bioihbjkbjnl/mcl2 huggingface dataset:
Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania
Condition: Femoral Fractures
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Observational

Summary: 
      This is a prospective observational study of patients with femur fractures in Dar es Salaam,
      Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open
      reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of
      reoperation for any reason, and the secondary outcomes are fracture healing, return to work,
      and health-related quality-of-life. The investigators hypothesize that there will be a
      difference in the rate of reoperation for patients with femur fractures treated with an IMN
      compared to ORIF with a plate.
    

Detailed description: 
      The study will be a prospective clinical trial conducted at Muhimbili Orthopaedic Institute
      (MOI) in Dar es Salaam, Tanzania. All adult patients with diaphyseal femur fractures meeting
      the eligibility criteria will be invited to enroll. Study subjects will be treated at the
      discretion of the surgeons at MOI. This could include an intramedullary nail, a plate,
      external fixation, or skeletal traction. Potential confounders recorded will be age, gender,
      body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury
      to presentation, time from presentation to surgery, and associated injuries. The primary
      outcome considered will be reoperation for any reason. Secondary outcomes will be clinical
      union, defined as full-painless weight bearing on the injured extremity, radiographic union,
      return to work, and health-related quality-of-life. Follow up will be scheduled at 2 weeks, 6
      weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and
      radiographic evaluation.
    

Intervention name(s): Intramedullary Nailing; Open Reduction Internal Fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical treatment that includes closed or open reduction and stabilization of the femur fracture with an intramedullary rod inserted using antegrade or retrograde technique; Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate
Other intervention name(s): SIGN Intramedullary Nail
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with diaphyseal fractures of the femur presenting to Muhimbili Orthopaedic
        Institute in Dar es Salaam, Tanzania will be considered eligible for enrollment.
      
Keywords: femur fracture; internal fixation; intramedullary nailing
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants
Condition: Autoimmune Disease
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetic and safety and tolerability
      profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC)
      administration at escalating dose levels in healthy participants.
    

Detailed description: 
      The drug being tested in this study is TAK-079. TAK-079 is being tested to find a safe and
      well-tolerated dose and to assess how TAK-079 is processed by the body. This study will look
      at pharmacokinetics, side effects, and laboratory results in people who take TAK-079 and is
      designed as a randomized single dose-rising study.

      Therefore, each subsequent cohort will not start until the previous cohort has completed and
      the results are reviewed. Each participant will receive TAK-079 or placebo once only as an IV
      infusion or by SC administration. The starting dose for IV will be 0.0003 mg/kg and SC dose
      of 0.01 or 0.03 mg/kg was determined based on the no-observed-adverse-effect-level (NOAEL)
      results from the 13-week good laboratory practice (GLP) monkey toxicology study. If this dose
      is well-tolerated, the next group will receive a higher dose, etc, until a maximal tolerated
      dose is reached with the highest dose not to exceed 1.0 mg/kg.

      This single-center trial will be conducted in the United Kingdom. The overall time to
      participate in this study is up to 17 weeks. Participants will make 11 visits to the clinic,
      including one 10-day period of confinement in the clinic. All participants will be contacted
      by telephone 14 days after the last visit to the clinic for a follow-up assessment.
    

Intervention name(s): TAK-079; Placebo to TAK-079
Intervention type(s): Drug; Drug
Intervention description(s): TAK-079 solution; Placebo to TAK-079 solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Safety Study of Adoptive Transfer of Autologous IKDC-like Cells
Condition: Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of adoptive transferring autologous
      IKDC-like cells
    

Detailed description: 
      Cancer immunosurveillance in mice and human protects the host from outgrowth of tumor cells.
      This may establish a sufficient rationale for cancer immunotherapy that aims to control or
      eradicate tumor by an induction of effective anti-tumor immunity. The interest in developing
      cancer immunotherapy has intensified by the recent trials results showing durable responses
      in approximately 20% of patients who received various kinds of immunotherapy including
      adoptive transfer of tumor-specific T cells, cancer vaccines, and T cell response checkpoint
      blockade inhibition. Discoveries to date, natural killer (NK) cell function positively
      associates with reduction of cancer risk and with better survival of gastrointestinal stromal
      tumor patients. Interferon-producing killer dendritic cells (IKDCs) are a subpopulation of NK
      cells discovered in the mouse spleen, which can lyse tumor cells and acquire antigen
      presentation cell (APC) activity. We found putative IKDCs in human peripheral blood
      mononuclear cells (PBMCs); meanwhile, we also developed a method to expand IKDC-like cells
      from murine bone marrow and human PBMC ex vivo. The expanded human IKDC-like cells are
      cytotoxic toward several human leukemia cell lines and are capable to activate allogeneic T
      cells. For the in vivo anti-tumor activity, we found that two transfers of syngeneic murine
      IKDC-like cells reduced tumor burden in B16/OVA and B16/F10 melanoma and Lewis lung carcinoma
      models, and enhanced interferon (IFN)-γ production by the splenocytes of the tumor-bearing
      mice. Moreover, six transfers of IKDC-like cell significantly prolonged the survival of mice
      bearing B16/F10 melanoma. Based on these preclinical results, we hypothesize anti-tumor
      activity of human IKDC-like cells. We thus propose a phase 1 clinical trial to assess the
      safety of autologous IKDC-like cell therapy in metastatic cancer patients for determination
      of the maximum tolerated dose, and to monitor the immune parameters in patients before and
      after the IKDC-like cell transfer to investigate the therapeutic mechanism and biomarkers.
    

