bioihbjkbjnl/mcl2 huggingface dataset:
Accuracy of Pleth Variability Index (PVI) in Children
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Plethysmographic Variability index is a simple index accurate in predicting fluid
      responsiveness.

      The aim of this study was to investigate its accuracy in predicting fluid response to
      intravenous fluid challenge during scoliosis surgery in children.
    

Detailed description: 
      The goal of the present study is to assess the validity of PVI in predicting the response to
      a fluid challenge during scoliosis surgery in children.

      During this observational non-interventional study, each fluid challenge will be monitored by
      esophageal Doppler and PVI (Massimo Radical 5).

      Anesthesia, surgery and intraoperative fluid administration id standardized according to our
      clinical protocol.

      An increase in indexed Stroke Volume (iSV) by more than 15 % will define the positive
      response to the fluid challenge.

      Fluid challenges will be performed in the supine position and in the prone position.

      Statistical analysis will performed using the Receiving Operator Characteristics (ROC) curve
      with determination of the gray-zone allowing an error tolerance of 10 %.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children undergoing scoliosis surgery
      
Keywords: Plethysmographic Variability Index; Esophageal Doppler; Scoliosis; Children; Age < 18 years; Scheduled for Scoliosis Surgery
Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Failed in Telmisartan 80 mg
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is
      superior to telmisartan 80 mg alone in patients, who fail to respond adequately to
      telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight
      weeks of treatment.
    

Detailed description: 
      This is a multi-centre, prospective, randomized, double-blind, parallel-group study in
      approximately 244 patients with a history of mild-to-moderate hypertensive who have been
      shown not to respond to telmisartan monotherapy.

      All patients will enter a one-week screening phase prior to starting the eight-week
      open-label T80 mg period. At the end of four weeks, only patients who fail to respond to T80
      mg (DBP >= 90 mm Hg) will continue the treatment with T80 mg for another four weeks. At the
      end of eight weeks, only patients who fail to respond to T80 mg (DBP >= 90 mm Hg) will be
      randomized, double-blind, to receive either T80 mg alone or the fixed dose combination of T80
      mg plus HCTZ 12.5 mg for eight weeks. Seated BP will be taken 24 hours post-dose at each
      visit. Labs, ECG, and physical examination will be done at screening, at baseline and at the
      final visit.

      Study Hypothesis:

      The primary objective of the study, showing that fixed dose combination is superior to
      telmisartan 80 mg alone will be tested using the hypotheses given below.

      H0: u T80/H12.5 - uT80 = 0 mm Hg versus H1: uT80/H12.5 - uT80 not equal 0 mm Hg, where
      uT80/H12.5 anduT80 represent the average reduction from baseline (Visit 4) in trough seated
      DBP for the fixed dose combination and telmisartan 80 mg, respectively.

      Testing of the null hypothesis will be performed using a two-sided test of significance at an
      a-level (type-I error rate) of 0.05.

      Comparison(s):

      The primary efficacy endpoint will be the change from baseline in seated DBP 24 hours
      post-dose at the last visit during the double-blind treatment phase. The pre-dose measurement
      on visit 4 will be viewed as the baseline measurement.
    

Intervention name(s): Telmisartan/HCTZ; Telmisartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Back and Neck Pain in Adolescence
Condition: Back Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and
      neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.
    

Detailed description: 
      In two settings (school, clinics) back and neck pain of 10 to 16 years old adolescents will
      be assessed by the German Version of the Young Spine Questionnaire at 6 points in time during
      one year.

      Validity, reliability and responsiveness of the G-YSQ will be determined and the development
      of back and neck pain within a year will be described.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents between 10 and 16 years with and without back and neck pain.
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted with the aim of investigating the efficacy, safety and
      tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active
      comparator (venlafaxine extended release 150 mg/day).
    


