bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Delivery Route on PK of Sufentanil NanoTab
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine whether the amount of drug absorbed is different if the tablet is placed under the
      tongue, placed between the cheek and gum, or swallowed.
    


Intervention name(s): Treatment A: Sufentanil IV; Treatment B: Sufentanil NanoTab Sublingual; Treatment C: Sufentanil NanoTab Buccal; Treatment D: Sufentanil NanoTab Oral
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV); Single Sufentanil NanoTab 15 mcg given sublingually (SL); Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU); Single Sufentanil NanoTab 15 mcg swallowed (PO)
Intervention MeSH terms: Sufentanil; Dsuvia
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; area under curve; time to maximum concentration
Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      Tat is a key HIV regulatory protein produced very early after infection, prior to virus
      integration, and necessary for viral gene expression, cell-to-cell virus transmission and
      disease progression. Previous studies in natural HIV infection, indicated that the presence
      of a Tat-specific immune response correlates with a lower incidence and reduced risk of
      progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune
      response to Tat may exert a protective role and control the progression to AIDS in vivo.

      On the basis of the above mentioned consideration, the present study was directed at
      investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African
      patients.
    

Detailed description: 
      This is an observational, cross-sectional study aimed at assessing the frequency, magnitude
      and quality of the anti-Tat antibody response in both antiretroviral (ARV)-treated and
      treatment-naïve HIV-infected South African adults, and at exploring the correlation between
      the presence of anti-Tat antibody response and the immunological status of participants as
      well as with the presence of co-infections such as HBV, syphilis and HPV (the latter only for
      female participants).

      The study has involved 531 participants and provided important information for the planning,
      design and conduction of future therapeutic clinical trials with the Tat-based HIV vaccine in
      South African individuals.

      This study is conducted in the frame of the Government-to-Government cooperation program N.
      AID 8421, funded by the Italian Ministry of Foreign Affairs-Directorate General for
      Development Cooperation (MAE-DGCS) and jointly implemented by the Italian Istituto Superiore
      di Sanita' (ISS) and the South African Department of Health in collaboration with the South
      African AIDS Vaccine Initiative of the Medical Research Council (MRC-SAAVI)
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV positive, ARV-treated and treatment-naïve participants.
      
Biospecimen description: 
      Whole blood, cervical samples
    
Keywords: HIV; HAART
Myeloid to Adipocyte Transdifferentiation in Human Cells
Condition: Obesity
Study type: Observational

Summary: 
      In order to design new programs to help prevent weight gain, promote successful and
      sustainable weight loss, and help treat diseases related to obesity, the investigators need a
      better understanding of why accumulating fat in certain regions of the body is bad for
      health. It is known that not all fat cells are the same, but it was recently discovered that
      some fat cells may arise from stem cells that come from the bone marrow (bone marrow
      progenitors), a previously unrecognized origin. This discovery has been paradigm shifting,
      because dogma has long held that all white fat cells arise from fat tissue resident
      mesenchymal stem cells. This is also important because fat cells arising from the bone marrow
      lineage may be linked to worse health outcomes. The aim of this study is to determine if
      cells that were not previously believed to contribute to fat generation in humans are indeed
      capable of becoming fat cells. To answer this question the investigators will take samples of
      cells from the blood and the fat tissue of younger and older men and women, isolate the cells
      that came from the bone marrow and grow them in culture to determine if they will turn into
      fat cells. The results of this investigation may reveal potential mechanistic targets for
      future therapies to reduce the negative health outcomes associated with obesity related
      chronic diseases.
    


Intervention name(s): Adipose Tissue Biopsy
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Community sample
A Study Investigating the Safety and Tolerability of Deferiprone in Patients With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to demonstrate the safety and tolerability of
      deferiprone in subjects with Friedreich's ataxia (FRDA).

      The secondary objective is to evaluate the efficacy of deferiprone for the treatment of FRDA,
      as assessed by a 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), Low-Contrast Letter
      Acuity test (LCLA), International Cooperative Ataxia Rating Scale (ICARS), and Friedreich's
      Ataxia Rating Scale (FARS).

      The tertiary objectives are to evaluate the effect of deferiprone on:

        1. cardiac function as measured by changes in Left Ventricular Shortening Fraction (LVSF),
           Left Ventricular Ejection Fraction (LVEF) and Left Ventricular (LV) mass using
           echocardiogram (ECHO),

        2. quality of life using quality-of-life surveys, and

        3. functional status using Activities of Daily Living (ADL).
    

Detailed description: 
      This will be a multi-centre, double-blind, randomized, placebo-controlled clinical trial. A
      total of 80 patients with Friedreich's ataxia will be enrolled. Eligible patients will
      receive deferiprone oral solution or placebo at a total daily dose of 20 mg/kg/day, 40
      mg/kg/day or 60 mg/kg/day, divided into two-daily doses for 6 months.
    

Intervention name(s): placebo; deferiprone; deferiprone; placebo; deferiprone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Same dose and frequency as treatment; 100 mg/mL; 100 mg/mL; Same dosage and frequency as study drug; 100 mg/mL
Intervention MeSH terms: Deferiprone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Friedreich's ataxia
Observational, Prospective, Single-center Study: Should Body Mass Index (BMI) be Added to the Scoring Criteria of Hepatic Critically Ill Patients in Intensive Care Unit??
Condition: ICU Stay & Mortality
MeSH terms: Critical Illness
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in
      critically ill patients that are having abnormal BMI.
    

Detailed description: 
      All demographic data will be obtained including the patients' age, sex, body mass index (BMI)
      & categorized into; BMI < 18.5Kg/m2 = underweight, BMI between 18.5-24.9Kg/m2 = normal
      weight, while BMI between 25-29.9Kg/m2 = overweight & obese = BMI ≥ 30Kg/m2, associated
      co-morbidities (diabetes mellitus, hypertension, chronic renal failure, cancer& chronic liver
      disease), the cause of admission to ICU, Sequential Organ Failure Assessment (SOFA),
      nutritional risk screening (NRS) on admission & discharge, prior cardiac arrest, previous ICU
      admission within 6months, nosocomial infection, organ failure e.g. cardiovascular,
      respiratory, renal & organic support requirement e.g. hemodynamic support, mechanical
      ventilation, renal replacement therapy (RRT).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that will be admitted to ICU will be categorized into; BMI < 18.5Kg/m2
        =underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 =
        overweight & obese = BMI ≥ 30Kg/m2
The Effects of Increased Central Serotonergic Activity on Information Processing
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      It is of great clinical relevance to know if selective serotonin re-uptake inhibitors affect
      information processing. Our hypothesis was that aspects of information processing would be
      disturbed whereas others would improve.
    

Detailed description: 
      Numerous studies point to an increased serotoninergic activity in schizophrenia.
      Additionally, patients with schizophrenia often show reduced filtering of sensory
      information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of
      the startle refex (PPI). Currently, the reports in literature on the effects of serotonergic
      agonists on sensory gating in humans are inconclusive. In an initial study performed in our
      laboratory, however, we found reduced P50 suppression following administration of imipramine
      (a combined serotonin- and noradrenalin reuptake inhibitor) to healthy volunteers. This
      result provides evidence for the involvement of either serotonergic, noradrenergic, or a
      combination of both pathways in sensory gating. In numerous animal studies however, sensory
      gating is reduced by agonists of 5-HT, which suggests a serotonergic, rather than a
      noradrenergic, involvement in sensory gating. Therefore, in a follow-up study, the effects of
      a selective serotonin reuptake inhibitor (escitalopram) will be investigated on sensory
      gating parameters of healthy volunteers. To further extend the data of our initial study, the
      subjects will additionally be tested for two more psychophysiological parameters of attention
      that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch
      negativity and selective attention. The design will be a double blind, placebo controlled
      experiment, in which a single dose of escitalopram or placebo will be given to healthy,
      non-smoking male volunteers on two occasions, separated by at least a week, after which the
      subjects will be tested in the psychophysiological test battery.
    

Intervention name(s): Escitalopram; escitaolpram
Intervention type(s): Drug; Drug
Intervention description(s): Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers; Either 15 mg of escitalopram or placebo will be administered to healthy volunteers
Other intervention name(s): Cipralex; Cipralex
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: PPI; P50 suppression; P300; mismatch negativity; escitalopram
Risk of Hepatitis B Virus Reactivation in Patients Undergoing Allografting
Condition: Hepatitis B Virus; Allograft; Hematological Malignancies
MeSH terms: Hepatitis A; Hepatitis B; Hematologic Neoplasms; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the risk of hepatitis B reactivation in patients
      undergoing allografting.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A cohort of patients undergoing allografting for hematological malignancies
      
Keywords: Incidence of hepatitis B after allografting; Risk of hepatitis B reactivation; Lamivudine prophylaxis
Haploidentical NK Cell Infusion in Malignant Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We hypothesized that haploidentical NK cells kill tumor cells more efficiently than
      autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study
      to investigate the role of haploidentical NK cell therapy in patients with refractory or
      relapsed malignant melanoma.
    

Detailed description: 
      Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion, suggesting
      the role of cancer immunotherapy. However, autologous NK cells showed the lack of significant
      clinical effects, because they are inhibited by self MHC class I molecules, based on the
      missing-self hypothesis. Contrarily, haploidentical NK cells with KIR-ligand incompatibility
      can mediate graft-versus-leukemia effect and protect patients with acute myelogenous leukemia
      (AML) from graft-versus-host disease. In addition, adoptive transfer of haploidentical NK
      cells following high-intensity conditioning induced complete remission (26%) in
      poor-prognosis AML patients. Thus, this study was designed to investigate the role of
      adoptive NK cell therapy in patients with refractory or relapsed malignant melanoma using
      CD3+ depleting CliniMACS® system.
    

Intervention name(s): Haploidentical NK cell
Intervention type(s): Biological
Intervention description(s): Collection of PBMCs by leukapheresis
CD3+ depletion of apheresis product using CliniMACS®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma, Experimental
Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This study evaluates the addition of an interdental cleaning device paired with a manual
      toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival
      bleeding and reduction of gingival inflammation.
    


Intervention name(s): Interdental cleaning device; Manual Tooth brush
Intervention type(s): Device; Device
Intervention description(s): Water Flosser; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies
Condition: Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study aims to determine whether different concentrations of nitrous oxide
      (N2O) have different antidepressant effects for adults with treatment-resistant major
      depression.
    

Detailed description: 
      Most clinical major depression responds to standard treatments (medication and
      psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond
      to these treatments and are referred to as treatment-resistant major depression (TRMD). New
      treatments for TRMD are needed, and one promising line of research are drugs known as
      N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our
      group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD.

      All patients will receive 3 randomized, one hour nitrous oxide inhalations to placebo (0%
      N2O), low dose (25% N2O), and high dose (50% N2O). Inhalation sessions will be at least 4
      weeks apart. Mood will be assessed at baseline, 2 and 24 hours, and 1, 2, and 4 weeks
      post-inhalation for each dose.
    

Intervention name(s): Nitrous Oxide 25%; Nitrous Oxide 50%; Placebo Gas
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at a concentration of 25% nitrous oxide/50% oxygen/25% nitrogen.; Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at a concentration of 50% nitrous oxide/50% oxygen.; Placebo gas given at 50% nitrogen [inert]/50% oxygen.
Other intervention name(s): One hour inhalation of 25% nitrous oxide; One hour inhalation of 50% nitrous oxide; One hour inhalation of placebo gas
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant receives the 3 inhalation types in randomized, one hour sessions separated by at least 4 weeks
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; treatment-resistant
Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?
Condition: Budd-Chiari Syndrome
MeSH terms: Budd-Chiari Syndrome; Syndrome
Study type: Interventional

Summary: 
      Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small
      hepatic veins to the confluence between inferior vena cava and right atrium, which often
      leads to the life-threatening complications, such as liver failure and portal
      hypertension-related complications. At present, a stepwise treatment strategy is employed,
      including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous
      transluminal angioplasty [PTA] alone or in combination with stent placement), transjugular
      intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of
      BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization
      is the most common treatment modality used in China.

      Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has
      shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with
      stent placement group (31% versus 7.7%, p<0.001). In addition, re-occlusion was regarded as
      the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might
      have a worse survival than PTA combined with stent placement in Chinese patients with primary
      BCS.
    


Intervention name(s): Stent; Balloon
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Budd-Chiari syndrome; percutaneous recanalization; treatment; reocclusion; patency
Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome
Condition: Septic Shock; Acute Respiratory Distress Syndrome
MeSH terms: Shock, Septic; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Shock
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      PiCCO has been widely used in critical care settings for several decades. Together with
      pulmonary artery catheter, it is regarded as the important tool for guiding fluid management
      in patients with shock or acute respiratory distress syndrome. However, its effects on
      patients' outcome remain untested. The investigators study is a pilot study that is designed
      to test whether the use of PiCCO will improve patients' outcome, as compared to those without
      PiCCO monitoring.
    

Detailed description: 
      PiCCO comprises techniques of pulse contour analysis and transpulmonary thermodilution, and
      can provide important information on hemodynamics and pulmonary functions. It has been widely
      used in critical care settings for several decades. Together with pulmonary artery catheter
      (PAC), it is regarded as the important tool for guiding fluid management in patients with
      shock or acute respiratory distress syndrome. During last two decades, many well designed
      clinical trials have been conducted to see whether the use of PAC would benefit patient
      outcome. The result consistently showed that PAC added no benefit in terms of mortality, ICU
      length of stay, organ failure free survival days, and the length of mechanical ventilation.
      Since PiCCO is relatively new to PAC, and its effects on patients' outcome remain untested.
      The investigators study is a pilot study that is designed to test whether the use of PiCCO
      will improve patients' outcome, as compared to those without PiCCO monitoring.
    

Intervention name(s): PiCCO monitoring (PULSION); central venous catheter
Intervention type(s): Device; Procedure
Intervention description(s): Patients are monitored with PiCCO system.; patients in this arm can receive central venous catheter
Other intervention name(s): PiCCO (pulsion medical system, PULSION PiCCO plus)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: septic shock; acute respiratory distress syndrome; transpulmonary thermodilution technique; mortality
A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics of various TRV734
      formulations in healthy male subjects.
    


Intervention name(s): TRV734
Intervention type(s): Drug
Intervention description(s): Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Male; Pharmacokinetics