bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery
Condition: Breast Cancer; Exercise; Upper Extremity Dysfunction
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The main purpose of this study is to compare two different exercise approaches during the
      radiotherapy period in patients who have undergone breast cancer surgery.
    

Detailed description: 
      Exercise therapies are effective methods in the treatment of complications after breast
      cancer surgery. The study aims to compare exercise practices with virtual reality-based
      exercise training during radiotherapy period after breast cancer surgery. Patients were
      randomly divided into 3 groups as virtual reality group, exercise group, and control group,
      considering the order of arrival at the clinic and the type of surgery (mastectomy and
      breast-conserving surgery). Patients in virtual reality group received virtual reality-based
      exercise training using Microsoft Xbox 360 Kinect (Redmond, WA). Patients in exercise group
      received an exercise program including range of motion, posture, stretching and breathing
      exercises. Both exercise groups participated in the exercise program for 30- 40 minutes, 3
      days a week, as long as radiotherapy continued (5-6 weeks). Patients in the control group did
      not receive any exercise intervention as is done in the current practice. Assessment methods
      were applied at the beginning and at the end of the radiotherapy for all groups. Shoulder
      range of motion was measured using universal goniometer. Hand grip strength was measured
      using Jamar hand dynamometer. Shoulder proprioception was measured using Cybex (Lumex,NY,USA)
      isokinetic dynamometer. Upper extremity functional status, kinesiophobia, anxiety and
      depression level, fatigue and quality of life were evaluated with various questionnaires.
    

Intervention name(s): Virtual reality-based exercise; Exercise
Intervention type(s): Other; Other
Intervention description(s): Virtual reality-based exercises with "Microsoft Xbox 360 Kinect" and breathing exercises.
Patient education; Shoulder range of motion, stretching, posture and breathing exercises. Patient education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality Exercises; Breast cancer; Radiotherapy
Postoperative Analgesic Effect Of Dexmedetomidine Administration in Wound Infiltration for Total Abdominal Hysterectomy
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to investigate the analgesic efficacy of dexmedetomidine
      administration in wound infiltration for total abdominal hysterectomy.
    

Detailed description: 
      Abdominal hysterectomy is associated with moderate to severe postoperative pain, effective
      analgesia after hysterectomy essential and several techniques are used such as administration
      of opioids, nonsteroidal anti-inflammatory drugs and wound infiltration of local
      anaesthetics. Different local anaesthetics can be used for the wound infiltration
      techniques.Ifiltration of the surgical wound with bupivacaine following outpatient provides
      pain relief in the postoperative period , allows the early discharge from the outpatient
      surgical units.There has been increased interest in administration of analgesic prior to
      surgical injury. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with
      sedative , anxiolytic, analgesic, sympatholytic and antihypertensive effects.Dexmedetomidine
      has been used intravenously before initiation of anaesthesia and it has shown to provide some
      analgesic effect after surgery but there were some adverse hemodynamic effects. Surgical
      wound administration of dexmedetomidine may be useful to avoid the adverse haemodynamic
      effects of intravenous administration while still providing the postoperative analgesia.
    

Intervention name(s): Dexmedetomidine; Levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 2mcg.kg-1 dexmedetomidine wound infiltration; 0.25% levobupivacaine (40ml) wound infiltration
Other intervention name(s): precedex; chirocaine
Intervention MeSH terms: Dexmedetomidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dexmedetomidine; wound infiltration; postoperative analgesia
Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, tolerability and immunogenicity of
      Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered
      intradermally in varied dosing schedules and via different methods of administration
      (conventional needle/syringe versus needle-free PharmaJet® injector).
    

Detailed description: 
      This is an exploratory trial to assess the safety, tolerability and immunogenicity of
      vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally
      using the conventional needle/syringe or a needle-free PharmaJet® injector.

      Two (2) intradermal injections of either vaccine or placebo will be administered to qualified
      participants (one in each arm) on Day 0 of the study. A subsequent injection will also be
      given on Day 90 with either vaccine or placebo (in one arm only).

      Participants will be evaluated for safety and dengue neutralizing antibody to all four
      serotypes. All participants will also be evaluated for injection site reactions and have
      blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.

      Participants will be required to participate for approximately 10 months from recruitment and
      collection of data for primary outcomes (through Day 120) including collection of additional
      samples for measurement of longer term antibody titers (through Day 270).

      This project has been funded in whole or in part with Federal funds from the National
      Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of
      Health and Human Services, under Contract No. HHSN272201000034C.
    

Intervention name(s): TDV; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): TDV suspension for intradermal administration; Phosphate buffered saline (PBS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prophylactic vaccination
The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers
Condition: Breast Cancers; Gynecologic Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Women with breast cancer and other gynecologic cancers often suffer significant distress and
      disability from their disease. A practice of meditation-based stress reduction and
      cognitive-affective-behavioral learning may help women with these conditions decrease their
      suffering and improve their quality of life.
    

Detailed description: 
      The objective of this project in women recently treated for breast or other gynecologic
      cancer is to determine whether an intervention program consisting of group and individual
      instruction in a meditation-based practice of stress-reduction and
      cognitive-affective-behavioral learning has the potential for reducing disabling distress and
      improving quality of life in a population vulnerable to the progression or recurrence of
      disease. Quality of life will be assessed at 12 months.
    

Intervention name(s): Mindfulness based meditation program
Intervention type(s): Behavioral
Intervention description(s): Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.
Other intervention name(s): Meditation and Breast Cancer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast cancer; Gynecologic cancers; Meditation; Stress-reduction; Cognitive-affective behavioral learning
Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology.
      Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend
      to conduct this trial in strict accordance with the requirements of evidence-based medicine,
      through a multi-center, randomized, controlled study, using a double-blind, randomized,
      placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe
      restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the
      characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level
      evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.
    


Intervention name(s): Zishen Qingre Lishi Huayu Granules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu（Anemarrhena asphodeloides Bge.）, Shengdi（Rehmannia glutinosa Libosch.）, Maidong（Ophio pogon japonicus (L.f) KerGawl.） , Bixie（Dioscorea septemloma Thunb.）, Huanglian（Coptis chinensis Franch.）, Zhuling（Polyporus umbellatus（Pers.）Fries）, Xuanshen（Scrophularia ningpoensis Hemsl.）, Zelan（Lycopus lucidus Turcz. Var. Hirtus Regel）, Danshen（Salvia miltiorrhiza Beg.）， Gancao（Glycyrrhiza uralensis Fisch.）. Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.; The treatment group used Caramel pigment、 Ku Ding Cha Extracts、Maltodextrin、Starch and 5% Zishen Qingre Lishi Huayu Granules .
Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Condition: Tibial Fracture
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a case-control prospective, clinal trial to assess the safety and efficacy of
      the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent
      tibial fracture in 40 patients.
    

Detailed description: 
      In this study all eligible patients divided in 2 group.20 patients received allogeneic
      adipose derived mesenchymal stem cell in the fractured site (case group) and other patients
      received the placebo in the fractured site (control group) .

      To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after
      transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.
    

Intervention name(s): Mesenchymal stem cell injection; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
Other intervention name(s): stem cell transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allogenic adipose derived mesenchymal stem cell tibial fracture
Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to observe the occurrence of adverse events, seroconversion rate
      and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.
    


Intervention name(s): varicella-1; varicella-3; varicella-5
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day; Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day; Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pre Post Evaluation of Temperature, Steps, and Glucose With Additional Time Spent Outdoors in an Urban and Rural Setting
Condition: Temperature; Exercise; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This research was designed with partners to determine differences in temperature exposures in
      urban and rural communities in Alabama. The investigators hypothesized that significant
      differences in temperature exposure exist between urban and rural settings. Time spent
      outdoors has been previously positively associated with greater physical activity. Built
      environment components in urban versus rural environments and ambient temperatures
      experienced during the summer may pose barriers to time spent outdoors. Persons with Type II
      Diabetes Mellitus may find it more difficult to overcome temperature barriers due to reduced
      thermoregulation capacity. This analysis will result in a more precise picture of temperature
      exposure as well as behavioral factors that may mediate exposure.
    

Detailed description: 
      The investigators gathered individual-level temperature exposure data by asking 180 female
      participants to wear a small thermometer on their shoe for 7 days. Ninety participants were
      recruited from Birmingham AL (urban) and 90 from rural West Central Alabama. The first two
      days participants were asked to go about their normal daily activities. During the next 5
      days of participation, participants were asked to add an additional 30 minutes of time spent
      outdoors. As a secondary outcome, steps were measured via pedometers worn by participants. A
      subgroup of participants with self-reported doctor diagnosed Type II Diabetes also recorded
      their fasting glucose each morning of participation.
    

Intervention name(s): 30 minutes outdoors
Intervention type(s): Behavioral
Intervention description(s): Participants were asked to add an additional 30 minutes of time spent outdoors during the last 5 days of participation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: rurality
Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes
Condition: Hepatic Steatosis
MeSH terms: Fatty Liver; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to assess the Safety, Tolerability, and Pharmacodynamics effect of IONIS
      DGAT2Rx in up to 45 Adult Patients with Type 2 Diabetes.
    

Detailed description: 
      This short-term study will assess changes in hepatic steatosis over a 13-week treatment
      period in a patient population with higher risk for development of Nonalcoholic fatty liver
      disease (NAFLD) and Nonalcoholic steatohepatitis (NASH), obese type 2 diabetes mellitus
      (T2DM) with elevated HbA1c.
    

Intervention name(s): IONIS DGAT2Rx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single Dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks; Saline 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatic Steatosis; IONIS-DGAT2Rx; Type 2 Diabetes
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
Condition: Congenital Heart Defect; Congenital Heart Disease; Anesthesia, Local; Opioid Use
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The erector spinae plane block is a novel regional anesthetic technique that allows for
      analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study
      are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for
      congenital heart repair in high risk children and adults can decrease outcomes such as
      duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days
      in the intensive care unit (ICU) and length of stay (LOS).
    


Intervention name(s): Bilateral Erector Spinae Plane Block (ESPB)
Intervention type(s): Procedure
Intervention description(s): Bilateral ESPBs will be placed after anesthesia induction in eligible and consented patients who are undergoing a sternotomy for congenital heart repair. Patients will receive a local anesthetic agent through each catheter prior to surgery start. If possible, levels of the local anesthetic will be measured during the case. After surgery, patients will be admitted to the CVICU and extubation will be managed by the CVICU team. The ESPB group will have an automatic, alternating side boluses of the local anesthetic started through their nerve block catheters. Levels of the local anesthetic will be measured at intervals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Obstructive sleep apnea (OSA) is a clinical condition characterized by the repetitive
      obstruction of the upper airway during sleep, resulting in nocturnal hypoxaemia and
      fragmented sleep. Fragmented sleep leads to daytime sleepiness that causes alterations in
      reaction times and reflexes . Postural stability is an important function of the human body.
      It is shown that the sleep deprivation disturbs daytime postural stability and balance. Aim
      of this study is to examine the influence of OSA severity and daytime sleepiness on postural
      stability, balance and fall risk.
    


Intervention name(s): Assessments with Biodex Balance System®
Intervention type(s): Other
Intervention description(s): Postural Stability, limits of stability and fall risk tests will be applied with the Biodex Balance System®
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects aged between 30-65 years who are recently diagnosed with mild, moderate or severe
        OSA (AHI≥5) and not receiving any treatment yet will be included in the study.
Palliative Care in Spinal Muscular Atrophy (SMA) 1
Condition: Spinal Muscular Atrophy 1
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the quality of supportive and palliative care for
      SMA type 1 patients.
    

Detailed description: 
      Spinal Muscular Atrophy Type I (SMA I) is the most severe form of SMA. It presents in infancy
      and death occurs by 2 years. There is actually no curative treatment for this pathology.
      Support and help must be provided from the time of presentation till death and usually this
      period is quite short, about a couple of months. Variations in medical practice have be seen,
      depending on the medical experience and sometimes coupled with differences in family
      resources and values. The aim of the study is to evaluate the needs of the patients and their
      families, the medical practices, and to describe a cohort of SMA type 1 patients with the
      natural history of this disease. For this, a follow-up diary will be done, and this diary
      will be completed by the families and the different practitioners working with the patient.
      Will be noted in it : physical signs, all therapeutic choices and actions, evaluation of the
      pain and treatments. A special part of this follow-up diary will be completed by the medical
      doctors, after the death of the patient, with all the medication used at time of death and
      the conditions of the death. One year after the death of the patient, a questionnaire will be
      proposed to the parents of the child by a psychologist. This questionnaire will estimate the
      benefice of the follow-up diary, and the improvements to give in the diagnostic strategies,
      recommendations for assessment and monitoring, and therapeutic interventions in SMA type 1.
    

Intervention name(s): Follow-up diary and questionnaire
Intervention type(s): Other
Intervention description(s): A follow-up diary will be completed by the families and the different practitioners working with the patient. One year after the death of the patient, a questionnaire will be proposed to the parents of the child by a psychologist.
Other intervention name(s): Supportive and Palliative care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Spinal Muscular Atrophy (SMA) type 1; Supportive care; Palliative care
Remifentanil and Nitroprusside for Controlled Hypotension
Condition: Hypotension, Controlled
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is the comparison of the cardiovascular effects of remifentanil and
      nitroprusside for controlled hypotension
    


Intervention name(s): remifentanil; nitroprusside
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nitroprusside; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: remifentanil; nitroprusside; hypotension