bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy
Condition: Physical Therapy
MeSH terms: Muscle Spasticity; Deglutition Disorders; Cerebral Palsy
Study type: Interventional

Summary: 
      Children with CP encounter swallow and feeding impairments, especially in infancy and
      childhood with long meal times with late development of oral motor skills resulting in poor
      growth.
    

Detailed description: 
      this study will be conducted to explore the feasibility of oral sensorimotor stimulation
      combined with sequenced trunk co-activation on oropharyngeal dysphagia in children with
      spastic quadriplegic CP.
    

Intervention name(s): conventional physical therapy training; oral motor training.
Intervention type(s): Other; Other
Intervention description(s): The program focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms. The program was applied via certified physical therapists five days/week for 4 successive months. The intended goals of the treatment program were achieved through:
Neurodevelopmental based training (NDT)
Functional stretching exercises to preserve muscle and soft tissues elasticity
Sequenced trunk co-activation (STA) exercises
Righting and protective reactions It is worth mentioned that the exercises applied in each session was influenced by the age and the specific functional abilities within the selected activity.; Children in the experimental group received 30 minutes of oral motor training five days week. The training included oral stimulation (facilitation) conducted before the child's actual meal time.
The designed protocol comprised modified perioral and intraoral maneuvers based on Fucile's protocol. The utmost aims of the protocol were to decrease hypersensitivity of oral structures, increase jaws movement, and reinforce muscle strength, improve tongue movement and enhance oral motor organization
Other intervention name(s): Neurodevelopmental based training (NDT); Functional stretching exercises; Sequenced trunk co-activation (STA) exercises; - Righting and protective reactions:
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spastic Quadriplegia; Cerebral Palsy; Oropharyngeal Dysphagia; Oral Sensorimotor Stimulation
Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery
Condition: Technology
Study type: Observational

Summary: 
      The goal of this observational substudy is to evaluate the feasibility, performance and
      behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new tissue
      perfusion device using urethral photoplethysmography in patients undergoing major abdominal
      surgery and in whom an advanced hemodynamic monitoring is placed.
    

Detailed description: 
      Continuous monitoring of tissue perfusion in patients undergoing major surgery remains
      challenging because of the lack of tools available. Through using urethral
      photoplethysmography, the urethral perfusion index (uPI) could allow tissue perfusion
      monitoring through a modified urinary catheter. The goal of this observational study is to
      evaluate the feasibility , performance and behavior of the IKORUS (Advanced Perfusion
      Diagnostics, Villeurbanne, France), a new device in the field. We aimed to assess its
      performance (duration and signal quality), the uPI variations during hemodynamic events
      (fluid challenge) in patients undergoing major abdominal surgery and equipped with an
      advanced hemodynamic monitoring.
    

Intervention name(s): IKORUS technology
Intervention type(s): Device
Intervention description(s): Ikorus technology is a new micro perfusion device measuring via urethral photoplethysmography, the urethral perfusion index (uPI) in patients equipped with an urinary catheter.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing major abdominal surgery
The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      Postpartum hemorrhage is the most common cause of maternal death across the world,
      responsible for more than 25% of maternal deaths annually. Although effective tools for
      prevention and treatment of are available, most are not feasible or practical for use in the
      developing world where many births still occur at home with untrained birth attendants .
      primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24
      hours of delivery of the fetus which affects the general condition.

      Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide ,
      reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of
      long-term severe morbidity, and approximately 12% of women who survive postpartum
      hemorrhagewill have severe anemia.

      Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of
      the activation of plasminogen to plasmin. At much higher concentrations it is a
      non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen
      activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times
      greater than that of aminocaproic acid.
    


Intervention name(s): Tranexamic Acid; 5% glucose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Investigation of the Safety of Intranasal Glulisine in Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot
      study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo
      in patients with DS. Subjects will be randomized into this cross-over study and within
      subject comparisons conducted between single treatment of intranasal insulin glulisine and
      single treatment of intranasal placebo. All subjects will also receive a single treatment of
      placebo prior to randomization to ensure adherence to study procedures.
    


Intervention name(s): Insulin glulisine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study; Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Other intervention name(s): insulin, glulisine, Apidra; Placebo
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Testosterone and rHGH in FSHD
Condition: Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of combination
      therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients
      with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.
    

Detailed description: 
      This is a single-center, open-label study of daily human growth hormone (Genotropin®, 5.0
      μg/kg via subcutaneous injection) and testosterone (testosterone enanthate, 140mg via
      intramuscular injection every two weeks) for 24 weeks in men with FSHD with a 12 week washout
      period. A total of 20 subjects will be enrolled at the University of Rochester Medical Center
      in Rochester, NY.
    

Intervention name(s): Testosterone Enanthate; Somatropin
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.; Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
Other intervention name(s): Delatestryl; Tesostroval; Testro LA; Andro LA; Durathate; Everone; Testrin; Andropository; Testosterone heptanoate; Genotropin; Humatrope; Norditropin; Nutropin; Serostim; Zorbtive
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity of Cholera Vaccine in Children With IBD
Condition: Cholera; Inflammatory Bowel Diseases
MeSH terms: Cholera; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Assessment of the immunogenicity and safety of immunization against cholera in children with
      inflammatory bowel disease.
    


Intervention name(s): Vaccination against cholera
Intervention type(s): Biological
Intervention description(s): Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Obstructive Sleep Apnea and Telomere Length
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is a highly prevalent and morbid sleep disorder. Among the
      factors associated with its pathophysiology, the role of intermittent hypoxia stands out,
      contributing to the development of oxidative stress and inflammation. It is known that
      cumulative levels of these factors negatively influence the final portion of the DNA, known
      as telomere. In this sense, the investigators hypothesize that OSA is capable of accelerating
      aging process through telomere shortening mediated by inflammatory and oxidative markers.
      Thus, the aim of this study is to investigate the effect of OSA and its treatment with CPAP
      on the variation of telomere length and their associated mechanisms. For this, a randomized,
      double-blind, sham-controlled clinical study with 6 months duration will be conducted. We
      will recruit male participants with OSA diagnosis (apnea-hypopnea indexe15/hour), aged
      between 35-65 years and body mass index<35 kg/m2, which will be randomized to use CPAP or
      sham-CPAP for 6 months. Participants will visit the laboratory 7 times (baseline and after 1,
      2, 3, 4, 5 and 6 months) and will be submitted to clinical and otorhinolaryngological
      evaluation, sleep questionnaires, polysomnography and blood collection for DNA and extraction
      and measurement of telomere length, as well as the expression of telomerase and oxidative and
      inflammatory markers (ADMA, homocysteine, cysteine, TBARS, 8-oxodG, TNF-a, IL-6 and IL-10).
      This project aims to contribute to the elucidation of the effect of OSA on telomere length
      maintenance, as well as the adjacent mechanisms to this relationship.
    


Intervention name(s): Continuous airway positive pressure
Intervention type(s): Device
Intervention description(s): The continuous airway positive pressure will be used as the gold-standard treatment for obstructive sleep apnea for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep; Telomere; CPAP
GSK706769 Repeat Dose Study
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine safety, tolerability and Pharmacokinetics of GSK706769
    


Intervention name(s): GSK706769; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50mg, 100mg, 200mg, or 400mg; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; CCR5; Healthy volunteers; GSK706769
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
Condition: Vasculitis; Systemic Lupus Erythematosus (SLE)
MeSH terms: Vasculitis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study will be to evaluate the safety and tolerability of single
      and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female
      participants.
    


Intervention name(s): CCX168; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Complement; C5aR; Vascular diseases; Cardiovascular diseases
Acute Oral Effects of Heated Tobacco Products
Condition: Nicotine Dependence, Cigarettes
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Heated tobacco products (HTP) are devices which heat, but not burn tobacco. They do not
      produce cigarette smoke but rather an aerosol. HTPs are marketed as less harmful alternatives
      to smoking. Use and awareness of these devices have grown exponentially in recent years, with
      probably millions of people currently using them. There is very little literature about them,
      so it is quite important to study the effects caused on the human body by these products.

      The benefits and risks of HTP use are uncertain. There is no research on the acute oral
      effects of HTPs in the scientific literature.
    

Detailed description: 
      Measurements of acute oral effects before and after using HTP with bland flavour (HEETS
      Bronze Selection), with methol flavour (HEETS Blue Selection), conventional cigarette and
      placebo device:

      measurement of exhaled CO changes by Smokerlyzer piCO measurement of oral mucosal blood flow
      changes by Perilam PSI System High Resolution (LASCA method) measurement of blood pressure
      and pulse by an automatic blood pressure monitor (Omron M2, Omron Healthcare Inc., Kyoto,
      Japan)
    

Intervention name(s): IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product); IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product); Marlboro Gold (Conventional cigarette); IQOS 3.0 DUO turned off with a bland taste unit
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.; Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.; Conventional cigarette; Placebo device
Other intervention name(s): IQOS 3.0 DUO; HEETS Bronze Selection; IQOS 3.0 DUO; HEETS Blue Selection; Marlboro Gold 0,5 mg; IQOS 3.0 DUO; HEETS Bronze Selection
Intervention MeSH terms: Menthol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nicotine; heated tobacco product; blood flow; cigarette
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of single and multiple ascending oral doses of
      DWP14012 in healthy Japanese, Caucasian and Korean subjects
    


Intervention name(s): DWP14012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DWP14012 tablets; DWP14012 placebo-matching tablets
Intervention MeSH terms: Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fed Conditions
Condition: Hypertension
MeSH terms: Hypertension; Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet
      under fasted conditions.
    


Intervention name(s): losartan potassium
Intervention type(s): Drug
Intervention description(s): 100 mg tablet
Other intervention name(s): COZAAR
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus
Condition: Subacute Cutaneous Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of KRP203 in clinically active subacute
      cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard
      treatment, such as antimalarials.
    


Intervention name(s): KRP203 - 1.2mg; Placebo to KRP203 - 1.2 mg
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus erythematosus; skin lupus
Effects of Black Tea Intake on Serum Lipids
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      A diet-controlled clinical trial which attempts to provide estimates of the effect of black
      tea consumption on serum lipids under tightly controlled conditions, including a controlled
      diet. Mildly hypercholesterolemic individuals (total cholesterol levels between 4.9 and 6.7
      mmol/L, 190 and 260 mg/dl), non-smoking, chronic disease-free individuals were enrolled in a
      15-week, double blind, randomized crossover trial, during which they consumed a controlled
      low-flavonoid diet plus 5 cups of black tea or a tea-like placebo over two 4-week treatment
      periods.
    


Intervention name(s): Tea Treatment Group; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms
Other intervention name(s): Brewed black tea beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: serum lipids; cholesterol; serum cholesterol; black tea; flavonoids; crossover trial; randomized control trial; diet controlled
Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution
Condition: Perforated Appendicitis
MeSH terms: Infections; Surgical Wound Infection; Appendicitis
Study type: Interventional

Summary: 
      This study is to evaluate the effectiveness of peritoneal lavage with super-oxidised solution
      in reducing surgical site infection after open surgery for perforated appendicitis.
    

Detailed description: 
      Open appendicectomy for perforated appendicitis is associated with significant morbidity from
      surgical site infection. The standard practice is to perform peritoneal and wound lavage
      using normal saline solution. The investigators propose the use of superoxidized solution for
      peritoneal and wound lavage to decrease the incidence of surgical site infection.

      Superoxidized solutions contain hypochlorous acid (HOCl) which has bactericidal properties.
      The reactive oxygen species that is produces damages cell wall membrane of unicellular
      organisms, however remains safe when in contact with human or animal tissue. It is commonly
      used for topical treatment of wounds.
    

Intervention name(s): Superoxidized Water; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Super-oxidized solution contains hypochlorous acid (HOCl) which exhibits bactericidal activity. These reactive species create an imbalanced osmotic gradient which damages the cell membrane integrity of single celled organisms, and subsequently denaturing its lipid and protein content. Multicellular organisms including host tissue are not susceptible to such changes in osmolarity hence spared from damage.; Normal saline contains 0.9% sodium chloride.
Other intervention name(s): Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Perforated Appendicitis; Super-oxidised solution; Surgical site infection; Peritoneal lavage
Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
Condition: Dystonia, Focal, Task-specific
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigated the short term effects of repeated administrations of
      repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate
      neurophysiologic responses to rTMS of the activated motor system in patients with FHD.
    

Detailed description: 
      Purpose: The ability of low-frequency repetitive transcranial magnetic stimulation (rTMS) to
      enhance intracortical inhibition has motivated its use as a potential therapeutic
      intervention in focal hand dystonia (FHD). In this preliminary investigation, we assessed the
      physiologic and behavioral effects of multiple sessions of rTMS in FHD. Methods: 12 patients
      with FHD underwent five daily-sessions of 1 Hz rTMS to contralateral dorsal premotor cortex
      (dPMC). Patients held a pencil and made movements that did not elicit dystonic symptoms
      during rTMS. We hypothesized that an active but non-dystonic motor state would increase
      beneficial effects of rTMS. Five additional patients received sham-rTMS protocol. The area
      under curve (AUC) of the motor evoked potentials and the cortical silent period (CSP) were
      measured to assess changes in corticospinal excitability and intracortical inhibition,
      respectively. Behavioral measures included pen force and velocity during handwriting and
      subjective report.
    

Intervention name(s): rTMS; Sham rTMS
Intervention type(s): Device; Device
Intervention description(s): rTMS; Sham rTMS
Other intervention name(s): Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK; Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: focal hand dystonia; rehabilitation; rTMS; writer's cramp; clinical