bioihbjkbjnl/mcl2 huggingface dataset:
Cingularbio® Heart Valve Clincial Study
Condition: Diseases of Mitral and Aortic Valves
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in
      Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
    

Detailed description: 
      single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of
      Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients
    

Intervention name(s): Cingularbio® Aortic valve replacement
Intervention type(s): Device
Intervention description(s): the patients will be replaced by Cingularbio heart valve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of
      the printed etafilcon A with polyvinylpyrrolidone (PVP).
    


Intervention name(s): etafilcon A (A); etafilcon A (B); etafilcon A (C)
Intervention type(s): Device; Device; Device
Intervention description(s): Daily wear contact lens; Daily wear contact lens; Daily wear contact lens
Other intervention name(s): printed etafilcon A Lens with PVP (A); printed etafilcon A Lens PVP (B); printed etafilcon A Lens PVP (C)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Dietary Supplement of Coenzyme Q10（CoQ10） on Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      In previous study the investigators found that CoQ10 can improve cholesterol efflux from
      macrophages in cell model, ApoE mice model and small-scale of healthy volunteers. In
      addition, CoQ10 has strong antioxidant activity and is an essential factor of mitochondria
      electron transport chain. So the investigators hypothesize that CoQ10 may have some health
      promotion effect on dyslipidemia, risk factor of atherosclerosis and other cardiovascular
      diseases. On this purpose, the investigators are going to recruit 150 dyslipidemia patients
      to supply CoQ10+vitamin E or CoQ10 alone or placebo in different doses for 24 weeks to
      explore the effects of CoQ10 on cholesterol efflux and lipid profiles on dyslipidemia.
    


Intervention name(s): coenzyme Q10 vitamin E softgel; coenzyme Q10 softgel; placebo softgel
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.; 4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.; 4 placebo softgels per day. Keep normal lift style unchanged.
Intervention MeSH terms: Vitamin E; Coenzyme Q10; Ubiquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cholesterol efflux; dyslipidemia
Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
Condition: Cholelithiasis; Biliary Dyskinesia
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Biliary Dyskinesia; Dyskinesias
Study type: Interventional

Summary: 
      Prospective randomized trial of single incision versus standard 4 port laparoscopic
      cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
    

Detailed description: 
      This will be a prospective, randomized clinical trial involving patients who present to the
      hospital with an indication for cholecystectomy. We will offer enrollment to several
      institutions provided they receive institutional approval.

      This will be a definitive trial design. Based on our operative times with SILS compared with
      our recent experience in standard laparoscopy, a sample size of 60 patients will give us a
      power of 0.8 with an α of 0.05.

      After the procedure, both groups will be managed in the same manner per routine care. They
      will be discharged when tolerating a regular diet and their pain is well-controlled on oral
      pain medication.
    

Intervention name(s): SILS; Standard Laparoscopic Cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Single Incision Laparoscopic Cholecystectomy; 4 port technique
Other intervention name(s): Laparoscopic Cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SILS; Laparoscopic Cholecystectomy; Children
Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma
      patients carrying a reasonable risk for metastases. In numerous studies the prognostic role
      of micro metastases in the sentinel node (SN) was described. However, the prognostic value of
      a complete lymph node dissection in patients with a positive SN is still unclear.

      This study was planned to analyse the survival outcome of patients with a positive SN
      receiving complete lymphadenectomy versus watchful waiting.
    


Intervention name(s): Completion Lymphadenectomy; Clinical Monitoring (Palpation and node ultrasound)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sentinel Lymph Node Biopsy; Lymph Node Excision
Sleep Timing and Energy Balance
Condition: Sleep; Meals
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of sleep and meal timing, independent of
      sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in
      normal weight adults.

      This study will be a 4-phase, randomized controlled study of 5 days each in which
      participants will undergo 2 phases of late sleep times that differ in meal timing (normal or
      late) and 2 phases of normal sleep times that differ in meal timing (normal or late).

      The Aims and Hypotheses of this study are:

      Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response
      to altered sleep and meal timing.

        -  Hypothesis 1: There will be an interaction between sleep and meal time on glucose,
           insulin, and glucose and insulin area under the curve after the glucose tolerance test
           such that the late sleep/late meal will result in the worst metabolic profile, normal
           sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal
           sleep/normal meal will result in the best metabolic profile.

        -  Hypothesis 2: There will be an interaction between sleep and meal time on leptin and
           ghrelin concentrations such that the late sleep/late meal timing phase will result in
           low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will
           have an intermediate profile, and normal sleep/normal meal timing will result in high
           leptin/low ghrelin.

      Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal
      timing.

      • Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase
      compared to normal sleep timing.
    


Intervention name(s): Normal sleep; Normal meals; Late sleep; Late meals
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Normal sleep= sleep 2300-0700; Normal meal times=approximately 1.5, 5, and 11 h after wake up for breakfast, lunch, and dinner, and snack at 13 h after wake up time; Late sleep=sleep at 0230-1030 hours; Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sleep; Sleep duration; Meals; Food intake; Obesity
A Retrospective rEal-life daTa Study to Assess the exaceRbations and Lung functIon in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
Condition: COPD; COPD Exacerbation
MeSH terms: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
Study type: Observational

Summary: 
      Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combination is commonly prescribed
      to treat COPD; we will perform a retrospective analysis on the effect of adding a long-acting
      muscarinic receptor antagonist (LAMA) to ICS/LABA combination in COPD.
    

Detailed description: 
      According to the current guidelines for the treatment of COPD, it is recommended to use
      combination therapies with different or complementary mechanisms of action . Data suggest
      that open triple therapy incorporating LAMA with ICS / LABA combination products administered
      through different delivery devices may be beneficial for improving pulmonary function in
      patients with COPD. However, there is little evidence of the effect of triple therapy on
      pulmonary function and the incidence of exacerbations in COPD patients.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients
Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      In patients with chronic heart failure ACE-inhibitor treatment improves lung diffusion and
      prevents pulmonary edema after fluid overload. In the western country, 3 population types of
      ACE genotypes exist (DD, ID, II). It is unknown whether the ACE genotype influences the
      response to fluid overload in ACE-inhibitor treated chronic heart failure patients.
    

Detailed description: 
      Patients with chronic heart failure in stable clinical condition treated with ACE-inhibitors,
      but not aspirin, will be evaluated by means of maximal cardiopulmonary exercise test and lung
      function including lung diffusion measurements. These tests will be done before and after
      rapid 500 ml isotonic saline infusion. Patients will be grouped according to their ACE
      genotype.
    

Intervention name(s): isotonic saline infusion
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Heart failure; pulmonary edema; ACE-inhibitors; lung diffusion; exercise capacity; Chronic heart failure
Effects of High-Flow Nasal Cannula Therapy Assessed by Electrical Impedance Tomography
Condition: High-flow Nasal Cannula; Electrical Impedance Tomography
Study type: Observational

Summary: 
      This study aimed to determine the effects of HFNC therapy on lung recruitment and lung strain
      change assessed by electrical impedance tomography (EIT)
    


Intervention name(s): High-flow nasal cannula (HFNC)
Intervention type(s): Other
Intervention description(s): 24 patients who receiving HFNC within 24 hours after extubation were prospectively enrolled in this study. EIT was used to monitor regional lung ventilation distributions at baseline (conventional oxygen therapy) and three flow rate levels of HFNC therapy (20, 40 and 60 L/min).
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult critically ill patients, who received a HENC therapy within 24 h after the
        extubation, were enrolled.
NOTES Transvaginal Cholecystectomy and Appendectomy
Condition: Gallbladder Diseases; Appendicitis
MeSH terms: Appendicitis; Gallbladder Diseases
Study type: Interventional

Summary: 
      Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert
      surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving
      area of preclinical research and several groups worldwide are developing this surgical
      approach together with industry support. In this new surgical technique, abdominal operations
      are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal
      cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of
      minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall
      and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any
      visible scar and could also potentially reduce post operative pain due to the elimination of
      abdominal wall trauma.

      In this trial we intend to operate healthy women who need to undergo cholecystectomy or
      appendectomy. The operations will be performed through the vagina as the access port to the
      peritoneum and it will be monitored with laparoscopic vision for safety reasons.
    


Intervention name(s): NOTES Transvaginal Cholecystectomy; NOTES Transvaginal Appendectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The gallbladder will be dissected free and will be removed through an incision in the vagina.; The appendix will be dissected free and will be removed through an incision in the vagina.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety of ramelteon, once daily (QD), in
      individuals with obstructive sleep apnea.
    

Detailed description: 
      Insomnia is characterized by difficulties initiating and maintaining sleep, or complaints of
      non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third
      to one-half of the US population, based on the results of 2 surveys of representative samples
      of the adult US population conducted by the Gallup Organization in which respondents were
      asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent"
      sleep difficulty, results from the same studies suggest that approximately one-tenth of the
      US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the
      latency to onset of sleep and increase total sleep time, without a negative impact on sleep
      architecture and without safety concerns or next-day effects.

      Ramelteon is under global development by Takeda Chemical Industries, Ltd., for the treatment
      of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

      This study is being conducted to assess the safety of Ramelteon in subjects with obstructive
      sleep apnea. Participation this this study is anticipated to be about 1.5 months.
    

Intervention name(s): Ramelteon or Placebo
Intervention type(s): Drug
Intervention description(s): Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2.
Other intervention name(s): Rozerem; ramelteon; TAK-375
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Apnea, Obstructive; Insomnia; Drug Therapy
Therapeutic Touch for Wrist Fractures in Postmenopausal Women
Condition: Osteoporosis; Fractures
MeSH terms: Osteoporosis; Fractures, Bone; Wrist Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures
      in women past menopause.
    

Detailed description: 
      In the United States, the use of complementary and alternative medicine (CAM) increased by
      approximately 25% between 1990 and 1997. The number of visits to CAM practitioners exceeded
      visits to primary care physicians by about 250 million in 1997. Energy medicine modalities,
      including therapeutic touch, healing touch, and reiki, are commonly utilized for conditions
      ranging from headache to cancer, yet understanding of the human energy field and how it may
      be used in healing is limited. This study will examine the effect of therapeutic touch on
      fracture healing in postmenopausal women.

      Women will be enrolled in the study within one week of a wrist fracture and will receive
      either therapeutic touch or a sham (placebo) treatment daily for 3 weeks. Assessments will
      include blood and urine analysis and measures of pain and function in the affected wrist.
    

Intervention name(s): Therapeutic Touch
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bone Metabolism; Therapeutic Touch
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults
Condition: Pneumococcal Vaccines
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the study is to evaluate the safety and tolerability of a single injection
      of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in
      Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single
      injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age
      in Phase 2.
    


Intervention name(s): 24 valent pneumococcal conjugate vaccine; 20 valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1; 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This study was conducted to provide preliminary data for the main trial to compare efficacy
      between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and
      switching monopolar RFA using separable clustered electrodes in the treatment of recurrent
      hepatocellular carcinoma (HCC) after locoregional treatment.
    


Intervention name(s): Bipolar RFA; SM-RFA; Twin internally cooled-wet electrodes; Separable clustered electrodes
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Bipolar RFA in which RF currents flow between two electrodes; Monopolar RFA using multiple electrodes with switching mode; Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity; A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
Other intervention name(s): CWTN-T; Octopus®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RFA
The Effects of Human Endotoxemia on Functional Capacity of Hematopoietic Stem and Progenitor Cells
Condition: Sepsis, Endotoxemia, Immunosuppression
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      We will investigate whether human endotoxemia induces changes in human bone marrow cells and
      their downstream effector cells. To comprehensively investigate underlying mechanisms behind
      functional and transcriptional changes in these cell types, we will use state-of-the-art
      systems biology techniques, including single cell transcriptomics (epi)genetics, and
      metabolomics.
    

Detailed description: 
      In the present study, we want to further elucidate the mechanisms behind systemic
      inflammation and endotoxin tolerance in vivo in humans by focusing on functional changes in
      hematopoietic stem and progenitor cells. Healthy male volunteers will be challenged with
      endotoxin to evoke a transient systemic inflammatory response. To evaluate the responses over
      time, blood and bone marrow aspirates will be collected at multiple timepoints. To
      comprehensively investigate underlying mechanisms behind functional changes, we will use
      state-of-the-art systems biology techniques, including single cell transcriptomics,
      epigenetics (e..g. scATACseq), and metabolomic. As such, this study will yield a
      comprehensive insight into inflammatory signaling in the different compartments of the body
      and will thereby improve our understanding of systemic inflammation, endotoxin tolerance,and
      sepsis, possibly revealing new therapeutic targets to improve sepsis outcome.
    

Intervention name(s): LPS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is a non-investigational product. LPS is used as challenge agent to achieve a controlled inflammatory state.; Injection of NaCl 0.9%.
Other intervention name(s): Lipopolysaccharide (LPS from Escherichia coli Type O11); Endotoxin; NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An pilot study to explore the effects of a LPS-challenge on functional capacity and gene expression of human stem and hematopoietic progenitor cells and blood leukocytes. Subjects will be allocated to a LPS group (n=8 healthy volunteers) that will be challenged with endotoxin twice, or to a placebo group (n=4) who will undergo the same study procedures but receive a placebo challenge (NaCl 0.9%).
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sepsis, immunosuppression, systemic inflammation, human endotoxemia, bone marrow stem and progenitor cells, myelopoiesis, monocytes, transciptomics