bioihbjkbjnl/mcl2 huggingface dataset:
Syringe or Continuous Amnioreduction for Symptomatic Polyhydramnios. A Prospective Randomized Study.
Condition: Polyhydramnios
MeSH terms: Polyhydramnios
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficiency and maternal and fetal tolerance of two techniques of
      amnioreduction used in cases of symptomatic second and third trimester polyhydramnios:
      syringe manual aspiration technique (S group) and continuous suction technique (C group) set
      to - 250 mmHg
    

Detailed description: 
      Polyhydramnios is defined as more than 2 liters of amniotic fluid. Ultrasound diagnosis is
      made either by measurement of a deepest vertical pocket exceeding 8 cm, or by use of an
      amniotic fluid index (AFI) exceeding 25 cm. Potential complications of polyhydramnios are
      preterm labor, premature rupture of membranes, altered utero-placental perfusion, and
      maternal discomfort.

      Amniodrainage has become an established technique to improve maternal comfort and reduce the
      risks of severe polyhydramnios in both singleton and twin pregnancies, decreasing uterine
      contractility, as well as over-stretching of membranes and uterus. It also acts on the
      pathological processes of twin to twin transfusion syndrome.

      Several techniques are used to reduce symptomatic polyhydramnios. Passive gravitational
      drainage is long, does not allow to evacuate larger amounts of amniotic fluid and continuous
      maternal and fetal monitoring is difficult. The standard syringe technique is often a source
      of discomfort for both the patient and the operator. Continuous aspiration is faster and
      limits patient's discomfort.

      The aim of this study was to compare the efficiency and maternal and fetal tolerance of these
      two latter techniques of amnioreduction.

      A preliminary study permitted to assess the depression value created at the tip of the needle
      during amniodrainage: the syringe aspiration technique showed large depression variations
      from 0 to - 300 millimeters of mercury (mmHg). The continuous wall suction was thus chosen to
      be set to - 250 mmHg: depression at the needle's tip didn't vary during the procedure.
    

Intervention name(s): syringe aspiration; Wall suction
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amniodrainage; Pregnancy; Amniocentesis
Safety and Efficacy of a Probiotic Supplement
Condition: Gastrointestinal Discomfort
Study type: Interventional

Summary: 
      Exercise-induced gastrointestinal dysfunction is common amongst endurance athletes and is
      characterized by gastrointestinal permeability, also known as "leaky gut." Probiotics have
      been shown to improve gut permeability through the secretion of mucin, immunoglobulin A and
      improvement in stability of tight junctions between epithelial cells. This study will
      determine the efficacy of a probiotic containing the bacterial strains P. acidilatici, CECT
      7483, L. plantarum CECT 7484, L. plantarum CECT7485) in altering markers of gut inflammation
      and dysfunction, and symptoms of gastrointestinal distress.
    

Detailed description: 
      This study is a randomized, placebo-controlled, double-blinded crossover study where trained
      runners that experience moderate gastrointestinal discomfort with exhaustive runs will be
      subjected to the probiotic intervention/placebo supplementation for one month with a one
      month washout period. The intervention consists of the probiotic strains Lactobacillus
      plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1
      at a dose of 3b cfu/day. Probiotic/Placebo capsules will be taken once daily. Biological
      samples and symptom data collection will be collected at baseline and after one month of
      probiotic/placebo supplementation. Data are also collected after an in-house treadmill run
      after one month of supplementation.
    

Intervention name(s): I3.1; Placebo treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1.; Capsule containing maltodextrin.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
Condition: Cirrhosis; Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was aimed at testing the hypothesis that supplementing a meal with dark chocolate,
      which holds potent antioxidant properties, might attenuate the postprandial increase in the
      hepatic venous pressure gradient (HVPG, clinical equivalent of portal pressure) in patients
      with cirrhosis
    

Detailed description: 
      Previous studies showed that the intrahepatic circulation in cirrhosis is not able to adapt
      to sudden increases in blood flow, such as that occurring after a meal, due to endothelial
      dysfunction. This leads to a brisk increase in portal pressure (estimated by the HVPG). This
      method is therefore useful to assess the efficacy of compounds potentially ameliorating
      intrahepatic endothelial dysfunction. Dark chocolate, which contains a high proportion of
      cocoa flavonoids such as cathechin and epicatechin- powerful antioxidants, increases NO
      availability in the systemic circulation and improves systemic endothelial function. We
      hypothesised that the antioxidant properties of dark chocolate could be beneficial in
      patients with cirrhosis, since they might improve intrahepatic endothelial dysfunction.
      Consequently, the aim of this study was to evaluate whether a dark chocolate-containing test
      meal may attenuate the post-prandial increase in HVPG in patients with cirrhosis and portal
      hypertension.

      HVPG was measured at baseline and 30 minutes after the administration of a test meal
      supplemented by either dark or white chocolate. Portal vein blood flow and hepatic artery
      blood flow were measured by Doppler ultrasound. Catechins and NOx were determined for both
      timepoints.
    

Intervention name(s): DarkChocolate; WhiteChocolate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dark chocolatee 0.55 g/kg of body weight was given together with the test meal in sitting position after the baseline measurement of HVPG. The meal + chocolate was ingested in 8 minutes.; White chocolate 0.63 g/kg white chocolate (Lindt Excellence Natural Vanilla, Lindt & Sprüngli España) in an iso-caloric and iso-volumetric proportion adjusted to body weight was used as a control
Other intervention name(s): Lindt Excellence 85% Cocoa, Lindt & Sprüngli España
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dark chocolate; Catechins; Intrahepatic endothelial dysfunction; Cirrhosis; Portal Hypertension
Dermatological Evaluation of Topic Compatibility - Dermacyd Breeze
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the
      product Dermacyd Pocket BR.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hygiene
A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in
      healthy participants.
    

Detailed description: 
      This study will consist of six treatment periods.

      A total of 16 healthy male and female participants of non-childbearing potential will be
      randomized in this study to ensure at least 12 evaluable participants at the end of the last
      treatment period.

      The study will comprise of a Screening Period, six Treatment Periods, and a follow-up phone
      call:

        -  A screening period of maximum 28 days.

        -  Six treatment periods during which participants will be residents at the study center
           from Day -1 until Day 17.

      Each participant will receive 6 treatments.

      The following treatments will be given:-

        -  Treatment A: Dose A of AZD5462 film-coated tablet in a fasted state.

        -  Treatment B: Dose A of AZD5462 film-coated tablet in a fed state.

        -  Treatment C: Dose B of AZD5462 film-coated tablet in a fasted state.

        -  Treatment D: Dose B of AZD5462 oral solution in a fasted state.

        -  Treatment E: Dose C of AZD5462 film-coated tablet in a fasted state.

        -  Treatment F: Dose C of AZD5462 film-coated tablet in a fed state.

        -  A follow-up phone call will take place on Day 21 (± 1 day) to record adverse events
           (AEs) and concomitant medication.
    

Intervention name(s): AZD5462
Intervention type(s): Drug
Intervention description(s): Participants will receive AZD5462 orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Food effect; Relative bioavailability
Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Polymorphism at codon 16 of the beta2-adrenoceptor (beta2-AR) affects the responsiveness to
      salmeterol in asthmatics. Data concerning formoterol are more controversial in literature.
      The aim of this study was to verify whether homozygote for arginine-16 (ArgArg16) and
      homozygote for glycine-16 (GlyGly16) genotypes differently influence the long-term
      responsiveness to formoterol.
    


Intervention name(s): Formoterol
Intervention type(s): Drug
Intervention MeSH terms: Formoterol Fumarate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pneumological outpatient clinic
      
Biospecimen description: 
      white cells
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Condition: Healthy; Major Depression
MeSH terms: Depressive Disorder, Major
Study type: Interventional

Summary: 
      Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the
      growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach
      but has been also identified in a variety of other organs. Alike, a wide range of central and
      peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing
      factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and
      apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study
      are:

      A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the
      hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the
      hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30,
      35-45, 60-70 years).

      B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the
      HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with
      major depression (age range: 20-65 years).
    


Intervention name(s): ghrelin
Intervention type(s): Drug
Intervention description(s): acylated ghrelin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Comparing VR and Balance Exercises In Rehabilitation of Adolescent Athletes
Condition: Sport Injury
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      Ankle sprains are common injuries in active young people. Most of these injuries recovery
      quickly on their own, do not require imaging, and do better with early motion and
      rehabilitation. High ankle sprains and fractures are much less common but more serious. They
      may require imaging and more treatment.
    

Detailed description: 
      Phases of rehabilitation for ankle sprain Phase I treatment involves resting and protecting
      the ankle to permit healing, to prevent further injury, and to control pain and swelling.

      Phase II treatment begins once pain and swelling have subsided to the point where the athlete
      can comfortably bear weight and walk from place to place.

      Virtual reality (VR) is a simulated experience that can be similar to or completely different
      from the real world. Applications of virtual reality can include entertainment (i.e. video
      games) and educational purposes (i.e. medical or military training). Other, distinct types of
      VR style technology include augmented reality and mixed reality.

      Biodex Balance Training is one of the main tool that used to assess dynamic balance and
      dynamic limits of stability also it can used as training tool to improve the participant
      balance training
    

Intervention name(s): balance exercising
Intervention type(s): Other
Intervention description(s): selected physical therapy program strengthening the muscles of upper and lower limbs, balancing exercise, gait training in open environment,stretching for elbow flexors and forearms pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: G 1 (control) received traditional physical therapy program for 60 min. G 2(study) received traditional physical therapy program for 30 min. and virtual reality for 30 min. G 3 (study) received traditional physical therapy program for 30 min. and Biodex Balance Training all groups treated for four successive months.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: BalanceTraining,; Virtual Reality,; Ankle Instability.
Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
Condition: Influenza Infection
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with
      CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in
      healthy adults. Safety will be assessed by observation of symptoms, physical examination
      findings and laboratory safety testing.
    


Intervention name(s): Subunit influenza vaccine; Adjuvanted influenza vaccine; Adjuvanted influenza vaccine combined with CpG7909; Adjuvanted influenza vaccine combine with CpG7909; Adjuvanted influenza vaccine combine with CpG7909
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL single dose vaccine; 0.5 mL single dose vaccine; 0.5 ml influenza vaccine combined with 10 mcg of CpG7909; 0.5 mL single dose vaccine combined with 30 mcg of CpG7909; 0.5 mL single dose vaccine combined with 100 mcg of CpG7909
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Adjuvanted Influenza Vaccine
The Effect of Alternative Keyboards on Discomfort and Typing Kinematics
Condition: Pain
Study type: Interventional

Summary: 
      Awkward postures during computer keyboard use have been hypothesized to be one cause of
      musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity
      (MSD-UE). Alternative computer keyboards purport to reduce musculoskeletal pain/discomfort
      and have been shown to change aspects of keyboard users' kinematics under laboratory
      conditions. However, research that has examined the effectiveness of alternative keyboards in
      reducing musculoskeletal pain/discomfort in the workplace is equivocal, and no study has
      examined the association between postures and musculoskeletal pain. The Aims of this 3-year
      prospective double cross-over trial are: 1) To examine the effectiveness of an alternative
      keyboard in reducing reports of pain over 6-months; 2) To examine the neutrality and
      stability of postures during keyboard use; and 3) To identify which postures are associated
      with lower levels of musculoskeletal pain. Seventy-five computer users will be randomly
      assigned to one of two keyboard use orders: Group 1 - AB (standard keyboard, alternative
      keyboard); Group 2 - BA (alternative keyboard, standard keyboard). All subjects will use
      their assigned keyboards for 6-months before switching to the next keyboard. Every week,
      subjects will report their musculoskeletal pain levels. Just prior to and just after each
      6-month intervention subjects' kinematics performances on the keyboards will be recorded at
      the worksite using the Keyboard - Personal Computing Style (K-PeCS) instrument and in a
      laboratory setting using 3-dimensional motion capture technology.

      Aim 1: To examine the effectiveness of an alternative keyboard in reducing pain over
      6-months.

      Hypothesis 1 (H-1) - At six months subjects using an alternative keyboard will have
      significantly lower musculoskeletal pain levels than when using a standard keyboard.

      Aim 2: To examine the neutrality and stability of postures during keyboard use.

      Hypothesis 3 (H-2) - Subjects using an alternative keyboard will have significantly more
      neutral postures than when using a standard keyboard at baseline and at 6 months Hypothesis 3
      (H-3) - Subjects 6-months keyboarding postures will remain equivalent to the keyboarding
      postures documented at baseline.
    


Intervention name(s): Alternative Keyboard
Intervention type(s): Device
Intervention description(s): Subjects use either a typical or alternative keyboard
Other intervention name(s): Microsoft Natural Ergonomic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Clinical Carbetocin Myocardium Trial
Condition: Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized comparison of different cardiotoxicity of carbetocin and oxytocin.
    

Detailed description: 
      Carbetocin has been in clinical use in EU for some years and the efficacy is documented in
      several RCTs. Circulatory adverse events leading to death has been reported after intravenous
      injection of oxytocin. Some studies indicate that oxytocin may lead to dose dependent
      ischemic ECG changes, prolongation of QT time and liberation of biomarkers of myocardial cell
      death. Previously we have demonstrated comparable vasodilatory effects of oxytocin and
      carbetocin. There is no clinical study comparing the specific myocardial effects of oxytocin
      with carbetocin. It may have great impact on the choice of standard medication if the
      cardiotoxicity of carbetocin is lower compared with oxytocin. The study of potential
      cardiotoxicity has to be performed in healthy women. Knowing that millions of laboring women
      have had uneventful injections of oxytocin and carbetocin after delivery, there is probably
      no reason to fear long lasting negative effects of either drug. If there are differences in
      cardiotoxicity, this new information should be taken into consideration when planning
      delivery in pregnant women with heart disease.

      The aims of this study are to compare 0h (before C-section), 4h, 12h, 24h, and 48h plasma
      concentrations of Troponin I, Troponin T, proBNP, CK, and other relevant myocardial markers
      in elective healthy C-section patients randomized to oxytocin 2.5 U or carbetocin 100 µg, 1
      minute injection immediately after delivery.
    

Intervention name(s): Carbetocin; Oxytocin
Intervention type(s): Drug; Drug
Other intervention name(s): Pabal; Syntocinon
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine the bioavailability of cogniVida™ in 10 healthy male
      subjects after consumption of two different doses of cogniVida™ (50 mg and 100 mg) and to
      compare the plasma values with values obtained in subjects receiving rebaudioside A (303.68
      mg). In addition, also safety and tolerability parameters 24 hours after ingestion of the
      study compounds will be determined.

      cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by
      the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug
      Administration does not strictly regulate herbs and dietary supplements. The investigators do
      not claim that this supplement is meant to treat any ailment.
    


Intervention name(s): cogniVida 50mg/day; cogniVida100mg/day; Rebaudioside-A 303.7mg/day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules 25 mg (total 50 mg) cogniVida™ once a day; 4 capsules 25 mg (total 100 mg) cogniVida™ once a day; 4 capsules 75.92 mg (total 303.68 mg) rebaudioside A once a day
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety
Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and
      consumption of opioid after mastectomy.
    


Intervention name(s): Ultrasound guided serratus anterior block with ropivacaine; intravenous PCA only
Intervention type(s): Drug; Drug
Intervention description(s): After induction of anesthesia, patients take ultrasound guided serratus anterior plane block with 0.5ml/kg of ropivacaine 0.375%. 30minutes before the end of operation, intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient.; same dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: serratus anterior block; ultrasound; breast cancer; postoperative pain