bioihbjkbjnl/mcl2 huggingface dataset:
Ticagrelor in Human Endotoxemia Response to Human Endotoxemia
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      Rationale:

      In patients suffering a myocardial infarction the P2Y12 receptor antagonists prasugrel and
      ticagrelor improve outcome and prognosis compared to clopidogrel. Moreover, ticagrelor lowers
      mortality from pulmonary infections and sepsis, which cannot solely be explained by its
      platelet-inhibiting effect. An effect on the inflammatory response in the setting of acute
      myocardial might underlie this phenomenon and if substantiated support a novel beneficial
      mechanism of the new the P2Y12 receptor antagonists.

      Objective:

      To study whether ticagrelor, added to acetylsalicylic acid, modulates the inflammatory
      response to the administration of lipopolysaccharide (LPS) in humans in vivo, and to compare
      this effect with the P2Y12 antagonist clopidogrel.

      Study design:

      Prospective randomized placebo-controlled trial, according to a PROBE design (prospective
      randomized open blinded-endpoint study).

      Study population:

      Forty healthy male volunteers aged ≥ 18 and ≤ 35 years. Intervention (if applicable):
      Participants will be randomized to receive either placebo (twice daily), acetylsalicylic acid
      (80 mg once daily, after a loading dose of 160 mg) + placebo (once daily), acetylsalicylic
      acid (80 mg once daily, after a loading dose of 160 mg) + ticagrelor (90 mg twice daily,
      after a loading dose of 180 mg) or acetylsalicylic acid (80 mg once daily, after a loading
      dose of 160 mg)+ clopidogrel (75 mg once daily, after a loading dose of 300mg).

      Main study parameters/endpoints:

      Endpoints: area under the curve of the proinflammatory cytokines TNF-alpha, IL6, IL-10, IL1ra
      IL-8, IL-1β, MCP-1 MIP-1a, MIP-1b en IFN; peak concentrations of the various cytokines;
      plasma concentration of HMGP1; platelet-monocyte complex formation and markers of platelet
      function; plasma concentration of adenosine.
    


Intervention name(s): ticagrelor; Clopidogrel; Acetylsalicylic acid lysinate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 7 day treatment of ticagrelor 2dd90mg after a loading dose of 180mg; 7 day treatment of clopidogrel 1d75mg after a loading dose of 300mg; 7 day treatment of acetylsalicyclic acid 1d80mg after a loading dose of 160mg; 7 day treatment with placebo
Other intervention name(s): brillique; Plavix; Aspirin
Intervention MeSH terms: Aspirin; Acetylsalicylic acid lysinate; Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: endotoxin; LPS; ticagrelor; clopidogrel; acetylsalicyclic acid; placebo
Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the impact of the intake of a dietary supplement
      STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic
      syndrome.
    


Intervention name(s): Stablor; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bad News- Diagnosis: Epilepsy in Childhood
Condition: Epilepsy in Children
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      "Bad news" are defined as"any information which adversely and seriously affects an
      individuals' view of future. Families of chronic ill children are exposed to a high stress
      load. This project is to investigate the stress burden directly after diagnosis of epilepsy
      in childhood and coping capabilities in the course of time and how quality of communication
      at the time of diagnosis effects stress perception and coping behaviour in the following 12
      months.

      Perceived/ experienced advisory skills of the physician will be assessed by parents and
      children (older than eleven) on the basis of SPIKES - a Six-Step Protocol for Delivering Bad
      News.

      The subjective perception regarding quality of dialogue in relationship to childrens and
      their parents quality of life and their coping strategies will be assessed.
    


Intervention name(s): assessment of perception and evaluation of physicians advisory skills per questionnaire
Intervention type(s): Other
Intervention description(s): questionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with newly diagnosed epilepsy at the Universitäts-Kinderspital beider Basel
        (UKBB), Abteilung Entwicklungs-und Neuropädiatrie, Switzerland and their parents
      
Keywords: SPIKES - a Six-Step Protocol for Delivering Bad News; advisory skills
Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases
Condition: Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.

      PURPOSE: This clinical trial is studying the side effects and how well percutaneous
      cryoablation works in treating patients with painful bone metastases.
    

Detailed description: 
      OBJECTIVES:

        -  To confirm the safety of percutaneous cryoablation in the palliative treatment of
           patients with painful bone metastases.

        -  To determine the benefits of cryoablation of painful bone metastases by assessing pain
           intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life
           using a standardized SF-8 both before and after treatment.

        -  To determine the secondary benefits of cryoablation of painful bone metastases by
           assessing change in analgesic use following therapy.

        -  To determine the level of anesthesia required for cryoablation with a baseline level of
           conscious sedation planned for each treatment.

      OUTLINE: This is a multicenter study.

      Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using
      the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2
      decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at
      the same site or a new painful site ≥ 1 month after initial treatment may undergo one
      additional cryoablation treatment.

      Patients complete pain and quality of life questionnaires periodically.

      After completion of study treatment, patients are followed periodically for 2 years.
    

Intervention name(s): questionnaire administration; cryosurgery; pain therapy; quality-of-life assessment
Intervention type(s): Other; Procedure; Procedure; Procedure
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone metastases; pain; unspecified adult solid tumor, protocol specific
The Effect of Anaesthesia Depth on Oculo-cardiac Reflex
Condition: Strabismus; Anesthesia, General
MeSH terms: Strabismus
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to determine the effect of the depth of anesthesia on the
      oculocardiac reflex (OCR) during pediatric strabismus surgery.
    

Detailed description: 
      The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on
      the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients
      during strabismus surgery. It is presumed that the depth of anesthesia is one of the
      influencing factor on the OCR. But the clinical trials which are evaluating the relationship
      between the anesthesia depth and OCR are scarce. The main objective of this study is to
      determine the impact of the depth of anaesthesia that is adjusted with the bispectral index
      (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.
    

Intervention name(s): Desflurane; Bispectral index monitoring
Intervention type(s): Drug; Device
Intervention description(s): Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring; Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia
Other intervention name(s): BIS
Intervention MeSH terms: Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: reflex, oculocardiac; monitoring, intraoperative
Evaluation of the Effect of a Shiitake Extract on Lipid Profile in Subjects With Moderate Hyperlipidemia
Condition: Hypercholesterolemia; Hyperlipidemias; Dietary Supplements; Cardiovascular Risk Factor
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Effect of a dietary supplement with Shiitake extracts (Lentinula edodes) on lipid profile and
      other cardiovascular risk factors in subjects with moderate hyperlipidemia without
      pharmacological treatment.
    

Detailed description: 
      Prospective, parallel, randomized and double-blind clinical-nutritional study of 8 weeks of
      duration and 2 study groups (1) Food supplement with extracts of the fungus Shiitake; 2)
      Placebo supplement with maltodextrin) to evaluate the effect of a food supplement derived
      from the Shiitake mushroom (Lentinula edodes) on the lipid profile, other cardiovascular risk
      factors and the intestinal microbiota in subjects with hyperlipidemia moderate without
      pharmacological treatment.
    

Intervention name(s): Experimental product; Placebo product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 g/day; 10 g/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Milnacipran in Chronic Neuropathic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Low back pain is a public health problem affecting between 70-85% of adults at some time in
      their life. This study is being done to study the safety and effectiveness of the drug
      Milnacipran in treating chronic low back pain.
    

Detailed description: 
      This exploratory study aims to evaluate Milnacipran in individuals with chronic neuropathic
      low back pain. A sample of 40 individuals with chronic low back pain will be enrolled in a
      double-blind, randomized, parallel group study comparing twice daily administration of
      milnacipran with placebo (total 100 mg bid-or equivalent placebo dosing). The study will last
      6 weeks with subjects being evaluated at the start of the study, at the end of a one-week
      drug-free period, and at 1, 2 and 6 weeks of treatment. Additionally, subjects will evaluated
      after treatment has ended. Both standard endpoint outcome measures as well as validated daily
      self-report measures of pain and activity/disability will be utilized.
    

Intervention name(s): Milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.; 2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to
      the number of oocytes retrieved in women for assisted reproductive treatment.
    


Intervention name(s): Follitropin alfa
Intervention type(s): Drug
Intervention description(s): 150IU per day subcutaneously for a maximum of 16 days
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Assisted reproductive treatment; Superovulation; Follitropin alfa; r-hFSH; AFOLIA
The OBstetric Lidocaine Patch (OBLido) Trial
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be a single-center, single blind, randomized controlled trial. The study will
      be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of
      Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean
      delivery at UnityPoint-Health Meriter will be eligible.
    

Detailed description: 
      The purpose of this study is to determine whether transdermal lidocaine administered at the
      time of Cesarean delivery and for 12 hours postoperatively will reduce the total dose of
      opioids received. Our hypothesis is that a lidocaine patch will reduce the total dose of
      opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include
      patient self-reported pain scores, patient-reported incidence of side effects, such as
      pruritis, development of objective complications, such as serious skin reactions (examples
      are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal
      necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include
      length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours,
      use of supplemental oxygen during hospitalization, total dose of opioids during
      hospitalization, breastfeeding rates, both exclusive and in combination with formula use,
      amount of opioid prescribed at discharge and whether refills were requested or administered,
      rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen
      scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse
      outcomes will also be collected.
    

Intervention name(s): Transdermal Lidocaine Patch; Transdermal Hydrocolloid Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): Transdermal Lidocaine Patch; hydrocolloid placebo patches
Other intervention name(s): Actavis US; NDC 0591-3525-30; DuoDerm; ConvaTec
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, single blind, randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: lidocaine; patch
A Single Dose, Cross-over Bioequivence Study Comparing Galantamine IR (Immediate Release) Table and Galantmine OS (Oral Solution) in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is
      to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and
      galantamine tablet.
    

Detailed description: 
      This is an open-label, single dose, two-treatment, two-period, cross-over study to evaluate
      the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine
      tablet. All patients are healthy male patients who are 18-45 years old with BWI (Body Weight
      Index) between 18-28 kg/m2. All patients must sign informed consent before being enrolled. 24
      patients were randomized in the study. The duration of study is 9 days. All patients must
      stay at site unit for 12 hours after single oral administration otherwise patients could stay
      home but must return to site at specific date and time. The day before dosing day (baseline),
      patients were randomized to one of the two groups to be administered either 4mg galantamine
      oral solution (1ml) or galantamine tablet (1 tablet). After 7-day washout period, patients
      were crossed over to receive the other formulation. Pharmacokinetic observation will last to
      32 hours after dosing. Plasma were collected at immediately before dosing and 0.25, 0.5,
      0.75, 1.5, 2, 3, 4, 6, 8, 12, 24 and 32 hours after dosing to determine plasma concentration
      of galantamine. Safety and tolerance evaluation will last until Day 9. Safety evaluation
      include adverse events, vital signs, physical examination, electrocardiogram and laboratory
      tests. On study Day 1, patients will take either 4mg galantamine oral solution (1ml) or 4mg
      galantamine tablet (1 tablet). After 7-day washout period, on Day 8, patients will cross over
      to take the other formulation, the dosage and administration are the same.
    

Intervention name(s): Galantamine oral solution
Intervention type(s): Drug
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Galantamine oral solution; Galantamine tablet; Bioequivalence
Physiology of Weakness in Movement Disorders
Condition: Movement Disorders
MeSH terms: Movement Disorders
Study type: Observational

Summary: 
      This study will compare electroencephalograph (EEG) recordings in healthy volunteers and in
      people with movement disorders to examine brain activity associated with the weakness. EEG
      records the electrical activity of the brain ("brain waves").

      Healthy volunteers and patients with arm or leg weakness who are between 18 and 80 years of
      age may be eligible for this study. Healthy subjects are screened with a medical history,
      physical and neurological examinations, and a questionnaire. They must be right-handed and
      never have had a neurological disease or head trauma.

      All participants have an EEG. An elastic cap with electrodes is placed on the subject's scalp
      to record the brain's electrical activity. During the EEG, subjects are required to resist
      against a force with their arm, elbow, shoulder or leg for as long as they can. Several
      recordings are done with short breaks between them.
    

Detailed description: 
      Objective

      Give way weakness is a symptom often associated with psychogenic etiology, but its
      neurophysiological basis is poorly understood. Our objective in this study is to identify the
      cerebral mechanism of give way weakness.

      Study population

      We will study 6 patients with give way weakness and 6 healthy volunteers all age 18 years old
      or older.

      Design

      In this study, patients will try to resist against the examiner's force and subsequently give
      way. Electroencephalography (EEG) will be recorded while this maneuver is performed
      repeatedly.

      Outcome measures

      Movement-related cortical potential (MRCP) analysis will be performed on the data and its
      amplitude (in volts) and latency (in seconds) in each individual patient will be described in
      contrast to the data obtained from healthy volunteers.
    

Keywords: Movement-Related Potential; Electroencephalogram; Psychogenic Movement Disorders; Psychogenic Movement Disorder; Healthy Volunteer; HV
Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.
Condition: Iron Status; Fatty Acid Status
Study type: Interventional

Summary: 
      The objective of this study is to determine the influence of an increase of meat in
      complementary food on iron status and the effect of an exchange of vegetable oil in the same
      food on the status of omega-3 fatty acids in infants in the second six months of life.
    

Detailed description: 
      Because of rapid growth in the first year of life, infants are at a high risk to develop iron
      deficiency (ID) or even iron deficiency anaemia (IDA). Iron metabolism in infancy seems to be
      immature and to be affected by developmental changes and is not yet fully understood.
      Therefore studies with both, detailed dietary intake and a full set of biomarkers to
      characterize iron status or the risk of IDA are welcome.

      LC-PUFA, especially docosahexaenoic acid (DHA, n-3), are of important meaning in infants´
      neural development because neural tissues have a unique pattern of FA. DHA is predominantly
      found in brain and retina. LC-PUFA can be either supplied preformed by diet or converted from
      their essential precursors the polyunsaturated fatty acids (PUFA) linoleic acid (LA, n-6) and
      α-linolenic acid (ALA, n-3) by the organism dependent on the ratio of n-6/n-3 FA in the diet.

      In the case of iron as well as of PUFA and LC-PUFA very little is known about the nutritional
      supply and its effect on status in the second half of the first year of life. Therefore the
      objective of DINO is to examine the feasibility of increasing meat and of exchanging n-6 rich
      corn oil vs. n-3 rich rapeseed oil in common commercial menus and to examine the effects on
      iron status and on blood FA pattern respectively as primary outcome variables in a
      double-blinded randomized controlled intervention trial (RCT).
    

Intervention name(s): more meat and a vegetable oil rich in omega-3 fatty acids; Babyfood with usual meat content and corn oil
Intervention type(s): Other; Other
Intervention description(s): The vegetable-potato-meat-meal was given 5 to 7 times a week for at least during the seventh to tenth month.
The intervention meals had more meat (about 13 % of weight) and rapeseed oil (rich in omega-3 fatty acids).; The active comparator (which is the control group) got babyfood with usual meat content (8%) and with corn oil, which is rich in omega 6 linoleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: infant, complementary food, iron, meat, LC-PUFA, omega-3,; rapeseed oil, diet