bioihbjkbjnl/mcl2 huggingface dataset:
Home-based Exercise Training in Cardiac Patients
Condition: Physical Fitness; Patient Adherence; Quality of Life; Autonomic Nervous System Imbalance
Study type: Interventional

Summary: 
      The investigators hypothesize that exercise training program guided by virtual augmented
      reality glasses or by video from computer screen used at home will improve motivation into
      exercise training and results in superior adherence to exercise training compared to current
      practice. The primary objectives of this research project are to study the effects of
      exercise training guidance by novel technology on 1) exercise capacity, 2) adherence to
      exercise training, 3) changes in cardiac autonomic function and 4) quality of life in acute
      coronary syndrome (ACS) patients.
    

Detailed description: 
      The subjects of the study will be recruited from the consecutive series of patients of men
      and women admitted to Oulu University Hospital due to an acute coronary syndrome (ACS). The
      study population will be randomized into control group (n=25) and study group (n=25) matched
      with age and gender. For all subjects, clinical status including quality of life
      questionnaire, exercise capacity and autonomic function measurements will be performed at
      baseline and after exercise training. Exercise training program is six months for both groups
      according to current guidelines. All the patients will have a detailed and personalized
      training prescription. Study group will have virtual augmented reality glasses or computer
      with training video to motivate and control exercise training prescription at home.
    

Intervention name(s): Current guidelines rehabilitation; Mobile device guided rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. All the patients will have a detailed and personalized training diary.; Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. Study group will have virtual glasses or mobile device to motivate and control exercise training program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise tolerance; Heart rate variability; Baroreflex sensitivity
Effects of Galantamine on Cognition
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early
      twenties, with cognitive impairments and negative symptoms frequently emerging much earlier.
      Such cognitive impairments and negative symptoms but much milder are also observed in
      high-risk groups (such as relatives of schizophrenia patients), who may or may not develop
      the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test
      the effects of galantamine on clinical/physiological/cognitive measures. This study serves
      several goals: If a drug is found effective in treating subtle deficits, then it will provide
      treatment strategy in individuals with schizophrenia spectrum personality disorders and for
      early intervention in schizophrenia. In addition, one of the difficulties of testing a drug
      on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can
      change the effects of the test drug. The proposed study will be in subjects who will not be
      taking antipsychotic medications. Our study will be carried out in two sessions, at least one
      month apart. Subjects will be randomly assigned to the two possible order of administration:
      the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3
      days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th
      day, the day of testing. We will administer a battery of
      clinical/cognitive/neurophysiological tests after the 8 mg drug dose.
    


Intervention name(s): Galantamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.; Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
Other intervention name(s): Razadyne; 01RZ437
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Galantamine; Schizophrenia; working memory; cognitive
A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1
Condition: Human Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a first in human, phase I, open label study of the MVA viral vector (produced in the
      novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP
      and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone
      intramuscularly as a single dose.

      There will be 1 study group and a total of 6 volunteers will be enrolled. Staggered
      enrollment will apply for the first three volunteers within the group.
    


Intervention name(s): MVA-NP+M1
Intervention type(s): Biological
Intervention description(s): Intramuscular injection of novel vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics
Condition: Advanced Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug
      Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,
      Ltd.

      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and
      VEGFR3. It has the obvious resistance to new angiogenesis.
    

Detailed description: 
      The primary objective of this trial is to explore the maximum tolerated dose(MTD),
      dose-limiting toxicity(DLT) of ALTN and rational dosage regimen for phase II study, to
      investigate the pharmacokinetics with single and multiple doses of ALTN from
      5mg/d,10mg/d,16mg/d,12mg.
    

Intervention name(s): anlotinib
Intervention type(s): Drug
Intervention description(s): oral medicine.
Other intervention name(s): ALTN
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced cancer
Stability of Anterior Open Bite Treatment Using Extrusion Arches
Condition: Anterior Open Bite Malocclusion
MeSH terms: Malocclusion; Open Bite
Study type: Interventional

Summary: 
      This study investigated treatment effects and stability of anterior open bite cases using
      extrusion arches
    


Intervention name(s): extrusion arch
Intervention type(s): Device
Intervention description(s): A stainless steel pre-formed arch wire custom made by placing V-bends 3-5 mm mesial to the molar tubes, placed into the auxiliary molar tubes after leveling phase and tied over the main arch wire distal to the lateral incisors
Intervention model: Single Group Assignment
Intervention model description: Before and after design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extrusion arches; anterior open bite; stability; extrusion; intrusion
Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the bioavailability of a generic product of gliclazide
      (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals
      Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product
      (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie,
      France) when administered to healthy volunteers under fasting conditions. The plasma
      pharmacokinetic data of gliclazide obtained from two formulations will be used to access the
      interchangeability of the products.
    

Detailed description: 
      The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a
      washout period of one to two weeks. During each study session, healthy male subjects will be
      administered a single oral dose of 80 mg gliclazide (one BF-Gliclazide Tablet 80 mg or one
      Diamicron 80 mg Tablet) after an overnight fast of approximately 10 hours. 20% glucose will
      be given orally to each subject at 2 h after drug administration to minimize the risk of
      hypoglycaemia. Venous blood samples will be collected at pre-dose (0 h) and up to 72 hours
      post-dose. The plasma concentrations of gliclazide will be determined by a validated assay.
      The non-compartmental method will be used to analyze the plasma concentration-time data and
      calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf and
      T1/2. ANOVA will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf.
      The two one-sided tests will be used to calculate the 90% confidence intervals for the mean
      difference in AUC0-last, AUC0-inf and Cmax, and to assess the bioequivalence of the two
      products.
    

Intervention name(s): BF-Gliclazide Tablet 80mg; Diamicron 80mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): BF-Gliclazide Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited; Diamicron 80mg Tablet is manufactured by Les Laboratoires Servier Industrie, France
Other intervention name(s): Gliclazide Tablet 80mg; Gliclazide Tablet 80mg
Intervention MeSH terms: Gliclazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Chiauranib in Combination With Chemotherapy in Patients With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial will evaluate the efficacy and safety of chiauranib added to chemotherapy
      in patients with relapsed or refractory ovarian cancer, in the meantime, explore the
      pharmacokinetics characteristic after the combined treatment.
    

Detailed description: 
      This clinical trial will evaluate the efficacy and safety include adverse events, vital
      signs, laboratory tests, etc., of chiauranib added to chemotherapy (Paclitaxel/Etoposide) in
      patients with relapsed or refractory epithelial ovarian, fallopian tube or primary peritoneal
      cancer, in the meantime, explore the pharmacokinetics characteristic after the combined
      treatment.
    

Intervention name(s): chiauranib; etoposide; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily; 50mg orally once daily for 21 days, 7 days off, every 28 days for a cycle, 6 cycles at most; 60mg/m2, i.v infusion on day 1, 8 and 15, every 21 days for a cycle, 6 cycles at most
Other intervention name(s): CS2164; Lastet; Anzatax
Intervention MeSH terms: Paclitaxel; Etoposide; Chiauranib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian cancer, relapsed or refractory; chiauranib, chemotherapy
Safety, Pharmacodynamics, and Pharmacokinetics of BIBT 1011 BS in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011
      BS, on coagulation parameters.
    


Intervention name(s): Single rising doses of BIBT 1011 BS; BIBT 1011 BS placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect Of Low Back Pain on Paraspinal Muscles
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Low back pain is frequently seen in the adolescent age group, with a prevalence approaching
      that of the adult age group. The most common type is non-specific, self-limiting low back
      pain. LDH is rare in children and adolescents and generally presents with low back pain, with
      or without radiculopathy. The condition is usually unilateral (especially L4-5 or L5-S1). LDH
      is also mostly central type. Although there are many studies that have investigated the
      relationship between paraspinal muscle volumes and LBP and/or LDH in the adult age group,
      there are very few studies in adolescents. The principal aim of this study was to compare MF,
      ES, and PM volumes in adolescents with LBP with and without LDH using magnetic resonance
      imaging (MRI) and to determine whether these two conditions cause paraspinal muscle volume
      loss.
    

Detailed description: 
      The medical records of 229 patients who underwent MRI due to low back pain persisting for a
      minimum of twelve weeks between January 2018 and January 2020 were evaluated retrospectively.
      Twenty-four patients were excluded due to the presence of spondylolysis-listhesis, spinal
      alignment disorders including scoliosis and kyphosis, inflammatory diseases, or histories of
      spinal surgery and multilevel disc hernia. Two hundred five patients were finally enrolled.
      Age, gender, weight, and height were recorded, and BMI was calculated as weight/(height)².
      Participants were divided into two groups - with LDH (Group A) and without LDH (Group B).
      Right- and left-side PS, MF, and ES muscle volumes at intervertebral disc levels L4-L5 and
      L5-S1 were measured on Axial T2-weighted fast spin-echo sequences. All cross-sectional images
      at both levels (L4-5 and L5-S1) were generated by means of multiplanar reformat images. The
      muscles were identified by means of manual contouring at both disc levels. The fat components
      were then eliminated by application of the threshold technique, based on visual differences
      in pixel signal intensities. Volume measurement from cross-sectional images was based on the
      use of an automatic volume calculation tool.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients (aged 10-17) with low back pain persisting for a minimum of twelve weeks
      
Keywords: adolescent; low back pain; lumbar disc herniation; paraspinal muscle; magnetic resonance imaging
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
Condition: HIV Infection; Vaginal Atrophy; Menopause; Menopause Related Conditions; Aging; Premature Aging; Atrophic Vaginitis; Dysbiosis; Vaginitis
MeSH terms: HIV Infections; Vaginitis; Atrophic Vaginitis; Atrophy; Dysbiosis; Aging, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      During menopause, there is a decrease in a hormone estrogen, which leads to aging of the
      vagina. Vaginal aging includes changes in the type and amount of healthy bacteria in the
      vagina, inflammation and a breakdown of natural barriers that keep the vagina healthy and
      protected from infections. Some menopausal women develop a condition called vaginal atrophy,
      which causes vaginal dryness, irritation, pain with sex, and itching. We are testing whether
      an estradiol tablet placed inside the vagina will lead to fewer changes in the types of
      bacteria present in the vagina, improve vaginal atrophy symptoms and ultimately keep the
      vagina healthier for a longer. This is important for women with HIV as they are living
      longer, healthier, sexually active lives due to successful treatment with antiretrovirals.
    

Detailed description: 
      HIV may be associated with premature aging in the female genital tract including alterations
      in the vaginal microbiome and mucosal inflammation, which may increase risk for vaginal
      atrophy, urinary tract infections (UTI) and other genital tract infections. This study will
      determine whether use of vaginal estradiol for 12 weeks in menopausal women living with HIV
      with symptomatic vaginal atrophy will improve atrophy symptoms and the vaginal microbiome and
      reduce mucosal inflammation thereby improving vaginal health. This study will include 50
      participants randomized to treatment with a vaginal estradiol insert or no therapy for 12
      weeks and will have 4 study visits.
    

Intervention name(s): Estradiol Vaginal Insert
Intervention type(s): Drug
Intervention description(s): Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks.
Other intervention name(s): Vagifem®; Vagifem (estradiol vaginal tablet)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive treatment with estradiol vaginal tablets or no treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Infection; Vaginal Atrophy; Menopause; Vaginal Microbiome; Microbiome; Dysbiosis; Aging; Premature Aging; Atrophic Vaginitis
Early Physical Therapy Intervention in Preterm Infants
Condition: Preterm Infant; Physical Therapy; Early Intervention; NICU; Home; Motor Development
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The hypothesis of this study is that early physical therapy intervention, initiated during
      the NICU stay and up to 2 months corrected age, based on the family-centered model, could
      promote preterm infants motor development in short-term (2 months corrected age) and
      long-term (8 months corrected age).

      There is a high evidence level of different systematic reviews, which support the effectivity
      of early intervention with preterm infants.

      The principal aim of this randomized controlled trial is to evaluate the effectiveness of
      early physiotherapy intervention to promote motor development in preterm infants at 2 and 8
      months corrected age.

      The secondary purpose is to study the motor development of those preterm infants who received
      early physical therapy intervention.
    


Intervention name(s): Physical Therapy Early Intervention; Usual Care
Intervention type(s): Other; Other
Intervention description(s): At the UCIN:
Parental education to empower them on motor development and parent-infant relationship. Consisted on 6 sessions during the first weeks at the NICU.
Tactile and kinaesthetic stimulation managed by parents. 2 times a day, 15 minutes each, during 10 days.
At home:
Psychomotor Development Program for the baby; comprised of different exercises, in different phases, depending on child maturation stage. Started after hospital discharge until 2 months corrected age.; NICU usual care
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Cannabinoid Receptor Function & Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      This study attempts to characterize the effects of tetrahydrocannabinol (THC).
      Tetrahydrocannabinol is the active ingredient of marijuana, cannabis, "ganja", or "pot". This
      study will involve healthy volunteers who 1) have no history of alcoholism in their family or
      2) have a family history of alcoholism. This study looks at individuals with or without a
      family history of alcoholism to determine if there is a difference between the two groups in
      the response to THC.
    


Intervention name(s): THC; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): High dose: 0.036 mg/kg (2.5 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking a full joint
Low dose: 0.018 mg/kg (1.25 mg in a 70kg individual) IV (in the vein) dissolved in ethanol.Equivalent to smoking ½ of a joint
Very low dose: 0.0036 mg/kg (0.25 mg in a 70 kg individual)IV (in the vein) dissolved in ethanol. Equivalent to smoking 1/10 of a joint; Placebo: Small amount of ethanol IV (in the vein), (quarter teaspoon).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to assess the clinical effect of montelukast sodium with concomitant administration
      of inhaled budesonide in asthmatic patients.
    


Intervention name(s): MK0476; montelukast sodium/Duration of Treatment: 16 weeks; Comparator: placebo / Duration of Treatment: 16 weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment