bioihbjkbjnl/mcl2 huggingface dataset:
Acupuncture for Mild Traumatic Brain Injury：A Functional Magnetic Resonance Imaging Study
Condition: Acupuncture; Mild Traumatic Brain Injury; MRI
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      The overall goal of this study is to examine if acupuncture intervention can reduce the
      post-concussion symptom (PCS), and affective and cognitive complaints among mild traumatic
      brain injury (TBI). This study also hypothesized that compared to those in the sham
      acupuncture and waiting list control groups, patients in the real acupuncture group will have
      fewer symptoms of depression, sleep problems and post-concussion symptoms.
    

Detailed description: 
      Project Background: Acupuncture has been shown in other settings to alleviate symptoms of TBI
      that are reported to be precursors of post-concussion symptom, including affective
      (depression, anxiety) and somatic (headache, sleep difficulties) complaints. Evidence
      suggests that the increased intensity of these symptoms, particularly greater affective
      distress and injury-associated pain, increases vulnerability to neurodegenerative disease and
      PTSD. By treating post-TBI symptoms with acupuncture, these predisposing conditions will
      improve, and, as a result, the incidence of PCS in this patient population will be reduced.

      Research plan: The overarching focus of this study is the use of acupuncture treatment,
      targeted to symptoms of mild TBI. The investigators propose a randomized, sham procedure and
      usual care-controlled clinical trial of acupuncture beginning at acute phase following mild
      traumatic brain injury (TBI). Participants meeting eligibility requirements will be
      randomized to 1 of 3 groups: verum acupuncture, sham acupuncture or waiting-list control.
      Acupuncture treatments will continue for one month, at which point all participants will be
      assessed for presence of mild TBI symptoms. Participants will be evaluated again after
      one-month acupuncture treatment and follow-up post-hospital discharge. The investigators
      hypothesize that true acupuncture will be more effective than sham acupuncture in reducing
      these outcomes at after treatment and follow-up stage. Patients were also scanned by 3T MRI
      scanner at baseline, one-month (after acupuncture treatment).
    

Intervention name(s): acupuncture; sham acupuncture
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: mild TBI; post-concussion sydrome; Acupuncture
Role of Hemostatic Powder (Endo-clotTM) in Prevention of Bleeding Within High Risk Patients After ESD
Condition: Iatrogenic Ulcer After ESD
Study type: Interventional
Phase: Phase 3

Summary: 
      SD has become a standard treatment of gastric neoplasm confined to mucosa(epithelium). But
      after procedure, formation of iatrogenic gastric ulcer is inevitable. And Post ESD ulcer
      bleeding rate reported about 5% ~ 10% of all cases. Antiplatelet or anti-coagulation
      treatment might be associated higher incidence of rebleeding after ESD and iatrogenic ulcer
      bigger than 40mm in size is also associated.

      Though several previous study have failed to show efficacy of 2nd look EGD, but those reports
      pointed out that visible vessels with current bleeding or highly suspect of recent bleeding
      (Forrest type IA~IIB) was observed about 10~20% of patients. Such patients are at high risk
      of bleeding.

      So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a
      significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus
      visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And
      finally this protective effect might have an effect for prophylaxis of post ESD ulcer
      bleeding.
    


Intervention name(s): Endo-Clot(TM)
Intervention type(s): Drug
Intervention description(s): After patients treated with ESD, Hemostatic power was applied on the post-resection surface by Endo-Clot™ system. And treated with proton pump inhibitor as usual.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Post ESD ulcer; Bleeding; Prophylaxis
A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess safety and tolerability when taking GSK189075 at doses that are likely
      to be higher than the expected prescribed doses. The study will also measure the level of
      GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests
      performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and
      will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo).
      Volunteers will not know which of the three doses they are receiving. In each period,
      volunteers will dose every morning for three straight days. Before and after dosing, blood
      pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs
      will be taken to assess safety. Volunteers will also be asked to provide information should
      they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in
      the blood will be assessed by multiple blood draws, most of these will follow the third dose
      in each period. Depending on the results from the preceding periods, a fourth period may be
      added to the study to assess another dose level. The fourth period, if this is to occur, will
      be the same design as the other three periods, and the dose received will be less than
      4000mg.
    


Intervention name(s): GSK189075
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Dose Escalation;; Supratherapeutic;; GSK189075;; Diabetes
Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in 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 demonstrate the efficacy and safety of vildagliptin 50mg qd
      as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled
      with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting
      the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in
      the treatment of type 2 diabetes.
    


Intervention name(s): vildagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus; vildagliptin
Assessing the Feasibility of Integrating Ear Acupuncture Into the Aeromedical Evacuation System From RAB to AAFB
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Observational

Summary: 
      The purpose of this study is twofold: 1) to test the feasibility of integrating a simple
      bilateral ear acupuncture procedure (Auricular Stimulation Procedure - ASP) into the standard
      care delivered in the Aeromedical Evacuation system and 2) to observe and document any
      changes in pain scores and in-flight related symptoms and factors (e.g. sinus block/pain, ear
      block pain, nausea/air sickness) typically monitored during transportation of wounded
      warriors from Ramstein Air Base (RAB) to Andrews Air Force Base (AAFB).
    


Intervention name(s): Ear acupuncture
Intervention type(s): Device
Intervention description(s): Ear acupuncture
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Military beneficiaries undergoing aeromedical evacuation from Ramstein Air Base to Andrews
        Air Force Base who are experiencing pain.
      
Keywords: pain; acupuncture
Effects of Vitamin B12 Treatment in Singers
Condition: Vitamin B 12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study, the investigators aim to assess if vitamin B12 treatment demonstrates a
      beneficial effect on voice performance. If so, they wish to examine the relationship between
      the vitamin B12 treatment and the study participant's general well-being.
    

Detailed description: 
      Through the investigators' experience, they have observed that amongst singers and voice
      professionals, there is a common belief that there are voice benefits from cobalamin
      treatment. Consequently, some singers and voice professionals tend to ask for cobalamin
      injections in order to enhance their vocal performance. However, there are no previous
      reports that illustrate the effects of vitamin B12 deficiency or treatment on voice
      performance.
    

Intervention name(s): Cyanocobalamin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1,000 mg, Once; 0.9% Sodium Chloride, Once
Other intervention name(s): Vitamin B12; Normal Saline Solution
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Volume Deficit Prior to Surgery
Condition: Hypovolemia; Surgery
MeSH terms: Hypovolemia
Study type: Observational

Summary: 
      It is the purpose of the researchers to identify the variation in intravascular deficits
      which can have relevance in high risk patients for minor and medium sized surgery.

      The investigators will also estimate fluid deficit in healthy, non-fasting subjects for
      comparison.
    

Detailed description: 
      Intravascular volume optimization has shown to improve outcome after surgery. In minor and
      medium surgery , however, the preoperative volume deficit has not been estimated with
      functional parameters. Patient scheduled for minor surgery are included. After the patient is
      anesthetized the intravascular volume is optimized by stroke volume maximization by colloid
      boluses. Stroke volume is obtained by esophageal Doppler technique which is a minimally
      invasive method.

      The volume estimated for optimization is considered as the functional volume deficit.

      In the healthy subjects the probe will be placed in the awake subject. A standardized meal
      and fluid intake secures that the subjects are in a non-fasting state.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients for surgery in 3 procedures:

          -  mastectomy

          -  rad. prostatectomy

          -  open adb. surgery

        And 20 healthy subjects
      
Keywords: Minor surgery; Volume optimization; Volume deficit; Epidural anesthesia
Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)
Condition: Alzheimer's Disease; Stroke; Parkinson's Disease; Traumatic Brain Injury
MeSH terms: Parkinson Disease; Alzheimer Disease; Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of
      Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes
      of uncontrolled crying and/or laughter).
    

Detailed description: 
      This is an "open label" study which means there is no placebo group. Each subject enrolled
      into the study will receive AVP-923.
    

Intervention name(s): AVP-923
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS; MS; CNS; AD; TBI; Dextromethorphan; IEED; Emotional
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
Condition: Poliomyelitis; Poliomyelitis Vaccines
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when
      administered to healthy Chinese infants at 2, 3 and 4 months of age.
    


Intervention name(s): Poliorix™; Oral Poliovirus vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses, intramuscular administration; 3 doses, oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Poliorix; IPV
Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg,
      10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers
    


Intervention name(s): PBF-999; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5, 10, 20 and 40 mg of PBF-999; Placebo for all dosis of PBF-999
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PDE10 inhibitor; Huntington's disease; phosphodiesterase 10 inhibitor; psychiatric disorders
Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus
Condition: End-Stage Renal Disease; Pruritus
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity
      of pruritus in patients with end-stage renal disease.
    

Detailed description: 
      Uremic Pruritus is still a common complication in end-stage renal disease patients. The
      pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According
      to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic
      inflammatory disease with a deranged balance of T helper cell differentiation. In this study
      investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a
      double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora
      L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and
      high-sensitive C reactive protein (hs-CRP).
    

Intervention name(s): Wheat; Fumaria
Intervention type(s): Drug; Drug
Intervention description(s): 3 times a day each time 2 capsules before eating meal for 8 weeks.; 3 times a day each time 2 capsules before eating meal for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pruritus; End-Stage Renal Disease
Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.
Condition: Healthy Term Infants
Study type: Interventional

Summary: 
      A randomised, controlled, double-blind, parallel group, multi-country study to investigate
      the safety and tolerance of infant formula with prebiotics and postbiotics in healthy term
      infants.
    


Intervention name(s): milk based infant formula
Intervention type(s): Other
Intervention description(s): Cows milk ased infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Condition: Headache
MeSH terms: Headache
Study type: Observational

Summary: 
      To investigate headache score and accompanying symptoms during and after infusion of
      carbachol.
    

Detailed description: 
      To investigate headache score and accompanying symptoms during and after infusion of
      carbachol.

      Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery
      (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery
      (RA)
    

Intervention name(s): carbachol
Intervention type(s): Drug
Intervention MeSH terms: Carbachol
Time perspective: Prospective
The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
Condition: Ischemia
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To test the effect of atorvastatin or placebo in combination with ticagrelor on ACh-induced
      vasodilatation of the forearm resistance vasculature as assessed by forearm blood flow (FBF)
      measurement before and 10 min after a 20 min forearm ischemia. The area under the dose-effect
      curve (AUC) of different ACh doses will be calculated and compared between treatment groups
      (atorvastatin + ticagrelor vs. placebo + ticagrelor) and different time points (pre-ischemia
      vs. post-ischemia).
    


Intervention name(s): Atorvastatin; Placebo; Ticagrelor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive 80 mg atorvastatin once daily for 14 days (until study day 15). On study day 15, 80 mg atorvastatin in combination with a loading dose of 180 mg ticagrelor will be administered.; Subjects will receive placebo once daily for 14 days (until study day 15). On study day 15, placebo in combination with a loading dose of 180 mg ticagrelor will be administered.
Intervention MeSH terms: Ticagrelor; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blinded, placebo-controlled adaptive, dose finding study to
      investigate the safety, tolerability, PK, PD and efficacy of single and repeat intravenous
      infusions of GSK315243A in patients with active rheumatoid arthritis. The study is divided
      into 2 parts: Part A is an adaptive, dose finding phase which will provide safety,
      tolerability, PK and PD on single intravenous infusions. Part B is a repeat dose phase which
      will provide safety, tolerability, PK, PD and efficacy following repeat intravenous infusions
      of a selected dose level.
    


Intervention name(s): GSK3152314A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A single IV dose; Part B 3 repeat IV dose at Day 1, Day 28 and Day 56; Part C single SC dose; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adaptive study,; DAS28,; monoclonal antibody; GSK315234A;; rheumatoid arthritis,
Study of an Exercise Program (STEP) for Youth With Concussion
Condition: Persistent Concussion Symptoms
Study type: Interventional

Summary: 
      To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile
      health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth
      with persistent concussion symptoms.
    

Detailed description: 
      This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an
      exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6
      months inclusive). The investigators are utilizing an active control (light stretching). The
      primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI)
      in the first month after randomization. Long-term efficacy will be examined using
      standardized measures of quality of life and function over 6 months, and potential mediators
      will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and
      physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.
    

Intervention name(s): Subthreshold exercise (STEP) with mobile health coaching; Light stretching (LS)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching; Brief daily stretching routine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concussion; mild traumatic brain injury; post concussion syndrome; child
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA
      treatment for glabellar lines
    


Intervention name(s): AbobotulinumtoxinA dose level 1 or 2; placebo; AbobotulinumtoxinA dose 3; AbobotulinumtoxinA dose 4
Intervention type(s): Biological; Other; Biological; Biological
Intervention description(s): Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of LY2189265 and Sitagliptin in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the effect of LY2189265 on how the body absorbs and
      processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects
      LY2189265 when they are taken together.

      The duration of participation in this study is expected to be approximately 61 days. The
      study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).

      The study involves 3 injections, subcutaneous, of 1.5 milligrams (mg) LY2189265 and 18 daily
      doses of 100 mg sitagliptin tablets administered orally.
    


Intervention name(s): LY2189265; Sitagliptin
Intervention type(s): Biological; Drug
Intervention description(s): Administered subcutaneously; Administered orally
Other intervention name(s): Dulaglutide
Intervention MeSH terms: Sitagliptin Phosphate; Dulaglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment