bioihbjkbjnl/mcl2 huggingface dataset:
Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy
Condition: Pregnancy Related Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Ear acupuncture can be used as a treatment for pregnancy induced low back pain.
    

Detailed description: 
      Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low
      back pain can be debilitating for pregnant women but there is lack of effective treatment.
      Owing to the unique circulation system between mother and fetus, prenatal care providers and
      gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal
      of this clinical investigation is to determine whether ear acupuncture can be used as
      treatment for this special clinical entity. The participants are randomized into one of the
      three interventions based on a computer generated randomization table. These three
      interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture.
      All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC
      consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest
      and topical warm/cold compress. The participants in group 1 & 2 received a total of three
      continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand
      in preselected ear acupuncture points for one week then after day 7. All participants are
      followed/observed for a total 2 weeks after the initiation of the study.
    

Intervention name(s): acupuncture; Sham acupuncture; standard of care
Intervention type(s): Other; Other; Other
Intervention description(s): ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain; ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain; participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
Other intervention name(s): retained ear acupuncture treatment; retained ear acupuncture treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: auricular acupuncture; pregnancy related low back pain; acupuncture
A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia
Condition: Critical Limb Ischemia; Vascular Diseases; Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to confirm the feasibility of study procedures and the
      tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)
    

Detailed description: 
      The primary objectives of the study are:

        1. To confirm the feasibility of study-related activities and the tolerability of a
           modified dosage regimen of AMG0001 in CLI

        2. To evaluate safety of AMG0001
    

Intervention name(s): HGF Plasmid
Intervention type(s): Biological
Intervention description(s): Intramuscular injection in the affected limb.
Other intervention name(s): AMG0001
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Arterial Disease; Vascular Disease; CLI; Critical Limb Ischemia; PAD; AnGes; HGF Plasmid; HGF; Hepatocyte Growth Factor Plasmid; gene therapy
The Effect of Laughter Therapy on Nursing Students
Condition: Mental Stress; Insomnia; Sleep Disorder; Mental Health Disorder
MeSH terms: Sleep Wake Disorders; Mental Disorders; Stress, Psychological
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of laughter therapy on the general health
      status, sleep quality, and stress level of nursing students.
    

Detailed description: 
      H1.1: Students who receive laughter therapy will have lower mean scores in the general health
      questionnaire than students who do not receive laughter therapy.

      H1.2: Students who receive laughter therapy will have a lower Pittsburgh sleep quality index
      score than students who do not receive laughter therapy.

      H1.3: Students who receive laughter therapy will have a lower mean stress level than students
      who do not receive laughter therapy.
    

Intervention name(s): Laughter Therapy
Intervention type(s): Behavioral
Intervention description(s): The effect of the Laughter Therapy on nursing students
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Sleep Quality; Psychological Stress; General Health; Nursing Students; Laughter Therapy
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the relative bioavailability (rate and extent of absorption) of 180
      mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.
      with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral
      dose (1 x 180 mg tablet) in healthy adult volunteers under fed conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Fexofenadine 180 mg tablets; ALLEGRA® 180 mg tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 180 mg; 1 x 180 mg
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Metadoxine as a Therapy for Severe Alcoholic Hepatitis
Condition: Severe Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether metadoxine is effective for improve
      survival and reduced oxidative stress in patients with severe alcoholic hepatitis.
    


Intervention name(s): Prednisone plus Metadoxine; Pentoxifylline plus Metadoxine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pyridoxine; Prednisone; Pentoxifylline; Metadoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe alcoholic hepatitis; survival; oxidative stress
A Randomized Phase 1 Dose-Escalation Study of Subcutaneously(SC) Administered RUC-4
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess tolerability of the weight-adjusted dose of RUC-4 (mg/kg)
      required to achieve 80% or more inhibition of the initial slope of platelet aggregation to 20
      µM ADP by Light Transmission Aggregometry (LTA) within 15 minutes of SC administration of
      RUC-4 with return toward baseline values within 4 hours in healthy volunteers and subjects on
      aspirin with stable coronary artery disease (CAD). In the Dose Expansion Part, VerifyNow
      PRUTest will be used to measure platelet aggregation in addition to LTA.

      Since the goal of RUC-4 therapy is to achieve maximal antiplatelet therapy as rapidly as
      possible, first the tolerability of the weight-adjusted dose (mg/kg) that inhibits
      ADP-induced platelet aggregation by 80% or more in 5 of 6 healthy volunteers will be
      identified. A similar dose escalation will be subsequently performed in subjects with CAD who
      are taking aspirin. To facilitate administration using a single weight-adjusted (mg/kg) dose
      for a defined group of subjects weighing between 55 and 120 kg, the study will also evaluate
      the safety and biologic effect on platelet aggregation of the weight adjusted (mg/kg) dose
      when administered to subjects with weights at either end of this range.
    

Detailed description: 
      Part 1 Dose Escalation:

      Drug: RUC-4 0.05 mg/kg (Cohort 1) Drug: RUC-4 0.075 mg/kg (Cohort 2) Drug: Placebo (Cohorts
      1-2)

      Part 2 Dose Escalation Drug: RUC-4 (Cohort 1-3 doses to be defined) Placebo (Cohorts 1-3)

      Part 2 Dose Expansion Drug: RUC-4 (dose to be defined, 1 Cohort) Drug: Placebo (1Cohort)
    

Intervention name(s): RUC-4 Compound
Intervention type(s): Drug
Intervention description(s): single subcutaneous administration of RUC-4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 2

Summary: 
      Intra-operative blood loss is an important attribution and predictor of the lumbar spine
      surgery and patient outcome. Stripping the muscle off bone makes more exposed bleeding spine
      surface is one of causes for blood loss during lumbar surgeries. The importance to decrease
      the bleeding is to improve the surgical field visibility which provides technical ease for
      surgeon and decreases the surgical time besides maintaining the hemodynamic stability. In
      past, there were many trials to minimize surgical blood loss by different drugs such as Na
      Nitroprusside, magnesium sulfate, volatile anesthetics and beta-adrenergic antagonist.
    

Detailed description: 
      Sample size:

      Assuming mean and standard deviation of mean arterial pressure in lidocaine group versus
      esmolol group is 90±27.9 versus 73± 22.5 so the sample size will be 70 (35 in each group )
      using Open Epi program with confidence level 95%, power of test 80% All patients will be
      hospitalized and visited a day before the surgery, full history with physical examination and
      routine investigation will be done, the nature and complications of the study will be
      explained in detail to the patient and informed written consent will be obtained from every
      participant.

      All patients will be kept nil orally 6 hours before the operation. All surgeries will be done
      by the same surgeon to decrease observer's bias. The surgeon and the outcome assessor
      (anesthesiologist collect the data) will be blinded to study drugs.

      Using computer generated randomization table, each group consists of 35 patients.
    

Intervention name(s): Lidocaine; Esmolol
Intervention type(s): Drug; Drug
Intervention description(s): IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h; IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min
Other intervention name(s): lignocaine; Brevibloc
Intervention MeSH terms: Lidocaine; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group L (lidocaine group) (n=35): the Patient will receive IV bolus of 1.5mg/kg lidocaine 1% over ten minutes followed by continuous infusion of 1.5mg/kg/h and will be terminated 10 minutes before the end of surgery.
Group E(esmolol group) (n=35): the Patient will receive IV bolus of esmolol 0.5 mg/kg over ten minutes followed by continuous infusion of 100-300 ug/kg/min and will be terminated 10 minutes before the end of surgery.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: esmolol; lidocaine; surgical field
A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the
      action of a drug in the body over a period of time) of multiple intravenous (IV)
      administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic
      lupus erythematosus (SLE). The secondary goal of this study was to assess the
      pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of
      action), immune response, and clinical response.
    

Detailed description: 
      In Part A of this study, patients with CLE were randomly assigned (like flipping a coin) to
      receive multiple IV doses of CNTO 136, a human anti-IL 6 monoclonal antibody (an immune
      protein that binds to interleukin 6) or placebo (a substance that appears identical to the
      treatment and has no active ingredients). Patients and study personnel did not know the
      identity of the administered treatments (double-blind study). Increasing doses were given,
      based on safety data collected during the initial weeks of treatment. In Part B, which was
      also double-blind, patients with SLE were randomly assigned to receive multiple IV doses of
      the highest well-tolerated dose, as determined in Part A, of CNTO 136, or placebo.
    

Intervention name(s): 1 mg/kg CNTO 136; 4 mg/kg CNTO 136; 10 mg/kg CNTO 136; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=1, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.; Type=exact number, unit=mg, number=4, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.; Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.; Form=liquid for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cutaneous lupus erythematosus; Systemic lupus erythematosus; Lupus erythematosus; Human anti-IL 6 monoclonal antibody; Sirukumab
Safety Trial of Atrovent® in Pediatric Patients With Rhinorrhea Associated With a Common Cold or Allergy
Condition: Cold
MeSH terms: Common Cold; Rhinorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5
      years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from
      symptoms of rhinorrhea associated with allergies
    


Intervention name(s): Atrovent®
Intervention type(s): Drug
Intervention MeSH terms: Ipratropium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study will detect the effect of virtual reality in spider cage on gross motor
      performance and balance in children with spastic diplegia.
    

Detailed description: 
      The current study will be directed to investigate effect of virtual reality on gross motor
      and balance as the weakness of the trunk muscles and lower limb muscles along with spasticity
      potentially predispose balance and walking issues of children with bilateral spastic CP .

      The balance deficits in children with CP are multifactorial. According to the system's model
      proposed by Woollacott and Shumway-Cook, multiple systems contribute to postural dysfunction
      in children with CP. Muscle weakness and stiffness of lower limb muscles account for
      biomechanical constraints and postural malalignment during standing and functional balancing.

      Virtual reality is one of the novel technology-based approaches to treat balance and motor
      function in children with CP. It utilizes the interactive simulations created in computer
      hardware and software, in which the children find opportunities to engage in environments
      appearing real to them .

      After reviewing the available previous published studies, it was found that there is no
      previous study directly compared between the effects of virtual reality and physical therapy
      in spider cage on gross motor performance and balance with diplegic children CP children.
      Both therapeutic modalities were found to induce good clinical outcomes when studied
      separately, so this study will be conducted to examine the effectiveness of virtual reality.

      The greater demand for physical therapy for Paediatrics' signifies the need for more
      effective, safer and evident therapeutic modalities. The findings of this study will help
      both; the therapists and the children to save time, effort and reach the best results in
      concise times.
    

Intervention name(s): virtual reality glasses; The traditional exercise program
Intervention type(s): Device; Other
Intervention description(s): A specialized VR glasses will be used and VR games application in spider cage; The selected physical therapy program:
Neurodevelopmental approach: aims to facilitate typical motor development and function and to prevent secondary impairments (figure 4).
Approximation: aims to control spasticity and stimulate the joint mechanoreceptors (figure 5).
Stretching exercise: aims to maintain length and flexibility of shorten muscles (figure 6).
Strengthening exercise: aims to improve the functional ability (figure 7).
Spider suspension exercise for 30 minutes (figure 8).
5. Gait training activities: aims to improve balance (figure 9). 6. Balance training program: aims to improve balance (figure 10).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Physical Telerehabilitation in Veterans With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The primary objective of this study will be to assess the feasibility and patient acceptance
      of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients.

      Our hypothesis is that home telemanagement will be effective and useful in the rehabilitation
      of multiple sclerosis patients. Specifically, the investigators hypothesize that home
      telemanagement using a daily exercise diary, monitoring of compliance with a tailored
      exercise program and regular assessment of strength and motor functions will: 1. Be feasible
      and acceptable in patients with multiple sclerosis 2. Improve patient compliance with home
      exercise program 3. Increase patient mobility and motor functions 4. Be a feasible and
      effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve quality
      of life
    


Intervention name(s): Multiple Sclerosis Home Automated Telemanagement (MS HAT) system
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Multiple Sclerosis; Telerehablitation
Esophageal Motility in Reflux Induced Cough
Condition: Cough
MeSH terms: Cough
Study type: Observational

Summary: 
      To determine whether contraction abnormalities in the esophagus plays a role in
      gastroesophageal reflux induced cough, and thus cough severity in patients with chronic
      cough.
    


Intervention name(s): Citric Acid
Intervention type(s): Other
Intervention description(s): Subjects will undergo cough reflex sensitivity testing to citric acid.
Intervention MeSH terms: Citric Acid; Sodium Citrate
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Chronic cough patients
      
Keywords: Chronic Cough; Gastroesophageal Reflux; Esophageal Motility; Cough Sensitivity
Gaze Contingent Feedback in Social Anxiety Disorder
Condition: Phobia, Social
MeSH terms: Phobia, Social
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether giving gaze-contingent feedback is an
      effective attention modification procedure, helping in the treatment of social anxiety
      disorder (SAD)
    

Detailed description: 
      The study examines giving social anxious participants gaze-contingent feedback as a novel
      attention training procedure. Half of the participants will receive contingent feedback while
      the other half would receive non-contingent "placebo" feedback.
    

Intervention name(s): attention modification; Placebo
Intervention type(s): Behavioral; Other
Intervention description(s): participants will receive gaze-continent feedback according to their viewing patterns; participants will receive non-gaze-continent feedback unrelated to their viewing patterns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
Condition: Candidiasis, Oral; HIV Infections
MeSH terms: Candidiasis; Candidiasis, Oral
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that
      of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive
      patients.
    

Detailed description: 
      This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of
      SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive
      patients.
    

Intervention name(s): Posaconazole; Fluconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluconazole; Posaconazole
Masking: Double
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Fluconazole; Antifungal Agents; Candidiasis; Triazoles
Survival Analysis of Oral Cancer Patients
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients
      following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to
      identify risk factors influencing the overall survival rate and postoperative outcomes.
    


Intervention name(s): tumor resection and mandible reconstruction
Intervention type(s): Procedure
Intervention description(s): The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The files of patients diagnosed and treated between January 1996 to June 2019 for OSCC were
        retrospectively reviewed. The patients who underwent primary ablative tumor resection with
        segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database
      
Keywords: Squamous cell carcinoma; Free fibula flap; Prognosis; Survival; Mandibular reconstruction