bioihbjkbjnl/mcl2 huggingface dataset:
Scheme of Limb Warming Blanket Combined With Dexmedetomidine
Condition: Spine Surgery; Postoperative Delirium and Chills
MeSH terms: Delirium; Emergence Delirium; Chills
Study type: Interventional

Summary: 
      Objective: To observe the clinical effect of lower limb warming blanket combined with
      dexmedetomidine (DEX) in preventing postoperative delirium (POD) and chills in elderly
      patients undergoing spinal surgery. Methods: A total of 160 elderly patients undergoing
      posterior spinal surgery under general anesthesia were selected and divided into control
      group (group N), heating group (group T), DEX group (group D) and heating combined with DEX
      group (group TD) according to the random number table method, 40 cases in each group. T group
      and TD group routine insulation and lower limb heating blanket. DEX was injected in group D
      and group TD. The dosage of anesthetics, the changes of body temperature and heart rate at
      different time points during operation, and the occurrence of postoperative chills and POD
      were compared among the groups.
    


Intervention name(s): Dexmetomidine; Lower limb heating blanket
Intervention type(s): Drug; Device
Intervention description(s): Dexmetomidine (H20183219) 0.4μg / (kg·min)；; Beijing Maikang Medical Device Co., Ltd., Model: Warm-1-1.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Elderly spinal surgery; Delirium and chills
Immunogenicity and Safety of Pentaxim™ in an Indian Population
Condition: Diphtheria; Tetanus; Polio; Pertussis; Haemophilus Infections
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The present clinical study will assess the immunogenicity as the primary objective and the
      reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined
      vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of
      age followed by a booster dose during the second year of life.

      Safety:

      This study will describe the safety after each dose of the primary series of the study's
      combined vaccine (Pentaxim™).
    


Intervention name(s): Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, IM
Other intervention name(s): PENTAXIM™
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphteria; Tetanus; Polio; Acellular Pertussis; Hib; Haemophilus influenzae type B
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate safety,
      tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single
      doses of NNC 0113-0987 in healthy male subjects.
    


Intervention name(s): oral NNC 0113-0987; oral NNC 0113-0987; I.v. NNC 0113-0987; oral placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.; Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.; Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.; Subjects will be randomised to receive a single dose of placebo.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in
      pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, efficacy, and tolerability of a 0.5% BID
      concentration of RVT-501 in pediatric patients 2-17 years of age with mild to moderate atopic
      dermatitis. The pharmacokinetics of RVT-501 will also be evaluated in patients 2-11 years of
      age.
    

Intervention name(s): RVT-501 0.5% ointment; Vehicle ointment
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.; Placebo comparator - ointment twice daily (BID) for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Prior to the first infusion, patients will be randomized into one of two groups (placebo or
      infliximab). All patients will continue to receive the same does of methotrexate (MTX) during
      the study as received prior to the study. The objective of the study is to evaluate the
      efficacy and safety result of infliximab with Korean patients in reducing clinical signs and
      symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to
      review whether the result is comparable to the result of the ATTRACT trial.
    


Intervention name(s): Placebo; MTX; Infliximab; MTX
Intervention type(s): Other; Drug; Biological; Drug
Intervention description(s): Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week; Infliximab 3 mg/kg given as an infusion at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; 3 mg/kg infliximab infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose >=12.5 mg/week given orally or parenterally, maximum 20 mg/week
Other intervention name(s): Remicade; SCH 215596
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Rapid Titration Protocols of Lacosamide
Condition: Focal Epilepsy
MeSH terms: Epilepsies, Partial
Study type: Interventional
Phase: Phase 4

Summary: 
      Three different dose titration schedules are tested to find a way to reduce the titration
      period of lacosamide
    

Detailed description: 
      The investigators intend to find a way to reduce the titration period of lacosamide. Dosage
      of lacosamide is increased from 100-200 mg/d to 400 mg/d by three different titration
      schedule. Safety of lacosamide administration is primary endpoint. 50% responder rate
      (seizure reduction) and blood level of lacosamide are investigated for secondary endpoints.
    

Intervention name(s): Lacosamide - conventional titration; Lacosamide - rapid titration 1; Lacosamide - rapid titration 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID; Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week; Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy
MeSH terms: Diabetic Neuropathies; Polyneuropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to study the clinical effects of the investigational drug, SB-509
      versus placebo in patients with diabetic neuropathy.
    

Detailed description: 
      SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a
      researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around
      the injection site and causes these cells to make a protein. This protein causes your cells
      to increase production of another protein called vascular endothelial growth factor (VEGF),
      which may improve the structure and function of nerves. In addition, there are changes in the
      levels of 28 additional proteins in your cells. These proteins function to promote the growth
      of cells, are structures in cells, help synthesize products, and affect immune cells, and
      some have unknown functions. This increase in your own VEGF proteins may protect and repair
      the damaged nerves caused by diabetic neuropathy.
    

Intervention name(s): SB-509; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 60 mg dose; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetic neuropathy; Diabetes Type 1 or 2; Moderate to severe sensorimotor diabetic polyneuropathy; Unmeasurable nerve conduction velocity
Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in
      combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12
      weeks administration and to evaluate the safety and efficacy of MP-513 in combination with
      thiazolidinedione with an extension treatment for up to 52 weeks.
    


Intervention name(s): Placebo / Teneli (Teneligliptin) + pio (pioglitazone); Teneli / Teneli + pio
Intervention type(s): Drug; Drug
Intervention description(s): Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.; Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
Condition: Narcolepsy, Excessive Daytime Sleepiness
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the safety, tolerability, blood distribution and
      effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
    

Detailed description: 
      This is a Phase 1, single center, single-ascending dose, sequential, randomized, and
      crossover study.

      Following a Screening period of up to 21 days, eligible subjects will be randomized different
      dosing sequences, with approximately 4 subjects allocated to each dosing sequence. The total
      in-clinic duration for each subject will be 24 days (including the admission day prior to the
      first dosing period).
    

Intervention name(s): Placebo; Sodium Oxybate; JZP-386
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Xyrem®
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: JZP-386, Xyrem, sodium oxybate
Effects of Foot Strengthening on the Incidence of Injuries in Long Distance Runners
Condition: Leg Injuries
MeSH terms: Wounds and Injuries; Leg Injuries
Study type: Interventional

Summary: 
      The main objective of this trial is to investigate the effects of a training protocol for the
      foot and ankle complex on the prevalence of running related injuries on long distance
      runners.
    

Detailed description: 
      Using a web software as a follow up tool, subjects can be scanned for injuries and have them
      confirmed by a physician, determining the injuries prevalence in one year.

      Through force platform and infrared cameras, the kinematics and kinetics during gait will
      allow assessment of joint moments, power during propulsion, ankle and knee range of motion.

      The hypothesis is that a strengthening program for foot and ankle muscles can alter the
      prevalence of lower limbs injuries on long distance runners, lowering the harmful forces that
      these segments receive. The participants will be randomly assigned into control group
      (placebo intervention) or into intervention group, that will receive an 8 weeks strengthening
      intervention, twice a week with the supervision of a physiotherapist and three times a week
      being remotely supervised by a software at home, for 30 minutes each session. This will aim
      for increasing foot and ankle range of movement and muscle strength.

      Every exercise has its own progression depending on the subjects execution, increasing in
      intensity and difficulty.
    

Intervention name(s): Foot and ankle strengthening
Intervention type(s): Other
Intervention description(s): Group will be trained during 2 months at the university by a physiotherapist and at home with a training software for foot and ankle strengthening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following
      administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK)
      and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD
      relationship.
    


Intervention name(s): BI 1291583; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1291583; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      We would like to test the effect of opioid medication on pain sensitivity in subjects who
      have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to
      other subjects without OSA. Patients with OSA may have an altered sensitivity to the
      sedative, analgesic, and respiratory depressant effects of opioids.
    

Detailed description: 
      The purpose of the study is to test the hypothesis that patients who suffer from
      moderate-to-severe OSA have increased pain thresholds and are more sensitive to the analgesic
      effects of opioids compared to patients with normal sleep-related breathing physiology. We
      will evaluate the effect of remifentanil, a short acting mu-opioid receptor agonist, on pain
      using an experimental heat and cold-induced pain tests, and compare it between volunteers
      with and without a polysomnography (PSG)-based diagnosis of obstructive sleep apnea.
    

Intervention name(s): Remifentanil; Cold pain threshold and tolerance; Heat pain threshold and tolerance; Polysomnography
Intervention type(s): Drug; Procedure; Device; Procedure
Intervention description(s): Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order.; Ice water was used to assess cold-related pain threshold and tolerance, defined as the time that the volunteers could keep their hands in the water before they started feeling pain or this feeling becomes unbearable, for threshold and tolerance, respectively.; TSAII Neuroanalyzer (Medoc Advanced Medical Systems, Durham, NC), was used to assess the heat-related pain and tolerance of the volunteers defined as the respective temperatures where they started feeling as painful or unbearable.; All volunteers underwent a polysomnography study at home or at Stanford Sleep Center, approximately one week before their experimental pain assessment in the laboratory
Other intervention name(s): sleep study
Intervention MeSH terms: Remifentanil
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Males at risk for obstructive sleep apnea (OSA). We invited male volunteers (18 55 years
        old) with a history of habitual snoring and/or a formal diagnosis of OSA to participate in
        a study evaluating sleep and experimental pain processing.
Study of Genetic Differences in People With Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this study is to identify genes involved in depression. Specifically, the
      investigators will analyze some genes that may be related to whether or not a person responds
      to antidepressant medication. This project is part of basic scientific research to increase
      understanding of the role of genetic influences in psychological and mental processes
      involved in the response to treatment for depression.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from previous studies conducted at the Laboratory of Brain,
        Behavior, and Pharmacology, where subjects' response to treatment has already been
        determined. This strategy offers the advantage that no new subjects need to be enrolled in
        placebo-controlled treatment studies.
      
Keywords: Depression; genetic; gene; antidepressant; research
Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
Condition: Type 2 Diabetes; Glycemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Hyperglycemia forms a direct and independent risk factor for the development of
      cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft
      drinks might further increase the prevalence of hyperglycemic episodes.

      The objective of the study was to assess glycemic control in type 2 diabetes patients and
      healthy lean and obese controls under strict dietary standardization but otherwise free
      living conditions, with and without the consumption of soft drinks.
    


Intervention name(s): Sucrose consumption; water consumption
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sucrose; water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Glycemic control; (postprandial) Hyperglycemia; Sucrose
The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear
Condition: Rotator Cuff Tears; Shoulder Pain; Myofascial Trigger Point Pain
MeSH terms: Shoulder Pain; Myofascial Pain Syndromes; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study is to determine the effects of ischemic compression and IASTM
      techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis
      of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were
      aimed to compare and to reveal which application would be more useful.
    

Detailed description: 
      In this study participants were randomly divided into two groups. While ischemic compression
      was applied to one group for the determined active trigger points, instrument assisted soft
      tissue mobilization (IASTM) was applied to the other group for active trigger points. In
      addition to the treatment, both groups were subjected to a joint rehabilitation program.
    

Intervention name(s): ischemic compression; IASTM; Rehabilitation Program
Intervention type(s): Other; Other; Other
Intervention description(s): ATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks.; In order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds.
For each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way.; A rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ischemic compression; instrument assisted soft tissue mobilization; trigger point
Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
Condition: Bacterial Infections
MeSH terms: Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A study of the safety and pharmacokinetics of solithromycin capsules in adolescents
    


Intervention name(s): Solithromycin
Intervention type(s): Drug
Intervention MeSH terms: Solithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment