bioihbjkbjnl/mcl2 huggingface dataset:
Povidone-Iodine for Nasal Decolonization
Condition: Surgical Wound Infection; Preoperative Care; Methicillin-Resistant Staphylococcus Aureus
MeSH terms: Wound Infection; Surgical Wound Infection; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal
      carriage of Staphylococcus aureus and MRSA. To determine whether a more convenient,
      single-dose, pre-operative 10% povidone-iodine (PI) application is effective in reducing
      nasal carriage of S. aureus and MRSA. We expect a statistically significant decrease in S.
      aureus/MRSA colonization in nasal cultures taken perioperatively after intervention in
      patients who received pretreatment with PI as compared to patients who received normal saline
      (NS).
    

Detailed description: 
      This will be a prospective single-blinded randomized placebo-controlled trial of two
      applications of a nasal 10% Povidone Iodine (PI) solution used on the intranasal mucosal
      surfaces of each nostril in the preoperative holding area within 2 h prior to surgical
      incision compared with NS using the same technique. Both the PI and NS will be applied by
      rotating the swab over the intranasal mucosal surface for 15 seconds; this process will be
      performed twice for both nostrils, using a new swab for each application. Nasal cultures will
      be obtained prior to PI or NS application as well as intraoperatively 1 hour and 2 hours
      after first surgical incision. The primary study end point is the decrease in S. aureus/MRSA
      colony forming units (CFU) in nasal cultures taken within 2 hours after intervention in
      patients who presented with a positive preintervention nasal culture. A secondary endpoint is
      the presence or absence of surgical site infections within 30 days postoperatively
    

Intervention name(s): Povidone-Iodine 10%; 0.9% NaCl Solution
Intervention type(s): Drug; Drug
Intervention description(s): Nasal swab stick application of Povidone-Iodine 10% prior to surgery; Nasal swab stick application of 0.9% NaCl Solution prior to surgery
Other intervention name(s): Profend; Normal Saline (NS)
Intervention MeSH terms: Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are assigned to treatment group or placebo
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
Condition: Hypertensive Anal Canal
Study type: Interventional

Summary: 
      Idiopathic hypertensive anal canal is a fact and already exists presented by anal pain
      aggravated by defecation. It can be managed safely by closed lateral sphincterotomy but
      chemical sphincterotomy had a minor role in its management.
    

Detailed description: 
      Patient and methods: Sixty three patients complaining of anal pain without any anal pathology
      and 10 healthy volunteers were examined. All patients underwent clinical evaluation,
      neurological examination, anorectal manometry, and measurement of pudendal nerve terminal
      motor latency (PNTML). All patients with hypertensive anal canal were randomized into three
      groups. Group I (surgical group) underwent closed lateral sphincterotomy LS, group II using
      nitroglycerine ointment (GTN) and group III received injection of botulinum toxin in internal
      sphincter. Post procedures data were recorded at follow up period.
    

Intervention name(s): lateral internal sphincterotomy (LIS); Glycerin trinitrate (GTN); botulinum toxin injection (BTX A)
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): closed lateral internal sphincterotomy was done under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.; All were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.; All were injected with botulinum toxin injection (BTX- A) in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
Other intervention name(s): GTN ointment; BTX A
Intervention MeSH terms: Nitroglycerin; Botulinum Toxins; Glycerol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anal hypertonia; sphincterotomy; incontinence; manometry
Safety and Efficacy of Probiotics in Bangladeshi Infants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Here the investigators propose to preliminarily investigate the safety and effects of
      probiotics in infants in Bangladesh through a pilot randomized clinical trial. The
      investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have
      an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i)
      to confirm the safety of administering probiotic strains to infants in low-income countries,
      ii) to determine the effects of dosing frequency on colonization and persistence of
      probiotics in the GI tract, iii) to measure markers of intestinal and immune function and
      microbiota structure.
    


Intervention name(s): Lactobacillus reuteri DSM 17938; Bifidobacterium longum infantis
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10^8 CFU; 10^9 CFU
Other intervention name(s): BioGaia Protectis Baby; Align
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: probiotics
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and efficacy of lucinactant for
      inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks
      gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for
      Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.
    

Detailed description: 
      The purpose of this study is to investigate the safety and efficacy of lucinactant for
      inhalation in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA). Efficacy
      and safety are based on clinical evaluations. The endpoints specified are similar to those in
      Protocols 03-CL-1201 and 03-CL-1401 to allow for potential comparison and pooling of results.

      The objective of this study is to evaluate the safety and efficacy of lucinactant for
      inhalation in conjunction with nCPAP, compared to nCPAP alone, in preterm neonates with RDS,
      as assessed by the time to and incidence of respiratory failure and/or death due to RDS over
      the first 72 hours of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks
      PMA, and change in physiologic parameters (FiO2 and PCO2) over the first 72 hours of life.
    

Intervention name(s): Lucinactant delivered via investigational delivery device; nCPAP
Intervention type(s): Drug; Drug
Intervention description(s): Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product); Nasal CPAP
Other intervention name(s): AEROSURF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PET and/or MRI Scans in Assessing Tumor Response in Patients Receiving Antiangiogenesis Therapy
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Diagnostic procedures, such as PET and MRI scans, may help to measure a patient's
      response to treatment.

      PURPOSE: This diagnostic trial is studying how well PET and/or MRI scans work in assessing
      changes in tumor blood supply in patients receiving antiangiogenesis therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the ability of positron emission tomography (PET) to assess the effect of
           therapy directed against tumor vasculatures on tumor blood flow and tumor blood volume
           in patients enrolled on a treatment protocol evaluating a therapeutic modality effecting
           the tumor associated vasculature.

        -  Evaluate the ability of PET to assess the effects of this type of therapy regimen on
           tumor uptake of fluorodeoxyglucose in these patients.

        -  Evaluate the ability of magnetic resonance imaging (MRI) to assess the effects of
           therapy directed against the tumor vasculature on tumor blood flow and tumor vascular
           density in these patients.

        -  Compare the findings on PET and/or MRI with those obtained from conventional CT in this
           patient population.

      OUTLINE: This is a diagnostic study conducted concurrently with a therapeutic modality study.

      Patients have magnetic resonance imaging and/or positron emission tomography (PET) scans
      performed prior to start of therapy, 6 weeks and 16 weeks following the initiation of
      therapy, and 6 weeks following the completion of therapy. Each scan requires about 1-3 hours.
      Patients receive up to 3 different PET scans including tumor blood flow scan with H2015,
      tumor blood volume scan with 11CO, and glucose uptake scan with fludeoxyglucose F 18.

      PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 2 years.
    

Intervention name(s): magnetic resonance imaging; positron emission tomography; fludeoxyglucose F 18
Intervention type(s): Procedure; Procedure; Radiation
Intervention MeSH terms: Fluorodeoxyglucose F18
Primary purpose: Diagnostic
Keywords: unspecified adult solid tumor, protocol specific
Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
Condition: Methamphetamine Abuse; HIV
Study type: Interventional

Summary: 
      The purpose of this protocol is to learn more about impulsive decision making in people who
      use methamphetamines. The investigators would like to know if a medication called naltrexone
      changes how people make decisions. The investigators would also like to know whether changes
      in decision making can be observed by MRI (magnetic resonance imaging).

      The research is conducted in Portland, OR.
    


Intervention name(s): Extended release naltrexone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
University Of Pennsylvania Weight Loss Study
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial
      incentives to motivate and sustain long-term weight loss. The study will recruit eligible
      employees at a large health management company to participate in a 6-month weight loss
      program and have weight measurements for an additional 3-month follow-up period. The primary
      outcome measure in this randomized controlled trial will be pounds of weight lost. The
      experimental groups will include variations of deposit contracts (participants put their own
      money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed
      payments. The use of deposit contracts is a powerful mechanism for inducing behavior change
      that is based on loss aversion, a psychological concept first described by Nobel Prize winner
      Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the fact that
      people typically feel the pain of a loss more than the pleasure of a gain, increasing ones
      motivation to reach a goal.

      The study hypotheses are 1) mean weight loss will be greater in all intervention groups
      compared to the control group by the end of 24 weeks; and 2) individuals in the intervention
      groups will have a lower mean weight at the end of the 3-month follow-up period than
      individuals in the control group.
    


Intervention name(s): Deposit contract with a 1:1 match; Deposit contract with a 2:1 match; Deposit Contract with no match
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.; Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.; Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; Motivation; Contracts
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
Condition: Lipid Metabolism, Inborn Errors; Heart Disease
MeSH terms: Heart Diseases; Metabolism, Inborn Errors; Lipid Metabolism, Inborn Errors
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 6-month study with patients who have the rare disease, sitosterolemia which may
      result in heart-related diseases. These patients have unusually high absorption of
      non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether
      absorption of these non-cholesterols can be reduced in these patients.
    

Detailed description: 
      The duration of treatment is 26 weeks.
    

Intervention name(s): MK0653, ezetimibe; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sitosterolemia
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
Condition: Chronic Lymphocytic Leukemia (CLL)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on
      the quality of life of participants including those with with relapsed/refractory (R/R)
      chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow)
      with or without the 17p deletion or TP53 mutation, including participants with an unknown
      status, as well as R/R CLL participants who had been previously treated with B-cell receptor
      inhibitor (BCRi) therapy. The starting dose of venetoclax was 20 mg once daily. The dose must
      have been gradually increased over a period of 5 weeks up to the daily dose of 400 mg.
      Participants may have continued receiving venetoclax for up to 2 years. After the treatment
      period, participants may have continued on into a 2-year follow-up period.
    


Intervention name(s): Venetoclax
Intervention type(s): Drug
Intervention description(s): Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.
Other intervention name(s): ABT-199; VENCLEXTA; VENCLYXTO
Intervention MeSH terms: Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed CLL; Refractory CLL; 17p deletion; TP53 gene; B-Cell receptor inhibitor (BCRi); European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30); Overall response rate (ORR); Duration of overall response (DOR); Complete remission rate (CR + CRi); Progression-free survival (PFS); Overall survival (OS)
Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To assess the safety and tolerability of single and multiple ascending intravenous doses
           of AAI101 (SAD & MAD) in healthy male subjects.

        -  To assess the safety and tolerability of single and multiple ascending intravenous doses
           of AAI101 in combination with fixed intravenous doses of piperacillin or cefepime in
           healthy male subjects
    


Intervention name(s): AAI101 i.v.; Saline 0.9% infusion; Piperacillin i.v.; Cefepime i.v.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h); Vehicle infusion; piperacillin 3 g i.v.; cefepime 1 g i.v.
Other intervention name(s): AAI101; Vehicle; Beta-lactam antibiotic; Beta-lactam antibiotic
Intervention MeSH terms: Anti-Bacterial Agents; Piperacillin; Cefepime; Lactams; beta-Lactams; Enmetazobactam; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Visual Pain Score and Perfusion Index in Postoperative Patients
Condition: Perfusion
Study type: Interventional

Summary: 
      The relationship between visual pain score and perfusion index in postoperative patients.
    

Detailed description: 
      The patients' operated with general anesthesia and who had visual pain score(VAS) above 3
      will be measured postoperatively perfusion index. .If the VAS score is above 3, 2 mg of
      morphine will be made. When the VAS score is below 3, the perfusion index will be measured
      again.Thus, the changes between vas and perfusion index will be measured.
    

Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): patients with the visual analog scale over 3 will receive morphine
Other intervention name(s): opioid analgesic
Intervention MeSH terms: Morphine; Analgesics, Opioid; Analgesics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two
      e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt)
      e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label,
      cross-over clinical study conducted in 15 healthy US adult smokers.
    


Intervention name(s): Conventional cigarette; myblu 25 mg freebase; myblu 16 mg nicotine salt; myblu 25 mg nicotine salt; myblu 40 mg nicotine salt; blu PRO 48 mg nicotine salt
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals; E-cigarette used for 10 inhalations every 30 seconds; E-cigarette used for 10 inhalations every 30 seconds; E-cigarette used for 10 inhalations every 30 seconds; E-cigarette used for 10 inhalations every 30 seconds; E-cigarette used for 10 inhalations every 30 seconds
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Minocycline and Aspirin in the Treatment of Bipolar Depression
Condition: Bipolar Disorder Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether minocycline and aspirin are effective in
      the treatment of depression in individuals with bipolar disorder.
    

Detailed description: 
      Abstract:

      New medication classes are needed to improve treatment effectiveness in the depressed phase
      of bipolar disorder (BD). Extant evidence suggests that BD is not only characterized by
      reduced monoaminergic signaling, but also by neural changes such as dendritic remodeling,
      demyelination, and glial and neuronal cell loss. These changes have been hypothesized to
      result from chronic inflammation, based partly on convergent evidence that proinflammatory
      cytokines are elevated in depressed patients with BD. The principal aims of the proposed
      research is to evaluate the antidepressant efficacy in bipolar depression of minocycline, a
      drug with neuroprotective and immune-modulating properties, and of aspirin, at doses expected
      to selectively inhibit cyclooxygenase 1 (COX-1), within the context of a randomized,
      double-blind, placebo-controlled, parallel-group clinical trial following a 2 x 2 design.

      Specific Aims Specific Aim 1: To evaluate the efficacy of augmentation therapy with
      minocycline and/or aspirin for bipolar depression.

      The investigators will test the hypothesis that compared with placebo, participants receiving
      minocycline and/ or aspirin will show a greater treatment response rate (defined as a >50%
      increase on the MADRS for the final two consecutive visits).

      Specific Aim 2: To investigate the relationship between the response to minocycline, aspirin
      and markers of inflammation (serum concentrations of IL-6 and CRP).

      The investigators will test the hypotheses that: a) minocycline treatment will reduce
      inflammation to a greater extent than placebo; b) during minocycline treatment the change in
      inflammatory cytokine expression will correlate with the change in depression ratings; c) the
      baseline elevation of inflammatory markers will predict greater antidepressant response to
      minocycline.
    

Intervention name(s): Minocycline; Aspirin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg po bid for 6 weeks; 81 mg po bid for 6 weeks; placebo for minocycline and/or aspirin
Intervention MeSH terms: Aspirin; Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Minocycline