bioihbjkbjnl/mcl2 huggingface dataset:
Whole Body Vibration in Children With Cerebral Palsy
Condition: Cerebral Palsy; Spastic
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Some positive effects of whole body vibration applications in reducing spasticity, improving
      walking ability, and increasing walking speed have been reported in children with CP, but the
      evidence is not strong enough. Therefore, this study was planned to evaluate the effect of
      whole body vibration treatment on spasticity, gait, balance, and motor performance in
      children with spastic CP. This study hypothesis that whole body vibration provides an
      additive improvement on spasticity, balance, gait and motor performance.
    

Detailed description: 
      Participants will be evaluate at baseline, after the conventional physiotherapy program, and
      after whole body vibration training program. During this period, the participants who were
      recruited whole body vibration training program, whole body vibration will be applied in
      addition to conventional physiotherapy sessions comprised 45 min, 2 days a week, during 8
      week.
    

Intervention name(s): conventional physiotherapy program; whole body vibration training program
Intervention type(s): Other; Other
Intervention description(s): The conventional physiotherapy program consists of stretching exercises for lower extremities, strength exercises for core, upper, and lower extremity muscles, sit to stand exercises, and balance exercises.; The whole body vibration training program sessions consisted of three 3-min bouts of vibration of 20 Hz and a peak-to-peak amplitude of 2mm with a 3-min rest in between, in addition to conventional physiotherapy exercises for children with cerebral palsy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: cerebral palsy; whole body vibration; gait; balance
Near-Infrared Spectroscopy for Blood Glucose Measurements
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the performance of a near-infrared transmission
      measurement in blood samples collected from healthy volunteers. We propose that NIR
      spectroscopic blood glucose measurements in healthy patients are as accurate as handheld
      glucometers and a Yellow Springs Instrument (YSI). We will also evaluate in vitro blood
      samples spiked with pharmacological interferents to test if the spectroscopic glucose
      measurement is affected by common medications.
    

Detailed description: 
      Luminous Medical is developing an automated glucose measurement system that addresses the
      rapidly growing clinical demand for tight glycemic control in the intensive care unit (ICU),
      operating room (OR), and intermediate care units. The system automatically measures glucose
      and other analytes by spectroscopically analyzing blood as it passes through a disposable
      Sensor Set. Our unique optical measurement does not chemically interact with blood, is
      insensitive to sensor fouling, and, unlike a biosensor, does not require frequent
      recalibration.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Males and females between the ages of 18 and 65
Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether QR-333 is safe and effective in the
      treatment of diabetic neuropathy as compared to placebo.
    

Detailed description: 
      Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and
      numbness, which affects the patients sleep, functioning and well-being. The pain is often
      accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting.
      The pain is usually symmetrical and occurs in the upper and lower extremities following a
      "glove and stocking" distribution.

      To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored
      individually according to subject complaints and may be selected from categories including
      Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic
      antidepressants and anticonvulsants).

      The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the
      treatment of diabetic neuropathy as compared to placebo.
    

Intervention name(s): QR-333
Intervention type(s): Drug
Intervention description(s): QR-333 or placebo will be applied three times a day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetic; peripheral; neuropathy
Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
Condition: Heart Failure With Reduced Ejection Fraction (HFrEF); or Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, randomized, sponsor open-label, participant- and
      investigator-blinded, placebo-controlled, single and multiple dose study to investigate the
      safety and tolerability of XXB750 in HFrEF/HFmrEF.
    

Detailed description: 
      A screening period of up to 29 days will be used to assess participants' eligibility. This
      study will consist of 2 cohorts. Cohort 1 will include participants on stable therapies of
      ACEi/ARB and beta-blockers, in addition to other standard of care medications. Cohort 2 will
      consist of participants treated with sacubitril/valsartan and beta-blockers, in addition to
      other standard of care medications.

      For Cohort 1 participants will be randomized in a 2:1 ratio to receive a single dose of
      subcutaneous (s.c) XXB750 or placebo. For Cohort 2, participants will be randomized in a 3:1
      ratio to receive three doses of either s.c. XXB750 or placebo.

      Cohort 1: After an initial domiciling period following study drug administration,
      participants will be followed for 13 weeks post-dosing for safety, tolerability and PK until
      the End of Study visit on Day 91.

      Cohort 2: After a domiciling period following first study drug administration of XXB750 or
      placebo, participants will be followed for 27 days post dosing for safety, tolerability and
      PK. On Day 28, participants will be re domiciled and receive a second dose of either XXB750
      or placebo. Participants will be followed for another 27 days post-dosing for safety and
      tolerability. On Day 56, participants will be re-domiciled and receive a third dose of either
      XXB750 or placebo. After the third domiciling period, participants will be followed for 13
      weeks post-dosing for safety, tolerability and PK until the End of Study visit on Day 146.
    

Intervention name(s): XXB750; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): XXB750; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, placebo-controlled safety study of XXB750
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: heart failure; reduced ejection fraction; mildly reduced ejection fraction; HFrEF; HFmrEF; XXB750
Self-Management in Young Adults With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25
      years achieve glycemic targets (glycosylated hemoglobin A1C <7.0%). Achieving glycemic
      targets is associated with reduced risk for both micro-and macrovascular complications,
      better neurocognitive function, and better diabetes quality of life. In lab studies, sleep
      deprivation led to impaired glucose tolerance and insulin sensitivity in adults without
      chronic condition and in one study of adults with T1D. Extending sleep in natural
      environments contributes to improved insulin sensitivity and glucose levels, neurocognition,
      and psychological symptoms in young adults without chronic conditions. Modifiable dimensions
      of sleep health (appropriate sleep duration, stability, and timing) are associated with
      better glycemic control in adults with T1D. Therefore, improving sleep duration, stability,
      and timing may be potential therapeutic targets to improve glucoregulation and clinical
      outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk
      population.

      The overall objective is to test and compare the effects of a cognitive-behavioral sleep
      self-management intervention (sleep extension and consistency in sleep timing) compared to an
      attention control condition (habitual sleep duration + diabetes self-management education) on
      improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose
      variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.
    

Detailed description: 
      This is a two-arm randomized controlled trial, with participants assigned to either the Sleep
      Self-Management arm or the attention control arm (Diabetes Self-Management Education). The
      Sleep Self-Management condition involves an initial 50-minute face-to-face consultation with
      brief 5-10 minute weekly follow-ups in a format TBD by aim 1 (e.g., call, text, video
      conference) with 3-week booster sessions in person. The Sleep Self-Management intervention
      activities are provided in addition to "usual care."
    

Intervention name(s): Sleep Self-Management
Intervention type(s): Behavioral
Intervention description(s): Intervention delivered by a sleep coach will include 1) initial in-person 50 min consultation; 2) brief 5 min weekly follow ups in a format TBD; and 3) in-person 30 min booster sessions every 3 weeks (total 13 sessions).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Behavioral: Sleep self-management
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Young Adult
Dental Plaque Microbiota in Caries-free and Caries-active Children
Condition: Caries; Plaque
MeSH terms: Dental Plaque
Study type: Observational

Summary: 
      Dental caries is a polymicrobial infection originally thought to be caused by Streptococcus
      mutans and Lactobacilli. However, unprecedented developments in modern molecular techniques
      have demonstrated that several microbial species are associated with the disease in addition
      to streptococci and lactobacilli. Dental caries initiation and progression is a dynamic
      process in which demineralization of the tooth structure, as a result of acid production from
      acidogenic bacteria (due to carbohydrate metabolism) is being counteracted by the
      remineralization of the tooth surface by strong alkali production by certain bacteria in the
      dental biofilm. The aim of the present study is to identify the different microbiota in the
      oral biofilm using new laboratory techniques as well as the levels of salivary proteins in
      caries-free compared with caries active Arab children.
    

Detailed description: 
      The objective of this study will be to investigate the dental plaque's microbial diversity
      using Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) technology
      in the mixed dentition as well as the levels of salivary proteins in caries-free compared
      with caries active Arab children. The study protocol was approved by the Health Science
      Center Ethical Committee at Kuwait University.

      One hundred 6-9 year-old children with caries active and caries-free status will be recruited
      from randomly selected public schools in Kuwait. After DNA purification from supragingival
      plaque samples, HOMINGS will be performed. To get an insight into the host factors involved
      in this complex interplay between the host and the bacteria, stimulated saliva from the study
      subjects will be analyzed by proteomics. For children in both groups supragingival plaque
      samples will be collected from the buccal and lingual surfaces of all teeth. After preparing
      the samples, the aliquots of purified DNA samples will be shipped to The Forsyth Institute
      for Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) protocol.
    

Intervention name(s): Plaque from each subject will be collected but there will be no intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Pupils from randomly selected public schools
      
Biospecimen description: 
      Plaque sample from each subject
Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks
Condition: Porphyria
MeSH terms: Porphyria, Erythropoietic; Porphyrias
Study type: Interventional

Summary: 
      OBJECTIVES:

      Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and
      effective for the prevention of cyclic attacks of acute porphyria in women.
    

Detailed description: 
      PROTOCOL OUTLINE: All patients receive a gonadotropin-releasing hormone (GnRH) analogue.
      Treatment begins on days 1 to 3 of a menstrual cycle.

      Low-dose estrogen begins at approximately 3 months. All patients must have a daily calcium
      intake of at least 1 gram; supplements are allowed.

      Patients are followed for at least 1 year.
    

Intervention name(s): luteinizing hormone-releasing factor
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Primary purpose: Prevention
Keywords: inborn errors of metabolism; porphyria; rare disease
The Role of TVSG and HS in Determining Endometrial Pathologies
Condition: Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the
      diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to
      determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB)
      .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital,
      Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These
      patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS
      and endometrial sampling were performed both groups after TVSG.The success of these methods
      was assessed by kappa analysis
    


Intervention name(s): Transvaginal ultrasound; Hysteroscopy
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: transvaginal ultrasonography; hysteroscopy; abnormal uterine bleeding
Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology
Condition: Ectopic Pregnancies
MeSH terms: Pregnancy, Ectopic
Study type: Observational

Summary: 
      The purpose of this study is to determine the predictive value of a single serum
      determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in
      Vitro Fertilization (IVF) cycles, in both native and donated oocytes.
    

Detailed description: 
      Ectopic pregnancy (EP) is one of the most common pathologies seen in emergency gynaecology
      practice. Early diagnostic of this situation is a clinical objective because it remains an
      important cause of maternal morbidity and mortality worldwide. Currently, transvaginal
      ultrasound scan (TVS) allow ascertain the location of the pregnancy. However, the diagnosis
      of EP is complicated by a nonspecific clinical presentation and the inconclusive results in
      some cases of transvaginal ultrasound at first presentation. For this reason several
      biomarkers have been investigated to accurately detect the establishment of pregnancy and
      predict its outcome as early as possible.

      These biomarkers include: markers of abnormal embryo/trophoblast growth (β-subunit of HCG,
      Activin A, etc), markers of abnormal corpus luteum function (progesterone, inhibin A, etc),
      markers of a growing pregnancy in the Fallopian tube (creatine kinase, vascular endothelial
      growth factor, etc), markers of inflammation and peritoneal irritation (cancer antigen 125,
      interleukin-6, etc), and uterine markers of normal implantation (leukaemia inhibitory factor
      and glycodelin). Β-HCG and progesterone are usually used in clinical practice and activin A
      and inhibin A have recently shown promising results.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In the first control, made 22-27 days after oocyte retrieval, all women underwent a
        transvaginal ultrasound (TVS) examination using a 6.5-MHz transducer (Voluson 730 Pro V;
        General Electric, Madrid, Spain). They were diagnosed with an ectopic pregnancy (EP) or an
        intrauterine pregnancy (IUP) on the basis of this examination and where there was no clear
        ultrasound evidence of pregnancy were classified as pregnancy of unknown location (PUL).
        Women were followed up until the final pregnancy outcome was known.
      
Biospecimen description: 
      Blood samples are to be taken at the time of the first ultrasound examination and stored at
      -20ºC. Inhibin A and activin A to be determined by ELISA. β-hCG and P were also determined
      using Microparticle Enzyme Inmunoassay (MEIA).
The Effect of a Citrus Extract on Exercise Performance in Moderately Trained Athletes
Condition: Exercise Performance
Study type: Interventional

Summary: 
      In this study, the effect of citrus extract on exercise performance will be investigated. The
      study consists of three groups: one group will receive a high dose citrus extract, one group
      will receive a low dose citrus extract and the last group will receive a placebo. After four
      and eight weeks the effects on performance are measured through a Wingate cycling test. It is
      expected that exercise performance will increase in the citrus extract groups, compared to
      the placebo group.
    


Intervention name(s): citrus extract; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will receive either a low or high dose citrus extract; participants will receive 500mg of maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: performance; polyphenols; nutrition; sports
An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study was conducted to test whether a focused education and counseling intervention
      delivered by a nurse will decrease time of delay in seeking treatment for the signs and
      symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as
      having ischemic heart disease.
    

Detailed description: 
      Delay to treatment from the onset acute coronary syndrome (ACS)continues to be a significant
      cause of morbidity and mortality. This study was conducted to evaluate a tailored education
      and counseling program designed for individuals at high risk for a future event. Study
      Hypothesis: The central hypothesis of this study was that a focused education and counseling
      intervention delivered by a nurse will decrease time of delay in seeking treatment for the
      signs and symptoms of AMI in patients already identified as having ischemic heart disease.
      Patients were randomized to receive a nurse-administered education and counseling
      intervention designed to promote early presentation for medical treatment in the face of
      cardiac symptoms or to usual instructions by their healthcare provider. Primary & Secondary
      Endpoints: The primary endpoint of this trial was prehospital delay time, i.e., time from
      onset of symptoms to arrival at the hospital. The secondary endpoints were: use of the
      emergency medical system; use of aspirin; healthcare resource utilization; and knowledge,
      attitudes and beliefs about heart disease.
    

Intervention name(s): education
Intervention type(s): Behavioral
Intervention description(s): face-to-face education and counseling intervention
Other intervention name(s): none applicable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: patient education; acute coronary syndrome; prehospital delay to treatment
Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity
Condition: Dietary Exposure
Study type: Interventional

Summary: 
      In this project, the investigators aim to explore the impact of dietary L-carnitine
      supplementation on the TMAO production capacity of gut microbiota.
    

Detailed description: 
      Recent studies have established plasma trimethylamine N-oxide (TMAO) levels as a strong,
      independent risk factor for cardiovascular disease. TMAO is produced by the interaction
      between gut microflora and ingested L-carnitine from food. Research indicates that both
      plasma TMAO concentration and the TMAO production capacity of gut microbiota in vegetarians
      are significantly lower than in omnivores, likely due to the reduced L-carnitine intake in
      vegetarian diets. This study aims to explore the impact of L-carnitine supplementation on the
      TMAO production capacity of human gut microbiota and to identify TMAO-producing bacteria
      within the gut microflora. The study plans to recruit both omnivore and vegetarian volunteers
      to undergo a one-month L-carnitine supplementation, followed by an evaluation of changes in
      TMAO production using an oral L-carnitine challenge test, along with gut microbiota
      assessment. TMAO concentration will be measured using LC-MS/MS, and gut microbiome analysis
      will be conducted through shotgun metagenome sequencing. Bioinformatic analysis may reveal
      potential TMAO-producing bacteria. Understanding the changes in TMAO production and gut
      microbiota composition post-L-carnitine supplementation may enhance our knowledge of the
      interplay between L-carnitine supplements, TMAO, and gut microflora.
    

Intervention name(s): L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Intervention model description: All participants received L-carnitine supplementation (500 mg per tablet per day, GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gut microbiota; Trimethylamine N-oxide; L-carnitine supplementation; Oral carnitine challenge test