bioihbjkbjnl/mcl2 huggingface dataset:
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Insulin Resistance; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by
      Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.
    


Intervention name(s): DMMET-01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 days: 30 days; dose 1050.6 mg per day (before dinner)+ 30 days; dose 1050.6 mg twice a day 30 more days (before breakfast ando before dinner); 60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; Type 2; monotherapy; antidiabetics; metformin
Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Condition: Herpes Simplex Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.
    

Detailed description: 
      Zinc salts irreversibly inhibit herpes virus replication in vitro and are effective in
      treating herpes infections in vivo and have been shown in a clinical trial to be a effective
      topical treatment for HSL. Zinc salt solutions applied to herpetic lesions decrease viral
      load and markedly improve healing rates, relieving the symptoms of herpes as healing occurs.
      Zinc swabs contain 33 mmol/l of ionic Zinc in an emulsification of Benzalkonium chloride,
      glycerin, hydroxyethylcellulose, sodium chloride, and sodium hydroxide (ph 7.2). Zinc
      gluconate is monographed in the Homeopathic Pharmacopoeia of the United States (HPUS) and one
      of OTC indications for Zinc and its salts is for the treatment of cold sores.
    

Intervention name(s): Zicam (Ionic zinc); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 33mmol/l of ionic zinc; placebo swab
Other intervention name(s): Homeopathic Zinc gluconate; placebo swab
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cold sores; Zinc; HSL; Herpes simple labialis
To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of
      efficacy as determined by clinical response according to the change from baseline in disease
      activity.
    


Intervention name(s): CT-P13; Remicade
Intervention type(s): Biological; Biological
Intervention description(s): 3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid; 3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Family Centred Early Intervention of Infants With Congenital Heart Disease
Condition: Congenital Heart Disease in Children
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      In this study the investigators aim to test the feasibility for therapists and acceptability
      to parents of an early motor intervention for infants with congenital heart disease (CHD)
      after open heart surgery. This intervention will be compared to the standard care of
      treatment that is recommended for infants with congenital heart disease at the University
      Children Hospital Zurich.
    

Detailed description: 
      In this feasibility pilot randomised study children will be randomly assigned to a control
      and an intervention group. Children of the control group will receive standard of care for
      infants with severe CHD: cardiac surveillance, counselling and screening at the University
      Children's Hospital Zurich and standardised developmental checkups by their paediatrician.
      Physiotherapy is normally not comprised in standard of care, but some infants may receive
      physiotherapy, if they present with obvious signs of motor developmental delay, detected by
      the paediatrician later on in their life. Once enrolled in this study, an infant of the
      control group will not receive early motor intervention as an infant enrolled in the
      intervention group.

      Infants randomly assigned to the intervention group will receive early motor intervention,
      which will be based on the results of our qualitative study. It will comprise supporting
      parents by a paediatric physiotherapist. Parents will be guided on how to best stimulate
      their infant's development during daily activities. Parents will be actively involved in the
      intervention with the aim to challenge their infant at the limit of its postural capacity and
      thus help the infant to optimize its motor repertoire. The intervention will start after
      baseline with infants aged 3-6 months and end after three months with infants aged 6-9
      months.

      The intervention will start at home, then alternating at the Children's Hospital and at home.
      Telephone or video counselling will be provided to support parents if needed. The order may
      change according to the needs of the family when necessary and adjusted to best fit the daily
      routine the family.
    

Intervention name(s): early motor intervention
Intervention type(s): Other
Intervention description(s): infants with CHD after open heart surgery will receive early intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective monocentric single-blinded, two-arm feasibility randomised controlled interventional pilot trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: congenital heart diseases; open heart surgery; motor development; early intervention; family centred; physiotherapy
Use of Virtual Reality Game Playing During Venipuncture
Condition: Autism; Development Delay; Typical Development
Study type: Interventional

Summary: 
      To evaluate the impact of using virtual reality, VR, game playing on successful completion
      and reduction of distress and pain in pediatric venipuncture, and to increase adherence in
      obtaining the desired blood volume.
    

Detailed description: 
      Participants will be randomly assigned using a random number generator to either the virtual
      reality condition, or to the standard procedure that includes using books and/or watching
      movies as a standard method of distraction.

      Participants will take part in the study during their scheduled research venipuncture. The
      venipuncture lasts approximately 15-30 minutes. Pre and post venipuncture questionnaires for
      both participant and parent will take 15 minutes to complete. Total study time is between 30
      and 45 minutes. Questionnaires completed by research personal will take 15 minutes to
      complete.
    

Intervention name(s): Virtual Reality; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Samsung VR Go (VR head set), Samsung S7 (phone), and programmed distraction; Books, movies, TV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of
      escalating single-dose of UB-921 in healthy male volunteers.
    

Detailed description: 
      This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of
      UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main
      Study) and comparative pharmacokinetics study (Sub-study).
    

Intervention name(s): UB-921; Herceptin
Intervention type(s): Biological; Biological
Intervention description(s): 150 mg/vial; 440 mg/vial
Intervention MeSH terms: Trastuzumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: UB-921; anti-HER2 monoclonal antibody; breast neoplasm; breast cancer; Herceptin; Trastuzumab; HER2
Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of platelet-rich plasma versus
      hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint.

      The hypothesis is that PRP intra-articular injection is comparable or even better than
      hyaluronic acid injection.
    

Detailed description: 
      Osteoarthritis (OA) has a significant impact on our society. The limited regenerative
      capacity of cartilage is part of this problem. Existing degenerative lesions lead to
      accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. In
      particular, the most recent knowledge regarding tissue biology highlights a complex
      regulation of growth factors (GFs) for the normal tissue structure and the reaction to tissue
      damage. The influence of GFs on cartilage repair is now widely investigated in vitro and in
      vivo. Platelet Rich Plasma (PRP) is a simple, low- cost and minimally- invasive method that
      allows one to obtain a natural concentrate of autologous GFs from the blood, and it is
      increasingly applied in the clinical practice to treat knee degenerative pathology, such as
      chondropathy and early OA. The biological rational of PRP is that platelets contain storage
      pools of GFs, cytokines, chemokines and many other mediators.Although its widespread
      application, there are little high level studies in the literature to demonstrate the real
      efficacy of PRP.

      The investigators hypothesized that intra-articular injections of PRP to treat knee
      osteoarthritis could determine pain relief and recovery of knee function with overall
      clinical outcome comparable or even better than viscosupplementation, which is a common
      injective approach applied in this kind of pathology. To this purpose the investigators
      designed a double blind randomized controlled trial comparing PRP vs viscosupplementation.
    

Intervention name(s): PRP; Hyaluronic acid
Intervention type(s): Biological; Drug
Intervention description(s): 3ml of PRP; 3ml hyaluronic acid
Other intervention name(s): GPS III, Biomet Biologics, Warsaw, Ind, USA; LBSA0103, 60 mg/3ml, LG Life Sciences, Korea
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, platelet-rich plasma, hyaluronic acid
E7070 in Treating Patients With Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have
      solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors.
      II. Assess the qualitative and quantitative toxicity in terms of predictability, duration,
      intensity, onset, reversibility, and dose relationship of this treatment regimen in this
      patient population. III. Determine a safe dose for phase II evaluation. IV. Assess the
      pharmacokinetics of this treatment regimen in these patients. V. Determine any possible
      antitumor activity of this regimen in these patients.

      OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour once every 3
      weeks. Treatment continues for at least 2 courses in the absence of disease progression or
      unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of E7070 until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which at least 2 of 6 patients experience dose limiting toxicity.

      PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 12 months.
    

Intervention name(s): indisulam
Intervention type(s): Drug
Intervention MeSH terms: N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma
Condition: Advanced Hepatocarcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the overall survival (OS) in order to assess the
      efficacy and safety of pravastatin as adjuvant treatment to sorafenib.
    


Intervention name(s): Pravastatin
Intervention type(s): Drug
Intervention description(s): Treatment:
Patients will be randomized in two groups, A and B:
Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
NSAID Treatment of Patients With Osteoarthritis
Condition: Osteoarthritis,Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The study investigates associations between pre treatment pain intensity and central pain
      mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.
    


Intervention name(s): NSAID
Intervention type(s): Drug
Intervention description(s): NSAIDs are among the most common pain treatments for patients with osteoarthritis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
CP-690-550 Ointment For Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is being conducted to see whether CP-690,550 ointment has potential as a safe and
      effective treatment for adult patients with mild to moderate chronic plaque psoriasis.
    


Intervention name(s): CP-690,550 Ointment 1; Vehicle 1; CP-690,550 Ointment 2; Vehicle 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2% CP-690,550 Ointment 1 twice daily for 4 weeks; Vehicle 1 twice daily for 4 weeks; 2% CP-690,550 Ointment 2 twice daily for 4 weeks; Vehicle 2 twice daily for 4 weeks
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multi Site; Randomized; Placebo Controlled; Double Blind; Parallel Group; chronic plaque psoriasis; topical treatment; skin diseases; papulosquamous
Gastric Motor Function Measurement in Dyspepsia and Normal Subjects
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      This study is being done to measure the functions of the stomach after eating a meal and to
      develop a new method that will simultaneously measure both gastric emptying and the
      relaxation of the stomach after a meal using nuclear medicine testing. This would make the
      testing more convenient for patients and will also offer better understanding of these two
      gastric functions.
    


Intervention name(s): Gastric Motor Function Measurement
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Increasing Colorectal Cancer Screening Among Filipino Americans
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Develop and evaluate in a randomized trial an educational small group intervention to
      increase colorectal cancer screening among Filipino Americans.
    

Detailed description: 
      The purpose of this research study is to increase colorectal cancer (CRC) screening among
      older Filipino Americans, specifically the use of fecal occult blood tests (FOBTs). We will
      design a culturally specific intervention, an educational small group discussion with a
      Filipino health professional. The effect of the intervention will be tested with 620 Filipino
      Americans. Subjects will be recruited at community-based organizations and churches and
      invited to join a 1 1/2 hour discussion of health issues with their partner and some of their
      friends. A third of the subjects will discuss exercise (control group), another third will
      discuss CRC and receive an FOBT kit, and the remaining third will discuss CRC and will not
      receive an FOBT kit. Three months after the group session, subjects in the CRC (intervention)
      groups will receive a letter reminding them to get screened. All subjects will be interviewed
      before and 6 months after the group sessions to assess CRC screening levels in the three
      groups. Self-reported CRC screening will be verified by a review of their medical records.
    

Intervention name(s): Arm 1; Arm 2; Arm 3
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Educational small group session with free FOBT kit; Educational small group session with no FOBT kit; Educational small group session, exercise
Other intervention name(s): Intervention 1; Intervention 2; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Colorectal cancer screening; Fecal occult blood test; Endoscopies; Filipino American immigrants; Community based organizations and churches
A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
Condition: Smoking; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety
      and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily
      reducing the desire to smoke
    

Detailed description: 
      Subjects will orally self-administer 2 study products, each in the form of a dissolvable
      lozenge, and will complete questionnaires on demographics, urges to smoke, and product
      rating.
    

Intervention name(s): CigRx Lozenge; Tobacco Lozenge
Intervention type(s): Dietary Supplement; Other
Intervention description(s): lozenge made of dietary supplements; lozenge made of compressed cured tobacco extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dietary supplement; nutraceutical
A Multiple Dose Study of MK-3614 (MK-3614-002)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      multiple doses of MK-3614 in male participants with mild to moderate hypertension. The
      primary hypotheses are: 1) Multiple oral doses of MK-3614 are sufficiently safe and well
      tolerated to permit continued clinical investigation 2) Aortic Augmentation Index (Aix) is
      reduced 24 hours post the last dose of MK-3614 administered compared to placebo and 3)
      Increase in the 12-hour weighted averages (TWA 0-12hours) of the heart rate is within 15
      beats per minute (bpm) of baseline on first day of multiple dosing of MK-3614 and within 10
      bpm of baseline on last day of multiple dosing of MK-3614.
    


Intervention name(s): MK-3614; Placebo for MK-3614
Intervention type(s): Drug; Drug
Intervention description(s): Participants were administered 0.25 mg tablet, orally for a total daily dose according to randomization.; Participants were administered dose matched placebo tablets according to randomization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic and Safety of GSK573719 and GW642444 Administered Individually and Concurrently, With Verapamilin in Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if the Pharmacokinetics and the Safety Profile of
      GSK573719 and GSK573719/GW642444 are effected by concurrent dosing with the PGP inhibitor
      verapamil.
    


Intervention name(s): GSK573719; GW573719/GW573719
Intervention type(s): Drug; Drug
Intervention description(s): 13 days dosing with GSK573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13.; 13 days dosing with GSK573719/GW573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Verapamil; Anticholinergic, β2 agonist; P-GP; LABA; Muscarinic Receptor Antagonist; LAMA