bioihbjkbjnl/mcl2 huggingface dataset:
Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19
Condition: SARS (Severe Acute Respiratory Syndrome); Coronavirus
MeSH terms: Severe Acute Respiratory Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related
      infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to
      refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric
      oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory
      hypoxemia due to acute respiratory distress syndrome (ARDS). In-vitro and clinical evidence
      indicate that inhaled nitric oxide gas (iNO) has also antiviral activity against other
      strains of coronavirus. The primary aim of this study is to determine whether inhaled NO
      improves oxygenation in patients with hypoxic SARS-CoV2. This is a multicenter single-blinded
      randomized controlled trial with 1:1 individual allocation
    

Detailed description: 
      Severe acute respiratory syndrome (SARS-CoV-2) due to novel Coronavirus (2019-nCoV) related
      infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to
      refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric
      oxide is a selective pulmonary vasodilator gas used as a rescue therapy in refractory
      hypoxemia due to acute respiratory distress syndrome (ARDS). In has also shown in-vitro and
      clinical evidence that inhaled nitric oxide gas (iNO) has antiviral activity against other
      strains of coronavirus.

      The primary aim of this study is to determine whether inhaled NO improves oxygenation in
      patients with hypoxic SARS-CoV2.

      This is a multicenter randomized controlled trial with 1:1 individual allocation. Patients
      will be blinded to the treatment.

      Intubated patients admitted to the intensive care unit with confirmed SARS-CoV-2 infection
      and severe hypoxemia will be randomized to receive inhalation of NO (treatment group) or not
      (control group). Treatment will be stopped when patients are free from hypoxemia for more
      than 24 hours.
    

Intervention name(s): Nitric Oxide Gas
Intervention type(s): Drug
Intervention description(s): 80 ppm of inhaled nitric oxide for 48 hours, followed by 40 ppm, followed by weaning before stop.
Weaning criteria: maintenance of a PaO2/FiO2 ratio >/= 300 for at least 24 hours consecutively.
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Corrected QT (QTc) Study With Flucticasone Furoate and GW642444
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose
      FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in
      healthy male and female subjects. Key assessments will include 12- lead electrocardiogram
      (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood
      pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.
    

Detailed description: 
      This is a randomised, placebo controlled, four way crossover thorough QT study to evaluate
      the effect of repeat dose fluticasone furoate/GW642444M combination on the QTc interval in
      healthy male and female subjects. Up to 85 subjects will receive inhaled placebo and inhaled
      fluticasone furoate/GW642444M combination (200/25 microgram (mcg) or 800/100 mcg) and oral
      moxifloxacin (400 milligram (mg)). The inhaled treatments will be given double-blind once
      daily in the morning for 7 days with a single-blind placebo tablet also administered on Day
      7. Moxifloxacin (positive control) will be given as a single-blind single dose on Day 7 in
      the morning with inhaled double-blind placebo administered in the morning on Days 1-7.
      Individual time-matched changes from baseline in QT duration corrected for heart rate by
      Fredericia's formula (QTcF) (difference from placebo) for fluticasone furoate/GW642444M
      200/25mcg will be determined 0-24 hours (h) after dosing on Day 7 (primary endpoint).
      Secondary endpoints will include changes from baseline in QTcF, QT individual correction
      factor (QTci), QT duration corrected for heart rate by Bazett's formula (QTcB), and QT
      interval at each timepoint after 7 days dosing of fluticasone furoate/GW642444M 800/100mcg
      and single dose oral moxifloxacin (400mg) and changes from baseline in QTci, QTcB, and QT
      interval at each timepoint after 7 days dosing of fluticasone furoate/GW642444M 200/25mcg.
      Plasma concentrations (0-24h) and pharmacokinetic parameters of GW642444 and fluticasone
      furoate will also be derived.
    

Intervention name(s): Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination; Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination; Placebo Inhaler; Moxifloxacin 400mg; Moxifloxacin placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Novel dry powder inhaler; Novel dry powder inhaler; Matching placebo Novel dry powder inhaler. Lactose monohydrate and magnesium stearate.; Film coated oral tablet; Film coated oral tablet
Intervention MeSH terms: Fluticasone; Xhance; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fluticasone furoate (GW685698); moxifloxacin; QTc; GW642444; pharmacokinetics
Salvage Docetaxel for Pretreated Urothelial Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on the previous clinical experience in other cancers, and considering the absence of
      current standard salvage regimens, the single agent docetaxel is selected as the regimen for
      this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe
      myelosuppression observed in other cancer trials warrants further study in urothelial cancer.
      The objective of the study is to evaluate the safety and activity of weekly docetaxel given
      as salvage therapy for advanced urothelial cancer.
    

Detailed description: 
      Study scheme

      Patients eligible for this study will be offered participation. Screening numbers are endowed
      to all subjects who sign the informed consent forms. These screening numbers are used as
      'Subject Identification Code" along with subject initials. Subjects withdrawn from the study
      retain their screening number.

      Patients will have study drug discontinued at the time of progression and will then remain on
      study for a 4-week safety follow-up. Those without progression may continue to receive
      docetaxel as long as this is considered to be in their interest by their physician. After
      progression, patients will remain on study for the purpose of collecting follow-up and
      survival information.

      VII-3. Study treatment

      The study drug doses should be calculated taking the body surface area into consideration.
      Docetaxel 30 mg/m2 will be administered on days 1 and 8 every 3 weeks. Docetaxel will be
      diluted in 250 ml 0.9% saline or 5% dextrose to produce a final solution with concentration
      of 0.3-0.74 mg/ml. It will be administered as an infusion over 60 min on each infusion day.
      Patients will be premedicated with iv dexamethasone 15 mg, antihistamines and a prophylactic
      antiemetic treatment prior to docetaxel infusion in order to reduce the incidence and
      severity of fluid retention as well as the severity of hypersensitivity reactions. Patients
      experiencing adverse events attributed to irinotecan should have treatment delay as needed
      and/or may be interrupted or reduced depending on individual tolerability and according to
      the protocol.

      Treatment will be continued until disease progression, unacceptable toxicities, or consent
      withdrawal. After failure of study treatment, further treatment can be administered at the
      discretion of investigators.
    

Intervention name(s): Docetaxel
Intervention type(s): Drug
Intervention description(s): Treatment will be continued until progression, unacceptable toxicity, or refusal
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Preliminary Study of Bone Density in Neonates
Condition: Osteopenia Of Prematurity
MeSH terms: Bone Diseases, Metabolic
Study type: Observational

Summary: 
      The study is to measure how dense or solid the infant's bones are using a new ultrasound
      machine and how that density changes over time.
    

Detailed description: 
      premature infants weighing less than 1500 gms and less than 33 weeks gestation are eligible
      for the study
    

Intervention name(s): Ultrasound machine
Intervention type(s): Device
Intervention description(s): Weekly Bone Density measurements using the Sonometer
Other intervention name(s): Omnisense 7000P Ultrasound Bone Sonometer
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premature Infants In the Neonatal Intensive Care Unit
      
Biospecimen description: 
      Measuring proteins in the blood plasma
    
Keywords: weakening of the bones
Text Messaging and Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Atopic dermatitis is a common problem faced by patients of all ages and backgrounds.
      Treatment regimens and specific therapies may be time consuming and multiple studies have
      documented a parallel decrease in compliance as time after an office visit increases. The
      adolescent population is an extremely challenging sub-group of patients in terms of complying
      with a treatment regimen. Not only are they striving for independence and thus lacking
      supervision of a regimen by a parent, but their complex thinking skills are immature, leading
      to forgetful behavior. By introducing a reminder system for these vulnerable patients that is
      easily incorporated into their daily lives, the investigators propose that patients will have
      better compliance at applying their medication and thus improving their atopic dermatitis.
      Text-messaging via cell phones has become very popular among teenagers and adults and
      provides a non-obtrusive method of sending a treatment reminder.
    

Detailed description: 
      We propose to conduct a randomized, controlled 6-week trial to evaluate the impact of a text
      message-based reminder program on adherence to health maintenance behaviors among adolescents
      diagnosed with Atopic Dermatitis. After obtaining informed consent, subjects will be
      randomized into either an intervention or control group. Subjects in the intervention group
      will receive a daily text message with a tailored message regarding atopic dermatitis, while
      control group subjects will receive a weekly text message with information on local weather,
      sport or news without any reference to atopic dermatitis. Of note, the decision to send a
      weekly text message to the control group reflects the expectation that a message will be
      sent, although the frequency and content of the message will not be revealed.
    

Intervention name(s): Text message to cell phone
Intervention type(s): Procedure
Intervention description(s): Subjects will receive a daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: adherence; text message; reminder; adolescents
Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The purpose of the study was to determine whether mindfulness training could be more
      effective than another active intervention in reducing borderline personality disorder (BPD)
      symptoms. The main hypothesis was that patients allocated to the mindfulness group would show
      a greater improvement on global BPD symptomatology. As a second objective, we explored some
      of the possible underlying mechanisms of both active treatments. For that purpose, changes in
      decentering, mindfulness facets and cognitive processing of social interactions were also
      evaluated.
    

Detailed description: 
      The present study aimed at evaluating the efficacy of mindfulness skills (M) versus
      interpersonal effectiveness skills (IE) on borderline symptoms. For that purpose, a
      randomized, active-controlled clinical trial was designed. 64 participants with borderline
      personality disorder (BPD) diagnosis were allocated to mindfulness (n=32) or interpersonal
      effectiveness skills (n=32). Both interventions were delivered over a 10-week period. The
      borderline symptom list (BSL-23) was elected as the primary outcome measure. Mindfulness
      related capacities, decentering and cognitive processing of social interactions were also
      evaluated with the Five Facet Mindfulness Questionnaire (FFMQ), the Experiences Questionnaire
      (EQ) and the Multidimensional Scale of Social Expression (EMES-C), respectively. Assessments
      were conducted pre and post interventions.
    

Intervention name(s): Mindfulness; interpersonal effectiveness
Intervention type(s): Behavioral; Behavioral
Intervention description(s): weekly psychotherapy sessions for 10 weeks (120 min each); weekly psychotherapy sessions for 10 weeks (120 min each)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: borderline personality disorder; mindfulness
PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to characterize the single-dose and steady-state pharmacokinetics of tofacitinib
      Modified Release (MR) formulation as well as to compare the extent of absorption of the MR 11
      mg formulation (once daily) to that of the Immediate Release (IR) 5 mg formulation (twice
      daily) of tofacitinib in Chinese healthy subjects under fasted conditions.
    


Intervention name(s): tofacitinib MR 11 mg; tofacitinib IR 5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.; Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to one of the two treatment sequences. Each treatment sequence will consist of two periods, separated by a washout phase of no less than 72 hours from the AM dose on Day 7.
Treatment A (Test): Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
Treatment B (Reference): Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
Masking: None (Open Label)
Primary purpose: Other
Effects of Soft Tissue Mobilization Technique and Piriformis Muscle Stretching Among Patients Having Piriformis Syndrome
Condition: Piriformis Syndrome
MeSH terms: Piriformis Muscle Syndrome; Syndrome
Study type: Interventional

Summary: 
      It is a randomized control trail in which soft tissue mobilization and piriformis stretching
      will be compared and study duration will be of five months
    

Detailed description: 
      Piriformis syndrome is one of the misdiagnosed syndromes and there is no evidence available
      for the proper diagnosis of this syndrome. Several interventions have been adopted in the
      clinical setting for improvement of piriformis syndrome including therapeutic ultrasound,
      myofascial release, stretching, dry needling, strengthening exercises of hip muscles and
      activity modification. There are several treatments available for this syndrome but no
      comparison studies have been reported yet on soft tissue mobilization and piriformis muscle
      stretching. The purpose for conducting this research is to assist in establishing the
      effectiveness of soft tissue mobilization technique and piriformis muscle stretching in
      piriformis syndrome by comparison between two abovementioned treatments
    

Intervention name(s): Soft Tissue mobilization; Piriformis Syndrome (Piriformis muscle stretching)
Intervention type(s): Other; Other
Intervention description(s): mobilization of soft tissues of body; Stretching of Piriformis muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Clinical Trial in which group 1 will be of experimental group and group 2 will be of control group
Masking: Single (Participant)
Primary purpose: Other
Glycemic and Satiety Response Study of Fibre-Enriched Pudding Products
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the specific properties of a variety of dietary
      fibres that lead to different postprandial glycemic and satiety responses in individuals at
      risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that
      demonstrate a wide range of properties in a pudding product, and by examining the ability of
      each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion,
      and improve satiety, versus a low fibre control product.
    

Detailed description: 
      The purpose of this study is to determine the specific properties of a variety of dietary
      fibres that lead to different postprandial glycemic and satiety responses in individuals at
      risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that
      demonstrate a wide range of properties in a pudding product, and by examining the ability of
      each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion,
      and improve satiety, versus a low fibre control product. To accomplish this, a randomized,
      double-blinded, placebo controlled, crossover study design will be used, in order to
      determine the different effects of a variety of fibre-enriched pudding products on markers of
      type 2 diabetes and satiety response, versus low-fibre control puddings.
    

Intervention name(s): Yellow Mustard Gum Fibre; Soluble Flaxseed Gum Fibre; Fenugreek Gum Fibre
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Risk for Type 2 Diabetes Mellitus; Fibre; Postprandial Glucose; Postprandial Insulin; Postprandial Acetaminophen; Satiety
Bioequivalency Study of Amlodipine Tablets Under Fed Conditions
Condition: Hypertension; Chronic Stable Angina; Vasospastic Angina
MeSH terms: Angina Pectoris; Angina, Stable; Angina Pectoris, Variant
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine
      Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Two Modes of Survivorship Care
Condition: Childhood Cancer
Study type: Interventional

Summary: 
      The main purpose of this study is to research the comparative effectiveness of two potential
      models of health care to deliver preventive services and chronic care management to the
      growing population of adult and pediatric survivors of childhood cancer. The central
      hypothesis is that survivorship care delivered by a subject's primary care doctor after the
      subject is empowered with individualized follow-up recommendations prepared by a cancer
      survivor specialist is similar to care provided in a specialty survival clinic.
    

Detailed description: 
      Although 80% of children with cancer will be cured of their primary disease, at least 70% of
      survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a
      complication of their therapy. Most of these conditions are amenable to prevention and early
      intervention. In response, the Institute of Medicine strongly advised that all cancer
      patients should receive survivorship care with the following key elements: 1) a summary of
      previous cancer therapy, 2) individualized life-long screening for potential adverse
      therapy-related effects, and 3) education regarding desirable health behaviors. However, less
      than 30% of survivors receive recommended care. There is a tremendous need for research that
      addresses how to best implement evidence-based recommendations for this population.

      Two main health care delivery models have been advocated for survivorship care, but no
      comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer
      treatment center. The second model, termed the empowered primary care model, involves
      patients receiving an individualized "prescription" for follow-up care prepared by a cancer
      survivor specialist to be implemented by the primary care doctor. Each model poses unique
      strengths and weaknesses. Specialty survivor clinics can be expensive and geographically
      inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers
      of patients. Primary care doctors may lack adequate expertise and time for these complex
      patients. Unless we know how these approaches compare with regard to quality of care and
      risks, advocates and policy makers will be stymied in their efforts to support the health
      needs of cancer survivors. This study seeks to compare subjects randomized to the empowered
      primary care model vs. a specialty survivor clinic.
    

Intervention name(s): empowered primary care model; specialty survivor clinic
Intervention type(s): Other; Other
Intervention description(s): mode of survivorship care; mode of survivorship care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: survivorship care; health services; barriers