bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factors for Early Remodelling in Severe Asthma in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      -  Background: Asthma is a frequent disease characterized by bronchial hyperresponsiveness,
           inflammation and remodeling. Consistent epidemiological data indicate that outcome of
           asthma in adults may be determined in early childhood. This may be due to bronchial
           remodeling, an abnormal repair process that contributes to the development of poorly
           reversible airway narrowing. It appears very early in the natural history of the disease
           and involves increased mass of bronchial smooth muscle (BSM). The mechanism of such an
           increase has been related with an increase in smooth muscle cell proliferation.
           Recently, we have demonstrated that in severe asthma, BSM increased proliferation is
           induced by an enhanced mitochondrial biogenesis. Moreover, we have also shown that
           immature human, non-asthmatic airway smooth muscle cells (ASMC) proliferate to a greater
           extent than normal adult ASMC, in a similar fashion to adult asthmatic ASMC. Immature
           ASMC may thus have great potential to stimulate airway remodeling. We thus hypothesized
           that remodeling is an early process and certain characteristics of ASMC in severe
           preschool asthma may predispose such children to persistent remodeling with airway
           obstruction later in life.

        -  Purpose: To investigate prognostic factors of airway remodeling in preschool children,
           with special attention to ASMC proliferation (mitochondrial mass & biogenesis).

        -  Methods: In the initial phase of the project, 75 severe asthmatic preschool children (<5
           yr) will be prospectively recruited from the "CHU de Bordeaux" and the "CHU de Toulouse"
           according to the "Haute Autorité de Santé" criteria. Inclusion visit will include
           written informed consent, asthma control evaluation, clinical examination, lung function
           testing (exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for
           total IgE levels. Bronchial specimens from all subjects will be obtained by fiberoptic
           bronchoscopy at visit 2. Airway remodeling will be evaluated by morphological analysis.
           After smooth muscle mitochondria will be analyzed by electronic microscopy &
           immunoblotting. Comparison between the 2 groups will be performed by unpaired t tests
           for parametric data and x2-tests for non-parametric data. In the second phase of the
           project, patients will then be followed-up till the age of 7-10 yrs, when another
           bronchoscopy with biopsies will be performed.
    


Intervention name(s): Fiberoptic bronchoscopy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis; Exercise Program; Telerehabilitation; Autoimmune Disorder
MeSH terms: Multiple Sclerosis; Autoimmune Diseases; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, and autoimmune disease
      that progresses with progressive neurological dysfunction and affects the central nervous
      system. A multidisciplinary rehabilitation approach is crucial in the systematic and
      supportive treatment of MS. Exercise training is a therapeutic approach that minimizes
      functional capacity loss and slows progression in MS. Randomized controlled studies have
      shown that exercise training improves physical fitness, reduces motor fatigue, and improves
      the quality of life and psychological state in individuals with MS.

      When the literature is examined, it is seen that popular exercises such as pilates, yoga, and
      Tai-Chi are used in addition to aerobics, strengthening, endurance, and stretching exercises
      in the treatment of individuals with MS. In order to eliminate the economic burden, which is
      one of the exercise barriers of individuals, and to gain exercise habits, home exercise
      programs should be expanded. When the literature is examined, it is emphasized that the
      importance of home exercise programs is emphasized, and it is very important in the treatment
      of patients who cannot attend an exercise program, especially by going to any center for
      various reasons. However, there is little information on the effectiveness and content of
      home exercise programs in patients with MS. From this point of view, this study is capable of
      supporting the missing part of the literature.
    


Intervention name(s): Fatigue Severity Scale; Berg Balance Test; Time up and go- 25 steps walking test; Multiple Sclerosis Quality of Life; Brief International Cognitive Assessment for MS (BICAMS); Beck Depression and Anxiety Scale
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Evaluation for severity of fatigue; Evaluation of balance; Evaluation for walking; Evaluation of quality of life; Evaluation of cognitive functions; Evaluation of depression and anxiety
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS (Multiple Sclerosis); Exercise, Physical; Exercise Therapy; Physical Exertion
Efficacy and Safety of Total Glucosides of Paeony Combined With NB-UVB on Treating Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      1. Total Glucosides of Paeony(TGP) As a traditional Chinese medicine, peony root is the
           dried root of peony of Ranunculaceae, cultivated all over the country.The main
           ingredient is a group of glycosides, including paeoniflorin, hydroxy paeoniflorin,
           paeoniflorin, paeoniflorin, benzoyl paeoniflorin etc, collectively referred to as total
           glucosides of paeony（TGP）. Paeoniflorin accounted for more than 90% of the TGP, is the
           main active ingredient of white peony root.By pharmacological and clinical studies of
           TGP, it have found that the mechanism of TGP is unique and mainly acts on the upstream
           of the immune response - inhibiting the presentation of antigens. It is different from
           immunosuppressive agents on T, B lymphocytes, or hormones and other drugs acting on the
           whole process.

        2. Vitiligo Vitiligo is a pigment deprived skin disease caused by the destruction of
           melanocytes, the global incidence of about 1%. The pathogenesis is not yet clear, the
           current study shows that oxidative stress and autoimmunity is an important part of its
           occurrence and development.

        3. The basic and clinical research of TGP used in vitiligo The ratio of cluster of
           differentiation 4+ / cluster designation 8+ T cell vs. cluster of differentiation 4+
           chronotropic dose 25+ in the peripheral blood of patients with vitiligo could be
           significantly increase, after patients treatment by TGP combined with tacrolimus.
           Thereby enhancing the patient's maintenance of immune self-stability and Immune
           tolerance ability, promoting the healing of skin lesions. It showed significant effect
           in stable vitiligo,when patients treated by autologous epidermal grafting combined with
           TGP.
    


Intervention name(s): Total Glucosides of Paeony(TGP); Narrow band-ultraviolet b（NB-UVB）; Total Glucosides of Paeony(TGP) analogue
Intervention type(s): Drug; Device; Drug
Intervention description(s): Total Glucosides of Paeony(TGP) as a traditional Chinese medicine, peony root is the dried root of peony of Ranunculaceae, cultivated all over the country.TGP is new drug of western medicine, original discovered by Professor Xu who is a famous pharmacologist. The main ingredient is a group of glycosides, including paeoniflorin, hydroxy paeoniflorin, paeoniflorin, paeoniflorin, benzoyl paeoniflorin etc, collectively referred to as total glucosides of paeony（TGP）; phototherapy on treating vitiligo; Total Glucosides of Paeony(TGP) analogue as a placebo for Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vitiligo; Total Glucosides of Paeony(TGP); narrow-band ultraviolet B (NB-UVB)
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee; Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to
      compare the efficacy, safety, and clinical benefit of the test and reference product after
      treatment for 84 days in patients with osteoarthritis of the knee.
    


Intervention name(s): Tramadol HCl Contramid® Once A Day; Tramadol HCl Twice a day
Intervention type(s): Drug; Drug
Intervention description(s): The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.; The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
Condition: Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction; Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      A crossover study to assess the effect of repeated doses of fostamatinib on the levels of
      oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will
      consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days
      each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib.
      The study will also evaluate the safety and tolerability of fostamatinib in combination with
      an oral contraceptive
    


Intervention name(s): fostamatinib; Microgynon® 30 (Oral contraceptive); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets, repeated doses for 21 days (2 x 50mg BID); Oral tablets, repeated doses; Oral tablets BID, repeated doses for 21 days
Intervention MeSH terms: Contraceptive Agents; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination; Contraceptives, Oral
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Phase 1, healthy female volunteers, oral contraceptive, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib
Microbotox for Lower Face Rejuvenation
Condition: Botulinum Toxin; Rejuvenation; Therapy; Neck
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficiency of the intradermal injection of
      botulinum toxin in lower face rejuvenation. The study will also compare this intervention
      with the "Nefertiti Lift" intramuscular injection technique.
    

Detailed description: 
      The abobotulinumtoxinA will be used for the intervention. The abobotulinumtoxinA will be
      prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK)
      vial. Further dilution to the appropriate Microbotox concentration will be done in the
      syringe itself. Each 1mL syringe of Microbotox solution will contain 20-28 units of
      onabotulinumtoxinA per mL of solution.

      Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with
      contraction)

      Injection points:

      A series of 100-150 intradermal microdroplets injection points 1 cm apart will be delivered
      in the lower face. The area to be injected is bounded by a line 3 fingerbreadths above and
      parallel to the lower border of the mandible, 1 fingerbreadth posterior to the depressor
      anguli oris, and all the way down over the cervicomental angle and anterior neck to the upper
      border of the clavicle, and posteriorly to the anterior border of the sternocleidomastoid.

      In the average patient, 2 syringes of 28 units per mL of microbotox will be used to cover the
      entire area.

      In heavier necks, 3 syringes of 28 units per mL will be used. In thinner necks, 2 syringes of
      20 units per mL will be used.

      Follow up will be done at 15 days for post injection pictures. A total of 15 patients will be
      recruited
    

Intervention name(s): Microbotox
Intervention type(s): Procedure
Intervention description(s): Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD
Condition: Interstitial Lung Disease; Scleroderma; Idiopathic Inflammatory Myositis; Mixed Connective Tissue Disease
MeSH terms: Myositis; Lung Diseases; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse; Connective Tissue Diseases; Mixed Connective Tissue Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Interstitial lung disease (ILD) is characterised by inflammation and scarring of the lung and
      is the leading cause of death in patients with systemic sclerosis, and contributes
      significantly to morbidity and mortality in many other connective tissue diseases (CTDs) such
      as polymyositis/dermatomyositis and mixed connective tissue disease. When ILD is extensive
      and/or progressive, immunosuppressive medication is often required to stabilize lung disease
      and alleviate symptoms. Current standard care for CTD associated ILD is extrapolated from
      studies performed in individuals with systemic sclerosis and comprises low dose
      corticosteroids and intravenous cyclophosphamide followed by oral azathioprine. In some
      individuals even this intensive immunosuppression is insufficient to prevent deterioration,
      and in a significant minority of affected individuals this results in respiratory failure and
      death. Rituximab has recently been reported as an effective 'rescue therapy' for stabilizing
      and even improving ILD in this patient group. Based on observations gained from this
      experience, the investigators believe that rituximab is a potential important alternative to
      current best therapy for this patient group. This study has therefore been initiated to
      evaluate the efficacy of rituximab (compared with standard therapy) in patients with
      progressive CTD related ILD.
    


Intervention name(s): Rituximab; Cyclophosphamide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: connective tissue disease; interstitial lung disease; pulmonary fibrosis; rituximab; scleroderma; polymyositis; dermatomyositis
Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      There is considerable evidence that increased blood glucose results in the generation of
      reactive oxygen species, ultimately leading to increased oxidative stress in a variety of
      tissues. This may lead to the activation of stress-sensitive intracellular signaling
      pathways, causing cellular damage and late complications of diabetes including renal injury.
      Although the investigators understanding of how hyperglycemia-induced oxidative stress
      ultimately leads to tissue damage has advanced considerably in recent years, effective
      therapeutic strategies to prevent or delay the development of this damage remain limited. The
      flavonoid complex silymarin, an extract from the milk thistle, and its major pharmacological
      active component silibinin are free radical scavengers and potent membrane stabilizers by
      preventing lipid peroxidation. Furthermore, during early stages of diabetes, flavonoids
      minimize oxidative stress, and inflammation which represent important factors in the
      development of diabetic nephropathy.

      In this study the investigators plan to evaluate the renoprotective effect of milk thistle
      extract on type II diabetic patients with kidney disease.
    


Intervention name(s): placebo; Milk Thistle extract
Intervention type(s): Drug; Drug
Intervention description(s): 140 mg placebo tablets, 3 times per day for 3 months; 1 tablet equal to 140mg silymarin administered 3 times a day for 3 months
Other intervention name(s): Livergol made by Goldaru Pharmaceutical Company (Iran)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic nephropathy; Type II Diabetes; Milk Thistle extract; Silymarin
Extension Study of Gelesis100 on Body Weight
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is designed to assess the effect of Gelesis100 on body weight after an additional
      exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least
      3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.
    


Intervention name(s): Gelesis100 (2.25 g)
Intervention type(s): Device
Intervention description(s): Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Condition: Ossification, Heterotopic
MeSH terms: Ossification, Heterotopic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether Arcoxia is effective in preventing
      heterotopic ossification after total hip arthroplasty.
    

Detailed description: 
      Rationale: Heterotopic ossification is a frequent complication after total hip replacement.
      Nonsteroidal anti-inflammatory drugs (NSAIDs) are known to effectively prevent heterotopic
      ossification, but gastrointestinal complaints are reported frequently. Selective
      cyclooxygenase-2 (COX-2) inhibiting NSAID produce less gastrointestinal side effects.

      Objective: Preventing heterotopic ossification. Study design: A prospective two-stage study
      design for phase-2 clinical trials with 42 patients to determine if Arcoxia (a COX-2
      inhibitor) 90-mg oral prevents heterotopic ossification. In the first stage, 19-patients are
      included. Another 23-patients are included when at least 90-percent of patients in first
      stage have Brooker classification 0, 1 or 2 at 6-months follow-up.

      Study population: 42-patients with cemented total hip arthroplasty age 18 - 75 yr old.

      Intervention: All subjects receive 90-mg Arcoxia oral for 7-days. Main study
      parameters/endpoints: The main study parameter is the degree of heterotopic ossification
      assessed on AP radiographs using the Brooker classification.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: No risks are associated with participating into the research. Besides the oral
      intake of Arcoxia, no extra burden is associated with participating in the study. The
      postoperative care does not change. Radiographic examinations will be routinely performed the
      day before surgery, immediately after operation, at 6-weeks and 6-months after surgery. The
      degree of heterotopic ossification will be determined by x-ray assessment.
    

Intervention name(s): Etoricoxib (Arcoxia)
Intervention type(s): Drug
Intervention description(s): Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
Other intervention name(s): Etoricoxib, Arcoxia
Intervention MeSH terms: Etoricoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Arthroplasty; Hip; Cemented; Heterotopic ossification; Selective Cyclooxygenase-2 Inhibitors; Arthroplasty, Replacement; Hip Prosthesis; Cyclooxygenase Inhibitors
Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster
Condition: Healthy
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will be conducted with the aim to investigate the dermal response (skin
      irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as
      compared to a Placebo TEPI Plaster in two phases:

      Induction Phase: multiple dose application of one active and one placebo plaster on 5
      consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and
      Challenge Phase: single dose application of one active and one placebo plaster which remain
      in place for 48 hours ± 30 min.
    


Intervention name(s): Ibuprofen 200 mg TEPI Medicated Plaster; Placebo TEPI Plaster
Intervention type(s): Drug; Other
Intervention description(s): Ibuprofen 200 mg TEPI Medicated Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK; Placebo TEPI Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment