bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
Condition: Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age
      2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness
      (spasticity) due to cerebral palsy.
    


Intervention name(s): IncobotulinumtoxinA (16-20 Units per kg body weight)
Intervention type(s): Drug
Intervention description(s): Active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total dose per injection cycle: up to 500 units; Mode of administration: intramuscular injection into spastic muscles.
Other intervention name(s): Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral
      therapeutic- and [14C]-labeled intravenous microdoses.
    


Intervention name(s): YH4808 PO and [14C]-YH4808 IV
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: absolute bioavailability,; microdose,; AMS
Rho Kinase in Patients With Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the effects of atorvastatin (Lipitor) and
      rosuvastatin (Crestor), United States Food and Drug Administration (FDA) approved drugs
      commonly prescribed by doctors to lower cholesterol, on certain functions of platelets (cells
      that cause blood clots), white blood cells (cells that are responsible for inflammation), and
      blood flow regulation by arteries. This is important because we are looking at ways to more
      effectively prevent atherosclerosis (plaque buildup in blood vessels) and heart disease. Many
      studies have demonstrated that these drugs are effective at reducing inflammation and
      stabilizing plaques. We are interested in better understanding the effects of these medicines
      on inflammation (pain and swelling) and the mechanism by which they act.

      Hypothesis: Atorvastatin (40mg) will reduce inflammatory markers and activity more than
      Rosuvastatin (10mg) in spite of equal LDL-C reduction.
    

Detailed description: 
      A double-blind controlled trial with two arms will be conducted at Brigham and Women's
      Hospital (BWH). We will screen subjects with stable atherosclerosis to complete enrollment of
      40 subjects in the study (see inclusion and exclusion criteria section below). A central
      pharmacist at BWH will randomize the patients to 40mg of atorvastatin (n=20) or 10mg of
      rosuvastatin (n=20) for 28 days. If the patient is already on a statin a two-week washout
      period will be required prior to trial initiation. Our subjects, clinicians, data collectors,
      outcomes assessors and statisticians will be blind with regards to the patient allocation.
      There are a total of 3 visits for each patient: a short screening visit, an initial visit for
      baseline data (90 min.) and a final visit after 28 days. Our participants will be asked to
      take the medication every day at the same time between 9pm and 10pm. Each visit will take
      place between 7am and 9am. Patients will be instructed to fast overnight for a minimum of
      8hrs. They will also be advised not to make any other changes to their current medications
      and lifestyle for 28 days while in the study and to record in a diary any side effects,
      missed doses, or changes in concomitant medication.
    

Intervention name(s): Atorvastatin; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Near Infrared Transillumination of the Paranasal Sinuses
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      This research project designed to diagnose sinusitis using a simple and low-cost optical
      tool. Healthy sinuses are typically filled with air, and show up as bright spots on the
      camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images
      of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments
      on the sinuses have been successful.
    

Detailed description: 
      This device consists of a specialized flashlight that uses mostly non-visible light, and a
      small camera to record the light. The tool is the size and shape of spoon. The technique of
      shining light into the mouth, face, and sinuses is known as "transillumination" and has been
      used for nearly a century to aid in the diagnosis of sinusitis. The tool described in this
      study is a custom made device that uses light that is invisible to the eye.
    

Intervention name(s): Optical Measurement transillumination
Intervention type(s): Device
Intervention description(s): Optical Measurement of sinus
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic,
      
Keywords: Sinusitis
Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis
Condition: Urolithiasis; Ultrasonography; Hydronephrosis
MeSH terms: Urolithiasis; Urinary Calculi; Hydronephrosis; Emergencies
Study type: Interventional

Summary: 
      An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by
      an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is
      intended to be a readily assessable test performed at the bedside, to quickly and safely
      determine the presence of a disease state; it answers a binary question, as compared to
      formal ultrasound imaging which seeks to determine the cause of a patient's symptoms.

      The objective of this study is to determine the accuracy of EDTU in patients suspected of
      renal colic. By demonstrating excellent test characteristics, these investigators hope that
      this research will be used to incorporate EDTU for hydronephrosis into standard emergency
      care in Canada.
    


Intervention name(s): emergency department targeted ultrasound imaging
Intervention type(s): Other
Intervention description(s): bedside ultrasound performed by emergency physician to identify hydronephrosis
Other intervention name(s): EDTU
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: urolithiasis; ultrasound; hydronephrosis
The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.
Condition: Anxiety; Satisfaction With Life; Loneliness
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness
      scores in students and staff in a global study. Assessments at baseline will include the GAD,
      SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and
      Week 8. The Google form questionnaire will ask the high schoolers and staff for their email
      address and their parent's email address (if they are under 18). The form will also include a
      question eliciting interest in participation in the 4-weeks Heartfulness program. The program
      will include tools that promote a heart-based nurturing environment focusing on relaxation,
      positivity, and developing growth mindsets.
    

Detailed description: 
      The specific aim of this study is to assess changes in scores measuring symptoms of anxiety
      using GAD-7 (and GAD-Child), Satisfaction with Life Scale (SWLS and SWLS-C), and UCLA
      Loneliness Scale (Version 3).
    

Intervention name(s): Self-Care Program through Heartfulness
Intervention type(s): Behavioral
Intervention description(s): A four-week Self-Care program through Heartfulness will be offered to participants in the Heartfulness group. This would include a daily practice of relaxation tools for 15 minutes a day using an app and once a weekly webinar for 30 minutes. Guided relaxation and meditation sessions will be offered to the participants during the intervention weeks. These virtual sessions were conducted by Heartfulness Champions and certified trainers from Heartfulness Institute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Circulating Tumour Cells in Patients With Peritoneal Metastases
Condition: Circulating Tumor Cell; Peritoneal Metastases; Hyperthermic Intraperitoneal Chemotherapy
MeSH terms: Neoplasm Metastasis; Neoplastic Cells, Circulating; Hyperthermia; Fever
Study type: Observational

Summary: 
      This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in
      patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due
      to gastrointestinal cancers that have spread to the peritoneum.
    

Detailed description: 
      CTCs har extracted by way of a new method at baseline, during surgery, and postoperatively.
      The occurence of such CTCs will be investigated for prognostic evaluation. Patients will be
      follow-up by Clinical routine. Disease recurrence and overall survival will be the endpoint
      used.
    

Intervention name(s): iCellate
Intervention type(s): Diagnostic Test
Intervention description(s): New method of circulating tumour cell detection and capture.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients being treated in Uppsala with CRS and HIPEC will be asked to join the study.
Management of Postoperative Pain Following Total Knee Arthroplasty by Using Acupuncture-moxibustion Therapy
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage
      following major orthopedic surgery often involves a large, deep incision with considerable
      tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such
      surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay
      mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical
      costs.

      We design a prospective randomized study for postoperative pain control following total knee
      arthroplasty.
    


Intervention name(s): acupuncture-moxibustion therapy; Regular therapy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Neurophysiological Attention Test (NAT) for Objective Assessment of Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The purpose of this study is develop a new assessment tool for Attention
      Deficit-Hyperactivity Disorder (ADHD) and to then test its validity (i.e. ability to
      discriminate between individuals with ADHD and healthy controls).
    

Detailed description: 
      The purpose of this study is to develop a novel approach and software for analyzing
      electroencephalography (EEG) data to identify biomarkers of ADHD. Then to test the ability of
      this assessment tool to differentiate between adults with ADHD and healthy controls by
      comparing the classification accuracy of the metrics from the new tool to the classification
      accuracy of existing behavioral tests for ADHD.
    

Intervention name(s): Behavioral assessment and NAT EEG tests
Intervention type(s): Other
Intervention description(s): Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults with Attention Deficit Hyperactivity Disorder (ADHD) from local clinics, clinicians.
        ADHD community resources in the greater Los Angeles area.
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR
      Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval
      System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™
      Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
    


Intervention name(s): SOLITAIRE™ Device; MERCI® Device
Intervention type(s): Device; Device
Intervention description(s): The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure; The MERCI® Device is the control device that will be used in the interventional procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic Stroke; SOLITAIRE™ Device; SOLITAIRE™; MERCI® Device; MERCI®; Stroke; Ischemic; Mechanical Thrombectomy; Brain; Brain Clot; Brain Artery Revascularization; Recanalization; Brain Stroke; Clot Retriever; Device; Neurosurgery; Neurovascular Intervention; Interventional Neuroradiology; Brain study; neurovascular clinical trial
Pharmacokinetics of Plant-based Ingredient
Condition: Healthy
Study type: Interventional

Summary: 
      The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two
      different matrices, at different dose levels.
    


