bioihbjkbjnl/mcl2 huggingface dataset:
Study Investigating the Effects of JNJ-54861911 on Amyloid-beta Processing in Cerebrospinal Fluid (CSF) and Plasma in Japanese Participants Asymptomatic at Risk for Alzheimer Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and effect of JNJ-54861911
      on level of amyloid-beta in Cerebrospinal Fluid (CSF) and plasma following 4 weeks of
      treatment in Japanese participants asymptomatic at risk for Alzheimer Dementia (ARAD) at the
      intended target dose range.
    

Detailed description: 
      This is a multi-center (when more than one hospital or medical school team work on a medical
      research study), double-blind (neither physician nor participant knows the treatment that the
      participant receives), placebo-controlled (the experimental treatment or procedure is
      compared to an inactive substance), randomized (study medication assigned by chance),
      multiple dose, Proof of Mechanism (POM) study in Japanese participants ARAD. All eligible
      participants will be randomly assigned to 1 of 3 treatment groups (that is, placebo,
      JNJ-54861911 10 milligram [mg] or JNJ-54861911 50 mg once daily regimen). This study will
      consist of Screening Phase (8-week), Double blind Treatment Phase (4-week), and Follow-up
      Phase (2-week). The maximum study duration for a participant will be 14 weeks. Participant's
      safety will be monitored throughout the study.
    

Intervention name(s): JNJ-54861911, 10 mg; JNJ-54861911, 50 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-54861911, 10 mg (2*5 mg tablet) orally once daily for 4 weeks.; JNJ-54861911, 50 mg (2*25 mg tablet) orally once daily for 4 weeks.; Placebo matching to JNJ-54861911 tablet orally once daily for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Alzheimer Dementia; JNJ-54861911; Beta Secretase Inhibitor
The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Condition: Renal Transplant
Study type: Interventional
Phase: Phase 1

Summary: 
      Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss.
      Angiotensin-II may play a role in the development and progression of CAN. Angiotensin
      converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of
      angiotensin-II. However these drugs have been reported to cause elevated potassium and
      creatinine levels in some renal transplant patients. Yet, there are now several retrospective
      reports of long term benefits of improved renal function and graft survival in renal
      transplant recipients. There have been no reports of prospective randomized controlled trials
      of ACEI in renal transplant patients in the early post transplant period.

      The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI
      class, when started 1-3 month post transplant. This is a double-blinded, randomized control
      trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values
      no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be
      administered for 6 months. Patients will be monitored in the renal transplant clinic every
      1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium
      >5.9mEQ/L or sustained increase in serum creatinine >30% from baseline.
    

Detailed description: 
      All new renal transplant recipients with functioning allografts and serum creatinine less
      than 2.6 mg/dl within the first 3 month post transplant would be eligible for this study of
      the safety of enalapril 5 mg vs placebo. Patients with serum potassium persistently over 5.5
      mEQ/L would be excluded. This is a double-blinded randomized control study. End-points of the
      study are a persistent rise in serum creatinine of >30% from baseline not otherwise explained
      by clinical evaluation, and persistent serum potassium >5.9mEQ/L. Study duration is 6 month.
      At the end of the study patients will be continued on ACEI if clinically stable
    

Intervention name(s): enalapril; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg enalapril daily for 6 months; 5mg enalapril-matching placebo daily for 6 months
Intervention MeSH terms: Enalapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: renal transplant, ACE inhibitor
Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Condition: Aortic Regurgitation
MeSH terms: Aortic Valve Insufficiency
Study type: Observational

Summary: 
      Velocity Vector Imaging may provide reliable and detailed information on left ventricular
      segmental function in asymptomatic patients with moderate-to severe AR. This may help to
      identify subclinical myocardial dysfunction in order to operate early enough to prevent
      postoperative heart failure and restrict unnecessary early operation which could be
      associated with operative risks and mortality related to prosthetic valves.
    

Detailed description: 
      Chronic aortic regurgitation (AR) is a progressive process which causes both left ventricular
      volume and pressure overload. While the volume overload is associated with the degree of the
      aortic regurgitant volume, the pressure overload occurs as a result of systemic hypertension
      developed due to increased stroke volume. In early stages, excentric hypertrophy occurs
      aiming to compensate the volume overload in the left ventricle. Therefore , ejection fraction
      remains in normal range despite the increasing volume overload. Left ventricular dilatation
      and impairment in ejection fraction only occur in the end stages of the disease. Asymptomatic
      patients with chronic aortic regurgitation (AR) have a good prognosis in the presence of
      preserved systolic function. Therefore it is a challenge to identify patients with
      subclinical left ventricular (LV) dysfunction. Velocity vector imaging (VVI) is a new
      echocardiographic method based on two dimensional gray scale imaging, which is angle
      independent and can provide more accurate data about cardiac function.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary care clinic
      
Keywords: Aortic regurgitation,velocity vector imaging
Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)
Condition: HCG
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Subjects are female patients, randomized to HCG group or placebo group, during a prospective
      trial, in order to determine the significance, if any, of HCG on maintaining muscle mass
      during a very low calorie diet in order to demonstrate the potential significance of HCG
      administration on preserving lean body mass while losing weight.
    

Detailed description: 
      Four-week clinical trials were conducted on 59 females between the ages of 20 and 55, over an
      18 month period. Exclusion criteria included thyroid conditions or prior significant medical
      history. Patients were randomized to receive daily subcutaneous injections of either hCG
      (200-300IU) or saline (placebo). All were placed on a VLCD resembling a protein-sparing
      modified fast. The caloric intake was between 500 and 600 calories, with 50% protein and 50%
      complex carbohydrates consisting mostly of fruits and vegetables. Measured parameters:
      weight, body composition via bio-impedance, blood pressure, and blood labs. A subset also
      underwent weekly electrocardiograms (EKG).
    

Intervention name(s): Human Chorionic Gonadotropin; Placebo; Low calorie diet
Intervention type(s): Drug; Drug; Other
Intervention description(s): The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.
Other intervention name(s): Pregnyl, Novarel
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: hcg
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Condition: Postmenopausal Osteoporosis; Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone
      strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment
      increases bone formation less and less over time. This study will test whether increasing the
      daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies
      will test several potential reasons why PTH's effects on bone formation decline over time.
    

Detailed description: 
      In women with postmenopausal osteoporosis, PTH increases bone mineral density more than
      anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine
      fractures. Still, PTH is not a cure for osteoporosis in many patients because PTH-stimulated
      bone formation declines as PTH therapy continues. Biochemical analyses suggest that bone
      formation and resorption peak after 6 to 9 months of daily PTH therapy and then decline
      progressively.

      The study will last 18 months. Blood, urine, and bone density tests will occur at screening.
      At the start of the study, participants will be randomly assigned to one of two PTH dose
      regimens. Patients will go to Massachusetts General Hospital at Months 0, 3, 6, 9, 12, 15,
      and 18 for blood and urine collection. In addition, bone density tests by DXA will be
      performed at Months 0, 6, 12, and 18, and by quantitative CT scans at Months 0 and 18.
      Approximately 6 weeks after any change in PTH dose, each participant's blood calcium will be
      checked 4 to 6 hours after that day's PTH injection, and her 24-hour urine calcium excretion
      will also be checked.

      Participants may enroll in optional substudies that will test whether reduced skeletal
      responses to long-term treatment with PTH are accompanied by changes in its absorption and/or
      destruction and whether reduced skeletal responses to long-term treatment with PTH are
      accompanied by parallel reductions in kidney responses to PTH.
    

Intervention name(s): synthetic hPTH 1-34
Intervention type(s): Drug
Intervention description(s): Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34
Other intervention name(s): synthetic human parathyroid hormone 1-34
Intervention MeSH terms: Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoporosis; Parathyroid hormone; Teriparatide; Bone formation; Bone resorption
Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study supplements patients' current medications with Pravastatin, a cholesterol-lowering
      medication, to try to improve residual symptoms of schizophrenia, and also to improve
      cognitive functioning.
    

Detailed description: 
      This study supplements patients' current medications with Pravastatin, a cholesterol-lowering
      medication, to try to improve residual symptoms and also to improve cognitive functioning. It
      consists of 15 total study visits over a 28-week period of time, one visit every 2 weeks.

      Blood draws will be done once every 4 weeks throughout the study to monitor lipid levels,
      C-Reactive protein, AST, ALT, and CPK Total. Cognitive testing will be completed at the
      beginning of the study and at the end of the study. During the study visits, the staff will
      be monitoring vitals signs (weight, height, blood pressure, pulse, waist/hip ratio), possible
      side effects, positive and negative symptoms, mood symptoms, and overall functioning.
    

Intervention name(s): Pravastatin
Intervention type(s): Drug
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; positive symptoms; negative symptoms; cognitive functioning; pravastatin
Chloral Hydrate to Perform Auditory Brainstem Response (ABR)
Condition: Auditory Brainstem Response in Children; Sedation With Chloral Hydrate
Study type: Interventional
Phase: Phase 2

Summary: 
      Chloral Hydrate (CH) is a well known drug for sedative and hypnotic purposes used in
      pediatric and dental procedures owing to the low depressive effect it has over respiratory
      and cardiac systems. Despite that, the literature reports cases of heart arrhythmia and
      sudden death in children, especially when using high doses, probably due to accumulation of
      serum trichloroethanol, an intermediate metabolite resulting from the liver metabolism of the
      drug. A possible carcinogenic action observed in guinea pigs has also been reported, even
      though it has not been confirmed in human beings.

      Among the least severe complications there are paradoxical agitation, nausea, vomiting and
      excessive sleepiness.

      CH is the drug of choice to sedate children undergoing Auditory Brainstem Response test
      (ABR), in which any movement or muscle contraction may generate artifacts that interfere in
      the analysis.

      Profound sleep that lasts on average one hour is rapidly induced depending on the used dose,
      causing no residual sleepiness after this period; however, there is consensus in the
      literature about the best dose, which may range from 40 to 100 mg/kg.

      Objective:

      To assess the efficacy of CH as a sedative agent in performing ABR in children and to
      systematize its use.
    


Intervention name(s): Chloral Hydrate
Intervention type(s): Drug
Intervention MeSH terms: Chloral Hydrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ABR; Chloral Hydrate; Sedation; Children
Study of AR-13324 in Patients With Elevated Intraocular Pressure
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized
      to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye),
      once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be
      administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated
      in the clinic throughout the study.
    


Intervention name(s): AR-13324 Ophthalmic Solution 0.01%; AR-13324 Ophthalmic Solution 0.02%; AR-13324 Ophthalmic Solution 0.04%; AR-13324 Ophthalmic Solution Vehicle
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Administered to study eye, once daily (QD) in the morning (AM) for 7 days; Administered to study eye, QD AM for 7 days; Administered to study eye, QD AM for 7 days; Administered to study eye, QD AM for 7 days
Other intervention name(s): Netarsudil
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intraocular pressure; visual field; Ocular hypertension or open angle glaucoma
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Condition: Acute Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this pilot clinical study is to compare healing rates, pain levels, and
      incidence of wound complications including infection with the use of a moist PROCELLERA™
      Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite,
      following curettage and electrodesiccation of skin lesions.
    


Intervention name(s): Procellera™ Antimicrobial Dressing; Mepilex® Border Lite; Adhesive Bandage
Intervention type(s): Other; Other; Device
Intervention description(s): Dressing indicated for partial and full-thickness wounds.; Self-adherent foam dressing; Adhesive bandage
Other intervention name(s): PROCELLERA™; Prosit™ Antimicrobial Dressing; Prosit™ Technology; Mepilex®; Band-Aid® Adhesive Bandage
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Curettage and electrodesiccation; acute wounds; partial thickness wounds
Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Concomitant administration of recombinant human growth hormone (rhGH) may boost the expansion
      of immune reconstitution and broaden specific T cell responses not achievable by vaccination
      alone. The main objective of that study is to test the validity of this hypothesis with
      vaccines which are routinely administered to HIV-1 patients(tetanus toxoid and hepatitis A
      virus vaccines) in order to, if proven of value, use this strategy of HIV vaccination in the
      near future. This is a pilot, randomized, clinical open label study aimed to investigate
      thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1
      infected patients in highly active antiretroviral therapy (HAART) regimen.
    

Detailed description: 
      The purpose of a therapeutic vaccine is to control, induce and expand humoral and cellular
      immune responses capable to control HIV infection. The administration of a conventional
      vaccine results in the expansion of peripheral clones. Concomitant administration of rhGH may
      boost this expansion and reconstitute specific T cell responses not achievable by vaccination
      alone. In this study we want to investigate whether the administration of rhGH expand T cell
      repertoire and whether there is an increase in the specific cellular responses to HIV-1 and
      recall antigens and, lately, whether this responses can be further amplified after
      immunization with tetanus toxoid and hepatitis A vaccines. This Hypothesis will be evaluated
      by the measurement of thymic volume, the expansion of naïve, memory and effector cell
      subsets, analysis of thymic emigrants (TRECs) before, during and after rhGH administration
      and vaccination. Moreover, T cell receptor rearrangement, specific antibodies and cellular
      responses to antigenic peptides will be determined.
    

Intervention name(s): recombinant human Growth Hormone; Vaccination; HAART
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Growth Hormone during 6 months (30UG/KG/DAY); Vaccination (Hepatitis A+B + tetanus toxoid) at week 16; HAART all over the trial
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth Hormone; HIV-1; Vaccination; Thymopoiesis; HIV-specific responses; Treatment Experienced
Pentoxifylline Treatment in Acute Pancreatitis (AP)
Condition: Acute Pancreatitis (AP); Gallstone Pancreatitis; Alcoholic Pancreatitis; Trauma Acute Pancreatitis; Hypertriglyceridemia Acute Pancreatitis; Idiopathic (Unknown) Acute Pancreatitis; Medication Induced Acute Pancreatitis; Cancer Acute Pancreatitis; Miscellaneous (i.e. Acute on Chronic Pancreatitis)
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Gallstones; Pancreatitis, Alcoholic; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the effects (good and bad) of giving a drug called
      pentoxifylline to patients with acute pancreatitis.
    

Detailed description: 
      Participants were randomized to either the treatment group (Pentoxifylline medication) or the
      control group (Placebo).

      Participant took a pill orally, starting from the time of admission. Participants received a
      total of 9 doses over the three days of hospitalization (72 hours).

      Research blood draws were done at baseline and on 5 successive days or until the time of
      discharge, whichever occured earlier. The study gathered clinical follow up information up to
      4 months following hospitalization regarding the diagnosis of acute pancreatitis.
    

Intervention name(s): Pentoxifylline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits Tumor Necrosis Factor (TNF) and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors; A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug
Other intervention name(s): Trental; Pentox; Pentoxil; Flexital
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis
A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of
      Avonex.
    


Intervention name(s): Serum containing Avonex; Serum Free Avonex
Intervention type(s): Drug; Drug
Intervention description(s): 60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15; 60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.
Other intervention name(s): Avonex; Avonex
Intervention MeSH terms: Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Multiple Sclerosis; Interferon beta-1a