bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Ciclosporin Eyedrops on Sjögren Syndrome
Condition: Dry Eye Syndromes
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Syndrome
Study type: Interventional

Summary: 
      Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common
      ophthalmological diseases and is treated with tear substitutes to moisten the surface of the
      eye and, in more severe cases of this disease, with local anti-inflammatory therapy with
      corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as
      Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which
      is why topical anti-inflammatory therapy is often necessary in these patients.

      Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical
      cyclosporin eyedrops with and without topical corticosteroids at the beginning of the
      treatment.
    


Intervention name(s): Cyclosporin; Hydrocortisone
Intervention type(s): Drug; Drug
Intervention description(s): Cyclosporin eyedrops; Hydrocortisone eyedrops
Intervention MeSH terms: Cyclosporine; Hydrocortisone; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Dexamethasone-implant for the Treatment of RVO
Condition: Macular Edema Caused by Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with
      bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated
      with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive
      bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with
      dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly
      intervals. The primary endpoint was BCVA at twelve months.
    


Intervention name(s): Dexamethasone implant; Bevacizumab
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone; Bevacizumab
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supportive Measures in Treatment of Aluminum Phosphide Poisoning
Condition: Detection of Different Prognostic Factors and Their Relation With the Outcome; Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning
MeSH terms: Poisoning
Study type: Interventional
Phase: Phase 4

Summary: 
      Aluminum phosphide poisoning (ALP) is a global public health problem, and self-poisoning
      accounts for one-third of the world's suicide rate. In fact, in some parts of developing
      countries, pesticide poisoning causes more deaths than infection. ALP is very common in our
      government and the prognosis of the cases is usually so bad. Toxicity by ALP is caused by the
      liberation of phosphine gas, which causes cell hypoxia due to inhibition of oxidative
      phosphorylation leading to circulatory failure.
    

Detailed description: 
      Aluminum phosphide poisoning is a major problem, accounting for many Emergency Unit visits
      and hospitalization, the incidence of aluminum phosphide poisoning increasing in the last few
      years.

      ALP is used as pesticides for many years to protect grains in stores and during its
      transportation. The availability of these tablets and their low cost make it an easy and
      common method of suicide in our country with the increasing incidence of social and financial
      problems that face the youth.

      In management, the main objective is to provide effective oxygenation, ventilation, and
      circulation until phosphine is excreted. All patients of severe ALP poisoning require
      continuous invasive hemodynamic monitoring and early resuscitation with fluid and vasoactive
      agents. N- acetylcysteine as an antioxidant and cytoprotective agent reduces myocardial
      oxidative injury and increase survival time. Magnesium sulfate helps in scavenging free
      radicals through glutathione (GSH) recovery hence is effective as a parenteral antioxidant in
      this poisoning as well as has been tried for its general membrane stabilizing effect in
      cardiac cells .

      Death after 24 hours occurs usually owing to shock, cardiac arrhythmia, metabolic acidosis,
      and acute respiratory distress syndrome.
    

Intervention name(s): N-acetyl cysteine
Intervention type(s): Drug
Intervention description(s): effect of N-acetyl cysteine in Aluminum phosphide poisoning patients
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aluminum phosphide; N-acetylcystein; Assiut; prognostic factors
Mother and Child Education Program in Palestinian Refugee Camps
Condition: Parenting
Study type: Interventional

Summary: 
      The purpose of the Mother Child Education Program (MOCEP)-a group-based early childhood
      development parenting education program-is to provide school-readiness and parenting skills
      to mothers of young children who do not have access to preschool education services. The
      MOCEP intervention also provides a setting in which caregivers can model pro-social behaviors
      and practice conflict resolution techniques directly with young children.
    

Detailed description: 
      The purpose of the evaluation study is to rigorously evaluate the impact of MOCEP on child
      and parent outcomes among Palestinian refugees in Beirut, Lebanon. This evaluation employs an
      innovative, mixed-methods bio-behavioral approach to investigate the associations among
      social contexts; maternal, child and family functioning; and reduction in violence through
      the promotion of harmonious family relationships. The results of this study have implications
      for improving the lives of and reducing violence for the hundreds of thousands of families
      with young children living in fragile contexts. We hypothesize that when MOCEP is implemented
      with fidelity (i.e., delivered as intended by design), participating families will experience
      reduced violence in their homes and have better individual and intra-family outcomes than
      families who do not participate in the program.
    

Intervention name(s): MOCEP
Intervention type(s): Behavioral
Intervention description(s): Through parent support and an evidence-based curriculum, MOCEP uses education to reduce risk factors that hinder children's health and wellbeing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax
      which are indicated for active immunization for prevention of varicella. Total of 488
      subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and
      each subject is administered with single dose of vaccine which is randomly assigned.
    

Detailed description: 
      This is a multi-national, multi-center, randomized, double blinded, parallel-group study to
      assess the Immunogenicity and safety of NBP608 compared to varivax which are indicated for
      active immunization for the prevention of varicella. Total of 488 subjects of 12 months to 12
      years of age are enrolled, and each subject is administered with single dose of vaccine which
      is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve
      the balance of treatment assignment within age strata.

      Total of four visits are scheduled including two visits via telephone contact. Blood sampling
      is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1
      and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination
      through Visit 2*, Visit 3 and Visit 4* (* telephone contact)
    

Intervention name(s): NBP608; Varivax
Intervention type(s): Biological; Biological
Intervention description(s): Preparation of the Oka/SK strain of live, attenuated varicella virus; Preparation of the Oka/Merck strain of live, attenuated varicella virus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention of varicella; Varicella-zoster vaccine
Mass Balance Study of [14C]HLX208 in China Healthy Subjects
Condition: Mass Balance Study in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Mass Balance Study of [14C]HLX208 in China Healthy Subjects.
    

Detailed description: 
      A phase I study to quantify the total mass balance in healthy subjects after a single dose of
      [14C]HLX208.
    

Intervention name(s): [14C]HLX208
Intervention type(s): Drug
Intervention description(s): Carbon-14 labeled HLX208
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Combining Language Therapy With rTMS in Aphasia
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      With the present RCT, the investigators aimed at finding an optimal protocol for the
      neurorehabilitation of chronic post-stroke aphasia by combining two promising methods, ILAT
      (Intensive language action therapy) and 1-Hz rTMS to the right-hemispheric homologue of the
      anterior language area of Broca (pars triangularis), thus taking advantage of recent research
      in speech and language sciences, neurorehabilitation and brain research.
    

Detailed description: 
      New neuromodulation technologies, such as transcranial magnetic stimulation (TMS), are
      promising tools for neurorehabilitation, aphasia therapy included. Combined with behavioral
      techniques, Intensive Language-Action Therapy (ILAT), TMS could substantially amplify the
      beneficial effect of such behavioral therapy alone.

      In this randomized study of 17 subjects with post-stroke aphasia in the chronic stage will be
      studied the combined effect of ILAT and 1-Hz placebo-controlled navigated repetitive TMS
      (rTMS) to the right-hemispheric inferior frontal cortex (pars triangularis). Participant will
      be randomized to groups A and B. Participants in group A will receive a 2-week period of rTMS
      during naming training where they name pictures every ten second displayed on the screen,
      followed by 2-weeks of rTMS and naming combined with ILAT. Those in group B will receive the
      same behavioral therapy but TMS is replaced by sham stimulation.

      Language performance will be measured before, during and after the interventions for 3
      months.
    

Intervention name(s): Intensive Language-Action Therapy (ILAT); Repetitive navigated Transcranial Magnetic Stimulation during naming training
Intervention type(s): Behavioral; Device
Intervention description(s): ILAT includes communicative language games played in an interactive small-group setting. Three persons with aphasia and one therapist sit around a table and have picture cards in front of them. The card sets include two items of each object or action picture. All participants take turns in making verbal requests. There will be 5 daily sessions (3 hours per session) for two weeks.; Magnetic stimulation will delivered with a figure-of-eight cooled coil of Navigated Brain Stimulation System during picture naming training. The primary targeted area is the right pars triangularis. In each session, rTMS will be applied at 1-Hz for 20 minutes, 5 daily sessions per week for four weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic aphasia; rehabilitation; randomized controlled trial (RCT)
A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the safety, tolerability and pharmacokinetics
      (PK) of multiple ascending oral doses of E6742 in Japanese healthy adult participants.
    


Intervention name(s): E6742; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E6742 tablets.; E6742-matched placebo tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: E6742; Healthy participants; Pharmacokinetics
Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
Condition: Injury of Anterior Cruciate Ligament
MeSH terms: Wounds and Injuries; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      In response to high injury rates in soccer, the Fédération Internationale de Football
      Association (FIFA) developed an injury prevention program called the "11+". It is designed to
      replace a standard warm-up and takes about 20 minutes to complete. The program has proven
      remarkably effective in decreasing the rate of injury in soccer players. However, uptake of
      the 11+ has been less than desired. Adoption of the program may be increased if additional
      benefits can be demonstrated and the program is introduced at a younger age. The goals of
      this study are to (1)establish that young athletes can tolerate the program, and (2)measure
      the effects of the 11+ program on the physical performance of 10-12 year old girls. Three
      teams will be randomly assigned to the intervention group and carry out the 11+ program for
      the duration of the indoor soccer season. Another 3 teams will continue with their usual
      warm-up. Pre- and post-intervention, balance, agility, core strength and movement control
      will be assessed in all athletes. The investigators hypothesize that the athletes will
      tolerate the program well and that the intervention group will improve on the performance
      tests significantly more than the control group.
    


Intervention name(s): FIFA 11+ warm-up
Intervention type(s): Other
Intervention description(s): A sequence of 15 exercises performed before soccer practices and games. The exercises include strength, agility, balance and motor control components and take about 15-20 minutes to perform. The intervention replaces any previous warm-up the athletes may have done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      The purpose of this study is to compare marginal bone level changes between ASTRA TECH
      Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial
      edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical
      protocol will be used. Implants will be loaded within 15 weeks from installation. The
      subjects will be followed for 3 years.
    


Intervention name(s): ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.; 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics of NP101 with a currently approved oral formulation of
      Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a
      non-migraine period.
    


Intervention name(s): Sumatriptan succinate; NP101 Study Patch
Intervention type(s): Drug; Drug
Intervention description(s): Sumatriptan succinate 50 mg taken orally; NP101 study patch 4 hour application
Intervention MeSH terms: Sumatriptan
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, open label, single-centre study to evaluate the safety and immunogenicity of
      GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM),
      administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female
      subjects aged 15 - 45 years.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      The rationale for the protocol posting amendment was to change the study population from
      18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g.
      Hepatitis A&B vaccines, meningococcal vaccines, Tetanus vaccine, Diphteria Tetanus Pertussis
      etc. up to 8 days before each HPV dose.
    

Intervention name(s): GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 3 doses
Other intervention name(s): GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccine,; Cervical cancer; Human papillomavirus infection,
Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia
Condition: Type 2 Diabetes
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      This study will look at two FDA approved medications that improve how the pancreas works in
      patients with Type 2 Diabetes. In order to understand how these medications work in patients
      with diabetes we must first measure the normal response in healthy volunteers without
      diabetes. We will be looking at the body's normal physiological response to low blood sugar
      and whether this will be modified by these medicationsThe hypothesis would be that
      glimepiride induced insulin secretion will be inhibited by hypoglycemia.
    

Detailed description: 
      In patients with type 2 diabetes, sulfonylurea drugs are a mainstay for effective glucose
      control. These agents produce their hypoglycemic effects via stimulation of endogenous
      insulin secretion. Oversecretion of insulin, per se, or a continued relative increase of the
      hormone even when plasma glucose is normal will result in hypoglycemia. This latter situation
      commonly occurs if a patient decides to omit, delay, or reduce the size of a meal. An
      important defense against hypoglycemia in the above situations is glucose dependent
      regulation of insulin secretion. In other words, a low ambient glucose concentration could
      regulate the magnitude of the amount of insulin released in response to a sulfonylurea. Thus
      during hypoglycemic conditions, the sulfonylurea would result in little or no insulin
      secretion, whereas its effects during hyperglycemia would be amplified. Glimepiride and
      glyburide are both second-generation sulfonlyurea drugs used commonly for treatment of type 2
      diabetes. This study will compare the two and ask the following question:

      Is Glimepiride insulin secretion dependent upon glucose concentration in-vivo?
    

Intervention name(s): Glimepiride; glyburide; glucose clamp; glucose clamp
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Glimepiride (Amaryl) 4 mg oral dose during protocol, given once during each protocol.; Glyburide (Dia-Beta) 10 mg oral dose during protocol, given once during each protocol.; Hyperinsulinemic euglycemic glucose clamp procedure-120 minutes; hypoglycemic glucose clamp procedure -120 minutes
Other intervention name(s): Amaryl; Dia-Beta
Intervention MeSH terms: Glimepiride; Glyburide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Keywords: epinephrine; glucose clamp
MOBile Instruction for Low Back Pain (MOBIL)
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this project is to measure the impact of a short educational session on
      outcomes for patients consulting in primary care for low back pain. Subjects will be patients
      consulting to their primary care provider for a primary complaint and new episode of low back
      pain. Subjects will be randomized to receiving the educational tool versus usual care
      (information only without an educational component) in the clinic immediately prior to seeing
      their PCP. Patients will be followed for a 6-month period, and outcome measures will be
      collected and compared across both groups.
    

Detailed description: 
      Patients that arrive for an initial evaluation for low back pain will be randomized to either
      receive the video education via an application (app) on a tablet computer, or usual care
      (which consists of information in the form of a handout but no further education prior to
      seeing the Primary Care Provider - PCP). To control for exposure to the tablet computer,
      subjects in both groups will use the tablet computer to fill out the self-reported outcome
      measures.

      This will all take place while the patient is waiting to see their PCP, who will be blinded
      to the educational intervention that the patient received. After enrollment and completion of
      baseline outcome measures and surveys, the subject will be randomized to one of the 2 arms,
      receive the intervention, and then proceed to have their appointment with their PCP. The
      appointment with the PCP will proceed per usual care standards, with no additional research
      interventions. The subjects will be contacted for a follow-up at 1 and 6 months for
      assessment of self-reported outcomes measuring pain, function, and disability. The
      investigators will also abstract healthcare utilization from claims data and compare
      variables of healthcare use between both groups over the 6-month period following enrollment
      (radiographs, MRIs, prescription opioids, and specialty referrals).
    

Intervention name(s): Educational Video App
Intervention type(s): Behavioral
Intervention description(s): The content of the app will be grounded in a biopsychosocial model and modeled on the Back Book, a booklet developed to help modify beliefs and behavior of patients with LBP. Essentially this will take the primary concepts and ideas often given in print or verbal form, and present it in a more engaging and dynamic fashion.
Other intervention name(s): Mobile Technology Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: patient education; low back pain; technology