bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the
      pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult
      volunteers.
    

Detailed description: 
      Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per
      sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701
      FA once daily for 5 days during each treatment period, with a 2 day washout between periods
      (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive
      oral 60 mg PSE.
    

Intervention name(s): TR-701 FA with PSE; TR-701 FA Placebo with PSE
Intervention type(s): Drug; Other
Intervention description(s): TR-701 FA Oral 200 mg oral with PSE; TR-701 FA Placebo Oral 200 mg with PSE
Other intervention name(s): Tedizolid Phosphate
Intervention MeSH terms: Tedizolid phosphate; Tedizolid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Retrospective Study of Cough Variant Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      this study aimed to compare characters in pulmonary function of patients with cough variant
      asthma and chronic cough and establish a diagnostic model.
    

Detailed description: 
      the investigators retrospectively collected information from patients with chronic cough who
      underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical
      University from January 2019 to December 2019. Data of external test were also from the First
      Affiliated Hospital of Zhejiang Chinese Medical University, and time period was from January
      2023 to April 2023.Pulmonary function test and methacholine challenge test was performed by
      professional technicians. Characters between patients with cough variant asthma and chronic
      cough were compared to establish a diagnostic model.
    

Intervention name(s): positive bronchial provocation test
Intervention type(s): Diagnostic Test
Intervention description(s): Patients were asked to inhale gradually increasing doses of methacholine (0.9% saline, 0.078, 0.312, 1.125 and 2.504 mg), and FEV1 was measured after each inhalation. This test was stopped until a reducing in baseline FEV1 of 20%.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We retrospectively collected information from patients with CC who underwent pulmonary
        tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January
        2019 to December 2019.
      
Keywords: small airway dysfunction; cough variant asthma; Chronic cough
Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology
Condition: Syndrome X; Takotsubo Cardiomyopathy
MeSH terms: Cardiomyopathies; Microvascular Angina; Takotsubo Cardiomyopathy; Syndrome
Study type: Interventional

Summary: 
      Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and
      chronic cardiac conditions whose clinical presentation, mimicking the onset of acute
      myocardial ischemia in absence of epicardial coronary disease, has progressively gained the
      interest of the scientific community. However, despite significant progress, their underlying
      pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial
      dysfunction and autonomic imbalance have both been individually implied in their puzzling
      pathogenesis.

      The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and
      healthy volunteers with the following primary objective: to assess the response of
      endothelial function (through the Endopat score) to the autonomic tone activation induced by
      a 10-minute stress mental test. The assessment of autonomic tone during activation through
      the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with
      endothelial function (Endopat score) will represent secondary objectives.

      Our study will enroll 15 patients with TTC at least six months after the event, 15 patients
      with classic CSX and 15 healthy volunteers who will serve as control.
    


Intervention name(s): BaroReflex Sensitivity, endothelial function measurement
Intervention type(s): Other
Intervention description(s): no other
Other intervention name(s): BaroReflex Sensitivity measurement by volume-clamp method (Finapress); Endothelial function measured by Endopat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Effects of Breakfast on Cognitive Processes in Children
Condition: Cognitive Function
Study type: Interventional

Summary: 
      The objective of this study is to test the effects of breakfast on cognitive processing
      ability in children.
    

Detailed description: 
      Breakfast consumption has previously been shown to positively affect cognitive and academic
      performance in children. Specifically, breakfast consumption has been reported to improve
      memory, attention, problem solving, and logical reasoning compared to the absence of
      breakfast. This has been found under both short-term laboratory conditions and within a
      school environment in children from both a low and high socioeconomic background, although
      some studies have failed to find favorable effects.
    

Intervention name(s): breakfast cereal; water
Intervention type(s): Other; Other
Intervention description(s): breakfast cereal and milk; water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
NAC as a Potential Treatment for Methamphetamine Dependence
Condition: Methamphetamine Abuse; Methamphetamine Dependence; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of treatment with NAC, compared to
      treatment with placebo, on cue- and methamphetamine (MA)-induced craving and MA subjective
      effects in non-treatment-seeking MA-dependent human volunteers. We also aim to determine the
      effects of treatment with NAC, compared to treatment with placebo, on the reinforcing effects
      of MA by measuring MA self-administration in non-treatment-seeking MA-dependent human
      volunteers.
    

Detailed description: 
      N-acetyl-l-cysteine (NAC) treatment is associated with reduced susceptibility to
      reinstatement of cocaine seeking behavior in rats (Baker et al 2002) and with reduced
      cue-induced craving in cocaine-dependent human volunteers (LaRowe et al 2006). We propose
      these aims to evaluate the potential of NAC as a treatment for methamphetamine (MA)
      dependence: Specific Aim 1: To determine the effects of treatment with NAC(placebo, 1800 and
      3600mg daily), compared to treatment with placebo, on cue- and MA-induced craving and MA
      subjective effects in non-treatment-seeking MA-dependent human volunteers. We hypothesize
      that treatment with NAC will reduce craving for MA reported following exposure to MA cues and
      will reduce craving and MA subjective effects reported following non-contingent
      administration of MA (0mg,9mg, and 30 mg, IV). Specific Aim 2: To determine the effects of
      treatment with NAC (placebo, 1800 and 3600mg daily), compared to treatment with placebo, on
      the reinforcing effects of MA by measuring MA self-administration in non-treatment-seeking
      MA-dependent human volunteers. We hypothesize that treatment with NAC will reduce the number
      of choices made for MA during choice sessions.
    

Intervention name(s): Placebo; N-acetylcysteine; N-acetylcysteine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo administration will be started on day 2 and stopped on day 5. Methylsulonylmethane (MSM) will serve as a placebo for MA.; Study medication (NAC 1800 mg) will be started on day 2 and stopped on day 5.; Study medication (NAC 3600 mg) will be started on day 2 and stopped on day 5.
Other intervention name(s): Methylsulonylmethane (MSM); NAC; NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Methamphetamine; NAC; N-acetylcysteine
The Turkish Version of the Simple Physical Activity Questionnaire (SIMPAQ)
Condition: Psychiatric Disorder
MeSH terms: Mental Disorders; Problem Behavior
Study type: Observational

Summary: 
      The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to
      assess physical activity level particularly people with mental illnesses. The purpose of this
      study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its
      psychometric properties.
    

Detailed description: 
      The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to
      assess physical activity level particularly people with mental illnesses. The purpose of this
      study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its
      psychometric properties. Eighty individuals with mental illnesses (major depression, bipolar
      disorder, anxiety disorder, schizophrenia, alcohol and substance addiction) will include. For
      cross-cultural adaptation and validation procedure, developers' manual in the official site
      will be followed (http://www.simpaq.org/). Within a 5-to-7-day period after the first
      assessment, the participants completed the Turkish version of the SIMPAQ to evaluate
      test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The
      correlations with the Turkish version of the International Physical Activity-Short Form
      (IPAQ-SF) and Brief Psychiatric Rating Scale (BPRS) and Turkish version of the DSM-5
      Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version (DSM XC) will determine to check
      the validity.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will include 80 patients diagnosed with major depression, bipolar disorder,
        anxiety disorder, schizophrenia, alcohol and substance addiction by the psychiatrists in
        Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research
        Hospital, University of Health Sciences. The individuals who volunteers and meets the
        inclusion criteria will be included in the study.
      
Keywords: physical activity; measurement; assessment; sedentary behaviour; mental illness
Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects
Condition: Obesity; Cardiovascular Risk Factor; Diet Modification
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This project will examine whether long-term consumption of healthy Nordic foods can maintain
      a healthy weight also after weight loss, and decrease abdominal fat accumulation and
      cardiometabolic risk. The study will be performed with the aim to achieve a substantial body
      weight loss in the first phase by prescribing a standardized low caloric dietary formula. The
      follow-up phase will be a body weight-maintenance period and the subjects will be randomised
      to a healthy Nordic diet group and a control diet group. During the study body weight will be
      monitored and other measurements will include insulin sensitivity, blood lipids and
      inflammation markers.
    


Intervention name(s): Nordic diet; Control diet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Influence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).
Condition: Periimplant Crestal Bone Level Changes
Study type: Interventional

Summary: 
      The concept of platform-switching has been introduced to implant dentistry based on clinical
      observations of reduced periimplant crestal bone loss. However, published available data are
      controversial and most studies are limited to 12 months. The aim of the present RCT was to
      test the hypothesis that platform-switching has a positive impact on crestal bone level
      changes after 3 years.
    

Detailed description: 
      Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25
      subjects. After three months of submerged healing, single-tooth crowns were randomly placed,
      either with (3.3mm platform, test) or without platform-switching (4mm platform, control).
      Patients were followed up at short intervals for monitoring of healing an oral hygiene.
      Statistical analysis for the influence of time and platform-type on bone levels employed the
      Brunner-Langer Model.
    

Intervention name(s): platform-shifted implant
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bacteria; bone level; bone loss; dental implants; implant design; platform-shifting; platform-matching
Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations
Condition: Healthy
Study type: Interventional

Summary: 
      A prospective, multi-country, open label study to describe the stool characteristics and
      behaviour as well as the parents' experience in infants receiving a recently launched infant
      formula in a real life situation.
    


Intervention name(s): Infant formula
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Posterior cerebraL ArTery Occlusion Study
Condition: Stroke, Acute Ischemic
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      For this retrospective study, the investigators will collect and analyze data of patients who
      presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of
      endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular
      stroke treatment).

      The electronic health records will be queried for the demographic, medical history, and
      outcomes data of all patients with posterior cerebral artery occlusion who underwent
      mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.
    

Detailed description: 
      The primary aims of the research are to evaluate, in patients presenting with posterior
      artery occlusion (PCA), whether favorable outcome would be superior for EVT compared to
      Medically Management (MM), inclusive of intravenous thrombolysis (IVT), as measured by:

        -  90-day modified Rankin Scale (mRS) ordinal shift or

        -  decrease in NIH Stroke Scale/Score (NIHSS) by two points at 24 hours or at hospital
           discharge

      The secondary aims are to evaluate in patients presenting with PCA occlusion, other outcome
      and safety metrics:

        -  90-day functional independence, mRS 0-2

        -  90-day excellent outcome, mRS 0-1

        -  Visual field recovery (none, partial, complete) by 90-days

        -  rate of reperfusion by modified thrombolysis in cerebral infarction (TICI) scale grade

        -  any intracranial hemorrhage

        -  symptomatic intracranial hemorrhage

        -  mortality

      In subgroup analysis, the investigators aim to identify subgroups that may confer
      differential treatment benefit by:

        -  location of occlusion on the PCA segment (P1, P2, P3)

        -  NIHSS strata (0-6, 7-15,>16)

        -  time from symptom onset to treatment (0 to <6h vs 6-24h)

        -  posterior circulation (PC) Acute Stroke Prognosis Early Computed Tomography Score
           (ASPECTS)

        -  visual field defect on presentation

      The investigators hypothesize that greater benefit in outcomes would be seen in EVT treated
      patients with higher NIHSS, more proximal PCA occlusion, higher PC ASPECTS scores, and
      shorter time from symptom onset to treatment.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients identified from electronic health records who have undergone stroke medical
        management treatment from 1/01/2003 to 01/01/2022 and patients who have undergone EVT
        stroke treatment from 01/01/2015 - 01/01/2022.
      
Keywords: Posterior occlusion artery (PCA); Intravenous thrombolysis (IVT); Endovascular therapy (EVT); Modified Rankin Scale (mRS)
Lung Bioavailability With Continuous or Discontinuous Nebulization
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      To compare the continuous and sicontinuous delivery of drug with AKITA.
    


Intervention name(s): AKITA
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Optimal Dosage of Ropivacaine for Arthroscopic Knee Surgery
Condition: Arthroscopic Knee Surgery; Ropivacaine; Combined Spinal Epidurai Anesthesia; ED50; ED95
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Fast-track Surgery (FTS ) refers to the application of various proven effective methods in
      perioperative period to reduce stress and complications and accelerate the recovery of
      patients.Nowadays, FTS has been successfully applied in clinical practice."FTS" truly
      embodies the concept of "patient-centered" and the direction of medical development.

      Lower limb joint damage (the meniscus, and patellar ligament, etc.) is the joint movement
      orthopedic common disease, often characterized by joint swelling, pain, sports relaxation
      instability, thigh muscle atrophy, most can't continue to pursue the original movement, even
      unbend and flexor limited activity, result in patients with walking difficulties, serious
      impact on the patient's quality of life.Practice has proved that minimally invasive surgery
      under arthroscopy is the best way to treat such injuries. According to literature reports,
      the average hospital stay after arthroscopy is 5~7 days, while successful application of FTS
      can shorten it to 2~3 days.

      Anesthesia plays an important role in the process of FTS.Compared with general anesthesia,
      intra-spinal anesthesia can effectively reduce the incidence of postoperative complications
      in patients, such as ventilator-related lung injury, deep vein thrombosis, cardiovascular and
      cerebrovascular accidents, and acute renal failure.Ropivacaine is a long-acting amide local
      anesthetic. Compared with bupivacaine, it is more and more widely used in spinal anesthesia
      due to its advantages of lower degree of motor nerve block and weaker toxicity to central
      nervous system and cardiac.However, the optimal dosage of ropivacaine for arthroscopic
      surgery is still unclear. Conventional dosage makes patients unable to move 2-4h after
      surgery and unable to urinate autonomically. Therefore, this study aims to optimize the
      dosage of ropivacaine for spinal anesthesia and enable patients to recover motor function at
      an early stage.
    


Intervention name(s): ropivacaine
Intervention type(s): Drug
Intervention description(s): According to previous clinical experience, 0.5% ropivacaine was given in the subarachnoid cavity, and the initial dose was set at 2.5 mL (12.5mg). Dixon's up-and down method was adopted to adjust or down-adjust the dose of ropivacaine in the next patient according to the experimental results of the previous patient, and the adjusted dose was 0.1 mL (0.5mg).
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to
      Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe
      Uncontrolled Asthma
    

Detailed description: 
      This is a multicentre, randomized, double-blind, placebo controlled, parallel group study
      designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with
      severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma
      controller medication with or without OCS. Approximately 1060 subjects will be randomized
      globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous
      injection at the study site, over a 52-week treatment period. The study also includes a
      post-treatment follow-up period of 12 weeks.
    

Intervention name(s): Experimental: Tezepelumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Tezepelumab subcutaneous injection; Placebo subcutaneous injection
Other intervention name(s): Tezepelumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma
Karma Intervention Study
Condition: Risk Reduction; Mammographic Density Reduction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose determination study aiming to identify the optimal tamoxifen dose for reducing
      the risk of breast cancer. Instead of following a very large number of women, for many years,
      treated with different doses of tamoxifen and see if they develop breast cancer, the
      investigators will include 1,440 healthy women participating in the mammographic screening
      program at two Mammography units (Unilabs mammography, Lund and Södersjukhuset Breast Centre,
      Stockholm) and measure their change in mammographic density. The change in mammographic
      density is a very good marker of therapy response. Investigators will test if 1 mg, 2.5 mg, 5
      mg and 10 mg reduce the mammographic density to the same extent as 20 mg. In summary Karisma
      2 will be a randomized, double-blinded, six-armed placebo controlled study to identify the
      dose of tamoxifen with the most favourable side effect spectra and with a density reduction
      non-inferior to 20 mg tamoxifen.
    


Intervention name(s): Tamoxifen Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Randomised dose of tamoxifen 1 pill/day for 180 days; Randomised dose of tamoxifen 1 pill/day for 180 days
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention