bioihbjkbjnl/mcl2 huggingface dataset:
Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to
      severe rheumatoid arthritis after infusion.
    

Detailed description: 
      Rheumatoid arthritis(RA) is a chronic and progressive autoimmune disease characterized by
      synovial hyperplasia and joint damage leading to clinically significant functional
      impairment. In RA, for some unknown reason, immune cells infiltrate into synovium of joint
      and produce the 'rheumatoid factor', prostaglandins, cytokines and other mediators. It
      damages joint and cartilage, even other organs. 80% of the RA patients have Rheumatoid factor
      which is caused by high expression ratio of auto-antibodies in blood. Produced immune
      complexes, immune cells and antigen-presenting cells(including macrophages, B cells,
      dendritic cells) activate and release cytokines and then synovial tissue becomes thickened
      and damaged.

      It has been reported that synthetic DMARDs(disease-modifying antirheumatic drugs) including
      methotrexate(MTX), sulfasalazine and biological DMARDs such as tumor necrosis factors(TNF)-α
      blockers, abatacept and rituximab, often in combination with MTX, are effective. But they
      still are limited by lack or loss of efficacy in certain patients and serious complications
      such as serious infections and malignancies. So, there is a need to identify new treatment.

      FURESTEM-RA Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood
      derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord
      blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability
      and capable of differentiating into a wide range of cell types including osteocytes and
      chondrocytes. Therefore, FURESTEM-RA Inj. has huge possibility as cell therapy products for
      RA patients.
    

Intervention name(s): FURESTEM-RA Inj.
Intervention type(s): Biological
Intervention description(s): Patients will be treated FURESTEM-RA Inj.+DMARDs(Disease-Modifying antirheumatic drugs)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Rheumatic Disease; RA; Stem cell; Cell therapy; furestem; Umbilical cord Blood; hUCB-MSC; UCB-MSC
Data Collection After Intensity IOL Implantations
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high
      efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near
      vision and minimal loss of light energy. The main purpose of this study is to collect
      existing post-operative data based on standard of care follow up visits at the clinic.
    

Detailed description: 
      Different multifocal intraocular lens (MIOL) designs have been used for more than 25 years1.
      Unlike conventional mono focal intraocular lenses (IOLs), which bend light to a single focus
      point on the retina, MIOLs are designed to help patients to see at varying distances using
      different points of focus2. MIOLs used in clinical practice were either refractive initially,
      or later diffractive in their optical design. Refractive MIOLs incorporate a lens optic with
      different optical powers in different parts of the lens, while diffractive MIOLs use
      diffractive steps on the lens to distribute light rays into two or more principal foci.
      Irrespective of the design type, however, all MIOLs involve some form of optical compromise
      and a process of neuroadaptation for the patient.

      Intensity SL intraocular lenses (IOLs) represent the latest in premium lens technology.
      Intensity SL lenses provide clear vision at all distances - from near to far - thus offering
      the best chance of true spectacle independence.

      Despite the promising results obtained with the latest generation of MIOLs, many surgeons
      remain reluctant to implant these lenses. Visual symptoms such as glare and haloes, reduced
      contrast sensitivity and night vision problems are all known complications of multifocal
      implants and have served to hamper wider acceptance of these IOLs4.

      Hanita Lenses new Intensity IOL and Intensity Toric were been designed to have very high
      efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near
      vision and minimal loss of light energy. The main purpose of this study is to collect
      existing post-operative data based on standard of care follow up visits at the clinic.
    

Intervention name(s): Intra Ocular Lens
Intervention type(s): Device
Intervention description(s): Intensity SL Intra Ocular Lens
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women that had implantation with Hanita Intensity IOL or Intensity Toric Lenses in
        the clinic participating in the study. The patients that suffered from cataract and
        operated with implantation of Hanita Intensity MIOL or Intensity Toric MIOL in the clinic
        participating in the study.
      
Keywords: Intra Ocular Lens; Intensity SL; Hanita Lenses; Cataract
Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus
      placebo in patients suffering from Friedreich Ataxia
    


Intervention name(s): EGb 761 120 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EGb 761® 120 mg bid, orally for 12 to 14 weeks; Placebo 1 tablet BID, orally for 12 to 14 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Crossover Post-herpetic Neuralgia (PHN)
Condition: Post-Herpetic Neuralgia (PHN)
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared
      to placebo in the treatment of patients with post-herpetic neuralgia (PHN).
    

Detailed description: 
      Allocation: Randomized Stratified

      Interventional model: Cross-over Placebo Controlled
    

Intervention name(s): BMS-954561; BMS-954561; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the tolerability, safety, and efficacy of
      brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD
      with and without anxious distress
    

Detailed description: 
      The introduction of atypical antipsychotics has created a renewed interest in adjunctive
      therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics
      have been shown to enhance the response to ADT. This is a phase 3, multicenter, randomized,
      double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy
      of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in
      depressed subjects with and without anxious distress.
    

Intervention name(s): Placebo + ADT; Brexpiprazole +ADT
Intervention type(s): Drug; Drug
Intervention description(s): Placebo + ADT Placebo + FDA Approved Antidepressant (ADT); Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment; Anxious Distress
Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines
Condition: Lateral Canthal Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks,
      which will assess dose-related safety/tolerance, and the potential to improve the appearance
      of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will
      evaluate the long term-safety of MBA-P01
    


Intervention name(s): MBA-P01(Botulinum toxin A); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular injection; Dose varies by group; Intramuscular injection; normal saline
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
Condition: Pediculosis
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 1

Summary: 
      In children, pediculosis is a common ectoparasitic infestation. Infestation of head lice
      (Pediculus humanus capitis) causes a variety of physical symptoms, including pruritus,
      excoriation, cervical lymphadenopathy, and conjunctivitis1. It also has a number of negative
      social consequences, including parental anxiety and stigmatization of infested children2.

      It is a significant public health issue that primarily affects school-aged children aged 8 to
      113. In developing nations, prevalence rates of up to 40% have been reported4. The four urban
      areas of KPK (NWFP) reported prevalence of 36.7%5. People with a low socioeconomic background
      and poor hygiene are more likely to be affected6.

      Pediculosis capitis has been treated using a variety of treatment modalities. They include
      both physician prescription and over-the-counter medications. Permethrin or ivermectin had
      been used topically or orally. Permethrin is a neurotoxin that is synthesized. It is a
      pyrethroid neurotoxic that targets voltage-sensitive Sodium ion receptors in the neurological
      system of the insect, triggering nerve depolarization, hyperexcitation, muscular paralysis,
      and, eventually, parasite death7. Ivermectin is antiparasitic medication, it is possible to
      treat diseases like lymphatic filariasis, and ectoparasite infestations, primarily scabies,
      with ivermectin because it binds to glutamate gated chloride ion receptors of invertebrates
      and disrupts neurotransmission8.

      The rationale of this study is to study while comparing effectiveness of oral ivermectin and
      topical permethrin in management of pediculosis. The topical medication usage is problematic
      and had reported drug resistance9. There has been less regional or national research on the
      effectiveness of oral Ivermectin, so doctors less frequently use it in our department.
      Instead, the patients are treated for pediculosis capitis with topical Permethrin.
    


Intervention name(s): Permethrin 5% topical lotion; Ivermectin
Intervention type(s): Drug; Drug
Intervention description(s): patients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart; patients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart
Intervention MeSH terms: Ivermectin; Permethrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ivermectin; permethrin 5% lotion
Study of Inactivity on Metabolism of Elderly Muscles
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Skeletal muscle mass declines with inactivity (casting is a good example) and increases with
      activity (such as weightlifting). Whether muscle mass increases or decreases, is determined
      by whether more new proteins within muscle are made than are broken down. The investigators
      know that feeding protein increases the synthesis of new proteins but that the response of
      older muscles to protein feeding is blunted compared with the young. This resistance of the
      elderly to muscle building stimuli may be the primary reason that muscle mass is lost in
      aging. The investigators also know that periods of muscle disuse such as casting result in a
      person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new
      muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at
      approximately 1% for every year after. Elderly persons would likely fare well with advancing
      age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is
      a 'population view' and does not represent what occurs during short periods of muscle disuse
      (i.e. during hospitalization or illness), which occur with increasing frequency in elderly
      persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may
      be worsened. The investigators will measure how quickly new proteins are made at rest and
      after protein feeding in elderly men, before and after a 14 day period of reduced activity
      brought on by having people reduce their daily step count.
    


