bioihbjkbjnl/mcl2 huggingface dataset:
Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
Condition: Catheter Complications; Ambulation Difficulty; Bleeding; Back Pain; Oozing; Hematoma
MeSH terms: Hematoma; Mobility Limitation
Study type: Interventional

Summary: 
      The study aimed to assess the effect of position change and back massage versus early
      ambulation on post transfemoral coronary angiography complications.
    

Detailed description: 
      Post transfemoral coronary angiography (TFCA) may be associated with complications such as
      oozing, bleeding, ecchymosis, hematoma, and back pain. As a result, nursing practice must be
      geared toward enhancing patient safety post-transfemoral coronary angiography procedure. This
      study aimed to assess the effect of position change and back massage versus early ambulation
      on post transfemoral coronary angiography complications. A quasi-experimental research design
      was used to conduct this study at the Coronary Care Unit of the selected university hospital
      in Egypt. A convenience sample of 185 patients undergoing transfemoral coronary angiography
      was included in the study during the first 6 hours post-transfemoral coronary angiography and
      randomly assigned to two groups: 92 patients received position change and back massage (PCBM
      group), and 93 patients underwent early ambulation after the first 3 hours post-transfemoral
      coronary angiography (EA group). The used tool was "Post Transfemoral Coronary Angiography
      Complication Assessment".
    

Intervention name(s): Position change and back massage; Early ambulation
Intervention type(s): Other; Other
Intervention description(s): Changing the patient's position every two hours as follows in the same order: supine position with a head angle of 15°, semi-fowler position with a head angle of 30°, lateral right or left position with a head angle of 15°. Also, the researcher applied a simple stroke of lower back massage for 5 minutes every 2 hours; The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: coronary angiography; Complications; Early ambulation; Position; Transfemoral; Back massage
Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a combination of methotrexate and minocycline
      works better than methotrexate alone in early Rheumatoid Arthritis
    

Detailed description: 
      The purpose of this study is to determine if a combination of methotrexate and minocycline
      works better than methotrexate alone in early Rheumatoid Arthritis (RA). Specific aims of
      this study are:

      A. To demonstrate that the combination of minocycline and methotrexate is well tolerated when
      used in the first year of RA.

      B. To compare the efficacy of the combination of minocycline and methotrexate with
      methotrexate and placebo therapy in early sero-positive RA patients.
    

Intervention name(s): Combination of Minocycline and MTX or MTX alone; methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Methotrexate Dosing:
1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week.
3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week.
4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg; Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.
2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week.
4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week.
6, 8 and 10 month evaluations:
If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week.
If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 12 month evaluation: End of the blinded portion of the study.
Other intervention name(s): Rheumatrex®; Trexall®; Dynacin®; Minocin®; Myrac®; Rheumatrex®; Trexall®
Intervention MeSH terms: Minocycline; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study was to determine the efficacy and tolerability of 20 mg of
      Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic
      Rhinitis.
    


Intervention name(s): Bilastine; Desloratadine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg (encapsulated) tablets QD/14 days; 5 mg (encapsulated) tablets QD/14 days; (encapsulated) Tablets QD/14 days
Other intervention name(s): Aerius
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to
      assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated
      oral doses of SAR442168 with a food effect investigation in healthy adult participants.

        -  In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters
           of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed
           conditions

        -  In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid
           (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat
           meal)

        -  In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and
           metabolite(s) (high-fat)

        -  In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and
           metabolite(s) (standardized high-fat meal)

        -  In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters
           of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168
           given in fed conditions (moderate-fat meal).
    


Intervention name(s): Tolebrutinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, oral; Tablet, oral
Other intervention name(s): SAR442168
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery
Condition: Strabismus
MeSH terms: Strabismus; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of remifentanil on postoperative vomiting
      in children undergoing strabismus surgery during sevoflurane anesthesia.
    

Detailed description: 
      Children undergoing strabismus surgery frequently experience postoperative vomiting (POV)
      that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as
      well as decreased parental satisfaction and an unpleasant experience for the pediatric
      patients. Although administration of perioperative opioids increases POV incidence,
      remifentanil has less affect the incidence of POV than other opioids such as fentanyl.
      However, there are few study that evaluate the effects of remifentanil on the incidence of
      POV. Therefore, the investigators will conducted the study that the effects of remifentanil
      on the incidence of POV in children undergoing strabismus surgery during sevoflurane
      anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were
      assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0
      mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1
      mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the
      incidence of POV for 24 hours postoperatively, will be compared between three study groups.
    

Intervention name(s): High dose remifentanil; Low dose remifentanil; No remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes; Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes; Intervention: no remifentanil will be administrated
Other intervention name(s): High dose remifentanil (Ultiva,Glaxosmithkline, UK); Low dose remifentanil (Ultiva, Glaxosmithkline, UK); No remifentanil (Ultiva, Glaxosmithkline, UK)
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Postoperative Vomiting
Effects of Dark Chocolate on Exercise Capacity, and Mitochondrial Structure and Function
Condition: Heart Failure; Type 2 Diabetes
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The major goal of this study is to characterize the ability of dark chocolate enriched in
      epicatechin (a component of dark chocolate) to improve the structural and functional features
      of mitochondria in two groups

        1. Patients with heart failure (HF) and type 2 diabetes (DM2) and

        2. Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed
           by VO2 max)

      We propose that a 3 month treatment with dark chocolate will lead to a significant
      improvement in exercise capacity which will be secondary to the improvement in skeletal
      muscle structure from epicatechin.
    

Detailed description: 
      The flavanol epicatechin (which is derived from cocoa and has no known toxicity in humans)
      has been shown in clinical trials to increase levels of nitric oxide (NO) as assessed by
      flow-mediated dilation (FMD) in the brachial artery and measurements of circulating NO in
      plasma. NO is thought to be an activator of PGC-1 alpha [PPAR (peroxisome
      proliferator-activated receptor) alpha coactivator 1] which stimulates mitochondrial
      biogenesis. In both patients with heart failure and diabetes there is nitric oxide deficiency
      and mitochondrial dysfunction. In our proposed double-blinded placebo controlled clinical
      trial, we will test the hypothesis that chronic administration of epicatechin to patients
      with both heart failure and diabetes will increase levels of NO and PGC-1 alpha leading to
      increased mitochondrial biogenesis and improved mitochondrial function. We believe similar
      changes will occur in sedentary individuals.

      In a preliminary study with 5 patients with heart failure and diabetes (conducted under UCSD
      IRB protocol number #090688) we have shown that epicatechin enriched dark chocolate improves
      mitochondrial structure (Taub PR, Ramirez-Sanchez I, Ciaraldi TP, et al. Alterations in
      Skeletal Muscle Indicators of Mitochondrial Structure and Biogenesis in Patients with Type 2
      Diabetes and Heart Failure: Effects of Epicatechin Rich Cocoa. Clin Transl Sci.
      2011;5(1):43-47.)
    

Intervention name(s): Epicatechin-enriched dark chocolate; Low-epicatechin dark chocolate
Intervention type(s): Dietary Supplement; Other
Intervention description(s): For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days.; As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: mitochondrial biogenesis; skeletal muscle; epicatechin
Impact of Culture Conditions on the Embryo Quality
Condition: Embryo Development
Study type: Interventional

Summary: 
      The purpose of this study is to compare different culture conditions. The effect of the type
      of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5%
      versus 20%) will be evaluated on the embryo quality
    


Intervention name(s): Standard incubator; Mini incubator; 5% oxygen; 20% oxygen
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      There is an increasing interest in the use of metformin in CV diseases and there is an
      increasing interest in studying its potential new roles in heart failure patients. There were
      some concerns related to the safety of metformin in such diabetic patients due to the risk of
      lactic acidosis. However, recent studies showed that metformin was safe or even beneficial in
      HF patients. We hypothesized that metformin might improve morbidity, mortality, cardiac
      function, and HR-QoL in non-diabetic patients with HFrEF.
    

Detailed description: 
      Metformin is an anti-diabetic drug that is known improve insulin sensitivity and reduce
      insulin resistance. A published meta-analysis of randomized controlled trials (RCTs) reported
      a reduction of weight and insulin resistance in metformin users. Animal models also showed
      that metformin reduces cardiac hypertrophy. Observational studies showed a beneficial effect
      for metformin in patients with type 2 diabetes mellitus (T2DM) and heart failure. A recent
      study found that metformin reduced oxidative stress in non-diabetic patients with CAD.

      Metformin has multiple modes of actions involving both AMP-activated protein kinase (AMPK)
      dependent and AMPK-independent mechanisms that may be implicated in cardiac hypertrophy. At
      the systemic level, a review of clinical and experimental data showed that metformin improves
      endothelial function, protects from oxidative stress and inflammation, as well as the
      negative effects of angiotensin II. Observational studies also reported cardiovascular
      benefits in metformin users especially in patients with type 2 diabetes mellitus (T2DM) and
      heart failure. Metformin has also been shown to exert a cardio protective effect and it has
      been shown to reduce oxidative stress which is a common finding in heart failure patients.
      For these reasons, there is an increasing interest in the use of metformin in CV diseases and
      there is an increasing interest in studying its potential new roles in this aspect. We
      hypothesized that metformin might improve morbidity, mortality, cardiac function, and HR-QoL
      in non-diabetic patients with HFrEF.
    

Intervention name(s): Metformin Hydrochloride
Intervention type(s): Drug
Intervention description(s): Metformin 2000 mg/day
Other intervention name(s): Glucophage; Cidophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, interventional, randomized controlled, open label study. The study sample will include heart failure patients with pre-diabetes
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metformin; Heart failure; Non-diabetic; left ventricular mass index
The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
Condition: HIV Infections; Pregnancy
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether the rate of HIV transmission from mother to infant can be reduced by
      continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT
      during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of
      age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and
      the newborn infant.

      No method exists to prevent transmission of HIV from an infected mother to her newborn
      infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in
      theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to
      maternal virus, or by preventive treatment of the fetus before exposure.
    

Detailed description: 
      No method exists to prevent transmission of HIV from an infected mother to her newborn
      infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in
      theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to
      maternal virus, or by preventive treatment of the fetus before exposure.

      Patients are enrolled during their pregnancy, between 14 and 34 weeks of gestation. They are
      chosen by random selection to receive AZT or placebo. Treatment continues until labor at
      which time they begin to receive continuous intravenous study drug. Study drug treatment is
      discontinued after the umbilical cord is clamped. AZT is then offered all women as per
      labeled indications for 6 weeks postpartum, while appropriate medical followup is being
      arranged. Mothers who develop an AIDS defining illness or whose CD4+ cell counts decrease to
      less than 200 cells/mm3 during pregnancy are offered open-label drug at that time. The mother
      is followed by her primary obstetrician at an AIDS Clinical Trials Unit (ACTU) or subunit
      facility. The mother may deliver at the ACTU or a non-ACTU site. Treatment of the infant is
      started in the newborn nursery and continues on an outpatient basis. Infants receive the same
      study treatment as the mother for 6 weeks, and are monitored to week 78.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Primary purpose: Treatment
Keywords: Pregnancy; Pregnancy Complications, Infectious; Prenatal Exposure Delayed Effects; Administration, Oral; AIDS-Related Complex; Zidovudine
Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine
Condition: Open Reduction Internal Fixation(ORIF) of Lateral Malleolus
Study type: Interventional
Phase: Phase 4

Summary: 
      Regional anaesthesia has become the cornerstone of multimodal analgesia. With the advent of
      ultrasound guided nerve blocks regional anaesthesia has achieved both greater efficacy and a
      better safety profile as the injection of local anaesthetic is performed under direct vision.
      This has allowed a reduction of the amount of local anaesthetic injected as compared to
      peripheral nerve stimulation technique . Blockade of sciatic nerve combined with saphenous
      nerve provides anaesthesia and analgesia for ankle/foot surgeries. Various combinations of
      local anaesthetics have been used to provide optimal blockade . A mixture of lidocaine with a
      long acting local anaesthetic is commonly used. This provides a rapid onset of blockade, but
      of a consistently shorter duration compared to a long acting local anaesthetic alone. We
      hypothesize that sequential perineural injection of lidocaine and bupivacaine provides
      similar onset but a longer duration of sensory block compared to the same dose and volume of
      local anaesthetic mixed in advance.
    


Intervention name(s): 2% lidocaine/adrenaline and 0.5% bupivacaine
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sciatic nerve block; ORIF lateral malleolus; sequential injection; premixed injection; local anaesthetics
Audio-enhanced Analgesia in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether enhanced audio methods can be used to
      improve analgesia for experimental pain in healthy subjects.
    


Intervention name(s): Enhanced Audio; Audio
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science