bioihbjkbjnl/mcl2 huggingface dataset:
Interventions for Adolescent Obesity
Condition: Adolescent Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study will evaluate whether the short-term use of activity tracking devices improves
      short-term weight loss in adolescents. The investigators will evaluate whether weight loss
      translates into a change in obesity-related biomarkers associated with adolescent obesity. In
      addition, the investigators will report outcomes after the implementation of activity
      tracking devices in conjunction with an intense adolescent weight loss program.
    

Detailed description: 
      This study will evaluate the short-term use of activity tracking devices and their effects on
      short- and long-term weight loss in adolescents. The investigators plan to establish whether
      weight loss translates into a change in obesity-related biomarkers associated with adolescent
      obesity. Each participant with an activity tracking device will have the goal of reaching
      10,000 steps per day, in addition to their individual fitness plan.
    

Intervention name(s): Activity Tracker
Intervention type(s): Behavioral
Intervention description(s): Fitbit Alta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; adolescent; tracking device; fitbit
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
Condition: Mammary Cancer; PONV
MeSH terms: Breast Neoplasms; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Breast cancer is one of the three most common cancers worldwide, and the primary treatment
      method is surgery.Since most patients are non-smokers who use opioids in the postoperative
      period, which are known risk factors for postoperative nausea and vomiting (PONV) according
      to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV.
      According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the
      breast cancer surgery, which not only gives patients unpleasant and painful experience, but
      also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We
      compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6)
      electrical stimulation or granisetron for inhibition of PONV in women undergoing breast
      cancer surgery.
    

Detailed description: 
      186 patients who are planed to undergo elective breast cancer surgery under general
      anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu,
      n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm,
      n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6,
      24, and 48 h after surgery.
    

Intervention name(s): electric stimulation therapy
Intervention type(s): Device
Intervention description(s): Transcutaneous electrical acupoint stimulation (TEAS) was achieved by an electrical neuromuscular stimulation device (JNR2; designed by the Department of Hand Surgery, Huashan Hospital, Fudan University, manufactured by Energy Conservation and Environment Protection Technology Company, Jiatong University, Shanghai,China)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mammary Cancer; PONV; electric stimulation therapy; antiemetics
Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's
      syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized
      by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS
      patients are most liable to oral candidiasis , so they need prophylaxis aganist oral
      candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate
      amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral
      candidosis.
    


Intervention name(s): Probiotic Product - Cap
Intervention type(s): Drug
Intervention description(s): probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Drug Eluting Stent for the Management of PERipheral Arterial Disease Of the SFA (DESPERADO-SFA Study)
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      This is a prospective, nonrandomized, single-arm study using the Zilver PTXTM stent in
      patients with Superficial Femoral Artery (SFA) disease (total occlusions or significant
      stenosis).
    

Detailed description: 
      Endovascular therapy is widely used for the treatment of peripheral artery disease (PAD).
      Primary nitinol stenting for superficial femoral artery (SFA)) lesions has been shown to be
      superior to balloon angioplasty alone. Zilver PTX a paclitaxel -eluting nitinol stent has
      been approved by the Food and Drug Administration (FDA) for femoro-popliteal artery use.
      Previous study have reported safety and effectiveness of the Zilver PTZ in patients with de
      novo or re-stenotic lesions of the femoro-popliteal artery.

      Optical Coherence tomography (OCT) is a novel intravascular imaging modality with a unique
      and fine resolution of 10 µm at the level of a red blood cells providing detailed images of
      vascular wall following stent implantation for evaluation of optimal stent apposition and
      expansion as well as intraluminal clot.

      20 patients with symptomatic critical limb ischemia (CLI) and claudication without CLI
      (Rutherford class 2-6) and identifiable SFA disease on angiogram requiring percutaneous
      peripheral intervention (PPI)will be enrolled in this study. We would like to study the
      vessel apposition and expansion immediately after initial implantation as well as evaluation
      of late stent malapposition and neointimal hyperplasia at the 12 months follow up after
      Zilver PTXTM stent implantation using intravascular OCT imaging. Follow up visits will take
      place at 1 month, 6 month, 12 month and 13 month after the procedure.
    

Intervention name(s): Balloon Angioplasty; Optical Coherence Tomography
Intervention type(s): Device; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Use of Virtual Reality (VR) and the Change in Emotion in Hong Kong Elders
Condition: Virtual Reality; Emotions
Study type: Interventional

Summary: 
      Virtual Reality (VR) is a technology that combines virtual technology and real-world
      scenario. In recent years, more and more neuroscience and psychology scientists utilised VR
      technology in their research. In Hong Kong, many of the community-dwelling elders are
      immobile. Long-term homestay may negatively affect the emotional state. Measuring the
      emotional change after administration of VR may prove it as an alternative tool for emotion
      intervention.

      The primary objective is to compare the improvement in the emotional changes between
      intergeneration interaction and the use of VR technology.

      The secondary objective is to evaluate the side effect after using VR technology.

      This is a randomized, open label-controlled trial with a crossover design. The subject will
      be randomized in a ratio of 1:1 into two different intervention groups, the VR group and the
      Intergeneration Interaction group. After 2 weeks of washout period, the VR group will receive
      Intergeneration Interaction and vice versa. The intervention phases last approximately 2
      hours. The change in the emotional state will be assessed using the Positive and Negative
      Affect Scale. Any adverse event that causes by the VR will be recorded using the Simulator
      Sickness Questionnaire(SSQ).

      This trial is the first study in Hong Kong to investigate the change of emotional state after
      the administration of VR technology, targeting community-dwelling elders in Hong Kong.
    


Intervention name(s): Virtual Reality; Inter-generation interaction
Intervention type(s): Device; Behavioral
Intervention description(s): Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.; Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
    

Detailed description: 
      This is a multicenter, randomized, double-blind, active comparator, parallel two arm study to
      compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1406 to Humira® in
      patients with active ankylosing spondylitis (AS) to demonstrate clinical equivalence of
      BAT1406 and Humira®.
    

Intervention name(s): BAT1406; Humira
Intervention type(s): Drug; Drug
Intervention description(s): 40mg/0.8ml; 40mg/0.8ml
Other intervention name(s): No Other Intervention Names; Adalimumab
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SKAMo-1: Characterization of the Upper Layers of Skin
Condition: Diabetes
Study type: Interventional

Summary: 
      Diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is
      increasing worldwide. Historically, patients with diabetes were required to monitor capillary
      blood glucose concentration up to several times a day through fingertip sampling.

      Recently marketed devices now allow measurements of interstitial fluid blood glucose
      continuously, thus limiting pain associated with sampling. However, they are still invasive
      and have to be changed every 14 days.

      Therefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and
      the risk of infection, non-invasive methods are needed. Among the different strategies being
      developed, optical wearable sensors with specific signal processing are a promising option.
      The sensors detecting this optical signal will be included in a device. Yet, wearing a device
      may slightly modify several properties of the skin, such as its humidity and thermal
      regulation, and subsequently have an impact on the measured optical signal. Therefore, it is
      important to better understand how a device affects these characteristics to include these
      parameters in the future device algorithms.
    


Intervention name(s): Experimental
Intervention type(s): Other
Intervention description(s): At the first visit, effects of skin preparations (cleaning or sanding) on skin parameters and wearing a sham device will be evaluated. At the second visit the effect on skin parameters of a local heating and an OGTT will be evaluated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Antibody Response to Influenza Vaccine in Patients With Sarcoidosis
Condition: Pulmonary Sarcoidosis
MeSH terms: Influenza, Human; Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Observational

Summary: 
      The purpose of this study is to determine the efficacy of influenza vaccine (antibody
      response) in patients with sarcoidosis.
    

Detailed description: 
      Sarcoidosis is a multisystem disease with unclear etiology characterized by the presence of
      noncaseating granuloma[1]. T helper cells response is exaggerated at the site of disease and
      cellular immunity depressed in peripheral blood[2]. Cutaneous anergy, lymphopenia and
      inversion of CD4/CD8 ratio in peripheral blood suggest T helper cells involvement[3].

      The action of humeral immune system in sarcoidosis is a matter of controversy. Standard
      hepatitis B virus vaccination did not provoke protective antibody titer in patients with
      sarcoidosis[3]. Although antibody response against influenza vaccine in patients with
      sarcoidosis is not well described, this vaccine is highly recommended in patients with
      chronic pulmonary diseases such as asthma, COPD and fibrosis [4, 5, 6]. In this study we aim
      to evaluate the humeral response to the influenza vaccine in sarcoidosis patients and assess
      vaccine safety.
    

Intervention name(s): Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): One 0.5 ml dose of influenza vaccine injected intramuscular.
Other intervention name(s): 2008-2009 vaccination campaign of influenza (Solvay Pharma)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Caes are defined as patients known as sarcoidosis and are under follow up at a tertiary
        care hospital clinic. Age and sex matched healthy healthcare workers serve as controls.
      
Keywords: Influenza Vaccine; Sarcoidosis; Antibody
Innervated Sensory Cross-Finger Flap
Condition: Transplantation
Study type: Interventional

Summary: 
      The purpose of this study is to introduce a new operative technique for reconstruction of
      fingertip degloving injury.
    

Detailed description: 
      Incidence of fingertip degloving injury is common and can result in functional morbidity. A
      cross-finger flap based on the dorsal branch artery (DBA) including sensory nerve is a useful
      reconstructive technique.In our modification, the innervated sensory flap is vascularized by
      the DBA, both its pedicle is narrow and its coverage is extended, the projecting tip of
      exposed distal phalanx of adjacent digits therefore can be wrapped.
    

Intervention name(s): The innervated sensory cross-finger flap
Intervention type(s): Procedure
Intervention description(s): The innervated sensory cross-finger flap is a modified method for repair fingertip degloving injury
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cross-finger flap; finger injuries; fingertip reconstruction; proper digital artery; proper digital nerve.
Kanagawa Combination Anti-hypertensive Therapy (K-CAT)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effect and safety of the antihypertensive
      combination therapies between losartan/amlodipine and fixed dose drug of
      losartan/hydrochlorothiazide.
    

Detailed description: 
      The combination therapy with multiple antihypertensive drugs is recommended in the patients
      who are uncontrolled with monotherapy. Diuretics increase the activities of
      renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress
      blood pressure potently in the state of increased RAS activities. Thus, the combination
      therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This
      combination therapy is also expected to reduce the side effects of each drug. In this study,
      we will compare the effect and safety of the combination therapies between
      losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.
    

Intervention name(s): Losartan/amlodipine or losartan/hydrochlorothiazide
Intervention type(s): Drug
Intervention description(s): Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.
Other intervention name(s): Preminent (Hyzaar)
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; angiotensin receptor blocker; diuretic; combination therapy
LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women
Condition: Menopause; Brain Activity; Cognition
Study type: Interventional
Phase: Phase 4

Summary: 
      This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on
      executive function and prefrontal cortex activation in menopausal women ages 45-57, who
      report subjective cognitive difficulties. This protocol will recruit women from Dr.
      Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation
      during performance of cognitive tasks specifically probing prefrontal cortex function.
    


Intervention name(s): Lisdexamfetamine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.; To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
Other intervention name(s): Vyvanse®; Sugar pill
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Menopause; fMRI; Vyvanse
Protector™ Versus Supreme® Laryngeal Mask Airway
Condition: Anesthesia
Study type: Interventional

Summary: 
      The goal of this study is to compare the oropharyngeal leak pressure of the Protector
      Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.
    

Detailed description: 
      The OLP as the primary outcome measurement will be evaluated after insertion of the LMA in
      each group. We hypothesize that there will be a difference of 4 cm H2O between the 2 masks,
      because of the different material and slightly different form of the masks. Secondary
      outcomes will be measured after insertion of the LMA as by protocol. Finally postoperative
      airway morbidity will be evaluated 3 hours after removal of the LMA.
    

Intervention name(s): Protector; Supreme
Intervention type(s): Device; Device
Intervention description(s): All patients which are assigned to the Protector are studied with this laryngeal mask; All patients which are assigned to the Supreme are studied with this laryngeal mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laryngeal mask; Supreme; Protector
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
Condition: Total Knee Replacement; Total Knee Arthroplasty; Pain; Postoperative Pain; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine if electrical stimulation (small levels of
      electricity) in addition to the standard of care can safely and effectively reduce pain
      following total knee replacement more than the standard of care, alone. This study involves a
      device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical
      stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System
      includes a small wire (called a "lead") that is placed through the skin in the upper leg. It
      also includes a device worn on the body that delivers stimulation (called the SPRINT Beta
      Stimulator). About half the subjects in this study will receive the SPRINT Beta system
      (treatment group) and half will not (control group). Both groups will receive the standard of
      care.
    


Intervention name(s): SPRINT Beta System
Intervention type(s): Device
Intervention description(s): The SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT Beta System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator).
Other intervention name(s): SPRINT Beta Peripheral Nerve Stimulation (PNS) System; SPRINT Peripheral Nerve Stimulation (PNS) System; SPRINT System
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Half of the subjects enrolled will be randomized (like flipping a coin) to the treatment group and half will be randomized to the control group. Both groups will receive the standard of care for pain management following total knee replacement surgery. Subjects in the treatment group will receive SPR's SPRINT Beta Peripheral Nerve Stimulation (PNS) System in addition to standard of care.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electrical stimulation; neurostimulation; TKA pain; pain following total knee replacement; total knee arthroplasty