bioihbjkbjnl/mcl2 huggingface dataset:
Study Of Asthma In Patients Of African Descent
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic
      visits will include physical examination, medical history review and lung function tests. The
      purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is
      better in reducing the number of asthma exacerbations compared with another drug (fluticasone
      propionate alone)
    


Intervention name(s): fluticasone propionate/salmeterol powder; fluticasone propionate powder
Intervention type(s): Drug; Drug
Other intervention name(s): fluticasone propionate/salmeterol powder
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: asthma exacerbation; asthma
RDEA3170 and Febuxostat Drug Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD)
      interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor
      RDEA3170 and provide information for potential future clinical studies using this
      combination. Combination treatment using 2 drugs with different mechanisms of action may
      achieve improved response and may allow the use of lower doses, resulting in fewer side
      effects than the use of either drug alone.
    


Intervention name(s): RDEA3170 10 mg; Febuxostat 40 mg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RDEA3170 10 mg once daily (qd); Febuxostat 40 mg qd; placebo qd
Intervention MeSH terms: Febuxostat; Verinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
BRITEPath- Phase 2
Condition: Depression; Suicidal Ideation
MeSH terms: Depression; Depressive Disorder; Suicidal Ideation
Study type: Interventional

Summary: 
      BRITEPath (BP) aims to support co-located mental health clinicians in the development of a
      high quality, effective, and personalized safety plan for referred patients who screen
      positive for depression and/or suicidal ideation.

      BRITEPath utilizes BRITE, a safety planning and emotion regulation app that is loaded on the
      patient's smart phone and has previously been shown to be well accepted and to reduce suicide
      attempts compared to usual care in psychiatric inpatients (HR = 0.49). To support mental
      health clinicians in the development of effective safety plans, study investigators will
      develop Guide2Brite (G2B), which provides step-by-step instructions for the mental health
      clinician on how to populate BRITE onto the patient's smartphone and BRITEBoard, a clinician
      dashboard that tracks patient symptoms, app use, and rating on helpfulness of different
      interventions assessed through BRITE.
    

Detailed description: 
      BRITEPath has 3 components: 1) BRITE, an emotion regulation and safety planning phone app
      that is delivered by a co-located mental health (MH) clinician to adolescents at the time of
      their first therapy appointment; 2) Guide2Brite, which will guide the co-located MH clinician
      in working with the adolescent to population content onto BRITE; and 3) BRITEBoard, which is
      a clinician dashboard delivered to the MH clinician and PCP.

      Assignment of Interventions: This study will utilize a 1:1 randomization scheme to randomize
      participants to receive BRITEPath intervention or Treatment as Usual (TAU).

      Hypothesis: The use of BRITEPath will decrease depressive symptoms, distress, and suicidality
      (any self-injurious ideation, urges, or behavior) as well as improve overall functioning
      compared to TAU.
    

Intervention name(s): BRITEPath; Treatment As Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): BRITEPath will guide co-located mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt.; Participants in this group will receive usual care from their mental health care provider.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will use a parallel study design, where participants are randomized into two groups, BRITEPath or TAU, and will receive interventions in parallel.
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: depression; suicidal ideation; anxiety; treatment; app; safety planning; provider
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80
      mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured
      at the Wilson, NC facility in the fasted state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (Totowa) (oxycodone HCl); Reformulated OXY (Wilson) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food.; Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid; Healthy volunteers
Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration
Condition: Zinc Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the use of plasma zinc concentration for assessing
      the impact of targeted zinc fortification programs.
    

Detailed description: 
      The objectives of the present study are to determine whether plasma zinc concentration
      changes in response to additional zinc consumption, as provided by zinc-fortified
      cereal-based complementary foods fed to young children. The following specific steps will be
      completed:

        1. Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours
           will be developed with assistance from experts in food technology.

        2. A two-week feeding trial will be implemented to assess the change in plasma zinc
           concentration among young children who receive: a) the zinc-fortified cereal porridge
           and a liquid vitamin preparation between meals; b) a non-zinc-fortified cereal porridge
           and a liquid vitamin preparation between meals [negative control group]; or c) a
           non-zinc-fortified cereal porridge and a zinc-containing liquid vitamin preparation
           between meals [positive control group].
    

Intervention name(s): Zinc fortified food; Zinc supplement; Placebo supplement; Non-fortified food
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Daily consumption; Liquid supplement containing zinc sulfate; Liquid placebo supplement; Non-fortified complementary food.
Other intervention name(s): Provital, CoAID; Zinc sulfate and B vitamins, DSM; B vitamins, DSM; Provital, CoAID
Intervention MeSH terms: Vitamins; Zinc; Vitamin B Complex; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zinc fortification; Plasma zinc concentration; Assessment of zinc status
Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to study the effects of BMS-955176 on the single-dose PK
      parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole,
      midazolam, digoxin, and pravastatin
    


Intervention name(s): CYP and transporter probe substrates; BMS-955176; BMS-955176 plus CYP and transporter probe substrates
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cocktail of CYP (cytochrome P450) and transporter probe substrates; BMS-955176; BMS-955176 plus the cocktail of CYP and transporter probe substrates
Intervention MeSH terms: BMS-955176
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Improving Outcomes in Underserved Women With GDM
Condition: Diabetes Mellitus; Pregnancy
Study type: Interventional

Summary: 
      Our objective is to test an innovative approach to improve outcomes among underserved women
      with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR)
      -enabled telephone system to facilitate diabetes control and thereby improve pregnancy
      outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby
      reducing infant birth weights and leading to improved pregnancy outcomes.
    

Detailed description: 
      Using a step care design, women will be randomized into standard of care or Telemonitoring.
      In the standard of care group, women will monitor their blood glucose levels four times a
      day, perform fetal movement counting three times a day and also record insulin doses. The
      women will record this information in a logbook, which will be reviewed by the medical team
      at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd
      will also transmit their blood glucose and fetal movement information to their health care
      providers.
    

Intervention name(s): telemonitoring; Standard of care
Intervention type(s): Other; Other
Intervention description(s): Women will transmit their blood glucose levels, fetal movement counts, and insulin doses via the Internet and/or IVR system at least three times per week; Health data (blood glucose levels and insulin doses) will be recorded in a paper log book which will be reviewed at prenatal visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: GDM, pregnancy, macrosomia
Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy
Condition: Tendinopathy; Achilles Tendon Injury; Achillodynia
MeSH terms: Tendinopathy; Tendon Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to compare the treatment of 2 groups in patients with Achilles
      tendinopathy: autologous tenocytes injection in combination with exercises versus saline
      injection in combination with exercises
    

Detailed description: 
      Overuse injury of the Achilles tendon is a common entity. When the exact origin of tendon
      pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment
      is an eccentric exercise programme, according to the Dutch guidelines. However, a recent
      systematic review on the effectiveness of eccentric exercises to treat lower extremity
      tendinoses concluded that it is unclear whether eccentric exercises are more effective than
      other forms of treatment. Recent studies described new treatment strategies in
      tendinopathies, such as the use autologous Tenocyte Implantation (ATI). This treatment option
      can participate actively in tissue repair processes on cell level. The only published
      clinical pilot study in tendon research reported 60% improvement in all scores after 6 months
      follow-up.
    

Intervention name(s): Autologous Tenocyte Implantation; Saline
Intervention type(s): Other; Other
Intervention description(s): Intratendinous ATI (autologous tenocyte injection) with eccentric exercises; Intratendinous saline injection with eccentric exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autologous tenocytes; cell therapy; eccentric exercises
A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine
      doctors can already prescribe) in people with type 2 diabetes. Different ways of switching
      from the insulin which the participants are already on to insulin 287 are also compared. This
      is done to find the best way to switch to insulin 287. The participants will either get
      insulin 287 that they will have to inject once a week or insulin glargine that they will have
      to inject once a day. Which treatment any participant gets is decided by chance. The study
      will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6
      phone calls with the study doctor. At 3 of the clinic visits participants will be asked not
      to eat or drink anything (except for water) in the last 8 hours before the visit. During the
      study, the doctor will ask the participants to: 1) measure their blood sugar every day with a
      blood sugar meter using a finger prick; 2) write down different information in a diary daily
      and return this to their study doctor. 3) wear a medical device (sensor) that measures the
      participants blood sugar all the time for 18 weeks (about 4 months) during the study.
    


Intervention name(s): Insulin icodec; Insulin glargine U100
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.; Participants will receive s.c. injections of insulin glargine OD for 16 weeks
Other intervention name(s): Insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor
      effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell
      Non-Hodgkin's Lymphoma.
    

Detailed description: 
      Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy
      using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide,
      doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent
      Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride
      has a unique structure compared with the marketed agents, and has an innovative mechanism of
      action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives
      for patients with indolent B-cell Non-hodgkin's lymphoma.
    

Intervention name(s): bendamustine hydrochloride
Intervention type(s): Drug
Intervention description(s): 1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
Intervention MeSH terms: Bendamustine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin's Lymphoma; Malignant lymphoma
Maternal High Blood Pressure and Newborn's Blood Profile
Condition: Maternal-Fetal Exchange
Study type: Observational

Summary: 
      Maternal high blood pressure remodels the intrauterine environment of the fetus by altering
      hormonal and cellular signaling patterns and, as a result increases the risk of fetal and
      neonatal mortality and morbidity. Newborns of these mothers have an increased risk of
      intrauterine growth restriction, premature birth and hematological abnormalities, such as
      thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review
      neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure
      and to establish the optimal management of these cases.
    

Detailed description: 
      Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have
      an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains
      unknown, two interconnected mechanisms have been identified to play an important role in the
      pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the
      maternal systemic vasculature. The endothelium has been identified as the target tissue of
      the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia.
      The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a
      result of inhibition of fetal bone marrow production of the myeloid lineage due to
      intrauterine hypoxic environment. This study aims to investigate the hematological profile in
      term and preterm infants born to mothers with preeclampsia. The current retrospective
      observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of
      the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to
      December 2016. All inborn patient files were analyzed as anonymised limited data sets from
      archived records of the Neonatology Department.
    

Intervention name(s): AGA - Control group; SGA - Control group; AGA-PIH Study group; SGA-PIH Study group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Data processing from Patient Medical Files; Data processing from Patient Medical Files; Monitoring PIH-related changes in the newborn; Monitoring PIH-related changes in the newborn
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All newborns admitted to the Neonatology Department who met the Inclusion Criteria.
      
Keywords: Maternal PIH; Neonatal thrombocytopenia; Neonatal neutropenia
Comparison of Qigong Exercises on Two Different Digital Platforms
Condition: Health Behavior; Sedentary Behavior
Study type: Interventional

Summary: 
      Mild effort requiring, body-mind oriented, effective on multiple physical fitness parameters,
      ancient exercise method Qigong would be beneficial for a great number of people by using
      popular technological mediums in order to increase overall physical activity and wellbeing.
      Our aim is to evaluate the effects of Qigong exercises on endurance, muscle strength, sleep
      quality, level of anxiety and stress by using two different tele-rehabilitation methods.
    

Detailed description: 
      Physical inactivity and sedentary behavior is a serious public health problem which
      categorized as a pandemic. One of the common risk factors for cardiovascular diseases,
      cancers, chronic respiratory diseases and diabetes, known as chronic non-communicable
      diseases, is physical inactivity. Mild effort requiring, body-mind oriented, effective on
      multiple physical fitness parameters, ancient exercise method Qigong would be beneficial for
      a great number of people by using popular technological mediums in order to increase overall
      physical activity and wellbeing. Based on reasons as previously described, our aim is to
      evaluate the effects of Qigong exercises on endurance, muscle strength, sleep quality, level
      of anxiety and stress by using two different tele-rehabilitation methods.
    

Intervention name(s): Qigong exercises
Intervention type(s): Other
Intervention description(s): Specific Qigong exercises 1- Painting the rainbow 2-Raising the arms 3-Looking at the moon 4- Pushing the waves
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 30 volunteer research subjects will be selected in an age range of 18 to 65, who categorized as "inactive (<600 metabolic equivalent-min/hf)" with respect to International Activity Readiness Survey. Groups will be randomized as Group A (n=15) and Group B (n=15).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Qigong; telerehabilitation; physical activity
Prevention and Treatment of Immersion Pulmonary Edema
Condition: Immersion Pulmonary Edema (IPE); Swimming Induced Pulmonary Edema (SIPE)
MeSH terms: Pulmonary Edema; Edema
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Immersion pulmonary edema (IPE) is a condition in which fluid fills the lungs during diving
      or swimming, particularly in cold water. Some individuals appear to be predisposed to
      developing IPE. DNA samples will be collected and stored, in order to compare the genetic
      profiles of individuals who have experienced IPE with those who have not. In a few
      individuals who have experienced IPE, we plan to measure the effects of cold water immersion
      on the blood pressure, cardiac output and the pressures in the pulmonary artery. These will
      be compared with similar measurements already obtained from normal individuals.
    

Detailed description: 
      Immersion pulmonary edema (IPE) is a condition that has sudden onset in swimmers and divers,
      and is characterized by cough, shortness of breath, decreased blood oxygen levels, and
      hemoptysis. The purpose of this study is to examine the effects of cold water immersion and
      the dive reflex on pulmonary arterial pressure and pulmonary capillary wedge pressure in
      those who have already experienced IPE, as well as explore the possibility of a genetic
      predisposition. Healthy nonsmoking subjects who have experienced IPE will be recruited for
      several cold-water immersion experiments and DNA analysis. Their pulmonary arterial and
      pulmonary arterial wedge pressures will be measured as they undergo immersed rest and
      exercise trials in thermoneutral and cold water. If the pressures increase with these trials
      as hypothesized, the effects of sildenafil administration (a pulmonary vasodilator) will be
      tested during a second trial. Blood will also be drawn for DNA analysis of certain genes with
      possible relation to IPE. Results of these tests will be compared with those of the general
      population.
    

Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention description(s): After measurement of the effect of cold water on cardiac output and pulmonary artery and wedge pressures, a single dose of sildenafil (50 mg) will be given orally, followed by similar hemodynamic measurements.
Other intervention name(s): Viagra
Intervention MeSH terms: Sildenafil Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immersion pulmonary edema; Diving; Swimming; Pulmonary edema; Cold water immersion