cyrilzakka/clinical-trials huggingface dataset:
Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia

The purpose of the study is to evaluate the cardiac output changes after an intravenous bolus of ephedrine, phenylephrine, ondansetron or norepinephrine during a spinal anesthetic for a cesarean delivery.

For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study includes 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of four groups.

This study will be a prospective, randomized, double-blind controlled trial. After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 4 treatment groups prior to cesarean delivery.

Group A: 9 mg of ephedrine Group B: 100 mcg of phenylephrine Group C: 8 mg of ondansetron Group D: 0,25 mcg/kg of norepinephrine Baseline arterial blood pressure and heart rate will be measured in the left lateral tilt position, before anesthesia and then every minute.The cardiac output is calculated on the apical cut 5 cavities, before anesthesia and then every 5 miutes. No fluid preloading will be administered till delivery.

The primary endpoint is cardiac output changes in each groups. The secondary endpoint is the number of provider interventions needed to maintain the SBP within 80-120% of baseline for each groups.

Bradycardia (HR less than 50 BPM) will be treated with 1 mg of Atropine. Hypotension ( decrease of more than 20% of the baseline value or a PAS \<90 mm Hg) will be treated with 6 mg of ephedrine, without any fluid loading.

The spinal anesthesia will be carried out in a seated position, level L3-L4 or L4-L5 with a slow injection over 30 seconds of a mixture of 10 mg of 0.5% Bupivacaine with 5 mcg of Sufentanil. The hot / cold test to determine the block level is required. A spinal anesthesia is validated if the cold test reaches the T4 level. The 10 ml syringe will be administered immediately after spinal anesthesia. The patient will be placed in the left lateral tilt position of 15¤, then put back into strict DD immediately after the delivery. Cardiovascular parameters (PAS, PAM, PAD, HR) will be recorded every minute until delivery. Echocardiographic measurement of cardiac output will be recorded every five minutes until delivery.

Measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, cardiac output, incidence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.

Eligibility Criteria:
Inclusion Criteria:

* ASA I / II
* Caesarean section, non-twinned

Exclusion Criteria:

* heart disease
* HTA
* non-gestational diabetes
* pre-eclampsia
* sepsis
* BMI greater than 40
* contraindication to spinal anesthesia: patient refusal, medicinal allergy, long QT syndrome.
Small Doses of Dexmedetomidine for Emergence Agitation

Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and adults,especially in elderly patients(\>64 years) after using sevoflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. obtain informed consent;
2. patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time \> 2h;
3. the American society of anesthesiologists (ASA) class I-II;
4. age\>64 years old;
5. BMI\<28kg/㎡;

Exclusion Criteria:

1. systolic pressure≥180mm Hg or\<90mm Hg, diastolic pressure≥110mm Hg or\< 60mm Hg;
2. serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
3. patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
4. HR\<50times/min
5. a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
6. a history of alcoholism
7. diseases of the neuromuscular
8. a tendency to malignant hyperthermia
9. allergy to test drugs or have other contraindications
10. participated in other clinical drug researches over the past 30 days
Frailty Screening in the Swedish Emergency Department Setting

This prospective observational study will investigate the correlation of frailty in relation to serious outcomes. Serious outcomes are defined as: mortality within 30 days, admission to hospital, length of stay in the Emergency Department(ED), in hospital length of stay and revisits to the ED.

The exposure, frailty, will be assessed according to Clinical Frailty Scale. ED patients \>65 years of age in a Swedish regional health care system (Region Östergötland, Sweden) comprising three EDs in Linköping, Norrköping and Motala. The outcomes will be compared according to the degree of frailty and censored over 7, 30 and 90 days respectively.

Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality.

The clinical frailty scale (CFS) is a measure of frailty based on clinical judgement in a 9 level scale, categorized as "vulnerable" (1-4), "mildly frail" (5), moderatly frail (6) and severely and very severely frail (7-8).". A validation study of the CFS in community-dwelling older people showed that it performed better than measures of cognition, function or comorbidity in assessing risk for death. In a prospective observational study including consecutive ED patients aged 65 years or older The Hosmer-Lemeshow test indicated a good agreement between predicted probability and observed frequency of 30-day mortality and ICU admission.

The aim of this study will be to investigate if the fraily, assessed according to CFS, is associated with increased 30-day mortality. in a Swedish Emergency Care context. Secondary outcomes included 7-and 90-day mortality, ED length of stay, hospital admission, hospital length of stay, subsequent falls and medication changes. Additionally, we collect data on morbidity and comorbidities to assess the association with the level of frailty. Since this is a multicenter study, possible geographic differences will be studied as well. Based on the results of this study, possible interventions could be identified to improve the care of the frail geriatric patients presenting at the ED.

Eligibility Criteria:
Inclusion Criteria:

* ≥65 years, able to answer any questions, alternatively have a proxy

Exclusion Criteria:

- Patients: \<65 years
Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)

This is a pilot study to measure levels of albumin and inflammatory cytokines \[including Transforming Growth Factor-Beta (TGF-β) and Interleukin-1 Beta (IL-1β)\] in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of H.P. Acthar®, an adrenocorticotropic hormone (ACTH) analog. The study will be conducted at the Wilmer Eye Institute, Johns Hopkins Hospital. A total of 15 patients will be enrolled and randomized 2:1 to H.P. Acthar® or standard of care. Treatment duration will be 8 weeks and study duration will be 12 weeks. There will be a total of 7 study visits (baseline, day of surgery, post-operative day 1, week 1, week 4, week 8, and week 12).

Subjects will self-administer subcutaneous injections of 80 units of H.P. Acthar® starting on post-operative day 1 for twice a week until week 8. Subjects in the control arm will be managed per the standard of care. Aqueous samples will be obtained at the onset of surgery, 1 day, 1 week and 8 weeks after surgery. Aqueous levels of albumin and inflammatory cytokines (including TGF-β and IL-1β) will be measured at each time point.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed informed consent and authorization of use and disclosure of protected health information
* Patients undergoing surgery for retinal detachment due to PVR

Exclusion Criteria:

* Patients with poorly controlled diabetes mellitus (defined as HbA1C ≥ 8.0% on any anti-diabetic medications or insulin. If the patient is using any anti-diabetic medication/insulin, he becomes eligible if the medication is used continuously for \>30 days)
* Patients with poorly controlled hypertension (defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>100 mm Hg at rest with up to 3 anti-hypertensive medications. If a patient's initial measurement exceeds these values, a second reading may be taken 30 or more mins later. If the patient is using any anti-hypertensives, he becomes eligible if the medication is used continuously for \>30 days)
* Patients with congestive heart failure
* Patients with scleroderma
* Patients with osteoporosis
* Patients with active systemic fungal infection
* Patients with active ocular herpes simplex
* Patients with prior or active bleeding peptic ulcer
* Pregnant patients or patients who wish to become pregnant during the course of the study (females of child-bearing age will be counselled to use contraception for the duration of the study)
ACTIVE SCHOOL - Effects on Academic Performance of Novel Approaches to Increase Physical Activity in School-children

The overall aim of ACTIVE SCHOOL is to investigate the effects of two different physical activity (PA) interventions on academic performance (AP), cognition, wellbeing, health and motivation. The two different approaches to PA in schools are based on;

1. 'Embodied cognition' focusing on fine and gross motor PA closely related and highly relevant to the learning task. 'Embodied cognition' builds upon theory suggesting that movement and performing actions leads to the construction of enhanced mental representations e.g. strengthening memory recall. This intervention is called 'MOVE \& LEARN'.
2. 'Exercise and cognition theory focusing mainly on gross motor movements (e.g. aerobic exercise) which is not relevant to the learning task and with no temporal connection to the learning task. The assumed positive effects are explained by physiological adaptations leading to changes in cognition, which potentially can affect AP. This intervention is called 'RUN, JUMP \& FUN'.

Based on this, the aims of ACTIVE SCHOOL are to develop two types of school-based PA interventions in close collaboration with the participating teachers, students and schools AND to investigate the effects of these two interventions on AP in a large school-based cluster-RCT with an intervention length of one school year.

The ACTIVE SCHOOL study consists of three phases: Phase 1) Development of the intervention, Phase 2) Pilot testing and, Pase 3) A three-armed randomized controlled trial (RCT). Participants will be students in 3rd grade (8-10 years-old) and their teachers/school pedagogues.

The development phase started in August 2021 and is still ongoing. The pilot study will run in September-November 2022 and the RCT from August 2023 to June 2024. In the RCT, schools will be randomly allocated to one of three intervention/control arms: 1) 'MOVE \& LEARN', 2) 'RUN, JUMP \& FUN' or 3) control. Primary and secondary outcomes will be collected before and after the intervention period to assess the intervention effects. Both the pilot and RCT study has been granted approval by the local ethics committee, and all rules from the Danish Data Protection Agency and GDPR will be followed. The RCT study will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for RCT studies.


Eligibility Criteria:
Inclusion Criteria:

* Children in 3rd grade

Exclusion Criteria:

* Children with cognitive or physical disabilities hindering participation in the project activities
Desipramine for Improving Cellular Signaling and Decreasing Symptoms of Major Depression

This study will determine the effectiveness of desipramine in improving cellular signaling, and thereby decreasing symptoms of depression in people with major depressive disorder (MDD).

MDD is a serious mental illness that can interfere with a person's ability to eat, sleep, work, and enjoy activities that were once pleasurable. It is characterized by several symptoms, including as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. The receptor-G protein-adenylate cyclase enzyme complex (AC enzyme complex) is a major cell signaling system in the brain, blood, and other tissues in the body. Changes in this signaling system among blood cells have been observed in people with major depressive disorder. Research has shown that treatment with the benzodiazepine alprazolam corrects the signaling problem, and thereby improves symptoms of MDD. This study will determine whether impairments in the AC enzyme complex exist among depressed individuals. This study will also evaluate the effectiveness of desipramine, an antidepressant, in improving blood cell signaling, and thereby decreasing symptoms of depression in people with major depressive disorder.

Both healthy and depressed participants will be recruited for this study. All depressed participants in this study will first be assessed for depression severity using the Hamilton Depression Rating Scale. If eligible for the study, participants will be examined to determine AC enzyme complex functioning in both platelets and mononuclear leukocytes. A cohort of the depressed participants will be treated with desipramine. They will be examined to determine the drug's effect on AC enzyme complex functioning, as well as its effect on MDD symptoms, at Weeks 1, 4, and 6.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MDD (as defined by SCID \[DSM III-R\] and a score of at least 15 on the 21-item Hamilton Depression Scale)
* Able to swallow tablets, give urine and blood samples, and participate in periodic evaluations during the study
* Healthy volunteers show no current Axis I or Axis II disorders and score less than 8 on the Hamilton Depression Scale

Exclusion Criteria:

* Use of any of the following medications within the 2 weeks prior to study entry: psychoactive medication; aspirin; or nonsteroidal anti-inflammatory agents
* Any alcohol or drug abuse within the 6 months prior to study entry
* Any major medical disorder
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.

The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (PAB) surgery, arteriovenous (AV) graft formation for hemodialysis access, and skin graft surgery following burn injury. Limited data on rThrombin reexposure currently exist. This study will assess the immunogenicity and safety of rThrombin in participants who are undergoing a surgical procedure during which topical rThrombin application is planned and who previously received rThrombin in Phase 3 clinical trials or during prior spine, AV graft formation, or PAB surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
* Age of 18 years or older at time of consent
* Bleeding indicating treatment with rThrombin during the course of the surgical procedure
* Signed informed consent document approved by an institutional review board or independent ethics committee

Exclusion Criteria:

* Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
* Known hypersensitivity to rThrombin product or any of its components
* Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
* Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
* Treatment with any experimental agent within 30 days of study enrollment or treatment
Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers.

The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.

Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.

Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.

Hypotesis:

The krill oil will infleunce the gut barier integrity.

All competitors will be randomly divided into two groups (double-blind):

A. supplemented (n = 15), who will receive one capsule of THYROX (Atlantic krill oil) four times a day.

B. control (n = 15) receiving placebo. The supplementation period will be six weeks.

Characteristic of the supplement:

THYROX (Atlantic krill oil). The daily recommended intake of krill oil is 2000 mg, which includes 350 mg of omega-3 fatty acids, 240 mg of EPA, 110 mg of DHA, 800 mg of phospholipids, and 200 mg of astaxanthin.

Placebo will be produced by MLB Bitrade Sp. z o.o., Poznan.

Measurement: The project contractors will measure all parameters using the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and commercial assay kits.

Polyethylene clotting activator tubes (9 ml) will be centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum will be pipetted into several Eppendorf tubes, then frozen (temp. -80 °C). All the following biochemical parameters will be determined from the extracted serum:

using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:

a food diary will be filled day before the study and in the morning before the test, markers of gut injury: I-FABP (intestinal fatty acid binding protein), CLDN-3 (claudin 3) intoxication: LBP (lipopolysaccharide binding protein) stress hormones: ACTH and cortisol will be determined using the colourimetric method on the SPECTROstar Nano reader.

The lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Diaglobal, Germany).

Eligibility Criteria:
Inclusion Criteria:

* training experience of a minimum of five years,
* minimum training time per week 240 minutes,
* all competitors qualified for the Polish Youth Rowing Team,
* completing a food diary,
* finishing 2000m ergometer test.

Exclusion Criteria:

* Probiotics, prebiotics and antibiotic therapy within the last three months,
* dietary regime,
* gastrointestinal diseases,
* lactose intolerance.
Zithromax EV in Community-Acquired Pneumonia (CAP)

The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide.

This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must require hospitalization and intravenous therapy.
* Subjects must have a Fine pneumonia score \> 70 (Fine Class \> II).
* Subjects must have a medical history and clinical and radiological findings consistent with a community-acquired bronchopneumonia or lobar pneumonia. The following criteria must be met:

  * new infiltrate(s) on chest X-ray; AND
  * at least two of the CAP signs or symptoms.

Exclusion Criteria:

* Treatment with any systemic antibiotic for 24 hours or longer within 72 hours of the baseline visit, or treatment for more than 7 days within 15 days.
* Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug, including:

  * Known acquired immunodeficiency syndrome (AIDS) or suspected Pneumocystis carinii pneumonia;
  * Neutropenia;
  * Cavitary lung disease by chest X-ray;
  * Primary lung cancer or other malignancy metastatic to the lung;
  * Aspiration pneumonia;
  * Empyema;
  * Known or suspected tuberculosis;
  * Neoplastic disease;
  * Cystic fibrosis;
  * A history of any form of epilepsy or seizure;
  * DDM;
  * Bronchiectasis, bronchial obstruction or history of post-obstructive pneumonia (this does not exclude patients with chronic obstructive pulmonary disease);
  * Significant gastrointestinal or other conditions which may affect study drug absorption; and
  * Significant cardiovascular disorders.
* Immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
* Impaired hepatic function, as shown by, but not limited to, AST, (SGOT), or ALT (SGPT) greater than three times the laboratory upper limit of normal, or total bilirubin greater than two times the upper limit of normal.
* Subjects already hospitalized or who resided in a long-term-care facility for greater than 14 days before the onset of symptoms.