bioihbjkbjnl/mcl2 huggingface dataset:
Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers
Condition: CNS Oxygen Toxicity, Ketogenic Diet
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      The purpose of this research study is to understand the effect of nutritional ketosis on CNS
      oxygen toxicity in undersea divers. The investigators hope this will provide a starting point
      to develop methods for improving the safety of Navy divers, warfighters and submariners.
    

Detailed description: 
      Participants in the study will undergo a physical exam and testing as well as training on
      cognitive testing software as part of the screening process. Eligible subjects will be
      assigned a normal diet or a ketogenic diet (a diet high in fat/protein and low in
      carbohydrates) for three days before testing. Subjects will be immersed in water to the
      shoulders, inside a hyperbaric (high pressure) chamber while breathing 100% oxygen at
      increased atmospheric pressure, and doing cycling exercise. Testing on the cognitive
      software, as well as blood sampling and physical monitoring will be done while in the
      chamber. All tests and procedures will be completed again at least one week later with the
      diet not assigned for the first session.
    

Intervention name(s): Ketogenic Diet
Intervention type(s): Dietary Supplement
Intervention description(s): Eat a ketogenic diet (low carbohydrate, high fat diet) for 72 hrs prior to the experiment and consume a dietary ketone supplement 60 minutes before the experiment.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will randomize to one of two arms and will crossover to the other arm at least one week later.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Rhythmic Auditory Stimulation on Balance in Children With Cerebral Palsy.
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with
      cerebral palsy.
    


Intervention name(s): Rhythmic auditory stimulation (RAS)
Intervention type(s): Other
Intervention description(s): A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cerebral palsy, Rhythmic Auditory Stimulation, Balance
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and
      safety of Larazotide Acetate in the treatment of patients with celiac disease who have
      persistent symptoms despite being on a gluten-free diet.
    

Detailed description: 
      This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety
      of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to
      gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD
      must have been established by jejunal biopsy as well as serology at some point in time prior
      to entry into the study. Patients must have symptoms despite being on a gluten-free diet as
      defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or
      more than 2.0.
    

Intervention name(s): Larazotide Acetate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): gelatin capsule; gelatin capsule
Other intervention name(s): AT-1001; INN-202
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: larazotide acetate
Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?
Condition: Emergence Agitation, Post Operative Behavioral Changes
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Observational [Patient Registry]

Summary: 
      Emergence agitation (EA) is one of the unpleasant symptoms after general anesthesia. The
      patient can be irritable, uncooperate, cry, moan and combative behaviors. Sometimes the
      patient may need to be thrashed to prevent physical harm. The mechanism of EA is still
      unknown. EA is usually self limiting within 45 to 60 minutes after wake up from anesthesia.
      The incidence of EA is much higher in pediatric group when compared with adult. In some
      centre the incidence of EA can be up to 67 % depends on anesthesia technique, race, and
      child's temperament. Kain et al, reported that the patient who had marked EA tended to have
      post operative maladaptive behaviors. These maladaptive behaviors such as insomnia, eating
      disturbance, aggressive behavior and even developmental regression can be happen until one
      year after anesthesia.

      From the previous study, reported that fast emergence was associated with a high incidence of
      agitation.

      This prospective observation study is conducted to determine that emergence time has any
      effect on EA or not. The authors use process electroencephalogram (entropy) to monitor
      emergence time which defined as the time which state entropy level over sixty to eighty.
      Meanwhile, we will evaluate the emergence time by the conventional method which used the time
      from ceasing anesthesia to the time of eye opening by normal voice stimuli.

      The primary outcome of this study is the correlation between emergence time (both from
      Process EEG and clinical presentation) and incidence of emergence agitation. Two secondary
      outcomes will be measured. Firstly, the correlation between emergence time and postoperative
      behavioral changes. Secondly, the relationship between entropy monitoring and clinical
      symptoms.
    


Intervention name(s): Emergence agitation scale
Intervention type(s): Diagnostic Test
Intervention description(s): Emergence agitation scale: PAED scale > 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ
Other intervention name(s): Post operative behavioral changes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patient aged between 3-12 years
Laparoscopic Tubal Patency Assessment
Condition: Methylene Blue; Laparoscopy; Tubal Patency
Study type: Interventional

Summary: 
      1. Methylene blue in laparoscopy use for tubal patency assessment

        2. Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and
           fertility.

        3. tubal washing after Methylene blue administration could be effective in pregnancy rate
           after operation.
    

Detailed description: 
      women with unexplained infertility and without any problem during laparoscopy and
      hysteroscopy entered in the study.After randomization in one group after dye test,washing
      with normal saline was done until all of visible Methylene blue removed.In second group
      washing with normal saline did not done. pregnancy rate until three months after operation
      was followed without any intervention.
    

Intervention name(s): methylen blue &normal saline; methylene blue; metheylne blue with normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Washing after dye injection
Other intervention name(s): DYE; Methylene BLUE
Intervention MeSH terms: Methylene Blue
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pilot Project of Health Promotion for People With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Limited participation in health promotion activities is noted in people with diabetes, even
      though lifestyle changes have been found to be essential in decreasing the risk of
      complications of the disease. The purpose of this study is to gather preliminary data to
      assess the feasibility of an intense, customized health promotion program in people with
      diabetes, and to evaluate outcome measures following participation to determine effect size
      for future studies. Subjects with type 2 diabetes will participate in a 10-week health
      promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic
      and strength training exercises with a schedule of progression, individual nutrition
      counseling, and diabetes health education sessions.
    


Intervention name(s): Health Promotion Program
Intervention type(s): Behavioral
Intervention description(s): 10 week health promotion program 3-4 times per week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: diabetes
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
Condition: Low Birth Weight Infant; Enteral Nutrition
MeSH terms: Premature Birth; Dehydration; Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective randomised study comparing administration of a hypo-osmolar oral hydration
      solution with the classical hydration via IV (intravenous) infusion in premature infants of
      more than 32 weeks GA (gestational age) aims to determine whether administration of a
      hypo-osmolar oral hydration solution is as efficient as intravenous infusion.
    

Detailed description: 
      In order to prevent dehydration of the premature infant during the first days of life,
      enteral nutrition with milk must be complemented by an additional fluid supply, commonly
      administered intravenously. We propose to perform a prospective randomised multi-centric
      study comparing administration of a hypo-osmolar oral hydration solution with the classical
      hydration via IV (intravenous) infusion in premature infants of more than 30 weeks GA
      (gestational age).

      We define success as a weight loss inferior to 15 % of birth weight and a weight at day 15
      superior to birth weight. Failure was defined hence as a weight loss superior to 15% of birth
      weight or a weight at day 15 inferior to birth weight or a severe complication or death.
      Major violations of the protocol in the study group will be counted as failures. The other
      objectives were to determine whether oral hydration demonstrates practical advantages: less
      complications in initial management, more comfort for the baby and less technical challenges
      for the nurses/doctors in charge. Furthermore to evaluate the clinical tolerance of oral
      hydration from a nutritional point of view and to examine it's effects on intestinal function
      (defecation, gastric residues), signs of intestinal inflammation and GI flora.
    

Intervention name(s): Oral rehydration therapy; classical hydration via intravenous infusion
Intervention type(s): Procedure; Procedure
Intervention description(s): oral rehydration solution; intravenous infusion
Other intervention name(s): SRO; IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preterm babies hydration; Oral rehydration solution; Continuous gastric drip; Fluid therapy; Premature babies comfort; Infant care; Technical challenge for the nurses/doctors in charge
Sorafenib Gastric Cancer Asian Phase I Study
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of
      sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable /
      recurrent gastric cancer.
    


Intervention name(s): Sorafenib (Nexavar, BAY43-9006); Sorafenib (Nexavar, BAY43-9006); Sorafenib (Nexavar, BAY43-9006)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 2 weeks off) + CDDP (60 mg/m2 on Day 8) / 35 days / cycle; Sorafenib (400 mg bid) + S-1 (25 mg/m2 bid, 3weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days / cycle; Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days cycle
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unresectable / recurrent gastric cancer; Sorafenib; S-1; Gastric; Cisplatin; CDDP
Role of Inflammatory Mediators in AERD
Condition: Asthma, Aspirin-Induced
MeSH terms: Asthma, Aspirin-Induced
Study type: Observational

Summary: 
      The purpose of this research study is to learn new information about the underlying cause of
      aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy.
      AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to
      aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on
      individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for
      clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and
      subsequent treatment with daily high-dose oral aspirin is standard of care for patients with
      AERD who do not respond adequately to steroids and have recurrent nasal polyposis or
      symptomatic asthma. This study will involve five visits to Brigham and Women's Hospital and
      will align closely with the standard of care for the treatment of AERD.
    


Intervention name(s): aspirin
Intervention type(s): Drug
Intervention MeSH terms: Aspirin
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with aspirin-exacerbated respiratory disease who are undergoing aspirin
        desensitization and starting high-dose aspirin therapy
      
Keywords: asthma; nasal polyps; aspirin sensitivity; AERD
Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement
Condition: TMJ Disc Disorder
Study type: Observational

Summary: 
      the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk
      displacement with predication of the risk factors
    

Detailed description: 
      : the study aimed to evaluate the clinical and MRI finding of TMJ with posterior disk
      displacement with predication of the risk factors. Study design: this retrospective study
      included patients diagnosed as TMJ internal derangement and all the patients examined by MRI
      from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior
      attachment of the disk were considered as positive cases.
    

Intervention name(s): MRI
Intervention type(s): Diagnostic Test
Intervention description(s): MRI of TMJ
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The retrospective study included patients seeking treatment for TMD at Al-Azhar University
        Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr
        University. The sample originally included patients who provided consent to participate in
        this study and who ultimately underwent treatment for TMJD between 2008 and 2019.
      
Keywords: posterior disk displacement
MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in
      learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan
      better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed.

      PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in
      women receiving chemotherapy for infiltrating breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the feasibility (reproducibility and repeatability) of MRI for assessing tumor
           vascularity in women receiving neoadjuvant chemotherapy for infiltrative breast cancer.

      Secondary

        -  Compare the results obtained by semiquantitative measurement of vascularization (MRI) vs
           traditional empirical evaluation.

        -  Evaluate the MRI accuracy for the measurement of tumoral volume after completion of
           chemotherapy.

      OUTLINE: This is an uncontrolled, nonrandomized study.

      Patients receive neoadjuvant chemotherapy comprising epirubicin hydrochloride IV and
      docetaxel IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of
      disease progression or unacceptable toxicity.

      Patients undergo dynamic-contrast MRI before treatment, 3 weeks after the first course of
      chemotherapy, and 3 weeks after the completion of chemotherapy. They also undergo a bilateral
      mammogram and sonography and clinical examination.

      Within 22-35 days after completion of chemotherapy, patients undergo breast-conserving
      surgical resection of tumor and lymph nodes or mastectomy.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): docetaxel; epirubicin hydrochloride; conventional surgery; dynamic contrast-enhanced magnetic resonance imaging; neoadjuvant therapy; radiomammography
Intervention type(s): Drug; Drug; Procedure; Procedure; Procedure; Procedure
Intervention MeSH terms: Docetaxel; Epirubicin
Allocation: Non-Randomized
Primary purpose: Diagnostic
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
Ginkgo Biloba Extract and the Insulin Resistance Syndrome
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine whether the ingestion of the herbal dietary
      supplement Ginkgo biloba extract has any effect on the efficacy of three classes of diabetic
      medications - (Glucotrol, Glucophage and Actose). Additionally, the study will examine the
      effect of Ginkgo biloba extract on pancreatic insulin production in non-diabetic subjects
      between the ages of 20 and 75 years old.
    

Detailed description: 
      Herbal remedy is popular among those with chronic diseases, who may already be taking several
      prescription medications, thereby increasing the risk of drug-herb interactions. Ginkgo
      biloba extract is a popular dietary supplement that is ingested by the general population to
      enhance mental focus and by the elderly to delay onset of age-acquired loss of cognitive
      function. In subjects with non-insulin dependent diabetes (NIDDM), ingestion of Ginkgo biloba
      may decrease efficacy of the hypoglycemic agents and increase whole body insulin resistance.
      Because aging is a significant risk factor for the development of NIDDM as a result of a
      progressive decline in pancreatic function, and because the elderly chronically take multiple
      prescription medications, the increased use of Ginkgo biloba in this population may increase
      drug-herb interactions. Therefore, we shall examine the effect of Ginkgo biloba on the
      pancreatic function in the elderly to determine whether it may produce pancreatic dysfunction
      and a potential for the development of insulinopenia. The results of this study should
      provide valuable information for designing new therapeutic strategies for the treatment of
      diseases in the insulin resistance syndrome.
    

Intervention name(s): Ginkgo biloba extract
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ginkgo biloba; type 2 diabetes; platelet function; antioxidant
Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia
      glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne
      Vulgaris in a randomized, double-blind, placebo-controlled study for the duration of 56 days.
    

Detailed description: 
      In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia
      glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne
      Vulgaris in a randomized, double-blind, placebo-controlled study. The participants will
      consume one capsule per day containing active ingredient for the duration of 56 days.
      Throughout the duration of the clinical trial, The Investigator will be studying the
      formulation's effects on the change in the Global Acne Grading System (GAGS) score, facial
      sebum secretion, the number and irritability of inflammatory lesions, quality of life via the
      Acne-QoL questionnaire, skin wrinkle severity through the Modified Fitzpatrick Wrinkle
      Severity Scale (MFWS) and the percentage population of responders at the end of the study.
      The Investigator will also assess the change in skin radiance, luminosity, smoothness,
      texture, firmness, and skin hydration through a participant based self-assessment
      questionnaire as well as the safety and tolerability of the formulation through a global
      evaluation by the participants and the investigators.
    

Intervention name(s): Rehmannia glutinosa leaf extract; Microcrystalline Cellulose (MCC)
Intervention type(s): Other; Other
Intervention description(s): One capsule to be taken after breakfast.; One capsule to be taken after breakfast.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1: Rehmannia Glutinosa leaf extract
Arm 2: Placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other