bioihbjkbjnl/mcl2 huggingface dataset:
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to develop innovative immunological read-outs and new technologies in order
      to further characterise the early immune response and its kinetics as well as the adaptive
      immune responses to adjuvanted vaccines.

      This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults
      vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals'
      Adjuvant System.
    

Detailed description: 
      This study will be conducted in 2 steps with 2 study groups in each step. The entire study
      period for Step 1 is from Day -30 to Day 210 (240 days) The entire study period for Step 2 is
      from Day 0 to Day 180 for Group C and from Day 0 to Day 330 for Group D.

      Subjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day
      60 visit. Step 2 will be conducted in an open-label manner.
    

Intervention name(s): Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.; EngerixTM-B; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Other intervention name(s): HBsAg/AS; Engerix-B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Adults; Reactogenicity; Naive; Immune responses; Read-outs; Hepatitis B; Healthy
All on Six Versus Parallel Implant Distribution for Maxillary Denture Opposing Mandibular All on Four
Condition: Peri-Implantitis; Occlusal Trauma; Implant Complication
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      Thirty maxillary edentulous patients with previous mandibular All-on-4 screw retained
      prosthesis and their age ranged from 55 to 65 years were selected from the outpatient clinic,
      of prosthodontics Department, Faculty of Dentistry, Mansoura University from March 2022 to
      July2022 and 80% power was used to calculate patients sample according to the results of a
      previous study 1 which showed no significant difference was reported when comparing occlusal
      stability ,implant stability and periimplant soft tissue changes between different implants
      angulation of both groups. (Effect size=.70mm and α=.05). The power analysis was performed
      using the G*Power program (version 3.1.5, Kiel, Germany)
    

Detailed description: 
      the aim of this study is to compare between All-on-Six distributed dental implants "Anterior
      4 Implant Parallel and Posterior 2 Implant Distally Tilted" versus parallel distribution
      supporting screw retained maxillary single denture regarding soft tissue changes around
      implants, implant stability and occlusal stability.

      The primary outcome is to study implant stability and occlusal stability. The secondary
      outcome is to evaluate periimplant soft tissue changes. The null hypothesis of this study
      will be there is no difference between the two studied groups.All patients were informed
      about the proposal of this study, the line of treatment, and the need for regular and
      frequent recalls. Their acceptance to participate in this study was confirmed and they signed
      the consent form of the ethical committee of the faculty of dentistry. This study gained the
      approval of the ethical committee of the Faculty of Dentistry, with approval number
      (A05080622).

      all the patients were divided randomly into two equal groups as follows Group I patients
      received four axially placed anterior Implants(*General system) in lateral and first premolar
      region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal
      plane supporting screw retained maxillary single denture.

      Group II patients received 6 implants in parallel distribution in anterior, premolar and
      molar region
    

Intervention name(s): implant
Intervention type(s): Procedure
Intervention description(s): All on six versus parallel implant distribution
Other intervention name(s): prothesis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: soft tissue changes; occlusal stability; implant stability
Tips for Infant and Parent Sleep (TIPS)
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      A randomized controlled trial design will be used to answer whether a behavioral-educational
      sleep intervention and support from a nurse in the immediate postpartum improves maternal and
      infant sleep 6 weeks later.
    

Detailed description: 
      Infant and maternal sleep in the postpartum are related, and influenced by the mother's
      understanding of infant sleep behavior, the environmental and social cues for sleep presented
      to the infant, development of the infant's sleep physiology, maternal sleep habits and
      behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may
      be modifiable through the use of behavioral-educational interventions. A randomized
      controlled trial design will be used to answer whether a behavioral-educational sleep
      intervention and support from a nurse in the immediate postpartum improves maternal and
      infant sleep 6 weeks later. Sleep-wake patterns will be analyzed through the use of
      actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study
      which will test the usefulness and practicality of this type of program, so that a larger
      scale study can be developed.
    

Intervention name(s): TIPS Intervention
Intervention type(s): Behavioral
Intervention description(s): A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; neonates; mothers; behavioural intervention
Energy-efficient and Health Promoting Light for Elderly People
Condition: Sleep
Study type: Interventional

Summary: 
      to investigate the effect of two lightning conditions on sleep hypothesizing that sleep
      length is influenced by the color of light during daytime
    

Detailed description: 
      Lightning conditions seems to be important for the length and quality of sleep, as light have
      an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm.
      Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive
      retinal ganglion cells and these cells are sensitive to blue light.

      Based on previous research, blue light early in the day and abscence of blue light during
      evening is important for the entrainment.

      In this study, lightning conditions in the home of healthy subjects are set to either blue
      enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a
      randomization protocol in a cross-over study for 3 weeks in each condition, separated by a
      one week pause.
    

Intervention name(s): blue light
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: sleep; circadian; melatonine; pupil response
Efficacy of Muscle Energy Technique Alone and in Combination With Interferential Therapy for the Treatment of Non-specific Low Back Pain.
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Single blind randomized control trail in which two groups were formed. Group A was given
      Muscle energy technique and Group B was given muscle energy technique in combination with
      Interferential therapy.
    

Detailed description: 
      After getting the REC approval from The Neurocounsel Clinics, study was initiated from 21
      May, 2023 to 20 September 2023. Sample size was calculated by Epitool which came 30.
      Following participants were included a) both genders b) age 20-50 years and followings were
      excluded a) DM b) Parkinson disease c) disc disorder d) MSK disorder were excluded from this
      study. Simple random sampling technique was used to randomize participants into two equal
      groups. group A was given MET and group B was given MET plus IFT. 2 sessions/week for 4 &
      half weeks. Evaluation was done at PNS & EQ-5D-5L (QoL). Pre and post test analysis was done
      by use of SPSS version 21 and level of significance was kept p<0.05.
    

Intervention name(s): muscle energy technique; Muscel energy technique along with interferential therapy
Intervention type(s): Other; Other
Intervention description(s): Muscle energy technique is used at a rate of three sessions per week for four and half weeks; Muscle energy technique along with interferential therapy is used at a rate of three sessions per week for four and half weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind RCT in which Two groups were formed
Masking: Single (Participant)
Primary purpose: Treatment
COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Rupture
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID
      or COX-2 selective inhibitor gives better pain relief than either of the drugs used
      separately. The investigators group has also shown that adding dexamethasone on top of a
      regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest
      after ambulatory breast cancer surgery.

      The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The
      investigators want to evaluate whether a selective COX-2 selective inhibitor or a
      glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can
      provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL
      surgery.
    


Intervention name(s): parecoxib, valdecoxib, etoricoxib; Dexamethasone; parecoxib, valdecoxib, parecoxib and dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery.
After retraction of parecoxib from the market:
Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery; 8 mg IV; combination of both drugs
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Etoricoxib; Parecoxib; Valdecoxib; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthroscopic reconstruction; Anterior crucial ligament; Coxib; Dexamethasone
A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury
Condition: Injury of Nerves at Wrist and Hand Level
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Participants with a traumatic sensory nerve injury in the hand will be recruited to the
      study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will
      undergo repair with the Polynerve. Participants will be followed up regularly, observed for
      device-related complications and to assess the return of sensory innervation.
    

Detailed description: 
      Peripheral nerve injuries are a common occurrence, with approximately 9000 cases in the
      United Kingdom (UK) occurring each year. Most are in a predominantly young and working
      population. Where surgical reconstruction is required to repair the peripheral nerve injury,
      techniques employed have changed little in the last 50-60 years with many factors influencing
      the outcomes, such as age of patient, timing, level and extent of injury, method of repair
      and the surgeon's skill .

      Despite advances in microsurgical nerve repair techniques, functional recovery is often poor
      e.g. resulting impaired hand sensation, reduced motor function and frequent pain and cold
      intolerance. This can have a profound and permanent impact on the patient's recovery and
      subsequent quality of life. Nerve repair has significant health, social and cost implications
      with the treatment and rehabilitation of an employed person, estimated to be EUR 51,238.

      Peripheral nerve injury usually presents with nerve stumps that can be approximated in
      surgical repair: direct, end-to-end suture repair of the epineurium (neurorrhaphy). Excessive
      tension over the suture line leads to poor results; therefore when the nerve stumps cannot be
      approximated without tension, an alternative surgical method is required.

      Where the nerve gap exceeds more than 5 mm, there are two fundamental options, either 'nerve
      grafting' or 'tubulisation' using a bridging material. This trial will examine the
      first-in-man use of a new nerve conduit device 'Polynerve' to repair small nerve gaps in
      digital sensory nerves of the hand. Polynerve is a degradable co-polymer of Poly
      ε-caprolactone (PCL) and Poly (L-lactic acid) (PLA) which is shaped as a cylinder with a
      novel internal lumen consisting of a specific micro-grooved architecture.
    

Intervention name(s): Polynerve
Intervention type(s): Device
Intervention description(s): Polymer biomaterial nerve conduit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nerve regeneration; Peripheral nerve injury; Nerve conduits; Sensory nerve transection
Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold
Condition: Pain
Study type: Interventional

Summary: 
      Therapeutic massage has been thought to reduce anxiety and increase relaxation in human
      patients.This study is meant to determine the immediate effects of therapeutic massage on
      pain tolerance and threshold.
    

Detailed description: 
      Patients participated in two trials of a pain stimulus test that measured pain threshold and
      pain tolerance. One trial was titled "Massage Protocol" and the other, "No-Massage Protocol."
      During the "Massage Protocol," they received a therapeutic massage to the forearm before
      participating in the pain stimulus test. During the "No-Massage Protocol" they did not
      receive a massage before participating in the pain stimulus test. Their pain threshold and
      tolerance for both trials were compared against each other. Each patient was randomized as to
      which protocol they participated in first.
    

Intervention name(s): No Massage Protocol; Prophylactic Therapeutic Massage
Intervention type(s): Other; Other
Intervention description(s): Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.; Participants received a 5 minute prophylactic therapeutic massage prior to completing the Cold Pressor Test. The massage was completed distally-to-proximally in the following order: superficial strokes to the entire forearm, deep strokes to the entire forearm, one-handed palmar kneading of the entire forearm with participant's forearm stabilized by the massager's the other hand, bilateral thumb kneading of the forearm in strips until the entire forearm was addressed, bilateral transverse thumb motions over palmar surface of the hand, single thumb kneading of thenar and hypothenar eminences simultaneously, bilateral thumb kneading to the dorsum of hand, deep stroking to the entire forearm, and superficial stroking to the entire forearm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: massage therapy; pain tolerance; pain threshold
A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)
Condition: Hypertension; Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers
      (ARB) have been shown to slow the decline in kidney function of patients with type 2
      diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The
      purpose of this research study is to determine if after one year of treatment telmisartan
      (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg,
      another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR)
      100 mg in reducing the level of urinary protein (indicative of improved kidney function).
    


Intervention name(s): telmisartan; losartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Losartan; Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
Condition: Immunogenicity; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative
      immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6
      mL; Intas Pharmaceuticals Ltd. proposed biosimilar INTP5 compared to innovator product,
      US-Neulasta) in healthy, adult, human subjects under fed conditions.
    


Intervention name(s): INTP5; US Neulasta
Intervention type(s): Combination Product; Combination Product
Intervention description(s): INTP5, a pegfilgrastim biosimilar to US Neulasta.; US Neulasta: FDA approved pegfilgrastim innovator product.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Pegfilgrastim; Biosimilar; Immunogenicity; Pharmacokinetics; Pharmacodynamics; Safety; Healthy Volunteers
Investigation of Human Laryngeal Evoked Brainstem Potentials
Condition: Thyroidectomy
Study type: Interventional

Summary: 
      The primary purpose of this study will be to determine whether the proposed study protocol
      will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR).
      Laryngeal evoked brain stem responses will be recorded from five test subjects under general
      anesthesia in the operating room with the assistance of an electrophysiologist with expertise
      in evoked potentials. Once the feasibility of obtaining tracings are established on the first
      few subjects, responses will be recorded from other test subjects with the aim of determining
      the optimal placement of stimulating electrodes and detection leads necessary to elicit an
      adequate response. The effect of varying the stimulus intensity will also be studied. Once
      parameters for testing have been standardized, normative configurations for the laryngeal
      evoked brainstem response tracings can be determined by patients both in the office setting
      and in the operating room.
    


Intervention name(s): Placement of a needle electrode through the thyrohyoid membrane into the submucosal space within the false vocal fold
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Laryngeal evoked brainstem response (LEBR); laryngopharyngeal sensory discrimination testing (LPSDT); brainstem activity
Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study evaluates the pathophysiological effects of a single dose Methylprednisolone
      administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the
      effect on immune signaling and recovery after surgery.

      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
      receive placebo.

      The investigators hypothesize that the group receiving Methylprednisolone will experience a
      positive modulation of the immune response and an enhanced recovery.
    

Detailed description: 
      The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on
      postoperative pain, postoperative nausea and vomiting are well-documented.

      Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential
      of recovery. The basic physiological mechanisms behind restoration of recovery after surgery
      are still unresolved. The many different immune cells involved in the complex signal response
      enables wound healing and recovery, and the individual immune signal pattern might be able to
      predict recovery. The effects of glucocorticoids on this immune signal pattern is unknown and
      calls for further investigation.

      The study is to be considered as exploratory. This study is embedded in a primary study
      registrated as: NCT02445898

      For further details please view the EudraCT registration:

      EudraCT nr.: 2015-000102-19
    

Intervention name(s): Methylprednisolone; Isotonic Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo); Placebo
Other intervention name(s): Solu-Medrol; Placebo
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Glucocorticoids; Immune Signaling; Recovery; Hip arthroplasty, total