bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects
Condition: Diphtheria
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the use of a single infusion of S315 at different doses in healthy
      volunteers to help understand its safety and tolerability. S315 is a monoclonal antibody that
      is being developed for treatment of diphtheria. The study will assess for any side effects
      when S315 and will also look at the levels of S315 in the blood over time.
    


Intervention name(s): S315; 0.9% Sodium Chloride (NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Human monoclonal antibody against Diphtheria Toxin; Placebo 0.9% Sodium Chloride (NaCl)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Sensory Processing in Subjects With Painful Bladder Syndrome
Condition: Painful Bladder Syndrome
MeSH terms: Cystitis, Interstitial; Syndrome; Pain
Study type: Observational

Summary: 
      The purpose of this study is to determine if clinically relevant subsets exist in patients
      meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential
      responses to treatments and if verified, this will be important for the stratification of
      patients in clinical studies related to PBS.
    

Detailed description: 
      Patients with the diagnosis of painful bladder syndrome (PBS) constitute two or more
      phenotypes that are distinguished by differential neurophysiological processing of sensory
      information. Further, these differing phenotypes can be predicted by the presence or absence
      of the co-morbidity fibromyalgia.
    

Intervention name(s): Physical examination
Intervention type(s): Other
Intervention description(s): Physical examination and multiple questionnaires will be administered
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with condition will be from Kirklin Clinic Urology Clinic and the Highlands Pain
        Treatment Clinic. Healthy subjects will be recruited via advertisements.
      
Keywords: Painful Bladder Syndrome; Urinary Bladder
Sleep and Girls' Emotions Study
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study evaluates whether increasing sleep duration can increase neural and behavioral
      response to rewards and decrease depressive symptoms in 18- to 22-year-old women with
      insufficient sleep and depressive symptoms.
    


Intervention name(s): Typical sleep opportunity; Extended sleep opportunity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Typical sleep opportunity with consistent sleep timing for 1 week; Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Clinical Trial to Evaluate the Effect of Food on PK and PD of Vicagrel Capsules in Healthy Adult Subjects
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will adopt a randomized, open-label, single-dose, 3-cycle, 3-way
      crossover design to explore the PK and PD profiles of a single oral dose of vicagrel capsules
      under fasted and fed conditions in health subjects.
    


Intervention name(s): vicagrel
Intervention type(s): Drug
Intervention description(s): Oral administration after fasting/high-fat meal/low-fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, open-label, single-dose, fasted/high-fat meal/low-fat meal, 3-cycle, 3-way crossover
Masking: None (Open Label)
Primary purpose: Treatment
Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
Condition: Parkinson Disease; Movement Disorders
MeSH terms: Parkinson Disease; Movement Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of
      the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain
      Stimulation System as an adjunctive treatment for reducing some of the symptoms of
      Parkinson's Disease that are not adequately controlled with medication.
    

Detailed description: 
      This is a prospective, controlled, multi-centered, 12 months post-implantation study. A
      maximum of 15 sites will enroll a total of 136 patients.

      All study participants will have the study device surgically implanted. After implant
      surgery, study participants will return to the clinic for evaluation 30 days after surgery,
      three months after surgery, six months after surgery and twelve months after surgery. At the
      baseline, three, six and twelve month visits the patient's Parkinson's symptoms and ability
      to perform daily activities will be evaluated using a number of accepted assessment tools
      including a Dyskinesia diary, evaluation of PD symptoms, quality of life scoring and patient
      extension study to monitor the safety and efficacy of the ANS Libra/Libra Deep Brain
      Stimulation System.

      After the 1 year study, patients may enter another protocol (C-06-04) to continue to monitor
      the safety and efficacy of the Libra Deep Brain Stimulation System. Patients may be followed
      for an additional 4 years.

      If necessary, patients may continue to have access to the investigational device under
      protocol (C-13-02) which allows for compassionate use access to it.
    

Intervention name(s): Libra Deep Brain Stimulation System; Libra Deep Brain Stimulation System
Intervention type(s): Device; Device
Intervention description(s): Active DBS Therapy; Implanted system but no stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson disease; Movement disorders; Deep Brain Stimulation; Libra; l-dopa; levodopa; neuromodulation; neurostimulation; Electrical stimulation of the brain; STN; Subthalamic nucleus
Impact of a Standing Program in a Child With Spina Bifida: A Case Report
Condition: Spina Bifida With Hydrocephalus
MeSH terms: Hydrocephalus; Spinal Dysraphism
Study type: Interventional

Summary: 
      The purpose of this case study is to investigate a child with MMC who has significant knee
      and hip flexion contractures to answer the following research questions: 1) Is a home
      standing program effective in reducing hip and knee flexion contractures in a child with MMC?
      2) Does a home standing program result in a change in the quality of functional movement?

      A Physical therapist, PT, will administer the Peds NRS and goniometric measurements prior to
      the start of the study and at the end of the study. The PT will also provide the parent
      instruction on the standing home program with weekly check-ins to ensure the parent and child
      are able to follow the home program. The home standing program will last 8 weeks. The parent
      will keep a written log of stander use. The Peds NRS scores and goniometric measurements will
      be compared pre and post intervention. The expected outcome is that the Peds NRS scores and
      hip and knee extension range of motion measurements will improve.
    


Intervention name(s): Altimate Medical EasyStand Bantam
Intervention type(s): Device
Intervention description(s): The child will stand in the device for 60 min per day, 5 days per week for 2 months.
Intervention model: Single Group Assignment
Intervention model description: Single participant case study
Masking: None (Open Label)
Primary purpose: Treatment
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate the safety of telbivudine for up to 21 months of open-label
      treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial.
      Patients treated with telbivudine during core phase will continue telbivudine and patients
      treated with entecavir during core phase will be switched to telbivudine if the patient is
      willing to enroll this study.
    


Intervention name(s): telbivudine
Intervention type(s): Drug
Intervention MeSH terms: Telbivudine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HBeAg-positive; chronic hepatitis B; telbivudine
Feasibility of AI-based Heart Function Prediction Model Using CXR
Condition: Chest X-ray for Clinical Evaluation
Study type: Observational

Summary: 
      The investigators will develop an artificial intelligence model to predict left ventricular
      ejection fraction using chest radiographic images and transthoracic echocardiography data.
    

Detailed description: 
      Echocardiography should be considered at an early stage in patients who have first developed
      heart failure or who do not have information about heart function, but the examination may be
      delayed due to lack of time and manpower in the actual medical field.

      Primary Objective: Use chest radiographs to predict the left ventricular ejection fraction
    

Intervention name(s): Scanning Chest X-rays and performing AI algorithms on images
Intervention type(s): Diagnostic Test
Intervention description(s): Chest X-Rays; AI CNNs; Results
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing a transthoracic echocardiogram will be enrolled.
Early Limb Rehabilitation Therapy Within 48 h of Acute Stroke Onset(ERTAS)
Condition: Time of First Rehabilitation Therapy
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy
      took place within 48h with therapy took place after 48h for patients with stroke (modified
      Rankin Scale Score 3-4).
    

Detailed description: 
      Early rehabilitation after stroke is thought to contribute to the effects of stroke-unit
      care. However, time of initial rehabilitation therapy is poorly defined and not underpinned
      by strong evidence in patients with stroke (modified Rankin Scale Score 3-4). The
      investigators do this parallel-group, single-blind, randomized controlled trial in shengjing
      hospital of China Medical University. Participants (aged≥18 years) with ischaemic or
      haemorrhagic stroke, first or recurrent, who meet physiological criteria are randomly
      assigned (1:1), to receive usual stroke therapy. Treatment with recombinant tissue
      plasminogen activator is allowed. Randomisation is stratified by study site and stroke
      severity. The primary outcome was a outcome 3 months after stroke, defined as a modified
      Rankin Scale score of 3-4. The investigators do analysis on an intention-to-treat basis.
    

Intervention name(s): stroke rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Physical rehabilitation exercise between 24 and 48 hours and after 48 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human
      breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a
      humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment
      for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has
      been shown to increase both survival and response rate, in comparison to trastuzumab alone.
      CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical
      Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine
      were evaluated in patients with HER2-overexpressing metastatic breast cancer.
    

Detailed description: 
      The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human
      breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a
      humanized anti-HER2/neu receptor monoclonal antibody, has been proved valuable treatment for
      HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has
      been shown to increase both survival and response rate, in comparison to trastuzumab alone.
      CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical
      Co.Ltd. Previous Phase I study showed that CMAB302 was well tolerated as monotherapy and the
      pharmacokinetic data exhibited a non-linear profile over the dose range of 100 to 500 mg,
      similar to that of trastuzumab. In this study, efficacy and safety of CMAB302 as a single
      agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing
      metastatic breast cancer.
    

Intervention name(s): humanized anti-HER2 antibody; Vinorelbine
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.; Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks
Other intervention name(s): brand name:Cipterbin®; brand name:NAVELBINE®
Intervention MeSH terms: Vinorelbine; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HER2-Overexpressed
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
Condition: Acanthosis Nigricans; Obesity
MeSH terms: Acanthosis Nigricans
Study type: Interventional

Summary: 
      Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.
    

Detailed description: 
      The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in
      patient with obesity and acanthuses nigrican.
    

Intervention name(s): melatonin
Intervention type(s): Dietary Supplement
Intervention description(s): Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acanthosis nigricans; Obesity
Comparison of Systemic Response After Laparoscopies Performed With Standard and Low-Pressure Pneumoperitoneum
Condition: Laparoscopy.
MeSH terms: Pneumoperitoneum
Study type: Observational

Summary: 
      The purpose of the study was the comparative assessment of the influence of low and standard
      pressure CO2 pneumoperitoneum on the systemic inflammatory and angiogenic responses during
      the postoperative period after laparoscopic management of cholelithiasis.
    

Detailed description: 
      Objective: The purpose of the study was to access the influence of low pressure CO2
      pneumoperitoneum on the inflammatory and angiogenic responses during the postoperative period
      after laparoscopy. Summary background data: Surgical procedures enhance production of pro-
      and anti-inflammatory cytokines and angiogenic factors that play a pivotal role in the
      immunological response to surgical trauma and take part in the pathogenesis of tumor growth
      and adhesions formation. Methods: Study group consisted of 40 patients, operated on due to
      cholelithiasis using standard- (n=20) and low-pressure (n=20) CO2 pneumoperitoneum. Serum
      concentration of IL-6, IL-8, IL-10, VEGF-A and endostatin were measured before the surgeries
      and thereafter at 6, 24 and 48h with commercially available ELISA assays. Results:
      Concentrations of IL-6 increased significantly after the operations in both groups. No
      differences were observed between the groups in regards to IL-6, IL-8 and IL-10 levels.
      Concentrations of VEGF-A measured at 6 and 48h were significantly lower in patients who
      underwent laparoscopies performed with low pressure pneumoperitoneum. No significant
      variations were observed in endostatin serum concentration. Concentrations of the studied
      parameters were not influenced by the duration of surgeries, age, gender, or BMI of the
      patients. Conclusions: The results obtained in our study do not show any significant
      differences between studied operative procedures with regards to systemic inflammatory
      response. Changes in the concentrations of VEGF-A and endostatin observed in the studied
      population may suggest this technique to be more favorable with regards to angiogenesis
      process intensity, along with all its consequences and implications.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with cholelithiasis and indications for surgical treatment; the median age of the
        patients included in the study was 48,5 and ranged from 18 to 70 years. The ratio of female
        to male patients was identical within each group and amounted 7:3.
      
Biospecimen description: 
      serum
    
Keywords: low-pressure pneumoperitoneum; laparoscopy; cytokines; VEGF-A; endostatin
Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic
      stress disorder (PTSD).

      Comparing real to sham treatment.
    


Intervention name(s): Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Intervention type(s): Device
Other intervention name(s): Brainsway H-Coil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD
Observational Study of HIV-associated Neurocognitive Disorder
Condition: HIV Associated Neurocognitive Disorder; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Neurocognitive Disorders
Study type: Observational

Summary: 
      It is estimated that over 1 million people in the United States have HIV infection. While HIV
      is treatable, there are still high rates of HIV-associated neurocognitive disorder (HAND).
      HAND is defined by low scores on memory testing. To meet the criteria for HAND, an
      HIV-infected individual has to have a low score on at least two different memory tests. It is
      estimated that 20-50% of people living with HIV have HAND. It is therefore still a common
      problem. While individuals with HAND typically improve on antiretroviral therapy for HIV,
      often this improvement is incomplete. Also, there are over 20 antiretroviral medications
      approved for HIV in the US. It is not clear if the specific choice of antiretroviral
      medication makes a difference in the improvement of HAND.

      The investigators have designed a small preliminary study in which subjects with and without
      HAND who have never been on treatment for HIV or have been off treatment for at least 6
      months are followed for the first 12 months after starting antiretroviral therapy.The
      investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will
      also be followed by their primary HIV medical provider. For the study, subjects will be
      followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks.
      Memory testing will be performed at baseline and each followup visit. Blood will also be
      taken at baseline and the three followup visits to measure changes in inflammation. A lumbar
      puncture will be performed at baseline and at 24 weeks to measure changes in inflammation and
      amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at the
      last study visit of 48 weeks
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will be identified through referrals from HIV medical providers in the Atlanta
        metropolitan area. Potential subjects will be recruited from the Grady Infectious Diseases
        clinic as well as other clinics in the metropolitan Atlanta area, which include the Fulton
        and Dekalb county health departments, the Emory Infectious Diseases clinic, as well as
        private HIV medical practices in the area.
      
Biospecimen description: 
      Blood (plasma) samples and cerebrospinal fluid (CSF)
Electrolyte State in Patients With COVID-19
Condition: Electrolyte Imbalance
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Initial case reports and cohort studies have described many clinical characteristics of
      patients with coronavirus disease 2019 (COVID-19), an emerging infectious disorder caused by
      the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In early COVID-19 studies,
      some evidence has been provided that electrolyte disorders may also be present upon patients'
      presentation, including sodium, potassium, chloride and calcium abnormalities

      the aim of the study is Identification of elements that affect COVID-19 pathology to improve
      survival and decrease mortality rate.
    

Detailed description: 
      SARS-CoV-2 invades human cells through binding angiotensin I converting enzyme 2 (ACE2) on
      the cell membrane. ACE2 is widely distributed in many types of human tissues, especially in
      the vital organs, such as heart, liver, kidney, and lungs. ACE2 is viewed as the principal
      counter-regulatory mechanism for the main axis of renin-angiotensin system (RAS) that is an
      essential player in the control of blood pressure and electrolyte balance. The final effect
      is to increase reabsorption of sodium and water, and thereafter increase blood pressure and
      excretion of potassium (K+). Besides, patients with COVID-19 often had gastrointestinal
      symptoms such as diarrhea and vomiting

      Early studies proved that high percentage of COVID-19 patient were presented with electrolyte
      disorders, including sodium, potassium, chloride and calcium abnormalities. Such electrolyte
      disturbances have important implications not only for patient management but also for
      identifying potential pathophysiologic mechanisms underlying COVID-19 that could drive novel
      therapeutic opportunities
    

Intervention name(s): electrolytes
Intervention type(s): Other
Intervention description(s): measuring level of electrolytes
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients ≥ 18 years old with diagnosis of COVID-19 infection who admitted to Isolation
        hospital of Zagazig University Hospitals during the period from 1 May 2020 to 1 August
        2020.
      
Keywords: Electrolytes; COVID-19