cyrilzakka/clinical-trials huggingface dataset:
Carotid Artery Corrected Flow Time and Inferior Vena Cava Collapsibility Index for Prediction of Hypotension After Induction of General Anesthesia in Geriatric Patients Undergoing Elective Surgery

In this observational study, we will assess cFT by Carotid ultrasound and IVC collapsibility index for prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.

Following the onset of general anesthesia, hypotension is frequently observed, and intraoperative hypotension is linked to end organ damage following surgery, including cardiac ischemia and severe renal injury. postoperative end-organ damage depends on the duration and magnitude.

The incidence of hypotension after induction of general anesthesia varies and is influenced by the induction agent, patient characteristics, and the definition of hypotension.

Hypotension was defined by a 30% reduction in the SBP or 20% reduction in the MAP from baseline or an absolute SBP of less than 90 mm Hg and MAP of less than 65 mm Hg within 3 minutes after induction of general anesthesia.

Elderly people are more likely to experience hemodynamic fluctuation and hypotension due to the high prevalence of left ventricular diastolic failure, lower vascular reactivity and higher sensitivity to anesthetics. More significantly, older patients can't tolerate hypotension for a long time.

A variety of hemodynamic monitoring techniques have been used to predict post- anesthetic hypotension. Non-invasive cardiometry, ultrasound evaluation of fluid status, and pulse oximetry variables, such as the perfusion index and pulse variability index, were utilized.

Zhang and Critchley demonstrated that preoperative hypovolemia predicted postinduction hypotension as determined by the inferior vena cava (IVC) diameter and IVC collapsibility index.

In many clinical situations, volume-responsive patients have been identified using Doppler-derived metrics such as the peak blood flow peak velocity variation (ðVpeak) and the common carotid artery corrected flow time (cFT).

The carotid artery Doppler measures provide several benefits, including being noninvasive and being technically simple to obtain due to the carotid artery's superficial nature. Since the common carotid artery cFT is unaffected by respiratory attempts, it can also be used to assess a patient's volume responsiveness when they are breathing on their own.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists Physical Status I to Ⅱ
* receiving general anesthesia for elective surgery
* fasted for at least 6 to 8 hours were recruited in this study

Exclusion Criteria:

* • patients who refused to participate in the study

  * American Society of Anaesthesiologists Physical Status Ⅲ or Ⅳ
  * Patients with a history of peripheral arterial diseases or atherosclerosis
  * Patients with body mass index of greater than 30 kg/m2
  * Patients with arrhythmia or cardiomyopathy
  * Chronic obstructive pulmonary disease (COPD)
  * baseline systolic arterial pressure (SAP) ≥ 180 mmHg or \< 90mmHg
  * Any episode of desaturation or difficult intubation during general anasethia induction
A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium

Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. Maribavir is a medicine approved for treating CMV infection in adults after transplant.

The main aim of this study is to check the use of maribavir and learn how safe and effective in treating adults with CMV infection after transplant in Belgium in line with the Belgian reimbursement criteria.

During the study, a participant's data will be collected for 2 years. The study does not have fixed visits to the hospital, but it is recommended collect data from routine visits and contacts.


Eligibility Criteria:
Inclusion Criteria:

* Participant signed an informed consent form.
* Aged greater than or equal to (\>=) 18 years at the time of consent.
* Received an HSCT/SOT.
* Diagnosed with CMV infection/disease any time after the HSCT/SOT date.
* Starting maribavir for the first time and in line with the Belgian reimbursement criteria.

Exclusion Criteria:

• Participant treated with maribavir before the start of the study.
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects

The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.

To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 45 years of age, inclusive.
* Healthy males and females with no clinically significant abnormalities.
* Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2

Exclusion Criteria:

* Sustained supine systolic blood pressure \>140 or \<100 mmHg or a diastolic blood pressure \>90 or \<60 mmHg at the Screening and Day 1 Visit.
* Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS \>110 msec, QTcF \>450 msec for males and \>470 msec for females, PR interval \>200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection
* History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome
Craniofacial Microsomia: Accelerating Understanding of the Significance and Etiology

The CAUSE study is a multicenter study, with domestic (n=4) and international (n=6) study sites. Children and young adults (ages 0-18) who have microtia and/or craniofacial microsomia and their parents are invited to participate. Children and parents are asked to provide a DNA sample (blood or saliva) and are asked to upload a few photos of their face. Parents are asked a short interview. Participants are able to participate from home or at one of four domestic sites.


Eligibility Criteria:
INCLUSION:

Cases:

* Participant with CFM is 0-18 years of age
* Participant has diagnosis of at least one of the following conditions:

  * Microtia
  * Anotia
  * Facial asymmetry AND preauricular tag(s)
  * Facial asymmetry AND facial tag(s)
  * Facial asymmetry AND epibulbar dermoid
  * Facial asymmetry AND macrostomia (i.e., lateral cleft)
  * Preauricular tag AND epibulbar dermoid
  * Preauricular tag AND macrostomia
  * Facial Tag AND epibulbar dermoid
  * Macrostomia AND epibulbar dermoid
* Participant's parent or legal guardian has provided written informed consent prior to enrollment into study (for participants younger than 18 years of age).
* Participant speaks a language in which they are eligible for consent at their enrolling site

Parents:

* Parent participant is the biological parent of a case participant already eligible and participating in the CAUSE study. Non-genetic parents will be interviewed about their child's known prenatal and genetic family history but will not be asked to provide DNA or have facial photographs taken.
* Participant speaks a language in which they are eligible for consent at their enrolling site

Other relatives:

* Other relatives participants, of any age, are related biologically to a case participant already eligible and participating in the CAUSE study from a multiplex family (multiple affected individuals with CFM).
* Participant speaks a language in which they are eligible for consent at their enrolling site

EXCLUSION:

Cases:

* Participant is diagnosed with a known syndrome that involves microtia and underdevelopment of the jaw (Townes-Brocks, Treacher-Collins, Branchiootorenal, Nager, or Miller syndromes).
* Participant has abnormal chromosome studies (karyotype).
* Participant has mandibular asymmetry due to deformational plagiocephaly or torticollis.
Immune Profile of Saliva and Serum of Patients with Primary Sjögren´s Syndrome

Primary Sjögren's syndrome (pSS) is a chronic systemic inflammatory disease, which mainly affects the lacrimal and salivary glands, leading to sicca syndrome. pSS has a probable autoimmune etiology, with the production of several autoantibodies such as antinuclear antibodies (ANA), anti-Ro/SS-A, anti-La/SS-B, rheumatoid factor (RF) and cryoglobulins. Recently, our group described a high frequency of antibodies directed to DNase I in the serum of pSS patients and these antibodies were associated with the presence of the anti-Epstein-Barr (EBV) early antigen diffuse (anti-EA-D). This finding becomes interesting considering the recent description of reduction of DNase I activity in the tear of patients with xerophthalmia of different causes, which would result in an accumulation of extracellular DNA and neutrophilic inflammatory infiltrate on the ocular surface. This hypothesis is reinforced by the observation that treatment with DNase I as eye drops results in clinical improvement of dry eye. In addition, it has been shown that periodontal disease is an aggravating factor of xerostomia in pSS, as it leads to a chronic inflammatory process and, consequently, to the destruction of minor salivary glands. Therefore, the objective of the present study will be to evaluate the presence of antibodies directed to DNase I in the saliva and serum of pSS patients and its possible capacity of inhibition of the enzyme before and after treatment of periodontal disease. Such findings will be correlated with the presence of periodontal disease, with the glandular and extraglandular manifestations of SSp and also with the presence of EBV DNA in the serum and oral lavage of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary Sjögren's syndrome according to 2016 EULAR/ACR Classification Criteria, and healthy people without any rheumatic disease/symptoms of sicca syndrome
* Patients regularly followed at the Sjögren's Syndrome outpatient clinic of Rheumatology Division

Exclusion Criteria:

* Use of drugs that cause oral dryness (mainly antidepressants and antihistamines).
* Patients with history of head and neck radiation therapy.
* Current smoking.
* Pregnancy and/or lactation.
* History of periodontal treatment for at least 6 months prior to enrollment.
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 (deleted CH2 region) in patients with colorectal cancer.

II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients.

III. Determine the ability of this drug to localize to tumor sites in these patients.

IV. Determine the immune response in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8.

Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.

Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the colon or rectum

  * Not amenable to surgical resection
  * Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan
* TAG-72 positive
* Performance status - ECOG 0-2
* WBC greater than 3,500/mm\^3
* Platelet count greater than 125,000/mm\^3
* Hemoglobin greater than 10 g/dL
* No nucleated RBC or significant teardrop RBC morphology
* Bilirubin less than 1.5 mg/dL
* SGOT/SGPT less than 4 times normal
* Hepatitis B surface antigen negative
* Creatinine less than 2.0 mg/dL
* HIV negative
* No other malignancy within the past 5 years except basal cell skin cancer
* No allergy to iodine
* No detectable antibody to monoclonal antibody CC49
* Not pregnant or nursing
* Fertile patients must use effective contraception
* At least 3 weeks since prior immunotherapy and recovered
* No prior bone marrow or stem cell transplantation
* No other concurrent immunotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
* No concurrent chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of red marrow
* No concurrent radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior surgery and recovered
Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department

Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures).

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.


Eligibility Criteria:
INCLUSION CRITERIA

1. Children age 6 to 16 years
2. The managing physician determines need for procedural sedation
3. Parents will sign a consent form and children will sign an assent form

EXCLUSION CRITERIA

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate)
2. Triage category 1 (resuscitation)
3. Facial features or injury prohibiting wearing the VR goggles
Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease

Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval skin disorders are common and the diagnosis of these conditions can be difficult. Reliable discrimination between benign vulval skin conditions, precancerous conditions or vulval cancer often requires tissue biopsies. In addition the monitoring of patients with vulval disease at risk cancerous change is currently limited to visual assessment often supplemented by multiple invasive tissue biopsies. There are currently no established non invasive tests available for the diagnosis of vulval skin diseases.

The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform infrared spectroscopy are non invasive diagnostic tools that use the interaction of light within tissues to identify the chemical composition of different tissues. The use of these tools may reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease.

The aim of this project is to explore the use of vibrational spectroscopic techniques in the diagnosis of vulval skin disease. This will be achieved by performing vibrational spectroscopy on samples of tissue previously taken from women with vulval skin disease treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy will be compared with the routine tests and the accuracy of spectroscopy determined.

Design Ex vivo vibrational spectroscopic analysis of existing stored vulval and lymph node tissue samples collected from patients who have undergone treatment for vulval disease. Vibrational spectra are to be correlated with consensus histopathology and multivariate analysis to be used to evaluate the classification accuracy of vibrational spectroscopy ex vivo.

Aims

1. To establish vibrational spectral signal characteristics across a range of known vulval skin conditions.
2. To evaluate the ability of vibrational spectroscopic techniques to differentiate different vulval skin conditions.
3. To evaluate the ability of vibrational spectroscopy to detect diseased lymph nodes in women who have undergone surgery for vulval cancer.
4. To further the understanding of biochemical changes in a range of known vulval skin conditions.

Eligibility Criteria:
Inclusion Criteria:

* Vulval skin tissue stored after routine histopathological analysis from women treated or investigated for a vulval skin condition.
* Inguinofemoral lymph nodes stored after routine histopathological analysis from women treated for vulval cancer.

Exclusion Criteria:

* Tissue specimens inadequate for analysis.
An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial

Gastric cancer is a major health issue and one of the most common malignance in Korea. With the popularization of cancer screenings and increasing the average lifespan, the number of gastric cancer patients is increased. In the past, most of the research were concerned with survival and recovery after cancer surgery. However, as the medical technology had been developed and recovery rate and survival rate of cancer patients had risen, the patients wanted to return to a daily life and desire for participation for leisure. In other words, the patients who underwent surgery wants to maintain a high quality of life(QOL) level as like prior to cancer surgery.

There are many reports on the effect of the exercise program after cancer surgery. In addition, exercise program was associated with improving the QOL and functional recovery, decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.

However, the subject patients of previous studies were Western people. Therefore, The results were not disclosed whether the exercise program suited to the body characteristics of Korean people. Furthermore there was no exercise program studies for the gastric cancer patients.

Medical service for cancer patients care should include not only diagnosis, treatment as like surgery but efforts on enhancing the quality of life. In other words, post-management education and management program as like exercise program are necessary for the cancer patients after surgery. Thus, the investigators have done the pilot study about how to practice the exercise program and how to evaluate the effect on the recovery. Based on the result of pilot study which could identify the safety and the feasibility , the investigators would like to do a prospective randomized controlled study to prove the effect of exercise program after surgery

Eligibility Criteria:
Inclusion Criteria:

1. Early gastric cancer patients
2. Undergoing minimally invasive surgery
3. AGE: 20-70
4. ECOG: 0-1
5. A patient who did not exercise regularly for the last 6 months
6. A patient who signed the informed consent

Exclusion Criteria:

1. Pregnancy or plans to become pregnant
2. Cognitive disabilities
3. Other primary cancer history
4. History of major abdominal surgery except current surgery
5. Cardiopulmonary medical comorbidity
6. Living \> 60 km from the hospital
Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy

Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis

Parent/s of babies born to mothers with pregestational diabetes who have normal clinical examination and have no radiographs showing a normal sacrum will be approached for a spinal US

Eligibility Criteria:
Inclusion Criteria:

* Infants born to mothers with pregestational diabetes
* Normal spinal examination

Exclusion Criteria:

* Infants born to mothers with pregestational diabetes
* Abnormal spinal examination such as a sacral dimple
* Radiograph with abnormal sacrum
* Spanish speaking parents
Parents Perception and Compliance With Pre Operative Fasting Instructions in Paediatric Patients

This study evaluates the perception and compliance with the fasting instructions given to parents of children undergoing surgery. A questionnaire was provided to the parents indicating fasting time requested and actual time of fasting.

American Society of Anesthesiologists (ASA) have recommended fasting guidelines of 8 hours of solids, 6 hours for formula milk, 4 hours for breast milk and 2 hours of clear liquids, for preoperative patients undergoing elective surgery. Parents of Children undergoing surgery are instructed to adhere to these guidelines. Parents might not be compliant with these instructions. They may fast their children less than or more than the recommended time.

Main aim of this study is to find out the incidence of non compliance with the fasting instructions and try to find the reasons for such non compliance.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to 12 years
* ASA I and II category
* Elective day care surgery
* General anaesthesia planned

Exclusion Criteria

* Parent's refusal to participate.
* Children with complex nutritional requirements eg. feeding via gastrostomy tube
* Parents who cannot read or understand English, Hindi or Punjabi
Clinical Reporting to Alleviate the Nocebo Effect

Terminology in radiology reports may cause patients harm by anchoring to or justifying a particular diagnosis. This phenomenon is known as the nocebo effect. MRI may cause patients to pursue more invasive procedures with little added benefit. This study aims to reproduce a study to determine the impact of clinical reporting on patient care and outcomes for those suffering from lower back pain.


Eligibility Criteria:
Inclusion Criteria:

* History of lower back pain undergoing MRI
* Greater than 18 years of age
* Able to understand and willing to comply with all study procedures and is available for the duration of the study

Exclusion Criteria:

* A potential subject who meets any of the following criteria will be excluded from participation in the study:

  * Acute lower back pain secondary to trauma within 1 months
  * Severe cord compression on MRI
  * Cord signal abnormality on MRI
  * Metastatic cancer
  * Spinal epidural abscess
  * Vertebral osteomyelitis
  * Judgement of the ordering physician (e.g. focal neurologic deficit)
  * Anything that, in the opinion of the investigator or team, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study