bioihbjkbjnl/mcl2 huggingface dataset:
Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
Condition: Autism Spectrum Disorders; Psychosis; Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Autism Spectrum Disorder; Neurodevelopmental Disorders
Study type: Observational

Summary: 
      The purpose of the proposed research is to study the potential changes in biomarkers of
      patients with neurodevelopmental disorders in response to treatment in clinical trials or in
      private psychiatry practice utilizing non-invasive psychophysiological measurements. The
      investigators plan to obtain psychophysical measurements throughout several periods of
      treatment.
    

Detailed description: 
      This study will employ a non-invasive custom-built four-point vertical displacement
      stimulator. This is used to deliver sinusoidal vibrations at very low amplitudes (0-400
      microns) to the tips of the fingers. The forearm of the subject rests on the stimulator, the
      finger tips are vibrated, and the subject answers questions prompted by a computer monitor
      about their perception of the stimuli. Research staff may explain questions and prompts in a
      way that may be better understood by the subjects if the subjects experience any difficulty.

      This device will be used to obtain objective psychophysical measurements as subjects undergo
      treatment. The investigators hope that this study will eventually assist in the long term
      goal of studying ways to develop diagnostic methods, based on changes in cortical information
      processing capabilities that occur with neurodevelopmental disorders. This would enable
      clinicians to more objectively determine prognosis and the best course of intervention for
      their patients.

      This study will consent up to 60 subjects who are have initiated or changed pharmacologic
      treatment as either a participant in a clinical trial or as a private patient of one of the
      study doctors. Subjects who are a participant in another clinical trial may be one an active
      medication or a non-active medication(placebo). Subjects will have 7 visits in this study (w0
      prior to initiating new treatment, and 4,8, 26 52,78 and 104 weeks after starting the the new
      treatment. The latter visits may occur either while the individual is taking the medication
      or after the individual has stopped treatment (in order to assess persistence of
      treatment-related changes).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants recruited for a clinical trial conducted by Dr. Sikich, or are private
        patients of one of the study doctors.
A Trial of APPA in the Treatment of Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      A placebo controlled study of APPA in 150 participants with Osteoarthritis of the knee
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week
      trial of a fixed-dose combination of apocynin and paeonol (APPA) administered orally twice
      daily versus placebo twice daily. Approximately 150 subjects will be randomized to one of the
      two treatment groups.
    

Intervention name(s): APPA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): APPA, an oral combination of two isomers: 4-hydroxy-3-methoxyacetophenone (4H3MA) & 2-hydroxy-4-methoxyacetophenone (2H4MA).; Placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Quantification of Proteomes: L-plastin , Lipocalin and Adiponectin in Chronic Periodontitis and Diabetic Subjects
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis
Study type: Observational

Summary: 
      The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in
      the subgingival tissue samples of generalized severe chronic periodontitis patients with and
      without diabetes mellitus.The demographic and the periodontal parameters were assessed and
      the correlated with the quantification of the proteins. The mRNA expression was analyzed with
      RT-PCR and the quantification of protein was done using ELISA.
    

Detailed description: 
      The quantification of the proteomes : L-plastin, lipocalin and adiponectin was analysed in
      the subgingival tissue samples of generalized severe chronic periodontitis patients with and
      without diabetes mellitus.A total of 70 subjects with generalized severe chronic
      periodontitis were selected and divided into two groups. Group I comprised of 35 subjects who
      were diagnosed with generalized severe chronic periodontitis without any systemic conditions.
      Group II comprised of generalized severe chronic periodontitis patients with type II diabetes
      mellitus. Demographic variables such as age, weight, height, BMI and income and the clinical
      parameters such as plaque index, bleeding on probing, probing pocket depth and clinical
      attachment level were recorded. Subgingival tissue samples were collected from both the
      groups from the periodontal surgical site. The collected samples were subjected to further
      molecular analysis for the mRNA expression of L-plastin, lipocalin and adiponectin using
      RT-PCR and for their protein quantification using ELISA.The elevated levels of mRNA
      expression and elevated quantification of L-plastin and Lipocalin proteins in the subgingival
      tissue samples of generalized severe chronic periodontitis subjects with diabetes denoted the
      localized involvement of these molecules in the pathogenesis of both periodontitis and type
      II diabetes mellitus. Since adiponectin was reduced in periodontitis patients with type II
      diabetes mellitus, it can be used as an anti-inflammatory and anti-diabetic biomarker for the
      early identification of patients at risk for diabetes mellitus and periodontitis.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All male patients within the age group of 35-60 years. The subjects were from the South
        Indian population.
      
Keywords: proteomes, chronic periodontitis
Study of Adolescent Immunization Recall Systems
Condition: Immunization; Reminder Systems
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether contacting the parents of adolescents
      overdue for routine vaccines or contacting both the parents AND adolescents overdue to
      routine vaccines improves immunization rates as compared to usual care.
    

Detailed description: 
      This randomized controlled trial is a 3-armed study designed to evaluate an immunization
      recall system in adolescents. In the control arm (Group 1), the adolescents will receive
      usual care, in which they will primarily receive immunizations at annual physical exams, or
      as recommended by providers at urgent care visits. In one intervention arm (Group 2), the
      parent/guardian will receive a telephone call informing them that the adolescent is overdue
      for one or more immunizations (conjugated Neisseria meningitidis (MCV4) vaccine,
      tetanus-diphtheria-pertussis (Tdap) booster, and/or the second varicella (VZV) vaccine). In
      the second intervention arm (Group 3), both the parent/guardian and the adolescent will
      receive a telephone call informing them that the adolescent is overdue for one or more
      immunizations. Immunization rates will be compared between the 3 groups at a four week and a
      twelve month follow up period.
    

Intervention name(s): Parent Only Phone Call; Parent and Adolescent Phone Call
Intervention type(s): Other; Other
Intervention description(s): A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites.; A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites. We will also ask permission to speak with the adolescent as well, and if granted, will make up to 4 phone calls to the adolescent to convey the same message.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunization; reminder systems
A Study of Gaboxadol in Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and tolerability of gaboxadol in primary insomnia.
    

Detailed description: 
      To obtain long-term safety and tolerability data with gaboxadol.
    

Intervention name(s): Gaboxadol
Intervention type(s): Drug
Intervention MeSH terms: Gaboxadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Primary insomnia
Study of Safety and Tolerability of DCR HBVS
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic
      hepatitis B patients.
    

Detailed description: 
      DCR HBVS is being developed for the treatment of chronic hepatitis B (CHB) in adults. The
      study will be conducted in 3 parts, a single ascending-dose (SAD) phase in normal healthy
      volunteers (Group A), a single-dose (SD) phase in patients with CHB (Group B), and a multiple
      ascending-dose (MAD) phase in patients with CHB (Group 1c-3c). Cohort 4c is a single
      ascending dose with a possible duration of up to 48 weeks. Cohort 5c is a multiple dose
      cohort with a possible duration of up to 72 weeks.
    

Intervention name(s): DCR-HBVS; Placebo for DCR-HBVS
Intervention type(s): Drug; Drug
Intervention description(s): DCR-HBVS is a synthetic ribonucleic acid interference (RNAi) drug that consists of a double-stranded oligonucleotide conjugated to N-acetyl-D-galactosamine (GalNAc) ligands. DCR-HBVS is a sterile solution of the siRNA (DCR-S219) at a concentration of 195 mg/mL in water for injection (WFI).; Sterile 9% saline for injection.
Other intervention name(s): DCR-S219; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Progression from the SAD phase to the first cohort in the MAD phase is contingent upon the Safety Review Committee (SRC) review of a minimum of 14 days post-dose safety and tolerability data from all NHV in at least the first 2 SAD cohorts. The SRC will select one (or more) well-tolerated dose(s) from the SAD phase for administration in the SD and MAD phases. Group B at 3 mg/kg will start in parallel with Group C at the 3 mg/kg dose level. In all study phases, dosing will be staggered with the use of sentinel participants to allow time for the assessment of safety before additional subjects are exposed to study drug. The fixed dosing regimen for Cohorts 4c and 5c was determined following SRC review and assessment of all data up to Cohort 3c. No sentinel dosing will occur in Cohorts 4c and 5c.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; DNA Virus Infections; CHB; HBsAg; Liver Disease; RNAi
To Check Effectiveness of Medistus Antivirus Lozenges for Cough
Condition: Throat Infection; Pharyngitis; Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A thraot infection sometimes called pharyngitis can be either a bacterial or a viral
      infection leading to inflammation of the tissues of the throat that causes redness, pain and
      swelling of the walls and structure of the throat.

      The throat or Pharynx is the tube like structure that carries both food to the oesophagus and
      air to your wind pipe (called the larynx). Infective agents of the throat most often enters
      through the month or nose. Many of these infections are viral, other can be caused by
      bacteria such as Streptococcus Pyogenes, or Group A streptococcus.

      Symtoms of throat infections most commonly includes pain and a sensation of heat in the
      throat or Pharynx.

      Viral infections accounts for approx. 70% of all pharyngitis. Rhinovirus is the most common
      cause of viral infections. The other common causes of viral infections in descending order
      are corona virus, adeno virus, para influenza, and influenza virus. Viral infections are more
      common during the winter month with the exception of adeno viruses which occur year round.

      Viral Pharyngitis is spread through similar mechanism as other viral infections. Hand to
      mouth contact, contact with oral secretions, and sharing common utensils, all contributes to
      viral spread.

      Prevention of the spread of diseases is based on frequent hand washing, and clinical symptoms
      of different viruses are more prevalent during certain seasons. Coryza, conjectivitis,
      malease, or fatigue, hoarseness, and low grade fever such as the presence of viral
      phayngitis. Subjects with viral pharyngitis can also have atypical symptoms such as mouth
      breathing, nausea, abdominal pain, and diarrhoea.

      Medistus Antivirus is a medical device product with a noble impact. Kistosyn 100 extract
      contains polyphenols, and with the help of gum arabic, it forms a protective film over the
      mouth and throat mucus membranes. This protective Barrier lead to a physical (mechanical)
      barrier against viruses and bacteria which prevent their penetration into body cells, and
      their further propagation. Due to this physical effect, resistance development is not
      possible.
    


Intervention name(s): Medistus Antivirus Lozenges
Intervention type(s): Device
Intervention description(s): A blend of Kistosyn Extract with Gum Arabic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medistus; nutrin gmbh; throat infection; Pharyngitis; Antivirus
T-Wave Alternans in Dialysis Patients
Condition: Sudden Cardiac Death; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Death, Sudden, Cardiac; Death
Study type: Observational

Summary: 
      Sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal
      disease (ESRD) patients treated with hemodialysis (HD). As it is anticipated that the number
      of individuals with ESRD will exceed 1.2 million in the next 20 years, sudden death in this
      population has enormous public health impact. Research has shown that arrhythmic events are
      temporally associated with longer periods between HD with a three-fold risk of events in the
      12 hours preceding the longest inter-dialysis interval. The exact cause of these findings is
      unknown.
    

Detailed description: 
      The purpose of this study is to assess the degree of cardiac electrical instability at
      various times in the dialysis cycle. The hypothesis is that longer time intervals between
      hemodialysis results in sympathetic and electrolyte-induced alterations in ventricular
      repolarization that can be measured non-invasively using microvolt T-wave alternans (TWA).
      This increase in cardiac electrical instability may serve as a link between the clinically
      observed periods of increased risk and the occurrence of sudden cardiac death.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with end-stage renal disease (ESRD) treated with hemodialysis three (3) times per
        week for at least 3 continuous months will be enrolled. No limitations for gender, race,
        socioeconomic status or any other parameters will be applied.
      
Keywords: T wave alternans (TWA); dialysis; end stage renal disease; sudden cardiac death; T-wave alternans; Cardiac electrical instability; Sympathetic and electrolyte-induced alterations; Ventricular repolarization
A Study of the Dose Proportionality of Extended Release Paliperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets
      of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and
      to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men.
    

Detailed description: 
      This is a randomized, open label, single center, single dose, 2 treatment, 2 way crossover
      study. It consists of 3 phases: A screening phase beginning within 21 days before the first
      study drug administration; an open label treatment phase consisting of 2 treatment periods
      (Period 1 and Period 2) during which volunteers will receive a single oral 1.5 or 3 mg dose
      of study drug; and end of study evaluations upon completion of all the study procedures in
      Period 2. All volunteers will receive each of the following 2 treatments in random order:
      Treatment A: One tablet of 1.5 mg paliperidone ER to-be-marketed formulation in the fasted
      state; Treatment B: One tablet of 3 mg paliperidone ER Phase 3 formulation in the fasted
      state. Successive study drug administrations will be separated by a washout period of at
      least 9 days and no more than 21 days. A 1.5-mg dose of paliperidone ER was selected to be
      studied as the availability of a 1.5-mg tablet would make dose-adjustments across the
      existing range of doses of paliperidone ER easier in patients with reduced renal function or
      tolerability issues. Safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER
      in healthy men will be monitored throughout the study.

      A single oral doses of 1.5 mg and 3 mg paliperidone ER
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mood Disorders, Antipsychotic drugs; Schizophrenia; Paliperidone ER
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
Condition: Drug-Induced Liver Injury
MeSH terms: Chemical and Drug Induced Liver Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety, effective dosage and treatment of
      Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared
      with the Tiopronin Injection.
    

Detailed description: 
      The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly
      decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and
      Thioacetamide. It could also significantly reduce the injury on the liver coursed by
      D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong
      anti-inflammatory effect could protect the liver cell and improve the liver function.
    

Intervention name(s): Magnesium Isoglycyrrhizinate Injection 100mg OD; Magnesium Isoglycyrrhizinate Injection 200mg OD; Tiopronin Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Magnesium Isoglycyrrhizinate Injection 100mg OD; Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks; Tiopronin Injection 200mg OD
Other intervention name(s): Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jinan Limin Pharmaceutical Co., Ltd.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug-Induced; Acute Liver Injury
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
Condition: Vitamin B 12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in
      infants. We have earlier investigated cobalamin status in healthy children and we observed
      metabolic evidence of impaired cobalamin status during the first 6 months, but not later in
      life.

      The purpose of this study is to determine if cobalamin supplementation may influence the
      metabolic profile related to cobalamin status in infants.
    

Detailed description: 
      During fetal life and infancy, an adequate cobalamin status is important for normal growth
      and central nervous system development. A metabolic profile consistent with impaired
      cobalamin status is prevalent in breast-fed infants. Whether this profile reflects immature
      organ systems or cobalamin deficiency has not been clarified.

      Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or
      methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.

      The purpose of this randomized, controlled study is to determine if cobalamin supplementation
      may influence the metabolic profile related to cobalamin status in infants.

      Six weeks old infants will be randomly assigned to receive either an intramuscular injection
      with 400 µg cobalamin or no intervention. Concentrations of cobalamin and folate in serum,
      and total homocysteine (tHcy), methylmalonic acid (MMA) and cystathionine in plasma will be
      determined at inclusion and at the age of 4 months. A questionnaire on infant and maternal
      nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco
      will be completed.
    

Intervention name(s): Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
Intervention type(s): Drug
Intervention description(s): an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cobalamin; methylmalonic acid; homocysteine; folate; newborns; infants; Deficiency Disease; Breastfeeding; Infant