bioihbjkbjnl/mcl2 huggingface dataset:
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV
      transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal
      population. This study is important for establishing a baseline to analyze results obtained
      in MS patients (another dedicated study is performed in parallel in MS patients). The study
      will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env
      protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines
      levels will be analysed to define control levels in the normal population and their variation
      during one year. The data obtained in this study in healthy controls will be compared to
      those obtained in a parallel similar study, GN-E-002, conducted in different types of MS
      patients.
    


Intervention name(s): No study treatments administered
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Blood donors coming for regular blood draw in the center of transfusion.
      
Biospecimen description: 
      Serum, plasma and PBMC.
    
Keywords: Multiple Sclerosis (MS); Multiple Sclerosis associated RetroVirus (MSRV); MSRV envelop protein (MSRV-Env); Temelimab
Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor
Condition: Labor
Study type: Observational

Summary: 
      Objective of the study: to obtain new data on the dynamics of the labor process, cervix
      dilatation and head station on the labor process and to develop a new progress indices.

      Background: the best method used today to supervise the labor process is to follow cervix
      dilatation and head station. Today, the physician or the midwife use manual examination to
      estimate cervix dilatation and head station. This examination is perform many times in a
      normal labor process, and even more if there is any delay. The information from these
      examinations is inaccurate and non-continuous. In case of delay in the labor process, the
      delay will diagnosed late, because the frequency of the manual examination is about once an
      hour.

      With the assistance of the BirthTrack device we can get continuous data on the labor process
      and get indices to estimate the labor process progress without the use of vaginal (manual)
      examination.

      40 women in an active labor will take part in the study.

      Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we
      follow the cervix dilatation and the fetus head station.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Nulliparous women over 18 years admitted to the labor in active labor
Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of phone counselling support as a
      strategy to increase physical activity in people with diabetes.
    


Intervention name(s): Diabetes Education Group; Telephone Counseling
Intervention type(s): Other; Other
Intervention description(s): Diabetes Education Group: Diabetes Education for four month, one time per week.; Telephone counseling: 12 phone calls for four months about physical activity. During the first and second month, was done four phone calls each month. During the third and fourth month, was done two phone calls per month.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes Mellitus; Telephone; Physical activity
Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The thermal stimulation have been proven effective in upper extremity of stroke patients.
      Therefore, this study explored the efficacy of thermal stimulation in lower extremity of
      stroke patients.
    

Detailed description: 
      There are two groups of stroke patients (onset > 3 months) in this study. The independent
      factor is temperature of the alternated heat and cold applying.
    

Intervention name(s): thermal stimulation
Intervention type(s): Other
Intervention description(s): hot and cold/warm and cool pads applying.
Other intervention name(s): Thermal stimulation (FIRSTEK, Model-B401L,local company).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thermal stimulation; lower extremity; temperature; efficacy
A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
Condition: Acute Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical
      Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
    


Intervention name(s): AGS (Experimental); AGU (Active Comparator)
Intervention type(s): Drug; Drug
Intervention description(s): tid; tid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of single doses of
      SBI-087 in subjects with rheumatoid arthritis.
    


Intervention name(s): SBI-087
Intervention type(s): Drug
Intervention description(s): Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ascending Single Dose; Safety; Pharmacokinetics; Open-label
Autism Spectrum Disorders (ASD) Driving Study
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      The proposed pilot study will begin to assess whether driving impairments are included in the
      functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed
      by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who
      drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6
      hours of assessments) and one driving simulation visit (approximately 2.5 hours). The
      investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have
      been identified as having an ASD from a prior diagnosis or participation in community
      conferences for individuals with ASDs.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.
      
Keywords: Driving; Autism Spectrum Disorders; ASD; Attention Deficits; Adults; Adolescents; Pervasive Developmental Disorders
A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
Condition: Chronic Hepatitis c
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after
      3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.
    


Intervention name(s): Ravidasvir 50mg; Ravidasvir 200mg
Intervention type(s): Drug; Drug
Intervention description(s): 50mg, Tablet; 200mg, Tablet
Other intervention name(s): ASC16; ASC16
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Human: A Single/Multiple Ascending Dose Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data
      following single ascending and multiple ascending doses of X842 in healthy subjects.
    

Detailed description: 
      This is a single-centre, open label, first-in-human study with the primary objective to
      evaluate safety and tolerability of X842 after administration of single and multiple oral
      ascending doses to healthy male and female subjects. The study comprises a Single Ascending
      Dose (SAD) part and a Multiple Ascending Dose (MAD) part including an open-label multiple
      dose cohort administered active comparator (omeprazole). Four subjects will be included in
      each of the SAD and MAD cohorts.
    

Intervention name(s): Single ascending dose of X842; Multiple ascending dose of X842; Losec
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each subject in a the same cohort will be assigned to the same single dose of X842. The subjects in the subsequent cohort will be assigned to a single dose of X842 based on safety and efficacy data generated from the previous cohort.; Each subject in a the same cohort will be assigned to the same dose of X842 once daily for five days. The subjects in the subsequent cohort will be assigned to same dose of X842 once daily for five days based on safety and efficacy data generated from the previous cohort.; Each subject in one cohort will be assigned to a standard dose of omeprazole once daily for five days.
Other intervention name(s): X842; X842; omeprazole
Intervention MeSH terms: Omeprazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: SAD and MAD study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Potassium competitive acid blocker; X842; Gastroesophageal reflux disease; Esophagitis; Intragastric pH; Acid inhibition
Effects of Deer Bone Extract NS on Improvement in Cognitive-Bio-Markers of Cognitive Functions
Condition: Healthy Adults With Subjective Memory Complaints
Study type: Interventional

Summary: 
      This study aims to elucidate the effects of deer bone extract NS on cognitive function
      improvement and its safety in healthy adults aged 40 to 65 years who report decline in
      subjective cognitive functions using multimodal neuroimaging and neurocognitive assessments.
    


Intervention name(s): NS 550mg; NS 1100mg; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
Condition: Hodgkin Lymphoma; Hodgkin Disease
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional

Summary: 
      Chemotherapy as one of the basic modalities of oncology treatment often leaves permanent
      implications and among the most common is infertility as a result of irreversible gonadal
      damage. This project sets the primary target to verify the protective effect GnRH analogues
      administration to protect ovarian tissue during three different regimens of chemotherapy in
      patients with Hodgkin disease (HD) in reproductive age.
    

Detailed description: 
      During the first two years of the project duration the curative anti-tumorous combined
      treatment in fertile patients with Hodgkin disease diagnosis will be carried out. Patients
      are to be divided into three groups according to the clinical stage of the disease and
      treated with the three types of the chemotherapeutic regimens comparable with toxicity.
      Patients will receive GnRH analogues during the chemotherapy for the gonadal protection by
      the mechanism of foliculogenesis inhibition in pre-pubertal stage. At the end of successful
      treatment according to stated criteria the ovarian function of every patient will be
      repeatedly evaluated in relation with toxicity of chemotherapy used. These ovarian function
      results will be compared with control group of patients without gonadal protection, which
      reproductive functions will be evaluated according the same method.
    

Intervention name(s): triptorelin
Intervention type(s): Drug
Intervention description(s): Throughout the course of chemotherapy, patients were administered triptorelin (Diphereline SR 3 mg, Ibsen) in the form of i.m. injections, always once a month and simultaneously with the chemotherapy.
Other intervention name(s): triptorelin (Diphereline SR 3 mg, Ibsen)
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hodgkin lymphoma; Hodgkin disease
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a
      single dose of telotristat etiprate in subjects with various stages of hepatic impairment
      compared to healthy control subjects.
    


Intervention name(s): telotristat etiprate
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis
Condition: Plantar Fascitis; Achilles Tendon Pain
MeSH terms: Fasciitis; Fasciitis, Plantar; Tendinopathy
Study type: Interventional

Summary: 
      The aim of this study is to evaluate and compare the changes of heel pain, functional health
      and well-being after high-intensity and low-level laser therapy for plantar fasciitis or
      Achilles tendinopathy
    

Detailed description: 
      Plantar heel pain, also known as plantar fasciitis, causes soreness or tenderness of the sole
      of the foot under the heel, which sometimes extends into the medial arch. Pain associated
      with the condition may cause substantial disability and poor health-related quality of life.
      Achilles tendinitis is a common etiology of posterior heel pain that results in significant
      pain and loss of function. Calf exercise is initial management that may be supported by laser
      therapy. A treatment possibility high-intensity laser therapy is little explored.
      High-intensity lasers can deliver more energy deeper into tissue. The hypothesis is that both
      lasers are effective in treatment of plantar fasciitis or Achilles tendinopathy, but
      high-intensity laser therapy is more effective.

      The aim of this study is to evaluate and compare the changes of heel pain, functional health
      and well-being after high-intensity and low-level laser therapy for plantar fasciitis or
      Achilles tendinopathy.

      The study was approved by Committee on Biomedical Research Ethics of Kaunas Region
      (2016-07-14 No. BE-2-32). Patients are recruited in out patient clinic of Physical Medicine
      and Rehabilitation Department in The Hospital of Lithuanian University of Health Sciences
      (LSMU) Kauno klinikos.
    

Intervention name(s): High-intensity laser therapy; Low-level Laser therapy
Intervention type(s): Device; Device
Intervention description(s): tissue photobiostimulation for pain reduction and healing enhancement.; tissue photobiostimulation for pain reduction and healing enhancement.
Other intervention name(s): BTL-6000 High Intensity Laser 12 W with 10 mm pen; LAS-Expert with laser shower
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: High-Intensity Laser Therapy; Low-level Laser Therapy
Retinal and Choroidal Microvascular Parameters in School-age Children in a COVID-19 Infection Pandemic Peak in China
Condition: COVID-19 Pandemic
MeSH terms: Infections; COVID-19
Study type: Observational

Summary: 
      We designed this study to examine whether COVID-19 infection could lead to retinal and
      choroidal microvascular involvement in school-age children (6-18 years) in a pandemic peak in
      China.
    

Detailed description: 
      This is an observational case-control study. One hundred school-age children who visited the
      Department of Ophthalmology at Guangzhou First People's Hospital in China from February 1,
      2023 to March 31, 2023 were included in this study. Eighty children with COVID-19 infection
      were included in the case group. Controls without COVID-19 infection were matched to COVID-19
      infection cases by a ratio of 1:4 using frequency matching on age and gender. The primary end
      point of this study is the retinal and choroidal microvascular changes in school-age children
      during the COVID-19 pandemic. Secondary endpoint is the
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Totally 100 school-age children (6-18 years) were enrolled in this study. All subjects had
        visited the ophthalmology clinic for routine ocular examinations.Eighty children with
        COVID-19 infection were included in the case group. Controls without COVID-19 infection
        were matched to COVID-19 infection cases by a ratio of 1:4 using frequency matching on age
        and gender. The following age subgroups were used for matching: 6-10, 10-14 and 15-18
        years. A list of numbers computer-generated by a research member (Xu Zhang) was used to
        match the controls. The collected data included demographic and clinical data, as well as
        retinal and choroidal microvascular parameters.
      
Keywords: COVID-19 infection; retinal microvascular involvement; choroidal thickness; school-age children
The Pharmacokinetics and Pharmacodynamics of Hemp-based Topical Cannabinoid Products
Condition: Cannabis; Drug Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetic and pharmacodynamic effects of hemp-based
      Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels
      of delta-9-tetrahydrocannabinol (THC).
    

Detailed description: 
      A total of 5 topical cannabinoid products will be examined in this study. The study will be
      conducted in 5 discrete stages, one for each product. In each stage, participants (N=20),
      will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a
      topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical
      product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid
      ingredients to the active product. Thus, overall 100 participants will complete the study (75
      active, 25 placebo).

      Participants in each stage will complete a three-phase outpatient protocol that will last a
      total of 17 days. Phase 1 (Day 1) will be an acute laboratory dosing session (approximately 7
      hours in duration). Phase 2 (Days 2-10) will be an outpatient dosing period, during which
      participants will continue to use participants' assigned product twice daily (morning and
      evening) in participants' own environment. During Phase 2, participants will visit the
      laboratory for brief study sessions on Days 2, 3, 7, and 10. Phase 3, will consist of a final
      follow-up visit on Day 17, after a 1-week drug washout. Pharmacokinetic and pharmacodynamic
      assessments (subjective and cognitive effects) will be assessed during each phase.
    

Intervention name(s): CBD; THC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CBD will be topically applied; THC will be topically applied; a placebo product (without cannabinoids) will be topically applied
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the
      laboratory may help doctors learn more about changes that occur in DNA and identify
      biomarkers related to cancer.

      PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly
      diagnosed high-risk acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children
           and matched non-tumor and blast DNA from patients with high-risk (HR) acute
           lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.

        -  To identify loci enriched for genetic variation between DNA of unaffected children and
           DNA of these patients.

        -  To individually validate novel, putatively functional single nucleotide polymorphisms
           (SNPs) identified via pooled sequencing with another genotyping platform.

        -  To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to
           the genes or pathways found to harbor a significant increase in genetic variation.

      OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor
      (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute
      lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3
      PCR pools of DNA.
    

Intervention name(s): DNA analysis; genetic linkage analysis; microarray analysis; nucleic acid sequencing; polymerase chain reaction; polymorphism analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Genetic; Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients With High-Risk Acute Lymphoblastic Leukemia
      
Biospecimen description: 
      DNA
    
Keywords: B-cell adult acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; untreated childhood acute lymphoblastic leukemia