bioihbjkbjnl/mcl2 huggingface dataset:
Psychological Counselling in Diagnostic Screening
Condition: Cancer
Study type: Interventional

Summary: 
      Diagnostic tests have a deep emotional impact on oncology patients. Anxiety and worries can
      lead people to avoid screening tests, with high risks for health. A single arm, pilot study
      was organized to evaluate the feasibility and efficacy of psychological counselling for
      cancer patients who demonstrated anxiety for diagnostic tests. The hypothesis was that taking
      part in Psychoeducative Training could offer a new modality to reduce anxiety, before and
      during tests, and also the possibility to reinforce coping strategies.
    

Detailed description: 
      The Psychoeducative Training was organized in 6 weekly meetings lasting two hours. Each group
      was composed of 6 participants. The Training follows the cognitive-behavioural model. In the
      first part of every meeting, theoretical aspects about stress and anxiety were explained,
      while in the second part some relaxation techniques were taught. During relaxation, we used a
      selected music that was also going to be used during the diagnostic tests. Since the first
      meeting, patients experienced these relaxing techniques in order to learn them. In order to
      support the adaptability, at the end of every meeting the participants received some
      homework. They had to take notes on how many times they repeated the relaxation exercises and
      on the anxiety level before and after the training.

      For the study, 43 people were recruited. Anxiety was measured with Beck Anxiety Inventory
      (BAI); it values the seriousness of the physiological behaviour connected with anxiety. This
      test an "anxiety gauge", which allows us to obtain numerical data on emotional changes. The
      test is composed of 4 interpretative levels: serious, moderate, small and minimal anxiety.

      The coping style was measured with Coping Orientation to Problems Experienced-New Italian
      Version (COPE-NIV); this test evaluates the way in which people resolve and face traumatic or
      usual stressful situations.

      The research project was approved by the Ethics Committee of Veneto Institute of Oncology.

      Every patient signed a written informed consent to process the data for research purposes and
      to publish it.

      Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI,
      Mammography, Endoscopy, Colonoscopy) took part in the study. The average age was 52.4 and
      61.5% were married.
    

Intervention name(s): Psychoeducative training
Intervention type(s): Behavioral
Intervention description(s): The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
Other intervention name(s): Systematic Desensitization; Psychological counseling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: anxiety; psychoeducational training; coping; relaxation
Optimising the Propranolol Block Model
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Optimising the propranolol block model
    

Detailed description: 
      The bronchodilatory effects of inhaled beta2 agonists and anti-muscarinic drugs are the
      mainstay of symptomatic treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD).
      A new approach is to combine both pharmacological approaches in a single molecule - ie a dual
      pharmacophore. It will be necessary to explore the relative contribution of the beta2 agonist
      versus anti-muscarinic bronchodilator properties of such a molecule. One way to do that is to
      block one of the components. Inhibition of beta2 agonist-mediated bronchodilatation by the
      non-selective beta-blocker propranolol is an established experimental method. Therefore this
      method may be useful in exploring the pharmacology of a dual pharmacophore.

      Published studies have generally looked at the effect of a single dose of propranolol on a
      beta2 agonist over a relatively short period of time (a few hours). There is a desire to
      develop long acting bronchodilators that require once daily dosing only. Thus any dual
      pharmacophore developed is likely to have 24 hour duration of action after a single dose.
      Therefore to use this method of beta blockade to inhibit beta2 agonist mediated
      bronchodilation, it is necessary to confirm a dosing regimen of propranolol that has
      acceptable tolerability and is effective in blocking the effects of a beta2 agonist over 24
      hours. That is the main purpose of this study.

      It is also important to confirm that the bronchodilator effect of an antimuscarinic is
      unaffected by beta blockade. In addition, it is of interest to examine the bronchodilator
      effect of a combination of an antimuscarinic and beta2 agonist in healthy volunteers and the
      effect of propranolol on the combination.
    

Intervention name(s): Propranolol; Salbutamol; Ipratropium; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 40 mg tablets; Metered dose inhaler (600 μg); Metered dose inhaler (40 μg); Placebo for propranolol tablets
Intervention MeSH terms: Propranolol; Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Subjects; muscarinic receptor antagonist; propranolol; beta-blocker; beta-agonist
Role of the Isomerase Pin-1 in the Development and Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil
      survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal
      pathways in multiple cells in asthma.
    

Detailed description: 
      The investigators will test their hypothesis that Pin1 regulates TLR/IL-1R signaling pathways
      in asthma by examining Pin1 and related pathway activation in BAL-derived eosinophils after
      house dust mite allergen challenge. The investigators will perform segmental allergen
      challenge. BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr
      later and activation of Pin1 and related pathways will be examined.
    

Intervention name(s): installation of D. pteronyssinus allergens
Intervention type(s): Biological
Intervention description(s): We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Other intervention name(s): D. pteronyssinus allergens exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Role of Pin-1 enzyme in Asthma
Systemic Vitamin D Supplementation in Dental Implants Patients
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation
      and remodeling.
    

Detailed description: 
      Evidence has demonstrated that vitamin D deficiency plays an important role in dental
      implants outcomes.

      Low serum levels of Vitamin D is considered as a risk factor, not only for low mineral bone
      density but also in other metabolic pathways such as those involved in immune response and
      chronic inflammatory diseases.

      There are few studies demonstrating the role that vitamin D deficiency in the
      etiopathogenesis of oral diseases and the consequences in Dental Implants.

      Dentists have not yet well understood the importance of a good bone metabolism response for a
      successful bone regeneration and osseointegration of implants.

      An insufficient bone response can not guarantee the necessary stability of the implants
      placed in it, has been one of the biggest problems of implantology.

      Thus, the aim of this study is to evaluate the efficacy of Systemic vitamin D supplementation
      in menopausal women cadidates for dental implants.
    

Intervention name(s): Vit D
Intervention type(s): Drug
Intervention description(s): 20 mg/day
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacotherapy in Depression With Panic Spectrum
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This research study is being conducted to find out if certain individuals benefit from taking
      medication for their depression with a low dose of the antidepressant medication Zoloft.
    

Detailed description: 
      Researchers at the University of Pittsburgh Medical Center Health System are currently
      recruiting men and women, ages 18 to 60, to examine the effectiveness of the FDA-approved
      medication sertraline (Zoloft) for major depression.

      Participants will be randomly assigned to one of two groups. Each group will begin and
      continue taking Zoloft at different doses. A physician will follow eligible participants
      weekly for approximately 12 weeks
    

Intervention name(s): sertraline hydrochloride
Intervention type(s): Drug
Intervention description(s): The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines.
Other intervention name(s): sertraline hydrochloride low versus high dose titration
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: depression; anxiety
A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Condition: Active Non-segmental Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an
      extension period. The study will have a maximum duration of approximately 60 weeks. This
      includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week
      extension period and a 8 week Follow up Period.
    


Intervention name(s): PF-06651600; PF-06651600; PF-06651600; PF-06651600; PF-06651600; placebo; PF06700841; narrow-band UVB phototherapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Device
Intervention description(s): Induction dose 1. Oral tablet taken QD; Induction dose 2. Oral tablet taken QD; Maintenance dose A. Oral tablet taken QD; Maintenance Dose B. Oral tablet taken QD; Maintenance Dose C. Oral tablet taken QD; placebo; Oral tablet taken QD; Phototherapy will be combined with PF-06651600
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose ranging period is a parallel design. Extension period is a sequential design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Examining the Long-Term Risks of Oophorectomy
Condition: Coronary Heart Disease; Stroke; Breast Cancer; Ovarian Cancer; Cancer; Hip Fracture; Death
MeSH terms: Ovarian Neoplasms; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hip Fractures
Study type: Observational

Summary: 
      At the time of hysterectomy for benign disease, the overall health benefits of preserving
      ovarian function in a large population of women have not been established.
    

Detailed description: 
      We are conducting a prospective, observational study of 32,175 women participants of the
      Nurse's Health Study who had a hysterectomy with or without removal of both ovaries. We are
      evaluating mortality and morbidity due to the following conditions: coronary heart disease,
      stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nurses' Health Study I, which included 122,701 married registered nurses living in 11 U.S.
        states and who were ages 30 to 55 in 1976
      
Keywords: oophorectomy; ovarian conservation; stroke; breast cancer; ovarian cancer; other cancer; hip fracture
The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers
Condition: Smoking
Study type: Interventional

Summary: 
      A total of 20 subjects will participate in this four week, between groups, double-blind,
      placebo controlled study. Subjects will participate in two experimental sessions separated by
      approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or
      placebo combined with cue exposure. Several physiological and subjective outcome measures
      (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the
      sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions
      lasting approximately thirty minutes. Our aims are:

        1. To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity
           in overnight abstinent smokers. Reactivity to smoking cues will be captured with
           self-report smoking urges and physiological measures (heart rate, blood pressure, and
           skin conductance).

           We hypothesize that cycloserine, relative to placebo, will facilitate extinction of
           smoking cue reactivity.

        2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour
           laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking
           behavior will be measured with self-report smoking and saliva cotinine levels.

        3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine
           dependent smokers. Memory performance will be measured with verbal learning, recognition
           and recall tasks.

      4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize
      that cycloserine will be well tolerated by smokers.
    


Intervention name(s): Cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg Cycloserine given in two separate experimental sessions separated by approximately one week.; Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.
Other intervention name(s): Closina Aspen, Austral.; Cycloserine Capsules USP 29; Cycloserine (TM)King, UK; D-cycloserin IFET (IFET), Gr.; Proserine Hawon, Thai.; Seromycin - 250 MG - Capsule Dura Pharmaceuticals; Seromycin - 250 MG - Oral Capsule Eli Lilly; Seromycin (FM) Lilly, Canad.; Seromycin Dura, USA; Seromycin Lilly, Hong Kong; Seromycin With Isoniazid - 250 MG - Capsule Eli Lilly; Siklocap
Intervention MeSH terms: Isoniazid; Cycloserine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Tailored Therapy for Helicobacter Pylori Rescue Treatment
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      With increasing antibiotic resistance and unsatisfactory results of empiric eradication
      regimens, tailored therapy may be the best choice to achieve high efficacy for rescue
      treatment. This study aimed to evaluate the eradication rates, safety, and compliance of
      antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with
      Helicobacter pylori infection.
    


Intervention name(s): esomeprazole; bismuth Potassium Citrate; amoxicillin; clarithromycin; metronidazole; levofloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): proton pump inhibitor; gastric mucosal protective drug with anti-H. pylori effect; antibiotic for H. pylori eradication; antibiotic for H. pylori eradication; antibiotic for H. pylori eradication; antibiotic for H. pylori eradication
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Levofloxacin; Potassium Citrate; Esomeprazole; Bismuth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Rescue therapy; Tailored therapy; Antimicrobial susceptibility testing
Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer
Condition: Brain Metastases From Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of veliparib and
      whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer
      (NSCLC).
    


Intervention name(s): Veliparib; Placebo; Whole brain radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Veliparib capsules for oral administration; Placebo to veliparib capsules for oral administration; 30.0 grays (Gy) of WBRT given in 10 daily fractions of 3.0 Gy each, excluding weekends and holidays
Other intervention name(s): ABT-888
Intervention MeSH terms: Veliparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Bone Mineral Density and Trabecular Bone Score in Patients With Ankylosing Spondylitis
Condition: AS
MeSH terms: Spondylitis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      Osteoporosis is a common complication of AS even in the early stages of disease. Yet, AS is
      also characterized by new bone growth that leads to syndesmophytes formation and subsequent
      vertebral ankyloses.
    

Detailed description: 
      Accordingly, previously-published studies have demonstrated large discrepancies in the
      reported incidence of osteoporosis, based on measurement of bone mineral density (BMD), in
      patients with AS ranging from 18.7% to 62%. Measurement of trabecular bone score (TBS) is a
      novel tool used to evaluate bone microarchitecture. Aim of the work: to compare bone quality
      using TBS between AS patients and healthy controls and to evaluate factors associated with
      TBS in patients with AS. Patients and methods: A total of 40 male AS patients recruited from
      Outpatient Clinic of Rheumatology, Mansoura University Hospital. 40 age-matched healthy males
      as matched control. TBS was analyzed using DXA images over exactly the same region as the
      lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight
      software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups
      according to guidelines for fracture risk: any TBS >1.31 was considered as normal; TBS values
      between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS <1.23 was
      considered as degraded structure
    

Intervention name(s): Bone Mineral Density and Trabecular Bone score
Intervention type(s): Device
Intervention description(s): structural damage in the cervical and lumbar spine was scored according to the modified Stoke AS Spinal Score (mSASSS) which yielded a final summation score ranging from zero to 72.
BMD was measured using DXA (Lunar Prodigy densitometer, GE Healthcare, Madison, WI, USA).
BMD was measured at the lumbar spine (L1-L4) and the left hip (femoral neck and total proximal femur).
TBS was analyzed using DXA images over exactly the same region as the lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups according to guidelines for fracture risk [22]: any TBS >1.31 was considered as normal; TBS values between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS <1.23 was considered as degraded structure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pharmacokinetics Study for Probucol
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in
      healthy male subjects.
    

Detailed description: 
      To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of
      one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol
      tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily
      after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.
    

Intervention name(s): probucol; probucol; probucol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): group 3: 250 mg 1 tablet in the morning and evening; group 1: 250 mg; group 2: 250 mg 2 tablets at once in the morning
Other intervention name(s): Brand name: Lorelco; lorelco; Lorelco
Intervention MeSH terms: Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: PK assessment for healthy male volunteer; Healthy male subjects aged 20 to 40 years