bioihbjkbjnl/mcl2 huggingface dataset:
A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, parallel group study will evaluate the effect of renal function on the
      pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and
      assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or
      females with either normal renal function or mild or moderate renal impairment will receive
      RO5024048 orally for 5 days. Target sample size is <50.
    


Intervention name(s): RO5024048
Intervention type(s): Drug
Intervention description(s): multiple oral doses for 5 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Study of Donated Amnion, Fetal Placental Membrane, as Skin Substitute for Burn Patients
Condition: Wounds
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair
      safe and efficacious.

      Will the incorporation of liposomal gene constructs to amnion enhance the functionality of
      human amnion and improve wound repair.
    


Intervention name(s): blood draw
Intervention type(s): Procedure
Intervention description(s): blood collection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Burns; Wound healing; Amnion
Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles
Condition: Décolleté Wrinkles
Study type: Interventional

Summary: 
      To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté
      wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.
    


Intervention name(s): MRZF111
Intervention type(s): Device
Intervention description(s): MRZF111 kit consisting of one syringe of RADIESSE® Volume injectable implant, injection needles and additional components. Physiological saline solution (0.9% NaCl) is used to dilute Radiesse Volume by 1:2. Radiesse consists of calcium hydroxylapatite particles suspended in an aqueous-based gel carrier.
Other intervention name(s): Radiesse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Indicated Prevention of Psychotic Disorders With Low-dose Lithium
Condition: Schizophrenia; Bipolar Disorder; Psychotic Disorders
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the neuroprotective properties of low-dose lithium in young
      individuals at ultra-high risk of developping a first psychotic episode. Fourty individuals
      having some symptoms of an emerging psychotic disorders (without meeting the threshold for a
      full-blown mental illness) will be treated with a low dose of lithium (about a third of the
      dose that is usually used to treat acute mania). We will assess the progression of the
      conditions of these individuals on a montly bases for a year. We will do behavioural,
      cognitive and imaging assessments prior start of the treatment, after three months and one
      year. We hope to demonstrate that low dose lithium will stop or even reverse the progression
      of disease. We expect that behavioral, cognitive and in vivo brain imaging parameters in
      those individuals treated with low dose lithium improve, compared to the monitoring group.
    

Detailed description: 
      To investigate whether low-dose lithium is an effective agent in indicated prevention amongst
      subjects at ultra-high risk of developing a psychotic disorder. This aim will be achieved by
      treating a high-risk patient population with low-dose lithium (450mg/day) and investigating
      its effects using clinical, neuropsychological, neuroimaging and cell biological approaches.
      We will recruit 30 patients considered to be at ultra-high risk of developing a first
      psychotic episode, currently receiving treatment at the Personal Assessment and Crisis
      Evaluation (PACE) clinic in Melbourne, Australia. PACE criteria for identifying patients at
      high risk include subjects with a family history of psychosis and a decrease in functioning
      (30% GAF) AND/OR attenuated psychotic symptoms AND/OR brief psychotic symptoms (BLIPS)
      resolving without treatment. Patients who give informed consent will receive treatment with a
      slow release form of low dose lithium for a period of a year, plus supportive therapy.
      Patients who do not consent will receive supportive therapy only. Assessments will be
      conducted at baseline, twelve weeks and one year post-recruitment. Assessments will include
      cognitive functioning, structural MRI, 1H-MRS at 3Tesla and cell biological parameters
      (bcl-2, AP-1; NIMH, Washington DC). In addition, all patients will be seen on a monthly basis
      for a clinical interview, covering psychopathology, global functioning, and quality of life.
    

Intervention name(s): lithium carbonate
Intervention type(s): Drug
Intervention MeSH terms: Lithium Carbonate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: at risk mental state; prodrome; ultra high risk; first episode psychosis; schizophrenia; bipolar disorder
Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women
Condition: Menopause
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone
      in comparison with tibolone on the breast metabolic markers, in particular the total
      insulin-like growth factor-1 (IGF-1), in postmenopausal women.
    


Intervention name(s): 17ß-Estradiol/Dydrogesterone; Tibolone
Intervention type(s): Drug; Drug
Intervention description(s): 1/5 mg/day for 12 cycles of 28 days; 2,5 mg/day for 12 cycles of 28 days
Intervention MeSH terms: Tibolone; Estradiol; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopause, IGF-1, HRT
Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a new counseling tool for patients deciding whether
      or not to undergo prostate cancer screening. This screening decision aid is a computer
      program that provides individual patients estimates of their risks of prostate cancer
      diagnosis, prostate cancer related death, or death from any cause. The researchers are
      evaluating whether or not patients find this screening decision aid helpful. As part of this
      study, participants will be asked for their response on questionnaires.

      If patients find the screening decision aid helpful, the researchers will make it available
      at other clinic locations.
    

Detailed description: 
      To conduct a feasibility study on implementing the computer-based screening decision aid for
      prostate cancer screening in a primary care setting during a 60-minute interview. To aid in
      informed decision making, the screening decision aid will include a graphical representation
      of predicted probabilities of prostate cancer diagnosis, prostate cancer-specific mortality,
      death from competing causes based on a man's unique demographic information. The study team
      will provide standardized counseling followed by individualized counseling with the screening
      decision aid. It will assess the quality of the decision making process (patient feels
      knowledgeable, informed of the risks/benefits, feels clear about their values, is involved in
      the decision), and quality of the decision.
    

Intervention name(s): Prostate cancer decision aid
Intervention type(s): Behavioral
Intervention description(s): Patients will undergo standardized counseling and individualized counseling with the screening decision aid. The screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause
Other intervention name(s): screening decision aid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Decision Aid
A Study to Investigate the Effect of Oral Doses of Pilocarpine on Salivary Secretion and Static Pupillometry in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacodynamic effect of oral doses of
      pilocarpine on salivary secretion in healthy male and female subjects. In addition,
      pharmacodynamic effect on static pupillometry will be evaluated as well as pharmacokinetics
      and safety and tolerability of oral doses of pilocarpine in healthy subjects.
    


Intervention name(s): Pilocarpine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Salagen
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pilocarpine
LCI and Bronchial Inflammation in Patients With BO
Condition: Bronchiolitis Obliterans
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome; Inflammation
Study type: Observational

Summary: 
      The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the
      results of the Lung Clearance index (LCI) . Further this study evaluates bronchial
      inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years
      compared with an age- and sex-matched control group. The investigators will perform a
      pulmonary function test (body plethysmography with DLCO) and compare the results with the
      LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood
      sample to determine the level of systemic inflammation. Finally induced sputum is collected
      and a cell count is performed, and cells and supernatants are analyzed for inflammatory
      markers. This study will set baseline markers for future interventional studies.
    

Detailed description: 
      The purpose of this study is to compare lung function values with the Lung clearance index of
      20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to
      compare the bronchial Inflammation between the patients and a reference group with similar
      age conditions to determine possible outcome-parameters for following interventional studies.

      The sputum samples will be processed and quantitatively analyzed to get a profile of the
      cytological composition.

      (Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction
      (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)

      Methods and Work Programme:

        -  Measurement of nitric oxide in expired air (FeNO)

        -  Lung function testing with spirometry and body plethysmography

        -  Lung clearance index (LCI)

        -  Bronchodilation

        -  Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of
           the non-specific pulmonary defense system)

        -  Induced sputum for inflammatory mediators and microbiological investigations
    

Intervention name(s): no intervention - just observational
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from Bronchiolitis obliterans and controls
      
Biospecimen description: 
      blood, sputum cells, sputum supernatans
    
Keywords: bronchial inflammation; Bronchiolitis obliterans; Sputum; Blood; Inflammation; adaptive immune system; innate immune system
A Study of Macitentan, in Healthy Japanese Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability after multiple-dose
      administrations of macitentan with titration regimen starting from Dose 1 once daily (qd) up
      to Dose 2 qd in Japanese healthy adult male participants (Part 1) and to evaluate the effect
      of food on pharmacokinetics of macitentan and its active metabolite (ACT-132577) in Japanese
      healthy adult male participants with macitentan Dose 3 tablet (Part 2).
    


Intervention name(s): Macitentan Dose 1; Macitentan Dose 2; Macitentan Dose 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive Dose 1 of macitentan tablet in Part 1.; Participants will receive Dose 2 of macitentan tablet in Part 1.; Participants will receive Dose 2 of macitentan tablet in Part 1 and 2.; Participants will receive matching placebo from Day 1 up to Day 13.
Other intervention name(s): JNJ-67896062; JNJ-67896062; JNJ-67896062
Intervention MeSH terms: Macitentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Mass Balance Study of ASP1941
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the pharmacokinetics, in particular the routes and extent of
      metabolism and excretion, of ASP1941 after a single oral dose.
    


Intervention name(s): ASP1941
Intervention type(s): Drug
Intervention description(s): Oral solution
Intervention MeSH terms: Ipragliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Mass Balance; ASP1941; Pharmacokinetics
Virtual Reality on Pain and Range of Motion on Burn
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      The Purpose of the study is to determine the effect of virtual reality exercise on pain and
      shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries.
    

Detailed description: 
      Burns are an important cause of injury to young children, being the third most frequent cause
      of injury resulting in death behind motor vehicle accidents and drowning. Burn injuries
      account for the greatest length of stay of all hospital admissions for injuries and costs
      associated with care are substantial. The majority of burn injuries in children are scald
      injuries resulting from hot liquids, occurring most commonly in children aged 0-4 years.
      Other types of burns include electrical, chemical and intentional injury. Mechanisms of
      injury are often unique to children and involve exploratory behavior without the requisite
      comprehension of the dangers in their environment.

      Immersive virtual reality (VR) is a new form of cognitive distraction and has been found to
      be an effective adjunctive, nonpharmacologic analgesic for postburn physical therapy. The VR
      gives the individual the illusion of "going into" the 3-dimensional computer generated
      environment, as if it were a place in which they are actually physically present. The
      strength of the presence is thought to reflect the amount of attention that is drawn into the
      virtual world. Because VR is a highly attention-grabbing experience, it can be an effective
      psychological pain control technique. Less attention to pain can result in reductions in pain
      intensity, unpleasantness, and the amount of time patients spend thinking about their pain.
    

Intervention name(s): active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con; active assisted range of motion exercise
Intervention type(s): Device; Other
Intervention description(s): VR is mainly created by generating visual effects through head-mounted display (HMD) systems. An HMD is a device worn on the head or as part of a helmet with a built-in display and lenses, allowing the user to experience the virtual world with the help of a wide viewing angle, head and hand movements tracking as well as objects interacting by controllers.; Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: burn injuries
Effect of Salpingectomy During Conservative Hysterectomy
Condition: Genital Diseases, Female; Hysterotomy; Affecting Fetus; Leiomyomata Uteri; Adenomyosis, Endometriosis; Dysfunctional Uterine Bleeding; Cervical Dysplasia; Uterine Prolapse
MeSH terms: Leiomyoma; Uterine Cervical Dysplasia; Endometriosis; Uterine Hemorrhage; Adenomyosis; Genital Diseases; Uterine Prolapse; Metrorrhagia; Genital Diseases, Female; Prolapse
Study type: Interventional

Summary: 
      The study compares the effect of bilateral salpingectomy associated with conservative
      hysterectomy on ovarian function to the standard hysterectomy with conservation of both
      ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications,
      quality of life.
    

Detailed description: 
      Hysterectomy is one of the most common gynecologic procedures performed in clinical practice.
      In this study we focused on non menopausal patients under 52 years having hysterectomies for
      benign disease : uterine leiomyomas, adenomyosis, endometriosis, dysfunctional uterine
      bleeding, genital prolapse, cervical dysplasia... with failure of conservative treatment.

      the standard procedure during hysterectomy with conservation of the ovaries has been the
      preservation of fallopian tubes with the clamps placed as close to the uterine corpus as
      possible. this is suggested to decrease interference with the vascular structures in the
      mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of
      hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be
      considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube,
      theoretically, these cases could be prevented if tubal excision is performed during
      hysterectomy The study compares the effect of bilateral salpingectomy associated with
      conservative hysterectomy on ovarian function to the standard hysterectomy with conservation
      of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation,
      complications, quality of life.

      impact of treatments on ovarian reserve are tested by measuring AMH at baseline and 3 days, 6
      weeks and 6, 12 months after surgeries.

      quality of life is also assessed at these time points, with a questionnaire (Women Health
      Questionnaire WHQ).
    

Intervention name(s): conservative hysterectomy I; Conservative hysterectomy II
Intervention type(s): Procedure; Procedure
Intervention description(s): conservative hysterectomy for benign disease; bilateral salpingectomy during hysterectomy without conservation of the ovaries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
Condition: Colon Cancer Stage II
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical investigation examined the influence of cytostatic chemotherapy with
      5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time
      following surgery for colon carcinoma Stage II.
    


Intervention name(s): Fluorouracil; Leucovorin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fluorouracil; Leucovorin; Colon cancer
Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment
      and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who
      have failed conservative therapy including physical therapy, have had an initial >80% pain
      relief on a diagnostic medial branch block, and are scheduled to undergo a routine second
      medial branch block for facet mediated pain will be randomized. Both groups will receive the
      standard of care, a medial branch block. The treatment group will also receive one set of
      intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive
      intra-articular normal saline.
    

Detailed description: 
      Subjects will have failed conservative treatment, including, but not limited to oral
      medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will
      be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics
      and will be schedule for a medial branch block as standard of care. As part of usual and
      standard care, patients will undergo lumbar medial branch blocks for diagnosis of
      zygapophysial joint pain.

      Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial
      branch blocks will be offered the opportunity for possible inclusion in the study if they are
      scheduled to receive a second medial branch block. The definition of a positive response to
      MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement)
      AND the restoration of the ability to perform at least one previously painful posture,
      movement, or activity without increase in pain, during the anesthetic phase of the blocks. If
      subjects are unable to render NPR scores or percentage estimate of improvement, then a 5
      point global perception of effect tool will be used.
    

Intervention name(s): Intra-articular corticosteroid injection; Intra-articular saline injection
Intervention type(s): Drug; Drug
Intervention description(s): Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint; Intra-articular injection of 0.5 cc normal saline in each joint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; zygapophysial joint pain; medial branch block; > 6 months duration; non-radicular