bioihbjkbjnl/mcl2 huggingface dataset:
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
Condition: Pancreatic Pseudocyst; Pancreatic Necrosis; Biliary Obstruction; Acute Cholecystitis
MeSH terms: Pancreatic Pseudocyst; Cholecystitis; Cholecystitis, Acute; Pancreatitis, Acute Necrotizing; Necrosis
Study type: Interventional

Summary: 
      To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided
      transenteric drainage of PFC or of biliary tree including GB
    

Detailed description: 
      Patients with the following conditions would be recruited for drainage under EUS guidance
      with the new lumen apposing FCSEMS

        -  Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or
           10 mm)

        -  Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)

        -  Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)

        -  Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)

        -  Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary
           approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm)

      Outcome paramaters include technical and clinical success, adverse events.
    

Intervention name(s): EUS-guided drainage
Intervention type(s): Device
Intervention description(s): Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage.
EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen.
After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm).
After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen.
After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Research Questions:

        1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a
           Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e.
           quality of life, function, range of motion) than similar patients who undergo total knee
           arthroplasty (TKA) using the Sigma fixed bearing knee?

        2. Do patients with knee OA who undergo TKA with a Sigma rotating platform have different
           knee kinetics and kinematics as measured by gait analysis than similar patients who
           undergo TKA using the Sigma fixed bearing knee?

        3. Do patients with knee OA who undergo TKA with or without computer assistance have better
           clinical outcomes at two years following surgery (quality of life, function, range of
           motion)?

        4. Do patients with knee OA who undergo TKA with or without computer assistance have
           different knee kinematics and kinetics as measured by gait analysis?
    


Intervention name(s): DePuy P.F.C.® Sigma Rotating Platform Knee
Intervention type(s): Device
Intervention description(s): no details
Other intervention name(s): no other name
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: arthroplasty; knee; computer-assist; gait; Total knee arthroplasty; knee prostheses
A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants
Condition: Healthy-volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and
      caucasian healthy-volunteer study participants.
    


Intervention name(s): Rozanolixizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous infusion; Pharmaceutical form: solution for injection
Route of administration: subcutaneous infusion
Intervention MeSH terms: Rozanolixizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Rozanolixizumab; Caucasian healthy-volunteers; Japanese healthy-volunteers; Phase 1; UCB7665; Chinese healthy-volunteers
BRP1802 Smoking Abstinence Study
Condition: Smoking; Smoking Cessation; Tobacco Use
Study type: Interventional

Summary: 
      A single-center study designed to evaluate changes in short-term biomarkers of potential harm
      (BoPH) in healthy adult cigarette smokers of two age groups (Group A: 24-34 years; Group B:
      35-60 years) during 14 days of smoking abstinence.
    

Detailed description: 
      The overall goal of the smoking abstinence study is to discover and assess biomarkers that
      respond rapidly to smoking abstinence and explore whether the smokers' age influences the
      responsiveness of biomarkers to changes in smoking status. The study is a single-center,
      parallel cohort, in which generally healthy adult male and female smokers participated.
      Smokers of 10-30 cigarettes per day for at least 5 years prior to screening were recruited.
      Plasma and urine (24h and spot urine) samples and other biological specimens will be
      collected at the baseline and at specified timepoints during the course of the study. The
      study will include two primary study cohorts, smokers ages 24-34 years and 35-60 years, to
      determine whether age could be a confounder in the qualification of biomarkers. Starting on
      Day -2, eligible smokers will be confined at the clinical site for 17 days. Biological
      samples will be collected on Days -2 and -1 for baseline study endpoints. On Day 1, smokers
      will be switched to smoking abstinence for 14 days. Samples will be collected for endpoint
      analysis throughout the 14-day abstinence period.
    

Intervention name(s): Smoking Abstinence
Intervention type(s): Other
Intervention description(s): Smokers will be switched to smoking abstinence for 14 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
Condition: Sodium Imbalance; Nocturnal Blood Pressure; Obstructive Sleep Apnea of Adult
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular
      disease.
    

Detailed description: 
      A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular
      disease. Patients with hypertension resistant of antihypertensive treatment have a high
      frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to
      analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal
      pauses in breathing in this patients population.
    

Intervention name(s): Dietary sodium restriction
Intervention type(s): Behavioral
Intervention description(s): Selfemployed dietary sodium restriction
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
Masking: None (Open Label)
Primary purpose: Treatment
Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Hypothermia
Study type: Interventional
Phase: Phase 3

Summary: 
      Therapeutic hypothermia after cardiac arrest har shown to improve the rate of survival in a
      significant way. However hypothermia also causes leak of fluid into the surrounding tissue.
      This edema could lead to damage to the same tissue, not beneficial for the patients. We
      therefore try to evaluate if hyperosmolar, hyperoncotic fluid as an alternative to std.
      treatment (NaCl/RA)could affect the edema in a positive way, and result to a better outcome
      neurological for the patients.
    

Detailed description: 
      After the patients are admitted to our hospital we randomise them to either std. fluid
      therapy (NaCl/RA) or HyperHAES. After PCI we state the rate of cerebral edema by carrying out
      a cerebral MRI before the cooling starts. We treat the patients with the different fluids for
      24 hours. We then evaluate the edema after 24 and 72 hours by the same method. In addition we
      state the rate of peripheral capillary leak by Wick'S method. The capillary leak is
      calculated every 8.th hour for the 1. day the patients are treated in our ICU. AFter 1 year,
      those who survive are invited to a follow-up where we test the patient using Mini MEntal
      Status, SF-36, in addition to neurophysiological tests as EEG and the P300-test. We then
      relate the results to the fluid given initially after the cardiac arrest.
    

Intervention name(s): HyperHAES vs. RA-solution/NaCl
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: cardiac arrest; hypothermia; neurologic outcome; edema
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities
Condition: Infantile Hemangiomas
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Observational

Summary: 
      A combined set of quantitative skin imaging methods will quantitatively describe the natural
      ontogeny and the response to standard treatments over time in patients with infantile
      hemangiomas.
    

Detailed description: 
      Infantile hemangiomas (IH) are relatively common benign vascular neoplasms, which appear
      shortly after birth and grow rapidly in the following weeks and months. The proliferative
      phase involves a rapidly dividing endothelial cell proliferation. The tumors generally
      stabilize and then involute over time. They are usually clinically insignificant; however, a
      small percentage of them can be life threatening secondary to location, associated syndrome,
      and physical findings such as ulceration. Treatment options have included steroids,
      interferon, vincristine and more recently propranolol. There are few published prospective
      research studies on the effectiveness of these treatment options. Because of several factors,
      it has been difficult to objectively measure response of these lesions. The purpose is to
      determine (1) whether multiple quantitative skin imaging modalities can quantitatively
      describe the clinically relevant features of infantile hemangiomas, including color (red,
      blue), lightness, size (height, volume), biomechanical properties, temperature and perfusion
      and (2) the natural ontogeny and response to treatment over time. The treatments are oral
      propranolol, topical timolol and untreated (observation).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients being seen at the the Hemangioma and Vascular Malformation Center of Cincinnati
        Children's Hospital Medical Center
      
Keywords: skin imaging; image analysis; infrared thermography; infantile hemangioma; three dimensional imaging; color imaging and analysis; propranolol; timolol; ontogeny
Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
Condition: Insulin Resistance
MeSH terms: Overweight; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on
      insulin sensitivity in normal weight and overweight adults.
    

Detailed description: 
      Polyphenols may have several favourable effects on health. Dark chocolate (DC) is one of the
      highest sources of polyphenols in foods. The aim of the study is to determine the effect of
      polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.
      Seventy four volunteers with no history of hypertension, cardiovascular diseases or diabetes
      will be recruited. Participants will randomly receive 20g daily of one of the two different
      types of DC: Placebo DC (low in polyphenols) or DC rich in polyphenols (500mg) for a period
      of four weeks. Participants will be asked to make two appointments to the university clinical
      lab. Anthropometric measurements (height, weight, waist circumference), blood and saliva
      samples will be taken during each of the 2 visits. Compliance will be tested by the measure
      of total polyphenols in a 24-hour urine sample in some random samples before and at the end
      of the intervention. To monitor any fluctuations in the participants' diet or physical
      activity during the study period, a three-day diet diary and a physical activity
      questionnaire will be collected before the start of the study and after four weeks. Data will
      be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as
      between-subject factor.
    

Intervention name(s): Polyphenol-rich Dark chocolate; Placebo Dark chocolate
Intervention type(s): Other; Other
Intervention description(s): Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks; Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Diabetes type II, Insulin sensitivity
Validating a Self-fitting Hearing Aid
Condition: Hearing and Vision Loss
MeSH terms: Deaf-Blind Disorders; Seizures
Study type: Interventional

Summary: 
      Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows
      adults with mild-to-moderate hearing loss to test their hearing sensitivity and program
      hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom
      programmed by a hearing health professional based on a professional hearing test. This
      technology has the potential to improve affordability and accessibility of hearing aids for
      adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting
      software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing
      aid fit by a professional following usual clinical best practice for fitting hearing aids.
    

Detailed description: 
      The study will recruit 30-50 adults age 18 and over with mild-to-moderate hearing loss in
      both ears. We will aim to recruit a sample with roughly equal number of males and females and
      new and experienced hearing aid users (defined by any hearing aid use within the previous 6
      months). Hearing loss will be measured using the results of a standard clinical hearing test.

      We will use a within-subject, crossover design in which all participants will complete both
      field trial hearing aid conditions (self-fit and clinically fit hearing aids). The order of
      the field trials will be randomized across participants to account for any potential order
      effects. After each field trial, participants will visit the lab to complete study outcome
      measures, including hearing aid benefit, subjective sound quality, and speech in noise
      intelligibility testing.
    

Intervention name(s): Fitting algorithm
Intervention type(s): Other
Intervention description(s): The best fitting algorithm will be selected by the audiologist (arm 1) or software.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomly assigned to arm 1 (audiologist fit) or arm 2 (self fit) first. After 2-3 weeks they will be tested and then assigned to the opposite arm.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: hearing aids, self-fitting
An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach
      to treating dyslipidemia.
    

Detailed description: 
      The duration of treatment is 7 days.
    

Intervention name(s): niacin (+) laropiprant; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Other intervention name(s): MK0524A
Intervention MeSH terms: Niacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Study type: Observational

Summary: 
      The purpose of this study is to examine whether tobacco smoking is associated with bipolar
      affective disorder (severity of depressive and manic symptoms, presence of psychotic
      symptoms, history of a suicide attempts and other clinical features.)
    

Detailed description: 
      An association exists between smoking and schizophrenia, independent of other factors and
      related to psychotic symptomatology. Only a few small descriptive studies have examined the
      prevalence and correlates of tobacco use among bipolar patients with conflicting results.
      Patients who smoke score higher on rating scales for psychotic symptoms than their
      non-smoking peers. While the association of smoking with psychotic symptomatology in
      schizophrenia is established, such association according to bipolar affective disorder has
      been reported in a few studies and remains unclear. Also a few studies reported about
      association of smoking with depressive and manic symptoms, and with suicidal behavior in
      bipolar patients. Thus further investigation of these issues is warranted.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The sample will consist of all patients ascertained in database of Tirat Carmel Mental
        Health Center and Psychiatric Outpatients Clinic, Rambam Medical Center
      
Keywords: bipolar affective disorder, Smoking
The Effect of Sedation on Eye Movements
Condition: Saccadic Eye Movements
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether sedation affects saccadic eye movements.
    


Intervention name(s): propofol; dexmedetomidine; Midazolam; saline placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sedative; Sedative; sedative; saline placebo
Intervention MeSH terms: Midazolam; Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Sedation; Eye Movements
Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether treating sleep difficulties in patients
      with seasonal affective disorder also improves their depressive symptoms.
    

Detailed description: 
      Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive
      symptoms worsen in the winter. These patients' depressive symptoms often lessen in the spring
      and summer months. Much of the focus of the treatment of SAD (light therapy and melatonin)
      has involved the brain's suprachiasmatic nucleus(SCN), as it is hypothesized that one
      potential reason for SAD is a desynchronized SCN. Ramelteon offers a new and more
      pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon
      for this patient population may improve sleep, and in addition, do so in a manner that may
      also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment
      will be administered either ramelteon or placebo and return to the study office for 4 monthly
      visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep
      and mood.
    

Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one 8 mg tablet at bed for up to 4 months; one tablet at bedtime for up to 4 months
Other intervention name(s): Rozerem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Seasonal Affective Disorder; Ramelteon; Psychiatry; Randomized Controlled Trial; Hamilton Depression Rating Scale- SAD Version; Circadian Rhythm
Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the combination of 2007RD01, a natural extract,
      and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms
      associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.
    


Intervention name(s): Combination of 2007RD01 and saw palmetto lipidic extract; Saw palmetto lipidic extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration of one capsule containing a combination of 250 mg of 2007RD01 (a natural extract) and 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals; Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
Intervention MeSH terms: Saw palmetto extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prostate; dietary supplements; saw palmetto; canada