bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
Condition: Pain, Postoperative Arthroscopy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with
      acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.
    


Intervention name(s): MK0966 / Duration of Treatment: 1 Days; Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days; Comparator: placebo (unspecified) / Duration of Treatment: 1 Days
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Rofecoxib; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Condition: Gastrointestinal Mucosal Damage
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluated the effect of oral fast-dissolving formulations of paracetamol and
      ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic
      examinations were conducted to determine the gastrointestinal damage produced post a 7 day
      treatment regimen.
    


Intervention name(s): Ibuprofen; Paracetamol; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Liquid gelation capsules or tablets of 400 mg strength; Paracetamol fast dissolving tablets of 500 mg strength; Placebo tablets
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the open multi-center study is to determine an efficient and safe dose and dosing
      schedule of NKT-01 in induction of response in treatment of lupus nephritis.
    

Detailed description: 
      The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to
      complete response during a minimum of 6 cycles of treatment without causing WHO grade 3
      leukopenia (WBC < 2x10^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and
      took OCS (<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the
      aim of the open multi-center study is to determine an efficient and safe dose and dosing
      schedule of NKT-01 in induction of response in treatment of lupus nephritis.
    

Intervention name(s): NKT-01
Intervention type(s): Drug
Intervention description(s): SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles.
Other intervention name(s): Deoxyspergualin, gusperimus
Intervention MeSH terms: Gusperimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupus nephritis; Deoxyspergualin; Immunosuppression
Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth
Condition: Overcoming the Failure of Anaesthesia; Maxillary Teeth; Dental Extraction
Study type: Interventional
Phase: Phase 4

Summary: 
      Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients
      were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines.
      Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of
      anaesthesia was objectively evaluated by using electronic pulp testing.
    

Detailed description: 
      85 patients in this study had successful local anaesthetic followed by extraction within the
      study duration time (10 minutes). However, there were six patients with failure anaesthesia
      (5 in prilocaine group and 1 in articaine group). By application Person's Chi-square test
      (x2), there were no significant differences in the number of the episodes of the anaesthetic
      success between articaine and prilocaine groups at time intervals (P-value = 0.5). T- test
      showed there have been no important variations within the mean onset time of anaesthesia for
      articaine and prilocaine buccal infiltrations (P-value =0.1).
    

Intervention name(s): Articaine 4%; Prilocain 3%; Adrenalin; Felypressin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Articaine 4% is dental local anaesthetic agent; prilocaine is dental local anaesthetic agent; adrenaline is a vasoconstrictor; Felypressin is a vasoconstrictor
Intervention MeSH terms: Felypressin; Carticaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blinded randomised trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Carticaine; dental extraction; injections; prilocaine
Conventional Impressions Versus Digital Impression Techniques for Implant Supported Screw Retained Prosthesis
Condition: Partial Edentulism Class 1
Study type: Interventional

Summary: 
      The purpose was to evaluate the accuracy of traditional and digital implant level impression
      procedures by using three-dimensional superimposition analysis , and evaluate the passive fit
      of screw- retained implant supported restorations fabricated using conventional and digital
      impression techniques in bilateral distal extension cases (class I kennedy classification)
    

Detailed description: 
      Eight patients who had missing all mandibular posterior teeth except first premolars were
      included in this study. In each patient, 4 implants were placed, 2 in each side to support 3
      units screw retained zirconia restorations. Three months after implant placement, each
      patient underwent two implant level impression techniques (n=8) for each technique:
      Conventional implant impressions CII (pick-up, splinted transfers), and digital implant
      impressions DII were captured with TRIOS 3 Shape intraoral optical scanner. In this study,
      digital impression was considered as a reference data.
    

Intervention name(s): Implant placement
Intervention type(s): Procedure
Intervention description(s): 4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar
4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Digital impression; implant impression; impression accuracy; Digital work flow
Telerehabilitation in Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Randomized controlled study on the effectiveness of Telerehabilitation intervention on
      subjects with knee osteoarthritis. Subjects will be randomized into two groups. The
      experimental group perform 3 sessions a week for 4 weeks of TR, the control group 3 sessions
      a week for 4 weeks of conventional rehabilitation c/o IOR rehabilitation gym. Follow-up at 3
      months.

      Inclusion criteria

        1. Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more
           indications, OARSI criteria.

        2. Male or Female, aged &gt; 18 years

        3. Participant is willing and able to provide informed consent for participation in the
           study.

        4. Subjects must be able to use an electronic device (pc, tablet, smartphone). Exclusion
           criteria

      1. Participation in another clinical study with any investigational agent within 30 days
      prior of the study screening.

      2. Inability to use an electronic device (pc, tablet, smartphone) 4. Diagnosed with dementia
      or neurological disease that impairs speech comprehension e Not verbal.

      5. Uncontrolled intercurrent illnesses including, without limitation, current infection or
      active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or
      psychiatric illnesses/social situations that would limit compliance with study requirements,
      illnesses neurological.

      6. Children under the age of 18 8. NPRS value <3 7. BMI >25
    


Intervention name(s): Exercises for Knee
Intervention type(s): Other
Intervention description(s): Four exercises for strengthening and mobility of the knee joint two in a sitting position and two in a standing position for a total of 20-25 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant
Condition: Anemia of Pregnancy
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is
      one of the most common complications during pregnancy. Anemia in pregnancy is defined as a
      hemoglobin level < 110 g/L . Anemia is an important risk factor in pregnancy which leads to
      both maternal and fetal morbidity and mortality.

      The pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common
      during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant
      women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to
      cover their increased need. The pregnant women should start taking a daily supplement of 30mg
      of elemental iron as a preventive measure against iron deficiency anemia especially in poor
      countries.

      Obesity is defined as having an excessive amount of body fat. The body mass index, a
      measurement based on height and weight, determines the obese if the figure more than 30
      kg/m2. There is an increased rate of overweight and obesity among pregnant women. According
      to the World Health Organization, 46% of adult females in Egypt are obese.

      Many researches in the literature revealed a strong relationship between high BMI in
      pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body.
      Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks
      iron absorption from the diet, so; hepcidin production is suppressed in the case of iron
      deficiency.
    


Intervention name(s): Iron; Complete blood count; Serum ferritin; Serum hepcidin; Serum Iron; Serum total iron binding capacity
Intervention type(s): Drug; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): PharaFerro27; Devart Lab Company, Egypt; to assess the anemia; to assess the anemia; to assess the iron abosrption; to assess the anemia; to assess the anemia
Intervention MeSH terms: Iron; Hepcidins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne
Condition: STAPHYLOCOCCAL INFECTIONS
MeSH terms: Staphylococcal Infections
Study type: Interventional

Summary: 
      Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and
      colonic) of S. aureus in patients without chronic digestive disease who are going to have a
      colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity
      of strains isolated from each site will be analyzed using molecular tools. The aim of this
      study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous
      infections due to this bacterium.
    


Intervention name(s): Staphylococcus aureus carriage
Intervention type(s): Other
Intervention description(s): nasal, throat, rectal and groin sampling with swabs. Colonic sampling by colonic biopsy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: staphylococcus aureus; digestive carriage; mucosal colonization
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to
      severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is
      more effective than placebo (inactive drug).
    


Intervention name(s): Placebo; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablets twice daily; oral tablets twice daily; oral tablets twice daily
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of the Efficacy & Safety of Natural Eggshell Membrane (NEM) for Joint & Connective Tissue Disorders
Condition: Osteoarthritis; Fibromyalgia
MeSH terms: Osteoarthritis; Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell
      Membrane (NEM) for the treatment of joint and connective tissue discomfort, pain, and
      flexibility.
    

Detailed description: 
      It is estimated that 140 million adults in the U.S. suffer from some form of joint or
      connective tissue (JCT) disorder (i.e. arthritis, lupus, gout, fibromyalgia, neck or back
      pain, etc.). As the population ages, this estimate is expected to grow rapidly. Traditional
      treatments for most of these disorders attempt to address only the symptoms (pain,
      inflammation, and discomfort) associated with the diseases. This usually involves the use of
      analgesics (i.e. acetaminophen, oxycodone, propoxyphene) or non-steroidal anti-inflammatory
      drugs (NSAIDs) (i.e. ibuprofen, diclofenac, celecoxib), alone or in combination. Most of
      these treatments have shown limited effectiveness in randomized controlled clinical trials
      (RCTs) or are known to have significant and sometimes severe side effects. To avoid the
      cardiac risks, gastrointestinal issues , and dependency issues associated with traditional
      JCT treatments (particularly with long-term use), many patients have turned to complementary
      and alternative medicines (CAMs) such as dietary supplements.

      Glucosamine, chondroitin, and methylsulfonylmethane (MSM) alone and in combination, are
      widely marketed as dietary supplements to treat joint pain due to osteoarthritis (OA). Other
      vitamins, minerals, and botanicals such as kava, pine bark extract, capsicum, boswellia root
      extract, turmeric/curcumin, etc. are also marketed for various JCT pain maladies. We present
      here the use of eggshell membrane as a possible new natural therapeutic for JCT disorders. A
      single center, open label human clinical study was conducted to evaluate the efficacy and
      safety of NEM® as a treatment for pain and inflexibility associated with joint and connective
      tissue disorders. Subjects were to take NEM, 500mg, once daily for 30 days. Subjects were
      then evaluated for pain and range of motion.
    

