bioihbjkbjnl/mcl2 huggingface dataset:
Technical Feasibility Evaluation of Mucosal Staining During Colon Capsule Endoscopy (CCE) Procedure in Colorectal Cancer (CRC) High Risk Population, When Using MB-MMX
Condition: Colorectal Cancer; Polyp, Colonic
MeSH terms: Colorectal Neoplasms; Colonic Polyps
Study type: Interventional

Summary: 
      A prospective, single-center, single-arm, non-randomized, post-market pilot study evaluating
      the technical feasibility of mucosal staining during COLON2 Capsule Endoscopy (CCE) procedure
      in population at high risk for Colorectal Cancer (CRC), when using MB-MMX (Methylene Blue).

      Up to 15 subjects will be enrolled in 1 center located in Spain. Study duration- up to 10
      months from study approval.
    

Detailed description: 
      Single-center, prospective, non-randomized clinical trial designed to evaluate the technical
      feasibility during CCE procedure, when using MB-MMX as a contrast- enhancement technique of
      mucosal staining in CRC high risk population.

      Subjects will undergo a bowel preparation (single dose, 4L PEG), including 200 mg
      Methylthioninium chloride, corresponding to eight 25 mg MB-MMX tablets and 1 tab of Resolor
      (Prucalopride 1mg). An experienced Gastroenterologist will read the CCE procedure and
      complete a subjective questionnaire, to evaluate mucosal enhancement during a CCE procedure,
      when using MB-MMX as a contrast-enhancement technique.
    

Intervention name(s): PillCam Colon2 procedure with MB-MMX
Intervention type(s): Device
Intervention description(s): Subjects will undergo a bowel preparation (single dose, 4L PEG), including 200 mg Methylthioninium chloride, corresponding to eight 25 mg MB-MMX tablets and 1 tab of Resolor (Prucalopride 1mg). An experienced Gastroenterologist will read the CCE procedure and complete a subjective questionnaire, to evaluate mucosal enhancement during a CCE procedure, when using MB-MMX as a contrast-enhancement technique.
Intervention model: Single Group Assignment
Intervention model description: Single-center, prospective, non-randomized clinical trial designed to evaluate the technical feasibility during CCE procedure, when using MB-MMX as a contrast- enhancement technique of mucosal staining in CRC high risk population.
Subjects will undergo a bowel preparation (single dose, 4L PEG), including 200 mg Methylthioninium chloride, corresponding to eight 25 mg MB-MMX tablets and 1 tab of Resolor (Prucalopride 1mg). An experienced Gastroenterologist will read the CCE procedure and complete a subjective questionnaire, to evaluate mucosal enhancement during a CCE procedure, when using MB-MMX as a contrast-enhancement technique.
The technical feasibility will be evaluated by:
The percent of colonic polyps which have a visible contrast to the healthy colonic mucosa during CCE.
The interference level of detrimental effects on the visualization of the colonic mucosa during CCE, due to use of MB-MMX per colonic segment.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
Condition: Skin Diseases, Infectious; Skin Diseases, Bacterial
MeSH terms: Communicable Diseases; Infections; Skin Diseases, Infectious; Skin Diseases, Bacterial; Skin Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200
      mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with cSSTI.
    

Detailed description: 
      A randomized, single-blind, multicenter, Phase 3 study of IV and/or oral tedizolid phosphate
      200 mg once per day for 6 days compared with IV and/or oral comparator for 10 days for the
      treatment of cSSTI, also known as acute bacterial skin and skin structure infections, in
      participants 12 to <18 years. cSSTI includes major cutaneous abscess, cellulitis/erysipelas,
      and wound infection.
    

Intervention name(s): Tedizolid Phophate; Antibiotic comparator; Aztreonam; Metronidazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tedizolid Phophate 200 mg, IV and/or oral for 6 days; Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.; In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens.; Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens.
Other intervention name(s): TR701-122; MK-1986; SIVEXTRO®; Vancomycin: Vancocin, Firvanq, Lyphocin; Linezolid: Zyvox; Clindamycin: Cleocin; Flucloxacillin: Floxapen, Flopen, Staphylex; Cefazolin: Ancef, Kefzol; Cephalexin: Keflex, Zartan, Panixine, Biocef; Azactam, Cayston; Flagyl, Metro
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Vancomycin; Clindamycin; Cefazolin; Linezolid; Cephalexin; Aztreonam; Tedizolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Neem Extract, Propylene Glycol and Salicylic Acid Combination in the Treatment of Arsenical Palmar Keratosis
Condition: Chronic Arsenic Poisoning
MeSH terms: Arsenic Poisoning; Keratosis; Poisoning
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to find out the effectiveness of combination of ethanol extract of
      neem leaf, propylene glycol (40%) and salicylic acid (10%) in the treatment of palmar
      arsenical keratosis.
    

Detailed description: 
      Arsenic, a non-essential trace element, is a major water pollutant in Bangladesh. Arsenical
      keratosis, which occurs in the palm and sole, is a common symptom of arsenicosis. The
      objective of this study is to find the effectiveness of combination of topical administration
      of the ethanol extract of leaf of neem (Azadirachta indica), propylene glycol (40%) and
      salicylic acid (10%) in the treatment of palmar arsenical keratosis. On the basis of
      inclusion and exclusion criteria, 30 patients of moderate palmar arsenical keratosis will be
      recruited from an arsenic affected area. They will be divided into two groups: study group
      and placebo comparator group. Each group consisting of 15 members. Study group will be given
      combination of ethanol extract of leaf of neem, propylene glycol (40%) and salicylic acid
      (10%) to apply on palm overnight once daily for 12 weeks. On the other hand placebo
      comparator group will be given salicylic (10%) acid to apply on palm overnight once daily for
      12 weeks. Water and nail samples will be collected before starting recruitment to confirm
      arsenicosis. After conclusive recruitment of the subjects the objective, nature, purpose and
      potential risks and benefits of all procedures of the study will be explained in details to
      the patients and informed written consent will be taken from them. Detail history, clinical
      examination and photograph (palm) will also be collected. Clinical improvement will be
      assessed by measuring palmar nodular size on both hands, before starting treatment and after
      12 weeks completion of treatment and perception of patients about their improvement. The
      study will explore the effectiveness of topical use of combination of ethanol extract of
      neem, propylene glycol and salicylic acid for the treatment of palmar arsenical keratosis.
    

Intervention name(s): Neem plus propylene glycol plus salicylic acid; Salicylic acid
Intervention type(s): Drug; Drug
Intervention description(s): Leaf extract of neem plus propylene glycol (40%) plus salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks; salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks
Other intervention name(s): In house prepared; In house prepared
Intervention MeSH terms: Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single
      Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in
      Chinese Healthy Subjects.
    


Intervention name(s): ASC42; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ASC42 tablet administered orally; Matching placebo administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Healthy Subjects; ASC42; FXR agonist
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration
      of Rivastigmine patch in the Japanese population.
    


Intervention name(s): Active Comparator; ENA713
Intervention type(s): Drug; Drug
Intervention description(s): 1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.; -3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rivastigmine, Alzheimer's disease, Transdermal patch
Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
Condition: Brain Death
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Death; Diffuse Axonal Injury; Death
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the proof of concept study with multi-modality approach (using intra-thecal bioactive
      peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as
      adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury
      to document possibility of reversal of brain death (BD).
    


Intervention name(s): BQ-A Peptide Extract; Mesenchymal Stem Cells; Transcranial Laser Therapy; Median Nerve Stimulator
Intervention type(s): Biological; Biological; Device; Device
Intervention description(s): BQ-A Peptide Extract; Mesenchymal Stem Cells; Transcranial Laser Therapy; Median Nerve Stimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline
      Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects
      aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group
      will receive the control.
    


Intervention name(s): CervarixTM; Control
Intervention type(s): Biological; Other
Intervention description(s): Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule.; Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Immunogenicity; Safety; Human papillomavirus; China; HPV vaccine
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome; Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will determine whether characteristics of women with Premenstrual Syndrome
      influence response to treatment with serotonin reuptake inhibitors and whether SRIs can
      alleviate premenstrual symptoms.
    

Detailed description: 
      Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have
      shown the use of serotonin reuptake inhibitors (SRIs) during the luteal phase of the
      menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric
      disorder (PMDD). Unfortunately, SRI treatment has only been evaluated in controlled clinical
      trials, and evidence suggests that patients in these clinical trials are not representative
      of women commonly seen in clinical practice. Thus, the real-world feasibility of intermittent
      dosing is questionable.

      Patients in this study receive sertraline (Zoloft) during the luteal phase of their menstrual
      cycle every month for 6 months. The dose may be modified based on structured interviews with
      the patients. Assessments include questionnaires and interviews which take place at study
      start, at midpoint, and at the end of the study.
    

Intervention name(s): Sertraline; Treatment as usual (TAU)
Intervention type(s): Drug; Other
Intervention description(s): Patients who meet study criteria will be given 50 mg per day of sertraline to be taken an estimated 2 weeks before menstruation.; At the TAU baseline visit, patients will be told of their diagnosis of PMS/PMDD. Those patients who decide to seek treatment outside of the study protocol or do not wish to seek treatment will be asked to participate in the TAU part of this protocol. Patients in TAU will be contacted monthly to obtain monthly information about how they have been feeling (blinded ratings) using the study measures.
Other intervention name(s): Zoloft; TAU
Intervention MeSH terms: Sertraline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy
Condition: Postoperative Pain Following Radical Cystectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study compares analgesic efficacy, and safety of three different doses of peri-operative
      pregabaline to placebo following radical cystectomy.
    


Intervention name(s): pregabaline 300 mg once.; pregabaline 300 mg twice.; pregabaline 600 mg once.; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): patients received pregabaline 300 mg 2 hours pre-operatively.; patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.; patients received pregabaline 600 mg 2 hours pre-operatively.; patients received placebo
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder
Condition: Autistic Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      The clinical study evaluates in an open-label, crossover design the comparative efficacy and
      safety of intranasal oxytocin and autologous umbilical cord blood for improving the
      functioning of children with autistic spectrum disorder
    

Detailed description: 
      Children aged 3-7 years diagnosed with autistic spectrum disorder and who did not previously
      receive oxytocin or umbilical cord blood treatments, will be enrolled to receive both
      treatments in random order. Assessment of functioning impairment will be done with
      QCHAT/M-CHAT/CAST questionnaires initially, at 2 months, 6 months and 1 year after first
      treatments. Either oxytocin or cord blood will be administered initially and at visit 2,
      which will take place at 2 months. All children will receive both treatments. A total of
      25-40 children are expected to enroll and complete the study.
    

Intervention name(s): Intranasal oxytocin; Autologous umbilical cord blood
Intervention type(s): Drug; Biological
Intervention description(s): daily administration of oxytocin, 10 UI intrnasal, 5 UI bid, and if needed curcumin orally 250 mg bid, and/or lecithin 500 mg bid, and/or pironoquinolinquinone, 20 mg qd; patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth
Other intervention name(s): non-invasive treatment; invasive treatment
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, multi-center, parallel-group study to evaluate the
      efficacy and safety of subcutaneous (SC) tocilizumab (162 milligrams [mg] every 2 weeks
      [Q2W]) given as monotherapy and in combination with MTX versus MTX given as monotherapy, in
      participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate
      response to current DMARD therapy. The study comprises a 24-week double-blind treatment
      phase, followed by a 24-week extension phase.
    


Intervention name(s): Tocilizumab; MTX; Placebo Matched to MTX; Placebo Matched to Tocilizumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive tocilizumab 162 mg given as 0.9 milliliter (mL) of a 180 mg/mL solution in a prefilled syringe, administered by SC injection Q2W.; Participants will receive MTX stable doses at 10 to 25 mg orally.; Placebo matched to MTX.; Placebo matched to tocilizumab.
Other intervention name(s): RO4877533
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Glycemic Response to Oral Nutrition Supplements
Condition: Diabetes
Study type: Interventional

Summary: 
      This will be a randomized, cross-over study of two oral nutrition supplements in individuals
      with Type 2 Diabetes.
    


Intervention name(s): ONS
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a
      prodrug of aciclovir (ACV)
    


Intervention name(s): Tipranavir; Ritonavir; Valaciclovir
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir; Valacyclovir
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The COOL-BP study is part of the Remote Hypertension Program and will investigate the data
      provided by Aktiia Bracelet (a cuffless Blood Pressure monitor at the wrist) when integrated
      into the Remote Hypertension Program.

      The COOL BP study aims to compare weekly and monthly Blood Pressure averages measured
      manually by traditional Home Blood Pressure Monitoring to those measured automatically by the
      Aktiia bracelet.
    

Detailed description: 
      This is a prospective open-label single arm study. The investigational device of this study
      is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor
      intended to track systolic and diastolic Blood Pressure trends. The Aktiia Bracelet can also
      measure heart rate.

      Participants who consent to participate in COOL-BP will be shipped an Aktiia device to
      participants' residence.

      For 6 months, patient will continue the procedures of the Remote Hypertension Program in
      parallel to wearing the Aktiia Bracelet. The Remote Hypertension Program is run remotely
      according to a clinical algorithm, where study navigators contact patients at regular
      intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to
      ensure safety of the protocol's prescribed medications. Any symptoms will be evaluated by the
      program nurse practitioner or physician and managed per standard of care. During the study,
      the patient completes several surveys to give opinion on Aktiia product versus Home Blood
      Pressure Monitoring.

      Following six months of using the Aktiia.product, the participant's participation in this
      study will end. Participants continued participation in the Remote Hypertension Program will
      depend on whether participants have met the blood pressure goals outlined in that program.
    

Intervention name(s): Aktiia Bracelet
Intervention type(s): Device
Intervention description(s): Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The optical signals at the wrist are recorded non-invasively by means by the Aktiia bracelet. The Blood Pressure measurements are further determined from these optical signals and are compared to weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring.
Intervention model: Single Group Assignment
Intervention model description: This is a prospective open-label single arm study.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hypertension