bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess sustained efficacy in patients who have responded to a 6
      month treatment with open-label pramipexole.

      Secondary objectives are the measurement of severity of the RLS, assessment of early
      withdrawal phenomena after termination of trial medication, augmentation under treatment,
      sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of
      symptom severity and improvement. Another secondary objective is safety and tolerability of
      treatment.
    


Intervention name(s): Pramipexole
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which dose of prucalopride is safe and effective in
      patients with chronic idiopathic constipation.

      Hypothesis:

      Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic
      constipation whereas 0,5 mg is a suboptimal dose.
    

Detailed description: 
      This is a phase II trial with a parallel-group design, consisting of a drug-free run-in phase
      (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients will
      receive either R093877 0.5 mg o.d., 1 mg o.d. or 2 mg o.d. or placebo for a period of 4
      weeks.

      Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented
      and the existence of constipation confirmed. At the start of this period all existing
      laxative medication is withdrawn but patients will be instructed not to change their dietary
      habits, in particular their fibre intake during the trial. Patients will enter the
      double-blind phase if constipation has been shown to be present during the run-in period.

      If the definition of constipation was not met during the 4 weeks of the run-in period,
      double-blind treatment will not be started.

      Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be
      treated for 4 weeks with either 0.5 mg, 1 mg or 2 mg of R093877 or placebo given once daily
      (one capsule is taken before breakfast).

      Patients admitted to the double blind treatment period will be randomly allocated to one of
      the 4 treatment arms.
    

Intervention name(s): Prucalopride; Placebo; Prucalopride; Prucalopride
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): 0.5 mg once daily; o.d.; 1 mg o.d.; 2 mg o.d.
Other intervention name(s): Resolor; Resolor; Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
Condition: Endothelial Dysfunction; Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to measure the effect of moderate and intensive lipid-lowering
      treatment with rosuvastatin on the endothelial function.
    


Intervention name(s): Rosuvastatin 5mg/day; Rosuvastatin 40mg/day
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 5mg/day; Rosuvastatin 40mg/day
Other intervention name(s): Crestor; Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Retinal Oxygen Function After Radiation Therapy
Condition: A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s)
Study type: Observational

Summary: 
      The investigators propose using retinal oximetry to assess for abnormalities in regional
      retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities
      to changes in regional retinal function (i.e. visual field abnormalities). Since different
      regions of retina receive different radiation doses, the investigators will assess for a dose
      response as well.
    

Detailed description: 
      Radiation therapy (RT) is a common treatment for patients with cancers of the sinonasal area,
      orbit, skull base, nasopharynx, and brain. Because of the close proximity of these targets to
      the eyes, the retina is often incidentally and unavoidably irradiated. As a result, some
      patients develop radiation retinopathy and possibly vision loss. Clinicopathologic studies
      suggest similar microvascular mechanisms for both radiation- and diabetic retinopathy: small
      vessel occlusion and ischemia that can lead to neovascularization, increased capillary
      permeability, and visual loss in the regions of retina perfused by damaged vasculature. UNC
      has a novel, non-invasive retinal imaging technology called a Retinal Oximeter which measures
      hemoglobin oxygen saturation of retinal vessels. The difference in oxygen saturation between
      a retinal arteriole and venule pair reflects the oxygen consumption of the retinal region
      supplied by that vessel pair.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with a history of radiation therapy for a tumor in the vicinity of the
        retina(s) at the Department of Radiation Oncology, UNC-CH.
      
Keywords: Sinus/nasal cancer
Satiety Effects of Beef Compared to Beans
Condition: Food Selection
Study type: Interventional

Summary: 
      The satiety effects of beef will be compared to beans. Beef is hypothesized to be more
      satiating than beans.
    

Detailed description: 
      Subjects will consume 2 different meatloaf lunches and satiety will be measured by visual
      analogue scales. They will consume an ad lib snack after 3 hours and food intake will be
      measured.
    

Intervention name(s): Other: Bean patty; Other: Beef patty
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in
      participants with mild, moderate, and severe hepatic impairment compared to matched healthy
      control participants.
    

Detailed description: 
      The study comprised of a screening period up to 28 days, one Baseline evaluation on Day -1, a
      single dose administration of 200 mg of iptacopan followed by PK sampling to 240 hr, and an
      End-of-Study (EOS) visit (Day 11). All participants had a post study safety follow-up call
      conducted approximately 30 days after last administration of study drug.
    

Intervention name(s): Iptacopan; Iptacopan; Iptacopan; Iptacopan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of iptacopan 200 mg oral capsules; Single oral dose of iptacopan 200 mg oral capsules; Single oral dose of Iptacopan 200 mg oral capsules; Single oral dose of Iptacopan 200 mg oral capsules
Other intervention name(s): LNP023; LNP023; LNP023; LNP023
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: LNP023; iptacopan; hepatic impairment; single-dose
Open-label PET Study With [11C]Osimertinib in Patients With EGFRm NSCLC and Brain Metastases
Condition: Non-small Cell Lung Cancer
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single centre, Phase I study to determine the brain exposure of
      [11C]osimertinib in patients with EGFRm NSCLC with brain metastases.
    

Detailed description: 
      A Single-centre, Open-label, PET imaging and Pharmacokinetic Study of IV Administered
      [11C]osimertinib in EGFRm Non-small cell lung cancer patients with brain metastases. The
      study will consist of 2 phases, an imaging phase and a continuous access phase.
    

Intervention name(s): Osimertinib; [11C]osimertinib
Intervention type(s): Drug; Drug
Intervention description(s): Osimertinib 80 mg once daily p.o. will be taken continuously by the patient from the day of the second PET exam.; Patients will receive 3 single IV microdose administrations of [11C]osimertinib and PET exams on: Day 1, Day 2 (or up to Day 8) and Day 29.
Other intervention name(s): Tagrisso; AZD9291; [11C]AZD9291
Intervention MeSH terms: Osimertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Carcinoma, Non-Small-Cell Lung
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety and clinical utility of the active,
      SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in
      pediatric participants.
    

Detailed description: 
      An open label evaluation of the safety and clinical utility of the active, SSEC fentanyl 40
      mcg for the management of acute postoperative pain in pediatric participants 12 to less than
      18 years of age.
    

Intervention name(s): fentanyl
Intervention type(s): Drug
Intervention description(s): An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
Other intervention name(s): IONSYS
Intervention MeSH terms: Fentanyl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatric; Postoperative; Pain Management
Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods
Condition: Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.
Study type: Observational

Summary: 
      Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform
      analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac
      magnetic resonance imaging (CMRI)
    

Detailed description: 
      20 healthy volounteers between age of 20-40 years, no previous medical history undergo
      simoultaneous left ventrikular strokevolume measurements using three different methods at
      rest. After datasampling and without moving, the subject then undergo Cardiac Magnetic
      Resonance Imaging with 2D-throughplane and cine tecnology for validation of volume
      measurements. The data is then analyzed using Bland-Altman calculation.
    

Intervention name(s): Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.
Intervention type(s): Procedure
Other intervention name(s): Vigileo/FloTrac, Edward Lifesciences (arterial waveform analysis); CardioQ, Deltex medical (esofageal doppler); Philips, Magnetic Resonance Imaging; Vivid S6, GE, Cardiac ultrasound
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volounteers
      
Keywords: Left ventricular stroke volume; Arterial waveform analysis; Esofageal doppler; Ultrasound; Cardiac magnetic Imaging; Limits of agreement
Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
Condition: Sexual Dysfunction; Male Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is to provide additional important information on the impact of the treatment of
      the man its ED with vardenafil on partnership. This study is being run at up to 50 study
      centers in Europe and South Africa to evaluate the use of vardenafil in adult men with
      erectile dysfunction (often called impotence), and their female partner's sexual quality of
      life. Many men experience occasional erectile problems during their lives. However, when this
      becomes a continued problem, it can affect both the man and his female partner. The causes of
      erectile dysfunction are varied and may be due to physiological or emotional reasons. This
      study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether
      treating a man its erectile dysfunction with vardenafil will improve his female partner its
      sexual quality of life. The second part (week 12) of the study (Educational program) a
      subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an
      educational program concerning ED in the from of a DVD.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability, pharmacokinetic, and pharmacodynamic
      profile, and drug-drug interaction (DDI) of AB521 in healthy participants.
    


Intervention name(s): AB521; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule; Capsule; Syrup solution
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AB521; HIF-2α; hypoxia-inducible factor 2 alpha; Single ascending dose (SAD); Multiple ascending dose (MAD); Drug-drug interaction (DDI)
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine
      Extended-Release (OXC XR)
    

Detailed description: 
      NAP
    

Intervention name(s): Oxcarbazepine XR
Intervention type(s): Drug
Intervention description(s): Open Label Study
Other intervention name(s): SPN-804O
Intervention MeSH terms: Oxcarbazepine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of 3 Doses of ARD-0403 in Testosterone Deficient Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which dose, if any, results in testosterone levels
      within the normal range for men.
    


Intervention name(s): ARD-0403
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Gait Training for Persons With Stroke
Condition: Stroke; Middle Cerebral Artery Infarction
MeSH terms: Stroke; Infarction, Middle Cerebral Artery; Infarction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study is to investigate the effects of an automatic gait trainer
      (Lokomat) handled by physical therapists compared with categorized gait training by physical
      therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are
      used to evaluate study effects.

      Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more
      than categorized gait training.
    


Intervention name(s): Lokomat - Physical therapy; Physical therapy - Lokomat
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A: Lokomat training, 30 minutes per day for 3 weeks, 5 days per week. B: Categorized gait training by physical therapist, 30 minutes per day for 3 weeks, 5 days per week; B: Daily 30 minutes of gait training with a physical therapist, 5 days per week for 3 weeks.
A: Daily 30 minutes of Lokomat training, 5 days per week for 3 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ambulatory stroke patients; Gait training; Lokomat; Physical therapy
Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation
Condition: Thyroidectomy
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate if intraoperative neuromonitoring associated to
      neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy
      respect to neurostimulation alone.
    

Detailed description: 
      Anatomic and functional preservation of the recurrent laryngeal nerve is a key element of
      thyroid surgery. Surgical exposure and visual identification of the nerve during thyroid
      surgery has been shown to provide the best rates of normal postoperative vocal fold function.
      Nevertheless, identification of the nerve sometimes can be difficult in patients who are
      heavily scarred or who have undergone previous surgery. Moreover, an anatomical intact nerve
      does not always correlate with normal vocal fold function. So it is mandatory to identify the
      nerve and to establish its function. Two techniques are described to facilitate
      identification of the nerve and to test its function. One is the neurostimulation with
      laryngeal palpation which is an intermittent monitoring techniques that permits to evaluate
      the contraction of cricoarytenoid muscle (laryngeal twitch ) after stimulation of RLN or
      vagal nerve with an electric stimulator probe. More recently some authors have suggested a
      continuous intraoperative neuromonitoring which provide audio and visual feed back when the
      nerve is electrically or mechanically stimulated during thyroidectomy. However controversy
      remains as to whether intraoperative neuromonitoring confers any significant benefit in
      injury prevention of recurrent laryngeal nerve.
    

Intervention name(s): thyroidectomy
Intervention type(s): Procedure
Intervention description(s): total thyroidectomy and lobectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurostimulation; intraoperative neuromonitoring; recurrent laryngeal nerve; palsy of recurrent laryngeal nerve; RCT
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies
      Immunoglobulin) in children ages 0 months to <17 years, when administered as part of
      post-Rabies Exposure Prophylaxis (PEP).
    


Intervention name(s): KamRAB - HRIG
Intervention type(s): Drug
Intervention description(s): wound infiltration or IM injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cryolipolysis and Subcision for Treatment of Cellulite
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      This study intended to investigate and compare the changes that may occur in response to
      cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The
      cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational
      in the treatment of cellulite. It has previously been used for fat reduction on love handles
      or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes
      the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die,
      with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat
      scars left behind by acne or other skin diseases and has been noted to improve moderate to
      severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a
      specially designed needle under the skin after local numbing medication is injected. The
      needle is moved in a repetitive motion parallel to the skin to separate the surface tissue
      from the deeper scar tissue with the goal to improve the dimpling caused by these tissues
      sticking together. This study was a pilot study designed to determine feasibility of these
      procedures.
    


Intervention name(s): cryolipolysis; Subcision; Control
Intervention type(s): Device; Procedure; Other
Intervention description(s): During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite; Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
Other intervention name(s): No intervention in this group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cellulite; Cryolipolysis; Zeltiq; Subcision