bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Controlled Clinical Trial to Evaluate The Efficacy and Safety of Healthtone as Prophylaxis for COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Background : Coronavirus disease known as COVID-19 is caused by the SARS-CoV-2. Transmission
      of SARS CoV-2 is spreading from human to human through direct or indirect droplets, this
      disease then spreads very quickly to various countries until it becomes a pandemic. Rhea®
      Health Tone is an essential oil made from Gardenia jasminoides, Commiphora myrrha, Boswellia
      serrata, Daucus carota, Foeniculum vulgarae, and Olea Europeae that have antimicrobial and
      anti-inflammatory effects. Rhea® Health Tone also has been registed on BPOM. Even so, the
      efficacy of Rhea® Health Tone still needs to be studied further.

      This research aimed to assess the efficacy and safety of healthtone as prophylaxis for
      COVID-19 in human resources at persahabatan central general hospital.The intervention group
      received Rhea® Health Tone 2 times supplementation 1 ml a day; meanwhile, the control group
      received placebo 2 times supplementation 1 ml a day.
    

Detailed description: 
      This study is a double-blind randomized clinical trial on the human resources population at
      Persahabatan Central General Hospital, Jakarta.

      Subjects who have agreed to be included in the study will undergo an initial examination and
      a serological examination of IgG SARS-CoV-2 to ensure that there is no adequate immunity
      against COVID-19 before the study begins. After confirmed that all subjects are not included
      in the exclusion criteria and not infected with COVID-19, randomization will be conducted to
      determine who gets the Rhea®️ Health Tone or a placebo.

      Evaluation will be carried out until the 84th day of giving the intervention. The subject
      will be monitored everyday by the research team to ask whether there are symptoms experienced
      by the subject, both symptoms related to COVID-19 and symptoms related to side effects drugs
      and adverse events.

      The statistical test used in this study was the Chi-square test or Fisher's exact test.
    

Intervention name(s): Rhea® Health Tone
Intervention type(s): Dietary Supplement
Intervention description(s): Rhea® Health Tone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Healthtone; Prophylaxis COVID-19
Clinical Evaluation of Investigational Multifocal Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in
      a population of presbyopic patients. Subjects will wear the contact lenses for a total of
      12-16 days.
    


Intervention name(s): etafilcon A
Intervention type(s): Device
Intervention description(s): Investigational Contact Lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study of a New Medicine NNC0113-6856 in Healthy Males
Condition: Healthy Volunteers; Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study NN0113-6856 will be given to humans for the first time. We will be looking into
      how safe different single doses of the new investigational product NNC0113-6856 is and we
      will measure its amount as well as the amount of specific parts of the new investigational
      product in blood. The study will look at the effects of different single doses of
      NNC0113-6856. This could either be as an oral dose (cohort 1 to 5) or one injection into the
      vein (intravenous [IV]-cohort). Participant will get the investigational product either as
      one or two tablets (oral dose in cohort 1 to 5) or as injection into the vein (IV cohort).
      The study will last for about 6-10 weeks (up to 14 weeks in case of rescheduling for stand-by
      participants).
    


Intervention name(s): NNC0113-6856; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive NN0113-6856 orally or intravenously.; Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      In this pilot prospective non-commercial clinical trial the investigators will study the use
      of dexmedetomidine as an adjuvant to the patient-controlled propofol sedation in a
      placebo-controlled and randomized manner in patients with drug addiction during Endoscopic
      Retrograde Cholangiopancreatography (ERCP). Dexmedetomidine is a sedative medication used
      mostly in intensive care units,and is marketed under the brand name Precedex. Dexmedetomidine
      has sedative, analgesic, sympatholytic, and anxiolytic properties. It produces sedation
      without causing significant respiratory depression. Recent research has suggested
      dexmedetomidine to be effective in treatment of alcohol withdrawal signs. In previous studies
      dexmedetomidine was insufficient as an only sedative agent in ERCP and colonoscopy, but it
      has not been assessed for sedation in patients with chronic pancreatitis. The main objective
      of this trial is to evaluate if dexmedetomidine can reduce propofol and opioid consumption
      and facilitate the performance of ERCP in patients with chronic pancreatitis due to drug
      addiction.Secondary objectives of the trial are the stability of vital signs and safety,
      patients´ satisfaction plus recovery time from sedation.

      50 elective ERCP patients with chronic pancreatitis after written informed consent and
      randomisation will be recruited to the study. Exclusion criteria are:allergy to propofol,
      opioid or dexmedetomidine, ASA class greater than 3. All the patients will receive
      patient-controlled propofol sedation. In dexmedetomidine group dexmedetomidine infusion will
      be started before sedation beginning and in placebo group placebo-solution (NaCl0,9%) will be
      administered in the similar manner.Standard monitoring for vital signs will be applied,also
      sedation degrees will be evaluated with sedation scores. At the end of procedure total amount
      of propofol and opioid will be calculated,patients and endoscopists satisfaction and the
      difficulty of ERCP will be assessed.
    


Intervention name(s): Precedex; sodium chlorid 0,9%
Intervention type(s): Drug; Drug
Intervention description(s): mkg/ml,continuous infusion at rate 0.7 µg/kg/h; continuous intravenous infusion
Other intervention name(s): dexmedetomidine hydrochloride injection; NaCl 0,9%
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ERCP; dexmedetomidine; propofol; patient-controlled sedation; Chronic Alcoholic pancreatitis
Anti-adhesive Effect and Safety of MEDICURTAIN Applied to Undergoing Thyroid Surgery (Pivotal Study)
Condition: Tissue Adhesion, Surgery-Induced
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      This study was designed to demonstrate the non-inferiority of MEDICURTAIN® (investigational
      device) compared to commercially available GUARDIX-SG® (control device) in treatment of
      subject who underwent total thyroidectomy for prevention of adhesion formation at 6 weeks
      after the surgery.
    

Detailed description: 
      This clinical trial is a randomized, multi center, subject and evaluator blinded, parallel,
      comparative and non-inferiority clinical trial study to assess the prevention of adhesion
      formation in the subjects treated either MEDICURTAIN® or GUARDIX-SG at 6 weeks after total
      thyroidectomy.

      The primary endpoint was defined as abnormal findings of esophageal motility evaluated by the
      independent third evaluator using marshmallow esophagography. The objective of this study was
      to demonstrate the non-inferiority of investigational device versus control device for
      adhesion formation at 6 weeks after the administration of investigational or control devices.

      Esophageal motility score and clinical symptoms assessed by the independent third evaluator
      using marshmallow esophagography at 6 weeks after administration of investigational device
      were secondary outcome.
    

Intervention name(s): GUARDIX-SG®; Medicurtain®
Intervention type(s): Device; Device
Intervention description(s): GUARDIX-SG® 6g prefilled syringe; Medicurtain® 5ml prefilled syringe
Other intervention name(s): GUARDIX-SG; Medicurtain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Medicurtain®; Medicurtain; Anti-adhesion barrier; Sodium hyaluronate
Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
Condition: Excessive Sleepiness; Shift Work Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Disorders of Excessive Somnolence; Sleep Disorders, Circadian Rhythm; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether treatment with Armodafinil
      (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness
      associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from
      the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600,
      and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.
    


Intervention name(s): Armodafinil 150 mg/day; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.; Matching placebo tablets once daily
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Excessive Sleepiness; Chronic Shift Work Sleep Disorder; Chronic SWSD; Circadian Rhythm Disorder; Shift Worker; Cephalon; Cephalon, Inc; Nuvigil
Community-based Study Comparing Extended-release Methylphenidate and Atomoxetine in Children With Attention-deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to better understand the treatment outcomes of extended-release
      methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder
      (ADHD) as evaluated by physicians and parents in a community setting.
    

Detailed description: 
      Methylphenidate and atomoxetine are available for the treatment of ADHD in children.
      Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the
      presynaptic neuron and increase the release of these monamines into the extraneuronal space.
      The mechanism by which atomoxetine produces its therapeutic effect is thought to be related
      to selective inhibition of the presynaptic norephinephrine transporter. This was a
      multi-center, randomized, open-labeled, parallel design study of extended-release
      methylphenidate and atomoxetine in children aged 6 to 12 years with ADHD as evaluated by
      physicians and parents. Children were randomly assigned (2:1, respectively) to 3 weeks of
      treatment with extended-release methylphenidate or atomoxetine. Physicians evaluated
      treatment using the ADHD Rating Scale (ADHD-RS) and the Clinical Global
      Impression-Improvement of Illness scale (CGI-I). Assessments were made prior to beginning
      treatment (screening), at a telephone interview 1 week after beginning treatment, at a clinic
      visit 2 weeks after beginning treatment, and at the final clinic visit (3 weeks). Parents
      assessed treatment using the Parent Satisfaction Questionnaire (PSQ) from treatment days 2 to
      13 and at the clinical visit 3 weeks after beginning treatment. The questions of interest
      included whether there is a difference between treatment in the improvement of behavior and
      the timing of such differences. Vital signs, height, and weight were also recorded as were
      adverse events. Study drug was to be taken orally once each day. Patients randomly assigned
      to extended-release methylphenidate began treatment with 18 mg/day. Patients randomly
      assigned to atomoxetine began treatment with 0.5 mg/kg/day. The study medication was to be
      titrated as considered appropriate by the patient's physician. The duration of treatment was
      21 days.
    

Intervention name(s): Methylphenidate extended-release; Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention deficit hyperactivity disorder; Methylphenidate; Atomoxetine; Concerta
Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple ascending
      intravenous infusions of BMS-986168 and to assess the pharmacokinetics and immunogenicity of
      BIIB092, and pharmacodynamics of BIIB092 on cerebrospinal fluid (CSF) extracellular tau
      (eTau) concentrations in participants with Progressive Supranuclear Palsy.
    

Detailed description: 
      This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a
      licensing agreement.
    

Intervention name(s): BIIB092; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See Arm Descriptions for dosing information.; See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
Other intervention name(s): BMS-986168
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to
      establish pharmacokinetic equivalence of BI 695501 to adalimumab.
    


Intervention name(s): adalimumab; BI695501; adalimumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40mg adalimumab single s.c. injection; BI 695501 single s.c injection; 40mg adalimumab single s.c. injection
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112 Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Study type: Interventional

Summary: 
      The purpose of this study is to determine wether NP031112 is safe and effective in the
      treatment of mild to moderate Progressive Supranuclear Palsy
    


Intervention name(s): tideglusib; tideglusib; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 800 mg of tideglusib as a powder for oral suspension once daily in fasting conditions for 52 weeks; 600 mg of tideglusib as a powder for oral suspension, administered once daily in fasting conditions for 52 weeks; powder for oral suspension administered once daily in fasting conditions for 52 weeks
Other intervention name(s): NP031112; NP031112
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Prospective Investigation of the ColubrisMX ELS System
Condition: Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenoma; Colorectal Adenomatous Polyp
MeSH terms: Adenoma; Colorectal Neoplasms; Adenomatous Polyps; Polyps
Study type: Interventional

Summary: 
      This study is a prospective, single-arm, open-label, multi-center, feasibility study to
      evaluate the safety and efficacy of ColubrisMX ELS System in patients undergoing transanal
      endoluminal procedures, specifically colorectal Endoscopic Submucosal Dissection.
    

Detailed description: 
      Current treatment options for colorectal lesions most often include flexible endoscopy or
      open/laparoscopic surgery. Both approaches have procedural limitations that can have
      considerable impact on patient care. Traditional endoscopic tools have technical
      inadequacies, ones that inhibit the physician's ability to complete more complex tasks
      consistent with a surgical technique. Conversely a traditional open or laparoscopic surgical
      approach involves increased chance of complications (such as surgical site infection), more
      pain & blood loss, longer recovery and larger surgical scars.

      This clinical study proposes the use of an endoluminal robotic technology that is designed to
      improve patient outcomes for colorectal lesions. This system allows physicians to perform
      many types of complex endoluminal procedures with more precision, flexibility, and control
      than that of conventional endoscopic, open or laparoscopic surgical techniques. Using this
      robotic system, surgeons can perform delicate and complex endoluminal procedures that may
      have been difficult or impossible with other methods, and could have positive impact on
      outcomes, recovery time, and overall patient care.

      Patients will undergo the procedure using the ColubrisMX ELS System, and its initial safety
      and efficacy outcomes will be assessed intraoperatively and postoperatively at discharge and
      days 7 and 30.
    

Intervention name(s): Robotic Endoluminal Resection
Intervention type(s): Device
Intervention description(s): Robotic Resection of mucosal neoplasms in the colon and rectum using the ColubrisMX ELS system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenoma
Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation
Condition: Monitored Anaesthesia Care; Loco-regional Chronic Subdural Hematoma Evacuation
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Study type: Interventional
Phase: Phase 1

Summary: 
      investigators assume that administration of preoperative melatonin will reduce the required
      dose of propofol in participants undergoing loco-regional chronic subdural hematoma
      evacuation, it may as well provide better postoperative analgesia and decrease the incidence
      of delirium.
    

Detailed description: 
      A number of studies showed that premedication with melatonin was associated with sedation
      without impairment of cognitive and psychomotor skills or prolonging recovery. Some studies
      demonstrated that melatonin decreases the amount of propofol required to produce an adequate
      depth of hypnosis at induction time

      The effects of the oral administration of melatonin on the dose of propofol sedation in
      participants undergoing loco-regional chronic subdural hematoma evacuation have not been
      documented before.

      The present study will be conducted to detect the efficacy of oral administration of
      melatonin on the reduction of the sedative dose of propofol in participants undergoing
      loco-regional chronic subdural hematoma evacuation.
    

Intervention name(s): Placebo (Group P); Melatonin (Group M)
Intervention type(s): Drug; Drug
Intervention description(s): Group P: 20 patients will receive a placebo tablet preoperatively.; Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
Other intervention name(s): Placebo Group; Melatonin Group
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland. It is primarily responsible for the sleep awake cycle as its level decreases in the morning and increases by night; owing to reduced light intensity, leading to circadian rhythm. It provides circadian and seasonal timing through activation of G protein-coupled receptors (GPCRs) in target tissues. Melatonin exerts its hypnotic effects through the activation of the MT1 and MT2 melatonin receptors
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Oral Melatonin Premedication
Pioglitazone and Losartan Provides Additional Renoprotection
Condition: Type 2 Diabetes; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are
      currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or
      in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of
      proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional
      renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.
    


Intervention name(s): pioglitazone+losartan; losartan
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone (30 mg/daily) losartan (100 mg daily); losartan (100 mg daily)
Intervention MeSH terms: Pioglitazone; Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pioglitazone; losartan; proteinuria; end stage renal disease (ESRD)
A Study of RG7625 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled, single ascending dose
      study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic
      effects of single doses of RG7625 in healthy male and female volunteers.

      The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated
      between two cohorts and each individual within a cohort will receive study drug dosing on
      four occasions - in effect giving a four treatment, four period, four-way crossover for each
      individual. The minimum duration for each participant is approximately 8 weeks.
    


Intervention name(s): Placebo; RG7625
Intervention type(s): Drug; Drug
Intervention description(s): Matching oral placebo capsules to RG7625, according to treatment schedule; oral administration, capsules, single ascending dose according to treatment schedule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)