bioihbjkbjnl/mcl2 huggingface dataset:
Time, Touch, Attention and the Autonomic Nervous System
Condition: Stress
Study type: Interventional

Summary: 
      The purpose of this study is to describe the onset, duration and dose-response of
      interpersonal mindful compassion on respiratory rate and heart rate variability in healthy
      adults in order to prepare for research evaluating the impact of this intervention in patient
      populations and to prepare for basic research investigating the CNS mechanisms for observed
      effects.

      Previous research has found that mindfulness meditation, including mindful compassion,
      results in autonomic changes in the practitioner. Emerging neuroscience of dyadic
      interactions suggests that through the effects of mirror neuron isopraxis, one person's
      physiologic state may be mirrored by another. However, no research has directly evaluated the
      impact of one person's mindful compassion on another person's autonomic activity. This study
      paves the way for an entirely new avenue of research inquiry.
    


Intervention name(s): Interpersonal Mindful Compassion with Touch; Reading while extending loving kindness
Intervention type(s): Other; Other
Intervention description(s): A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.; The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Interpersonal mindful compassion; Loving kindness meditation; Autonomic Nervous System; Heart rate variability; Respiratory rate; Relaxation
Task-Oriented Aerobic Exercise Training in Chronic Stroke Patients
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The study is designed to investigate (1) the effects of task-oriented aerobic exercise
      training on cardiorespiratory fitness, cerebral blood flow, oxygenation, functional
      performance, and physical activity in patients with chronic stroke. (2) the association
      between outcomes
    


Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): aerobic exercise training
Other intervention name(s): Exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Physical fitness; Cerebral circulation; Walking
Effects of Mindfulness on PTSD
Condition: Mindfulness; Stress Disorder, Posttraumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this randomized control trial is to examine the effects of a Mindfulness-Based
      Stress Reduction (MBSR) program on women with posttraumatic stress disorder related to
      intimate partner violence.
    

Detailed description: 
      Posttraumatic stress disorder is a prevalent, chronic, and debilitating disorder
      characterized by a reduced capacity to adapt to stressors, marked by poor regulation in the
      following domains: emotion, attentional function, and physiological stress. Mindfulness-based
      stress reduction (MBSR) holds promise for treating symptoms of trauma and PTSD as evidence
      suggests it targets these domains. The central hypothesis is that MBSR, which teaches
      non-judgmental awareness, can improve emotion regulation and attentional function, and
      diminish physiological stress dysregulation, which in turn will improve PTSD symptoms. We
      will examine changes in stress capacity and PTSD symptom severity among women survivors of
      intimate partner violence with PTSD after participation in an MBSR program.
    

Intervention name(s): Mindfulness-based stress reduction; Wellness Group
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: mindfulness; posttraumatic stress disorder
Optic Nerve Sheath Diameter Difference
Condition: Optic Neve Sheath Diameter
Study type: Interventional

Summary: 
      Intracranial pressure is measured indirectly using optic nerve sheath diameter with
      ultrasound. It is reported that epidural pressure varies according to different posture (
      lateral decubitus vs. sitting position).

      This study is designed to measure the optic nerve sheath diameter in lateral decubitus and
      sitting position, respectively.
    

Detailed description: 
      According to previous study, injection of different volume of local anesthetics (1.0 ml/kg
      vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in
      significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional
      cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of
      ICP can result in headache, syncope, and transient loss of visual acuity. Although it is very
      invasive method, ICP can be measured directly at the brain parenchyme. Among methods to
      measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is
      known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases
      when higher volume of medication is injected during epidural anesthesia. Previous reports
      showed that epidural pressure varies according to different posture. When epidural pressure
      was measured in patients of spinal stenosis, lumbar flexion showed lower epidural pressure
      than epidural pressure of lumbar extension. In addition, when epidural pressure was measured
      in the sitting position, it showed lower pressure than pressure of lateral decubitus.
    

Intervention name(s): thoracic epidural catheterization
Intervention type(s): Other
Intervention description(s): thoracic epidural catheterization with different posture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Optic Nerve Sheath Diameter Different Position
Effects of the Breath Stacking Technique After Upper Abdominal Surgery
Condition: Abdominal Surgery
Study type: Interventional

Summary: 
      This study evaluates the effects of the breath stacking technique in patients after upper
      abdominal surgery. Half of the patients receive routine physical therapy associated with the
      Breath Stacking technique, while the other half will receive only routine physical therapy.
    

Detailed description: 
      This randomized controlled study aims to evaluate the effects of the Breath Stacking
      technique in patients undergoing upper abdominal surgery on clinical, physiological and
      cardiopulmonary variables. These individuals were randomized to compose the control group
      (CG) and the intervention group (GBS). The routine physical therapy was performed in both
      groups and in the GBS two daily sessions of up to 20 minutes of Breath Stacking technique
      were applied. To verify the effect of this intervention, before and after the protocol,
      patients underwent the following evaluations: algometry, cirtometry in the axillary line ,
      umbilical line and the xiphoid process, ventilometry, spirometry and manovacuometry.
    

Intervention name(s): Breath Stacking
Intervention type(s): Device
Intervention description(s): The patients will perform the maneuver through successive inspiratory efforts for 20 s. Subsequently, the expiratory branch will be unobstructed to allow expiration. This maneuver will be repeated 5 times in each series, with intervals of 30 seconds between them. The technique will be performed with the trunk inclined 30º in relation to the horizontal plane, in 3 series, with interval of 2 min completing 15 min of therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: surgery; abdomen; pulmonary ventilation; physical therapy techniques
Group Intervention to Increase Physical Activity in Childhood Cancer Survivors
Condition: Pediatric Cancer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary aim of this randomized, controlled study is to evaluate the impact and
      feasibility of a prolonged physical activity intervention in school-aged childhood cancer
      survivors who self-report sedentary lifestyles. The study will test the hypothesis that
      childhood cancer survivors participating in a physical activity intervention guided by Social
      Cognitive Theory will increase the amount of time spent daily in moderate to vigorous
      physical activity, and improve exercise self-efficacy compared to children randomized to
      usual care. A secondary aim is to assess the impact of the intervention on cardiovascular
      risk factors including fitness and body composition.
    


Intervention name(s): Intervention, Camp plus reunions
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Childhood Cancer Survivors
A Study of Bevacizumab Plus 5-Flurouracil (5-FU) Based Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This open-label, single arm, multicenter study evaluated the resection rate in participants
      with colorectal cancer and previously untreated unresectable liver-only metastases after
      adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting.
      Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams
      per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and
      postoperatively, unless they experienced progressive disease or unacceptable toxicity.
    


Intervention name(s): 5-FU based doublet chemotherapy; bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Standard 5-FU based doublet chemotherapy. Protocol did not specify any particular chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels.; 5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Assessment of the Inferior Vena Cava in Children
Condition: Surgery
Study type: Observational

Summary: 
      This is a prospective, non-blinded observational study to compare measurement of inferior
      vena cava (IVC) dimensions with two placement sites of the ultrasound probe (sub-xiphoid and
      the side or right lateral position).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing elective dental surgery.
Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study aims to explore the effectiveness of body constitution classification based
      comprehensive health management intervention on obese population.
    

Detailed description: 
      This study aims to explore the effectiveness of body constitution classification based
      comprehensive health management intervention on obese population, compare the differences in
      effectiveness between body constitution classification based management vs usual health
      management, and explore the influence of different food composition on the effectiveness of
      body constitution classification based comprehensive health management intervention on obese
      population.
    

Intervention name(s): Health Management; General Management; Placebo; SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®
Intervention type(s): Behavioral; Behavioral; Other; Dietary Supplement
Intervention description(s): We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants.; We provide general information about health. Information is provided through telephones and materials.; We use placebo to replace the health product.; We use dietary supplement products to help balance the constitution of participants. Each participant got one of the three dietary supplement products. SCHSANDRA PLUS, INFINITUS® is a health product made of Schisandra, ginseng, Ginseng, Radix and other plant materials which can help enhance the body's antioxidant capacity. YI RUI CAPSULE , INFINITUS® is a health product made of salvia, hawthorn, alisma, perilla oil microcapsules, panax powder, ginkgo biloba and other plant materials which can assist lower the blood lipid level. Gest Aid Plus, INFINITUS® is a health product made of yam, codonopsis, poria, white beans, dried tangerine peel and other plant materials which can help regulate intestinal flora.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Body Constitution Classification; Health Management; Obese Population
Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
      Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this
      case, observation may be sufficient. It is not yet known whether chemotherapy is more
      effective than observation in treating colorectal cancer.

      PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they
      work compared to observation in treating patients with stage II colorectal cancer that has
      been completely removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with
           curatively resected stage II colorectal cancer.

      Secondary

        -  Compare relapse-free and overall survival of patients treated with these regimens.

        -  Compare the occurrence of adverse events in patients treated with these regimens.

      OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients undergo observation.

        -  Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7 days
           for 1 year in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for 5 years.

      PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
    

Intervention name(s): UFT adjuvant chemotherapy
Intervention type(s): Drug
Intervention description(s): UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
Other intervention name(s): Adjuvant chemotherapy with tegafur-uracil
Intervention MeSH terms: Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II colon cancer; stage II rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
Condition: Healthy Men; Male Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU)
      as a male hormonal contraceptive.

      The study has two parts. The first is a dose escalating study in healthy to assess the safety
      and tolerability of single dose oral administration of DMAUin healthy men.(Completed)

      The second is to study the safety and tolerability of DMAU after 28 days of repeated daily
      dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will
      also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral
      administration of DMAU.
    

Detailed description: 
      The study will be conducted in two centers.

      28-Day Repeat-Dose, Dose-Escalation Study: Based on the safety and tolerability of the single
      dose study and serum DMA levels attained, three doses of two formulations of DMAU were
      selected for a dose-escalating 28-day repeat dose study. Safety will be assessed in subjects
      receiving lower dosages before additional men receive higher doses for 28 days. Up to 100 men
      will be randomized to receive either active drug or an identical number of capsules of
      placebo. The 24-hour detailed PK of DMA will be assessed on day 1 and 28. Trough levels of
      DMA will be obtained throughout the 28-day period and at 48 and 72 hours after the last dose.
      In addition to safety and tolerability, suppression of serum T, gonadotropins, and SHBG will
      also be assessed as secondary pharmacodynamic (PD) endpoints. Psychosexual diaries for 7
      consecutive days and PHQ-9 (questionnaire)will be obtained before and at the end of the study
      period.
    

Intervention name(s): Dimethandrolone Undecanoate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily doses of 100, 200 and 400mg of dimethandrolone undecanoate; Placebo with capsules that look like the DMAU capsules but with no active ingredients
Other intervention name(s): No other names; no other names
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: androgen; male contraception; dimethandrolone; healthy men
Capsular Repair in FAI Impingement Surgery
Condition: Hip Injuries
MeSH terms: Hip Injuries
Study type: Interventional

Summary: 
      The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular
      Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient
      outcomes in the short, mid and long term, both clinically and radiographically, compared to
      those without capsular repair. The objective of this clinical trial is to evaluate the
      clinical efficacy with regards to pain, range of motion and return to work and activities of
      daily living. Secondary objective is to evaluate radiographic characteristics between both
      groups.
    


Intervention name(s): Capsular Repair; No Capsular Repair
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Capsular Repair; FAI; Hip
Psychological Treatments for Scleroderma
Condition: Pain; Depression; Scleroderma; Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Sclerosis; Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effectiveness of two psychological treatment approaches designed
      to help people who have scleroderma with three important areas of daily living: pain,
      depression, and distress about changes in appearance. The study will also evaluate the impact
      of depression on the two psychological treatments. Because psychological approaches requiring
      a trained professional can be expensive and are often not available to most patients, this
      study will also look at the effectiveness of a self-help treatment approach.
    

Detailed description: 
      This study will examine the efficacy of psychological interventions designed to target
      important areas of daily living for people with scleroderma: pain, depression, and distress
      about disfigurement. The study will also examine the effect of clinical depression on impact
      of the psychological treatments. Because psychological interventions requiring a trained
      professional can be costly and are often not available to the majority of patients, the study
      will also examine the efficacy of a self-help intervention.

      The study will recruit 201 patients with systemic sclerosis who report symptoms of pain,
      depression, or distress about disfigurement and will randomly assign them to one of three
      interventions: individual cognitive behavioral therapy, self-help cognitive behavioral
      intervention facilitated by a psychologist, or a disease/health education intervention. An
      individual blinded to intervention assignment will collect measures of pain, functioning,
      distress about disfigurement, and mood at baseline and following the 8-week intervention
      period.

      Both the cognitive-behavioral self-help materials and the educational materials (eight
      written chapters and audiotapes) will be designed for home use but will be supplemented by
      two individual sessions and two telephone contacts with the professional. Patients will be
      followed for 1 year after completing the active intervention phase.

      These findings will increase understanding of the quality of life of individuals with
      scleroderma and determine whether self-help interventions can be used effectively to manage
      pain, depression, and distress about disfigurement.
    

Intervention name(s): Cognitive behavioral therapy; Disease/health education; Self-help cognitive behavioral intervention facilitated by a psychologist
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scleroderma; Systemic sclerosis; Depression; Pain; Disfigurement; Body image dissatisfaction; Cognitive-behavioral therapy; Self-help; Psychological intervention
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
Condition: KNEE OSTEOARTHRITIS
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double-blind clinical trial in a Chinese population.
    

Detailed description: 
      This study is a randomized, double-blind clinical trial in a Chinese population. Active drug
      and placebo were used as controls to observe the relative efficacy of X0002 spray.
    

Intervention name(s): X0002 Spray; Ibuprofen Tablet; Ibuprofen Placebo Tab; X0002 Placebo Spray
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.; Ibuprofen Tab 400mg, tid.; Ibuprofen Placebo Tab 400mg, tid.; According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.
Other intervention name(s): Test drug; Active drug; Placebo Oral Tablet; Placebo Spray
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment