bioihbjkbjnl/mcl2 huggingface dataset:
Buspirone as a Candidate Medication for Methamphetamine Abuse
Condition: Methamphetamine Dependence; Methamphetamine Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      Methamphetamine use disorders are an unrelenting public health concern. Intensive research
      efforts have yielded behavioral interventions that reduce methamphetamine use, however, these
      interventions are not universally effective and treatment effects diminish over time.
      Development of a pharmacotherapy that enhances the efficacy of these interventions is a
      priority for the National Institute on Drug Abuse. This study proposes to determine the
      impact of buspirone maintenance on self-administration of methamphetamine. These preliminary
      data will be used to support further research developing buspirone as a pharmacotherapy for
      methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate
      the reinforcing effects of methamphetamine.
    


Intervention name(s): Methamphetamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.; The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Safety, Tolerance, PK, and Anti-tumour Activity of AZD1775 Monotherapy in Patients With Advanced Solid Tumours
Condition: Ovarian Cancer, TNBC, SCLC, Other Solid Tumours
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multi-centre, Phase Ib study of AZD1775 designed to assess the safety,
      tolerability, pharmacokinetics, and anti-tumour activity of AZD1775 monotherapy in patients
      with advanced solid tumours.
    

Detailed description: 
      This study is being conducted in two parts, designated Parts A and B. Part A is a safety
      lead-in consisting of a cohort of approximately 12 patients with advanced solid tumours.

      Part B expansion cohorts will investigate AZD1775 monotherapy in advanced tumour types with
      molecular biomarkers of interest. The tumour types to be evaluated are: 1) ovarian cancer
      (BRCA1/2 mutation [PARP-failures]), 2) ovarian cancer (BRCA wild-type) with more than three
      prior lines of treatment, 3) triple negative breast cancer (TNBC), and 4) small-cell lung
      cancer (SCLC).
    

Intervention name(s): AZD 1775
Intervention type(s): Drug
Intervention description(s): AZD1775 will be taken orally approximately every 12 hours over 3 days at the start of week 1 and week 2 of each 21-day cycle (Days 1-3 and 8-10), for a total of 12 doses with each treatment cycle.
AZD1775 should be taken approximately 2 hours before or 2 hours after food.
Intervention MeSH terms: Adavosertib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD1775; Ovarian cancer (BRCA1/2 mutation); Ovarian cancer (PARP-failure); Triple negative breast cancer (TNBC); Small-cell lung cancer (SCLC); Solid tumours
Vascular Effect of Estrogens Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Condition: Unspecified Injury of Brachial Artery, Left Side, Initial Encounter
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the vascular effects of estrogens on climacteric women
      measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound
      and compare to placebo.
    

Detailed description: 
      The interruption of the secretion of sex steroids that occurs after menopause, determines a
      change in vascular pattern at various levels. As a result, several side effects might appear
      and interfere with women's quality of life and health. The use of hormone replacement therapy
      has contributed to the improvement in these effects. It has been observed vascular beneficial
      effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in
      climacteric women, on the central retinal arteries. The objective of this study is to
      evaluate the effects of conjugated equine estrogen on flow-mediated dilation of the brachial
      artery.
    

Intervention name(s): Estrogens, Conjugated (USP); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental group will use 0.625mg/day during 30 days; Placebo group will use placebo once/day during 30 days
Other intervention name(s): Premarin
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hormone replacement therapy; Doppler velocimetry; Flow-mediated dilation; menopause
Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
Condition: Trauma-related Wound; Burn, Partial Thickness
MeSH terms: Wounds and Injuries; Burns
Study type: Interventional

Summary: 
      The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial
      wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is
      that when the dressing is moistened, the low electric field created by moisture-activated
      elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to
      disrupt existing biofilm.
    

Detailed description: 
      The healing of traumatic wounds, to include burns, can be compromised by the presence of
      infection so efforts are made to prevent or diagnose infection early in order to mitigate the
      negative impact on healing. Electric stimulation has previously been shown to have both
      bacteriostatic and bactericidal effects in wounds. Until now, administering low intensity
      electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound
      healing was not feasible. In this study the investigators will use Procellera® , a FDA
      approved fabric based wireless electroceutical dressing (WED) consisting of a silver-zinc
      electro-couple for the prevention of wound biofilm formation. The dressing generates a low
      electric field (~1V) upon activation by a moist environment, which mitigates biofilm
      formation and promotes wound healing. The objectives of the study are to evaluate the
      efficacy of a wireless electroceutical dressing to prevent the formation or disrupting
      existing biofilms. The investigators will conduct a prospective, randomized controlled
      clinical trial using the Procellera® dressing compared to the standard of care. Treatment
      sites will be randomized to either receiving Procellera® or the standard of care treatment.
      Objective measurements and assessments will be completed during subject follow-up visits for
      up to one month post treatment. This includes biopsies to calculate bacterial load by
      assessing colony forming unit (CFU) count and bacterial film visualization using scanning
      electron microscopy, histology, clinical assessment of infection, Transepidermal Water Loss
      (TEWL) and wound photography.
    

Intervention name(s): Procellera®; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): Application of Procellera® dressing.; Application of standard of care dressings as prescribed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will have two wound sites that will be randomized to receive either the standard of care treatment or the Procellera® (electroceutical) dressing.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Prospective Feasibility Study for TAMIS
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with
      single-port technology has allowed that pelvic surgery can be laparoendocopically performed
      from both its abdominal and perineal aspects.Previously, a strong negative association
      between medium- and long-term survival and male gender with narrow pelvis have been reported.
      TAMIS has a significant potantial for improving the quality of the surgical resection of
      rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have
      also a high rate of conversion to open surgery. Focusing on improvement in intraoperative
      conditions and surgical techniques rather than routine conventional procedures may be the way
      to go concerning favorable short- and long-term outcomes. The selection of adequate surgical
      approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or
      limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a
      prospective observational feasability study of the TAMIS-procedure.
    


Intervention name(s): laparoscopic assisted transanal surgery (TAMIS)
Intervention type(s): Procedure
Intervention description(s): all patients included recieve laparoscopic assisted transanal minimally invasive surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with a solitary rectal cancer, who is eligible for surgery. Patients
        with rectal cancer (T1-3 stages verified by MRI), regardless regional lymph-node status and
        distant metastasis, will be offered the operative procedure with TAMIS technique.
A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of
      epileptic patients with refractory simple or complex partial seizures with or without
      secondary generalization.
    

Detailed description: 
      This clinical trial was performed as a multicentre, add-on, double-blind, randomised,
      placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks)
      patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG -
      once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo
      group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg,
      800 mg and 1200 mg).

      On completion of the 12-week double-blind treatment period, a 1-week tapering period was
      scheduled.
    

Intervention name(s): BIA 2-093; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route; Placebo tablets administered orally
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; BIA 2-093
Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders
Condition: Corneal Epithelial Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine if SJP-0035 ophthalmic solution is effective in
      promoting corneal epithelial wound healing in conditions associated with corneal epithelial
      disorders.
    

Detailed description: 
      There is currently no product approved for corneal epithelial wound healing. A Phase 1 Study
      SJP-0035/1-01 was conducted in healthy volunteers to investigate the safety, tolerability,
      and pharmacokinetic profile of SJP-0035 ophthalmic solution and to determine the appropriate
      dose to be evaluated in patients with moderate to severe corneal epithelial disorders.

      This Phase 2a study is being conducted to evaluate the safety and efficacy of SJP-0035
      ophthalmic solution in patients to promote corneal epithelial wound healing in conditions
      associated with corneal epithelial disorders.
    

Intervention name(s): SJP-0035 Ophthalmic Solution; Vehicle of SJP-0035 Ophthalmic Solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Continuous Versus Repetitive Sevoflurane Administration for Preconditioning
Condition: Myocardial Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      Pharmacologic preconditioning by volatile anesthetics may depend on the mode of
      administration. The researchers hypothesize that a continuous administration in patients
      scheduled for CABG surgery prebypass will be less effective in terms of attenuating
      myocardial cell damage compared to a repetitive administration with a double wash in/wash out
      schedule. A control group will receive propofol as their primary anesthetic.
    


Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention description(s): 1 MAC Sevoflurane will be given either continuously after induction of anesthesia until initiation of cardiopulmonary bypass or will be repetitively washed in and out twice before initiation of cardiopulmonary bypass.
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: myocardial protection; pharmacological preconditioning; volatile anesthetics; myocardial injury following CABG surgery
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
Condition: Abnormalities, Cardiovascular
MeSH terms: Cardiovascular Abnormalities
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the corrected QT interval (QTc) effect of
      volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300
      mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy
      adult male and female subjects.
    


Intervention name(s): Volanesorsen; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial; Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Thorough QTc, Therapeutic dose, supra therapeutic dose
Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone treatment
      vs. placebo, initiated within the first month of life, on long-term pulmonary and
      developmental outcomes in premature infants with evolving bronchopulmonary dysplasia.

      II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal
      function.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to
      1 of 3 treatment groups. The first group receives intravenous dexamethasone tapered over 42
      days.

      The second group receives daily intravenous dexamethasone for 6 days, then intravenous
      methylprednisolone (MePRDL) tapered over the next 34 days, beginning on day 8. A placebo is
      given on "off" MePRDL days.

      The third group receives an intravenous placebo for 42 days, with a tapering schedule
      beginning day 35.

      All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 and/or 30,
      as clinically indicated. Study drugs are suspended during rescue therapy.
    

Intervention name(s): dexamethasone; methylprednisolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: bronchopulmonary dysplasia; cardiovascular and respiratory diseases; neonatal disorders; rare disease
Hydrogen Inhalation for Health and Exercise Performance
Condition: Exercise Performance
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      In this randomized double-blind, placebo-controlled, crossover pilot trial, we evaluated the
      effects of 7-day H2 inhalation on exercise performance outcomes and serum hormonal and
      inflammation profiles in a cohort of young men and women.
    

Detailed description: 
      All participants were allocated to receive either gaseous hydrogen (4%) or placebo (room air)
      by 20-min once-per-day inhalation for 7 days, with wash-out period of 7 days to prevent the
      residual effects of interventions across study periods. The primary treatment outcome was the
      change in running time-to-exhaustion from baseline to day 7. Additionally, assessment of
      other exercise performance endpoints and clinical chemistry biomarkers were performed at
      baseline and after 7 days after each intervention.
    

Intervention name(s): Placebo; Hydrogen
Intervention type(s): Other; Other
Intervention description(s): Inhalation of room air for 20 min per day during 7 days; Inhalation of 4% hydrogen for 20 min per day during 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
      14 days of treatment with PF-05180999 in healthy subjects.
    


Intervention name(s): PF-05180999; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single oral doses of 0.1, 0.3, 1.0, 3, 10, 30, 100, and 250 mg oral solution or capsules; Placebo oral solution or capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF 05180999; safety; pharmacokinetics
Japanese phase1 Study of Belimumab (IV vs SC)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomized, 2 parallel group, single dose study in healthy
      Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous
      administration and single subcutaneous administration of GSK1550188. Serial blood samples for
      the determination of GSK1550188 concentration will be collected and safety assessments will
      be performed for each treatment group
    


Intervention name(s): GSK1550188 IV; GSK1550188 SC
Intervention type(s): Drug; Drug
Intervention description(s): Single IV dose of belimumab 200 mg; Single SC dose of belimumab 200mg
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GSK1550188, belimumab, SLE, healthy, Japanese, pharmacokinetics, safety
Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia
Condition: Postoperative Complications; Postoperative Pain; Weakness, Muscle; Motor Activity
MeSH terms: Muscle Weakness; Postoperative Complications
Study type: Interventional

Summary: 
      In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic
      option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed
      pericapsular nerve group block or PENG block, that selectively targets the articular branches
      of the femoral and obturator nerves while sparing their motor components. In this randomized
      trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing
      primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was
      selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the
      hypothesis that PENG block will result in significantly less motor block compared to SFIB.
    


Intervention name(s): Ultrasound-guided suprainguinal fascia iliaca nerve block; Ultrasound-guided pericapsular nerves group of the hip block
Intervention type(s): Procedure; Procedure
Intervention description(s): After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.; After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized comparison between two analgesic techniques
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care