bioihbjkbjnl/mcl2 huggingface dataset:
Limb Loss Self-Management Program
Condition: Congenital or Acquired Limb Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the project is to develop and test the efficacy of a community-based
      self-management intervention for reducing pain, depression, and improving self-efficacy and
      function in person with limb loss
    

Detailed description: 
      Approximately 1.2 million Americans are living with the loss of a limb and the incidence is
      increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced
      functional abilities are common conditions following limb loss and reduce quality of life.
      Self-management interventions have been found to be effective in reducing the secondary
      conditions associated with arthritis and diabetes. Self management uses the principles of
      cognitive-behavioral therapy including education, self monitoring, problem solving, and skill
      acquisition.

      The goal of the project is to develop and test the efficacy of a community based self
      management intervention for reducing pain, depression, and improving self efficacy and
      function in persons with limb loss using a randomized controlled design.

      50 groups of 8-10 persons will be randomized to either a control group or a treatment group.
    

Intervention name(s): Community-based eight session group self-management program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon
      like peptide 1) reduces intestinal production of lipoprotein particles. The investigators
      therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will
      reduce intestinal lipoprotein production in humans. The investigators are unable to speculate
      whether sitagliptin will affect hepatic lipoprotein production because of lack of of data
      from animal studies or in vitro data. Sitagliptin is already an approved treatment for type 2
      diabetes.
    

Detailed description: 
      Each subject will be studied twice 4-6 weeks apart in random order in this single blinded
      study. In study A they will receive a single dose of sitagliptin 100mg od. In study B they
      will receive placebo. A nasoduodenal tube will be sited under fluoroscopic guidance the day
      prior to the study. On the day of the study regular liquid formula (Great shake plus) will be
      infused from 4am through the tube to maintain a constant fed state. A pancreatic clamp
      (octreotide with replacement glucose, insulin and growth hormone) along with
      saline/sitagliptin will be started at 7am. From 9am an iv bolus of deuterated-glycerol
      (d5-glycerol) along with a regular infusion of deuterated leucine (L-[5,5,5-2H3]. Regular
      blood samples will be drawn to assess lipoprotein kinetics.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin, 100mg, oral, single dose; Placebo, oral, single dose
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intestinal lipoprotein; Apolipoprotein B48 and apolipoprotein B100; Pancreatic clamp; DPPIV inhibitor
Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability
      and pharmacokinetics of multiple ascending doses of PF-05231023.
    


Intervention name(s): PF-05231023; PF-05231023; PF-05231023; PF-05231023; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 5 mg IV twice a week for 4 weeks; 25 mg IV twice a week for 4 weeks; 100 mg IV twice a week for 4 weeks; 200 mg IV twice a week for 4 weeks; 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week IV for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; safety; multiple dose; intravenous
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction
Condition: Coronary Artery Disease; Acute Myocardial Infarction With ST-segment Elevation; Primary Percutaneous Coronary Intervention; Early Discharge
MeSH terms: Coronary Artery Disease; Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The aim of the study is to prove that early discharge (within 72 hours) in selected group of
      patients after myocardial infarction with elevations of ST-segment is feasible and safe
    

Detailed description: 
      The aim of the study is to prove

        -  that early discharge (within 72 hours) in selected group of patients with low risk of
           follow-up complications after myocardial infarction with elevations of ST-segment,
           treated with primary percutaneous coronary intervention, is feasible and safe

        -  that early discharge is comparable with the group of patients, discharged in a standard
           way accordingly with present practice and physician´s decision (usually 4th-7th day),
           thus it is not associated with higher incidence of complications in 90th day after
           myocardial infarction
    

Intervention name(s): Early discharge; Standard discharge
Intervention type(s): Other; Other
Intervention description(s): Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention; Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ST-segment elevation myocardial infarction; Primary percutaneous coronary intervention; Low risk; Early discharge
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20
      mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
    

Detailed description: 
      This study aims to compare the absorption and disposition kinetics of two products containing
      rosuvastatin under fasting conditions. These products are: Rosuvastatin/ Verisfield 20 mg
      film-coated tablets, a Test product manufactured by HELP S.A., Greece and Crestor™/
      AstraZeneca 20 mg film-coated tablets, a Reference product manufactured by AstraZeneca, UK.
      The bioequivalence of a single 20 mg dose of both products will be assessed by comparing the
      pharmacokinetic parameters derived from the plasma concentration-time profiles for
      rosuvastatin.
    

Intervention name(s): Rosuvastatin 20 mg film-coated tablets; Crestor 20 mg film-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 20 mg; Single oral dose of 20 mg
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; two rosuvastatin-containing products
Chronic Widespread Pain and White Blood Cell Activation
Condition: Widespread Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Our goal is to conduct a proof-of-concept trial to test the efficacy of KF treatment in
      adolescents with severe CWP not responding to the standard of care (SOC) treatment program in
      a multidisciplinary tertiary care chronic pain clinic. The changes associated to the
      interventions (KF or placebo) will be quantified using the Patients' Global Impression of
      Change (PGIC) scale after 16 weeks of treatment. Secondary, we aim to evaluate the effects of
      KF on the pain sensitivity, physical and emotional functioning, and we will also explore the
      potential biological underlying mechanisms.
    

Detailed description: 
      We have designed a proof-of-concept (POC) trial composed of three arms. The first two arms
      will be a randomized, controlled, double-blind, parallel-group study, designed to assess the
      potential efficacy of KF for the treatment of pain and associated symptoms in adolescent with
      CWP. The third arm will consists of assessing standard of care (SOC) data from patients who
      do not wish to participate in the study, but agree to allow us to use their SOC data to be
      compared with that of patients participating in the study. This arm will help to evaluate the
      potential beneficial effect of being part of the study ("placebo" effect) receiving a new
      treatment for a condition where the SOC have limited success rate.
    

Intervention name(s): Ketotifen Fumarate; Placebo; Standard of Care
Intervention type(s): Drug; Drug; Other
Intervention description(s): Ketotifen is a second-generation noncompetitive H1-antihistamine and mast cell stabilizer. It is most commonly sold as a salt with fumaric acid, ketotifen fumarate, and is available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis, or the itchy red eyes caused by allergies. In its oral form, it is used to prevent asthma attacks.
Other intervention name(s): Zaditen
Intervention MeSH terms: Ketotifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pain; ketotifen; pediatric; mast cell
Randomized Controlled Trial to Compare Two Anti-scorpion Serums
Condition: Scorpion Sting
MeSH terms: Scorpion Stings
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficiency and safety of the treatment against
      sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum
    

Detailed description: 
      We consider relevant conduct this study because the poisoning scorpion bite represents a
      public health problem.

      This is a randomized clinical trial, which included 120 subjects of both sexes aged 15 and 60
      years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients
      received antiscorpion serum of Birmex and 60 patients receive other commercial serum.
    

Intervention name(s): serum antiscorpion
Intervention type(s): Biological
Intervention description(s): The dose may be required for the patient according to clinical manifestations and evolution
Other intervention name(s): anti-Scorpion venom Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Rhythmic Auditory Stimulation & Gait Training
Condition: Multiple Sclerosis; Gait Disorders, Neurologic
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic; Sclerosis
Study type: Interventional

Summary: 
      This study will enroll patients with Multiple Sclerosis and some difficulty with walking. The
      purpose of this study is to use Rhythmic Auditory Stimulation (RAS) a music therapy technique
      that provides rhythmic auditory cues (like a beat) to help improve a patient's movements,
      especially when walking.

      Participants will be asked to participate in a walking program (WP) with Rhythmic Auditory
      Stimulation (RAS), or a WP without RAS.
    

Detailed description: 
      Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic
      auditory cues (like a beat) to help improve patients' movements, especially when walking. The
      RAS can be delivered at a fixed tempo or interactive tempo.

      The device used in this study will deliver an interactive tempo. The equipment will include a
      mobile device app and sensors that are attached to the participant's shoes. Headphones and
      smartphones will be required to use the device and will be provided to the study team and
      kept at the center for this study. The device is designed to use audio cues to facilitate
      improvements in the participant's walking speed while listening to music.

      The overall purpose of this study is to assess the safety and acceptability of interactive
      RAS music combined with gait training in individuals with MS and walking impairment, and to
      gather preliminary efficacy data for future studies.
    

Intervention name(s): Rhythmic auditory stimulation; Gait Training
Intervention type(s): Other; Other
Intervention description(s): RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.; Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.
Other intervention name(s): RAS; GT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Gait analysis; Music therapy; Multiple sclerosis
Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the effects of GLP-1 analogues combined with metformin and metformin on gonadal and
      metabolic profiles in PCOS patients with BMI ≥ 24 in China. 60 cases of overweight PCOS
      patients were collected from Shengjing hospital. The intervention period was 3 months after
      intervention with met or met + GLP-1. To evaluate the improvement of met or met + GLP-1 in
      the treatment of hyperandremia, glucose metabolism, BMI, waist circumference, menstruation,
      hairiness and acne in PCOS patients with different BMI.
    


Intervention name(s): Metformin; Exenatide
Intervention type(s): Drug; Drug
Intervention description(s): Use Metformin for 3 months to treat PCOS; Use Exenatide for 3 months to treat PCOS
Intervention MeSH terms: Metformin; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4
Condition: Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone
      antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation
      study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will
      participate in a multiple dose escalation study of increasing intravenous doses of MRX-4
      given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable
      intravenous dose of MRX-4 to determine bioavailability.
    


Intervention name(s): Single intravenous doses of MRX-4; Single intravenous doses of placebo; Multiple intravenous doses of MRX-4; Multiple intravenous doses of placebo; Single dose of intravenous and oral MRX-4
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous single escalating doses of MRX-4; Intravenous single doses of placebo to match MRX-4; Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days; Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days; Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 3

Summary: 
      The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute
      cough as compared to a placebo syrup.
    

Detailed description: 
      Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other
      natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will
      be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough
      score) and symptoms, impediment of normal life activities (school, sleeping), the number of
      medical visits and type of medication needed if any.
    

Intervention name(s): AboMeg-B-09; Placebo
Intervention type(s): Device; Other
Intervention description(s): Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period; Placebo syrup: 5ml to be taken 4 times a day during the entire study period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatric; children; acute cough; treatment; syrup; protective natural extracts
Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain
Condition: Postmastectomy Pain
Study type: Interventional

Summary: 
      Perioperative analgesia for surgery in carcinoma breast utilizes significant quantities of
      opioids as compared to cosmetic breast surgeries. Regional anesthesia reduces the need for
      perioperative opioids and thus may improve the outcome. The investigators decided to perform
      the modified pectoral nerve block ( Pec II) under vision after resection of tumor, without
      ultrasound and compare the postoperative analgesic and opioid sparing effects of the nerve
      block with ultrasound guided modified pectoral nerve block (Pec) in patients undergoing
      modified radical mastectomy.
    


Intervention name(s): Direct pecs block; Ultrasound guided pecs block; general anaesthetic technique only
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Patients will receive direct PECS block by surgeon after closure of pectoralis muscle under direct vision and before skin closure.
All patients will receive the same general anaesthetic technique: In the form of iv induction by propofol 2mg /kg ,fentanyl 2 mic/ kg and intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane 1.5 MAC and incremental doses of atracurium 0.15 mg/kg every 20 min. At the end of surgery neuromuscular blocker reversed by neostigmine 50 micg/kg + atropine 20 micg /kg i.v.; Patients will receive ultrasound guided pecs block after induction and before skin incision.
All patients will receive the same general anaesthetic technique: In the form of iv induction by propofol 2mg /kg ,fentanyl 2 mic/ kg and intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane 1.5 MAC and incremental doses of atracurium 0.15 mg/kg every 20 min. At the end of surgery neuromuscular blocker reversed by neostigmine 50 micg/kg + atropine 20 micg /kg i.v.; All patients will receive the same general anaesthetic technique: In the form of iv induction by propofol 2mg /kg ,fentanyl 2 mic/ kg and intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane 1.5 MAC and incremental doses of atracurium 0.15 mg/kg every 20 min. At the end of surgery neuromuscular blocker reversed by neostigmine 50 micg/kg + atropine 20 micg /kg i.v.
Other intervention name(s): 10 ml bupivacaine 0.25%; 10 ml bupivacaine 0.25%
Intervention MeSH terms: Bupivacaine; Anesthetics; Anesthetics, General
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Ultrasound guided pecs block; Direct pecs
An Open Label Phase I/II Study of Dopamine Transporter Receptor Occupancy With OROS and Immediate Release Methylphenidate as Measured With C-11 Altropane in Human Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      The specific aim of this study is to document the pharmacokinetics of DAT receptor occupancy
      of OROS and immediate release (IR) MPH using PET scanning with C-11 altropane as the ligand.
      We hypothesize that the time to maximal receptor occupancy and the degree of receptor
      occupancy of immediate release (IR) MPH will be shorter and greater (respectively) than with
      an equipotent dose of OROS MPH.
    

Detailed description: 
      This protocol seeks to document the pharmacokinetics of DAT receptor occupancy of OROS and
      immediate release (IR) MPH using PET and C-11 altropane. The main target of MPH in the brain
      is the dopamine transporter (DAT). We have an exquisitely sensitive methodology to measure
      DAT occupancy using C-11 Altropane and Positron Emission Tomography (PET). This research will
      provide novel and unique information toward a better understanding of the mechanism of action
      of long-acting stimulant formulations to enable new drug development and an estimation of the
      relative abuse potential of the current formulation.
    

Intervention name(s): OROS methylphenidate hydrochloride; immediate release methylphenidate hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Phase 1 Study of SK3530 to Investigate of the Effect of Food
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to investigate the food effect of SK3530 on the pharmacokinetics
      (PKs).
    

Detailed description: 
      The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food
      interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already
      accomplished and the results have provided useful information to the patients. The objective
      of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541)
      under the fasted and fed (low-fat meal and high-fat meal) conditions.
    

Intervention name(s): SK3530
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SK3530; Food effect; Pharmacokinetics