cyrilzakka/clinical-trials huggingface dataset:
Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects

This study is designed to compare the serum sphingolipidomic analyses in healthy, pre-diabetic and diabetic subjects. age, sex and BMI are matched among these three groups. As ceramide, sphingosine, sphingosine-1-phosphate and sphinganine are involved in inflammation, immunity and cancer, investigators proposed a hypothesis that sphingosine-1-phosphate and other sphingolipids may be associated with the progress of type 2 diabetes. sphingolipids may be a biomarker for diabetes.

The first purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the weight among type 2 diabetes. 60 patients with diagnosed type 2 diabetes will be recruited. The serum concentrations of sphingolipid metabolites of 20 type 2 diabetic patients with obesity will be compared to age- and sex-matched series of 40 type 2 patients without obesity.

The second purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the process and severity of type 2 diabetes. The serum concentrations of sphingolipid metabolites of 20 subjects with type 2 diabetes will be compared to age-, sex- and BMI-matched series of healthy and pre-diabetic subjects. Investigators speculate that the serum concentration of sphingolipid metabolites are positively related with the progression of diabetes. In order to discover why serum sphingolipid metabolites correlates with the progression of diabetes, detailed information on HbA1c, duration of diabetes history and insulin resistance defined by homeostatic model assessment (HOMA-IR) will be analysed. These three parameters may affect the serum concentrations of sphingolipid metabolites.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of diabetes mellitus, type 2
* clinical diagnosis of prediabetic status
* older than 18 and younger than 90 years-old
* clinical diagnosis of insulin-resistance
* clinical diagnosis of newly onset of diabetes mellitus, type 2
* those who are willing to participate in the trial and sign the consent form

Exclusion Criteria:

* any cardiovascular disease (myocardial infarction, heart failure, cerebrovascular accident)
* missing information of BMI
* sever liver, kidney dysfunction
* sever pancreatitis or those who received pancreatectomy
* on medications of hormone, immunosuppressive therapy or drugs that may affect the bioactivity or concentration of sphingolipids (e.g. asprin )
* patients on pregnancy
* sever systematic diseases including carcinoma, mental disorder, sever anemia et al.
BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.

Stomach cancer is still the leading cause of cancer deaths globally and is reported to be the second leading cause of cancer deaths in Korea (18.7%). Although the number of radical resection has increased due to the development of early diagnosis, many patients experience recurrence after radical resection. It is also diagnosed as a non - resectable disease locally advanced at the time of initial diagnosis, or with a metastasis. In patients with recurrent / metastatic gastric cancer, conventional palliative chemotherapy is the best treatment, and in advanced gastric cancer, combination therapy with fluoropyrimidine (fluorouracil, capecitabine, S1) and platinum (oxaliplatin, cisplatin). The progression-free survival was 3-5 months, and overall survival of 6-10 months in metastatic gastric cancer patients.

The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic gastric cancer( Adenocarcinoma)
* Eastern Cooperative Oncology Group (ECOG) performance 0-2
* one more measure lesion
* White blood cell count (WBC) \> 3000/ul , Platelet \> 75,000/ul
* Normal kidney function (serum creatinine \< 1.5 ULN)
* Normal Liver function (Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) \< 3 times of upper normal limit, if liver metastasis, AST/ALT \< 5 times of upper normal limit)
* life expectancy is more than 3 months
* Conventional surgery that does not cause the transformation of the target lesion is allowed
* The patient who voluntarily decided to participate in this study and agreed in writing

Exclusion Criteria:

* Her-2 positive advanced gastric cancer
* Central nervous system metastases requiring treatment with symptoms
* Major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months)
* Uncontrolled infection or other serious diseases
* Patients with serious medical conditions or serious illnesses
* Patient who is pregnant or lactating
* Adjuvant chemotherapy before 6 months (patients who have not received platinum-based chemotherapy even if they are 6 months old can register)
* In the past, if the primary lesion or target lesion was treated with radiation (if the recurred lesion is outside the range of radiation therapy)
Evaluating the Analgesic Efficacy of Combined Individual Nerve Block in Comparison to Interscalene Nerve Block

Patients undergoing total shoulder arthroscopic adhesiolysis may experience severe postoperative pain. Inadequate pain management can result in unfavourable hospital outcomes and the development of persistent neuropathic manifestation the aim of the study is to compare both ultrasound techniques (combined individual nerve block to interscalene nerve block) as regards the postoperative analgesic effect and shoulder range of movement.

60 patients will be attached to standard monitoring, will have a secured intravenous line Then the skin overlying the procedure area will be sterilized. all patients will be randomly divided into two equal groups; group A will receive ultrasound-guided interscalene block (ISNB), and group B will receive ultrasound-guided selective nerve block (SNB) of the following nerves; suprascapular nerve block (SSNB), axillary nerve block (ANB), lateral pectoral nerve block (LPNB) and musculocutaneous nerve block (MCNB).

after delivering the nerve block and confirming sensory blockade by loss of cold sensation, all the patients will receive general anaesthesia with endotracheal intubation using Propofol 200mg, Atracurium 0.5 mg/kg, 100 micrograms fentanyl.

After the procedure ends, the patient will be extubated and transferred to the postoperative anaesthesia care unit. All patients will receive patient-controlled analgesia (PCA) in the form ketorolac 30 mg and paracetamol one-gram iv infusion.

The following parameter will be assessed and measured;

1. Intra-operative inhalation agent consumption
2. Intraoperative opioid consumption (fentanyl) if required.
3. Duration of postoperative analgesia and time for first rescue analgesia will be recorded. Rescue analgesia in the form of 100mg pethidine IM and 1 gm paracetamol IV will be given on the first call for analgesia and then repeated on demand. The total dose of pethidine and paracetamol are given throughout the first 24 hours will be recorded.
4. The time for asking for rescue analgesia in the first 24 h and the dose of the analgesic used will also be recorded.
5. The degree of postoperative pain assessed by Visual Analogue Scale (VAS)
6. Duration of the block: time from completing LA injection till complete recovery of sensory function, i.e., the patient feels a cold sensation
7. Postoperative range of motion of the operated shoulder
8. Patients" satisfaction (yes or no or somewhat satisfied)
9. Block-related complications will be also recorded e.g. paraesthesia, and postoperative motor weakness 24 hours after the surgery, pneumothorax and vascular puncture.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II
* scheduled for arthroscopic assisted adhesiolysis

Exclusion Criteria:

* restrictive lung disease,
* refusal of the procedure,
* coagulopathy,
* allergy to any of the used medications
Evaluation of Antagonist Wear Behavior and Patient Satisfaction of Zirconia Reinforced Lithium Silicate Glass When Compared to Monolithic Zirconia

evaluation of wear behavior and patient satisfaction of monolithic zirconia and zirconia reinforced glass crowns after follow-up periods 0,3,6,12 months.

two groups of patients will be selected according to special inclusion criteria n=13 in each group total of 26. each group will receive one of the crowns used in this study either ( monolithic zirconia or zirconia reinforced lithium silicate glass) after crown delivery wear and patient satisfaction will be recorded at 0,3,6,12 moths follow-up periods.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age range from 20-60 to be able to read and write in order to sign the informed consent document.
2. Patients physically and psychologically able to tolerate conventional restorative procedures.
3. Patients with no active periodontal and or pulpal diseases, having teeth with good restorations.
4. Patients with root canal treated teeth requiring full coverage restorations.
5. Patients indicated for full coverage (e.g. moderate to severe discoloration, coronal fracture, malposed or malformed teeth).
6. Patients willing to return for follow-up examinations and assessments

Exclusion Criteria:

1. Patients in the growth stage with partially erupted teeth.
2. Patient with poor oral hygiene.
3. Patients with psychiatric problems or unrealistic expectations
4. Patient with no opposite occluding dentition in the area intended for restoration.
5. Patient suffering from Para functional habits.
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Japanese Volunteers

The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy Japanese male volunteers aged ≥20 to ≤45 years and healthy Japanese male and female volunteers aged ≥65 to ≤80 years with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between ≥17 and ≤27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg
* Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator(s)

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator(s), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)
A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

The purpose of this study is to identify approximately 100 - 150 patients who have received Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South Carolina, and North Georgia from February 2004 - April 2009. Information regarding the incidence and severity of hypersensitivity infusion reactions to Vectibix (Panitumumab)will be captured. In patients who experienced hypersensitivity reactions, the following information will also be collected: premedication, treatment cycle symptoms that were experienced during chemotherapy, changes required in subsequent Vectibix (Panitumumab) or chemotherapy treatment, and outcome of the hypersensitivity reaction.


Eligibility Criteria:
Inclusion Criteria

* All patients treated with at least one treatment of Vectibix(Panitumumab) from February 2004 -April 2009 are eligible for the study. Patients may or may not have had an infusion reaction to Vectibix (Panitumumab). Major infusion reactions are defined as rapid onset airway obstruction(bronchospasm, stridor, hoarseness), urticaria, erythema, and/or hypotension, anaphylaxis. Minor infusion reactions are defined as transient flushing or rash, urticaria, dyspnea, drug fever.
* Patients who have received treatment with an EGFR in the past are eligible.

Exclusion Criteria

* There will be no exclusions based on age, sex, medical history, or use of concomitant therapies. All charts will be abstracted for the same information, through completion of the last chemotherapy cycle.
Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.

Neck pain ranks as the 4th leading cause of disability, with high prevalence of mechanical neck pain in young population. As high as 30% of %. Individuals suffering from neck often report difficulty in performance of daily life, absence from work and decreased productivity. Several manual therapy treatment approaches are used for mechanical neck pain. The focus of this study is to compare the effectiveness of thrust and non-thrust thoracic manipulation for the treatment of mechanical neck pain in young population

craniovertebral angle, cervical range of motion and pain will be noted for each participant.

Eligibility Criteria:
Inclusion Criteria

* Both genders
* Age: 18-24 years
* Symptoms \<30 days
* FABQPA score \<12
* Increased upper thoracic spine kyphosis (visual estimate)
* CVA \< 48 Degrees

Exclusion Criteria

* Symptoms distal to shoulder
* Aggravation of symptoms with looking up
* Radiating lower back pain
* Neurological deficit
* Previous surgery
* Spondylolisthesis
* Spinal stenosis
* Inflammatory disease
* Vertebrobasilar artery insufficiency
* Pregnancy
Improving Provider Counseling Interventions in HIV Practice

Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues from a brief computer survey on risk behaviors of their patients can counsel have an impact on patient's risk behaviors.

This is a randomized controlled study. The purpose of this study is to assess the impact of the cue sheet as an aid to targeted provider behavioral counseling. All enrolled participants are HIV+ adults seen for regular medical care at a site affiliated with the Johns Hopkins AIDS Service. After consenting, participants will take an audio-assisted computer interviews to collect patient risk assessment data. For participants randomized to the intervention arm, the printed output on risk behaviors is then given to the provider along with cues for staged-based counseling for use during the same visit. Participants in the control arm take the same computerized risk assessment but there are no printed cue sheets. Risk behaviors of all participants are assessed at entry, at 6 months, and at 12 months. The main outcome measure is change in HIV transmission behaviors at 12 months for those in the intervention arm compared to the control arm.

Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive
* English speaking

Exclusion Criteria:

* Cannot give informed consent
Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study

Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Hypotonic fluids are still the most commonly prescribed IV fluids for pediatric hospitalized patients. However, previous studies, including children older than one month of age revealed that traditionally used hypotonic fluids may lead to hyponatremia.

Because of the absence of evidence-based data, there is currently no clear consensus on the optimal composition of maintenance intravenous fluid therapy in newborns, leading to wide practice variation.

The National Clinical Guideline Center (NICE) 2015 recommends the use of isotonic fluids in term newborn infants and some newborn centers has begun to use isotonic fluids since guidelines recommendations. Since the publication of the NICE guideline, no studies have addressed this topic.

In this prospective, observational , multicentric study, conventional hypotonic fluids containing sodium chloride (NaCl) \< 130 mmol/L compared with isotonic fluids (containing NaCl between 131-154 mmol/L) in terms of the risk of hyponatremia, hypernatremia, plasma sodium (pNa) level change, treatment morbidities, hospitalization duration and mortality.


Eligibility Criteria:
Inclusion Criteria are:

* Term newborns (\>37 + 0/7 weeks) aged 24 hours to 30 days with a normal baseline serum sodium level between 135-145 mmol/L,with a treatment plan to include IV fluids at \> 50% of maintenance
* Infants not received parenteral fluids in the last 24 hours before participation
* Infants receiving IV fluid administration at 50% to 100% of maintenance

Exclusion Criteria:

* Newborns with diagnoses that required specific fluid tonicity and volumes such as:

  * Severe dehydration presenting with shock
  * Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
  * Renal insufficiency
  * Adrenal insufficiency
  * Diabetes mellitus and diabetes insipidus
  * Hypoxic ischemic encephalopathy
  * Major congenital anomaly
  * Patients receiving diuretic therapy
  * Patients with obvious edema
  * Heart or liver failure, portal hypertension with acid
  * Pre-post operative patients
  * Infants receiving total parenteral nutritional therapy
  * Other: all conditions that require non-standard liquid content and quantities
Effects of L-ARGinine and Liposomal Vitamin C Supplementation On Physical Performance

In older age, reduced mobility is associated with an increased risk of reduced quality of life, disability, institutionalisation, and death, as well as increased healthcare expenditures. Sarcopenia is a condition characterised by a reduction in muscle mass and strength and/or function. It is associated with several adverse outcomes, such as falls, increased risk of infection, disability, institutionalisation, and death. Currently, no pharmacological treatments are available to combat sarcopenia. The management of sarcopenia relies on the adoption of an active lifestyle, comprising resistance exercise, which may be supported by an adequate intake of protein with the diet. Recently, treatment with L-arginine and liposomal vitamin C has been shown to significantly reduce fatigue, and improve physical performance and endothelial reactivity in adult patients with Long COVID. Long COVID may be considered a model of accelerated ageing, as it recapitulates several age-associated biological processes, including chronic inflammation, oxidative stress, endothelial dysfunction and malnutrition.


Eligibility Criteria:
Inclusion Criteria:

* probable sarcopenia defined according to EWGSOP2 criteria

Exclusion Criteria:

* Inability or unwillingness to provide informed consent;
* NH residents;
* schizophrenia or other psychotic disorders, bipolar syndrome;
* consumption of more than 14 alcoholic beverages per week;
* reduced cognitive performance (Mini-Mental State Examination score \<26);
* severe arthrosis;
* malignancies requiring treatment in the previous 3 years;
* lung disease requiring chronic corticosteroid therapy or oxygen therapy;
* severe cardiovascular disease;
* Parkinson's disease or other developmental neurological disorders;
* renal failure undergoing dialysis treatment;
* chest pain, severe dyspnea or conditions that may pose safety concerns when performing the 6-minute test or chair test;
* other medical, psychiatric or behavioral factors that, in the judgment of the researcher, may interfere with participation in the study;
* other illnesses related to an estimated life expectancy of less than 12 months.
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline

This clinical trial will evaluate the ease of conducting a randomized trial on patients with severe head injury who are cared for by paramedics in the out of hospital setting. The trial will compare two different kinds of fluids that are commonly used to elevate blood pressure and minimize the impact of the brain injury. The two solutions are a salt solution of different concentrations. One is a normal saline solution similar to the consistency of human blood and the other is a higher concentration mixed with a sugar that helps to keep the solution in the blood stream longer. This study is conducted without patient consent at the time of the study enrolment. The study will report on whether this trial is feasible in the out of hospital setting before launching into a larger definitive trial.

The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT) is a randomized, placebo-controlled out of hospital trial of blunt trauma patients with head injuries. The study compares a group receiving normal saline according to a paramedic's protocol, with a treatment group receiving a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 (RescueFlow BioPhausia AB, Stockholm Sweden).

The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds\*, specifically addressing:

1. baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial.
2. randomization compliance rate.
3. ease of protocol implementation in the out-of-hospital setting.
4. adverse rate of HSD infusion.

The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.

\*Lancaster, G.A., S. Dodd, and P.R. Williamson, Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract, 2004. 10(2): p. 307-12.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16;
* Initial assessment of GCS 8 or less;
* Blunt traumatic mechanism of injury.

Exclusion Criteria:

* Known pregnancy;
* Primary injury penetrating;
* VSA prior to randomization;
* Previous Intravenous therapy ≥ 50 ml;
* Time interval between arrival at scene and intravenous access exceeds four hours;
* Amputation above wrist or ankle;
* Any burn (thermal, chemical, electrical, radiation)
* Suspected hypothermia;
* Asphyxia (strangulation, hanging, choking, suffocation, drowning)
* Fall from height ≤ 1m or ≤ 5 Stairs