bioihbjkbjnl/mcl2 huggingface dataset:
EEG & Behavioral Predictors of Changes in Smoking Trajectories in Young Light Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The purpose of the proposal is to identify new predictors of smoking progression in young
      light smokers (YLS: 18-25 years & cpd < 5) using an 18-month longitudinal design and to
      relate these predictors of progression to the genetic profile most highly associated with
      smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors
      will include individual differences (IDs) in EEG, reward sensitivity, attentional
      performance, and mood during abstinence and in response to standardized and to self-selected
      acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking
      history. The associations of a compelling genetic functional variant polymorphism,
      rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking
      progression and the novel predictors. The study is expected to provide insights into IDs in
      mechanisms and predictors that contribute to smoking trajectories in YLS and thereby lead to
      targeted pharmacotherapy and behavioral interventions for at-risk YLS.
    

Detailed description: 
      The purpose of the proposal is to identify new biobehavioral endophenotypes that predict
      smoking progression in young light smokers (YLS: 18-25 years & cpd < 5) using an 18-month
      longitudinal design and to relate these endophenotypes and progression to the genetic profile
      most highly associated with smoking progression. A number of novel predictors will be
      assessed in 128 YLS. Predictors will include individual differences (IDs) in EEG, reward
      sensitivity, attentional performance, and mood during abstinence and in response to
      standardized and to self-selected acute nicotine doses (ANIC), as well as genetically
      influenced affective traits, and smoking history. The associations of a compelling genetic
      functional variant polymorphism, rs16969968, in the alpha5 nicotinic receptor subunit will
      also be related to smoking progression and the novel predictors. The study is expected to
      provide insights into IDs in mechanisms and endophenotypes that contribute to smoking
      trajectories in YLS and thereby lead to targeted pharmacotherapy and behavioral interventions
      for at-risk YLS.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of young light smokers
      
Biospecimen description: 
      blood, saliva
    
Keywords: Nicotine; Smoking Progression; EEG; Young adults; Light smokers; rs1051730 genotype
Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder
Condition: Generalized Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness and tolerability of atomoxetine
      (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder
      characterized by a fear of interpersonal interactions).
    

Detailed description: 
      Controlled studies show that approximately 50% of patients with generalized social anxiety
      disorder(GSAD)will respond to treatment with available pharmacotherapeutic agents such as
      SSRI's. This still leaves 50% that respond partially or not at all. Those who do respond,
      often experience adverse events (e.g., sexual dysfunction), which leads them to discontinue
      treatment. Thus, there is a strong rational for identifying alternatives to SSRI's that are
      effective with fewer side effects (or with a different side-effect profile, that features
      less sexual dysfunction)for the treatment of GSAD. Available data demonstrate that
      sustained-release venlafaxine, a dual reuptake inhibitor, is also effective for GSAD.(Stein
      et al., 2005). It is unclear from these studies whether serotonin reuptake is integral to
      efficacy for social anxiety disorder, or whether norepinephrine reuptake will convey similar
      efficacy. Atomoxetine (Strattera)an inhibitor of the presynaptic norepinephrine transporter,
      is an ideal candidate to address both these issues.
    

Intervention name(s): atomoxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flexible dose, up to 50 mg per day; placebo (matching to atomoxetine)
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      ABT-122 in subjects with Rheumatoid Arthritis.
    

Detailed description: 
      This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose
      study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate.
      Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be
      administered as subcutaneous (under the skin) injections in three dosing groups.
    

Intervention name(s): ABT-122; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Injection; Placebo Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tolerability; Immunogenicity; Safety; Rheumatoid Arthritis; Pharmacokinetics
Sarcopenic Obesity in the Elderly
Condition: Sarcopenic Obesity; Diabetes
MeSH terms: Obesity
Study type: Observational

Summary: 
      Ageing is associated with progressive and generalized loss of muscle mass and muscle
      function, also known as Sarcopenia. Increasingly, obesity has become a compounding factor in
      ageing-related sarcopenia. The coexistence of obesity and sarcopenia is termed sarcopenic
      obesity (SO). Older adults with SO are at higher risks of developing diabetes, hypertension,
      stroke, cardiovascular diseases, and cognitive dysfunction than those older adults who suffer
      from sarcopenia alone or obesity alone. However, there is insufficient information with
      regard to the interplay between obesity and sarcopenia. The primary objective of this study
      is to investigate the impact of SO on insulin resistance in people aged 65-85. Our hypothesis
      is that SO positively influences insulin resistance in the elderly. We propose to investigate
      sarcopenia and obesity as risk factors for insulin resistance in the geriatric (65-85 years
      old) population.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include both men and women who are aged 65-85. We plan to recruit a minimum
        of 25 men and 25 women but no more than 60 of each gender. The maximum sample size is 100.
        We estimate that less than 10% of the consented participants will not meet the inclusionary
        criteria and will be withdrawn. As this study involves a solitary study visit, we estimate
        that less than 5% of the participants will withdraw/be withdrawn/ or be lost to follow up
        prior to study completion.
Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease
Condition: Type 2 Diabetes Mellitus; Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao
      Capsule on diabetic kidney disease in T2DM patients.
    

Detailed description: 
      Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of
      diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood
      pressure control, combined with renin - angiotensin system blocking therapy (including ACEI
      and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot
      completely block its development. Cordyceps sinensis is a traditional Chinese medicine and
      Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However,
      its clinical application in diabetic kidney disease is not well-defined so far. The aim of
      this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in
      T2DM.
    

Intervention name(s): Jinshuibao Capsule
Intervention type(s): Drug
Intervention description(s): 1.98g t.i.d. p.o. for 6 months
Other intervention name(s): Jinshuibao Jiaonang; Cordyceps sinensis; Artificial Cordyceps sinensis powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea
Condition: Gonorrhea
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phaseIV, multicenter, open-label，single arm study which will be performed to
      evaluate efficacy and safety of Ceftriaxone sodium and Sulbactam Sodium for injection for the
      treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae in adolescent
      and adult subjects.
    

Detailed description: 
      In this study, adults will be administered as one 3g IV dose at the study site,Children under
      12 will be administered as one 75mg/kg IV dose . Approximately 100 subjects will be recruited
      to receive study treatment. The duration of the study will be approximately 14 days.
    

Intervention name(s): Ceftriaxone sodium and Sulbactam Sodium for injection
Intervention type(s): Drug
Intervention description(s): Ceftriaxone sodium and Sulbactam Sodium for injection is available as sterile powder for reconstitution.It will be administered as one 3g IV dose for adult or one 75mg/kg IV dose for children under 12.
Other intervention name(s): CRO-SBT
Intervention MeSH terms: Ceftriaxone; Sulbactam
Intervention model: Single Group Assignment
Intervention model description: Ceftriaxone sodium and Sulbactam Sodium for injection
Masking: None (Open Label)
Primary purpose: Treatment
Cholinergic Urticaria - Efficacy of Dupilumab
Condition: Cholinergic Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy in reducing disease activity and safety
      of Dupilumab in adult patients with cholinergic urticarial (CholU) who are symptomatic
      despite H1-antihistamine treatment (licensed dose).
    

Detailed description: 
      Treatment with Dupilumab has been shown to reduce clinically significant exacerbations and to
      improve skin symptom control as well as quality of life in moderate to severe atopic
      dermatitis patients and in moderate to severe asthma patients. It has been approval by
      European Medicines Agency (EMA) for the treatment of atopic dermatitis patients in September
      2017.

      Dupilumab is a novel monoclonal antibody that inhibits interleukin-4 (IL-4) and
      interleukin-13 (IL-13) signaling and was previously found to be effective in atopic
      dermatitis and asthma. Considering that CholU and atopic diseases share many common features
      (e.g. key pathogenic role of mast cells and immunoglobulin E (IgE), itch is a dominant
      symptom, Th2 dominance), it is reasonable to expect that Dupilumab is beneficial in CholU.

      These results suggest that Dupilumab may provide an effective treatment option for patients
      with insufficient treatment responses to H1-antihistamines exhibiting wheal and flare type
      skin reactions.

      The gold standard treatment of CholU consists of administration of antihistamines. In most
      patients, symptoms persist with standard dosing of antihistamines. In
      antihistamine-refractory patients with cholinergic urticaria, no other licensed treatment is
      currently available. In 2014, omalizumab has been licensed for add-on therapy in chronic
      spontaneous urticaria (CSU) patients who still have symptoms despite standard-dosed
      antihistamine treatment, but not for chronic inducible forms of urticaria. Accordingly, there
      is still a great medical need for additional treatment options of CholU patients that are
      refractory to antihistamine treatment.

      Dupilumab has excellent potential to provide symptom control in CholU. This study will
      provide additional valuable insights into the therapeutic potential of Dupilumab in improving
      quality of life in these patients, in addition to managing CholU symptoms.
    

Intervention name(s): Dupilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): anti-IL4-Receptor alpha; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2 multicenter, randomized, double blind, placebo controlled, proof of concept, parallel group, two-arm, investigator-initiated trial (IIT)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hives; itch; exercise
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of cariprazine relative to
      placebo in the prevention of relapse of symptoms in participants with schizophrenia.
    

Detailed description: 
      There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the
      first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose
      could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the
      last 14 weeks of this Open-label Phase. At the end of Week 8, participants had to meet the
      following criteria to continue in the study.

        -  Positive and Negative Syndrome Scale (PANSS) total score ≤ 60 at the end of Week 8

        -  At least 20% decrease in PANSS total score from baseline to the end of Week 8

        -  Clinical Global Impressions - Severity (CGI-S) score ≤ 4 at the end of Week 8

        -  Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at
           the end of Week 8

        -  Stable dose during the previous 2 weeks

        -  No significant tolerability issues as judged by the Investigator at the end of Week 8

      At the end of the Open-label Phase, participants were randomized into 2 treatment groups,
      cariprazine or placebo, if they met the following criteria:

        -  PANSS total score ≤ 60 at the end of Week 20

        -  At least 20% decrease in PANSS total score from baseline to the end of Week 20

        -  CGI-S score ≤ 4 at the end of Week 20

        -  Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at
           the end of Week 20

        -  No significant tolerability issues as judged by the Investigator During this
           Double-blind Treatment Phase, participants received either placebo or cariprazine at the
           same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the
           Open-label Phase.

      All participants entered the 4 week Safety Follow-up Phase. They received a treatment other
      than the investigational product at the discretion of the Investigator.
    

Intervention name(s): Placebo; Cariprazine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo was supplied in capsules.; Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Other intervention name(s): RGH-188
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Schizophrenia; Schizophrenic disorder
Gait Modifications and Cutaneous Stimulation
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to quantify differences in joint mechanics between different
      types of walking in healthy individuals and individuals with knee pathology. The
      investigators will determine how modifying gait through feedback and/or cutaneous stimulation
      changes joint loading.
    


Intervention name(s): Cutaneous stimulation
Intervention type(s): Device
Intervention description(s): A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Pathology
The Germinal Peptide Eye Drops in Healthy Volunteers in a Clinical Study
Condition: Corneal Defect
Study type: Interventional
Phase: Phase 1

Summary: 
      The subjects of this study were healthy subjects, who were given medicine in a single dose
      group: 0.004%.
    

Detailed description: 
      Tear collection was conducted on the single dose D1 (that is, the day of administration).
      Collection points: 10 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, and 12 h after
      administration.Each time 5-50 mg (generally 20 mg), a total of 160-1600 mg of tears will be
      collected (during the screening period, all subjects will retain the tear samples collected
      by the Schirmer filter paper, among which, qualified tear samples will be used for blank
      samples or methodological investigation.After administration, only 1 tear collection site
      will be collected for each subject.
    

Intervention name(s): Germinal peptide eye drops
Intervention type(s): Drug
Intervention description(s): Germinal peptide eye drops of 0.004%
Other intervention name(s): shengfatai-eye drops
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Levator Ani Muscle Injury in Primiparous
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Observational

Summary: 
      pelvic floor muscles play an important role in supporting the pelvic organs. Vaginal birth
      leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and
      fecal incontinence can occur . Transperineal ultrasonography study pelvic floor pathology
      with minimal discomfort to the patient and lower cost than magnetic resonance imaging.
    

Detailed description: 
      355 eligible Egyptian women had been enrolled Maternal Medical, surgical and obstetrical
      history was obtained. Demographic data (maternal age, maternal body mass index, duration of
      second stage labor, episiotomy, maternal injuries, neonatal birth weight, and neonatal head
      circumference were obtained. A modified questionnaire on symptoms of pelvic floor dysfunction
      was filled by the patients in both visits. vaginal examination with the women to detect any
      pelvic organ prolapse (quantified according to POP-Q classification system.

      All ultrasound volumes were acquired 7days after delivery and another examination 6weeks
      post-delivery by one experienced sonographers using a GE Voluson p8 (GE Healthcare) equipped
      with a 4-8-MHz curved array 3D/4D ultrasound transducer. After emptying the bladder,
      ultrasound was done while the patient in the supine position. The probe was covered with
      clean glove adjusted and wrapped with an adhesive tape to make it firmly contacted to the
      probe and then placed on the perineum in the sagittal plane. The field of view angle was set
      to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the
      axial plane. Two 3D volumes (one with the patient at rest and one during Valsalva maneuver)
      were recorded.
    

Intervention name(s): transperineal 3D ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GEVoluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3Dultrasound transducer
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study was performed at Shatby maternity university hospital in Alexandria where 12000
        deliveries per year are achieved . Over a 4-months period (February-June 2021.

        355 eligible Egyptian women
      
Keywords: levator hiatus
Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection
Condition: Catheter Related Blood Stream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis
Study type: Interventional

Summary: 
      Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed
      replacement, versus exchange over a guidewire to treat catheter related blood stream
      infection
    

Detailed description: 
      The aim of this study was to compare the clinical outcomes of catheter-related (CRBSI)
      managed with two different strategies: Guidewire exchange of the infected catheter with a new
      one over a guidewire versus catheter removal with delayed replacement.
    

Intervention name(s): catheter replacement
Intervention type(s): Device
Intervention description(s): catheter removal and delayed replacement, versus exchange over a guidewire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit
Condition: Serum Bilirubin
MeSH terms: Jaundice
Study type: Interventional

Summary: 
      A randomized double-blind clinical trial will be performed in the neonatal intensive care
      unit of Makassed General Hospital in Beirut, Lebanon from December 2021 till August 2022.
      Randomized opaque envelopes to allocate the treatment will be used. The study will include
      neonates aged between 26 and 42 gestational weeks, who require phototherapy in the neonatal
      intensive care unit. Patients will be randomized into two groups.Both groups will receive
      standard conventional phototherapy, but the intervention group will receive 10 mg per day
      oral zinc sulfate until discharge.
    


Intervention name(s): Zinc sulfate; Placebo; Phototherapy
Intervention type(s): Drug; Other; Other
Intervention description(s): 10 mg of oral zinc sulfate will be given to neonates per day; 10 mg of normal saline will be given to neonates per day; Neonates will be put under phototherapy
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other