bioihbjkbjnl/mcl2 huggingface dataset:
Memantine in Patients With Chronic Glaucoma
Condition: Open-Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized double-masked clinical trial of memantine in patients with glaucoma
    


Intervention name(s): memantine
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Sedation by Dexmedetomidine and Propofol
Condition: Anesthesia, Spinal
Study type: Interventional

Summary: 
      Under the hypothesis that dexmedetomidine sedation would result in less upper airway
      obstruction, we evaluated the occurrence of upper airway collapse or the requirement of
      airway intervention in patients with obstructive sleep apnea during dexmedetomidine or
      propofol sedation.
    


Intervention name(s): Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): As a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3; Propofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program
Condition: Geriatric
Study type: Interventional

Summary: 
      To evaluate the impact of clinical pharmacist-led appropriate acid suppression therapy
      stewardship program in hospitalized older patients.
    

Detailed description: 
      This prospective, nonrandomized controlled study was conducted in older patients who ordered
      proton pump inhibitor (PPI) at admission in an internal medicine service of tertiary training
      and research hospital. In the intervention group, clinical pharmacist-led services (including
      medication reconciliation and medication review) were conducted during hospitalization and at
      discharge by using the guidelines and potentially inappropriate medications (PIM) criteria
      [American Geriatric Society-AGS Beers Criteria©, 2019]. Medication Appropriateness Index
      (MAI), inappropriate PPI cost, and hospitalization for gastrointestinal bleeding within 1
      year after discharge were calculated in both groups
    

Intervention name(s): Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program
Intervention type(s): Other
Intervention description(s): Clinical pharmacist provided medication reconciliation and medication review during the hospital stay.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Acute Effects of Two Different Trainings on Balance and Performance in Young Footballers
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      The aim of this study is to investigate the acute effect of two different training on the
      balance and performance of healthy young football players. Cognitive-Based Neuromuscular
      Education (CBNE) will be applied to one group and Game Based Education (GBE) will be applied
      to the other group. In addition to study groups, there will also be a control group.
      Individuals will be randomly placed in groups. Sociodemographic data will be recorded at the
      beginning for all athletes. Then the first measurements of dynamic balance and performance
      will be taken. Star Balance Excursion Test will be used to assess the dynamic balance.
      Measurements shall be taken in 8 directions including anterior (A), anterolateral (AL),
      lateral (L), posterolateral (PL), posterior (P), posteromedial (PM), medial (M) and
      anteromedial (AM) for the right and left sides. Performance will be evaluated by Speed
      Dribbling test. After the first measurements, two study groups will be trained. The control
      group will spend this time relaxing. After the trainings, the final measurements will be
      taken.

      Purposes The primary purpose; The aim of this study was to investigate the acute effect of
      CBNE and GBE on dynamic balance and performance in healthy young football players.

      Secondary objectives; The aim of this study is to investigate the relationship between
      dynamic balance and performance in healthy young football players.

      hypotheses H0: In healthy young soccer players, CBNE and / or GBE has no acute effect on
      balance.

      H0: In healthy young soccer players, CBNE and / or GBE has no acute effect on performance.

      H1: CBNE and / or GBE have an acute effect on balance in healthy young football players.

      H2: CBNE and / or GBE have an acute effect on performance in healthy young football players.
    


Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Cognitive-Based Neuromuscular Training has the content of focusing on different tasks at the same time and coordinating on neuromuscular functions as well as football-specific movements. Game-Based Training (OTE), which includes football, tennis, bowling, shooting, racing and climbing games, consists of active video games of game consoles, which are frequently used among young people.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sports; Athletic Injuries; Exercise
Nicotine Metabolism and Low Nicotine Cigarettes
Condition: Smoking
Study type: Interventional

Summary: 
      This study examines the effects of smoking low nicotine cigarettes in different groups of
      smokers. The investigators are focusing on differences in how smokers' bodies break down and
      eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning
      they break down and eliminate nicotine from their bodies more quickly. Other people are
      slower metabolizers meaning they break down and eliminate nicotine more slowly. The
      investigators are comparing these two groups of smokers for their responses to low nicotine
      cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes
      may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine
      levels, and as a result continue to be exposed to significant toxin levels.
    

Detailed description: 
      This study examines the effects of smoking low nicotine cigarettes on smoking behaviors and
      toxin exposure in fast and slow nicotine metabolizing smokers. We will recruit current
      smokers (split between slow and rapid nicotine metabolizing smokers) for a 35-day protocol.
      Participants will smoke their own brand cigarettes during a baseline 5 day period, followed
      by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine
      content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08
      mg nicotine content. This application is designed to provide empirical science to inform the
      FDA on the effect smoking low nicotine content cigarettes will have on use patterns and harm
      exposure.
    

Intervention name(s): Low nicotine cigarettes
Intervention type(s): Other
Intervention description(s): 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: low nicotine; cigarettes; NMR
Women's Health Initiative Silent Atrial Fibrillation Recording Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of the WHISH STAR study is to investigate whether or not those who are randomized
      to exercise intervention have higher rates of atrial fibrillation on review of medical
      records and, in a subset, on screening with a cardiac ECG patch monitor. We will also study
      whether those with a known history of AF have any changes in AF hospitalizations due to
      exercise.
    

Detailed description: 
      The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the
      NIH-funded Women's Health Initiative Strong and Healthy (WHISH). The purpose of the Women's
      Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate
      exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline
      AF. The purpose of the STAR study is to investigate the effect of exercise intervention on
      incident atrial fibrillation ascertained with diagnostic codes. In a subset of women,
      subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring
      technology (iRhythm's ZIO® XT Patch). This subgroup of WHISH study participants will undergo
      an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): The PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility. The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting. This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Assess the Efficacy and Safety of Fospropofol Disodium
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of
      Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by
      electroencephalogramderived assessment (Bispectral Index [BIS]) and to compare the dynamic
      properties of PropofolF to those of Propofol.
    

Detailed description: 
      After local ethics committee (West China Hospital, Sichuan University, Chengdu, China)
      approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40
      females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were
      to follow a diet with limited amounts of alcohol and caffeine. Ingestion of caffeine,
      alcohol, products containing aspartame (aspartame may increase formate concentrations), or
      use of paracetamol within 24 h before study drug administration resulted in ineligibility.
      Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious
      disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding;
      participation in an investigational drug study within the previous month; known or suspected
      pregnancy; anatomical malformations expected to produce a difficult intubation and known or
      suspected history or family history of malignant hyperthermia.
    

Intervention name(s): Fospropofol disodium
Intervention type(s): Drug
Intervention description(s): Fospropofol disodium： 0.5g
Intervention MeSH terms: Fospropofol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014
Condition: Advanced Solid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to establish a safe dose of the drug by providing
      information on any potential side effects this drug may cause and collecting data about how a
      patient's cancer responds to the drug. The study will also assess the blood levels and action
      of AZD2014 in the body over a period of time and will indicate whether the drug has an effect
      on the types of cancer the patients have.
    


Intervention name(s): AZD2014
Intervention type(s): Drug
Intervention description(s): Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase I; cancer; advanced solid malignancies; dose escalation; AZD2014; mTor kinase inhibitor; safety; pharmacokinetics
Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism
Condition: Parkinson Disease; Gaucher Disease; Idiopathic Rapid Eye Movement Sleep Disorder
MeSH terms: Parkinson Disease; Sleep Wake Disorders; Parasomnias; Gaucher Disease; Parkinsonian Disorders
Study type: Observational

Summary: 
      The purpose of this study is to determine if participants have changes in dopamine cells in
      their brain using DaTSCAN™ brain imaging. Dopamine cell loss occurs in Parkinson's disease
      (PD) and other degenerative Parkinsonian disorders, but does not occur in most other movement
      disorders such as essential tremor or dystonia. DaTSCAN, which is also known as
      123I-Ioflupane, is a new compound that has been developed by General Electric, Inc. and has
      been approved by the US Food and Drug Administration (FDA) to help doctors detect changes in
      dopamine. This test is performed by injecting DaTSCAN into a vein in the arm, and after a few
      hours, a large amount of DaTSCAN temporarily accumulates in an area of the brain where there
      are a lot of dopamine brain cells. Because DaTSCAN contains a small amount of radioactive
      iodine, it allows doctors to use a special machine called single photon emission computed
      tomography (SPECT) scanning to detect the location and amount of radioactivity in the brain
      and help determine if there are changes in brain dopamine. It is hoped that this study will
      help doctors detect the presence of dopamine changes even before symptoms are present. This
      study will evaluate DaTSCAN in people with PD, those who are at risk for developing PD (e.g.,
      those with idiopathic rapid eye movement sleep disorder (iRBD) and those who are heterozygous
      or homozygous for Gaucher's disease (GBA) mutations) and those who are healthy volunteers.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Investigators' clinical practice (e.g., neurology clinic, sleep disorder clinic, etc).
      
Keywords: Parkinson disease; idiopathic rapid eye movement sleep disorder; Gaucher disease; healthy volunteer
Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
Condition: Local Anesthetic
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: The use of local anesthetics as a supplement to conventional techniques in breast
      surgery is widely reported in the literature. Currently there is controversy regarding the
      efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this
      study demonstrate the efficacy of administering a local anesthetic into the surgical bed of
      women operated radical mastectomy for breast cancer for the control of postoperative pain.

      Material and methods: double-blind randomized clinical trial. The investigators recruited
      patients who underwent modified radical mastectomy that met inclusion and exclusion criteria.
      The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline
      control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic
      and rescue medication was identical in both groups.

      Statistical analysis: The baseline patient characteristics of the patients were analyzed by
      Chi square or Student t always meet criteria of normality, otherwise it will use the
      Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse
      events will be held on chi-square test.
    


Intervention name(s): levo-bupicaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention; Women of this group be infused saline 2 ml / h for 48h.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: levo-bupicaine; Radical; Mastectomy
Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine whether co-administration of rifampin with neratinib
      has an effect on the pharmacokinetics (how the body absorbs, distributes, metabolizes and/or
      excretes) of neratinib.
    


Intervention name(s): Neratinib
Intervention type(s): Drug
Intervention description(s): HKI-272
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feeding for Accesible, Affordable and Healthy Childhood
Condition: Healthy Children
Study type: Interventional

Summary: 
      The main objective of this study was to evaluate the effectiveness of implementing a healthy
      eating vs traditional recommendations on the Medkid index of children in primary school. To
      do so, different companies involved in ALINFA project developed with the assessment of UNAV,
      CNTA and UPNA, a healthy bi-weekly menu.
    


Intervention name(s): ALINFA; Control
Intervention type(s): Other; Other
Intervention description(s): Comparing the usual recommendations with the healthy diet designed and developed; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Preserving Left Colonic Artery During Radical Resection of Rectal Cancer
Condition: Postoperative Complications; Proteinosis
MeSH terms: Rectal Neoplasms; Postoperative Complications
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the feasibility and clinical significance of preserving left colonic artery in
      rectal cancer surgery.The investigators will focus on the effect of preserving left colonic
      artery during radical resection of rectal cancer on anastomotic leakage and oncology
      efficacy.
    

Detailed description: 
      The investigators performed three-dimensional (3D) reconstruction to investigate the vascular
      anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help
      make pre-operative strategies of rectal cancer surgery.The investigators will preserving the
      left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical
      significance.The investigators will focus on the effect of preserving left colonic artery
      during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
    

Intervention name(s): Preserve the left colonic artery; The left colonic artery is not preserved
Intervention type(s): Procedure; Procedure
Intervention description(s): Preservation of left colonic artery in rectal cancer surgery.; The left colonic artery was dissected in rectal cancer surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent laparoscopic or robotic anterior rectal resections carried out by
        two surgeons at Daping Hospital.
      
Keywords: rectal cancer; Postoperative Complications; Preserve the left colonic artery
Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to formally evaluate the impact of famotidine, an H2R antagonist, on
      the pharmacokinetics of telaglenastat.

      This study will be conducted in up to 22 healthy volunteers, who meet all of the inclusion
      criteria and none of the exclusion criteria. The study is double-blinded, randomized 2-way
      crossover in design.

      Subjects will receive four 200 mg tablets of telaglenastat either in the presence or absence
      of 20 mg famotidine (H2R-antagonist) with a 4-day wash-out period in between each regimen.
    


Intervention name(s): Telaglenastat; Famotidine; Placebo for famotidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Glutaminase inhibitor; Histamine-H2 Receptor Antagonist; Placebo for Histamine-H2 Receptor Antagonist
Other intervention name(s): CB-839; Pepcid
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other