bioihbjkbjnl/mcl2 huggingface dataset:
Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial is to determine the relationship within a participant between the
      time to manual detection of the reappearance of the fourth twitch (T4) measured using a
      peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch
      (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex
      administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last
      maintenance dose of 0.15 mg/kg rocuronium.
    

Detailed description: 
      The TOF-Watch® SX has been used for neuromuscular monitoring in all

      clinical trials with sugammadex. In clinical practice however, a PNS is commonly

      used in many hospitals worldwide. A disadvantage of a PNS is that it is not objective
      monitoring like the TOF-Watch® SX, and it can detect only the number of twitches. In this
      trial, the relationship between the time to reappearance of T4 using PNS (i.e. Ministim®
      model MS-IV) and the time to recovery of the T4/T1 ratio to 0.9 using the TOF-Watch® SX was
      determined after a dose of 4.0 mg/kg sugammadex was administered 15 minutes after the last
      dose of rocuronium. Determining this relationship will enable the provision of advice on when
      it is safe to extubate participants after administration of 4.0 mg/kg sugammadex for
      reversing neuromuscular block while using a PNS. The time to reappearance of T4 was assessed
      by a blinded PNS-assessor. This assessor was blinded for the dose of sugammadex used and for
      the TOF results measured with the TOF-Watch® SX.
    

Intervention name(s): sugammadex
Intervention type(s): Drug
Intervention description(s): Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.
Other intervention name(s): Org 25969; Bridion®; MK-8616; SCH 900616
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Clopidogrel Tablets 75 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's
      Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75
      mg tablet under fed condition.
    

Detailed description: 
      Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet
      (Dr. Reddy's Laboratories Ltd., India) and Plavix® (Bristol-Myers Squibb Company, USA)
      Following a 75 mg Dose In Healthy Subjects Under Fed Conditions.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): Clopidogrel Tablets 75 mg
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Clopidogrel; crossover
Attitudes and Stigma Towards Suicidal Behavior in Intensive Care and Emergency Service Nurses
Condition: Suicide; Stigma, Social
MeSH terms: Emergencies; Suicide
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to determine the attitudes and stigmatization levels of nurses
      working in the intensive care and emergency departments towards suicidal behavior.
    

Detailed description: 
      Suicide is an important and priority public health problem. In the last 45 years, the suicide
      rate in the world has increased by 60%. About 800,000 people die each year due to suicide.
      Suicide can be prevented with timely, evidence-based, and often low-cost interventions. The
      first places that individuals who attempt suicide apply are often the emergency departments
      of hospitals. These individuals are then referred to intensive care units for close follow-up
      of physical findings and treatment according to the results of the suicide attempt. Nurses
      working in the emergency room and general intensive care unit should consider the need for
      psychosocial support while taking precautions against the physiological consequences of
      suicide in order for the individual to survive. In the care of an individual who has
      attempted suicide, the nurse has responsibilities such as providing education to the patient,
      creating a safety plan, counseling for the restriction of deadly vehicles, quick referral to
      the necessary places, and providing contact with post-discharge care. It is a priority in the
      care of the individual that the nurse reduces the sense of hopelessness of the individual who
      comes with a suicide attempt, re-establishes the sense of commitment to other people,
      increases compliance with the treatment, motivates for change, and establishes therapeutic
      communication. In this regard, the knowledge level of healthcare professionals and nurses who
      provide primary care to patients, and their attitudes towards suicide are important. When the
      literature is examined, studies on the attitudes of health professionals working in the
      emergency room toward suicide attempts have been observed, but no research has been found
      that determines both the attitudes and stigmatization levels of intensive care and emergency
      room nurses toward suicidal behavior. For this reason, this study was planned to determine
      the attitudes and stigmatization levels of nurses working in the general intensive care and
      emergency departments towards suicidal behavior.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Volunteer nurses working in the general intensive care and emergency departments of the
        hospital.
      
Keywords: suicide; stigma
Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately
Condition: Peptic Ulcer Disease
MeSH terms: Peptic Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate whether treatment with a combination capsule of
      Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within
      the body) as these medications taken separately. Two different forms of esomeprazole (tablets
      and capsules) will be investigated.
    


Intervention name(s): Esomeprazole/ASA Fixed Combination; Esomeprazole - Nexium; ASA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, oral, single dose; Clinical Trial Capsule or MUPS Tablet, oral, single dose; Tablet, oral, single dose
Other intervention name(s): Aspirin
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; ASA; Esomeprazole; peptic ulcer disease; primary cardiovascular protection; healthy volunteers
Acupuncture in the Treatment of Depression
Condition: Depressive Disorders; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The current large randomized placebo-controlled trial is testing the ability of acupuncture
      to treat major depression. The study is unique in that treatment effects will be from the
      perspective of both Western psychiatry and Chinese medicine.
    

Detailed description: 
      Depression is an unfortunately common condition for which people often seek alternative
      (non-Western) treatments, perhaps because conventional treatments do not consistently provide
      lasting relief. A pilot study (Allen, Schnyer and Hitt, 1998) suggests that acupuncture, a
      popular but under-researched alternative treatment derived from Chinese medicine, holds
      sufficient promise as a treatment for depression to warrant a larger-scale clinical trial.
      The investigators propose to conduct a larger-scale test of the efficacy of acupuncture in
      this trial. Because relapse and recurrence of Major Depression are quite common, the
      investigators also will assess the clinical status of participants for 18 months after
      treatment concludes. In the first phase of this double-blind randomized clinical trial, 150
      men and women meeting criteria for Major Depression will be randomly assigned to a treatment
      approach or to a waitlist control. All participants will ultimately receive acupuncture
      designed to address their own particular constellation of depressive symptoms. At the end of
      this first phase, blind assessments will be used to compare treatment effects from the
      perspectives of both Western psychiatry and Chinese medicine. After this treatment phase,
      participants will be assessed several times over the next 18 months. The study is designed to
      evaluate the efficacy and clinical significance of acupuncture as a treatment for Major
      Depression, and to examine the convergence of Western-based and Chinese-medicine-based
      outcome measures. Finally, the study will determine whether changes in energetic pattern
      mediate changes in Western defined depression severity, and explore whether patient and
      history variables predict responses to acupuncture treatments.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men
      and non-Asian men.

      Japanese participants will either get NNC0194-0499 or placebo - which treatment participants
      get is decided by chance. Non-Asian participants will get NNC0194-0499.

      Participants will get 1 or 2 injections of the study medicine. It will be injected with a
      needle into a skin fold on the stomach.

      The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with
      the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5
      nights).

      The study includes blood sampling. Participants will not be able to take part in the study if
      the study doctor thinks there is a risk for participants health.
    


Intervention name(s): NNC0194-0499; Placebo (NNC0194-0499 )
Intervention type(s): Drug; Drug
Intervention description(s): 1 single dose administered subcutaneously (s.c. - under the skin); 1 single dose administered subcutaneously (s.c. - under the skin).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ATV/Ritonavir Nevirapine Interaction (USPAC)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the
      pharmacokinetics of atazanavir in HIV-infected individuals.
    


Intervention name(s): Nevirapine; Nevirapine + Atazanavir/Ritonavir; Nevirapine + Atazanavir/Ritonavir; Atazanavir + Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 200 mg, Twice daily, 3 days.; Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days.; Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days.; Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Other intervention name(s): Reyataz; Reyataz; Reyataz
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Nevirapine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Efficacy of NAT-FM Treatment for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The main objective of this study is to analyse the efficacy of the NAT-FM multicomponent
      treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.

      In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of
      NAT-FM treatment in the short- and long-term, the research team will seek to identify
      relevant moderators and mediators of clinical change.
    

Detailed description: 
      -  This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent
           program NAT-FM as coadjuvant of treatment-as-usual (TAU) vs. TAU alone.

        -  NAT-FM combines Classical Structural Assessment (CSA) and Ecological Momentary
           Assessment (EMA) to obtain more reliable information about the dynamics of the variables
           to be evaluated, to record the affective and cognitive impact of each activity, and to
           explore its potential delivery in real-world clinical practice.

        -  The main hypothesis is that improvement on functional impairment of patients with
           fibromyalgia can be achieved by the direct intervention on mechanisms such as
           self-efficacy and pain catastrophizing.
    

Intervention name(s): TAU + multicomponent treatment NAT-FM; Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order):
Pain neuroscience education (30 min.)
Cognitive restructuring (30 min.)
Mindfulness techniques (30 min.)
Physical exercise in a natural environment / nature exposure (30 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.; Standard pharmacological treatment usually provided to patients with fibromyalgia.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blind, parallel-group, randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multicomponent treatment; Nature therapy; Mindfulness; Physical therapy; Pain Neuroscience Education (PNE)
Presyncope (Syncope) Prevention Study
Condition: Syncope, Vasovagal
MeSH terms: Syncope; Syncope, Vasovagal
Study type: Interventional

Summary: 
      This study was a prospective, randomized clinical trial that was conducted in adolescents (10
      through 14 years of age) receiving at least one recommended intramuscularly administered
      vaccine to evaluate the efficacy and acceptability of using two different, simultaneously
      administered interventions that might prevent post-vaccination presyncope, and by extension
      syncope. The two interventions evaluated together were Buzzy®, which is a medical device
      designed to reduce vaccination pain, and an electronic game. The investigators evaluated both
      interventions when administered simultaneously (Buzzy® and electronic game). The
      investigators enrolled approximately 340 subjects into this study. Eligible adolescents were
      randomized (1:1) to either the intervention or control group: 1) intervention (Buzzy® and
      electronic game); or 2) control (usual care) to assess for acceptability and efficacy.
      Detailed data were collected and described from study participants including demographics,
      medical history, baseline generalized and state anxiety, and needle phobia. Participants were
      observed for 20 minutes following receipt of vaccines and reassessed for post-vaccination
      state anxiety, immediate and subsequent post-vaccination pain (within 1 minute and at 10
      minutes), and the occurrence of witnessed syncope or presyncope, and presyncopal symptoms as
      rated by the modified Blood Donation Reactions Inventory (BDRI). Participants were asked to
      assess their acceptability of the intervention.
    


Intervention name(s): Buzzy® and Electronic Game
Intervention type(s): Device
Intervention description(s): Buzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Child; Buzzy®; Electronic Game; Syncope; Pain Mitigation; Anxiety; Presyncope; Vaccination; Syncope Prevention
Effect of Doula in Nulliparas and Multiparas
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Psychological care during labor is considered as an important supplemental procedure for
      alleviating delivering stress and pain. Although Doula has been recommending that should be
      given for parturients, its precise effect on nulliparous and multiparous women is still
      unknown. The investigators hypothesized that multiparas had experienced the process of labor,
      but the nulliparas were not, so Doula support would produce different effect on these two
      population.
    


Intervention name(s): Doula; Doula
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Doula support for nulliparous women from the beginning of regular contraction of uterus to the end of delivery; Doula support for multiparous women from the beginning of regular contraction of uterus to the end of delivery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Doula; Psychological care; Labor analgesia
The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
Condition: Breast Biopsy
Study type: Interventional

Summary: 
      This will be a single-center prospective randomized control trial that is Institutional
      Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the
      University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a
      prospective and will target approximately 250 patients. This will be a HIPPA-compliant
      randomized control trial planned on spanning approximately six months' time. Patients will be
      entered into the study only based on their already scheduled stereotactic biopsy procedure.
      Patients will be informed of the study and they will be offered the opportunity to
      participate or not participate in the study. Their participation is completely voluntary.
      This study will not involve any intervention that is not already a part of standard care.
      Patients will be randomized to two groups, one group that will undergo clip placement with
      approximately with a 5 mm retraction of the biopsy clip post-placement and one that will
      involve no retraction prior to deployment.
    


Intervention name(s): 5mm retraction of clip deployment apparatus.; No retraction of clip deployment apparatus.
Intervention type(s): Device; Device
Intervention description(s): Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.; This is one method of standard of care and the clip will be deployed at the biopsy site.
Intervention MeSH terms: Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stereostatic procedure
Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed as a single center, randomized, double-blind, placebo-controlled study
      to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study
      will be conducted as a 2-part study.
    

Detailed description: 
      The study is designed as a 2-part study:

      Part 1 is designed as single ascending dose (SAD) escalation study investigating 5 dose
      levels. Each cohort will consist of participants (N=8) to be randomly assigned to receive a
      blinded oral dose of CB-0406 (n=6) or placebo (n=2). Dose levels of CB-0406 in the sequential
      cohorts will be 100 mg, 200 mg, 400 mg, 800 mg or 1000 mg to be administered once on each
      cohorts study Day 1.

      Part 2 is designed as multiple ascending dose (MAD) escalation study investigating up to 5
      dose levels as determined by the SAD cohort. Doses will be determined following completion
      and review of the safety and PK findings for Cohorts 1 to Cohort 5 in Part 1.
    

Intervention name(s): CB-0406 100 mg; CB-0406 200 mg; CB-0406 400 mg; CB-0406 800 mg; CB-0406 1,000 mg; Matched placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose; Single oral dose; Single oral dose; Single oral dose; Single oral dose; Color and size matched placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: single ascending dose (SAD); multiple ascending dose (MAD); CymaBay; CB-0406; arhalofenate; peroxisome proliferator-activated receptor gamma
Family Intervention Following Traumatic Injury
Condition: Acquired Brain Injury; Spinal Cord Injuries
MeSH terms: Brain Injuries; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of a manualized intervention
      (FITS) to families living with brain injury or spinal cord injury. The intervention will be
      provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes
      duration. The intervention group will be compared to a control group receiving treatment as
      usual, one psycho-educational group session of a 2 hour duration.
    


Intervention name(s): Group session psycho-education; FITS
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Active comparator - control group; Manualized family intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment