bioihbjkbjnl/mcl2 huggingface dataset:
Losartan and Memory
Condition: PTSD
Study type: Interventional

Summary: 
      This study investigates the effect of a single dose of 50mg losartan vs placebo on BOLD
      signal during memory encoding.
    

Detailed description: 
      The commonly prescribed antihypertensive drug losartan targets the renin-angiotensin system -
      a hormone system regulating blood pressure - by acting as an angiotensin receptor antagonist.
      The drug prevents a docking of the protein angiotensin IV to AT1 receptors, which leads to a
      dilation if vessels and a reduction in blood pressure. However, the increase in free
      angiotensin IV has also been associated with an increase in synaptic plasticity, the cellular
      mechanism involved in learning and memory. As such, losartan appears to have
      cognition-enhancing properties, in a way that a single dose of 50mg improves prospective
      memory in healthy humans . However, preliminary pre-clinical results also suggest that a
      single injection of the drug improves fear extinction in rodents, which is the equivalent to
      human cognitive-behavioural therapy for anxiety disorders . Furthermore, compared to other
      antihypertensive drugs, regular losartan treatment appears to prevent the development of
      post-traumatic stress disorder following trauma exposition . Such results suggest that the
      renin-angiotensin system may play a key role in the prevention of anxiety.

      In this study, we investigate the effect kof probing the renin-angiotensin system on memory
      encoding, which has previously been shown to be impaired in PTSD. In a double-blind,
      randomised between-groups design, 40 healthy volunteers with moderate to high levels of trait
      anxiety are randomised to a group receiving a single dose of losartan (50mg) versus placebo.
      When peak plasma levels are reached, participants work on a battery of behavioural and neural
      measures of emotional information processing. These tasks will include an fMRI task where
      participants will see images of animals and landscapes on the screen and categorise these
      accordingly, to be tested for memory for these images in a later task.

      The results from this study will help us understand how the renin-angiotensin system affects
      memory formation, and they will help us establish a battery of tasks that sensitively respond
      to such manipulations. Such information will ultimately lead to the development of losartan
      and similar agents for the more effective and more compact treatment of anxiety disorders.
    

Intervention name(s): Losartan Potassium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet, over-encapsulated; oral tablet, over-encapuslated
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised double-blind
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses of BI 44370 BS Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for
      intravenous (i.v.) infusion
    


Intervention name(s): BI 44370; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Analgesic Effects of LED Light on Temporomandibular Disorders.
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical
      situations. With the advent of new LED-based (light emitting diode) light sources, the need
      of further clinical experiments aiming to compare the effectiveness between them is
      paramount.
    

Detailed description: 
      Aims: Low intensity laser therapy (LILT) has been widely applied in pain relief in several
      clinical situations. With the advent of new LED-based (light emitting diode)light sources,
      the need of further clinical experiments aiming to compare the effectiveness between them is
      paramount. Method: This study proposes an evaluation of analgesic effect in TMD
      (temporomandibular disorders) using two different LEDs systems, one emitting at the spectral
      band of red (630 +/-5 nm) and the other at infrared band (850 +/-5 nm), and compare the
      results with a laser treated control group (780nm diode laser using 105.7 J/cm2). Mandibular
      range of motion and report of pain were evaluated via appropriate equipment developed to do
      this end. Power output was 150mW, tip area was 0.5 cm² for both sources. Fluency or dose
      chosen was 18 J/cm² for each point of application, around the TMJ, on both sides. Five points
      were irradiated on TMJ, temporal and masseter muscles. Eight irradiation sessions were done
      and follow up was performed 7 and 30 days, after last session. Thirty patients were enrolled
      and they were selected randomly for each treatment, resulting in 10 patients per group
      (infrared LED, red LED and Control Group using infrared Laser).
    

Intervention name(s): Red LED; INFRARED LED; LASER
Intervention type(s): Radiation; Radiation; Radiation
Intervention description(s): Phototherapy with red LED on temporomandibular area; Phototherapy with infrared LED on temporomandibular area; Phototherapy with LASER INFRARED on temporomandibular area
Other intervention name(s): Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.; Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point; Irradiation parameters: 780 nm, 60 sec and 105 J/cm²
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Lasertherapy; Ledtherapy; TMJs; pain relief; oral aperture
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the
      acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will
      be tested by pretreating healthy individuals with PREG and then assessing their responses to
      THC.
    


Intervention name(s): Active Delta-9-THC; Active Pregnenolone; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Active Delta-9-THC (0.036 mg/kg) given intravenously.; A dose given sublingually.; A placebo dose given sublingually.; Placebo dose given intravenously.
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cannabis; Marijuana; THC; Pregnenolone; Psychotic Disorders; PREG
Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir
Condition: Hepatitis C, Chronic; HIV Infection
MeSH terms: Hepatitis A; Hepatitis C; HIV Infections; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be
      affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues
      (NRTIs) in HCV/HIV-co-infected patients.
    

Detailed description: 
      Objectives

        1. Primary Outcome Measures: evaluate the changes in the plasma pharmacokinetic parameters
           (Cmax, Cmin, AUC, t 1/2, and Cl) of Telaprevir (TVR) administered at 750 mg/8h together
           with un-boosted Atazanavir (200 mg/12h), taking as reference the pharmacokinetic
           parameters observed when TVR is administered with Atazanavir/ritonavir (300/100 mg/day)

        2. To assess the changes in the plasma pharmacokinetic parameters of Atazanavir
           administered as 200 mg/12h with respect to its administration as 300/100 mg/day when
           administered together with TVR (750 mg/8h or 1125 mh/12h).

      Method: open labelled clinical trial with a planned duration of 24 weeks in which 14
      HIV/Hepatitis C virus genotype 1 patients under treatment with pegylated α-interferon,
      Ribavirin and Telaprevir will be enrolled. A 24 hours pharmacokinetic profile will be
      obtained after a supervised drug intake while taking TVR and ATV/rtv. Afterwards, the
      patients will take un-boosted ATV 200 mg bid for 7 - 10 days. Subsequently, a new
      pharmacokinetic profile will be obtained.
    

Intervention name(s): Ritonavir withdrawal, atazanavir 200 mg/12h; Telaprevir interactions
Intervention type(s): Drug; Drug
Other intervention name(s): Reyataz; Norvir; Incivo; Incivo; Reyataz; Norvir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; HIV-infection; Drug interaction
Definitive QT Study With MT-8554
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to definitively assess the effects of MT 8554, adjusted for placebo, on the
      change of the QT interval corrected for heart rate (HR) using the Fridericia formula (QTcF)
      from Baseline in healthy adult subjects
    


Intervention name(s): MT-8554 Low dose; MT-8554 High dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, 7 days; Oral, 7 days; Oral, 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, placebo controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Effects of Delta-9-THC and Iomazenil in Healthy Humans
Condition: Schizophrenia; Mental Disorders; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or
      THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity
      of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot".
      Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to
      determine whether the administration of iomazenil will alter the effects of THC.
    


Intervention name(s): THC and Iomazenil; Placebo (control)
Intervention type(s): Drug; Drug
Intervention description(s): Iomazenil: 3.7 μg/kg intravenously over 10 minutes
Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes.; Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia and Disorders with Psychotic Features; Cannabis
Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue
Condition: Stress; Fatigue; Sleepiness
MeSH terms: Fatigue; Sleepiness
Study type: Interventional

Summary: 
      Objective: This study was conducted to assess the effect of therapeutic touch on stress,
      daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery.

      Design: Randomized placebo-controlled study.
    

Detailed description: 
      The trial was conducted between April and July 2018. The students who met the inclusion
      criteria were separated into three groups through randomization method as in therapeutic
      touch (n=32), placebo (n=32) and control (n=32), and a total of 96 students participated in
      the study. In this randomized placebo controlled study, the therapeutic touch group were
      subjected to therapeutic touch for twice a week throughout 4 weeks with each session of 20
      minutes. The data was acquired via Student Information Form, Epworth Sleepiness Scale,
      Pittburgh Sleep Quality Index, Perceived Stress Scale and Visual Analogue Scale for Fatigue.
    

Intervention name(s): Therapeutic Touch; Control group; Sham Therapeutic Touch
Intervention type(s): Other; Other; Other
Intervention description(s): Therapeutic Touch; Making measurements at the beginning of the research and 4 weeks; Sham Therapeutic Touch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Therapeutic touch; Daytime sleepiness; Sleep quality; Stress; Fatigue; Nurse-midwifery student
Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the late and early asthmatic response after an
      allergen inhalation challenge in adults with mild atopic asthma after receiving multiple
      doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and
      pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.
    


Intervention name(s): Placebo; Tezepelumab
Intervention type(s): Drug; Biological
Intervention description(s): Administered in a 1-hour intravenous infusion; Administered in a 1-hour intravenous infusion
Other intervention name(s): AMG 157; Tezspire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amgen; AMG 157; Asthma
Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of
      enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI),
      and in matched healthy control subjects with normal hepatic function.

      Degrees of hepatic impairment will be determined during screening by the subject's score
      according to Pugh's Modification of Child's Classification of Severity of Liver Disease.

      Subjects will be enrolled in 4 Groups as follows:

        -  Group A: Approximately 8 subjects with mild hepatic impairment (with a Child-Pugh score
           of < 7) will be enrolled in Group A.

        -  Group B: Approximately 8 subjects with moderate hepatic impairment (with a Child-Pugh
           score of ≥ 7 to ≤ 9) will be enrolled in Group B.

        -  Group C: Approximately 8 subjects with severe hepatic impairment (with a Child-Pugh
           score of ≥ 10 to ≤ 15) will be enrolled in Group C.

        -  Group D: Approximately 8-24 healthy subjects with normal hepatic function will be
           enrolled in Group D. Subjects in Group D will be matched to subjects in Groups A-C with
           respect to sex, age (± 10 years), and weight (± 30 pounds). More than 1 subject with
           differing degrees of HI can be matched to a single control; however, all subjects with
           HI must be matched to at least 1 healthy match subject.
    


Intervention name(s): Enasidenib
Intervention type(s): Drug
Intervention description(s): 100 mg enasidenib (CC-90007)
Other intervention name(s): AG-221; AG-221 mesylate; AGI-12910; AGI-12910 mesylate; CC-90007; IDHIFA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; CC-90007; Phase 1; Enasidenib
Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel
      following combination treatment with with doxycycline and Aczone 5% gel can maintain
      therapeutic response.
    

Detailed description: 
      This is a two-center, open-label pilot study. The study is apprised of 7 study visits:
      Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and
      doxycycline 100mg by mouth once daily at Baseline. Those subjects achieving treatment
      response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID
      at Week 12. Subjects not achieving treatment response will discontinue study participation.
    

Intervention name(s): Doxycycline 100mg; Aczone 5% gel
Intervention type(s): Drug; Drug
Intervention description(s): Doxycycline 100mg by mouth once daily; Aczone 5% gel twice daily
Other intervention name(s): Vibramycin, Oracea, Adoxa, Atridox; Dapsone
Intervention MeSH terms: Doxycycline; Dapsone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topical Application of Latanoprost in Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized double-blinded two-year intervention study with topical application of latanoprost
      or placebo eye drops in patients with diabetic retinopathy.
    

Detailed description: 
      The primary objective is to study if a sustained contraction of pathologically dilated
      retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to
      increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.

      The secondary objective is to study whether the intervention can halt the development of
      diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and
      fundus photography.
    

Intervention name(s): Latanoprost
Intervention type(s): Drug
Intervention description(s): Topical application
Other intervention name(s): No other names
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Latanoprost; vasodilation; diabetic retinopathy
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects.
      Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of
      XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also
      without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be
      assessed following dosing for 10 days in Part 3.
    


Intervention name(s): 10mg XEN-D0103; Placebo; 30mg XEN-D0103; 60mg XEN-D0103; 120mg XEN-D0103; 200mg XEN-D0103; 150mg XEN-D0103
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: S66913
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers
Condition: Healthy Individual
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active
           metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine
           at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for
           4.5 days at the same doses twice daily versus placebo and to use the study results for
           bridging with Caucasian data.

        2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on
           heart rate after single and then after repeated administrations.

        3. Clinical safety of ivabradine versus placebo.
    


Intervention name(s): Ivabradine and placebo
Intervention type(s): Drug
Intervention description(s): Single and repeated oral administrations of 3 doses of ivabradine (2.5, 5, and 10 mg). Subjects were given a single administration of ivabradine during Period 1 (P1), following a 3-day washout, they were given repeated administrations twice daily for 4.5 days during Period 2 (P2).
Other intervention name(s): Ivabradine; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Tangerina Mix
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the
      product Dermacyd Tina Gel Tangerina Mix
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hygiene
VR for Burn Dressing Changes at Home
Condition: Burns; Acute Pain; Procedural Pain
MeSH terms: Acute Pain; Pain, Procedural; Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation
      Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with
      a burn injury in comparison with a control group of children with a burn injury who will not
      use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT
      will report less pain during their dressing changes.
    

Detailed description: 
      Subjects will be randomly assigned to either the VR-PAT intervention group or Control group.
      Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by
      their physician) and afterward will answer questions about their pain and any medications
      used. Subjects and caregivers in the intervention group will answer additional questions
      about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be
      repeated with each dressing changes for one week.
    

Intervention name(s): VR-PAT
Intervention type(s): Device
Intervention description(s): Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset
Other intervention name(s): Virtual Reality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; VR; Burns; Pain; Dressing Changes