bioihbjkbjnl/mcl2 huggingface dataset:
Arginine Therapy for Sickle Cell Disease Pain
Condition: Sickle Cell Disease; Vaso-occlusive Pain Episode
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine whether giving extra arginine, a simple amino acid, to
      patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful
      events (VOE) will decrease pain scores, decrease the need for pain medications or decrease
      length of hospital stay or emergency department visit. Funding Source - FDA OOPD.
    

Detailed description: 
      The purpose of this study is to determine the effects of IV L-arginine hydrochloride therapy
      in children with sickle cell disease (SCD) and vaso-occlusive pain events (VOE).
      Specifically, the impact on total opioid use (mg/kg) over the duration of their emergency
      department (ED) visit and hospital stay will be evaluated.
    

Intervention name(s): L-arginine; L-arginine Loading Dose; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.; One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg; Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
Other intervention name(s): Arginine; Arginine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Arginine Therapy
Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children
Condition: Antibiotic Associated Diarrhea; Clostridium Difficile Infection; Gastroenteritis
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus
      reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections
      in children and adolescents.
    

Detailed description: 
      Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving
      antibiotics (Bartlett, 2002). In hospitalized patients, AAD is related to significant
      increases in mortality, length of stay, and cost of medical care (McFarland, 2006).
      Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use;
      therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of
      significant medical and economic advantage (McFarland, 1998). A promising tool in this area
      is the probiotic Lactobacillus reuteri
    

Intervention name(s): L reuteri in children on antibiotics
Intervention type(s): Dietary Supplement
Intervention description(s): Each patient will be assigned to receive either a probiotic supplement containing 1 x 10 8 CFU Lactobacillus reuteri DSM 17938 in the form of one chewable tablet once per day (BioGaia AB, Stockholm, Sweden) or placebo, identical in taste and appearance. The probiotic or placebo will be taken 2 hours after lunch each day, during the entire period of antibiotic treatment and for an additional 7 days.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: probiotic; AAD; Lactobacillus reuteri; diarrhea
COUREUR Study Myocardial Inflammation in Cyclist Part 1
Condition: Myocardial Inflammation
MeSH terms: Myocarditis; Inflammation
Study type: Interventional

Summary: 
      The study will evaluate myocardial inflammation in cyclists after high intense and sustained
      exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be
      associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is
      associated with life-threatening arrhythmic events and sudden death. Although myocarditis
      seems to be the most likely underlying cause, it remains unclear if strenuous and sustained
      physical exercise can cause myocardial inflammation with development of myocyte necrosis and
      possibly myocardial fibrosis in athletes.

      Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride
      (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this
      study.

      In part 1 of the study, each participant will complete a detailed questionnaire detailing
      their training history and an echocardiography at rest will be performed. All participants
      will have exercise testing approximately 1 week before the EDT stage to set aerobic and
      anaerobic gas exchange thresholds, as well as VO2max.
    


Intervention name(s): exercise testing; Echocardiography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): To define the strenuous physical exercise in this study, each participant will be asked to perform two hours of high intensity (HIT)-effort during the endurance exercise of at least 6 to 7 hours. Therefore all participants will have exercise testing approximately 1 week before the physical exercise to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.; Measurements of mass, volumes and function will be obtained of both the left and right ventricles at rest enabling comparisons with cardiac MRI and traditional echo measures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the blood sodium level after 12 hours
      following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose
      5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
    

Detailed description: 
      Background: Despite prescription of maintenance IV fluids in hospitalized children is widely
      used since 1957 (Holiday & Segar), it is not always adequate for children with acute
      diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion
      in this group of patients due to nausea, stress, pain, and surgical interventions, and the
      use of hypotonic maintenance IV fluids.

      0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There
      is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not
      provide the adequate amount of sodium they require, leading to an increased risk of
      developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these
      children would prevent hyponatremia, but this treatment has not been totally studied yet.

      Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of
      the exclusion criteria will be considered for the enrolment after written informed consent.

      Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium.
      After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard
      maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg,
      and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45%
      NaCl/dextrose 5%, IV, at the same rate.

      Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.

      Children who required oral fluids will be excluded from per-protocol analysis, and only
      analyzed for intention to treat.
    

Intervention name(s): 0.45% NaCl/dextrose 5%; 0.3% NaCl/dextrose 5%
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface.; Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface.
Other intervention name(s): half saline; third saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyponatremia; Water-Electrolyte Imbalance
Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The aim of this study is to evaluate the quality of life of AMD patients related to vision
      using the short version of the National Eye Institute Visual Function Questionnaire
      (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical
      variables.
    

Detailed description: 
      Background and study aims. Age-related macular degeneration (AMD) is the most prevalent
      chronic progressive ocular disease. It has been shown in several studies that AMD affects the
      quality of life of patients. The aim of this study is to evaluate the quality of life of AMD
      patients related to vision using the short version of the National Eye Institute Visual
      Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with
      demographic and clinical variables.

      Who can participate? Patients with AMD, who wish to participate, will be recruited. Patients
      will be recruited from three locations of the Kazakh Scientific - Research Institute of Eye
      Diseases in Almaty, Nur-Sultan and Shymkent.

      What does the study involve? The study involves collecting demographic data of the
      participants, collecting baseline visual testing data from medical records, filling out of
      the NEI-VFQ-25, and answering two yes/no questions related to the social support and
      reliability of social support.

      What are possible benefits and risks of participating? Assessment of quality of life and
      social support of the AMD patients is a first step of developing targeted psycho-social
      support programs for AMD patients.

      Where is the study run from? Patients will be recruited from three locations of the Kazakh
      Scientific - Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent.

      When is the study starting and how long it is expected to run for? Start date 03/02/2020. End
      date 27/08/2022.

      Who is funding the study? No funding for this study. Who is the main contact? Principal
      investigator: Inara Ismailova; +380 73 200 0688; i.ismayilova@gmail.com
    

Intervention name(s): National Eye Institute Visual Function Questionnaire
Intervention type(s): Other
Intervention description(s): National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) measures the quality of life related to vision. This questionnaire has been validated for use on low vision patients.
Other intervention name(s): NEI-VFQ-25
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with diagnosed age-related macular degeneration
      
Keywords: age-related macular degeneration; quality of life; social support; reliability of social support; vision related quality of life
Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L in Children
Condition: Local Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to evaluate and compare the anesthetic efficacy of
      Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of
      badly decayed or unrestorable maxillary first primary molars.
    

Detailed description: 
      To our knowledge, no clinical trials in literature have been done to compare anesthetic
      efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly
      decayed upper first primary molars. Thus, the purpose of the present study was to fill this
      knowledge gap.

      This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine
      anesthetic solution where no clinical trials have been conducted on it yet in literature.
    

Intervention name(s): 4% Articaine Hydrochloride with 1:100,000 Adrenaline; 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin
Intervention type(s): Drug; Drug
Intervention description(s): new Egyptian articane anesthetic solution.; Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.
Other intervention name(s): %4 Alexadricaine; 2% Mepicaine-L
Intervention MeSH terms: Epinephrine; Racepinephrine; Nordefrin; Carticaine; Mepivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Accolade® TMZF® Hip Stem Outcomes Study
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate clinical and radiographic outcome data in patients
      implanted with the Accolade® TMZF® femoral stem.
    

Detailed description: 
      A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip
      stem device. All patients enrolled will receive the study device. All study patients will
      undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone
      mineral density (BMD) values.
    

Intervention name(s): Accolade® TMZF® Hip Stem
Intervention type(s): Device
Intervention description(s): Accolade® TMZF® Hip Stem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis
Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Stomatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer
      patients with radioactive stomatitis. Half of participants will receive ChiNing decoction,
      while others will receive recombinant human epidermal growth factor (rhEGF) spray.
    

Detailed description: 
      This study uses randomized, controlled clinical research methods, through the observation of
      the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal
      growth factor rhEGF spray on oral mucosal surface ) at different time points before and after
      radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG
      grade), quality of life score (EORTCQLQ-H&N35 scale), oral pain (VAS score) and patient body
      weight changes of the two groups. At the same time，this study takes cast-off cells of oral
      mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method
      to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.
    

Intervention name(s): ChiNing decoction
Intervention type(s): Drug
Intervention description(s): ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.
Other intervention name(s): Addition and subtraction of Liangge San
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: head and neck cancer; chemoradiotherapy; radioactive stomatitis
Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions
Condition: Relative Bioavailability; AUC; Cmax; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, cross-over study in healthy subjects performed at a
      single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of
      the study is to compare the pharmacokinetics (PK) of three different prototype capsule
      formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg
      under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be
      used as basis for choice of formulation for further pharmaceutical development.
    

Detailed description: 
      To assess the relative bioavailability of the different omega-3-carboxylic acids prototype
      capsule formulations in relation to Epanova® capsules 1000 mg under fed and fasted
      conditions.
    

Intervention name(s): D1400147; D14000136; D14000137; Epanova®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A; Treatment B; Treatment C; Treatment D
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Omega-3-carboxylic acids,; Phase I,; Healthy Subjects,; Pharmacokinetics,; Relative bioavailability
Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4
Condition: Stage 3 Chronic Kidney Disease; Stage 4 Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      a prospective, multicenter (outpatient clinics of the three participating hospitals in
      Beijing), double blinded and randomized placebo-controlled study.

      The study consisted of a 2-week run-in period and a 12-month treatment period.
    


Intervention name(s): Fu-zheng-qu-zhuo (FZQZ) oral liquid
Intervention type(s): Drug
Intervention description(s): FZQZ oral liquid is a herbal medicine, composed of astragalus, angelica root, rhubarb, etc, with the effect of reinforcing Qi and activating blood, dissolving dampness and downbearing turbid.
Other intervention name(s): FZQZ oral liquid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease; eGFR slope; Herbal medicine Fu-zheng-qu-zhuo Oral liquid
Hypnosis for Smoking Relapse Prevention
Condition: Smoking
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      A majority of smokers who quit return to smoking within three months of their quit date. This
      study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural
      counseling to promote maintenance of abstinence or relapse prevention in quitting smokers.
      The hypothesis is that hypnosis will be at least as effective as behavioral counseling in
      preventing relapse to smoking in smokers who are able to quit for at least three days.
    

Detailed description: 
      We will enroll 520 current smokers in the study. All subjects will participate in an initial
      smoking cessation intervention involving brief counseling and nicotine replacement therapy.
      Participants who are able to achieve at least 3 consecutive days of abstinence will be
      randomized to one of two relapse prevention interventions. The participants in Study Arm 1
      will receive a hypnosis intervention designed to facilitate relapse prevention. Participants
      in Study Arm 2 will participate in empirically-supported behavior relapse prevention
      counseling, utilizing the National Cancer Institute's Forever Free materials. Both
      interventions will be conducted in two 60-minute individual sessions scheduled one week apart
      in addition to counseling phone calls on their quit date and after relapse prevention
      treatment.

      Outcomes for the two study arms will be compared by assessing biochemically-validated
      point-prevalence smoking status at 9 weeks(end of treatment), 26 weeks and 52 weeks. Hypnosis
      for relapse prevention is designed to sustain the ex-smokers commitment to remain abstinent,
      to provide a review of behavioral skills to resist the temptations to smoke, and to encourage
      attempts to quit again if relapse occurs.
    

Intervention name(s): behavioral relapse prevention counseling; hypnosis for relapse prevention
Intervention type(s): Behavioral; Other
Intervention description(s): Behavioral relapse prevention counseling conducted in two one-hour sessions; Hypnosis for relapse prevention conducted in two one-hour sessions
Other intervention name(s): relapse prevention; hypnotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking
Neuromuscular and Cognitive Fatigue During a 24 Hour Treadmill Running Exercise
Condition: Healthy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The main purpose of the present study is to determine the relative contributions of central
      and peripheral fatigue during an ultra-endurance exercise.
    

Detailed description: 
      For that purpose, 14 subjects running 24 hours on a treadmill will be compared with a control
      group being awake during the same period. Subjects who running will have electrically evoked
      forces on the muscles associated EMG activity, blood samples and muscle biopsy.
    

Intervention name(s): running during 24 hours without sleep; no sleeping
Intervention type(s): Procedure; Other
Intervention description(s): patients running during 24 hours without sleep; patients without sleep during 24 hours
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Running during 24 hours; Voluntary evoked force on the muscles; Electrically evoked force on the muscles; EMG activity; Muscle biopsy; subjects will be recruited among experienced ultra-runners