bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study represents the first investigation of anrukinzumab in patients with active
      ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism
      based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and
      hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics
      (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
    


Intervention name(s): Anrukinzumab; Anrukinzumab; Anrukinzumab; placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): 200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12; 200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12; 200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.; 200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Other intervention name(s): PF-05230917; PF-05230917; PF-05230917
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Active Ulcerative Colitis; Phase 2A; Double-blind; Randomized; PK/PD Biomarker Study
Maternal Oxygen Administration for Fetal Distress
Condition: Oxygen Inhalation Therapy; Second Stage of Labour; Fetal Distress
MeSH terms: Fetal Distress
Study type: Interventional

Summary: 
      Supplementary oxygen is routinely administered to patients, even those with adequate oxygen
      saturations, in the belief that it increases oxygen delivery. However, oxygen delivery
      depends not just on arterial oxygen content but also on perfusion.

      Maternal oxygen administration has been used in an attempt to lessen fetal distress by
      increasing the available oxygen from the mother. However, the effect of supplemental maternal
      oxygen therapy on fetal acid base status has been debated for more than seven decades.

      Hypothesis: Prophylactic maternal low flow nasal oxygen administration during the second
      stage of labor can relieve fetal distress.
    

Detailed description: 
      A report from the cochran library (Cochrane Database Syst Rev. 2012 Dec 12;12:CD000136.):

      Too little evidence to show whether oxygen administration to the woman during labour is
      beneficial to the baby.

      Some babies show signs of distress, such as unusual heart rates or the passing of a bowel
      motion (meconium) during their mother's labour. This may be caused by a lack of oxygen
      passing from the woman to the baby through the placenta. Sometimes, women may be encouraged
      to breathe extra oxygen through a facemask (oxygen administration) to increase the oxygen
      available to the unborn baby. A review of two trials found too little evidence to show
      whether oxygen administration to the woman during the second stage of labour is beneficial to
      the baby. No trials of oxygen administration when the baby is showing signs of distress were
      found. Further research is needed.
    

Intervention name(s): Low flow nasal oxygen; Low flow room air
Intervention type(s): Device; Device
Intervention description(s): Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery; Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, comparative randomized controled trial. The general purposes of this
      study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for
      female urinary stress incontinence.
    


Intervention name(s): TVT-O; TVT-S
Intervention type(s): Device; Device
Intervention description(s): Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).; Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
Other intervention name(s): TVT-O™ (Gynecare™, USA).; TVT-Secur™ (Gynecare™, USA).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: TVTO; TVTSecur; Mini sling; stress urinary incontinence
ET-blockade and Exercise Induced Blood Flow in T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to establish the effect of ET blockade on the acute exercise
      induced blood flow and endothelial function in subjects with T2DM. We hypothesize that
      combining ET - blockade with exercise training leads to an acute increase of exercise induced
      blood flow when compared with exercise alone. We expect that this will lead to an
      optimization of vascular training effect in T2DM.
    


Intervention name(s): Bosentan; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Tracleer; actelion pharmaceuticals; 125 mg oral dose; actelion pharmaceuticals; 125 mg oral dose
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: diabetes; endothelial function; exercise; blood flow; bosentan
Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH
Condition: Post Partum Haemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral,
      is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum
      period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum
      hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal
      delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when
      blood loss arose within 24 hours after birth.
    

Detailed description: 
      This trial includes three arms of treatment :

        -  arm A (IMP1Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5
           minutes from the delivery(third stage af labor)

        -  arm B (IMP2Control): OXY 5 IU/ml/ 2 vials (10 International Unit) intramuscularly within
           5 minutes from the delivery (third stage af labor) The clamping of the umbilical cord
           will be executed immediately after birth.

      The randomization 1:1 (block design), generated by the computer.

      Primary outcomes: assessment of total blood loss expressed in mL:

        -  immediately after delivery

        -  two hours after delivery

      The measurement of the overall blood loss at delivery (ml) will be performed by the graduated
      bag, immediately after birth.

      The measurement two hours after delivery will be performed by weighing of the adsorbent
      material [ N.ml = N. gr indicated by the balance - dry weight of the sanitary napkin]. The
      overall loss in blood measured (ml) two hours of delivery will then be performed by adding
      the two collections.
    

Intervention name(s): Tranexamic Acid; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): 2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor); 2 vials (=10 IU/International Unit) of Oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
Other intervention name(s): TXA; OXY
Intervention MeSH terms: Tranexamic Acid; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TXA; PPH
Are Character Building Lessons Effective in Decreasing Bullying Behaviors?
Condition: Aggression
MeSH terms: Aggression; Bullying
Study type: Interventional

Summary: 
      Through the use of an educational intervention, the object of this study is to reduce the
      prevalence of bullying behaviors among fifth grade school age children. Bullying behaviors
      promote an environment of violence , fear, and hostility. The study will arrange to present
      six character education lessons in the classroom of fifth grade students in a New York City
      public school. Questionnaires will be administered to the students before and after all the
      lessons have been completed. Questionnaires will collect information about the students self
      perception of their levels of misconduct, impulsivity, confidence, value of non violence,
      ways of handling anger, opinions of their leadership behaviors, prevalence of bullying
      behaviors, and indications of levels of self esteem. Also, their fifth grade teachers will
      complete pre and post treatment student behavioral questionnaires.
    

Detailed description: 
      This is a 2 X 2X 2 research design that will study the constructs of self esteem, leadership
      skills, and prevalence of bullying among a fifth grade school age population. Before data
      collection, a letter describing the study along with an informed consent sheet, will be
      mailed to the student's parent/guardian. The written material will state that their child
      participation is not mandatory. A 48 item likert style questionnaire pre-treatment,
      post-treatment survey design will be administered to students. Basic demographic questions
      will also be asked about.

      All fifth graders will be given questionnaires before they receive the six classroom lessons
      of 45 minutes duration and then after all the six lessons have been completed. Lessons will
      be offered on a weekly basis. The fifth graders will be divided into small groups of
      approximately 10 individuals. The lessons will be delivered by baccalaureate nursing students
      in their last semester of college. The groups will be formed at the beginning and membership
      will remain consistent to enhance development of trust and ease of authentic communication.
      The lessons will be selected from the program, Overcoming Obstacles, a formal educational
      program designed to assist students to communicate well and set meaningful goals for their
      lives. In addition, the classroom teachers will be asked to complete a 14 item likert style
      pre-treatment, post-treatment, both before and after the six lessons about their opinions of
      each student's behaviors pattern.

      A statistician is a co-investigator and will identify the type of statistical analysis to be
      done.
    

Intervention name(s): Six classroom based character building education lessons
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Classroom violence, character, bullying, self esteem
Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional

Summary: 
      Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral
      rehydration therapy is the key treatment. According to the 2014 guidelines developed by the
      ESPGHAN probiotics may be considered in the management of children with AGE in addition to
      rehydration therapy. Considering that evidence on L reuteri remains limited, the
      investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in
      children. Children vaccinated and not vaccinated against rotavirus will be evaluated
      separately.

      Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
    


Intervention name(s): Lactobacillus reuteri DSM 17938; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus reuteri DSM 17938 vs Placebo; Lactobacillus reuteri DSM 17938 vs Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations:
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The main purpose is to compare overall alignment time (OAT) in days in alleviating mandibular
      incisors crowding between control group and MOPs group.Furthermore, to investigate the
      presence of volumetric root resorption from CBCT, gingival recession and formation of black
      triangle post lower labial segment alignment between micro-osteoperforations group and
      control group.
    

Detailed description: 
      Prolonged treatment time in orthodontics is an undesirable side effect for both the patient
      and clinician. Usually, an average course of comprehensive orthodontic treatment with fixed
      appliances requires less than 2 years to complete (19.9 months). This prolonged treatment
      time may cause adverse effects such as root resorption, gingival recession, caries & enamel
      demineralization. Micro-osteoperforations is safe, minimally invasive technique which
      perforations are performed through the gum tissues, penetrating the bone without the need to
      raise a ﬂap.Control group will not received any MOP and will receive standard orthodontic
      treatment.
    

Intervention name(s): Micro-osteoperforations
Intervention type(s): Device
Intervention description(s): MOPs will be performed using SIA Excalibur Mini-Implant with dimension 1.6 mm in width and length of 6 mm, screw 3 mm depth into buccal bone of intervention sites
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the MOP group until the completion of lower labial segment alignment (LLS), which is when the LII scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine. At the end of alignment stage, the date for completion of alignment was recorded (T2), from which the overall alignment time (OAT) in days, required to complete LLS alignment, were calculated. Measurements were done clinically using an electric digital caliper. At this point, perforations were stopped. Gingival recession and black triangle were then recorded and measured. Patients were referred for CBCT images to evaluate for root resorption.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: micro-osteperforation; orthodontic tooth movement; treatment duration
The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
Condition: Mycobacterium Avium-intracellulare Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; Mycobacterium Infections; Mycobacterium avium-intracellulare Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium
      complex (MAC) infection who are receiving concurrent antiretroviral therapy.

      Before more extensive evaluation of this promising drug for treatment of MAC infection in
      children can be done, it is important to study the pharmacokinetics of this drug in this
      population, to get information regarding its use in pediatric patients receiving currently
      available antiretroviral drugs, and to get information on the antimycobacterial activity of
      this drug.
    

Detailed description: 
      Before more extensive evaluation of this promising drug for treatment of MAC infection in
      children can be done, it is important to study the pharmacokinetics of this drug in this
      population, to get information regarding its use in pediatric patients receiving currently
      available antiretroviral drugs, and to get information on the antimycobacterial activity of
      this drug.

      Patients that are included are HIV infected and have started zidovudine (AZT) or didanosine
      (ddI) at least 4 weeks before entry into this study. Patients continue taking the medications
      at prescribed doses. In addition they also take clarithromycin. Patients continue treatment
      with AZT or ddI plus clarithromycin for 12 weeks.
    

Intervention name(s): Clarithromycin; Zidovudine; Didanosine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Clarithromycin; Zidovudine; Didanosine
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Mycobacterium avium-intracellulare Infection; Didanosine; Drug Evaluation; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Zidovudine
A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the levels of study drug called LY3502970 in
      the blood stream when administered alone and in combination with clarithromycin in healthy
      participants. This study will last up to approximately 85 days for each participant.
    


Intervention name(s): LY3502970; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Intervention MeSH terms: Clarithromycin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Argatroban Plus R-tPA for Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of
      morbidity, mortality and disability. A large number of studies have confirmed that the
      thrombolytic therapy can effectively open blood vessels and improve the functional prognosis
      of acute ischemic stroke. Therefore, all guidelines recommend intravenous thrombolysis as the
      first treatment of ischemic stroke patients within 4.5 hours of onset. However, about 1/3
      patients receiving thrombolysis will have good prognosis, while a large number of patients
      will still be disabled and even dead. How to improve the neurological prognosis of
      thrombolytic patients has been a hot topic in the world.

      Recent studies have found that the combined application of argatroban and rt-PA in the
      treatment of AIS might improve the clinical prognosis and not significantly increase
      bleeding. Some studies have reported that the combined application of argatroban and rt-PA
      could improve the blood vessel opening rate, and prevent re-occlusion after opening.

      Based on the discussion, the present study is designed to explore the efficacy and safety of
      argatroban plus rt-PA in the treatment of AIS.
    


Intervention name(s): rt-PA; Argatroban
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous throbolysis with 0.9mg/kg rtPA; 100 ug/kg bolus over 3 to 5 minutes was administered intravenously, followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%)
Intervention MeSH terms: Argatroban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger
Condition: Dermatofibrosarcoma Protuberans
MeSH terms: Dermatofibrosarcoma
Study type: Interventional

Summary: 
      The purpose of this proposed study is to assess effectiveness of MOHS micrographic surgery as
      a form of treatment for dermatofibrosarcoma protuberans in patients who are 10 years of age
      or younger through review of the patients at Mayo Clinic treated from 1988-2017, and to
      explore the challenges that providers face which may prevent them performing this potentially
      superior treatment. This study will provide a comparison of outcomes and recurrence rates in
      pediatric patients treated by MOHS versus traditional excision.
    


Intervention name(s): MOHS micrographic surgery; Wide local excision
Intervention type(s): Procedure; Procedure
Intervention description(s): Mohs surgery is a precise surgical technique used to treat skin cancer. Thin layers of cancer-containing skin are progressively removed and examined microscopically until only cancer-free tissue remains.; A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment