bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetic profile of a single
      dose of IVIb administered over 5-7 minutes.
    


Intervention name(s): IVIb
Intervention type(s): Drug
Intervention description(s): 800mg IVIb diluted in 200mL NS will be given IV (in the vein) concurrently with an oral placebo on Day 1 and 200ml Normal Saline will be given IV (in the vein)concurrently with 800mg oral ibuprofen on Day 8
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: To evaluate the Pharmacokinetic Profile of IVIb
BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Seizures; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The landmark study Diabetes Control and Complication Trial (DCCT) clearly showed that
      intensive insulin management delays the onset and progression of longterm complications in
      adolescents with type 1 diabetes mellitus (T1DM). The same clinic trial also showed increased
      rate of severe hypoglycemia which required assistance. The risks of severe hypoglycemia,
      defined as loss of consciousness or seizure associated with hypoglycemia, include lower
      HbA1C, younger age, higher insulin dose, male sex, lower parental socioeconomic status,
      non-Hispanic white ethnicity, longer duration of disease, the presence of psychiatric
      disorders, and underinsurance.

      The purpose of this protocol is to explore the relationship between hypoglycemic seizures and
      BMI.
    

Detailed description: 
      This is a retrospective study using questionnaire/survey/interview. We will give subjects a
      letter stating the purpose and describing the study. We will answer all questions they have
      about the study. Once the parents and patient verbally agree to participate in the study, we
      will proceed with the survey.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are patients with type 1 diabetes mellitus
Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Osteoporosis is a major health problem in men and women in this country and the incidence of
      this disease is rising. We think that environmental factors such as nutrition may play a role
      in the increasing prevalence of osteoporosis. In particular, we think that a diet that is too
      low in protein may be contributing to bone loss. The primary purpose of this study is to
      compare the long-term impact of a low protein diet on measures of bone and calcium
      metabolism.
    

Detailed description: 
      The protocol is composed of a 9.5-week study, consisting of a 3-week adjustment period
      followed by a 6.5-week experimental period. During the adjustment period, subjects consume a
      well-balanced lead-in diet designed to stabilize baseline Ca homeostasis. In the subsequent
      experimental period, subjects will consume the experimental diet containing 0.7 g protein/kg,
      800-1200 mg phosphorus, 800 mg calcium and 2300 mg sodium. During days -6 to -1 of the
      adjustment diet, 5-10 and days 40-45 of the experimental period, we will measure Ca
      absorption and kinetics. Weekly assessments of Ca homeostasis will be done using our standard
      measures of calcitropic hormones, markers of bone turnover, and urine and serum minerals.
    

Intervention name(s): Low protein diet
Intervention type(s): Other
Intervention description(s): Low protein diet for 6.5 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: protein; calcium; parathyroid hormone; bone markers; calcium kinetics; absorption
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test how the body absorbs a new form of oral testosterone
      (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at
      the University of Washington to monitor blood testosterone levels over a 24-hour period.
    

Detailed description: 
      We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will
      be given on Day 0 to turn off the body's testosterone production for about 10-14 days.

      The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by
      mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.

      There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels
      over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn
      at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24
      hours after the morning dose.

      Acyline is an experimental drug. The FDA allows its use only in research with a small number
      of volunteers. We have used acyline in over 125 men without serious side effects. The use of
      testosterone in this study is experimental and there may be unknown or unanticipated risks.
    

Intervention name(s): Oral Testosterone; Acyline
Intervention type(s): Drug; Drug
Intervention description(s): Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills); 300 ug/kg injection on Day 0
Intervention MeSH terms: Testosterone; Acyline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Experimental; Acyline plus 27 oral testosterone pills; taken 3x/day
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)
Condition: Paranoid Schizophrenia; Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction; Schizophrenia, Paranoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of an investigational
      drug for the treatment of cognitive impairment in patients with schizophrenia.
    


Intervention name(s): MK0557; Comparator: Placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): MK0557 10mg tablet qd for a 15-wk treatment period; MK0557 Pbo tablet qd for a 15-wk treatment period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Undifferentiated schizophrenia; Residual schizophrenia
Blood Glucose Awareness Training for Parents
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to test a training program for parents of children with T1DM.
    

Detailed description: 
      Successful diabetes management relies on a process of self-regulation in which treatment
      behavior is guided by feedback about changing blood glucose (BG) levels and decision-making.
      The processes involved in self-regulation have been studied extensively in adults with Type 1
      Diabetes Mellitus (T1DM), leading to the development of sophisticated research tools that
      have significantly advanced our understanding and ability to predict clinical outcome.
      Additionally, this research has led to the development of a highly effective, empirically
      based,pyschobehavioral intervention, Blood Glucose Awareness Training (BGAT) that improves
      self-regulation and clinical outcome in adults with T1DM. Unfortunately, the processes
      involved in the self-regulation of pediatric diabetes have received virtually no empirical
      attention. The purpose of this project is to correct the scientific neglect of the
      self-regulation in pediatric diabetes by adapting the conceptual and methodological tools
      used in adult studies to investigate the process of diabetes regulation by school-aged
      children (6-11 years) with T1DM and their parents and to develop and test an intervention to
      enhance the skills critical to this process.
    

Intervention name(s): Blood Glucose Awareness Training for Parents
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: BG perception; hypoglycemic awareness; pediatric T1DM
Comparative Study Between Tonometers
Condition: Glaucoma Eye
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      Comparative study between the Goldmann Flattening Tonometer and the Non-Contact Tonometer in
      patients of a Reference Ophthalmological Hospital
    


Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with glaucoma diagnosed who are monitorated in the hospital
The Effects of Immunotherapy in the Nose
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and
      other environmental insults. About 20 % of the European population suffers from pollen
      allergies. Birch pollen allergic rhinitis is the most common allergic disease in the
      Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of
      pollen allergies may be reduced by understanding the molecular biology of the nasal barriers
      during allergic response. Our aim is to observe the effect of season and birch pollen
      immunotherapy on the molecular biology of nasal epithelium and the microbiome.
    

Detailed description: 
      This is a controlled study with an intervention arm, and a control group of healthy
      volunteers. The population is composed of nonsmoking healthy adults and patients having birch
      or timothy pollen allergy with rhinoconjuctivitis symptoms and without other diseases. The
      diagnosis of pollen allergy is verified with positive history, skin prick test, and allergen
      specific IgE antibodies. Subjects undergo a spirometry with a bronchodilatator test and a
      histamine challenge. Quality of life and patient history data is collected by questionnaires.
      Four peripheral blood samples, as well as nasal cell swabs from nasal mucosa without local
      anesthesia are collected from each patient; in spring and winter before the group of the
      intervention arm starts with birch pollen subcutaneous immunotherapy; and during the first
      spring and winter when a subgroups has received the birch pollen immunotherapy. We plan to
      perform the following analyses for the nasal specimens: transcriptomics and their regulators,
      sequencing of 16SrRNA and RT-qPCR for assessing mucosal microbiome, mass spectrometry for
      analyses of proteins and protein-protein complexes, immunohistochemistry for tissue level
      localization and quantitation of proteins, in silico analyses for the data mining,
      integration and display. In addition we observe the alterations in inflammatory mediators
      after in vitro allergen activation of purified peripheral blood leukocytes by ELISA and real
      time qPCR.
    

Intervention name(s): birch pollen subcutaneous immunotherapy
Intervention type(s): Drug
Intervention description(s): birch pollen subcutaneous immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Topical Analgesic Versus Saline Mouth Rinses in Post Extraction Healing
Condition: Tooth Extraction Site Healing
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There is no evidence based guidelines on using saline rinses for post extraction oral care
      among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to
      orally administered analgesic is questionable.
    

Detailed description: 
      Objective: To compare the post dental extraction healing among subjects who took simple
      analgesic tablets dissolved in water versus those who used saline rinses post operatively.

      Methods: A study will be done among patients who underwent dental extractions at AKHSP dental
      clinic, Karachi, Pakistan. Carious, periodontally mobile, traumatized or broken down teeth
      among 20-70 years old in either gender will be included.

      In addition to the routine prescription of antibiotics and oral analgesics, the hypertensive
      subjects (n=20) will be advised to take dissolved Aspirin tablet as an oral care while
      non-hypertensive will be divided into two sub groups (n=20 each), advised saline mouth rinses
      or dissolved Aspirin for 5 days, respectively.

      The outcome (healing of the extraction socket) will be evaluated 7 days from the day of
      extraction on an ordinal scale.
    

Intervention name(s): Aspirin Powder; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Aspirin powder to be dissolved in water and to be used as mouthwash twice daily for 7 days after tooth extraction.; Normal saline to be used as mouthwash twice daily for 7 days after tooth extraction among non-hypertensive subjects.
Other intervention name(s): Acetyl salicylic acid; 0.9% NaCl; Saline
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Proof of Mechanism in ELT
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the administration of GSK958108 can delay
      ejaculation in patients with primary premature ejaculation as measured by the ejaculatory
      latency time (ELT) using the masturbation model and sexual visual stimulation, and to
      evaluate the safety and tolerability of GSK958108 in healthy men with PE
    


Intervention name(s): GSK958108; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Coated Tablets 1 mg; Coated tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing
      Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will
      increase GH pulse height and will not affect insulin sensitivity.
    

Detailed description: 
      The primary objective of this study is to determine the effects of growth hormone releasing
      hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as
      well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg
      Tesamorelin, subcutaneously, daily for two weeks. At baseline and after two weeks of
      treatment, we will assess overnight growth hormone by frequent sampling as well as insulin
      stimulated glucose uptake by clamp. Subjects will then stop the Tesamorelin and will return
      for an identical assessment after a 2 week withdrawal period.
    

Intervention name(s): Growth Hormone Releasing Hormone (Tesamorelin)
Intervention type(s): Drug
Intervention description(s): Tesamorelin 2mg subcutaneous daily x 2 weeks
Other intervention name(s): Tesamorelin
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone; Tesamorelin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: growth hormone releasing hormone
Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single administration of recombinant FVIII/placebo in healthy male subjects who have been
      treated with a single dose of anti-factor VIII antibody, TB-402
    


Intervention name(s): Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
Intervention type(s): Drug
Intervention description(s): Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Interaction with recombinant FVIII
"Family-centered" Pediatric Rehabilitation Services in Children With Developmental Disabilities
Condition: Developmental Disabilities; Autistic Spectrum Disorder
MeSH terms: Developmental Disabilities; Autism Spectrum Disorder
Study type: Observational

Summary: 
      Developmental disability is a severe chronic disabled condition caused by mental or physical
      impairments. Children with developmental disabilities may face life-long difficulties in
      motor functioning, self-care, condition, communication, and independent living. They often
      receive rehabilitation services to promote daily functions and participation in home, school,
      and community lives.

      "Family-centered" service has been considered as "best practice" in pediatric rehabilitation.
      Therapists encourage children with developmental disabilities and their parents to
      participate in decision making and implementing process of intervention, and provide
      intervention plan that best fit their family needs. Research shows that for children with
      developmental disabilities, family-centered services can enhance children's development,
      decrease parenting stress, promote emotional wellness, and increase parental satisfaction to
      services. Though the "family-centered" concept has been considered as relevant in pediatric
      rehabilitation, there are still difficulties, as well as a lack of evidence regarding its
      implementation in practice.

      Reflecting the trend of family-centered medical care, the benefits of national health
      insurance in Taiwan for early intervention outpatient care will emphasize on family-centered
      intervention. The range of benefits may include communication with parents, parental
      education, consultation and instructions for home programs. Besides, outcomes of
      family-centered intervention will be treated as an important index for monitoring the quality
      of medical services.

      Given that there is a lack of investigation regarding the family-centered pediatric
      rehabilitation, the purposes of this one-year research project are to investigate the
      implementation of family-centered pediatric rehabilitation for children with developmental
      disabilities and to identify related influencing factors. This study will provide empirical
      evidence for family-centered services in Taiwan.
    


Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with developmental disabilities (DD) aged 2-12 years. Children with DD refer to a
        diverse group of severe, chronic disability that is attributed to mental and/or physical
        impairments, resulting in substantial functional limitations in major life activity.
      
Keywords: Developmental Disabilities; Family-centered services; Pediatric rehabilitation
Clinical Evaluation of CelluTite Treatment
Condition: Cellulite of Thighs
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with
      Morpheus8 handpiece for the treatment of cellulite.
    

Detailed description: 
      The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:

        -  The CelluTite - based on a minimally invasive, temperature-controlled
           Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a
           handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and
           external electrode.

        -  The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner
           via an array of 24-electrode pins.
    

Intervention name(s): CelluTite
Intervention type(s): Device
Intervention description(s): CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Other intervention name(s): Morpheus8
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive the treatment and outcome will be followed
Masking: None (Open Label)
Primary purpose: Treatment
Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
Condition: Zygomatic Fractures
MeSH terms: Zygomatic Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      this study was made on fifteen patients who will undergo fracture repair of the
      zygomaticomaxillary complex.

      Postoperative patient evaluation performed with specific attention paid towards,
      accessibility the exposure duration(time from incision till exposure of the field), esthetic
      appearance, post-operative pain, post-operative edema, orbital movement, wound healing,
      scarring infection, and the post-operative ocular complications such as ectropion, entropion,
      enophthalmos, scleral show and corneal abrasion.

      Postoperative clinical examinations along with radiographic examination was done to evaluate
      the position of zygoma and determine the adequacy of fracture reduction.
    


Intervention name(s): Y modification of transconjunctival approach
Intervention type(s): Procedure
Intervention description(s): Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor.
Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region.
The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach.
A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment