bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of Neu-P11,
      following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching
      placebo) given nightly over 2 periods of 5 days to male and female subjects with primary
      insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11
      after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well
      as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated
      and have significant sleep promoting effects.
    

Detailed description: 
      The effects of four multiple ascending doses of orally administered Neu-P11 will be evaluated
      in a double- blind, placebo-controlled, crossover design. Following a screening visit, the
      recruited subjects will undergo an inclusion/habituation full night PSG screening recording
      in the sleep clinic to exclude subjects with sleep disorders. Eligible subjects will be
      divided into 2 cohorts of 12 subjects each. Following screening, each cohort will be
      randomised to receive Neu-P11 or placebo for a first period of 5 days and will be crossed
      over following at least 21 days to receive placebo or a higher dose of Neu-P11 for a second
      period of 5 days. Each cohort will receive a different dose of Neu-P11, chosen from 2, 5, 20
      and 50 mg. The starting dose is 5 mg but a smaller dose (2 mg) is also included for the
      purpose of pharmacodynamic evaluation. Before proceeding from 5mg to the next higher dose
      safety will be evaluated based on adverse events, clinical and biological data. Subjects of
      Cohort A will be randomised to dose levels 2 and 3 (doses 5 and 20 mg). Subjects of Cohort B
      will be randomised to dose levels 1 and 4 (doses 2 and 50 mg).
    

Intervention name(s): Neu-P11; Neu-P11 placebo
Intervention type(s): Drug; Drug
Intervention description(s): comparison of different dosages of drug; comparison of different dosages
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neu-P11; Insomnia; PSG; safety
Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
Condition: Metastatic Breast Cancer; Pancreatic Cancer; Metastatic Colorectal Cancer
MeSH terms: Breast Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin
      (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast
      Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the
      recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety
      profile, to explore the feasibility of PM01183 dose optimization, to characterize the
      pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity
      of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.
    


Intervention name(s): lurbinectedin (PM01183); capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): lurbinectedin (PM01183) 1 mg and 4 mg vials; capecitabine 150 mg tablets
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy
      to individuals suffering from erectile dysfunction. The study was randomized controlled trial
      with two arms involving a control group. The study was conducted with an aim of pilot and
      feasibility study to evaluate the efficacy and suitability of cognitive behavior
      psychotherapy with individuals suffering from erectile dysfunction.
    


Intervention name(s): Cognitive Behavioral Psychotherapy; Sildenafil Citrate 50Mg Tab
Intervention type(s): Behavioral; Drug
Intervention description(s): The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.; The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.
Other intervention name(s): Cognitive Behavior Psychotherapy; PDE5i
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Sexual Dysfunctions, Men Health
The Effect of Taping in Reducing the Intensity of Pain in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      To determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea
    

Detailed description: 
      Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before
      or during menstruation, in the absence of other diseases.

      About 50-90% of the women experience menstrual pain, and approximately 15% of them suffer
      from a severe level of pain It is a common cause of absenteeism and reduced quality of life
      in women.

      From 21% to 96% of women with menstrual pain, reported to practice self-treatment either by
      pharmacological or nonpharmacological interventions. However, there are adverse events
      associated with the use of these drugs, including stomach ache, diarrhea, nausea, cutaneous
      reactions, liver or kidney damage or cardiovascular risk after discontinuing medication .
      Therefore, many patients with menstrual pain usually seek complementary and alternative
      techniques.

      Medical taping concept is an alternative treatment that use elastic adhesive tape, which is
      applied to the patient's skin under tension.

      It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure
      on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive
      stimuli.
    

Intervention name(s): Medical taping; Analgesic self-medication (OTC)
Intervention type(s): Device; Drug
Intervention description(s): For the medical taping group, a piece of Kinesio tape 5 cm in width and 7-8 cm in length will be applied right from below the navel and will reach to where the pubic hair begins, and another piece of tape 10 cm in length will be applied to make a cross shape with the first piece. A tape of 20cm in length will be placed horizontally to the lower back.; Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary Dysmenorrhea; Taping; Pain
HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy
Condition: High-Grade Lymphomas
MeSH terms: Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is planned to compare the outcome of aggressive NHL patients in partial remission
      after four courses of front-line therapy, randomly assigned to receive either additional four
      courses of the same regimen or a modified HDS program.
    


Intervention name(s): HDS vs ProMECE/CytaBOM
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sodium Tungstate in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy and safety of sodium tungstate versus
      placebo in patients with obesity (grade I and II).
    


Intervention name(s): Sodium Tungstate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sodium Tungstate, 200 mg BID, oral route during 6 weeks; Placebo, BID, oral route during 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain
Condition: Shoulder Pain; Musculoskeletal Disease; Joint Disease; Shoulder Injury
MeSH terms: Shoulder Pain; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries
Study type: Interventional

Summary: 
      Interventions focused on the scapula have been frequently used to treat shoulder pain.
      However, most studies do not assess the contribution of scapular movement alteration for the
      symptoms.

      Objectives: To compare the effects of two interventions for shoulder pain: Scapular Movement
      Training and General Exercises.
    

Detailed description: 
      This is a double-blinded randomized controlled trial. Sixty-four subjects with shoulder pain,
      scapular dyskinesis, and positive scapular assistance test will be randomized in two groups:
      1) Scapular Movement Training, and 2) General Exercises. The Scapular Movement Training Group
      will receive the orientation about proper scapular position and movement, and will be trained
      to modify the scapular movement pattern. The General Exercises Group will perform
      scapulothoracic stretching and strengthening exercises.

      Both groups will be treated twice a week for eight weeks. The following outcomes will be
      collected at baseline and follow-up: scapular kinematics, electromyographic muscle activity
      of the upper, middle and lower trapezius, and serratus anterior, as well as pain intensity,
      function, and fear avoidance beliefs. Also, pain intensity, function, and fear-avoidance
      beliefs will be assessed at the fourth week of follow-up after the end of treatment's period.
    

Intervention name(s): Scapular Movement Training; General Exercises
Intervention type(s): Other; Other
Intervention description(s): Orientation about the proper scapular position and movement and training to modify the scapular movement pattern.; Strengthening and stretching exercises.
Other intervention name(s): Orientation and training; Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scapula; Physical Therapy; Movement; Rehabilitation
Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)
Condition: Healthy Volunteers
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Alterations of functional brain networks have been frequently demonstrated in schizophrenia,
      although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to
      exert its schizophrenia-like effects through modulation of the glutamatergic system, thus
      facilitating the investigation of the impact of this specific transmitter system on resting
      state functional brain networks. The aim of the study is therefore to use pharmacological
      functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved
      in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects
      (15 females) will be examined twice using a double-blind, placebo-controlled, randomized,
      crossover, counterbalanced-order design. Resting state fMRI will be investigated before,
      during and after either placebo or ketamine intravenous infusion for 20 minutes. Prior to the
      main trial 10 additional participants will be included in an open pilot trial.

      Hypothesis: Ketamine application will induce changes in resting state networks previously
      associated with schizophrenia and in the connectivity of relevant brain regions such as the
      striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of
      ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed
      before and after ketamine infusion.
    


Intervention name(s): Esketamine hydrochloride
Intervention type(s): Drug
Intervention description(s): Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.
Other intervention name(s): Ketanest S; Ketamine
Intervention MeSH terms: Ketamine; Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Siblings of those with type 1 diabetes are at an increased risk of developing the disease
      themselves. Through prior research, the investigators have found that siblings as well as
      those with type 1 diabetes have a general level of inflammation in the body. The
      investigators are examining the role that diet plays in this level of inflammation by asking
      siblings of children with type 1 diabetes to go on a gluten and Amylase Trypsin Inhibitors
      (ATI)-free diet for 4 weeks. Blood and stool samples will be measured before the diet, after
      the diet is completed and again 4 weeks after participants resume their normal diet.
    


Intervention name(s): Gluten and Amylase Trypsin Inhibitors (ATI)-free diet
Intervention type(s): Other
Intervention description(s): Participants will be asked to avoid foods containing gluten and ATI (a similar protein found in grains) for 4 weeks.
Intervention MeSH terms: Trypsin Inhibitors
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive a dietary intervention. They will be instructed and asked to follow a diet free of gluten and the protein amylase trypsin inhibitors (ATI), which is frequently found in gluten-containing foods, for four weeks. They will then be asked to resume their normal diet.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Siblings
Quantitative Evaluation of Aerosols Produced in the Dental Office
Condition: Aerosol Disease; Caries,Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Background: Maintaining biosafety in dental practice requires an efficient elimination of
      aerosols produced during dental treatment. The objective of this research was to assess the
      quantity of aerosols and aerobic bacteria present in the air during the treatment of caries.
      Methods: This study was divided into two groups based on the caries treatment method
      involving 60 patients with 60 m olar teeth (n=60) in the mandible. Group 1 (n=30) received a
      conventional dental turbine W&H Synea TA-98LC (W&H, Bürmoos, Austria), while Group 2 (n=30)
      received an Er:YAG laser (LightWalker, Fotona, Slovenia). Measurements of aerosol particles
      between 0.3 - 10.0 μm near the operator's mouth were taken using the PC200 laser particle
      counter (Trotec GmbH, Schwerin, Germany). The number of aerobic bacteria in the air was
      determined using 60 micro-biological plates with a microbiological medium (Columbia Agar with
      5% Sheep Blood) and the sedimentation method. A control group G3 was established to measure
      the initial aero-sol level and the initial total number of bacteria CFUs (colony-forming
      units) before each treatment.
    


Intervention name(s): Caries treatment with a dental turbine; Caries treatment with Er:YAG laser
Intervention type(s): Procedure; Procedure
Intervention description(s): G1 (n=30) conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.; G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: laser; Er:YAG; disinfection; bacteria; high-volume evacuator
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light
      Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.
    


Intervention name(s): OrthoPulse™
Intervention type(s): Device
Intervention description(s): Patients carry out daily OrthoPulse™ treatments at home.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alignment phase; Photobiomodulation; Orthodontic treatment; Malocclusion; OrthoPulse™
Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery
Condition: Pharmacological Action
Study type: Interventional

Summary: 
      This study aims to evaluate the short-term effects and safety of prophylactic intra-vitreal
      injection of triamcinolone-moxifloxacin combination after cataract surgery. 84 patients
      underwent cataract surgery associated with intra-vitreal injection of
      triamcinolone-moxifloxacin combination after surgery.
    

Detailed description: 
      All the patients underwent the surgical removal of cataract by the same surgeon according to
      the standard protocols for modern phacoemulsification. Surgery was done under local
      anesthesia by peri-bulbar injection of local anesthetic. All operations were performed in an
      operating room by using an operating microscope under complete aseptic condition by using 10%
      povidone iodine solution applied to the skin of eye lid, eye lashes, side of the nose, eye
      brow and the skin of forehead. Before the operation, sterile drape and eyelid speculum were
      used, then 5% povidone iodine solution was applied to the bulbar conjunctiva and fornices for
      about 5 minutes, then was irrigated by balanced salt solution (BSS).

      All the patients were followed up at the 1st day, 1st week, 1st month and at the 3rd month
      after the operation. At each visit the followings should be assessed: the post-operative
      refraction, the best corrected visual acuity and anterior and posterior segments examination
      for any sign of postoperative inflammation as cells and flare. Intra-ocular pressure (IOP)
      assessment and optical coherence tomography (OCT) images were also taken at the 1st and the
      3rd postoperative months to assess the central macular thickness in suspected cases of
      cystoid macular edema (CME) based upon symptoms or signs observed on fundus examination, were
      confirmed by OCT of the macula through subjective interpretation via presence of cysts or an
      objective measurement of retinal thickness > 250 microns.
    

Intervention name(s): intra-vitreal triamcinolone-moxifloxacin injection after cataract surgery as a prophylactic measures against post-operative endophthalmitis
Intervention type(s): Drug
Intervention description(s): At the end of surgery, 4mg triamcinolone acetonide and 0.2mg moxifloxacin from 0.5 moxifloxacin preservative-free eye drop) were injected once inferotemporally 3.5 mm posterior to the limbus via pars plana into the vitreous cavity by using 30 G needle.
Intervention MeSH terms: Moxifloxacin; Triamcinolone
Intervention model: Single Group Assignment
Intervention model description: cataract surgery followed by intravitreal injection of triamcinolone and moxifloxacin combination as a prophylaxis against endophthalmitis
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endophthalmitis
Immune and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy
Condition: Food Allergy; Peanut Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine whether allowing ingestion of
      sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg
      peanut protein on supervised double-blind, placebo-controlled oral food challenge [DBPCFC])
      will be associated with attaining even higher thresholds over time in children with high
      threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives
      include assessing the development of sustained unresponsiveness (SU, a surrogate term for
      tolerance without daily ingestion), effects on quality of life, and safety compared to those
      avoiding peanut. Additionally, this study will phenotype the allergic response to peanut
      based on threshold and response to exposure. Mechanistic study objectives will determine the
      immune and molecular basis of the high threshold endotype, identify predictors of response to
      exposure, and determine mechanisms and biomarkers of remission.
    


Intervention name(s): Peanut Protein
Intervention type(s): Biological
Intervention description(s): up to 9043 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 200-250 children undergoing DBPCFC to peanut to identify 72 with high threshold peanut allergy for randomization in trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allergy; food; peanut; threshold; immunotherapy
Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for
      immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One
      hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups
      according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate
      and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate
      nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to
      the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline,
      immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used
      to assess the sensitivity level.
    


Intervention name(s): Colgate; Sensodyne; Nano P; Cocorico
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure; Digital application for 60 seconds.; Slow-speed handpiece with a Robson brush for 10 seconds; Digital application for 60 seconds
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment