bioihbjkbjnl/mcl2 huggingface dataset:
Internet-administrated Treatment of Anxiety Symptoms for Young Adults
Condition: Anxiety Disorders; Depression
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether tailored internet-administrated CBT is a
      feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive
      symptoms in a clinical setting.
    


Intervention name(s): Tailored Internet-administrated CBT-Treatment
Intervention type(s): Behavioral
Intervention description(s): This intervention contains 6-8 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune
      cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety
      and biological response for approximately one month or more.
    

Detailed description: 
      A total of seven cohorts of healthy volunteers are planned with doses of CDX-301 (rhuFlt3L)
      ranging between 1 and 75 μg/kg and dosing durations between 5 and 10 days.

      Volunteers will be admitted to an inpatient unit during the Treatment Period. Blood samples
      will be collected periodically to assess the effect of CDX-301. Volunteers will be followed
      for safety for 28 days following the last dose. Any volunteer who develops anti-CDX-301
      antibodies will be followed monthly until the antibody response is below the limit of
      detection. In general, the total duration of the study will be between approximately 33-38
      days.
    

Intervention name(s): CDX-301
Intervention type(s): Drug
Intervention description(s): CDX-301, administered in multiple dosages and frequencies depending on arm:
n=3-6 at between 1-75 μg/kg over 5 days
n=3-6 at 25 μg/kg over 7 days
n=3-6 at 25 μg/kg over 10 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Arm Pump in Motorcross Training
Condition: Healthy Individuals; Patients With Arm Pump
Study type: Observational

Summary: 
      Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment
      Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood
      pressure in forearm muscle compartments. No strategies nor methods have been used to diminish
      the risk to suffer from arm pump within motor cross.

      This project aims to look at ergonomics of driving and its relationship with the occurrence
      of arm pump.

      The investigators will first investigate the experience of motor cross athletes with arm pump
      through motor cross federations in Belgium and The Netherlands (survey).

      Two groups of athletes will be selected (20 persons within each group) who will be invited to
      the motor cross track to investigate their hand grip strength, motor driving position, muscle
      activity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recreational or competitive motor cycle athletes
Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The primary aim of the study is to compare migration of the cemented Corail stem representing
      polished surfaced versions of the femoral stem. Two different methods will be used for
      reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be
      used in migration measurements.

      Furthermore pain, postoperative outcome and patient satisfaction will be assessed.
    


Intervention name(s): line-to-line reaming and cementing technique; standard over-reaming with 2 broach sizes
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hip Prosthesis; surgery; cements; Radiostereometric Analysis
Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a
      standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.
    

Detailed description: 
      This randomized, open-label, 2-period, 2-sequence, crossover study is designed to evaluate
      the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered
      RP-G28, which is being developed for the treatment of lactose intolerance. The study consists
      of a screening visit (during the interval from Day -21 to Day -3), baseline/check-in to the
      clinical research unit (Day -2 to Day -1), 2 treatment periods (Day 1 and Day 3), a 48-hour
      washout between doses, check-out from the clinical research unit (Day 4), and 1 follow-up
      phone call conducted 7 to 10 days after the final dose of the study drug (i.e., during the
      interval from Day 10 to Day 13). The duration of subject study participation is approximately
      5 weeks. Plasma samples for PK analysis will be taken at specified timepoints from 24 hours
      prior to each dose through 24 hours after each dose.
    

Intervention name(s): RP-G28
Intervention type(s): Drug
Intervention description(s): RP-G28 is a purified galacto-oligosaccharide (GOS) product
Other intervention name(s): galactic-oligosaccharide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)
Condition: Depression
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of
      MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
    

Detailed description: 
      This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in
      participants with major depressive disorder. In Part I of the trial, four different cohorts
      of six participants each will receive multiple rising doses of MK-8777 (ranging from 100 mg
      twice a day [BID] to 300 mg BID) or placebo for up to 16 days. In Part 2, a new cohort of
      participants will be randomly assigned to receive 100 mg BID of MK-8777, 400 mg BID of
      MK-8777, or placebo. Following titration (3 days per step), participants will be maintained
      on the assigned BID dose until Day 27, followed by one day of once a day (QD) dosing, for a
      total of 28 days. There were 11 treatment arms in total for Part 1 and Part 2 (see
      Interventions).
    

Intervention name(s): MK-8777; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Orally administered capsules containing either 50 mg or 100 mg MK-8777.; Orally administered matching placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized; placebo controlled; maximum tolerated dose
Effect of Teleprevir in Triple Therapy on Intrahepatic Immunological Mechanisms
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million
      people. The previous standard of care therapy of chronic HCV patients consists of
      pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in
      only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has
      previously proven to offer therapeutic options to previous non-responders to the standard of
      care. Although, not all chronic HCV patients benefit from telaprevir and it is still not
      known why certain patients are also non-responsive to this triple therapy. In this study we
      try to understand why certain patients are also non-responsive to telaprevir, how triple
      therapy modulates the responsiveness to IFN-α and what the immunological consequences are of
      treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of
      HCV-RNA levels.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic hepatitis C, genotype 1
      
Biospecimen description: 
      Whole Blood
    
Keywords: Hepatitis C; Liver; Immunology; Genotype 1; Treatment; Chronic; RNA Virus Infections; Ribavirin; Peginterferon alfa-2a; Protease Inhibitors; Telaprevir
Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children
Condition: Vitamin A Status
Study type: Observational

Summary: 
      The goal of this study is to assess whether children 12-18 months of age who are exposed to
      multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above
      the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers
      of excessive vitamin A status, compared to children 12-18 months of age who have adequate
      vitamin A intake.
    

Detailed description: 
      This is an observational study with 3 groups, which are identified using a screening tool to
      obtain information on exposure to vitamin A programs and consumption of vitamin A-rich foods
      and supplements. Children and their mothers are studied over the course of one month to
      determine 1) child total body vitamin A stores, using the 13C retinol isotope dilution
      method, 2) the child's vitamin A intake, using multiple dietary assessment methods, 3) total
      breast milk intake (among breastfeeding children), using the dose-to-mother deuterium
      dilution method, and 4) potential biomarkers of excessive vitamin A status, including markers
      of bone and liver health. Blood collection is structured in a "Super-Child" design, to
      construct plasma retinol kinetic curves. Other indicators related to vitamin A nutrition
      among children will be measured, in addition to the vitamin A intake and breast milk vitamin
      A concentration (for breastfeeding mothers) of the mother.
    

Intervention name(s): High VA intake, recent VAS; High VA intake; Low/adequate VA intake
Intervention type(s): Other; Other; Other
Intervention description(s): Children who are exposed to multiple VA programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake.; Children who are exposed to multiple VA programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.; Children who are not exposed to multiple VA programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 12-18 months of age and their mothers in selected neighborhoods in the National
        Capital Region of the Philippines
      
Biospecimen description: 
      Serum, plasma, red and white cells, dried blood spots, breast milk
    
Keywords: Vitamin A status; infant; dietary assessment; retinol isotope dilution; breast milk intake
Acquiring Convalescent Specimens for COVID-19 Antibodies
Condition: COVID-19; Coronavirus Infection; Corona Virus Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      Blood samples from participants who have recovered from COVID-19 infection will be obtained
      and studied. The goal of the research is to identify antibodies that have been generated by
      the patient to fight the COVID-19 infection. By identifying the most effective antibodies,
      scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to
      treat patients with severe disease.
    

Detailed description: 
      Coronavirus disease (COVID-19), an infectious disease caused by severe acute respiratory
      syndrome coronavirus 2 (SARS-CoV-2), has caused over 1,273,712 infections and over 69,458
      deaths worldwide. Columbia University Irving Medical Center/NewYork-Presbyterian (CUIMC/NYP)
      has assembled a team of committed virologists, molecular biologists, chemists, and
      technologists to address this emerging threat. Monoclonal antibodies have become great
      additions to our therapeutic arsenal, primarily in treating cancer or autoimmune diseases.
      Recently, the use of monoclonal antibodies in combating infections such as respiratory
      syncytial virus and HIV have also become clear. In recent years, advanced cell sorting and
      sequencing technologies have been utilized to identify neutralizing antibodies from human B
      cells. This protocol will outline our approach to obtaining blood specimens from participants
      who are recovering from COVID-19 infection. Potential participants will be referred by health
      care providers from within the CUIMC/NYP system and from outside institutions. If the
      potential participant agrees to be contacted, study staff will call them to review the
      informed consent, eligibility criteria and study procedures, and set up a study visit for
      blood draw. Monoclonal antibodies that could potently neutralize 2019 novel coronavirus
      (2019-nCoV) and related coronaviruses will be isolated from these specimens. Candidate
      monoclonal antibodies will then be optimized and evaluated for therapeutic potential. The
      ultimate goal would be able to produce a monoclonal antibody that could confer protection
      during an outbreak or be utilized to treat patients with severe COVID disease.
    

Intervention name(s): Blood draw
Intervention type(s): Procedure
Intervention description(s): Participants will have approximately 45 ml of whole blood drawn (3 Tablespoons) drawn at the study visit.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants who have recovered from COVID-19 infection.
      
Biospecimen description: 
      Whole blood from which peripheral blood mononuclear cells (PBMCs) and plasma will be
      processed.
Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System
Condition: Immunization; Human Influenza; Common Cold; Constipation; Dyspepsia; Flatulence; Abdominal Pain
MeSH terms: Common Cold; Influenza, Human; Constipation; Dyspepsia; Abdominal Pain; Flatulence
Study type: Interventional

Summary: 
      Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on
      Immunity and Physical Intestinal Canal
    


Intervention name(s): Yili "Mei Yi Tian" active lactobacillus drink; recombined milk drink contains no lactobacillus
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention; 100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Nutrition, Exercise, and Breast Cancer Survivorship
Condition: Breast Cancer Survivorship; Sarcopenia
MeSH terms: Breast Neoplasms; Sarcopenia
Study type: Interventional

Summary: 
      The purpose of the study is to examine the effects of resistance training on the reasons
      (mechanisms) underlying the development of fatigue, muscle weakness and wasting (sarcopenia),
      and impaired physical functioning (poor balance and walking) associated with breast cancer
      survivorship.
    

Detailed description: 
      Breast cancer is the most frequently diagnosed cancer in women, representing 26% of all
      female cancers. It is also the second leading cause of cancer related deaths in the US for
      women. Side effects of the cancer and treatment therapies may result in inactivity and
      inadequate intakes of various nutrients, including protein and vitamin D, associated with
      cardiovascular disease (CVD) and type 2 diabetes. High concentrations of systemic and local
      inflammation correlate well with CVD and diabetes risk. There is substantial evidence to
      support that incorporating physical activity and nutrition into one's lifestyle can reduce
      inflammation and, ultimately, the progression to CVD and diabetes. Understanding the role of
      exercise and diet management in the health of breast cancer survivors will allow us to
      translate these findings into therapy guidelines.
    

Intervention name(s): Resistance Training
Intervention type(s): Other
Intervention description(s): RT 3x/wk for 4 months
Other intervention name(s): Exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
Condition: Sedation; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety
      of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through
      <24 months, administered as an intravenous loading dose followed by continuous infusion for a
      minimum of 6 hours and up to 24 hours in an intensive care setting.
    

Detailed description: 
      Phase II, randomized, open-label, single-center, study evaluating the pharmacokinetics and
      pharmacodynamics of dexmedetomidine in pediatric subjects across two dose levels (Dose Level
      1 consists of a 0.7 mcg/kg loading dose immediately followed by a 0.5 mcg/kg/hr maintenance
      infusion; Dose Level 2 consists of a 1.0 mcg/kg loading dose immediately followed by a 0.75
      mcg/kg/hr maintenance infusion). The study population will consist of intubated and
      mechanically ventilated pediatric subjects who require sedation in an intensive care setting
      for a minimum of 6 hours but not to exceed 24 hours. Subjects eligible for enrollment are 12
      months to <24 months of age.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): For sedation according to protocol
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
Condition: Neuropathic Pain; Child, Only
MeSH terms: Neuralgia
Study type: Observational [Patient Registry]

Summary: 
      Some children experience chronic pain that is related to damage or diseases that affect the
      nerves that send pain signals. This is known as neuropathic pain. This is not well understood
      and can be difficult to diagnose. It can often produce unusual feelings such as sensitivity
      of the skin to light touch. Neuropathic pain is often severe and difficult to treat, and can
      affect quality of life for the child and family. This study aims to better characterise the
      symptoms and signs, and impact of neuropathic pain in children.
    

Detailed description: 
      The Investigators will determine whether a questionnaire to identify neuropathic pain in
      adults is also useful in children. This will help paediatricians and other doctors to
      recognise neuropathic pain and start appropriate treatment or know when to refer children to
      a chronic pain clinic.The Investigators will also measure the effects of neuropathic pain on
      mood, sleep, and quality of life (using questionnaires); identify changes in the sensitivity
      of the skin to touch and other sensations (using specialised sensory tests); and determine
      the feasibility of brain imaging for assessing changes in the brain (using magnetic resonance
      imaging or MRI), in children with neuropathic pain. This information will allow the
      investigators to measure how effective different types of treatment are, and help ensure
      children get the most appropriate treatment or interventions to reduce pain and effects on
      quality of life.

      This pilot study of 10-18 year olds diagnosed with neuropathic pain will involve completion
      of questionnaires by the child and parent, and sensory testing in the child, after their
      clinic appointment. For some families, there will be an additional visit for MRI. Children
      will be recruited from the Chronic Pain Outpatients service at Great Ormond Street Hospital
      NHS Trust. This research is funded by Great Ormond Street Hospital Children's Charity.
    

Intervention name(s): quantitative sensory testing; neuroimaging; Patient Reported Outcome Measures
Intervention type(s): Diagnostic Test; Diagnostic Test; Other
Intervention description(s): multiple modality testing of generalized and localized changes in somatosensory perception; magnetic resonance imaging (MRI); neuropathic pain screening tool; validated questionnaires
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will recruit children and adolescents aged 10-18 years referred to the Great
        Ormond Street Hospital Pain Service who are clinically diagnosed as having neuropathic
        pain.
      
Keywords: pain; neuropathic; children; QST