bioihbjkbjnl/mcl2 huggingface dataset:
Reducing Seizure Frequency Using Cooling of the Head and Neck
Condition: Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      Doctors use cooling of the brain to help stop seizures. This procedure is usually
      accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding
      the need for surgery.

      The purpose of this study is to assess a head-neck cooling device that the patient can wear.
      Researchers will determine whether the device can change the frequency of seizures in people
      with epilepsy.

      Study participants must be 21 years of age or older and must experience seizures that occur
      once a week on a regular basis. Participants will be asked to keep a detailed seizure diary
      for a 12-week period before the date of the first cooling session. For each of the four
      cooling sessions, participants will be admitted to the hospital overnight. They will undergo
      a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a
      temperature-sensor pill. Participants will have one 60-minute cooling session once a week for
      4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm,
      abdomen, and leg. Participants will then be fitted with the cooling unit and the session will
      begin.
    

Detailed description: 
      Previous experimental as well as clinical reports have clearly shown that cooling of the
      brain does have inhibitory effects on epileptiform discharges and seizures. We hypothesize
      that mild cooling of the brain has anti-epileptic effects in epileptic patients who either
      have no identifiable seizure foci, who have multiple foci, or who have frequent
      localization-related seizures that are refractory to antiepileptic drugs. We have studied the
      feasibility and safety of a head-neck cooling device in 10 adult normal volunteers, and found
      that the head-neck cooling was feasible and safe, without significant complaints or problems
      voiced by the subjects. Overall, a slight reduction of core temperature was shown. Since
      cooling on a twice-a-week basis was well tolerated by normal volunteers, we would like to
      extend our study to patients with epilepsy to learn the optimal duration and frequency of
      head-neck cooling in terms of reducing seizure frequency. This will be a pilot study, as
      directed by PIRC and the IRB, in which we will evaluate 60 minutes of cooling performed once
      a week for 4 weeks in 5 epileptic patients. We will then report the results to PIRC and the
      IRB before we proceed with further study.
    

Intervention name(s): Head and Neck Cooling System
Intervention type(s): Device
Primary purpose: Treatment
Keywords: Brain; Epilepsy; Core; Temperature
A Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to compare the effect of PM101 I.V. administered as an
      immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives
      include evaluation of change from baseline in heart rate and change from baseline to the
      lowest value in mean arterial pressure and diastolic pressure.
    


Intervention name(s): PM10
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Pharmacodynamics
Program Evaluation of an In-school Daily Physical Activity Initiative
Condition: Physical Activity; Children, Only
Study type: Interventional

Summary: 
      The school system is one setting in which children's physical activity levels may be
      increased through daily physical activity (DPA) policies and initiatives. Adherence to DPA
      policies is typically poor and results are limited in regard to the associated benefits for
      participating children. Therefore, the purpose of this study was to evaluate a range of
      psychosocial outcomes following a community-led, in-school DPA initiative for 9-14 year old
      children and youth. This program evaluation examined the impact of a DPA program consisting
      of 20 minutes of teacher-led DPA for 20 consecutive weeks. Student outcomes were measured
      using a questionnaire administered at three time points: baseline, mid-intervention, and
      post-intervention. A teacher questionnaire regarding program adherence and student behaviour
      was completed at post-intervention.
    


Intervention name(s): Daily physical activity intervention
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intervention; health policy; psychosocial health; education
Functional Resistance Training to Improve Knee Function After ACL Reconstruction
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to examine if thigh muscle weakness and the lack of muscle
      activation that accompanies ACL injury and reconstruction can be improved with functional
      resistance training.
    

Detailed description: 
      Profound quadriceps weakness is ubiquitous after anterior cruciate ligament (ACL)
      reconstruction, and current rehabilitation approaches are not successful in optimizing
      quadriceps strength and knee function even years after the surgery. We hypothesize that
      suboptimal strength and functional outcomes after ACL surgery are due to the lack of
      task-specific exercise elements during strength training. This application seeks to assess
      whether progressive functional resistance training during gait will significantly improve
      quadriceps function, neural excitability, and knee mechanics during gait. The proposed
      studies will not only lay the foundation for a novel training paradigm, but will also improve
      our understanding of the mechanisms mediating neuromuscular and biomechanical changes after
      functional resistance training.
    

Intervention name(s): Functional Resistance Training with Brace; Control; Functional Resistance Training with Elastic Band
Intervention type(s): Other; Other; Other
Intervention description(s): A brace will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.; A brace will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill.; An elastic band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL; Quadriceps; Muscle; Resistance Training
Frequency of Oral Hygiene
Condition: Gingivitis; Oral Health
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of
      gingival health in patients with an adequate method of oral hygiene.
    

Detailed description: 
      The study was a randomized blinded clinical trial. Eligible patients underwent a pre-clinical
      period in order to eliminate factors that could interfere with the proper plaque control.
      Forty-five non dental students with healthy gingival (maximum 5% of sites showing gingival
      bleeding) were randomized into four groups according to the frequency of oral hygiene (every
      12h, 24h, 48h or 72h). Plaque Index (PLI) and Gingival Index (GI) were evaluated by two
      trained examiners at baseline, 15 days and 30 days.
    

Intervention name(s): frequency of oral hygiene
Intervention type(s): Other
Intervention description(s): the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Vinorelbine in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with
      metastatic prostate cancer that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic
      hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these
      patients. III. Evaluate the quality of life of these patients, and correlate quality of life
      with PSA response.

      OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day
      8 of a 21-day course. Patients with stabilization of their disease, partial response, or
      complete response, receive a maximum of 12 courses of treatment. Patients showing disease
      progression or severe toxic side effects discontinue treatment. Quality of life and pain are
      assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment.
      Patients are followed every 3 months until disease progression.

      PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.
    

Intervention name(s): vinorelbine tartrate
Intervention type(s): Drug
Intervention MeSH terms: Vinorelbine
Primary purpose: Treatment
Keywords: stage IV prostate cancer
Caribbean Island Urinary Iodine Survey 2018
Condition: Iodine Deficiency
Study type: Observational

Summary: 
      Many of the Caribbean island nations have no data on iodine status in their populations.

      Iodine deficiency in children can reduce IQ but can be easily corrected through a program of
      salt iodization.

      The study will be located at 11 islands of the Caribbean region. At each of the 11 study
      sites, we will measure the iodine status in school-age children by collecting morning spot
      urine samples for measurement of urinary iodine concentration (UIC). We will also measure
      height and weight in all children. We will collect a repeat, next-day spot urine sample in
      1/3rd of children to adjust for intra-individual variation in spot UIC and calculate the
      distribution of population intake.
    

Detailed description: 
      In well-controlled randomized trials in Europe and New Zealand, even mild-to-moderate iodine
      deficiency in school-age children reduces IQ (1); thus, its critical to avoid iodine
      deficiency in this age group. In countries effected by iodine deficiency, its sustainable
      elimination through iodized salt can contribute to socioeconomic development. The goal to
      eliminate iodine deficiency was first adopted globally at the World Summit for Children in
      1990, and in 1994, WHO and UNICEF concluded that salt iodization is a safe, cost-effective
      and sustainable strategy to control iodine deficiency (2). In 2005, the World Health Assembly
      called on national governments to report on their iodine nutrition every three years.
      However, before the present survey, the ten countries included in this project had no data on
      iodine status in their populations, and household access to adequately iodized salt was also
      unknown. Thus, the study objectives were:

        -  Assess the distribution of iodine intake of school-age children and their iodine status
           by measuring urinary iodine concentrations;

        -  Assess the iodine content of household salt and of seasoning powders;

        -  Based on the above, provide the preliminary evidence base on which to make initial
           recommendations for iodine strategy/programs in the region.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children of school age
      
Biospecimen description: 
      Spot Urine Samples
Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF
Condition: Subarachnoid Hemorrhage, Aneurysmal
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      Investigate the role of inflammasome and blood coagulation response in human cerebrospinal
      fluid after subarachnoid hemorrhage.
    

Detailed description: 
      Investigate the role of inflammasome and blood coagulation response in human cerebrospinal
      fluid after subarachnoid hemorrhage (SAH).

      1.40 patients with SAH will be included. The CSF will used for ELISA test for inflammatory
      factors and cogulation factors.

      2.CSF obtained from 4 patients with non-neuroloogical disease with 4 addittional SAH patients
      will be used for Mass Spectrometry
    

Intervention name(s): Lumbar puncture
Intervention type(s): Diagnostic Test
Intervention description(s): Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with SAH
      
Keywords: subarachnoid hemorrhage; coagulation; inflammation
Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To compare the pharmacodynamic properties of two different doses of a new insulin glargine
      formulation with 0.4 U/kg Lantus®

      Secondary Objective:

      To compare the pharmacokinetic properties of two different doses of a new insulin glargine
      formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin
      glargine formulation
    

Detailed description: 
      The study duration per patient will be 4 to 12 weeks including 3 treatment periods each
      separated by a wash-out period of 6-20 days
    

Intervention name(s): Insulin glargine HOE901; Insulin glargine - New formulation HOE901
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution for injection Route of administration: subcutaneous; Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other intervention name(s): Lantus®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation
Condition: Neck Pain; Cervical Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Neck Pain; Hernia
Study type: Interventional

Summary: 
      The aim of the study is to examine the effects of graston and dry cupping techniques applied
      in addition to the conservative treatment program on neck awareness, grip strength, balance
      and sleep quality in patients with cervical disc herniation between the ages of 18-65.
    

Detailed description: 
      The research will be carried out on 50 cases diagnosed with cervical disc herniation between
      the ages of 18-65. The patients will be divided into 2 groups as control and experimental
      groups by simple randomization method. While the conservative physical therapy program is
      applied to the control group, the patients in the experimental group will be applied 1 day
      graston and 1 day dry cup technique in addition to the ones in the experimental group. All
      patients will be treated for 20 sessions, 5 days / 4 weeks. Fremantle Neck Awareness
      Questionnaire to assess neck awareness, hand dynamometer to assess grip strength, Berg
      Balance Scale to assess balance and Jenkins Sleep Scale to assess sleep quality will be used.
      All tests will be measured at the start of treatment and after 4 weeks of intervention. Pre-
      and post-intervention data were statistically analyzed and compared.
    

Intervention name(s): conventional; traditional and complementary medicine methods
Intervention type(s): Other; Other
Intervention description(s): hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises; The Graston Technique is a form of manual therapy known as instrument assisted soft tissue mobilization. Graston massage is performed using titanium-coated metal rods specially designed for different parts of the body.
Cupping therapy is a treatment method that creates a regional vacuum to increase the blood circulation of the person and provide healing.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: conservative and traditional physiotherapy
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: graston technique; cupping therapy
Relevance of Trichoscopy in Differential Diagnosis of Focal Non-cicatricial Alopecia in Children
Condition: Focal Non-cicatricial Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Observational

Summary: 
      Alopecia is a common, distressing condition that is sometimes difficult to diagnose and
      treat.

      Losing hair is not usually health threatening; it can scar a young child's vulnerable
      self-esteem by causing immense psychological and emotional stress, not only to the patient,
      but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed
      and treated early to overcome the resulting problems.
    

Detailed description: 
      The majority of alopecia in children is presented as patchy alopecia, which is most commonly
      diagnosed as alopecia areata. However, other causes of patchy alopecia such as tinea capitis,
      trichotillomania, temporal triangular alopecia (TTA), nevus sebaceous and aplasia cutis
      congenita (ACC) can be easily missed.

      Trichoscopy (hair and scalp dermoscopy) is a non-invasive diagnostic tool that allows the
      recognition of morphologic structures not visible by the naked eye.

      Trichoscopy allows visualization of hair shafts at high magnification and performing
      measurements, such as hair shaft thickness, without the need of removing hair for diagnostic
      purposes. It also allows in vivo visualization of the epidermal portion of hair follicles and
      perifollicular epidermis.

      The advantages of trichoscopy in evaluating hair loss in children are numerous, as it is a
      fast in-office technique , non-invasive, inexpensive, and painless , and therefore it will be
      accepted by children and their parents.

      Tinea capitis and alopecia areata are considered to be the most common causes of hairless
      patches of the scalp in pediatrics. Tinea capitis especially non-scaly type may have the same
      clinical appearance of alopecia areata, so trichoscopy has recently become a useful
      diagnostic tool for alopecia areata and tinea capitis, especially in doubtful cases as lab
      investigations like fungal culture or biopsy may take several weeks.
    

Intervention name(s): Trichoscopy
Intervention type(s): Device
Intervention description(s): Trichoscopy (hair and scalp dermoscopy) is a noninvasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye Structures which may be visualized by trichoscopy include hair shafts of different types, the number of hairs in one pilosebaceous unit, hair follicle openings (dots), the peri and interfollicular areas and the vasculature.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        100 Patients with focal non-cicatricial alopecia will be recruited from the outpatient
        clinic of Dermatology , Venereology and Andrology department at Assiut University Hospital
TDAP Safety in Pregnant Women
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Observational

Summary: 
      The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced
      Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0
      days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be
      verified by medical record review when possible. There will be an emphasis on enrolling women
      who have received Tdap before the current pregnancy, to the greatest extent possible.
      Non-pregnant women who are receiving their initial Tdap will also be recruited.

      Injection-site (local) and systemic reaction data will be assessed on the vaccination day and
      during the 7 days following vaccination using either identical web-based or paper diaries,
      depending on the preference of the study participant.

      Pregnant women will be followed until delivery with comprehensive obstetric and neonatal
      outcomes obtained from review of the electronic medical record.
    

Detailed description: 
      This is an observational study of both pregnant and non-pregnant women. Vaccine
      administration in the pregnant population will be part of routine care. Vaccine
      administration in the non-pregnant women will be provided as either routine care or as part
      of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during
      the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women
      who have received Tdap prior to the current pregnancy in order to attempt to address the
      question of closely-spaced repeated dosing. Detailed data will be collected from study
      participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap
      naïve and those who have received Tdap previously. With Day 0 serving as the day of
      vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For
      Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared
      between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed
      through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study
      participants will be compared with historical outcomes from summary data from both Vanderbilt
      and Duke. In addition, follow-up will be conducted for infants born to mothers who received
      Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of
      life.
    

Intervention name(s): TDAP
Intervention type(s): Biological
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        375 healthy pregnant women at ≥ 20 weeks 0 days gestation through ≤ 34 weeks 0 days
        gestation and their infants and 225 healthy non-pregnant women, age range 18-45 years
      
Biospecimen description: 
      Serum Samples