bioihbjkbjnl/mcl2 huggingface dataset:
Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)
Condition: MV(Mitral Valve) Repair
Study type: Interventional
Phase: Phase 3

Summary: 
      1. objectives: The primary aim of ENAVLE is to explore the efficacy of edoxaban in patients
           with post mitral valve repair or bioprosthetic valve implantation

        2. Primary / Secondary Endpoint

      1) Efficacy Endpoint Evaluation: Occurrence of thromboembolic events and any thrombus at
      repaired ring or bioprosthetic valves detected by follow up echocardiography or 3D CT scan

      2) Safety Endpoint Evaluation

        -  Dysfunction of treated valve caused by thrombosis on echocardiography or 3D CT scan

        -  Major or minor bleeding described in safety outcomes
    

Detailed description: 
      This study is an open labeled, parallel group, and randomization study. At 7 days after
      mitral valve repair, bioprosthetic MV or AV replacement surgery, warfarin or edoxaban will be
      started per oral route. All study patients started to receive bridging therapy with
      parenteral anti-coagulant (UFH) according to local practice before switching to warfarin or
      edoxaban. Among patients who take warfarin, international normalized ratio will be used to
      monitor the effectiveness of the anticoagulant warfarin as usual daily practice. All patients
      who are assigned to VKA group, bridging with warfarin and UFH is mandatory until INR reach
      therapeutic target range (INR 2-3). Warfarin dose will be adjusted for maintain therapeutic
      range (INR 2-3) during follow up period. Patients who are randomly assigned to edoxaban group
      will be received 60mg qd or 30mg qd ( creatinine clearance 30-49ml/min, body weight <60kg or
      concomitant use of certain P-glycoprotein inhibitors). Both drugs will be maintained for 3
      months. During study period, all patients will be carefully monitored for thromboembolic
      events including valve dysfunction, and stroke or bleeding complication. At 3 months after
      surgery, 3 dimensional CT scan and echocardiography will be performed for detecting valvular
      dysfunction, any thrombus or bleeding in heart & lung.
    

Intervention name(s): Edoxaban; Warfarin; parenteral anti-coagulant (UFH)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients who are randomly assigned to edoxaban group will be received 60mg qd or 30mg qd (creatinine clearance 30-49ml/min, body weight <60kg or concomitant use of certain P-glycoprotein inhibitors).; All patients who are assigned to VKA group, bridging with warfarin and UFH is mandatory until INR reach therapeutic target range (INR 2-3). Warfarin dose will be adjusted for maintain therapeutic range (INR 2-3) during follow up period.; parenteral anti-coagulant (UFH)
Intervention MeSH terms: Warfarin; Edoxaban; Anticoagulants; Coagulants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369
      following administration of single ascending oral doses (SAD) in healthy adult participants.
      The study will also explore the effect of high-fat meal on the single-dose drug level of
      BMS-986369 in healthy adult participants.
    


Intervention name(s): BMS-986369
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BMS-986369; Healthy Volunteer; CC-99282
Efficacy of the Yoga and Aromatherapy on Salivary Hormone and Immune Function in Pregnant Women.
Condition: Stress, Psychologic
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This study's aims are to examine the effects of yoga and aromatherapy on women's stress and
      immune function during pregnancy.
    

Detailed description: 
      This longitudinal, prospective, randomized controlled trial recruited 75 healthy pregnant
      women from a prenatal clinic in Taipei using convenience sampling. The participants were
      randomly assigned to the aromatherapy group (n=25), yoga group (n=25) or control (n=25) group
      using Clinstat block randomization.

      The aromatherapy group received 70 minutes of aromatherapy massage once biweekly for 20
      weeks; the yoga group participated in two weekly 70-minute yoga sessions led by a midwife
      certified as a yoga instructor for 20 weeks; the control group received only routine prenatal
      care. All participants' salivary cortisol and immunoglobulin A levels were collected before
      and after yoga or aromatherapy every 4 weeks from 16 to 36 weeks' gestation.

      To collect a sufficient quantity of saliva, we used Salivette® cotton swabs (Salimetrics,
      State College, PA, USA), which were stored in double-layer plastic tubes with a lid. When
      participants chew a swab for about 2 to 3 minutes, saliva flow is stimulated to a sufficient
      amount (1 mL) for collection. After the tube was centrifuged at 1000 x g for 2 minutes,
      saliva was stored at -80°C until assay for salivary cortisol and IgA concentrations.

      Cortisol was measured using a competitive enzyme-linked immunoassay (ELISA) kit (Cayman
      Chemical Company, USA), and salivary IgA was measured using double-antibody sandwich ELISA
      method per the manufacturer's instruction (ICL, Inc., USA).
    

Intervention name(s): Aromatherapy massage; Yoga exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All of the participants in the aromatherapy group underwent aromatherapy massage for 70 minutes every two weeks between 16 to 36 weeks GA (ten sessions total). The aromatic massage oils were composed of 2 c.c. lavender (Lavandula angustifolia) blended with 98 c.c. almond oil. This concentration of the mixed essential oil was kept at room temperature for massage use.; Prenatal yoga was offered in six 70-minute yoga sessions per week for 20 weeks, with 10-12 women in each session. Each participant should attend two sessions of yoga every two days, held in a quiet room near the prenatal clinic. Yoga specifically designed for women during the second and third trimesters, was guided by a midwife who was certified as a yoga instructor. Yoga included physical postures/ stretch, deep breathing, guided imagery, and deep relaxation. Before each posture/stretch, the instructor guided participants to relax each body part and calm their mind.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: aromatherapy massage, yoga
Mobilization With Movement for Shoulder Impingement
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      Controversy exists regarding the effectiveness of manual therapy techniques for the
      management of impingement syndrome. However, no adequately powered clinical trials have
      examined the effects of mobilization-with-movement. The purpose of the current study was to
      perform a randomized controlled trial comparing the effects of real MWM to a group receiving
      a sham intervention on shoulder pain at different moments and active shoulder range of motion
      in an adequately powered sample of patients with shoulder impingement syndrome.
    


Intervention name(s): Real mobilization-with-movement (MWM); Sham mobilization-with-movement (MWM)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder impingement, manual therapy, pain, motion.
Outcomes After Esophageal Cancer Surgery
Condition: Esophageal Neoplasm; Esophageal Disease
MeSH terms: Esophageal Neoplasms; Esophageal Diseases
Study type: Observational

Summary: 
      Background

        -  Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the
           eighth most common cancer worldwide

        -  The incidence is increasing rapidly

        -  The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes
           are related to diagnosis at advanced stages.

        -  Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but
           treatment of esophageal carcinoma remains challenging and need to be considered through
           a multimodal approach. However the modalities and the impact of this multimodal approach
           at a national level are unknown Primary objective: To identify predictors of recurrence
           after esophageal cancer surgery

      Secondary objectives :

        -  5-year recurrence free survival

        -  5-year overall survival

        -  Predictors of postoperative mortality and morbidity after surgery

        -  Impact of pCR on recurrence and survival

        -  Impact of neoadjuvant treatments on recurrence and survival

        -  Impact of patient preconditioning (such as nutritional support, esophageal prosthesis,
           mini-invasive approach…) on outcomes

      Methodology : European French-speaking retrospective multicentric study Inclusion criteria:
      All consecutive patients operated on, for a histologically proven carcinoma of the esophagus,
      the oesophago-gastric junction (Siewert type I and II), in surgical investigator centers
      between January 2000 and December 2010 Exclusion criteria: Siewert III type carcinoma of the
      oesophago-gastric junction , non surgical treatment of esophageal carcinoma Planned study
      period: The data will be collected over a 11-year period from January 2000 to December 2010.
      Follow up will be ascertained in May 2013.
    

Detailed description: 
      Patients with an esophageal or junctional carcinoma (including SIewert type I and II) with
      surgical resection of the primary tumor inclusion date will be date of surgery all patients
      will be followed during 5 years after surgery or time of death
    

Intervention name(s): Esophagectomy
Intervention type(s): Procedure
Intervention description(s): Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the
        oesophago-gastric junction
      
Keywords: Esophageal Neoplasm; Esophagus; Surgery; Outcome assessment
Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream.
      Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis
      with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area)
      score of 1%-10% were included.
    

Detailed description: 
      A randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an
      IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls
      using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for
      two weeks to measure clinical responses and pruritus change.
    

Intervention name(s): Medihoney Derma Cream; Hydrocortisone 1% cream
Intervention type(s): Drug; Drug
Intervention description(s): applied topically, twice a day, on all affected areas in the body for two weeks.; applied topically, twice a day, on all affected areas in the body for two weeks.
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: We conducted a randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eczema; atopic dermatitis; Medihoney dermacream
Short Moderate-intensity Continuous Training on Sedentary Women's
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      Purpose: To determine the effects of three Short Moderate Intensity Continuous Training
      (SMICT) exercise programs with different durations, on functional capacity, resting heart
      rate (RHR) and physical activity enjoyment in sedentary women.

      Methods: A randomized clinical trial was performed. 45 sedentary women were randomly
      allocated to either a: i) 8-minutes short exercise group; ii) 10-minutes short exercise
      group; and iii) 15-minutes short exercise group. All three groups received a short exercise
      training program at moderate intensity for 3 sessions/week, over 3 weeks. Before and after
      the interventions, functional capacity was evaluated through the 6-minute walking test, and
      RHR with a pulse oximeter. Physical activity enjoyment was measured with the Physical
      Activity Enjoyment Scale after the intervention.
    

Detailed description: 
      Sedentary lifestyles contribute to 3.2 million annual deaths globally, correlating with
      increased risks of cardiovascular diseases, obesity, and certain cancers. With women showing
      notably low physical activity rates, implementing tailored exercise interventions becomes
      crucial to enhance their activity levels and functionality, potentially mitigating risks
      associated with high resting heart rates linked to increased mortality, particularly from
      cardiovascular causes.

      This was a randomized clinical trial involving 45 sedentary women split into three groups:
      8-minute, 10-minute, and 15-minute exercise durations. All groups underwent
      moderate-intensity short exercise programs, differing only in duration. Functional capacity
      (measured by the 6-minute walking test) and resting heart rate (RHR) were assessed at
      baseline and after the 3-week intervention. Physical activity enjoyment was measured at the
      intervention's end.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Exercise with a cycle ergometer in three phases:
Warm-up: the exercise intensity was determined at 50-60% of HRmax obtained in the effort test, and lasted 2 minutes.
Short exercise at moderate intensity for 8, 10 or 15 minutes according to group allocation. The exercise was cycling at 75% HRmax determined with an effort test.
Cool down: the exercise intensity was determined at 50-60% of HRmax obtained in the effort test, and lasted 2 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Optimal Physiologic Intravascular Ultrasound Imaging Criteria After Drug Eluting Stent Implantation
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational

Summary: 
      Invasive imaging criteria of the Coronary arteriography (CAG) and intravascular ultrasound
      imaging (IVUS), satisfying procedural optimization after drug eluting stent (DES)
      implantation, were used in < 10% DS by CAG and 5-5.5mm2 MSA by IVUS. Whether these criteria
      satisfy not only relieving visible stenosis but also relieving lesion specific ischemia or
      not were unclear. Fractional flow reserve (FFR), an index of lesion specific ischemia, was
      proposed 0.9 as a physiologic criteria satisfying successful stent implantation by previous
      studies with bare metal stent. FFR after drug-eluting stent implantation can be an useful
      predictor for clinical outcome. But, direct comparative evaluation of the invasive imaging
      criteria defining as an indicator relieving myocardial ischemia were not reported. The aim of
      this study was to investigate angiographic and IVUS parameters in which corresponding FFR and
      evaluate their optimal physiologic criteria after DES implantation.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who underwent coronary angiography and percutaneous coronary intervention for the
        diagnosis and treatment purposes because of clinical angina pectoris. Patient who underwent
        simultaneous IVUS and FFR measurement after DES implantation would be enrolled
        consecutively.
      
Keywords: coronary atherosclerosis; drug eluting stent; intravascular ultrasound; fractional flow reserve
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load
      changes and liver tests change.
    


Intervention name(s): rosuvastatin; atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia
Condition: Hypertension
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity,
      especially in developing countries. Postpartum hypertension can be related to persistence of
      gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could
      develop de novo secondary to other causes. The available data in the medical literature have
      primarily focused on antenatal and peripartum management. There are few data regarding the
      evaluation in women who are diagnosis with postpartum hypertension. Some medications that
      cause vasoconstriction are often used for pain relief, in women having perineal lacerations,
      episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal
      antiinflammatory drugs that are associated with vasoconstriction and sodium and water
      retention, this drugs can result in severe hypertension.

      The purpose of this study is to evaluate maternal postpartum hypertension in women with
      severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.
    

Detailed description: 
      Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum
      period in women with severe pre-eclampsia. We include only women with vaginal delivery.
    

Intervention name(s): Ibuprofen; Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 400 mg each 8 hours; Control group
Other intervention name(s): Ibuprofen in pre-eclampsia; Acetaminophen in pre-eclampsia
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Research Exploring Sleep Education & Technology
Condition: Sleep Health
Study type: Interventional

Summary: 
      A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking
      technologies, and optimal sleep health educational strategies among users of mobile wearable
      technologies that track sleep.
    


Intervention name(s): Specialized sleep-related message interventions; GAD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.; Survey responses will be merged with objective GAD data (sleep time, time in deep sleep, physical activity) which will assist in developing message design formats for message testing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sleep health
Effect of TEAS on Rocuronium Injection Pain
Condition: Injection Pain
Study type: Interventional

Summary: 
      Pain from the injection of rocuronium is a common side effect during anesthetic practice,
      occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This
      prospective, randomized study was designed to determine the efficacy of transcutaneous
      electrical acupuncture point stimulation in reducing the rocuronium injection pain.
    


Intervention name(s): TEAS
Intervention type(s): Device
Intervention description(s): Transcutaneous electrical acupuncture stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
Condition: Bronchiolitis; Chronic Bronchitis
MeSH terms: Bronchiolitis; Bronchitis; Bronchitis, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease
      dyspnea and improve physiologic and respiratory measures in patients with a previous exposure
      to Sulfur Mustard gas.
    


Intervention name(s): helium:oxygen mixture
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: noninvasive ventilation; helium; oxygen; sulfur mustard; chronic bronchitis; bronchiolitis
Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The purpose of this study was to compare the antiemetic efficacy of aprepitant plus
      palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic
      cholecystectomy.
    

Detailed description: 
      The purpose of this study was to compare the antiemetic efficacy of aprepitant plus
      palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic
      cholecystectomy.

      Study is performed during 24 hours after surgery.
    

Intervention name(s): aprepitant; palonosetron; Ramosetron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): aprepitant 80 mg is given to all patients before surgery; palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia; ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia
Intervention MeSH terms: Aprepitant; Palonosetron; Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention