bioihbjkbjnl/mcl2 huggingface dataset:
The Role of Apathy in Glycemic Control
Condition: Apathy; Diabetes
Study type: Interventional

Summary: 
      In spite of several new medications and insulins for the control of blood sugars in patients
      with diabetes, a large number of patients do not have good control. This likely due to
      inability to carry out regular activities and self-care behaviors such as taking meds
      regularly, keeping a good diet, exercise etc. This inability to carry out self care lifestyle
      changes may be due to a condition called apathy. Apathy is a lack of motivation and
      persistence. In this study we will attempt to treat apathy with a medication called
      methylphenidate for 6 months and see if blood sugar/diabetes control improves.
    

Detailed description: 
      The incidence of diabetes in the US is at epidemic proportions. A large number of diabetes
      patients in the VA system have uncontrolled diabetes with high HbA1c. The inability to carry
      out important self-care behaviors such as measuring blood sugars regularly, following diet,
      exercise and medication programs may be due to apathy. Apathy is the lack of motivation,
      persistence and novelty. We have found this to be very prevalent in the VA diabetes
      population. We now do a randomized placebo controlled trial to see if treatment of apathy
      with methylphenidate will improve glycemic control in patients with A1c >8. Treatment will be
      for 6 months. The primary end point is HbA1c.
    

Intervention name(s): methylphenidate or placebo
Intervention type(s): Drug
Intervention description(s): treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Apathy; Diabetes; Self-care behaviors
A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy Adults
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      Rabies infection is a disease that is caused by a virus and which is transmitted in many
      countries by rabid animals (dogs, monkeys, bats, etc.) through bites, scratches or licking of
      wounds. In most cases, humans die from it once the disease has broken out.

      CV7202 is a new vaccine which has not yet been studied in humans and does not consist of
      virus protein. Instead, the "building block" for the protein in the form of a so-called
      messenger RNA (mRNA) will be used. All living organisms have mRNA in their body. mRNA is the
      carrier of the information that the cells require to form proteins. In this study, mRNA that
      carries the information for the formation of the rabies virus protein called RABV-G will be
      injected into the muscle. Following the vaccination, the vaccinated individual's own cells
      will produce the RABV-G protein. The immune system recognizes the protein and an immune
      response is triggered.

      This clinical study will assess the safety, reactogenicity and immunogenicity of CV7202
      mRNA-rabies vaccine in healthy adults.
    


Intervention name(s): Rabipur®; Rabies mRNA vaccine CV7202 Dose level 1; Rabies mRNA vaccine CV7202 Dose level 2; Rabies mRNA vaccine CV7202 Dose level 3
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm; 1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm; 1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm; 1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm
Other intervention name(s): Licensed rabies vaccine containing inactivated rabies virus
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rabies; Vaccine; Safety; Ractogenicity; Immunogenicity
Studies of Frontal Lobe Brain Functioning in Schizophrenia
Condition: Healthy Subjects; Schizophrenia; Parkinson Disease
MeSH terms: Parkinson Disease; Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to use brain imaging technology to investigate the role of the
      frontal lobe of the brain in the thinking of individuals with schizophrenia and other
      neuropsychiatric disorders and healthy volunteers.

      Participants in this study will undergo a positron emission tomography (PET) scan of the
      brain while performing neuropsychological tests. Some of the tests involve cognitive
      operations that depend upon the frontal cortex. Interactions between frontal lobe activation,
      cognitive behavior, and neuropharmacology will be assessed by measuring regional cerebral
      blood flow (rCBF) during treatment with drugs that may affect frontal lobe physiology.
    

Detailed description: 
      The purpose of this work is to investigate the role of the frontal lobe, and its connections
      for cognition in health and in neuropsychiatric diseases, particularly schizophrenia.
      Regional cerebral blood flow (rCBF) will be measured with oxygen-15 water positron emission
      tomography (PET) while subjects are either at rest or are performing a variety of
      neuropsychological tests. Some of these tests involve cognitive operations that are posited
      to depend upon the frontal cortex, such as the use of working memory for abstract reasoning
      and problem solving, formation and maintenance of conceptual sets, set shifting, sequencing,
      and delayed response; others control for nonspecific sensory and motor aspects of these
      measurements or are contrast conditions posited to depend on other brain regions.
      Interactions between regional activation, cognitive behavior, and neuropharmacology will be
      assessed by measuring cognitively-related rCBF during treatment with drugs that may affect
      frontal lobe physiology. Hypotheses about the genetic determinants of these relationships
      will also be tested by comparing rCBF measures across individuals harboring different
      genotypes (detemined through protocol 95-M-0150).
    

Intervention name(s): Oxygen-15 Water
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with schizophrenia spectrum disorder and normal volunteers
      
Keywords: Neuropsychology; Brain Activity; Cognitive Disorders; Prefrontal Cortex; rCBF; Psychosis; Neuroimaging; Brain Scan; PET Imaging; Schizophrenia; Natural History
Tarp Assisted Cooling of Hyperthermic Individuals
Condition: Healthy
MeSH terms: Hyperthermia; Fever
Study type: Interventional

Summary: 
      This is a randomized controlled trial exploring the difference in cooling rates between two
      treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in
      the wilderness.
    

Detailed description: 
      This is a randomized controlled trial exploring the difference in cooling rates between two
      treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in
      the wilderness. 12 healthy participants (6 males, 6 females) will participate. Visit 1 will
      be a screening visit, consisting of informed consent followed by completion of questionnaires
      to determine study eligibility. Participants will have their resting vital signs (heart rate,
      blood pressure), height, weight, and percent body fat measured. Visits 2 and 3 will be
      experimental trials. Participants will complete a treadmill protocol consisting of brisk
      walking wearing a weighted backpack (40 lb) until core temperature reaches 40.0°C. Upon
      completion of exercise, participants will exit the environmental chamber and be cooled in one
      of two ways in a randomized, counterbalanced manner: 1) tarp-assisted cooling or 2) Standard
      of Care. Cooling will take place for 20 minutes.
    

Intervention name(s): Tarp Assisted Cooling; passive cooling
Intervention type(s): Other; Other
Intervention description(s): Body cooling utilizing a tarp and water; Supine rest.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heat; Cooling
Social Cognitive Training for Psychosis: Treatment Development
Condition: Schizophrenia; Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this proposal is to develop, refine, manualize and assess the feasibility
      and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for
      individuals with psychosis. The intervention will focus on helping individuals interpret
      social situations, specifically the intentions and feelings of others.

      Study methods include preliminary treatment and manual development based on series of
      uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly
      developed intervention.
    


Intervention name(s): social cognitive training
Intervention type(s): Behavioral
Intervention description(s): social cognitive training, 8-10 sessions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; treatment; social cognition
Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the dose-ranging efficacy and safety profile of
      encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome
      (IBS).
    

Detailed description: 
      The pathogenesis of irritable bowel syndrome (IBS) may have a a post-infectious inflammatory
      component, suggesting that altered gut bacterial flora are of relevance and that probiotics
      may be beneficial. This clinical trial examined the efficacy of an encapsulated probiotic in
      subjects with Rome II IBS. After a 2 week baseline, 362 female subjects were randomized to
      placebo or one of three doses of B. infantis 35624 once daily for 4 weeks. IBS symptoms were
      monitored daily and scored according to a 6-point Likert scale; stool frequency and form were
      also monitored daily. The primary efficacy variable was the abdominal pain score; secondary
      efficacy variables included other IBS symptom relief and quality of life.
    

Intervention name(s): Bifidobacterium infantis 35624
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
Condition: Stroke
Study type: Interventional

Summary: 
      The research project is intended to provide information pertaining to the feasibility of the
      BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral
      Vascular Accident. The aims are to: a) determine clinical benefit to motor and cognitive
      function as well as mood; 2) to ascertain technology acceptance by patients and therapists.
      The experimental training consists of 12 integrative arm/hand and cognitive training by
      playing therapeutic games. Participants are evaluated pre-and post-intervention and provide
      subjective evaluation of the system.
    

Detailed description: 
      This study targets participants, who had suffered a first stroke recently, and who may or may
      not have been diagnosed with mild cognitive impairments or dementia (including Alzheimer's
      disease). It is important to find out if these improvements can be obtained with the computer
      game-based integrative (motor-cognitive) bilateral rehabilitation developed by Bright Cloud
      International Corp, and if these gains transfer to daily activities.

      Specific aims are:

        -  BAC technology acceptance;

        -  improvement in motor function for the upper extremity;

        -  strengthening of shoulder and fingers;

        -  increased active (self initiated) range of motion for shoulder, arms and fingers;

        -  improved independence in activities of daily living;

        -  improvement in cognitive areas of memory, attention and decision making;

        -  improved mood (as in reduced depression severity);
    

Intervention name(s): Rehabilitation Therapy, Experimental on the BrightArm Compact device
Intervention type(s): Device
Intervention description(s): Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). An Occupational Therapist will assist as needed.
Other intervention name(s): BrightArm Compact rehabilitation through games
Intervention model: Single Group Assignment
Intervention model description: 6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Efficacy and Safety of Shen Que (RN8) Moxibustion in Unexpected POR
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Moxibustion of Shen Que (RN8) can increase the number of embryos available for transfer, thus
      improving pregnancy outcomes in women of advanced reproductive age who experience unexpected
      poor ovarian response.
    

Detailed description: 
      According to the traditional Chinese medicine (TCM) theory, Shen Que (RN8) is the place where
      the vitality converges under the navel, and is closely connected with the vitality generated
      by the kidney Qi. Therefore, stimulating Shen Que may stimulate the essence stored in the
      kidney, and improve the fertility of "五七" (≥ 35 years old) women.

      Shen Que moxibustion has been shown to improve ovarian functional reserve in patients with
      ovarian insufficiency in previous studies. Nevertheless, studies on Shen Que moxibustion in
      advanced women with unexpected poor ovarian response (POR) who undergo IVF-ET are very
      limited. Consequently, we designed this randomized controlled trial to validate the
      hypothesis that Shen Que moxibustion improves reproductive outcomes in unexpected POR women.
    

Intervention name(s): Shen Que Moxibustion
Intervention type(s): Other
Intervention description(s): Herb-partitioned moxibustion was administered at RN8 (Shen Que), once every 72 hours from the beginning of previous menstrual cycle day 2 until oocyte retrieval. Approximately 10 moxa cones will be used for this procedure, which will take approximately two hours. It is recommended that patients close their eyes during the procedure and rest. Following moxibustion, the umbilicus will be affixed and sealed with a medical applicator and removed after 24 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shen Que (RN8); Moxibustion; In Vitro Fertilization and Embryo Transfer (IVF-ET); Poor Ovarian Response (POR); Poseidon Criteria
Multimodal Exercise Program on Parkinson's Disease Patients With Depression
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Depression
Study type: Interventional

Summary: 
      Depression symptoms are common in Parkinson's Disease, it affects health-related quality of
      life. The evidence showed that exercise improved depression and HRQOL in PD patients.
      However, studies rarely considered the appropriate exercise program for PD patients, we want
      to find the best exercise program for PD patients.
    

Detailed description: 
      Objective: Evaluate the effectiveness of a 8-week multimodal exercise program on depression
      and HRQOL in PD Patients.

      Methods: Single-blinded, randomized controlled trial, from March 2016 to January 2017.
      Ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n =
      49). The primary outcomes were depression and HRQOL; the secondary outcomes were activity of
      daily living, motor ability, fatigue, sleep quality and anxiety. Data collection at baseline,
      week 4 and 8 after intervention. Intervention were Multimodal Exercise Program, at least
      three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to
      accumulate 150 minutes a week for 8 weeks.
    

Intervention name(s): exercise group
Intervention type(s): Other
Intervention description(s): A step aerobics exercise lasted a total 30 minutes, including:
a warm-up with 10 minutes of stretching exercises.
A step aerobics exercise (step aerobics for 30 minutes; step by step, step exercise, or stepping the ground repetitively)23,24 a total of 30 minutes then cool down (5 minutes).
Resistance training (10 minutes), stretching and relaxation for 10-15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Parkinson's Disease; A Multimodal Exercise Program; Aerobic Exercise; Depression; Health Related Quality of Life
B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      In this exploratory study, investigators will be looking at immune response differences
      between age groups and between the two different influenza vaccines given to identical twins,
      vaccine-naive young adults and elderly participants.
    

Detailed description: 
      This is an exploratory study of healthy children and adults who are given either standard
      trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV).
      There are no exclusions for gender, ethnicity or race. Following confirmation of written
      informed consent, baseline blood samples will be drawn from all study participants prior to
      immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been
      immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A
      will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The
      non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV.
      Non-twin elderly adults in Group C will be given standard TIV. All participants will receive
      a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection
      (TIV) or intranasal application (LAIV).
    

Intervention name(s): Fluzone; FluMist
Intervention type(s): Biological; Biological
Intervention description(s): Influenza Virus Vaccine Suspension for Intramuscular Injection; Influenza Virus Vaccine Live, Intranasal Intranasal Spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Child identical twins and non-twins; Young and elderly non-twin adults
Nanoparticles in Nasal Mucosa
Condition: Chronic Hypertrophic Rhinosinusitis; Chronic Polypous Rhinosinusitis
MeSH terms: Sinusitis; Hypertrophy
Study type: Observational

Summary: 
      The aim of this prospective study is to evaluate presence and quantity of nano-sized
      particles and interindividual differences in their distribution and elemental composition in
      human nasal mucosa obtained by mucotomy in patients diagnosed with chronic hypertrophic
      rhinosinusitis and to compare the obtained results with control specimen obtained from
      stillborn children.
    

Detailed description: 
      Samples of nasal mucosa are obtained by mucotomy in general anesthaesia from adult patients
      with chronic hypertrophic rhinosinusitis. Each tissue sample is divided into 4 parts based on
      the distance from the nostrils and is dehydrated, thinly sliced and mounted on glass slides.
      Then the tissue is analyzed with scanning electron microscopy (SEM) and Raman
      microspectroscopy (RMS) to detect solid particles and characterize the morphology and
      compositions of the detected particles. A novel method of quantification of distribution of
      the particles has been designed and used to evaluate interindividual differences in
      distribution of the particles. History of employment is obtained from the patients and the
      data are compared with the findings in the tissue samples.

      The data acquired from the group of adult patients are compared with the results obtained
      from a group of control specimen of nasal mucosa harvested from stillborn children. It is
      presumed that no nano particles will be present in the stillborn children specimen since the
      mucosa was not exposed to airborne particles.
    

Intervention name(s): Mucotomy
Intervention type(s): Procedure
Intervention description(s): Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia
Other intervention name(s): turbinoplasty
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with chronic hypertrophic rhinosinusitis, with or without polyposis
        Stillborn children
      
Biospecimen description: 
      nasal mucosa of the inferior nasal turbinate obtained by mucotomy in adult pacients nasal
      mucosa of the inferior nasal turbinate obtained by mucotomy in stillborn children
    
Keywords: nasal mucosa; chronic hypertrophic rhinosinusitis; mucotomy; nanoparticles; scanning electron microscopy; Raman microspectroscopy; nasal polyposis
Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
Condition: Chronic Migraine; Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Migraine Disorders
Study type: Interventional

Summary: 
      The aim of this study is to determine whether treatment of temporomandibular joint is more
      effective than usual care in patients with chronic migraine and temporomandibular disorders
      to reduce pain.
    

Detailed description: 
      The aim of this study is to determine whether treatment of temporomandibular joint added to
      the control group treatment and drug therapy patient base is more effective than just using
      the control group treatment and drug therapy in patients with chronic migraine and
      temporomandibular disorders to reduce pain and improve the quality of life related to health
      of patients.
    

Intervention name(s): Manual therapy; Home physical therapy; Manual therapy in cervical region; Home physical therapy in cervical region
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 6 treatments: 2 treatments for week
1 treatment = 30 minutes; once a day: 15 minutes; 6 treatments: 2 treatments for week
1 treatment = 30 minutes; once a day: 15 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Chronic Migraine; Temporomandibular Disorders; Physical Therapy; Manual Therapy; Home physical Therapy