bioihbjkbjnl/mcl2 huggingface dataset:
Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given
      3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with
      induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a
      cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the
      combination in this regimen.
    


Intervention name(s): Panobinostat
Intervention type(s): Drug
Intervention description(s): Oral administration of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine.
Other intervention name(s): LBH589
Intervention MeSH terms: Panobinostat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; bone marrow; abnormal blast cells of myeloid; acute leukemia; cytogenetic abnormalities; HDACi
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Condition: Gastric Acid; Human Experimentation
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to
      compare effects on stomach acid; 30 participants will continue treatment for 7 days and will
      have repeat evaluations at Day 7. The other 30 participants will receive a single
      administration of sodium bicarbonate.
    

Detailed description: 
      Enrolled participants were divided into 2 groups, with 30 participants in each group.

      Group 1: This group was randomized into a 2-way crossover design with an added third period.
      These participants received single administrations (day 1 dosing only) of Zegerid Powder for
      Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized
      order, with a minimum of a 2-week washout period between treatment legs. Following completion
      of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all
      participants then received a single administration of sodium bicarbonate (at same dose as
      contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour
      intragastric pH study on each of the 3 dosing occasions.

      Group 2: This group was randomized into a 2-way crossover design in which they received 7
      days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets,
      respectively. As with the prior group, there was a minimum of a 2-week washout period between
      treatment legs. Participants assigned to this treatment group also underwent 24-hour
      intragastric pH recordings on the days on which they received their 1st and last (7th) dose
      of the two treatment drugs.

      In addition to the above detailed procedures, all participants (both groups) underwent a
      24-hour baseline intragastric pH study prior to starting their randomized treatments. This
      study design enabled all 60 participants to be evaluated for effects of the first dose of
      Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the
      subsequent 24-hour period following the first dose.
    

Intervention name(s): Omeprazole/sodium bicarbonate; omeprazole magnesium; sodium bicarbonate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.; Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.; Sodium bicarbonate. Single dose.
Other intervention name(s): Zegerid; Prilosec OTC Tablet
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
Condition: Infertility; Autoimmune Thyroiditis
MeSH terms: Infertility; Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the work is to determine whether the use of immunomodulatory drugs could improve
      the reproductive of outcome of infertile patients who have autoimmune thyroiditis with
      positive autoimmune antibodies undergoing IVF-ET.
    


Intervention name(s): Immunomodulatory; Thyroxine
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
Moreover, patients will receive a treatment course of immunomodulatory drugs for 3 -6 months before ICSI cycle:
Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued
Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin.
Immunoglobulins will be used in cases not responding to treatment.; Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
Patients will not receive immunomodulatory drugs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Examination of the Pressure Ulcers in Intensive Care Patients.
Condition: Pressure Ulcer; İntensive Care; Nurse's Role
MeSH terms: Pressure Ulcer; Ulcer
Study type: Observational

Summary: 
      A pressure sore was localized skin and/or subcutaneous tissue injury, usually caused by
      pressure alone or a combination of shear and pressure, at bony prominences. Pressure sores,
      which are an indicator of the quality of health care, increase mortality, morbidity and cost.
      Pressure ulcers are the most common problem in intensive care patients and should be
      prevented. In the literature, the incidence of pressure ulcers in intensive care patients is
      between 1-59.9%.

      A pressure sore is a localized injury to the skin and/or underlying soft tissue, usually over
      a bony prominence or associated with medical or other devices. This injury occurs when
      intense and/or prolonged pressure or pressure is accompanied by shear. Soft tissue tolerance
      to pressure and shear; temperature and humidity can affect nutrition, perfusion, concomitant
      conditions, and condition of soft tissue.

      This study was carried out to determine the prevalence of pressure ulcers and influencing
      factors in patients hospitalized in the 3rd level intensive care unit of a university
      hospital.

      Design: It is a descriptive, prospective, observational type study. Materials and Methods:
      The sample of the study consisted of 176 patients aged 18 years and above, 24 hours after
      hospitalization in the intensive care units of a University Hospital. Patient Information
      Form and Braden Scale for Predicting Pressure Ulcer Risk, Glasgow Coma Scale were used to
      collecting data. Statistical Package in statistical analysis for the social sciences 20.0
      program was used.
    

Detailed description: 
      Due to the renovation initiated in the intensive care units, the work was started in November
      2019, but the working time was extended due to the Covid 19 pandemic that developed
      immediately after. The sample of the study consisted of patients who met the inclusion
      criteria and accepted participation, among the patients who were hospitalized on Wednesday,
      which was determined as the middle of each week, between November 2019 and February 2021 in
      the 3rd-level intensive care units of a university hospital.

      Data Collection: "Personal Information Form" prepared by the researcher as a result of the
      literature review for data collection, "Braden Scale for Predicting Pressure Ulcer Risk" for
      evaluating pressure ulcers, "Glasgow Coma Score" for evaluating patient's consciousness
      status, and ulcer used by National Pressure Ulcer Advisory Panel and European Pressure Ulcer
      Advisory Panel staging classification was used.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients hospitalized in 3rd level intensive care units
      
Keywords: Intensive Care Unit; Pressure Ulcer; Risk Factors; Prevalence
Peer Comparison Feedback on Opioid Prescribing
Condition: Opioid Use
Study type: Interventional

Summary: 
      We aim to determine if descriptive normative feedback of peer prescribing reduces opioid
      analgesic prescribing by emergency medicine providers
    

Detailed description: 
      State-based Prescription Drug Monitoring Programs (PDMPs) are being implemented to reduce
      prescription drug abuse and diversion. On August 24, 2016, Pennsylvania initiated its
      mandated PDMP. In prior research, we found that ED providers reduced opioid prescribing by
      17% immediately after PDMP went live. Still, there is variability between providers in the
      frequency of opioid prescribing even after PDMP initiation. Changing clinician prescribing
      behavior is difficult, but recent research has shown that using peer comparisons can assist
      behavior change (Meeker D et al., JAMA, 2016). In this study, we will randomize a convenience
      sample of ED providers to receive either their opioid prescribing history data with peer
      comparative data or without peer comparative data. We will examine the effect on immediate
      perceived norms as well as impact on opioid prescribing in the subsequent 3 months. Results
      could inform behavioral feedback to alter clinician prescribing behaviors
    

Intervention name(s): Personal Feedback; Peer Normative Comparison Feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One-time summary report of their individual history of opioid prescribing over the past 14 months; One-time summary report of their individual history of opioid prescribing over the past 14 months WITH comparisons to (a) other providers at their site and (2) other providers at all 15 ED sites with similar prescribing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents'
      satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve
      and facilitate the surgical procedure after lip closure. This might decrease the need of
      further interventions to improve esthetics and function of CLP patients. This trial will help
      the patients and practitioners in taking the decision of inclusion of NAM in the CLP
      treatment protocol as a mandatory step or skip a useless procedure with all of its burden.
    

Detailed description: 
      In this randomized trial, 4 groups will be included. The first group will receive a modified
      nasoalveolar molding appliance in addition to taping. In the second group, the patient will
      receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated.
      the follow-up period will be 3 months till surgical lip closure. the assessment will be
      through a questionnaire for the parents' satisfaction outcome, photographs for nasal
      esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change
      outcome.
    

Intervention name(s): Modified Nasoalveolar molding; Taping; CAD/NAM
Intervention type(s): Device; Device; Device
Intervention description(s): Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).; Infants will receive a tape only on the upper lip segments to mold it to touch each other.; computer aided design NAM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Condition: Respiratory Insufficiency; Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to compare a new noninvasive ventilator to existing ventilators
      already used for patient care.
    

Detailed description: 
      This study compares the Respironics California V60 Mask ventilator to conventional
      noninvasive ventilators in a cross-over study with the patient as his/her own control.
    

Intervention name(s): Use of the V60 Mask Ventilator
Intervention type(s): Device
Intervention description(s): The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.
Other intervention name(s): V60 is the Philips V60 Ventilator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: noninvasive ventilation
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
Condition: Biliary Atresia
MeSH terms: Biliary Atresia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical
      trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG
      treatment administered to infants after hepatic portoenterostomy (HPE) for biliary atresia,
      as well as investigate preliminary evidence of activity and explore mechanisms of action.
    

Detailed description: 
      In this multicenter prospective phase 1/2A open label trial, the feasibility, tolerability
      and safety of intravenous immunoglobulin (IVIG) therapy following hepatic portoenterostomy
      (HPE) will be assessed in 29 infants with biliary atresia (BA), efficacy will be estimated
      and exploratory mechanistic research studies will be performed. After written consent is
      obtained from the parent or guardian, the subject will be enrolled and will receive three
      intravenous doses of IVIG at designated intervals over the first 60 days following HPE and
      will be followed for 360 days after enrollment. Blood will also be obtained during this study
      to assess potential mechanisms by which the IVIG may alter or reduce bile duct inflammation
      and injury and improve bile flow. All infants in this trial will also be treated with
      standardized doses of other routine standard-of-care treatments for BA during this trial
      (ursodeoxycholic acid, trimethoprim-sulfamethoxasole, and fat-soluble vitamin supplements).
      This routine clinical care will not be modified by participation in this study. Subjects in
      this study will not receive corticosteroid therapy for treatment of biliary atresia, as this
      is of unproven benefit at the present time.
    

Intervention name(s): Intravenous immunoglobulin (IVIG)
Intervention type(s): Drug
Intervention description(s): All participants will receive the same dose of IVIG at the same intervals in an open-label fashion as long as the subject does not have any increased risk for toxicity for any IVIG infusion. IVIG will be initiated on day 3 (up to day 5) after HPE surgery (HPE is day 0) at a dose of 1 gm/kg body weight by slow intravenous infusion over at least 4 hours. The same dose (1 gm/kg) and duration of infusion will be repeated on day 30 and day 60 after HPE.
Other intervention name(s): Gamunex-C®; Gamunex®
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biliary atresia; Hepatic portoenterostomy; Intravenous immunoglobulin
Single-dose Escalation Trial of M2ES in Healthy Volunteer
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized double-blinded placebo-controlled，single-dose escalation trial in
      healthy volunteer.
    

Detailed description: 
      Randomized double-blinded placebo-controlled，single-dose escalation trial in health
      volunteer,to determine the safety and the max tolerate dose in health volunteer.
    

Intervention name(s): placebo; M2ES
Intervention type(s): Other; Drug
Intervention description(s): placebo; M2ES IV 7.5mg-90mg
Other intervention name(s): placebo conparator; M2ES esculating
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cancer
A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents
Condition: Health Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect
      of the "healthy Living Study," a brief outpatient problem-solving intervention to promote
      healthy eating and activity habits in adolescents.
    

Detailed description: 
      This study will refine, evaluate the feasibility, and estimate the effect of a brief
      problem-solving intervention to promote healthy eating and activity habits in adolescents.
      Intervention participants will receive 2 sessions of individual behavioral counseling on
      problem-solving skills utilizing educational videos, handouts, and worksheets. Intervention
      participants will be asked to generate unique health goals and practice utilizing
      problem-solving skills to achieve these goals.Control participants will receive standard of
      care. Outcomes will explore the ability to shorten the intervention, integrate the
      intervention into busy outpatient clinics, and estimate the effect of the intervention on
      confidence to maintain or improve healthy habits and to improve problem-solving skills.
    

Intervention name(s): Problem-solving intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Problem solving therapy; Behavior change
Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute
      uncomplicated influenza.
    

Detailed description: 
      A multicenter randomized double-blind placebo controlled trial designed to evaluate efficacy
      and safety of NTZ 600 mg administered orally twice daily for five days compared to a placebo
      in the treatment of acute uncomplicated influenza.
    

Intervention name(s): Nitazoxanide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nitazoxanide 600 mg administered orally twice daily for five days; Placebo administered orally twice daily for five days
Other intervention name(s): NTZ, Alinia
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Influenza
Medication Development for Opioid and Alcohol Abuse
Condition: Opioid-use Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse
      liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants
      with both Opioid Use Disorder and Alcohol Use Disorder.
    

Detailed description: 
      Currently, the abuse of prescription opioid medications is a pervasive problem in the U.S. In
      addition, co-abuse of opioids and alcohol represents a significant problem from the
      perspective of increased toxicity and decreased success in treatment. Surprisingly few
      studies have examined the effects of combined administration of opioids and alcohol in
      humans, and no clinical studies have examined the reinforcing effects of this combination.
      The current 8-9-week inpatient study will systematically evaluate gabapentin because it shows
      promise for treating both opioid and alcohol use disorders (OUD and AUD). The guiding
      principle is that a medication's effects on positive subjective responses and reinforcing
      effects are the best laboratory procedures to date in predicting its clinical efficacy. We
      will examine the ability of gabapentin (0 mg or 1800 mg) to alter opioid-, alcohol-,and
      combined opioid/alcohol-mediated responses. Participants will meet DSM-5 criteria for
      moderate-severe OUD and be physically dependent on opioids. In addition, participants will
      meet DSM-5 criteria for moderate-severe AUD, but they will not be physically dependent on
      alcohol. All of the participants will be maintained on oral morphine throughout the study and
      different doses of gabapentin will be evaluated.
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention description(s): Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to receive one of two treatment conditions: gabapentin 0 mg or gabapentin 1800 mg/day first. Participants crossover to the 2nd gabapentin condition following a washout period.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food
      effect in healthy participants.
    


Intervention name(s): BMS-986278 Tablet; Esomeprazole; BMS-986278 suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): NEXIUM
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment