bioihbjkbjnl/mcl2 huggingface dataset:
Inpatient Single Dose Interventions for Alcohol Use Disorder
Condition: Alcohol Use Disorder, Severe
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Every year, alcohol use disorder (AUD) generates millions of emergency department (ED) visits
      and hospital admissions, costing the U.S. health sector over $90 billion. These hospital
      admissions are critical opportunities to start patients on addiction pharmacotherapy, but
      factors like medication non-adherence and post-discharge relapse contribute to frequent
      re-admissions. Two single-dose interventions are well suited to facilitate treatment
      retention and prevent re-admissions due to their prolonged, adherence-independent effects:
      extended-release (XR) naltrexone injection and intravenous (IV) ketamine infusion. These have
      not been thoroughly investigated in the hospital setting among high-utilizer, safety-net
      populations. Therefore, the investigators aim to:

        1. Test the feasibility of randomizing hospitalized patients (n=45-60, age 18-65) with
           multiple AUD-related admissions to treatment with either extended-release (XR)
           naltrexone, intravenous (IV) ketamine, or no single-dose medication, all with enhanced
           linkage to care. Feasibility outcomes such as recruitment rate, patient acceptability,
           post-discharge follow-up rate, and adverse events will help to identify key lessons for
           a future comparative effectiveness study.

        2. Estimate the 30-day re-admission rate for patients randomized to treatment with XR
           naltrexone, with IV ketamine, or no single-dose medication, all with enhanced linkage to
           care. The investigators hypothesize that the re-admission rate will be lower for each of
           the two single-dose medication groups than for the "linkage-alone" group.
    


Intervention name(s): Naltrexone 380 MG; Ketamine Hydrochloride; Enhanced linkage
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): XR naltrexone to be given once prior to hospital discharge; IV ketamine infusion to be given once prior to hospital discharge; Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up
Intervention MeSH terms: Naltrexone; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo
Condition: VITILIGO
MeSH terms: Vitiligo
Study type: Observational

Summary: 
      This study aims to evaluate some differences in the immune system between patients with
      vitiligo and patients without the disease.

      These differences will be evaluated by the extraction of peripheral blood that will be
      analyzed before the treatment and after the treatment that, in the habitual way and at the
      discretion of the responsible dermatologist.

      Patients agreeing to participate in the study will be subjected to extraction of two tubes
      (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.

      Therefore, neither treatment nor follow-up visits will be modified by participation, but will
      be the same whether or not participate in the study.

      In the case of controls, two peripheral blood tubes (20ml) will be removed in a single
      participation.

      Patients with vitiligo will also be asked to complete questionnaires to measure stress,
      depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12
      weeks (+/- 5 days) of therapeutic intervention .

      This study will include 20 patients with active non-segmental vitiligo and 10 controls
      without the disease. The duration of participation in this study will be 12 weeks (+/- 5
      days) for patients with vitiligo and a single participation (extraction of 20 ml of
      peripheral venous blood) for the controls.
    


Intervention name(s): CD 91 levels; Tregs
Intervention type(s): Diagnostic Test; Diagnostic Test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        18 to 65 years-old both sex
      
Biospecimen description: 
      Periferic blood /serum
    
Keywords: TREGS; CD91; LRP1
The Effect of Osteopathic Manual Therapy on Vascular Supply
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the use of osteopathic manual therapy can
      influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a
      group of subjects with knee osteoarthritis. It is also the objective of this study to
      determine if there is a difference between the osteopathic evaluation and the combination of
      an osteopathic evaluation and treatment.
    


Intervention name(s): Osteopathic evaluation; Osteopathic evaluation with treatment
Intervention type(s): Other; Other
Intervention description(s): evaluation of movement and tissue mobility; osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; manual therapy; osteopathy
Platelet-rich Plasma for Meniscus Repair
Condition: Platelet-Rich Plasma; Knee Injuries; Meniscus Disorder
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by
      comparing the imaging and clinical outcomes between patients receiving PRP with meniscus
      repair surgery and those receiving meniscus repair surgery only.
    

Detailed description: 
      Damage to meniscal tissue is challenging for orthopedic surgeons because of the absence of
      healing at the avascular zone. Additionally, the accelerated degeneration of articular
      cartilage and increased rate of knee osteoarthritis that can occur following a meniscal
      injury. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and
      multiple growth factors concentrated at high level. Because activated platelets have the
      potential to release growth factors, PRP has been clinically used to accelerate wound healing
      and tissue regeneration in orthopedic and oral surgery. Several in vivo and in vitro studies
      have reported favorable outcomes of PRP on meniscal repair; however, the clinical results
      varied between studies.This clinical trial will investigate the effect of PRP on on meniscus
      injury. Eligible patients will be randomly assigned to receive PRP with meniscus repair
      surgery or to receive meniscus repair surgery only. The postoperative imaging and clinical
      outcomes will be compared and analyzed.
    

Intervention name(s): platelet-rich plasma; control
Intervention type(s): Other; Other
Intervention description(s): Autologous platelet-rich plasma gel applied during meniscus repair surgery; Meniscus repair surgery only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet-Rich Plasma; Meniscus; Knee Injuries
Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of
      progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous
      immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease.

      This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI over
      24 months after the first infusion. This study will also document conversion from MCI to
      Alzheimer's Disease.
    

Detailed description: 
      Screening procedures at visit 1 will take place up to 28 days prior to Visit 2 (Day 1)
      dosing. Screening labs and assessments will be performed during the screening period. A brain
      MRI will be obtained as standard of care within 6 months prior to the screening period. The
      first dose of study drug is administered on Day 1. Visits 2 through 6 have a ±1 day window
      and occur every 14 days over two months. The investigator will determine if a subject is
      suitable to continue following the missed infusion. Visits 7 through 12 (Month 4 through
      Month 24) have a ±7 day window.

      All study screening data from Visit 1 including laboratory results must be reviewed for study
      eligibility prior to receiving first dose of study drug. Visit 2 physical exams and
      neurological exams prior to infusion may occur within 72 hours prior to the first infusion.
      Prior to infusion, a review of concomitant medications and adverse events takes place to
      ensure that no excluded medications have been added or medication discontinued or dose
      changed that were required to have been stable. If the subject continues to be eligible for
      enrollment, the subject will be randomized, infused with study medication and will remain in
      the infusion clinic for at least 4 hours following the start of the infusion for safety
      assessments on Visit 2 (Day 1).
    

Intervention name(s): NewGam 10% IVIG; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo.; Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Intravenous immunotherapy; Conversion to Alzheimer Disease
Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a
      chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of
      treatment.

      Main outcome parameter is the non-inferiority in number of responders between the two
      treatment groups. A responder is defined as a reduction by 50% of the total baseline score
      taken prior to treatment start. The symptoms are assessed with a symptom score.
    

Detailed description: 
      Further secondary parameters are :

      Responders during at day 4 and 5, single symptom scores during 1 to 5 days of observation,
      pain at begin and end (100mm VAS), assessment of efficacy by physician and patient,
      consumption of rescue medication

      Assessment of safety by physician and patient, frequency of adverse events
    

Intervention name(s): chlorhexidine/lidocaine; echinacea/sage
Intervention type(s): Drug; Drug
Intervention MeSH terms: Chlorhexidine; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sore throats,; Pharyngitis; Acute
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
Condition: Postmenopausal Symptoms
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the efficacy and safety of repeated administration of
      G-CSF for the treatment of hot flashes and vasomotor symptoms in women with
      naturally-occurring or surgically induced menopause. G-CSF will be administered three times
      at 28 day intervals to postmenopausal women, ages 40 to 65, suffering at least 49 moderate to
      severe hot flashes per week.
    

Detailed description: 
      This is a 12-week, multicenter, randomized, double-blind, placebo-controlled study. Eligible
      subjects will be stratified by natural or surgical menopause and randomized (1:1) to receive
      3 single injections, 28-days apart, of either G-CSF or placebo.

      This study will consist of a 14-21 day screening period. Subjects enrolled will be given
      three single 1.0 mL subcutaneous (SC) injections (repeated 28-days apart), in the outer area
      of either upper arm, of either G-CSF or placebo (sterile physiological saline) at Baseline,
      Day 28 and Day 56. Subjects will be followed for 12 weeks and will complete hot flash diary
      entries every day for the duration of treatment. Safety will be assessed by adverse events,
      clinical laboratory tests (clinical chemistry and complete blood count with differential) and
      vital signs. A follow-up phone call will occur 60 days after the last dose of study drug.

      Eligibility will be assessed via physical examination, clinical laboratory testing, vital
      signs.

      Subjects will receive a diary in which to record daily hot flashes symptoms during the
      duration of the screening period. Subjects must have at least 14 days of hot flash recordings
      to participate in the study. The diary will be reviewed by study site staff on Baseline (Day
      0) to confirm study eligibility.

      During the treatment period, subjects will return to the study site at Days 1, 21, 28, 29,
      49, 56, 57, and 84 for assessments.

      The follow-up phone call will occur approximately 60 days following the last dose of study
      drug.
    

Intervention name(s): G-CSF; Placebo/Saline
Intervention type(s): Biological; Other
Intervention description(s): G-CSF injected subcutaneously 3 times (Days 0, 28, 56); Placebo/saline injected subcutaneously 3 times (Days 0, 28, 56)
Other intervention name(s): Filgrastim; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot Flashes; Vasomotor Symptoms; Menopause
A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503)
      dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in healthy
      Japanese male participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      randomized (the study drug is assigned by chance), 2-way crossover study (participants may
      receive different interventions sequentially during the trial). All participants will receive
      a single 50-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two
      25-mg TRF tablets and one 50-mg TRF tablet. All participants will be randomly assigned to 1
      of 2 possible treatment sequences and receive both of the following treatments, 1 in each
      period:

      Treatment A: two tapentadol (CG5503) ER 25-mg TRF tablets, administered as a single oral dose
      under fasted condition Treatment B: one tapentadol (CG5503) ER 50-mg TRF tablet, administered
      as a single oral dose under fasted condition Each period will be separated by 7 - 14 days
    

Intervention name(s): tapentadol (CG5503) ER 25-mg TRF; tapentadol (CG5503) ER 50-mg TRF
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg TRF single oral dose; 50 mg TRF single oral dose
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: tapentadol; NUCYNTA; CG5503; R331333; pharmacokinetics; healthy volunteer
N-acetylcysteine for Tobacco Use Disorder
Condition: Nicotine Dependence; Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to
      assist in initial cessation and/or relapse prevention in adult cigarette smokers.
    

Detailed description: 
      The aim of this study is to assess the effects of N-acetylcysteine (NAC) on initial cessation
      and relapse prevention in adult cigarette smokers. Specifically, this study has the following
      aims: Aim 1) Examine the efficacy of NAC, compared to placebo, in helping smokers achieve
      three days of continuous abstinence; Aim 2) Among those who maintain initial 3-day
      abstinence, examine the time to relapse over the 8-week intervention between NAC and placebo
      groups; Aim 3) Assess 7-day point prevalence abstinence at the 8-week end-of-treatment study
      visit in order to obtain effect sizes and estimates of variability to power a randomized
      clinical trial.
    

Intervention name(s): N-acetylcysteine (NAC); Placebo
Intervention type(s): Drug; Other
Intervention description(s): NAC or matched placebo will be given to study participants for 8 weeks.; Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support.
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nicotine; tobacco; smoking; cessation; N-acetylcysteine; NAC; pharmacotherapy; relapse; tobacco use disorder
Open-label, Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of this open-label Phase Ia study are to evaluate the Pharmacokinetics (PK)
      profiles of new novel single-dose Ondansetron Pulsatile Release (Ond-PR) formulations in
      normal healthy volunteers. After this initial phase, the investigators will follow with the
      Phase Ib study to determine Pharmacokinetic/Pharmacodynamic (PK/PD), safety, and tolerability
      interactions following simultaneous administration of these ondansetron formulations with a
      10 mg Methylphenidate Immediate Release (MPh-IR) tablet in normal healthy volunteers.
    

Detailed description: 
      We will compare 2 different pulsatile-release formulations of ondansetron, PR1 and PR2.
      Ond-PR1 is a pH-sensitive formulation while Ond-PR2 is osmotic-sensitive.
    

Intervention name(s): Ond-PR1; Ond-PR1 + MPh-IR; Ond-PR2; Ond-PR2 +_ MPh-IR
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1); Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1) plus 10 mg methylphenidate immediate release (Mph-IR); Single oral dose of 8 mg ondansetron pulsatile-release formulation 2 (Ond-PR2); Single oral dose of 8 mg of ondansetron pulsatile-release formulation 2 (Ond-PR2) plus 10 mg methylphenidate immediate release (Mph-IR)
Other intervention name(s): Zofran (ondansetron hydrochloride); Zofran (ondansetron hydrochloride); Ritalin (methylphenidate hydrochloride); Zofran (ondansetron hydrochloride); Zofran (ondansetron hydrochloride); Ritalin (methylphenidate hydrochloride)
Intervention MeSH terms: Ondansetron; Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ondansetron; Methylphenidate
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Parts A and B: The primary objective of this study is to evaluate the safety and tolerability
      of single and multiple ascending oral doses of BIIB113 in healthy participants. The secondary
      objectives of this study are to evaluate the single and multiple oral dose pharmacokinetic
      (PK) profile of BIIB113 in healthy participants and to evaluate the effect of food on the
      single oral dose of BIIB113 in healthy participants of Part A cohort 3.

      Part C: The primary objectives of this study are to evaluate the safety and tolerability of
      single and multiple ascending oral doses of BIIB113 in healthy participants and to determine
      target occupancy (TO) as measured by O-GlcNAcase-Positron Emission Tomography (OGA-PET) of
      single and multiple oral doses of BIIB113 in healthy participants.
    

Detailed description: 
      BIIB113 is a small molecule inhibitor of OGA being evaluated in Alzheimer's disease.
    

Intervention name(s): BIIB113; BIIB113-Matching Placebo; 11^C]BIO-1819578
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome
Condition: KERATOCONJUNCTIVITIS SICCA; XEROSTOMIA; SICCA SYNDROME; PRIMARY SJOGREN SYNDROME
MeSH terms: Sjogren's Syndrome; Xerostomia; Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Syndrome
Study type: Interventional

Summary: 
      This study was designed to test the efficacy and safety of low laser therapy to treat the
      xerostomia of patients with primary Sjogren's Syndrome.
    

Detailed description: 
      The Sjogren's Syndrome is a disease that affects around 0,5% of the population and is mainly
      characterized for inflammatory involvement of salivary and lacrimal glands.

      The xerostomia leads to low quality of life caused by dry sensations that can disturb the
      taste, the speaking, the swallow and chewing functions in the affected patients. The absent
      saliva can cause increase of dental caries and decays.

      Until now, there is no effective treatment that increases the amount of saliva and the
      patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline.
      These drugs can cause unpleasant collateral effects.
    

Intervention name(s): Lasertherapy; Sham Lasertherapy
Intervention type(s): Device; Device
Intervention description(s): Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group); Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sjogrens Syndrome; Syndrome, Sjogren's; Sjogren Syndrome; Sicca Syndrome; Syndrome, Sicca