bioihbjkbjnl/mcl2 huggingface dataset:
COGNIShunt® System for Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of the effect on the progression of Alzheimer's Disease of a surgically
      implanted shunt (tube) to increase the flow of cerebrospinal fluid and improve the clearance
      of potential neurotoxins from the fluid bathing the brain.
    

Detailed description: 
      Cerebrospinal fluid (CSF) is the protective fluid that fills the empty spaces around the
      brain and spinal cord. CSF is naturally produced and absorbed, but with age abnormal
      metabolism and clearance of amyloid beta proteins can lead to accumulation of these proteins,
      resulting in plaque formation, a leading contributor to the progression of Alzheimer's
      disease (AD). The shunt treatment is designed to drain CSF with these toxic elements from the
      skull and allow replenishment of normal CSF. This clinical study is designed to determine if
      this device will stop or slow the progression of Alzheimer's disease.

      The COGNIShunt® System is a proprietary device designed to increase the flow of cerebrospinal
      fluid (CSF) and improve clearance of putative neurotoxins from the CSF that are believed to
      contribute to the progression of Alzheimer's disease symptoms. This clinical study is
      designed to determine if this device will stop or slow the progression of Alzheimer's
      disease. The pivotal study is a prospective, randomized double-blinded, placebo-controlled
      trial to evaluate the effect of flow-regulated ventriculoperitoneal CSF drainage with the
      COGNIShunt® system on cognitive and clinical function in approximately 250 participants with
      Alzheimer's Disease (NINDS/ADRDA criteria). Study participants will be permitted to continue
      anti-dementia drug therapy if their drug regime has been stable for 3 months prior to entry.
      This is a two-part study. In Part I, participants will be randomized to receive either a
      functioning COGNIShunt® System (test/intervention group) or an occluded shunt
      (control/placebo group). The duration of Part I is nine months, to be followed by an
      extension phase of an additional 9 months, constituting Part II. During Part II, subjects
      with occluded shunts have the opportunity to receive a functioning COGNIShunt®, so that all
      study participants may have open devices during Part II. The total duration of the study is
      18 months. Visits to the site include: for screening and baseline (may be done in one or two
      visits); surgery; and a visit the 1st, 3rd, 6th, 9th, 12th, 15th, and 18th month after
      surgery.
    

Intervention name(s): The COGNIShunt® System
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer disease; Dementia; Ventriculoperitoneal shunt; Tau; ABeta
Early Hospital Discharge Program in Neonatology
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Early discharge of premature infants from the Neonatal Intensive Care Unit will have
      substantial benefits:

      (i) diminish parental stress;

      (ii) increase parental - child bonding;

      (iii) diminish medical complications derived from prolonged hospitalization;

      (iv) reduce cost;

      (v) increase number of point of attendance disponible for future patients.
    

Detailed description: 
      Extremely premature infants have to remain for very prolonged time in the hospital. As a
      consequence, difficulties for establishing an adequate parental-infant bonding arise causing
      a substantial parental stress manifested as anxiety and depression, and increasing the risk
      of short and longterm consequences (neglect, abuse, maltreatment, abandonment). In addition,
      prolonged hospital stay will increase the probability of having medical complications
      (infections, excessive blood tests or image studies) and the cost of staying. Once the baby
      has improved sufficiently early discharge may be given independently of the baby's weight. In
      order to be successful, caregivers, psychologist and parents have to put forward an
      established protocol to be able to face satisfactorily this situation. We hypothesize that,
      with an adequate Early Discharge Program, we could substantially reduce length of
      hospitalization, cost, and reduce parental stress.
    

Intervention name(s): Early Discharge
Intervention type(s): Other
Intervention description(s): Application of an early discharge protocol from the neonatal intensive care unit.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Parental stress; Early discharge; Anxiety; Depression; Neonatal Intensive Care Unit
Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen
      participants with T2D participating in two OGTTs.
    

Detailed description: 
      The study is an acute, double-blinded, randomized, cross-over intervention study with sixteen
      participants with T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0,
      the participants will ingest a tablet containing either 12 mg cafestol or placebo.
      Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the
      following 3 hours blood samples are collected at time points 0, 15, 30, 60, 90, 120 and 180
      min. The samples will be used for determination of plasma glucose, insulin and cafestol, as
      well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same
      set-up again, however now with the opposite intervention / placebo.
    

Intervention name(s): Cafestol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsule with 12 mg cafestol; Placebo capsule without cafestol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2
Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Condition: Endophthalmitis
MeSH terms: Endophthalmitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of
      intracameral moxifloxacin for prevention of postcataract endophthalmitis.
    

Detailed description: 
      Although cataract surgery is generally considered a safe procedure resulting in a favourable
      visual outcome, surgical complications do occur. The most feared complication is
      postoperative endophthalmitis which is an infectious condition caused by micro-organisms
      introduced to the interior of the eye during or after the surgical procedure.

      As endophthalmitis is an infection, it should be preventable by antibiotic treatment.

      Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during
      surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as
      topical treatment postoperatively.

      The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of
      intracameral moxifloxacin for prevention of postcataract endophthalmitis.
    

Intervention name(s): Moxifloxacin
Intervention type(s): Drug
Intervention description(s): Moxifloxacin intracameral
Other intervention name(s): Vigamox
Intervention MeSH terms: Moxifloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: endophthalmitis; antibiotic therapy; cataract surgery; prevention
Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety and pharmacodynamics of an oral formulation
      of insulin in subjects with Type 2 Diabetes.
    

Detailed description: 
      This is a single-center, Phase II(a), randomized, double-blind, placebo-controlled, parallel
      group, inpatient study preceded by a 5-day single-blind outpatient placebo run-in period.
    

Intervention name(s): ORMD-0801 Dose # 1; ORMD-0801 Dose # 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Insulin Formulation; Oral Insulin Formulation; Oil Capsules
Other intervention name(s): Oral Insulin; Oral Insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral Insulin; Diabetes Mellitus Type 2; Safety; Pharmacodynamics; Pharmacokinetics
ACY-7 Oral Administration of Acyline
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We propose oral dosing of gastrointestinal permeation enhancement technology [GIPET] enhanced
      oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose)
      pharmacokinetics of oral acyline in four normal, healthy young men.
    

Detailed description: 
      The purpose of this study is to test how the body responds to a new oral form of acyline
      given for seven days and to also look at the safety of oral acyline.

      Acyline temporarily blocks the production of the hormone testosterone in healthy men. It has
      been tested in over 100 men in an injection form. This study will be testing acyline in a
      pill form for seven days.

      This study may help develop an oral form of testosterone-blocker which may be useful in the
      treatment of diseases such as prostate cancer, premature puberty and possibly in a male
      contraceptive.

      This study will evaluate a single dose of oral acyline given once a day for seven days and
      subsequent effects on Testosterone, FSH and LH blood serum concentrations.
    

Intervention name(s): Acyline
Intervention type(s): Drug
Intervention description(s): 20 mg GIPET enhanced oral dose, daily for 7-days
Intervention MeSH terms: Acyline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male Contraception; Acyline
A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate efficacy and safety of SPM 962 in
      advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study
      following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg
      (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also
      to be investigated with distribution of the maintenance dose and accumulated response rate of
      efficacy.
    


Intervention name(s): SPM 962; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SPM 962 transdermal patch once a daily up to 36.0 mg/day; Placebo transdermal patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SPM 962; rotigotine; Parkinson's disease; concomitant use of L-dopa
Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety,
      pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years
      of age with moderate-to-severe atopic dermatitis (AD).
    

Detailed description: 
      1. Part A (open-label, single-ascending-dose, sequential cohort phase 2 study):

             -  Primary objective is to characterize the safety and PK of dupilumab administered as
                a single dose in pediatric participants, 6 months to less than 6 years of age, with
                severe AD.

             -  Secondary objective is to evaluate the efficacy and immunogenicity of a single dose
                of dupilumab in participants 6 months to less than 6 years of age with severe AD.

        2. Part B (randomized, double-blind, parallel-group, placebo-controlled phase 3 study):

             -  Primary objective is to demonstrate the efficacy of multiple doses of dupilumab
                over 16 weeks of treatment when administered concomitantly with topical
                corticosteroids (TCS) in pediatric participants, 6 months to less than 6 years of
                age, with moderate-to-severe AD.

             -  Secondary objective is to assess the safety and immunogenicity of multiple doses of
                dupilumab over 16 weeks of treatment when administered concomitantly with TCS in
                participants 6 months to less than 6 years of age with moderate-to-severe AD.
    

Intervention name(s): Dupilumab; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection, subcutaneous (SC); Solution for injection, subcutaneous (SC)
Other intervention name(s): DUPIXENT®; REGN668; SAR231893
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Part A: Single-ascending-dose cohorts staggered by age;
Part B: Parallel Group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eczema
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to
      placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12
      weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The
      study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B
      (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The
      safety of ezetimibe in this subject population will also be evaluated.
    


Intervention name(s): ezetimibe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets: ezetimibe 10 mg once daily for 12 weeks; oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period
Other intervention name(s): SCH 58235; MK-0653; Zetia
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: heterozygous familial hypercholesterolemia; nonfamilial hypercholesterolemia
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immune response of an
      investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis,
      tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.
    

Detailed description: 
      The duration of treatment is 65 weeks.
    

Intervention name(s): V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
Intervention type(s): Biological
Other intervention name(s): V441
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Low Risk Acute Coronary Syndrome
Condition: Low Risk Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      A large number of patients are diagnosed with low risk ACS, and these individuals are at
      significant cardiovascular risk. Though guidelines recommend stress testing to manage low
      risk ACS patients, evidence supporting this recommendation is not based on trials examining
      this population. A well-designed, randomized trial is warranted to determine if stress
      testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the
      investigators hypothesize, healthcare expenditures could be reduced and patients may not be
      exposed to the harms associated with more invasive cardiac testing such as coronary
      angiography.
    


Intervention name(s): Stress Test; No Stress Test
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing
BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
Condition: Coronary Heart Disease; Stable Angina Pectoris; Unstable Angina Pectoris; Silent Myocardial Ischemia
MeSH terms: Heart Diseases; Angina Pectoris; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Angina, Stable; Angina, Unstable; Ischemia; Neointima
Study type: Interventional

Summary: 
      The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in
      terms of the extent of neointima formation at 3 months after implantation using OCT.

      This is a prospective, single center, randomized, open-label, non-inferiority study, which
      will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned
      undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was
      met, superiority test will be planned.
    

Detailed description: 
      About 70 patients with clinical evidence of ischemic heart disease and / or a positive
      functional study and documented stable angina pectoris (Canadian cardiovascular society
      classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native,
      previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing
      implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).

      All of the patients will receive 6 months dual antiplatelet therapy and they will be followed
      (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3
      months (including angiographic/OCT investigation), 6 months, 1 and 2 years post percutaneous
      coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
    

Intervention name(s): BuMA stent; EXCEL stent
Intervention type(s): Device; Device
Intervention description(s): About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.; About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: BuMA; EXCEL; OCT; stent; neointima formation
A Survey on Blood Transfusions in Major Artrhoplasty Operations
Condition: Arthropathy of Hip; Arthropathy of Knee
MeSH terms: Joint Diseases
Study type: Observational

Summary: 
      The rate of hip, knee arthroplasties and their revision are increasing every year. The
      incidence of blood transfusion in these operations are reported 18%, 68%, and 39%, 67%,
      respectively. Blood transfusion is known to increase the risk of pulmonary, septic, wound and
      thromboembolic complications and is related to mortality. Restrictive transfusion protocols
      has cost-effective results in terms of reducing these complications, promoting early
      discharge and reduced frequency of re-admission.

      Within this context, we aimed to evaluate the transfusion practice in our hospital, define
      the transfusion indicators and compare the transfused and non transfused patients in terms of
      recovery.
    

Detailed description: 
      After obtaining ethical approval Patients undergoing hip or knee arthroplasty or revision
      arthroplasty will be included in this prospective observational study.

      Patient characteristics (age , gender, body mass index, ASA physical status, anticoagulant
      medication) Preoperative: hemoglobin, hematocrit, platelet, INR, APTT, PT values, the
      precence of preoperative anemia, anemia treatment modalities will be recorded.

      Intraopreative: type and duration of surgery, anesthesia method, monitoring methods used, the
      amount of intraoprative adminestred fluids (crystalloid-colloid), amount of hemorrhage
      Postoperative: hemoglobin-hematocrit-platelet leve The amount of blood transfusion and the
      product used (erythrocyte suspension, fresh frozen plasma, thrombocyte-fibrinogen-factor
      concentration-cryoprecipitate-other ) Hemoglobin-hematocrit-platelet level before and after
      transfusion Indications for transfusion; hemoglobin threshold / physiological transfusion
      indicator; tachycardia, hypotension, low flow rate, desaturation, low SvO2, inotropic
      requirement, etc. / comorbidities / monitorisation findings, other, Discharge time of
      patients Early upright position (postoperative 2nd day), information on walking capacities
      (TUG - The Time Up and Go test) will be recorded and compared between transfused and
      non-transfused patients
    

Intervention name(s): Transfusion
Intervention type(s): Other
Intervention description(s): Transfusion of red blood cells, fresh frozen plasma, platelets
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing major atrhroplasty
Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare treatment with both teriparatide and raloxifene with
      teriparatide alone. The study will evaluate any side effects that may be associated with the
      two drugs and may help to determine whether teriparatide and raloxifene together can help
      patients with osteoporosis more than teriparatide alone.
    


Intervention name(s): teriparatide; raloxifene; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Teriparatide; Raloxifene Hydrochloride
Primary purpose: Treatment