bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
Condition: Microvascular Decompression Surgery; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting (PONV) is a common problem and may lead to catastrophic
      complications, especially in neurosurgical cases. The aim of this study was to evaluate the
      effects of dexamethasone and ondansetron for preventing PONV in patients who underwent
      microvascular decompression surgery (MVD).
    

Detailed description: 
      A prospective, double-blinded randomized control trial was conducted with 54 patients who
      underwent MVD. Patients were allocated into two groups. The study group (Gr. D) received
      intraoperative dexamethasone 4 mg iv and ondansetron 4 mg iv, whereas the control group (Gr.
      N) received placebo (0.9% normal saline 1 ml iv and 0.9% normal saline 2 ml iv). The
      incidence and severity of PONV were observed at 1, 2, 4 and 24 hr post-surgery.
    

Intervention name(s): Dexamethasone; Ondansetron; 0.9% Sodium Chloride Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The 4 mg of dexamethasone in 1 ml intravenous was administrated after patient received general anesthesia; The 4 mg of ondansetron in 2 ml intravenous was administrated at the end of the operation.; The 0.9% sodium chloride in 1 ml intravenous was administrated after patient received general anesthesia. At the end of operation, the 0.9% sodium chloride in 2 ml intravenous was administrated.
Other intervention name(s): Lodexa; Onsia
Intervention MeSH terms: Dexamethasone; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized control trial was conducted. The investigators allocated patients into two arm.
The study group (Gr. D) received intraoperative dexamethasone 4 mg iv and ondansetron 4 mg iv, whereas the control group (Gr. N) received placebo (0.9% normal saline 1 ml iv and 0.9% normal saline 2 ml iv)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease
Condition: Parkinson Disease(PD)
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The proposed control intervention trial, aims to analyse the effects of Dance in the turning
      characteristics in patients with Parkinson Disease (PD) using three- dimensional (3D)
      analysis during the timed up and go (TUG) test.
    

Detailed description: 
      Experimental Design: control intervention non-randomized trial. Search Location: University
      of Wolverhaptom, Walsall Campus, United Kingdom; Federal University of Rio Grande do Sul,
      Brazil.

      Participants: 15 adults aged between 50 and 80 years, with a clinical diagnosis of idiopathic
      PD, staging between 1 and 4 of the Hoehn & Yahr Scale, recruited from Dance for Parkinson's
      Projects, West-Midlands County, United Kingdom, and from Parkinson's UK (United Kingdom).

      Interventions: Dance intervention for 3 months, 2 times/week (1 instructor lecture session
      and 1 home session following a prepared video), 2 hours per week. Controls, not alter their
      personal lifestyle, but undergo the same testing as the exercise intervention group.

      Outcomes: clinical-functional parameters (number of steps and total time of the 180 turning
      phase of the Timed up and go Test - TUG - and biomechanics parameter - girdle dissociation)
      Data Analysis: Data will be described by average values and standard deviation values. All
      statistical analyses will be carried out using SPSS version 23, and Microsoft Excel Program
      version 16.44. The significance level is set at p<0.05. The Cohen's d is going to be used to
      predict effect interpreted as small d= 0.2, medium d=0.5, and large d=0.8, and 95% confidence
      intervals were presented.
    

Intervention name(s): Dance; No intervention
Intervention type(s): Other; Other
Intervention description(s): The dance program consists of 3 months of dance classes. Classes are specifically designed for people with Parkisnon's and lead by a qualified dance instructor experienced in teaching this population. The in-person dance classes are conducted in an appropriate room with chairs and ballet barres once a week. In addition, the participants received a CD containing a video of the recorded dance routine to be performed at home once a week. The class typically included a warm-up (10-15 min.), barre ballet exercises (10-15 min.), general dance-related activities (15-20 min), and a cool-down (10-15 min).; Controls, not alter their personal lifestyle, but will undergo the same testing as the exercise intervention group.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dance; Functional Mobility; Turning
Comparison of Different Prophylaxis Regimens for Moderate to Severe Hemophilia A Pediatric Patients
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      Title: Comparison of different prophylaxis regimens for hemophilia A pediatric patients
      Principal Investigator: Assistant Professor Darintr Sosothikul, MD Research Question: Does
      different factor VIII dosage effect outcome of hemophilia treatment in term of breakthrough
      bleeding, number of hospital stay and day-off from school? Type Research: Clinical research

      Study design: Single center clinical trials

      Concise methodology:

        1. Study Population: Children with hemophilia A who received treatment at KCMH from May
           2015 to March 2016 will be enrolled in this study. The consent will be obtained before
           the study.

        2. Observation and measurement:

             1. History, interesting clinical data and laboratory data will be recorded in Clinical
                record Form (CRF)

             2. Measurement:

           i. Complete blood count (CBC), Factor VIII level, Factor VIII inhibitor level ii. Number
           of breakthrough bleedings, number of hospital stay and day-off from school iii. Joint
           score from Hemophilia Joint Health Score 2.1 iv. EQ-5D-5L quality of life assessment
           score

        3. Data analysis: The p-value of less than 0.05 will be considered statistically
           significant. Mann-Whitney test will be used to test correlation of these variables (CBC,
           Factor VIII level, Factor VIII inhibitor level, Number of breakthrough bleedings, number
           of hospital stay, day-off from school, Hemophilia Joint Health Score 2.1, EQ-5D-5L
           quality of life assessment score) Sample size: 16 patients

      Potential impacts:

      The outcomes of different factor VIII concentrate dose between 15-20 U/kg/dose 2 times/week
      and 35-40 U/kg/dose 1 time/week will be revealed. These outcomes include number of
      breakthrough bleeding, number of hospital stay, day-off from school, joint health and quality
      of life. The result of this study will guide further study on optimal dose and duration of
      factor VIII treatment of hemophilia A patients in the future.
    


Intervention name(s): FVIII; FVIII
Intervention type(s): Drug; Drug
Intervention description(s): FVIII concentration 35-40 U/kg/dose 1 time/week for 5 months; FVIII concentration 15-20 U/kg/dose 1 time/week for 5 months
Other intervention name(s): Hemofil-M; Hemofil-M
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate hemophilia A; Severe hemophilia A; Intermediate dose prophylaxis; Low dose prophylaxis
Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose of the study is to determine midazolam's safety and dose-linearity when delivered
      intramuscularly via an autoinjector. The proposed initial treatment dosage for seizures
      induced by exposure to nerve agents.
    

Detailed description: 
      The investigational drug product being evaluated in this study is the Midazolam Autoinjector.
      This system is composed of an autoinjector filled with the drug product midazolam EP. The
      study drug is administered IM into the anterior thigh using the preloaded autoinjector. This
      method of administration was selected as it is the method that will be used in later clinical
      trials and for the marketed product. The autoinjectors were preloaded with midazolam 5 mg or
      10 mg with a total volume of 1 or 2 mL. Healthy subjects are assigned to one of six target
      dosage groups (0.10, 0.18, 0.25, 0.33, 0.40, 0.49 mg/kg) and, based on their weight, received
      the necessary combination of fixed 5 or 10 mg doses to provide the assigned target dose.
    

Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention description(s): The study drug was administered IM into the anterior thigh using the preloaded autoinjector. The autoinjectors were preloaded with midazolam 5 mg or 10 mg with a total volume of 1 or 2 mL. Healthy subjects were assigned to one of six target dosage groups (0.10, 0.18, 0.25, 0.33, 0.40, 0.49 mg/kg) and, based on their weight, received the necessary combination of fixed 5 or 10 mg doses to provide the assigned target dose.
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nerve agent; Midazolam; Seizures; Severe recurrent convulsive seizures induced by nerve agent exposure
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from
      healthy children receiving the 2007-2008 formulation of the inactivated, split-virion
      influenza vaccine Fluzone® for further study.
    


Intervention name(s): 2007-2008 Influenza Virus Vaccine; 2007-2008 Influenza Virus Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular; 0.25 mL, Intramuscular
Other intervention name(s): Fluzone®; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza Vaccine; Influenza Virus; Orthomyxoviridae Infections; Fluzone®
Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients. Effetti Del Temperamento, Dell'Ansia e Della Depressione Sulla Sopravvivenza Globale e Sulla Risposta Immunitaria Del Paziente Affetto da Adenocarcinoma Colo-Rettale.
Condition: Temperament; Anxiety; Depression; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Depression; Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity
      and influence Survival in Colorectal Cancer Patients
    

Detailed description: 
      120 prospective patients, with non-metastatic colorectal cancer, will be evaluated with
      questionnaires and auto-questionnaires in order to assess temperament, anxiety and
      depression. The immunity status will be assessed by a blood sample with the aim to evaluate
      cell-mediated immunity.

      Survivall will be related to level of anxiety/temperament/depression and cell-mediated
      immunity.

      Univariate and multivariate model analisys will be performed in order to evaluate if
      anxiety/temperament/depression and cell-mediated immunity can be considered as prognostic
      factors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Biospecimen description: 
      Blood samples for cell-mediated immunity evaluaion
    
Keywords: Temperament; Anxiety; Depression; Colorectal Cancer
Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, single oral dose, crossover study in up to three parts to
      investigate the relative bioavailability and bioequivalence of two different formulations of
      risdiplam 5 mg (dispersible tablets) versus the current risdiplam oral solution formulation
      in healthy male and female participants. The effect of food on these two dispersible tablets
      and the current oral solution will be studied, as well as the effect of omeprazole on the
      dispersible tablets.
    

Detailed description: 
      Part 1 of the study is an exploratory comparison of the relative oral bioavailability of the
      two dispersible tablets versus risdiplam powder for oral solution as the reference. The
      effect of food on the bioavailability of the two dispersible tablets will be assessed by
      comparing fed and fasted states in a five-way crossover manner. It will also be assessed
      whether antacids (omeprazole) have an impact on the bioavailability of the dispersible
      tablets in a two-way crossover manner. The food effect on the risdiplam oral solution will
      also be assessed by comparing fed and fasted states in a two-way crossover manner.

      In Part 2, based on the data obtained in Part 1 and provided data support further evaluation,
      a bioequivalence assessment and a food-effect evaluation will be conducted in two groups with
      the selected dispersible tablet formulation. Each group will randomly receive, in a four-way
      crossover, a single dose of risdiplam oral solution 5 mg in both fed and fasted states, and a
      single dose of the selected dispersible tablet in both fed and fasted states.

      In Part 3, provided Part 1 data support further evaluation of the second formulation, the
      second formulation may be assessed for bioequivalence in the same way as described in Part 2.

      Enrollment of the same participant in more than one cohort or group will not be permitted
      regardless of the study part.
    

Intervention name(s): risdiplam; omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Risdiplam will be administered orally at a single dose of 5 mg in different formulations. Dispersible tablet formulations (F21/F22) will be administered as swallowed tablet or as tablet dispersed in water. The powder for constitution to an oral solution will be administered as an oral solution constituted with purified water.; Omeprazole will be administered orally as a capsule at a dose of 40 mg per day
Other intervention name(s): Evrysdi; Non-investigational medicinal product
Intervention MeSH terms: Omeprazole; Risdiplam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
Condition: Establishing Dose of Sr-hGH in ISS Patients
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess dosing requirements and establish the efficacy of
      SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as
      multi-center, randomized, active comparator-controlled, parallel, open-label.

      45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of
      daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the
      other arm received daily hGH at 0.37 mg/kg/week.

      Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And
      patients randomized to daily hGH group injected for 6 days a week.

      Patients visited study centers five times, firstly at screening (Visit 1), at randomization
      (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for
      follow-up (Visit5).
    


Intervention name(s): human growth hormone self-injection
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in
      approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening
      diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce
      the development and progression of diabetic retinopathy, intensive control of glucose is
      usually not achieved in clinical practice.
    


Intervention name(s): Octreotide Acetate in Microspheres; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetic retinopathy, Octreotide Acetate in Microspheres
Short-term Evaluation of Motor and Sensory Function in Post-COVID-19 Patients
Condition: Motor Neuropathy; Sensory Neuropathy
MeSH terms: COVID-19; Peripheral Nervous System Diseases
Study type: Observational

Summary: 
      SARS-COV-2 infection reframed medical knowledge in many aspects, yet there is still a lot to
      be discovered. our aim is to evaluate neurological impact of covid-19; if there is any.
    

Detailed description: 
      Coronavirus disease 19 (COVID-19) can cause neuropsychiatric, psychological and psychosocial
      impairments. Literature regarding the sensory and motor affection of COVID-19 is still
      limited.

      Public health emergencies as COVID-19 are likely to cause adverse neuropsychiatric impacts.
      Cognitive impairments after SARS-COV-2 infection were noticed, COVID-19 patients complain of
      poor concentration, declined memory, and insomnia, as well as anxiety and depression
      symptoms.

      in a study; Neurological manifestations described in 36.4% of 214 patients with confirmed
      COVID-19. However, the symptoms described [dizziness (not further defined), headache, and
      impaired consciousness] are commonplace in many severe infections and represent disturbances
      in neurological function rather than a neurological disease per se. Anosmia and ageusia have
      received much attention, but are ubiquitous in other common upper respiratory tract
      infections. While a reported increased risk of cerebrovascular disease.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        20 RT-PCR-confirmed COVID-19 patients with neurological manifestations presented at
        outpatient clinics of chest and neurology departments were recruited. Twenty healthy age
        and gender-matched volunteers were enrolled in the study.
      
Keywords: Covid-19; Nerve conduction studies; Neuropathy; Complication
Phototherpy Versus Tapwater Iontophoresis for Management of Atopic Dermatitis in Children.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      this study is conducted to compare the effect of phototherapy" psoralen plus UVA " bath puva
      to tap water iontophoresis in the treatment of atopic dermatitis in children.
    

Detailed description: 
      Sixty children were selected from the department of dermatology, Banha University Hospital.
      Patients were randomly assigned to (Group- A):- 20 children Patients, aged between 6-16 years
      old. be treated with Phototherapy, for 3 sessions per week for 8 weeks Plus the traditional
      medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a
      day for 8 weeks. (Group B): 20 children Patients, in Group-B are treated with tap water
      iontophoresis, for 8 weeks, 3 sessions /week: the intensity were increased according to the
      patient's tolerance, for 20 minutes. Plus the traditional medical treatment. (Group -C) the
      control group will treated by only the traditional medical treatment which is the
      betamethasone dipropionate 0.05% " diprolene" cream, two times a day for 8 weeks Skin
      thickness by ultrasonography and Patient Oriented Eczema Measure(POEM) are measured before
      and after 8 weeks of treatment.
    

Intervention name(s): Ultra Violet A Device.+ Topical medical treatment; Iontophoresis device + Topical medical treatment; Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )
Intervention type(s): Device; Device; Drug
Intervention description(s): Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen "meladenine capsule".; Tap-water iontophoresis was given 3 times weekly for 10 min. The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30 mA.; thin film of the cream is being applied to the affected areas for 2 times per day.
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic dermatitis, Phototherapy, iontophoresis