings to alleviate acute or chronic pain. BFA uses five predetermined locations in a
      defined sequence to place semi-permanent needles in the ear. Subacute lower back pain is pain
      that has persistently lasted from four to twelve weeks. Chronic lower back pain is pain that
      lasts more than 12 weeks.

      Hypothesis 1: Participants with subacute or chronic LBP will have reduced pain using BFA as
      compared to placebo.

      Hypothesis 2: Participants with subacute or chronic LBP will have improved physical activity
      using BFA as compared to placebo.

      Hypothesis 3: Participants with subacute or chronic LBP will have improved sleep quality as
      compared to placebo.

      The secondary study aims are:

        1. To explore the effects of BFA two weeks following the treatment for LBP.

             1. Do positive outcomes appreciated with BFA persist over two weeks?

             2. What is the pain medication usage during and after intervention treatments?

        2. To explore the effectiveness of BFA on trunk flexion mobility and balance.

             1. Does pain reduction improve trunk flexion and balance?

             2. Does improved truck flexion mobility and balance contribute to increased physical
                activity?
    


Intervention name(s): Auricular Acupuncture; Sham Treatment
Intervention type(s): Other; Other
Intervention description(s): Up to five small ASP needles placed in each ear until pain is reduced to 1/10.; Laser pointer pointed at the ear, but not turned on.
Other intervention name(s): Battlefield Acupuncture (BFA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Regulatory Post Marketing Surveillance Study on Nexavar®
Condition: Carcinoma, Hepatocellular; Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Study type: Observational

Summary: 
      This surveillance are to identify problems/questions regarding adverse events, factors that
      are considered to affect on safety and efficacy in the clinical practice of using Nexavar
    

Detailed description: 
      The objectives of this surveillance are to identify problems/questions regarding the
      followings in the clinical practice of using Nexavar®.

        1. Unknown adverse events (in particular, serious adverse events)

        2. Identification of adverse events occurred in the real practice.

        3. Factors that are considered to affect on safety.

        4. Factors that are considered to affect on effectiveness
    

Intervention name(s): Sorafenib (Nexavar, BAY43-9006)
Intervention type(s): Drug
Intervention description(s): Daily dose, dosage frequency and duration will be decided by physicians.
Intervention MeSH terms: Sorafenib
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with diagnosis of advanced renal cell carcinoma or hepatocellular carcinoma and
        decision taken by the physician to precribe Nexavar
      
Keywords: Carcinoma, Hepatocellular; Carcinoma, Renal Cell
755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars
Condition: Benign Pigmented and Vascular Lesions and Scars
Study type: Interventional

Summary: 
      Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign
      pigmented and vascular lesions and scars
    


Intervention name(s): 755nm Alex laser
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment