bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations
      change over time) of abiraterone acetate after oral administration of abiraterone acetate at
      different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under
      fasted conditions.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (the
      treatment sequence is assigned by chance), 3-way crossover study (method used to switch
      participants from one dose level to another in a clinical study) of single doses of
      abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases:
      screening, open-label treatment, and follow up phases. After screening, randomly assigned
      participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg;
      Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods
      according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 =
      BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period
      (period when participant is not receiving any study medication) of at least 7 days. In the
      follow-up phase, study-related adverse events will be monitored by the investigator. Serial
      blood samples for pharmacokinetic analysis will be collected and safety will be monitored
      throughout the study. The total study duration will be approximately 42 days.
    

Intervention name(s): Treatment A: abiraterone acetate; Treatment B: abiraterone acetate; Treatment C: abiraterone acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250 mg/day tablet administered orally on Day 1 of each treatment period.; 500 mg/day tablets administered orally on Day 1 of each treatment period.; 1000 mg/day tablets administered orally on Day 1 of each treatment period.
Other intervention name(s): ZYTIGA; ZYTIGA; ZYTIGA
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Pharmacokinetics; Abiraterone acetate; Abiraterone; JNJ-212082; Zytiga; Chinese; Fasted
Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis
Condition: Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease
Study type: Interventional

Summary: 
      The purpose of this research study is to examine the effects of two weeks of daily dosing of
      inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and
      cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary
      Disease (COPD.

      Defective mucociliary clearance (MCC) is central to the development and/or worsening of
      several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis (CF),
      and bronchiectasis. In each case, defective MCC leads to the development of lung infections
      and damage to the airways from ongoing inflammation caused by a person's inability to clear
      mucus from the lungs.

      The investigators' previous studies have shown that the administration of inhaled HS
      (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use
      "resets" the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of
      HS on MCC was responsible for the ~60% reduction in the frequency of pulmonary disease
      exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS
      in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and
      its success raises optimism that similar benefits might occur in patients with CB.

      In this study the investigators will use mildly radioactive particles, technetium bound to
      sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks
      of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects with
      CB. We will also be collecting sputum and breath condensation to analyze for protein and
      inflammatory changes that might occur with exacerbations.

      Our long term goals are to improve our understanding of MCC in health and disease and to
      develop better therapies that support and/or restore MCC in patients with these diseases to
      reduce lung infections.
    


Intervention name(s): Inhaled 7% HS (NaCl) home treatment
Intervention type(s): Other
Intervention description(s): Administering inhaled 7% NaCl for two weeks of home treatment vs. a placebo of 0.12% NaCL during a separate home treatment period, and assessing the effects of each primarily by MCC study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Chronic Bronchitis; Hypertonic Saline
Follicle Activation by Inhibition of the Hippo Pathway
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim of this project is to activate recruitment and growth of resting primordial follicles
      in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to
      become pregnant, either naturally or after assisted reproduction.
    

Detailed description: 
      For this study investigators will carefully select 20 women with low AMH and imminent POI.

      They will be randomized to have cortical ovarian biopsies taken from either the left or right
      ovary. The biopsies will be fragmented in 1x1 mm2 pieces and immediately auto-transplanted in
      a peritoneal pocket under the right ovary.

      The contralateral untouched ovary will act as the control, making each woman their own
      control.

      Follow up: each week in 2,5 months the women will be assessed by transvaginal ultrasound and
      hormonal status. After 2,5-6 months the women will receive a FSH stimulation cycle (rFSH 300
      IU or Corifollitropin) followed by standard IVF/ICSI,

      Hypothesis: the ovaries contain a pool of resting primordial follicles. By fragmentation of
      cortical ovarian tissue, manipulation of the local environment in the tissue will inhibit the
      Hippo Pathway and hereby active recruitment and growth of primordial follicles.
    

Intervention name(s): Biopsy of ovarian cortical tissue
Intervention type(s): Procedure
Intervention description(s): Biopsies will be taken from either right or left side. The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: IVA; Hippo Pathway; Follicle activation; Low Responder; POI; Poor Ovarian Reserve; Poor Ovarian Response; Salvador/Warts/Hippo pathway
Cognitive Processing Therapy for Syrian Patients With PTSD
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Background: Studies among Syrian refugees showed high prevalence rates of PTSD. The objective
      of the present study was to investigate the effectiveness of Cognitive Processing Therapy
      (CPT) in treating patients with posttraumatic stress disorder (PTSD) using a clinical trial.
      Methods: Data will be obtained through interviewing patients seeking for PTSD treatment.
      Patients will be interviewed by a clinician and asked to complete the Clinician-Administered
      PTSD Scale (CAPS-5), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI).
      Assessments will be conducted at baseline, 3-, and 12-months posttreatment. The primary
      outcomes will be the scores of CAPS, BDI-II, and BAI. Results: we predict that CPT will
      result in greater reductions in CAPS scores.
    

Detailed description: 
      Although individuals with PTSD experience significant suffering, disability, and a
      challenging clinical course, there are still significant gaps in the evidence addressing
      effective treatment options. Therefore, in the current study CPT will determine the
      effectiveness in treating Syrian patients with PTSD. Current study significantly adds to the
      existing literature. It is a novel study in Egypt and adds to the literature.
    

Intervention name(s): Cognitive Processing Therapy (CPT)
Intervention type(s): Behavioral
Intervention description(s): Cognitive processing therapy (CPT) (Resick et al., 2016) which is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of Post-Traumatic Stress Disorder (PTSD) that may have developed after experiencing a variety of traumatic events including child abuse, emotional abuse, combat, rape war, and natural disasters. CPT helps patients learn how to challenge and modify unhelpful beliefs related to the trauma and emotional pain. In so doing, the client creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life.
Intervention model: Single Group Assignment
Intervention model description: Patients will be interviewed by a clinician and asked to complete the Clinician-Administered PTSD Scale (CAPS-5), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI). Assessments will be conducted at baseline, 3-, and 12-months post treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Processing Therapy (CPT); Posttraumatic stress disorder (PTSD); Syrians
Does Skyla Insertion Timing Impact Bleeding?
Condition: Vaginal Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      Women presenting for contraception will be offered the IUS Skyla and study participation.
      Daily bleeding will be collected for a total of 90 days and correlated with insertion timing
      and baseline endometrial thickness.
    


Intervention name(s): Intrauterine system
Intervention type(s): Device
Intervention description(s): Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.
Other intervention name(s): Intrauterine device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women presenting for intrauterine device insertion.
      
Keywords: intrauterine device; bleeding
The Role of Vitamin D in the Pathophysiology of Chronic Failure
Condition: Vitamin D Deficiency; Chronic Heart Failure
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients will undergo at baseline and regular intervals:

        -  clinically indicated bloodwork/urine and echocardiogram testing

        -  biomarker studies

      Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient
      and severely deficient. Normal and mild vitamin D levels will receive no treatment while
      severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D
      treatment. They will be seen in the heart failure clinic every 6 months. The patients will be
      followed for 26 months.
    

Detailed description: 
      The inclusion criteria for the study is:

        -  an EF ≤40% within the last 12 months before recruitment

        -  established diagnosis of heart failure

        -  >18 years of age

        -  patients will vitamin d levels of sufficient, mild deficiency and severe deficiency

      The exclusion criteria is:

        -  hypercalcemia

        -  known hypersensitivity to Vitamin D

        -  patient unwilling to comply with study requirements

        -  any other disease other than heart failure that can alter the patients quality of life
           over a period of 6 months

        -  women of child bearing potential

        -  a patient currently taking vitamin d

        -  severe renal impairment estimated glomerular filtration rate (eGFR) <30
    

Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to assess the single-dose relative bioavailability of Actavis Group
      hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fasting conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study
      of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy
      Adult Volunteers under Fasting Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose; Norvasc® 10 mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fasting conditions; B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fasting conditions
Other intervention name(s): amlodipine besylate; amlodipine; amlodipine besylate; amlodipine
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; amlodipine besylate; amlodipine; Healthy subjects
Hip Fracture in Individuals Under 60 Years of Age
Condition: Hip Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      This study prospectively analyses and describes a cohort of non-elderly hip fracture patients
      at four orthopaedic departments in two Scandinavian countries regarding epidemiology,
      treatment, Patient Reported Outcome Measures, functional outcome as well as clinical results.
    

Detailed description: 
      Hip fracture is common and well studied in the elderly population, but quite rare in the
      non-elderly and scarcely investigated in the literature. This prospective observational study
      focuses on individuals between 18 and 59 years old who have incurred a hip fracture and been
      treated at any of the participating orthopaedic departments in Sweden or Denmark. The study
      group is analysed and described at the time of the fracture and are followed during two
      years.

      The patients' treatment follows the departments' standard rationale, there is no intervention
      in the study. Patients are included, after being informed and consent to participate is
      given, at the ward when they are admitted at the time of the fracture. The study comprises
      written enquiries (Patient Reported Outcome Measures, PROM) regarding hip- and global health
      before the fracture as well as interview and medical files and x-ray information regarding
      previous illness and use of medication, information about the injury, fracture type and
      treatment. Blood samples are used to investigate possible comorbidities and evaluate the
      hormonal and nutritional status and dual energy x-ray absorptiometry (DXA) is analysed with
      regards to reduced bone mineral density (osteopenia/-porosis). For patients with a femoral
      neck fracture who are treated with osteosynthesis, MRI with metal reduction is performed
      post-operatively and at 4 and 12 months to assess fracture healing and avascular necrosis of
      the femoral head.

      Patients are followed up at 6 weeks by written PROM-enquiries by mail, and at 4, 12 and 24
      months post-operatively with x-ray and visits in the outpatient clinic.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Among hip fracture patients treated at the participating departments, patients aged 18 to
        59 years, who sustain an acute non-pathological hip fracture and are treated within four
        weeks, are invited to participate in the study. All patients are invited, regardless of
        medical, cognitive and functional pre-fracture status. The participating orthopaedic
        departments are part of local hospitals, treating all patients in the catchment area who
        seeks medical care at low (Sweden) or no cost (Denmark).
      
Keywords: hip fractures; adult; middle-aged; DXA-scan; osteoporosis
Treatment Time Comparing Digital & Conventional Workflows
Condition: Dental Implant
Study type: Interventional

Summary: 
      This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations
      out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside
      digital workflow (Test) and a conventional protocol (Control). The primary outcome was to
      investigate the treatment time of the overall operation. The null hypothesis of this RCT was
      that both workflows had comparable results with respect to the defined outcomes.
    


Intervention name(s): Treatment of implant single crown
Intervention type(s): Procedure
Intervention description(s): Digital or Conventional Workflows for treatment of implant single crown and materials used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Digital and conventional workflows for treatment of implant single crowns, and also the material used.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinical Research; Dental Implant; Digital Workflow; Crowns; Treatment time
Validity of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma
Condition: Cough Variant Asthma
MeSH terms: Asthma; Cough
Study type: Interventional

Summary: 
      The aim of the research is to evaluate the clinical value of fractional exhaled nitric
      oxide(FeNO) ,impulse oscillometry(IOS) and mid-expiratory flow (MEF) in patients with cough
      variant asthma.
    

Detailed description: 
      The present study has the following objectives:

      to evaluate the relationship between BHR and mid-expiratory flow, to assess the diagnostic
      accuracy of fractional exhaled nitric oxide，impulse oscillometry and mid-expiratory flow in
      CVA with special regard to its discriminating value between CVA and other causes of a chronic
      cough, to estimate prognostic value of BHR and fractional exhaled nitric oxide (FeNO) count
      in predicting response to asthma treatment.
    

Intervention name(s): fractional exhaled nitric oxide(FeNO); impulse oscillometry(IOS)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): FeNO level was evaluated according to the American Thoracic Society (ATS)/ERS recommendations using a NIOX MINO analyzer (Aerocrine, Solna, Sweden) .Subjects were informed to deeply inhale NO-free air and immediately exhale in full via a mouthpiece at a constant flow rate (50 ml/s) for 10s.; The patient take seats, body relax, make sure the mouthpiece is fully covered by mouth, then clip nose with both hands to cover both sides of the cheek, and then calm breathing 1 minutes, the computer is automatically collected data calculation and print out the measurement results.
Intervention MeSH terms: Nitric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cough variant asthma; chronic cough; fractional exhaled nitric oxide; impulse oscillometry; forced mid-expiratory flow
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
Condition: Adult Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and
      safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
    


Intervention name(s): Testosterone gel (FE 999303)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-73763989 in Healthy Japanese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of
      JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous
      administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2
      (Panel B) or Dose Level 3 (Panel C).
    


Intervention name(s): JNJ-73763989; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-73763989 as single subcutaneous injection.; Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
Condition: Melanoma; Liver Cancer; Pancreatic Cancer; Lung Cancer
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds
      of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.
    


Intervention name(s): Recombinant hGM-CSF Herpes Simplex Virus Injection
Intervention type(s): Biological
Other intervention name(s): OrienX010
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment