bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
Condition: Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of
      development of ibuprofen-associated ulcers in patients who require long-term daily use of
      ibuprofen.
    

Detailed description: 
      HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine.
      The study is designed to determine whether the combination product reduces the rate of ulcer
      development in subjects who require long-term daily use of ibuprofen.

      Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either
      HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a
      24 week treatment period or until they develop either an endoscopically-diagnosed upper
      gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for
      Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical
      laboratory measurements made, at selected times during the study. Endoscopic exams will be
      performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks
      following study completion.
    

Intervention name(s): Ibuprofen/famotidine; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks; Ibuprofen 800mg administered orally 3 times daily for 24 weeks
Intervention MeSH terms: Ibuprofen; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ibuprofen; famotidine; ulcers; NSAIDS; pain; arthritis; chronic regional pain syndrome; chronic soft tissue pain; osteoarthritis; rheumatoid arthritis; chronic low back pain
Effects of Therapeutic Exercise in Patients With Fibromyalgia
Condition: Therapeutic Exercise; Chronic Pain
MeSH terms: Fibromyalgia; Chronic Pain
Study type: Interventional

Summary: 
      Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated
      with fatigue, sleep disturbances and some biochemical markers. The European League Againts
      Rheumatism (EULAR) described an algorithm how to treat step by step these patients.

      The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue,
      pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic
      markers.

      For this purpose, the investigators conduct a randomized controlled trial double-blind
      (patient and examiner). The investigators included patients diagnosed of fibromyalgia
      according to the American College of Rheumatology (ACR).

      Patients included one group receiving exercise therapy consisting of 3 treatment sessions a
      week over 10 weeks.

      The variables are measured at the beginning and end of treatment.
    


Intervention name(s): Therapeutic Exercise
Intervention type(s): Other
Intervention description(s): Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Molecular Assessment of Oral Mutans Streptococcus Isolated From Different Patients
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      90 saliva samples will be isolated from patient who possess different ages and caries
      activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then
      the determination of the best selective media for mutans streptococcus isolated from saliva
      and authenticate the MS via PCR technique.
    


Intervention name(s): oral mutans streptococcus
Intervention type(s): Other
Intervention description(s): quantitative assessment of mutans streptococcus of each group by using PCR and protein pattern
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients attending out patient clinic of October University for Modern Sciences and Arts.
      
Keywords: human saliva; mutans streptococcus; PCR; caries activity
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Condition: Improve Quality of Life; Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow,
      frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual
      abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml
      or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic
      disease.
    


Intervention name(s): combined contraceptive pills (microcept); medroxyprogesterone acetate (progest); mefenamic acid (ponstan forte)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral combined contraceptive once daily; oral 5 mg medroxyprogesterone acetate daily; oral 500 mg mefenamic acid three times per day
Other intervention name(s): microcept; progest; ponstan forte
Intervention MeSH terms: Mefenamic Acid; Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls
Condition: Healthy; Type 2 Diabetes; Endotoxemia
MeSH terms: Endotoxemia; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the present protocol is to study gene activity in fat and muscle tissue in type 2
      diabetics and healthy volunteers after injection of E. coli endotoxin.We hereby hope to gain
      insight in some mechanisms behind the association between inflammation and insulin
      resistance.
    

Detailed description: 
      Numerous studies have shown an association between low-grade inflammation and
      insulin-resistance in type 2 diabetics. It is also well-known that septic patients often
      develop insulin-resistance. The pathogenetic mechanisms behind the association between
      inflammation and insulin-resistance is not fully understood.

      In this study we create an experimental inflammation by giving E. coli endotoxin 0,3 ng/kg iv
      to type 2 diabetics and healthy controls. Muscle biopsies are taken at 0, 2, 4 and 6 hours
      after injection, while fat biopsies are taken 0, 2, 4, 6 and 8 hours after endotoxin. mRNA
      for adiponectin, leptin, PPAR-gamma, PGC-1, PAI-1 and cytokines in tissue is later measured
      by RT-PCR.

      Blood samples are drawn on an hourly basis until 8 hours after endotoxin injection for common
      biochemical analyses including white blood cell count. Plasma is spared and later analyzed
      for cytokines, PAI-1 and VCAM-1/ICAM-1.
    

Intervention name(s): Escherichia Coli Endotoxin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Low-grade inflammation; insulin resistance; Metabolism; Type 2 diabetes; Endotoxemia; Fat tissue; Muscle tissue; RT-PCR
Effect of Brief Mindfulness and Relaxation Inductions on Anxiety, Affect and Brain Activation in Athletes
Condition: State Anxiety; Affect; Electroencephalography
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The athlete population has a high risk of suffering from mental health problems (e.g.,
      anxiety), especially for athletes with individual sports. As such, various forms of mental
      training were used to maintain the mental health of athletes, such as mindfulness training or
      relaxation training. However, differences pertaining to the electrophysiological mechanisms
      resulting from both mental training in athletes are unknown. Therefore, the purpose of the
      current study was to examine the differential effects between the brief mindfulness induction
      (MI) and relaxation induction (RI) on state anxiety, affect and the activation of the brain
      in track and field athletes.
    

Detailed description: 
      The purposes of this study are: (1) examining the effect of brief mindfulness induction (MI)
      and relaxation induction (RI) on anxiety and affect in athletes with individual sports, (2)
      and we sought to identify the different brain activity (i.e., theta, alpha) changes between
      MI and RI using EEG. In the present study, subjects were contrasted using a within-subject
      comparison across MI, RI, and control condition. According to past works on the comparison of
      mindfulness and psychological skill training, we hypothesized that MI and RI would both
      improve anxiety and affect, compared with control condition. Furthermore, we also
      hypothesized that RI would elicit greater theta power (i.e., more cognitive control) than MI.
      In addition, when compared with control condition, participants might be elicited greater
      alpha power during the MI and RI.
    

Intervention name(s): Mindfulness induction (MI); Relaxation (RI)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In the MI condition, participants were guided to focus on present experiences regarding the thoughts, emotions and sensations through the three classic mindfulness exercises (i.e., focused breathing, meditation, and body scanning). The duration of MI was 30-minutes.; In the RI condition, participants were guided to relax each muscle group following the audio for 30-minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In a counterbalanced order, participants completed three conditions that incorporated two 30-minute experimental conditions (i.e., MI or RI) and a control condition (i.e., opened thinking)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Relaxation; Mental health; EEG; Cognitive resource
Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study will enroll people with SCI who have spasticity and some ability to walk. The goal
      is to understand if standing on a platform and receiving WBV results in decreased spasticity
      and improved walking ability. Published article is available (PMID: 29959653)
    

Detailed description: 
      Phase 1 of this study has been successfully completed. The results of Phase 1 indicate that a
      single session of WBV lasting for a total of 6 minutes (delivered in eight 45-sec bouts) at a
      high-frequency (50Hz) was associated with the largest decrease in spasticity (as measured by
      the pendulum test). The goal for Phase 2 is to determine whether longer doses of WBV result
      in greater reductions in spasticity as well as improvements in walking ability. Two different
      doses of WBV, a short dose and a long dose, will be tested.
    

Intervention name(s): Short Duration; Long Duration
Intervention type(s): Procedure; Procedure
Intervention description(s): During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 6 minutes of WBV at a frequency of 50 Hz.; During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 12 minutes of WBV at a frequency of 50 Hz.
Interventions will occur for a total of 20 sessions over 4 consecutive weeks .
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spasticity; whole body vibration; walking
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients
      with Parkinson's Disease
    


Intervention name(s): ONO-2506PO
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ONO-2506PO, Parkinson's disease
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.
    


Intervention name(s): Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories); Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Low-Level Laser Therapy and Flapless Corticopuncture Effect on Accelerating Six Maxillary Anterior Teeth Retraction
Condition: Malocclusion, Angle Class II, Division 1
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      The long time needed for orthodontic treatment is considered one of the biggest obstacles
      that make patients refuse to undergo orthodontic treatment. It also has many disadvantages
      including higher caries rates, gingivitis, and root resorption. Therefore, the purpose of
      this study is to evaluate the efficiency of two new noninvasive methods (Low-Level Laser
      Therapy and Corticopuncture) in accelerating orthodontic tooth movement for the implant
      supported En-Masse retraction of the six maxillary anterior teeth.
    

Detailed description: 
      This study will be a randomized controlled trial with a 1:1:1 allocation ratio. Sample size
      was calculated using Minitab version 15. 36 Participants recruited from patients attending
      the Department of Orthodontics and Dentofacial Orthopedics at Damascus University with class
      II division 1 malocclusion that indicates the extraction of first maxillary premolars will be
      randomly assigned into one of three groups: Low-Level Laser Therapy (LLLT) group, flapless
      corticopuncture group, or control group. Titanium mini-implants (1.6 mm diameter and 7 mm
      length) will be inserted between the maxillary second premolar and first molar at
      approximately 8-10 mm height above the archwires below the mucogingival junction. After
      complete leveling and alignment of the maxillary dental arch, which will be defined by
      passive insertion of 19*25 inch S.S. archwire, the retraction stage of the six maxillary
      anterior teeth will begin.
    

Intervention name(s): Low-Level Laser Therapy (LLLT); Flapless Corticopunture; Control
Intervention type(s): Radiation; Procedure; Other
Intervention description(s): LLLT will be applied in this group; Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur; Typical orthodontic treatment with no LLLT or flapless corticopuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthodontic Tooth Movement Acceleration
Safety/Tolerability Study of Alcohol Injection for Treatment of BPH (Enlarged Prostate)
Condition: Prostate Disease; BPH; Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy
MeSH terms: Prostatic Hyperplasia; Prostatic Diseases; Hyperplasia; Hypertrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Multi-center, prospective randomized dosing and safety research study. A maximum of 150 men
      will be enrolled in the study. Qualifying patients will receive one of three possible doses
      of the study drug. Symptoms will be evaluated before treatment, and then 1-week, 1-month,
      3-months, and 6-months following treatment.
    


Intervention name(s): dehydrated alcohol
Intervention type(s): Drug
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Prostate; BPH; Prostatitis
Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy
Condition: High Risk Pregnancy
Study type: Interventional

Summary: 
      The aim of the current study was to produce a high quality evidence on the best frequency of
      performing umbilical artery Doppler for high risk pregnant women in the third trimester.
    

Detailed description: 
      Nowadays, high risk pregnancy forms a significant increasing proportion of any pregnant
      population, according to some authors up to 50% of all pregnancies would have the label of
      high risk pregnancies.

      At present, it is recommended that high risk pregnancies, thought to be at risk of placental
      insufficiency should be monitored with Doppler studies of the umbilical artery. Doppler
      assessment of the placental circulation plays an important role in screening for impaired
      placentation and its complications of intrauterine growth restriction.

      The purpose of umbilical artery Doppler surveillance is to predict fetal academia thereby
      allowing timely delivery prior to irreversible end-organ damage and intrauterine fetal death.

      According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis,
      in which Published and unpublished randomised and quasi-randomised trials evaluating the
      effects of one or more described antenatal fetal surveillance regimens were searched, the
      optimal frequency of umbilical artery Doppler surveillance is unclear.

      Our randomized controlled study was conducted on patients with high risk pregnancies at their
      third trimester who attended Ain Shams University Maternity Hospital. A total of 292 high
      risk pregnant women fulfilling the inclusion criteria were selected by random sampling and
      divided between two groups with 146 patients in each group. Group I underwent Doppler every
      other week and Group II underwent Doppler once weekly.
    

Intervention name(s): Umbilical artery Doppler
Intervention type(s): Diagnostic Test
Intervention description(s): Umbilical artery Doppler ultrasound will be performed by most expert sonographer in umbilical artery Doppler at the special care unit, using a 3.5MHz transabdominal probe of SAMSUNG MEDISON, SONOACE R5 ultrasound machine, using the standard protocol of the unit for minimizing the interobserver variations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Our randomized controlled study was conducted on patients with high risk pregnancies at their third trimester who attended Ain Shams University Maternity Hospital. A total of 292 high risk pregnant women fulfilling the inclusion criteria were selected by random sampling and divided between two groups with 146 patients in each group. Group I underwent Doppler every other week and Group II underwent Doppler once weekly
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Plyometric and Eccentric Training in Improving the Strength, Stability and Ability of Women Soccer Players
Condition: Female Athlete
Study type: Interventional

Summary: 
      Introduction. The high rate of recurrence and clinical involvement of muscle injuries in
      lower limbs, makes the hamstring musculature a very important structure in the development of
      athletes. Excentric movements, where eccentric force and flexibility are fundamental, and the
      quadriceps-hamstrings contraction cycle are risk factors for hamstring muscle injury.

      Aim. ascertain the effectiveness of plyometric and excéntric exercises in the improvement of
      hamstring strength.

      Study design. Randomized, prospective, multicenter, single-blind clinical study with
      athletes.

      Methods. This study will be carried out with a sample of 40 women, federated players from 18
      to 30 years old. They will be randomized into two groups: experimental (plyometric work and
      eccentric exercises) and control (eccentric exercises). The intervention will last 6 weeks in
      which, before each training, they will carry out the intervention, for 20 minutes, 3 days a
      week. An inter-judges piloting will be carried out. We will analyze the normality of the
      sample with the Kolmogorov-smirnov test and for the inferential analysis, we will use the
      t-student test of paired data to observe the difference between each evaluation in each study
      group, and the repeated measures ANOVA to calculate the effect intra and intergroup. Using
      Cohen's formula we will calculate the size of the effect.

      Expected results. The eccentric work along with the plyometrics improves strength in
      hamstrings, jumping and stability.
    


Intervention name(s): Leg Squat Lounge; Control group
Intervention type(s): Other; Other
Intervention description(s): The players assigned to the experimental group will receive an intervention through plyometric and eccentric hamstring exercises; The subjects included in the control group will perform an eccentric work protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Isquiotibial; Plyometrics; Eccentric; Soccer; Prevention