bioihbjkbjnl/mcl2 huggingface dataset:
Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 3

Summary: 
      The main goals of the study are to assess benefits of higher doses of the nicotine patch
      prior to smoking cessation for high- and low-dependent smokers, and to investigate the
      potential relationship between genetic factors and smoking cessation success. There will be a
      two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240
      high-dependent & 240 low-dependent smokers; half of each group will wear two 21mg nicotine
      patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo
      patch daily, resulting in the following four conditions (120 subjects each) during the 2-week
      pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More
      Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will
      continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no
      longer be double-blind as only nicotine patches will be used: all subjects will wear one
      21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg
      patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites:
      Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have
      7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3
      weeks, 6 weeks and 10 weeks after the quit-smoking date.
    


Intervention name(s): Nicotine Patch
Intervention type(s): Drug
Intervention description(s): Groups 1 & 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day
Groups 2 & 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Cigarette; Nicotine
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Provides up to six months treatment with CuATSM for subjects who have successfully completed
      study CMD-2019-001
    

Detailed description: 
      Provides up to six months treatment with CuATSM for subjects who have successffulyl completed
      study CMD-2019-001. [This allows subjects randomized to placebo on study CMD-2019-001 to
      receive up to six months treatment with CuATSM and provides an up to an additional six months
      treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001]
    

Intervention name(s): Cu(II)ATSM
Intervention type(s): Drug
Intervention description(s): cooper-containing synthetic small molecule
Other intervention name(s): diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)
Intervention MeSH terms: Copper
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Condition: Major Depressive Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effectiveness of a combination of antidepressant medication and
      sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
    

Detailed description: 
      Difficulties falling and/or staying asleep are common in people who suffer from depression.
      Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia
      does not resolve with standard antidepressant therapy are at increased risk for recurrence of
      their depression. Between 60% and 84% of people who have major depressive disorder report
      symptoms of insomnia. This study will assess the efficacy of combining antidepressant
      medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and
      depression.

      Participants in this double-blind study will be randomly assigned to receive either
      desensitization therapy or cognitive behavioral therapy to target insomnia. All participants
      will also receive escitalopram oxalate, an antidepressant medication. The study will last 12
      weeks. The severity of participants' depression and insomnia will be assessed. Study visits
      will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months
      post-intervention.
    

Intervention name(s): Escitalopram; CBTI; CTRL
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): 5 to 20 mg for 12 weeks; Cognitive Behavioral Treatment for Insomnia; Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
Other intervention name(s): Escitalopram plus Cognitive behavioral Therapy; Escitalopram plus Pseudo-desensitization Therapy; Cognitive Behavioral Treatment for Insomnia; Pseudo-desensitization Therapy for Insomnia
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Insomnia; Sleep; Mental Health
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy
Condition: Knee Arthroscopy; Spinal Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric
      prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side
      effects
    


Intervention name(s): Isobaric 2-chloroprocaine; Hyperbaric prilocaine
Intervention type(s): Drug; Drug
Intervention description(s): intrathecal injection of 50 mg isobaric 2-Chloroprocaine; intrathecal injection of 50 mg hyperbaric prilocaine 2%
Other intervention name(s): Ampres; Tachipri
Intervention MeSH terms: Prilocaine; Chloroprocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Local Anaesthetic; spinal anesthesia; Knee arthroscopy
Effect of LY333531 on Vascular and Neural Functions
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine if protein kinase C beta plays a significant role in vascular endothelial
      dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes
      mellitus.
    

Detailed description: 
      32mg Ruboxistaurin; 4 week cross-over treatment.
    

Intervention name(s): Ruboxistaurin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ruboxistaurin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Temperature Changes During Induction of General Anesthesia in Pediatric Patients
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      We aim that uncovering patients during induction of general anesthesia does not decrease core
      body temperature in pediatric patients.
    

Detailed description: 
      Some anesthesiologists cover the pediatric patient with a blanket during the induction of
      general anesthesia, while others do not. Complaints have been raised by pediatric surgeons
      that if a pediatric patient is not covered during induction of general anesthesia, the
      child's core body temperature will be lower than normal following surgery and in the recovery
      room.

      Children are at risk of significant heat loss in the operating room due to multiple factors,
      such as, exposure to cold temperatures, decrease in metabolism following induction of general
      anesthesia, increased surface-area-to-volume ratio, and through considerable respiratory heat
      loss.1

      A decrease in temperature of 0.5ºC to 1.5ºC can occur during induction of general anesthesia
      in pediatric patients2. The use of heating blankets and warmers may increase temperature or
      result in a constant temperature on pediatric patients intra-operatively3. We want to
      investigate the differences in temperature between the two approaches, covering and not
      covering pediatric patients, during induction of general anesthesia of a urologic procedure
      with a caudal block and the difference in temperature post-operatively. We hypothesize that
      the core temperatures of:

        1. the covered and warmed group during induction of general anesthesia will be greater by
           0.5ºC than the uncovered group during induction of general anesthesia.

        2. both groups, covered and uncovered, will be equal during surgery and post-operatively.
           In other words, due to the active warming procedures during surgery and post-operatively
           in the PICU, core temperatures of the uncovered group will catch up to the covered
           group.
    

Intervention name(s): Covered and uncovered anesthesia induction
Intervention type(s): Procedure
Intervention description(s): We hypothesize that the core temperatures of:
the covered group during induction of general anesthesia will be greater by 0.5ºC than the uncovered group during induction of general anesthesia.
both groups, covered and uncovered, will be equal during surgery and post-operatively. In other words, due to the active warming procedures during surgery and post-operatively in the PICU, core temperatures of the uncovered group will catch up to the covered group.
Other intervention name(s): Temperature; Pediatric; Urology; Anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children in an academic center
      
Keywords: Children core temperature,; Pediatric surgery,; Anesthesia induction
Role of Vitamin D in Innate Immunity to Tuberculosis
Condition: Vitamin D Deficiency; Tuberculosis
MeSH terms: Tuberculosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The investigators proposed a pilot study preparatory to developing a randomized trial of
      vitamin D for the prevention of TB infection. The specific aims are presented below:

        1. To recruit subjects, obtain consent, distribute vitamin D supplements to the children in
           the schools, obtain blood samples and transport them to the United States.

        2. To test the hypothesis that daily vitamin D supplementation will increase plasma levels
           of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages
           tested in vitro.
    


Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily dose of 800IU of vitamin D; Identically appearing capsules
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: vitamin D deficiency; tuberculin sin test; immunity; tuberculosis
The Influence of Oxytocin on Automatic Imitation Behaviour in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, the influence of oxytocin on automatic imitation behaviour is investigated.
      Healthy adults will be administered with either oxytocin or a placebo, and will perform an
      imitation-inhibition task (as a measure of automatic imitation behaviour). To determine the
      specificity of the oxytocin effect, an unrelated cognitive task (Stroop task) will also be
      presented.
    


Intervention name(s): Oxytocin; Sea water
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Influence; oxytocin; automatic imitation; behaviour; volunteers
Effect of Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study was conducted to assess the effects of commercially available probiotic drink on
      the number of salivary mutans streptococci in school going children, aged 12-14 years in
      Bangalore city in India
    

Detailed description: 
      Probiotic bacteria are thought to reduce the risk of diseases in oral cavity, namely dental
      caries. Studies have suggested that oral cavity can benefit immensely from these friendly
      bacteria, although more clinical trials are needed to establish concrete results. Hence, this
      study was undertaken as a 6 month clinical trial to assess the effects of probiotic on the
      most frequent resident of oral micro flora- the mutans streptococci.

      Method- Design: parallel arm design Sample size: 60 subjects (30 subjects in each group)
      Duration: 6 months

      Material used- Intervention/manipulation: 50ml commercially available probiotic drink for one
      group (30 subjects in study group) and 50 ml of plain, unsweetened and unflavored milk to
      control group (30 subjects in control group)for a period of 6 months.

      Indices used: plaque index- Turskey Gilmore-Glikman modification of Quigley-Hein, Plaque
      Index (1970)

      Gingival Index-Loe.H and Silness P. gingival index (1963)

      Both the indices were used twice, at the start of the study, that is, to collect base line
      data and at the end of the intervention period (6 months)as final data collected.

      Sample collection: stimulated saliva was collected (5ml) and analyzed for CFU of
      streptococcus mutans and lactobacilli at the start of the study and after 6 months, at the
      end of the intervention.

      Statistical analysis: students t test, fisher exact test and chi-square test were used to
      compare the baseline data with the final data collected at the end of the intervention.
    

Intervention name(s): probiotic drink; Placebo Comparator: plain, unsweetend, unflavored pasturised milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): comparison of study group (probiotic group) with the control group regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices; comparison of control group with the study group (probiotic group) regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices
Other intervention name(s): yakult probiotic drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: probiotics,; streptococcus mutans,; lactobacilli,; plaque index,; gingival index
A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
Condition: Healthy Volunteers; Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the safety, tolerability and pharmacokinetic
      profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at
      single escalating doses.
    


Intervention name(s): OP0595; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation; Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single
      and multiple doses in healthy volunteers.
    


Intervention name(s): M281; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention
Condition: Ischemic Heart Disease; Acute Coronary Syndromes
MeSH terms: Heart Diseases; Acute Coronary Syndrome; Myocardial Ischemia; Coronary Artery Disease; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary
      intervention has been proven. However, patients with low response to those agents are
      reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet
      therapy for individual patients based on platelet function assay may improve long-term
      outcomes especially in patients with high risk of thrombosis. In this prospective randomized
      study, patients in control group all receive standard dual antiplatelet therapy, and patients
      in optimized group receive different antiplatelet therapy according to risk stratification.
    


Intervention name(s): cilostazol in addition to aspirin and clopidogrel
Intervention type(s): Drug
Intervention MeSH terms: Aspirin; Cilostazol; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic heart disease; acute coronary syndromes; percutaneous transluminal coronary angioplasty; platelet function; aspirin; clopidogrel; cilostazol
Topical Penlac Nail Lacquer for Onychomycosis in Children
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of
      onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior
      cost and safety profile compared to systemic therapy.
    

Detailed description: 
      Therapeutic trials for the treatment of onychomycosis have been conducted in the adult
      population, but there is limited data available in the pediatric population.
    

Intervention name(s): Ciclopirox; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ciclopirox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Accumbo Home Blood Pressure Trial
Condition: Hypertension,Essential
MeSH terms: Essential Hypertension
Study type: Interventional

Summary: 
      Aim of the study was to investigate a new clinical medical system for treatment of
      hypertension with a clinical decision system,a smartphone patient app and a home blood
      pressure monitor.
    

Detailed description: 
      Despite the extensive knowledge of the importance of treating and thus preventing
      complications of hypertension, the incidence of high blood pressure is increasing, and it is
      still the main cause of cardiovascular disease and premature death, partly due to
      deficiencies in preventive care and control of the disease in an aging world. Blood pressure
      values obtained by self-measurement at home (HBPM) have been shown to predict the
      cardiovascular prognosis equally well as or better than blood pressure values obtained in the
      clinic (CBPM) in several observational studies. Aim of the present study was to investigate a
      new clinical medical system for treatment of hypertension with a clinical decision system and
      a electronic health record, a patient app and a home blood pressure monitor. " The patient
      app and the doctor's record reflect each other and basically contain the same information.
      Doctors can treat their patients remotely and the patients are able to manage some health
      issues by themselves by using the applications. Some patients need the physical examination.
      We therefore included patients after a so-called triage step with medical questions.
    

Intervention name(s): Treatment of hypertension using blood pressure self-measurement at home
Intervention type(s): Other
Intervention description(s): The primary aim of the present study is to investigate whether home blood pressure recording via Bluetooth and continuous communication between doctor and patient will give improved blood pressure values when comparing the initial values with the blood pressure values recorded after 3 months. Secondary examinations include treatment of hypotension and adverse events, the patient's experience, the user's potential problems with the blood pressure cuff, app downloading, problems with history issues or problems with technical
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Home blood pressure monitor; Telemedicine; mHealth; eHealth
Parent Telehealth Intervention for Children With Autism
Condition: Autism Spectrum Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent
      importance. Given this, parents in the study will receive parent coaching through weekly
      video calls. To help us understand the best types of telecoaching, we will offer all
      participants responsive coaching, with half of the participants receiving an additional
      opportunity to reflect on their own use of language strategies with a therapist using video
      feedback and the other half receiving responsive coaching as usual, without video feedback.
      This information is important in helping us to understand the best way to coach parents using
      a telepractice model so that parents implement the intervention at high fidelity.
      Furthermore, we will aim to understand how parent learning style may also influence the
      implementation of these strategies.
    


Intervention name(s): Responsive training with no video feedback; Responsive training with video feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.; Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
Other intervention name(s): No Video Feedback; Video Feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children will enroll in the study between 18-48 months of age and will be randomly assigned to either receive responsive training with video feedback or responsive training without video feedback.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism; parent intervention; parent coaching; early intervention; parent-mediated intervention