Intervention name(s): Step reduction
Intervention type(s): Behavioral
Intervention description(s): taking less than 1500 steps/d
Other intervention name(s): Sedentary behaviour
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sarcopenia; muscle; reduced activity; insulin sensitivity; protein; step reduction; muscle protein synthesis; whey protein; leg strength; whole body protein
Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate efficacy and safety of a testosterone patch as treatment
      for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin
      therapy.
    

Detailed description: 
      Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into
      a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients
      were stratified based on presence/absence of uterus and randomized to receive placebo or
      testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin
      throughout the study. Patients who completed the first 52 weeks of the study were given the
      opportunity to participate in year 2-4 open-label (active treatment) study extension which
      was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum
      chemistry with hepatic, renal and carbohydrate metabois in evaluation, coagulation testing,
      and hermatology. Physical exam including clinical assessments of facial hair and acne were
      monitored.
    

Intervention name(s): Testosterone Transdermal System; Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): testosterone patch (300 mcg/day) patch changed 2 times/week, for one year; placebo patch changed twice a week for one year
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Natural Menopause; HSDD
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose
      study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants.
    


Intervention name(s): E6742; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): gelatin capsules; gelatin capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy participants; E6742; pharmacokinetics
Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Condition: Allergic Rhinitis; Allergy; Growth
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the
      leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS).
      One of the major long-term safety concerns is whether ICS interferes with normal growth in
      allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased
      growth. However, the effect of nasal ICS on long-term growth and the attainment of final
      adult height is unknown. Another potential systemic adverse effect of ICS use is suppression
      of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is
      that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult
      height in relation to target adult height in children with allergic rhinitis.
    


Keywords: Allergic Rhinitis; Allergy; Growth
Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases
Condition: Primary Immune Deficiency Disorder
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical phase 3 study to evaluate the efficacy, tolerability and safety of subcutaneous
      human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases.
    

Detailed description: 
      Octanorm (cutaquig®) is a 16.5% human normal immunoglobulin solution developed by Octapharma
      for subcutaneous administration (SCIG). It is supplied as a liquid formulation ready to use.
      One important therapeutic use of immunoglobulins is to provide antibodies to prevent viral
      and bacterial diseases (replacement therapy). Children and adults with a Primary
      Immunodeficiency Disease (PID) have an increased risk of recurrent bacterial and viral
      infections. These diseases can be severe and can lead to substantial morbidity. Responses to
      antibacterial therapy are often poor. At present, most primary immune deficiencies are not
      curable, but SCIGs have been shown to decrease the total number of severe infections and the
      duration of hospitalization. This study evaluated the efficacy, safety and tolerability of
      octanorm in adult PID patients in an open-label, multi center, phase 3 study with an 8-week
      wash-in/wash-out period followed by a 6-month efficacy period
    

Intervention name(s): Octanorm
Intervention type(s): Biological
Intervention description(s): Octanorm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Accessing the efficacy and safety of pregabalin when used alone and in combo with
           acetaminophen in a dental pain model.

        -  To test whether pre-operative dose of pregabalin increases the time to significant
           post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed
           post-operatively.
    

Detailed description: 
      This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled
      study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the
      prevention and treatment of post-surgical dental pain in healthy patients.

      Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not
      required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5.
      Dose 2 will be given post-surgically when patients report at least moderate pain on the
      categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can
      request rescue analgesic at any time.
    

Intervention name(s): Pre-Op pregabalin; Pre-Op Placebo 1; Post-Op pregabalin; Post-Op Placebo 1; Post-Op Placebo 2; Post-Op acetaminophen
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pre-op pregabalin will be administered 60 min prior to surgery.; Placebo 1 will be administered 60 min prior to surgery.; Post-op pregabalin will be administered Post-operatively.; Placebo 1 will be administered post-operatively.; Placebo 2 will be administered post-operatively.; Acetaminophen will be administered Post-operatively.
Other intervention name(s): pre-op placebo
Intervention MeSH terms: Acetaminophen; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
STA-5326 in Crohn's Disease Patients
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of STA-5326 given once
      daily or twice daily to Crohn's Disease patients with moderate disease.
    


Intervention name(s): STA-5326
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease