bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Tadalafil After Radical Prostatectomy
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will include patients with localized prostate cancer who experience erectile
      dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be
      randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on
      demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for
      9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for
      recovery of unassisted erectile function (without medication). An open-label extension for
      three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day.
      Further objectives are to evaluate the treatment satisfaction of the respective therapies.
    


Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by mouth for 9 months; Administered by mouth, daily or on demand for 9 months
Other intervention name(s): Cialis; LY450190
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Radical Prostatectomy
Lamotrigine Bioequivalence
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in
      patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food
      and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and
      patients with epilepsy have believed that brand and generic lamotrigine have had clinically
      significant differences in efficacy and tolerability. The brand name and generic tablets have
      been shown to be the same when blood levels were measured in healthy volunteers without
      epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study
      will do this comparison, by switching patients between brand and generic in a very structured
      manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other
      comparisons will also be made secondarily, looking for any differences in adverse effects and
      seizure control.
    

Detailed description: 
      As is commonly done in a bioequivalence study, the null hypothesis is that the generic (i.e.
      test) is bioINequivalent to the brand name (i.e. reference). Hence, the alternative
      hypothesis is that the generic is bioequivalent to the brand name.
    

Intervention name(s): Brand lamotrigine; Generic lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks; Generic lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: bioequivalence; lamotrigine; epilepsy
LNG-IUS at 2 Weeks Postpartum
Condition: Contraception; Malposition of Intrauterine Contraceptive Device
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for
      contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides
      contraception for 5 years with excellent effectiveness. Women enrolled in this study will
      only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants
      will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for
      satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months
      postpartum, and participants will be able to keep their LNG-IUS following study completion.
    


Intervention name(s): Levonorgestrel Intrauterine System (LNG-IUS)
Intervention type(s): Drug
Intervention description(s): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled
Other intervention name(s): Mirena
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: postpartum; contraception; intrauterine device; intrauterine system; mirena; uterine involution
T-GENVIH-003 LTFU (Long Term Follow Up) Study
Condition: Hernia; Hernia, Ventral; Pathological Conditions, Anatomical; Hernia, Abdominal
MeSH terms: Hernia; Hernia, Ventral; Pathological Conditions, Anatomical; Hernia, Abdominal; Internal Hernia
Study type: Observational

Summary: 
      The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix®
      Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population
      (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002
      study.
    

Detailed description: 
      The purpose of this study is to collect additional safety data and demonstrate the
      performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs
      from a sub-population of twenty-one participants from the previous T-GENVIH-002 study,
      specifically those with laparoscopic or robotic repair. Prospective data will be collected
      via a one-off study follow-up visit and assessed for later post-operative surgical site
      events and complications in the post-operative period from the last timepoint of data
      collection in T-GENVIH-002 to present.
    

Intervention name(s): Integra® Gentrix® Surgical Matrix
Intervention type(s): Device
Intervention description(s): Integra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects from the sub-population of minimally invasive surgical approach (e.g.,
        laparoscopic or robotic) ventral hernia repair of the prior T-GENVIH-002 study.
Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients
Condition: TMD
Study type: Interventional

Summary: 
      Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern
      dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD
      patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of
      TMD. To our knowledge, no specific trials have been designed for the evaluation of the
      efficiency of physiotherapy vs neuromuscular bites in TMD patients.

      The aim of this trial is to evaluate the efficiency in term of cranial muscles
      electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs
      manual physiotherapy therapy compared to placebo.
    


Intervention name(s): Neuromuscular Bite (orthotic/sub-lingual); Mandibular Physiotherapy; Placebo
Intervention type(s): Device; Procedure; Other
Intervention description(s): Bite is a device which simulates a set of properly positioned teeth; Mandibular Stabilisation Exercises
Place knuckle of index finger between top and bottom teeth.
Remove it, keeping the teeth separated one-knuckle apart.
Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.; No interventions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Testing Bite device "A"
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
Condition: Hypertrophic Obstructive Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Mitral Valve Insufficiency; Hypertrophy
Study type: Interventional

Summary: 
      Compare the results of reconstruction and mitral valve replacement in the surgical treatment
      of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
    

Detailed description: 
      Many years myoectomy for Morrow was the gold standard in the treatment of obstructive
      hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the
      good results the extended septal myectomy. But the question remains what is best for patients
      with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended
      myoectomy with mitral valve repair a or replacement.
    

Intervention name(s): myoectomy; Mitral valve surgery; Mitral valve surgery
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The scheme of Extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.; 41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.; 41 patients will be performed mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.
Other intervention name(s): Extended myoectomy; mitral valve replacement; mitral valve repair
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hypertrophic cardiomyopathy; mitral valve
Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions
Condition: Dry Mouth
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine
      tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose,
      randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Pilocarpine
Intervention type(s): Drug
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chiropractic Manual Therapy and Neck Pain
Condition: Chronic Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Eligible subjects with chronic neck pain will be randomly allocated to one of two
      intervention groups: real vs control spinal manipulation. They will receive three
      intervention sessions.

      H1: Chronic neck pain patients treated longitudinally over a series of three encounters in
      one week by random assignment to treatment group with either of the dual delivery procedures
      (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate
      of self-report of group allocation at exit interview.

      H2: Patients treated by the typical-control dual procedure over a typical sequence of
      encounters (3 times in one week) will show statistically significant improvement in clinical
      outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index
      (NDI), range of motion and pressure algometry; compared to those treated by the
      control-control dual procedure.

      H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no
      significant difference in self-report of group allocation or clinical outcome measures.

      A total of 372 subjects will be recruited.
    


Intervention name(s): Spinal manipulation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck; pain; chronic; manipulation; control; randomized trial
Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy
Condition: Hematological Malignancy (Leukemia- Lymphoma)
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl
      and ketorolac) or (ketamine and ketorolac) analgesic therapy
    

Detailed description: 
      regarding patient registry; a prior G power analysis was done. Based on the assumption that
      the pain score in intramuscular ketamine group will be similar to similar to those in
      previously published data; forty children would be required per group to detect a difference
      of 30% in CHEOPS pain scores with a power of 90% (α =0.05, β =0.1)

      - Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social
      Sciences), program version 22. Distribution of data will be first tested by the Shapiro test.
      Data will be presented as the mean and standard deviation (SD), median and range or numbers
      and percentages. For normally distributed data, the unpaired t-test will be used to compare
      the mean values of both groups. For pain and emergence behaviour scores, Mann Whitney U test
      will be used. Fisher's exact test will be used for comparison of categorical data. The P
      value ≤ 0.05 will be considered as the level of statistical significance.
    

Intervention name(s): ketamine-ketorolac; fentanyl- ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.; The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
A Phase 3 Clinical Study of KHK4827
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in
      subjects with moderate to severe plaque psoriasis who have completed the preceding Study
      4827-002.
    


Intervention name(s): KHK4827
Intervention type(s): Drug
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced
      Parkinson's disease (PD) patients with severe motor complications. The complications of
      medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be
      investigated.
    


Intervention name(s): ABT-SLV187; Oral Levodopa/Carbidopa; Infusion Pump: CADD-Legacy® 1400 Pump; NJ-Tube: Silicon ED Tube; Adaptor: Hakko Adaptor
Intervention type(s): Drug; Drug; Device; Device; Device
Intervention description(s): Tablet; contains 100 mg levodopa and 10 mg carbidopa; General infusion pump, manufactured by Smiths Medical (US); Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan); Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)
Other intervention name(s): DUOPA™ (carbidopa and levodopa Enteral Suspension); DUODOPA®; Levodopa-carbidopa intestinal gel (LCIG)
Intervention MeSH terms: Silicon; Levodopa; Carbidopa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levodopa-carbidopa intestinal gel; Advanced Parkinson's disease; Severe motor fluctuations; Dyskinesia
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective:

      To assess the efficacy and safety of different dose regimens of ALX-0061 administered
      subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus
      erythematosus (SLE) compared to placebo.

      Secondary objectives:

      To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate,
      steroid reduction and health-related quality of life, with different dose regimens of
      ALX-0061.
    


Intervention name(s): ALX-0061; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology
Condition: Peri-Implantitis; Dental Implant Failed; Dental Implant Failure Nos
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      The primary purpose of this study is to determine what effect, if any, do different dental
      materials used to seal the prosthetic screw channels of implant supported restorations have
      on dental implant health parameters and microbiology.
    


Intervention name(s): Cotton Pellet; Polytetrafluoroethylene Tape; Synthetic Foam; Polyvinylsiloxane
Intervention type(s): Device; Device; Device; Device
Other intervention name(s): Richmond Dental Bleached Cotton; Teflon; Merco M55 Thread Seal Tape; Jordco Endoring Foam Inserts; Dentsply Aquasil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery
Condition: Acute Kidney Injury (AKI)
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      The incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in
      adults and 18.3% in hospitalized individuals. Surgery-related AKI is a severe complication
      that is related not only to short-term complications as increases in mortality rate and
      development of cardiac complications but also with complications on long term, such as
      development of chronic kidney disease. A better understanding of the mechanism of this
      hypthesis will lead to better management of this complication.
    

Detailed description: 
      A randomized blinded prospective study included 206patients who the candidate for major
      surgery at South Egypt Cancer Institute, Assiut University, Assiut, Egypt. From April 2018
      till April 2019, a detailed history and careful examination, routine laboratory
      investigations were done, Baseline ECG was recorded 24hours before surgery and 48hours
      postoperative at ICU.
    

Intervention name(s): Kidney function test
Intervention type(s): Diagnostic Test
Intervention description(s): Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who were candidates for major surgery in the Cancer Institute of South Egypt,
        Assiut University, Egypt. Patients excluded from this study were patients with chronic
        cardiac diseases (myocardial ischemia, heart failure, Active severe infection, pregnancy,
        chronic kidney disease, DM, and advanced malignancy on chemotherapy or radiotherapy.
[C-11]PiB PET Imaging in Alcohol Use Disorders
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+)
      compared to an age-matched cognitively normal control group (HC).
    

Detailed description: 
      There is a long-established relationship between alcohol use disorders (AUD), cognitive
      impairments, and the development of dementia. Some, but not all basic data suggest that
      alcohol abuse can alter the expression of amyloid precursor protein, and the enzymes that
      process it. Thus, there is a need for in vivo PET studies to further investigate the
      relationship between AUD and AD and the mechanism through which alcohol abuse exerts its
      effect on this type of dementia. Here, we propose to use the amyloid Beta (ABeta) radiotracer
      carbon-11 labeled Pittsburgh Compound-B ([C-11]PiB) and PET (Klunk et al., 2004) to determine
      whether AUD increase the risk to be brain ABeta+ in middle aged adults.
    

Intervention name(s): [C-11]; Pittsburgh Compound B
Intervention type(s): Radiation; Drug
Intervention description(s): Radiolabel; Tracer
Intervention MeSH terms: Corticosterone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: [C-11]PiB
Masking: None (Open Label)
Primary purpose: Basic Science
Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in
      developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children
      under 5 years. This rate was 2% in 2007.

      Some studies have shown that supplementing with vitamin D reduces disease of the respiratory
      tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell
      lines. Studies about the role of vitamin D supplementation in pneumonia in children are
      inadequate to conclude about its role.

      The aim of this study is to determine the efficacy of vitamin D supplementation in
      Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of
      hospitalized patients with community-acquired pneumonia.
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): vitamin D at a dose of 50,000 IU per day for 2 days; Placebo for 2 days
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment