bioihbjkbjnl/mcl2 huggingface dataset:
Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic
      manipulation for the prevention of further ear infections in children with recurrent ear
      infections (otitis media).
    

Detailed description: 
      Acute otitis media (inflammation of the middle ear) occurs in 60% of infants during the first
      year of life and in 85% by age 3. Approximately 17% of children suffer recurrent otitis media
      during the first year of life. Following acute otitis media, middle ear fluid effusions can
      persist for weeks to months. Approximately 40% of children with middle ear effusions have
      mild to moderate hearing loss for the duration of the effusion, and several studies have
      found evidence for impaired speech and language development among children with prolonged
      middle ear effusion. Since antibiotic use has become widespread, concern has emerged
      regarding antibiotic resistant S. pneumoniae strains and other bacteria. Children with
      recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion
      of tubes to prevent accumulation of middle ear effusion. The prevalence of pediatric use of
      complementary alternative medical (CAM) approaches for prevention of otitis media has not
      been widely quantified. This study will evaluate the use of osteopathic manipulation and
      echinacea therapy to prevent ear infection in children with recurrent otitis media.
    

Intervention name(s): Craniosacral Osteopathic Manipulative Treatment; Botanicals
Intervention type(s): Procedure; Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety and tolerability of PRO 140, an
      investigational anti-HIV drug, administered via intravenous infusion.

      Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans
      and will result in measurable concentrations of the product in serum.
    

Detailed description: 
      PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a
      co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and
      potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO
      140 is being developed for therapy of HIV infected individuals. The purpose of this study is
      to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The
      pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study.

      Participants in this study will be randomly assigned to receive a single dose of one of
      several possible doses of PRO 140 or placebo. Participants will remain in the clinic for
      observation and evaluation for 24 hours after the single-dose administration. Follow-up
      visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams,
      electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and
      urine collection will occur at most visits.
    

Intervention name(s): PRO 140
Intervention type(s): Drug
Intervention description(s): Monoclonal antibody to CCR5
Other intervention name(s): Humanized monoclonal antibody to CCR5
Intervention MeSH terms: Leronlimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin
Condition: Kidney Diseases; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of renal function on the biological
      activity of telavancin using blood samples obtained from subjects with normal renal function,
      severe renal impairment, and end stage renal disease.
    


Intervention name(s): telavancin
Intervention type(s): Drug
Intervention description(s): Intravenous
Other intervention name(s): VIBATIV®; TD-6424; ASP9809
Intervention MeSH terms: Telavancin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: telavancin; Pharmacokinetics; Severe renal disease; VIBATIV®; ASP9809
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to investigate the relative bioavailability of two BIIL
      284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg
      following a standard breakfast in healthy male volunteers
    


Intervention name(s): BIIL 284 BS tablet C; BIIL 284 BS tablet D; BIIL 284 BS WIF tablet
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction.
Condition: ST-Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to examine the effect of the cholesterol lowering agent Ezetimibe
      when used in addition to optimal treatment with Atorvastatin in patients with acute
      ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy.

      An area with arteriosclerosis not demanding intervention in a coronary vessel other than the
      infarct related is used as measuring point and is examined at time of the infarction and
      after 12 month using intravascular ultrasound and optical coherence tomography. At the same
      time the same techniques are used to examine the implanted stent.
    

Detailed description: 
      Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) with tissue
      characterization (IVUS-TC) are relatively new expansions to intravascular assessments, and
      has the capacity to assess plaque composition and, potentially, to identify vulnerable
      plaques. One of the mechanisms by which statins improve patient outcomes may be by changing
      the composition of a "vulnerable" plaque. The main effect is believed to rely on a lowering
      of LDL-c. The question is whether a further reduction of LDL by adding ezetimibe to optimal
      cholesterol lowering therapy using statins may result in further plaque stabilization or
      reduction. This is the hypothesis of the current study.

      100 patients are randomized to Ezetimibe 10 mg per day or placebo. All patients are treated
      with Atorvastatin 80 mg. OCT and IVUS are performed at inclusion (typically the day after
      Primary PCI) and again at follow-up after 12 month.
    

Intervention name(s): Ezetimibe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.; 100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
Other intervention name(s): Ezetrol; Zarator; Ezetrol; Zarator
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: ST-Segment Elevation Myocardial Infarction; Intravascular ultrasound; IVUS; Optical coherence tomography; OCT; Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Randomized trial; Hypolipidemic Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses
Olmesartan Medoxomil in Hypertension and Renal Impairment
Condition: Essential Hypertension; Renal Impairment
MeSH terms: Renal Insufficiency; Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study in hypertensive patients with mild to moderate renal impairment. The
      antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
    


Intervention name(s): Olmesartan medoxomil; Losartan; Furosemide oral tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.; Medications are taken once daily before breakfast with water.; If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator
Intervention MeSH terms: Losartan; Olmesartan; Olmesartan Medoxomil; Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation and Characterization of Behavioural Disorders and Dementias by the Behavioural Dysexecutive Syndrome Inventory (BDSI)
Condition: Frontotemporal Dementia; Huntington Disease; Alzheimer Disease; Semantic Dementia; Dementia, Vascular
MeSH terms: Alzheimer Disease; Dementia; Huntington Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular
Study type: Observational

Summary: 
      Behavioural disorders are very common right from the initial stage of dementia and contribute
      to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their
      prevalence and their diagnostic importance, as they often constitute the initial symptoms of
      Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they
      are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD).
      The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been
      partially evaluated and would increase the risk of progression to dementia. These classical
      data are based on non-standardized assessments and non-validated diagnostic criteria. The
      Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a
      standardized assessment tool for behavioural dysexecutive disorders, the Behavioural
      Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this
      syndrome.
    


Intervention name(s): prevalence of behavioural dysexecutive syndrome
Intervention type(s): Behavioral
Intervention description(s): Behavioural Dysexecutive Syndrome Inventory (ISDC)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        French-speaking subjects between the ages of 40 and 85 years with an MMSE score > 15/30,
        followed for AD or MCI or VaD or FTD or SD or HD will be selected by their neurologist
        during a routine memory assessment visit.
      
Keywords: behavioural disorders
Levetiracetam for Benign Rolandic Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to test if the language problems commonly seen in children with benign
      rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.
    

Detailed description: 
      This is a 6 month study in which children on another anticonvulsant would have EEG, language
      testing, and a clinic visit at baseline. They would then be rapidly transitioned off of their
      current anticonvulsant and onto levetiracetam (Keppra). Repeat EEG and language testing would
      be done after 6 months to evaluate for improvement.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Benign rolandic; Levetiracetam
Protein Supplementation and Exercise Training in Burn Patients
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle
      strength, muscle mass and impairment of functional mobility. Purpose: The purpose of this
      study is to investigate the efficacy of combination of exercise training and protein
      supplementation on lean body mass (LBM) and muscle strength in patients with severe burn.
    

Detailed description: 
      Sixty participants with severe burn > 30% total body surface area (TBSA) were randomly
      distributed into 4 equal groups of 15 participants per group. Group A (Protein+ Exercise
      group) received oral protein supplementation, exercise program and traditional burn care,
      group B (Protein group) received oral protein supplementation and traditional burn care,
      group C (Exercise group) received exercise program and traditional burn care, group D
      (Control group) received traditional burn care. LBM was measured using Dual-energy x-ray
      absorptiometry (DXA) while muscle strength was measured using Biodex 3 Dynamometer System
      before treatment and 12 weeks after treatment.
    

Intervention name(s): whey protein supplementation powder (Inkospor X-TREME; France); Exercise training program; traditional burn care
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): Protein requirements for burned adults are estimated as 1.5-2.0 g/kg/day. The participants asked to take the calculated serving of whey protein dissolved in 150ml of water two times / day in the morning and in the evening; After healing of the burn (6 weeks after injury), participants in group A and group C started resisted exercise program with a qualified therapist for 1 hour three times/week on nonconsecutive days over 12 weeks. In addition, aerobic exercises were conducted on the treadmill. Peak oxygen consumption was assessed for all patients by using the exercise test on treadmill before participation in aerobic exercises.; ROM exercises, stretching, ADL activities and scar management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Exercise training; Protein supplementation; Muscle strength; Lean body mass; Burn
Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the overall efficacy of aripiprazole
      intramuscular (IM) depot as acute treatment in subjects with schizophrenia.

      The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot
      administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.
    


Intervention name(s): Aripiprazole IM Depot; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Matching Placebo
Other intervention name(s): OPC-14597; Lu AF41155
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture
Condition: Distal Radius Fracture; Pain
MeSH terms: Radius Fractures; Wrist Fractures
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery
      (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was
      carried out on 36 patients. These patients were randomly assigned to two groups: classic
      treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week)
      physical therapy and rehabilitation intervention. Outcome measurements were based on upper
      extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand
      Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale),
      range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation
      with goniometer), grip strength (standard grip strength with Jamar hydraulic hand
      dynamometer; lateral, palmar and pinch strength with pinch meter).
    


Intervention name(s): Cognitive Therapy
Intervention type(s): Procedure
Intervention description(s): Graded Motor Imagery has three stages:
Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks)
Other intervention name(s): Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Combined Pharmacotherapy for Cannabis Dependency
Condition: Cannabis Dependence; Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to see if Lofexidine in combination with Marinol is superior to
      placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in
      cannabis-dependent patients seeking treatment for their marijuana use.
    

Detailed description: 
      Cannabis use disorders remain the most common illicit drug use disorder and options for
      treatment remain limited. Compared to other abusable substances, there has been little
      investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy
      for cannabis dependence has yet to been developed. The development of effective cannabis
      dependence pharmacotherapy is an important unmet public health need. Agonist pharmacotherapy
      strategies have been effective for other substance use disorders (e.g., opioid and nicotine
      use disorders) and the endocannabinoid system represents a promising target for agonist
      pharmacotherapy with dronabinol. Lofexidine, a noradrenergic system suppressant, is effective
      in treating opioid withdrawal and shows promise as a cannabis use disorder pharmacotherapy.
      Haney et al. (2008) found that the combination of lofexidine and dronabinol (Lofex-Dro) was
      superior to placebo, lofexidine alone, or dronabinol alone in improving sleep and other
      cannabis withdrawal symptoms. Further, reduction in craving and relapse was greater for this
      combined pharmacotherapy relative to either medication alone or placebo. The proposed
      protocol is a 2 group, double blind, placebo-controlled outpatient study of the safety and
      efficacy of the combination of dronabinol and lofexidine for the treatment of cannabis
      dependence. We plan to enroll 180 subjects in a 12-week trial. The primary hypothesis is that
      dronabinol will act as an agonist treatment while lofexidine will suppress craving- and
      cue-induced related stress such that the combination will act in a complementary manner to
      induce prolonged abstinence from marijuana.
    

Intervention name(s): Dronabinol; Placebo; Lofexidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dronabinol: 20 mg/TID; Placebo control; Lofex: .6 mg/ TID
Other intervention name(s): Marinol
Intervention MeSH terms: Lofexidine; Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabis Dependence; Marijuana Dependence; Marinol; Lofexidine
Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax
Condition: Malaria, Vivax
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine
      to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to
      justify an IND and formal phase II evaluation.
    

Detailed description: 
      This is a randomized, open-label study that will treat adult subjects with Plasmodium vivax
      infection with chloroquine for 3 days and tinidazole for 5 days concomitantly to assess
      efficacy for radical cure (clearance of blood and liver stages of infection). There will be
      randomization to a positive comparator arm treated with chloroquine and primaquine
      (definitive radical cure) in order to obtain an estimate of the rate of re-infection during
      the monitoring period in the study population.

      A simple randomization procedure will assign subjects to one of the two arms (treatment arm
      or comparator arm). The ratio of assignment will be 2:1, treatment arm to the comparator arm.
      The exact number assigned to the treatment arm will vary depending on the initial outcome of
      early enrollees per the sequential analysis design of the trial. In the worse case scenario
      of no clear trend developing early, no more than 50 subjects will be required to complete the
      trial in the study drug arm in order to arrive at a conclusion regarding the study drug.

      Follow-up period will be for 90 days. This will allow us to capture essentially all early
      relapses that would occur under normal circumstances, as well as assess if tinidazole may
      delay but not fully eliminate recurrence. Subjects without a recurrence at 90 days will be
      considered to have achieved radical cure.

      This study will use a modified triangular test, a form of sequential analysis designed to
      enable repeated statistical analyses throughout the study recruitment period, while
      maintaining a pre-specified power and type I error. The trial can be stopped as soon as the
      information accumulated is considered sufficient to reach a conclusion and it will limit
      enrollment and exposure to a failing treatment regimen.

      Results of this study will be sufficient to determine whether tinidazole should be designated
      as an "early kill" (an ineffective drug for vivax malaria radical cure with no future
      evaluation) or whether it is sufficiently efficacious to warrant further investment with an
      IND and formal phase II study to seek an SNDA.
    

Intervention name(s): Tinidazole; chloroquine
Intervention type(s): Drug; Drug
Intervention description(s): 2gms, p.o. q.d. for 5 days
Intervention MeSH terms: Chloroquine; Tinidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria, Vivax/*drug therapy; Tinidazole/pharmacology/*therapeutic use; Recurrence; Plasmodium vivax/*drug effects