bioihbjkbjnl/mcl2 huggingface dataset:
Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
Condition: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are
      undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related
      fatigue is not yet known.

      PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in
      treating fatigue in patients who are receiving chemotherapy for cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the degree to which modafinil can reduce fatigue in cancer patients receiving
           chemotherapy.

        -  Assess the relationship between depression and fatigue in patients treated with this
           drug.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are randomized to 1 of 2 treatment arms.

        -  Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral
           modafinil once daily.

        -  Arm II: Beginning on day 5 of the second course of chemotherapy, patients receive oral
           placebo once daily.

      Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of
      disease progression or unacceptable toxicity.

      Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy.

      PROJECTED ACCRUAL: A total of 837 patients will be accrued for this study within
      approximately 2.5 years.
    

Intervention name(s): modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Masking: Double
Primary purpose: Supportive Care
Keywords: fatigue; unspecified adult solid tumor, protocol specific
CT Analysis Comparing Cast and Three-Point Indexes in Distal Radius Fracture Care
Condition: Distal Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Observational

Summary: 
      Objectives: To compare the cast index and three-point index measurements obtained using
      computed tomography (CT) with those acquired using conventional methods for treating distal
      radius fractures Design: A retrospective cohort study Setting: Level 1 trauma center
      Patients: One hundred and thirteen (45 men and 68 women) patients with distal radius
      fractures Interventions: Patients with distal radius fractures were retrospectively analyzed
      and received either conservative cast treatment or surgical intervention through open
      reduction and internal fixation between 2016 and 2022.

      Main outcome measurements: The study evaluated the cast index and three-point index in the
      cast-treated group and their effectiveness using the Sarmiento index. Furthermore, radial
      height, volar tilt, and radial inclination were compared between the surgically treated and
      cast-treated groups.
    


Intervention name(s): cast treatment
Intervention type(s): Other
Intervention description(s): Surgical intervention vs cast treatment
Other intervention name(s): Open reduction volar plate fixation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients diagnosed with distal radius fractures.
      
Keywords: distal radius fracture; cast index; three point index; computed tomography
Comparison of Miller's Blade and Airtraq Laryngoscope in Children
Condition: Intubation, Intratracheal
Study type: Interventional

Summary: 
      The Airtraq optical laryngoscope has recently been available in pediatric sizes. The
      investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation
      devices in paediatric patients. This prospective, randomized study was conducted in a
      tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade I-II
      paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation
      were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30)
      laryngoscope. The primary outcome measures were time of intubation, ease of intubation,
      number of attempts and POGO score. We also measured hemodynamic changes and airway trauma.
    

Detailed description: 
      After approval from the institutional Ethical Committee, 60 patients were studied. A
      randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A.,
      Vizcaya, Spain) with Miller blade of same size.

      The children included in the study were 2-10 years of age, American Society of
      Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring
      tracheal intubation. The following were excluded from the study: (i) patients with upper
      respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii)
      those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.
      Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30
      each for airway management using a computer-generated randomization program.

      Written informed consent was taken from the parents prior to intervention and a standardized
      protocol for anesthesia was maintained for all cases. All the children were kept nil per
      mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a
      random basis.
    

Intervention name(s): Intubation with Miller's blade; Intubation with Airtraq
Intervention type(s): Device; Device
Intervention description(s): Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.; Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
New Heart Failure Biomarkers in Early Stage Chronic Kidney Disease-Mineral and Bone Disorder
Condition: Kidney Disease, Chronic; Heart Failure
MeSH terms: Bone Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure
Study type: Observational

Summary: 
      the objective of this study is to :

      -Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker
      of HF in patients with CKD-MBD.
    

Detailed description: 
      The disorders of mineral metabolism and bone disease are common complications in CKD patients
      and they are associated with increased morbidity and mortality.

      Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness
      contributing to left ventricular hypertrophy and its pathophysiology involves newly
      discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho.

      The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate
      early in in the advancement of CKD stage to attain levels in CKD stage 5D.

      But we still have few knoweledges if these markers can have some drawbacks for predicting CVD
      in early stage CKD.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        subjects who visited the emmergency departement or the nephrology departement , meeting the
        criteria inclusion and have given a written consent .
      
Biospecimen description: 
      Blood samples were centrifuged, the plasma were collected and stored at -80°C until
      utilization.
    
Keywords: FGF23; klotho; Mineral Bone Disorder
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Uterine Cervical Dysplasia
Study type: Observational

Summary: 
      The investigators hypothesis is HPV integration could result in expression of oncogene
      transcripts, and not only constitutive expression but also the level of expression will be
      decisive for transformation and the maintenance of the malignant phenotype. Moreover, the
      expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the
      severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).
    

Detailed description: 
      In the investigators proposal, the investigators will examine at least 250 baseline
      liquid-based cytology specimens from women with normal cytology, low-grade squamous
      intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs),
      microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV
      blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6,
      and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are
      the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral
      DNA tested by real-time PCR and FISH, along with level of expression in mRNA.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will examine 250 baseline liquid-based cytology specimens from women with 100 low-grade
        squamous intraepithelial lesions (LSILs), 100 high-grade squamous intraepithelial lesions
        (HSILs), 10 microinvasions and 40 invasive cervical cancers.
      
Biospecimen description: 
      HPV DNA and mRNA
    
Keywords: mRNA,; DNA,; integrated HPV DNA; human papillomavirus,; cervical neoplasia
Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
Condition: Skin Irritability; Skin Sensitization
Study type: Interventional

Summary: 
      The purpose of this study is to prove the product tested does not cause photoirritation or
      photosensitization reactions when exposed to sun light.
    


Intervention name(s): KL029 Intimate Lubricant Gel
Intervention type(s): Device
Intervention description(s): All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial
Condition: Normal Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves
      analgesia and reduces the frequency of motor blockade during epidural analgesia. several side
      effects are possible mostly somnolence and hypotension. Association of continuous clonidine
      infusion with low concentrations of levobupivacaïne and sufentanil was not studied during
      labour. The objective of this study is to compare the effectiveness and the side effects of a
      PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of
      clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.
    


Intervention name(s): Clonidine; Levobupivacaine; Sufentanil
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Clonidine; Sufentanil; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Labor analgesia - clonidine - epidural
NISCI - Nogo Inhibition in Spinal Cord Injury
Condition: Spinal Cord Injury, Acute
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the NISCI trial is to test if an antibody therapy can improve movement and
      quality of life of tetraplegic patients. A previous trial showed this treatment is safe and
      well accepted. This is a placebo controlled, randomized, double blind, multicenter,
      multinational study to assess the safety, tolerability, feasibility and preliminary efficacy
      of early (within 4-28 days post injury) initiation of treatment with repeated bolus
      injections of NG-101 in cervical acute SCI patients. The study has 3 phases:
      screening/baseline Phase, treatment phase, and a follow-up phase.

      The study design will allow simultaneous enrolment of patients with complete or incomplete
      SCI. Enrolment and stratification of the patients is based and individualized prediction of
      upper limb outcomes.

      For further information please visit NISCI website: https://nisci-2020.eu
    


Intervention name(s): NG-101; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 6 intrathecal bolus injections, each of 45mg; 6 intrathecal bolus injections, each of 45mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tetraplegia; Trauma; Upper limbs function
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomized, active-controlled, double-blind, phase 3 study to compare the
      efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque
      psoriasis.
    

Detailed description: 
      CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody
      that is being developed as a biosimilar medicinal product to the reference product, Stelara.
      The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara
      in patients with moderate to severe plaque psoriasis.
    

Intervention name(s): CT-P43; Stelara
Intervention type(s): Biological; Biological
Intervention description(s): 45mg or 90mg dose subcutaneous administration; 45mg or 90mg dose subcutaneous administration
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Condition: Thrombosis; Cancer; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as
      anticoagulant therapy, when administered to patients with advanced or metastatic cancer and
      at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk
      profile could lead to significant reduction in this serious and sometimes fatal complication
      of ongoing cancer and its treatment.
    


Intervention name(s): Apixaban; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets administered once daily in 5-, 10-, or 20-mg dose; Oral tablets administered once daily
Other intervention name(s): BMS-562247
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: anticoagulant
Safety, PK and PD Study in Healthy Male Japanese Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of
      SCA-136 in healthy male Japanese subjects
    


Intervention name(s): SCA-136
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Rectal Balloon Training in Female Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 2

Summary: 
      Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle
      training(PFMT) is the standard recommendation for conservative treatment but some patients
      had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not
      perform the PFMT properly or increase intensity of the exercise. The authors hypothesized
      that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as
      it is another option of progressive strengthening of pelvic floor muscle. This study's aim is
      to combine RBT with PFMT using the water-filled balloons of Foley catheters
    

Detailed description: 
      This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley
      catheters. The catheter would be inserted into the rectum and used as a tool to help the
      patient recognize the pelvic floor muscles. The advantages of Foley catheters are that they
      are cheap, safe for contacting the mucosa, easy for self-insertion, and can be reused.
      Furthermore, we can increase the load of exercise by increasing the amount of water pushing
      into the balloon, and can use that as a tool for progressive resistive exercise.
    

Intervention name(s): Rectal Balloon Training; Pelvic floor muscle training (PFMT)
Intervention type(s): Other; Other
Intervention description(s): Subjects in combined RBT and PFMT group are taught for foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water starting at 10 cc. Then the volume is progress to 15 cc in 3rd week and 20 cc in 5th week; Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary incontinence, Pelvic floor muscle training
Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the short-term effects of ACEi and angiotensin II
      receptor blockers on cardiac and renal protection in black type 2 diabetics patients CARE-PLP
      is a double-arm, double-blind, randomized and parallel clinical trial conducted at the
      National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes
      patients, with hypertension and / or microalbuminuria and who are not taking ACEi or
      angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg
      Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients
      are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise
      induced urinary albumin excretion after 08 weeks of intervention.
    

Detailed description: 
      Given the particularity of the renin-angiotensin system in black subjects, the CARE-PLP study
      fulfills this objective with the comparison of Losartan and Perindopril after 08 weeks of
      administration in a subsaharan African population.

      Aim: The aim of this study is to compare the short-term effects of ACEi and angiotensin II
      receptor blockers on cardiac and renal protection in black type 2 diabetics patients

      Methods: CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial
      conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of
      Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking
      ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group,
      10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The
      patients are followed-up for a period of 08 weeks. The primary outcome is the variation of
      exercise induced urinary albumin excretion after 08 weeks of intervention.

      Progress: Recruitment for CARE-PLP was completed in february 2018 with 29 patients.
    

Intervention name(s): Perindopril Arginine; Losartan Potassium
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.; 100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.
Other intervention name(s): Perindopril; Losartan
Intervention MeSH terms: Losartan; Perindopril
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Angiotensin Converting Enzymes Inhibitor; Angiotensin II Receptor Blockers; Type 2 Diabetes; Exercise induced urinary albumin excretion; Blood pressure