bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP
Condition: Vaccination
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV
      and DTaP, (2) Sabin-IPV only and (3) DTaP only.

      After finishing the two basic vaccine EPI procedures, the immunogenicity and safety of both
      combined immunization group and individual vaccination groups will be compared and the data
      will be analyzed.
    

Detailed description: 
      It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous
      immunization of Sabin-IPV and DTaP be implemented soon and the immunogenicity and safety
      studies should be conducted. In China according to the current vaccination schedule, the
      arrangement of Sabin-IPV and DTaP falls on the same date -- at infants' 3rd and 4th months of
      age. In order to avoid the vaccination time conflict and explore the feasibility of
      simultaneous immunization, we design this phase 4 clinical trial of simultaneous vaccination
      of the two vaccines.

      To be specific, the subjects were divided into 3 groups. Group 1 : Sabin-IPV (1st, 2nd, and
      3rd doses) and DTaP (1st, 2nd, and 3rd doses) are simultaneously administrated at 3,4,5
      months old ; Group 2 : subjects receive 1 dose of sIPV only at 3,4,5 months old ; Group 3 :
      subjects receive 1 dose of DTaP only at 3,4,5 months old .

      Blood samples would be collected both before vaccination and 28-40 days after the 3rd dose of
      vaccination. Neutralization antibody will be detected to evaluate the seroprotection rates
      and antibody geometric mean concentrations. The safety of both immunization schedules will be
      monitored too.
    

Intervention name(s): Sabin-IPV and DTaP; Sabin-IPV; DTaP
Intervention type(s): Biological; Biological; Biological
Intervention description(s): simultaneously administration of Sabin-IPV and DTaP; administration of Sabin-IPV only; administration of DTaP only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Eco-guided PENS on Handgrip Strength
Condition: Electrical Stimulation; Neuromodulation
Study type: Interventional

Summary: 
      Low-frequency percutaneous electrical stimulation is the application of an electrical current
      of <1000Hz through acupuncture needles located on the epineurium of the peripheral nervous
      system.

      The hypothesis is that by placing the electrode, needle, closer to the nerve, a greater
      stimulation of the same will be achieved, thus being able to obtain greater effects. The goal
      is to determine if this technique has any effect on grip strength in the short term.
    

Detailed description: 
      Single-blind randomized clinical trial of n = 12 healthy subjects. 4 assessments of the grip
      strength of the non-dominant hand will be made using a digital dynamometer, by a blinded
      investigator. A V0-pre-intervention, a V1-post-intervention, a V2 at 24 hours and a V3 at 10
      days after the intervention. Subjects will be randomly assigned by EPIDAT 3.1, to an
      experimental group or a control group, with n = 6 each group. In the experimental group, an
      ultrasound-guided percutaneous electrical stimulation will be performed. With a pointer, a
      symmetrical biphasic low-frequency current of 10 Hz and 240 microseconds will be applied to
      the median nerve and ulnar nerve, until reaching the excitomotor threshold, with applications
      of 10 seconds and rests of 5 seconds until reaching a stimulation of 1 minute. total over
      each nerve. In the control group, the same invasive procedure will be performed, but no type
      of electrical stimulation will be applied.

      Statistical analysis will be performed by another blinded assessor, using IBM SPSS Statistics
      24. A two-factor ANOVA (intervention-time) with Bonferroni correction will be performed.
    

Intervention name(s): Eco-guided Percutaneous Electrical Stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Pointer 10 hz. A symetric, biphasic current of 10 hz and 240 microsecond. The stimulation intensity will be reaching the excitomotor threshold, producing visible but comfortable contractions.; Application of the needles only on the median and ulnar nerve of the arm, for 1 minute on each nerve without current intensity and applying a son.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PENS; low-frecuency stimulation; handgrip strength; percutamos electrical stimulation; Neuromodulation
Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility
Condition: Infertility
MeSH terms: Infertility; Abortion, Spontaneous
Study type: Observational

Summary: 
      Unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in
      this group. 65 women with unexplained infertility and 65 healthy controls will collect daily
      urine samples form the luteal phase. hCG and creatinine levels are measured in order to
      detect pregnancies and early pregnancy loss.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with unexplained infertility and healthy controls have collected urine samples in
        the luteal phase of the menstrual cycle for detection of hCG rise and pregnancy
      
Biospecimen description: 
      urine
    
Keywords: unexplained infertility; hCG; early pregnancy loss
Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction
Condition: Conservative Pharmacotherapy; Staged Percutaneous Coronary Intervention; Non-culprit Vessels; ST-Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      To compare the different effect of conservative pharmacotherapy and Staged Percutaneous
      Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment
      elevation myocardial infarction (STEMI) at presentation remains controversial
    


Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        STEMI patients after culprit vessels treated by PPCI
Probiotics for Prevention of Antibiotic-associated Diarrhea
Condition: Antibiotic-Associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus
      EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving
      antibiotic therapy.
    

Detailed description: 
      A common complication of antibiotic use is antibiotic-induced diarrhea (AAD). AAD is the
      result of disrupted microflora, occurring two to eight weeks after antibiotic use. Probiotic
      supplementation may rebalance the intestinal flora, thus reducing the incidence of diarrhea,
      improving quality of life and reducing symptoms associated with antibiotic administration.

      The proposed study will be a prospective, randomized, double blind, placebo-controlled trial
      that will assess the efficacy of the Jarro-Dophilus EPS probiotics formula for the prevention
      of AAD.

      In addition,a subgroup of participants will be requested to provide one fecal sample at the
      initiation of the study and one sample in the last three days of probiotic (or placebo)
      treatment. The samples will undergo microbial analysis for routine C & S(Salmonella,
      Shigella, Campylobacter, Ecoli 0157, Yersinia), VRE, Yeast, Fungus culture (moulds) and C.
      difficile toxin.
    

Intervention name(s): Jarro-Dophilus EPS probiotics
Intervention type(s): Other
Intervention description(s): Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antibiotic-associated diarrhea; Probiotic; Quality of life; Antibiotics
A Pragmatic Trial of Corticosteroid Optimisation in Severe Asthma
Condition: Severe Persistent Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study explores if a composite biomarker strategy predicts exacerbation risk in patients
      with asthma on high dose inhaled corticosteroid (+/-long-acting beta agonist) treatment and
      to evaluate the utility of this composite score to facilitate personalised biomarker specific
      titration of corticosteroid therapy in this population.
    

Detailed description: 
      Asthma affects an estimated 300 million people worldwide with a population prevalence of ca
      15% in the UK. The WHO has estimated UK disability adjusted life-years per 100,000 population
      for asthma to be greater than diabetes and breast cancer. Much of this excessive disability
      is in the 10-20% of patients with asthma which is difficult to control despite currently
      available therapies. This high morbidity and disproportionate use of health care resources
      reflects the considerable unmet need in this patient group, and their significance for health
      care providers.

      Asthma has been traditionally 'stratified' on the basis of response to 'step-wise'
      incremental treatment with inhaled corticosteroid (ICS) therapy forming the cornerstone of
      this approach. However, more recently, asthma has been stratified on the basis of
      inflammatory phenotype to better understand disease heterogeneity with a view to developing
      biomarkers of therapeutic response and for the better targeting of both new and existing
      treatments.

      Investigators have recently examined the predictive value of a composite biomarker strategy
      using FeNO, blood eosinophils and serum periostin together to predict exacerbation risk in
      the placebo arms of clinical trials. Investigators propose to examine if this composite
      biomarker strategy predicts exacerbation risk in patients with asthma on high dose ICS
      (+/-long-acting beta agonist) treatment and to evaluate the utility of this composite score
      to facilitate personalised biomarker specific titration of corticosteroid therapy in this
      population. This study will examine subjects with FeNO<45 ppb and the scoring system will
      potentially allow identification of a 'low-risk' group who can safely reduce corticosteroid
      dose. This study will address a second important question of estimating the proportion of
      patients with severe disease who develop typical (T2)-driven eosinophilic inflammation on
      progressive corticosteroid withdrawal.
    

Intervention name(s): Biomarker based adjustment of corticosteroid dose
Intervention type(s): Other
Intervention description(s): The subject's corticosteroid dose will be adjusted based upon biomarker results (FeNO, eosinophils and periostin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of PiQo4 Device for Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      Single center, Prospective, Open Label with Split-face Study Design. Face sides will be
      randomized to receive either 1064nm alone or 1064nm & 585nm combination treatment.

      Each subject will receive up to 3 treatments at monthly intervals (±4 days). Follow-up visits
      will take place at 1, 3, and 6 months following the last treatment.
    


Intervention name(s): PiQo4
Intervention type(s): Device
Intervention description(s): PiQo4 Laser System for treatment of Melasma
Intervention model: Single Group Assignment
Intervention model description: Face sides will be randomized to receive either 1064nm alone or 1064nm & 585nm combination treatment
Masking: None (Open Label)
Primary purpose: Treatment
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
Condition: Active Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterise long-term safety and tolerability of intravenous
      anifrolumab.
    

Detailed description: 
      This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled
      extension study to characterising the long term safety and tolerability of of an intravenous
      treatment regimen of anifrolumab versus placebo in subjects with moderately to severely
      active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or
      D3461C00005) through the 52-week double-blind treatment period.
    

Intervention name(s): Anifrolumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses; Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases,Immune System Diseases
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis; Sialorrhea
MeSH terms: Sialorrhea; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients
      who are having excessive drooling.

      The primary goal of the study is to determine if the patient perceives a benefit from the
      Myobloc in controlling excessive drooling.
    

Detailed description: 
      The secondary goals of this study are to:

        -  determine the safety of bilateral injections of Myobloc into the parotid and
           submandibular glands as an effort to control sialorrhea;

        -  determine by objective measures if the Myobloc injection decreases the saliva produced;

        -  determine caregiver perceived benefit from Myobloc injection.
    

Intervention name(s): Botulinum toxin type B (Myobloc); Injection of salivary glands
Intervention type(s): Drug; Procedure
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ALS; Lou Gehrig's Disease; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sialorrhea; Hypersalivation; Excessive Drooling; Myobloc; botulinum toxin type B; Clostridium botulinum B toxin; botulinum B toxin; botulinum neurotoxin B; NeuroBloc
Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)
Condition: Amphetamine-Related Disorders
MeSH terms: Amphetamine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in
      treating alcohol dependence and prevention of relapse to opioid dependence. It has shown
      promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently
      amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work
      to determine whether monthly intramuscular injections of naltrexone will reduce
      methamphetamine (meth) use among actively using, meth-dependent men who have sex with men
      (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus
      placebo. The investigators will focus on MSM because of the disproportionate and intertwining
      epidemics of meth use and HIV in this population.
    

Detailed description: 
      The investigators will enroll 100 sexually active, meth-dependent MSM who will be randomized
      1:1 to receive monthly injections of extended-release naltrexone (n=50) or placebo (n=50) for
      12 weeks at weeks 0, 4, and 8. Study participants will be seen weekly at our site at the HIV
      Prevention Section of the San Francisco Department of Public Health, where they will provide
      urine for drug testing and participate in substance use counseling. All participants will
      receive HIV risk-reduction counseling. Behavior will be assessed using standardized measures
      via audio computer-assisted self-interview (ACASI).
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 monthly intramuscular injections of naltrexone 380 mg (extended release); 3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)
Other intervention name(s): XR-NTX; VIVITROL
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methamphetamine; high-risk sexual behavior; HIV prevention
Assessment of Bone Mineral Density During Pregnancy
Condition: Bone Mineral Density Quantitative Trait Locus 3
Study type: Interventional
Phase: Phase 1

Summary: 
      BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams
      Maternity hospital.
    

Detailed description: 
      Consecutive patients with singleton pregnancies between 36 and 39 weeks booked at a general
      obstetric clinic in a regional hospital will be recruited for the study. The obstetric
      department is a tertiary referral center in the region and part of a university teaching unit
      which catered to an annual delivery of around 10,000 women. A group of first trimester
      pregnant women with nearly the same age is recruited as controls.
    

Intervention name(s): calcaneal quantitative ultrasound assessment
Intervention type(s): Radiation
Intervention description(s): QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Almond Butter and Fasting Glucose
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A two-period randomized crossover study will be conducted to determine the effect of almond
      butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not
      taking insulin.
    

Detailed description: 
      Control of fasting blood glucose is a challenge for many individuals with diabetes.
      Researchers want to better understand how a nighttime snack can affect morning fasting blood
      glucose. A two-period randomized crossover trial will be conducted. Participants will be
      randomized to receive each treatment for 1 week. During the almond butter treatment,
      participants will consume 2 tbsp of almond butter per day as an evening snack. The control
      treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will
      be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take
      simple cognitive tests on a study-provided smartphone each day of the study and report their
      daily food intake and physical activity.
    

Intervention name(s): Almond Butter
Intervention type(s): Other
Intervention description(s): Natural almond butter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
Condition: Carcinoma, Non Small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804
      taken daily, as single agent in patients with advanced NSCLC who failed at least one
      chemotherapy + erlotinib.
    


Intervention name(s): PF-00299804; PF-00299804
Intervention type(s): Drug; Drug
Intervention description(s): PF-00299804 orally at 45 mg daily, on continuous schedule; PF-00299804 orally at 45 mg daily, on continuous schedule
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; advanced; previously treated
A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects
    

Detailed description: 
      This is a two-part Phase 1 study. Part 1 is a single dose, randomized, open label, parallel,
      single site study designed to evaluate the effect of a high fat meal on the PK of rodatristat
      ethyl, rodatristat and metabolite(s). Part 2 is a randomized double-blind, placebo-controlled
      study to evaluate the safety and tolerability of repeat supratherapeutic dose of rodatristat
      ethyl when administered twice daily with a standard meal.
    

Intervention name(s): Rodatristat Ethyl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 600mg, QD; Tablets, Oral, 0mg, BID
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single and multiple dose
Masking: Double (Participant, Investigator)
Primary purpose: Treatment