bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Antimuscarinics on Cognition in Spinal Cord Injury
Condition: Mild Cognitive Impairment; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Cognitive Dysfunction
Study type: Observational

Summary: 
      Prospective evaluation of the cognitive function of in-house patients suffering from an acute
      traumatic spinal cord injury before and three months after the initiation of antimuscarinic
      treatment.

      The following hypothesis will be tested: Antimuscarinic treatment results in significantly
      worse cognitive test results three months after traumatic spinal cord injury compared to the
      pre-treatment results and the results of the control group.
    

Detailed description: 
      There will be two groups: 1) patients receiving antimuscarinic treatment 2) patients without
      antimuscarinic treatment (control).

      The control group will be investigated in order to determine the effects of traumatic spinal
      cord injury on cognition and the natural history of potential cognitive impairment within the
      first three months after spinal cord injury.

      Six to eight weeks after traumatic spinal cord injury, patients are examined in order to
      determine the type of neurogenic bladder dysfunction they are suffering from. Patients
      suffering from an overactive bladder will receive antimuscarinic treatment in order to
      prevent high urine storage and voiding pressures, that put the kidneys at risk.

      Prior to the urologic examination, patients fulfilling inclusion criteria will be contacted.
      If informed consent is given, cognitive function will be evaluated in both patient groups
      using different standard neuropsychologic tests. The same neuropsychologic tests will be
      repeated three months later. Evaluation will take place under standardized conditions (e.g.
      time of day).

      Furthermore,different factors influencing cognition, e.g. depression, pain, medication, will
      be assessed at the beginning and end of the study.
    

Intervention name(s): antimuscarinic treatment
Intervention type(s): Drug
Intervention MeSH terms: Muscarinic Antagonists
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with acute (4-8 week post-injury) traumatic spinal cord injury during first
        rehabilitation
      
Keywords: Mild Cognitive Impairment; Muscarinic Antagonists; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Overactive Detrusor
Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study is a prospective randomized controlled study of different treatments for knee
      osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma
      (PRP) injection versus only exercise or only PRP treatments.
    


Intervention name(s): Exercise; PRP
Intervention type(s): Other; Biological
Intervention description(s): Supervised exercise program; Intra-articular PRP injections to knee joint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
Condition: Asthma; Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air
      cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during
      an allergen exposure in ALYATEC environmental chamber (EEC)
    

Detailed description: 
      A monocentric, double-blind, placebo-controlled, cross-over study conducted outside of the
      pollen season. The study lasts 3 months for each patient, which includes a screening period,
      two exposure visits in the Alyatec Environmental Exposure Chamber (EEC) with active or
      placebo air cleaners, and a follow-up visit.

      Patients with early asthmatic reaction during baseline exposure are randomly allocated to one
      of two sequences: active air cleaners /placebo or placebo/active air cleaners. Randomization
      is balanced (1:1) between the two sequences. There is a 3-week wash-out period between the
      two exposures.
    

Intervention name(s): Active intense Pure Air XL air cleaner; Placebo Intense Pure Air XL air cleaner
Intervention type(s): Device; Device
Intervention description(s): Cat allergen is nebulized in the EEC. When the concentration is stable, air cleaners are switched on. The number of air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of active air cleaners in the EEC; Cat allergen is nebulized in the EEC. When the concentration is stable, placebo air cleaners are switched on. The placebo effect is obtained thanks to the removal of air cleaners filters prior to the exposure. The number of placebo air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of placebo air cleaners in the EEC.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, cross-over, double-blind placebo-controlled study including 24 cat-asthmatic patients with GINA 1 asthma.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Asthma; Cat allergy; Environmental Exposure Chamber; Air cleaner
Study of AC0058TA in Healthy Male and Female Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      AC0058TA is a small molecule compound that potently, selectively and irreversibly inhibits
      Bruton's tyrosine kinase (BTK) phosphorylation and downstream signals, resulting in
      inhibition of inflammatory cytokine production in monocytes and inhibition of lymphocyte
      activation (predominantly B-cell activation) in the preclinical studies. The nonclinical
      program has demonstrated that AC0058TA has the potential to interfere with signaling
      functions mediated by tyrosine kinases and may be useful for controlling excessive or
      aberrant T- and B-cell activation in autoimmune diseases.

      As an investigational targeted therapy for RA and SLE, AC0058TA is expected to address the
      unmet need of this patient population, for whom there are currently no effected therapies and
      there is a great unmet medical need, AC0058TA may inhibit the key pathway which involves the
      disease process.
    

Detailed description: 
      This is a 2-part, randomized, double-blind, placebo-controlled, single-dose-escalation (Part
      1) and multiple-dose-escalation (Part 2) study to evaluate the safety, tolerability, PK, and
      PD of AC0058TA administered orally to healthy subjects. Part 1 of the study will also to
      evaluate the effect of food on the pharmacokinetics of a single oral dose of AC0058TA.
    

Intervention name(s): AC0058TA; Placebo capsules
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg AC0058TA 100 mg AC0058TA 200 mg AC0058TA 400 mg AC0058TA; Placebo capsules
Other intervention name(s): AC0058; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
7-week Study With CT-155 in People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia
    

Detailed description: 
      CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click
      Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based
      intervention to treat schizophrenia.

      This is a multi-center, exploratory, single-arm study to evaluate the feasibility and
      acceptability of treatment with an abbreviated version of CT-155 in adults diagnosed with
      schizophrenia. Eligible participants must have a diagnosis of schizophrenia per the
      Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

      Participants that meet eligibility criteria will be enrolled in the study on Day 1. The study
      consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day
      follow-up period.
    

Intervention name(s): CT-155 smartphone app
Intervention type(s): Device
Intervention description(s): The CT-155 study app is designed to provide treatment monitoring and educational components of a full treatment cycle with CT-155. This design allows inferences to be made about the usability and acceptability of CT-155. Eligible participants will be enrolled during an in-person clinic visit on Day 1. Participants will then be directed to access the study app and perform tasks each day for the 49-day engagement period.
Intervention model: Single Group Assignment
Intervention model description: This is a multi-center, exploratory, single-arm study to evaluate the overall effects of use of an abbreviated version of CT-155 in adults diagnosed with schizophrenia
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prescription digital therapeutic (PDT); Software-as-a Medical Device (SaMD); Smartphone app; Schizophrenia
Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was a prospective, open-label comparative effectiveness clinical trial, comparing
      magnetic seizure therapy (MST) to ECT in patients with Major Depressive Disorder (MDD).
    

Detailed description: 
      Magnetic seizure therapy (MST) has previously demonstrated fewer cognitive side effects than
      ECT in randomized trials of efficacy. However, there are currently no real-world
      effectiveness trials guided by the clinical decision making of the ECT psychiatrist as deemed
      best for the patient. The aims of this study are to: (1) Evaluate the comparative
      effectiveness of MST versus ECT in patients with MDD, and (2) Compare the cognitive adverse
      effects of MST and ECT, (3) Explore changes in SPECT that is associated with MST treatment
      and treatment response.

      Patients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week.
      Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21);
      primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily
      cognitive battery. Brain SPECT will be done for patients before and after MST.
    

Intervention name(s): Electroconvulsive Therapy (n=30); Magnetic Seizure Therapy (n=30)
Intervention type(s): Device; Device
Intervention description(s): Right unilateral (RUL) ECT (n=15) or bitemporal (BT) ECT (n=15) using a Thymatron IV device (Somatics LLC, USA) twice weekly.; High-dose magnetic seizure therapy (HD-MST) over the vertex using Magstim Theta device (Magstim Company Limited, Whitfield, Wales, UK) at 100% maximal output of the device (constant), with pulse frequency 100Hz and train duration 10 seconds twice weekly.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: MST (Magstim Theta device, Magstim Company Limited, Whitfield, Wales, UK) versus ECT (Thymatron IV device, Somatics LLC, USA) assigned per the clinical decision making of the ECT psychiatrist as deemed best for the patient.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MST; ECT; MDD; Depression; Major Depressive Disorder; Magnetic seizure therapy; Electroconvulsive Therapy; Treatment Resistant Depression (TRD)
Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer
Condition: Pancreatic Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to determine the efficacy of bevacizumab and gemcitabine in combination with
      radiation therapy in the preoperative treatment of potentially-resectable subjects with
      pancreatic cancer.
    

Detailed description: 
      This is a 2 stage phase II study of bevacizumab (10 mg/kg) and fixed dose rate (FDR)
      gemcitabine (1500 mg/m2 at 10 mg/kg/min) in combination with sequential rapid fractionation
      radiotherapy (30 Gy total) in the preoperative treatment of potentially-resectable subjects
      with adenocarcinoma of the pancreas. The purpose of this study is to determine the rate of
      margin negative surgical resection (R0 resection rate) and the rate of complete pathological
      response in patients with resected pancreas cancer. The overall goal of this study is to
      determine the merit of this novel regimen for further study in a Phase III trial examining
      time to progression and overall survival. Based on the need for 48 evaluable subjects to
      evaluate the primary endpoints, the study will be opened with a target accrual of 60 subjects
      given an expected 20% rate of attrition observed in prior studies of subjects with pancreas
      cancer at UPCI.
    

Intervention name(s): Avastin (bevacizumab); Gemzar (Gemcitabine); external beam radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 10 mg/kg, days 1, 15, 29 and 43; On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).; 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy
Intervention MeSH terms: Bevacizumab; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreas; pancreatic; cancer; resectable
Open Label Safety Study of a Birch Pollen Allergen Extract
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is performed to assess safety of a sublingual birch pollen extract.
    


Intervention name(s): Biological: AL0206st
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I - Allergy, rhinoconjunctivitis
Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study
Condition: Infectious Disease by Haemophilus Influenzae Type b
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study
      to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus
      toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same
      vaccination with primary one in healthy toddlers who completed the primary vaccination with
      LBVH0101 or Hiberix™ in LG-VHCL002 study.
    

Detailed description: 
      Primary objective: This study was purposed to compare and assess immunogenicity of 4th
      LBVH0101 or Hiberix™ vaccination in toddlers who completed the primary vaccination with
      LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.

      Secondary objective: This study was purposed to compare and assess safety of 4th LBVH0101 or
      Hiberix™ vaccination in toddlers who completed primary vaccination with LBVH0101 or Hiberix™
      in LG-VHCL002 study. It was also purposed to assess persistence of immunogenicity prior to
      4th vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™,
      respectively, in LG-VHCL002 study.
    

Intervention name(s): LBVH0101 (Hib vaccine); Hiberix™ Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5mL; 0.5mL
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Communicable Diseases; Infection; Influenza; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

        -  Efficacy assessment of the percentage of positive responders patients receiving Lantus
           plus glucophage association. Positive responders patients are defined by a final value
           of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final
           - HbA1c basal).

      Secondary objectives:

        -  Determination of the predictive criterion of HbA1c final,

        -  Determination of the predictive criterion of weight variation,

        -  Description of the glycemic and therapeutic criteria in the both groups of responders
           (positive and negative responders),

        -  Assessment of the lipidic parameters according to the HbA1c and weight changes during
           the study (final value - basal value).

      Safety:

        -  Adverse Event (AE)/Serious Adverse Event (SAE) assessments
    


Intervention name(s): Lantus (insulin glargine) + Glucophage (Metformin)
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Prospect of Using Serum Taurine Level as a Potential Biomarker for Early Detection of Colorectal Carcinoma and Its Correlation With Other Prognostic Markers
Condition: Taurine in Cancer Colon
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Serum taurine results in this study showed that, besides CRC biomarkers; it is most
      attractive, more precious and more accurate early biomarker for early detecting of any
      malignant change which may led to CRC by other mean it is the most sensitive and more
      specific tumor marker for CRC. As a result, we can recommend measuring its level regularly
      with other prognostic tumor biomarkers and screening examination for all people with
      abdominal and gastrointestinal problems and for precancerous patients as a pre-early
      biomarker for colorectal carcinoma. So, it needs further studies to confirm that observations
      on large scale of population as it obvious the small sample size in early stage and lack data
      due to limited financial resources and it needs more efforts to collect first and
      precancerous stages patients.
    

Detailed description: 
      Two-hundred and fifty Egyptian patients (males and females) who attended National Cancer
      Institute, Cairo university; most of them were referred from private clinics and
      non-specialized hospitals, complain with abdominal troubles and gastrointestinal problems and
      bleeding per rectum, after full investigation, clinical examination, biochemical analysis,
      screening examination according to their cases (Ultra sound, CT or endoscopy either rectal or
      colonoscopy) and histopathological examination, we choose 'after their approval' one-hundred
      patients and six which diagnosed as CRC patients aged (19-69 years old) and excluded the
      others from participated in these studies because they diagnosed as non-colonic diseases
      like; Irritable colon, Gastroenteritis, Pancreatitis, Liver flexure or Chronic cholecystitis.
      According to Histopathological architecture, we divided patients to:

        1. Inflammatory group number=7.

        2. Benign tumor group number=8 which was assessed preoperatively and postoperatively.

        3. Malignant tumor group number=91 Lastly, ten health volunteers were enrolled as a frank
           control. For all included subjects, the measured biochemical analysis were CBC, ALT,
           AST, Albumin, Total Bilirubin, Creatinine, Blood urea, Sodium, Potassium, CEA, CA19.9
           and Taurine.
    

Intervention name(s): Taurine
Intervention type(s): Diagnostic Test
Intervention description(s): Serum taurine was determined by High Performance Liquid Chromatography (HPLC) according to the pre-column extraction and derivatization methodology of McMahon et al. In the present work, we use Shimadzu HPLC model LC-10AT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever
Condition: Fever, Sweats, and Hot Flashes
MeSH terms: Fever; Hot Flashes
Study type: Interventional

Summary: 
      RATIONALE: Comparing results of three different thermometers used to measure body temperature
      may help doctors find the most accurate thermometer to detect fever and plan the best
      treatment.

      PURPOSE: This clinical trial is studying three different types of thermometers to measure
      temperature in young patients with fever and without fever.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine agreement between three different types of temperature-measuring instruments:
           the temporal artery scanner, the digital oral thermometer, and the infrared tympanic
           thermometer calibrated to an oral setting, in pediatric patients who are febrile and
           afebrile.

      Secondary

        -  Determine similarities or differences in the percent of fevers detected with oral, ear,
           and temporal artery monitoring in these pediatric patients.

        -  Determine differences in agreement of the various temperature devices in non-neutropenic
           pediatric patients versus neutropenic pediatric patients.

      OUTLINE: This is a prospective study.

      During an afebrile episode, the patient's temperature is measured twice using the following 3
      devices: a temporal artery scanner, a digital oral thermometer, and an infrared tympanic
      thermometer calibrated to an oral setting (total of 6 temperature measurements per afebrile
      episode).

      During a febrile episode, the patient's temperature is measured twice using all 3 devices as
      above, and then at 2 and 4 hours after administration of an antipyretic medication (total of
      18 temperatures per febrile episode).

      Patients' temperatures are recorded for a maximum of 3 afebrile or febrile episodes.

      PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
    

Intervention name(s): infrared thermography
Intervention type(s): Procedure
Primary purpose: Diagnostic
Keywords: fever, sweats, and hot flashes
Adolescent Knowledge of Their Medications
Condition: Subjects' Understanding of Prescribed Medications
Study type: Observational

Summary: 
      Do adolescents know about their medications?
    


Intervention name(s): Counseling for subjects who do not know their medications
Intervention type(s): Other
Intervention description(s): Physician interviewer will provide counseling to subjects who indicate through answers that they do not know their medication names.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents enrolled in an primary care clinc.
      
Keywords: MRL; Adolescents; Health Literacy