bioihbjkbjnl/mcl2 huggingface dataset:
Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
Condition: Pain
Study type: Interventional

Summary: 
      The goal of the clinical study was to see if applying low level laser light therapy to the
      breasts during breast implant surgery could lessen pain experienced by 24 hours after the
      surgery.
    

Detailed description: 
      Substantial pain, discomfort and swelling following breast augmentation surgery is not
      uncommon. The ability of low level laser therapy to reduce swelling and inflammation that
      subsequently reduces pain has been well documented. This study aimed to evaluate the ability
      of low level laser therapy to reduce post-operative pain and swelling for individuals
      undergoing bilateral breast augmentation surgery, by 24 hours post-surgery.
    

Intervention name(s): Erchonia(R) EML Laser; Placebo Laser
Intervention type(s): Device; Device
Intervention description(s): Low level laser red light of 635 nm and delivering 1.5 joules/cm2.; Inactive light
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate standard of care exercise education alone or in
      combination with a wearable physical activity tracker in people with epilepsy (PWE) to
      determine the most effective way to increase physical activity and measure impact on
      depression, anxiety, quality of life, sleep, and seizure frequency.
    


Intervention name(s): Activity Tracker Group; Standard of Care Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to the standard of care exercise education, participants in the activity tracker group will be provided a Fitbit physical activity tracker at no cost to the participants. They will be asked to download the Fitbit application (app) to their personal smartphone device to allow them to see their own data collected by the Fitbit. They will also be asked to download the Stridekick app for the purpose of sharing their activity tracker data electronically with the study team and having the opportunity to participate in fitness challenges through the app. App accounts will be created by the participants with usernames that do not contain the participant's identifiable personal information. Optional fitness challenges will be created once per month by the study investigators, and participants will also receive a weekly message of encouragement from the study team.; Participants will receive standard of care exercise education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: epilepsy; exercise; activity tracker
Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis
Condition: Plaque; Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study
      involving approximately 160 subjects to complete. Subjects were randomly assigned to either
      the test product (Arm & Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity
      Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and
      age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated
      for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product
      use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.
    


Intervention name(s): Arm & Hammer Advance White Brilliant Sparkle (Test product); Crest Cavity Protection Regular Toothpaste (Negative Control)
Intervention type(s): Drug; Drug
Intervention description(s): 20% sodium bicarbonate; Negative control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
In Vivo Tracking of USPIO Labeled MSC in the Heart
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic
      resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium in patients
      with ischemic heart disease.
    

Detailed description: 
      Aims:

      To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic
      resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium.

      To evaluate the safety and efficacy of treatment with iron oxide-labeled mesenchymal stromal
      cells to form new heart muscle cells and blood vessels in the myocardium submitted by
      NOGA-guided injection therapy in the myocardium in order to improve myocardial blood flow and
      reduce patients' symptoms.

      Patient Population:

      Patients with coronary artery disease not treatable with additional bypass surgery or
      percutaneous coronary intervention who have angina pectoris (Canadian Cardiovascular Society
      (CCS) class II-III) or angina equivalent shortness of breath (New York Heart Association
      (NYHA) class II -III).

      Study Design A prospective, non-randomized, pilot study including 5-10 patients. Patients
      will by means of the percutaneous NOGA injection catheter system receive 12-15
      intramyocardial injections. The number depending on the amount of cultured cells and
      distributed uniformly in the peripheral zone of a presumed ischemic area in the left
      ventricle demonstrated by angiography, magnetic resonance imaging and NOGA mapping.
    

Intervention name(s): USPIO labeled MSC injection
Intervention type(s): Combination Product
Intervention description(s): USPIO labeled MSC injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery.
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective double blind study comparing two remifentanil dosing protocols (0.1 and 0.3
      mcg/kg/min) during cardiac surgery. Main outcome measures are postoperative opioid
      requirements (PCA oxycodone) and postoperative pain (VAS, verbal rating scale).
    


Intervention name(s): remifentanil; remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): remifentanil infusion; remifentanil infusion
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain, postoperative, opioid, PCA, cardiac surgery
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
Condition: Contraception; Contraception, Postcoital
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover,
      randomized, prospective design was chosen with a washout of 21 days between the two study
      periods. Treatment groups were balanced with the same number of male healthy volunteers who
      were randomly assigned to the study drug administration sequences.
    


Intervention name(s): Levonorgestrel Emergency Pill (BAY86-5028/Opxion); Levonorgestrel (Postday)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 1.5 mg coated tablet; Single dose of two 0.75 mg tablets
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the LAP-BAND system is safe and effective
      in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2.
    

Detailed description: 
      LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is
      to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30
      kg/m2 and < 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post
      LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5
      year data was evaluated in Post-Hoc outcome measures.
    

Intervention name(s): LAP-BAND System
Intervention type(s): Device
Intervention description(s): Reduction of food intake due to creation of smaller stomach pouch
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Study on Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a multicentre observational study which involves 43 of the major Italian centres that
      treat MS. The duration expected for the study participation of each subject was exclusively
      the necessary one for the screening visit and execution of the ecocolor-Doppler test, which
      could have also been executed on the same day.
    


Intervention name(s): neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler; neurological evaluation, ecocolor-Doppler; medical history, vital signs, ecocolor-Doppler
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): For the subjects diagnosed with MS (group A), who did not need to be in a period of clinical relapse of the disease (at least 30 days from the last clinical relapse), the duration and the form of the disease was indicated (CIS, RR, SP or PP). The Investigator has submitted these subjects to a neurological examination which included the standard neurological examination, the Kurtzke EDSS (Kurtzke Expanded Disability Status Scale) comprising the functional systems of Kurtzke and the Barthel scale. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.; For the subjects affected by OND and ONDi, as in the groups C and D respectively, the Investigator has performed, beside the anamnesis and the physical examination, a specific neurological evaluation which included the compilation of the Barthel scale for the disability evaluation. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for performing the ecocolor-Doppler examination which was performed in blind.; For the healthy subjects (HC) of the group B, the Investigator has solely performed the medical history and a check of the vital signs, reporting the demographic and clinical data of the subjects. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects aged 18-55 years, non-gender based, non-sex based.
Study Evaluating Safety, Tolerability, and PK of Multiple Ascending Doses of GC021109 in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, multi-center, randomized, double-blind, placebo-controlled study designed
      to evaluate the safety, tolerability, and pharmacokinetics of GC021109 in subjects with mild
      to moderate Alzheimer's Disease (as determined by 2011 National Institute on Aging-
      Alzheimer's Association [NIA-AA] criteria and Mini Mental State Examination [MMSE]). The
      Investigator, study site staff, (with exception of a designated pharmacist/pharmacy
      technician) and all study subjects will be blinded to randomized study medication assignment
      until database lock. Treatment assignments may be unblinded for select pre-authorized
      individuals involved in the safety and PK data reviews in order to accurately determine how
      to proceed with dose escalation.
    


Intervention name(s): GC021109; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
Condition: Burns
MeSH terms: Cicatrix, Hypertrophic; Burns
Study type: Interventional

Summary: 
      This is a randomized, controlled, within-patient, single-blinded, pilot study that will
      evaluate the impact of laser treatment on burn HSc relative to self-matched control scars.
      The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain,
      itch and patient satisfaction.
    

Detailed description: 
      Prior to treatment initiation, two independent scars sites will be selected and an
      anatomically- on each individual. At the selected treatment site the scar will be treated
      with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4
      weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd
      treatment and 12 weeks after their final treatment session.
    

Intervention name(s): Laser treatment
Intervention type(s): Procedure
Intervention description(s): CORE fractional CO2 laser treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
Condition: Growth Hormone Deficiency; Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients
      With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the
      investigators wanted to collect data about the long-term efficacy and safety of this kind of
      therapy.
    


Intervention name(s): Somatotropin
Intervention type(s): Drug
Intervention description(s): Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
To Study the Mechanisms of Acupuncture Through Functional Magnetic Resonance Imaging and Peripheral Neurosensory Testing
Condition: Healthy
Study type: Interventional

Summary: 
      Acupuncture may affect nerve functions. This study assesses the effect of acupuncture on both
      the peripheral and the central nerve systems
    


Intervention name(s): Electroacupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Acupuncture; Analgesia; Functional magnetic resonance imaging (fMRI); Neuronal Mechanisms; Quantitative Peripheral Sensory Testings; Normal Volunteers
Ticagrelor Therapy for RefrACTORy Migraine Study
Condition: Migraine; Headache; Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the
      hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg
      by mouth (PO) twice a day) reduces episodic and/or chronic migraine headache symptoms in
      patients with right to left shunt. Headache frequency while on Brilinta/ticagrelor will be
      compared with the documented baseline for each subject. If the Brilinta/ticagrelor therapy
      was effective (> 50% reduction in monthly headache days), the subject could elect to continue
      therapy for an additional two months (56 days), while continuing to complete daily headache
      logs.
    

Detailed description: 
      Migraine headaches are poorly understood, and can be severely debilitating. Many types of
      drugs have been tried in migraine sufferers including anti-depressants, anti-seizure
      medications, blood pressure medicines and others. The investigators have shown that in a
      small number of patients, a certain type of blood thinner (Clopidogrel) can reduce or
      eliminate migraine headaches in patients who also have a hole in the heart wall that allows
      flow from the right side of the heart to the left. Ticagrelor is a blood thinning drug which
      works in the same way as the clopidogrel, but is broken down by the body differently and thus
      allows everyone to use it. The investigators wish to test this medication to see if it works
      as well, or better than the clopidogrel.
    

Intervention name(s): Ticagrelor 90 mg twice per day
Intervention type(s): Drug
Intervention description(s): Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches.
Other intervention name(s): Brilinta
Intervention MeSH terms: Ticagrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: headache; chronic; migraine; right to left shunt
A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide
Condition: Overweight; Obesity; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn more about how tirzepatide affects stomach emptying in
      overweight/very overweight participants. Participants include those without diabetes and
      those with type 2 diabetes.

      The study will last about 13 weeks for each participant, including screening.
    


Intervention name(s): Tirzepatide; Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): Tirzepatide administered SC.; Acetaminophen administered orally.
Other intervention name(s): LY3298176
Intervention MeSH terms: Acetaminophen; Tirzepatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
Condition: Primary Immunodeficiency Diseases
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the efficacy of NewGam in preventing serious
      bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of
      NewGam and its effect on quality of life were also evaluated.
    

Detailed description: 
      NewGam is a new 10% human normal immunoglobulin (IVIG) solution developed by Octapharma for
      intravenous administration. It is supplied as a liquid formulation ready to use. The primary
      therapeutic use of immunoglobulins is to provide antibodies to prevent viral and bacterial
      diseases (replacement therapy). IVIG has proved to be useful in a variety of clinical
      conditions other than for replacement of immunoglobulins; IVIG exhibits an immunomodulatory
      effect. Children and adults with a Primary Immunodeficiency Disease (PID) have an increased
      risk of recurrent bacterial and viral infections that typically attack the respiratory tract
      (sinusitis, bronchitis, pneumonia) but can also affect the gastrointestinal tract
      (gastroenteritis). Theses diseases can be severe and can lead to substantial morbidity.
      Responses to antibacterial therapy are often poor. At present, most primary immune
      deficiencies are not curable, but IVIGs have been shown to decrease the total number of
      severe infections and the duration of hospitalization.
    

Intervention name(s): NewGam
Intervention type(s): Biological
Intervention description(s): The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as minimum trough levels of serum immunoglobulin G (IgG) was above 5 g/L. If serum IgG trough levels dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion.
Other intervention name(s): Human normal immunoglobulin
Intervention MeSH terms: Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PID
Ultrasound-Guided Intermediate Cervical Plexus or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery
Condition: Analgesia
Study type: Interventional

Summary: 
      • Neck pain and stiffness or sore throat, are common after anterior cervical spine surgery.
      Complications are rare but can be serious and even potentially life-threatening if they do
      occur. Rapid recovery and emergence from general anesthesia are important in cases of
      anterior cervical spine surgery.
    

Detailed description: 
      -  Null hypothesis (H0): No difference between the regional analgesia effects of bilateral
           ultrasound-guided superficial cervical plexus block and bilateral cervical erector
           spinae block in patients undergoing anterior cervical spine surgery under general
           anesthesia.

        -  Alternative hypothesis (H1): There are differences between the regional analgesia
           effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral
           cervical erector spinae block in
    

Intervention name(s): intermediate cervical plexus block; Cervical Erector spinae block
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will receive bilateral ultrasound guided intermediate cervical plexus block using 15 ml of bupivacaine 0.25% for each side.; patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Impacts of Static Magnetic Fields on Dysmenorrhea Pain
Condition: Period Pain
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Study to determine the effectiveness of a certain type of magnet to reduce period pain
    

Detailed description: 
      Young women with their period pain levels of 6 or greater on a pain scale of 0-10 will wear a
      concentric magnet or a sham that is positioned close to the maximum pain site. The pain score
      after wearing either the magnet or sham will be recorded.
    

Intervention name(s): Magnet
Intervention type(s): Device
Intervention description(s): Magnet or Sham is worn by subject in close proximity to their described maximum pain site
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment