bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study Of Schizophrenia in Both Men and Women
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the effectiveness of a marketed drug in the
      treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period.
      Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and
      who fulfill the screening entrance criteria will have an assessment 1-7 days after the first
      visit to confirm eligibility.
    


Intervention name(s): lamotrigine
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; lamotrigine
Comparing Strategies for Translating Self-management Support Into Primary Care
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This project will test different ways of helping primary care practices to do a better job of
      self-management support (SMS) for their patients with diabetes.
    

Detailed description: 
      The specific aims of the proposed study are:

        -  Primary Specific Aims

             1. To conduct a cluster randomized trial to examine the reach, effectiveness,
                adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for
                patients with type 2 diabetes in primary care practice settings. Primary
                effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood
                pressure and Low Desity Lipprotein (LDL) cholesterol.

             2. To determine the incremental benefit, using the RE-AIM framework, of brief targeted
                practice coaching on the implementation of CTH in diverse primary care practices.

        -  Secondary Specific Aims

             1. To identify key practice characteristics (e.g., practice size, organization,
                setting, and level of experience with practice redesign efforts) that impact CTH
                RE-AIM. These results will inform dissemination of the CTH intervention.

             2. To determine the relative costs associated with implementing CTH and practice
                coaching to further inform dissemination efforts.
    

Intervention name(s): Self-management support education; Connection to Health Interactive Behavior Change Technology; Connection to Health plus Coaching (CTH+C)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Same as Arm Description; Same as Arm Description; Same as Arm Description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Primary Health Care; Self care
GEBT Lot-to-Lot and Biological Variability
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      The purpose of this study is to collect information regarding lot-to-lot variability in
      13C-Spirulina test meal lets and within-subject biological variability.
    

Detailed description: 
      In this study participants will participate in one or two arms of the study. In one arm the
      participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix
      drug lots. In the second arm, the participants will be administered GEBT tests from the same
      13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the
      FDA-approved labeling.
    

Intervention name(s): 13C-Spirulina GEBT
Intervention type(s): Diagnostic Test
Intervention description(s): Various lots of 13C-Spirulina GEBT test meals
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gastroenterology; Gastric emptying breath test
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
Condition: Neutropenia in Prematures
MeSH terms: Infections; Cross Infection; Premature Birth; Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Prevention trial of nosocomial infections in neutropenic prematures with G-CSF
    


Intervention name(s): filgrastim; dextrose 5%
Intervention type(s): Drug; Drug
Intervention description(s): The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%.; The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes.
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: neutropenia; prematurity; nosocomial infection; G-CSF
Human Mass Balance Study of Pyronaridine
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The combination of pyronaridine and artesunate is an antimalarial therapy in development.
      This mass balance study is intended to determine the rate and extent of excretion of total
      radioactivity in urine and feces following administration of a single oral micro-dose of
      14C-pyronaridine in humans.
    

Detailed description: 
      This is a monocenter, open-label, non-placebo-controlled, single-group, single-dose study.
      Six male subjects will receive a single dose of Pyronaridine 720 mg orally administered
      together with 14C-Pyronaridine (approx. 100 µg, 800 nCi (29600 Bq)).

      Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) and adverse
      events will be monitored throughout the study. Subjects will come to the clinic the evening
      before the dosing of Pyronaridine. After the drug intake at day 1, subjects will have regular
      in-house periods for specimen collection up to 87 days after the drug administration. Blood,
      feces and urine will be collected during the hospitalisation periods. Samples will be
      analyzed for radioactivity by Accelerator Mass Spectrometry (AMS).
    

Intervention name(s): 14C-labeled Pyronaridine
Intervention type(s): Drug
Intervention description(s): Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).
Intervention MeSH terms: Pyronaridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mass Balance; Accelerated Mass Spectrometry (AMS); microdose; Focus of the study: ADME
Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging
Condition: Breast Cancer
Study type: Observational

Summary: 
      The investigators hope to prove that radiation and surgical scarring does not result in
      changes that affect the MBI pattern 6-12 months after completion of treatment.
    

Detailed description: 
      The study will allow us to evaluate whether surgery and radiation have persistent effects on
      the breast tissue with regards to whether and how such changes impact MBI images and to
      determine whether the inflammatory changes due to treatment resolve within 6-12 months of
      completing treatment.
    

Intervention name(s): Molecular Breast Imaging
Intervention type(s): Device
Intervention description(s): Molecular Breast Imaging
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Women who are seen in the Mayo Clinic Breast Clinic
      
Keywords: Breast; MBI; Molecular; Molecular Breast Imaging; Dense breast tissue; Surgery; Radiation; BCT
Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients
      with osteoarthritis of the knee.
    

Detailed description: 
      Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low
      dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 weeks.
    

Intervention name(s): DA-5202 20mg; DA-5202 10mg; Na Hyaluronate 20mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once a week, intra-articular injection, for 3 weeks; once a week, intra-articular injection, for 3 weeks; once a week, intra-articular injection, for 3 weeks
Other intervention name(s): DA-5202 high dose; DA-5202 low dose; Hyruan Plus®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single-sided Deafness and Cochlear Implants
Condition: Sensorineural Hearing Loss (Disorder)
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      -  As the left and right hemisphere are specialized for different auditory tasks, the
           proposed study aims at demonstrating different consequences of right or left-sided
           deafness for the affected individual.

        -  Furthermore, the question should be answered if auditory deficits and plastic changes
           can be partially reversed by cochlear implantation of the deaf ear.

        -  Multicenter, prospective, open, non-randomized clinical trial with 5 patients with
           right-sided and 5 patients with left-sided sensineural deafness.

        -  Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG

        -  Comparison of pre-operative investigations with 10 healthy subjects (age and gender
           matched control group)

        -  Cochlea implantation

        -  Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization
           Audiometry, PET, EEG, Questionnaires

        -  Trial with medical device
    

Detailed description: 
      Postlingual single-sided deafness (SSD) is a type of hearing impairment with normal hearing
      in one ear and severely impaired hearing in the other ear. The condition induces multiple
      changes of neural plasticity in central auditory pathways. One manifestation reflects an
      increased common activation of the contralateral and ipsilateral pathways after stimulation
      of the normal hearing ear which is correlated with an increased activity between the
      contralateral and ipsilateral hemispheres. As the left and right hemisphere are specialized
      for different auditory tasks, the proposed study aims at demonstrating different consequences
      of right or left-sided deafness for the affected individual. Furthermore, the question should
      be answered if auditory deficits and plastic changes can be partially reversed by cochlear
      implantation of the deaf ear. It is assumed that some changes induced by SSD can be detected
      only by reversal through a cochlear implant.
    

Intervention name(s): cochlear implant
Intervention type(s): Device
Intervention description(s): Surgical implantation of a cochlear implant device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hearing loss; cochlear implant; PET; EEG; MEG
Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children
Condition: Postoperative Analgesia
Study type: Interventional

Summary: 
      The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal
      block compared with penil block for pediatric patients undergoing circumsion concerning
      postoperative analgesic consumption within 24 hours.
    

Detailed description: 
      In this prospective study, patients will be randomized into 2 groups, either receiving penil
      Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will
      be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to
      assess postoperative pain.
    

Intervention name(s): penil or pudendal nerve block in circumcision
Intervention type(s): Procedure
Intervention description(s): regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin
Condition: Erectile Dysfunction; Benign Prostatic Hyperplasia
MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and
      Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both
      together in a 3 period repeatedly.
    


Intervention name(s): Tadalafil; Tamsulosin; Tadalafil + Tamsulosin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tadalafil; Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents
Condition: Teen Pregnancy Prevention
Study type: Interventional

Summary: 
      Youth who participate in the Circle of Life (COL) program will report less sexual risk taking
      behavior compared to youth who do not receive the program.
    

Detailed description: 
      Youth who participate in the Circle of Life (COL) program will report less sexual risk taking
      behavior and fewer pregnancies compared to youth who do not receive the program.
    

Intervention name(s): mCOL; AS+
Intervention type(s): Behavioral; Other
Other intervention name(s): mCircle of Life; After-School Science Plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Teen pregnancy prevention; American Indian; Group-randomized trial
A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers
Condition: Diabetes Mellitus; Healthy Subjects
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effects of inhaled albuterol & fluticasone on one dose of TI
      Inhalation Powder. A total of 12 eligible subjects will be enrolled.
    


Intervention name(s): Technosphere Insulin (TI) Inhalation Powder; Albuterol (Salbutamol); Fluticasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3.0 U of human insulin. 5 or 10 mg or Technosphere Inhalation Powder, containing 15 0r 30 U of insulin.; 2 puff= 200ug total dose; 2 puffs= 500ug total dose
Intervention MeSH terms: Fluticasone; Albuterol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Males or Females subjects
Inflammatory Stress Response in Pediatric Inguinal Hernia Repair
Condition: Inguinal Hernia, Indirect; Children, Only; Inflammatory Response; Surgery; Interleukin-6; Tumor Necrosis Factor Alpha; C Reactive Protein; White Blood Cell Count, Leukocytes
MeSH terms: Hernia; Necrosis; Hernia, Inguinal
Study type: Interventional

Summary: 
      Today there are various surgical techniques for inguinal hernia. In this study, investigators
      want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating
      technique with open inguinal access. Investigators would compare both groups to find out
      witch one does the lesser inflammatory stress response on the organism.
    

Detailed description: 
      Inguinal hernia represents the protrusion of the abdominal cavity contents through the
      inguinal canal. Today there are various surgical techniques for inguinal hernia. In this
      study, investigators want to compare two standard methods that are regularly performed at the
      University hospital of Split at department of pediatric surgery. These are the ''PIRS''
      operating technique laparoscopy and modified "Marcy" operating technique with open inguinal
      access. The choice of operating technique depends solely on the choice of a chosen pediatric
      surgeon. Given the fact that the child is indicated for an operation, regardless of
      participation in the study, there are no significant risks of participating in this study,
      except for possible but rare complications resulting from the peripheral venous blood draw
      (haematoma, soreness and pain). To carry out this study, the child should be taken (drawn) 3
      peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after
      surgery) from which the laboratory parameters are taken and counted (Leukocytes, C - Reactive
      Protein, Interleukin 6 and Tumor necrosis factor α).

      Lab results would be compared between both groups to find out witch one does the lesser
      inflammatory stress response on the organism.
    

Intervention name(s): Operation - PIRS; Operation - MARCY
Intervention type(s): Procedure; Procedure
Intervention description(s): Operation by its known design for PIRS group; Operation by its known design for MARCY group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Inguinal Hernia, Indirect; Children, Only; Inflammatory Response; Surgery; Interleukin-6; Tumor necrosis factor alpha; C reactive protein; Leukocytes
Mindfulness Based Stress Reduction: Supportive Treatment for Adult Patients With Cancer and Their Partners
Condition: Cancer
Study type: Interventional

Summary: 
      The main purpose of this study is to evaluate the effects of the Mindfulness Based Stress
      Reduction (MBSR) training program that is offered in the investigator hospital, more
      specifically on quality of life, coping strategies and partner relationship by using
      questionnaires. To asses the possible impact of this treatment on the latter domain, partners
      of the patients with a cancer diagnosis are invited to join the training program.
    

Detailed description: 
      Patients with breast cancer often experience anxiety, depression, stress and reduced quality
      of life. As such, there is an increased interest in the implementation of the
      Mindfulness-Based Stress Reduction program as an additional supportive treatment. MBSR is a
      structured group program that aims at reducing stress levels by enhancing awareness of the
      present moment in combination with a non-judgemental attitude.

      The study evaluates the effects of an 8-week MBSR program on quality of life, mood,
      depression, stress and coping skills in breast cancer patients.

      Breast cancer patients of the Breast Clinic of the Universitair Ziekenhuis Brussel
      participate in the MBSR program. Before and after the training program patients filled out
      questionnaires evaluating quality of life, coping skills, emotional functioning, stress and
      aspects of mindfulness.
    

Intervention name(s): mindfulness based stress reduction program
Intervention type(s): Behavioral
Intervention description(s): 8-week mindfulness training program
Other intervention name(s): MBSR
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cancer patients; relatives or partners of cancer patients
Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common
      cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a
      placebo device.
    


Intervention name(s): ColdZyme; ColdZyme Placebo
Intervention type(s): Device; Device
Intervention description(s): ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol.
ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.; The placebo mouth spray solution has the following composition: ethanol (<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy
Condition: Healthy Volunteer
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in 2 parts. Part A will investigate the potential effect of
      PF-06865571 on the pharmacokinetics (PK) of PF-06882961 in healthy adult participants. Part B
      will evaluate the effect of PF-06882961 on the PK of PF-06865571, as well as the effect of
      PF-06865571 on the PK of PF-06882961 in overweight adults or adults with obesity who are
      otherwise healthy.
    


Intervention name(s): PF-06882961 followed by PF-06882961/PF-06865571; PF-06882961/PF-06865571 followed by PF-06882961; PF-06882961 + PF-06865571
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A - PF-06882961 20 mg single dose followed by Treatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose. There will be a washout interval between periods of at least 3 days.; Treatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose followed by Treatment A - PF-06882961 20 mg single dose. There will be a washout interval between periods of at least 3 days.; Period 1: PF-06865571 300 mg single dose (Day 1), Period 2: PF-06882961 10 mg twice daily dose titration up to 200 mg twice daily dosing (Days 3-46), Period 3: PF-06865571 300 mg single dose (Day 47) and PF-06882961 200 mg twice daily dosing (Days 47-48), Period 4: PF-06865571 300 mg twice daily dosing and PF-06882961 200 mg twice daily dosing (Days 49-62)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science