bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men
Condition: Obese
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism.
      It is currently not know if vitamin B3 has the same positive effects in humans. In the
      current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and
      substrate metabolism in obese men will be investigated.
    


Intervention name(s): Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA ); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Best Biliary Drainage Option in Advanced Klatskin Tumor
Condition: Cholangitis
MeSH terms: Klatskin Tumor; Cholangitis
Study type: Interventional

Summary: 
      To investigate the biliary drainage-related cholangitis and other complications of
      percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT)
      compared with endoscopic biliary drainage (EBD).
    

Detailed description: 
      Operative treatment combined with preoperative biliary drainage (PBD) has been established as
      a safe management strategy for KT. Preoperative cholangitis was an independent risk factor
      for patients undergoing resection for KT. However, controversy exists regarding the preferred
      technique for PBD.
    

Intervention name(s): ERCP Drainage; PTBD Drainage
Intervention type(s): Procedure; Procedure
Intervention description(s): When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.; When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERCP; PTBD; EBD; Cholangitis; Complication; Klatskin tumor
Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy
Condition: Anticoagulants; Quality of Life; Drug Monitoring; Pharmacy; Ambulatory Care
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether self-management of oral anticoagulation
      therapy with warfarin has an effect on patient's quality of life following a specific
      training program led by pharmacists.
    


Intervention name(s): Self-monitoring and adjustment of oral anticoagulation
Intervention type(s): Other
Intervention description(s): Weekly self-monitoring of oral anticoagulation with a portable coagulometer and predefined adjustment algorithms for 4 months following a training program led and designed by hospital pharmacists
Other intervention name(s): warfarin; coumadin; coaguchek XS; coaguchek
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Coaguchek; Portable coagulometer; Self-monitoring; Coumadin; Warfarin; Quality of life; Pharmacist
Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
Condition: Pain; Analgesics
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A single center trial to evaluate the efficacy, tolerance, and acceptability of Oxygenated
      Glycerol Triesters (OGT) mentholated cream on acute musculoskeletal pain in normal healthy
      adult volunteers suffering from a recent inflammation of muscles and joints. Patient who met
      eligibility requirements were instructed to identify one area on their body where they were
      experiencing the most acute musculoskeletal pain/discomfort. Patients were provided with
      visual analog scales in order to quantify their pain. Patients either received mentholated
      cream with or without OGT and instructed to rub on the identified site 3 times a day for 7
      days. Pain and other observations were written in a diary for each day.
    


Intervention name(s): Mentholated Cream; Mentholated Cream with OGT
Intervention type(s): Other; Other
Intervention description(s): A topical cream containing menthol without the addition of the oxygenated glycerol triesters.; A Topical Cream that contained both menthol and oxygenated glycerol triesters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute Pain; Musculoskeletal Pain; Topical Analgesic
755nm Alex Laser for Treatment of Stretch Marks
Condition: Striae
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm
      Alexandrite laser.
    


Intervention name(s): 755nm Alexandrite Laser
Intervention type(s): Device
Intervention description(s): 755nm Alexandrite laser with array handpiece
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose,
      crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after
      administration of tablet and capsule dosage forms under both fed and fasted conditions.
    


Intervention name(s): Pirfenidone
Intervention type(s): Drug
Intervention description(s): Pirfenidone 801 mg single oral doses will be given either in the form of tablet or capsules under fed or fasted conditions on Days 1, 4, 7 and 10.
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Online Interactive Courses on Loneliness and Quality of Life of Older Adults
Condition: Older Adults
Study type: Interventional

Summary: 
      Background:

      The early stage of the COVID-19 pandemic can be marked as a critical period in human history
      as it increased loneliness in people's lives. This is particularly true for the older adults
      who are single, living alone, and suffering from chronic diseases. However, there is
      insufficient existing research on associated interventions and their effectiveness.

      Objectives:

      To investigate the effectiveness of an 8-week online interactive course on the loneliness,
      depression, social support, and quality of life (QOL) of older adults in the community during
      the COVID-19 pandemic.

      Methods:

      This pilot study, also a single-blind randomized controlled trial, collected data from a
      community in central Taiwan. Participants were randomly divided into an experimental group
      and a control group. Subsequently, participants in the experimental group received an 8-week
      intensive (Monday to Friday) online interactive course, whereas those in the control group
      consumed 8 weeks of unidirectional online video and audio programs (such as from YouTube).
      Assessments were conducted both before and after the intervention, with the primary outcome
      being the UCLA Loneliness Scale (UCLA), and secondary outcomes being the Geriatric Depression
      Scale Short Form, the Inventory of Socially Supportive Behavior (ISSB) Scale, and the WHO
      Quality of Life-BREF (WHOQOL-BREF) Scale.
    


Intervention name(s): Online Interactive Courses
Intervention type(s): Other
Intervention description(s): In the experimental group, after consensus was reached in the expert meeting (consisting of a doctor specializing in occupational therapy, a doctor specializing in nursing, and a doctor specializing in public health), a 5-days-per-week (Monday to Friday) 8-week intensive online interactive course was designed. The course was made accessible to the participants through a social network app (Line) from 12:00 to 20:30.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
Condition: Hepatitis C Virus Infection, Response to Therapy of
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine the safety, tolerability, pharmacokinetics and
      anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on
      reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by
      genotypic resistance monitoring for up to one year after study drug treatment.
    


Intervention name(s): JTK-853; Dose 2 JTK-853; Dose 3 JTK-853; Dose 4 JTK-853; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, twice a day for 3 days; Tablets, twice a day for 3 days; Tablets, three times a day for 3 days; Tablets, twice a day for 3 days; Tablets, twice a day or three times a day for 3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; JTK-853
Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx)
      versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in
      recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while
      the other half will be treated by EXTREME regimen.
    

Detailed description: 
      The EXTREME regimen, i.e. cetuximab added to platinum (100 mg/m² every 3 weeks ) and 5FU (96h
      continuous infusion at 1000 mg/m²/day every 3 weeks) during 6 cycles of treatment and
      continued as maintenance in patients with stable disease, is currently the standard of care
      in first line recurrent metastatic HNSCC.

      From our previous experience (phase II GORTEC "TPEx" study), the TPEx regimen of 4 cycles of
      docetaxel-cisplatin-cetuximab followed by maintenance with cetuximab every 2 weeks seems more
      efficient (overall survival) compared to EXTREME regiment. Docetaxel combined with cisplatine
      (each administered at 75mg/m² every 3 weeks) also appeared more convenient than the standard
      Cisplatin-5FU-Cetuximab EXTREME regimen (4 cycles of chemotherapy instead of 6 cycles and no
      i.v. continuous infusion). Toxicity was manageable with G-CSF support. In addition the
      toxicity / efficacy profile also seems favourable as suggested by the excellent dose
      intensity achieved and the high rate of patients (78%) who were able to start maintenance
      therapy.

      Taking together all these considerations, the TPEx regimen might be a good substitute for
      EXTREME as first-line treatment in patients with recurrent metastatic HNSCC, and it is
      justified and necessary to perform a direct comparison in a randomized trial to further test
      this hypothesis.
    

Intervention name(s): Cisplatin; 5-Fluorouracile; Docetaxel; Cetuximab; granulocyte colony-stimulating factor (G-CSF)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Docetaxel; Cetuximab; Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent/Metastatic HNSCC; Taxanes
Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Endometriomas
Condition: Ovarian Endometrioma
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Endometriosis is a benign chronic gynaecological disease that affects 10% of women of
      reproductive age and takes 40% of them to assisted reproduction techniques.

      The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular
      count (AFC) , with the most common serological markers of ovarian reserve. The investigators
      intend to confirm their clinical utility in the assessment of ovarian function, and to
      promote their use in predicting decreased ovarian reserve.

      The work therefore moreover arises the objective to validate the bibliographic data about
      using the laser for haemostasis after stripping endometriomas, to amplify knowledge available
      in the literature on the surgical treatment of ovarian endometriomas and on the diode laser
      application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the
      possible surgical implications on fertility .
    


Intervention name(s): Diode laser coagulation; Bipolar coagulation
Intervention type(s): Procedure; Procedure
Intervention description(s): Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy; Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laparoscopic surgery; diode laser; AMH; AFC
Pilot Trial for Implementation of a MPA PK Monitoring Strategy
Condition: Transplant, Kidney
Study type: Interventional

Summary: 
      This study is a prospective interventional trial of de novo renal transplant recipients,
      aiming to validate a strategy which combines the use of early post transplant MPA AUC
      sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a
      clinically applicable fashion.
    

Detailed description: 
      Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid
      (MPA), the active immunosuppressant.

      MMF significantly decreases the episodes of acute rejection in kidney transplant patients;
      but as with any medication without adequate pharmacokinetic drug monitoring, the issue of
      under or over immunosuppression arises. For this reason, the biggest challenge lies with
      establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown
      that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the
      concentration time Curve (AUC), due to the large incidence of inter- and intra-patient
      variability.

      This is the first prospective blinded trial set up to analyze the correlation between
      individualized MPA AUC and trough levels of kidney transplant patients in hopes of
      establishing a more efficacious way of monitoring MPA. MPA target trough levels that
      correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance
      measurements.
    

Intervention name(s): Mycophenolate mofetil + Tacrolimus; Mycophenolate mofetil + Cyclosporin
Intervention type(s): Drug; Drug
Intervention description(s): Target MPA exposure to 30-60 mg/L/h during first month post-transplant; Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Other intervention name(s): MMF; CellCept; Ro 70-0003; Prograf; MMF; CellCept; RO 70-0003; Neoral
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Tacrolimus; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplant; Cellcept; Therapeutic drug level; Mycophenolate mofetil (MMF); Mycophenolate Acid (MPA); Oral Bioavailability; Immunosuppression
Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19
      Vaccine) and determine the recommended dose in Japanese healthy adults and elderly
      participants.
    


Intervention name(s): DS-5670a; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total; Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19 Prevention; SARS CoV-2; Coronavirus Vaccine
Effect of Kinesio Taping on Muscle Strength in Quadriceps Femoris
Condition: Anterior Knee Pain; Muscle Weakness; Knee Symptoms
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The purpose of this project is to investigate the effect of Kinesio tape on muscle strength
      of the quadriceps femoris in people with knee pain or symptoms and decreased muscle strength
      in the quadriceps femoris - a randomized controlled trial.
    

Detailed description: 
      The aim of the study is to investigate the effect of recoil tape with 0-30% tension, by using
      one application of Kinesio tape over the muscle fibers of the quadriceps femoris from its
      origin to its insertion. The participants will be divided into intervention group (taping)
      and control group (no intervention). Muscle strength test will be performed before and
      immediately after taping (20-30 minutes) for both groups using hand-held dynamometer
      measurements (MicroFET 3).

      Work is based on the following hypothesis: "Kinesio taping using recoil taping provides
      increased isometric muscle strength in quadriceps femoris immediately after application".
    

Intervention name(s): Kinesio tape
Intervention type(s): Other
Intervention description(s): Application of one Kinesio tape with 0-30 % tension over the muscle fibers of the quadriceps femoris in a stretched position. The tape can be divided into several tails to cover the whole muscle from origin to insertion.
Other intervention name(s): Kinesio taping; Kinesio tex taping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prucalopride in Pediatric Subjects With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional
      constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label
      comparator (PEG) controlled part will follow, to document safety and tolerability up to 24
      weeks.
    


Intervention name(s): prucalopride; Placebo; PEG 4000
Intervention type(s): Drug; Drug; Drug
Intervention description(s): prucalopride
subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
subjects with weight >50 kg: prucalopride 2 mg tablet once daily; Matching oral solution or oral tablets given once daily
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Green Tea Extract on Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to examine the effect of green tea extract (GTE) on type 2
      diabetes and to explore the relationship between GTE and related hormone peptides.
    

Detailed description: 
      Green tea is one of the most popular beverages in the world. It is believed to have
      beneficial effects in prevention and treatment of many diseases, one of which is anti-obesity
      and anti-diabetes.

      The benefit effects of green tea are mainly attributed to its polyphenol content, especially
      the most abundant one-epigallocatechin gallate (EGCG), which might inhibit adipocyte
      proliferation and differentiation in vitro studies

      We hypothesized that GTE would improve insulin resistance in type 2 overweight diabetes and
      related hormone peptides will be influenced. Thus, we conducted this randomized clinical
      trial to examine the effect of GTE on type 2 diabetes and to explore the relationship between
      GTE and related hormone peptides.
    

Intervention name(s): Green tea extract
Intervention type(s): Dietary Supplement
Intervention description(s): main content is epigallocatechin gallate (EGCG, 58%)
Other intervention name(s): A:GTE (500 mg) tid/day; B:Placebo (cellulose, 500 mg) tid/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Green tea extract; overweight
The Impact of a Diagnosis of Parkinson's on Work
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Parkinson's disease leads to loss of employment on average within less than 10 years of
      disease onset and has been found to be associated with an increased absence from work. This
      combined with hospitalisation; use of secondary health services; drug usage; and caregivers
      needing to give up work contributed to the costs associated with the conditions. It has been
      estimated that early support for working age newly diagnosed would cost the government about
      1.5 million Euro in the UK but might lead to a potential cost saving of over half a billion
      over 5 years.

      The study will explore the impact of a Parkinson diagnosis on employment. The study will be
      survey based and will include demographic questions: age, age at diagnosis of PD, educational
      level, and Nationality; questions pertaining to employment type, history, and reasons for
      leaving if this happened; and also general health.
    


Intervention name(s): Usual care
Intervention type(s): Other
Intervention description(s): For this cross sectional survey, participants will be receiving usual care according to there health care systems
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A (European) community based convenience sample. The survey will be available to the
        European Parkinson's Disease Association (EPDA) network using the Members' forum and
        website and will be sign posted through ongoing Member Outreach communication channels.
      
Keywords: employment; work; diagnosis; early support