bioihbjkbjnl/mcl2 huggingface dataset:
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
Condition: Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      This study was a retrospective cohort study of patients to assess the early insights into
      real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to
      describe their patient characteristics and clinical outcomes. The study was conducted using
      the IRIS Registry.
    

Detailed description: 
      IRIS Registry EHR data from patients with wet AMD who initiated brolucizumab were analyzed in
      this study.

      Identification period of the index date (index period): The patients fulfilling the selection
      criteria was identified

        -  Index date: Defined as the date of the earliest brolucizumab injection

        -  Study Period: The period from the first patient eye exposure to brolucizumab to the last
           follow-up recorded

        -  Pre-index period: The period 36 months prior to the index date. Data within 36 months
           prior to the index date will be used to assess baseline characteristics.

        -  Post-index period: The period 180 days after the index date
    

Intervention name(s): Brolucizumab
Intervention type(s): Drug
Intervention description(s): Participants received brolucizumab injection during the index period
Other intervention name(s): BEOVU®
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with wet AMD who initiated brolucizumab were analyzed in this study.
      
Keywords: Brolucizumab,; intravitreal injection,; neovascular age-related macular degeneration,; visual acuity
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)
Condition: Acute Migraine With or Without Aura in Adolescents
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To provide long term safety data for rizatriptan in children and adolescents. The primary
      hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of
      acute migraine in pediatric patients age 12-17 years.
    


Intervention name(s): rizatriptan benzoate
Intervention type(s): Drug
Intervention description(s): Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack
Other intervention name(s): MK-0462; Maxalt
Intervention MeSH terms: Rizatriptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute migraine with or without aura in adolescents
A New Surgical Approach to Treat Medial or Low Condylar Fractures
Condition: Fracture of Condylar Process
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      The aim of the study was to compare the new approach and the retromandibular approach, so
      that the therapeutic effect and the advantages of the new approach would be clear.
    

Detailed description: 
      Sixty patients (72 sides) with medial or low condylar fractures were treated with surgical
      intervention. Thirty-six patients (42 sides) were treated with minor parotid anterior
      approach, and the other 24 patients (30 sides) were treated with retromandibular approach.
      The data about the operations and complications were recorded. The follow-up periods were
      3-12 months.
    

Intervention name(s): the minor approach
Intervention type(s): Procedure
Intervention description(s): Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach
Other intervention name(s): the minor parotid anterior approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medial or low condylar fractures; the minor parotid anterior approach; the retromandibular approach
Impact of Labour Kinesiotherapy in the Quality Life of Auxiliary Nursing in the Surgery Center
Condition: Quality of Life; Pain
Study type: Interventional

Summary: 
      The quality of life and daily activities can be affected by muscleskeletal pain and one of
      the forms of assessment is through the SF-36 questionnaire. The investigators know that the
      working kinesitherapy is a way to improve the quality of life.
    

Detailed description: 
      The activities in the work routine can cause pain and negatively affect quality of life.
      There is the hypothesis that gymnastics may be used for pain and injuries relating to
      repetitive movement at work. Objective the study is assess the impact of labor kinesiotherapy
      in the quality of life of the operating room nursing assistants.
    

Intervention name(s): kinesio therapy
Intervention type(s): Other
Intervention description(s): during for fifteen minutes the nursing assistants will perform stretching exercises and muscle relaxation of large muscle groups the orthostatic position
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Public Health; Nursing Staff, Hospital
A Study of Aripiprazole in Patients With Schizophrenia in General Psychiatric Practices
Condition: Schizophrenia and Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to evaluate the overall effectiveness of 8
      week of aripiprazole treatment.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Long-Acting Growth Hormone in Children Compared to Daily rhGH
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of
      treatment effect against daily injections of rhGH.
    

Detailed description: 
      This study is designed as a pivotal study to compare the safety and efficacy of a selected
      dose regimen of somavaratan to daily rhGH. The study is a randomized, multi-center, open
      label study of 12 months duration. The primary endpoint is height velocity at 12 months.
    

Intervention name(s): Somavaratan; rhGH
Intervention type(s): Drug; Drug
Intervention description(s): Somavaratan will be administered per dose and schedule specified in the arm description.; rhGH will be administered per dose and schedule specified in the arm description.
Other intervention name(s): Long-acting recombinant human growth hormone; VRS-317; daily growth hormone; recombinant growth hormone therapy
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VRS-317; Growth Hormone Deficiency; Long Acting Recombinant Growth Hormone; Long Acting Growth Hormone; Pediatric Growth Hormone Deficiency; Growth Hormone Replacement Therapy; Versartis; Xten; Human Growth Hormone; somavaratan; growth failure
Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus
Condition: Virtual Reality
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      Virtual reality exercises have become increasingly popular in recent years. After the
      increase in usage areas in daily life, its use in healthcare has become widespread. Flatfoot
      is one of the orthopedic problems with high prevalence, especially in young individuals. In
      the literature, conservative treatment methods of flat soles are mentioned as exercise, shoe
      modifications, and orthotic methods. In the study, it is planned to investigate whether
      individuals with flat-footed virtual reality exercises contribute to conservative treatment.

      The aim of this study was to investigate the effect of virtual reality exercises on
      individuals with pes planus.
    

Detailed description: 
      To show whether virtual reality exercises will contribute to decrease of flat footing,
      improvement of balance and increase of performance of individuals with flat foot.
    

Intervention name(s): Exercise; Virtual Reality
Intervention type(s): Other; Device
Intervention description(s): Short Foot Exercises; Exercise with virtual reality
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group only are treated with short foot exercises. Second group are treated with short foot exercises and virtual reality.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: virtual reality; foot posture; navicular drop; short foot exercise
A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial
Condition: Dystrophic Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
Study type: Observational

Summary: 
      This is an open-label follow up study to evaluate the safety for the subjects with
      ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.
    

Detailed description: 
      This is an open-label follow up study to evaluate the efficacy and safety for the subjects
      with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 months.

      ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells.
      Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as
      vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can
      enhance wound healing and regeneration of new tissue, finally may provide a new option in
      treating a Dystrophic Epidermolysis Bullosa.
    

Intervention name(s): ALLO-ASC-DFU
Intervention type(s): Biological
Intervention description(s): ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Dystrophic Epidermolysis Bullosa.
This study is a follow-up study without intervention.
Other Names:
Allogenic adipose-derived mesenchymal stem cells
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of
        ALLO-ASC-EB-101
      
Keywords: Epidermolysis Bullosa; Stem cell
Comparative Efficacy of 4 Oral Analgesics
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of
      the comparative efficacy of 4 oral analgesics in the initial management of acute
      musculoskeletal extremity pain presenting to the ED.
    

Detailed description: 
      To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4
      oral analgesics in the initial management of acute musculoskeletal extremity pain presenting
      to the ED. The 4 groups are as follows:

        1. Oxycodone/acetaminophen (5/325)

        2. Hydrocodone/acetaminophen (5/325)

        3. Codeine/acetaminophen (30/300)

        4. Ibuprofen/acetaminophen (400/1000)
    

Intervention name(s): Oxycodone/acetaminophen; Hydrocodone/acetaminophen; Codeine/acetaminophen; Ibuprofen/acetaminophen
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Percocet; Norco; Tylenol with codeine
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Oxycodone; Hydrocodone; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pain
Study In People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a
      range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects
      with T2DM (Type 2 Diabetes Mellitus).
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled,
      Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15
      And 20 Mg Once A Day) As A Monotherapy (Diet and/or exercise treated) Or As An Add-On To
      Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus
    

Intervention name(s): Pioglitazone; GW677954
Intervention type(s): Drug; Drug
Other intervention name(s): Pioglitazone
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Efficacy; PPARpan; Type 2 Diabetes Mellitus; Phase IIb; Safety; Pharmacokinetics; GW677954; Pharmacodynamics; Tolerability; Dose-Ranging
Immediate Changes After Manual Therapy in Patients With Non-specific Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      The purpose of this trial is to investigate the immediate effects of neuro-lymphatic
      treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical
      and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.
    

Detailed description: 
      Subjects:

      The study was conducted at the Faculty of Physiotherapy of the University of Valencia
      (Spain). Persistent non-specific back pain subjects between 20 and 30 years old were
      recruited and voluntarily participated in the study. Excluded subjects with musculoskeletal
      injuries such as spine or balance disorders, those which were recovering from an injury of
      the locomotor or neurological system, or those who had sequelae from any trauma suffered in
      the past six months that could affect the results of the study.

      Study design:

      The conducted study was an experimental, longitudinal and prospective, controlled, randomized
      and single-blind design (subjects and therapists didn't know the objectives of the treatment
      nor how many treatments were offered, evaluators were unaware of the treatments applied).
      There were 3 groups: a) neuro-lymphatic treatment; b) vertebral articulatory treatment; c)
      proximal costal articulatory treatment.
    

Intervention name(s): Neuro-lymphatic treatment; Articulatory spinal manual therapy; Articulatory costal Manual therapy
Intervention type(s): Other; Other; Other
Intervention description(s): The physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement.; Then the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached.; The therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Back pain; Manual therapy
Telephone-Based Re-education for Hp Eradication
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      It was suggested that the patient compliance plans an important role in the Hp eradication.
      However, data on whether re-education could improve the eradication rate are lacking. We
      consider that re-education on patients by telephone during the process of drug administration
      could increase the eradication rate in Hp infected patients.

      We hypothesized that telephone re-education during the whole process of drug administration
      would improve the compliance of patients and ultimately increase the Hp eradication rate.
    


Intervention name(s): telephone-based re-education; First education at the clinic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.; Patients will receive an instruction card about the drug administration at the clinic by doctors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: helicobactor pylori
Everolimus and LongActing Octreotide Trial in Polycystic Livers
Condition: Polycystic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to reduce polycystic liver volume by treating with octreotide,
      whether or not combined with everolimus; to assess whether combination therapy of everolimus
      and octreotide gives a bigger reduction of polycystic liver volume than octreotide
      monotherapy.
    

Detailed description: 
      This is a single center randomized, open-label, parallel study comparing the safety and
      efficacy of everolimus-octreotide LAR treatment to monotherapy octreotide LAR in adult
      symptomatic patients with polycystic livers because of polycystic liver disease (PCLD).

      We aim to include 44 patients affected by a polycystic liver either due to PCLD, 22 patients
      in the combination group and 22 patients in the mono therapy group.The duration of the trial
      will be 52 weeks. The treatment will be 48 weeks and the last control visit will take place
      four weeks after the treatment.
    

Intervention name(s): Everolimus; Octreotide LAR
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg every day orally; 40 mg every 28 days IM
Other intervention name(s): Afinitor; Sandostatine LAR
Intervention MeSH terms: Everolimus; Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver cyst
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation
      treatment for tinnitus.
    

Detailed description: 
      Participants with chronic tinnitus will be provided with a CE marked neuromodulation device.
      Participants are randomized to one of four different treatment arms. The treatment period is
      intended for 12 weeks of use. Based on the clinical investigation plan, participants are
      informed that their stimulation settings can change between the first and second halves of
      the treatment period and that the differences may be perceptually noticeable. Differences in
      tinnitus severity scores will be compared between and within treatment arms.
    

Intervention name(s): PS1-PS4; PS6-PS10; PS7-PS4; PS9-PS6
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Participants in this arm shall be given PS1 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.; Participants in this arm shall be given PS6 during the first half of treatment and PS10 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.; Participants in this arm shall be given PS7 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.; Participants in this arm shall be given PS9 during the first half of treatment and PS6 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Dairy Foods and Blood Pressure in Multi-Ethnic Children
Condition: Blood Pressure, High
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To prevent excess increases in blood pressure in children by providing two servings of dairy
      foods as snacks daily at school. We hypothesize that children who receive the two dairy
      snacks will exhibit significantly less of an increase in blood pressure over six months as
      compared to control children.
    

Detailed description: 
      The primary aim of the study is to determine the impact of dairy foods on blood pressure;
      however, we will also evaluate the effect of the intervention on body weight and composition.
      Specifically, we will evaluate change in body mass index (BMI, kg/m2], waist circumference in
      all subjects and body composition by bioelectrical impedance (BIA) in a subset. We
      hypothesize that children receiving the dairy snacks will exhibit less increase in BMI and
      body fat than control subjects. We are studying a group of children at high risk for elevated
      blood lipids and glucose intolerance due to their racial/ethnic makeup and high prevalence of
      overweight and obesity. Thus, we will evaluate the impact of the intervention on blood
      lipids, glucose and insulin in a subset of subjects.

      We hypothesize that children receiving the dairy foods will exhibit improvements in their
      lipids, glucose and insulin as compared to control children. We also plan to determine their
      eating habits through a 24 hour dietary recall at the beginning, middle and end of the study,
      with 2 additional recalls for the subset at each time point. Dietary behavior and self
      efficacy will be analyzed before and after the intervention through a questionnaire. Physical
      activity levels will be assessed by a short physical activity questionnaire on all students
      and through the utilization of accelerometers in the subset. Our control schools will undergo
      the same testing, but will not receive any intervention.
    

Intervention name(s): Two Servings of Dairy Snacks
Intervention type(s): Behavioral
Intervention description(s): 2 servings of dairy products as snacks at school to third, fourth, and fifth grade students each day for 24 weeks. The serving size of each dairy snack is based on its calcium content with the goal of adding an extra 300 mg of calcium to the intervention group's daily intake.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention