bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome
Condition: Intrauterine Adhesion
MeSH terms: Gynatresia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to find out the benefit of the platelet-rich plasma in preventing
      reformation of intrauterine adhesions after adhesiolysis in cases of Asherman syndrome
    

Detailed description: 
      Patients fulfilling criteria will be randomized into three equal groups. The patients who are
      diagnosed previously with severe AS will choose an envelope which determines the treatment
      method. There will be 60 envelops assigning for the groups mixed together in one box. This
      will ensure a randomized allocation of patients to either group of this study.

      Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group,
      Adhesiolysis will be followed by intrauterine use of PRP then insertion of intrauterine Foley
      balloon catheter that will be inflated and left for 2 weeks. in the second group,
      adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter covered by
      freeze-dried amniotic graft and will be inflated and left for 2 weeks. In the third group,
      Adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter that will
      be inflated and left for 2 weeks. All patients will be given antibiotics and hormonal
      treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.
    

Intervention name(s): platelet rich plasma; amniotic membrane graft group; Intrauterine balloon
Intervention type(s): Biological; Combination Product; Device
Intervention description(s): Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions; amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions; intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients who are diagnosed previously with severe AS will choose an envelope which determines the treatment method. There will be 60 envelops assigning for the groups mixed together in one box. This will ensure a randomized allocation of patients to either group of this study. Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group, Adhesiolysis will be followed by intrauterine use of PRP then insertion of Foley balloon catheter. in the second group, adhesiolysis will be followed by insertion of Foley balloon catheter covered by freeze-dried amniotic graft. In the third group, Adhesiolysis will be followed by insertion of Foley balloon catheter. All foley ballon removed 2 weeks postoperative. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s
      while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell
      auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an
      association with T helper cells. In this study investigators aimed to investigate the
      difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects.

      The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used
      oral antidiabetics but insulin before and 31 healthy subjects (CG).

      Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)
      levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were
      compared with those in T2DPs and controls.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not
        used oral antidiabetics but insulin before and 31 healthy subjects (CG).
      
Biospecimen description: 
      Blood
    
Keywords: Type 1 diabetes; Type 2 diabetes; T helper 1 cytokines
Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether antiepileptic drug oxcarbazepine is
      effective in the treatment of chronic asthma.
    

Detailed description: 
      Effective therapy of asthma still remains quite serious problem. According GINA definition,
      asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides
      wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many
      specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides
      this, according to some authors, neurogenic inflammation may play important role in asthma
      mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are
      migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and
      valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in
      80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and
      trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in
      asthma therapy.

      We performed a double-blind, placebo-controlled 3-month trial for evaluation of oxcarbazepine
      efficacy in therapy of bronchial asthma. Oxcarbazepine is antiepileptic drug of new
      generation, produced by Novartis, and it is more effective and safe derivative of well-known
      antiepileptic drug carbamazepine.

      Comparison: Patients received investigational drug in addition to their usual routine
      antiasthmatic treatment, compared to patients received placebo in addition to their usual
      routine antiasthmatic treatment.
    

Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchial asthma; Oxcarbazepine; Antiepileptic drug; Efficacy
Acetaminophen Concentration in Cerebrospinal Fluid in Infants
Condition: Fever
MeSH terms: Fever
Study type: Observational

Summary: 
      Acetaminophen is the most commonly used drug in children. Inhibition of COX-3 in the brain
      has been suggested as the primary central mechanism by which acetaminophen decrease pain and
      possibly fever. However there is very limited data about acetaminophen concentrations in the
      brain and no such data is available for newborns. The objective of the current study is to
      describe concentrations of acetaminophen in the fluid around the brain of infants after
      administration of acetaminophen.
    

Detailed description: 
      The mechanism by which acetaminophen causes analgesia and antipyretic effect is not entirely
      clear. Recently a new COX isoenzyme was identified and termed COX 3. In humans this isoenzyme
      is most abundant in cerebral cortex and heart. Inhibition of COX-3 could represent a primary
      central mechanism by which acetaminophen decrease pain and possibly fever (10). An effect on
      of acetaminophen on presynaptic 5-HT(2) receptors in the hypocampus has been demonstrated
      (11) suggesting again that the primary effect of acetaminophen is in the CNS.

      Many studies (12-16) described the pharmacokinetics of oral and rectal acetaminophen in
      infants and neonates. Yet, the data on acetaminophen concentrations in the CSF is very
      limited. Two studies in adults (17;18) used intravenous propacetamol and described
      concentrations of acetaminophen in the plasma and CSF. Acetaminophen was detected as early as
      15 minutes after the administration and reached peak concentrations in the CSF at the 4th
      hour. A small study (19) of nine children who had indwelling ventricular drains found that
      cerebrospinal fluid concentrations lagged behind those of plasma with an equilibration half
      time of 0.72 h. This study did not describe CSF concentrations in neonates and used a dose of
      40mg/kg, which is higher than the recommended dose in children. To the best of our knowledge
      there is no data on acetaminophen CSF concentrations in neonates.

      The objective of the current study is to describe concentrations of acetaminophen in the CSF
      of infants after single administration of acetaminophen. A better understanding of the
      pharmacokinetics of acetaminophen and its penetration into the CSF will enable us to better
      predict the effects of this commonly used drug.
    

Time perspective: Prospective
Keywords: Acetaminophen; Fever; cerebro spinal fluid; Infants
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Condition: Type 1 Diabetes; Preservation of Insulin Secretion; Newly Diagnosed Type 1 Diabetes; Canakinumab in Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1
      class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the
      bioactivity of this pro-inflammatory cytokine.

      The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical
      trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous
      injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive
      standard intensive diabetes treatment with insulin and dietary management.

      Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12
      injections over one year.

      All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up
      until study end. Enrollment is expected to occur over two years.
    


Intervention name(s): canakinumab (anti IL-1beta); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months; Placebo subcutaneous injections
Other intervention name(s): canakinumab; anti IL-1beta
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: type 1 diabetes; newly diagnosed T1D; T1D; canakinumab; anti IL-1
Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents
Condition: Obesity
Study type: Interventional

Summary: 
      Large studies of children show that over half of the children in the United States of America
      do not have enough vitamin D stored in their bodies. In children who are overweight or obese,
      the percentage of children who do not have enough vitamin D is even higher.

      Vitamin D is essential for the body to maintain normal calcium levels and strong bones.
      Recent research shows that through the actions of inflammatory markers, levels in the blood
      that measure inflammation in the body, vitamin D plays many other important roles in the body
      like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.

      The purpose of this study is to determine the effect of vitamin D supplementation on
      inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like
      to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin
      D stores and inflammatory cytokines.

      In an observed, randomized controlled trial over 6 months we will provide observed vitamin D
      supplementation or placebo to healthy obese and overweight adolescents and measure changes in
      inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that
      administration of vitamin D to these patients will improve their inflammatory profile and
      cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).
    

Detailed description: 
      Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum
      25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese
      youth. Further studies are needed to establish the dose of vitamin D required to increase
      25OHD and determine potential effects on metabolic risk factors in obese teens.

      During the course of the study, blood pressure removed from the prespecified outcome
      measures.
    

Intervention name(s): Drisdol (Ergocalciferol) Vitamin D2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.; Placebo pill - 3 pills every 12 weeks for total of 24 weeks
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adolescents, Vitamin D
Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in
      total knee arthroplasty (TKA).
    

Detailed description: 
      The investigators conducted a prospective randomized controlled study in 165 patients
      American Society of Anesthesiologists (ASA) score I-III scheduled for primary TKA, divided in
      3 groups: group A (Etoricoxib 120 mg orally one hour before surgery), group B (Etoricoxib 120
      mg orally at the end of surgery) and group C placebo. Surgery has been performed under spinal
      anesthesia.

      All groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with
      intravenous (IV) Perfalgan and morphine on demand for the following 48 h.

      The effectiveness was evaluated by the time from the initiation of spinal anesthesia until
      the first analgesic dose at NRS > 3, the total amount of morphine in the first 24 and 48
      hours postoperative, the side effects and necessary amount of adjuvant medication.
    

Intervention name(s): Etoricoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.; Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.
Other intervention name(s): Arcoxia; Tauxib; Algix; Exxiv; Etozox; Sham pill
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: preemptive; postoperative pain; etoricoxib
Nitrate and Vitamin C on Vascular Health Oxidative Stress
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      The objective of this study is to examine whether the co-administration of dietary nitrate
      combined with vitamin C for 4 weeks in patients at risk for CVD would yield robust effects on
      endothelial function using blood measures and a non-invasive technique (Peripheral Artery
      Tonometry) compared to dietary nitrate supplementation alone.
    

Detailed description: 
      This is a 10 week randomized, cross-over, double-blinded, placebo-controlled study. This
      study was designed to compare the magnitude changes in RHI (primary outcome), plasma NO
      metabolites (nitrate and nitrite), and plasma vitamin C, plasma oxidized LDL, and blood
      (secondary outcome) following treatment with inorganic nitrate and vitamin C placebo (N) and
      inorganic nitrate combined with vitamin C (NC). Following baseline testing, eligible subjects
      were randomized to receive either treatment (N) or treatment (NC) for 4 weeks (period1), and
      participants were then crossed over to the alternate treatment for another 4 weeks (period
      2). There was a 2-week washout at crossover.
    

Intervention name(s): Dietary nitrate in the form of beetroot juice for all participnats; Nature Made vitamin c 1000 mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): participants asked to consume dietary nitrate in the form of beet juice everyday in the morning and then one hour later, the vitamin C capsules.; vitamin C and the placebo were provided as supplement capsules. Participants were asked to consume one dose/shot of sport Beet IT (70ml) that delivers on average 300-400mg of inorganic nitrate every day in the morning during the four-week study period, except for the test days and washout weeks. Accordingly, the participant were asked to consume the daily vitamin C supplement (1000 mg) or placebo one-hour post beetroot juice supplementation.; Vitamin C matched Placebo capsules that made from starch.
Other intervention name(s): Sport Beet IT shot
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover double blinded crossover study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nitrate; Vitamin C; Endothelial function; Nitric Oxide
The Impact of FIFA 11+ on Isokinetic Muscle Strength and Balance
Condition: Injury Prevention
Study type: Interventional

Summary: 
      FIFA 11+ program; It consists of simple, easily remembered, and time-consuming,
      sport-specific exercises underlying fair play. Although the FIFA 11+ program is a
      well-established warm-up protocol for injury prevention among football players, the
      performance improvement aspect of the program is not often discussed in the literature. The
      study's objective is to investigate the efficacy of the FIFA 11+ program on sports
      performance parameters such as dynamic balance, isokinetic muscle strength performance in
      adolescent amateur male football players.
    

Detailed description: 
      This study was planned in a randomized controlled experimental type. The footballers of a
      team from an amateur league will be included in the research. All participants will be tested
      at baseline and 9 weeks after baseline. The participants will be submitted to the following
      testing procedures: dynamic balance (Star Excursion Balance Test), muscle strength assessment
      (Isokinetic assessment). After the baseline measurements will be completed, the control group
      members will be advised to continue their regular warm-up program. This program consists of
      jogging and stretching exercises. The experimental group will complete the FIFA 11+ training,
      which consisted of six different types of running exercises; six exercises with three levels
      of increasing difficulty to improve the participants' strength, agility, core stability,
      eccentric control, etc.; and advanced running exercises, such as running across the pitch,
      bounding, planting, cutting. The FIFA 11+ will be applied to the experimental group 3 times a
      week for 9 weeks. The control group's warm-up duration will be matched to the experimental
      group's duration (20-25 min). This routine workout will perform 3 times a week for 9 weeks.
      At the end of 9 weeks, the evaluations will be repeated (Star Excursion Balance Test,
      Isokinetic assessment).
    

Intervention name(s): FIFA 11+ exercise program; routine program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): FIFA 11+ program; It consists of simple, easily remembered, and time-consuming, sport-specific exercises underlying fair play. The F 11+ consisted of 3 parts: the first part consisted of running exercises (part 1); the second part included six exercises, which were made up of three levels of difficulty and aimed at enhancing balance, strength, muscle control, and core stability (part 2). The final and the third part covered advanced running exercises (part 3) .; This program consists of jogging, and stretching exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: adolescent; football; physical performance
Sun Protection Factor Assay (SPF Assay 206/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code:Z09-067)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy of Chronic Hypnotic Use 2
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This proposal will assess risks for transition from therapeutic hypnotic use to abuse in
      people with insomnia. The investigators will study a hypothesized at-risk sub-population,
      insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects,
      eszopiclone, versus one without mood effects, zolpidem.
    


Intervention name(s): placebo; Zolpidem CR; Eszopiclone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Zolpidem; Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of our research study is to assess whether patients with EoE who have achieved
      control of their disease on topical Fluticasone or Budesonide are able to cycle or take
      breaks from their treatment with continued remission of their EoE. There will be 30
      participants enrolled in this study. There will be 15 patients who will stay on steroid
      therapy every day and 15 patients who will cycle their steroid therapy on and off to help us
      compare the two groups. The cycling group will cycle their steroid therapy in a three-months
      on three-months off fashion.
    


Intervention name(s): Fluticasone Propionate; Budesonide
Intervention type(s): Drug; Drug
Intervention description(s): Participants will cycle topical steroid in a three-months on three-months off fashion; Participants will cycle topical steroid in a three-months on three-months off fashion
Intervention MeSH terms: Fluticasone; Xhance; Budesonide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fluticasone; Budesonide; Adolescent; Cycling