bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Findings in General Paresis
Condition: General Paresis
MeSH terms: Neurosyphilis; Muscle Weakness; Paresis
Study type: Observational

Summary: 
      This is a study of the clinical and neuroimaging of general paresis. The investigators
      studied six patients with general paresis.
    

Detailed description: 
      Inclusion Criteria:

        -  Mental disorders

        -  positive TPHA in CSF and sera

        -  HIV-negative serology by ELISA

      Exclusion Criteria:

        -  Negative TPHA in CSF and sera

        -  No image data
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        6 cases
      
Keywords: EEG; general paresis; MRI; neurosyphilis
Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery
Condition: Cervical Spine Surgery
Study type: Interventional

Summary: 
      Posterior cervical spine surgery often requires a large posterior midline incision, resulting
      in poorly controlled postoperative pain, which arises from iatrogenic mechanical damage,
      intraoperative retraction, and resection to structures such as bone, ligaments, muscles,
      intervertebral discs, and zygapophysial joints.
    

Detailed description: 
      Ultrasound-guided Inter-semispinal plane (ISP) block, was proposed as a novel technique for
      analgesia in posterior cervical spine surgeries. The ISP block involves an injection of local
      anesthetic into the fascial plane between the semispinalis cervicis and semispinal capitis
      muscles and results in blocking the dorsal rami of the cervical spinal nerves. ISP block can
      provide effective analgesia in posterior cervical spine surgery
    

Intervention name(s): Inter-semispinal plane block
Intervention type(s): Procedure
Intervention description(s): Ultrasound Inter-semispinal plane block in block group
Other intervention name(s): No block intervention in control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be performed in neurosurgical operating rooms at Zagazig University Hospitals and included 52 patients allocated randomly into two groups: 26 patients recruited in the block group (I) for the Inter-semispinal plane block and 26 patients recruited in the (C) control group.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Other
Pulsatile Perfusion Preservation in Kidney Transplantation From Expanded Criteria Donors
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to
      improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow,
      pressure, resistance index, venous effluent pH) are correlated with better recovery of renal
      function (without dialysis during the first week after transplant).

      Observation or Investigation Method Used :

      The study is multicenter, prospective, open, controlled and randomized:grafts are divided
      into two parallel groups:

        -  group 1 corresponds to a conservation of grafts in static incubation

        -  group 2 corresponds to conservation using a pulsatile perfusion machine

      Duration and Organizational Arrangements for Research :

      The total duration of the study is planned for 36 months. This duration includes:

        -  an inclusion period that will last 24 months,

        -  the follow-up of recipient patients from the day of transplantation until twelve months
           after the operation
    


Intervention name(s): Static incubation; Pulsatile perfusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted.
.; Kidneys in this group are placed in the pulsatile perfusion machine(RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic renal failure; Transplantation; Marginal kidney graft; Pulsatile perfusion machine
Blood Pressure Monitor Clinical Test (Cuff Range: 22 Cm-42cm)
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to monitor the blood pressure level of the patient using a
      preformed cuff ranged 22 cm-42 cm.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        resident of a community
      
Keywords: BP
Classroom Standing Desks for Reducing Sitting Time in Children
Condition: Sedentary Lifestyle; Cognitive Ability, General
Study type: Interventional

Summary: 
      In this trial the investigators aim to verify the potential impacts of a multi-level
      intervention with standing desks on behavior and cognitive function in children
    

Detailed description: 
      This is a cluster controlled trial conducted in a school setting. Two classes (intervention
      and control) of sixth grade will be selected from a large, centrally located school in
      Lisbon. The intervention will take place over a period of 16 weeks and will be composed of
      physical environmental (standing desks), social environment, and education/behavior
      components. Objective measurements of physical activity and sedentary behavior (ActiGraph
      GT3X+ accelerometer and activPAL inclinometer), school performance (students grades),
      attention (D2 test), memory (Rey complex figure), fluid intelligence (Raven's Progressive
      Matrices), visuo-spatial short term working memory (Corsi block-tapping test), processing
      speed and inhibitory function (Stoop test) will be assessed. Finally, anthropometry and
      stakeholders' perceptions will also be obtained at baseline and after the intervention.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Multi-level intervention focused on school environment (furniture) will be conducted.
Device: Sit-to-stand desks (Ergotron LearnFit®); Device: (Actigraph, Pensacola, FL, USA); Device: ActivPALTM .
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in
      degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing
      effect on knee cartilage degenerative injuries are not conclusive to establish a standard of
      behavior, although PRP has shown to improve joint functionality and reduce pain.

      Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to
      a more effective and lasting functional recovering than corticosteroid intra-articular
      injections.
    


Intervention name(s): platelet-rich plasma; Corticosteroid
Intervention type(s): Biological; Drug
Intervention description(s): a single intra-articular injection; A single betamethasone and bupivacaine intra-articular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; comparing platelet-rich plasma; intra-articular knee injections
First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in
      treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab)
      in combination with FOLFOX.
    


Intervention name(s): Cediranib; Bevacizumab; 5-fluorouracil ( in FOLFOX); Leucovorin (in FOLFOX); Oxaliplatin (in FOLFOX)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral tablet once daily; intravenous infusion; intravenous infusion; intravenous infusion; intravenous infusion
Other intervention name(s): RECENTIN™; AZD2171; Avastin®; 5-FU; Eloxatin®
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Oxaliplatin; Cediranib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metastatic Colorectal Cancer; RECENTIN
A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures
Condition: Absence Seizures
MeSH terms: Seizures; Epilepsy, Absence
Study type: Interventional
Phase: Phase 2

Summary: 
      This long-term open label follow-up trial gave pediatric subjects suffering from typical
      absences in CAE or JAE the opportunity to continue levetiracetam treatment after
      participation in the pilot study (study N162) or the double-blind study (study N163). Safety
      and efficacy data were obtained.
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levetiracetam; Keppra
Improving Bone Health in Adolescence Through Targeted Behavioral Intervention
Condition: Bone Development; Dietary Adequacy
Study type: Interventional

Summary: 
      School based educational intervention to educate on bone health among Hispanic, Asian or
      non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium
      intake and bone density in . The hypothesis was that the educational program would increase
      knowledge, improve dairy food and calcium consumption and enhance bone health in this
      population. A secondary hypothesis was that lactose maldigestion would be an impediment to
      improved dairy food consumption.
    

Detailed description: 
      A targeted behavioral intervention to improve calcium intake and bone mass was conducted at
      middle schools in 6 states. The primary outcomes of bone mass and dietary calcium were
      assessed among Asian, Hispanic, or non-Hispanic white girls between 10 -13 y. Lactose
      maldigestion (LM) was determined by a breath hydrogen test (BHT). Perceived milk intolerance
      (PMI) and calcium intake were assessed by questionnaires and bone mineral content (BMC) was
      determined by dual energy X-ray absorptiometry (DXA). Data from 473 girls were used in a
      multiple linear regression to examine the impact of the intervention while accounting for PMI
      and LM and adjusting for covariates.
    

Intervention name(s): Adequate Calcium Today
Intervention type(s): Behavioral
Intervention description(s): A school-randomized behavioral intervention study called the Adequate Calcium Today (ACT) project was conducted in sixth grade classrooms located in six states (Arizona, California, Hawaii, Indiana, Nevada, and Ohio).
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescents; Bone mass; Calcium; Perceived milk intolerance; lactose maldigestion
Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the toxicity and secondary the efficacy of the combination
      vinorelbine plus capecitabine in metastatic breast cancer patients
    

Detailed description: 
      The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been
      studied in a phase [I]/[II], with favourable profile of toxicity in pretreated patients with
      anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003).

      In a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR) in
      21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe
      leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin
      Oncol 19: Abstract 420, 2000)
    

Intervention name(s): Vinorelbine oral; Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday; Capecitabine at dose levels of 800 mg/m2, 950mg/m2, 1100mg/m2, 1250mg/m2 per os from day 1 to day 14 every 21 days
Other intervention name(s): Navelbine oral; Xeloda
Intervention MeSH terms: Capecitabine; Vinorelbine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Breast Cancer; Vinorelbine oral; Capecitabine
Protection Against Pneumococcal Infection in Children With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Children/ young people with diabetes may be at a higher risk of acquiring certain infections.
      These infections include those caused by a bacterium called the pneumococcus which can cause
      pneumonia, meningitis and ear infections. In the UK older children with diabetes are given a
      vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). Although PPS23
      causes a good immune response in children over 2 years of age it is not actually known how
      well PPS23 protects against infection in children of any age. In addition there is some data
      in adults and children that PPS23 may result in a reduced response to future doses of
      pneumococcal vaccines (hyporesponsiveness). Because of the lack of information on how well
      PPS23 protects and potential hyporesponsiveness the investigators would like to study the use
      of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13). This vaccine is
      known to be safe and to work well in babies and young children and there have been no
      concerns about hyporesponsiveness. It has been approved for use in children up to 17 years of
      age but there is little information on the size and duration of immune response to PCV13 in
      children aged 6 years and older.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine (PCV13)
Intervention type(s): Biological
Other intervention name(s): Prevenar13®
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetes; pneumococcal
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a 24-month, open-label extension study that followed an 8-week double-blind study
      (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study
      LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid
      ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum
      triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone.
      This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza
      (omega-3-acid ethyl esters) [formerly known as Omacor] therapy in hypertriglyceridemic
      subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.
    

Detailed description: 
      Three studies comprise this program. Study LOV111859/OM5 (double-blind study) was followed by
      two open label extensions - LOV111860/OM5X (1st open label extension - 8 weeks) and
      LOV111821/OM5XX (2nd open label extension - 24 months).

      Studies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.
    

Intervention name(s): Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Intervention type(s): Drug
Intervention description(s): Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention MeSH terms: Fenofibrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omega-3-acid ethyl esters; Very high triglycerides; Lovaza; fenofibrate
Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental Drug
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Experiment in the test tube indicated that CP-945,598 becomes less soluble with increase of
      pH (less acidity). Changes in stomach acid levels may affect the solubility of CP-945,598,
      therefore, alters its availability in the blood. Omeprazole decreases acid levels in stomach.
      This study will compare the time course of drug concentrations in the body, safety, and
      tolerability of CP-945,598 given with and without omeprazole.
    


Intervention name(s): CP-945,598; CP-945,598
Intervention type(s): Drug; Drug
Intervention description(s): Administration of CP-945,598 alone in period 1; Adminstration of CP-945,598 with omeprazole in period 2
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release
      Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of
      Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7
      days.

      Study Design:

      randomized, open label, two treatment, two period, two sequence, single dose, crossover study
      in healthy human adult subjects
    


Intervention name(s): Torrent's Pantoprazole Sodium Delayed - Release Tablets
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022)
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a multi-site, 4-visit, brand-masked, bilateral, 2x2 cross-over dispensing study to
      evaluate visual acuity.
    


Intervention name(s): TEST LENS; CONTROL LENS
Intervention type(s): Device; Device
Intervention description(s): etafilcon A with cosmetic pattern; Acuvue 1-Day Define Fresh Honey
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PBMT Influence on Alveolar Socket Preservation
Condition: Extraction Socket Healing
Study type: Interventional

Summary: 
      Goal of this study is to compare between the effect of two different low power lasers on
      extraction socket healing.
    

Detailed description: 
      After molar tooth extraction, 6 Low power (PBMT) laser sessions.

      Evaluation:

      Visual Radiographic Histological
    

Intervention name(s): Low power laser
Intervention type(s): Procedure
Intervention description(s): Phototherapy for extraction sockets using two different lasers.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparing between 2 laser' effect on extraction socket healing
Masking: Single (Participant)
Primary purpose: Supportive Care
Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Ganglion Cysts; Synovial Cyst; Parkinson Disease
Study type: Interventional

Summary: 
      Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing
      neuronal activations during motor or cognitive tasks. The MRI sequences used are currently
      optimized for the study of cortex activations, particularly concerning the echo time
      (TE).Very few studies are interested in optimizing the fMRI for the study of the basal
      ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The
      T2 * is a tissue parameter dependent of iron content, which differs with brain structures and
      probably also with age and in case of neurodegenerative disease. Optimal TE s should
      correspond to the T2 * of studied brain structure The primary purpose is to optimize the fMRI
      by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The
      secondary purpose is to study the effect of age and Parkinson's disease on T2*.
    

Detailed description: 
      80 subjects (40 PD patients and 40 paired healthy volunteers (on sex and age)) aged 40-80
      years will be included. PD patients will be recruited in the Department of Neurology of CHU
      of Clermont-Ferrand. Healthy volunteers will be selected in clinical trial database. This
      study will consist of one visit (at J0) during which subjects will undergo a MRI (a single
      acquisition of 40 minutes approximately). PD patients will be further questioned on their
      disease and will benefit from a neurological examination
    

Intervention name(s): MAGNETOM Avanto (MRI device)
Intervention type(s): Device
Intervention description(s): The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Functional magnetic resonance imaging; T2*; cortex and basal ganglia; Parkinson's disease