bioihbjkbjnl/mcl2 huggingface dataset:
Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)
Condition: Degenerative Disc Disease, Lumbar
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      This study is being conducted to determine the percentage of patients with solid spinal
      fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique
      processing conditions, Osteocel Plus retains a high concentration of stem cells in
      conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with
      Osteocel Plus will be comparable to published data for autograft. The Osteocel product family
      has already been used in approximately 15,000 cases worldwide.
    

Detailed description: 
      This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus
      in subjects who receive ALIF surgery at one or two levels. These subjects will present with
      degenerative conditions in the lumbar spine that are amenable to surgical treatment and will
      be screened prior to study enrollment. Subjects will receive Osteocel Plus during their ALIF
      operation. Subjects will be followed for 24-months following surgery to determine the number
      of study subjects that are solidly fused at or before 24 months postoperatively, and to
      determine the mean time to fusion. This data will be compared to published and/or
      retrospective data for autograft, synthetic ceramics and BMP.
    

Intervention name(s): Osteocel Plus
Intervention type(s): Biological
Intervention description(s): biologic
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Existing clinic patients
      
Keywords: biologics; fusion rates; lumbar fusion; ALIF
Rivastigmine For Methamphetamine Dependent Individuals
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Methamphetamine abuse has been steadily increasing over the past decade. Rivastigmine is a
      medication that may be helpful in treating methamphetamine dependence. The purpose of this
      study is to evaluate the effectiveness of rivastigmine in treating methamphetamine dependent
      individuals.
    

Detailed description: 
      Methamphetamine is a powerful stimulant that affects the central nervous system. Chronic
      methamphetamine use often leads to psychotic behavior. Rivastigmine is an
      acetylcholinesterase inhibitor that is currently approved to treat Alzheimer's-related
      dementia. The purpose of this study is to assess the efficacy of rivastigmine in treating
      methamphetamine dependent individuals.

      Participants will be randomly assigned to either one of two dose levels of rivastigmine or
      placebo for 12 weeks. Participants will be assessed for cardiovascular, subjective, and
      reinforcing effects that are produced by methamphetamine. All participants will partake in
      contingency management sessions through Week 4.
    

Intervention name(s): Rivastigmine
Intervention type(s): Drug
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to
      MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.
    


Intervention name(s): MK-6213; Atorvastatin calcium; Placebo for MK-6312 160 mg; Placebo for Atorvastatin 20 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): MK-6213 160 mg for 4 weeks.; atorvastatin calcium 20mg for 4 weeks.
Other intervention name(s): atorvastatin; LIPITOR ®
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders
Condition: Poor Responders; Dehydroepiandrosterone
Study type: Interventional

Summary: 
      To investigate whether the DHEA supplementation could improve mitochondrial quality in poor
      ovarian responders
    

Detailed description: 
      Women who underwent in vitro fertilization (IVF) treatment participated, including normal
      ovarian responders (NORs) and poor ovarian responders (PORs). PORs were assigned to receive
      DHEA supplementation or not before the IVF cycle. For all patients, cumulus cells (CCs) were
      obtained after oocyte retrieval. In the CCs, mRNA expression of mitochondria-related genes
      was measured. To compare the mRNA expression of mitochondria-related genes in the CCs among
      the three groups.
    

Intervention name(s): dehydroepiandrosterone (DHEA)
Intervention type(s): Dietary Supplement
Intervention description(s): Participants take DHEA 90 mg daily for two months at least before in vitro fertilization cycles.
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of LNP023 in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active Hemolysis
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal; Hemolysis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase 2, open label, single arm, multiple dose study to assess efficacy, safety,
      pharmacokinetics and pharmacodynamics of iptacopan when administered in addition to Standard
      of care (SoC) in patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active
      hemolysis.
    

Detailed description: 
      LNP023 is a novel oral small molecular weight compound that inhibits factor B (FB) of the
      alternative pathway (AP). Blockade of the AP with oral LNP023 has the potential to prevent
      both intra - and extravascular hemolysis.

      This two-cohort study consisted of a screening period of up to 68 days, a baseline visit, and
      Treatment periods Part 1 and Part 2. The planned duration of Treatment Part 1 was 13 weeks;
      the planned duration of Treatment Part 2 (treatment extension for patients who benefit from
      LNP023 treatment in Part 1 of the study based on reduced hemolytic parameters) was between
      approximately 2 to 3 years.

      Cohort 1: Orally administered iptacopan 200 mg b.i.d. in Part 1 and Part 2 in addition to
      SoC.

      Cohort 2: Orally administered iptacopan 50 mg b.i.d. for a minimum of 2 weeks in addition to
      SoC; this could be increased to iptacopan 200 mg b.i.d. at study day 15 or at any time later
      in the study if LDH was not within limit of normal or reduced by at least 60% as compared to
      baseline values.

      End of Study (EoS) visit happened 2 weeks after last LNP023 administration for patients not
      joining the roll over extension program (REP).

      A safety follow-up call was conducted 30 days after last administration of study treatment
      (applicable only for patients not joining the REP).
    

Intervention name(s): iptacopan; Standard of Care
Intervention type(s): Drug; Combination Product
Intervention description(s): iptacopan bid orally administered; Standard of Care (SoC) is defined as an antibody with anti C5 activity. At the time of study start, eculizumab was the only available SoC; eculizumab will be hereafter referred to as SoC.
Other intervention name(s): LNP023
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, non-randomized study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Complement; alternative pathway; paroxysmal nocturnal hemoglobinuria; hemolysis
Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to offer subjects from centers in Taiwan who successfully
      complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF
      for up to three additional years (144 weeks). Subjects will be followed per local standard of
      care. Serious adverse events (SAEs), drug accountability and patient disposition will be
      recorded.
    


Intervention name(s): Tenofovir DF
Intervention type(s): Drug
Intervention description(s): Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators
Other intervention name(s): Viread®
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
Condition: Anemia; Renal Insufficiency, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of
      anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on
      dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin
      alfa, epoetin beta, or darbepoetin alfa.
    


Intervention name(s): Mircera
Intervention type(s): Drug
Intervention description(s): The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.
Other intervention name(s): Methoxy polyethylene glycol-epoetin beta
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Yohimbine on Cocaine Cue Reactivity
Condition: Cocaine Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent
      individuals. In addition, there appears to be gender differences in determinants of relapse
      to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of
      the present study is to study the role of hormonal status on the response to cocaine-related
      cues with or without stress in cocaine-dependent women and men.
    

Detailed description: 
      Cocaine dependence is an insidious disease underscored by a strong propensity to relapse
      despite knowledge of the repercussions of continued drug-use. Stress and cocaine cues produce
      craving and ultimately relapse in cocaine dependent individuals. Pre-clinical research has
      demonstrated sex differences in response to cocaine-conditioned cues and cocaine-primed
      reinstatement, which correlates well with reduced plasma progesterone levels. Interestingly,
      this is consistent with a growing body of clinical literature indicating that progesterone
      may decrease the reinforcing properties of stimulants in women. Gender differences in the
      response to a social stressor and cocaine cues in cocaine-dependent individuals have been
      demonstrated in human laboratory studies, however, the interaction of stress and cues and the
      effect of hormonal status on response have not been explored. This study examines the role of
      hormonal status on the response to cocaine-related cues with or without a pharmacological
      stressor (yohimbine) in cocaine-dependent women and men. As a further integration of the
      research focus this study also explores the relationship between impulsivity and craving.
    

Intervention name(s): Yohimbine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants were pre-treated with either yohimbine or placebo.
Intervention MeSH terms: Yohimbine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine Addiction; Cocaine Dependence
Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial investigates the effects of FE 999049 compared to placebo.
    


Intervention name(s): Follitropin delta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg.
Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early ovarian hyperstimulation syndrome (OHSS) with the exception of gonadotropin-releasing hormone (GnRH) agonist for triggering of final follicular maturation, was not allowed; Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049.
Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed.
Other intervention name(s): FE 999049; REKOVELLE
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Topical Pharyngeal Anesthesia With Articaine for Gastroscopy
Condition: Gastroscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      Topical Pharyngeal anesthesia (TPA) is widely used during upper endoscopy. Articaine is local
      anaesthetic that have not been previously evaluated in pharyngeal anesthesia for upper
      endoscopy. The aim of this study was to compare pharyngeal anesthesia with 4% articaine to
      placebo (Na0,9%) during gastroscopy in terms of benefit on patients' and endoscopists'
      satisfaction.
    

Detailed description: 
      Topical Pharyngeal anesthesia (TPA) is widely used as an adjunct to sedation during upper
      endoscopy. TPA improves patient tolerance and the ease of endoscopy.1 Methemoglobinemia and
      anaphylactic reactions are serious complications of such topical anaesthetic agents, as
      lidocaine, tetracaine, and benzocaine. Articaine is as a unique amide local anaesthetic that
      possesses both an amide and an ester linkage and this is of clinical significance in
      minimizing the risk of overdose (toxic reaction). In routine dental procedures, articaine is
      a superior anaesthetic to lidocaine. Also, in comparison to lidocaine articaine acts faster
      and its duration of action is shorter what may be an advantage in such relatively fast
      procedures as gastroscopy. Articaine have not been previously evaluated in pharyngeal
      anesthesia for upper endoscopy. The aim of this randomised double-blind placebo controlled
      study was to compare pharyngeal anesthesia with 4% articaine to placebo (Na0,9%) during
      gastroscopy in terms of benefit on patients' and endoscopists'satisfaction.
    

Intervention name(s): articaine; 9% Sodium Chloride solution for injection
Intervention type(s): Drug; Other
Intervention description(s): Articaine is intermediate-acting local anesthetic (amide type). Like other local anesthetic drugs, articaine causes a transient and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.
In dentistry, articaine is used both for infiltration and block injections.; 9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer.
Other intervention name(s): Septocaine; Articadent; NaCl 0.9%
Intervention MeSH terms: Carticaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: topical pharyngeal anesthesia; articaine
Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication
Condition: Mercury Poisoning
MeSH terms: Poisoning; Mercury Poisoning
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of
      mercury intoxication.
    

Detailed description: 
      The objectives of this study are to evaluate the efficacy and safety of two doses of NBMI
      compared to placebo in mercury intoxicated patients.
    

Intervention name(s): Emeramide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide); NBMI Placebo
Other intervention name(s): NBMI; Irminix
Intervention MeSH terms: N,N'-Bis(2-mercaptoethyl)isophthalamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mercury toxicity poisoning
Pecs II Block and PaB Could be an Alternative in Breast Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The association between ultrasound-guided Pecs II block and parasternal block can represent a
      valid alternative in the management of acute and postoperative pain syndrome after
      quadrantectomy with or without axillary dissection.
    

Detailed description: 
      The combination of Pecs II block and PaB provides good management of postoperative pain and
      can be considered a viable alternative to common anesthetic procedures performed for breast
      cancer surgery.
    

Intervention name(s): Pecs II and parasternal blocks
Intervention type(s): Procedure
Intervention description(s): Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected.
An ultrasound-guided ipsilateral parasternal block was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib.
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for quadrantectomy with or without axillary dissection.
Mold Exposure and Impact on Asthma Control in French Asthmatic Children
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Observational

Summary: 
      Observational, multicenter, study conducted in 12 hospitals in the Nord and Pas-De-Calais
      departments. The aim of this study is to describe the relationship between reported exposure
      to molds and asthma control in a pediatric population.

      Each patient followed by a specialized asthma pediatrician in one of the study center will be
      proposed to participate in the study.

      Children aged 1 to < 18 years, with asthma diagnosis, based on the assessment of a
      specialized physician after a follow-up of at least 6 months Inclusion, non-inclusion and
      exclusion criteria will be verified by the investigators. The questionnaires will be
      completed during the consultation, collected by the physician in charge of the consultation
      and sent to the principal investigator for data entry.

      Inclusion will take place over a period of 12 consecutive months from the date of obtaining
      regulatory approval.
    


Intervention name(s): Questionnaire of Mold / moisture exposure
Intervention type(s): Other
Intervention description(s): Mold / moisture exposure is assessed by the 5 following questions, whose positive response has been associated with the actual presence of mold in the household (according to data from the literature data), asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home:
Presence of visible mold
Impression of dampness
Apparent dampness
Existence of recent water damage in the last year
Presence of a moldy odor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children follow-up by a specialized asthma pediatrician in secondary (general hospital) and
        tertiary care (Lille university hospital) centers.
      
Keywords: Asthma; Children; Mold; Moisture; Asthma Control
Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia
Condition: Pain
MeSH terms: Mydriasis
Study type: Interventional

Summary: 
      In this study, the pupillary dilation reflex is measured as a nociceptive indicator during
      elective abdominal surgery under general anesthesia.
    

Detailed description: 
      An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in
      response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in
      sedated patients, can be generated by various pain stimuli (built in standardized protocol,
      surgical incision, …) The PDR is a robust reflex, even in patients under general anesthesia,
      and provides a potential evaluation of the autonomous circuit within the nociceptive
      evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic
      stimulation. This mono-centric project involving American Society of Anesthesiologists (ASA)
      classification I-II patients undergoing elective abdominal surgery under general anesthesia
      are recruited. Enrolled patients perioperative undergo PDR measurements at four different
      standardized times.
    

Intervention name(s): Pupil dilation reflex measurement
Intervention type(s): Device
Intervention description(s): Pupillometry (PDR) at four standardized times perioperatively
after induction, before opioid administration
after opioid administration, steady state
surgical incision
end of procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Heart Rate; Reflex, Pupillary; Monitoring, Intraoperative