bioihbjkbjnl/mcl2 huggingface dataset:
Stress-induced Sleep Deficits and a Complementary Therapy
Condition: Insomnia Due to Anxiety and Fear
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The COVID-19 pandemic and social isolation order induced stress/anxiety as well as cellphone
      dependence. As a result, sleep disruption and mental distress became major health concerns.
      Gamma-aminobutyric acid type-A receptor (GABAAR) is one of the key players in modulating
      sleep. Dihydromyricetin (DHM), an herbal compound, plays a role in GABAAR modulation and
      mitigating anxiety. The investigators' partner in China obtained 288 participants who
      completed the online survey to gain insight into how stress/anxiety and time spent on
      cellphones affected sleep and mood. The participants were then enrolled in a randomized
      placebo-controlled double-blind study to assess the effects of DHM on sleep and improvement
      on stress/anxiety and cellphone using time.
    


Intervention name(s): DHM; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): DHM is a positive modulator of GABA. We hypothesize the DHM could reduce stress/anxiety induced insomnia during the pandemic; Excipients including extracts of celery, strawberry, oranges, rose, and beet blended in powder form of 1 g
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 288 subjects were recruited for the study. The sample size was based on a prior power analyses using G-Power 3, for a Mixed Model Repeated Measures Analysis of Variance (MMRMA) design, assuming a statistical power of 0.8, moderate effects of the DHM effects on sleep outcomes, and hypothesis tests conducted at a probability value of .05.
Masking: Single (Participant)
Primary purpose: Prevention
Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia
Condition: Heart Rate Variability; Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      Discuss the objective assessment of patients with insomnia by pulse diagnosis, and measure by
      subjective questionnaire and physiological instruments.
    

Detailed description: 
      In Taiwan, insomnia is a prevalent illness. Clinical symptoms of sleep disturbances are
      rather typical now that the epidemic has taken hold. Pulse diagnosis is an important
      diagnostic method for insomnia in traditional Chinese medicine(TCM). TCM pulse diagnosis is
      not yet a widely used clinical diagnostic method for illnesses, nevertheless. Clinical use
      and teaching should benefit greatly if pulse diagnosis or learning can be made more objective
      or data-based.
    

Intervention name(s): Pittsburgh sleep quality index (PSQI); ANSWatch
Intervention type(s): Other; Device
Intervention description(s): The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general people.; Measure eight physiological parameters including heartbeat, systolic blood pressure, diastolic blood pressure, heart rhythm variability HRV, low frequency component LF, high frequency component HF, LF/HF low frequency high frequency component ratio, and irregular heartbeat within five minutes
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        In the experimental group, select subjects who meet the following conditions: aged 40-79
        years, who complained of insomnia symptoms in the past month, at least three times a week
        for one month, such as: difficulty falling asleep, waking up in the middle of the night,
        unable to wake up Falling asleep, waking up in the morning still feeling sleepy. Control
        group: healthy voluntary subjects aged 40-79 without insomnia.
      
Keywords: Insomnia; Pulse; Heart rate variability
Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase 1/2a study in dentin hypersensitivity patients to assess the safety,
      tolerability, efficacy and pharmacokinetics of single and multiple doses of KH001.
    


Intervention name(s): KH001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug is applied to teeth; The placebo is applied to teeth
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dentin regeneration; Hypersensitivity; Sensitivity; Tooth sensitivity
Study of Postoperative Chest Tube Management
Condition: Lung Resection
Study type: Interventional
Phase: Phase 4

Summary: 
      A 2 x 2 randomized study testing active versus passive drainage and regulated versus
      unregulated pleural pressure in patients undergoing anatomic lung resection
    

Detailed description: 
      This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative
      evaluation and the decision for surgical intervention will proceed as currently performed at
      each center. That is, neither inclusion in nor exclusion from this study will affect the plan
      of care for patients other than the approach to chest tube management, which is determined by
      randomization among 4 methods that are in common clinical use. Each enrolled patient will be
      randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage
      device or unregulated pleural pressure using a traditional system (multi-chambered system
      e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also
      randomized to either active suction (-20 cm H2O) or passive drainage.
    

Intervention name(s): Reg Pressure; Unreg Pressure; Active Suction (Dig); Active Suction (Trad); Passive Drainage (Dig); Passive Drainage (Trad)
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Regulated Suction using the Thopaz+ digital chest drainage device; Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution); Thopaz+ digital chest drainage device set at -20cmH2O at the patient; Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.; Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic"); Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chest tube
Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study
Condition: Prostate Cancer
MeSH terms: Carcinoma; Prostatic Neoplasms
Study type: Interventional

Summary: 
      An exploratory, feasibility and proof-of-concept study to evaluate the capability of a rectal
      probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent
      (ProstaScintÂ®; as a surrogate marker for prostate cancer) in patients who have undergone a
      radical prostatectomy for their disease, patients with multiple negative prostate biopsies
      and patients with known primary prostate cancer. Developed by Hybridyne Imaging Technologies,
      Inc. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera. It is
      the same size as a trans-rectal ultrasound (TRUS), currently used for prostate biopsy
      guidance. Men with multiple positive biopsies will be considered controls. Prostate cancer
      sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, MRI and SPECT/CT.
      The investigators hypothesize that it will be safe and feasible to utilize a rectal probe
      scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScintÂ®, thus identifying and
      localizing the tumour sites within the prostate and surrounding areas.
    


Intervention name(s): ProxiScan; Magnetic Resonance Imaging; SPECT-CT
Intervention type(s): Device; Device; Device
Intervention description(s): ProxiScan probe will be coupled with ProstaScint (a radioactive tracer) and used to perform imaging to detect small lesions in the pelvis that will otherwise be hard to detect with conventional imaging modalities.; Used as a comparative to ProxiScan.; Used as a comparative to ProxiScan.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate; Local Recurrence; Radical Prostatectomy
Effects of Obex in Overweight and Obese Patients
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      -  Obesity is an important and growing public health worldwide

        -  Obesity is highly related to the development of metabolic syndrome, diabetes,
           cardiovascular diseases and cancer

        -  An extensive body of evidence from efficacy trials has shown that weight loss is
           achievable, however, a modest weight loss is achieved in a small proportion of patients

        -  Important adverse events have been reported with the use of antiobesity drugs.

        -  The use of natural products with potential effects inducing weight loss is an
           alternative strategy for treating patients with overweight and obesity. However,
           efficacy and safety should be evaluated in RCT.

        -  Obex combines different molecules with potential effects inducing weight loss and
           control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.

        -  Therefore, the administration of Obex in overweight and obese patients with impaired
           fasting glucose could be an excellent strategy to induce weight loss and ameliorate the
           metabolic disturbances related to obesity and overweight.
    


Intervention name(s): Obex
Intervention type(s): Dietary Supplement
Intervention description(s): Obex® will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during three months. Participants will be not trained about changes of lifestyle on their diets, or physical activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impaired fasting glucose; Prediabetes; Obesity; Overweight; Insulin sensitivity; Weight loss; Nutritional supplement; Waist; Body composition
Dysphagia After Different Swallowing Therapies
Condition: Dysphagia; Videofluoroscopy; Stroke
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional

Summary: 
      Dysphagia after stroke is associated to increased pulmonary complications and mortality. The
      swallowing therapies could decrease the pulmonary complications and improve the quality of
      life after stroke. The swallowing therapies include dietary modifications, thermal
      stimulation, compensatory positions, and oropharyngeal muscle stimulation. Most researchers
      used clinical assessments and videofluoroscopy to evaluate the effect of the swallowing
      therapies. Some authors performed functional magnetic resonance imaging (fMRI) to investigate
      the brain neuroactivity during swallowing with tasks in normal adults and unilateral
      hemispheric stroke patients. The aim of this study is to explore the effect of swallowing
      therapies not only in clinical swallowing function but also brain plasticity of acute stroke
      patients with dysphagia by videofluoroscopy and fMRI.
    

Detailed description: 
      In the study, 10 healthy controls and 48 patients with a single and acute hemispheric or
      brain stem stroke will be enrolled. Both 24 hemispheric and 24 brain stem stroke patients
      will be divided into 3 groups. General swallowing therapy, oropharyngeal neuromuscular
      electrical stimulation (NMES), and combined general and NMES therapies will be randomly
      provided for the 3 groups. Each patient will receive clinical assessment of food oral intake
      scale, functional dysphagia scale of videofluoroscopy, and brain neuroactivity in fMRI.

      The investigators hope to find the benefit of the swallowing therapies both in clinical
      swallowing function and in brain functional neuroactivity/reorganization after acute stroke.
      While comparing the 3 swallowing therapies, different functional neuroactivity may be
      facilitated by different swallowing therapies. Finally, the investigators could also find out
      the most effective swallowing therapy among the 3 therapies in acute stroke patients with
      dysphagia according to the findings of videofluoroscopy and fMRI.
    

Intervention name(s): general swallowing therapy; NMES therapy
Intervention type(s): Other; Other
Intervention description(s): including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.; he NMES therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dysphagia; stroke; magnetic resonance imaging; videofluoroscopy
Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
Condition: Breast Cancer
MeSH terms: Carcinoma in Situ; Breast Carcinoma In Situ
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer.

      PURPOSE: This research study is studying biomarkers in tissue samples from patients with
      ductal breast carcinoma in situ.
    

Detailed description: 
      OBJECTIVES:

        -  To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS)
           genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from
           patients with DCIS enrolled on clinical trial ECOG-E5194.

      OUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile
      by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).
    

Intervention name(s): RNA analysis; gene expression analysis; reverse transcriptase-polymerase chain reaction; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patient enrolled on E5194
      
Keywords: ductal breast carcinoma in situ
Environmental Influences on Early Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Few treatments have been developed for young children with obesity from diverse backgrounds.
      The present study will develop and test an intervention designed to improve preschool obesity
      in Latino children. The intervention will focus on improving eating, activity, and sleep
      behaviors and the home environment for improved weight status.
    

Detailed description: 
      Children from low income families of minority status are at greater risk for development of
      obesity. There are no known existing treatments for pediatric obesity that focus on improving
      parental behaviors and the home food and activity environment. The objective of this study
      will be to address this limitation by developing and testing a novel treatment for low-income
      minority families. The objective will be attained by testing the following hypothesis: A
      parent-focused, home-based treatment aimed at improving parental feeding behaviors, child
      exposure to fruits and vegetables, and the home food and activity environment will result in
      significantly greater decrease in percent overweight / obesity compared to recommended
      practice. The hypothesis will be tested by using the approach of a pilot randomized control
      trial (RCT). The rationale for this aim is that success of the planned research will derive a
      treatment package that will provide the basis for the RCT. The planned research is expected
      to show the level of impact of changing parental feeding behaviors and the home environment
      on childhood overweight / obesity.
    

Intervention name(s): Healthy Homes; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): The Healthy Homes Behavioral Intervention (HHBI) will be delivered during 8 sessions over 10 weeks using home visitations. The first 6 sessions occur weekly and provide education about healthy dietary intake including caloric recommendations for preschool aged children, healthy sleep goals, active play and screen time limits, and family routines and organization. Each session will include a parent-child interaction component to teach child behavior management skills related to intervention goals. Two final sessions occur every other week to provide problem solving and planning for maintenance of treatment effects.; A pediatrician with experience delivering weight management treatment to children will deliver a single session, 1-hour treatment to families. Content to be delivered during the session will include lifestyle recommendations currently recommended by the AAP.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ziprasidone in Early Onset Schizophrenia Spectrum Disorders
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open trial of ziprasidone (ZIP) in children and adolescents. It is designed to
      provide pilot data on the magnitude of ZIP's antipsychotic effects in psychotic youth, dosing
      ranges, acute safety, and tolerability. This would then inform the design of a rigorous,
      randomized controlled trial of ZIP in the pediatric population. The primary study hypothesis
      is that the proportion of pediatric subjects responding to treatment with ziprasidone will be
      comparable or greater than reported in trials of ziprasidone in adults.
    

Detailed description: 
      The study will consist of two phases: an eight week acute phase and a 44 week continuation
      phase for those subjects who show a response during the first eight weeks. All treatment will
      be open label and monitored by research clinicians with expertise in treating psychotic
      youth. The initial titration is relatively slow to minimize side effects. A flexible dose
      strategy in which each individual's ultimate dose is determined by his/her response and side
      effects will be used. The maximal dose will be 160mg split as a BID dose. We estimate that
      the average dose will be 120mg/d. Concurrent use of benztropine, propranolol, and
      benzodiazepines (lorazepam and clonazepam) will be permitted as needed to treat any emergent
      extrapyramidal side effects and agitation. Concurrent use of antidepressants and mood
      stabilizers will be permitted in those subjects who have been on stable doses of
      antidepressants or mood stabilizers for at least four weeks at time of entry, or those with
      emergence of significant affective symptoms during the maintenance phase of the study.
    

Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): 20mg pills, dosing will be flexible, ranging from 10 to 160 mg divided BID or TID for the duration of the 52 week trial. In very rare cases, if the subject has shown some benefit and no side effects at a dose of 160mg and the treating clinician feels a further dose increase is necessary, the case would need to be presented to all of the other Principal Investigators for special consideration of further dose increases in 20 mg increments to an absolute maximal dose of 220mg.
Other intervention name(s): Geodon
Intervention MeSH terms: Ziprasidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia Spectrum Disorders
Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This
      trial will determine the maximum tolerated dose and the efficacy of this combination
      administered weekly in patients with platinum -resistant ovarian cancer.
    


Intervention name(s): Hycamptin; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): 1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression; Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks.
Number of cycles: until progression
Other intervention name(s): Topotecan; Gemzar
Intervention MeSH terms: Gemcitabine; Topotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer;; Ovarian cancer;; Recurrent ovarian cancer platinum-resistant
Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondyliti
Study type: Interventional

Summary: 
      Background:

      Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together
      with medication. Last years, increased risk of cardiovascular diseases in patient with
      inflammatory diseases is reported, probably caused by inflammation and increased prevalence
      of traditional risk factors. In both healthy adults and other patient groups,
      cardiorespiratory and muscular strength exercises have been shown to have a positive effect
      on inflammation as well as on cardiovascular risk factors. To our knowledge this has not been
      shown in patients with ankylosing spondylitis.

      Objective: The aim of this study is to investigate the effects of a cardiorespiratory and
      muscular strength exercise program on disease activity and cardiovascular risk factors in
      patients with ankylosing spondylitis
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): The exercise intervention will be carried out at a fitness center with supervision from a physiotherapist.
A cardiorespiratory and muscle strengthening exercise program following the American College of Sports Medicine (ACSM) recommendations for maintenance and improvement of physical fitness. Cardiorespiratory fitness: two interval sessions (4 x 4 min), one continuous moderate exercise session (40 min) on a treadmill. The muscle strength exercises will consist of: 15-20 repetitions, large muscle groups as thighs, back and abdomen.
Dose: 12 weeks. Three times a week, 60 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment