bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Behavioral Therapy for Early-Onset Depression
Condition: Major Depressive Disorder; Dysthymic Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional

Summary: 
      Depression is a debilitating illness affecting large numbers of young people. In this study,
      children and adolescents ages 10 to 17 meeting criteria for clinical depression will
      participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches
      strategies for overcoming depressed mood. For half the participants, their parents will also
      participate in a parent group. By studying the role of parental involvement, we hope to
      develop more effective treatments for depressed children and teens in the future.
    

Detailed description: 
      Depression is a debilitating illness affecting large numbers of young people. Psychotherapy
      approaches have shown some promise in teens, but few studies have examined these
      interventions when offered in a group format. The role of parents in treatment outcome has
      also received little attention.

      In this study, children and adolescents ages 10 to 17 meeting criteria for clinical
      depression will participate in a 15-session group therapy (cognitive behavioral therapy or
      CBT) that teaches strategies for overcoming depressed mood. For half the participants, their
      parents will also participate in a parent group to help them better manage their depressed
      children and teens. We will randomly assign children to CBT with or without parental
      involvement. We hope to show that involving parents results in additional improvements in the
      children. We will also study factors that predict which children do best in treatment, and
      maintenance of gains at 6 month and 1 year follow-up. These findings will allow us to provide
      more effective treatments to depressed children and teens in the future.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive behaviour versus standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cognitive behavioral therapy; depression; group therapy; parenting; children and adolescents
Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.
Condition: Dose Finding Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized, single-blind, parallel group, placebo-controlled,
      multi-cohort, first-in-human dose escalation study of a single IV 3-hour administration of
      Cilastatin as stand-alone in healthy male and female volunteers.

      The study objectives are:

      The evaluation of safety and tolerability of single intravenous doses of cilastatin in
      healthy volunteers administered as a 3-hour infusion.

      The evaluation of the pharmacokinetic characteristics of Cilastatin after a single 3-hour
      infusion dose.
    

Detailed description: 
      The study is designed as a phase I, randomized, single-blind, parallel group,
      placebo-controlled, multi-cohort, first-in-human dose escalation study of a single IV 3-hour
      administration of Cilastatin as stand-alone in healthy male and female volunteers.

      The study will involve 24 healthy male and female healthy subjects, divided in three study
      cohorts (8 subjects per cohort). The study is a dose escalating study, starting from 3 g of
      Cilastatin administered intravenously in 3 hours.

      Eight subjects will be randomized and assigned to either the study drug or placebo group for
      each study cohort in a 3:1 ratio (6 actives and 2 placebos). Randomization will also be
      gender balanced within each study cohort. The planned dose escalation scheme should not occur
      before participants in the previous dose level have been treated and safety profile of
      Cilastatin from those participants are assessed in accordande with the protocol.
    

Intervention name(s): Cilastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation 3-hour single intravenous administration; 3-hour single intravenous administration
Other intervention name(s): Cilastatin sodium
Intervention MeSH terms: Cilastatin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Reliability and Validity of the NCS (NCS-R)-Chinese Version
Condition: Minimally Conscious State; Vegetative State
MeSH terms: Persistent Vegetative State
Study type: Interventional

Summary: 
      The aim of this study was to translate the NCS from English into Chinese and determine the
      validity of this Chinese version.
    

Detailed description: 
      The assessment and early diagnosis of pain is of great importance for pain management and
      treatment in patients with disorders of consciousness. The Nociception Coma Scale (- Revised)
      is only applicable to assess pain of DOC patients in international clinical setting. The aim
      of this study was to translate the NCS from English into Chinese and determine the validity
      of this Chinese version. To test internal reliability and inter-rater reliability, both rater
      A and rater B assess the perception of pain on day 1; and to obtain test-retest reliability,
      rater A assessed all patients repeatedly on day 2. 'Faces, Legs, Activity, Cry,
      Consolability' (FLACC) was used to analysis concurrent validity by rater A.
    

Intervention name(s): Nociception Coma Scale (NCS)
Intervention type(s): Diagnostic Test
Intervention description(s): Patients have been assessed with both the Nociception Coma Scale (NCS) and the FLACC.
Other intervention name(s): the Face Legs Activity Cry and Consolability (FLACC)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The order of the administration was randomly selected. All patients' total scores assessed by rater A were recorded to test the internal consistency of NCS-R (A1). Meanwhile, to assess the concurrent validity, the scores of the FLACC were recorded together with NCS-R by rater A on day 1. In order to analyze the test-retest reliability, rater A complete the second evaluation of NCS-R on day 2 (A2)
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: disorders of consciousness; vegetative state; minimally conscious state; consciousness; pain assessment; nociception test
Novel Imaging Markers in SPMS
Condition: Secondary Progressive Multiple Sclerosis; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron
      oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system
      within MS lesions. Activity of innate immunity has been hypothesized as one of the critical
      pathologic processes underpinning neurologic worsening in progressive MS. As such, in the
      short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising
      in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive
      lesions.
    


Intervention name(s): Ferumoxytol infusion; Gadoteridol; MRI Brain and Cervical Spine
Intervention type(s): Drug; Drug; Diagnostic Test
Intervention description(s): Subjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline.; Subjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg).; 3T MR imaging of the brain and cervical spine pre- and post-administration of gadolinium, then pre- and 96 hours (±24 hours) post-administration of ferumoxytol
Other intervention name(s): Feraheme; ProHance, gadolinium-based MRI contrast agent
Intervention MeSH terms: Ferrosoferric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Perilesional microglia; Ferumoxytol; USPIO; Utrasmall superparamagnetic iron oxide nanoparticles; Infiltrating macrophages; Activated microglia; USPIO enhancement
Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
Condition: Haemofiltration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, non-randomised, prospective study to assess the safety of the
      MediSieve blood filtration system in healthy volunteers
    

Detailed description: 
      The MediSieve Magnetic Haemofiltration System (MMHS) is a system to filter selected moieties
      from blood in an extracorporeal circuit by magnetic means. Initially, it is developed for the
      treatment of severe malaria to capture malaria-infected erythrocytes (who are weakly
      magnetic) to reduce the parasitaemia. However, the use of MMHS can be extended, with the use
      of antibodies coupled to magnetic beads, to other diseases, such as sepsis.

      The MMHS has to be used first in healthy volunteers to determine its clinical safety.

      To this end, 6 healthy male and female volunteers (ratio 1:1) will undergo blood filtration
      using the MediSieve Magnetic Haemofiltration System (without magnetic beads) for five
      consecutive hours. Vital signs will be continuously monitored and blood samples will be
      obtained serially to determine laboratory safety and immunological parameters. Furthermore,
      volunteers will have two follow up visits at 24 hours and 7 days post filtration.
    

Intervention name(s): MediSieve Magnetic Haemofiltration System
Intervention type(s): Device
Intervention description(s): The MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream. Healthy volunteers will undergo filtration for 5 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Northern Manhattan Diabetes Community Outreach Project
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The objective of this study is to examine the effectiveness of a community health worker
      intervention at helping to control diabetes among Latinos with poorly controlled Type 2
      diabetes.

      Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the
      intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density
      lipoprotein (LDL); and (3) systolic and diastolic BP.
    

Detailed description: 
      The objective of this project is to examine the effectiveness of a community health worker
      (CHW) intervention at addressing glycemic control among Latinos with poorly controlled Type 2
      diabetes. Our group has worked with a promising model of intervention that utilizes CHW's
      based at one of our major community partners. Pilot data from this program has shown
      clinically significant prepost test improvements in HgA1C. Using the Chronic Care Model as an
      overarching framework, the study design of NOCHOP is a randomized controlled trial of 360
      Latinos, mostly of Caribbean descent, aged 35-70 years with HgA1C >=8.0. At a minimum,
      subjects in the intervention group will receive four home visits, ten group level visits and
      monthly phone calls by CHWs based at Alianza. The control groups will receive three separate
      mailings of bilingual diabetes health education materials. The primary outcome is glycemic
      control at 12month follow up, as measured by HgA1c. The secondary outcomes are changes in
      cholesterol and blood pressure (BP). We will also collect exploratory data on potential
      mechanisms through which our intervention resulted in hypothesized improvements including
      medication adherence, medication Intensification, diet and exercise. If successful, our
      project will make an important contribution to ongoing national and local debates about the
      sustainability of CHW programs. In particular, data from this study would be extremely useful
      for local Medicaid managed care plans who have expressed strong interests in data from
      rigorously designed clinical trials addressing the role of CHWs in delivering culturally
      appropriate and effective diabetes care.
    

Intervention name(s): Community Health worker
Intervention type(s): Other
Intervention description(s): Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Diabetes; Community health worker; Community outreach
Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions
      utilizing the SKAMP deportment scale.
    


Intervention name(s): Mixed amphetamine salts (ADDERALL XR); Atomoxetine hydrochloride
Intervention type(s): Drug; Drug
Other intervention name(s): Strattera
Intervention MeSH terms: Amphetamine; Adderall; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Human IgGs and Endothelial Function in Vivo in Humans
Condition: Common Variable Immunodeficiency
MeSH terms: Common Variable Immunodeficiency
Study type: Interventional

Summary: 
      Endothelial dysfunction and insulin resistance play a key role in the onset and development
      of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently
      demonstrated that circulating immunoglobulins G (IgG) could be involved in the process.
      Patients with common variable immunodeficiency (CVID), who are characterized by low
      circulating levels of IgG, might represent an ideal model to clarify the role played in vivo
      in humans by circulating IgG. Polyclonal IgG, obtained from multiple donors, given
      intravenously (IVIgG), are used to treat various immunodeficiencies and autoimmune diseases,
      including CVID. By using this disease and its treatment by IVIgG as a model, aim of the
      current study is to clarify whether IgG affect endothelial function and insulin sensitivity
      in humans in vivo and whether the action of IgG on the endothelium involves a direct
      interaction with the endothelial cells.
    

Detailed description: 
      For this purposes, 24 patients with CVID, receiving the last therapeutic dose of IVIgG
      infusion 5-weeks before the baseline measurements (CVID-IVIgG group), are studied. In all
      subjects, endothelial function is evaluated as flow mediated dilation (FMD) of the brachial
      artery, measured by ultrasonographic technique at baseline and 1, 7, 14, and 21 days after
      IVIgG infusion. FMD is also measured in a group of IVIgG naive CVID patients (number of
      patients recruited depending on availability) and a group of control healthy subjects. The
      latter FMD measurements serve only as a mere reference of pathological or normal values in
      condition of deficiency or normal levels of circulating IgG and are not used for primary
      outcome evaluation. To dissect further the mechanisms of improved endothelial function after
      IVIgG infusion, we investigate the role of human IgG on the production of Nitric Oxide (NO)
      in vitro on Human Coronary Artery Endothelial Cells (HCAEC) isolated from normal human
      coronary arteries.
    

Intervention name(s): Polyclonal IgG
Intervention type(s): Drug
Intervention description(s): Measurement of vascular reactivity before and after Infusion of plyclonal Immunoglobulins G in patients with Common variable immunodeficiency
Other intervention name(s): Immunoglobulins
Intervention MeSH terms: Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
Condition: Polycystic Ovary Syndrome; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether dual treatment with metformin and
      alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in
      the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin
      resistance and beta cell function.
    


Intervention name(s): Vipdomet; Incresync
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study
Condition: Reproductive Health; Time to Pregnancy; Infertility; Risk Factor; Medical Care
MeSH terms: Infertility
Study type: Observational

Summary: 
      This community based prospective cohort study was established to investigate the
      fecundability of couples of childbearing age. Data are collected regarding age, body mass
      index, education, menstrual regularity as well as childbearing history. Results of routine
      examination of leucorrhea, blood glucose, liver function of the female spouse, and semen
      analysis of the male spouse are obtained from the National Free Pre-conception Check-up
      Projects (NFPCP) in China. Couples recruited will be followed every 6 months for at least 1
      year, and their time to pregnancy as well as behavior of seeking medical care would be
      recorded. Blood sample and/or information of antral follicle count would be collected from
      participants who fail to conceive after 12 months of attempts.
    

Detailed description: 
      Infertility is a heavy burden on families, with important implications for individuals and
      public health. In the last decades, the trend of delaying marriage and childbearing has
      further exacerbated the burden of infertility. From February 2010 to November 2011, a
      large-scale population-based cross-sectional study was conducted in northern and eastern
      China. It was reported that the overall prevalence of infertility was 15.5% among women 'at
      risk' of pregnancy, and 25.0% among women attempting to become pregnant in China. The
      prevalence of infertility was surprisingly high and aroused our great attention. To further
      explore the fecundability and associated risk factors in current China, this community based
      prospective cohort study was established. Recruitment will be performed at cites of National
      Free Pre-conception Check-up Projects (NFPCP). Besides of the information of sociodemographic
      characteristics and childbearing history of couples, their results of check-ups will also be
      obtained. By regular follow-ups, valid data of time to pregnancy will be collected. A
      prospective cohort would provide an opportunity to reveal the incidence of infertility, and
      explore the underlying risk factors of infertility, as well as the demand of assisted
      reproductive technology.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Couples of childbearing age from the cites of National Free Pre-conception Check-up
        Projects (NFPCP) in city of Guangzhou in Guangdong Province, or the city of Haikou in
        Hainan Province, will be recruited.
      
Biospecimen description: 
      Blood sample will be collected from participants who fail to conceive after 12 months of
      attempts.
    
Keywords: Reproductive Health; Time to Pregnancy; Infertility; Risk Factor; Assisted Reproductive Technology; Prospective Cohort
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and
      ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be
      evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate
    


Intervention name(s): Dabigatran; PF-07321332/ritonavir + Dabigatran; Ritonavir + Dabigatran
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of Dabigatran on Day 1; PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2; Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2
Intervention MeSH terms: Ritonavir; Nirmatrelvir; Dabigatran
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase1, open-label,3-treatment, 6-sequence, 3-period crossover study to estimate the effect of PF-07321332/ritonavir and ritonavir on the Pharmacokinetics of dabigatran in healthy participants
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Drug Interaction; Dabigatran; P-gp Substrate; SARS-Co-V2; COVID-19; protease inhibitor; ritonavir
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The changes in the trough systolic blood pressure from the baseline were assessed after 8
      weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg
    


Intervention name(s): Amlodipine; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): Amlodipine 5mg/ day; Amlodipine 10mg/ day
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioavailability Study of PF-06651600 Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period,
      cross over design in a single cohort of approximately 12 healthy male or female participants
      at a single center. Participants will be randomized into 1 of 4 sequences of treatment.
    


Intervention name(s): PF-06651600
Intervention type(s): Drug
Intervention description(s): PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; JAK inhibitor; PF-06651600