bioihbjkbjnl/mcl2 huggingface dataset:
Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis
      for schizophrenia has attracted increasing attention of the researchers, substantial
      evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α
      markedly elevated in patients with schizophrenia which may be particularly relevant for the
      cognitive impairment and metabolic disturbance of schizophrenia. In recent years, it has been
      demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism,
      reducing the proinflammatory status and improving cognition. As the investigators known, the
      report of berberine being used in schizophrenia is rare. This protocol is aim to evaluate
      berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism,
      cognition in patients with schizophrenia.
    


Intervention name(s): Berberine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.; Accept placebo(300 mg/tid)+SGAs monotherapy.
Other intervention name(s): Huang Liansu; Rhizoma coptidis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Berberine; Cytokine; CRP; Metabolism; Schizophrenia
Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function
Condition: Immune Health
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of 28-day supplementation with high-dose
      human recombinant lactoferrin, low-dose human recombinant lactoferrin, and an active control
      product formulated with bovine lactoferrin on indicators of immunity in healthy males and
      females.
    

Detailed description: 
      Samples will be retained for possible analyses such as lactoferrin absorption, distribution,
      metabolism, and excretion (ADME) and gut microbiota.
    

Intervention name(s): High dose Human Lactoferrin; Low dose Human Lactoferrin; Active Control Bovine Lactoferrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary Supplement and Food Ingredient; Dietary Supplement and Food Ingredient; Dietary Supplement and Food Ingredient
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
An Evaluation Of The Efficacy And Safety Of Donepezil Hydrochloride (E2020) In Migraine Prophylaxis
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this extension study was to evaluate the safety and efficacy of donepezil
      hydrochloride after extended use in migraine prophylaxis. Efficacy will continue to be
      evaluated.
    


Intervention name(s): Aricept (donepezil hydrochloride)
Intervention type(s): Drug
Intervention description(s): Donepezil hydrochloride tablet: initial 5 mg/day dose was taken orally, once a day. At Week 4 visit, the dose was increased to 10 mg/day at the discretion of the investigator.
Other intervention name(s): donepezil hydrochloride
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; headache
Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been
      characterized in a controlled laboratory setting. Accordingly, the proposed investigation
      seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused
      opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this
      investigation is to characterize the subjective effects of oxycodone under maintenance on
      various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers.
      Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive,
      and physiological effects of oxycodone.
    

Detailed description: 
      This 9-week investigation will use an inpatient/outpatient design in which participants will
      be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on
      PIO 15 mg followed by 3 weeks on PIO 45 mg). At the end of each maintenance period the
      effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session
      using a cumulative dosing procedure.
    

Intervention name(s): pioglitazone
Intervention type(s): Drug
Intervention description(s): A PPARγ agonist, also marketed as Actos. Participants will be maintained on ascending doses of Placebo, pioglitazone 15 mg and 45 mg, prior to completing a lab session at the end of each dosing period.
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Oxycodone; Opioid abuse
Newborns of Obese Mothers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand
      the potential independent effect of maternal obesity on fetal growth, investigators designed
      a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI < 25 kg/m2) or
      obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was
      screened and treated throughout pregnancy.
    

Detailed description: 
      The study population concerned obese pregnant women (BMI ≥ 30 kg / m² before pregnancy) and
      their newborn and normal weight pregnant women (18.5 ≤IMC <25 kg/m²) and their newborn as
      control. Inclusion criteria were body mass index (BMI) ≥ 30 kg/m2 or 18.5 ≤ BMI < 25 kg/m2,
      18 ≤ age ≤ 40 years, singleton pregnancy. Exclusion criteria were: 25 ≤ BMI <30 kg/m2, age <
      18 or > 40 years, multiple pregnancy, first consultation after 18 WG, pregestational
      diabetes, obesity due to genetic disorder or secondary to intracranial tumor or radiotherapy,
      bariatric surgery, chronic diseases other than the obesity, inability to converse in French
      language. The matching criteria for controls were: age ± 5 years, primigravida or
      multigravida, duration of gestation ± 4 weeks.

      The main objective of this project was to assess the independent effect of maternal obesity:

        -  on the weight and adipose tissue of newborn

        -  on the function of adipose tissue (production of leptin and adiponectin)

        -  on fetal growth factors (C-peptide, IGF-1)

        -  on carbohydrate metabolism of the newborn. Two maternities were involved in the study:
           Pitié Salpêtrière and Armand Trousseau, in Paris, France. This research was conducted
           over a 3 years period. The duration of participation of each woman corresponded to the
           duration of pregnancy care and duration of care for the newborn immediately after birth,
           usually the length of stay in the maternity.

      The only differences compared to the usual care included:

        -  Additional oral glucose tolerance test at 32 weeks of gestation;

        -  Determination of fasting blood glucose during late pregnancy

        -  Maternal blood samples on arrival at the delivery room

        -  Drawing blood from the umbilical cord after section;

        -  Skinfold measurement of the newborn within 72 hours of life.
    

Intervention name(s): Obstetric management
Intervention type(s): Procedure
Intervention description(s): Screening for gestational diabetes at 32 weeks of gestation, determination of fasting glucose during late pregnancy ; blood samples on arrival at the delivery room ; drawing blood from the umbilical cord after section; skinfold measurement of the newborn within 72 hours of life.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diabetes, obesity, skinfold, newborn
Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      It is proposed that using Virtual Reality as part of therapy will result in improvements in
      Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq
      and/or Afghanistan.
    

Detailed description: 
      In the treatment development phase, participants will be enrolled in Virtual Reality therapy.
      The therapy will be based on principals of exposure therapy, but will also incorporate
      aspects of physiological monitoring, and cognitive restructuring. The therapy will be
      modified as indicated by clinical feedback, with a fixed protocol to be developed (with
      length of treatment and exact methods to be used to be determined). After a fixed protocol is
      agreed upon, the project will enter the randomized phase. In this portion, subjects will be
      randomly assigned to receive either the Virtual Reality Treatment, or sent back to a waiting
      list during which time they will receive usual treatment. Participants will be assessed to
      determine which treatment (VR or treatment as usual) results in the greatest improvements in
      PTSD, as measured by independent assessors using the Clinician Administered PTSD scale.
    

Intervention name(s): Treatment as Usual; Virtual Reality Exposure with Stimulus Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 weeks of therapy and/or psychiatric medication as available; 10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control
Other intervention name(s): TAU; Virtual Reality Gradual Exposure Treatment; VRGET; Virtual Reality Exposure; VRE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Post Traumatic Stress Disorder; Combat; Military; Major Depressive Disorder; Anxiety; Virtual Reality Exposure with Stimulus Control; Treatment as Usual
Safety and Tolerability of PNT001 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This first in human study is a multi-center, randomized, double-blind, placebo-controlled
      single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
      immunogenicity of intravenous PNT001 in healthy adult participants.
    

Detailed description: 
      This Phase 1 clinical trial is a multicenter, double-blind, single ascending dose trial
      evaluating safety in up to a total of 48 participants across up to 6 dose cohorts, 5 planned
      and 1 to be determined if an additional dose group is required. Each cohort will include 8
      participants (6 active, 2 placebo) who will receive a single dose of either PNT001 or
      placebo. Within each cohort a sentinel group of 2 participants (1 active, 1 placebo) will be
      enrolled to evaluate safety and tolerability before enrolling the full cohort. If there are
      no safety concerns (as determined by the data and safety monitoring board [DSMB]), the
      remaining 6 participants (randomized as 5 active, 1 placebo) will be enrolled. This process
      will be followed for all additional cohorts.

      After screening, and laboratory assessments at Day -1, eligible participants will be admitted
      to the research unit on Day 1 (or Day -1 at Investigator's discretion), where they will
      remain for three (or four) nights with standardized meals provided during their inpatient
      stay. On Day 1, participants will be randomized to receive either active drug or placebo.
      Study medication will be administered as a single i.v. infusion over 30 minutes (up to 60
      minutes for doses greater than 2,700 mg), followed by collection of safety, tolerability, and
      PK data over 16 weeks. Participants will be discharged on Day 4 and will return for an
      outpatient study visit on Day 5 (may be phone or clinic visit), and to the study site on Days
      7, 14, 28, 42, 56, 70, 84, 98, and 112.
    

Intervention name(s): PNT001; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): PNT001 diluted in 5% dextrose; 5% dextrose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
Condition: Breast Cancer; Ovarian Insufficiency; Ovarian Failure
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      More than two million American women are breast cancer survivors. Approximately one-third of
      these women are premenopausal at diagnosis and face issues related to reproduction as they
      undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on
      breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire
      for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian
      function in breast cancer survivors could significantly impact physicians and patients in
      counseling, medical and surgical treatment choices, and consideration of fertility
      preservation options.

      The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian
      imaging markers that can predict ovarian failure and characterize the course of ovarian
      function after chemotherapy. The investigators plan to follow a group of young women from
      breast cancer diagnosis to five years after chemotherapy. The investigators will study the
      following risk factors: blood hormone levels that reflect ovarian function, genetic mutations
      that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI
      and ultrasound. The investigators hypothesize that these biomarkers are related to risk of
      ovarian insufficiency singly. After examining these individual risk factors for ovarian
      failure, the investigators will put them together into an Ovarian Failure Clinical Predictive
      Index. This index will be a tool similar to the Gail Model that can be used to determine
      individual risk for ovarian failure. This tool would assist young breast cancer patients and
      their physicians in making treatment decisions that would impact cancer survival and
      reproduction.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newly diagnosed breast cancer patients
      
Biospecimen description: 
      Serum DNA
    
Keywords: Breast cancer; Ovarian insufficiency; Ovarian failure; Reproduction
OC and ICTP in Gingival Crevicular Fluid During Piezocision Accelerated Orthodontic Treatment
Condition: Tooth Movement
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the tooth movement with and without piezocision with
      regard to the levels of osteocalcin and cross-linked C-terminal telopeptides of type I
      collagen in the gingival crevicular fluid.
    

Detailed description: 
      15 systemically healthy subjects requiring extraction of the maxillary 1. premolars with
      distalization of the maxillary canines were enrolled to the study. Piezocisions were
      performed on the distal and mesial sides of the right maxillary canines while the left
      maxillary canines served as controls. Canine distalization was performed via closed-coil
      springs applying 150 g of force per side by using miniscrews as anchorage. Gingival
      crevicular fluid samples were collected from both mesial and distal sides of right and left
      maxillary canines at 0, 1, 7, 14 and 28 days. The gingival crevicular fluid levels of
      osteocalcin and cross-linked C-terminal telopeptides of type I collagen were determined by
      using ELISA. The rate of tooth movement was measured on 14 and 28 days.
    

Intervention name(s): Piezocision; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Piezocisions were performed on the mesial and distal sides of the right maxillary canines. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.; The mesial and distal sides of the left maxillary canines served as controls and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tooth movement; Piezocision; Gingival crevicular fluid; Osteocalcin
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of pitavastatin with that of
      simvastatin in patients with risk factors for heart disease.
    


Intervention name(s): pitavastatin; simvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kowa; KRE; Hypercholesterolemia; combined dyslipidemia; dyslipidemia; pitavastatin; NK-104; simvastatin
Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      A multi-center and open study to compare the safety and effectiveness of switching treatment
      from lamivudine to clevudine for 24 weeks.
    


Intervention name(s): Clevudine
Intervention type(s): Drug
Intervention description(s): clevudine 30 mg qd for 24 seeks
Intervention MeSH terms: Clevudine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Motherhood and Microbiome
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      This is a prospective cohort, enriched with women with a prior term birth, of singleton
      pregnancies who will be followed for the outcome of preterm birth. The main exposure of
      interest is the characterization of the cervico-vaginal microbiota. Women will be recruited
      from a population seeking routine obstetrical care at obstetrical practices at Penn. They
      will have three research visits during pregnancy to complete questionnaires and collect
      samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the
      prenatal events and timing of delivery.
    

Detailed description: 
      Patients will be recruited around the time of their routine obstetrical visits. They will be
      asked to participate in three visits total. Visit one/enrollment occurs between 16 and 20
      weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. At each visit,
      vaginal swabs will be collected. The patient will also be asked to fill out a series of
      surveys related to stress, anxiety,and depression in pregnancy. Research coordinators will
      perform chart abstraction after delivery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women will be recruited from three locations: Penn ObGyn Associates, Helen O.
        Dickens Clinic, and Maternal Fetal Medicine at 2000 Courtyard. Potential subjects will be
        identified from clinical schedules and will be pre-screened in EPIC for eligibility. They
        may be approached during a clinical visit, or the research team may call them prior to or
        after a scheduled visit to introduce the study. Women can be enrolled anytime between the
        confirmation of pregnancy and 20 weeks/0 days gestation. For convenience, research visits
        can be conducted at the time of a scheduled clinical visit, or at a separate time.
      
Biospecimen description: 
      Women will self-collect samples of their cervicovaginal fluid using large cotton swabs.

      Subjects who have had a previous preterm birth will also have cervical cells collected in the
      same manner that cells are collected for a routine pap smear.
    
Keywords: Cervicovaginal microbiome; Microbiome; Preterm Birth; Cervical Remodeling; Preterm delivery; Microbiota
Reinforcing Exercise in Substance Abusing Patients
Condition: Substance Abuse; Contingency Management; Exercise
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of an exercise-based contingency management (CM)
      intervention. A total of 120 substance abusing patients in intensive outpatient treatment
      will be randomly assigned to one of two conditions: (a) standard care plus CM for completing
      goal-related activities not related to exercising (e.g., improving work, family, or
      transportation issues), or (b) standard care plus CM for completing exercise-related
      activities. Compared to those receiving goal-related CM activity contracting, it is expected
      that those in the exercise CM condition will participate in more physical activities and
      develop greater strength and flexibility, decrease drug use, reduce HIV risk behaviors,
      lessen depressive symptoms, and improve health indices.
    


Intervention name(s): Contingency Management
Intervention type(s): Behavioral
Intervention description(s): Participants earn the chance to win prizes for the targeted behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects
      with Rheumatoid Arthritis.
    


Intervention name(s): Etanercept; Autoinjector
Intervention type(s): Drug; Device
Intervention description(s): Etanercept PFS and Autoinjector; Autoinjector
Intervention MeSH terms: Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other