bioihbjkbjnl/mcl2 huggingface dataset:
Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the safety and efficacy of IVIG in combination with
      Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a
      transplanted organ in patients who are highly HLA-sensitized and are awaiting
      transplantation.
    

Detailed description: 
      Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive
      Antibody {PRA}) of >30%. If patients meet these criteria, patients will be asked to have an
      assessment of the ability of IVIG to reduce the anti-HLA antibodies activity in the test
      tube. Patients will receive IVIG 2gm/kg x1 on hemodialysis. Seven days later, patients will
      receive Rituximab 1gm in the CSMC Infusion Center as per protocol for Rituximab infusion. The
      second Rituximab infusion will be on day #22. Additional IVIG infusion will be given at month
      one.

      Patients will continue to be followed for an additional 12 months after the last IVIG
      infusion and will be asked to return for follow up visits at month 1 through 5, month 7 and
      12.
    

Intervention name(s): IVIG and Rituximab
Intervention type(s): Drug
Intervention description(s): IVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVIG; Rituximab; Highly Sensitized; Kidney Transplantation
Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
Condition: Delayed Onset Muscle Soreness (DOMS)
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed as a proof of concept, single-center, randomized, double-blind, placebo
      controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other
      ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).
    

Detailed description: 
      The study is designed as a proof of concept, single-center, randomized, double-blind, placebo
      controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other
      ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).
      Healthy adults ages 18-65 years who are exercise-trained (self-report exercising at least 3
      times per week for at least 30 minutes per session for the past year) will be recruited from
      existing panels of participants from past studies, local advertisements, and social media
      targeted advertisements. Those who meet the inclusion/exclusion criteria will be enrolled
      into the study, scheduled for the Exercise Visit (Study Visit 1; Day 0) within 2 weeks of
      screening, and randomized to active vs. placebo IP condition in a 1:1 ratio. One repetition
      maximum (1RM) method, the maximum amount of weight one can lift in a single repetition for a
      given exercise, will be used in order to induce DOMS. Following the completion of the
      Exercise Visit, participants will be scheduled for 3 follow-up visits that will occur 1, 2,
      and 3 days post-Exercise Visit. Participants will consume 7 scheduled doses of the study IP
      to which they have been randomly assigned (i.e., active or placebo) with instruction to
      consume the study IP prior to the exercise at Study Visit 1, at 8PM (±1 hour) that night, and
      then at 8AM and 8PM (±1 hour) every day until their final study visit. The last dose will
      occur at 8AM (±1 hour) on Day 4, i.e., immediately prior to Study Visit 4.
    

Intervention name(s): CHI-202; CHI-101
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Blend of cannabinoids & other ingredients; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM
Condition: Morbidly Obese; Intubationtime; Intubationattempts
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation
      of morbidly obese. Mainly we will try to clarify which of the instruments that produce the
      shortest intubationtime and lowest number of intubationattempts.

      The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of
      attempts, using the GlideScope®.
    

Detailed description: 
      The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result,
      surgery and anesthesia in obese patients becomes more frequent. Several potential problems
      related to anesthesia in this patient group exists, including airway management and
      sufficient oxygenation.

      Anaesthesia of obese patients are more likely to require intubation. In light of the
      foregoing, it is therefore important to find the methods that provide the fewest
      complications related to intubation. Therefore this study compare two instruments (Fastrach
      TM and GlideScope ®) to find out which of the methods that provides the best airway
      management, measured primarily in time and numbers of intubation attempts.
    

Intervention name(s): GlideScope; Fastrach
Intervention type(s): Device; Device
Intervention description(s): The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.; The Fastrach is an intubation laryngeal mask.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Observational

Summary: 
      This study examines the value of stem cell transplantation in managing light chain
      amyloidisis.
    

Detailed description: 
      1. How does age at diagnosis affect prognosis in primary amyloidosis?

        2. How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum
           gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis?

        3. How does degree of organ involvement/number of organs involved affect prognosis in
           primary amyloidosis?

        4. How does initial treatment affect prognosis in primary amyloidosis?

      4. How do the specifics the stem cell transplant protocol affect prognosis in primary
      amyloidosis?
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient receiving transplantation
      
Keywords: Amyloidosis
Testing the Effect of the Youth Mindful Awareness Program on Negative Affect
Condition: Mindfulness
Study type: Interventional

Summary: 
      Randomized controlled trial comparing a coached, app-based mindfulness intervention versus a
      no-intervention control condition. Primary outcome: adolescents' reports of affect as
      measured with ecological momentary assessment (EMA) at post-intervention. Participants will
      include 120 youth ages 12-17 years old.
    

Detailed description: 
      This is a randomized controlled trial testing a 9-session, coached, app-based mindfulness
      intervention on adolescents' reports of affect as measured with ecological momentary
      assessment (EMA). Participants will include 120 youth ages 12- to 17-years-old randomized to
      either the Youth Mindful Awareness Program (YMAP) or to an assessment only control condition.
      Participation is open to all genders and youth of all races and ethnicities.
    

Intervention name(s): Youth Mindful Awareness Program (YMAP)
Intervention type(s): Behavioral
Intervention description(s): The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Mindfulness vs. No intervention control
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mindfulness
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
Condition: Growth; Colic
MeSH terms: Colic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance
      and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant
      formula.
    

Detailed description: 
      This double-blind, placebo-controlled study was undertaken with 66 healthy infants with
      colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or
      with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and
      30.

      Both parents provided informed written consent.
    

Intervention name(s): Modilac Dahlia 1; Modilac 1
Intervention type(s): Other; Other
Intervention description(s): Infant formula used for non breastfed children with colic; Infant formula used for non breastfed children
Other intervention name(s): Dahlia; Modilac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Infant formula; Alpha-lactalbumin; Protein composition; Colic; Probiotics
Intensified Chemotherapy in CRC After Resection of Liver Metastases
Condition: Colorectal Cancer; Liver Metastases; Chemotherapy
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Randomized, open label, multicentre phase II trial followed by phase III comparing overall
      survival after having selected the best experimental arm.
    


Intervention name(s): FOLFIRI; FOLFOX-4; FOLFIRI-HD; FOLFOX-7; FOLFIRINOX
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks; FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks; High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks; FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks; FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Folfirinox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Sleep Quality in Patients With Chronic Neck Pain
Condition: Neck Pain; Sleep
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of chronic neck pain on sleep quality and to
      determine the factors that may be related to sleep disturbance.
    

Detailed description: 
      It is thought that chronic neck pain affects sleepiness negatively. However, there are no
      studies on chronic neck pain and sleep quality. In this study, we would like to determine
      whether there is a link between chronic neck pain and sleep quality and the factors that may
      be related.
    

Intervention name(s): Sleep Quality
Intervention type(s): Other
Intervention description(s): Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Cervicalgia
Global® AP™ Total Shoulder Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis
      using the anchor pegged glenoid component and clinical and radiographic evaluations.
    

Detailed description: 
      The purpose of the study is to determine the difference between pre-operative and
      post-operative levels of patient satisfaction, shoulder function, radiographic alignment,
      shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder
      prosthesis for glenohumeral arthritis.
    

Intervention name(s): Global® AP™ Total shoulder arthroplasty
Intervention type(s): Device
Intervention description(s): Total shoulder arthroplasty
Other intervention name(s): Global® AP™ Shoulder
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Glenohumeral joint; Glenoid; Shoulder arthroplasty
Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device
Condition: Oroantral Fistula; Displaced Tooth
MeSH terms: Oroantral Fistula; Fistula
Study type: Interventional

Summary: 
      Ten patients with displaced root in maxillary sinus will be included in this study. the root
      will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device
      then the bony window will be repositioned in its place.The patients will be received,
      clinically and radiologically examined, managed and followed up at the Oral and Maxillofacial
      surgery Department, Faculty of Dentistry, Tanta University
    

Detailed description: 
      Purpose: This study is designed to allow removal of displaced root from maxillary sinus with
      minimal surgical injury and simultaneous preservation of the integrity of the lateral wall of
      maxillary sinus by repositioning of osteotomized lateral bony window.

      Materials & Methods: Ten patients with displaced root in maxillary sinus will be included in
      this study.

      surgical procedure: A full thickness flap will be elevated to expose the lateral wall of the
      sinus and a rectangular bony window will be done, then the sinus lining will be incised, the
      displaced root will be delivered, the bony window will be repositioned, and the flap will be
      sutured.

      Preoperative evaluation: The patients will be evaluated clinically for presence of
      inflammation, infection or oroantral communication and radiographically using computed
      tomography (CT) scan to identify the position of the displaced root.

      Postoperative evaluation: The patients will be evaluated clinically each week for one month
      regarding to healing, presence of infection, inflammation. Radiographically, immediate
      panoramic view to evaluate the position of bony window and four months later to evaluate bone
      healing CT scan.
    

Intervention name(s): lateral bony window
Intervention type(s): Device
Intervention description(s): bony window will be made on lateral maxillary sinus wall using piezo-electric device after elevation of full thickness mucoperiosteal membrane
Intervention model: Single Group Assignment
Intervention model description: single group assignment patients
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: displaced root; maxillary sinus; lateral bony window; piezoelectric device
Biomarkers of Processed Meat Intake
Condition: Biomarkers of Processed Meat Intake in Healthy Subjects
Study type: Interventional

Summary: 
      The intake of processed meat products has been linked to several adverse health outcomes.
      However, estimation of their intake proves difficult. This study aims at identifying
      biomarkers of intake for processed meat products in blood and urine. For this, participants
      of a randomized cross-over dietary intervention will consume highly controlled diets
      containing non-processed pork, different processed meat products or no meat. Urine and plasma
      will be collected and analysed to identify sets of metabolites that are specific for the
      intake of the processed meat products.
    

Detailed description: 
      The intake of processed meat has been linked to several adverse health outcomes such as
      cancer. However, little is known about the respective effects of the single products in this
      diverse group.

      Most epidemiological studies rely on self-reported questionnaires to assess the intake of
      different foods. Even though this method is relatively easy to perform, it is prone to errors
      such as memory biases of subjects or difficulties in estimating portion size. The use of food
      specific biomarkers may overcome this limitation by offering an objective quantification of
      dietary exposure. No biomarkers for the consumption of processed meat products have been
      established yet.

      Twelve human healthy adults will participate in a randomized cross-over dietary intervention
      study and will consume three different processed meat products, fresh meat or no meat, each
      during 3 successive days followed by a 10-day washout period. The metabolite profile in urine
      and plasma samples will be analysed to find metabolites that are specific for the intake of
      the processed meat products.

      The identification of these biomarkers in blood and urine will allow a more precise
      estimation of intake of different processed meat products. This will enable a more robust
      estimation of the risk linked to the intake of processed meat products.
    

Intervention name(s): Processed meat dietary intervention
Intervention type(s): Other
Intervention description(s): Randomized cross-over dietary intervention with 5 different diets
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Volunteers consume five different diets in a randomized cross-over dietary intervention.
Masking: None (Open Label)
Primary purpose: Basic Science
Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Observational

Summary: 
      The aim of this study is to compare the incidence of tinnitus between mp3 users and
      non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença
      secondary schools. High frequency audiometry and otoacoustic emissions will be
      performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        teenagers and young adults (15 to 30 years old)
      
Keywords: tinnitus; mp3 players; noise induced hearing loss; high frequencies audiometry; acoustic otoemissions
The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of
      doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo
      challenge.
    

Detailed description: 
      1. Investigate the timing and dose of FTC-TDF and FTC-TAF as oral PrEP and in vitro PEP
           (applied directly to removed foreskin tissue) required to prevent ex vivo HIV infection
           in foreskin tissue and blood using the explant model

        2. Determine blood, rectal fluid and foreskin tissue concentrations of FTC, TFV, TAF and
           their active metabolites that are required for ex vivo HIV protection

        3. Evaluate inflammation, cellular activation, foreskin mucosal integrity, gene expression
           and microbiome in foreskin tissue following oral in vivo PrEP and in vitro PEP

        4. Evaluate the efficacy of in vitro post exposure dosing with PrEP in protection against
           ex vivo HIV infection using the explant model

        5. To investigate sexual behaviour, PrEP acceptability and feedback on HIV prevention
           trials implementation
    

Intervention name(s): Tenofovir
Intervention type(s): Drug
Intervention description(s): Pre-exposure prophylaxis
Other intervention name(s): Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, randomised controlled trial (RCT)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pre-exposure prophylaxis
Effects of Dry Needling on Neck and Shoulder Pain in Orchestral Musicians: a Prospective Case Series
Condition: Pain Syndrome; Musculoskeletal Pain; Trigger Point Pain, Myofascial
MeSH terms: Musculoskeletal Pain; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the effectiveness of Deep dry needling of active myofascial trigger
      points present in muscles of the neck and shoulder region in orchestral musicians.
    


Intervention name(s): Deep dry needling
Intervention type(s): Procedure
Intervention description(s): Insertion of a filiform needle in the active trigger point of musculoskeletal muscle
Intervention model: Single Group Assignment
Intervention model description: Deep dry needling
Masking: None (Open Label)
Primary purpose: Treatment