bioihbjkbjnl/mcl2 huggingface dataset:
Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis
Condition: Penile Neoplasms; Carcinoma, Squamous Cell
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Penile Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily
      on regional lymph-node involvement. Despite the fact that cure can be obtained in patients
      with low metastatic load (pN1) by monotherapy, combination therapy is required for more
      advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not
      very effective so far and the few chances for cure are solely dependent on multimodality
      treatment, either with surgery or radiation. Based on the observation that the epidermal
      growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming
      similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been
      investigated with promising early results at Istituto Tumori Milan and University of Texas MD
      Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor
      dacomitinib for advanced or metastatic penile SCC.
    


Intervention name(s): Dacomitinib
Intervention type(s): Drug
Intervention description(s): PF-299804 will be administered orally at a dose of 45 mg/day continuously until surgery, evidence of disease progression or onset of unacceptable toxicity.
Other intervention name(s): PF-00299804
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Molecular Targeted Therapy; Neoadjuvant therapy; Dacomitinib
Effect of Surfaces on Fall in Elderly
Condition: Falls, Accidental; Aging
Study type: Interventional

Summary: 
      To investigate the effects of Thai dance exercises over 6 weeks on functional outcomes and
      incidence of fall in community-dwelling older individuals.

      To compare effects of exercise training on hard, soft and sand surfaces in community-dwelling
      older individuals
    


Intervention name(s): Physical training on hard surface.; Physical training on sand surface.; Physical training on soft surface.
Intervention type(s): Other; Other; Other
Intervention description(s): Physical training on hard surface.; Physical training on sand surface.; Physical training on soft surface.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: fall prevention; Aging; surfaces
Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      To access the single-dose oral bioequivalence of sumatriptan succinate 100 mg tablet
      (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of OHM
      Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceutical Inc. USA) with IMITREX® 100 mg
      tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of
      GlaxoSmithKline in healthy, adult, male, human subjects under fed condition.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomized two-treatment, two-period,
      two-sequence, single-dose, crossover bioequivalence study comparing sumatriptan succinate
      tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg of sumatriptan)
      manufactured by OHM Laboratories Inc. with IMITREX® 100 mg tablets (containing sumatriptan
      succinate equivalent to 100 mg of sumatriptan) manufactured by GlaxoSmithKline Research
      Triangle Park NC 27709, Made in Canada in healthy, adult, male, human, subjects under fed
      conditions.

      Following an overnight fast of at least 10 hour, a single oral dose of sumatriptan succinate
      tablets 100 mg of either test or reference formulation was administered during each period of
      the study, along with 240 mL of drinking water at ambient temperature under supervision of
      trained study personnel 30 min after start of a high fat high calorie breakfast.

      Thirty-two 32 subjects were enrolled into the study. Twenty-four (24) subjects completed both
      the periods of the study.

      Pharmacokinetic and statistical analyses were performed on data from 24 subjects who
      completed both the periods of the study.
    

Intervention name(s): sumatriptan 100mg
Intervention type(s): Drug
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Immune Memory After Papillomavirus Vaccination
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Vaccines for human papillomavirus (HPV) have been available in the United States since 2006.
      Early studies have shown a high rate of effectiveness of these vaccines, however it is not
      known how long this protection will last. The IMAP study will look at various parts of the
      immune system and potential markers for long lived immune responses to this vaccine.
    

Detailed description: 
      Three groups of patients will be recruited for this study. One group will be women who have
      completed all three vaccinations. The second group will be women who are overdue for their
      final vaccination. We also recruit women who have not been vaccinated previously.
    

Intervention name(s): quadrivalent HPV vaccine
Intervention type(s): Drug
Intervention description(s): For the group who have received two prior doses of vaccine, the third and final dose of vaccine will be given. For the unvaccinated cohort, women will receive all three doses of the vaccine. The second dose of the vaccine will be given two months after the first dose. The third and final dose of the vaccine will be given six months after the first dose.
Other intervention name(s): Gardasil if the trade name of the quadrivalent HPV vaccine.
Intervention MeSH terms: Vaccines
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        we are seeking healthy female volunteers
      
Biospecimen description: 
      we will retain lymphocyte samples for testing immune function
    
Keywords: immunology; vaccination; human papillomavirus
Treatment of Recurrent Bladder Cancer With Dendritic Cells
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of recurrent bladder cancer with dendritic cells
    


Intervention name(s): Dendritic cells; Standard treatment according to the Clinical protocols
Intervention type(s): Biological; Other
Intervention description(s): Autologous dendritic cells primed with muc-1/wt-1 peptides; Standard treatment of bladder cancer according to the Clinical protocols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bladder Cancer; Dendritic cells
Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Balance and gait problems cause severe impairments for people with Parkinson's disease In
      some Parkinson's disease patients the investigators see a loss of acetylcholine in the brain.
      In previous studies the investigators have shown that this loss of acetylcholine is related
      to impaired balance and gait function in Parkinson's disease. In this study the investigators
      will take a closer look at this finding.
    

Detailed description: 
      Balance and gait problems cause severe impairments for people with Parkinson's disease and
      significantly affect their quality of life. Several changes occur in the brains of
      Parkinson's disease patients. The hallmark change is a loss of a neurotransmitter ("chemical
      messenger" between brain cells) called dopamine. To alleviate Parkinson's disease symptoms
      doctors prescribe dopamine replacement therapy, for example Sinemet (levodopa). Although
      effective for some of the symptoms, it typically does not sufficiently alleviate balance and
      gait problems. This study focuses on other changes in the brain that occur in Parkinson's
      disease that may contribute to balance and gait problems. In particular we will be looking at
      another neurotransmitter called acetylcholine. In some Parkinson's disease patients we see a
      loss of acetylcholine in the brain. In previous studies we have shown that this loss of
      acetylcholine is related to impaired balance and gait function in Parkinson's disease. In
      this study we will take a closer look at this finding.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ago 50 and over
      
Biospecimen description: 
      Saliva and Blood
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      This study will involve placing donor bone into the back of lower jaw then covering with a
      newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it
      will be removed. Implants will be placed in the newly formed bone.

      The goal of this study is to test how well using a newly designed titanium mesh and bone
      particles can grow bone in the back of the lower jaw. The investigators are also checking if
      the newly formed bone will stay around implants that will have been in use for 12 months.
    

Detailed description: 
      Inclusion Criteria

        -  Patients are at least 18 years old

        -  At least two adjacent back teeth in the lower jaw are missing

        -  No medical contraindication to dental surgery

        -  Inadequate vertical ridge height at edentulous region (less than 10mm)

      Exclusion Criteria

        -  Unstable systemic diseases or conditions that would compromise the healing potential

        -  Patients with osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)

        -  Patients who are pregnant or expect to get pregnant

        -  Patients with unstable dental disease (e.g. caries and periodontitis) in the surgical
           sextant
    

Intervention name(s): Bone/Mesh
Intervention type(s): Device
Intervention description(s): A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception
Condition: Pain; Pregnancy
Study type: Observational

Summary: 
      Recent studies have shown that women are more likely to experience pain in many medical
      situations. During pregnancy, women may experience an increase in pain threshold. This is
      thought to be related to hormonal changes and an increase in the level of certain natural
      pain-relieving substances in their bodies.

      It is important to develop simple tests to identify woman at higher risk for pain so the
      investigators can help them.

      Temporal summation is what happens when a person becomes more sensitive to a certain feeling
      on their skin when it is applied several times over the course of several seconds. The
      investigators hypothesize that pregnant women show decreased temporal summation and pain
      scores to venipuncture, compared to non-pregnant women.
    

Detailed description: 
      Recent epidemiologic studies have shown that women are at substantially greater risk for many
      clinical pain conditions, and there is a suggestion that postoperative and procedural pain
      may be more severe among women then men. During pregnancy, women experience an elevation in
      the threshold to pain and discomfort. In addition to hormonal changes, the changes in pain
      perception during pregnancy may be related to an increase in endogenous opioids.

      Pain is the most feared experience in the intra and postpartum period, and severe pain
      experienced during this time can lead to significant morbidity, including chronic pain and
      depression. Much attention has been paid to tests that can predict patients at higher risk
      for pain. Temporal summation (TS) has been shown to be a simple and reliable test. Temporal
      summation represents the physiological wind-up phenomenon taking place at the spinal level of
      the central pain pathways. TS extent can be measured in humans by administering a series of
      noxious stimuli of constant intensity and of various modalities in order to evoke an increase
      in perceived pain. It is a very simple and easy test to perform, and very well tolerated by
      patients. Whether TS changes in pregnancy and whether TS in pregnancy correlates with pain
      perception during acute stimuli such as venipuncture is unknown.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant patients presenting at the venipuncture clinic for routine bloodwork throughout
        their pregnancy.

        Full term pregnant patients admitted to the hospital for and elective cesarean section.

        Non pregnant volunteers.
      
Keywords: Temporal summation; Venipuncture pain
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Condition: Seizures; Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional

Summary: 
      Neurologically-impaired individuals may have significant neurologic morbidity related to
      epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures, and
      potentially reversing the epileptogenic process, is of paramount importance in improving the
      lives of those with epilepsy.
    


Intervention name(s): Music Exposure
Intervention type(s): Other
Intervention description(s): Twenty-seven subjects were randomly assigned to receive nightly exposure to music at periodic intervals between the hours of 9:00 PM and 8:00 AM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures; Epilepsy; Auditory Stimulation; Music
A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of apremilast
      once-daily formulation relative to a twice daily formulation when administered as multiple
      doses (Part 1), and when administered as a single dose under fasting and fed conditions (Part
      2). Information on safety and tolerability will also be obtained.
    

Detailed description: 
      Part 1: This is an open-label, randomized, two-period, two-sequence, crossover study in
      healthy subjects. The study will consist of a screening phase, a baseline phase, two
      treatment periods, and a follow-up phone call. Each period will be ten days in duration
      including 7 days of dosing and sample collection for up to 72 hours post Day 7 morning dose.
      There will be a washout between period 1 and period 2.

      Part 2: This is an open-label, randomized, four-period, four-sequence crossover study to
      evaluate the PK and exposure of apremilast following single dose administration of different
      formulations of apremilast. Part 2 will consist of a screening phase, baseline, four
      treatment periods, and a follow-up phone call. Each period will be four days in duration for
      dosing (Day 1) and sample collection for up to 72 hours post Day 1.
    

Intervention name(s): Apremilast IR; Apremilast XL
Intervention type(s): Drug; Drug
Intervention description(s): Apremilast immediate release tablet; Apremilast extended release formulation tablet
Other intervention name(s): Otezla®
Intervention MeSH terms: Thalidomide; Apremilast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Apremilast; Pharmacokinetic
Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders
Condition: Temporomandibular Joint Dysfunction Syndrome
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Muscular Diseases
Study type: Interventional

Summary: 
      This study aimed to evaluate the sustainability of the efficacy of using low level laser
      therapy and CAD/CAM Michigan splint in improving the range of mandibular movements, muscle
      activity and reducing the pain.
    

Detailed description: 
      56 female patients were randomly divided into two groups, Group A: Patients received
      applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm
      with continuous mode of operation, with time of application 180 sec per session for 12
      sessions. Group B: Patients received hard occlusal splints (Michigan splints) of 2 mm
      thickness constructed on their upper teeth, the hard occlusal splint was 3D digitally
      printed. ARCUS digma facebow was used to evaluate the range of mandibular movements affected
      from TMJ problems. The opening measurements of the patient were taken using a millimeter
      ruler. Electromyogram (EMG) was used to evaluate muscle activity. Visual analogue scale (VAS)
      was used to evaluate the pain intensity. All was done before the beginning of the treatment
      at three and six months follow up period.
    

Intervention name(s): Low Level LASER therapy; Hard occlusal splint
Intervention type(s): Radiation; Device
Intervention description(s): using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.; 2 mm thickness occlusal splint constructed over the maxillary arch using CAD/CAM technology.
Other intervention name(s): Michigan splint
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: Patients received applications of low-level laser therapy. Group B: Patients received hard occlusal splints (Michigan splints).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low level LASER therapy; Michigan splint; Electromyogram; Myofascial pain
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
Condition: End Stage Renal Disease; Anuria; Peritonitis
MeSH terms: Peritonitis; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to explore the impacts of different continuous ambulatory
      peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges
      CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in
      incident Chinese peritoneal dialysis patients.
    

Detailed description: 
      1. The primary end point for this study was changes in residual kidney function including
           GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated
           within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and
           24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis
           adequacy, peritoneal solute transport rate, and biochemical parameters etc. were
           assessed. Once an episode of peritonitis or other serious reversible intercurrent
           illness occurred, all the assessments were delayed one month after being cured. Anuria
           was termed by daily Uvol permanently less than 100 ml.

        2. The secondary end points included technique survival, patient survival and peritonitis.
           Technique failure was defined as switching to maintenance hemodialysis.
    

Intervention name(s): Three 2-liter exchanges daily CAPD; Four 2-liter exchanges daily CAPD
Intervention type(s): Other; Other
Intervention description(s): CAPD regimen of three 2-liter daily exchanges; CAPD regimen of four 2-liter daily exchagnes
Other intervention name(s): small volume CAPD; standard volume CAPD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peritoneal dialysis; dose; residual kidney function; technique survival; patient survival; peritonitis
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a non-randomized dose-escalating study that will evaluate the safety and tolerability
      of GE-145 at four different dose levels through the assessment of clinical laboratories,
      vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity
      of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145
      through the evaluation of serum and urine. It will evaluate the radiographic density in
      regions of interest (ROI) and the overall diagnostic quality following administration of
      GE-145.
    


Intervention name(s): GE-145 (AN113111) Injection; Visipaque (iodixanol) Injection
Intervention type(s): Drug; Drug
Intervention description(s): 40 healthy volunteers (10 per treatment group) will receive AH113111 320 mg I/mL at 1 of 4 possible doses (300, 450, 600, or 900 mg I/kg) as a single intravenous (IV) administration.; An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.
Other intervention name(s): AH113111; GE-145; Visipaque; Iodixanol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CECT - Contrast-enhanced computed tomography; HCG - Human Chorionic Gonadotropin; HU - Hounsfield Units; Patient Safety; Tolerance; Pharmacokinetic
Cognitive Embodiment Activation by tDCS
Condition: Healthy Young Adults
Study type: Interventional

Summary: 
      The main objective of the proposed research is to extend our understanding of how gesture and
      language interact, focusing on the role of cognitive embodiment in this interaction, and to
      explore the neural systems that support links between language and actions systems.
    


Intervention name(s): tDCS; sham-tDCS
Intervention type(s): Device; Device
Intervention description(s): Transcranial direct current stimulation (tDCS); sham stimulation
Other intervention name(s): Neuroconn; Neuroconn
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment