bioihbjkbjnl/mcl2 huggingface dataset:
Ondansetron Augmentation in Treatment-resistant OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve
      and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms
      among obsessive compulsive disorder resistant patients.
    


Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly
Intervention MeSH terms: Ondansetron
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of Modafinil for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      This 7 week, open-label pilot clinical trial will examine the safety and tolerability of
      modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in
      methamphetamine-dependent volunteers.
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention description(s): subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
Intervention MeSH terms: Modafinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Remediation for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar Disorder is a major mood disorder with periodic mood episodes that may be very
      distressing, both to the individual and to others. When ill, the person is at particular risk
      for disruptions to social and occupational functioning, physical health, and even premature
      death. When not in an episode, individuals with BD may still be feeling well but have ongoing
      neurobiological processes, as well as the psychological sequelae from illness episodes, that
      can lead to subtle neurocognitive impairment that impedes overall functioning. This study is
      a test of an existing, published intervention that ameliorates deficits in functioning in
      euthymic bipolar individuals.
    


Intervention name(s): Functional Remediation
Intervention type(s): Other
Intervention description(s): Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities.
Intervention model: Single Group Assignment
Intervention model description: This study is a single center, open-label, outpatient clinical trial with no randomization or blinding. The Barcelona Functional Remediation for Bipolar Disorder (FR) Program will be tested over a 21-week period using 30 participants split into two equal cohorts. The study will evaluate the feasibility and preliminary efficacy of the intervention.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cognition; Cognitive Remediation; Mood Disorder; Functional Impairment; Psychosocial intervention
The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purposes of study are to investigate the effect of therapeutic ultrasound for the
      inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on
      different inflammatory level.
    

Detailed description: 
      Therapeutic ultrasound for soft tissue repair has been used in clinical during the past
      decades. In some recent systematic review, the evidence of clinical trials were
      insufficiency. We assumed the reaserch biasin clinical trials may be due to the different
      inflammatory level of soft tissue under the similar ultrasound intensity. Our purpose of
      study is to investigate the effect of therapeutic ultrasound for the inflammatory skin repair
      and whether the tissue repair under ultrasound treament is depend on different inflammatory
      level.
    

Intervention name(s): Active Therapeutic Ultrasound; Non-active Therapeutic Ultrasound
Intervention type(s): Device; Device
Intervention description(s): For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.; For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sodium lauryl sulfate; Skin irritants; inflammation; therapeutic ultrasound
Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF
Condition: Primary Myelofibrosis (MF); Post-Polycythemia Vera (PV) MF; Post-Essential Thrombocythemia (ET) MF
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to determine the efficacy of INC424 as assessed by reduction
      in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF,
      or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the
      effects of INC424 on patient reported outcomes and the duration of response as assessed by
      reduction in spleen volume was also assessed.
    


Intervention name(s): Ruxolitinib
Intervention type(s): Drug
Intervention description(s): INC424 Tablet for oral use, provided in 5 mg bottles. The dosage strength was 5 mg/tablet INC424 phosphate (free base equivalent).
Other intervention name(s): INC424
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Myelofibrosis (MF); Post-Polycythemia Vera (PV) MF; Post-Essential Thrombocythemia (ET) MF; post-PV MF; post-ET MF; INC424; Ruxolitinib; Myelofibrosis; MF
Dextrose Concentration Decline Rate in Vivo
Condition: Dextrose Concentration
Study type: Interventional

Summary: 
      Measuring the speed of decrease in dextrose concentration to help design more accurate in
      vitro studies
    

Detailed description: 
      Rationale: In vitro studies of the potential mechanism of action of therapeutic dextrose
      injection commonly place human or animal cells in a dextrose (glucose) culture medium for a
      prolonged period of time, typically 24 hours, and expose them to high dextrose levels,
      typically 1-25% (1000- 25,000mg%). High glucose levels in culture media can cause cell death.
      Given that cellular apoptosis/death has not been shown to occur after therapeutic dextrose
      injection in vivo by histologic analysis, we expect that elevated glucose levels drop rapidly
      in vivo. In this study 12.5% dextrose will be injected intraarticularly (in the knee) and
      dextrose 5% will be injected subcutaneously, and dextrose level measurements will be obtained
      at timed intervals after each in order to produce a curve depicting the pattern and speed of
      decrease in dextrose levels after in vivo injection. In vitro studies can then utilize this
      information to alter the pattern and speed of decrease of dextrose levels to mimic in vivo
      conditions, and in so doing provide more useful data on potential mechanisms of therapeutic
      dextrose injection in soft tissue and joints.
    

Intervention name(s): Intrarticular and subcutaneous dextrose injection with timed measurement of dextrose levels
Intervention type(s): Procedure
Intervention description(s): Step one: 30 mL of 12.5%/0.1% lidocaine will be injected into the knee using an inferomedial approach. Using ultrasound guidance, a 20-gauge 2-inch I.V. catheter will be placed in the suprapatellar pouch, by which samples of synovial fluid from the pouch will be withdrawn and analyzed for glucose level.
Step two: 3 mL of D5W will be injected into a marked spot on the back of the upper arm. A sensor/transmitter (Dexcom G7 Dexcom) is placed at the site of injection. The sensor/transmitter will begin providing dextrose levels at 5 minute intervals beginning one-half hour after placement of the sensor/transmitter, transmitted to a paired smart phone.
Other intervention name(s): Glucose injection (Dextrose is the form of glucose that humans can metabolize)
Intervention model: Single Group Assignment
Intervention model description: Dextrose curve production from a single individual
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dextrose; Hydrodissection; Proliferation
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose pharmacokinetic study investigating two paracetamol formulations
    


Intervention name(s): Marketed paracetamol; Experimental paracetamol formulation
Intervention type(s): Drug; Drug
Intervention description(s): Marketed formulation; Experimental formulation
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: paracetamol; pharmacokinetic
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, mass balance and biotransformation study in healthy male
      subjects utilising a single oral dose of [14C] Antaitavir Hasophate.
    


Intervention name(s): [14C] Antaitavir Hasophate
Intervention type(s): Drug
Intervention description(s): 100 mg suspension containing 200µCi of [14C] Antaitavir Hasophate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in
      healthy Chinese, Japanese and Caucasian male volunteers.
    


Intervention name(s): BI 113608; Placebo; BI 113608; Placebo; BI 113608; BI 113608; BI 113608; BI 113608
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Medium dose (Multiple dosing); Placebo (Multiple dosing); Low dose (Multiple dosing); Placebo (Single dosing); High dose (Single dosing); Medium dose (Single dosing); Low dose (Single dosing); High dose (Multiple dosing)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
Condition: Tympanic Membrane Perforation
MeSH terms: Tympanic Membrane Perforation
Study type: Interventional

Summary: 
      Aim of this study is to compare results of double and single flap techniques for
      tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total
      or subtotal tympanic membrane perforations with limited anterior remnant and should be dry
      for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection
      or those with recurrent perforations after previous myringoplasty were excluded. Also,
      patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised
      patients are not included in this study. Patients are divided into two groups, endoscopic
      double flap group and endoscopic single flap group. Healing and hearing outcomes were
      evaluated 3 months postoperative. Also, post-operative pain scores and complications were
      assessed.
    


Intervention name(s): Endoscopic tympanoplasty
Intervention type(s): Procedure
Intervention description(s): In the double flap group, graft is placed via elevation of both posterior and anterior flaps.
In the single flap group, graft is placed via elevation of posterior flap only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      INTRODUCTION: Stress urinary incontinence is a common condition in women and can be defined
      as the involuntary loss of urine on exertion, exercise, sneezing or coughing. This pathology
      causes physical discomfort and impacts the quality of life in a negative manner.
      Physiotherapeutic exercises is a treatment with low cost and high patient attendance. It can
      be applied with focus on strengthening the pelvic floor muscles or on muscular synergism.
      OBJECTIVE: To compare the effectiveness of Kegel exercises performed alone or performed in
      association with the strengthening of the muscles of the hip in the treatment of stress
      urinary incontinence. METHODOLOGY: The study is a randomized, blinded clinical trial. It aims
      at assessing objectively the strength of the pelvic floor, the improvement in the number of
      episodes of loss and impact on quality of life. The study will accept up to 40 women, who
      will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic
      floor muscles with Kegel exercises) and group 2 (that will perform strengthening the pelvic
      floor muscles with Kegel exercises associated with the strengthening of muscles of the hip).
      The two groups will be evaluated at the beginning and at the end of treatment.
    

Detailed description: 
      the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer
    

Intervention name(s): Strengthening of pelvic floor muscles.; Strengthening of hip muscles.
Intervention type(s): Other; Other
Intervention description(s): Kegel exercises kinesiotherapy; Kegel exercises and strengthening of hip muscles as Gluteus Maximus and Medius and adductor muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
Condition: Anaphylaxis
MeSH terms: Anaphylaxis
Study type: Interventional

Summary: 
      This study is a preliminary report of pharmacokinetic data of epinephrine administered via
      intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.
    

Detailed description: 
      Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly
      training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI)
      may be more benefit such as intranasal route.
    

Intervention name(s): Epinephrine
Intervention type(s): Drug
Intervention description(s): Intranasal epinephrine 5 mg /spray
Intramuscular epinephrine 0.3 mg
Intranasal saline spray
Other intervention name(s): adrenaline
Intervention MeSH terms: Epinephrine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intranasal epinephrine; Plasma epinephrine level
A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2
Condition: Early Caries Lesions
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in
      orthodontic patients during fixed appliances.
    


Intervention name(s): CPP-ACP (GC Tooth Mousse); CPP-ACP (GC MI Paste Plus); Fluoride (Elmex Medical Gel)
Intervention type(s): Device; Device; Device
Intervention description(s): Calcium and phosphate; Calcium, phosphate and fluoride; Fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure
Condition: Heart Failure; Heart Decompensation
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This observational study is conducted to assess the evolution of multiple markers of
      congestion over 4 weeks after a worsening heart failure (WHF) event treated in an outpatient
      unit
    

Detailed description: 
      This is a multicenter, non-randomized, observational study designed to assess the evolution
      of multiple markers (physical, echocardiographic, and biomarkers) of congestion in 40
      patients with chronic heart failure (CHF) treated over 4 weeks with 40 to 120 mg daily oral
      furosemide after an event of WHF treated in an outpatient unit. Patients at selected centers
      may participate in a telemetry ancillary study, in which real-time, continuous, non-invasive
      measurements of physiologic parameters of heart failure will be obtained through use of a
      wearable medical telemetry device.

      Approximately 40 patients with CHF with reduced or mildly reduced left ventricular ejection
      fraction (EF < 50%) who had an admission for WHF in the preceding 1-12 months and who develop
      symptoms of WHF over the week before presentation to an outpatient clinic will be enrolled.
      Patients will attend five outpatient visits over the course of 4 weeks.

      At each visit, the patient's vital signs will be measured, clinical assessments (NYHA class,
      jugular vein distension, peripheral edema score, pulmonary rales) will be performed, and
      blood samples for central assays will be obtained. Detailed echocardiographic examination
      will be performed prior to enrolment in the first visit and at Visit 5.

      Biomarkers related to cardiac and renal function will be measured in blood and urine samples
      at each visit.
    

Intervention name(s): Observational study
Intervention type(s): Other
Intervention description(s): This is an observational study designed to assess the evolution of multiple markers of congestion over 4 weeks after a WHF event treated in an outpatient unit
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 40 adult male and female patients with a diagnosis of HFrEF (EF<40%) and
        HFmrEF (EF >40 < 50%) who had a hospital admission for HF within 1 to12 months prior to
        screening and developed worsening symptoms of HF during the week prior to presentation to
        an outpatient clinic.
      
Biospecimen description: 
      Blood samples (plasma) and urine samples for central laboratory assessment will be taken at
      Visits 1, and Visit 5. Sample aliquots will be stored frozen locally until shipped for
      longer-term storage and analysis. Unused samples will be discarded within 7 years after the
      study's completion.
    
Keywords: Worsening Heart Failure
Effectiveness of a Nutraceutical in Raising Circulating Serum Vitamin, Mineral and Amino Acid Levels in Patients.
Condition: Vitamin Deficiency
MeSH terms: Avitaminosis
Study type: Interventional

Summary: 
      The purpose of this study is to correlate the findings of an early study with current data.
    


Intervention name(s): EZPAK; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One packet with breakfast for three months; One packet with breakfast for three months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Triple blind
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Feasibility Study: Ulthera System for the Treatment of Rosacea
Condition: Erythematotelangiectatic Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy
      treatments on the cheeks, depending on their assigned study group. Follow-up visits will
      occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60
      min post-treatment, and at each follow-up visit.
    

Detailed description: 
      This study is a prospective, randomized, single-center clinical trial. The study will be
      conducted in two Phases. In Phase I, subjects will be assigned to one of two treatment
      groups. One study group will receive one dual depth Ultherapy treatment to a region on the
      cheeks, and one study group will receive two dual depth Ultherapy treatments to a region on
      the cheeks 14 days apart. Average pain scores will be obtained using a Numeric Rating Scale
      following each region of treatment and for each depth of treatment. In Phase II, based on
      observations of last follow-up visit in Phase I (at 90 days after treatment), subjects will
      be given the option to receive treatment of the affected area(s) for the protocol specified
      region, treated at the treatment depth showing the most efficacy in Phase I. Efficacy will be
      determined by improvement in Erythematotelangiectatic Rosacea in the treatment area versus
      control (an untreated area) as determined by primary investigator assessment at the last
      follow-up visit in Phase I.
    

Intervention name(s): Ulthera System providing one treatment per cheek; Ulthera System providing two treatments per cheek
Intervention type(s): Device; Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin per cheek.; Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™; Ultherapy™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rosacea; Ulthera System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for the skin