bioihbjkbjnl/mcl2 huggingface dataset:
Monocentric Feasibility Study for a New Medical Device for the Treatment of Anal Fissure With Botulinum Toxin
Condition: Anal Fissure
MeSH terms: Fissure in Ano
Study type: Interventional

Summary: 
      Monocentric feasibility study for a new device for the treatment of anal fissure with
      botulinum toxin.
    

Detailed description: 
      Anal fissure is a common anal disease. This is a longitudinal tear in the distal part of the
      anal canal. The fissure provokes a spasm of the internal anal sphincter and as such pain and
      eventually bleeding.

      There are currently 3 different treatments. All available treatments tend to relax the anal
      sphincter, which reduces pain and promotes fissure healing.

      The first treatment consists in the local application of cream into the anal canal.

      The second option is the injection of botulinum toxin into the internal or external anal
      sphincter. Finally the third option is a surgical intervention, most frequently a lateral
      sphincterotomy.

      Although the usefulness of botulinum toxin to treat anal fissure has been demonstrated, the
      results vary. This is most likely largely due to the fact that there is no standardized way
      to inject botulinum toxin and that there is a significant learning curve. In addition, the
      gesture is not without risk for the operator.

      The objective of the study is to assess the feasibility of injecting botulinum toxin into the
      anal canal with a new medical device for patients with anal fissure.

      The trial is a mono-centric pilot study conducted on 4 patients. The study is open,
      prospective and all patients will be treated with the botulinum toxin injected using the new
      medical device.

      The device (single-use) under investigation and the botulinum toxin will be made available
      free of charge to the patient.
    

Intervention name(s): Anuscope with needles
Intervention type(s): Device
Intervention description(s): Injection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational

Summary: 
      The goal of this project is to determine the long-term health outcome of children diagnosed
      with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in
      the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have
      compiled a database of more than 300 subjects that completed diagnostic testing for GER in
      the 1970's, 1980's, and 1990's. Subjects are being contacted initially by mail using a
      previously approved recruitment letter. Subjects that fail to respond to this recruitment
      letter are called by phone. In each case, contact information has been abstracted from the
      Children's Hospital database. Subjects are then given the opportunity to complete a
      questionnaire either by phone or in hard copy. Subjects receive no compensation for their
      participation in this study. Subjects will be compared to controls. Controls will complete
      the same questionnaire as the subjects. Inclusion of potential controls will be determined by
      a lack of medical history of gastroenterological diseases before the age of 21 and whether
      the potential control was born within a year of a subject in the study. Controls will receive
      $25 to participate in the study.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The subjects will be selected from a database of patients seen at Children's Hospital,
        Boston or Massachusetts General Hospital between 1977 and 1990 who had biopsies or pH probe
        for symptoms of GERD.
      
Keywords: GER
Comparative Study of Mandibular Dentures Immediately Loaded on Implants or Mini-implants
Condition: Problem With Dentures
Study type: Interventional

Summary: 
      3 groups of immediately Loaded implant-supported overdenture patients will be evaluated
      (overdentures supported by two standard-sized implant, overdentures supported by 4 mini
      implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability,
      masticatory efficiency, patient's satisfaction, oral health related quality of life,
      Peri-implant crestal alveolar bone loss.
    

Detailed description: 
      The implant-supported overdentures will be placed in immediate functional loading on the same
      day of implants placement. A direct restorative protocol will be applied to modify the
      existing prosthesis to implant-supported overdentures.

      The evaluations of the primary outcomes will be conducted before implantation and after (1 -
      3 - 6 - 12 - 18), except Peri-implant crestal alveolar bone loss will be conducted only after
      (0 - 3 - 6 - 12 - 18).
    

Intervention name(s): implant-supported mandibular overdenture
Intervention type(s): Other
Intervention description(s): The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Implant, overdenture, Immediate loading
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Prolonged Open Label Extension Phase
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of ascending oral doses
      of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
    


Intervention name(s): CHF 5074 1x; CHF 5074 2x; CHF 5074 3x
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablet, 1x, once a day in the morning for 48 weeks; oral tablet, 2x, once a day in the morning for 48 weeks; oral tablet, 3x, once a day in the morning for 48 weeks
Intervention MeSH terms: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts
Condition: Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts
MeSH terms: Hepatitis A; Hepatitis B; Warts; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Assessment of the effectiveness of intralesional and intramuscular hepatitis B vaccine in
      treatment of multiple common warts.
    

Detailed description: 
      Recently, intralesional immunotherapy by different antigens, including Candida antigen and
      purified protein derivative PPD has been proved effective in the treatment of different types
      of warts. Hepatitis B vaccine is one of the DNA vaccines that are regarded as being
      potentially safer, relatively cheap and easy to produce with no special storage requirements
      because they are extremely stable and allow for potential simultaneous immunization against
      multiple antigens or pathogens via co-expression of multiple epitopes on single plasmid.
      Hepatitis B vaccine could be a promising immunotherapeutic vaccine in the field of
      intralesional immunotherapy of warts. Moreover, the efficacy of intramuscular injection of
      hepatitis B vaccine would be assessed and compared to its intralesional injection.
    

Intervention name(s): hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India); Intralesional saline
Intervention type(s): Biological; Biological
Intervention description(s): Randomized placebo-controlled comparative effectiveness clinical trial; Intralesional saline
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of Cephalexin Capsules in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different preparations of an antibiotic called
      cephalexin in capsules to determine if they are essentially the same. The study has two
      periods. Participants will receive one preparation of cephalexin in each period. At least 7
      hours will pass between the study periods. The study is expected to last about 2 days for
      each participant, not including screening or follow-up.
    


Intervention name(s): Cephalexin
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): Keflex®
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Peri-Operative Pregabalin on Post-Operative Pain Following Breast Cancer Surgery With Axillary Node Dissection: A Pilot Study
Condition: Breast Cancer Surgery; Post Operative Pain
MeSH terms: Breast Neoplasms; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Breast cancer is a devastating disease. Some women with breast cancer undergo surgery to
      remove the breast and lymph nodes in the axilla (armpit). Unfortunately, surgery of this type
      is associated with pain both in the days immediately following the operation and in the long
      term. Pain that continues for more than three months after surgery is known as chronic pain
      and affects as many as 1/5 to more than ½ of patients having this surgery. Often this pain is
      of a particular type known as neuropathic pain. There have been studies demonstrating that
      the intensity of pain after surgery may be related to the likelihood of developing chronic
      pain. It is important to develop methods to reduce acute pain after breast cancer surgery and
      to reduce chronic pain for breast cancer survivors.

      Pregabalin is a medication used in the treatment of chronic pain. It has been shown to be
      effective for neuropathic pain. There has also been one study demonstrating its effectiveness
      in reducing pain after dental extraction. We are interested in determining whether pregabalin
      taken for 14 days starting the day of surgery will reduce acute (short term) pain and chronic
      pain from this type of breast cancer surgery.

      In order to test ability of pregabalin for the reduction of chronic pain it may be necessary
      to follow a large number of patients for up to one year after surgery. This may require
      studying patients in more than one institution. Prior to starting such a large study we are
      proposing a pilot or preliminary study. This study will follow a smaller group of
      participants (68) for 6 months. From the pilot study we will determine the effect of
      pregabalin on acute pain and logistic and statistical information required for the full
      study. We will randomly assign participants to receive pregabalin or placebo (sugar pills)
      for twice daily for 14 days starting one hour before surgery. We will monitor the
      participants' pain at one hour after surgery, 24 hours after surgery, one week, two weeks,
      three months and six months after surgery. We will also monitor for a number of other
      parameters such as medication side effects and the need for other pain medications.
      Recruitment of study participants is expected to take 6-7 months.
    


Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 75 mg twice a day; 75 mg twice a day
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an efficacy and safety study evaluating a new treatment for subjects with mild to
      moderate Alzheimer's disease.
    

Detailed description: 
      This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in
      approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable
      doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126
      dose arms or placebo for a 24-week treatment period.
    

Intervention name(s): ABT-126; ABT-126; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Low Dose; High Dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS).
Condition: Pulmonary Sarcoidosis
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is determining the non-inferiority in the overall success rate and the
      safety for a combination therapy with hydroxychloroquine plus low dose glucocorticoids
      compared to that for high dose glucocorticoids at 3 and 9 months in patients with pulmonary
      sarcoidosis.
    


Intervention name(s): Prednisone; Hydroxychloroquine + Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): Prednisone per os 0,5 mg/kg/die once/day for 3 months. After 3 months, between responders, prednisone was slowly tapered (5 mg/week maintaining the new reduced dose for one week) to 0,2 mg/kg/die for further 6 months.; Hydroxychloroquine per os 200 mg/die (or adjusted for body weight if less than 61 kg), twice/day + prednisone 0,15 mg/kg per os daily, once/day for 3 months, than for further 6 months between responders.
Intervention MeSH terms: Hydroxychloroquine; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sarcoidosis; treatment; lung; glucocorticoids; hydroxychloroquine
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Objective:

             -  Compare the bioequivalence of a test topiramate formulation (Torrent
                Pharmaceuticals Limited) to an equivalent oral dose of the commercially available
                topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of adult
                subjects under fed conditions.

        -  Clinical Design:

             -  Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human
                adult subjects.
    


Intervention name(s): topiramate
Intervention type(s): Drug
Intervention description(s): Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
The Method to Reduce Displacement of Double-lumen Tube
Condition: Double-lumen Tube Displacement
Study type: Interventional

Summary: 
      The purpose of this study is to devise the method to reduce displacement of a left-sided
      double-lumen tube during patient positioning.
    


Intervention name(s): pillow; neutral
Intervention type(s): Procedure; Procedure
Intervention description(s): bronchoscopic confirmation of double-lumen tube position with a head on a pillow; bronchoscopic confirmation of double-lumen tube position in neutral position of a head
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the efficacy and safety of an investigational drug
      in adult patients with allergic rhinitis.
    


Intervention name(s): montelukast sodium; Comparator: pranlukast
Intervention type(s): Drug; Drug
Intervention description(s): montelukast sodium; 5 mg, 10 mg QD 2-weeks.; Pranlukast 225 mg BID 2-weeks.
Other intervention name(s): MK0476; Singulair
Intervention MeSH terms: Montelukast; Pranlukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open label, pilot futility clinical trial of the safety,
      tolerability, pharmacodynamics and preliminary efficacy of oral salsalate in up to 10
      patients with PSP.
    

Detailed description: 
      This is a multi-center, open label, pilot futility clinical trial of the safety,
      tolerability, pharmacodynamics and preliminary efficacy of oral salsalate in up to 10
      patients with PSP. All participants will be administered 2,250 mg daily [1,500 mg every day
      before noon (every AM) and 750 mg every night at bedtime (every HS)] for 6 months.

      If ≥3 patients experience drug limiting toxicity (DLT), as defined below, the study will be
      terminated.

      A DLT is defined as: 1) any Grade 3 or higher adverse event (AE) per National Cancer
      Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) for which there is
      reasonable possibility that salsalate caused the event, 2) any Grade 2 AE in the CTCAE system
      organ class of nervous system disorders that is considered clinically significant and for
      which there is reasonable possibility that salsalate caused the event, or 3) any Grade 2 or
      higher treatment-related adverse events during administration that do not resolve promptly
      with supportive treatment.

      An interim futility analysis will be performed after five subjects have completed 6 months of
      study drug treatment. If the criteria listed in the Statistical Methods section of this
      synopsis are met, an additional 5 subjects will be enrolled in the trial. If not, the trial
      will be terminated.
    

Intervention name(s): Salsalate
Intervention type(s): Drug
Intervention description(s): Salsalate is a non-acetylated dimer of salicylic acid, and is classified as a NSAID. The chemical name of salsalate is 2-hydroxy-benzoic acid, 2-carboxyphenyl ester. Salsalate has a molecular weight (MW) of 258.226 Da and a molecular formula of C14H10O5.
Intervention MeSH terms: Salicylsalicylic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Salsalate
Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation
Condition: Severe Mood Dysregulation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and acceptability of utilizing an
      adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for
      Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood
      dysregulation disorder (DMDD).

      The investigators hypothesize that retention rates will be >80%, satisfaction scores will
      average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT
      intervention will have overall improvement in SMD/DMDD symptoms.
    

Detailed description: 
      This research is being done to learn more about how to help teenagers with a sad or angry
      mood, and emotional responses out of proportion to what would be expected in a situation.
      Together these symptoms are called Severe Mood Dysregulation (SMD), a research diagnosis, or
      disruptive mood dysregulation disorder (DMDD), a newer clinical diagnosis. Currently, there
      is no standard treatment for teens that have SMD/DMDD. These teens usually receive medication
      and some type of talk therapy. This research is being done to compare two types of talk
      therapy to see which is most effective in helping teens with SMD/DMDD. Investigators will
      compare treatment as usual (TAU) with Interpersonal Psychotherapy for Youth with Mood and
      Behavior Dysregulation (IPT-MBD). Investigators do not know if TAU and IPT-MBD work just as
      well, or if one is better than the other. When this study is over, investigators hope there
      will be a better idea of how to study treatments for teens with SMD/DMDD.

      For those participants who receive IPT-MBD, are prescribed an antipsychotic, and have
      significant improvement in symptoms, investigators will gradually taper the antipsychotic
      dose.
    

Intervention name(s): IPT-MBD
Intervention type(s): Other
Intervention description(s): IPT-MBD is a modified form of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), which emphasizes building skills in managing relationships, helping with problem solving, and strengthening communication skills.
Other intervention name(s): IPT for Mood and Behavior Dysregulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe Mood Dysregulation; Mood Disorders; Irritability; Disruptive Mood Dysregulation Disorder; Interpersonal Psychotherapy