bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Fatigue; Depression
Study type: Interventional

Summary: 
      The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and
      depression in Parkinson's disease. It is well established that exercise improves the motor
      symptoms of Parkinson's disease. However, it is not clear which types of exercise are most
      beneficial for specific non-motor symptoms.
    

Detailed description: 
      This is a multi-site trial (12 patients in each site). The investigators are recruiting 24
      patients who will be randomized into either a spinning class, yoga class, dance class, or no
      exercise intervention. Classes will be conducted twice a week for 6 weeks total at times
      convenient for the patients. Patients will also be asked to complete questionnaires after
      exercise classes to see if the exercise intervention improves measures of fatigue, anxiety,
      and depression - and what exercise intervention may be superior. All participants will be
      asked to complete questionnaires each week and will be asked to wear a "Microsoft exercise
      band" during the course of the study. Use of the exercise band is optional.
    

Intervention name(s): Spinning Class; Yoga Class; Dance Class
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Spinning Class twice a week for six weeks.; Yoga Class twice a week for six weeks.; Dance Class twice a week for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; fatigue; anxiety; depression; exercise
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
Condition: Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the relationship between BIS™ values including
      EEG profile and anesthetic agents in the pediatric population
    

Detailed description: 
      This is a multi-center, prospective, observational, non-invasive, randomized controlled study
      to collect data to compare the performance of standard practice (SP) group with the BIS™
      monitoring (BIS) group. Pediatric patients between the ages of 4 to 18 years undergoing
      routine sevoflurane general anesthesia with an expected surgical procedure duration of
      greater than 30 minutes will be recruited. If the surgery is less than 15 minutes, the data
      will continue to be collected, but will not be included in the data analysis and the subject
      will be replaced with an additional subject. General surgeries including abdominal,
      urological, orthopedic, or ophthalmological procedures with an American Society of
      Anesthesiologists physical status of I - III.
    

Intervention name(s): BIS Complete Monitoring System
Intervention type(s): Device
Intervention description(s): The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BIS™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Bioequivalency Study of Sertraline Under Fed Conditions
Condition: Depression
MeSH terms: Malnutrition; Depression
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline
      Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fed conditions using a
      single-dose, 2-treatment, 2-period, crossover design.
    


Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas
Condition: General Anesthesia
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      This study should compare the propofol concentration in breathing gas and in plasma (before
      and) after lung passage. Propofol concentrations in breathing gas are continuously measured
      by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for
      determination of depth of anesthesia are compared to the continuous measured propofol
      concentration in breathing gas.

      Study hypothesis: continuous measured propofol concentration in breathing gas correlates to
      propofol concentration in plasma and depth of anaesthesia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients having general anesthesia for cardiac and non-cardiac operation
      
Keywords: Monitoring; Breathing Gas; Propofol
Effects of Nicotinamide Riboside on Metabolism and Vascular Function
Condition: Aging; Lipemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of Nicotinamide Riboside (NR)
      supplementation on metabolism and vascular function following high-fat meal. Differences
      between young (18-35) and older (60-75) adults will be determined.
    

Detailed description: 
      The purpose of this study is to determine the effects of 7 days of Nicotinamide Riboside (NR)
      or placebo supplementation on metabolism and vascular function following high-fat meal.
      Differences between young (18-35) and older (60-75) adults will be determined.
    

Intervention name(s): Nicotinamide riboside chloride (Niagen); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 250 mg capsules 2x/day for 7 days; 2x/day for 7 days
Other intervention name(s): Nicotinamide Riboside, Niagen
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, cross-over
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: postpandial; lipemia; microvascular
Aspergillus and Chronic Obstructive Pulmonary Disease Evolution
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This is a prospective multicenter cohort study which includes all consecutive COPD patients
      who come for a visit in one the participating pneumologist. They will have to do a sputum and
      to complete some questionnaries. Questionnaries will be redone by phone after 1 and 3 months
      and during the visit after 6 months. We will correlate aspergillus presence in sputum with
      quality of life (QoL), and COPD symptoms evaluated by questionnaires.
    

Detailed description: 
      Aspergillosis disease is a growing problem. These diseases are not yet uncommon in chronic
      obstructive pulmonary disease patients. (COPD).

      Aspergillosis disease are very difficult to be diagnosed or treated. Isolation of aspergillus
      in sputum of patients is not always responsible of a real disease. Need of treatment is
      discussed. That is why, we will conduct a prospective cohort study to evaluate aspergillus
      rate in respiratory samples of COPD patients (GOLD stage III or IV)
    

Intervention name(s): Questionnaries
Intervention type(s): Diagnostic Test
Intervention description(s): patients will have to do a sputum and to complete some questionnaries
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Efficacy of Treadmill Training in Establishing Walking After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Being able to walk is a major determinant of whether a patient returns home after stroke or
      lives in residential care. For the family, the loss of the stroke sufferer from everyday life
      is a catastrophic event. For the community, the costs of being unable to walk after stroke
      are exorbitant, involving a lifetime of residential care. Therefore, an increase in the
      proportion of stroke patients who regain walking ability will be a significant advance.

      This trial will determine, in patients early after stroke who are unable to walk, whether
      training walking using a treadmill with partial weight support via an overhead harness will
      be more effective than current intervention in (i) establishing more independent walking,
      reducing the time taken to achieve independent walking, and improving the quality of
      independent walking, and (ii) improving walking capacity and participation 6 months later.
    

Detailed description: 
      Only half of the stroke patients unable to walk who are admitted to inpatient rehabilitation
      in Australia learn to walk again. Treadmill training with partial weight support is a
      relatively new intervention that is designed to train walking. However, a Cochrane Systematic
      Review (Moseley et al 2003) concludes that there is as yet no definitive answer about whether
      this intervention helps more non-ambulatory patients learn to walk compared to assisted
      overground walking.

      Participants will be 130 stroke patients who are unable to walk independently early after
      stroke. They will be recruited and randomly allocated to a control group or an experimental
      group.

      The control group will undertake routine assisted overground walking training while the
      experimental group will undertake treadmill walking with partial weight support via an
      overhead harness. Duration and frequency of intervention and the amount of assistance from
      therapists will be standardised across groups.
    

Intervention name(s): treadmill walking with partial weight support; assisted overground walking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 30 minutes per day of overground walking with the assistance of one therapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Stroke; health outcomes; physiotherapy; rehabilitation; treadmill
Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Study type: Observational

Summary: 
      The treatment of acute severe pain in pediatric emergencies required a quick and effective
      therapeutic support. Actually in France, only peripheral venous access or oral therapies with
      onset of action are commonly used and only few treatments can be used to manage the acute
      severe pain in children. In June 2017, an intranasal fentanyl use protocol has been
      established in the pediatric emergency department of Mercy hospital-Metz. The intranasal
      fentanyl treatment has proved his effectiveness and safe condition in many countries since
      few years even though has not yet obtained a marketing authorization for use in children in
      France. In view of the information, parental permission was obtained before the intranasal
      administration. The efficacy and surveillance data in all patient records of children who
      benefited this analgesic protocol were retrospectively collected between June 2017 and August
      2018. This retrospective study wants to describe the efficacy and safety of intranasal
      fentanyl on the pediatric emergency department.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        -  Pediatric patients of the emergency pediatric department of Mercy hospital

          -  Coming for acute severe pain : EVA or FLACC scale >=6 for less than 6 hours

          -  Age more than 12months

          -  Weight 10kg to 68kg

          -  Veinous access difficult to obtain

          -  No contra-indication for fentanyl use

          -  No contra-indication for intranasal administration
      
Keywords: pediatric; fentanyl; intranasal; emergency
Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin
      in alcohol dependent participants, demonstrate the feasibility of the integrated
      behavioral/pharmacologic intervention, and provide preliminary outcome and safety data.
      Participants will receive psilocybin orally in two all-day administration sessions, conducted
      in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in
      recent studies. Psilocybin administration will occur in the context of a behavioral
      intervention including a total of 12 sessions over 12 weeks, incorporating Motivational
      Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational
      Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before
      and debriefing after the psilocybin administration sessions. The MET will incorporate
      attention to spirituality as well as drinking behavior as a primary subject of change.
      Drinking outcomes and changes in several potential mediators of treatment effect, including
      motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the
      experience, will be measured during treatment and for 24 weeks after the end of treatment.
      The investigators hypothesize that drinking will decrease following the psilocybin sessions,
      and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks
      vs. baseline) will be observed among study participants.
    


Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): two doses of 0.3 mg/kg PO and 0.4 mg/kg PO, separated by 4 weeks in combination with 12 weeks of manualized outpatient psychosocial treatment including preparation, debriefing, and motivational enhancement therapy.
Intervention MeSH terms: Psilocybin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol dependence; psilocybin; clinical trial; motivational enhancement therapy
Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index
Condition: Elevated Body Mass Index
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and
      normoglycemic patients with elevated body mass index (BMI)
    


Intervention name(s): LIK066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LIK066 25 mg tablets; Matching placebo tablets
Intervention MeSH terms: Licogliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus
Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy Type 1
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance,
      ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and
      strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients
    

Detailed description: 
      Efficacy Measures:

      Endurance, Ambulation, Cognitive function, Insulin resistance, Cholesterol and triglycerides,
      Muscle function and strength, Pain, Gastrointestinal function, Quality of life

      MINIMUM INCLUSION CRITERIA

        1. A diagnosis of DM1, confirmed by DM1 genetic mutation

        2. Age 21 to 65 years (inclusive)

        3. Ability to walk 30 feet - assistance with cane and/or leg bracing permitted

        4. Able to self-administer study medication by subcutaneous injection or caregiver is
           available to administer study medication
    

Intervention name(s): rhIGF-I/rhIGFBP-3; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.; 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
The NOR-COR Study for Coronary Prevention
Condition: Secondary Coronary Prevention
MeSH terms: Neoplasm Metastasis
Study type: Observational

Summary: 
      The NOR-COR study is a cross-sectional, observational study designed to explore a large
      number of cardiovascular, inflammatory, genetic, behavioral, and psychosocial factors
      (including anxiety, depression, quality of life) in 1369 patients with established coronary
      heart disease (CHD) hospitalized in the Sections for Cardiology at the hospitals in Drammen
      (n=722) and Vestfold (n=647). Study data from an extensive questionnaire, clinical and
      laboratory data, and sputum/saliva for genetic analyses will be collected.

      The main overall aim of the NOR-COR study is to develop new strategies to improve secondary
      prevention for underserved high risk patient-groups with CHD. The first study phase aims to
      collect information necessary to develop empirically based future secondary coronary
      prevention interventions. In a genetic sub-project markers associated with CHD and
      personality type will be explored.

      The study will evaluate current secondary preventive programs and explore the mechanisms that
      link behavioral, psychosocial, inflammatory, and genetic factors to poor prognosis. The study
      will in short term provide new knowledge potentially useful for increasing participation in
      current cardiac rehabilitation/secondary preventive programs. For a longer perspective these
      associations may be useful for design of new intervention programs to selected high risk
      patient groups whom may be in need of programs with different content and/or of longer
      duration than those currently being applied.
    


Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        1365 CHD patients
      
Biospecimen description: 
      Salvia for genetic analyses
    
Keywords: Secondary coronary prevention; Psychosocial factors; Cardiac rehabilitation
A Randomized Controlled Trial for Hypertension Control by Integrating Cloud BP System and CPOE
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Importance: Less than fifty percent of patients with hypertensive disease manage to maintain
      their blood pressure (BP) within normal levels. Practical (Pragmatic) and sustainable models
      are needed in order to improve BP management in patients with hypertension.

      Objective: To evaluate whether cloud BP system integrated with computerized physician order
      entry (CPOE) is useful for improving BP management as compared with traditional care.
    

Detailed description: 
      Design, Setting and Patients: A randomized clinical trial study of 382 adults recruited from
      786 patients who had been diagnosed with hypertension and receiving treatment for
      hypertension in two district hospitals in the north of Taiwan. Physicians had access to
      cloud-based BP data from CPOE. Neither participants nor investigators were blinded to group
      assignment. The study was conducted for a period of seven months.

      Interventions: Patients from two hospitals were randomized into a control group which
      received traditional care (n=212) and an intervention group (n=170) which received a
      cloud-based home BP monitoring device. The device measured and transmitted BP data to the
      cloud server, which was integrated with the CPOE system in the hospitals. Physicians could
      access the BP data during the patient encounter to adjust the antihypertensive therapy
      accordingly. Meanwhile, patients could browse their own BP data from their computers, smart
      phones, tablets and so on.

      Primary Outcome(s) and Measure(s): The primary outcomes were control of systolic BP to less
      than 140 mm Hg and diastolic BP to less than 90 mm Hg at two, four and six months. The
      secondary outcomes were changes in BP and antihypertensive drug prescription at two, four and
      six months.
    

Intervention name(s): Cloud-based home BP monitoring
Intervention type(s): Device
Intervention description(s): a sphygmomanometer-style BP measurement device (Microlife®, "WatchBP Home") that stored and transmitted data to a secure cloud BP system directly via a General Packet Radio Service (GPRS) gateway through cell phone network.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Home Blood Pressure; Computerized physician order entry (CPOE); Telemonitoring; Hypertension