Intervention name(s): autologous IKDC-like cells
Intervention type(s): Biological
Intervention description(s): Subject received autologous IKDC-like cells every 14 days
Intervention model: Single Group Assignment
Intervention model description: 3+3 statistics model
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer immunotherapy; IFN-γ-producing killer dendritic cell-like cells; Natural killer cells
Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      To validate the morphine-sparing effect and safety of parecoxib administered intravenously
      for the treatment of Chinese subjects with postoperative pain following gynecological or
      orthopedic surgery.
    


Intervention name(s): Parecoxib and placebo
Intervention type(s): Drug
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in
      patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning.
      Simultaneously the additional benefit of subgingival application of probiotics via oil drops
      will be investigated.
    

Detailed description: 
      The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in
      patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning.
      Simultaneously the additional benefit of subgingival application of probiotics via oil drops
      will be investigated.

      Recruitment: This study will be a single centre (Department of Oral Health Sciences,
      University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial
      with within each patient a split mouth design. The randomization (by means of a computer
      program) and double blind design are thought to minimize the bias of the investigator and
      patients.

      Selection of the study population: Adults, who consult at the department of Periodontology at
      the University Hospital Leuven, and who fit the inclusion criteria will be asked to
      participate in this study.
    

Intervention name(s): Probiotic tablet- Biogaia; Placebo tablet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bracing or Kinesio Taping in The Management of Lateral Epicondylitis
Condition: Lateral Epicondylitis (Tennis Elbow)
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Lateral epicondylitis is an overuse syndrome of the forearm, which is associated with pain
      and sensitivity in the lateral elbow region.

      The aim of the study was to find out about is there any difference between the effects of
      traditional orthotic devices and adhesive taping, in the management of lateral epicondylitis.
      Therefore, the forearm counterforce brace, which was widely used in daily clinical practice
      for lateral epicondylitis, was compared with kinesio tape, a new technique of adhesive taping
      which has become increasingly popular. The study investigated and compared the effects of the
      two interventions (the forearm counterforce brace and kinesio tape) on pain severity,
      functional status and disability of patients with lateral epicondylitis.
    


Intervention name(s): forearm strap (counterforce brace); Kinesio tape application
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized and assessor-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Lateral epicondylitis; forearm counterforce brace; kinesio taping
Effects of Low Concentrations of Nitrous Oxide
Condition: Nitrous Oxide Poisoning
MeSH terms: Poisoning
Study type: Interventional

Summary: 
      The aim of the study is to test the effects of low concentrations of nitrous oxide on
      cognitive functions and reaction time in human.
    

Detailed description: 
      Nitrous oxide is a widely used gas in medicine, in standard concentrations above 50%. Its
      favourable physical properties and easy detectability by anaesthetic gas analysors predispose
      nitrous oxide to become a possible "tracing gas" for leak detection in experiments in which
      modified breathing system are in use. In these breathing experiments, the inspired
      concentrations of nitrous oxide would be well below the anaesthetic/analgesic concentrations.
      The aim of this study is to investigate the effects of these low concentrations of nitrous
      oxide (5, 7, 10, 12, 15, 20 %), compared to placebo (air, 0% nitrous oxide). The cognitive
      functions are tested using Digit Symbol Substitution Test, Reaction Time and Visual Analogue
      Scale.
    

Intervention name(s): Nitrous Oxide; Placebo - air
Intervention type(s): Drug; Other
Intervention description(s): Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.; Breathing air with 21 % oxygen, no nitrous oxide.
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants go through all study arms, in random order.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: nitrous oxide; tracing gas; breathing experiments; cognitive tests
Increasing Folate Status of a General Population(FOLSUPP STUDY)
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to determine the best source of folate to raise the folate status of
      a general population over a 16 week intervention period.
    

Detailed description: 
      This study is designed to assess whether increasing the consumption of natural food folates
      from a mixed diet is as effective as supplemental folic acid or supplemental natural folate
      in raising folate status, reducing biomarkers of cardio vascular disease (CVD) risk, and
      improving vascular function. Randomised placebo-controlled parallel studies will be
      undertaken in groups of individuals in Norwich and Sheffield. There will be four treatment
      arms: a) 200 µg folate per day from folate-rich foods, b) 200 µg folate per day from
      supplemental folic acid, c) 200 µg folate per day from supplemental Metafolin® (6S
      5-methyltetrahydrofolic acid) and d) a placebo group. Results from the two centres will be
      combined, thus ensuring a wide population is covered. Folate status, biomarkers of CVD risk
      and vascular function (pulse wave velocity) will be measured before and following the
      intervention period of 16 weeks, together with possible confounders (such as vitamins B2 &
      B12 status, and MTHFR genotype). 7-Day weighed intakes will be used to measure habitual
      B-vitamin intake during baseline and intervention, to determine changes in folate intake and
      assist compliance. Additionally, folate content of selected folate-rich foods will be
      determined for each volunteer. The results will aid the Food Standards Agency (FSA) in
      formulating public health policy related to improving folate status and reducing CVD risk.
    

Intervention name(s): Folic acid (supplement); Metafolin (supplement); Placebo; Folate rich foods
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug; Other
Intervention description(s): 200 µg folate per day from supplemental folic acid; 200 µg folate per day from supplemental Metafolin®; Placebo; 200 µg folate per day from folate-rich foods
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Healthy
Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone
Condition: Menstrual Pain
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effectiveness of additional self-care acupressure in
      women with menstrual pain compared to usual care alone.
    

Detailed description: 
      Menstrual pain is a common problem in young women and one of the the main reasons of short
      term absence from school or work. There is some evidence that acupuncture and acupressure
      might be successful in treating of menstrual pain. Compared with acupuncture, acupressure
      offers the possibility for women with menstrual pain to do self-care treatment at home.
      However, studies have been small and self-care acupressure had been only investigated in one
      study from Taiwan.
    

Intervention name(s): Self-care acupressure at three predefined points
Intervention type(s): Procedure
Intervention description(s): Self-care acupressure, one minute for each point, starting 5 days before menstruation, once up to twice daily; when pain is present: twice daily up to five times
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menstrual pain; Primary dysmenorrhea; Self-care acupressure
Immune Reconstitution in Tuberculosis Disease
Condition: Pulmonary Tuberculosis (TB)
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate
      together with standard anti-tuberculosis treatment to significantly improve clinical recovery
      among patients with untreated, active pulmonary tuberculosis.
    


Intervention name(s): vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate); Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
Intervention MeSH terms: Vitamin D; Cholecalciferol; 4-phenylbutyric acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary TB; cholecalciferol; sodium phenylbutyrate; antimicrobial peptides; immune response
Prevention Through Activity in Kindergarten Trial
Condition: Child, Preschool
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objectives: The PAKT project shall evaluate the effects of an exercise intervention in
      kindergarten combined with an educational training of parents and kindergarten teachers on
      behavior and health status of children.

      Study design: Baseline measurements were performed on more than 700 kindergarten children
      aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg
      in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a
      control (20 kindergartens) group. The intervention group offers a daily exercise class
      lasting at least 30 min. Parents and teachers of the children in the intervention program
      receive educational training. In addition, the children have activity homework involving the
      entire family. The control kindergartens keep their routine. Follow-up measurements of
      physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood
      pressure take place in January/February 2008, June/July 2008, and September/October 2008. The
      number of accidents in and outside of the kindergartens and the number of children missing
      the kindergarten due to infections are monitored continuously.

      Use of results: If the PAKT program should proof effective, the results will be published in
      scientific journals and made public using the press. With the help of the GEK, the program
      will then be implemented nationwide in kindergartens.
    


Intervention name(s): physical activity
Intervention type(s): Behavioral
Intervention description(s): activity program at kindergarten 5 * 30 min per week plus education of parents (letters, flyers, presentations, counselling) plus activity homework for children involving also the families
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Physical activity; Obesity; Motor skills; Kindergarten
Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane
Condition: Renal Dialysis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a novel haemodialysis membrane, compared
      with the standard dialysis membrane, will increase the removal of beta2-microglobulin in
      chronic dialysis patients.
    

Detailed description: 
      Despite advances in treatment of kidney diseases, morbidity and mortality of chronic dialysis
      patients remains unsatisfactory. Standard haemodialysis membranes remove middle-sized
      molecule solutes poorly such as beta2-microglobulin, which has a pathogenic role in
      dialysis-related amyloidosis. Pre-dialysis beta2-microglobulin concentration has been shown
      to be independently predictive of mortality. A new polyamide haemodialysis membrane has been
      developed with increased pore size to increase the removal of middle-sized uraemic toxins
      such as beta2-microglobulin. This study aims to evaluate the effectiveness of the new
      membrane in beta2-microglobulin removal compared with standard haemodialysis membrane in
      dialysis patients and the degree of increased loss of albumin as a potential limiting factor
      of its use.
    

Intervention name(s): Larger pore haemodialysis membrane; Standard haemodialysis membrane
Intervention type(s): Other; Other
Intervention description(s): Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.; Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.
Other intervention name(s): Gambro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: beta 2 microglobulin; haemodialysis; albumin