bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the
      medial branch nerves of the lumbar facet joint is effective for the treatment of low back
      pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that
      the brain does not receive the message that the low back is in pain. This technique is
      commonly performed by burning these nerves rather freezing them, but it is suspected that
      freezing them results in better pain relief. The CRFA blocks has been shown to effectively
      treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is
      suspected that CRFA will be effective when treating pain related to facet joints in the low
      back. We are performing this study in order to determine if that is the case.
    

Detailed description: 
      The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the
      pelvis), which is another reason that it is suspected that CRFA will be effective when
      treating pain related to facet joints in the low back. We are performing this study in order
      to determine if that is the case.
    

Intervention name(s): Conventional radiofrequency ablation (RFA); Cooled Radiofrequency Ablation (CRFA)
Intervention type(s): Procedure; Procedure
Intervention description(s): A conventional RFA electrode with a 10mm active tip will be used. RFA lesions will be performed for 90 seconds with the maximum electrode temperature raised to 80°C.; Following 18G C-RFA electrode positioning, 1cc of 2% lidocaine will be injected through the introducer needle for anesthesia during the ablation. The maximum electrode temperature is 60°C.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Lumbar Facet Syndrome
Human Bioequivalence Test of Liraglutide Injection
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing
      Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical
      Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical
      evaluation and clinical medication;To observe the safety of the test preparation liraglutide
      injection and the reference preparation Victoza ® in healthy subjects.
    


Intervention name(s): Liraglutide injection; Victoza
Intervention type(s): Drug; Drug
Intervention description(s): Human glucagon-like peptides-1 analogue; Human glucagon-like peptides-1 analogue
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar or Schizophrenia Illness
Condition: Obesity; Ketogenic Dieting; Metabolic Syndrome; Bipolar Disorder; Schizophrenia; Weight Gain; Psychotropic Agents Causing Adverse Effects in Therapeutic Use; Brain Metabolic Disorder
MeSH terms: Brain Diseases, Metabolic; Obesity; Metabolic Syndrome; Metabolic Diseases; Weight Gain; Schizophrenia; Bipolar Disorder
Study type: Interventional

Summary: 
      To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among
      a cohort of outpatients with either schizophrenia or bipolar illness who also have metabolic
      abnormalities, overweight/obesity, and/or are currently taking psychotropic medications
      experiencing metabolic side effects.
    

Detailed description: 
      Adults with mental illness represent a high-risk, marginalized group in the current metabolic
      and obesity epidemic. Among US adults with severe mental illness, metabolic syndrome are
      highly prevalent conditions having severe consequences, with patients estimated to die on
      average 25 years earlier than the general population largely of premature cardiovascular
      disease. Many psychiatric medications, particularly neuroleptics and mood stabilizers, may,
      in addition, contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat
      (LCHF) or ketogenic diets (KD) have been shown to reduce cardiovascular risk in those with
      insulin resistance. Recent findings support the idea that bipolar disorder, along with other
      psychiatric diseases schizophrenia, may have roots of metabolic dysfunction: cerebral glucose
      hypometabolism, oxidative stress, as well as mitochondrial and neurotransmitter dysfunction
      which has downstream effects on synapse connections. A KD diet provides alternative fuel to
      the brain aside from glucose and is believed to contain beneficial neuroprotective effects,
      including stabilization of brain networks, reduction of inflammation and oxidative stress.
      The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with a
      KD diet in this psychiatric population.
    

Intervention name(s): LCHF, Ketogenic Diet
Intervention type(s): Other
Intervention description(s): Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diagnostic Performance of a New Bio-marker During Bacterial Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and
      prompt implementation of the etiological treatment. The bacterial infections are the most
      common and are associated with high morbidity and mortality. Diagnosis is based on the
      detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor
      antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often
      based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination
      of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis,
      gram + and gram - are circulating and often present in small amounts; they can be detected by
      sensitive and specific tools following a pretreatment of the blood sample (innovative
      technology Bacti-DIAG).

      The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a
      suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary
      objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams)
      in the patient's care including diagnosis and treatment.

      All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS)
      sepsis suspects will be included: in addition to the samples taken for routine care of the
      patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or
      SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas
      under the ROC curves for the detection of gram + and gram will be calculated and associated
      detection limits will be determined to meet the objectives of the study.

      It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and
      analyze biometric and biological data based on the subsequent evolution of the patients. The
      care of patients will be blinded to the results of the new biomarker Bacti-DIAG
    


Intervention name(s): additional blood tubes
Intervention type(s): Other
Intervention description(s): four whole blood tubes 5 ml (2 + EDTA tubes separating gel and dry tubes 2 + separating gel ) will be taken in order to assay more bacterial biomarkers on day 0 , J1, J2, J3 and J5
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum
Condition: SARS-COV2 Infection; Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      For an antiviral agent to act as an effective biological barrier on nasal mucosal surface,
      the formulation preferably has to be maintained on the site of action for several hours, and
      the nasal spray dispenser can be utilized for administering the solution to the upper
      respiratory tract. A "first-in-man" clinical study of the nasal spray containing
      anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy
      volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on
      the nasopharyngeal surface after administration of nasal spray. In addition, the study
      enabled to determine which of the two concentrations of antibodies should be used in the
      final nasal-spray formulation. The volunteers were followed up for 4h after administration of
      antibody spray and sampling was done at different time-points during this period. The
      concentration of antibodies from patient samples was measured using ELISA analysis. In
      addition, as this was a "first-in-man" study any adverse events following the administration
      of spray were also monitored.
    

Detailed description: 
      To test the nasal biological availability of the BioBlock® immunoglobulin preparation, 16
      healthy volunteers were recruited in the phase 0 clinical trial. The study was conducted in
      the premises of the Ear Clinic of Tartu University Hospital. The study protocol was approved
      by Research Ethics Committee of the University of Tartu on March 17, 2021 (No 336/T-1).
      Written informed consent in accordance with the Declaration of Helsinki was obtained from
      each healthy volunteer. The study group was divided into two subgroups where the individuals
      were intranasally administered into both nostrils of BioBlock® formulation which contained
      either 0.1 mg/mL or 0.2 mg/mL of the colostrum immunoglobulin preparation (n=8 in both study
      groups). A filter paper with a volume capacity of 15 µL was placed on the medial nasal
      surface using surgical forceps and it was kept on nasal mucosa for 10 minutes. Following this
      the BioBlock was administered to the nasal cavity. The nasal mucosal sampling was done at 4
      timepoints. The samples were analyzed using a Cow IgG ELISA kit.
    

Intervention name(s): Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum
Intervention type(s): Other
Intervention description(s): Concentration of active substance on nasal mucosal surface in time
Intervention MeSH terms: Antibodies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC)
      doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.

      Secondary Objective:

      To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of
      SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.
    

Detailed description: 
      Healthy subjects:

      The total duration of study per subject is up to 4.5 weeks with 2 to 21 days screening
      period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.

      T1DM patients:

      The total duration of study per patient is up to 5.5 weeks with 3 to 28 days screening
      period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.

      One or more interim analyses may be performed to support decisions for the next steps of the
      study.
    

Intervention name(s): SAR438544; placebo; r-glucagon
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous
Other intervention name(s): GlucaGen® HypoKit, glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Assess Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban in Healthy Adult Participants
Condition: Healthy Volunteer
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The primary objective of the study is to determine whether aspirin alone or aspirin combined
      with various doses of rivaroxaban causes subclinical GI blood loss as determined by the
      HemoQuant assay.

      The secondary objective of the study is to evaluate the safety and tolerability of aspirin
      alone or in combination with rivaroxaban to healthy volunteers.
    


Intervention name(s): Aspirin; rivaroxaban low dose; rivaroxaban high dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally once per day (QD); Administered orally twice per day (BID); Administered orally QD
Intervention MeSH terms: Aspirin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: No gastrointestinal (GI) disease; No risk factors for bleeding; Direct oral anticoagulant (DOAC); Fecal occult blood testing (FOBT)
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of 2 sequential doses of
      RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.
    

Detailed description: 
      This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center
      study to evaluate the safety and efficacy of repeat application of RT001 in at least 30
      subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2
      treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).
    

Intervention name(s): Vehicle Control; RT001 (Botulinum Toxin Type A Topical Gel)
Intervention type(s): Other; Drug
Intervention description(s): Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2; Two sequential doses of RT001 at Baseline (Day 0) and Week 2
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles; Lateral Canthal Area
Fistiulation Rate Following Primary Cleft Repair≤
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Interventional

Summary: 
      Aim : The aim of present study was to evaluate the buccinator flap utilization in primary
      cleft palatoplasty on fistulation rate.

      Methodology: forty six patients suffering from complete wide cleft palate were randomly
      divided into two equal groups: study group: the cleft palate defect was repaired by
      buccinator myomucosal flap whereas the control group patients' clefts were repaired by
      Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6
      months interval to detect fistulation and measure palatal length by taking impressions and
      pouring casts to measure palatal length.
    

Detailed description: 
      Aim : The aim of present study was to evaluate the buccinator flap utilization in primary
      cleft palatoplasty on fistulation rate. The goal was to predict the risk of velopharyngeal
      insufficiency and to decrease the fistiulation rate.

      Methodology: forty six patients suffering from complete wide cleft palate were randomly
      divided into two equal groups: study group: the cleft palate defect was repaired by
      buccinator myomucosal flap whereas the control group patients' clefts were repaired by
      Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6
      months interval to detect fistulation and measure palatal length by taking impressions and
      pouring casts to measure palatal length from anterior reference point(incisive foramen) to
      posterior reference point(uvula) and calculation of change in palatal length.
    

Intervention name(s): Buccinator myomucosal flap; Bardach two flap palatoplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Buccinator myomucosal flap for primary cleft palate palatoplasty; Bardach two flap palatoplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cleft palate; Primary repair; Buccinator flap; Palatal fistula
Parent-Youth Teamwork in Pediatric Asthma Management
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to examine the effectiveness of a parent-youth teamwork
      treatment and an asthma education treatment in helping children use their asthma medicines
      correctly. We also want to learn about how these treatments affect parental involvement in
      asthma care, parent and youth relationships, and children's health care.
    

Detailed description: 
      Noncompliance with medication is a prevalent problem for pediatric asthma patients,
      particularly for pre-adolescents and adolescents. Families reportedly struggle with the
      transition of expecting adolescents to assume more independence and responsibility in asthma
      management. Parent-child collaborative management of pediatric chronic illness regimens has
      been related to better adherence to medical regimens and improved health outcome. This study
      has four aims. The first aim is to investigate the effectiveness of a low-intensity,
      behavioral intervention aimed at promoting parental involvement in children's asthma
      management, particularly in improving medication adherence. The second aim is to examine how
      the role of parental involvement changes across time and participation in a 5-month study. A
      third aim is to determine whether parent-adolescent conflict is changed by the intervention.
      The fourth aim is to evaluate whether participation in the treatment program is associated
      with improved health status (e.g., improved pulmonary function test results).

      Established asthma patients (ages 9-15) will be randomly assigned to one of three groups:
      Treatment Intervention (TI), Asthma Education (AE), and Standard Care (SC). The TI and AE
      groups will receive four 30-minute treatment sessions every two weeks. The TI intervention
      will consist of strategies aimed at promoting parent-youth management in asthma management.
      The AE group will receive structured reviews of asthma educational materials typically given
      to asthma patients. SC participants will have no contact with researchers beyond that
      necessary to gather data. Data will be collected from all participants every two weeks for
      the first 8-weeks of study involvement and also about 3-months after the final treatment
      session. Outcome data will include objective measures of medication adherence, parental
      involvement in asthma, and health outcome.
    

Intervention name(s): electronic medication monitoring system; parent-adolescent communication and problem-solving skills
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric asthma, medication adherence, adolescents
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare safety and efficacy of a single dose of
      empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients
      receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
    

Detailed description: 
      BCD-017-3 is an double-blind randomized phase III clinical study to compare the incidence of
      CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated
      filgrastim empegfilgrastim (Extimia®) at a dose of 6 or 7.5 mg versus daily administration of
      filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients
      receiving myelosuppressive chemotherapy.

      The study also includes the following determination of pharmacokinetic parameters after
      repeated administration of the study drug.
    

Intervention name(s): Empegfilrastim 6 mg; Filgrastim; Placebo №1; Placebo №2; Empegfilrastim 7.5 mg
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.; Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.; Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.; Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.; Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
Other intervention name(s): Extimia; metpegfilgrastim; pegylated filgrastim; peg-GCSF; GCSF; Extimia; metpegfilgrastim; pegylated filgrastim; peg-GCSF
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: empegfilgrastim; pegylated filgrastim; neutropenia; febrile neutropenia; chemotherapy-associated neutropenia; breast cancer; docetaxel; doxorubicin