bioihbjkbjnl/mcl2 huggingface dataset:
Acceptance Therapy During Methadone Detoxification
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop an opiate detoxification behavior therapy based on
      current Acceptance and Commitment Therapy (ACT) theory and method, and to test its
      feasibility and promise in the context of voluntary methadone detoxification.
    

Detailed description: 
      This Stage I pilot study will employ a randomized, controlled, between groups design in which
      70 opiate dependent patients seeking methadone detoxification will be randomized into one of
      two treatment conditions: ACT opiate detoxification therapy or Drug Counseling. Both
      therapies will be delivered in the context of a 5-month methadone dose reduction based on a
      linear dosing strategy. Efficacy variables will include: (1) abstinence rates during and
      1-month after detoxification as assessed by regular urine screens; (2) retention of patients
      in treatment; and (3) patient satisfaction and treatment acceptability. Reduction in
      HIV/Hepatitis C risk behaviors and changes in psychosocial functioning (e.g., employment,
      family, legal) will also be explored, along with mediators/moderators of the therapy (i.e.,
      experiential avoidance). Subjects will be recruited from Houston area methadone clinics and
      the general community via advertising and will receive methadone as part of this protocol. A
      2-4 week stabilization period will precede the 5-month methadone dose reduction. During the
      dose reduction, participants will attend the clinic twice each week and will receive weekly
      therapy. Participants will be contacted for follow up assessments up to one month post
      treatment.
    

Intervention name(s): Behavior Therapy; Drug Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Act-ODT intervention will consist of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opiate; Behavior Therapy; Methadone; Acceptance and Commitment Therapy (ACT)
Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the efficacy of Nile tilapia skin as a xenograft for the
      treatment of partial-thickness burn wounds in children.
    

Detailed description: 
      This is an open-label, monocentric, randomized phase II pilot study conducted in Fortaleza,
      Brazil. The study population consisted of 30 children between the ages of 2 and 12 years with
      superficial "partial-thickness" burns admitted less than 72 hours from the thermal injury. In
      the test group, the tilapia skin was applied. In the control group, a thin layer of silver
      sulfadiazine cream 1% was applied.
    

Intervention name(s): Tilapia skin; silver sulfadiazine cream 1%
Intervention type(s): Other; Drug
Intervention description(s): After cleaning the lesion with tap water and 2% chlorhexidine gluconate, the tilapia skin was applied and covered with gauze and bandage. These dressings were changed only if the tilapia skin did not adhere properly to the wound bed; After cleaning the lesion with tap water and 2% chlorhexidine gluconate, a thin layer of silver sulfadiazine cream 1% was applied and covered with gauze and bandage. In these patients, the dressings were changed daily
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an open-label, monocentric, randomized phase II clinical trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Burns; Wounds and Injuries; Biocompatible Materials; Nile Tilapia; Oreochromis niloticus
Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To evaluate the effect of fumigation in conjunction with acupuncture for knee osteoarthritis,
      participators were collected from acupuncture and Chinese traumatology clinic at Linsen
      Chinese Medicine and Kunming Branch, Taipei City Hospital. Participators were randomized into
      3 groups, one for acupuncture with fumigation, one for acupuncture with diluted fumigation,
      one for acupuncture only.
    

Detailed description: 
      Patient population. Between June 2015 and November 2017, research subjects were recruited via
      poster display and clinician referral, to participate in a three-armed, randomized,
      controlled trial to be conducted in the Traumatology Department Linsen Chinese Medicine and
      Kunming Branch, Taipei City Hospital.
    

Intervention name(s): Fumigation; Acupuncture
Intervention type(s): Other; Other
Intervention description(s): use Fumigation to increase the improvement of osteoarthritis of knee; Acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee; Fumigation; Acupuncture
Pharmacokinetic Study of an Acute Gout Regimen
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of
      1.8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this
      regimen in healthy volunteers. To this end, all study subjects will be monitored for adverse
      effects throughout the entire study period.
    

Detailed description: 
      This study aims to characterize the pharmacokinetic profile of colchicine and its three main
      metabolites, after a regimen of 1.8 mg over two hours. After a fast of at least 10 hours,
      fifteen healthy non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18
      and 55 will be given colchicine 1.2 mg (2 x 0.6 mg) orally followed by an additional single
      0.6mg dose one hour later. Fasting will continue for 4 hours after the first dose at which
      time a standardized meal will be served. Blood will be drawn from all participants at times
      sufficient to adequately define the pharmacokinetics of colchicine and its 3 major
      metabolites, 2, 3 and 10 demethylcolchicine. A further goal of this study is to evaluate the
      safety and tolerability of this regimen in healthy volunteers. To this end, subjects will be
      monitored throughout participation in the study for adverse reactions to the study drug
      and/or procedures. Seated and standing blood pressure and pulse will be measured prior to the
      first dose and 0.5, 1, 2, 4, and 12 hours post-dose. Twelve-lead electrocardiograms will be
      obtained at the same time points. All adverse events whether elicited by query, spontaneously
      reported, or observed by clinic staff will be evaluated by the Investigator and reported in
      the subject's case report form.
    

Intervention name(s): colchicine tablets
Intervention type(s): Drug
Intervention description(s): colchicine 1.2mg initially; then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours)
Other intervention name(s): COLCRYS TM
Intervention MeSH terms: Colchicine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; blood levels
A Comparative Study of Volume Replacement With HES 130/0.4 Versus Ringer's Lactate (RL) Regarding Their Effects on Inflammatory Biomarkers (Cytokines and Matrix Metalloproteinases) Responses to Major Abdominal Surgery.
Condition: Postoperative Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Various stimuli such as trauma, infection and major surgery may alter the physiologic immune
      balance and initiate systemic inflammatory processes. This pathophysiological event is
      characterized by the release of potent inflammatory mediators into the circulation.

      Among these, pro- and anti-inflammatory cytokines such as interleukin-6 (IL-6), IL-8 or
      IL-10, ICAM-1 play a dominant role as local or systemic regulators in the acute inflammatory
      response. Recent studies have also investigated the role of matrix metalloproteinases (MMPs)
      in the inflammatory response. The MMPs constitute a family of enzymes that are structurally
      related neutral proteinases. MMPs can degrade essentially all extracellular matrix (ECM)
      components and play an important role in wound healing and remodeling of the ECM. The
      Tissutal Inhibitor MetalloProteine (TIMPs) are important regulator of MMPs activity.

      The inflammatory response coming of surgery mainly affects surgical patients' outcome. Many
      factors may attributed to this response, such as the kind of operation, the extent of
      surgical trauma, the patient's medical history and therapy, as well as the type of anesthesia
      used. Apart from that, the kind of fluids administered for volume replacement was revealed to
      alter the inflammatory processes. Several studies have addressed on this issue mainly
      involved abdominal surgery and provided compelling evidence that perioperative fluid
      optimization produces benefits for the patient, with regard to inflammatory biomarkers such
      as cytokines, matrix metalloproteinases, intercellular adhesion molecule-1(ICAM-1). They
      support that the different volume replacement strategies, using only crystalloids or
      combination of crystalloids with colloids (HES 130/0,4), may have important impact on immune
      response. However, the relevant studies investigated different inflammatory biomarkers, and
      usually involved either metalloproteinases, and their inhibitors (TIMPs) or cytokines.

      In our study we investigated the hypothesis that intra- and postoperative volume replacement
      with HES attenuates inflammatory response to elective abdominal surgery compared to RL fluid
      therapy. For this purpose both metalloproteinases, MMP-9, MMP-13, their inhibitor, TIMP-1,
      cytokines, IL-6, IL-8 and the intercellular adhesion molecule-1, ICAM-1 were investigated
      postoperatively. Their changes during the first 24 postoperative hours consisted our primary
      outcomes.
    


Intervention name(s): Ringer's Lactate; HES 130/0.4 and Ringer's Lactate
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
Condition: Diabetes Mellitus, Non-Insulin-Dependent; Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to contrast the pharmacokinetic profiles of metformin
      and EPA delivered separately as co-administered products (metformin hydrochloride or
      Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin
      eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to
      evaluate the safety and tolerability of single and repeat single doses of TP-101.
    


Intervention name(s): Metformin Eicosapentaenoate; Metformin HCl and Vascepa
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; T2DM; hypertriglyceridemia; severe hypertriglyceridemia; dyslipidemia; triglycerides; lipids; omega-3 fatty acids; EPA; ethyl-EPA; Metformin; Glucophage; Lovaza; Vascepa; Epanova; Astra Zeneca; Amarin; GSK
Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Volunteers (14 Day Multiple Ascending Dose)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves the use of an investigational drug called NGP 555. In each group of
      healthy subjects, 2 people will receive placebo and 6 people will receive NGP 555.
    

Detailed description: 
      The purpose of this research study is to determine the safety, tolerability, and
      pharmacokinetics (PK) of multiple (14 days), oral doses of NGP 555 in healthy volunteers.

      NGP 555 has been created for the treatment of Alzheimer's disease (AD). NGP 555 is being
      developed to prevent Abeta 42 amyloid formation, a protein that is likely a key factor in the
      development of AD.
    

Intervention name(s): NGP 555
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The current project will use the Complete Health Improvement Program (CHIP) as an
      intervention for patients with chronic pain. CHIP is a nationally recognized program that
      encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social
      support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared
      to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that
      patients who complete CHIP will have increased telomerase activity and longer relative
      telomere length at follow-up when compared to those who do not enroll in the program.
      Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres
      are the caps on these chromosomes that protect them from damage. Telomere shortening occurs
      normally with aging and once they are too short to replicate cellular death occurs.
      Telomerase is a ribonucleic protein that counterbalances this shortening by extending the
      ends of chromosomes. Research has shown that patients with chronic pain may have shorter
      telomeres relative to others of the same age. This study will investigate this association
      further.
    


Intervention name(s): The Complete Health Improvement Program
Intervention type(s): Behavioral
Intervention description(s): The Complete Health Improvement Program is a nationally recognized program that encourages a diet of whole plant based foods, moderate exercise, stress reduction, and social support.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: chronic pain; telomere; telomerase; life style
"Information Technology Methodology for Patient Motivation in Diabetes Management."
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Type 2 diabetes is a chronic metabolic disorder requiring lifestyle modification and
      medicines, adherence to which has to be practised on a daily basis.

      Motivation of patients to adhere to treatment is difficult in clinical practice. It is well
      documented that majority of patients do not reach the glycaemic targets even in the centres
      of excellence. Regular short service messages (SMS) through cell phones could have a positive
      effect on behaviour and adherence to life style changes and compliance to drugs. It may be
      practical and feasible to use information technology as an effective and simple tool for
      motivating patients to adhere to the prescribed treatment regimen.

      In diabetic patients, frequent reminders regarding the need for adherence to LSM and drugs by
      the medical professionals will improve the compliance.
    

Detailed description: 
      In diabetic patients, frequent reminders by the medical professionals on the need for
      adherence to Life Style Modification (LSM) and drugs will improve the compliance. SMS may be
      an effective and cheap tool of communication. Improved compliance is likely to result in
      better glycaemic control.

      Out of total number of 200, consecutive randomization of 100 patients each to SMS or usual
      care arms will be done. Patients in the SMS group will get SMS once in 3 days as a reminder.
      Patients will be reviewed at 3, 6, 9 and 12 months from the date of randomization

      Fasting and 2hr postprandial glucose and HbA1c will be tested during each visit.

      At baseline and at the end of the study, lipids, and renal function test will also be done. A
      validated questionnaire will be used to assess physical activity, diet habits, adherence to
      drug prescriptions and frequency of monitoring of blood glucose. . Body weight, blood
      pressure, biochemical variables, scores for diet and physical activity and compliance to
      drugs, will be compared using students 't' test or chi-square test as relevant.
    

Intervention name(s): Pre-coded messages; Diabetes Treatment
Intervention type(s): Behavioral; Drug
Intervention description(s): Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder; Life style modification and drug therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Life style modification,; Type 2 diabetes,; SMS,; Patient adherence
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
Condition: Asthma in Children
Study type: Interventional

Summary: 
      This is an early phase pilot study designed to test the safety and feasibility of using a
      novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume,
      respiration rate, heart rate and indices related to tidal breathing flow volume loop) in
      children with respiratory condition (such as asthma).

      There is no product currently on the market that is comparable to this novel Leo device

      The study consists of a single visit to evaluate the feasibility and safety of using the Leo
      device on 20 children with clinically stable asthma.

      Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.

      There will be no disease-specific intervention, nor changes to the participant's care
      management program for their asthma.
    


Intervention name(s): Leo device
Intervention type(s): Device
Intervention description(s): Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.
Other intervention name(s): Pneumotachometer (BioPaC systems, Inc., Goleta, CA, USA) connected to anti-bacterial filter and mouth piece.
Intervention MeSH terms: Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Incretin Effect on the Immunological Phenotype
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune
      cells in healthy subjects and patients with type 1 diabetes
    

Detailed description: 
      Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the
      peripheral blood.
    

Intervention name(s): Liraglutide; Saxagliptin
Intervention type(s): Drug; Drug
Intervention description(s): once daily subcutaneous injection; once daily tablet
Other intervention name(s): Victoza; Onglyza
Intervention MeSH terms: Liraglutide; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autoimmune disease; diabetes type 1; incretin effect
The Effects of Dexmedetomidine on Early Stage Renal Functions in Pediatric Patients
Condition: Renal Function Disorder; Hemodynamic Instability
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage
      renal function.
    

Detailed description: 
      Background: Contrast-induced nephropathy is the third most common cause of acute renal
      failure in hospitalized patients in all age groups. In this study we aimed to investigate the
      effects of dexmedetomidine on early stage renal function in pediatric patients undergoing
      cardiac angiography.

      Methods: 60 pediatric patients between 6 and 72 months of age undergoing cardiac angiography
      were included in the study. Patients were divided into two groups. The patients in both
      groups were administered 1mgkg-1 ketamine, 1mgkg-1 propofol as bolus and followed by 1
      mgkg-1hour-1 ketamine and 50 µgkg-1min-1 propofol infusion. Additionally, a loading dose of 1
      µgkg-1 dexmedetomidine given over 10 minutes followed by 0.5 µgkg-1hour-1 dexmedetomidine
      infusion to patients in group D. The patients were evaluated for NGAL, creatinine, renin,
      endothelin-1, TAS and TOS blood levels before the procedure and 6th and 24th hours after the
      procedure. pRIFLE criteria were used to define CIN and its incidence in the study.
    

Intervention name(s): Dexmedetomidine; Ketamine; Propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a loading dose of 1 µg kg-1 dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) IV given over 10 minutes, followed by 0.5 µg kg-1 hour-1 IV dexmedetomidine infusion were administered. Dexmedetomidine was prepared as a 1 µg ml-1 solution using D5 0.3% NaCl solution.; ketamine was bolused with 1 mg kg-1(IV) and followed by 1 mg kg-1 hour-1 ketamine IV infusion during the procedure.; propofol was bolused 1 mg kg-1 and 50 µg kg-1 min-1 propofol (IV) infusion during the procedure.
Other intervention name(s): Precedex; Ketalar; Pofol
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Contrast-induced nephropathy, Dexmedetomidine, Endothelin-1