bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, balanced, randomized, two treatment, two sequence, two period, two way
      cross-over, single oral dose bioequivalence study of Empagliflozin 25 mg film coated tablets
      of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg film-coated tablets of Boehringer
      Ingelheim International GmbH, Germany in normal, healthy, adult, human subjects under fasting
      condition.
    


Intervention name(s): Empagliflozin film coated tablets; Jardiance film-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 film coated tablet of 25 mg Empagliflozin; 1 film coated tablet of 25 mg Empagliflozin
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study Between GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Tablets and Reference Product in Healthy Adult Participants Under Fasting Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ)
      (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and
      hepatic cirrhosis with ascites and edema. This first time in human (FTIH) study is aimed to
      determine whether the test product GSK3542503 is bioequivalent to the reference (ref)
      hydrochlorothiazide 50 milligram (mg)/amiloride hydrochlorothiazide 5 mg in healthy adult
      participants under fasting conditions based on pharmacokinetic (PK) endpoints. This is a
      phase I, open label, balanced, randomized, single dose, two-way crossover study, enroling
      approximately 42 healthy participants at a single center. Study participants will be
      randomized to one of two treatment sequences (A-B or B-A) in accordance with the
      randomization schedule. A single dose of one of the two treatments A (Test: GSK3542503, a
      hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination) or B
      (Reference: Moduretic, a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed
      dose combination), will be administered on Day 1, in each treatment period. Each participant
      will participate in both treatment periods and receive a single dose of each treatment. The
      treatment periods will be separated by a washout period of at least 7 days and no more than
      14 days. The total duration in the study for each participant is expected to be 5 to 7 weeks,
      from screening to his or her last visit. A maximum of 42 participants will be randomized such
      that at least 32 evaluable participants complete the study.
    


Intervention name(s): GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets); Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets)
Intervention type(s): Drug; Drug
Intervention description(s): GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets) are cream-colored, circular, flat faced uncoated tablets with beveled edges having break line on one side and "BD" embossed on the other side.; Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets) tablets are peach-colored, half scored, diamond shaped tablets marked "MSD917".
Intervention MeSH terms: Hydrochlorothiazide; Amiloride; Amiloride, hydrochlorothiazide drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cross-over; Hydrochlorothiazide; Amiloride hydrochloride; Phase I; GSK3542503; Bioequivalence; FTIH
An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
      open-label extension phase only will be described in this record. All participants will
      receive the same dose of GWP42003-P. However, investigators may subsequently decrease or
      increase the participant's dose until the optimal dose is found.
    


Intervention name(s): GWP42003-P
Intervention type(s): Drug
Intervention description(s): Clear, colorless to yellow solution containing cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other intervention name(s): Cannabidiol; CBD; Epidiolex
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cannabidiol; GWP42003-P; Epidiolex; Stiripentol; Valproate
A Musculoskeletal Ultrasound Program to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Non-adherence to medications can lead to sub-optimal treatment in rheumatoid arthritis (RA)
      patients. In order to improve disease modifying anti-rheumatic drugs (DMARDs) adherence, the
      investigators are conducting a randomized controlled trial to test out an intervention to
      improve medications adherence among low adherers. This intervention involves the use of a
      musculoskeletal ultrasound program which allows RA patients to visualize their joint
      inflammation and damage real time while treatment adherence is simultaneously reinforced. In
      doing so, the investigators hope to improve patients' understanding of their joint disease
      and motivate the participants to adhere to their medications.
    

Detailed description: 
      This is a single center randomized controlled clinical trial conducted in the Singapore
      General Hospital. Eligible RA subjects meeting the inclusion and exclusion criteria will be
      screened using a medication adherence measure questionnaire. Thereafter 132 patients who are
      low adherers on the questionnaire will then be recruited and randomized (in a 1:1 ratio) to
      either (a) intervention arm (with musculoskeletal US program) or (b) control arm (without
      musculoskeletal US program), and followed up over a period of about 6 month.
    

Intervention name(s): Musculoskeletal ultrasound program
Intervention type(s): Behavioral
Intervention description(s): Using a musculoskeletal ultrasound program to help improve medication adherence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in
      treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind
      placebo-controlled clinical trial design. This study includes 60 patients from SUMS
      endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as
      radiculopathies will be excluded. After giving the Informed consent the patients will be
      underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They
      will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic
      Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire
      and electrodiagnostic criteria will be evaluated.
    


Intervention name(s): Topical Citrullus colocynthis fruit oil (1%); Topical vehicle oil
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Diabetes complications; Pain
Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.
Condition: Chronic Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal
      preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.
    

Detailed description: 
      To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2%
      chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus
      bleeding index.
    

Intervention name(s): Cuminum Cyminum; herbal Mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): Cuminum Cyminum mouthwash in chronic gingivitis patients; herbal mouthwash in chronic gingivitis patients
Other intervention name(s): Cuminum Cyminum mouthwash; herbal mouthwash in chronic gingivitis patients
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group phase A
Group phase B
Group phase C
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mouthwash; chlorhexidine; stain
Neural Mechanisms of the Contextual Interference Effect: A fNIRs and EEG Study
Condition: Healthy Individuals; Learning
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this study is to gain insight into the neural mechanisms of learning
      multiple tasks. By examination of cognitive and behavioral output during the performance and
      learning of several computer maze tasks, and through a detailed examination of the neural
      activity obtained from functional near-infrared (fNIR) and electroencephalography (EEG), it
      may be possible to gain insight into the impact of the amount of practice and the
      organization of practice has on learning fine motor skills. This insight may provide
      direction as to how to better develop instructional and rehabilitation protocols in addition
      to clinical interventions to facilitate recovery of function, relearning and transfer of
      cognitive and fine motor skills based upon neural responses to physical practice.
    


Intervention name(s): Practice Order
Intervention type(s): Behavioral
Intervention description(s): Blocked order - predictable
Random order - unpredictable
Other intervention name(s): High contextual interference - random practice schedule; Low contextual interference - blocked practice schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: repeated measures design; random assignment to groups
Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial
Condition: Infertility Due to Nonimplantation
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient
      withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection
      (ICSI).
    

Detailed description: 
      the aim to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in
      patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm
      injection (ICSI).

      A total of 142 patients with history of unexplained RIF3 or more cycles were included in the
      study. Patient were randomized into two groups, study group (n=71) and control group (n=71).
      The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second
      dose on the day of pregnancy test. The control group underwent ET without
      intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic
      reactions.
    

Intervention name(s): intralipid 20%
Intervention type(s): Drug
Intervention description(s): milky soulation for energey supplement.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infertility , implantion failure, intracytoplasmic sperm injection
Prevention of Nausea and Vomiting in Patients After Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The
      incidence can be as high as 80 percent in high-risk patients. Investigators designed this
      randomized, double- blind, single-center study to compare the efficacy of the combination of
      dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic
      surgery.

      Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years
      patients scheduled for laparoscopic surgery were included in this study. Anesthesia was
      induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen /
      air mixture in all patients. Remifentanil was continuously infused during surgery. Patients
      were randomly divided into two groups. Patients in the dexamethasone and aprepitant group
      (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia
      and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the
      dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to
      aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the
      last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of
      anesthesia.

      PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The
      blindly evaluated primary outcome was complete response. The secondary outcomes were
      incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid
      consumption within 24 hours after surgery. Statistical analyses were performed using
      Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered
      statistically significant.Investigators hypothesized that the antiemetic efficacy of the
      aprepitant and dexamethasone combination is superior compared with ondansetron and
      dexamethasone combination following the laparoscopic surgery.
    


Intervention name(s): Dexamethasone and aprepitant; Dexamethasone and ondansetron
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexamethasone,; Ondansetron; Aprepitant; PONV; Laparoscopic surgery
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy; Stroke
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the
      treatment of pediatric upper limb spasticity.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Biological
Intervention description(s): Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Other intervention name(s): BOTOX® OnabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
Condition: Deep Caries; Molar Incisor Hypomineralisation
MeSH terms: Molar Hypomineralization
Study type: Interventional

Summary: 
      The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized
      system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that
      anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid
      local anesthesia compared to the anesthesia via conventional technique by infiltration.

      Design: split-mouth design AND parallel-arm design
    

Detailed description: 
      Local anesthesia is commonly used in oral health care and intra-mucosal infiltration
      anesthesia is most commonly used by practitioners. Anesthesia may cause children a great deal
      of anxiety because of the fear of the injection. The latter can be painful if the product is
      delivered too quickly in the mucosa. Recent developments in the techniques and anesthesia
      systems allow reducing pain during the injection. In particular, computerized systems
      (electronically assisted local anesthesia) allow a slow injection limiting pressure.
      Moreover, these systems look like a pen which prevents the negative impression of the image
      related to the syringe metal. The intraosseous electronically-assisted anesthesia could be an
      interesting alternative to conventional infiltration anesthesia by making the act less
      stressful but also less painful for the child.
    

Intervention name(s): intraosseous anaesthesia using a computerized system; conventional anasthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): "1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "; para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MIH of the first permanent molar
Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to determine if medical, biological, psychological, and social
      risk factors can be used to develop algorithms that will predict perinatal depression (PND).
      Data capture will include baseline participant medical, psychological and family history,
      blood biomarkers, and psychosocial assessments.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 300 pregnant women seeking maternal healthcare services in a department of
        Obstetrics and Gynecology at the University of North Carolina health center will be
        observed for perinatal depression.
Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential drug interactions between ALXN2050 and cyclosporine
      (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate
      mofetil (MMF) (Part 3).
    


Intervention name(s): ALXN2050; Cyclosporine; Tacrolimus; MMF
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet.; Oral capsule.; Oral capsule.; Oral tablet.
Other intervention name(s): ACH-0145228 (formerly)
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a 3-part study with each part being an open-label, fixed-sequence study in healthy adult participants. The 3 parts of the study may be conducted concurrently.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ALXN2050; Cyclosporine; Tacrolimus; Mycophenolate Mofetil; Drug-Drug Interaction; Pharmacokinetics; Safety; Factor D Inhibitor
Active vs Passive Distraction on Procedural Pain in the Pediatric Emergency Department
Condition: Pain Response
MeSH terms: Emergencies; Pain, Procedural
Study type: Interventional

Summary: 
      The investigators proposed study will investigate the efficacy of tablet computer distraction
      as an analgesic for the pain associated with various painful procedures in the emergency
      department. Since prior studies have shown that distraction by a parent or nurse can be an
      effective analgesic, there is reason to believe that tablet computer distraction will
      similarly reduce pain. Participants in the control group will receive a cartoon on the TV
      monitor in the patient room, while participants in the study group will receive a more
      immersive distraction of playing a game or watching a cartoon (for children too young to play
      a game) on a tablet computer. Data from this study will help inform best practices for
      administering painful procedures in a way that minimizes pain.
    


Intervention name(s): Active Distraction; Passive Distraction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): iPad will be used as active distraction; child will watch TV as passive distraction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention