bioihbjkbjnl/mcl2 huggingface dataset:
Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug
      combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib
      and aromatase inhibitor letrozole) as a first or second line of therapy in patients with
      metastatic hormone receptor positive and HER2-positive breast cancer.
    

Detailed description: 
      This is a multicenter, single arm, open-label, run-in phase Ib / roll-over phase II study of
      novel HER2-targeted tyrosine kinase inhibitor tucatinib in combination with CDK4/6 inhibitor
      palbociclib and aromatase inhibitor letrozole in subjects with HR+/HER2+ locally advanced
      unresectable or metastatic breast cancer. The study will enroll post-menopausal women and
      premenopausal women if on treatment with or willing to be treated with standard ovarian
      suppression. The phase Ib part of the study will determine safety and tolerability of the
      combination of tucatinib, palbociclib and letrozole to confirm that current RP2D of tucatinib
      and FDA approved dosing of palbociclib remains the same in the triplet combination. The dose
      of letrozole will be constant through the study period. Once the safety of the combination is
      established, we will move to the phase II part of the study in the expansion cohort of
      subjects at RP2D for the purpose of assessing efficacy while further refining assessment of
      safety of the combination treatment.
    

Intervention name(s): Tucatinib in Combination with Palbociclib and Letrozole; Tucatinib in Combination with Palbociclib and Letrozole
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose of combination therapy :
Tucatinib 300 mg PO BID Palbociclib 125 mg PO daily 21 day on, 7 days off Letrozole 2.5 mg PO daily; Subjects Tucatinib 300 mg PO BID Palbociclib 75mg PO daily 21 days on followed by 7 days off Letrozole 2.5 mg PO daily.
Other intervention name(s): ONT-380; IBRANCE; Femara; ONT-380; IBRANCE; Femara
Intervention MeSH terms: Letrozole; Palbociclib; Tucatinib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Breast Cancer; Tucatinib; Palbociclib; Letrozole; HR-positive; HER2-positive; ER-positive; PR-positive; HER2-targeted therapy; CDK4/6 inhibitor; ONT-380; Ibrance
VenaSeal Sapheon Closure System Pivotal Study (VeClose)
Condition: Great Saphenous Vein (GSV) With Venous Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal
      study in which patients with venous reflux in the great saphenous vein (GSV) were treated
      with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA)
      therapy.
    

Detailed description: 
      The purpose of the VeClose study was to demonstrate safety and effectiveness of the VenaSeal
      SCS as being both 1) non-inferior to RFA therapy in achieving anatomical closure of lower
      extremity superficial truncal veins in patients with venous reflux through endovascular
      transcatheter embolization with coaptation of the GSV at 3 months, and 2) superior in the
      reduction of intraprocedural and post procedural pain and symptoms as compared to treatment
      with RFA.

      The study was designed to demonstrate safety of the VenaSeal SCS by follow-up visits that
      evaluated, via duplex ultrasound and physical exam, the presence of deep vein thrombosis
      and/or pulmonary embolus.
    

Intervention name(s): VenaSeal SCS; ClosureFast Radiofrequency Ablation (RFA); Roll-in (VenaSeal SCS)
Intervention type(s): Device; Device; Device
Intervention description(s): Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.; Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.; Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Other intervention name(s): VenaSeal Sapheon Closure System; VSCS; ClosureFast; VenaSeal Sapheon Closure System; VSCS; Roll-in
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSV
Strongest Families (Formerly Family Help Program): Pediatric Anxiety
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the
      effectiveness of the Strongest Families distance intervention compared to usual or standard
      care that is typically provided to children with mild to moderate Anxiety symptomology. This
      is a single-center trial based at the IWK Health Center. The primary outcome is change in
      diagnosis.
    

Detailed description: 
      The purpose of the Strongest Families (formerly Family Help Program)is to deliver, primary
      care mental health services to children and their families in the comfort and privacy of
      their own home. Approximately 128 children (6-12 years of age)suffering from mild to moderate
      (but clinically significant) symptoms of pediatric anxiety will be randomized.

      The intervention is delivered from a distance, using educational materials (manuals,
      video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach"
      who is supervised by a licensed health care professional. The telephone coach delivers
      consistent care based on written protocols, with on-going evaluation by a professional team.

      Fifty percent of the eligible participants will receive Strongest Families (formerly Family
      Help Program) telephone-based treatment and 50% will be referred back to their family
      physician to receive standard care as determined by that physician. Those receiving standard
      care will be evaluated for outcome results and then compared to the Family Help treated
      participants. It is anticipated that Family Help treatment will be proven to be as or more
      effective than standard care.
    

Intervention name(s): Strongest Families (formerly Family Help Program): Anxiety Program
Intervention type(s): Behavioral
Intervention description(s): Evidence-based psychological and behavioural distance intervention
Other intervention name(s): Strongest Families (formerly Family Help Program)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Ready to Act - Health Education in People With Hyperglycaemia
Condition: Type 2 Diabetes Mellitus; Behavior
MeSH terms: Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional

Summary: 
      A pre-randomized study in primary health care was designed to investigate health education in
      a subpopulation extracted from general practitioners (GPs) in one Danish county in the
      treatment arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with
      Screen-Detected Diabetes in Primary Care) study, DK. The overall objective of the 'Ready to
      Act' health education programme was to support the participants' competences in daily life
      and act appropriately with respect to their dysglycaemic condition. The achievement of action
      competence involved four learning objectives: intrinsic motivation, informed decision-making,
      action experience and social involvement. The programme was delivered in primary care
      settings (health centre or GP surgeries) by nurses, dieticians, physiotherapists and GPs.
    


Intervention name(s): Ready to act
Intervention type(s): Behavioral
Intervention description(s): The Ready to Act programme aimed to promote health-related action competence including motivation, informed decision-making, action experience and social involvement The intervention was delivered across a number of primary care settings including the GP office, health centre and pharmacy. The programme consisted of two individual counselling interviews and eight group sessions, which totalled 18 hours within a three month period.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention; Screening; Type 2 diabetes; Action Competence; Family practice; Health Services Research
A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
Condition: Primary or Secondary Antibody Deficiency
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine:

        1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency
           (PAD or SAD).

        2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.

        3. The half-life of Vigam® Liquid after 4 months of treatment.

        4. The subclass and total gammaglobulin concentrations after each infusion of Vigam®
           Liquid.
    


Intervention name(s): Vigam® (Human Normal Immunoglobulin)
Intervention type(s): Biological
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Primary purpose: Treatment
Clinical Test for Armed-used Blood Pressure Monitor With Preformed Cuff
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to monitor the blood pressure level of the patient using a
      preformed cuff ranged 22 cm-36 cm.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        resident of a community.
      
Keywords: BP
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Condition: HIV Infections; Cytopenias
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Leukopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of
      sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human
      granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC )
      injection to patients with leukopenia in association with HIV infection.
    


Intervention name(s): Sargramostim
Intervention type(s): Drug
Intervention MeSH terms: Sargramostim
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukopenia; Drug Evaluation; Granulocyte-Macrophage Colony-Stimulating Factor
Dose-response of Albuterol in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine the lung function response after increasing doses
      of albuterol (a bronchodilator) in children and adults with asthma.
    

Detailed description: 
      Inhaled short-acting b2-agonists (SABA) are the most potent bronchodilators used today to
      treat acute symptoms of asthma and albuterol, a partial b2-agonist, is the most frequently
      prescribed asthma medication in the US. Although universally used in for acute asthma
      symptoms, SABA have been associated with a significant degree of interpatient variability.
      Many studies have characterized the SABA dose to bronchodilator response relationship under
      controlled conditions. However, few studies have explored the magnitude and sources of
      bronchodilator response variability, and no studies have characterized the dose versus
      bronchodilator response relationship using population pharmacokinetic/pharmacodynamic
      (PPK/PD) modeling. In the present study, we characterized the relationship between inhaled
      doses of albuterol and bronchodilation in 81 children and adults with moderate to severe
      persistent asthma using a population pharmacodynamic approach. The purpose of this study was
      to obtain estimates of the pharmacodynamic parameters that characterize the dose-response
      curve, including maximal dose for bronchodilation, and to quantify and identify sources of
      interpatient pharmacodynamic variability.
    

Intervention name(s): albuterol
Intervention type(s): Drug
Intervention description(s): Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)
Other intervention name(s): Proventil MDI; Proventil solution for nebulization
Intervention MeSH terms: Albuterol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Albuterol; Forced expiratory volume in one second; Dose at fifty percent of maximum effect; Maximum effective dose; Metered dose inhaler; Nebulizer
Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis
Condition: Gastroesophageal Reflux Disease (GERD); Chronic Laryngitis
MeSH terms: Laryngitis; Gastroesophageal Reflux; Croup
Study type: Observational

Summary: 
      -  Saliva plays a key role in the homeostasis of the digestive tract

        -  The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal
           and pharyngeal mucosas

        -  There seems to be no correlation between the severity of reflux episodes and the
           intensity of inflammatory changes, suggesting individual protective mechanisms to
           refluxate exposure

        -  Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux
           Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis
           (Laryngopharyngeal Reflux- LPR)

        -  Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in
           patients with GERD and LPR, but it is unclear if these are primary or secondary to the
           disease.

        -  Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis
           is primary and therefore would not change after treatment and control of the disease
    

Detailed description: 
      Background & Aims: Gastroesophageal Reflux Disease (GERD) is known to affect the upper
      airways and may cause a variety of inflammatory changes in the pharynx and larynx. The
      pathophysiology of the supraesophageal forms of GERD is widely unknown. Studies have
      suggested decreased salivary epidermal growth factor (EGF) concentrations in patients with
      reflux esophagitis and laryngitis. It is however unclear if these abnormalities are primary
      or secondary. The aim of the current cohort study was to compare salivary EGF concentrations
      in adults with reflux laryngitis before and after treatment and control of the disease to
      that of healthy individuals. Methods: Twenty-one patients with reflux laryngitis were studied
      prospectively at a tertiary teaching hospital. Spontaneous whole saliva was sampled before
      and after a 16-week course of full dose proton pump inhibitor (PPI) twice daily and compared
      to that of 13 healthy controls. Salivary EGF concentrations were established using a
      commercially available Elisa kit.
    

Intervention name(s): omeprazole
Intervention type(s): Drug
Intervention description(s): omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
Other intervention name(s): reflux group pre-treatment; reflux group post-treatment; control group
Intervention MeSH terms: Omeprazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        25 adults with reflux laryngitis 13 healthy controls
      
Biospecimen description: 
      whole saliva
    
Keywords: Larynx; GERD; saliva; epidermal growth factor
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
Condition: Group B Streptococcus (GBS) Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal
      vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody
      levels.
    


Intervention name(s): Group B streptococcus (GBS) vaccine
Intervention type(s): Biological
Intervention description(s): No vaccine will be administered in this study. Only one study visit is required.
Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P1 study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Group B streptococcus; GBS; Vaccine
Evaluation of INRS With BCSK in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.
Condition: Spastic Diplegia Cerebral Palsy
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      A randomized control trial investigating "Biomechanical Correction of the Spine according to
      Kozyavkin" (BCSK) which is a part of the treatment concept "Intensive Neurophysiological
      Rehabilitation System" (INRS). BCSK is used with the aims to reduce muscle tone and improve
      gross and fine motor function in children with Spastic Bilateral Cerebral Palsy.
    

Detailed description: 
      The study is a collaboration between the International Clinic of Rehabilitation (ICR) in
      Ukraine and the Karolinska Institute (KI) in Sweden. The intervention and the assessments are
      performed at ICR. The primary outcome measure, evaluation of gross motor function with the
      test GMFM 66 is filmed and the recordings are transferred to KI together with all assessment
      data. KI are responsible for study research design and collects, analyzes and processes all
      data. It is a double blinded study. Only two persons will know to which group the subject
      belongs, the person performing the randomization process in Sweden and the doctor performing
      the spinal corrections.

      There are two aims of the study;

        1. To evaluate the effect of "Biomechanical Correction of the Spine" (BCSK) in children
           with Spastic Bilateral Cerebral Palsy.

        2. To evaluate the effect of "Intensive Neurophysiological Rehabilitation System" (INRS) in
           children with Spastic Bilateral Cerebral Palsy.
    

Intervention name(s): BCSK; Traditional spinal manipulation; INRS
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The "BCSK" is a specific technique of polysegmental spinal manipulation developed by Professor Kozyavkin based on applying quick short impulse aimed on moving intervertebral joints outside restrictive barrier.; Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.; The "INRS" is a treatment program developed at the International Clinic of Rehabilitation where the spinal manipulation is one of several components. There may be some variation in treatment depending on the clinical situation. All children receive the main treatment components which are massage, physical therapy, warm wax and paraffin applications and low electro stimulation with a special portable device as a part of treatment called "Reflexotherapy".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy, spastic, diplegic,; children,; intervention study,; manipulation, spinal; randomized controlled trial
Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans
Condition: Alcohol Consumption; Tobacco Use
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the interactive effects of acute intravenous
      (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use
      alcohol.
    


Intervention name(s): Nicotine; Ethanol
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 microg/kg/min IV x 10 minutes; IV
Intervention MeSH terms: Ethanol; Nicotine
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Alcohol, nicotine
Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study devised an experimental focused pharmaceutical care program, allowed a clinical
      pharmacist to work in a physician office to assess and manage patients' metabolic syndrome
      status and its individual components. This study described the clinical benefits of
      physician- clinical pharmacist interaction in achieving improved glycemic control, lipid and
      blood pressure measurements, involving medication, diet, physical activity and patient heath
      care counseling.
    

Detailed description: 
      A single blinded prospective randomized controlled trial conducted in family medicine
      outpatients clinics in Jordan. The study enrolled 199 patients met the National Cholesterol
      Education Program Adult Treatment Panel III (NCEP/ATPIII) criteria for the diagnosis of MS
      upon the time of enrollment. Patients were randomized into: 110 participants into the
      intervention arm (pharmacist-physician collaborative approach) and 89 into the control arm
      (physician only team). Only patients in the intervention arm were provided pharmacist
      recommendations and pharmaceutical care counseling.
    

Intervention name(s): Pharmaceutical care services
Intervention type(s): Other
Intervention description(s): Patients' metabolic components were assessed and managed collaboratively by focused care plan designed by the clinical pharmacist and approved by the physician.Pharmacist emphasized the change in lifestyle, particularly weight loss and physical activity as a first line therapy for at least 3 months, patients were started on drug therapy when needed as recommended by clinical guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
Condition: Knee Injury
MeSH terms: Knee Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to test the ability of an allograft plug to provide a
      successful repair of an osteochondral defect left at the harvest site during OATS procedure.
    

Detailed description: 
      The objective of this study is to determine how effective a plug made out of human bone
      (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby
      filling the hole created during the OATS procedure.At the present, OATS is used for knee
      articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the
      areas that bear weight have been commonly treated by using a tiny cylinder of the subjects'
      own tissue called an osteochondral autograft (OATS).
    

Intervention name(s): CR Plug
Intervention type(s): Other
Intervention description(s): CR Plug will be placed in the harvest site
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cartilage injury; OATS; Knee injury; allograft; autograft