bioihbjkbjnl/mcl2 huggingface dataset:
Longitudinal Care: Smoking Reduction to Aid Cessation
Condition: Chronic Diseases
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an extended care treatment model lasting
      over a year will increase long-term smoking cessation rates compared to the standard 8 week
      treatment of care.
    

Detailed description: 
      Objective The objective of this project is to conduct a randomized controlled trial to
      compare 1) an extended quality care smoking cessation treatment delivered over a one-year
      period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period
      (QC) to determine if EQC improves prolonged smoking abstinence.

      Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and
      randomly assigned to the EQC or QC groups. Both groups will initially receive a
      state-of-the-science smoking cessation intervention including behavioral and pharmacological
      components, delivered by a combination of in-person and telephone care. EQC participants who
      fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the
      ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not
      to quit. We propose reduction as an intermediate goal in LC because this may increase the
      likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged.
      Reduction treatment will include behavioral treatment and nicotine replacement. QC
      participants will only receive occasional prompts to quit. The primary endpoint will be 6M of
      abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent
      abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect
      qualitative data from successful abstainers and reducers about decision making processes and
      intervention experiences.

      Clinical Significance This project will address the potential role of smoking reduction in
      the treatment menu for smokers interested in quitting. This project examines mechanisms,
      methods and a "real world" application for reducing toxin exposure.
    

Intervention name(s): smoking cessation
Intervention type(s): Behavioral
Intervention description(s): This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; smoking reduction; nicotine replacement therapy
Serum GPER-1 and Oxidant/Antioxidant Levels on Retinopathy in Diabetic Patients
Condition: Diabetes Mellitus; Diabetic Retinopathy; Hormones
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Observational [Patient Registry]

Summary: 
      Observational, comparative, cross-sectional study
    

Detailed description: 
      This study was conducted on G protein-mediated estrogen receptor 1 (GPER-1), which is thought
      to be effective in preventing the development of diabetic retinopathy (DR). There are studies
      proving that GPER-1 prevents neuroprotective effects and vascular pathology in many tissues.
      In the study, serum GPER-1 and oxidative stress biomarker levels were compared in diabetic
      patients and healthy control groups. GPER-1 was found to be significantly increased in
      diabetic patients. In addition, a positive correlation was found with oxidant markers. This
      may lead to new treatment models in the future.
    

Intervention name(s): The effect of GPER-1 on the formation of diabetic retinopathy
Intervention type(s): Diagnostic Test
Intervention description(s): Demonstrating the neuroprotective effect of GPER-1 in the formation of diabetic retinopathy and being a guide for new treatment models
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        People who applied to the tertiary eye outpatient clinic
      
Keywords: Diabetic retinopathy; GPER-1; oestradiol; progesterone; TSH; oxidative stress; neuronal damage.
Development and Evaluation of THRIVE
Condition: Oncology
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Investigators will test the feasibility and acceptability, as well as efficacy (exploratory
      aim) of a text messaging intervention for Adolescents and young adults (AYA) transitioning
      off active treatment for cancer. Texting Health Resources to Inform, motiVate, and Engage
      (THRIVE) is intended to improve knowledge about health promotion and health vulnerability and
      importance of continued engagement in care, while also providing support and improving
      efficacy to achieve health-related goals.
    

Detailed description: 
      Adolescents and young adults (AYA) with cancer are recognized as an understudied and
      underserved population in oncology. AYA engagement in ongoing disease management is
      compromised by lack of awareness of their continued health vulnerabilities and need for
      continued care, their desire to be "normal" and remove themselves from the cancer experience,
      and lack of AYA-appropriate support and services. Thus, AYA with cancer, especially those
      completing active treatment, are extremely vulnerable and in need of support to maintain
      remission and assure optimal health into adulthood. To address the immediate need for
      innovative interventions targeting AYA completing cancer treatment, the proposed study will
      test the efficacy, feasibility, and acceptability of a tailored text messaging intervention
      for AYA transitioning off active treatment called THRIVE (Texting Health Resources to Inform,
      motiVate, and Engage).

      A pilot randomized controlled trial testing the acceptability and feasibility (primary) and
      initial efficacy (secondary) of a health promoting mobile health texting intervention with
      AYA transitioning off active cancer treatment to follow-up care.

      The intervention compares a texting intervention to a receipt of an AYA survivorship
      handbook. Acceptability and feasibility are primary outcomes. Efficacy outcomes include
      measures of knowledge, healthcare utilization, adherence, engagement in care, and
      psychosocial well-being measures.
    

Intervention name(s): text messages
Intervention type(s): Behavioral
Intervention description(s): receive about one health-related text message a day for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Texting; mHealth; Adolescents and young adults transitioning of treatment
Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery
Condition: Anesthesia, Caudal
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal
      anesthesia in children who undergo renal surgery in our department.
    

Detailed description: 
      The kidney surgery is a significant part of surgical armamentarium in pediatric urology. The
      common operations are open and laparoscopic pyeloplasty, partial nephrectomy open and
      laparoscopic and laparoscopic nephrectomy.

      One of the main goals in the postoperative period is to provide a painless recovery following
      by early mobilization of the child and early discharge home. Caudal anesthesia has become a
      gold standard in the renal surgery providing painless postoperative period, allowing earlier
      child feeding and speedy recovery. However some researchers have pointed out that caudal
      anesthesia with supplemented with Marcaine may provide painless postoperative period only for
      a very limited period of time and required additional painkiller therapy during postoperative
      period. Caudal anesthesia supplemented with Morphine has demonstrated their benefits in
      children who undergo infraumbilical surgery.
    

Intervention name(s): caudal anesthesia; caudal anesthesia supplemented with morphine
Intervention type(s): Drug; Drug
Intervention description(s): Standard caudal anesthesia (Marcaine 2mg/kg); Caudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg)
Other intervention name(s): sacral epidural anesthesia
Intervention MeSH terms: Morphine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Caudal; anesthesia; morphine; children
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social Anxiety
Condition: Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Schizophrenia; Psychotic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the efficacy of a medication switch to Aripiprazole for the
      treatment of schizophrenia or schizoaffective disorder in patients with moderate to high
      symptoms of social anxiety. Specifically the study will test the possibility that a
      medication switch to Aripiprazole reduces symptoms of social anxiety in this patient
      population.
    

Detailed description: 
      Although research has shown that social anxiety is very common among patients suffering from
      schizophrenia or schizoaffective disorder, it is rarely diagnosed and treated in this patient
      population. This study will determine the efficacy of a medication switch to Aripiprazole for
      the treatment of schizophrenia in patients with moderate to high symptoms of social anxiety.
      Specifically the study will test the possibility that a medication switch to Aripiprazole
      reduces symptoms of social anxiety in this patient population. In addition, the study will
      test the possibility that Aripiprazole significantly improves social adjustment, quality of
      life and level of functioning in these patients. The study may also assess the ability of
      Aripiprazole to reduce sexual dysfunction.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder
The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood
Condition: Healthy
Study type: Interventional

Summary: 
      The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty
      acids affects learning and mood of healthy young adults.
    

Detailed description: 
      The long-chain polyunsaturated fatty acids (LCPUFA) EPA (eicosapentaenoic acid), DHA
      (docosahexaenoic acid) of the omega-3 series and AA (arachidonic acid) of the omega-6 series
      are building blocks of all cell membranes and are found in high concentrations in retina and
      brain. Food sources of LA and ALA are vegetable oils, nuts and seeds. Since low conversion
      rates from ALA to DHA are a characteristic of human metabolism, adequate dietary provision
      with the long-chained omega-3 molecules depends primarily on individual eating habits. While
      AA is abundant in meat and dairy products, EPA and DHA are found in noteworthy concentrations
      only in certain species of fatty fish, such as salmon or mackerel.

      The study investigates whether participants receiving an omega-3 supplement over a period of
      4 month, perform better on a series of cognitive tests, than the participants allocated to
      the placebo group.
    

Intervention name(s): Omega-3 fatty acids
Intervention type(s): Dietary Supplement
Intervention description(s): 600 mg EPA 120mg DHA daily, 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Young adults; Long-chain polyunsaturated fatty acids; Cognitive function; Mood; Supply with omega-3 fatty acids
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand how quickly lansoprazole, once daily (QD),
      improves feeding in premature babies or babies less than 28 days of age.
    

Detailed description: 
      A Phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates
      will be randomized in an open-label fashion to receive 5 days of open-label treatment with
      either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric
      suspension .5 mg/kg/day orally. On dosing Days 1 and 5, blood samples will be obtained for
      drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the
      study and will undergo pH monitoring, provided it is clinically indicated, at the discretion
      of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at
      baseline, on dosing Day 1 (or Day 2) and on dosing Day 5 (or Day 6). Intraesophageal pH may
      be done in addition to intragastric pH at the discretion of the investigator. Subjects will
      be evaluated for safety, including a follow-up visit on post-dosing Day 14.
    

Intervention name(s): Lansoprazole; Lansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.; Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric GERD; Pediatric Gastroesophageal Reflux Disease; Neonates; lansoprazole
Study of ASLAN004 in Healthy Subjects
Condition: Allergic Disorder
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, two-part, single-center, first in human (FIH), single ascending dose
      (SAD) study to assess the effects of single doses of ASLAN004 when administered to healthy
      subjects. The objective of this study is to evaluate the safety, tolerability, and
      Pharmacokinetics (PK) of ASLAN004 in healthy subjects.
    

Detailed description: 
      The plan is to enroll between 38 to 50 subjects at 1 study center.

      The study is divided into 2 parts:

      Part A is designed as a SAD study using intravenous (IV) administration of ASLAN004, as a
      single mg/kg IV dose and will consist of up to 6 IV cohorts.

      Part B is designed as a parallel SAD study using subcutaneous (SC) administration of
      ASLAN004, as a single fixed milligram SC dose and will consist of up to 4 SC cohorts.

      All cohorts will have sentinel dosing with the first subject of each cohort being spaced with
      adequate observation time of 24 to 48 hours before dosing the remaining subjects in the
      cohort.

      All subjects would be follow up for up to 85 days from the last dosing day.
    

Intervention name(s): ASLAN004
Intervention type(s): Biological
Intervention description(s): Single Dose
Intervention model: Single Group Assignment
Intervention model description: Single Ascending Dose
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic disorder
A Pilot Stress Management Intervention Study for High Risk Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of the proposed study is to conduct a randomized controlled pilot trial of a
      school-based stress management and coping skills training program among a sample of
      economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed
      asthma. The investigators aim (1) to establish feasibility of this approach by recruiting
      from different schools and (2) to learn whether individuals assigned to receive the
      intervention show improvements in psychological function, decreases in lung inflammation, and
      related improvements in asthma health when compared with disease severity-matched peers who
      receive education-only or standard care.
    


Intervention name(s): I Can Cope Intervention; Standard Education Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to the "I Can Cope" condition will receive 6 face-to-face individualized sessions over a 2-month period. Each session will last 50 minutes and take place at the child's school either during approved times during the school day or as part of the after-school program. Sessions are psychoeducational and experiential and include opportunities for the child with asthma to: (1) learn about the pathophysiology of asthma; (2) understand the biological impact of stress on the body; (3) learn the relationship among thoughts, feelings, actions, and asthma; (4) acquire a set of coping skills to help deal with asthma-related and day-to-day stressors in their lives, and (5) receive training in biofeedback-assisted relaxation techniques.; This group will receive the standard American Lung Association (ALA)"Open Airways for Schools" program. This program includes six 40-minute sessions covering the National Heart Lung and Blood Institute's recommendations for asthma education.
Other intervention name(s): Open Airways for Schools Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Stress; Children; Psychosocial Factors; Relaxation; Stress management
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
Condition: Rectal Cancer; Perioperative Complication
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer
      after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a
      suitable option for patients with middle and low rectal cancer. Robotic systems are expected
      to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This
      study aimed to investigate the safety and feasibility of robotic assisted transanal total
      mesorectal excision in patients with rectal cancer.
    

Detailed description: 
      TaTME is potentially a suitable option for patients with middle or low rectal cancer,
      especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive
      Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic
      transanal approach for rectal surgery. Da Vinci Si Surgical System or da Vinci Xi Surgical
      System would be used to performed Transanal total mesorectal excision. And the surgery would
      performed by two-team approach. This study aimed to investigate the safety and feasibility of
      robotic assisted transanal total mesorectal excision in patients with rectal cancer.
    

Intervention name(s): Robotic assisted transanal total mesorectal excision; Laparoscopic assisted transanal total mesorectal excision
Intervention type(s): Procedure; Procedure
Intervention description(s): Robotic assisted transanal total mesorectal excision for rectal cancer patients; Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rectal Cancer; Robotic surgery
Effect of Pyridorin in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of Pyridorin
      (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic
      kidney disease.
    


Intervention name(s): Pyridorin (pyridoxamine dihydrochloride)
Intervention type(s): Drug
Intervention MeSH terms: Pyridoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetic nephropathy; Advanced Glycation Endproduct Inhibitor; Pyridorin; Pyridoxamine
Effect of Intravenous Lidocaine on Propofol Requirements
Condition: Analgesia
Study type: Interventional

Summary: 
      Lidocaine, an amide local anesthetic, has advantages of low price and easily obtaining.
      Intravenous lidocaine (IVL)initially has been used in the treatment of arrhythmia. It was
      demonstrated that IVL had analgesic effect, especially in colorectal surgery, but remained
      controversy in other types of surgeries. Other beneficial effects, such as prevention of
      hyperalgesia and propofol-induced injection pain, reduction of incidence of postoperative
      ileus and nausea and vomiting and anti-inflammatory also were proposed.
    

Detailed description: 
      The most frequent drugs for procedural sedation and analgesia are propofol, benzodiazepines
      and opioids. However, these drugs may cause respiratory depression and circulatory
      instability. Combination will increase the risk of hypoxia and apnea.

      In China, most anesthesia for hysteroscopy and gastroenteroscopy is procedural sedation and
      analgesia(PAS) provided by anesthetists. Foester et,al. have been tested that IVL could
      significantly reduce propofol requirements 、postoperative pain and fatigue scores in
      colonoscopy. Chen,et,al. find the same effect of IVL in elderly. However, there is no
      research reporting IVL used in hysteroscopy and diagnostic curettage. So, our main objective
      is to evaluate the effect of intravenous lidocaine on propofol requirements in patients
      undergoing hysteroscopy and diagnostic curettage.
    

Intervention name(s): Lidocaine IV; 0.9% normal saline
Intervention type(s): Drug; Drug
Intervention description(s): A bolos of 1.5mg/kg lidocaine will be administered before induction. Then, infusion of 4mg/kg/h lidocaine will maintain during procedure.; 0.9% normal saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: intravenous lidocaine; propofol; pain score; fatigue score; dose