Intervention name(s): Vortioxetine (Lu AA21004); Venlafaxine extended release
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/day; 150 mg/day
Other intervention name(s): Brintellix; Efexor® XL
Intervention MeSH terms: Vortioxetine; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD
Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the tolerability and safety of increasing doses of
      primaquine in combination with artemether-lumefantrine in G6PD deficient males with an
      asymptomatic P. falciparum malaria infection.
    


Intervention name(s): Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine; Artemether-Lumefantrine (AL) combination; Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lumefantrine; Artemether; Primaquine; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: G6PD deficiency; safety; transmission
Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy and safety of three treatment regimens
      for the prevention of malaria during pregnancy.
    

Detailed description: 
      Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the
      neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child
      mortality in Africa. There are data from studies that show that intermittent preventive
      treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and
      effective in preventing maternal anemia, placental parasitemia, and LBW. Resistance to SP,
      however, is increasing rapidly in Africa and there is an urgent need to find alternative
      effective, safe and affordable drugs for the treatment and prevention of malaria in
      pregnancy.

      The investigators conducted a trial to determine the efficacy and safety of azithromycin and
      artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during
      pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on
      peripheral blood film were randomly assigned into 3 treatment groups and received two doses
      of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and
      artesunate 200mg/day for 3 days). The two doses of the study drug were administered
      approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were
      collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women presented
      with symptoms of malaria. The women were also given an insecticide-treated net (ITN) and
      followed until delivery. Adverse effects were assessed at each scheduled visit, any
      unscheduled visits during the study, and at delivery. Peripheral and placental blood films
      and placental biopsies were prepared at delivery. Newborns were weighed, examined, and
      gestational age was determined.
    

Intervention name(s): Sulfadoxine-Pyrimethamine; Azithromycin; Artesunate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Azithromycin; Artesunate; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Pregnancy; Efficacy; Azithromycin; Artesunate
Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia
Condition: Healthy
Study type: Interventional

Summary: 
      During general anesthesia lung collapses and atelectasis occurs. Preservation of atelectasis
      can cause pulmonary disfunction. The goal of safe anesthesia is to protect the lungs
      intraoperatively. Positive end-expiratory pressure (PEEP) is distending pressure that
      prevents alveolar collapse during mechanical ventilation and is a part of recruitment
      maneuver that is often used in patients on mechanical ventilation. Overall effect of PEEP is
      improvement in lung function. PEEP can have adverse effects on hemodynamics. The objective of
      this study was to assess the effect of step up and down PEEP titration on lung function and
      hemodynamics in healthy preschool children during general anesthesia. One group of children
      was ventilated with constant PEEP. the other was submitted to PEEP titration. Changes in lung
      compliance, gas exchange and hemodynamic status were documented as well as any unwanted
      effects.
    

Detailed description: 
      Seventy preschool children American Society of Anesthesiologists classification system (ASA)
      I and II scheduled for non-cardiothoracic surgery were allocated in two groups.
      Interventional group (n=35) received PEEP titration and Control group (n=35) didn't. They
      were ventilated only with PEEP 3. PEEP titration: In Intervention group, 20 minutes before
      the end of anesthesia PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP
      11 was maintained for 2 minutes. Then PEEP was reduced by 2 on every 5 breaths to 5 and
      remain as until awakening. Total time to perform titration was 5 minutes. Blood was collected
      in both groups, in equal points of time that is: after induction, 20 minutes before the end
      of surgery and after the end of surgery (20th minute). Investigators tested differences of
      outcome variables between groups and within the Interventional group before and after PEEP
      titration. Hemodynamic monitoring and monitoring of lung function were conducted in
      Interventional group to observe changes during PEEP titration.
    

Intervention name(s): increase and decrease positive end-expiratory pressure
Intervention type(s): Procedure
Intervention description(s): 20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then, PEEP was reduced by 2 on every 5 breaths to 5 cmH2O
Other intervention name(s): ventilation with PEEP 3
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized parallel controlled clinical trial
Masking: None (Open Label)
Primary purpose: Other
EFFECTS OF VESTIBULAR REHABILITATION THERAPY (VRT) ON BALANCE, SPEED AND AGILITY IN POST-CONCUSSION FOOTBALL PLAYERS
Condition: Concussion, Mild
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Traumatic brain injury (TBI) is one and utmost rampant attained neurological conditions which
      can happen in young adults. Vestibular Rehabilitation Therapy can help them improve their
      balance, speed and agility.
    

Detailed description: 
      Total 40 sample size out of which were divided into control and experimental group. Concussed
      football athletes with age ranging 15-25 year, those participating actively in the sports
      were included in the study in the region of Kyber Pukhtoonkhwa Peshawar.
    

Intervention name(s): Cawthorne Cooksey Exercises
Intervention type(s): Other
Intervention description(s): Activity sitting on the "Exercise Ball" swing (eye movements, first slow and then fast)
Swing sitting activity (head movements, first slow then fast - eyes open and eyes closed)
Trunk activities focusing on balance
Dynamic balance activity focusing on standing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Concussion; Vestibular Rehabilitation Therapy; Football; Balance
Safety and Efficacy of Mix Vaccine in Lung Carcinoma Patient
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).
      Enrolled patients will receive standard treatment according to National Comprehensive Cancer
      Network (NCCN) guide line with or without combining MV injection. The efficacy and side
      effect will be compared between the two groups.
    

Detailed description: 
      In the study, after evaluation of the general and physical status, eligible patients will be
      enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients
      will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN)
      guide line (control group) and in experimental arm, patients will be receiving simultaneous
      standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease
      progression.

      Blood sample will be obtained at baseline and every week before MV injection for the
      assessment of clinical hematology, biochemistry measurements and immunology index (including
      immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout
      the study. Side effect, progression free survival, immunology index and general status will
      be recorded.
    

Intervention name(s): MV mix vaccine; standard treatment
Intervention type(s): Biological; Other
Intervention description(s): MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), BCG (Bacille Calmette-Guerin vaccine), measles, Serratia and pneumococcus. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.; Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
Other intervention name(s): MV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mix vaccine, lung neoplasms, immunotherapy
Naltrexone for Impulse Control Disorders in Parkinson's Disease
Condition: Impulse Control Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in
      Parkinson's disease patients taking a dopamine agonist.
    

Detailed description: 
      Impulse control disorders (ICDs), including compulsive gambling, sexual behavior, buying, and
      eating, are increasingly recognized as a significant clinical problem in Parkinson's disease
      (PD), occurring in up to 15% of patients. Dopamine agonist (DA) treatment is thought to be
      the primary risk factor for the development of ICDs in PD. ICDs often lead to significant
      impairments in psychosocial functioning, interpersonal relationships, and quality of life.
      The management of ICDs in the context of PD can be complex. Patients may be reluctant to
      discontinue DA treatment due to the motor benefits derived from treatment, so patients often
      have chronic symptoms. Thus, additional treatment approaches are needed.

      A medication shown to be efficacious for the treatment of ICDs with minimal impact on
      parkinsonism would allow many ICD patients to continue on full-dose DA treatment. Naltrexone,
      a long-acting opioid receptor antagonist, helps in the treatment of alcohol and opioid
      dependence. In addition, placebo-controlled studies have demonstrated that it helps in the
      treatment of pathological gambling in the general population. Opioids regulate dopamine
      pathways in areas of the brain linked with impulse control disorders, and opioid antagonists
      block opioid receptors in these regions. In this study, 48 PD patients with an ICD will be
      treated either with naltrexone (50-100 mg/day) or placebo for a period of 8 weeks. The study
      will assess if naltrexone improves ICD symptoms in PD and is well tolerated. To our
      knowledge, the proposed study is the first controlled trial of an agent to treat ICDs in PD.
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50-100 mg qd for 8 weeks; 50-100 mg qd for 8 weeks
Other intervention name(s): Revia, Vivitrol
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Compulsive Gambling; Compulsive Buying; Compulsive Shopping; Compulsive Eating; Hypersexuality; Dopamine Agonists; Mirapex; Pramipexole; Requip; Ropinirole; Impulse Control Disorders
Persona of Central Serous Chorioretinopathy
Condition: Personality Type
MeSH terms: Central Serous Chorioretinopathy
Study type: Observational

Summary: 
      Purpose: Central serous retinopathy (CSCR) is characterized by macular detachment due to
      thickened choroid mostly affecting young men under perceived stress. While most previous
      studies in CSCR have been retrospective and have focused on a single facet of the patient's
      personality, the investigators conducted a prospective intercontinental controlled study to
      analyze the multifaceted personality profile in CSCR.

      Design: Prospective interview. Participants and Controls: Subjects with CSCR consented to
      participate in a questionnaire. Controls not having retinal disease were recruited from the
      same clinic.

      Main Outcome Measures: The main parameters registered were presence of stress, daily number
      of cups caffeine intake, personality traits (Type A; obsessive-compulsive; aggressive).

      Methods: The interview consisted of a 60-item questionnaire. Recruitment of participants was
      from January 2015 to February 2016. Controls were matched for age, gender and race.
      Statistical analyses were done using univariate and multivariate analysis.
    

Detailed description: 
      Central serous chorioretinopathy (CSCR) characterized by serous macular detachment is the
      fourth most common retinal disease after age-related macular degeneration, diabetic
      retinopathy and retinal vein occlusion. In a population-based retrospective cohort and case
      control study in Olmsted county, Minnesota, USA, Kitzmann et al4 reported a mean age-adjusted
      incidence of 9.9 (95% confidence interval [CI] 7.4-12.4) per 100, 000 in men, and 1.7 (95% CI
      0.7-2.7) in women. The mean age of onset of CSCR appears between 41 and 45 years5. The
      disease affects various racial groups5-8 and occasionally can be familial9. The pathogenesis
      remains poorly understood and currently the exudation is thought to result from
      hyper-permeable choroid secondary to venous stasis, ischemia, or inflammation2. Because of
      lack of proper animal models and lack of definite cure, clinical research has focused on risk
      factors such as stress, corticosteroid intake, and type A personality. Different
      hospital-based studies yielded different risk factors. Epidemiologic studies failed to
      ascertain many of these risk factors. Due to different methodology (retrospective vs.
      prospective case-control studies; selection of controls; questionnaire vs. interview by
      physician assistant vs. interview by physician) and focus on single risk factors in the
      literature, the investigators designed a study that targets a vast number of known or
      potential risk factors in various collaborative centers and compare it to results reported in
      the literature.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with central serous retinopathy
An Innovative Treatment for Cervical Pre Cancer
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      The purpose of this study is to test two innovative devices, the CryoPen® and
      thermocoagulator, against gas-based cryotherapy to determine whether the novel devices
      produce equivalent or improved destruction of cervical tissue compared to gas-based
      cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the
      CryoPen and gas-based cryotherapy will also be compared.
    

Detailed description: 
      The primary objectives of the study are to test the hypothesis that the CryoPen® and
      thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with
      traditional CO2-based cryotherapy and to test single versus double freeze applications. The
      secondary objectives of the study are to determine if the CryoPen® or thermocoagulator
      achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of
      cervical precancer, and to observe the relationship between depth of necrosis and variations
      in cervical anatomy.
    

Intervention name(s): CryoPen; CO2 standard cryotherapy; Thermocoagulator
Intervention type(s): Device; Device; Device
Intervention description(s): Provides a means of freezing tissue without the use of gases or liquids; Standard therapy using carbon dioxide for freezing of tissue; The use of heat produced by high-frequency electric current to bring about local destruction of tissues
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment