bioihbjkbjnl/mcl2 huggingface dataset:
Hematopoietic Stem Cell Transplant for Recurrent Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when
      combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell
      transplantation. The study will also compare the difference in response rates and time to
      treatment failure between historical control patients receiving high-dose BEAM or BEAC
      chemotherapy with autologous hematopoietic stem cell transplant and patients receiving
      radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem
      cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1
      radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM)
      chemotherapy, and autologous hematopoietic stem cell transplant.
    

Detailed description: 
      Thirty patients will be enrolled in this study. There will be two administrations of
      131I-anti-B1 given to patients, the "dosimetric dose" and the "radioimmunotherapy dose". The
      dosimetric dose will consist of an infusion of unlabeled Anti-B1 (450 mg) immediately
      followed by an infusion of Anti-B1 (35 mg) which has been trace labeled with 5mCi of
      131I-anti-B1. The total whole body dosimetry dose is then calculated over an approximated
      one-week time interval from the radioactive clearance data obtained by the Whole Body
      anterior and posterior gamma camera scans. Based upon dosimetric data calculations specific
      for each individual patient, a radioimmunotherapy dose will be given consisting of an
      infusion of unlabeled Anti-B1 (450 mg)immediately followed by an infusion of 35 mg Anti-B1
      including a patient specific dose of 131Iodine-Anti-B1. Calculations will be made such that
      in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result
      from the administration of the therapeutic activity of 131I-anti-B1. The amount of the
      unlabeled Anti-B1 administered is not calculated on a body surface area basis, but is given
      to provide an excess of Anti-B1 independent of tumor burden, splenic uptake, or other causes.
    

Intervention name(s): 131Iodine-Anti-B1 Radioimmunotherapy; BEAM
Intervention type(s): Radiation; Drug
Intervention description(s): Dosimetric dose of 450 mg unlabeled Anti-B1 followed by 35 mg Anti-B1 which has been trace labeled with 5mCi of 131I-Anti-B1.; Carmustine (B) also known as BCNU Etoposide (E) Cytarabine (A) also known as Ara-C and cytosine arabinoside Melphalan (M) also known as alkeran
Other intervention name(s): Carmustine, Etoposide, Cytarabine, and Melphalan
Intervention MeSH terms: Cytarabine; Etoposide; Melphalan; Carmustine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NHL; Non Hodgkins Lymphoma; 131Iodine-Anti-B1 Radioimmunotherapy; Autologous Hematopoietic Stem Cell Transplant; AHSCT
Human Photoallergy Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Photoallergic
Study type: Interventional

Summary: 
      To evaluate the potential of a test material to produce a photoallergic response.
    


Intervention name(s): Bain De Soliel - Solid; Untreated skin
Intervention type(s): Other; Other
Intervention description(s): 0.05gm/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.; One site is patched without treatment as control
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess
      the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will
      take place in the US at one clinical site.
    


Intervention name(s): ACHN-975; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous single dose; Intravenous single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine the amount of medicine absorbed in the
      lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated
      charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      This is a randomized, open-label, single-dose per dosing period, five-way crossover study in
      subjects 40 to 70 years of age with a diagnosis of moderate to severe COPD per Global
      Initiative for Chronic Obstructive Lung Disease guidelines. After a subject provides consent
      for study participation, there will be a Screening Period lasting up to 3 weeks to determine
      study eligibility and to allow for appropriate washout of prohibited medications.

      Eligible subjects will be randomized to one of 10 treatment Sequences. There will be a
      minimum of a 7-day washout period between each treatment visit. At each visit, subjects will
      receive one dose of study medication according to the sequence assigned.

      Subjects with a ≥ 20% decrease in forced expiratory volume in one second (FEV1) based on
      review of the Visit predose value compared with the Screening value will be evaluated by the
      investigator for continuation in the study.

      Subjects taking theophylline will not be able to participate in the study.
    

Intervention name(s): SUN-101 via eFlow nebulizer; SUN-101 via eFlow nebulizer with activated charcoal; Seebri® Breezhaler®; Seebri® Breezhaler® with activated charcoal; Glycopyrrolate Injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 mcg glycopyrrolate via Electronic Nebulizer; 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal; 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI; 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal; 50 mcg glycopyrrolate via IV
Other intervention name(s): Glycopyrrolate; Glycopyrrolate; glycopyrronium, glycopyrronium bromide; glycopyrronium, glycopyrronium bromide; Glycopyrrolate
Intervention MeSH terms: Glycopyrrolate; Bromides; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice
Condition: Headache Disorders, Primary; Migraine With Aura; Migraine Without Aura; Tension-Type Headache
MeSH terms: Migraine Disorders; Tension-Type Headache; Headache Disorders; Migraine without Aura; Migraine with Aura; Headache Disorders, Primary; Headache
Study type: Observational

Summary: 
      Headaches are a common medical problem that physicians frequently encounter in their
      practice. One of key findings of The Atlas of Headache Disorders prepared by World Health
      Organization (WHO) is: headache disorders, including migraine and tension-type headache
      (TTH), are among the most prevalent disorders of mankind. The fixed combination of
      indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute
      treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is
      widely used in common daily practice only in Italy from early 1970s, is available at the
      Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data
      regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing
      observational study which aimed to evaluate the effectiveness and patients' satisfaction of
      primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.
    

Detailed description: 
      The study is designed as a prospective, multicentre, observational, non-interventional,
      non-randomized, non-controlled, single arm, post-marketing study where IndoProCaf will be
      prescribed in the usual manner per standard clinical practice of the treating physician and
      in accordance with the terms of the locally approved instruction for medical use. No
      additional procedures (other than the standard of care) shall be applied to the patients.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with migraine (with or without aura) and/or episodic TTH
      
Keywords: Indoprocaf; Indomethacin; Caffeine; Prochlorperazine; Migraine with Aura; Migraine without Aura; Tension-Type Headache
Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics
      and pharmacologic activity of gemcabene.
    


Intervention name(s): Gemcabene 50 mg; Gemcabene 150 mg; Gemcabene 450 mg; Gemcabene 750/600 mg; Gemcabene 900 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Gemcabene 50 mg once daily (QD); Gemcabene 150 mg once daily (QD); Gemcabene 450 mg once daily (QD); Gemcabene 750/600 mg once daily (QD); Gemcabene 900 mg once daily (QD); Placebo once daily (QD)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Lipid Regulator
Ginseng in Treatment of Fatigue in Multiple Sclerosis
Condition: Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of
      fatigue and Quality of Life of MS patients.
    

Detailed description: 
      Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the
      world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System
      (CNS) which affects individuals in the productive ages and causes a large burden for years to
      come. Fatigue is a common complaint and one of the least understood symptoms of MS
    

Intervention name(s): Ginseng; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): it is kind of drug; it is placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Ginseng; Fatigue; Quality of life
Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to determine how best to treat adolescents with depression that
      is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of
      three other antidepressant medications, either alone or in combination with cognitive
      behavioral therapy.
    

Detailed description: 
      The TORDIA study aims to develop useful clinical guidelines for the care and management of
      adolescent depression. Adolescents ages 12 to 18, currently taking a prescribed selective
      serotonin reuptake inhibitor (SSRI) and still experiencing depression, participate in a
      12-week randomized treatment study that includes one of four conditions: (1) switching to an
      alternative SSRI, (2) switching to a different non-SSRI antidepressant, (3) switching to an
      alternative SSRI and receiving cognitive behavioral therapy (CBT), or (4) switching to a
      different non-SSRI antidepressant and receiving CBT. This is a double-blind study, which
      means that neither the participant nor the clinical staff will know which of the three
      possible medications has been assigned. Participants who respond to the assigned treatment
      will receive 12 additional weeks of the same treatment. Those who do not appear to be getting
      better will be offered 12 weeks of an alternative, individualized treatment plan based on
      each participant's particular needs. All participants will receive follow-up psychiatric
      evaluations for 12 months after the 12-week continuation phase of the study, regardless of
      treatment adherence.
    

Intervention name(s): Fluoxetine; Venlafaxine; Cognitive Behavioral Therapy (CBT); Citalopram
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): Standard anti-depressant treatment with the SSRI fluoxetine; Standard antidepressant treatment with the non-SSRI medication venlafaxine; CBT addresses maladaptive beliefs in order to encourage behavioral change; Standard anti-depressant treatment with the SSRI fluoxetine
Other intervention name(s): Prozac; Effexor XR; Celexa
Intervention MeSH terms: Fluoxetine; Venlafaxine Hydrochloride; Citalopram
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder; Adolescents; Teenagers; Teens; Cognitive Behavior Therapy
Experimental Overfeeding in Humans
Condition: Overfed; Obesity
Study type: Interventional

Summary: 
      The objective of this study is to determine the homeostatic mechanisms that counteract weight
      gain in response to experimental overfeeding.
    

Detailed description: 
      The homeostatic regulation of body weight implies that biological processes have evolved to
      protect energy stores from changes to the food environment. Accordingly, many individuals
      remain remarkably weight stable over years without carefully considering how much they eat or
      how much energy they expend, which has given rise to the theory that body weight is regulated
      around an individual biological 'set point'. Notably, overfeeding humans in experimentally
      controlled conditions, support this phenomenon, but the underlying mechanisms are unknown.

      To systematically map out the components of the overfed state, the investigators will execute
      a 2-week randomized controlled overfeeding trial in lean and overweight individuals. The
      trial is preceded by a 1-week lead-in period and followed by a 2-wk controlled ad libitum
      study period. The comparison between lean and overweight subjects, men and women, enables the
      determination of whether a differential response in overfeeding-induced signals is present in
      relation to BMI and sex.
    

Intervention name(s): Overfeeding diet; Isocaloric diet
Intervention type(s): Other; Other
Intervention description(s): Two weeks of overfeeding; Two weeks of isocaloric weight maintenance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
How Safe Are Our Pediatric Emergency Departments?
Condition: Adverse Effects; Adverse Drug Event
MeSH terms: Emergencies; Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      Patient safety is an internationally recognized health care priority. Canadian data suggests
      that about 8% of adults admitted to hospital experience unintended harm (or 'adverse events')
      from the health care provided during their hospital stay. On a national level, this
      represents almost 25,000 preventable deaths among hospitalized adults each year. The
      emergency department is recognized as a high-risk environment for adverse events but most
      patient safety research is not specific to the emergency department. As well, the vast
      majority of people treated in the emergency department are sent home after their visit; yet
      safety research focuses primarily on people who are admitted to hospital. Finally, although
      children have also been identified as particularly high risk for suffering adverse events,
      very little research has been done on how often these events occur among children who visit
      the emergency department. Our study will address this gap in our knowledge about patient
      safety and provide important information on the frequency, severity and preventability of
      adverse events occurring among children in the emergency department. This information will
      help us to improve the safety of emergency department care for all Canadian children.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects presenting to one the nine participating Canadian pediatric hospitals (BC
        Children's Hospital (BC), CHU Sainte-Justine (PQ), Children's Hospital of Eastern Ontario
        (ON), The Hospital for Sick Children (ON), Children's Hospital of Western Ontario (ON),
        Children's Hospital of Winnipeg (MB), Janeway Children's Health and Rehabilitation Centre
        (NL), Stollery Children's Hospital (AB) and Alberta Children's Hospital (AB)) Emergency
        Departments
      
Keywords: patient safety; pediatrics; emergency medicine
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
Condition: Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to investigate the relative bioavailability and
      pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations
      following oral administration in healthy adults.
    


Intervention name(s): Sitravatinib; Sitravatinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally as a free base capsule; Administered orally as a malate salt capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epidural Magnesium Sulfate for Post-thoracotomy Pain Control
Condition: Pain
Study type: Interventional

Summary: 
      Pain after thoracotomy is very severe and may cause pulmonary complications. Thoracic
      epidural analgesia has greatly decreased the pain experience and its consequences. However,
      new ways of decreasing post-operative opioid drugs consumption is an important issue of
      research. We aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine
      and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty
      patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled
      in a randomized double blind trial. Patients randomly will be allocated in two groups.
      Bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients
      at the end of operation. Patients in group I will be received epidural magnesium sulfate (50
      mg) and patients in Group II will be received normal saline as an adjuvant. Visual analog
      scale (VAS) score and the amount of morphine consumption will be measured during 24 hours
      post-operation.
    


Intervention name(s): magnesium sulfate; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 2cc of magnesium sulfate ( 50%) will be administered epidurally; 2cc of normal saline will be administered epidurally
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Promoting Development in Toddlers With Communication Delays
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Eighty parent-child dyads will be recruited and randomly assigned to either the experimental
      intervention or an active control condition. Subjects assigned to the experimental group will
      participate in 12 home-based intervention sessions.
    

Detailed description: 
      The experimental intervention is manualized, follows an illustrated workbook for parents, and
      uses individualized video-feedback, modeling, and coaching strategies to help parents
      establish play interactions that promote communication. All participants take part in
      comprehensive baseline and post-intervention/post-active control assessments, as well as 6-
      and 12-month follow up assessments. Families in the active control group will also be invited
      to participate in an oral feedback session to discuss the results from these assessments.
      Children's involvement in other forms of intervention will be monitored using a validated
      intervention log so that the moderating effects of these treatments can be examined.

      By targeting parent-child interactions, the current intervention ensures that new child
      behaviors generalize beyond the immediate context of the intervention and are maintained over
      time (Schreibman, 2000). In addition, by involving parents in the treatment of their children
      (e.g., by establishing a daily playtime routine), the current intervention ensures that the
      intervention strategies are implemented with sufficient intensity for causing developmental
      change (National Research Council, 2001).
    

Intervention name(s): Active Control vs Experimental Treatment
Intervention type(s): Behavioral
Intervention description(s): The parent education program involves 12 in-home training sessions (90 minutes each), is administered by trained graduate and postdoctoral students in developmental psychology or a related field, and follows a standardized treatment manual (Siller, 2005). The active control involves three 90 minute in-home training sessions. These training sessions will be administered by trained graduate students or a postdoctoral student in a developmental psychology or related field. The active control will follow a standardized treatment manual (Kasari, 2008). This treatment manual was based upon the teacher training workshops created by the Center on the Social and Emotional Foundations for Early Learning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: maternal synchrony; parent-child; parent child play; social communication