cyrilzakka/clinical-trials huggingface dataset:
Incidence of Hemidiaphragmatic Palsy After Interscalene Block

Primary objective of this study is to find out the incidence of hemi-diaphragmatic palsy associated with interscalene block done under ultrasound guidance.

Primary hypothesis:

• There is an incidence of hemidiaphragmatic palsy ranging fron 33-100 % after an interscalene block.

Secondary hypothesis

* The incidence of hemidiaphragmatic palsy is much less than 33% when the block is done using ultrasound.
* The incidence of hemi-diaphragmatic palsy is directly proportional to volume of local anaesthetic injected.
* The incidence of hemi-diaphragmatic palsy is directly proportional to concentration of local anaesthetic injected.

Patients of either sex belonging to American Society of Anesthesiologists status 1-3 scheduled for elective shoulder surgery as an outpatient basis, planned for an interscalene block will be included in this study over a period of one year.

Potential patients will be identified from the surgeons' list. The PI or one of the co-investigators will contact them in the surgical day care in the morning of surgery and will be given information about the study. Documented informed consent will be obtained.

After obtaining informed consent, they will be examined for their diaphragm position using an ultrasound prior to block placement .

All patients will have the block initiated in the block room using standard monitors and sedation as per the standard practice in this hospital.

The patients will undergo an ultrasound examination for their diaphragm position 5 mins and 10 mins after the completion of the nerve block. Ipsilateral ( same side as the block) and contralateral ( opposite side of block) hemi-diaphragmatic excursion will be measured with the patients in supine position during quiet inspiration ,deep inspiration and forceful sniff.

In addition, bedside spirometry using a compact spirometer will be performed and FVC, FEV1 and PEFR measurements will be performed.The oxygen saturation and any evidence of dyspnea or shortness of breadth will be noted at the above mentioned intervals after the completion of the block.

All patients will receive general anesthesia in the operating room. The patient will receive IV opioids during the procedure if required.

The above mentioned data will be collected postoperatively in the recovery room 30 mins, after arrival.

Eligibility Criteria:
Inclusion Criteria:

Control Group:

Age between 18 - 80 years old Elective shoulder surgery Same day discharge Inform consent signed

Exclusion Criteria:

Ongoing Major psychiatric problems Narcotic Abuse/ Drug dependency Mental impairment / inability to cooperate with postoperative evaluation/Inability to give informed consent

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Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients

The investigators hypothesize that dobutamine is able to revert negative redistribution of flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly at the sublingual and gastric mucosa, and at the peripheral tissues.

The investigators designed a randomized, cross-over, placebo-controlled study looking at the acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function, microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic shock patients.

The investigators hypothesize that dobutamine is able to revert negative redistribution of flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly at the sublingual and gastric mucosa, and at the peripheral tissues. Therefore, dobutamine improves microcirculatory alterations and regional perfusion in septic shock, independent of its effects on cardiac output.

The relevance of this concept is that it would support a more rational use of dobutamine in septic shock patients, not only as an inotrope to increase cardiac output, but more important, as a selective vasodilator aimed at restoring perfusion.

Therefore, the investigators designed a randomized, cross-over, placebo-controlled study looking at the acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function, microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic shock patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* Septic shock for less than 24 hours
* Arterial lactate \> 2.4 mmol/l
* Mechanical ventilation and pulmonary artery catheter in place

Exclusion Criteria:

* Pregnancy
* Refractory hypotension
* Acute coronary syndrome within the last 3 months
* Previous use of dobutamine during the last 72 hours
* Cardiac index \< 2.5 l/min/m2
* Non-sinus rhythm
* Heart rate \>140 BPM
* Anticipated surgery or dialytic procedure during the study period
* Child B or C liver cirrhosis
* Hemoglobin \< 8 gr/dl
* Uncontrollable fever \> 39ºC
Endothelial Dysfunction in Obese Children

The purpose of this study is to objectify the effect of diet and exercise on early markers of atherosclerosis in obese children.

The favorable responses of combined treatment strategies, consisting of exercise training and proper diet change, for childhood and adolescent obesity on vascular health are poorly understood. The overall objective of this research project is to investigate the underlying pathophysiological mechanisms that mediate these beneficial effects.

Particularly, the following aims are set forth:

1. To establish the effect of a combined lifestyle intervention, i.e. an individualized exercise training and caloric restriction program, on vascular function (primary endpoint) and structure in a substantial population of obese adolescents.
2. To characterize causal pathways between obesity and endothelial dysfunction with focus on classical risk factors, oxidative and inflammatory stress, metabolic adaptations, bone marrow derived progenitor cells, and blood microparticles.

This research knowledge will be instrumental for risk stratification and clinical management aimed to improve endothelial function by limiting damage and reinforcing regenerative mechanisms in obese adolescents.

Eligibility Criteria:
Inclusion Criteria: Children with severe obesity

* Younger than 16 yrs: BMI ≥97th sex and age specific BMI-percentile
* Older than 16 yrs: BMI ≥35 kg/m²

Exclusion Criteria:

* Acute or chronic inflammatory process, use of non-steroidal anti- inflammatory drugs or immunosuppressive drugs. (including inhalation corticosteroids).
* Structural heart disease or other cardiac diseases.
* Active malignant hematological disease
Contributing Factors to Local Bioimpedance Spectroscopy

This is an exploratory interventional study. The aim of the investigation is to identify and quantify contributing factors to local bioimpedance spectroscopy (BIS) measured by a wearable sensor patch, particularly the effect of fluid shifts caused by postural changes and lower body negative pressure (LBNP).

The investigational devices (patches) will perform near-continuous measurements of multifrequency bioimpedance (BIS), temperature, and body orientation (accelerometer) during the entire period of wear (2 days). Patches will be mounted at the upper body (back and thorax) and calf. The primary objective is to assess the effect of prolonged lower body negative pressure (LBNP) on the BIS of the calf. The target population is healthy volunteers between 18-50 years old.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age, at the time of signing the informed consent
* Overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound.
* Use of adequate birth control for women of childbearing potential. Inclusion is possible when an acceptable effective contraceptive measure is used (combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
* Breached skin at patch mounting area.
* Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.
* Planned magnetic resonance (MR) imaging during the investigation period
* Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).
* Pregnancy
* Breastfeeding
* History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).
* Any known cardiac disease that, at the investigator's discretion, warrants exclusion from the study, including but not limited to cardiac arrhythmia, esophageal varices, and aneurysms.
Measurement of the Distance Between the Corresponding Anatomical Landmarks in the Thoracic Cavity and the Incisors

Patients who agree to receive pneumonectomy will be arranged to measure the distance from the incisors to the corresponding anatomical landmarks, including the cardia, the inferior pulmonary vein, the carina, the azygos vein, the lower edge of the aortic arch, the upper edge of the aortic arch, and the cupula of pleura through " fiber measurement method within nasogastric tube " . After building regression equations with the above data, the distance from the incisors to these corresponding anatomical landmarks could be inferred by means of indexes including height and so on.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic operation(such as radical lung cancer resection, pulmonary lobectomy, pulmonary segmentectomy, etc.) under endotracheal anesthesia ,which can expose the corresponding anatomical landmarks;
* Patients undergoing nasogastric intubation due to their condition.

Exclusion Criteria:

* Patients with diseased or deformed esophagus;
* Patients with obvious thoracic deformity, spinal deformity or dysplasia;
* Patients whose thoracic anatomical landmarks can not be exposed or exposed clearly during operation;
* Patients who do not agree to be measured.
Accuracy of Non-contact Thermometry

Subjects will be admitted to hospital the evening prior, or the morning of surgery, whereupon they will undergo standard admission processes, including pre-operative assessment by the anaesthetist assigned to that list (One of the two study authors). The anaesthetist will then explain the study again, reiterating the potential risks and benefits of the study to the patient themselves, and to the population as a whole. Consent will be sought at this point.

Patients will be transferred to theatre, anaesthetised and operated on as per normal practice. Inclusive of this, in accordance with NICE guidelines, patients will have a nasal or oesophageal Doppler probe inserted to accurately measure core temperature. At this point, patients enrolled in the study will have temperature measurements taken every minute from the oesophageal probe and non-contact thermometers.

If the patients requested it previously, they will be informed of the results of the study at a later date.

Statistics will then be carried out on the data to compare accuracy of the two novel methods to the oesophageal probe.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be patients undergoing elective gynaecological, vascular or urological surgery at the Royal Sussex County Hospital, and as such will be seen at a pre-operative assessment clinic as part of their normal work up for theatre.

Exclusion Criteria:

- Lacking mental capacity Not speaking English Malignancy in medical history Undergoing open abdominal surgery
Zinc Absorption From Biofortified Rice

One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of 18 to 45 years old
* Body Mass Index in the range of 19 to 25
* No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

* Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
* Long-term medication during the whole study (except for contraceptives)
* Pregnancy
* Lactation
* Intention to become pregnant during the course of the study
* Lack of safe contraception
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st - Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study
Physiologic Study of Cerebral Perfusion

The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and without sedation) and in vasopressor-dependent patients


Eligibility Criteria:
Healthy Subjects :

* Inclusion criteria :

  * being over 18 years old
* Exclusion criterias :

  * having a positive serum pregnancy test
  * having a contraindication to MRI
  * having a contraindication to receive light sedation with propofol
  * suffering of claustrophobia or of anxiety disorder

Shock Subjects :

* Inclusion criterias :

  * being over 18 years old
  * being hospitalized to the medical intensive care unit of the CHUS Fleurimont
  * being in a stabilized shock state, primarily of distributive etiology
  * having received an appropriate fluid resuscitation, as judged by the attending physician
* Exclusion criterias :

  * having a different primary etiology of shock than distributive (cardiogenic, hypovolemic, obstructive)
  * needing vasopressor therapy as the result of extracorporeal circulation
  * having known cerebral lesions
  * having an intra-aortic balloon pump
  * being in a palliative or near end-of-life situation
  * having a contraindication to MRI
  * suffering of claustrophobia or of anxiety disorder
Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer

Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Eligibility Criteria:
Inclusion Criteria:

1. Female patient;
2. Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
3. Age greater than or equal to 65 years;
4. Breast-conserving surgery or mastectomy with or without axillary approach
5. With or without neoadjuvant or adjuvant systemic treatment

Exclusion Criteria:

1. Patients with previous thoracic irradiation;
2. Patients with indication for bilateral thoracic irradiation;
3. Patients with breast reconstruction with prosthesis or autologous tissue;
4. Patients with compromised surgical margins after resection;
5. pT1-pT2 pN0 patients undergoing radical mastectomy.
Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

The lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. Thus, the purpose of this study was to assess the efficacy of intervention program on metabolic syndrome subjects in Taiwan.

The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) \>150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol\<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and 4th months. All participants complete a structured questionnaire, including basic information, SOF, physical performance, physical activity, and food-frequency.

Eligibility Criteria:
Inclusion Criteria:

* older adult with age ≥ 40 years
* community-dwelling
* no hearing and visual acuity difficulties

Exclusion Criteria:

* Unconscious
* Cognitive impairment or dementia
PErfusion QUality ODds

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade. There are different "static" predictive scores for the CSA-AKI based on the patient and surgery-associated parameters.

Recently, in our Institution was developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI).

The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB.

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade which for the present study follows the AKIN criteria.

There are different predictive scores for the CSA-AKI based on the patient and surgery-associated parameters. These models could be defined as "static".

It's known that a number of CPB-associated parameters could influence CSA-AKI, as well. These include hematocrit (HCT), oxygen delivery (DO2), time of exposure to a critical DO2, and perfusion pressure. These parameters, taken separately, are associated with CSA-AKI development.

Recently, our Institution has developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI).

MDPI has higher discrimination power when compared to the static scores, in the original series and in the internal validation with the Bootstrap technique.

The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB. An enrollment of 400 patients is anticipated with a stopping rule for efficacy at interim analysis (for primary endpoint) at 50% enrollment (200 patients) if the c-statistics for any stage of CSA-AKI reaches at least 0.75. Futility is defined as an AUC of 0.6 or lower.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery with cardiopulmonary bypass
* age of 18 years and higher
* willingness to participate and sign the informed consent

Exclusion Criteria:

- patients requiring preoperative dialysis
The DECISION-CTO Extended 10 Y Follow-up

The goal of this clinical trial is to compare long term efficacy of drug-eluting stent implantation compare to optimal medical treatment in patient with chronic total occlusion in a very long-term follow-up (minimum 10 years) period.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age \>18 years
2. Angiographic 1) De novo lesion Chronic Total Occlusion (CTO) 2) Reference vessel size ≥ 2.5 mm by visual estimation 3) At least one CTO lesions located in proximal or mid epicardial coronary artery.

   (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)
3. CTO definition: TIMI (Thrombolysis in Myocardial Infarction) flow 0 or 1 with estimated duration over 3 months

   * The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or
   * In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion

     1. Angiographically defined total occlusion over 3 months
     2. If no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)

Exclusion Criteria:

1. History of bleeding diathesis or coagulopathy
2. Pregnant state
3. Three vessel CTOs
4. Known hypersensitivity or contra-indication to contrast agent and heparin
5. ST-elevation acute myocardial infarction requiring primary stenting
6. Culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion
7. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions 5) Two vessel proximal segment CTOs
8. Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
9. Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
10. Renal dysfunction, creatinine ≥ 2.0mg/dL
11. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
12. Left ventricular ejection fraction \<30%
13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
14. Non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment).
Antithrombotic Activities of a Novel Yogurt Drink

This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers

This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease.

In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Volunteers need to be off medication and off any dietary supplements.
* Subjects must not have any blood clotting disorders or dyslipidaemia.
* Dairy intake needs to be within a normal range of 1-2 portions a week.
* Unwilling to follow the study requirements.