bioihbjkbjnl/mcl2 huggingface dataset:
Stimulus-Stimulus Pairing Study
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of the current study is to deliver the SSP procedure to children diagnosed with
      autism that do not have vocal language. The study will also aim to gather data in the natural
      environment using a voice recorder.
    

Detailed description: 
      The purpose of this study is to teach children with autism who do not produce sounds or words
      to vocalize sounds or words by using the stimulus-stimulus pairing (SSP) procedure. The
      investigators will use SSP, an intervention based in behavior analysis, to try to help the
      child vocalize sounds. A vocal recorder will also be sent home so that the caregiver can
      record the child's vocalization at home. The caregiver will then be asked to return this so
      that the investigators can listen to it. By doing this, the investigators hope to learn if
      the treatment helps increase the child's vocalizations at home. Some children in the study
      will receive treatment immediately. Some children may enroll in the study now but not receive
      intervention until a later date. All children in the study will receive treatment within one
      year of enrolling in the study.
    

Intervention name(s): Stimulus-stimulus pairing; Vocal recorder
Intervention type(s): Behavioral; Other
Intervention description(s): The participants will attend clinic-based treatment sessions for one hour per day, five days per week, for 6-weeks.The stimulus-stimulus pairing procedure will consist of sounds and words being systematically paired with delivery of a preferred item.; The vocal recorder is a voice recording device that enhances vocalization data. The parent/ guardian will be instructed on how to use the vocal recorder. The vocal recorder will then be deployed at the participant's homes via parent/guardian. The parent/guardian will record vocalizations for approximately 1 hour while in the home or community setting pre, mid, and post treatment. The parent/guardian will return the vocal recorder to the study team for analysis of the recordings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stimulus-stimulus pairing
Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19
Condition: Covid19
MeSH terms: COVID-19; Disease Progression
Study type: Observational

Summary: 
      Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of
      population in a Chinese province, soon emerged as a pandemic, causing a huge strain on
      healthcare system and mortality all over the world. An ideal marker for predicting course of
      this illness should be easily available and reproducible; as the disease burden has spread to
      third world countries whose healthcare system is resource limited. Our study is aimed to
      study the utility of lymphocyte- monocyte ratio in the early stages to predict the
      progression of COVID 19 pneumonia.
    


Intervention name(s): LYMPHOCYTE MONOCYTE RATIO
Intervention type(s): Diagnostic Test
Intervention description(s): Absolute lymphicyte and absolute monocyte counts are recorded on admission of COVID -19 positive patient and ratio is derived. the patients are followed up for any progression of disease stage.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients who are tested positive for COVID 19 and presented within 7 days of symptom
        onset will be included
      
Keywords: LYMPHOCYTE MONOCYTE RATIO; COVID-19; DISEASE PROGRESSION
The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors
      in subjects with over weight and obesity, 50 patients will be randomly allocated to receive
      placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence
      the investigators' diet and exercise program too. At the first and the end of the
      intervention, weight, waist and hip circumference, lipid profile and some inflammatory
      markers will be assessed and compared between groups.
    


Intervention name(s): flaxseed; Placebo; Exercise recommendation
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TomVasc - Vascular Effects of Tomato Extract
Condition: Ischemic Heart Disease; Transient Ischemic Attack; Stroke; Peripheral Vascular Disease
MeSH terms: Ischemic Attack, Transient; Heart Diseases; Vascular Diseases; Myocardial Ischemia; Coronary Artery Disease; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia
Study type: Interventional

Summary: 
      Does tomato extract improve blood vessel function in healthy people and people with
      cardiovascular disease?

      Atherosclerosis ('furring' of the arteries) affects the functioning of blood vessels,
      narrowing and eventually blocking them, causing conditions like heart attack and stroke. The
      Mediterranean diet, which is rich in tomatoes and tomato-based products, has been shown to be
      associated with a reduced risk of blood vessel damage. In this double blind,
      placebo-controlled randomised study, the investigators will investigate whether a food
      supplement containing a standardised extract of tomato improves blood vessel function in both
      healthy people (aged 40-80), and people with a history of cardiovascular disease. The food
      supplement is on sale to the public, and the investigators are testing the standard dose.
      Approximately 72 people will take part at the Clinical Pharmacology Unit at the ACCI
      Building, Cambridge University Hospitals NHS Trust.

      After they have passed screening tests, participants will be allocated by chance to receive
      either the tomato extract product (Ateronon), or a matching placebo (a dummy capsule with no
      active ingredients), which they will take once a day for 8 weeks. At the beginning and end of
      the treatment period, the investigators will test blood vessel stiffness using an ECG machine
      and external probe. The investigators will also measure forearm blood flow, which involves
      infusing 3 separate agents that affect how the lining of the blood vessel wall works, and
      helps to assess whether this is affected by the study treatment. Blood tests will also be
      used to look at how the food supplement is working and its effects on cholesterol and markers
      of inflammation. Including the screening period, and a follow-up telephone call two weeks
      after the end of treatment, participants will be in the study for 14 weeks.
    


Intervention name(s): Ateronon; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Tomato extract (lycopene) capsule, taken once daily for 56 days; Matched placebo capsule, taken once daily for 56 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy adults
Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.
Condition: Solar Lentigo
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      This study evaluates the performance of "CRYOBEAUTY MAINS", a Cyto-selective Cryotherapy
      based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one
      application of "CRYOBEAUTY MAINS" in one hand (right or left hand according to the
      randomization code).
    


Intervention name(s): CRYOBEAUTY MAINS
Intervention type(s): Device
Intervention description(s): CYOBEAUTY MAINS diffuses Difluoroethane gas to the skin. The administration of the cryogenic gas is temperature controlled, accurate and contactless (by means of a spray nozzle), in small quantity (<1g) and during a predetermined short duration (3 seconds)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be treated on the randomized hand, the other hand is the comparator/control.
Comparison between the treated hand and the control hand will be performed.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Solar Lentigo, Cryotherapy, Difluoroethane
Gastric Emptying of Rice With Different Starch Properties
Condition: Appetitive Behavior
Study type: Interventional

Summary: 
      Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes,
      due to rapid digestion of starch into glucose. The specific properties of starch within these
      foods has been studied for the purpose of slowing their digestion rate and improving related
      physiological outcomes, such as gastric emptying rate. The current study investigated the
      relationship among starch digestion, gastric emptying rate and satiety in white and brown
      rice.
    

Detailed description: 
      Studies have indicated that starch-based foods with somewhat high amylose content have slower
      in vitro starch digestion rates, which relate to a low glycemic response. Low glycemic
      response is associated with delayed gastric emptying rate as well. Therefore, we hypothesized
      that rice with a slow starch digesting property would delay gastric emptying. White and brown
      rice with varying amylose contents were used in this study. A 13C-labeled octanoic acid
      breath test method was used to measure gastric emptying rate, and questionnaires were used to
      assess hunger and fullness during the testing sessions. Twelve healthy volunteers were
      recruited to participate in a crossover design study with six rice treatments and outcome
      measurements were gastric emptying and satiety assessments. One fermentable carbohydrate
      (fructooligosaccharide, FOS) solution was used to validate the production of breath hydrogen.
    

Intervention name(s): White rice, low amylose; White rice, high amylose; White rice, slow; White rice, resistant; Brown rice, low amylose; Brown rice, high amylose; Fructooligosaccharide (FOS)
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): White and brown rice were tested for differences in gastric emptying rate and appetitive response; White and brown rice were tested for differences in gastric emptying rate and appetitive response; White and brown rice were tested for differences in gastric emptying rate and appetitive response; White and brown rice were tested for differences in gastric emptying rate and appetitive response; White and brown rice were tested for differences in gastric emptying rate and appetitive response; White and brown rice were tested for differences in gastric emptying rate and appetitive response; White and brown rice were tested for differences in gastric emptying rate and appetitive response
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Sweat Evaporimeter Measurement
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The investigators hypothesize that measurement of beta adrenergic induced sweat rate using an
      evaporimeter can accurately and reliably determine different levels of CFTR dysfunction
      within a spectrum of patients expressing various degrees of cystic fibrosis disease.

      The investigators overall goal is to determine whether the evaporimeter technique of
      measuring beta-adrenergic induced sweat rate is capable of accurately and reliably
      identifying different levels of CFTR dysfunction, as a prerequisite before advancing this
      technique as biomarker assay into clinical trials.
    

Detailed description: 
      Preliminary data show that following β-adrenergic stimulation, evaporimetry can reliably
      measure sweat secretion that is: highly reproducible in healthy controls; reduced by 50% in
      CF obligate heterozygotes; and absent in CF patients carrying severe mutations on both
      alleles. Further, test- retest experiments suggest good intra-individual reliability. All
      these features satisfy the required criteria for a biomarker assay that is capable of
      assessing small increments in CFTR function in vivo in clinical trials designed to assess the
      effectiveness of correctors and potentiators of CFTR channel activity. Therefore, to provide
      additional evidence of the value of this novel technique the investigators will determine the
      accuracy and reliability of evaporimetry to measure Beta-adrenergic induced sweating in
      subjects with a range of CFTR channel activity.
    

Intervention name(s): Sweat Evaporimeter measurement
Intervention type(s): Other
Intervention description(s): The forearm will be cleaned with distilled water. Mineral oil will be applied to the surface of the skin after each injection.
intracutaneous injection of 0.2 ml of atropine
Stimulation and inhibition of sweating in an adjoining "test" area. Assessment of sweat secretion with an evaporimeter for 10 minutes after:
Intracutaneous injection of 0.1 ml carbachol for stimulation of the cholinergic sweat secretion.
intracutaneous injection of 0.2 ml atropine to Inhibit cholinergic sweat secretion
intracutaneous injection of 0.2 ml beta-cocktail (atropine isoproterenol and aminophylline) for stimulation of beta-adrenergic sweat secretion .
The procedure would take about 45 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cystic Fibrosis; Sweat Evaporimeter
Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study
Condition: Nasotracheal Intubation
Study type: Observational

Summary: 
      The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the
      surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are
      often not fitted in anatomy of Korean people because of small nostril. When the size of the
      tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the
      glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and
      depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are
      scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome
      is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the
      proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length
      from the nare to the carina and vocal cord are measured.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are scheduled for nasotracheal intubation for general anesthesia
Acute Effect of Passive Joint Mobilization in Non-Specific Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Aim of present study is investigating the acute effects of passive joint mobilization on pain
      perception and range of motion. Study protocol includes passive joint mobilization
      application to study group with neck pain and blood sample collection of study and healthy
      control group.
    

Detailed description: 
      Our purpose of planning this study is to examine the acute effect of passive joint
      mobilization application on pain perception and range of motion in women with non-specific
      neck pain.

      The hypotheses we will test for this purpose;

      H1- Passive joint mobilization application increases the range of motion of the cervical
      joint in women with non-specific neck pain.

      H2- Passive joint mobilization application increases the pressure pain threshold in women
      with non-specific neck pain.

      H3- Passive joint mobilization increases serum Orexin A and Neurotensin levels in women with
      non-specific neck pain.
    

Intervention name(s): Passive Cervical Joint Mobilization
Intervention type(s): Other
Intervention description(s): It will be applied to the cervical spine, whose dysfunction is detected as a result of the evaluation. The participant will be in the prone position and Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization with Maitland method will be applied for 3 sets, 30 seconds, to the segment to be treated.
Other intervention name(s): Maitland Mobilization
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study includes two groups. Intervention group including women with non-specific neck pain will applied cervical passive joint mobilization and assessment protocol. Control group including healthy women without pain will applied only assessment protocol.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-specific neck pain; passive joint mobilization; blood markers; neck range of motion
Bioavailability of Different Applications of Dabigatran in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on
      food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution,
      both with 150 mg of dabigatran etexilate as capsule in healthy volunteers
    


Intervention name(s): Dabigatran etexilate pellets; Dabigatran etexilate powder; Dabigatran etexilate capsule
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia
Condition: Measles
MeSH terms: Measles
Study type: Observational

Summary: 
      This is an observational study of HIV-1 infected children starting antiretroviral therapy to
      measure the magnitude and quality of general immune reconstitution and pathogen-specific
      immune reconstitution to measles virus.
    

Detailed description: 
      This is a prospective, observational cohort study of 230 HIV-1-infected children initiating
      ART at public clinics in Lusaka, Zambia to measure the magnitude and quality of general
      immune reconstitution and pathogen-specific immune reconstitution to measles virus.
      Non-specific immune reconstitution will be assessed by serial measurements of the number and
      percentages of CD4+ and CD8+ T-lymphocytes, number and percentages of activated CD4+ and CD8+
      T-lymphocytes (using cell surface staining for HLA-DR and CD38), changes in the proportions
      of naïve and memory CD4+ and CD8+ T-lymphocyte subsets (using cell surface staining for
      CD45RA and CCR7), and changes in thymic output as determined by TREC levels. Virologic
      responses to ART will be assessed by serial measurements of plasma HIV-1 RNA levels.

      Within the observational study, there is a nested study of revaccination against measles
      virus of HIV-1-infected children receiving ART who lack protective antibody titers to assess
      the proportion of revaccinated children who develop protective immunity and the duration of
      protective immunity. Anti-measles virus IgG antibodies will be measured 9 months after
      initiation of ART. The results will be available at the 12-month follow-up visit and measles
      revaccination will be recommended to those children lacking protective antibody levels to
      measles virus.
    

Intervention name(s): Measles vaccine
Intervention type(s): Drug
Intervention description(s): measles revaccination administered at 12 months from start of ART
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-1 infected children initiating ART in public clinics within Lusaka, Zambia.
      
Biospecimen description: 
      blood samples will be stored in a repository for five years beyond the end of the study
      period. Some samples may be exported to the Johns Hopkins Bloomberg School of Public Health
      when assays cannot be performed in Zambia.
    
Keywords: HIV; ART; children
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease
      (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different
      dose strengths. This study will also investigate the levels of CTAP201 in the body over time
      and determine the safety of CTAP201.
    


Intervention name(s): CTAP201 Injection; Doxercalciferol
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of different dose strengths of CTAP201 after single dose.; Comparison of different dose strengths of doxercalciferol after single dose.
Other intervention name(s): Hectorol
Intervention MeSH terms: 1 alpha-hydroxyergocalciferol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure