bioihbjkbjnl/mcl2 huggingface dataset:
Valproic Acid in Treating Cyanotic Breath Holding Spells
Condition: Breathhold
Study type: Interventional
Phase: Phase 1

Summary: 
      Breath holding spells (BHS) are common non-epileptic paroxysmal behavioral involuntary
      episodes occurring in up to 5.9% of healthy children. The attacks occur in early childhood
      (0.5-3 years) but are self-limited by school age (4-5 years old) (90%). Classically, BHS were
      classified as cyanotic (blue), pallid (pale) and mixed based on the color change of the child
      during the spell. In general, cyanotic spells have been classically described in a toddler
      with excessive temper tantrums [stubborn, easily frustration or annoyed. The mechanisms of
      BHS are controversial. The most suggested cause of BHS is instability of the autonomic
      nervous system, inhibition of respiratory effort and cyanosis in cyanotic BHS and bradycardia
      or a brief asystole and cerebral hypoperfusion in pallid BHS. Iron deficiency anemia (IDA)
      has been widely regarded as a risk factor for BHS in nearly 50% of children due to reduced
      brain oxygenation [4]. It is generally agreed that the long-term prognosis is considered good
      [1]. There is no definite therapy for BHS. In children with low frequency spells, parental
      reassurance are just enough; however, high frequency spells may result in anxiety to the
      parents or fear from sudden death of the child or development of mental subnormality.
      Treatment of iron has been reported to result in reduction of the frequency of spells or its
      stoppage. Some reported improvement of BHS with piracetam [a nootropic drug known to increase
      brain oxygenation]. We did not find systematized published reports evaluating the
      effectiveness of antiepileptic drugs (AEDs) in reduction of spells frequency of cyanotic BHS
      or their stoppage.
    


Intervention name(s): Valproic Acid
Intervention type(s): Drug
Intervention description(s): Treatment of children with frequent cyanotic breath holding spells (at least 4 spells per week) with 5 mg/kg/day for 6 months.
Other intervention name(s): sodium valproate
Intervention MeSH terms: Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breath holding spells; cyanosis; valproic acid
Bioequivalency Study of Zidovudine Under Fasting Conditions
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg
      tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV
Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients
Condition: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Syndrome; Pelvic Pain; Chronic Disease; Somatoform Disorders
Study type: Observational

Summary: 
      Chronic prostatitis/chronic pelvic pain syndrome (CPPS) is a common health problem among men
      and can cause severe quality of life. The pathophysiology of CPPS is still poorly understood
      and effective treatments are a challenging issue. This study aims to investigate the possible
      relationship between the presence of microorganisms in the prostatic fluid and symptom
      severity by presenting a retrospective analysis based on data from CPPS patients.
    

Detailed description: 
      This study is based on data from 112 CPPS patients aged 20-60 years. Various variables such
      as demographic information of the patients, International Prostate Symptom Score (I-PSS),
      which evaluates CPPS symptoms, inflammatory and non-inflammatory symptoms of CPPS, baseline
      scores of the International Index of Erectile Function (IIEF), which evaluates erectile
      function, and the presence of microorganisms in the prostate fluid were analyzed
      retrospectively.
    

Intervention name(s): Chronic prostatitis/chronic pelvic pain syndrome
Intervention type(s): Diagnostic Test
Intervention description(s): Chronic prostatitis/chronic pelvic pain syndrome UPOINT
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study is based on data from 112 CPPS patients aged 20-60 years. Various variables such
        as demographic information of the patients, International Prostate Symptom Score (I-PSS),
        which evaluates CPPS symptoms, inflammatory and non-inflammatory symptoms of CPPS, baseline
        scores of the International Index of Erectile Function (IIEF), which evaluates erectile
        function, and the presence of microorganisms in the prostate fluid were analyzed
        retrospectively.
Kudzu Treatment for Alcohol Abuse
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study designed to test whether a single administration of kudzu extract (2 mg) will
      significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session
      when given as pretreatment 2 ½ hours before the drinking session.
    

Detailed description: 
      In a laboratory experimental setting, subjects will be treated with placebo or 2 grams of
      kudzu extract 2.5 hours before an afternoon drinking session. The investigators hypothesis is
      that the kudzu pretreatment will reduce alcohol consumption in this free choice,
      self-administration paradigm.
    

Intervention name(s): Kudzu; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session.; Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
Other intervention name(s): Kudzu root extract (NPI-031); Puerariae lobata; Alkontrol-Herbal®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alcohol consumption; Kudzu extract
Hormones and Physical Exercise (HOPE) Study
Condition: Breast Cancer; Arthralgia
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor
      positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months
      and are experiencing at least mild arthralgia originating during AI treatment, the yearlong
      effect of exercise vs. attention control (health education), and on toxic side effects of AI.
    

Detailed description: 
      The investigators propose to examine, in 121 postmenopausal breast cancer survivors who have
      been taking an AI for at least 2 months and are currently experiencing at least mild
      arthralgia associated with AI use, the effect of a randomized controlled exercise
      intervention vs. attention control (health education) on severity of arthralgia,
      endocrine-related Quality of Life(QOL), Bone Mineral Density(BMD), and mediators/mechanisms
      influencing the effect of exercise on arthralgia severity. Women will be randomized to a year
      long exercise program or attention control group. Women randomized to exercise will
      participate in 150 min/wk of aerobic exercise and a twice-weekly strength training program.
      The investigators will conduct baseline, six-, and 12-month clinic visits, as well as a 3-
      and 9-month mailing to evaluate the effect of the intervention on study outcomes.
    

Intervention name(s): Exercise; Attention Control (Health Education)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.; The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preventative Misconception Intervention
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study will carry out a preliminary "proof of concept" to evaluate two types of
      supplemental information that would serve as an adjunct to the traditional informed consent
      in a Human Immunodeficiency Virus (HIV) vaccine clinical trial. These will be compared to the
      condition where the traditional informed consent form is used alone.

      Using four intervention sites, participants will be administered a standard HIV vaccine trial
      consent form. They will then be randomized into three conditions: 1) No supplemental
      information; 2) Supplemental information with 1-sided messages (emphasizes information
      content related to vaccine trial randomization and unproven efficacy of vaccine); and 3)
      Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds
      with the information content and seeks to neutralize those beliefs through counter-argument).
      An interviewer-administered questionnaire (IAQ) Part 1 will be administered before the
      traditional HIV vaccine trial informed consent is reviewed with the participant. An IAQ Part
      2 will be administered directly after the HIV vaccine trial informed consent in the control
      condition or after reading through the supplemental material. Debriefing interviews will be
      conducted with selected participants to review their understanding of the study procedures
      and their reactions to the supplemental materials and/or questionnaires.

      The proposed research is a "proof of concept" study and is therefore not designed to test
      hypotheses. Consequently, formal hypothesis and related power calculations to detect certain
      effect sizes are not required. Instead, the goal will be to enroll an appropriate number of
      subjects for purpose of determining the feasibility of developing a larger study of
      supplemental information to be used as an adjunct to the informed consent statement in HIV
      vaccine clinical trials and providing related descriptive statistics.
    


Intervention name(s): 1-sided messages; 2-sided messages
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine).; Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds with the information content and seeks to neutralize those beliefs through counter-argument).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccination; HIV prevention; YMSM; youth; HIV Preventative Vaccine
The Effect of Virtual Reality on Patients With Anxiety Over Surgeries Under Spinal Anesthesia
Condition: Virtual Reality
Study type: Interventional

Summary: 
      The main purposes of this study are as follows:

      First, to understand the effect of virtual reality on the subjective feelings of anxiety in
      patients with orthopaedic lower limb surgery for spinal anesthesia.

      Second, to understand the effects of virtual reality on the systolic blood pressure,
      diastolic blood pressure, mean arterial pressure, heartbeat, respiration and other
      physiological parameters in the operation of orthopedic lower extremity surgery patients with
      spinal anesthesia.

      Third, to understand the effect of using virtual reality in surgery to reduce the use of
      sedative drugs and the degree of pain in patients with orthopedic lower extremity surgery.
    

Detailed description: 
      Surgery is a serious source of stress for the general patient and can increase the patient's
      anxiety. which is It is normal to show obvious anxiety in patients undergoing surgery, but if
      the degree of anxiety is serious, it may lead Negative physiological manifestations, such as
      slow wound healing, increase the risk of infection and may affect the induction of anesthesia
      It requires more anesthesia dose during surgery, which hinders recovery time. Most studies
      have confirmed surgery Playing music in the room can alleviate the anxiety and pain of the
      patients, but the music preference is subjective and some people like it.

      There must be people who hate it, and the operating room is not a quiet space. There are many
      sound sources in the operating room., such as the sound of surgical instruments, the warning
      sound of physiological monitors, the voice of the staff, these It will be a source of anxiety
      for patients. Instrument noise averages up to 60 decibels, including neurosurgery,
      orthopedics It can even exceed 100 decibels. Foreign scholars believe that playing music at
      this time will only aggravate the noisy environment.The attention of the staff. Therefore, it
      is hoped that by using virtual reality to provide images and sounds during surgery, hijacking
      The patient's auditory, visual, and proprioception creates an immersive, distracting approach
      that reduces the cause of the ring Anxiety brought by the environment helps spinal anesthesia
      patients to reduce anxiety during surgery and increase psychological comfort To reduce the
      use of sedative drugs during surgery.
    

Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): The primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 50 people in the control group 50 people in the experimental group
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Virtual Reality；Anxiety
A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics,
      immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in
      subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild
      Alzheimer's disease.
    

Detailed description: 
      This is a multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose
      study in a total of 24 subjects (8 subjects per cohort) with MCI due to AD and mild AD. The
      study consists of three cohorts to evaluate the safety, tolerability and PK of BAN2401 at
      three dose levels (2.5, 5, and 10 mg/kg). Each cohort consists of Screening Period before
      randomization, Treatment Period from randomization to last dose, and Follow-up Period after
      last dose. Cohorts 1, 2, and 3 will receive 2.5 mg/kg, 5 mg/kg, and 10 mg/kg of BAN2401,
      respectively.
    

Intervention name(s): BAN2401 2.5 mg/kg; BAN2401 5 mg/kg; BAN2401 10 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401 for 60 +/- 10 minutes.; Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401 for 60 +/- 10 minutes.; Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401 for 60 +/- 10 minutes; Intravenous infusions of placebo for 60 +/- 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mild cognitive impairment; Alzheimer's disease
Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
Condition: Sinus Node Dysfunction
MeSH terms: Sick Sinus Syndrome
Study type: Interventional

Summary: 
      This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness
      of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle
      placement. Patients with sinus node dysfunction who have previously received a Biotronik
      pacemaker with His bundle lead placement as part of routine care will be recruited for the
      study. A hand-grip exercise will be performed at the conclusion of bicycle exercise testing
      in order to assess the performance of CLS during isometric exercise. After the study exercise
      testing is completed, data will be collected from the pacemaker.
    


Intervention name(s): Treadmill/Bicycle exercise testing
Intervention type(s): Diagnostic Test
Intervention description(s): Exercise testing will be scheduled on the same day as the enrollment visit and within 30 days after post-implant visit.
The standard protocol will be typically set at an initial workload of 15Watts and go up by increments of 10 Watts every 3 minutes, as follows:
Stage 1 - 15 W Stage 2 - 25 W Stage 3 - 35 W Stage 4 - 45 W
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Transtibial and Transfemoral Amputees' Posture Parameters
Condition: Amputation; Traumatic, Limb; Postural; Defect
MeSH terms: Amputation, Traumatic
Study type: Observational

Summary: 
      With the onset of prosthesis use following lower extremity amputations, body shows
      biomechanical changes according to the amputation level and consequently develops adaptation
      mechanisms both on the healthy and ampute side. The aim of this study is to determine the
      static postural adaptations that appear at different amputation levels.
    


Intervention name(s): Evaluation of the static posture
Intervention type(s): Other
Intervention description(s): Photographing from the back, front and side with ADIBAS posturography in standing position
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        With Unilateral Transfemoral and Transtibial Amputation Patients
      
Keywords: amputation, postural adaptations, transtibial, transfemoral
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
Condition: Insulin Hypoglycemia; Type 1 Diabetes Mellitus; Severe Hypoglycemia
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and
      safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime
      clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg
      during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by
      an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is
      brought into a state of severe hypoglycemia through IV administration of regular insulin
      diluted in normal saline. After a hypoglycemic state with plasma glucose < 54 mg/dL (3
      mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via
      subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes
      post-dosing, with a value of >70.0 mg/dL (3.89 mmol/L) or an increase of > 20 mg/dL (>1.11
      mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3
      hours, the subject is given a meal and discharged when medically stable. After a wash-out
      period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each
      subject crossed over to the other treatment. A follow-up visit as a safety check is conducted
      2-7 days following administration of the final dose of study drug.
    


Intervention name(s): G-Pen; Novo Glucagon
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector; 1 mg subcutaneous injection of Novo Glucagon (glucagon injection)
Other intervention name(s): glucagon; Glucagen Hypokit
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: glucagon; hypoglycemia