bioihbjkbjnl/mcl2 huggingface dataset:
First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and
      signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002
      in patients with rheumatoid arthritis.
    


Intervention name(s): NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; placebo; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; NNC0142-0002; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1; Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly; Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Validation of the French Adaptation of the MSWDQ-23 Questionnaire
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      MS is an autoimmune disease of the central nervous system that affects more than 120,000
      people in France. The average age of onset of the disease is between 25 and 35 years. Given
      the wide range of ages of the patients, from 4 to 80 years, the ethical and socio-economic
      stakes are high in order to maintain their autonomy, sociability, family and intimate life,
      and their employment in the best possible conditions and for as long as possible.

      However, to date, there are no evaluation tools in French that allow us to understand the
      difficulties at work of MS patients.

      The Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23) was developed specifically
      for MS patients and validated in English [1]. There is a short version of this questionnaire
      that facilitates its use in clinical practice [2]. It has been translated and validated in
      Spanish through a multicenter study, and is currently being validated in German, but does not
      currently exist in French [3]. The main objective of the WORKSEP project is to validate the
      French version of this questionnaire through a multicenter population-based cohort within the
      framework of the French-speaking Multiple Sclerosis Society (SFSEP). This validation study
      will involve the inclusion of 206 French-speaking MS patients, regardless of their
      professional status, all forms of MS combined, from the early stage (Clinically Isolated
      Syndrome) to the more advanced stages (primary and secondary progressive forms).
    


Intervention name(s): questionnaires
Intervention type(s): Other
Intervention description(s): Patients will complete the MSWDQ-23 in French, as well as the DEX, questionnaire for the evaluation of executive dysfunction in daily life, to evaluate their cognitive complaints and the SF36 questionnaire to evaluate their quality of life
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        French-speaking MS patients with or without cognitive complaints and regardless of their
        occupational status will be prospectively recruited at their scheduled disease follow-up
        consultation
Effect of Exercise Before Gastric Bypass
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Exercise training is proved to protect against premature cardiovascular mortality.
      Additionally there is evidence that relatively high exercise intensity may be an important
      factor for improving aerobic capacity and endothelial function in patients with
      post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in
      overweight and obese individuals.

      The aims of this study is to investigate if High-intensity exercise before a gastric bypass
      operation will decrease hospitalization days and complications after the gastric bypass.
    


Intervention name(s): High intensity exercise
Intervention type(s): Behavioral
Intervention description(s): High intensity exercise 3xweek for minimum 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: High intensity exercise; morbid obesity; gastric bypass
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function
Condition: Rehabilitation; Neck Pain; Shoulder Pain; Scapular Dyskinesis; Muscle Activation
MeSH terms: Shoulder Pain; Musculoskeletal Pain; Neck Pain
Study type: Interventional

Summary: 
      Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder
      pain, but it is uncertain whether training should focus directly on the upper trapezius -
      which is most often tender - or on the lower compartments and serratus anterior.

      We hypothesize that strengthening exercise for the lower and middle trapezius as well as the
      serratus anterior will decrease intensity of neck/shoulder pain among office workers
    


Intervention name(s): Training; Reference
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training of scapular function with strengthening exercises using bodyweight and elastic resistance; Health check and advice to continue ordinary physical activity
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms
Condition: IBS - Irritable Bowel Syndrome; Anxiety
MeSH terms: Irritable Bowel Syndrome; Heartburn
Study type: Interventional

Summary: 
      This is an open-label observational crossover trial to study the efficacy of a commercial
      dietary supplement and its effect on common symptoms of IBS (such as bloating, gas,
      heartburn, and other symptoms).
    

Detailed description: 
      It is hypothesized that the dietary supplement marketed as "Arrae Bloat" will improve
      subjective wellbeing in trial participants. It is further hypothesized that a second dietary
      supplement marketed as "Arrae Calm" will support the effects of "Arrae Bloat", while reducing
      stress, anxiety and panic and promoting restful sleep and easing tension in the body, which
      has previously been reported in customer feedback studies.
    

Intervention name(s): Arrae bloat supplement
Intervention type(s): Dietary Supplement
Intervention description(s): The supplement contains organic dandelion root extract, organic lemon balm herb top extract, organic peppermint leaf extract, organic bromelain, organic slippery elm inner bark extract. The capsule itself is made of cellulose, which is not a main active ingredient.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
Condition: Smoking Abstinence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine
      compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in
      healthy smokers. This study will also assess how the body interacts with AFQ056.
    


Intervention name(s): AFQ065
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Smoking, abstinence, craving, smoker, AFQ056, nicotine, placebo
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
Condition: Spinal Cord Injury; Acquired Brain Injury
MeSH terms: Brain Injuries; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Gait impairment in people with acquired brain injury (ABI) and spinal cord injury (SCI) can
      be very heterogeneous. For this reason, STELO has been developed: a new concept of
      exoskeleton based on modular technology for gait assistance. It allows a personalised
      configuration according to the functional capacity of each patient, as the therapist can
      choose which robotic joints to use depending on the therapeutic goal and on the patient
      recovery phase. The objective is to analyse the usability of the STELO modular exoskeleton in
      people with ABI and SCI.
    

Detailed description: 
      A test phase will be conducted in healthy volunteers as a proof of concept with the aim of
      evaluating safety and usability in healthy participants prior to the use of the device in the
      ABI or SCI population (Phase 2).

      After verifying that the device is safe in healthy people, phase 2 will begin: it consists of
      a total of 10 visits. These visits will include gait training sessions using the STELO
      modular exoskeleton.
    

Intervention name(s): Stelo
Intervention type(s): Device
Intervention description(s): Use of Stelo exoskeleton in nine rehabilitation sessions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exoskeleton; modular; SCI; ABI; gait; spinal cord injury; acquired brain injury
Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
Condition: Pertussis; Diphtheria; Poliomyelitis; Tetanus
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The present clinical study will assess the immunogenicity and reactogenicity of Sanofi
      Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months
      of age compared to commercially available vaccines in order to meet the requirements for
      registration of the product in South Korea.

      Primary objective To demonstrate the non-inferiority in terms of seroprotection rates
      (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to
      Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus
      commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV
      (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination.

      Secondary objectives

        1. Immunogenicity: To assess the non-inferiority in terms of seroprotection rates
           (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response
           rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine
           versus historical reference (Study E2I03294 - France). To assess and describe the
           immunogenicity of the study vaccines in both groups.

        2. Safety: To assess and describe the safety of the study vaccines after each dose.
    


Intervention name(s): DTaP-IPV combined vaccine; DTaP vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis; DTaP vaccine (CJ purified PDT vaccine ™)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphteria;; Tetanus;; Pertussis;; Poliomyelitis;; acellular
Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
Condition: Surgical Adhesions
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients
      with flexor tendon injury in zone I or II.
    

Detailed description: 
      This is a multi-centre, randomized, double blind, parallel study design in patient admitted
      for flexor tendon repair in zone II.

      The patients will undergo 9 visits within the time frame of the study. Patients will be
      randomized to receive treatment with PXL01 or standard care.

      Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at
      12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12
      weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion
      in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3).

      Before any study-related assessment takes place, patients are given verbal and written
      information about the study and informed consent is achieved from the patient and/or legal
      guardian. The study should be carried out in accordance with the Clinical Study Protocol
      (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory
      requirements.
    

Intervention name(s): PXL01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.; Placebo is a physiological sodium chloride solution, which is clear and colourless.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Surgical Adhesions; Post-surgical adhesions; Flexor tendon
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
Condition: Alcohol Dependence; Alcoholic Relapse
MeSH terms: Recurrence; Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective randomized double blind controlled trial in prevention of relapse in recently
      detoxified alcohol dependent patients with levetiracetam and placebo.
    

Detailed description: 
      Out-patients with alcohol dependence recently detoxified Primary goal size is the duration of
      the Abstinenz up to the heavy relapse.

      Secondary objective size are:

        -  Frequency of Lapses

        -  Time up to the first alcohol drinking

        -  cumulative times of do not drink

        -  Craving

        -  Alcohol drinking quantity

        -  Sleep quality

        -  Tolerability/Bearableness of the study medication

        -  Security

        -  Drop Out rate

        -  Side effects

        -  Changes with the neuropsychological testing HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, TLFB,
           SCL-90.

        -  Quality of life
    

Intervention name(s): levetiracetam (Keppra); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): levetiracetam daily application 1500-2000 mg; Sugar Pill
Other intervention name(s): KEPPRA
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: prevention of alcohol relapse
A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among
      hospitalized patients, with death occurring in approximately 6% of cases. It involves the
      formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the
      legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),
      hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to
      blood vessel wall), collectively known as Virchow's triad.

      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have
      been shown to improve lower limb blood flow. However, few studies have directly compared the
      two methods and those that have, have used dated NMES techniques.

      The objective of this study is to compare the two methods in terms of blood flow.
    

Detailed description: 
      Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among
      hospitalized patients, with death occurring in approximately 6% of cases. It involves the
      formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the
      legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),
      hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to
      blood vessel wall), collectively known as Virchow's triad.

      Intermittent Pneumatic Compression (IPC) involves the use of an inflatable cuff placed around
      the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the
      underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of
      muscles by delivering a series of controlled electrical pulses via skin surface electrodes
      placed over the motor points of the targeted muscle.

      Both IPC and NMES have been shown to improve lower limb blood flow. However, few studies have
      directly compared the two methods and those that have, have used dated NMES techniques.

      The objective of this study is to compare the two methods in terms of lower limb
      haemodynamics.
    

Intervention name(s): Duo-STIM neuromuscular electrical stimulator; AV Impulse System Model 6000
Intervention type(s): Device; Device
Other intervention name(s): Intermittent Pneumatic Compression Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Deep Vein Thrombosis; Neuromuscular Electrical Stimulation; Intermittent Pneumatic Compression; Doppler Ultrasound
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of
      treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as
      mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as
      mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety
      of both treatments, evaluated through hypoglycemic rates.
    

Detailed description: 
      Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment
      phases of 16 weeks each in two treatment groups:

        -  Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular
           insulin (phase 2)

        -  Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)
    

Intervention name(s): Insulin glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of
      musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for
      regeneration of peripheral neuropathy in animal study, the associated study in human is rare.
    

Detailed description: 
      The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of
      musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for
      regeneration of peripheral neuropathy in animal study, the associated study in human is rare.
      We performe a prospective study to investigate the effect of PRP in patients with carpal
      tunnel syndrome.

      Patients with carpal tunnel syndrome (CTS) were randomized into intervention and control
      group. Participants in intervention group received sono-guided injection with 3cc PRP and
      control group received night splint. The evaluation was performed pretreatment as well as on
      the 1st, 4th, 8th, 12th, 16th and 24 week after the treatment.
    

Intervention name(s): platelet rich plasma; splint
Intervention type(s): Biological; Device
Intervention description(s): Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment