cyrilzakka/clinical-trials huggingface dataset:
Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis

The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in sepsis and agreement of (EC) compared to transthoracic echocardiography (TTE).

Usual investigations \[complete blood count (CBC), C reactive protein (CRP), serum procalcitonin, serum lactate, arterial blood gases (ABG), blood culture, electrocardiogram (ECG) and liver and renal function tests\] will be done.

Once the diagnosis of sepsis is definite and the patient develops hypotension, all patients will undergo simultaneous measurement by (EC) using the ICON_ device and (TTE).

Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of (EC) will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of the neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of the anterior axillary line). The ICON continuously displays heart rate, stroke volume, and cardiac output.

Transthoracic echocardiography (TTE) measurements: will be performed by using Philips (CX50 - Extreme edition) equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and velocity time integral (VTI) measured in left ventricle outflow tract (LVOT) from apical 5 chamber view (by pulsed wave Doppler), respectively. The machine's built-in software uses the formula ''(πD2/4) × VTI × HR'' to calculate CO.

Management of sepsis will be done according to surviving sepsis campaign guidelines in 2016 and its update 2018.

Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if SV increases by \> 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure \> 65 mmHg (either by fluid or both fluid and vasopressor).

Eligibility Criteria:
Inclusion Criteria:

* Age from 19 to 65 years old.
* Clinical criteria of sepsis \[acute change in sepsis-related organ failure assessment (SOFA) variables ≥ 2 points consequent to the infection which include: PaO2/FiO2 ratio \< 300, Glasgow Coma Scale score \< 15, mean arterial pressure (MAP) \< 70 mmHg, serum creatinine \>1.2 mg/dl or urine output \< 0.5 ml/kg/h, serum bilirubin \> 1.2 mg/dL, platelet count \< 150 X 103 /µl\].
* Developing hypotension (mean arterial blood pressure ≤ 65 mmHg).

Exclusion Criteria:

* Other causes of shock
* Previous cardiac disease
* Rhythm other than sinus rhythm or heart rate \> 140 beats/min
* Chronic renal failure.
Effect of Thoracic SNAGS on Vitals Among Individuals With Forward Head Posture

To determine how vitals (heart rate, blood pressure, respiratory rate, oxygen saturation) and craniovertebral angle will be affected by thoracic SNAGs in individuals with forward head posture.

Forward head posture (FHP) leads to abnormal activation of neck muscles. This leads to respiratory complications and changes in blood pressure. Due to regional interdependence Upper thoracic spine can restrict the movement of cervical spine Thoracic spine is is closely related to Sympathetic nervous system. T1-T5 spinal sympathetic neurons provide sympathetic innervation to the vessels that supply to the heart tissues and upper portion of the body. Thus, thoracic mobilization can regulate main body vitals as well as other visceral activities that maintain homeostasis

There is a manual therapy technique called sustained natural apophyseal glides (SNAGs) in which patient performs active movements along with the passive movements performed by the physiotherapist. It not only has biomechanical efficacy which includes pain reduction and improvement in ROM, but it also has neurophysiologic effects. Previous studies lack to provide how thoracic SNAGs can affect vitals. Thus, this study aims to determine the effect of thoracic SNAGs on vital signs, including heart rate, blood pressure, respiratory rate, and oxygen saturation . Furthermore, this research will add to growing body of knowledge that how thoracic SNAGs can influence the correction of forward head posture

Eligibility Criteria:
Inclusion Criteria:

* Both males and females
* Age 30-50yrs.
* Craniovertebral angle \<50°
* Mild to moderate neck pain ranging between 3-6 on NPRS scale.
* Individuals with normal vitals:
* Heart rate (60-100 beats per minute)
* Respiratory rate (12-20 breaths per minute)
* Systolic BP (100- 139mmHg)(30).
* Diastolic BP (70-89 mmHg) (30).
* Oxygen saturation ≥96%

Exclusion Criteria:

* History of cervical/thoracic spine surgery
* Cardiopulmonary disorder or Hypertension ≥140/90mmHg (30).
* Vertebral instability
* Smokers
* Any infection or tumor
Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels

In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and strategy stratification are lacking. In this setting, a simple biological scoring system have recently been proposed, including LDH and CD138 binary status seric values, identifying one third of patients with worst prognostic.

Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E mutation, concerning 5-8% of first line mCRC.

For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard chemotherapy arm, in order to better discriminate treatment strategies, at metastatic diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Performance status ECOG-WHO 0 or 1
* Histologically proved metastatic colorectal adenocarcinoma, with non-resectable metastases
* Adequate hematological, hepatic, and renal functions
* Signed written informed consent

Exclusion Criteria:

* Previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease
* History of autoimmune disease
* Acute infectious disease
* Known hypersensitivity grade 3-4 or contraindication to any of the study drugs
* Patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
* Bevacizumab contraindication
* Brain metastases
* Other malignancy within the last 2 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Pregnancy, breast-feeding or absence of adequate contraception for fertile patients
* Patient under guardianship, curator or under the protection of justice.
PATIENT VOICES Integration of Systematic Assessment of Patient Reported Outcomes Within Clinical Oncology Practice

Listening to "patient voices" in terms of symptoms, emotional status, satisfaction with care and information received, represents a major shift in medicine. It is in fact crucial in medical decision making and patient empowerment, especially in cancer care.

Patient Reported Outcomes Measures (PROMs) and in particular electronically assessed PROMS (ePROMS), have been identified as potentially effective tools to systematically gather patient voices. Despite international extensive and growing interest, systematic PROM collection is not widely implemented in routine cancer care, due to barriers at various levels.

The PATIENT VOICES is a project aimed at achieving a stepwise inclusion and integration of PROMs within routine clinical practice at the FONDAZIONE IRCCS ISTITUTO NAZIONALE TUMORI-MILANO. Phase I of the Patient Voices project (pilot and feasibility testing), will be the focus of the present study and its results will be the base for subsequent phases (implementation and impact assessment).

Study aims of this phase are:

* Assessing the use and attitudes toward PROMs by clinicians in a comprehensive cancer centre.
* Reviewing and compare pre-existing ePROMS assessment systems.
* Developing and pilot testing a flexible system for electronic collection of PROMs.
* Assessing feasibility of ePROM assessment of physical symptoms, psychological distress and patient satisfaction.
* Identifying barriers to and developing strategies for the final implementation and integration of routine ePROMs into the clinical practice.

The project will last 2 years. Longitudinal and cross-sectional studies will be carried out with the aim to evaluate compliance, acceptability, and usability of a routine ePROM assessment system by both patients and clinicians. Participants will be enrolled among patients attending 3 out-patient clinics (physical symptom), 3 inpatient wards (psychological distress) and 5 multidisciplinary teams (patient satisfaction). The Edmonton symptom assessment scale, the Distress Thermometer, and a questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey, will be used in the three studies. Qualitative methods will be used identify patient and clinician related barriers to ePROM assessment and to pinpoint engagement strategies to promote its use in routine cancer care. Semi-structured interviews and focus groups will be carried out.

Quantitative and qualitative studies will respectively enroll 600 and 40 participants.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or above
* a verified cancer diagnosis

Exclusion Criteria:

* inability to fill in PROMs due to cognitive impairment, psychological disturbance or language problems as judged by the study personnel.
High-impact Exercise in Adults With Crohn's Disease

Crohn's disease increases the risk of poor musculoskeletal health, as the inflammatory disease process directly inhibits regulatory pathways involved in bone and muscle formation and maintenance. The negative effects of disease on muscle-bone health are compounded by poor nutritional status, vitamin d deficiency, prolonged exposure to glucocorticoid therapy, and reduced physical activity. Modern, steroid sparing therapies are successful at inducing clinical remission in terms of inflammation, however they have limited effect in remedying observed muscle-bone deficits. Subsequently, patients with Crohn's disease are at increased lifelong risk of pathological fractures and osteoporosis. Novel adjunctive therapies are therefore required to complement pharmacological treatments and target muscle-bone deficits, which are responsible for significant disease burden in Crohn's.

High-impact exercise may be a useful additional therapy for patients with Crohn's disease, as the mechanical strains produced during this type of exercise, through large magnitude muscular contractions and ground reaction forces, can promote bone formation and gains in muscle mass. There have been no previous studies assessing the effects of high impact exercise in Crohn's disease, so it is unknown if this type of exercise is safe and feasible in this population. The aim of this study is to assess the feasibility of high-impact exercise for improving markers of bone and muscle health in adults with Crohn's disease, and compare the effects of exercise with a group of healthy age and sex matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease diagnosed at least six months ago
* Stable medication for at least four weeks
* Disease in remission, or mildly/moderately active according to Harvey Bradshaw Index score
* Currently undertaking \<2 hours of structured exercise per week
* Able to mobilise and exercise independently
* Able to provide written informed consent

Exclusion Criteria:

* Surgery \<12 weeks or planned surgery during intervention period
* Comorbidity known to affect muscle / bone
* Contraindication to high-impact exercise
* Pregnancy or planned pregnancy during intervention period
* BMI \>40 kg/m2 (or body mass \>120kg)
Patient Education Videos to Improve Patients' Experience During Radiotherapy Treatment: a National Project

Patients often base their information on the experiences of other patients or on information they find on the internet. This information is in many cases incorrect, outdated or not applying to the patient's situation. This leads to misconceptions or inappropriate anxiety. During the intake consultation at the radiotherapy department, doctors, nurses and RTTs provide accurate and patient-specific information, but it can be overwhelming and it is known that only part of this information is remembered. Moreover, it remains difficult for a patient to imagine how the treatment will proceed.

The combination of verbal information, supplemented with video material, seems to be the ideal way to convey information. After all, a video can be viewed again afterwards, possibly together with loved ones, or can be shown in advance in preparation of the consultation. In Belgium, the existence of patient education videos about radiotherapy is very limited. Making these kinds of videos is expensive and time consuming. For that reason, BeSTRO (Belgian Society for Radiotherapy and Oncology) started a project to make videos for patients that can be used nationally by all radiotherapy centers. The project is sponsored by Foundation against Cancer.

A first video illustrating the general radiotherapy process is already available. This video will be used as a 'test video' to be shown to patients undergoing radiotherapy in one of the 4 participating centers. Questionnaires will evaluate the quality and the impact of the video and will assess the need for additional information. Moreover, 25 patients will be invited to participate in 5 focus groups, each focus group concentrating on one of the 5 most frequent tumor groups (breast tumors, lung tumors, head and neck tumors, urological tumors and gastro-intestinal tumors). The information gathered from the questionnaires and focus groups will be used to determine the content and format of the next videos. In total, about 10 videos on specific parts of the radiotherapy process will be produced.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cancer,
* age ≥ 18 years,
* undergoing radiotherapy as part of their treatment

Exclusion Criteria:

- history of previous radiation treatment
Study of Colorectal Anastomosis Failures With First Sigmoid or Left Colonic Artery Preservation With D3 Lymphadenectomy

This study is a randomized, controlled trial comparing the short- and long-term outcomes of left colonic artery or first sigmoid artery preservation for rectal surgery. Eligible patients will be randomized to D3-lymphodissection with preservation of the first sigmoid artery or left colonic artery in a 1:1 ratio according to a computer-generated randomization list created in advance (includes removal of 252, 253 l/u groups, 241 groups of distal sigmoid colon sites when the neoplasm is highly located).

The operation involves removal of the tumor with oncologically adequate clearance, adherence to the principles of operation in embryonic layers.

The criterion for performing D3-lymphodissection is visualization of the site of the inferior mesenteric artery (IMA) branching from the aorta. During the surgical intervention, l/u groups 252 and 253 are elevated along the superior rectus artery, the NBA is skeletonized circularly so that there are no l/u and no visible areas of fatty tissue.

In the group with preservation of the left colonic artery, the NBA is isolated, clipped and crossed immediately after the LCA, and in the group with preservation of the first SA, the NBA is skeletonized to the level of the first sigmoid artery, clipped and crossed immediately after the first sigmoid artery . After the intestinal resection stage, a colorectal anastomosis is formed, information on drain placement.

The primary endpoint is to assess the incidence of IA - communication of the intraluminal compartment of the intestine with the extraluminal compartment, anastomosis leakage in the area of the formed anastomosis - which will be performed at 30 days postoperatively and categorized according to the Clavien-Dindo scale. HA can be diagnosed by MRI, CT with proctography, endoscopic examination, or patient examination (if low anastomoses are formed).

Any adverse event in the postoperative period is also classified according to the Clavien-Dindo scale and recorded in the individual patient's chart.

Each patient will have an individual electronic record (eCRF open clinica.), where individual patient data will be entered and where the data obtained will be stored.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form
2. ECOG status is 0-2.
3. Age over 18 years
4. TNM stage according to version VIII T1b-4aN0-2M0 (M1 in case of resectable metastases confirmed by preoperative staging (colonoscopy, chest and abdominal CT).
5. Histologically confirmed adenocarcinoma of the colon, the proximal edge of which is not higher than or equal to 20 cm from the anus
6. Clinical indications for colorectal resection with anastomosis formation

Exclusion Criteria:

1. Medical or psychiatric reasons affecting the patient's decision to participate in the study
2. Pregnancy or breastfeeding
3. Medical conditions contraindicated for surgery
4. Synchronous or metachronous malignancies
5. Acute intestinal obstruction, bleeding or perforation
6. Preplanned obstructive bowel resection
A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes

The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.


Eligibility Criteria:
Inclusion Criteria:

* Participant willing to adhere to diet and exercise regimen as recommended by the investigator
* Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise, who in investigator's opinion are eligible to receive study drug as per prescribing information along with standard care for management of T2DM
* Women must be postmenopausal, defined as greater than (\>) 45 years of age with amenorrhea for at least 18 months, or \> 45 years of age with amenorrhea for at least 6 months and less than (\<) 18 months and a serum follicle stimulating hormone (FSH) level \> 40 International Units Per Liter (IU/L), or surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal occlusion), or otherwise be incapable of pregnancy, or sexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, tubal ligation, intrauterine device, double-barrier method (example, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, and consistent with local regulations regarding use of birth control methods for participant participating in clinical studies, for the duration of their participation in the study, or not sexually active
* Women of childbearing potential, regardless of age must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and negative UPT at baseline (predose, Day 1)
* Treatment naive participants or participants on stable antihyperglycemic agent (AHA) therapy (for at least 12 weeks before screening) and have a screening visit Glycosylated Haemoglobin (HbA1c) of greater than or equal to (\>=) 7.0 percent (%) and less than or equal to (\<=) 10.0 %

Exclusion Criteria:

* History of liver or renal insufficiency (estimated creatinine clearance below 45 milliliter per minute \[mL/min\]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to Canagliflozin, Metformin or Canagliflozin + metformin hydrochloride immediate release (IR) Fixed Dose combination (FDC) or its excipients
* Use of any other sodium glucose cotransporter 2 (SGLT2) inhibitor within 12 weeks before the screening visit
* If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after last dose of study medication; or intending to donate ova during such time period
* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis

When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. And alternative and more recently introduced technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the muscle at the front of the leg. In this study we compare the two surgical techniques in a so-called randomized trial. This means that we put people randomly into two groups, one group will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the 'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus approach recover quicker and have a better short-term functional outcome than people who receive the 'Medial parapatellar approach'.

This study is a prospective randomized controlled double blind trial in which both immediate post-operative recovery and functional outcome at 6 weeks, 3 and 6 months after total knee replacement surgery will be assessed for two different types of surgical approach; Medial Parapatellar and Mid-vastus.

Functional outcome will be assessed by recording the kinematics of the lower limb joints in addition to muscle activity (electromyography) during walking, stair ascending and descending and getting up from a chair through computerized 3D motion analysis. Outcome measures will be recorded immediate post surgery and at medium follow-up and will cover all areas of the World Health Organisation, International Components of Functioning, Disability and Health (ICF) components 'Body Structures and Functions/Impairments' ,'Activities and Participation' and 'Personal factors'. It is hypothesized that by minimizing the damage to the quadriceps, patients operated using the Mid-vastus approach will have better muscle function and will therefore have more normal knee range of motion, knee joint loading and muscle activity patterns compared to those with the Medial Parapatellar approach.

Eligibility Criteria:
Inclusion Criteria:

* Total knee arthroplasty
* Osteoarthritis
* Surgery at Royal Infirmary Edinburgh by participating surgeons

Exclusion Criteria:

* A Body Mass Index of more than 40
* Fixed valgus deformity of more than 15 degrees
* Inflammatory polyarthritis
* disorders of the feet, ankles or hips or spine causing abnormal gait or significant pain
* dementia
* severe visual impairment
* neurological conditions affecting movement
* inability to give informed consent