bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Pain Course After Uvulopalatoplasty
Condition: Snoring; Surgical Procedures, Operative; Pain, Postoperative; Quality of Life
MeSH terms: Pain, Postoperative; Snoring
Study type: Observational

Summary: 
      The aim of this study is to determine the postoperative course including effects on the
      quality of life following soft palate surgery with radiofrequency knife (RAUP).
    

Detailed description: 
      For the treatment of social snoring one common treatment modality is the surgical
      reconstruction of the soft palate. The procedure is a routine operation performed at nearly
      all Ear-Nose- and Throat departments in Norway. The surgery is done with local anaesthesia in
      an out-patient setting where the patients' postoperative observation at the hospital is
      limited to 1-2 hours. As the surgery is done in the sensitive mucosa and palatopharyngeal
      musculature the postoperative course might be unpleasant. The patients are therefore in the
      need of regular postoperative pain treatment extending into the 2 first weeks after surgery.

      At hospitals the uvulopalatoplasty is performed using a radiofrequency knife (RAUP) after the
      soft palate has been infiltrated with local anaesthesia (1% xylocain/adrenaline). The
      incision is done paramedialy to the uvular base and up into the musculature of the soft
      palate then making a smooth arch toward the pharyngeal tonsil upper limit. The then elongated
      uvula is amputated to about ½ cm. Occasionally, a suture is placed laterally and medially to
      lift the palate and prevent postoperative scaring. Coagulation is done if necessary with
      light bipolar diathermy.

      As the postoperative course might be unpleasant after RAUP it is of interest to study the
      time course and intensity of pain after surgery when using the standardised postoperative
      pain treatment at OmniaSykehuset. The result will be useful in future studies looking at ways
      to improve the pain treatment after uvulopalatoplasty.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of either sex, of Caucasian origin, between the age of 18 and 80, who are referred
        to the hospital for snoring that have been subjected to a sleep study indicating that
        uvulopalatoplasty might have a considerable affect on the snoring.
      
Keywords: uvulopalatoplasty; postoperative pain; quality of life
Indications for Gallbladder Surgery in Gallstone Disease
Condition: Gallstones
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Observational

Summary: 
      The aim of the study is to identify patients with gallstone disease that should be operated
      and those that may potentially be observed. This selection was based on symptoms and clinical
      presentation. The consequences that may arise for the patient if observation is chosen
      compared with outcome after cholecystectomy has been markers of outcome.
    

Detailed description: 
      1. Randomized clinical trial (RCT) of observation versus surgery for uncomplicated
           gallstone disease

        2. RCT of observation versus operation for acute cholecystitis

        3. Study of outcome after cholecystectomy in patients from 1. and 2.

        4. Study of symptoms in gallstone disease and symptom relief after cholecystectomy

        5. Long-term morbidity and mortality, including cancer, after cholecystectomy

        6. Long-term follow-up of patients with silent gallstones
    

Intervention name(s): Cholecystectomy operation
Intervention type(s): Procedure
Intervention description(s): Cholecystectomy after randomization
Other intervention name(s): Removal of gallbladder
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to a hospital for either acute cholecystitis or uncomplicated symptomatic
        gallstone disease randomized to observation or operation. Patients from a population
        screening study for gallstones performed in 1983. Patients operated for gallstone disease
        in 1983.
      
Biospecimen description: 
      Resected gallbladders for histological and bacteriological investigation
A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Condition: Tuberous Sclerosis Complex; Seizures
MeSH terms: Tuberous Sclerosis; Seizures; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
      blinded phase only will be described in this record. Participants will receive 1 of 2 doses
      of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a
      difference between GWP42003-P and placebo in their effect on seizure frequency.
    


Intervention name(s): GWP42003-P; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.; Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other intervention name(s): Cannabidiol; CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose
      (MAD), study to evaluate the safety/tolerability and pharmacokinetics (PK) of FP-045
      administered to normal health volunteers (NHVs). 3 cohorts of NHVs will be enrolled. Subjects
      in each cohort will be randomized to orally receive either FP-045 (6 subjects) or placebo (2
      subjects). Subjects will receive 7 daily doses of study drug.

      Subjects will be screened for study eligibility within 21 days before Day 1 and will have
      been admitted to the CRU on Day -1 to confirm eligibility and to undergo baseline
      assessments. Subjects will remain in the CRU for observation until completion of all
      assessments on Day 10. Subjects will return to the CRU on Day 11 for an additional PK sample,
      and again for an end of study (EOS) Visit on Day 14 (±2 days) for safety evaluations and
      collection of PK samples.
    


Intervention name(s): Cohort 1 - FP-045 oral solution; Cohort 2 - FP-045 oral solution; Cohort 3 - FP-045 oral solution; Placebo (for FP-045 oral solution)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.; FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.; FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.; Participants (cohorts 1-3) will receive FP-045 oral solution matching placebo.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Multiple Dose, Dose Escalation study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision
      in patients who require reading glasses
    


Intervention name(s): PresVIEW Device Implantation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Presbyopia; Reading Glasses; Near Vision
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)
Condition: COVID-19 Prevention
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S
      administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult
      participants during the second and/or third trimester of pregnancy and (potentially)
      post-partum; to assess the humoral immune response in peripheral blood of adult participants
      to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester
      of pregnancy, 28 days after vaccination.
    

Detailed description: 
      There is an increased risk of severe coronavirus disease-2019 (COVID-19) during pregnancy, as
      well as an increased risk of adverse birth outcomes. Therefore, the aim of this study is to
      assess the safety, reactogenicity and immunogenicity of Ad26.COV2.S in adult participants in
      the second and/or third trimester of pregnancy. Ad26.COV2.S (also known as Ad26COVS1) is a
      monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26
      (Ad26) vector, constructed to encode the S protein derived from a severe acute respiratory
      syndrome coronavirus-2 (SARS-CoV-2) clinical isolate, stabilized in its prefusion
      conformation. For each adult participant, the total study duration from screening until the
      last follow-up visit will be approximately 16 months. The study will consist of a screening
      phase (28 days), vaccination period (study period from vaccination to pregnancy
      completion/termination) and a follow-up period (up to 12 months post pregnancy
      completion/termination). For neonates/infants born to the participants in the study will be
      followed for approximately 12 months postpartum. Safety assessments will include
      immunogenicity assessments, physical examination, vital signs, clinical safety laboratory
      assessments, medical, obstetric and delivery history, pregnancy outcome, neonate safety
      assessment, adverse events (AEs), serious adverse events (SAEs), and adverse events of
      special interest (AESI).
    

Intervention name(s): Ad26.COV2.S
Intervention type(s): Biological
Intervention description(s): Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
Other intervention name(s): JNJ-78436735, Ad26COVS1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Treosulfan-based Conditioning for Transplantation in AML/MDS
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypotheses is that the introduction of dose escalated treosulfan, in substitution
      to busulfan, will reduce toxicity after allogeneic transplantation while improving
      myeloablation and and disease control in patients with AML and MDS not eligible for standard
      transplantation.
    


Intervention name(s): treosulfan; Treosulfan
Intervention type(s): Drug; Drug
Intervention description(s): 12 g/m2 x 3 days; 12 g/m2 x 3
Intervention MeSH terms: Treosulfan; Busulfan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myeloid leukemia; myelodysplastic syndrome; allogeneic stem cell transplantation; reduced-intensity conditioning; treosulfan
Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
Condition: Pre-diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the short-term effects of the antimalarial
      medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled
      intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin
      secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.
    

Detailed description: 
      Diabetes is approaching epidemic proportions in the United States. This study evaluates the
      mechanisms of action of a generic drug that may have effects on glucose metabolism.
    

Intervention name(s): hydroxychloroquine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules; Thirteen weeks of oral placebo provided as capsules
Other intervention name(s): Plaquenil; microcellulose placebo
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: pre-diabetes; hydroxychloroquine; frequently sampled intravenous glucose tolerance testing; insulin resistance; insulin secretion; glucose tolerance
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be
      evaluated in adult males with ADHD.
    


Intervention name(s): TD-9855; TD-9855; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily; Once daily; Once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adult ADHD; Attention-Deficit/Hyperactivity Disorder
Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
Condition: Primary Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate safety and efficacy of dimethyl fumarate treatment in patients
      with primary progressive multiple sclerosis (PPMS).

      Half of the patients will receive dimethyl fumarate and the other half will receive placebo.
    

Detailed description: 
      Multiple sclerosis (MS) is a chronic, inflammatory disease of the central nervous system and
      is presumed to be caused by T cell-mediated autoimmune processes. PPMS has no registered
      treatment options only symptomatic treatment exists. Progressive forms of MS are
      characterized clinically by gradual symptom development with or without superimposed
      relapses.

      Fumarates have long been known to have disease-attenuating effects in psoriasis. They have
      been in routine use in dermatology in Germany for several decades. Dimethyl fumarate has the
      interesting property of combining immunological effects, at least partly mediated by
      interference with nuclear factor kappa B and other transcription factors, and also
      anti-oxidative and neuroprotective effects mediated by activation of the transcription factor
      Nuclear factor (erythroid-derived 2)-Related Factor 2 (NRF2). Dimethyl fumarate is currently
      approved for treatment of relapsing-remitting MS by the European medicines Agency in a dose
      of 240 mg twice per day.

      Neurofilament light chain (NFL) is a treatment responsive biomarker of neuronal and axonal
      death when appearing in the cerebrospinal fluid (CSF) and it has been associated with
      long-term prognosis in MS. The concentration is often elevated in progressive MS patients.
      Treatment effect is measured by measuring changes in neurofilament light chain concentration
      over the course of 48 weeks of treatment with either active drug or placebo.
    

Intervention name(s): Dimethyl fumarate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Manufactured to mimic Dimethyl Fumarate capsules
Other intervention name(s): Tecfidera; BG-12
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms
Condition: Posttraumatic Stress Disorder; Aggressive Behaviour; Parental Maltreatment; Days Spent at the Landfill
MeSH terms: Stress Disorders, Post-Traumatic; Aggression
Study type: Interventional

Summary: 
      Children living at the landfills of Bujumbura are often exposed to maltreatment, including
      emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in
      severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by
      Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction
      difficulties of children by a group intervention, poverty by financial support and economic
      training for mothers, medical problems by medical assistance, legal conflicts by legal
      advice, and providing access to school, we aimed at reintegrating those children within the
      Burundian school system and improving familial relationships.

      The investigators want to provide evidence, that mental health interventions are an integral
      part of assisting children and families affected by poverty and violence.
    


Intervention name(s): Comprehensive family intervention including individual sessions of FORNET
Intervention type(s): Behavioral
Intervention description(s): A group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug abuse, anger management, roles within families, developing plans for the future, communication skills, sex education.
Access to schools and school material
Family visits
Their parents received training regarding agriculture and microcredit projects, and financial assistance
FORNET if affected by trauma-related symptoms, and/or acting aggressive
If needed medical assistance /.) If needed, legal assistance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Growing evidence over recent years supports a potential role for low grade chronic
      inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we
      will determine whether salsalate, a member of the commonly used Non-Steroidal
      Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2
      diabetes. The study will determine whether salicylates represent a new pharmacological option
      for diabetes management. The study is conducted in two stages. The first stage is a dose
      ranging study, administering salsalate compared to placebo over three months. The primary
      objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar
      control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes
      (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and
      cardiac risk.

      The second stage is a second trial and posted under alternate registration.
    

Detailed description: 
      The primary objective of the first stage of the TINSAL-T2D trial is to select a dose of
      salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic
      control. The trial is a multicenter, single mask lead-in, double masked placebo controlled
      dose ranging study, comparing salsalte to placebo over 3 months.
    

Intervention name(s): Salsalate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided; Placebo to Salsalate
Other intervention name(s): Disalcid; Salicylsalicylic acid; Placebo to Salsalate
Intervention MeSH terms: Salicylsalicylic acid; Sodium Salicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Inflammation; Obesity; Metabolic Syndrome
Generalization of Extinction Learning
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 1

Summary: 
      Fear, whether it occurs in humans suffering from an anxiety disorder or in experimental
      models with rodents, is reduced by exposing the frightened organism to the fearful stimulus
      in the absence of any negative consequences (i.e., extinction, or exposure therapy). However,
      fear often renews when the feared stimulus is encountered in a context different from the
      exposure context. In rats, the investigators found that interfering with the animal's ability
      to process contexts during extinction by administering an anticholinergic drug prevented fear
      renewal. This proposal will determine if the beneficial effect of this drug translates to
      exposure therapy in socially anxious humans. To this end, 100 individuals with Social Phobia
      who fear public speaking will undergo repeated sessions of exposure to public speaking,
      within a virtual reality context. Participants will be randomized to either drug placebo,
      .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via
      nasal drops, prior to each session of exposure therapy. One month after completion of
      exposure therapy, context renewal will be tested by comparing physiological and subjective
      responses to public speaking in the same virtual context as used during exposure therapy
      versus a context different than the one used during exposure therapy. The goal is to identify
      the dose of Scopolamine associated with the greatest reduction in context renewal. In
      addition, a secondary analysis will attempt to identify those individuals who benefit most
      from Scopolamine-augmentation of exposure therapy.
    


Intervention name(s): Scopolamine; intranasal placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be randomized to either, .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy; Participants will be randomized to a drug placebo, administered via nasal drops, prior to each session of exposure therapy
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exposure; scopolamine; extinction learning; social anxiety