bioihbjkbjnl/mcl2 huggingface dataset:
Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to compare migration patterns between mechanical and anatomic
      alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over
      the first 2 post-operative years.
    

Detailed description: 
      This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining
      total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be
      randomized to two study groups:

        1. Neutral mechanical alignment;

        2. Anatomical alignment.

      The principal objective of this study is to compare migration patterns between mechanical and
      anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based
      RSA over the first 2 post-operative years.

      Secondary objectives include; comparison of 2-year migration values against published
      thresholds for adequate short-term fixation, comparison of functional and health status of
      subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of
      complications and adverse events, and to assess several health economic parameters relating
      to the surgery.
    

Intervention name(s): Neutral Mechanical Alignment; Anatomical Alignment
Intervention type(s): Procedure; Procedure
Intervention description(s): Hip-knee-ankle angle of 180° ± 3°.; Restoring a patient's pre-diseased limb alignment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.
Masking: Single (Participant)
Primary purpose: Treatment
Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple
      sclerosis (MS), with oral carnosine might be applicable to tackle impaired bioenergetics and
      oxidative stress in MS, and perhaps win back neuromuscular function. However, several
      formulations of carnosine have shown limited applicability due to restraints in brain
      delivery or tissue performance. No human studies so far evaluated the impact of innovative
      carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of
      supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine
      metabolism, and health-related quality of life in a case series of patients with MS.
    

Detailed description: 
      Multiple sclerosis (MS) is a complex autoimmune disorder that affects millions of people
      around the world, negatively interfering with different aspects of health and everyday life.
      Being the most frequently seen demyelinating disease, MS prevalence varies considerably, from
      high levels in North America and Europe (> 100/100,000 inhabitants) to low rates in Eastern
      Asia and sub-Saharan Africa (2/100,000 population). Due to its rather high prevalence in
      developed countries, the development of effective and applicable strategies to prevent or
      manage MS becomes a must for the medical community. Among other factors, it appears that low
      levels of tissue carnosine and mitochondrial dysfunction accompany MS, with oral carnosine
      might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps
      win back neuromuscular function. However, several formulations of carnosine have shown
      limited applicability due to restraints in brain delivery or tissue performance thus pushing
      both industry and researchers to find bioavailable and effective formulation of carnosine. No
      human studies so far evaluated the impact of innovative carnosine formulation (Karnozin
      EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular
      performance, brain biomarkers of carnosine metabolism, and health-related quality of life in
      a case series of patients with MS.
    

Intervention name(s): Carnosine, capsulle, 2 g/day, 8 weeks
Intervention type(s): Dietary Supplement
Intervention description(s): We will administer supplemental carnosine (2 grams per day) for 8 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and immunogenicity of a single dose of the
      PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200,
      which is a live attenuated bacteria, can be transmitted to other adults living in the same
      household.
    

Detailed description: 
      Approximately 60 subjects and up to 120 household contacts will be enrolled in the United
      States. Vaccinees will be randomly assigned to receive either PXVX0200 or placebo in a 5:1
      ratio and will be followed for 180 days postdose.
    

Intervention name(s): PXVX0200; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension; Approx 2 grams of lactose reconstituted in water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine, Bacterial disease condition, Cholera
TDF Long Term Study
Condition: HIV-infected Thai Children
Study type: Observational

Summary: 
      This study will assess the safety and efficacy of generic TDF from Governmental
      Pharmaceutical Organization (GPO) in HIV-infected children
    

Detailed description: 
      TDF is a nucleotide reverse transcriptase inhibitor (NRTI) which can be taken only once per
      day and continues to have good efficacy even in patients who have resistance to other NNRTI
      in the absence of K65R mutation. TDF is a choice for patients with NRTI resistance, or those
      that require once-daily regimen to improve adherence. Currently, TDF has not been approved by
      the US FDA for children less than 18 years, but pediatricians has been using TDF in children
      who have treatment failure because of limitation of a more appropriate pediatric ARV. The
      Thai national guideline for pediatric 2009 recommend the use of TDF in children who have
      failed the first line therapy with multi-NRTI mutation and are more than 30 kilograms or have
      tanner stage 4 or more. However, the problem is that there is no pediatric TDF formulation.
      The available preparation of 300 mg tear drop tablet, if cut in half, may increase dosing
      errors, more or less by 18-37%. This will affect the blood level and/or toxicities.
      Therefore, the Thai Governmental Pharmaceutical Organization (GPO) has produced a generic TDF
      formulation that can be used in HIV-infected children. This study will assess the safety and
      efficacy information in children using this generic pediatric TDF formulation.
    

Intervention name(s): tenofovir (TDF)
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected children who are currently taking or are changing to tenofovir-(TDF) based
        regimen
      
Biospecimen description: 
      Phlebotomy will be for safety evaluation and will be drawn according to the schedule of
      visit.
    
Keywords: TDF-based regimen; HIV-infected children; Thai; generic; safety and efficacy; renal status; To assess effect of TDF on renal problem in HIV-infected children receiving TDF-based once daily regimen; To compare the effectiveness and clinical usefulness of different tools of adherence
Establishing the Vitamin D Requirements During Lactation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness and safety of maternal and infant
      vitamin D supplementation as a function of ethnicity and latitude in the prevention of
      vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will
      generate important new information for health care professionals and policy makers with
      regard to vitamin D requirements and the potential benefit to both mother and infant
    

Detailed description: 
      Mothers from two study sites at different latitudes will be randomized to receive 1 of 3
      treatment regimes of vitD3. Mothers, lactating or nonlactating controls will be randomized to
      either Group A: standard treatment(400 IU D3/d), Group B: (2,400 IU D3/d), or Group C: (6,400
      IU D3/d. Infants of mothers randomized to Group A will receive 400 IU D3/d (recommended
      practice) and infants of mothers assigned to Groups B or C will receive placebo. On 2/5/2009,
      the protocol was amended and the Group B arm was dropped; infants of active subjects
      randomized to Group B as of 2/5/2009 were put on open label treatment (400 IU D3/d) through
      study completion. Newly enrolled subjects after this date were randomized to Group A or Group
      C only.

      By measuring an array of indicators,calcium homeostasis and skeletal remodeling in the
      postpartum mother and the breastfeeding infant will be monitored. Through this study, the
      prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal
      therapeutic intervention with VitD3 will be assessed.
    

Intervention name(s): 400 IU Vitamin D3 (cholecalciferol); 2400 IU Vitamin D3 (cholecalciferol); 6400 IU Vitamin D3 (cholecalciferol)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant; 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant; 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breastfeeding; Vitamin D; Vitamin D deficiency
Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
Condition: HIV Infections; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with
      peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on
      Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions
      and the viral clearance was larger than mono-infected patients.

      The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus
      mono-infected is related with the loss of profited on treatment.

      In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates
      was only 2%.

      The present study want to evaluate is the treatment extent for 24 weeks more in patients
      genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the
      end of the follow-up period, to prevent relapsed in patients with response at the end of
      treatment.

      Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200
      mg/day of ribavirin during 24 weeks more or control.
    

Detailed description: 
      To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients
      with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in
      combination with ribavirin have RNA-HCV undetectable.
    

Intervention name(s): Peginterferon alfa-2a + ribavirin
Intervention type(s): Drug
Intervention description(s): Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Other intervention name(s): Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis C; co-infection; extend treatment; co-infected HIV-HCV
Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
Condition: Bone Fracture
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: The investigators initiated a pilot clinical study to test safety and preliminary
      efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and
      rehabilitation protocols.

      Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been
      considered as the most perspective among all bone substitutes, yet little progress of its
      clinical translation has been made. The concept of "micro-scaffolds" was proposed in this
      study to provide a trajectory to its clinical translation.

      Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further
      applied as an easy-to-operate filler for bone regeneration in a pilot clinical study.
      Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a
      similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2
      microffolds or traditional CPC paste (control group).
    

Detailed description: 
      Objective: The investigators initiated a pilot clinical study to test safety and preliminary
      efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and
      rehabilitation protocols.

      Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been
      considered as the most perspective among all bone substitutes, yet little progress of its
      clinical translation has been made. The concept of "micro-scaffolds" was proposed in this
      study to provide a trajectory to its clinical translation.

      Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further
      applied as an easy-to-operate filler for bone regeneration in a pilot clinical study.
      Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a
      similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2
      microffolds or traditional CPC paste (control group).
    

Intervention name(s): Minimally invasive internal fixation surgeries; CPC/rhBMP-2 micro-scaffolds; CPC paste
Intervention type(s): Procedure; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone substitute; CPC; rhBMP-2
A Study of LY2624803 in Participants With Transient Insomnia
Condition: Transient Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy
      people. The study has four treatment periods. Participants will receive a single dose of
      LY2624803, another sleeping pill, or placebo in each treatment period. The study will last
      approximately 1 month for each participant.
    


Intervention name(s): LY2624803 - Capsules; Zolpidem - Tablets; Placebo - Capsules; Placebo - Tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally as capsules.; Administered orally as tablets.; Administered orally as capsules.; Administered orally as tablets.
Other intervention name(s): Hypnion
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Evaluation of the Omnipod DASH in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1; Children; Metabolic Control; Patient Satisfaction
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational [Patient Registry]

Summary: 
      In this study the usability of the Omnipod DASH insulin administration system is evaluated
      prospectively by two questionnaires. The effect on the metabolic control is evaluated
      retrospectively by analysis of data from the medical records of the patients.
    

Detailed description: 
      In the study the usability of the Omnipod DASH (= insulin patch pump) is evaluated
      prospectively by two questionnaires. The first questionnaire concerns practical items on the
      application of the pump (e.g. Is it easy to fill to pod?), the wearing of the pump (e.g. Is
      it comfortable to wear the pump?) and the comparison with insulin administration with insulin
      pens or other insulin pumps (e.g. is it less painful to administrate insulin by the Omnipod
      DASH pump). The second questionnaire asks for possible problems that the patients experienced
      during the wearing of the pump (e.g. did you experience an allergic skin reaction). The
      questions are formulated to be answered by a 5-point likert scale.

      The metabolic control is studied retrospectively from data extracted from the medical
      records, i.e. the results of the determination of HbA1c and the results from continuous
      glucose monitoring (CGM) at the start, and after 2, 4 and 6 months of the wearing of the
      Omnipod DASH insulin pump.
    

Intervention name(s): Questionnaire
Intervention type(s): Behavioral
Intervention description(s): Questionnaire about usability of the Omnipod DASH insulin administration system
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with type 1 diabetes mellitus who started in 2021 in the Jessa
        Hospital with the Omnipod DASH insulin administration system
      
Keywords: Type 1 diabetes mellitus; child; insulin administration; Omnipod DASH; usability; metabolic control
Acupuncture for Obesity on Serum Metabolic Parameters
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This research is planned to build a basis about the effect of acupuncture on serum metabolic
      parameters in pre-menopausal obese women with economic evaluation.
    

Detailed description: 
      It is consisted with two sub research.

      First, clinical research to assess the effect of acupuncture for obesity on serum metabolic
      parameters will be processed with randomized, patient-assessor blinding, and sham-acupuncture
      controlled study design. 120 subjects would be collected and divided into two
      groups(experimental and placebo, 60 subjects each). Experimental group will undergo with real
      acupuncture treatment(manual acupuncture + electroacupuncture) twice a week, for 6 weeks. The
      effect on serum metabolic parameters will be assessed at 0 and 6 weeks.

      Second is qualitative research to make a basis through the evaluation of economic efficacy
      and patients' satisfaction with acupuncture treatment for obesity.
    

Intervention name(s): Real acupuncture; Sham acupuncture
Intervention type(s): Device; Device
Intervention description(s): manual acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + electroacupuncture (middle CV6, CV12), twice a week, for 6 weeks
common approaches for the treatment of obesity used by doctors of Korean medicine in Korea today; sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + placebo acupuncture without electrical stimulation (middle CV6, CV12), twice a week, for 6 weeks
sham acupuncture (0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) as control for manual acupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea)
placebo acupuncture without electrical stimulation as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; obesity; metabolomics
Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
Condition: Menopause; Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present research program is proposed deepening some pharmacological effects of the
      genistein therapy in order to individualize alternative treatments to the conventional
      hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and
      the osteoporotic consequences in postmenopausal women.
    

Detailed description: 
      Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial
      effects on endothelial function and bone metabolism. On the basis of the so far obtained
      results, aim of our research was to investigate for a two years period the effects of
      genistein on cardiovascular risk factors, endothelial function and oxidative stress markers,
      bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and
      endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass
      loss progression.

      Particularly, and in extreme synthesis the following parameters have been studied during the
      treatment:

        1. inflammation markers as fibrinogen

        2. lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides,
           lipoprotein(a)-

        3. endothelial function markers as VCAM-1 and ICAM-1

        4. oxidative stress by the evaluation of the F(2)-isoprostane

        5. cytokines as IL-6, OPG, RANK and RANKL

        6. bone mineral density, by DEXA, at lumbar spine and femoral neck

        7. Bone turnover markers as B-ALP, PYR, D-PYR

        8. PAP-test, transvaginal uterine ecography and mammography.
    

Intervention name(s): Genistein
Intervention type(s): Drug
Intervention MeSH terms: Genistein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Post-Menopausal Women; Osteoporosis; Phytoestrogen; Genistein