bioihbjkbjnl/mcl2 huggingface dataset:
Cytochrome P450's Pharmacogenomics in Chronic Pain Patients
Condition: Analgesia; CYP2D6 Polymorphism; Opioid Use; Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      The use of titrated drugs is at the base of a successful antalgic treatment in order to
      provide both an adequate relief and a satisfactory tolerability profile. These molecules,
      though, have a varying degree of efficacy in different subjects due to medical and genetic
      reasons. The latter are mainly represented by cytochrome (CYP) P450, in particular CYP2D6's
      polymorphisms are responsible for the diversified metabolism of analgesics used in chronic
      pain treatments.

      Four main types of enzymatic metabolism make up the population, each one defined by a
      different CYP2D6 allele: extensive metabolizers, ultra-rapid metabolizers, intermediate
      metabolizers and poor metabolizers.

      Moreover, regarding polytherapies, the analgesics' metabolism could be influenced by
      coadministration of other drugs, thus determining an inhibition or induction of the metabolic
      enzymes - known as phenocopying - and potentially also a change in the metabolic phenotype
      itself. The final outcome is the inconstancy of effectiveness and of the risk of developing
      side effects.

      The primary objective of this study is to define a genetic pattern for the gene CYP2D6 by
      assessing the incidence of poor or ultrarapid metabolizers in a population of chronic pain
      patients. This will also allow to observe phenocopying in the same population.

      Hence 100 patients diagnosed with chronic pain will be enrolled. The genetic pattern of the
      gene CYP2D6 of such patients will be examined by taking mouth samples. At the same time
      parametric tests for paired data to survey the correlations between phenotypical patterns and
      pharmacological therapies will be conducted.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Chronic pain patients who are treated in a pain therapy clinic
      
Biospecimen description: 
      buccal swab
    
Keywords: CYP2D6; Chronic pain; Cytochrome P450; Opioids
A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology
      (ACR)50 response scale at 24 weeks
    


Intervention name(s): LY2127399; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).; Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis
Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.
Condition: Bariatric Surgery Candidate; Pregnancy Complications; Pregnancy Related; Glucose Metabolism Disorders
MeSH terms: Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      In this study glucose metabolism of pregnant women with a history of bariatric surgery, obese
      pregnant women and normal weight pregnant women was investigated. Three to six months after
      delivery the assessment of Glucose metabolism was repeated and the amount of ectopic lipids
      in the liver, heart and muscle was measured.
    

Detailed description: 
      In this study pregnant women with a history of bariatric surgery, normal weight and obese
      pregnant women were invited to participate. Between the 24th and the 28th week of pregnancy
      an oral glucose tolerance test (OGTT), as well as an intravenous glucose tolerance test
      (IVGTT) was conducted. Three to six months after delivery the examinations were repeated. In
      addition the ectopic lipid content in the liver, heart and the muscle was measured with
      1H-magnetic resonance spectroscopy and imaging three to six months post partum. The aim of
      this study was to compare the glucose metabolism during pregnancy between the three groups as
      well as to investigate the changes three to six months after delivery.
    

Intervention name(s): OGTT; IVGTT; 1H-magnetic resonance spectroscopy
Intervention type(s): Other; Other; Other
Intervention description(s): A standardized 75g oral Glucose tolerance test was accomplished.; For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished; For the assessment of the ectopic lipid content in the liver, heart and the muscle a 1H-magnetic resonance spectroscopy was accomplished three to six months after delivery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: GLP-1; Ectopic Lipids
Calcineurin Free Immunosuppression in Renal Transplant Recipients
Condition: Kidney Transplantation; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to obtain preliminary information on the efficacy, safety
      and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF /
      steroid therapy, used in the prevention of acute rejection following renal transplantation.
    

Detailed description: 
      This pilot study is designed to show differences in efficacy, safety and cost between the two
      regimens. Its main purpose is to provide information, if calcineurin free immunosuppressive
      treatment is a valuable alternative in the treatment of de novo kidney transplant recipients.
      Furthermore, by investigating the side effects in both arms it will be possible to decide, if
      the absence of calcineurin inhibition and lack of nephrotoxicity will outweigh the adverse
      effects of Rapamycin. With the obtained information it will be possible to plan a larger
      trial, which is warranted to compare the mentioned treatment regimens in more detail.
    

Intervention name(s): Sirolimus; Cyclosporine A; Prednisone; Mycophenolate mofetil; Protocol biopsies
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention description(s): Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6; Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6; 0.5 mg/kg, tapering every two weeks until 0.1 mg/kg; 2 x 1000mg, through level above 2ug/ml; protocol kidney biopsies at month one and three
Other intervention name(s): Rapamune; Sandimmun neoral; CellCept
Intervention MeSH terms: Cyclosporine; Sirolimus; Mycophenolic Acid; Prednisone; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney transplantation; calcineurin inhibitor free; protocol biopsy; Cyclosporin A; Sirolimus
Study of Aripiprazole (Abilify) in Children With ADHD (Attention Deficit Hyperactivity Disorder)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      To look at the cognitive effects of abilify in children with a primary diagnosis of Attention
      Deficit Hyperactivity Disorder. To examine the safety, effectiveness and tolerability of
      abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.
    

Detailed description: 
      This will be a prospective, open-label, 6-week trial of APZ in outpatient children 8-12 years
      of age with a primary diagnosis of ADHD free of other major psychopathology. The six-week
      treatment phase will be proceeded by a 1-3 week screening phase.

      The study cohort will consist of 10 children with ADHD combined type and 10 children with
      ADHD predominantly inattentive type who complete the study.

      Cognitive measures will be assessed prior to APZ therapy and after 6 weeks of APZ treatment.

      Safety assessments and measures of ADHD symptomatology will be collected prior to and during
      APZ therapy.

      While receiving APZ treatment, patients will be seen at baseline, Week 1,2,3,4, and 6.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Open label
Other intervention name(s): As previously described.
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD
Infrared Bioeffect System for the Treatment of Cutaneous Warts
Condition: Cutaneous Warts; Human Papilloma Virus
MeSH terms: Warts; Papilloma
Study type: Interventional

Summary: 
      Local hyperthermia at 44℃ can promote some alterations of immulogical indicators. The
      procedure is convenient in clinic, has high tolerance with less trauma and less pain. Based
      on domestic and abroad clinical practice, the investigators observed initially that local
      hyperthermia brought great benefits to cutaneous warts. In comparison with liquid nitrogen,
      the safety and efficacy of controllable infrared bioeffect system to treat skin disease has
      been evaluated. This proved it could be used in treatment of skin warts, and clinical trial
      met the requirements of Standards for quality control of clinical trials on medical devices,
      and can be used in product registration and declaration.
    

Detailed description: 
      Mild local Hyperthermia with a certain temperature range has been successfully used in the
      treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal
      and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared
      HPV in more than half of the patients with plantar warts. Investigators also note the fact
      that in patients with multiple lesions, the clearance of the target lesion is commonly
      followed by clearance of other distant lesions, a phenomenon suggesting that local
      hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the
      purpose of the study is to evaluate the safety and efficacy of controllable infrared
      bioeffect system to treat cutaneous warts. This trial was designed into two groups, one was
      experimental group (thermal therapy group), the other one was control group (liquid nitrogen
      cryotherapy group). The ratio of participants was 1:1 in experiment group and control group.
      The main evaluation indicator was the recovery rate after 4 months of initial treatment.
    

Intervention name(s): liquid nitrogen; controllable infrared bioeffect system
Intervention type(s): Device; Device
Intervention description(s): As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied; As an experimental arm, for patients with cutaneous warts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperthermia; human papilloma virus; cutaneous warts
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in
      healthy male subjects to investigate the comparability of the pharmacokinetics of the
      fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using the
      proprietary on-body delivery system or a handheld syringe with hypodermic needle.
    


Intervention name(s): Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC); Handheld Syringe with Hypodermic Needle; On-Body Delivery System
Intervention type(s): Drug; Device; Device
Intervention description(s): A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the anterior thigh, using either a handheld syringe with hypodermic needle (Arm 1) or the on-body delivery system (Arm 2).; A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using a handheld manual syringe.; A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using the on-body delivery system.
Other intervention name(s): Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf; PHESGO®; RO7198574; RG6264
Intervention MeSH terms: Trastuzumab; Pertuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Multivitamin Comparison Study in Kidney Transplant Recipients.
Condition: Kidney Transplant Recipients
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being done to compare arteriosclerotic cardiovascular disease in kidney
      transplant recipient taking a standard multivitamin versus those taking a multivitamin
      augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.
    

Detailed description: 
      This is a multicenter, randomized, double-blind controlled clinical trial. The trial has been
      designed to determine whether total homocysteine lowering treatment with a standard
      multivitamin augmented by a multivitamin containing no folic acid B12, and vitamin B6, versus
      treatment with an identical multivitamin containing no folic acid, will reduce the pooled
      rate of recurrent or new cardiovascular disease outcomes or events. Participants will have a
      brief visit, at which the participant will have physical measurements, blood pressure and
      history taken. Urine and blood tests will be performed to determine the levels of
      homocysteine, vitamins and creatinine. Qualifying participants will be randomly assigned to
      receive multivitamins containing a high dose of folic acid, vitamin B6, and vitamin B12, or
      an identical multivitamin containing no folic acid, and estimated average requirement amounts
      of vitamin B6 and vitamin B12. The participant will be required to return annually throughout
      the next five years for physical exams, blood and urine tests.
    

Intervention name(s): Multivitamin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 tablet a day; 1 tablet a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
Condition: Liver Cirrhosis; Portal Vein Thrombosis
MeSH terms: Liver Cirrhosis; Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with
      nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
    

Detailed description: 
      Portal vein thrombosis (PVT) is a frequent complication of liver cirrhosis, referred to
      partial or complete thrombosis formed in the lumen of portal vein or/and branches of it.
      Currently, clinical guidelines of PVT in cirrhotic patients has not been addressed, and
      anticoagulant therapy of PVT patients with cirrhosis remains controversial. Although
      numerable studies have reported that anticoagulation therapy is effective, while a majority
      of them were respective and a few took control into consideration. In addition, no agreement
      has reached about the safety of anticoagulation. So, the efficacy and safety of anticoagulant
      therapy needs more prospective randomized controlled trial to be investigated.
    

Intervention name(s): Nadroparin calcium, warfarin
Intervention type(s): Drug
Intervention description(s): Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
Other intervention name(s): Experimental group
Intervention MeSH terms: Nadroparin; Warfarin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Portal vein thrombosis; Nadroparin calcium; Warfarin; Anticoagulation
Positioning and Gastric Aspiration in Ventilated Premature Infants
Condition: Respiratory Aspiration of Gastric Contents
MeSH terms: Respiratory Aspiration of Gastric Contents; Respiratory Aspiration
Study type: Interventional

Summary: 
      Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving
      mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific
      marker for aspiration. The objective of this study is to examine if TA pepsin will change
      when ventilated premature infants are positioned in two different positions; on their back
      vs. on their right side.
    


Intervention name(s): Right side position
Intervention type(s): Behavioral
Intervention description(s): Enrolled infants are positioned on their back or right side. Tracheal aspirate is assessed for pepsin concentration as an index of aspiration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design :

      - A single center, open, randomized, single dose, two-period, two-treatment, two-sequence,
      crossover study
    

Detailed description: 
      Primary Objective:

      - To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus
      two co-administered products containing amlodipine and losartan
    

Intervention name(s): Amlodipine plus Losartan; Amlodipine, Losartan
Intervention type(s): Drug; Drug
Intervention description(s): Amlodipine/Losartan high dose; Amlodipine, Losartan
Intervention MeSH terms: Losartan; Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Amlodipine, Losartan
Chiauranib in Combination With Chidamide in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma
Condition: Non-hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this dose-escalation study is to assess the safety and tolerability of
      treatment with Chiauranib and Chidamide administered orally over a range of doses in patients
      with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the
      pharmacodynamic profile and latent biomarkers accompany with Chiauranib and Chidamide , as
      well as the relevancy of which and clinical benefit.
    

Detailed description: 
      The purpose of this study is to assess the tolerability and safety include adverse events,
      vital signs, laboratory tests ,etc., of a range of doses of Chiauranib and Chidamide in
      patients with relapsed or refractory non-Hodgkin's lymphoma, and to determine the dose limit
      toxicity and the maximum tolerable dose.

      In the meantime, exploring the pharmacodynamic profile and latent biomarkers accompany with
      Chiauranib and Chidamide , as well as the relevancy of which and clinical benefit.
    

Intervention name(s): Chiauranib; Chidamide
Intervention type(s): Drug; Drug
Intervention description(s): In the lead-in period, patients take 50mg Chiauranib capsules on the forth day .
In the subsequent treatment cycles, Chiauranib capsules are given orally once daily, 28 days as a cycle.; In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8,11,15,18,22 and 25 of each cycle. 28 days as a cycle
Other intervention name(s): CS2164; CS055
Intervention MeSH terms: Chiauranib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to
      evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a
      single qualifying Tension-Type-Headache (TTH).
    

Detailed description: 
      The study will be conducted in 4 periods (the Screening Period, the Run-In Period, the
      Double-Blind Treatment Period and the Follow-up Period) and 4 visits (the Screening Visit,
      Enrollment Visit, Randomization Visit and End-of-Study Visit).

      Screening Period- Eligible subjects who provide written informed consent to participate will
      have study assessments performed at the Screening.

      Run-In Period- The Run-In Period will last for at least 28 days. During the Run-In period,
      subjects will be assessed for frequency of headache, study compliance and to ensure they meet
      all required study criteria for randomization.

      Double-Blind Treatment Period- The Double-Blind Treatment Period (Treatment Period) will last
      up to 4 weeks or until a qualifying headache episode has occurred and been treated using the
      study drug, whichever occurs first.

      Follow-up Period- All subjects will return to the investigational site for this visit,
      regardless of whether they have treated a qualifying TTH with study medication. Subjects who
      have not treated a qualifying TTH with study drug during the Treatment Period will be asked
      to return study materials and undergo safety evaluations at the End-of-Study Visit and will
      be discharged from the study. Subjects who have treated a qualifying TTH with study drug
      during the Treatment Period will ingest a 140 mg dose of open-label TNX-201 at this visit and
      undergo urine and blood sample collection for 3 hours post-dose to characterize each
      subject's genetic metabolism and PK profile.
    

Intervention name(s): TNX-201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TNX-201 capsule; Placebo capsule
Other intervention name(s): (R)-isometheptene mucate; TNX-201 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment