bioihbjkbjnl/mcl2 huggingface dataset:
Wheat Bioactives and Immune Function
Condition: Endocrine, Nutritional, Metabolic and Immunity Disorders
MeSH terms: Immune System Diseases
Study type: Interventional

Summary: 
      The purpose of this research was to understand the effects of bioactive compounds found in
      wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole
      wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function
      assays were performed at both sampling times. It was predicted that eating wheat bran would
      benefit immune function.
    

Detailed description: 
      Healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of
      mouth on the University of Florida campus and in the surrounding area, in May of 2010.
      Eligible subjects were randomly assigned to one of two experimental groups, to consume either
      50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. Blood was drawn from
      fasting subjects before consumption (baseline) and after three weeks of cereal consumption.
      Peripheral blood mononuclear cells (PBMC) were isolated and cultured with a broad based
      mitogen and autologous serum for 10 days. PBMC were stained with fluorochrome-conjugated
      antibodies on Day 0 and Day 10 of culture, at each blood draw. Data was acquired by flow
      cytometry and analyzed. Overall compliance was assessed using self-reported data and by
      counting left-over bags of cereal.
    

Intervention name(s): 50 grams of whole wheat bran cereal; 100 grams of whole wheat bran cereal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This arm was randomized to eat 50 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.; This arm was randomized to eat 100 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.
Other intervention name(s): Kellogg's brand whole wheat bran cereal; Kellogg's brand whole wheat bran cereal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: wheat bran; healthy immunity; T cells
Effects of the Insole on Balance Capacity in Chronic Stroke
Condition: Stroke, Cardiovascular
MeSH terms: Stroke; Myocardial Infarction
Study type: Interventional

Summary: 
      Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss
      balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift
      body weight or to with stand external pertubations. Postural movement patterns include three
      discrete control strategies: hip, knee, and ankle strategy. The ankle rocker is an important
      factor to maintain balance during standing and the ankle strategy restores the center of mass
      (CoM) to a position of stability through body movement. As a result, effective control of
      foot motion and ankle stability may decrease postural sway and the risk of fall in chronic
      stroke.The purpose of this study is to investigate the effects of the insole on balance
      capacity in chronic stroke.
    

Detailed description: 
      An important determinant of activities of daily living performance is standing balance.
      Therefore, poor balance, or postural stability, is significant predictors the risk of fall.
      After a fall, the patient can experience psychological, physical, social, economic, and
      sometimes fatal effects. The injuries can reduce the patient's mobility as well as
      independence and influence quality of life.Patients with chronic stroke wearing functional
      insoles and sham insoles to challenge balance tests.
    

Intervention name(s): insole
Intervention type(s): Other
Intervention description(s): The subjects are randomly assigned to assess balance capacity either with or without insole.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: stroke; balance; insole
Psychopharmacology of Psilocybin in Cancer Patients
Condition: Depressive Symptoms; Anxiety; Cancer
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to study the psychological effects of psilocybin in cancer
      patients. Psilocybin is a naturally occurring substance found in some mushrooms that some
      cultures have used for centuries in religious practices.
    

Detailed description: 
      This research is being done to study the psychological effects of psilocybin in cancer
      patients. Psilocybin is a naturally occurring substance found in some mushrooms that some
      cultures have used for centuries in religious practices. Psilocybin has not been approved for
      general medical use by the U.S. Food and Drug Administration (FDA). Its use in this study is
      investigational. Psilocybin is a mood-altering drug with effects similar to other
      hallucinogens like LSD and mescaline. Mescaline is the main psychoactive component of the
      peyote cactus used in Native American religious practices. Such substances have been used for
      centuries in some cultures as a way of inducing non-ordinary states of consciousness for
      religious and spiritual purposes.

      An earlier study that was done in our lab with healthy participants found that psilocybin,
      given in a comfortable and supportive setting, can provide an experience that is personally
      and spiritually meaningful for the participant. This study is being done to find out if
      psilocybin can also produce personally and spiritually meaningful experiences in cancer
      patients. This could be important because spirituality has been associated with increased
      psychological coping and decreased depression in serious illness. People with a diagnosis of
      cancer between the ages of 21 and 80 years old and who meet the medical requirements may
      join. About 44 people are expected to take part in this study.
    

Intervention name(s): psilocybin
Intervention type(s): Drug
Intervention description(s): The dose of psilocybin received in the two sessions will range anywhere from low to high.
Other intervention name(s): O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Intervention MeSH terms: Psilocybin; N,N-Dimethyltryptamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Clinical Pharmacy Guided Patient Counselling and Adherence Support on Renal Transplant Recipients
Condition: Transplant;Failure,Kidney
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      As a result of the shortage of donor organs and the close relationship between allograft or
      even life loss and non-adherence after kidney transplantation, improvement of patient
      adherence appears essential. So the current study aimed to monitor adherence barriers of
      renal transplant recipients and evaluate possible consequences of nonadherence on recipients'
      clinical outcomes as well as to implement a structured adherence management program
      consisting of intensified patient counselling and adherence support by a dedicated clinical
      pharmacist as an adjunct to standard post-transplant patient education carried out by
      transplant physicians to investigate the efficacy of the implemented program on patients
      adherence and health outcomes as compared to standard physician patient care. The study is a
      prospective self-controlled interventional study that recruited 69 living donors-renal
      transplant Patients attending the transplant clinic of Nasser institute and satisfying the
      inclusion criteria. On enrolment, patient-related baseline data that could determine and
      affect patients' adherence as well as patients' clinical outcomes were recorded. After all
      patients received the adjuvant adherence management program by the clinical pharmacist for 6
      month, patients' health outcomes were re-evaluated to compare them to baseline data
    


Intervention name(s): patient counseling and adherence support
Intervention type(s): Other
Intervention description(s): Technical interventions include; identification of possible reasons for non-adherence, adherence support by developing simplified schedules for taking medications that were customized to individualized patient's lifestyle. Reminders for dose as well as tools/strategies the RTR may use to follow the dosing schedules if needed as pillbox were provided as needed
Clinical pharmacists' guided patient training was individualized, repetitive, covered 6 months, and included more aspects and provided practical hints and strategies for medication management.
Initial clinical pharmacist face-to-face session will be up to 60-minute then 30-minute follow-up sessions will be conducted monthly for 6 months during the scheduled post-transplant clinic visits as coordinated with the transplant physician to allow for single office visits for transplant related issues and comorbidities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation
Condition: Aqueous Deficient Dry Eye; Meibomium Gland Dysfunction
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      Compare the objective tear film dynamic measurements in three different populations (MGD
      [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry
      eye]) and the subjective experience before and after instilling a single drop of saline in
      each eye.

      Currently available office-based tests for dry eye do not reliably correlate with patients'
      subjective symptoms. This study is interested in assessing how individuals with these two
      different ocular surface diseases compare with the normal population when measured
      objectively using two different instruments.
    

Detailed description: 
      There will be one study day with a single visit that will consist of taking two sets of
      measurements. Baseline measurements are taken in both eyes using a wavefront sensor to
      measure visual quality followed by saline instillation. Five minutes after drops, visual
      quality is again measured to evaluate changes in tear dynamics.
    

Intervention name(s): Subjective Questionnaire; Measurement with wavefront sensor (right eye, then left eye); Instill Saline Drop
Intervention type(s): Behavioral; Procedure; Drug
Intervention description(s): The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.; The wavefront instrument measures the eye's ability to create a sharp image by briefly shining a laser light from the wavefront sensor into the eye and measuring the light that bounces back through the cornea. For these measurements, subjects will sit on a chair and be instructed to place their chin in a chin rest and lean their forehead against a forehead rest. The subject will be instructed to hold his/her head steady, look in a certain direction, blink or not blink. We will obtain the measurements over a short period of up to approximately 45 seconds. We will start recording data asking the subject to either blink naturally or to hold his/her eye open for a few (up to 10) seconds, and repeat the blink and hold sequence usually for up to four times.; One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire and wavefront sensor. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.
Other intervention name(s): Ocufresh eye wash
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Aqueous deficient dry eye (ADDE); Meibomium Gland Dysfunction (MGD); Normal/Control (Non Dry Eye)
Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children
Condition: Burning Nose
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aims: The objective of the current study was to evaluate the effectiveness of topical
      lidocaine in relieving pain related to INM administration.

      Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative
      children, aged 4 - 11.
    

Detailed description: 
      Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with
      a burning sensation of the nasal mucosa. However, despite its significance, this subject has
      received little adequate research focus. The objective of the current study was to evaluate
      the effectiveness of topical lidocaine in relieving pain related to INM administration.

      Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative
      children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug
      nasally via a pre-calibrated spray as per the following assignments:

      A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam.

      C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain
      using Wong-Baker-Faces- (WBFS) Scale.
    

Intervention name(s): Midazolam; Lidocaine-Midazolam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received 0.5 mg/kg midazolam, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.; Patients received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg midazolam, with a maximum dose of 10 mg. , Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.; Patients received saline 9% (placebo), 0.5 mg/kg, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.
Other intervention name(s): A; B; C
Intervention MeSH terms: Lidocaine; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: blinded, randomized placebo-controlled trial, comparing three groups.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: midazolam; Lidocaine; Intranasal; Burning; Children
CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite; Laxity; Skin
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to investigate the safety and efficacy of collagenase clostridium
      histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic
      panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the
      buttocks or thighs with comparison between two (2) different CCH injection techniques.
    


Intervention name(s): collagenase clostridium histolyticum
Intervention type(s): Drug
Intervention description(s): Delivered via uniform grid injection techniques.
Other intervention name(s): EN3835; CCH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Detection of Circulating Tumor DNA Through Liquid Biopsies in Ovarian Cancer Patients and Evaluation of Prognostic and Predictive Values of Circulating Tumor DNA Assay.
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      Ovarian cancer is the eighth most common cancer in women in Korea, with 2,600 cases occurring
      annually, and the number of cases is steadily increasing. There is no practical method for
      early detection of ovarian cancer, and 75 percent of patients are diagnosed with advanced
      stage. The treatment of ovarian cancer is based on surgical removal and platinum-based
      chemotherapy. The cell-free DNA (cfDNA) test has the advantage of being able to track and
      monitor mutations of tumor origin noninvasive.

      The objective of this study was to assess the feasibility of circulating tumor DNA (ctDNA) as
      a biomarker for cancer recurrence in ovarian cancer after surgery. Diagnosis and prognosis
      evaluation using conventional methods such as CA-125, radiologic examination (CT), had
      limitations in diagnosing and prognostic observation of ovarian cancer. For precise
      diagnostic purposes, CA-125 had limitations because it was detected as positive value when
      the tumor size is enough large or states of metastasis, and CT-based diagnosis is practicable
      only when the size of tumor is detectable.

      However, cell-free DNA can be detected even if the tumor size is small because it detects
      very small amount of mutation gene in the blood. In addition, the detection of tumor cell DNA
      from circulating blood can be a clinical decision making point whether to continue or stop
      chemotherapy.

      In this study, the investigators collect whole blood from patients with ovarian cancer
      undergoing surgery. Control samples will be obtained from patients undergoing surgery for
      benign adnexal disease with CA125 >35U/ml. In ovarian cancer patients, blood samples will be
      collected prospectively every 3 months after surgery. Mutations found at the initial sample
      will be monitored during chemotherapy to investigate the ctDNA pattern. The primary outcome
      will be progression free survival (PFS).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, with epithelial ovarian cancer and patients with benign adnexal disease with
        serum CA-125 >35 U/mL
      
Biospecimen description: 
      cell-free DNA extracted from frozen plasma
D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
Condition: Heart Valve Disease
MeSH terms: Heart Valve Diseases
Study type: Observational

Summary: 
      The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve
      replacements is still controversial due to the different risk profiles of thrombophilia and
      bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or
      prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.

      This study was to evaluate whether elevated D-dimer levels could help to determine the
      intensity of oral anticoagulation in patients with mechanical heart valve prostheses.
    

Detailed description: 
      Background: The optimal intensity of oral anticoagulation in China patients undergoing
      mechanical valve replacements is still controversial due to the different risk profiles of
      thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a
      pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of
      oral anticoagulation.

      Objective: This study was to evaluate whether elevated D-dimer levels could help to determine
      the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

      Methods: A single-center, prospective study was performed. 748 Patients with mechanical valve
      replacement who had received oral anticoagulation. The patients were randomly assigned to
      three groups The intensity of anticoagulation for group one was standard intensity
      (INR:2.5-3.5). The intensity of anticoagulation for group two was kept at low intensity
      without adjustment (INR:1.8-2.6), and for group three , The intensity of anticoagulation
      maintained at low level initiatively (INR:1.8-2.6), D-dimer testing were analyzed two times
      at 3 month later. In case of D-dimer level elevated, adjusted the intensity of
      anticoagulation to standard level. The endpoint of the study was the subsequent
      thromboembolic and major bleeding during an average follow-up of 2 years.
    

Intervention name(s): Warfarin
Intervention type(s): Drug
Other intervention name(s): Warfarin Sodium Tablets
Intervention MeSH terms: Warfarin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffered mechanical valves replacement because of valves dysfunction; and oral
        anticoagulation therapy with warfarin
      
Biospecimen description: 
      Plasma
    
Keywords: mechanical valves replacement; INR; D-dimer; thromboembolic events
Atypical Antipsychotics in Improvement of Quality of Life in Bipolar Disorder
Condition: Naturalistic; Observational
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this study is to reassure the clinical study data on atypical antipsychotics
      effect on quality of life in Korean Bipolar patients.
    


Keywords: Bipolar; atypical antipsychotics; quality of life; observational