Intervention name(s): NEM
Intervention type(s): Dietary Supplement
Intervention description(s): see Treatment Arm
Other intervention name(s): Natural Eggshell Membrane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: arthritis; osteoarthritis; fibromyalgia; connective tissue disorder
Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      COPD patients have a reduced exercise tolerance due to a ventilatory limitation.

      Several studies have shown altered skeletal muscle function. The investigator will study the
      physiological response to knee-extensor exercise in COPD patients.
    

Detailed description: 
      Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise
      intolerance are ventilatory limitation leading to deconditioning and inactivity. However the
      weak correlation between exercise capacity and FEV1 implies that other factors than reduced
      pulmonary function contribute to this impairment as well. Several studies have found changes
      in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory
      cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction.

      Numerous exercise studies in COPD patients have shown physiological and physiological
      benefits of training and endurance training is now regarded as an important part in pulmonary
      rehabilitation.

      In this study we investigate training effects in patients with moderate to severe COPD with
      special focus on skeletal muscle.

      COPD patients will perform high intensity aerobic interval knee-extensor exercise training 3
      days/week for six weeks . At baseline and follow-up, muscle oxygen consumption and
      mitochondrial respiration will be measured.
    

Intervention name(s): High intensity knee-extensor training
Intervention type(s): Behavioral
Intervention description(s): High intensity aerobic knee-extensor exercise training, 4x 3 minutes interval training at < 90 % of peak power, 3 days/week for 6 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise; Knee extensor
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare and evaluate the single-dose oral bioavailability
      of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories
      Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fed conditions in
      healthy adult human subjects.
    

Detailed description: 
      Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose,
      Crossover, Oral Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets (Dr. Reddy's
      Laboratories Limited, India) With the Reference Formulation ZOLOFT® 100 mg Tablet (Pfizer,
      USA)Under Fed Conditions in Healthy Human Adult Subjects. 32 healthy, adult, human male
      subjects were enrolled in the study and all the subjected completed all the periods.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): Sertraline Hydrochloride Tablets 100 mg
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Sertraline; crossover
To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      In this study, the investigators demonstrated that in vivo THG microscopy can differentiate
      vitiligo lesions and normal skin based the optical nature of melanin. This THG-based
      procedure provides a valuable tool for noninvasive determination of third-order nonlinear
      susceptibility of melanin within the skin. It can also provide real-time histopathology
      information for treatment follow-up, without performing invasive skin biopsy.
    

Detailed description: 
      The investigators initiate this open, randomized, left-right comparative study to evaluate
      the efficacy of pulsed ultrasound in the treatment of vitiligo on the face or trunk. Face is
      included in this study because vitiliginous lesions on the face has a better treatment
      response and causes more psychological distress on the patients than vitiligo affecting other
      body areas. Thirty adult subjects with vitiligo affecting the face or trunk symmetrically
      will be recruited. After randomization, subjects will be administrated their ulrasound
      treatment twice a week for 24 weeks. Their original topical treatment and/or phototherapy
      will be continued. During follow-up visits, digital photographs will be taken for evaluating
      the extent of residual depigmentation. In vivo harmonic microscopy and three skin biopsy
      specimens will be performed at the indicated time points on the depigmented, repigmented
      areas and surrounding normal skin.
    

Intervention name(s): HGM
Intervention type(s): Device
Intervention description(s): To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Vitiligo; Harmonic Generation Microscopy; In Vivo
Belimumab Impacting Transplant Eligibility
Condition: Renal Transplant Rejection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a prospective, open label, phase I/II pilot study.
    

Detailed description: 
      This study is a prospective, open label, phase I/II pilot study. For Treatment Groups A and
      B, the duration of study will include a 5 month enrollment period and approximately 7 months
      of follow-up. For Treatment Group C, the duration of study will include a 3 month enrollment
      period and approximately 7 months of follow-up.
    

Intervention name(s): belimumab; Bortezomib; Rituximab; Plasmapheresis
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Belimumab will be administered per study protocol.; Bortezomib will be administered per study protocol.; Rituximab will be administered per study protocol.; Plasmapheresis will be administered per study protocol.
Other intervention name(s): benlysta; Velcade; Rituxan
Intervention MeSH terms: Rituximab; Bortezomib; Belimumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transplantation; belimumab; Velcade