bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion
Condition: Left Atrial Appendage Velocity; Left Atrial Structure; Left Atrial Function
Study type: Observational

Summary: 
      Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure
      can not only improve symptoms in patients with non-valvular atrial fibrillation, but also
      prevent left atrial appendage thrombosis. The safety and effectiveness of left atrial
      appendage occlusion have been confirmed by randomized controlled trials and actual
      experience. Among patients with different left atrial appendage emptying speeds, there are
      limited studies on the structure and function of the left atrial appendage after LAA closure.
      In this study, patients with persistent nonvalvular atrial fibrillation were selected for
      radiofrequency ablation combined with LAA closure. The sinus rhythm was restored after the
      operation. According to the different emptying speed of the left atrial appendage, they were
      divided into a high-flow rate group and a low-flow rate group. The differences in the
      structure and function of the left atrium between the two groups were analyzed.
    


Intervention name(s): Transesophageal ultrasound
Intervention type(s): Device
Intervention description(s): Patients with nonvalvular atrial fibrillation underwent radiofrequency ablation combined with left atrial appendage closure and recovered to sinus rhythm after the operation. To study the changes of left atrial organization and function of two groups of patients with different left atrial appendage emptying speeds.
Other intervention name(s): Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with non-valvular atrial fibrillation between the ages of 18 and 80 received
        atrial fibrillation radiofrequency ablation combined with left atrial appendage occlusion,
        and recovered to sinus rhythm after the operation. According to the different left atrial
        appendage emptying speed, it is divided into a higher left atrial appendage emptying speed
        group and a lower left atrial appendage emptying speed group.
Watermelon and Beetroot Products on Endothelial Function
Condition: Healthy Young; Older People With Cardiovascular Disease Risk
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cardiovascular disease is the main cause of death worldwide. Endothelial dysfunction is the
      first step to development of cardiovascular diseases. Endothelial dysfunction occurs due to
      reduction in nitric oxide, a molecule that plays an important role on vascular health. Due to
      important role of nitric oxide in endothelial function, several studies have evaluated the
      effect of its precursors, such as L-citrulline and nitrate on endothelial function
      parameters. The present study will evaluate the effect of L-citrulline and nitrate derived by
      watermelon and beetroot products, respectively, on endothelial function of young and older
      participants. Furthermore, we will evaluate the plasmatic amino acids, nitrate, glucose and
      insulin in response to ingestion of these products.
    


Intervention name(s): Watermelon; Beetroot; Watermelon + beetroot; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A single dose of watermelon powder containing 3g of L-citrulline; A single dose of beetroot powder containing 8 mmol of nitrate; A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate; A single dose of maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: endothelial function; L-citrulline; nitrate; nitric oxide
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study
      to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus
      Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer
    

Detailed description: 
      Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab +
      standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24
      months.
    

Intervention name(s): Durvalumab; Cisplatin; Carboplatin; external beam radiation therapy (EBRT) + brachytherapy
Intervention type(s): Biological; Drug; Drug; Radiation
Intervention description(s): IV infusion every 4 weeks; Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy; For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy; Radiation therapy per standard of care
Intervention MeSH terms: Carboplatin; Durvalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Durvalumab; Chemoradiotherapy; Locally Advanced Cervical Cancer
The Effects of Serratus Anterior Plane Block on Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery
Condition: Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery
Study type: Interventional

Summary: 
      Postoperative pain still remains a challenging problem in patients undergoing video-assisted
      thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for
      VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described
      recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the
      possibility to provide analgesia following thoracic surgery. Pain following surgery is a
      critical side effect of surgery, which increases the risk of complications and delays a
      recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the
      quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided
      SPB on the quality of recovery and pain in patients undergoing VATS.
    


Intervention name(s): Ropivacaine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 90 patients are randomly allocated into two groups: ropivacaine group (n=45), saline group (n=40). In the ropivacaine group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia. In the saline group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg saline after induction of anesthesia.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Association of Thyroid Autoimmunity and Chronic Urticaria
Condition: Skin Itching; Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Observational

Summary: 
      Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria.
      About 5-34% of chronic urticaria patients is associated with the presence of thyroid
      autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or
      hypothyroidism.
    

Detailed description: 
      There is no such report on the association of thyroid autoantibodies and chronic urticaria in
      Taiwan population yet. This study is designed to investigate the prevalence of thyroid
      autoimmunity associated with chronic urticaria in Taiwanese population. In addition, we
      intend to find out the change in the level of thyroid autoimmunity after the treatment in
      order to further understand their relationship. We also intend to find out the prognostic
      parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.
    

Intervention name(s): blood sampling
Intervention type(s): Behavioral
Intervention description(s): blood sampling 10ml from the study subjects
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18 and above with complaint of skin itching
      
Keywords: urticaria; goiter
SPARQ and Core Proprioception
Condition: Proprioception; Core Strength
Study type: Observational

Summary: 
      The purpose of this investigation is to determine the relationship of core stability to core
      proprioception
    

Detailed description: 
      As no previous research has been reported correlating the SPARQtm method of athletic
      performance with the McGill Side Bridge test and core joint position error, this study is
      designed as a pilot. The subject's core stability will be measured with the SPARQtm method of
      athletic performance and the McGill Side Bridge test for core stability. Core proprioception
      will be determined using the standard test for proprioception, Joint Position Error (JPE)
      testing, with the Skill Technologies motion capture device. All participants will receive the
      SPARQtm method of athletic performance testing, the McGill Side Bridge test for core
      stability and the core joint position error tests twice, one week apart.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): male & female college students ages 20 to 50, asymptomatic normals
Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        asymptomatic normals
The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
Condition: Schizophrenia; Psychotic Disorders; Bipolar Disorder
MeSH terms: Weight Gain; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes
      with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of
      obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight
      gain that may be associated with taking olanzapine.

      The purposes of this study are to determine the safety of olanzapine when given in
      combination with the Anti-obesity Agent and any side effects that might be associated with it
      and whether weight-gain agent can help treat weight gain that may be associated with taking
      olanzapine.
    


Intervention name(s): Sibutramine
Intervention type(s): Drug
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizoaffective disorder; schizophreniform disorder; bipolar I disorder
Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction
Condition: Refractory Meningioma
MeSH terms: Meningioma
Study type: Observational

Summary: 
      Tumor dosimetry with somatostatin receptor-targeted peptide receptor radionuclide therapy
      (SSTR-targeted PRRT) by 177Lutetium-DOTATATE might contribute to improve follow-up and
      treatment response of refractory meningiomas. This study aims to evaluate Standard Uptake
      Value mean (SUVmean) as a tumoral absorbed dose predictive predictive factor and propose
      semi-automated segmentation method to determine metabolic tumor volume with pretherapeutic
      68-Gallium-DOTATOC PET.
    


Intervention name(s): To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax
Intervention type(s): Other
Intervention description(s): Measure SUVmean (Standard Uptake Value) and SUVmax on PET exams
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        20 patients with meningioma will be included in this study, and 10 patients of 20 will have
        been treated with Lutathera®.
Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With Constipation
Condition: Functional Constipation; Gastric Emptying; Whole Gut Transit; Small Bowel Transit; Colonic Transit; Rectal Compliance; Rectal Sensation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the dose-related effects of TU-100, a botanical agent
      that modulates gastrointestinal nerves, on rectal compliance, rectal sensation thresholds and
      small bowel and colonic transit in female patients with functional constipation as compared
      to placebo.
    


Intervention name(s): Daikenchuto (TU-100); Daikenchuto (TU-100); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.; Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.; Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Digestive system diseases; Gastrointestinal diseases; Intestinal diseases; Colonic inertia
Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The goal of this study is to implement and in a controlled randomised trial test a program to
      identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH
      Chelsea HC.

      Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting
      staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities
      between patients with limited English proficiency and English speakers
    

Detailed description: 
      We developed a training program for five health center interpreters fluent in eight different
      languages. Patients randomly assigned to the study intervention receive an introductory
      letter in their native language. During the initial contact the navigator educates patients
      about CRC screening and explores patients' barriers to CRC screening. Based on results from a
      qualitative study conducted at in 2006, we developed interventions to overcome individual
      barriers to CRC screening tailored to each individual patient. Specific interventions include
      elucidation of culturally-specific health beliefs; teaching about cancer risk, colonoscopy,
      and colon prep administration; and help with appointment-making and transport.
    

Intervention name(s): Patient Navigation
Intervention type(s): Behavioral
Intervention description(s): Patient navigators will perform an initial interview with participants to identify and explore barriers, work with patients to overcome barriers, educate patients about CRC screening, motivate and coach patients, and schedule and accompany patients to colonoscopy testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal Cancer; Cancer Screening; Patient Navigation; Low English Proficiency
Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of
      cortical electrical stimulation to identify major anatomical and functional networks in
      epileptic patients candidates for surgery and explored by stereoencephalography, to minimize
      risk of post-surgical cognitive deficits.
    

Detailed description: 
      Cognitive deficits after epilepsy surgery are poorly known particularly because the tools
      used to evaluate them. In addition, the prevention of certain postoperative deficits, is
      extremely difficult because of the lack of robust markers to anticipate. The various
      examinations conventionally used for this purpose (neuropsychological testing, functional MRI
      and cortical stimulation) does indeed provide insufficient information or difficult to
      interpret, so the development of improved methods appears as an imperative in the field of
      the epilepsy surgery.

      SID appears as such particularly adapted to the case of epileptic patients explored SEEG to
      provide individualized cognitive map millimeter thereof without requiring, for additional
      invasive act, or risk of inducing unintended crisis. In practice, this clinical research
      project should lead to the definition of several simple cognitive tasks which, together,
      could be achieved by each volunteer patient in two or three hours, and then analyzed in a
      similar time to provide fast, even the patient is still explored SEEG and even before
      cortical electrical stimulation, a list of brain regions involved in most major cognitive
      functions.
    

Intervention name(s): Spectral Dynamic Imaging; Hybride electrode; Macro electrode
Intervention type(s): Procedure; Device; Device
Other intervention name(s): AdTech Medical Instrument Corporation; DIXI Microtechniques
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12
Condition: Healthy
Study type: Interventional

Summary: 
      In the Netherlands fortification of food products is not yet mandatory. One of the major
      arguments of the Dutch Health Council to advise against mandatory fortification is the
      possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the
      possibility of masking is: fortification of foods with both folic acid and vitamin B12. In
      this study we want to assess the effects of this fortification strategy on markers of folate
      and vitamin B12 status.
    

Detailed description: 
      During a 12 week period subjects will consume

        -  bread fortified with folic acid and vitamin B12 or

        -  placebo bread (not fortified)

      Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic
      acid and 6mcg vitamin B12 per 3 slices.

      We will study the effect of this fortification strategy on markers of folate and vitamin B12
      status.
    

Intervention name(s): consumption of fortified bread
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: no specific conditions
Phase1 Study of GR121167, Single and Multiple Dose Study in Healthy Japanese Males
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete
      crossover, single and multiple dose study in healthy Japanese male subjects to assess the
      pharmacokinetics and safety/tolerability of single and multiple intravenous administration of
      GR121167. Serial blood samples and pooled urine samples for the determination of GR121167
      concentration will be collected and safety assessments will be performed for each treatment
      period.

      The pharmacokinetics and dose proportionality of GR121167 after single intravenous
      administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed.
      In addition, in the final treatment period (600 mg), twice daily intravenous administrations
      for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.
    


Intervention name(s): GR121167 Solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GR121167 solution will be administered intravenously. For 100 mg subject will receive 10 milliliter (mL) of solution, 30 mL for 300 mg and 60 mL for 600 mg; Placebo solution will be administered intravenously.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lexapro®'s Efficacy After Dose Escalation in Remission Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and
      30 mg in patients with major depressive disorder.
    

Detailed description: 
      In this study, the investigators are going to examine the efficacy of escitalopram after dose
      escalation and evaluate remission rate. This study design is the double-blinded 6-week
      prospective study. It would be useful for clinicians because there were few study of
      high-dose antidepressant treatment in lack of remission in major depressive disorder
      patients. To control of bias, the investigators included patients with lack of remission
      after 4-week escitalopram treatment.
    

Intervention name(s): escitalopram; escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): escitalopram 20mg and 30mg p.o. daily, 6 weeks; escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups
Other intervention name(s): Lexapro®; Lexapro®
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder, remission, escitalopram