bioihbjkbjnl/mcl2 huggingface dataset:
Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program
Condition: Chronic Pain; Low Back Pain; Exercise
MeSH terms: Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      Chronic low back pain is one of the main causes of pain, dysfunction and disability
      worldwide. In Spain, 93% of the population has had back pain in the last year, and it is
      estimated that 50% of sick leave is due to this cause. This entails a great socioeconomic
      burden, since it is the main cause of absenteeism from work and the excessive use of
      therapeutic services.

      Musculoskeletal disorders are related and associated with psychologically stressful jobs,
      that is, with psychosocial factors at work and related work stressors, such as time pressure,
      low job control, poor social or supervisor support, effort-reward imbalance or work-life
      conflict. Clinical management of both situations encompasses a variety of approaches,
      including medication and early physical exercise, which have shown promise in reducing pain
      and improving function.

      A novel approach to address these problems is the use of Xiaxi, a patented postural hammock
      with multiple angles of inclination that promotes relaxation and elongation of the posterior
      chain, thereby improving overall well-being. Combining the use of Xiaxi with a comprehensive
      program of strengthening, stretching and relaxation exercises could offer benefits in the
      prevention and reduction of back pain.
    


Intervention name(s): Xiaxi postural hammock; Yoga mat
Intervention type(s): Device; Behavioral
Intervention description(s): Lie in the Xiaxi postural hammock for 10 minutes for 5 days.; Lie in the Yoga mat for 10 minutes for 5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The primary aim of this clinical study is to find signal characteristics of VOCs detected by
      Sokru device during fasting, insulin injection and after glucose intake and to find the
      association with blood glucose variation in variant states of glycemia and hypoglycemia.
    


Intervention name(s): Sokru device
Intervention type(s): Device
Intervention description(s): Different induced glycaemic states in people living with diabetes (PwD).
Intervention model: Single Group Assignment
Intervention model description: Sokru device, prototype
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Volatile Organic Compounds; Hypoglycaemia
Psychometric Validation of Cognitive Endpoints
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      The study will entail cognitive assessment of a single cohort of patients with Multiple
      Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no
      intervention or control group. Each participant will have a caregiver capable of responding
      to a brief report of observations regarding neuropsychological skills and abilities in the
      patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals with Multiple Sclerosis
      
Keywords: MS; Neuropsychological tests
Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination
Condition: Parasitic Diseases; Bacterial Diseases
MeSH terms: Filariasis; Trachoma; Elephantiasis, Filarial; Parasitic Diseases; Bacterial Infections; Elephantiasis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the triple co administration of
      albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that
      consists to treat with albendazole plus ivermectin together and a week later to treat with
      azithromycin in areas co endemic for lymphatic filariasis and trachoma.
    

Detailed description: 
      Infectious diseases such as trachoma and lymphatic filariasis are public health problems in
      regions of Africa and Asia. Elimination programs exist for the two diseases, and their
      treatment by different groups of health workers is both costly and inefficient.

      Thus, a study evaluating the safety and feasibility of an integrated mass treatment of
      trachoma and lymphatic filariasis with azithromycin associated with albendazole and
      ivermectin was instituted in 4 villages of the region of Sikasso in Mali (West Africa) co
      endemic for lymphatic filariasis and trachoma.

      It was an open label randomized clusters type on the assessment of the safety of the triple
      co administration of azithromycin, ivermectin and albendazole (experimental regimen) as
      compared to the administration of the co administration of albendazole plus ivermectin
      followed by the that of azithromycin a week later (current standard recommended regimen)
      within subjects of 5 to 65 years old, willing and able to swallow the study drugs.

      Clinical evaluation of adverse events in all study participants was done on day 0, day 8, and
      day 15 after the treatment.
    

Intervention name(s): triple co administration at once of the combination of Albendazole + ivermectin + azithromycin
Intervention type(s): Drug
Intervention description(s): Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once
Other intervention name(s): Albendazole; Mectizan; Zithromax
Intervention MeSH terms: Azithromycin; Ivermectin; Albendazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Albendazole; Ivermectin; Azithromycin; Lymphatic filariasis; Trachoma; Safety
Non-surgical Treatment of Peri-implant Mucositis: FMUD vs FMUD and Air-Flow Master Piezon®
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the adjunctive effect of glycine-powder
      air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of
      peri-implant mucositis, and to determine the predictive role of implant and patient-level
      variables for disease resolution. Both treatments are described in the literature, but few
      studies are available on their comparison.
    

Detailed description: 
      52 patients (132 implants) with peri-implant mucositis were included in this randomized
      parallel arm clinical study. Following baseline variables assessment, participants received
      Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP.
      Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and
      partial disease resolution were defined as absence of BoP (DR1) or <2 BoP+ sites (DR2),
      respectively.
    

Intervention name(s): Glycine powder air polishing; Full mouth ultrasonic debridement
Intervention type(s): Device; Device
Intervention description(s): Peri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®).; Peri-implant mucositis sites are treated with thin ultrasonic tips.
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peri-implant Mucosits; air polishing device; non-surgical treatment
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine in children with persistent AR the effect of the
      topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by
      acoustic rhinometry and subjective nasal symptoms.
    


Intervention name(s): Nasal Beclomethasone Dipropionate; CERCHIO 10 mg/ml OS
Intervention type(s): Drug; Drug
Intervention description(s): Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.; For Children < 12 years old 10 drops die (5 mg die) for 21 days. For Children > 12 years old 20 drops die (10 mg die) for 21 days.
Other intervention name(s): NBDP
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A System for Lengthening Contraction Training of Muscle
Condition: Healthy
Study type: Interventional

Summary: 
      Evaluation of a new exercise machine designed to improve strength and speed of movement in
      the leg muscles. Investigators are trying to learn whether a new training method results in
      greater strength improvements as compared to a traditional method.
    


Intervention name(s): Exercise; Exercise
Intervention type(s): Other; Other
Intervention description(s): Velocity-controlled variable resistance protocols enable trainees to load their muscles more optimally along the entire ROM in either or both of the shortening (VSC) and lengthening (VLC) phases of a training repetition; Standard training of leg extension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery
Condition: GI Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3
      PUFA on post-operative inflammatory processes.
    


Intervention name(s): MLF 541; Lipofundin MCT
Intervention type(s): Drug; Drug
Intervention description(s): 22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour; 22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post OP
Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of an oral Farnesyl
      Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous
      docetaxel in cancer patients with advanced solid tumors.
    


Intervention name(s): Farnesyl Protein Transferase Inhibitor
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer-Advanced Solid Tumors
Survival of Root Canal Treated Teeth Restored With Ceramic Onlays
Condition: Dental Pulp Diseases
MeSH terms: Dental Pulp Diseases
Study type: Observational

Summary: 
      Advances in digital dentistry coupled with increased demand for aesthetic restorations have
      led to developments in CAD CAM( Computer Aided Design and Computer Aided
      manufacturing)systems for manufacturing tooth restorations. CAD CAM restorations have the
      added benefit of digital impressions which eliminate the need to take conventional
      impressions, something patients find difficult to tolerate. CAD CAM restorations are now part
      of routine dental care. However there are no clinical studies evaluating these restorations
      on root canal treated teeth

      This study aims to compare the success and survival of root canal treated teeth and/or
      restoration with varying degrees of tooth structure loss restored using CAD CAM restorations.

      Null Hypothesis:- The amount of residual coronal dentin has no effect on the survival of root
      canal treated teeth and/or restoration.
    

Detailed description: 
      This study will be carried out at KCL Dental Institute at Guy's Hospital and will form part
      of the routine dental treatment done at the endodontic postgraduate unit. Potential
      volunteers will be given written information about the process and be given time to consider
      participation. Once any questions have been answered, fully informed written consent will be
      obtained if they are interested in taking part. Patients requiring endodontic treatment with
      varying degrees of tooth structure loss will be detected, diagnosed and treated by endodontic
      MClinDent postgraduate students at Guy's hospital using suitable clinical techniques. The
      teeth will then be restored using CAD CAM restorations. Dental periapical radiograph and cone
      beam computed tomography (CBCT)scans (Morita Accuitomo) will be taken at baseline, 12 months
      and 24 months. Clinical assessment and radiographical evaluation will be carried out
      immediately after endodontic treatments have been accomplished and 1 and 2 years post
      treatment and will be assessed independently by a group of examiners. It is hoped that data
      analysed from this study will provide a definitive clinical evidence base for the success and
      survival of endodontically teeth and/or restorations.
    

Intervention name(s): Root canal treatment
Intervention type(s): Procedure
Intervention description(s): Root Canal Treatment followed by Ceramic Onlay restoration
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Routine patients requiring root canal treatment at Guy's Hospital, London
A Study in Healthy Volunteers Investigating How Quickly and to What Extent BAY1817080 is Taken up, Distributed, Broken Down and Eliminated From the Body, as Well as the Difference Between 2 Different Types of Tablets of BAY1817080 and the Difference Between Oral Dose and Dose in the Vein
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to investigate how quickly and to what extent BAY1817080 is
      absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body
      (this is called pharmacokinetics). The pharmacokinetics of BAY1817080 administered as tablets
      will be compared to the pharmacokinetics of BAY1817080 administered as intravenous (iv; in
      the vein) infusion (this is called absolute bioavailability). Furthermore, 2 different types
      of tablets with BAY1817080 (Formulation A and Formulation B) will be compared with regard to
      pharmacokinetics (this is called relative bioavailability). The effect of a meal on the
      pharmacokinetics of BAY1817080 administered as tablets will be investigated as well. Finally,
      it will also be investigated how safe BAY1817080 is and how well BAY1817080 is tolerated.
    


Intervention name(s): BAY1817080 - Formulation A; BAY1817080 - Formulation B; [13C715N]-BAY 181708 stable isotope label (SIL)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Formulation A; Formulation B; 0.1 mg [13C715N]-BAY181708, 15 minutes i.v. infusion at the estimated tmax after administration of Formulation B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Endometriosis; Refractory chronic cough
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      A comparison of three products for oral nicotine replacement with respect to pharmacokinetics
      after single-dose of nicotine.
    

Detailed description: 
      This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™
      lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to
      nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of
      each treatment are given once in the morning during five separate treatment visits scheduled
      in a crossover setting with randomized treatment sequences. The study will include 45 healthy
      smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at
      least one year preceding inclusion. Subjects and study personnel will be aware of which
      treatment is administered at a given visit.
    

Intervention name(s): Oral Nicotine; NiQuitinTM Nicotine Lozenge; Nicorette® Nicotine Gum
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A new l mg oral nicotine product; A marketed 4 mg Nicotine lozenge; A marketed 4 mg Nicotine Gum
Other intervention name(s): Experimental nicotine 1 mg; NiQuitinTM lozenge; Nicorette® gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Nicotine pharmacokinetics
Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus
Condition: Type1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To demonstrate equivalence in exposure to insulin glargine given as test formulation T and
      reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses

      Secondary Objective:

        -  To assess relative Pharmacodynamic activity of the insulin glargine test formulation T
           to the insulin glargine reference formulation R in steady state conditions after 6
           once-daily SC doses

        -  To assess the safety and tolerability of the test and reference formulations of two new
           insulin glargine formulations
    

Detailed description: 
      Total study duration per subject: 29 to 64 days including screening visit

      Duration of each part of the study for one subject:

        -  Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)

        -  Treatment Period 1 and 2: 8 days (dosing on 6 days)

        -  Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially
           7 days) End-of-Study Visit: 7-10 days after last dosing
    

Intervention name(s): Insulin glargine new formulation HOE901
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution Route of administration: subcutaneous
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
10003 PRO Current Products
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      This post-marketing investigation will evaluate the functional knee performance of Subjects
      who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one
      of four contemporary knee configurations from different manufacturers will be pooled to
      establish a contemporary dataset.

      The primary objective of this study is to evaluate the functional performance as measured by
      the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score
      (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year
      post-operation. This will be carried out for all four implant configurations. The final
      endpoint is a 2-year evaluation.
    

Detailed description: 
      The study is designed as a prospective, single arm stratified, multi-center investigation.

      Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study
      site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is
      permitted. There will be no control group. Eight hundred forty (840) Subjects will be
      stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing
      posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating
      platform posterior stabilized (RP PS).

      Treatment assignment in this study is not randomized. Each site will only enroll patients in
      one of the four knee configuration sub-groups most commonly used as their standard of care.
    

Intervention name(s): Total Knee Replacement
Intervention type(s): Device
Intervention description(s): Subjects will receive one of the following total knee implants:
PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female Subjects with Non-inflammatory Degenerative Joint Disease (NIDJD) who
        require primary TKA with one of several designated knee systems currently on the market and
        are aged 22 to 80 years, inclusive.
      
Keywords: Arthroplasty, Replacement, Knee,
Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL)
Condition: Non-Hodgkin Lymphoma; Chronic Lymphocytic Leukemia
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objectives of this study are to determine the maximum tolerated dose (MTD) or
      optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or
      refractory advanced B-cell NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma
      [FL], mantle cell lymphoma [MCL]) or CLL.
    

Detailed description: 
      To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of CAT-8015 in
      participants with relapsed or refractory advanced B-cell NHL (DLBCL, FL, MCL) or CLL.
    

Intervention name(s): CAT-8015 20 mcg/kg; CAT-8015 30 mcg/kg; CAT-8015 40 mcg/kg; CAT-8015 50 mcg/kg; CAT-8015 60 mcg/kg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.; Participants will receive 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.; Participants will receive 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.; Participants will receive 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.; Participants will receive 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
Intervention MeSH terms: Immunotoxin HA22
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NHL; CLL