bioihbjkbjnl/mcl2 huggingface dataset:
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect on reduction of serum phosphate and the
      safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing
      continuous ambulatory peritoneal dialysis.
    


Intervention name(s): Lanthanum Carbonate (BAY77-1931)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
Secondary Prophylaxis After Variceal Bleeding in Non-Responders
Condition: Gastrointestinal Hemorrhage; Portal Hypertension; Cirrhosis
MeSH terms: Hypertension, Portal; Gastrointestinal Hemorrhage; Hypertension; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Controlled and randomized study comparing combined treatment (nadolol and endoscopic
      ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to
      hemodynamic response, in the prevention of esofagic verices rebleeding.
    

Detailed description: 
      The present is a prospective, randomized, open label study, in parallel groups, in which the
      patients with hemorrhage caused by esofagic varices will be randomized in two groups of
      treatment, after control of acute hemorrhage.

      All the patients included will receive standard medical treatment with beta - blockers and
      endoscopic ligation of the esofagic varices.

      The control group will be constituted by the patients assigned to receive endoscopic ligation
      and nadolol (N).

      The experimental group will be constituted by patients assigned to receive treatment
      according to the hemodynamic response.

      All patients included in the experimental group will receive pharmacologic treatment with
      nadolol combined with Isosorbide Mononitrate (MNI) or Prazosin (PZ).

      In both groups it will practice a basal hepatic hemodynamic study in the 4th-5th day after
      their admitance (after achieve hemodynamic stability for at least 48 h and with hemorrhage
      controlled) and a second control hepatic hemodynamic study 3-4 weeks after the beginning of
      the pharmacologic treatment, once adjusted doses.

      In the experimental group, the responders to N + MNI will keep on this treatment, but
      nonrespondent in the hemodynamic study will switch treatment to N + PZ and a third hepatic
      hemodynamic study will be performed 3 to 4 weeks after the dosage adjustement.

      The randomization will be stratified according to the degree of hepatic failure measured by
      Child-Pugh classification (classes A and B versus C) The design is random to avoid bias in
      the selection of the patients.
    

Intervention name(s): esofagic varices ligation; Nadolol; Isosorbide mononitrate; Prazosin
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention MeSH terms: Nadolol; Prazosin; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Variceal bleeding; Secondary profilaxis; Hemodynamic; Portal hypertension
Effect of Daily Music Listening on Stroke Recovery
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Single blind randomized clinical trial including 50 stroke patients to investigate the effect
      of daily music listening on behavioral, neural and physiological recovery. Patients are
      randomized (1:1:1) to listen instrumental or vocal music, or audiobooks (recorded book
      reading) (control). Outcome measures are change in neuropsychological tests, change in
      self-reported mood, structural and functional magnetic resonance imaging changes and hormonal
      changes performed at acute, 3-month and 6-month stages.
    

Detailed description: 
      Please see above
    

Intervention name(s): Music listening; Audiobook listening
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Recovery; Music
MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to determine lipid changing effects of MK0524A when compared to niacin extended
      release (NIASPAN) and placebo.
    


Intervention name(s): Comparator : placebo (unspecified) / Duraton of Treatment: 4 Weeks; MK0524A, niacin (+) laropiprant / Duration of Treatment : 4 Weeks; Comparator : niacin / Duraton of Treatment: 4 Weeks
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Safety/Efficacy Study of a Non-steroid, Topical Cream Treatment of Psoriasis Over 12-weeks
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation
      of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. This
      study, in patients with mild to moderate plaque psoriasis, is designed to further determine
      the efficacy, safety and tolerability of the novel, topically applied, non-steroid,
      anti-inflammatory WBI-1001 cream over a period of 12 weeks.
    

Detailed description: 
      A double-blinded, placebo-controlled study. Following screening, eligible patients will be
      randomized on Day 0 into one of two treatment groups in a 1:2 ratio:

      Group 1: placebo (vehicle) cream, twice daily (BID). Group 2: 1.0% WBI-1001 cream, BID.
      Patients will be randomized to treat all treatable lesion areas except for the face, scalp,
      groin and genital areas, and will be instructed to apply the cream twice daily for 84 days,
      at the same time each day, once in the morning and once in the evening.

      During the study patients will visit the study centre for assessment of efficacy, safety and
      tolerability at 0, 14, 28, 56 and 84 days after initiation, and patients will be phoned at
      Day 112 for a follow-up safety assessment.

      Patients that withdraw from the study before Day 56 due to reasons other than adverse events
      will be replaced as necessary to ensure that there are at least 16 patients from the placebo
      and 32 from the active cream treated groups remaining in the study at Day 56.
    

Intervention name(s): WBI-1001
Intervention type(s): Drug
Intervention description(s): Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plaque psoriasis; skin diseases; anti-inflammatory; non-steroid; topical cream
Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at addition of medications to the local anesthetic for the nerve blockade.
    

Detailed description: 
      Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital
      for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near
      nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also
      receive additional pain pills, including narcotics as needed. This study looks at addition of
      medications to the local anesthetic for the nerve blockade. The investigators hope that these
      medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve
      block. There are 3 groups in the study. One group is a control, and receives usual therapy:
      nerve block + pain pills. This is typically what the patient would receive as standard care
      if they were not in the study. One group uses a nerve block with additives (+ pain pills).
      One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine
      - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or
      indirectly acts on the brain.

      Patients will be followed while in the hospital, and contacted by telephone and/or email
      after discharge for 2-3 days. Patients will be asked about their pain levels and the duration
      of their block. The investigators will enroll 90 patients.
    

Intervention name(s): Dexamethasone; Buprenorphine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery
Condition: Kidney Stone
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      Due to the anatomic characteristics of the lower calyx, lower pole stones are difficult to be
      eliminated through the ureter, even if the stones had been fragmented. Retrograde intrarenal
      surgery (RIRS) can be used to deal with lower pole stones of 1.0-2.0 cm, while percutaneous
      nephrolithotripsy (PCNL) is mainly used to deal with lower pole stones with larger diameter
      or when RIRS failed to resolve the stone. This study was conducted to compare mini PCNL and
      retrograde intrarenal surgery (RIRS) for the management of lower pole kidney stones in terms
      of efficacy.
    


Intervention name(s): Mini-PCNL; RIRS
Intervention type(s): Procedure; Procedure
Intervention description(s): Mini-PCNL will done as follows. A 6 Fr ureteral catheter will be introduced through cystoscopy and dye will be instilled to opacify the pelvicalyceal system. After elaborating the calyceal system through fluoroscopy, selective calyceal will be punctured and tract will be dilated using 16 F sheath. Miniature nephroscope 14 Fr will be then introduced and stones will be fragmented by holmium: YAG laser. Afterwards the collecting system will be examined through nephroscope and fluoroscopic confirmation will be done to ensure complete stone clearance. In all the cases, 6 Fr 24 cm DJ stent will be placed and if remained uneventful, the patient will be discharged on postoperative day 2 with oral antibiotics.; RIRS will be performed as follows. In this procedure a double J stent will be placed to dilate the calyceal system 2 weeks prior the surgery. During the procedure, cystoscopy will be done, and 0.035-inch guide wire will be placed in the pelvi-calyceal system. Ureteric access sheath of 12 Fr will be placed and with the help of digital polyscope the stone will be fragmented using Holmium: YAG laser using 220 μm fiber. DJ stent 6F 24 cm will be placed in all the cases. In uneventful surgery patient will be discharged on postoperative day 1 with oral antibiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lower pole stone, mini PCNL, retrograde intrarenal surgery
Influence of a Monopoly Game on Subtle Behaviors
Condition: Obesity; Eating Behavior
Study type: Interventional

Summary: 
      This project will investigate the influence of experimentally manipulated perceived social
      standing on eating behavior and obesity risk.
    

Detailed description: 
      The scope of work outlined in this proposal will investigate experimentally manipulated
      social status on acute eating behavior, energy intake, and risk for obesity. This will be
      accomplished using a randomized, crossover design to place young adults in experimental high
      and low social status conditions. At visit 1, participants will complete baseline
      measurements, and then consume a standardized breakfast. In order to control for the
      influence of stress on eating behavior in both conditions, the participants will participate
      in the Stroop Test, a test known to induce stress in individuals, following breakfast. Using
      a computerized randomization scheme, each participant will be randomized to either the low or
      high social status condition (½ will receive high first; ½ will receive low first) and will
      receive the packet of rules and instructions for their respective condition. The participants
      will play Monopoly for up to 2 hours with another player they have not previously met. At the
      end of the game, the high social status player will be told that they won, and the low social
      status player will be told that they lost. The participants will participate in the Stroop
      Test again. Then the investigators will take the players into the Children's Eating
      Laboratory, where a buffet ad libitum lunch will be served in separate rooms. The
      participants will have 30 minutes to consume their lunch and plate waste will be measured to
      assess each participant's dietary intake. There will be a 4-week washout period and the
      second visit will be exactly like the first, except that they will participate in the
      alternate social status condition. The investigators will evaluate whether there was
      within-subject variation in dietary intakes based upon which social status condition they
      were placed in.
    

Intervention name(s): Low Social Status; High Social Status
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit.; The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: body weight; Hispanics; Energy Intake; Social Status
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to
      evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
    


Intervention name(s): PF-06700841; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.; Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spondyloarthritis
Cognitive, Emotional, and Neural Responses to Acute Inflammation
Condition: Healthy
MeSH terms: Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is a pilot study to examine the effects of acute inflammation on cognition and
      emotion in healthy participants using a between-subjects, randomized, double-blind design.
    

Detailed description: 
      The inflammatory response of the immune system is responsive to stress and it impacts brain
      function. Animal studies have shown that inflammation appears to alter threat- and
      reward-related brain activity. Accumulating evidence points to inflammatory proteins,
      specifically cytokines, as key players in this relationship. Although cytokines are typically
      too large to pass through the blood brain barrier (BBB), they can influence brain function
      and structure by transmitting signals from peripheral systems to the brain.

      The administration of endotoxin within the polysaccharide form of Salmonella typhi
      vaccination provides an ideal model for studying the causal effects of short-term
      inflammation on thinking patterns (i.e., cognition) and emotions in the brain. Endotoxin is a
      component of the cell walls of Gram-negative bacteria, which promotes the production of
      pro-inflammatory cytokines, such as interleukin-6 (IL-6) and tumor necrosis factor alpha
      (TNF-α) via toll-like receptor-4 (TLR-4) activation and nuclear factor- κB (NF-κB) signaling.

      To examine the effects of acute inflammation on brain functioning, 24 healthy participants
      will be recruited. The investigators will will randomize participants to placebo or
      inflammatory challenge using polysaccharide typhoid vaccine (i.e., endotoxin) and will use
      validated behavioral tasks and questionnaires to assess threat and reward sensitivity. They
      will assess chronic resting levels of inflammation as well as the inflammatory response to
      Salmonella typhi vaccination.
    

Intervention name(s): Typhoid Vi Polysaccharide Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Salmonella typhi capsular polysaccharide vaccine (Typhoid Vi Polysaccharide Vaccine): Each dose of 0.5ml Salmonella typhi capsular polysaccharide vaccine (Sanofi Pasteur, SA) is formulated to contain 25μg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7±0.3), 4.150mg of sodium chloride, 0.065mg of disodium phosphate, 0.023mg of monosodium phosphate and 0.5ml of sterile water for injection. It is indicated for use by humans aged 2 years and older for protection against typhoid fever.; The placebo injection will consist of 0.5mL of saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Inflammation; Threat sensitivity; Reward sensitivity
Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of repeated doses of the drug Lu AG06466
      on the exposure of metoprolol, midazolam and bupropion
    

Detailed description: 
      On Day 1, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK
      sampling will be performed for 48 hours.

      On Day 3, bupropion will be dosed as a single oral dose and PK sampling will be performed for
      48 hours.

      On Days 5-18, subjects will be dosed with Lu AG06466 once daily.

      On Day 15, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK
      sampling will be performed for 48 hours.

      On Day 17, bupropion will be dosed as a single oral dose and PK sampling will be performed
      for 48 hours.
    

Intervention name(s): Lu AG06466; Midazolam; Metoprolol; Bupropion
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): 10, 20, 30 mg/day oral capsules on Day 5-18; 4 mg syrup, oral single dose on Day 1 and Day 15; 100 mg tablets, oral single dose on Day 1 and Day 15; 100 mg tablets, oral single dose on Day 3 and Day 17
Intervention MeSH terms: Metoprolol; Midazolam; Bupropion
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
Condition: Renal Insufficiency, Chronic; Hepatic Insufficiency; Healthy
MeSH terms: Hepatic Insufficiency; Liver Failure; Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in
      subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic
      hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a
      randomized, open-label, crossover study in which they will receive Sporanox® to compare the
      safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.
    

Detailed description: 
      For the renal and hepatic subjects, following the screening visit, eligible subjects will
      return to the study site on Study Day 0 and remain at the site for 2 nights and 2 days. Study
      drug administration will occur on Study Day 1. Subjects will be discharged on Study Day 2
      after the last blood sample has been collected. Subjects will return 7 ± 3 days after dosing
      with study drug to have final safety assessments performed. For the healthy subjects,
      following the screening visit, eligible subjects will return to the study site on Study Day 0
      and remain at the site for 3 nights and 3 days. Study drug administration will occur on Study
      Day 1 and Study Day 2. Subjects will be discharged on Study Day 3 after the last blood sample
      has been collected. Subjects will return 7 ± 3 days after receiving the last dose of study
      drug to have final safety assessments performed.
    

Intervention name(s): Sporanox; Diclofenac Sodium
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg; 37.5 mg
Intervention MeSH terms: Itraconazole; Diclofenac
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Renal; Hepatic; Healthy
Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study was to obtain information about safety, tolerability and
      pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy
      male and female volunteers. With respect to pharmacokinetics, it was of particular importance
      to investigate whether therapeutic plasma levels (for treatment of migraine) could have been
      achieved by oral administration of a BIBN 4096 BS formulation.
    


Intervention name(s): BIBN 4096 BS - in single rising doses; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olcegepant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment