bioihbjkbjnl/mcl2 huggingface dataset:
Treatment With AX200 for Acute Ischemic Stroke
Condition: Cerebral Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa
      trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for
      acute ischemic stroke. The primary objective of the present phase IIa study is to assess the
      safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke.
      The secondary objective is to assess the effect of AX200 on subject outcome in comparison to
      placebo.
    


Intervention name(s): AX200 (G-CSF)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Effect of Bacillus Coagulans and Galactomannans on Obese Patients Undergoing Sleeve Gastrectomy
Condition: Obesity; Quality of Life
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of bacillus coagulans and galactomannans
      (LactoWise®) administration on obese patients undergoing sleeve gastrectomy by observing
      standard protocol measurements in patients following sleeve gastrectomy: laboratory
      measurements, ideal body weight, and percent estimated weight loss, in addition incorporating
      the Gastrointestinal Quality of Life Index (GIQLI)
    

Detailed description: 
      Loma Linda University's School of Allied Health Professions in collaboration with the
      Metabolic and Bariatric Surgery Department under the Surgery Division is conducting research
      to evaluate the influence of LactoWise® (a proprietary blend of probiotic and prebiotic -
      bacillus coagulans/galactomannans, respectively) on the normal microbiota of obese patients
      post bariatric sleeve gastrectomy. Pre-surgery, participants will be required to sign a
      consent form and to complete the Gastro-Intestinal Quality of Life Index (GIQLI). A total of
      60 bariatric sleeve patients will be recruited for this investigation. Post-surgery
      participants will be randomized into two groups, one will receive LactoWise® and one be the
      control (placebo). The LactoWise® blend has 300 mg of the bacillus coagulans and
      galactomannans and contains around 4.5 billion live cells. Daily intake of capsules coupled
      with bariatric sleeve standard of care will be conducted for the duration of 3 months, which
      is the anticipated clinical timeline. Participants will also be asked to complete the quality
      of life questionnaire at each of the following follow-ups post-surgery: 2nd week, 6th week,
      and 3rd month.

      Outcome measures will be the standard protocol for bariatric sleeve patients at the Metabolic
      and Bariatric Surgery Department which will include weight measurements, blood work. In
      addition to the standard of care procedures a research procedure to be added is the GIQLI.
      Pre and post clinical consults, administration of probiotic/prebiotic formulae, and
      follow-ups will be conducted at the Faculty Medical Offices - General Surgery - Bariatric
      Clinic at Loma Linda University Health.
    

Intervention name(s): LactoWise®; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): blend of bacillus coagulans and galactomannans; Placebo to be selected is calcium carbonate (since participant routine standard of care already includes intake of calcium citrate)
Other intervention name(s): blend of bacillus coagulans and galactomannans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Microbiota
The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      A preliminary study to determine the safety and efficacy of intravitreal aflibercept
      injection in patients with persistent central serous chorioretinopathy.
    

Detailed description: 
      Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A
      Prospective Pilot Study
    

Intervention name(s): Intravitreal Aflibercept Injection
Intervention type(s): Drug
Intervention description(s): GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
Other intervention name(s): Eylea
Intervention MeSH terms: Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Persistent; Central; Serous; Chorioretinopathy; Regeneron; CSR; CSCR
Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Interventional

Summary: 
      Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is
      suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET
      and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a
      similar protocol as they had used for PET (Positron emission tomography) or FDG
      (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States
      Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation
      Safety Committee in 1989 and 1994 for the study of neurological diseases and used
      uneventfully.
    

Detailed description: 
      Background: Pre surgical conventional imaging of neuroendocrine tumors (NETs) with CT, MRI,
      In-111 octreotide or 1-123-MIBG (metaiodobenzylguanidine) scintigraphy has limitations. This
      pilot study tried to improve the localization of these tumors with F-18-F-DOPA PET scanning.

      Methods: The investigators studied 22 patients, the majority referred with clinical diagnosis
      of carcinoid (9) or NETs (9) and a few with pheochromocytoma/paraganglioma (3). Carbidopa was
      administered prior to the F-DOPA injection in 12 patients. Comparison was made with prior
      conventional imaging. The F-DOPA findings, read blindly to the findings of other modalities,
      were compared with results of subsequent surgery (2), endoscopy (1), or a long-term follow up
      of mean duration of 49 months (for 20 patients). Two subjects were lost to follow-up.
    

Intervention name(s): F-18-F-DOPA
Intervention type(s): Procedure
Intervention description(s): F-18-F-DOPA i.v. injection of a dose of up to 8.5 mCi. PET scanning started 60-90 minutes post injection
Other intervention name(s): F-18 fluorodopa
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers
Condition: Healthy Volunteer Safety Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label Phase I pharmacokinetic (PK) study of Vasostrict® (vasopressin injection, USP) in
      healthy volunteers.
    


Intervention name(s): Vasostrict Injectable Product
Intervention type(s): Drug
Intervention description(s): Vasostrict® (vasopressin injection, USP)
Intervention MeSH terms: Vasopressins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Proof of Concept Study of Pradigastat in Patients With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      pradigastat 20 and 40 mg as compared to placebo in patients with Functional Constipation.
    

Detailed description: 
      This multicenter, randomized, placebo-controlled, double-blind study is designed to
      demonstrate the efficacy, safety and tolerability of pradigastat relative to placebo across 2
      doses (20 and 40 mg) for up to 6 weeks (4-week treatment, 2-week Follow-up) in patients with
      Functional Constipation.

      The primary endpoint is the change from baseline in the number of weekly spontaneous bowel
      movement (SBM), the key secondary endpoint is the change from baseline in the number of
      weekly complete spontaneous bowel movement (CSBM).An SBM is defined as a stool not induced by
      rescue medication, whereas a CSBM is defined as an SBM associated with a sensation of
      complete evacuation.

      Summary of Protocol Amendments:

        -  Original Protocol: 06 January 2020

        -  Amendment 1: 30 July 2020 (Reason: To respond Health Authority requests)

        -  Amendment 2: 05 March 2021 (Reason: Sponsor decided to amend the protocol. Key changes:
           inclusion/exclusion criteria, criteria for Discountinuation from study/Discontinuation
           from Study Medication, adding the instruction for evaluating and managing diarrhea AEs.
           )
    

Intervention name(s): Pradigastat Tablets 20mg; Pradigastat Tablets 40mg; Pradigastat Tablets 20mg matching Placebo; Pradigastat Tablets 40mg matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20mg, once daily, oral administration; 40mg, once daily, oral administration; once daily, oral administration; once daily, oral administration
Other intervention name(s): ANJ908 20mg; ANJ908 40mg; ANJ908 20mg matching Placebo; ANJ908 40mg matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind and placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pradigastat; Proof of Concept; Functional Constipation
Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment.
      Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and
      photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and
      24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients
      before and after treatment. The satisfaction and adverse reactions of the research
      participants were recorded at every follow-up visit.
    

Detailed description: 
      Hyperhidrosis Disease Severity Scale (HDSS)Score = 1 My sweating is never noticeable and
      never interferes with my daily activitiesScore = 2 My sweating is tolerable but sometimes
      interferes with my daily activitiesScore = 3 My sweating is barely tolerable and frequently
      interferes with my daily activitiesScore = 4 My sweating is intolerable and always interferes
      with my daily activities
    

Intervention name(s): Fractional microneedle RF(United, Peninsula Medical, China)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Acute Normovolemic Haemodilution on Allogenic Transfusion Needs In Laparotomy
Condition: Surgery
Study type: Interventional

Summary: 
      This study is aimed to determine if acute normovolemic hemodilution (ANH), an established
      blood conservation technique, reduces the requirement for allogeneic blood transfusion in
      operations with prediction of surgical bleeding over 20% of estimated blood volume (EBV)
    

Detailed description: 
      Allogeneic blood transfusion is often done during surgery to save life- threatening
      conditions. Blood conservation is a method that can reduce peri-operative allogeneic blood
      transfusion. This study has been conducted on 34 patients underwent laparotomy surgery with
      bleeding more than 20% of EBV. After being informed concent, research subjects were
      randomized into two groups: ANH (conducted ANH) and control group (without ANH). After
      starting general anesthesia, the ANH group was withdrawing blood based on Gross formula.
      Restoration of circulated volume was instituted by infusion of colloids. In control group,
      the operation was started right after the induction of anesthesia. The monitoring of blood
      pressure, heart rate, the amount of bleeding, total fluid, urine production, hemoglobin
      concentration and number of allogenic transfusion were recorded.
    

Intervention name(s): ANH
Intervention type(s): Procedure
Intervention description(s): After general anesthesia is applied, blood was taken through the cubital vein and collected into standard blood bags containing CPDA anti-coagulant. The blood obtained is then stored at temperature of 23 - 25 Celsius degree and given back to patients in the operating room after the bleeding stopped and as soon as there are indications of transfusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute normovolemic hemodilution; allogeneic transfusion
Investigating Neuronal and Peripheral Markers of Brain Heart Interaction in Healthy Participants Under Stress
Condition: Heart Rate; Magnetic Resonance Imaging; Stress, Physiological
Study type: Observational

Summary: 
      This study seeks to investigate which regions of the brain are relevant in the regulation of
      cardiac control and how the interplay between HRV and those regions change during different
      physiological states (stress versus relaxation). In order to achieve this, we will use
      functional magnetic resonance imaging (fMRI) during an experimental task consisting of deep
      breathing and a psychosocial stress task (Montreal Imaging Stress Task).
    

Detailed description: 
      Heart rate variability (HRV) is an important indicator of an organism's ability to adapt and
      regulate autonomic cardiac function. High heart rate variability is an indicator of good
      adaptability to physical and mental demands, while decreased HRV is associated with increased
      vulnerability to psychological and physical stressors. Previous studies have shown that the
      central autonomic network, composed of several regions of the brain such as the amygdala and
      prefrontal cortex, play an important role in regulating heart rate variability. However, the
      exact neural correlates and underlying neural mechanisms involved in autonomic cardiac
      control are still a subject of investigation. Furthermore, the dynamic connectivity between
      heart rate variability and the central autonomic network under changing physiological
      circumstances remains largely unexplored. This study seeks to investigate which regions of
      the brain are especially relevant in the regulation of cardiac control and how the interplay
      between HRV and those regions change during different physiological states (stress versus
      relaxation). In order to achieve this, we will use functional magnetic resonance imaging
      (fMRI) during an experimental task consisting of deep breathing and a psychosocial stress
      task (Montreal Imaging Stress Task). This paradigm will allow assessing the dynamic interplay
      between the heart and the brain. 30 healthy participants will be recruited, in addition to
      fMRI scanning participants will perform a psychometric test battery. A better understanding
      of these psychobiological mechanisms is a fundamental requirement for a better understanding
      of the autonomic regulation of HRV and the development of improved treatment strategies for
      disorders characterized by an impaired autonomic system and reduced HRV.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy participants
      
Keywords: fmri; heart rate variability
Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects
Condition: Eating Behavior
Study type: Interventional

Summary: 
      Male subjects with specific body characteristics were recruited for the study. Subjects did
      an acceptability test on custard and completed a screening questionnaire. Around 30 subjects
      (15 with a normal BMI and 15 obese) continued the study. At each test day, fasting blood
      samples were withdrawn by a registered nurse under sterile conditions. This procedure was
      followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples
      of 5 ml were collected at fasting and after ingestion of meals. At the end, subjects were
      given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood
      analysis for GLP-1, ghrelin, insulin and glucose levels were performed.
    

Detailed description: 
      Male subjects were recruited for the study based on the following criteria: age between 18
      and 50, body mass index normal or obese, non-smokers, non-alcoholic, and do not take
      medications. Subjects did an acceptability test on custard and completed a screening
      questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study.
      Subjects were randomly assigned to one of two meals. Each of the two meals was ingested after
      a 3-day adaptation period. The meals had similar macronutrient composition and provided
      energy equivalent to 30% of the subjects' resting energy expenditure. At each test day,
      fasting blood samples were withdrawn by a registered nurse under sterile conditions. This
      procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes.
      Blood samples of 5 ml were collected at fasting and after ingestion of meals at 15, 30, 60,
      120, 180 and 240 minutes. At the end, subjects were given ad lib access to cheese pizza to
      assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin
      and glucose levels were performed.
    

Intervention name(s): Acceptability
Intervention type(s): Other
Intervention description(s): Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: food, acceptability, appetite, hormones, ghrelin, GLP-1
The Effects of the Hopeful Outdoor Parkinson Exercise (HOPE) Program on Improving Balance Performance in Parkinsonian Non-fallers and Single Fallers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      To determine whether the 8-week Hopeful Outdoor Parkinson's Exercise (HOPE) Program would be
      effective in improving balance performance, physical functions, gait parameter, balance
      confidence, health-related quality-of-life, disease-specific motor performance and
      fall-related outcomes in Parkinson's disease (PD) non-fallers and single fallers.
    

Detailed description: 
      Previous studies demonstrated that multi-modal balance training program was effective in
      improving balance performance in people with PD. However they did not include all the balance
      domains and outdoor fall-prone activities have been overlooked. We designed a task- and
      context-specific balance training program based on the framework of the Balance Evaluation
      Systems Test (BESTest) to target all six balance domains including biomechanical constraints,
      stability limits and verticality, anticipatory postural adjustments, reactive postural
      responses, sensori-motor integration and dynamic gait control.
    

Intervention name(s): an 8-week blended indoor-outdoor exercise program; an 8-week upper limb and hand exercise program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice; upper limb stretching and strengthening, hand agility exercises, knot tying and Chinese calligraphy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: randomised controlled trial, postural balance, rehabilitation, exercise therapy, accidental falls
Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A
Condition: Healthy
Study type: Observational

Summary: 
      The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon
      product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon
      alpha-2A - Roche Laboratory).
    

Detailed description: 
      The Interferons (IFNs) are a group of cytokines produced by vertebrates in response to
      various stimuli, including the presence of foreign nucleic acids in the body, bacteria, tumor
      cells and viral antigens. These proteins have significant shares immunomodulatory,
      antiproliferative and antiviral drugs, the first line of defense of the body. Once produced,
      the IFNs block viral replication, maximize the lytic activity of natural killer cells,
      increase the expression of MHC class I in cells infected by viruses and induce the
      development of Th1 cells The production of interferon alpha-2A is now held by biotechnology
      with the establishment of a chain of DNA producer of interferon alpha-2a in the chain of
      original DNA of a bacterium, allowing the bacteria produce this drug on an industrial scale.
      In the process of synthesis, the 165 amino acids that are part of this molecule can change in
      your order with no reduction in activity or changes in the properties.

      Due to this fact, the biological and medicinal considered, especially those in manufacturing
      by genetic engineering, need to prove their clinical activity so that they can be marketed.
      In the case of interferon, the consequences of the use of a product without activity compared
      to treat patients with Hepatitis C can lead to serious health complications from them. It is
      therefore necessary to prove its clinical activity and pharmacokinetics before its clinical
      efficacy. The sponsor of this study aims to end the renewal of registration of interferon
      alpha-2A with the Ministry of Health So this study to evaluate the Pharmacokinetics and
      Pharmacodynamics of interferon alpha-2a may allow in the future this medicine can be used by
      a year in patients with hepatitis C, without risk to their health, besides those already
      known and inherent in the treatment of any interferon.
    

Intervention name(s): Interferon alpha 2a
Intervention type(s): Biological
Intervention description(s): 3MUI
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Will be studied 24 subjects divided Research and 2 parallel groups; The treatment is a dose of 3MUI of alpha interferon 2nd; There will be collection of blood at times: 0, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours.; The volunteers will be hospitalized 24 hours.; Will be measured labels the AUC, Tmax, Cmax, neopterin and beta2-microglobulin