bioihbjkbjnl/mcl2 huggingface dataset:
Heat Application to Quadriceps Effect on Pain After a Total Knee Arthroplasty
Condition: Arthritis Knee
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      The goal of this study is to explore an under-researched aspect of recovery. Typically,
      post-operative care after a knee arthroplasty consists of compression (stockings),
      medications, rest, ice, elevation, physical therapy, and wound care. All of these treatments
      perform their role well, however, medications such opiates run the risk of addiction. An
      additional method of pain management such as heat application to the surrounding musculature
      warrants exploration.

      The goal of this study is to reduce the amount of pain, and improve the quality of life in
      post-operative patients. Pain, stiffness, symptoms, quality of life and function of the knee
      will be evaluated utilizing patient-reported measures and range of motion. Patients will be
      assessed using the Knee Injury and Osteoarthritis Outcome survey (KOOS Jr), Visual Analogue
      Scale (VAS) and PROMIS. Patients will be given these surveys during their two and six week
      check-in with the surgeon. In addition to these patient-reported measures, the investigators
      will also be tracking range of motion (ROM) and opioid usage. The data will then be collected
      via the patient's electronic health record, or by the researcher directly. The treatment
      group will be given a written order to apply heat to the quadriceps at least three times per
      day for 10-15 minutes each. This can be done in four hour increments or when patients
      symptoms begin to worsen. The patient will receive a rice sock for heat application. The
      control group will not be withheld from heat application, but will not be instructed to do
      so. The control group will instead follow the current standard of care as advised by the
      physician.
    


Intervention name(s): Rice Sock and Instructions to heat the quadriceps.
Intervention type(s): Other
Intervention description(s): A rice sock will be provided to the experimental group to heat the quadriceps 3x per day for six weeks. The participants will be encouraged to heat before and after rehabilitation exercises as well.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Metacarpophalangeal Joint Reconstruction Using a Vascularized Cartilage and Bone Graft
Condition: Volar Plate Injury, Thumb, Metacarpophalangeal Joint
Study type: Interventional
Phase: Phase 1

Summary: 
      Traumatic cartilage loss of the joint is central to the development of joint failure in
      arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal
      joint defects.
    

Detailed description: 
      The metacarpophalangeal joint is vital for hand function. Cartilage loss of the joint is
      central to the development of joint failure in arthritis. Although various treatments have
      been proposed, the management remains a challenging problem.Previous anatomical studies have
      shown that, at the base of the metacarpal, there were nutrient arteries inserting into the
      dorsum of the metacarpal. The nutrient arteries arise from the distal and middle dorsal
      carpal arches that run distally to the first to fourth dorsal metacarpal arteries (DMAs.
      These studies prompt us to use a reverse vascularized cartilage and bone graft based on the
      DMA. The metacarpal consists of a widened proximal base. The joint surface to the capitate is
      convex anteriorly and dorsally concave, where it extends to the styloid process on the
      dorsolateral aspect of the metacarpal base. The unique contour stimulates our imagination and
      creativity to use a portion of the joint surface for reconstruction of metacarpophalangeal
      joint defects. The purpose of this study is to report the novel technique and to evaluate the
      effectiveness of the treatment.
    

Intervention name(s): MCP joint
Intervention type(s): Procedure
Intervention description(s): reconstruction of metacarpophalangeal (MCP) joint using a bone graft
Other intervention name(s): MCP joint reconstruction
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: reconstruction; metacarpophalangeal joint; bone graft; MCP joint
A Positive Psychology Intervention for Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Positive psychology (PP) uses targeted activities to increase the frequency and intensity of
      positive emotional experiences such as positive affect. Examples of PP activities include
      recalling positive life events and performing acts of kindness. This pilot study will examine
      the tolerability and efficacy of a PP training program to increase positive affect in
      patients with multiple sclerosis (MS). In the intervention phase, subjects randomized to the
      intervention group will complete five weeks of PP exercises, one exercise per week. Subjects
      will also have weekly calls with the study trainer. The control group will have no study
      activities. In the extension phase, subjects in the control group will complete PP training
      as described above. The investigators will examine the tolerability of the program by
      calculating the proportion of subjects who complete the program. The investigators will also
      examine exercise-specific ratings of ease and utility to measure the acceptability of each
      exercise. Finally, the investigators will evaluate the efficacy of PP training by comparing
      subjects in the intervention and control groups on measures of positive affect, emotional
      function, health-related quality of life (HRQOL) and self-reported functional activities such
      as work. If successful, this study will advance the use of PP as a low cost, innovative and
      effective tool for increasing positive affect, decreasing depression and anxiety and
      improving HRQOL in patients with MS.
    


Intervention name(s): Positive Psychology
Intervention type(s): Behavioral
Intervention description(s): 5-week positive psychology intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Positive Psychology; Positive Affect
Prevalence of Primary Aldosteronism in Patients With Resistant Hypertension in China
Condition: Hypertension, Resistant to Conventional Therapy
MeSH terms: Hypertension; Hyperaldosteronism
Study type: Observational

Summary: 
      Recent studies indicate that primary aldosteronism (PA) is a much more common cause of
      hypertension than had been demonstrated historically. In patients with resistant
      hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has
      been no such data in China, the investigators are conducting a PA study in different province
      of China to evaluate the prevalence of PA in patients with resistant hypertension.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with resistant hypertension from different provinces of China
      
Biospecimen description: 
      blood samples,including serum, plasma and whole blood.
9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      This is a 9-months extension to the following study, protocol number: 003-03: "A study to
      evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients
      undergoing coronary artery bypass grafting (GABG)". Participation is allowed exclusively to
      participants enrolled in the main protocol SOMVC001 (GALA).
    

Detailed description: 
      Patients enrolled in this 9-months extension study of SOMVC001 (GALA) will be contacted by
      phone twice: 6 months and 9 months after a coronary artery bypass graft (CABG) surgery.
      During these phone call visits and at twelve months post CABG surgery, adverse events and/or
      concomitant medication changes will be collected from the participant. Twelve months after
      the CABG surgery procedure, imaging will be performed using 64-slice or better MDCT-scan
      angiography. The study participation ends at this MDCT-scan visit.

      In detail, will be recorded incidence of composite safety outcomes consisting of Major
      Adverse Cardiac Events (MACE) (death, myocardial infarction [MI], and repeat
      revascularization), angina, arrhythmias, shortness of breath [SOB], decreased lumen change,
      graft occlusion and significant stenosis based on Fitzgibbon's scale B and O, following CABG
      surgery.

      Patients in this study are their own control; they receive two SVG; one exposed to GALA and
      the other exposed to heparinized dose saline. The effect of treatment (GALA vs. Saline) will
      be evaluated on paired grafts within-person. Therefore, treatment effect will be presented by
      graft and not by patient. Only adverse clinical events will be presented by patient including
      their potential relationship to the study product.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients who had a coronary artery bypass graft surgery (CABG), and took part in previous
        main study of SOMVC001 (GALA) protocol ID # 003-03 .
Treatments for Recovery of Hand Function in Acute Stroke Survivors
Condition: Stroke, Acute; Stroke; Hemiparesis; Hemiplegia
MeSH terms: Stroke; Hemiplegia; Paresis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Impaired hand function is one of the most frequently persisting consequences of stroke. The
      purpose of this study is to investigate whether two different types of treatment improve
      recovery of hand function after stroke.
    

Detailed description: 
      Loss of hand function is common after stroke. Previous research suggests that treatments that
      focus on movement of both hands at the same time or treatments that electrically stimulate
      the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this
      study, two electrical stimulation treatments will be compared in their effectiveness in
      restoring hand movement and hand function. One of the treatments is stimulation only, and the
      other is stimulation linked to movement of the contralateral hand.

      Study participants will be stroke survivors who are enrolled while they are still within
      their first 6 months after their stroke. After enrolling, their hand movement and function
      will be tested. Then they will be randomly assigned to one of the two treatments. Each
      treatment will last 6 weeks. The treatment will require the participant to perform specific
      exercises at home for a total of 2 hours every day and to come to the laboratory twice a week
      for study-related occupational therapy. At the end of the 6-week treatment, tests of hand
      movement and hand function will be repeated. The same tests will be repeated again at 1 and 3
      months after the end of treatment to see if the effects of the treatment persist as time goes
      on. Changes in upper extremity impairment and activity limitation will be compared across
      treatment groups.
    

Intervention name(s): Neuromuscular electrical stimulator
Intervention type(s): Device
Intervention description(s): Intervention Characteristics Common to Both Groups
• 6-week intervention
Home "exercise", daily
Exercise (at home) 2 sessions/day
A "session" consists of 3 (for CCFES) or 4 (for cNMES) 15-min sets separated by 5 min rest
A "set" entails hand opening, closing, and relaxing in response or synchrony to light and sound cues and according to group-specific instructions
Lab "therapy", 2x/week
Two 1.5-hr sessions/week, working on functional hand tasks and tracking task (if possible).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hand; stroke; hemiplegia; electrical stimulation; recovery
Probiotics in Prevention of Common Cold
Condition: Viral Infections of the Upper Respiratory Tract
MeSH terms: Virus Diseases; Common Cold
Study type: Interventional

Summary: 
      The objective of this study is to assess the benefit and tolerability of a probiotic product
      in subjects with increased susceptibility to common cold.
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Sophia Step Study - a Behaviour Change Program on Physical Activity in Persons With Pre- and Type 2 Diabetes
Condition: Type 2 Diabetes; Prediabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effects of two levels of primary care physical
      activity interventions on metabolic control and cardiovascular risk factors, compared to
      usual care in patients with pre- and type 2 diabetes.

      The hypothesis is that both levels of interventions have effect on HbA1c with the more
      intense Group intervention having superior effects.
    

Detailed description: 
      Regularly physical activity may decrease the risk for type 2 diabetes, cardiovascular
      diseases, overweight and premature deaths. Despite the evidence that physical activity is
      beneficial to health,it is often ignored and underused aspect in diabetes care. The aim of
      the study is to investigate the effects of two levels of primary care physical activity
      interventions on metabolic control and cardiovascular risk factors, compared to usual care in
      patients with pre- and type 2 diabetes.
    

Intervention name(s): Pedometer intervention; Group meetings; Individual consultations
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.; Participants receive 12 group meetings over two years' time.; Participants receive 10 individual meetings with a diabetes specialist nurse. Physical activity on prescription is used to set individual goals and to highlight the importance of physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Emotional Response in Psychiatric and Control Participants
Condition: Schizophrenia; Emotions
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this research is to understand how the emotions of people with different
      mental health concerns (e.g., people with schizophrenia, people with major depressive
      disorder) differ from individuals without mental health concerns. A large body of literature
      suggests that people with mental illnesses have emotional abnormalities compared to healthy
      individuals, but a number of these abnormalities are not well understood. For example, often
      people with schizophrenia report on questionnaires that they experience fewer pleasant
      emotions when talking with other people, but some evidence suggests these individuals report
      a similar amount of pleasant emotion when they are actually engaged in a pleasant activity.
      Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more
      real-world setting. In the tasks in the current proposal, participants will engage in a
      series of tasks designed to assess their emotional functioning. These tasks involve viewing
      emotional stimuli on the computer, engaging in social interactions, and consuming small
      amounts of food. In all tasks, participants will make ratings of their experiences of
      pleasure (and displeasure). We will then compare the experiences of patient groups to those
      of healthy individuals to test how emotional ratings might differ across these tasks.
    


Intervention name(s): social interaction; food consumption
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will engage in a social interaction with another person; Participants will be offered food stuffs to eat/drink
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Reiki on Stress
Condition: Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      Complementary therapies such as Reiki are becoming popular. Reiki is a practice used for
      relaxation and pain management that involves physical touch and social contact with a
      trained, empathetic practitioner. Unlike many relaxation therapies, Reiki requires no
      participation by the patient, a feature that makes Reiki particularly attractive in the
      hospital setting, where patients are often extremely anxious, depressed, in pain, or sedated.
      Our primary research questions are to determine whether physiological changes are induced
      during a Reiki session and whether a Reiki session affects responses to a subsequent acute
      stressor. Secondary research questions include assessing which benefits result from placebo
      or unique abilities of "attuned" Reiki practitioners and assessing background characteristics
      of recipients that are associated with acceptance and responsiveness. Based on its use to
      reduce pain and anxiety, we will study potential mechanisms by which Reiki decreases activity
      of the sympathetic nervous system and other stress pathways. Comparison of the responses in a
      Reiki group with those in supine-control and sham groups will allow us to gain insights into
      mechanisms by which Reiki effects are mediated. Information obtained from the proposed
      studies will provide detailed information on physiological pathways affected by Reiki. Should
      Reiki decrease stress pathways or reduce physiological responses to stressful situations, it
      could be a useful adjunct to traditional medicine and have significant health and economic
      benefits.
    

Detailed description: 
      See Brief Summary
    

Intervention name(s): Rest; Sham; Reiki
Intervention type(s): Other; Other; Other
Intervention description(s): 30 min supine rest; 30 min session with Sham practitioner; 30 min session with Reiki practitioner
Other intervention name(s): Touch; Pretend Reiki; Placebo Reiki; Energy Healing; Energy Therapy; Touch Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Reiki; Stress; CAM
Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart
      failure. In addition safety and effects on renal function and biomarkers will be assessed.
    


Intervention name(s): RLX030; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of RLX030 over 20 hrs; Intravenous infusion of placebo over 20 hours
Other intervention name(s): serelaxin*; *International Nonproprietary Name
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure; RLX030; Hemodynamics; Cardiovascular Diseases
Atelectasis After Inhalation or Intravenous Induction in Pediatric Anesthesia
Condition: Atelectasis; Pediatric Anesthesia
MeSH terms: Pulmonary Atelectasis
Study type: Observational

Summary: 
      Children have a highly compliant chest wall and atelectasis formation occurs often during
      pediatric anesthesia. Inhalation induction is commonly performed in pediatric anesthesia but
      it is still unclear if this can have an effect on the development of atelectasis. Aim of this
      study is to investigate the impact of inhalation versus intravenous induction on atelectasis
      formation during anesthesia induction in children. Atelectasis will be evaluated with lung
      ultrasound before induction and right after induction.
    

Detailed description: 
      Respiratory complications, among which atelectasis, are a common cause of adverse events in
      pediatric anesthesia. Lung ultrasound (LUS) examination is a point of care, non-invasive,
      radiation-free tool with high sensitivity and specificity for the identification of
      anesthesia-induced atelectasis in children.

      Inhalation induction is commonly performed in pediatric anesthesia to avoid pain at
      venipuncture or to facilitate vein cannulation. This technique has been associated with a
      higher rate of respiratory adverse events but no study has investigated the role of
      inhalation or intravenous induction on lung atelectasis development in pediatric anesthesia.

      The investigators will perform this study aiming to describe the impact of inhalation versus
      intravenous induction technique on atelectasis formation during anesthesia induction in
      children of different ages.
    

Intervention name(s): Type of anesthesia induction
Intervention type(s): Other
Intervention description(s): Patients will receive inhalatory or intravenous anesthesia at their choice; both groups will be evaluated with lung ultrasound after induction to detect ultrasonografic signs of atelectasis
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children under 18 years of age scheduled for general anesthesia due to surgery.