bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet
Condition: High Risk Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center,
      crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of
      rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs
      AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy
      Volunteers. The study will be performed at a single study center.
    

Detailed description: 
      The study will comprise:

        -  A Screening period of maximum 28 days;

        -  Five treatment periods during which subjects will be resident from the morning on the
           day before dosing with the IMP (Day -1) until at least 48 hours after dosing; discharge
           will be on the morning of Day 3, and

        -  A Follow-up Visit within 7 to 10 days after the last administration of the IMPs.

        -  There will be a minimum of a 7 days washout between each treatment period.

      Each subject will receive 5 treatments. The following treatments will be given:

        -  Treatment A: 10 mg rosuvastatin tablet alone (fasting state)

        -  Treatment B: 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet)
           (fasting state)

        -  Treatment C: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)

        -  Treatment D: 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state)

        -  Treatment E: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state)

      Each subject will be involved in the study for approximately 8 weeks.
    

Intervention name(s): AZD5718 IR tablet; AZD5718 oral suspension; Rosuvastatin tablet
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics (PK); Bioavailability (BA); Safety; Tolerability; Healthy Volunteers
School- and Home-Based Early Intervention for Toddlers With Autism
Condition: Autistic Disorder; Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      This study will determine the impact of early intervention on the communication and social
      development of toddlers with autism.
    

Detailed description: 
      Autism is a condition that affects brain development, often leading to difficulties in
      social, emotional, and educational functioning. This study will determine whether early
      intervention can improve such functioning in toddlers with autism.

      Each treatment session will last 6 months. Children with an autism spectrum disorder will be
      enrolled in one of two parallel classes and will receive one of two treatments 4 days a week
      for the duration of the session. Children in each class will receive the same amount and
      level of intervention, but with a different goal focus. Treatments will be school- and
      home-based; parents will receive instruction on administering the at-home part of the
      treatment. The intervention will include environmental engineering, developmental approaches,
      adaptations of traditional behavioral approaches, and contemporary behavioral approaches that
      apply principles of applied behavior analysis in more naturalistic teaching frameworks. A
      series of measures including scales, interviews, and observations will be used to assess the
      children at baseline, study completion, and 6 months after study completion. The children
      will be videotaped during the school-based intervention.
    

Intervention name(s): Early intervention blending several tx approaches, w/ focus; Early intervention blending several treatment approaches
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Early intervention blending several different treatment approaches, with a focus on certain skills; Early intervention blending several different treatment approaches
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Condition: Polycystic Ovarian Syndrome; Vitamin D Deficiency
MeSH terms: Polycystic Ovary Syndrome; Vitamin D Deficiency; Syndrome
Study type: Interventional

Summary: 
      The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium
      (Ca) supplementation in overweight (BMI > 27) premenopausal women diagnosed with Polycystic
      Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient
      in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels < 20 ng/mL).
    

Detailed description: 
      We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3,
      as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of
      calcium, both per oral (PO), over a three month period will improve their metabolic picture,
      and possibly hormone profile.

      Over the course of the trial, after the first 5 subjects had completed 3 month
      intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing
      vitamin D status in the study population; the dosing regimen was therefore modified to
      include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.
    

Intervention name(s): Vitamin D2 (Ergocalciferol); Medroxyprogesterone (Provera); Vitamin D3 (Cholecalciferol); Elemental Calcium
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months); 10mg, PO, daily for ten days; 2,000IU (or 2 tablets), PO, daily (supplements taken for three months); 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Medroxyprogesterone Acetate; Medroxyprogesterone; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Remediation for HIV-associated Neurocognitive Dysfunction
Condition: HIV-associated Neurocognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study is a validation study to document the acceptability of the revised
      Plasticity-based Adaptive Cognitive Remediation (PACR) program to patients with
      HIV-associated Neurocognitive Dysfunction (HAND). The primary objective of this study is to
      evaluate the effects of the revised PACR program on the cognitive abilities (e.g., attention,
      executive function), functional status and quality of life of individuals diagnosed with
      HAND. The secondary objective of the study is to collect relevant data to support a
      pre-investigational device exemption (IDE) submission to the FDA required before the pivotal
      randomized, controlled trial planned for Phase II.
    


Intervention name(s): Computerized plasticity-based adaptive cognitive training
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating Public Enthusiasm for Mammography Screening in Denmark
Condition: Breast Neoplasm Female; Mammography Screening; Decision Making; Information Seeking Behavior
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Based on an American study by Scherer et al., it is hypothesized that some women will make
      irrational choices regarding their participation in mammography screening. Therefore, the aim
      is to estimate the prevalence of Danish women having an irrational preference for mammography
      screening even when it confers no benefits, but only harms.
    

Detailed description: 
      The prevalence of women making an irrational decision will be compared to the participation
      rate in the Danish screening program. The study population will consist of a random sample of
      women aged 44-49. Similar to the American study, two types of information will be compared
      (detailed vs. non-detailed information about the harms of screening). Participants will be
      randomised to one of two information groups. Based on the American study, it is assumed that
      the willingness to participate in the hypothetical screening program will be 40 percent. To
      achieve the desired precision in this study, a standard error of 2.5 percent is required
      corresponding to a confidence interval spanning approximately 35-45 percent. This will
      require 384 women in each group, corresponding to a total study population of 768. The survey
      will be sent electronically (using "e-Boks") with a link to access the online survey trial.
      The survey will consist of screening and cancer related questions as well as questions on
      age, education, and health literacy. Five questions on appraisal of health information from
      the Health Literacy Questionnaire will also be included. After the data collection, data will
      be linked to data on income, residence, civil status, education, breast cancer diagnosis, and
      information on whether a participant is immigrant, descendent or of Danish origin.

      The original plan for the main analysis was to compare the two groups of women randomized to
      different information groups (detailed vs. non-detailed information about the harms of
      screening). However, due to lower participation rate and therefore smaller sample size than
      expected, information group was disregarded in the main analysis. The two groups will still
      be compared in a secondary analysis. This decision was made before getting access to data
      from the questionnaire.
    

Intervention name(s): Information about hypothetical mammography screening without benefits
Intervention type(s): Behavioral
Intervention description(s): We will present an online questionnaire with two types of information on the harms of screening. Then we will compare the prevalence of irrational decisions in the two arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Breast cancer; Mammography screening; Decision Making; Information Seeking Behavior
Study of the Chinese Prescription Weiqi Decoction on Chronic Atrophic Gastritis
Condition: Gastritis
MeSH terms: Gastritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription
      Weiqi decoction on Chronic Atrophic Gastritis.
    


Intervention name(s): Weiqi decotion
Intervention type(s): Drug
Intervention description(s): Decoction ,two times a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic atrophic gastritis; Traditional Chinese Medicine
Objective Assessment of Physical Activity in Before-school Physical Activity Programs
Condition: Physical Activity; Sleep
Study type: Interventional

Summary: 
      This study will determine the effectiveness of a free before-school physical activity
      program, BOKS (Build Our Kids' Success), in increasing objectively measured physical activity
      levels among children in elementary and middle school in 7 schools in Massachusetts.
    

Detailed description: 
      This study will determine the effectiveness of a free before-school physical activity
      program, BOKS (Build Our Kids' Success), in increasing objectively measured physical activity
      levels among children in elementary and middle school in 7 schools in Massachusetts. The
      study focuses on capturing valid and objective assessments of student-level physical activity
      during BOKS program time and assessing the impact of the BOKS program on overall daily
      physical activity levels using minute-by-minute physical activity level data among elementary
      aged students. Data is also collected to understand how increasing physical activity may
      impact students' sleep.
    

Intervention name(s): Before School Physical Activity Program
Intervention type(s): Behavioral
Intervention description(s): BOKS is a before school physical activity program offered at no cost to participating families that focuses on engaging elementary and middle school students in physical activity, skill development and brief nutrition education sessions that prepare them for a day of learning. The BOKS curriculum includes 12 weeks of instruction and 40 minutes of structured kid-friendly activities that include warm-ups, skill of the week, running, relay and obstacle course activities and nutritional tips. The BOKS team provides training for BOKS leaders free of charge each month. BOKS is currently being used in more than 1,800 schools in the US and Canada.
Other intervention name(s): Build Our Kids Success (BOKS)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pectoralis and Serratus Muscle Blocks
Condition: Post Operative Pain Control
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall
      Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 20% reduction on
      geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the
      minimal clinically important benefit.
    

Detailed description: 
      The primary aim is to determine whether a PECS/SAP block, using a mixture of bupivacaine and
      liposomal bupivacaine, provides superior recovery compared to routine parenteral and enteral
      analgesia in patients recovering from MICS. The primary outcome will be the simple
      multi-dimensional quality assessment, Overall Benefit Analgesia Score (OBAS score).53 Our
      secondary aims are to: 1) compare cumulative postoperative opioid consumption (pain
      medications administered over one-day periods quantified as morphine equivalents and provided
      by the EMR for the day of surgery and postoperative days 1, 2, and 3; 2) evaluate respiratory
      mechanics (forced expiratory volume in first minute (FEV1), forced vital capacity (FVC) and
      peak flow) after extubation on the postoperative days 1, 2 and 3 while patients remain
      hospitalized; and, (3) evaluate the Quality-of-Recovery-15 score on the postoperative days 1,
      2 and 3.
    

Intervention name(s): Exparel 266 MG Per 20 ML Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The local anesthetic (LA) used for the PECS II or serratus plane blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Treatment patients will also be given liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc. San Diego, CA) in a dose of 266 mg in 20 ml can be safely combined with bupivacaine HCL at a ratio not exceeding 2:1, but cannot be combined with other local anesthetics due to the concern of rapid release of encapsulated bupivacaine and subsequent local anesthetic toxicity.; Patients randomized to standard analgesia technique will be given pain medications.
Other intervention name(s): Pectoralis and Serratus Muscle Blocks; Standard analgesia technique (control, NO PECS /SAP blocks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
OMT as an Adjunctive Treatment in MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      participants will be receiving OMT 1x/week for 8 weeks. Each appointment with be a duration
      of 30 minutes. Patients will be required to fill out PHQ-9 and SSS-8 questionnaires before
      beginning the study and following the conclusion of the study.
    

Detailed description: 
      Individuals will receive weekly OMT for a duration of 8 weeks. Primary assessment will be
      performed on initial visit, making note of the most severe somatic restrictions, but highest
      priority will be given to cervical and shoulder regions (most tension is noted here in
      patients with MDD). Focusing on only the cranial, cervical, and shoulder regions will allow
      for a more standardized approach to treatment.

      Osteopathic manipulative treatment (OMT) is the manipulation of tissues (muscles, joints,
      fascia, etc.) that is used to help restore movement and function throughout the body by a
      combination of stretching, gentle pressure, and resistance. The techniques we have chosen to
      use will focus primarily on muscle and fascia in the cranial, cervical, and shoulder regions.

      Cranial techniques used include:

      Suboccipital release - this helps to relieve muscle and fascial tension surrounding the head
      and neck, patient is supine, physician places finger pads below occipital protuberance at the
      base of the occiput as patient's relaxes head and lets it rest on physician's finger pads,
      position is held until softening of musculature is felt

      Vault hold - helps to restore cranial motion, patient is supine, physician places index
      finger on greater wing of sphenoid, middle finger on squamous portion of temporal bone, ring
      finger on mastoid process of temporal bone, and pinky finger on squamous portion of occipital
      bone, hands remain in this position to monitor cranial motion and determine if there is a
      dysfunction

      They will NOT be performing any high velocity low amplitude (HVLA) techniques, which requires
      a rapid, therapeutic force within the motion of the joint (this is the technique that is
      often responsible for the "cracking" or "popping")
    

Intervention name(s): Osteopathic Manipulative Treatment
Intervention type(s): Procedure
Intervention description(s): Individuals will receive the following techniques during weekly OMT (osteopathic manipulative techniques) for a duration of 8 weeks: 1. Suboccipital release 2. Vault hold. 3. Soft tissue techniques at the cervical and shoulder region 4.There will be NO high velocity low amplitude (HVLA) techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting
Condition: Postoperative Nausea
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      optimal postoperative pain control with intrathecal morphine, with proper prevention of
      postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection
      against nausea and vomiting.
    

Detailed description: 
      One of the gold standards for analgesia following cesarean delivery is intrathecal morphine,
      which is not devoid of complications namely postoperative nausea and vomiting. We evaluated
      the antiemetic effect of intravenous dexamethasone combined with intrathecal atropine after
      cesarean delivery under spinal bupivacaine plus morphine anesthesia.
    

Intervention name(s): Intrathecal atropine; dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): 100ug intrathecal atropine will be injected with spinal anesthesia; intravenous 8 mg dexamethasone (2ml).
Intervention MeSH terms: Dexamethasone; Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative Nuasea
A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy
      subjects
    


Intervention name(s): ACT-541468; ACT-541468 placebo; Ethanol 10%; Ethanol placebo
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): One tablet of 50 mg ACT-541468 will be administered orally.; Matching ACT-541468 placebo will be administered orally as 1 tablet.; Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L.; Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-dummy, four-way crossover study design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Condition: Cancer; Refractory Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to establish the maximum tolerated dose and
      recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and
      adolescent patients with refractory solid tumors.
    


Intervention name(s): Cetuximab + Irinotecan; Cetuximab + Irinotecan
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.; Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
Intervention MeSH terms: Irinotecan; Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic