bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
Condition: Attention Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to determine whether an oral administration of
      Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children
      suffering from ADHD. Both the behavior and the academic achievements aspects will be
      evaluated. In addition, we intend to measure side-effects and adverse events and to examine
      the possible correlation between biochemical and behavioral alterations.
    

Detailed description: 
      This study is a single-center, double-blind, randomized, placebo-controlled 15-weeks duration
      trial to assess safety and efficacy of Phosphatidylserine-Omega3 in children diagnosed with
      ADHD, according to the DSM-IV. Following screening, the subjects will be randomized to one of
      two treatment groups:Phosphatidylserine-Omega3 or placebo, in a 2:1 manner. This will be
      followed by an open-label extension, in which Phosphatidylserine-Omega3 will be administered
      to all eligible participants.

      Primary measures of attention and behavior will be evaluated using Conners Rating Scale (CRS)
      teacher- rating scales. As a secondary endpoint, the attention and behavior will be measured
      by CRS and strength and difficulties questionnaires (SDQ) parental- and SDQ teacher-rating
      scales, assessment a continuous performance test (TOVA), and parental Child Health
      questionnaire (CHQ). Improvement in ADHD symptoms will be evaluated by Clinical Global of
      Impression - Improvement (CGI-I). Finally, tolerability will be monitored using Barkley Side
      Effects Rating Scale (SERS) and biochemical parameters, such as fatty acid profile and
      monoamines metabolites will be assessed as well.
    

Intervention name(s): Phosphatidylserine-Omega3; Colored cellulose tainted with fishy odor
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Phosphatidylserine-Omega3 conjugate capsules. Weeks 0-15: 300 mg/day. weeks 16-30: 150 mg/day and a 150 mg/day one year follow-up.; as arm 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; inattentive; impulsive; hyperactive; poor academic performance; poor self-discipline; low self-esteem
A Phase I Study of LY3471851 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different formulations (test & reference) of
      LY3471851 in healthy participants. This study will compare how much of each formulation gets
      into the blood stream and how long it takes the body to remove it. Information about any side
      effects that may occur will also be collected. Participants will remain in the study for
      about 12 weeks, after receiving the study drug that is LY3471851.
    


Intervention name(s): LY3471851; Placebo; Levocetirizine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered SC.; Administered orally.
Other intervention name(s): NKTR-358
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Interleukin-2; NKTR-358; Pharmacokinetics
Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
Condition: Pain; Intravitreal Injection; Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this prospective interventional study is to compare post-intravitreal
      injection pain between eyes receiving topical bromfenac versus artificial tears as an
      analgesic after intravitreal injection.
    

Detailed description: 
      This proposed study is a double-masked randomized trial of adult patients receiving bilateral
      intravitreal injections. Patient data from March 2021 to June 2022 will be collected. Patient
      pain perception, quantified using the Wong-Baker FACES and the short-form McGill Pain
      Questionnaire, will be utilized to compare post-intravitreal injection pain between eyes
      receiving pre-injection bromfenac 0.09% ophthalmic solution versus artificial tears.
    

Intervention name(s): Use of bromfenac 0.09% to reduce intravitreal injection pain; Use of artificial tears to reduce intravitreal injection pain
Intervention type(s): Drug; Drug
Intervention description(s): The eyedrop (bromfenac) will be given to the assigned eye.; The eyedrop (artificial tears) will be given to the assigned eye.
Intervention MeSH terms: Bromfenac; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients will receive both bromfenac 0.09% in the study eye and artificial tears in the control eye. Patients will be randomized to determine whether their right or left eye is the study eye.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Study of Nutrition of Children and Adolescents With GERD
Condition: GERD in Children; GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      This trial is to study the aspects of nutrition in children and adolescents with GERD
      compared to the sex and age-matched control group
    

Detailed description: 
      The aim of the study is to assess the differences in nutrition of pediatric patients with
      GERD compared to the control group. The secondary aim is to study possible associations of
      the data on nutritional habits revealed with the use of food frequency questionnaire (FFQ)
      and the data of 24-hours oesophageal pH-impedance examination.
    

Intervention name(s): diet assessment
Intervention type(s): Other
Intervention description(s): Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: gastroesophageal reflux; weight; obesity; nutrition; GERD; esophageal pH-impedance; food frequency questionnair
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with
      recurrent oligodendroglial tumors following combination chemotherapy.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial
      tumors to temozolomide treatment in patients with progressive disease during or after
      procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and
      toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients.

      OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on
      days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are
      followed every 2 months for the first 6 months and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.
    

Intervention name(s): temozolomide
Intervention type(s): Drug
Intervention MeSH terms: Temozolomide
Primary purpose: Treatment
Keywords: adult oligodendroglioma
RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like
      flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments
      include topical (metronidazole) and systemic (doxycycline) antibiotics with only a suspensive
      effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a device
      emitting an electromagnetic current inducing an increase in temperature when applied on the
      skin, potentiated by infrared light. The monopolar RF has already been used in rosacea on a
      small number of cases with positive and prolonged results. RF with Elos system has been
      evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex folliculorum
      (DF) is a long transparent mite which asymptomatically parasitizes pilosebaceous follicle of
      normal human skin sometimes responsible of inflammatory facial dermatoses. The prevalence and
      density of DF are increased in rosacea, and DF is suspected to play a role in the
      pathogenesis of rosacea. DF is sensitive to heat, and the investigators hypothesize that
      radiofrequency treatment may affect the survival of the mite and should be effective to treat
      papulopustular rosacea.
    


Intervention name(s): Radiofrequence; Doxycycline
Intervention type(s): Device; Drug
Intervention description(s): Associated to arm radiofrequence; doxycycline 100 mg / day for 3 months with clinical evaluation, photos, and confocal SSSB V1 and V4 (M6). Tour V2 M1 for clinical evaluation of safety review, collection of adverse events and issuing end of treatment. Visit V3 M3 on adverse effects.
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Adenocarcinoma; Brain Neoplasms; Adenocarcinoma of Lung
Study type: Interventional

Summary: 
      Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer
      (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally
      advanced or metastatic disease. Important to mention the number of patients that progress or
      recur in central nervous system (CNS). It has been reported that patients with
      adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are
      in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with
      prophylactic cranial irradiation (PCI) is the standard of care in patients without
      progression after locoregional or systemic treatment because the proven benefit in overall
      survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to
      prove any survival benefit, only in CNS PFS, probably because there is no trial, to our
      knowledge, of PCI in NSCLC that include only the specific group of patients considered in
      high risk of developing brain metastasis.
    

Detailed description: 
      Objectives:

        1. To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after
           locoregional or systemic treatment.

        2. Evaluate the benefit in OS in the specific group of patients who are at increased risk
           of developing brain metastasis

        3. Evaluate quality of life and mental function before and after treatment with PCI and
           compare it with patients in the observation group.

      Methods: One hundred and twenty eight patients with locally advanced or metastatic (except
      CNS metastasis) NSCLC will be included and randomized to receive either observation or PCI 25
      Gy in 10 fractions Whole Brain Radiotherapy (WBRT) once the initial treatment has been
      completed and progression of the disease ruled out.
    

Intervention name(s): Prophylactic Cranial Irradiation
Intervention type(s): Radiation
Intervention description(s): Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prophylactic Cranial Irradiation; Lung Cancer; Non Small Cell Lung Cancer; Carcinoembryonic Antigen
Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain
Condition: Toothache; Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Toothache; Facial Pain
Study type: Observational

Summary: 
      This proposal will investigate pain modulatory mechanisms and brain functional and structural
      characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder
      (PDAP) patients with and without temporomandibular disorders (TMD). All measures from
      patients will be compared to painfree controls.
    

Detailed description: 
      Chronic orofacial pain disorders may present localized in the mouth such as with persistent
      dentoalveolar pain disorder (PDAP) or widespread in the head/face/jaw such as with
      temporomandibular disorders (TMD). PDAP pain manifests in a tooth that usually underwent root
      canal treatment or in the site formally occupied by such tooth, while TMD pain is usually
      reported over the preauricular area, jaws and temples. These commonly comorbid disorders have
      a significant impact on the individual and society. Their mechanisms are poorly understood
      with evidence suggesting deficient pain modulation and abnormal brain features. PDAP and TMD
      patients, when compared to controls, have abnormal sensory/pain processing as well as brain
      structural and functional differences.

      This proposal will investigate pain modulatory mechanisms and brain functional and structural
      characteristics using multiple MRI modalities in PDAP patients with and without TMD. All
      measures from patients will be compared to painfree controls. This knowledge will support
      better understanding of mechanisms involved in PDAP and will support development of
      mechanistic-based clinical treatments for the patients the investigators serve. Findings from
      these investigations will likely contribute to our understanding of other chronic pain
      conditions.
    

Intervention name(s): Pressure pain threshold
Intervention type(s): Procedure
Intervention description(s): Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation
Other intervention name(s): PPT
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Females with age range 18-65 years
Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
Condition: Cerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized
      in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to
      dissolve blood, and may allow intraventricular catheters to be more effective for a longer
      period of time.
    

Detailed description: 
      IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal
      subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity
      and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required
      clinical management; however, EVD via intraventricular catheter alone fails to prevent much
      of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and
      efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood
      and altering morbidity and mortality. Patients will receive intraventricular injections of
      rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans
      during the acute-treatment phase and again between Days 28 and 32.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): Recombinant Tissue Plasminogen Activator (rt-PA)
Intervention type(s): Drug
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Intraventricular hemorrhage; Subarachnoid hemorrhage; Intracerebral hemorrhage; Pharmacokinetics; Recombinant Proteins; Anticoagulants; Tissue Plasminogen Activator; Pharmacology; Catheters, Indwelling; Cerebral Ventricles
Study of CPAP as Intervention After Lung Resection
Condition: Lung Cancer; Pulmonary Complications
Study type: Interventional

Summary: 
      The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and
      evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two
      groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive
      Airway Pressure (CPAP) patients.
    

Detailed description: 
      In pulmonary resection surgery complications that lead to significant functional losses of
      the lung parenchyma and alterations in the ventilatory function may trigger retention of
      secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of
      mechanical ventilation and hospitalisation and contribute to the increase in risk of
      mortality.

      In this study the oxygenation index (OI), Borg Scale, pain scale and the presence and
      duration of thoracic drainage was determined in the immediate postoperative (POi) period and
      in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective
      lung resection.

      Similar to Chest Physiotherapy, the preventive application of CPAP in the postoperative
      period after lung resection in our study also appeared to be a safe technique, which allowed
      improved oxygenation without increasing air leaks through the thoracic drains.
    

Intervention name(s): Cpap
Intervention type(s): Procedure
Intervention description(s): This study did not involved drugs. The Oxygenation index, Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection,in two groups of intervention: chest physiotherapy, and associate this with cpap
Other intervention name(s): Noninvasive ventilation; lung resection
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chest tubes,; Continuous Positive Airway Pressure,; lung resection, thoracic surgery,; noninvasive ventilation,; postoperative
Endometrial Safety Study
Condition: Postmenopause
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to investigate the safety of the investigational product for the lining
      of the uterus (endometrium).
    


Intervention name(s): 0.25mg DRSP / 0.5mg E2 (BAY86-4891); 0.5mg NETA / 1.0mg E2 (Activella)
Intervention type(s): Drug; Drug
Intervention description(s): One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).; One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postmenopausal Symptoms e.g.; Hot flushes; Sweating episodes; Vaginal dryness
Efficacy of Three Novel Bi-treated Long Lasting Insecticidal Nets
Condition: Malaria; Anaemia
MeSH terms: Malaria
Study type: Interventional

Summary: 
      The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in
      malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened
      by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN
      combining a mixture of two insecticides or an insecticide and a synergist have been developed
      to control resistant mosquitoes.

      The efficacy of three bi-treated LLIN are compared to a standard LLIN in a four-arm, single
      blinded, cluster-randomized trial in Misungwi district, Tanzania. The arms are; 1/ Royal
      Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and
      fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN
      incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a
      pyrethroid (alpha-cypermethrin), and 3/ Olyset Plus an LLIN which incorporates a synergist,
      piperonyl butoxide (PBO), to enhance the potency of pyrethroid insecticides, and 4/ The
      control arm: Interceptor treated a standard LLIN treated with alpha-cypermethrin.

      The primary outcome of the trial will be cross-sectional community prevalence of malaria
      infection (by RDT) in children aged 6 months to 14 years at 12 and 24 months
      post-intervention.
    


Intervention name(s): Chlorfenapyr LLIN; pyriproxyfen LLIN; Piperonyl butoxide LLIN; Standard LLIN
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Dual active ingredient Long Lasting Insecticidal Net; Dual active ingredient Long Lasting Insecticidal Net; Combination insecticide and synergist Long Lasting Insecticidal Net; Standard Long Lasting Insecticidal Net with one insecticide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Vector Control; Long lasting Insecticidal Net
A Study to Evaluate the Drug-drug Interaction Effect of Rifampin on the Pharmacokinetics of AMG 510 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of AMG
      510 alone and in combination with rifampin in healthy participants.
    


Intervention name(s): AMG 510; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral capsule
Intervention MeSH terms: Rifampin; Sotorasib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy participants; AMG 510; Rifampin