bioihbjkbjnl/mcl2 huggingface dataset:
AESCULAP® Plasmafit® Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene
Condition: Osteoarthritis, Hip; Rheumatic Arthritis; Degenerative Osteoarthritis
MeSH terms: Rheumatic Fever; Osteoarthritis; Osteoarthritis, Hip
Study type: Observational

Summary: 
      Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit
      Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked
      Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads
    

Detailed description: 
      Osteoarthritis is one most common disease in aged population, that most advanced stage needs
      surgical treatment. Surgical treatment usually include installation of implants. Every year
      new types of implants were fabricated from the new material. The effectiveness of this new
      devices need carefully independent assess in clinic.
    

Intervention name(s): Plasmafit® Vitelene® Vitamin E
Intervention type(s): Device
Intervention description(s): Plasmafit® Acetabular Cup System with an insert Aesculap ® Vitelene ® Vitamin E Stabilized Highly Crosslinked Polyethylene and BIOLOX delta Ceramic Femoral Head or ISODUR® Metal Femoral Heads
Other intervention name(s): Plasmafit® Acetabular Cup System; BIOLOX delta Ceramic Femoral Head; ISODUR® Metal Femoral Heads
Intervention MeSH terms: Vitamin E
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who need total knee replacmet surgury with a diagnosis

          -  Pertrochanteric fracture

          -  Disorder of continuity of tibia bone

          -  Osteoarthritis of hip

          -  Polyosteoarthritis

          -  Acquired deformity of musculoskeletal system

          -  Ankylosis of joint

          -  Rheumatoid arthritis
      
Keywords: Osteoarthritis hip; Orthopaedic surgery; Vitamin E crosslinked polyethylene; Hip arthroplasty; Ceramic femoral heads; Metal femoral heads
Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers
Condition: Polyuria-polydipsia Syndrome
MeSH terms: Diabetes Insipidus; Polyuria; Polydipsia
Study type: Interventional

Summary: 
      This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a
      ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.
    

Detailed description: 
      Copeptin measurements upon intravenous arginine stimulation discriminate patients with
      diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy.
      An oral test would be easier to perform, causes less risks and discomfort for the patients
      and would require less resources in clinical practice. This study investigates stimulation of
      the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel
      diagnostic test in the polyuria-polydipsia syndrome.
    

Intervention name(s): Macimorelin 0.5mg/kg body weight; Macimorelin 0.75mg/kg body weight
Intervention type(s): Drug; Drug
Intervention description(s): oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin; oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin
Intervention MeSH terms: Tryptophan
Intervention model: Sequential Assignment
Intervention model description: Prospective, proof-of concept diagnostic study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Copeptin; Macimorelin; Ghrelin receptor agonist; posterior pituitary gland; polyuria-polydipsia syndrome; hypothalamo-pituitary-adrenal axis
Retrograde Ejaculation and Sexual Dysfunction in Men With Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Diabetic men and controls are examined for retrograde ejaculation, and erectile dysfunction
      is registered with a validated questionaire (International Index of Erectile Function-15).
      Concentration, total number of sperm and motility is determined in freshly delivered
      ejaculates and postejaculatory urine. Our hypothetis is that diabetics exhibit significantly
      higher rate of retrograde ejaculation than healthy controls.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic men and non-diabetic men in Denmark.
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This exploratory study is the first study in a clinical program where the overall objective
      is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for
      the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and
      putative bone regeneration properties. Periodontitis is the major cause of tooth loss in
      people over 35 years of age. An effective pharmacological treatment is today lacking and the
      actual therapy would represent a new treatment option for the large patient group suffering
      from the disease.
    

Detailed description: 
      It is suggested that local administration of GM-CSF in the gingival tissue next to the
      periodontal destruction may reduce the infectious condition by an antibacterial effect via
      stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of
      monocytes and granulocytes, as well as stimulation of bone tissue recalcification.
    

Intervention name(s): sargramostim
Intervention type(s): Drug
Other intervention name(s): GM-CSF; Leukine
Intervention MeSH terms: Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nebivolol and the Endothelin (ET)-1 System
Condition: Prehypertension; Hypertension
MeSH terms: Prehypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone
      in adult humans with elevated blood pressure to a greater extent than either metoprolol or
      placebo.
    

Detailed description: 
      1. The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor
           tone in adult humans with elevated blood pressure to a greater extent than either
           metoprolol or placebo.

        2. The investigators further hypothesize that reducing ET-1 vasoconstrictor activity
           contributes to the improvement in endothelial vasodilator function associated with
           nebivolol.
    

Intervention name(s): Nebivolol; Metoprolol; Placebo; Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min); FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min); FBF response to Acetylcholine; FBF response to Sodium Nitroprusside; FBF response to BQ-123+BQ-788+ACh
Intervention type(s): Drug; Drug; Drug; Other; Other; Other; Other; Other
Intervention description(s): 5 mg tablet to be taken by mouth once per day for 12 weeks; 100 mg tablet to be taken by mouth once per day for 12 weeks; gelatin capsule to be taken by mouth once per day for 12 weeks; The forearm blood flow response to the endothelin (ET) -1 A receptor blocker BQ-123 (100 nmol/min) for 60 minutes at baseline and at 12 weeks.; The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.; The FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks.; The FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks.; The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.
Other intervention name(s): Bystolic; Toprol-XL; BQ-123; BQ-123+BQ-788; ACh; NTP; BQ-123+BQ-788+ACh
Intervention MeSH terms: Metoprolol; Nebivolol; Nitroprusside; cyclo(Trp-Asp-Pro-Val-Leu); BQ 788; Acetylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Validation of New Tools for the Assessment of Cognitive Functions and Connectivity Network in Hypertensive Patients
Condition: Hypertension; Cognitive Impairment
MeSH terms: Hypertension; Cognitive Dysfunction
Study type: Observational

Summary: 
      The relationship among hypertension, aging and cognitive decline is complex and not
      completely understood. Purpose of this project will be evaluating early markers of cognitive
      deterioration in patients with arterial hypertension. In particular, this cross-sectional
      observational study will be articulated in three phases:

        1. Neuropsychological evaluation of general cognitive abilities

        2. Identification and measurement of specific biomarker levels

        3. Correlation among hypertension, cognitive abilities and biomarkers.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients will be selected from the Department of Angiocardioneurology and Translational
        Medicine of the IRCCS Neuromed, according to specific inclusion criteria. Approximatey 80
        subjects per group, aged between 40 and 65 years, will be included in the study.
      
Keywords: Hypertension; Cognitive impairment; Biomarkers
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      In this clinical study the anti-hypertensive response to dietary salt restriction is compared
      with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult
      patients with chronic kidney disease.
    

Detailed description: 
      Patients with chronic kidney disease (CKD) are exquisitely salt-sensitive. Salt-sensitivity
      in CKD is linked to hypertension and cardiovascular outcomes. Dietary salt restriction is an
      accepted intervention for salt-sensitivity in CKD. Another strategy, however, could be to
      block sodium uptake by the kidney pharmacologically by diuretics. Especially diuretics acting
      on the distal tubule may be effective, because this appears to be the site of increased
      sodium reabsorption in CKD. It is currently unknown how these two strategies, diet or
      diuretics, relate. The investigators hypothesize that diuretics are non-inferior to diet.
    

Intervention name(s): Amiloride; Hydrochlorothiazide; Low-sodium diet
Intervention type(s): Drug; Drug; Other
Intervention description(s): Combined with hydrochlorothiazide; Combined with amiloride
Intervention MeSH terms: Hydrochlorothiazide; Amiloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Apixaban Discontinuation Prior to Major Surgery
Condition: Hemorrhage; Thromboembolism
MeSH terms: Thromboembolism; Hemorrhage
Study type: Observational

Summary: 
      The ADIOS study is a prospective, observational study will evaluate one hundred and thirty
      (130) patients with non-valvular atrial fibrillation who are currently receiving treatment
      with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who require
      an elective major surgical or invasive procedure will be included in the study. The purpose
      of the study is to evaluate the efficacy of the recommended pre-procedure washout period of
      48 hours.
    

Detailed description: 
      This study will estimate for what proportion of patients a 48 hour pre-procedure apixaban
      discontinuation is sufficient to achieve minimal apixaban plasma levels (less than 30 ng/mL)
      prior to surgery. The investigators hypothesize that this portion will be 80-95%.

      All patients will have a blood draw at 48 hours prior to procedure and then a second blood
      draw on the morning of the procedure to test apixaban plasma and anti-Xa levels. Patients
      will also receive a follow-up phone call at 30 days to collect information on clinical
      events.
    

Intervention name(s): Lab tests for plasma levels of apixaban and anti-10a factor
Intervention type(s): Other
Intervention description(s): All patients will have a blood draw at 48 hours prior to elective surgical procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-Xa levels.
Intervention MeSH terms: Apixaban
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        130 patients who are currently receiving treatment with apixaban for non-valvular atrial
        fibrillation and scheduled for an elective surgical procedure.
Schema Focused Therapy for Chronic Depression
Condition: Chronic Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Schema focused therapy (SFT) is an innovative treatment approach to chronic, lifelong
      problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and
      techniques. This study will determine whether SFT is a suitable and effective treatment for
      chronic depression in terms of acute effects and the prevention of relapse/recurrence. The
      secondary aim of this study is to identify the underlying mechanisms of change in SFT that
      lead to recovery from depression and the prevention of future relapse/recurrence.
    

Detailed description: 
      A single-case series design with multiple randomized baselines across participants will be
      used in this study. The study will last approximately 36 months and comprises three phases.
      The first phase is a 6-12 weeks waiting list/baseline phase during which participants will be
      repeatedly assessed with the main outcome measures and putative mediators. In the second
      phase participants will receive up to 75 individual sessions of SFT for chronic depression
      depending on the individual progress in therapy. Upon completion of the intervention phase,
      participants will have monthly follow-up assessments for the next 12 months.
    

Intervention name(s): Schema Focused Therapy
Intervention type(s): Behavioral
Intervention description(s): SFT is a novel treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. In the present study participants will receive up to 75 individual sessions of SFT depending on the individual progress in therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schema Focused Therapy; Chronic Depression; Mechanisms of Change
Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following
           single oral doses to healthy subjects.

        -  To evaluate the impact of formulation on the PK of rilzabrutinib following single oral
           doses to healthy subjects

      Secondary Objective:

      - To assess the safety and tolerability of single oral doses of rilzabrutinib administered
      under fasted and fed conditions
    

Detailed description: 
      The total study duration is approximately 43 days for each participant, including a screening
      period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days
    

Intervention name(s): rilzabrutinib SAR444671; rilzabrutinib SAR444671; rilzabrutinib SAR444671
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: caplet Route of administration: oral; Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral; Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its
      metabolite SEP-363854 in male and female subjects with schizophrenia.
    

Detailed description: 
      This multicenter study will be conducted in 2 parts (Part 1 and 2). Part 1 of the study is a
      multicenter, randomized, single-blind, placebo-controlled portion, ascending multiple oral
      dose study designed to evaluate the safety, tolerability, and PK of ascending multiple oral
      doses of SEP-363856 and its metabolite SEP-363854 in male and female subjects with
      schizophrenia. Part 1 This study will determine the MTD for once-daily multiple oral
      administration of SEP-363856, and characterize the plasma and urine PK profiles of SEP-363856
      and its metabolite SEP-363854 in male and female subjects with schizophrenia. The effect of
      SEP-363856 on the PANSS, CGI-S, and CDSS scales will also be assessed. For each of the
      dose-escalation cohorts, 12 subjects (9 active subjects and 3 placebo subjects) will be dosed
      for 7 consecutive days with serial collection of PK blood samples after the first and last
      doses, and daily collection of trough PK blood samples. An attempt will be made to have at
      least one-third of subjects in each cohort be female. Part 2 of the study is an open-label
      safety and tolerability study designed to gain longer-term safety and tolerability data for
      75 mg SEP-363856 given once-daily for 28 days in male and female subjects with schizophrenia.
      The effect of SEP-363856 on the PANSS, CGI-S, and CDSS scales will also be assessed. In Part
      2, 16 subjects will be dosed.
    

Intervention name(s): SEP-363856; Placebo; SEP-363856 Open Label
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP-36385625 as a single oral dose of 10, 25, 50, and 100 mcg; single oral dose placebo; 75 mg SEP-363856 given once-daily
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Schizophrenia
Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
Condition: Primary Open Angle Glaucoma (POAG)
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation
      as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary
      open angle glaucoma (POAG) who have failed at least one class of topical medical therapy
    


Intervention name(s): CyPass Micro-Stent
Intervention type(s): Device
Intervention description(s): The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glaucoma; Glaucoma device; Glaucoma surgery; Intraocular pressure
Effects of Immune Function on Prognositic Outcome in Critical Ill Patients With Acinetobacter Baumannii Infection
Condition: Acinetobacter Baumannii Infection
MeSH terms: Infections; Communicable Diseases
Study type: Observational

Summary: 
      The purpose of the present study is to evaluate the effects of immune function on prognositic
      outcome in critical ill patients with Acinetobacter baumannii infection.
    

Detailed description: 
      This is a single-center, observational study. Patients with Acinetobacter baumannii infection
      in the intensive care unit of Zhongda Hospital were enrolled. We recorded the data of age,
      ICU admission diagnosis, underlying diseases, APACHE II score and infection site. Body
      temperature, heart rate, white blood cell counts, procalcitonin, C-reactive protein, SOFA
      score and the level of CD4+, CD8+, Th1, Th2 and HLA-DR in the blood measured by flow
      cytometry on the D1, D3 and D7 were also recorded.We can get the results of the change of
      immune function of critical ill patients after Acinetobacter baumannii infection. After
      compare the patients who die of survive at 28 day after infection, we can get the results of
      the relationship between the immune function and the outcome. We also can calculate the
      effect immune function on prognositic mortality in patients with Acinetobacter baumannii
      infection.
    

Intervention name(s): None intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who admitted into ICU and infection with Acinetobacter baumannii.
      
Keywords: A baumannii infection; Immunosuppression; prognosis; immune function
REVIVE(Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic Liver Cirrhosis Patient)
Condition: Alcoholic Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      If the participant voluntarily agrees to participate in the clinical trial before
      registration, the investigator conducts a screening test to evaluate the participant's
      suitability.

      A participant that satisfies all selection and exclusion criteria is assigned randomly to a
      test group (1-time or 2-time injection group) or control group (no-cell therapy group).
      Participants assigned to the 1-time injection group conduct cell therapy within 1 month after
      bone marrow aspiration. Before implementing cell therapy, implement hepatic artery
      catheterization which inserts a catheter into the hepatic artery through the right aorta
      femoralis and inject 5X107 autologous bone marrow-derived mesenchymal stem cells.
      Participants assigned to the 2-time injection group store 1-time injection amount of
      mesenchymal stem cells while being cultivated after sampled from the bone marrow, and will
      re-inject autologous mesenchymal stem cells within 1 month after first injection.

      Participants will make a total of 8 hospital visits on a 4-week interval after registration,
      and effectiveness and safety will be evaluated based on a fixed procedure on every visit.
    


Intervention name(s): Livercellgram
Intervention type(s): Biological
Intervention description(s): Livercellgram
Dosage form and appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip ② Component: Autologous bone marrow-derived mesenchymal stem cell ③ Amount: 5X107 cells, 1-time or 2-time injection ④ Storage Method: Stored in airtight container at 20~25℃
Injection Method: Directly inject into liver through hepatic artery
Other intervention name(s): Autologous bone marrow-derived mesenchymal stem cell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment