bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Double Fortified Salt (DFS) to Improve Work Productivity in Women in India
Condition: Anemia; Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The main objective of the present study is to assess the impact of double fortified salt
      containing iron and iodine on work performance (productivity) of women plantation workers in
      India. Efficacy studies have shown that salt double-fortified with iodine and iron can
      significantly reduce the incidence rates of iron-deficiency anemia (IDA) and
      iodine-deficiency disorders. Double-fortified salt (DFS) can be prepared by mixing
      microencapsulated iron compounds into conventionally iodated salt (Yuan et al, 2008). Iron
      deficiency anemia affects the work productivity and physical activity. Many studies have
      shown that when the individuals with low Hb received iron supplement, their work performance
      improved markedly. Animal studies have demonstrated that iron deficient anemic rats had a
      lower work tolerance as measured by oxygen consumption than the adult rats with normal Hb
      levels (Ohira et al, 1981). Several human studies have demonstrated the effect of iron
      supplementation on endurance capacity and work productivity in women (Zhu and Haas, 1997,
      1998; Edgerton et al., 1979). Many human studies have also examined the possible linkages
      between iron deficiency and concurrent cognitive or behavioral outcomes. Iron supplementation
      effective in reducing iron-deficiency anemia would also result in better behavioral and
      developmental outcome. Many studies found that IDA had a great influence on cognitive
      functions in infants and school children (Lozoff et al., 2003, 1998 and Friel et al., 2003).
      However, studies of IDA and cognitive function in adults are few and controversial.

      This study will assess iron status and physical and mental performance at 2 time points,
      before and after approximately 10 months during which a controlled intervention will take
      place on tea estates at the Panighatta Tea Garden near Siliguri, West Bengal. Subjects will
      be women between 18 and 50 years of age who are actively employed as full time tea pickers.
      The study requires that 2 experimental groups of subjects be identified: a) an experimental
      group that consumes double fortified salt (DFS) containing iron + iodine, and b) a control
      group that consumes only iodized salt (IS).
    


Intervention name(s): double fortified salt
Intervention type(s): Other
Intervention description(s): Refined salt of particle size < 1 mm iodized with potassium iodate (KIO3) at a concentration of 30 µg I/g salt at the factory will be purchased and blended with encapsulated Ferrous Fumarate premix containing 15% iron. Premix to salt ratio of 1 to 150 will be used to arrive at 1000 ppm elemental iron in the final product.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective of this study was confirmation on non-inferiority and validation of similar safety
      profile of new anti-muscarinic medicinal product Uritos® (Imidafenacin) in comparison with
      other product from m-cholinergic antagonists group Urotol® (Tolterodine).
    

Detailed description: 
      To assess clinical efficiency and safety of Uritos® (Imidafenacin) in comparison to Urotol®
      (Tolterodine) according to its influence on urination frequency and number of urinary
      incontinence episodes a total of 327 patients underwent screening and 300 patients were
      randomized (150 patients in the Uritos® group and 150 patients in the Urotol® group).
      Screening period was not exceeding 2 weeks (14 days). Therapy was performed during 12 weeks
      (84 days). Every patient received only one treatment (Uritos® or Urotol®) during the
      treatment period. Patients were returning to the trial site to assessment visits on Weeks 2,
      4, 8 and 12 with permissible variation ± 3 days. Observation period after the end of
      treatment - 30 ± 5 days (could be performed through telephone connection without need for
      physician appointment by patient). Maximum observation period: 136 days.

      Efficacy and safety parameters were assessed as per primary and secondary endpoints.

      The results of this study could potentially provide new optimum approaches to OAB treatment.
    

Intervention name(s): Uritos®; Urotol®
Intervention type(s): Drug; Drug
Intervention description(s): film-coated tablets 0.1 mg; film coated tablets, 2 mg
Other intervention name(s): Imidafenacin; Tolterodine
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overactive bladder; urinary incontinence; frequent urination; urge incontinence; urgency episodes
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
Condition: Bronchopulmonary Dysplasia; Respiratory Tract Infections; Premature Birth of Newborn
MeSH terms: Respiratory Tract Infections; Bronchopulmonary Dysplasia; Premature Birth
Study type: Observational

Summary: 
      This is a 5-year long-term follow-up study of open label, single-center, phase I clinical
      trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with
      bronchopulmonary dysplasia.
    

Detailed description: 
      Bronchopulmonary dysplasia (BPD) is the most common cause of death for prematurely born
      babies with low birth weights. In addition, many children who recover from this disease
      suffer from various complications such as prolonged hospitalization, pulmonary hypertension,
      and failure to thrive.

      It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can
      differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies
      showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with
      pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the
      findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged
      lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes,
      and so on.

      PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is
      intended to treat BPD in premature infants. The purpose of the study is to evaluate 3-5 year
      long term safety and efficacy in patients who completed the earlier part of the phase I
      clinical trial of PNEUMOSTEM®.
    

Intervention name(s): PNEUMOSTEM
Intervention type(s): Biological
Intervention description(s): A single intratracheal administration
Low Dose Group (3 patients): 1.0 x 10^7 cells/kg High Dose Group (6 patients): 2.0 x 10^7 cells/kg
* The subjects were administered with Pneumostem in the earlier part of the Phase I study. No drug/biologics will be administered to any subject during this part of the study.
Other intervention name(s): human umbilical cord blood-derived mesenchymal stem cells
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants who were enrolled in the 2-year follow-up study (NCT01632475) of phase 1 clinical
        trial for the safety and efficacy evaluations of PNEUMOSTEM® treatment in premature infants
        with bronchopulmonary dysplasia
      
Keywords: human umbilical cord blood-derived mesenchymal stem cells; bronchopulmonary dysplasia; respiratory tract infection; Premature infants
VR-MARS Virtual Reality, Medical Assistance and Rescue for Space
Condition: Instructional Virtual Realities; Weightlessness Simulation; Space Simulation; Patient Simulation; High Fidelity Simulation Training
Study type: Interventional

Summary: 
      VRMARS is a medical simulation study in microgravity. Healthy volunteers (n=18) test in
      microgravity the functionnality of an augmented reality headset in which a medical assistance
      is displayed.
    


Intervention name(s): Augmented Reality Headset / Hololens 2 or Varjo XR3
Intervention type(s): Device
Intervention description(s): Augmented Reality Headset
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer
Condition: Colon Rectal Cancer Duke Stage Stageval
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam
      Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized
      (Non-Metastatic) Rectal Cancer
    

Detailed description: 
      Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in
      pts with locally advanced rectal carcinoma.
    

Intervention name(s): Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)
Intervention type(s): Drug
Intervention description(s): Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
Other intervention name(s): Capecitabine (Xelodaâ), XRT& Cetuximab (Erbitux®)
Intervention MeSH terms: Capecitabine; Cetuximab
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with Localized (Non-Metastatic) Rectal Cancer
      
Keywords: Rectal Cancer
Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
      more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel
      and cisplatin works in treating patients with advanced transitional cell cancer of the
      urothelium.
    

Detailed description: 
      OBJECTIVES:

        -  Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among
           patients with regional or distant metastases of transitional cell carcinoma of the
           urothelium or local/regional recurrence after cystoprostatectomy.

        -  Determine response in patients who receive GTP as the initial chemotherapeutic treatment
           as well as in patients who have received prior chemotherapy.

        -  Determine response duration, freedom from progression, and overall survival.

        -  Assess the toxicity of GTP.

      OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy
      (yes vs no).

      Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and
      gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days
      for up to 4 courses in the absence of disease progression or unacceptable toxicity.

      Patients achieving a partial response or complete response undergo surgical restaging and
      debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
    

Intervention name(s): cisplatin; gemcitabine hydrochloride; paclitaxel; conventional surgery
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Paclitaxel; Gemcitabine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter; transitional cell carcinoma of the bladder; regional transitional cell cancer of the renal pelvis and ureter; stage IV bladder cancer; recurrent bladder cancer
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects
      with schizophrenia.
    


Intervention name(s): ALKS 3831; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): Daily dosing; Daily dosing
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Olanzapine; Weight
Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of
      diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with
      respect to 50 mg diclofenac sodium administered alone.
    

Detailed description: 
      According to Xadago™ SmPC, safinamide may transiently inhibit BCRP, therefore a time interval
      of 5 h should be kept between dosing of safinamide and medicinal products that are BCRP
      substrates with a Tmax ≤2 h (e.g. diclofenac, pitavastatin, pravastatin, ciprofloxacin,
      methotrexate, topotecan or glyburide).

      Following a specific request of EMA CHMP, the present interaction study in healthy male and
      female volunteers was conducted to determine if co-administration of safinamide with a BCRP
      substrate alters plasma exposure of the BCRP substrate in vivo.

      Diclofenac was chosen among the other BCRP substrates considering its large use in the
      general population. Diclofenac in fact is an important analgesic and anti-inflammatory drug,
      widely used for the treatment of postoperative pain, rheumatoid arthritis, and chronic pain.
      Consequently, diclofenac is often used in combination regimens and undesirable drug-drug
      interactions may occur.

      Voltaren®, 50 mg soluble tablets, was selected among other possible diclofenac products
      because with this formulation peak concentration of diclofenamic acid is achieved at
      approximately 1 h, i.e. in less than 2 h.

      The present interaction study was designed in agreement with the FDA Guideline on Drug
      Interaction studies, taking also in consideration the EMA guideline on the Investigation of
      drug interactions.
    

Intervention name(s): Diclofenac sodium; Diclofenac sodium and safinamide
Intervention type(s): Drug; Drug
Intervention description(s): Diclofenac sodium 50 mg single dose; Diclofenac 50 mg single dose and safinamide 200 mg single dose
Other intervention name(s): Voltaren; Voltaren and Xadago
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: PK study
Vitamin D and Immunity: Photosynthesis Versus Supplementation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The optimal way to restore serum 25-hydroxyvitamin D sufficiency is currently debatable. UV
      irradiation through sunshine exposure promotes endogenous vitamin D synthesis, although this
      can also be associated with a risk of UVR-induced skin cancer. Dietary supplements represent
      an alternative, which are increasingly being used in clinical trials to correct deficiency.
      However, it is unclear whether sunshine exposure and vitamin D supplementation induce
      comparable changes in immune function, or whether additional UVR-induced molecules may be
      responsible for proposed health benefits. Several studies report an inverse correlation
      between exposure to UVR and immune-mediated diseases, further supporting the theory that UVR
      may also be protective through non vitamin-D mediated pathways. So far it has been difficult
      to distinguish between immune-regulation by vitamin D and other mediators induced by UVR as
      the downstream effects are similar. A direct comparison of the biological effects of vitamin
      D obtained by UVR versus supplementation has never been made. This study aims to elucidate
      the differences in vitamin D generated by UVR exposure versus supplementation by comparing
      immunological endpoints
    


Intervention name(s): Vitamin D; UVR (Solar simulated radiation)
Intervention type(s): Dietary Supplement; Radiation
Intervention description(s): Daily 4X 1000IU cholecalciferol; 1.25 SED Solar simulated radiation twice weekly
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin D; UVR; Immune system
Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged over the past decade as a
      post-transcriptional regulator of the LDL receptor (LDL-R). PCSK9 acts as an endogenous
      natural inhibitor of the LDL-R pathway. Monoclonal antibodies (mAb) directed against PCSK9,
      such as Alirocumab, are the most common method of PCSK9 inhibition.

      The goal of the present study is to assess, in the context of type 2 diabetes, a situation
      associated with an increased post-prandial hyperlipemia, whether PCSK9 inhibition with
      Alirocumab affects postprandial intestinal lipoprotein metabolism.
    

Detailed description: 
      Recently, human monoclonal antibodies directed against PCSK9 have been shown to be effective
      in reducing LDL cholesterol. Besides the liver, little is known about the role of PCSK9 in
      the small intestine, a tissue where it is expressed at a high level. Preclinical studies in
      mice indicate that PCSK9 inhibition reduces post-prandial hyperlipemia.

      Here, the investigators will test the effect of PCSK9 inhibition with alirocumab, a PCSK9
      mAb, on post-prandial hyperlipemia in 24 patients with type 2 diabetes. The investigators
      will perform a randomized, double-blind, placebo-controlled, cross-over trial with alirocumab
      75 mg every two weeks.

      In the cross-over design, two periods of 10-weeks treatment (i.e. 5 injections) will be
      separated by a 10-week wash-out period to avoid carry-over effect. The primary endpoint will
      be the total area under the post-prandial triglycerides concentration-time curve from
      meal-time until 8h (AUC0-8h) after a standardized meal test. As secondary endpoints, the
      investigators will explore the effect of alirocumab on plasma lipids, markers of cholesterol
      absorption and synthesis, and glycemic parameters.

      This study will help to decipher the function of PCSK9 on intestinal lipoprotein metabolism
      in human and to determine whether alirocumab can reduce post-prandial hyperlipemia, which is
      an independent cardiovascular risk factor. From a patient perspective, this study will give
      some important clues for the management of cardiovascular disease.
    

Intervention name(s): Alirocumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): prefilled pen containing 75 mg of Praluent (Alirocumab) in 1 ml of solution; prefilled pen containing 1 ml of solution without Praluent
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove the safety of the gynaecological formulation in normal conditions of use.
    


Intervention name(s): Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients
      with refractory partial seizures.
    


Intervention name(s): Zonegran
Intervention type(s): Drug
Intervention MeSH terms: Zonisamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MRI Findings in Throwing Shoulders of Waterpolo Players
Condition: Waterpolo Players; Non Throwing Shoulders
Study type: Interventional

Summary: 
      MRI examination of 60 shoulders of waterpolo players (30 throwing shoulders as well as the
      opposite side) and 15 healthy probands as control group (30 shoulders of non waterpolo
      players. The correlation of MRI alteration and clinical symptomatic findings in both groups
      will be investigated. The clinical examination is performed by 2 board certified orthopedic
      surgeons and based on the Constant Murley Score.
    


Intervention name(s): MRI
Intervention type(s): Other
Intervention description(s): MRI and clinical investigation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
H5N1 Vaccine Study in Japanese Adults
Condition: H5N1 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to obtain immunogenicity and safety data of two different dose
      levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18
      to 59 years.
    


Intervention name(s): H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
Intervention type(s): Biological
Intervention description(s): Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)