bioihbjkbjnl/mcl2 huggingface dataset:
Cost Effectiveness of OMT for Chronic Low Back Pain
Condition: Lumbar Radiculopathy; Lesion of Sciatic Nerve, Left Lower Limb; Lesion of Sciatic Nerve, Right Lower Limb; Lumbar Spinal Stenosis; Lumbar Spondylosis; Lumbago With Sciatica, Left Side; Lumbago With Sciatica, Right Side
MeSH terms: Spinal Stenosis; Spondylosis; Radiculopathy; Sciatica; Sciatic Neuropathy; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The specific aim of this study is to conduct a prospective, multicenter cohort study over
      four months to compare the cost of standard of allopathic care (control group, N=90) versus
      standard of care plus osteopathic manipulative treatment (experimental group, N=90) in a
      cohort of 180 consecutive patients seeking treatment for chronic low back pain at three
      osteopathic clinics and three allopathic medical clinics (offering only standard care)
      located in three different regions of the United States.
    


Intervention name(s): Osteopathic Manipulative Treatment (OMT)
Intervention type(s): Procedure
Intervention description(s): No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This prospective, multicenter, observational study will follow two groups of patients over
        four months. The first (experimental) group will be 90 new patients seeking treatment for
        chronic back pain at three osteopathic clinics. The experimental group will receive
        standard of care plus osteopathic manipulative treatment (OMT) for low back pain.

        The second (control) group will be 90 new patients who will receive only standard care
        without OMT for chronic low back pain as delivered at a local pain clinic.
      
Keywords: Chronic Low Back Pain; Osteopathic Manipulative Medicine
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomized, single dose, crossover study to evaluate the
      pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
    

Detailed description: 
      To healthy 32 subjects, following treatments are administered dosing in each period and
      wash-out period is a minimum of 7 days.

      Reference drug: D745, D759 / Test drug: CKD-371

      Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics
      and safety are assessed.
    

Intervention name(s): CKD-371
Intervention type(s): Drug
Intervention description(s): PO
Other intervention name(s): D745, D759
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 2

Summary: 
      The specific aim of the study is to compare the safety and efficacy of a single
      administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar
      fasciitis.
    


Intervention name(s): Botulinum Toxins, Type A; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection
Other intervention name(s): DaxibotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heel pain
Potential Effect for the Smoking on Periodontitis From the Perspective of Arginine Metabolites
Condition: Periodontitis; Smoking; Inflammatory Response
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Arginine metabolites are amino acids that are associated with vascular tone regulation and
      the level of inflammation, with critical roles in the synthesis of NO. Our aim was to
      determine the ADMA, SDMA, L-NMMA, L-arginine, L-homoarginine and IL-6 levels in saliva and
      serum samples from periodontitis patients and periodontally healthy individuals and to assess
      the levels of these compounds according to smoking status and compare these levels to those
      of healthy individuals.
    

Detailed description: 
      The study consisted of four groups: healthy individuals (control (C); n=20), smokers with
      healthy periodontium (S-C; n=20), nonsmokers with Stage III Grade B generalized periodontitis
      (P; n=20) and smokers with Stage III Grade C generalized periodontitis (S-P; n=18). Clinical
      periodontal parameters were measured. The determination of methylated arginine metabolites
      was carried out by LC-MS/MS.
    

Intervention name(s): Saliva and serum sampling
Intervention type(s): Other
Intervention description(s): Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Saliva and serum of periodontitis and smoking patients collected for analyzing arginine metabolites.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Periodontitis, Arginine metabolites, Smoking
Viral Shedding, Symptoms and Exposure of SARS-CoV-2 in Non-hospitalized Children With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Data on COVID-19 in children are still scarce, and their role in SARS-CoV-2 transmission is
      poorly described. Furthermore, documentation of the best SARS-CoV-2 sampling methods in
      children are limited. In adults, saliva seems like a promising specimen to collect by
      noninvasive procedure to diagnose and monitor viral load of SARS-CoV-2, but this has not been
      tested in children yet.

      We want to test the following hypothesis:

        1. Shedding load and duration of SARS-CoV-2 in children are related to age, gender,
           clinical symptoms and exposure

        2. Salvia samples have equal or higher sensibility than nasal swaps in children for
           detection of SARS-CoV-2

        3. Parental home testing of saliva and feces is feasible in children

      The study is a prospective cohort study of SARS-CoV-2 PCR-positive children from two test
      centers in the Capital Region of Denmark. Children aged 0-17 years with a PCR-positive
      SARS-CoV-2 test from a nasal or pharyngeal swab is included from May 2020 to January 2021 and
      followed-up for a period of 28 days with weekly sample collection and questionnaires.

      Samples include a saliva sample, a nasal swap and a rectal swap for children under four years
      of age. A semiquantitative RT-PCR method, will identify positive and negative samples and
      provide a Ct value estimating viral load. Saliva and fecal samples will be analyzed from
      November 2020-February 2021.

      Shedding duration will be related to medial history, clinical presentation, exposure, gender
      and age.
    


Intervention name(s): PCR
Intervention type(s): Diagnostic Test
Intervention description(s): RT-PCR for SARS-CoV-2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        SARS-CoV-2 PCR-positive children from two test centers in the Capital Region of Denmark
      
Biospecimen description: 
      feces, saliva, nasal secretions
Limits of the Social Benefit Motive Among High-risk Patients: a Field Experiment on Influenza Vaccination Behaviour
Condition: Influenza Vaccine; Behavioral Intervention; Self-benefit; Social-benefit
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Influenza vaccine uptake remains low worldwide, inflicting substantial costs to public health
      and health systems. Messages promoting social welfare have been shown to increase vaccination
      intentions, and it has been recommended that health professionals communicate the socially
      beneficial aspects of vaccination. This study aims to provide the first test whether this
      prosocial vaccination hypothesis applies to the actual vaccination behaviour of high-risk
      patients by comparing the effects of two motivational messages for promoting vaccination at a
      tertiary care public hospital in Istanbul, Turkey.
    


Intervention name(s): Self-benefit message; Other-benefit message
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A pamphlet consisting of a short text and an abstract figure. The top half of the pamphlet described the official criteria for qualifying to be in the risk group. Bottom half indicated that one can gain immunity against influenza by getting the vaccine and included a figure of one smiley face.; A pamphlet consisting of a short text and an abstract figure. The top half of the pamphlet described the official criteria for qualifying to be in the risk group. Bottom half indicated that one can gain immunity against influenza by getting the vaccine, and gaining immunity would lower the chances of transmitting the disease to others. The figure included one smiley face surrounded by three other smiley faces.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
A First-in-human Single Ascending Dose/Multiple Ascending Dose Study of ENN0403 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a FIH, randomized, double- blind, placebo-controlled, dose -escalation study to
      investigate the safety, tolerability, PK, and PD of ENN0403 after single and multiple oral
      dose administration in healthy adult subjects. The study will include 2 parts which will
      proceed in a parallel staggered manner: Part A, a single ascending dose (SAD) study and Part
      B, a multiple ascending dose (MAD) study.

      Approximately 80 healthy adult subjects will be enrolled at a single site in Australia, in up
      to 6 cohorts in Part A (SAD study), including a Food Effect (FE) study, and up to 4 cohorts
      in Part B (MAD study). Part A is for the single dose use of IP, while Part B is once daily
      use for 14 consecutive days. Each cohort will include 8 subjects (6 receiving ENN0403 and 2
      receiving placebo). Each subject will be enrolled in only 1 cohort and receive only one dose
      regimen in this study.

      Dosing will be escalated in a sequential fashion, contingent on a review of safety,
      tolerability, and available PK data of the previous dose level by a Safety Review Committee
      (SRC). The proposed dose levels/ dosing frequency of ENN0403 may be adjusted over the course
      of the whole study and cohorts may be added or removed depending on the emerging safety,
      tolerability, and available PK data.
    


Intervention name(s): ENN0403 1mg; ENN0403 4mg; ENN0403 10mg; ENN0403 20mg; ENN0403 30mg; ENN0403 20mg (Fed); ENN0403 6mg QD X 14 Days; ENN0403 12mg QD X 14 Days; ENN0403 20mg QD X 14 Days; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ENN0403 capsules for oral use; ENN0403 capsules for oral use; ENN0403 capsules for oral use; ENN0403 capsules for oral use; ENN0403 capsules for oral use; ENN0403 capsules for oral use; ENN0403 capsules for oral use; ENN0403 capsules for oral use; ENN0403 capsules for oral use; Placebo capsules for oral use
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Autologous Cytokine Induced Killer Cells (CIK) for Patients With Severe Psoriasis
Condition: Psoriasis; Adoptive Immunotherapy
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      to determine the therapeutic roles of CIK cells on patients with psoriasis
    


Intervention name(s): Adoptive Immunotherapy; CIK
Intervention type(s): Drug; Biological
Intervention description(s): Biological: in vitro expanded Cytokine Induced Killer (CIK) cells Procedure: Infusion of autologous CIK cells
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Condition: Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult
      subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day
      in combination with ceftriaxone sodium.
    


Intervention name(s): Metronidazole; Ceftriaxone sodium
Intervention type(s): Drug; Drug
Intervention description(s): Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition.; Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.
Other intervention name(s): ROCEPHIN
Intervention MeSH terms: Metronidazole; Ceftriaxone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metronidazole; intra-abdominal infection; pelvic inflammatory disease; anaerobe
Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink
Condition: Cognitive Change
Study type: Interventional

Summary: 
      To assess the efficacy of MelaGene+ on cognitive performance
    


Intervention name(s): placebo; MelaGene+
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume one bottle (30 mL) per day; consume one bottle (30 mL) per day
Other intervention name(s): Melaleuca-MelaGene+
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Stress & Premenstrual Symptoms Study
Condition: PMDD; Stress; Mood
Study type: Interventional
Phase: Phase 4

Summary: 
      This study that aims to evaluate the psychophysiology of premenstrual mood disorders (PMDs)
      at baseline and after treatment with sertraline. Participants will include women with PMDs
      and healthy female controls. Participation involves a baseline visit to determine eligibility
      and three study visits that include questionnaires and stress reactivity assessment via an
      acoustic startle paradigm. Female participants with PMDs will receive sertraline during the
      premenstrual phase.
    

Detailed description: 
      Among women with premenstrual mood dysphoric disorder (PMDD), baseline arousal is heightened
      during the luteal phase of the menstrual cycle compared to the follicular phase, as measured
      by acoustic startle response (ASR). Healthy female controls do not show cyclic changes in
      this measure of physiologic arousal. It has been suggested that such heightened physiologic
      arousal during the luteal phase may be due to differences in neurosteroid modulation of
      Gamma-aminobutyric acid (GABA)-A receptor function. Research indicates that women with
      premenstrual mood disorders (PMDs) may have sub-optimal sensitivity to the progesterone
      metabolite allopregnanolone (ALLO), a GABA-A receptor modulator. In animal models,
      intracerebroventricular injection of corticotrophin releasing factor (CRF) increases
      amplitude of the acoustic startle response, while ALLO administration attenuates this
      CRF-enhanced startle. The primary aim of this study is to examine differences in ASR by
      menstrual cycle phase (follicular, luteal) and group (control, PMDD). Secondary aim is to
      examine the impact of luteal phase treatment with a selective serotonin reuptake inhibitor
      (SSRI) on psychophysiology in women with PMDs. An exploratory aim is to examine immune
      function among these women.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine luteinizing hormone (LH) Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zoloft; premenstrual syndrome (PMS); Menses
Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders
Condition: Schizophrenia; Major Depressive Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major; Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      The investigators investigated the effects of high frequency (10Hz) repetitive transcranial
      magnetic stimulation (rTMS) on the symptoms and cognitive functioning in patients with
      psychiatric disorders
    

Detailed description: 
      OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency rTMS over left
      dorsolateral prefrontal cortex in the treatment of symptoms and cognitive functioning in 200
      chronic patients with schizophrenia and 200 patients with major depressive disorders

      METHODS:

        1. Clinical Trial：The study consists of 4 weeks of treatment.

        2. Assess Procedures:

      2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by
      three clinical trained staff, who were blind to treatment protocols, using the Positive and
      Negative Syndrome Scale (PANSS) or DSM-IV for depression, and repeatable battery for the
      assessment of neuropsychological status(RBANS).Patients are interviewed at screening, at at
      baseline, 4 weeks, 16 weeks.

      2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at
      baseline, 4 weeks, and 16 weeks.

      2.3 Weight gain measurement: weight gain every week
    

Intervention name(s): rTMS in schizophrenia Controls; rTMS in schizophrenia patients; rTMS in major depressive disorders controls; rTMS in major depressive disorders patients
Intervention type(s): Device; Device; Device; Device
Intervention description(s): all procedures were identical to "rTMS in schizophrenia patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.; 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks; all procedures were identical to "rTMS in major depressive disorders patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.; 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; smoking; rTMS; major depressive disorder
Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy
Condition: Hemodynamic; Sedation; Satisfaction, Personal
Study type: Interventional
Phase: Phase 4

Summary: 
      Operative shoulder arthroscopy under regional block anesthesia often presents with
      hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure
      is required to minimize the bleeding. Regional anesthesia is successfully performed to many
      patients in whom tracheal intubation or the placement of a laryngeal tube is undesired.
      Propofol has traditionally been used to provide sedation in patients undergoing shoulder
      arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly
      selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and
      anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on
      blood pressure, the investigators set out to compare intraoperative hemodynamics of both
      drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients
      undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators
      also assessed whether the type of anesthetic agent used for sedation accounted for other
      differences in intra and post-operative outcome measures.
    


Intervention name(s): Shoulder Arthroscopy; Regional Block; Propofol; Dexmedetomidine; BIS
Intervention type(s): Procedure; Procedure; Drug; Drug; Diagnostic Test
Intervention description(s): patients in both groups are programmed for an elective shoulder arthroscopy surgery; patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.; propofol 10mg/ml was used for sedation as described in the arms section; Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section; sedation level was monitored using bispectral index to achieve values described in the arms group
Other intervention name(s): Surgery; Interscalene brachial plexus block; Propofol-Lipuro; Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj; Bispectral index
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised controlled double blind trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Propofol; Dexmedetomidine; Regional anesthesia; Satisfaction; Shoulder arthroscopy