bioihbjkbjnl/mcl2 huggingface dataset:
Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects'
      subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who
      have responded inadequately to preceding adjunctive drug therapy.
    


Intervention name(s): ADT; Brexpiprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder, Depression
Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess differences in postoperative pain
      experienced by pediatric patients having transversus abdominis plane block block with
      bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv
      analgesia after Laparoscopic surgery.
    

Detailed description: 
      A prospective randomized controlled double blind study using a computer generated
      randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric
      patients undergoing laparoscopic surgery under general anesthesia.

      After induction of general anesthesia and endotracheal intubation, patients in group B and
      group C will be placed in the supine position and transversus abdominis plane block will be
      performed under ultrasound guidance. After skin preparation, the linear ultrasound probe
      connected to a portable ultrasound unit will be placed in the axial plane across the
      mid-axillary line midway between the costal margin and the highest point of iliac crest.
      needle attached to a syringe filled with the Local anesthetic solution will be inserted until
      it reaches the plane between the internal oblique and transversus abdominis muscles.

      After careful aspiration to exclude vascular puncture, injection of bupivacaine will be
      performed leading to separation between the internal oblique and the transversus abdominis
      muscles which will appear as a hypoechoic space on ultrasound. This procedure will be
      repeated on the opposite side .

      Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus
      abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra
      abdominal pressure will be maintained at 10-12 mmHg.

      The use of opioids during the procedure will based on the cardiovascular response to
      stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient
      analgesia and will be treated with fentanyl in doses of 1mcg / kg.
    

Intervention name(s): Bupivacaine 0.125%; Bupivacaine 0.25%
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.; Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.
Other intervention name(s): Plain marcaine; Plain marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: TAP block; pediatric; Laparoscopic; postoperative pain
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab)
      on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin [KLH])
      and a recall antigen (tetanus toxoid [Td]), and to evaluate the effect of Tysabri on
      circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants
      with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess
      alpha4-integrin saturation and alpha4-integrin expression levels over time.
    


Intervention name(s): BG00002 (natalizumab); keyhole limpet hemocyanin (KLH); tetanus diphtheria toxoid vaccine (Td)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): KLH 1 mg administered subcutaneously (SC) in accordance with the Immucothel investigator's brochure.; Td administered in accordance with the manufacturer's prescribing information.
Other intervention name(s): Tysabri; Immucothel
Intervention MeSH terms: Natalizumab; Keyhole-limpet hemocyanin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: MS; Multiple sclerosis; Relapsing forms of Multiple Sclerosis
Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
Condition: Acne Vulgaris; Microparticles
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how pretreatment with a topical medication for
      acne affects application and delivery of gold microparticles to the skin in acne patients. In
      addition, the investigators want to investigate the biodistribution of gold microparticles in
      pretreated skin and compare this with the biodistribution of untreated skin using the
      non-invasive imaging techniques optical coherence tomography and reflectance confocal
      microscopy
    

Detailed description: 
      Epiduo is a prescription gel that combines adapalene and benzoyl peroxide, two active
      substances for the external treatment of acne. Adapalene is a substance that resembles
      A-vitamin acid, which dissolves and prevents clog formation in the sebaceous glands. Benzoyl
      peroxide works by reducing the amount of bacteria while dissolving the clogs in the sebaceous
      glands. Epiduo is the only antibiotic-free combination for the treatment of acne.

      Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT) are non-invasive
      imaging technologies allowing for imaging of the upper skin layers. Gold microparticles have
      been shown to have a contrast effect on the images. In addition to the contrast effect on
      images, gold microparticles have proven to be effective in the treatment of skin disease
      acne. The treatment with gold microparticles uses a combination of the gold microparticles
      and a laser. The microparticles consist of very small particles of silica, surrounded by a
      shell of gold. These two components of the microparticles are selected from their way of
      absorbing light from a laser. The particles absorb the light from the laser and are thus
      heated. The surrounding skin can not absorb the light and therefore will maintain its normal
      temperature.
    

Intervention name(s): Adapalene-Benzoyl Peroxide Gel 0.1-2.5%
Intervention type(s): Drug
Intervention description(s): Topical gold microparticles (SEB-250) are delivered to two facial areas at baseline, patients are then prescribed a topical Adapalene-Benzoyl Peroxide Gel 0.1-2.5% for 6 weeks followed by a new exposure to gold microparticles (SEB-250)
Other intervention name(s): Seb-250
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Optical Coherence Tomography; Reflectance Confocal Microscopy; Gold microparticles; Adapalene; Benzoyl Peroxide
Hypoalgesic Effect of Median Nerve Neural Mobilization Compared to a Controlled Group
Condition: Cervicobrachial Neuralgia
MeSH terms: Neuralgia; Brachial Plexus Neuritis
Study type: Interventional

Summary: 
      The purpose of these study is to compare the effectivity of the Median Nerve Neural
      Mobilization technique to the complete absence of treatment in a group of patients who suffer
      cervicobrachial pain.
    

Detailed description: 
      Median Nerve Neural Mobilization (MNNM) is a non invasive physical therapy technique that
      achieves pain relief through mechanical stimulation of the Median Nerve and the brachial
      plexus. It is believed that the hypoalgesic effect offered by the neural tissue mobilization
      procedure is a consequence of descending nervous system pain modulation activity and an
      improvement in the distinct biomechanical and sensitive properties of the involved neural
      tissue. The neural tissue mobilization procedure is associated to an increase in nerve
      mobility, edema, inflammation and intraneural pressure reduction without any known side
      effects when applied properly which is an important contrast to the wide variety of side
      effects caused by commonly used drug therapy to treat cervicobrachial pain.

      Despite the crescent interest among the scientific community in evidence based options to
      treat pain there is a current lack of enough controlled double blind clinical trials that
      measure the effectiveness of neural tissue mobilization techniques such as the (MNNM) and its
      specific effect over cervicobrachial pain. For this reason the present investigation
      consisted in the application of a treatment protocol based on Median Nerve Neural
      Mobilization in a controlled double blind clinical trial with the aim to assess its clinical
      effectiveness in treating pain symptoms.
    

Intervention name(s): Median Nerve Neural Mobilization; Goniometer
Intervention type(s): Procedure; Device
Intervention description(s): Nonsurgical noninvasive Median Nerve neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The maximum level of elbow extension movement degree without the reproduction of symptoms during the application of the Median Nerve Neural mobilization treatment was determined through the baseline use of a Universal Goniometer Device.
Other intervention name(s): Neural Tissue Mobilization of the Median Nerve; Median Nerve Neurodynamics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CONSORT Randomized Controlled Trial in Assisted Reproductive Technology
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall objective of this trial is to compare the ovarian response in assisted
      reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in
      recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment'
      (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per
      day.
    


Intervention name(s): GONAL f® prefilled pen; GONAL f® prefilled pen
Intervention type(s): Drug; Drug
Intervention description(s): GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only; GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.
Other intervention name(s): Follitropin alfa; Recombinant human follicle stimulating hormone (r-hFSH); GONAL-f® Prefilled Pen; Follitropin alfa; r-hFSH; GONAL-f® Prefilled Pen
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Assisted reproductive technology
Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O)
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of ultrasound in the first trimester,
      assess the completion rate of ultrasounds for fetal anatomy in the first trimester compared
      to completion rates of ultrasounds for fetal anatomy in the second trimester and to assess
      the completion rate of the combination of one ultrasound in the first trimester and one in
      the second trimesters compared to the individual completion rates of both evaluations in
      obese pregnant women.
    


Intervention name(s): Group 1 (First trimester ultrasound); Group 2 (Second trimester anatomy ultrasound)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): A detailed first trimester anatomy ultrasound will be performed,at the visit when the subject is confirmed to be of eligible gestational age. After this detailed research ultrasound, which will be limited to 15 minutes, subject will then receive the clinically indicated dating ultrasound or nuchal translucency measurement. The patient will complete a survey about her satisfaction with this technique via email.as a safety measure, if an anomaly is suspected on the day of the detailed first trimester anatomy scan, the patient will be unblinded. Patients in this arm are later scheduled for a second trimester ultrasound by the clinical team, as this is part of standard obstetrical care.; Patients do not undergo a detailed first trimester ultrasound , but will receive the clinically indicated limited ultrasound for dating or for nuchal translucency. Patient will then undergoes a second trimester ultrasound by the clinical team as part of standard obstetrical care and completes a survey regarding her satisfaction with this technique via email.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Keywords: pregnancy; fetal ultrasound
Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion
Condition: Second Trimester Abortion
Study type: Interventional
Phase: Phase 4

Summary: 
      the investigators aimed to study the efficacy and safety of nitric oxide donors when combined
      with prostaglandins in induction of second trimester abortion expecting that both drugs when
      used together will be of greater efficiency and associated with less side effects.

      the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days
      indicated for pregnancy termination due to maternal or fetal cause.
    

Detailed description: 
      the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol
      and misoprostol when used alone in second trimester abortion, expecting that both drugs when
      used together will be more effective and associated with fewer side effects.

      In this study 60 women were enrolled, divided into two groups. The first group (group I), 30
      women received misoprostol and isosorbid mononitrate.

      The second group (group II), 30 women received misoprostol and placebo. The primary aim of
      the study was the occurrence of complete abortion in the first 24 hours.

      The study concluded that the combination of isosorbid mononitrate with misoprostol is more
      effective in second trimester abortion than misoprostol with placebo, but is associated with
      more side effects mainly headache.
    

Intervention name(s): Misoprostol; isosorbide mononitrate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): induction of abortion using misoprostol; isosorbide mononitrate; Placebo
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: second trimester abortion
Effects of Pennsaid on Clinical Neuropathic Pain
Condition: Neuralgia; Postherpetic Neuralgia; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndrome (CRPS)
MeSH terms: Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Neuralgia, Postherpetic
Study type: Interventional

Summary: 
      The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain
      felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2 weeks.

      The U.S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis
      (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain.

      The research study will compare Pennsaid to placebo.
    

Detailed description: 
      The research study will compare Pennsaid to placebo. The placebo looks like Pennsaid, but it
      doesn't contain any Pennsaid. The investigators use placebos in research to see if the
      results are due to the study drug or to other reasons. At some time during the study the
      investigators will give the patient Pennsaid. At another time, the investigators will give
      the patient placebo. The investigators are using Quantitative Sensory Testing (QST), which is
      temperature testing before and after using the study drug to see if Pennsaid is helpful in
      reducing people's nerve pain.

      In this test, a small metal plate, about the size of a matchbox, is put on the area where the
      patient has pain. The plate is connected to a computer that can warm or cool the plate. The
      patient will use a computer mouse button to tell us when the plate feels warm. The QST
      machine is approved by the Food and Drug Administration (FDA). It is often used by nerve
      doctors to see if a person has neuropathy (pain caused by damage to a nerve).
    

Intervention name(s): Pennsaid; Placebo (2.3% DMSO solution)
Intervention type(s): Drug; Drug
Other intervention name(s): Pennsaid topical 1.5% diclofenac; a non-steroid anti-inflammatory drug; Placebo (2.3% DMSO solution; 20-40 drops; 2-4 times daily).
Intervention MeSH terms: Diclofenac; Anti-Inflammatory Agents; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: neuropathic pain; postherpetic neuralgia; complex regional pain syndrome; reflex sympathetic dystrophy
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of
      PTI-125 in mild-to-moderate Alzheimer's disease patients.
    

Detailed description: 
      This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of
      PTI-125 in mild-to-moderate Alzheimer's disease patients. A total of sixty (60) patients will
      be enrolled in the study. Patients will receive Placebo, 50 mg or 100 mg b.i.d. of PTI-125.
      The objective of this study are to investigate the safety, and biomarkers of PTI-125
      following 28-day repeat oral administration.
    

Intervention name(s): Placebo oral tablet; Simufilam 100 mg tablet; Simufilam 50 mg oral tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral placebo tablet; Simufilam 100 mg oral tablet; Simufilam 50 mg oral tablet
Other intervention name(s): PTI-125; PTI-125
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately sixty (60) patients will be enrolled into the study and randomized to one of three cohorts. Cohorts will receive placebo or PTI-125 at 50 or 100 mg b.i.d. (n=20 per group)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand
      treatment for children with severe Hemophilia A.
    


Intervention name(s): Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention type(s): Biological
Intervention description(s): Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy
      of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who
      are not optimally controlled on clozapine.
    


Intervention name(s): aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).; Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vocal in Assessment of Endometrium in Postmenopause
Condition: Postmenopausal Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      The unbalanced estrogen with no progesterone will lead to endometrial thickening .This
      thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding
    

Detailed description: 
      Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial
      hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non
      invasive methods as Transvaginal ultrasound with 3 D application using different softwares .

      One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ
      Computer aided Analysis ) that can measure volume especially in tissues with irregular
      borders And this technology is considered to be superior than the conventional 2 D ultrasound
      . .
    

Intervention name(s): 3D ultrasound; Dilatation and curretage
Intervention type(s): Diagnostic Test; Procedure
Intervention description(s): it describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding; it describes the surgical maneuver that will be made to diagnose cause of bleeding
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.
      
Biospecimen description: 
      Dilatation and curettage endometrial biopsy