bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Fentanyl in Treatment of Labour Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Physiological changes during pregnancy are known to affect the pharmacokinetics of many
      drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in
      pregnant patients has not been established. The investigators studied pharmacokinetics of
      intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal
      safety after administration.
    


Intervention name(s): intranasal fentanyl 50 microg dose up to 250 microg
Intervention type(s): Drug
Intervention description(s): When contraction pain was ≥ 5/10 (numerical rating scale 0= no pain, 10= worst pain), the parturient was given a intranasal fentanyl 50 µg dose. After 15 minutes, if contraction pain was still ≥ 5/10, a second 50 µg intranasal dose was administered. Fentanyl was administered every 15 minute until contraction pain decreased to less than 5/10 or until the maximum fentanyl dose of 250 µg was administered.
Intervention MeSH terms: Fentanyl
Intervention model: Single Group Assignment
Intervention model description: Intranasal fentanyl
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Labor pain; Fentanyl; Transmucosal
Healthcare Costs and Resource Utilization in Aimovig Migraine Patients: a Retrospective Study Using United States Claims Data
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      The proposed study is a retrospective, non-interventional analysis that uses medical and
      pharmacy claims data in the US from Komodo Health
    

Detailed description: 
      The proposed study is a retrospective, non-interventional analysis that uses medical and
      pharmacy claims data in the US from Komodo Health.

      Study data included adjudicated and paid medical and pharmacy claims in the US between
      November 1, 2017 and September 1, 2019 provided by Komodo Health.
    

Intervention name(s): Aimovig
Intervention type(s): Other
Intervention description(s): patients newly initiating Aimovig therapy
Other intervention name(s): Erenumab
Intervention MeSH terms: Erenumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study included the Aimovig migraine patients
      
Keywords: Migraine,; Erenumab,; Aimovig
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The CELC200A2401 study has been designed in order to evaluate the hypothesis that
      administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy
      is initiated results in a decrease in the risk of the development of motor complications for
      patients with Parkinson's disease.
    


Intervention name(s): Carbidopa/levodopa/entacapone; Immediate release carbidopa/levodopa
Intervention type(s): Drug; Drug
Intervention description(s): Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.; Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
Other intervention name(s): Stalevo; Sinemet
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Entacapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Parkinson's disease, levodopa therapy, dyskinesia
Gastrointestinal Activation Post-elective CS (Cesarean Section) :A Comparison of Paula Method to Standard Care
Condition: Bowel Dysfunction
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      Women generally report discomfort and a delay in GI motility after CS. The Paula method,
      circular exercises of ring muscles has been shown to increase GI motility. This method had
      not been studied in women post CS. The current study is comparing the resumption of bowel
      sounds after CS in women utilizing the Paula exercises to standard care (no exercises).
    


Intervention name(s): Paula exercises
Intervention type(s): Other
Intervention description(s): structured exercises aimed to stimulate ring muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
WHIRLPOOL FOR OSTEOARHRITIS
Condition: Neuropathic Pain; Osteo Arthritis Knee; Sleep Disorder
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Neuralgia; Sleep Wake Disorders
Study type: Interventional

Summary: 
      Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims:
      The aim of this study was to determine the efficacy of warm whirlpool on pain, disability,
      quality of life (QoL) and sleep for patients with neuropathic pain.
    

Detailed description: 
      Whirlpool treatment method is used for medical and surgical conditions. In literature there
      are studies which recommend whirlpool therapy as a treatment for reducing pain in patients
      with osteoarthritis. The aim of this study was to determine the efficacy of warm whirlpool on
      pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.
    

Intervention name(s): Whirlpool
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuropathic Pain; Whirlpool; Osteoarthritis; Sleep
Bioavailability of Encapsulated Omega-3 Fatty Acids
Condition: Bioavailability of Omega-3s in Military Rations
Study type: Interventional

Summary: 
      Omega-3 fatty acids (n-3s), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid
      (DHA), have anti-inflammatory properties and other documented beneficial health effects that
      could warrant n-3 fortification of combat rations. However, military combat rations must meet
      rigorous shelf-stability guidelines (e.g.,, 3 years at 80°F or 6 months at 100°F), which is
      problematic for natural food sources of n-3s (e.g., oil and fish), which degrade when exposed
      to high temperatures and prolonged shelf-storage. Encapsulation, e.g., coating freeze dried
      n-3s with gelatin, can prevent this degradation, and Natick Soldier Research, Development and
      Engineering Center's (NSRDEC) Combat Feeding Directorate used encapsulated n-3 technology to
      produce n-3 enriched ration items that withstand environmental stressors and meet shelf-life
      specifications for military rations. However, the bioavailability of the encapsulated n-3s in
      these rations is unknown, particularly when they are incorporated into high-protein food
      items and exposed to high temperatures and prolonged storage. In this randomized, cross-over
      study, civilian and/or military personnel will be asked to consume: 1) a high protein food
      item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 2)
      a low-protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6
      months at 100°F; 3) a high protein food item with encapsulated n-3s (600 mg) that was not
      subjected to high-temperature and prolonged storage; and, 4) a low-protein food item with
      encapsulated n-3s (600 mg) that was not subjected to high temperature and prolonged storage.
      Serial blood sampling to measure acute changes in the circulating fatty acid profile will
      occur in the hour before and 6 hours after consumption of each ration component. The only
      known risks, which this study presents to participants, are those associated with venous
      catheter placement. The results will help military ration developers determine the ration
      components best suited for n-3 fortification.
    


Intervention name(s): encapsulated 600 mg EPA/DHA
Intervention type(s): Dietary Supplement
Intervention description(s): encapsulated 600 mg EPA/DHA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to understand the impact of the automated priming boluses on the
      safety and feasibility of a new fully automated AP controller.
    

Detailed description: 
      Study participants will be admitted to the hotel for a 4-night study, receiving the two
      sessions in random order: 1) Fully control loop (FCL) with the bolus priming system (BPS)
      activated, 2) FCL without the BPS, with a 24-hour washout period in between. During the
      admission, participants will receive structured meals and have blood glucose control followed
      to compare time in range 70-180 mg/dL between Controller sessions. After the first 24 hour
      period on the first FCL approach (BPS vs. no BPS,) that the participant has been randomized
      to, there will be a 24 hour challenge period before shifting to the other randomized
      approach; during this session participants will undergo further testing of the control
      algorithm, including meal challenges and a high-intensity interval training bout.
    

Intervention name(s): FCL+BPS; FCL
Intervention type(s): Device; Device
Intervention description(s): The automated insulin delivery system includes the Bolus Priming System, a software automatically analyzing past continuous glucose monitoring values to trigger priming insulin bolus delivery isn the suspected presence of meal like glycemic disturbances; The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses.
Other intervention name(s): Full closed-loop (FCL) with Bolus Priming System; Full closed-loop (FCL) without Bolus Priming System
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to the order that they experience the use of the Bolus Priming System (BPS) in fully automated closed loop (FCL) (for 24 hours each, with a 24-hour challenge period in between): 1) with the BPS active, 2) BPS inactive.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Continuous Glucose Monitor (CGM); Continuous subcutaneous insulin infusion (CSII); Closed Loop Control (CLC); Hybrid Closed Loop (HCL); High-intensity interval training (HIIT); Bolus Priming System (BPS); Fully Automated Closed Loop (FCL); Artificial Pancreas (AP)
Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis
Condition: Gingiva; Infection; Plaque, Dental
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      The clinical cross over study involves the use of two herbal based dentifirices moringa and
      miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are
      provided with details regarding the research format and consent taken.
    

Detailed description: 
      The clinical cross over study involves use of miswak and moringa dentifrices. The patients
      selected are 30 in no and are selected based on having gingival inflammation due to plaque
      accumulation. All other cases related to gingival inflammation along with patients with
      underlying systemic disease are excluded from the study.

      At baseline, plaque and gingival scores are recorded, followed by giving one of the
      dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked
      to report after 72 hrs, following which another recording of plaque and gingival scores are
      recorded.

      The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash
      out period and recalled after this 2 week interval.

      The patients are then given the second dentifrice and asked to brush for 72 hrs and then
      asked to report again for a plaque and gingival score evaluation.
    

Intervention name(s): dentifrice
Intervention type(s): Other
Intervention description(s): use of dentifrices for brushing
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: sample size of 30- First group of 15 subjects recording of plaque and gingival scores were recorded. Patients were given first dentifrice and asked to brush for 72 hours and then asked to report. A washout period of 2 weeks followed. The next round, the subjects were given the second dentifrice and asked to brush for 72 hrs and then after a period of 3days asked to report
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: miswak; moringa; plaque; gingival bleeding
Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This proposed pilot study will examine the tolerability, feasibility, acceptability, and
      preliminary effects of a gentle yoga intervention "Kids 2 Be & Breathe" (K2B2; a manualized
      30 minute gentle yoga and mindfulness session held one-on-one) in urban children aged 7-11
      with severe asthma.
    

Detailed description: 
      Pre-Intervention Assessment: permission/assent from the child and consent of the
      parent/guardian will be obtained and initial data and measurements will be collected to
      ensure continued eligibility; baseline measures will be assessed.

      Intervention: participants will engage in a one-time manualized, age appropriate, 1:1,
      30-minute intervention involving gentle yoga and mindfulness techniques in a private room in
      the Pediatric Research Unit at the Children's Hospital of Richmond. The intervention will be
      taught by certified and experienced child yoga instructors who have been trained in the study
      protocol by the applicant. These yoga instructors collaborated with the interdisciplinary
      research team in the development of manualized age-appropriate yoga sequences.
      Parents/guardians will be invited to observe the yoga session. Intervention fidelity will be
      maintained through the use of a manualized intervention and the PI observing all sessions for
      manual consistency. The intervention will cease if the participant suffers from any asthma
      symptoms during the intervention, such as wheezing, coughing, retractions, accessory muscle
      use, chest tightness or shortness of breath, or experiences any other adverse events which
      precludes the his or her ability to actively participate in the intervention.

      Post-Intervention Assessment: upon completion of the intervention, brief semi-structured
      interviews will be conducted with the child and parent/guardian separately in order to
      explore the acceptability of the intervention and the PI will again assess the child for any
      asthma symptoms or adverse events. Post-intervention pulmonary function test and vital sign
      measurements will then be collected.
    

Intervention name(s): Yoga and Mindfulness Skills
Intervention type(s): Behavioral
Intervention description(s): Single brief session in which children are taught yoga and skills in mindfulness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study is designed to compare the short-term effects of two different thoracic spine
      thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in
      people with neck pain.

      The null hypothesis is that there will be no differences between the two manipulation
      techniques for short-term effects on neck range-of-motion, pain, and self-reported disability
      in people with neck pain.
    

Detailed description: 
      Patients will be involved in the study over a 4 week period. Each participant will be asked
      to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline
      assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up
      assessment.

      Patients who meet the inclusion/exclusion criteria will be randomized to either a supine or
      prone thoracic spine thrust manipulation intervention.
    

Intervention name(s): Supine Thoracic Spine Manipulation; Prone Thoracic Spine Manipulation
Intervention type(s): Other; Other
Intervention description(s): Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.; Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neck pain; Thoracic spine manipulation; Range of Motion; Disability
Use of Thalidomide in Patients With Arachnoiditis
Condition: Arachnoiditis
MeSH terms: Arachnoiditis
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot study will evaluate whether thalidomide decreases pain in patients with
      arachnoiditis.
    

Detailed description: 
      Arachnoiditis, a neuropathic disease caused by inflamation of the arachnoid membrane that
      surrounds and protects the spinal nerves,can result in a debilitating state that is
      characterized by numbing and tingling, stinging and burning in the lower back or legs, and
      possible muscle cramps, twitching and spasms. Current treatments are not always effective in
      treating the pain associated with arachnoiditis. Recent research has indicated that a group
      of chemicals called cytokines that are produced by various cells in the body may be
      responsible for generating the pain response. Medications that effect the release of
      cytokines or block the action of cytokines may reduce the pain response. Various
      anti-cytokine medications are now being used to treat painful disease states such as
      rheumotoid arthritis and Crohn's Disease. In this study the anti-cytokine medication,
      Thalidomide, is being evaluated for it's effect in treating pain associated with
      arachnoiditis.
    

Intervention name(s): thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cytokine; arachnoiditis; neuropathic pain; tumor necrosis factor
Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, single-period, parallel group designed study to determine
      the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of CTP-543
      and its major metabolites following administration of a single 12 mg oral dose of CTP-543.
    


Intervention name(s): CTP-543
Intervention type(s): Drug
Intervention description(s): Single 12 mg oral dose administered on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CTP-543
Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
Condition: Knee Injuries
MeSH terms: Knee Injuries; Fractures, Stress
Study type: Interventional

Summary: 
      This study will investigate whether the treatment of damaged cartilage in the knee with
      BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with
      microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related
      pain and improving cartilage-related function in the knee will be assessed.
    

Detailed description: 
      Cartilage repair currently remains a problematic orthopedic concern with no effective
      solution. The development of new surgical techniques or therapies is critical in meeting this
      medical need.

      This Canadian trial will be a pivotal protocol study, conducted as a randomized, controlled
      trial. A total of 80 subjects, 40 subjects in each of the two groups (BST-CarGel applied to a
      microfractured lesion or microfracture alone), will be enrolled in this study. The subjects
      and investigative medical staff will not be blinded to treatment due to the difference in
      surgical incision size. However, although the treatment will not be blinded, the primary
      effectiveness assessment will be blinded. The primary endpoint of this study will be
      cartilage repair at 12 months proved by demonstrating that BST-CarGel treatment effectively
      fills cartilage lesions with high quality cartilaginous tissue. The secondary endpoints will
      be pain, stiffness and function while other tertiary endpoints will include safety,
      quality-of-life (QOL), as well as macroscopic characterizations of tissue repair. The primary
      measure of this study will occur at 12 months, when imaging of repair tissue using magnetic
      resonance (MR) and associated analyses will compare tissue volume, quality and other
      anatomical variables. Radiographic evaluations will be blinded. Volunteer biopsies at 13
      months may be obtained. Pain, stiffness, function and QOL will be assessed prior to
      treatment, and at 3, 6 and 12 months following treatment using self-administered validated
      scores (WOMAC and SF-36). In addition, subject safety will be assessed through a record of
      adverse events.
    

Intervention name(s): BST-CarGel with Microfracture; Microfracture without BST-CarGel
Intervention type(s): Device; Procedure
Intervention description(s): Microfracture performed with BST-CarGel added to the treated defect; Microfracture performed without BST-CarGel added to the treated defect.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cartilage repair; Cartilage; Knee; Knee Pain; Microfracture; arthroscopy; bone marrow stimulation; Chondrogenesis; Scaffold; Chitosan; A02.165.165; A10.165.382.332; G07.574.500.325.377.625.180; A10.165.382.400; Articular Cartilage Repair