bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the
      safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with
      fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523
      or placebo orally daily for 12 weeks.
    


Intervention name(s): Placebo; RO4917523; RO4917523
Intervention type(s): Drug; Drug; Drug
Intervention description(s): orally daily, 12 weeks; Dose A orally daily, 12 weeks; Dose B orally daily, 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Combined Effects of Alcohol and Caffeine
Condition: Alcohol or Other Drugs Effects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of caffeine on the
      self-administration of alcohol. The study will also examine the combined effects of alcohol
      and caffeine on behavioral performance, participant ratings of behavioral performance, and
      self-reported subjective effects.
    

Detailed description: 
      The purpose of this study is to examine the effects of caffeine on alcohol
      self-administration. Volunteers will participate in 7 experimental sessions in which they
      will be given the opportunity to self-administer an alcohol + caffeine or alcohol +
      caffeine-placebo beverage. The first 6 sessions will involve exposure to the two beverage
      conditions in mixed order three times each (e.g., A, B, B, A, A, B). The seventh session will
      be a choice session in which the participant will make a single choice at the beginning of
      the session about which beverage they will consume that day. In addition to the primary
      outcomes of quantity of alcohol self-administered and beverage choice, three additional
      outcomes will be measured including: 1). indirect measures of reinforcing effects (e.g.
      subjective ratings of liking, well-being, take again); 2). an alcohol-sensitive behavioral
      measure; and 3). participant ratings of degree of behavioral impairment.
    

Intervention name(s): Alcohol + Caffeine Beverage; Alcohol + Caffeine-placebo
Intervention type(s): Drug; Drug
Intervention description(s): 14 g alcohol per 180 ml total beverage combined with 60 mg caffeine per 180 ml total beverage. The alcohol and caffeine will be mixed in a fruit punch beverage. Participants may self-administer as much beverage as they like with several constraints to assure safety (e.g., participants must stop drinking if their blood alcohol content is above .12 g/dl).; 14 g alcohol per 180 ml total beverage combined with 2.2 mg quinine per 180 ml total beverage. The alcohol and quinine will be mixed in a fruit punch beverage. Participants may self-administer as much beverage as they like with several constraints to assure safety (e.g., participants must stop drinking if their blood alcohol content is above .12 g/dl).
Other intervention name(s): Alcohol 190 proof USP; Caffeine anhydrous USP; Alcohol 190 proof USP; Quinine hydrochloride dihydrate
Intervention MeSH terms: Ethanol; Quinine; Caffeine
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Different Support Surfaces on the Properties Skin After Loading
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer
Study type: Interventional

Summary: 
      Pressure ulcers are severe injuries and wounds causing a substantial burden on patients,
      caregivers, and on healthcare systems worldwide. There is common agreement, that effective
      pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in
      individuals at risk. Besides risk assessment and repositioning the use of special pressure
      ulcer preventive support surfaces are the key interventions in pressure ulcer prevention.
      Pressure ulcer preventive support surface modify the degree of skin and tissue deformation
      and/or skin temperature and moisture. Therefore, an association between the type and working
      mechanism of a pressure ulcer support surface and skin function after loading is highly
      likely. Furthermore, such a relationship may be used to characterize and/or to quantify the
      performance pressure ulcer support surfaces in terms of skin protection. The overall aim of
      this explorative study is to measure skin responses of the two most common pressure ulcer
      predilection sites (heel, sacral skin) after two hours loading on three different support
      surfaces and the sternal skin (control area).
    


Intervention name(s): Alternating low pressure mattress with air loss function; Gel mattress; Basic foam
Intervention type(s): Other; Other; Other
Intervention description(s): IsoAir, Stryker, USA; IsoGel, Stryker, USA; Standard hospital mattress
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo
      as maintenance treatment in adults with schizophrenia.
    

Detailed description: 
      Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the
      world population. Hallucinations and delusions are the most striking characteristic positive
      symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and
      lack of emotion, energy, and motivation) may also be present. The first antipsychotics
      developed for the treatment of schizophrenia were effective against positive symptoms, but
      showed little efficacy for negative symptoms and were also associated with a high incidence
      of side effects. Second generation antipsychotics, represent a significant advancement in the
      treatment of psychotic disorders because they are effective and at the same time exhibit
      fewer side effects than first generation antipsychotics. Although generally safer than first
      generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable
      side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these
      drugs vary considerably.
    

Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Brexpiprazole tablets 1 to 4 mg /day; Placebo comparator for 52 weeks
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a prospective, multi-endoscopist, single center, clinical study at tertiary referral
      center that addresses an important current challenge in the prevention of colorectal cancer
      (CRC), namely, how to improve the complete removal of CRC precursors. This study will observe
      the potential benefit of specific polypectomy technique in conjunction with a systematic
      submucosal injection prior to the polyp resection. This study will evaluate the completeness
      and incompleteness of the resection of colorectal neoplastic polyps during the procedures.
    

Detailed description: 
      Non-detection and incomplete resection of neoplastic colorectal polyps have been identified
      as the main risk factors for the development of CRC in patients after a colonoscopy. Between
      7% and 9% of all newly diagnosed CRCs are estimated to be such "interval cancers," occurring
      after a previous colonoscopy and before the next surveillance examination. The vast majority
      of interval cancers are caused by incomplete detection or resection during colonoscopy
      examination. The contribution of incomplete resection towards interval cancer has recently
      been pointed out by a panel of experts as one of the cornerstones of CRC prevention that need
      to be addressed in future research studies. The primary aim of this study is to examine the
      incomplete adenoma resection rates when performing a cold snare polypectomy in conjunction
      with a submucosal injection for endoscopic resection of 4-20 mm non-pedunculated colorectal
      polyps. The subjects are patients, men and women, aged between 45-80 years old that are
      scheduled for a colonoscopy. The secondary aims are to identify procedure-related
      complication rates and patient-, polyp-, and endoscopist-related factors associated with
      incomplete adenoma resection.
    

Intervention name(s): Cold snare polypectomy in conjunction with a submucosal injection
Intervention type(s): Procedure
Intervention description(s): The cold snare polypectomy in conjunction with a submucosal injection is a procedure during which the endoscopist resects the colorectal polyps during a colonoscopy, without any electrocautery.
Intervention model: Single Group Assignment
Intervention model description: prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: colorectal cancer; incomplete resection rate; submucosal injection; neoplastic polyps
A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a three-part, single-center, open-label phase I clinical study to characterize the
      DDIs potential of DBPR108 with Warfarin sodium, Digoxin, or Probenecid in healthy subjects.
      This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of
      Warfarin sodium, Digoxin, or Probenecid.
    

Detailed description: 
      DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. This study will be run in three parts to
      characterize the DDIs potential of DBPR108 with the expected concomitant drugs (Warfarin
      sodium, Digoxin, Probenecid) in Healthy Subjects. Each part of this study consists of a
      screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period, and a
      follow-up visit period. Approximately 14 subjects will be enrolled in each part of this
      study.
    

Intervention name(s): Warfarin sodium tablets; Digoxin tablet; Probenecid tablets; DBPR108 tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: Warfarin sodium, tablet, oral; Drug: Digoxin, tablet, oral; Drug: Probenecid, tablet, oral; Drug: DBPR108, tablet, oral
Other intervention name(s): DBPR108
Intervention MeSH terms: Probenecid; Digoxin; Warfarin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the potential therapeutic effects of the cardiac
      glycoside digoxin and the secondary bile acid ursodeoxycholic acid (UDCA) on synovial
      inflammation and disease activity when administered as add-on treatments to the current
      DMARDs treatments for rheumatoid arthritis patients with variant disease activity.
    

Detailed description: 
      This study is a randomized, open-labeled, controlled prospective study to evaluate the
      potential therapeutic effects of the cardiac glycoside digoxin and the secondary bile acid
      ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered
      as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients with
      variant disease activity. The study population will be rheumatoid arthritis patients
      attending the Physical Medicine, Rheumatology and Rehabilitation Department at Menoufia
      University Hospital, Menoufia, Egypt. A total of 90 rheumatoid arthritis patients who will
      meet the inclusion criteria will be enrolled in this study. The 90 participants will be
      divided into 30 rheumatoid arthritis patients who will receive placebo + the current DMARDs
      treatments of rheumatoid arthritis for 24 weeks and serve as the control group, 30 rheumatoid
      arthritis patients who will receive DMARDs + digoxin 25 mg every other day for 24 weeks and
      the last 30 rheumatoid arthritis patients who will receive DMARDs + ursodeoxycholic acid
      (UDCA) 500 mg/day for 24 weeks. Clinical Examinations and laboratory parameters will be
      performed and measured at the beginning of the study, 12 weeks and 24 weeks after
      randomization to evaluate the efficacy of digoxin and UDCA in the treatment of rheumatoid
      arthritis.
    

Intervention name(s): Placebo; Digoxin 0.25 mg; Ursodeoxycholic acid (UDCA) 500 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.; All subjects will receive digoxin administered at 0.25 mg every other day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.; All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Intervention MeSH terms: Digoxin; Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized controlled prospective study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Digoxin; Ursodeoxycholic acid; Synovial inflammation; leukocyte infiltration; Autoimmune diseases; Th17 and Treg cells; Synovial hypoxia
Single-dose Safety Study of APD916 in Healthy Volunteers
Condition: Narcolepsy With or Without Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional
Phase: Phase 1

Summary: 
      The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916
      when administered as a single dose
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study
      of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2
      to receive placebo, 6 to receive APD916). Each cohort will be assigned to receive a single
      dose of APD916. After dosing within the first cohort has been completed and safety data
      review identifies no tolerability issues, and the principal investigator (PI) and Sponsor
      have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.
    

Intervention name(s): APD916
Intervention type(s): Drug
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study
      evaluating the efficacy of SAGE-217 in the treatment of adult participants with major
      depressive disorder (MDD).
    

Detailed description: 
      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-217 hard gelatin capsules.; SAGE-217 matched placebo hard gelatin capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain
      of the right or left knee.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of
      herbal patch in subjects with OA knee pain. The overall objective of this study is to
      evaluate the efficacy and safety of the patch in relieving OA knee pain.
    

Intervention name(s): Herbal Patch; Placebo Patch
Intervention type(s): Other; Other
Intervention description(s): 1 herbal patch applied for approximately 8 hours per day for 14 days; Control patch with no herbal ingredients
Other intervention name(s): Traditional Chinese Medicine Topical Analgesic Patch; Not a marketed product
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Pain; Herbal medicine; Topical administration
The Sex Specific Waist Circumference Cut Off Points to Predict Overweight or Obesity
Condition: The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or Obesity
MeSH terms: Obesity; Overweight
Study type: Observational

Summary: 
      The waist circumference (WC) cut off levels of the Caucasian people may not represent the
      characteristics of different ethnic groups. The investigators aimed to determine sex specific
      WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in
      Turkish adults.
    

Detailed description: 
      Waist circumference (WC) is an easy and reliable measure of visceral adipose tissue and a
      simple index of cardiovascular risk. The World Health Organization (WHO) reported sex
      specific WC cut off values for the Caucasian people, named as action levels 1 and 2, to
      define the overweight or obese people. These cut off values, originally established in a
      Dutch population, were later adopted by several medical organizations in order to define
      Metabolic Syndrome. However, these cut off levels may not necessarily represent the
      characteristics of the other populations. Therefore it is recommended that the sex specific
      WC cut off points should be established for different ethnic groups.

      The investigators aimed to investigate whether the suggested sex specific WC cut off points
      for the Caucasian adults are appropriate for the Turkish adult population. The secondary aim
      of the study is to search for better WC cut off points to predict obesity, metabolic syndrome
      and increased cardiovascular risk in Turkish adult men and women.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This cross-sectional study was conducted in 24 provinces from the 7 regions of Turkey.
        Turkish adult males and non-pregnant females were randomly enrolled from both the
        provincial district centers and villages, considering the demographics, economic, social,
        and geographical statuses.
      
Keywords: Waist circumference, Metabolic Syndrome, Cardiovascular risk
Open-label Study of ASP2151 in Herpes Simplex Patients
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151
      in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes
      and Kaposi varicelliform).
    


Intervention name(s): ASP2151
Intervention type(s): Drug
Other intervention name(s): 200 mg once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation
Condition: Diabetes Mellitus; Pancreas Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by
      topic cooling and cold in situ flushing using special perfusion solutions designed to
      attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.

      For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used
      perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution
      has been increasingly used for abdominal organ procurement. Retrospective reports published
      so far have demonstrated the safety of both perfusion solutions.

      However, to date, no prospective study comparing both perfusion solutions has been published.
      Aim of this study was to prospectively evaluate early pancreas graft function in clinical
      pancreas transplantation after organ perfusion with HTK vs. UW solution.

      The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement
      in clinical pancreas transplantation.
    


Intervention name(s): Organ perfusion during pancreas procurement
Intervention type(s): Other
Intervention description(s): Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
Intervention MeSH terms: Pancrelipase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreas Clinical, Donor; Pancreas Clinical, Preservation Solutions; Organ Preservation and Procurement, Surgery; Organ Procurement, Ischemia reperfusion Injury; Organ Preservation and Procurement
Modafinil for the Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing
      cocaine use in subjects with cocaine dependence.
    

Detailed description: 
      This is a double-blind, placebo-controlled, parallel group design study to evaluate the
      efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.
    

Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Primary purpose: Diagnostic
Keywords: cocaine dependence