Intervention name(s): Plant-based ingredient added to starchy meal; Plant-based ingredient added to liquid; No Plant-based ingredient
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Blood glucose; subjects
Clinical Trial for Effect of TQB3616 Capsule on Pharmacokinetics in Healthy Adult Subjects
Condition: Recurrent/Metastatic Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical
      Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism
      of action is to inhibit the proliferation of tumor cells by reducing the phosphorylation
      level of retinoblastoma protein (Rb) in cancer cells and blocking the progression of cells
      from G1 phase to S phase. This study is a randomized, open-label, single-center, two-period,
      two-crossover phase I clinical trial to assess the effect of food on the pharmacokinetics of
      TQB3616 capsules in healthy adult subjects, to evaluate the effect of food on the
      pharmacokinetics of TQB3616 capsules after oral administration in healthy adult Chinese
      subjects and to observe the safety of TQB3616 capsules after single oral administration in
      healthy subjects.Each subject will be randomly assigned to one of two groups (group A and B).
      A total of 16 subjects were enrolled, all taking TQB3616 capsules 180mg, including 8 subjects
      in group A and 8 subjects in group B. The study included screening period, randomization,
      first cycle, washout period and second cycle. The first cycle and second cycle each contained
      3 return visits. 18 pharmacokinetic samples were collected every cycle for pharmacokinetic
      index analysis. Vital signs, physical examinations, 12-lead electrocardiograms, clinical
      laboratory tests, adverse events, drug combination and non-drug therapy information were
      collected during the study to ensure the safety of the subjects.
    


Intervention name(s): TQB3616 Capsule
Intervention type(s): Drug
Intervention description(s): It inhibits the proliferation of tumor cells by reducing the level of retinoblastoma protein (Rb) phosphorylation in cancer cells and blocking the progression of cells from G1 to S phase.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Office Hysteroscopy in Secondary Infertility After Cesarean Section
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      All women with history of secondary infertility after caesarean section will be subjected to
      office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to
      diagnose any subtle uterine abnormalities not detected by conventional means.

      Hysteroscopic examination will be done during the proliferation phase of the menstrual cycle.

      The hysteroscopic evaluation will include assessment of the cervical canal, intrauterine
      lesions, the endometrium and the uterotubal junction. .

      If hysteroscopy reveal a lesion, its type, size, location will be recorded. Transvaginal
      ultrasound will be done after the procedure to detect fluid in the douglas pouch to confirm
      patent tubes.

      Asses the uterine scar in details.
    


Intervention name(s): office hysteroscopy
Intervention type(s): Procedure
Intervention description(s): A speculum is first inserted into the vagina. The hysteroscope is then inserted and gently moved through the cervix into uterus. Carbon dioxide gas or a fluid, such as saline will be put through the hysteroscope into uterus to expand it. The gas or fluid helps see the lining more clearly. The amount of fluid used is carefully checked throughout the procedure
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study will include all secondary infertile cases after cesarean section who presented
        to infertility clinic at Women health Hospital, Assiut University
A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4
      different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate,
      recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular
      pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at
      least 1 of the 4 formulations of HR5I administered as a primary series at 2, 3, and 4 months
      of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody
      responses to all antigens.
    

Detailed description: 
      Participants will be randomized into 4 arms:

      AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol
      phosphate (PRP) conjugates to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface
      antigen (HBsAg)

      PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of PRP conjugated to the
      outer membrane protein complex of Neisseria meningitides (PRP-OMPC) and 10 mcg of HBsAg

      PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of
      HBsAg

      PR51 (6, 15): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of
      HBsAg
    

Intervention name(s): AR51 (12, 10); PR51 (3, 10); PR51 (6, 10); PR51 (6, 15)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg; vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg; vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg; vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Local Protocols on Duration of Chest Tube Therapy Following Thoracic Surgery
Condition: Pulmonary Air Leak
Study type: Observational

Summary: 
      The effect of local chest-tube management protocols on the duration of chest-tube therapy
      following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units.
      The primary study objective was the duration of chest tube therapy in postoperative patients.
    

Detailed description: 
      The management of chest tubes is probably one of the most critical aspects in patient care in
      thoracic surgery and defines the required length of postoperative hospital stay in the
      majority of patients. So far, no generally accepted recommendations exist for postoperative
      chest tube management to streamline the postoperative stay. Instead, decision making in most
      thoracic surgery units is based on team preferences and individual training rather than
      scientific data. Therefore, digital pleural drainage systems represent a useful tool to
      standardize existing intradepartmental protocols for chest tube management. However, for the
      development of generally accepted protocol-recommendations, the diverging interdepartmental
      treatment protocols have to be analyzed and compared for superiority. In this IIT, the effect
      of different chest tube management protocols on chest tube duration is analyzed in four
      German Thoracic Surgery units.
    

Intervention name(s): Chest tube removal
Intervention type(s): Procedure
Intervention description(s): Chest tube removal on the basis of local recommendations for postoperative chest tube management
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing pulmonary resection at one of the four participating thoracic surgery
        specialist units
      
Keywords: chest tube drainage; pulmonary air leak; lung resection