cyrilzakka/clinical-trials huggingface dataset:
Fluid Therapy and Glycocalyx Shedding During Moderate Surgery

Goal-directed fluid therapy is one of the most accepted strategies in intraoperative fluid therapy, although potential fluid overload is a possible drawback. Fluid overload has recently been shown to cause damage to the glycocalyx and to increase extravasation of fluids into the interstitial space.

This study aims to determine whether liberal fluid administration during moderate surgery results in impairment to the endothelial glycocalyx and causes edema.

Participants will be randomized to receive either a liberal or restrictive fluid protocol with vasopressor support. The investigators will measure interstitial edema by clinical signs, pulmonary congestion by ultrasound, and extracellular water by bioimpedance. Impairment of glycocalyx will be estimated by measuring blood levels of shedding markers. In addition, wound healing and early postoperative outcome will be estimated by POMS.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for abdominoplasty.
* American Society of Anesthesiologists Classification 1 or 2.

Exclusion Criteria:

* Pregnancy.
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed.

Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3.
* Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.

Exclusion Criteria:

* Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
* Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
High Intensity Physiotherapy for Hip Fractures

Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip fractures are a significant problem for the older people, the hospital system and community as a whole because of the increasing numbers of fractures and the cost of hospitalisation and ongoing care. After one year, less than half of all people with a hip fracture can walk as well as they did before the fracture. Physiotherapy in the acute hospital setting is an integral part of patient care, although the intensity of physiotherapy a patient receives is variable and the optimal number of treatment sessions per day remains unknown. Studies in other patient groups have shown that increased physiotherapy can improve patient outcomes by increasing muscle strength and mobility. It can also reduce the negative effects of bed rest such as muscle wasting, blood clots in the lungs or leg veins and chest infections such as pneumonia. This study aims to investigate the effectiveness of an intensive physiotherapy program in hip fracture patients to further understand this and the effect it has on patient function.

In this research the investigators will randomly allocate patients into 2 groups; usual care and intensive physiotherapy. The usual care group will have physiotherapy treatment daily whereas the intensive physiotherapy group will have an additional daily treatment by a physiotherapist as well as a daily treatment by an allied health assistant. The objectives are to achieve better functional outcomes in the patient's hospital stay (ie improved mobility), reduce the time for patients to be physically ready to go home, increase the number of patients able to go directly home or to fast stream rehabilitation (rather than a slow stream option).

If increased intensity of physiotherapy is found to improve patient's mobility outcomes, this research will provide the confidence to endorse a change to current clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above

Exclusion Criteria:

* fracture is in the sub-trochanteric region of the femur,
* if it is pathological,
* if post operative orders are for non-weight bearing on the operated hip,
* if they were unable to mobilise independently (or with gait aid) prior to admission,
* or if they were admitted from a nursing home.
Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women with Breast Cancer Receiving Chemotherapy

This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.

PRIMARY OBJECTIVES:

I. To describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy.

II. To examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy.

III. To examine associations between microbial composition functional profiles at T1 and T2, T3 as well as T4 in patients who report symptom severity in neuropsychological and GI symptoms at the last three timepoints.

IV. To evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and GI symptom occurrence at T2, T3 and T4.

OUTLINE: This is an observational study.

Patients undergo stool and blood sample collection, complete questionnaires, and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Female with a new diagnosis of breast cancer (stage I-III)
* Age 20 or older
* Able to read and write in English
* Chemotherapy naive and beginning the first cycle of moderately or highly emetogenic chemotherapy (For example, Taxotere + cyclophosphamide treatment +/- trastuzumab). Patients who have not received chemotherapy for five years or more are considered chemotherapy naive

Exclusion Criteria:

* Metastatic disease
* Cognitive impairment, based on clinician assessment, that would prevent completing measures
* Concurrent radiation therapy or radiation therapy within the last three months
* GI co-morbidities (i.e., irritable bowel syndrome, gastroesophageal reflux disease) or bowel surgery within the last three months
* A stoma preventing stool collection from the large intestine (i.e., ileostomy)
Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile

The purpose of this study is to evaluate whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Additionally, this intervention would provide a better quality of care and a more efficient health provision.


Eligibility Criteria:
Inclusion Criteria:

* Adults diagnosed with Hypertension and/ or Type 2 Diabetes

Exclusion Criteria:

* Severe mental illness and / or deterioration of cognitive abilities.
* Severe hearing loss.
* Diagnosed with cancer
* Stage 4 or 5 of chronic kidney disease
Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets

This study should estimate the dose proportionality of BAY94-8862 IR tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 46 years (inclusive) at the first screening examination
* Ethnicity: White
* Body mass index (BMI): \>= 18 and \<= 29.9 kg / m²

Exclusion Criteria:

* Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
* Systolic blood pressure below 100 or above 140 mmHg
* Diastolic blood pressure below 50 or above 90 mmHg
* Heart rate below 50 or above 95 beats/ min
* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
* Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome

This trial is conducted in Europe. The aim of this trial is to assess whether increasing doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and improve final height. This trial has two trial periods, a main period of 4 years and an extension period until final height is reached.


Eligibility Criteria:
Inclusion Criteria:

* Turner Syndrome
* Well documented growth rate during the previous year
* Height below the 50th percentile for the age in Dutch children
* Normal thyroid function

Exclusion Criteria:

* Any endocrine or metabolic disorder
* Growth failure due to disorders of genitourinary, cardio-pulmonary, gastro-intestinal and nervous systems, nutritional/vitamins deficiencies and chondrodysplasias
* Patients with hydrocephalus
Alcohol Use During Pregnancy in Finland According to Meconium Samples

Meconium samples are collected anonymously from newborns in Helsinki University Hospital maternity ward. The study tries to to find how many women continue to use alcohol during the second half of the pregnancy. Meconium samples are tested for ethylglucuronide (EtG), a metabolite of ethanol, that accumulates in the meconium. Altogether 1000 samples are taken. The sample results are compared to anonymously answered questionnaire about alcohol use.


Eligibility Criteria:
Inclusion Criteria:

* newborn baby

Exclusion Criteria:

-
Learning Effect of Onsite vs. Online Education in a Medical Context

The goal of this clinical trial is to learn about the effects of online medical education in PhD students. The main question it aims to answer is:

What is the effect of onsite compared to online research courses on theoretical knowledge of research methodology and motivation for young medical researchers? Participants will join 20 research courses which are computer randomised to be delivered online (intervention) or onsite (control group) with 10-12 PhD students of each course (200-240 participants). Participants will be followed for up to two years after their course. The outcomes are

* theoretical learning (main)
* academic achievements
* motivation
* self-efficacy

Researchers will compare online and onsite research courses to see if there is a difference in theoretical learning, academic achievements, motivation and self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* All PhD students on the courses if they are able to give informed consent

Exclusion Criteria:

* Declining to participate
* Withdrawal of informed consent
Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius

The primary objective of this study is to demonstrate safety and efficacy of an early strengthening and passive mobilization rehabilitation program for post-operative distal radius fracture fixation surgery compared to current conventional rehabilitation.

Functional outcome after distal radius fracture fixation has often been variable with multiple factors affecting final results. Early mobilization rehabilitation protocols have been the gold standard after fracture fixation surgery. Rehabilitation protocols vary from center to center's own practices. However, these commonly encompass an early mobilization protocol or otherwise known as accelerated rehabilitation or enhanced recovery after surgery (ERAS) programs. Such programs comprise of a short duration of immobilization followed by a period of active mobilization before strengthening exercises are employed.

The investigators have performed early motion protocol (EMP) rehabilitation in the last decade in the investigation center for post-operative fracture distal radius fixation patients. The early motion protocol allows immediate active mobilization without a period of immobilization or splint protection. Despite early mobilization rehabilitation, there are a subset of patients who develop significant stiffness and pain with poor functional outcomes, especially in the early post-operative period. Moreover, some patients may also develop complex regional pain syndrome (CRPS) albeit early active mobilization. Thus, an early strengthening protocol (ESP) was developed to allow for immediate strengthening and passive mobilization exercises post-operatively with physiotherapist and occupational therapist guidance. Herein this study, the investigators hope to demonstrate the safety and efficacy of an ESP rehabilitation compared to EMP for post-operative distal radius fracture fixation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years or older
* Diagnosed with an isolated closed injury, displaced, distal radius fracture (AO/OTA Classification 23-A1-3, B1-2, C1-2) without articular comminution
* Requires operative fixation
* Able to give consent

Exclusion Criteria:

* History of previous hand or wrist surgery
* Neurological injury or pre-existing neurological conditions to the upper limb
* Underlying osteoarthritis of the wrist
* Unfit for surgical anesthesia
* Subacute fractures with delayed presentation (\>2 weeks since initial injury)
* Unable to consent
* Refuse surgical intervention
* Unable to follow commands for rehabilitation
* Fixation construct or injuries requiring immobilization after surgery, such as unfixed distal ulna head or shaft fractures that require splintage or distal radio-ulnar joint instability planned for immobilization
Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration

A single-center, prospective, randomized clinical trial with a total of 100 patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak (JJV) will perform all surgeries. After the patient has consented they will be randomized to one of the following two groups:

1. Psoas compartment block (n=50)
2. Periarticular local anesthetic infiltration (n=50),

The patient will be blinded to the study group.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at Beaumont Hospital Royal Oak
* Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)
* Surgical approach is anterior

Exclusion Criteria:

* Minors (age less than 18 years)
* Pregnant (surgically sterile, post-menopausal, or negative blood test)
* Previous ipsilateral hip surgery
* Lumbar instrumentation
* Acute trauma
* Rheumatoid arthritis
* Avascular necrosis
* Hip dysplasia
* Known sensitivity, allergy, or contraindication to anesthetics being used in the study
* Narcotic sensitivity
* History of over 6 months of opioid dependency prior to surgery (excluding tramadol)
* Peripheral neuropathy
* Mental/cognitive impairment that would interfere with the patient's self-assessments of function, pain, or quality of life
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome

Muscle pain is frequently attributed to myofascial pain syndrome (MPS) in which myofascial trigger points (MTrP) are a characteristic feature. Dry needling is a frequent clinical practice to manage MPS but few evidence is published about percutaneous electrolysis effects for the treatment of MPS.

This is a randomized clinical trial with 3 parallel groups: 1) High intensity-short time percutaneous electrolysis; 2) Low intensity-long time percutaneous electrolysis; 3) dry needling control group.

The current study aimed to evaluate changes in rectus femurs active trigger points and patellar tendon pain pressure thresholds and subjective anterior knee pain perception after application of two percutaneous electrolysis methods using a same charge (high intensity and low intensity) compared to a dry needling group in patients with patellofemoral pain syndrome (PFPS)

Fifteen patients diagnosed with unilateral PFPS were divided in two experimental groups (high intensity percutaneous electrolysis and low intensity percutaneous electrolysis) and one active control group (dry needling. The duration of the study was 7 days with only one intervention. Pain pressure thresholds were assessed using an algometer before the intervention, immediately after the intervention and after 7 days and a Visual Analogue Scale was used before the treatment and after 7 days to rate the subjective anterior knee pain perception. Also a VAS was used to rate the pain perception during the intervention

Eligibility Criteria:
Inclusion Criteria:

* Athletes with knee pain
* Presence of at least one active Trigger point

Exclusion Criteria:

* Farmacologic treatment
* Surgery or traumas
* Skin alterations or infections
* Prior 6 weeks DN nor PT treatment
Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure

This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life and forming high quality evidence.

COPD is a highly prevalent disease, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. COPD complicated by CRF is serious and has a high mortality rate. At present, ideal and effective treatment is inadequate. Traditional Chinese medicine (TCM) has some potential in improving outcomes in COPD with CRF.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Yiqi Huoxue Huatan granule on reducing mortality and improving quality of life in COPD with CRF. After a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. The primary outcomes are all-cause mortality and frequency of acute exacerbation of COPD. The secondary outcomes include clinical symptoms, COPD assessment test (CAT), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. Safety will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of stable COPD;

  * Arterial blood gas analysis meets criteria of PaO2 \< 60mmHg and PaCO2 \> 50mmHg during quiet breathing at sea level;
  * Syndrome differentiation meets criteria of Qi deficiency, blood stasis and phlegm turbidity obstructing orifice syndrome；
  * Age ranges from 40 years to 80 years;
  * With informed consent signed.

Exclusion Criteria:

* • CRF resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.;

  * Acute exacerbation of CRF；
  * Patients with severe cardiovascular and cerebrovascular diseases;
  * Pregnant and lactating women;
  * Patients with psychiatric disorders；
  * Patients with diabetes;
  * Patients who have participated in other clinical studies in the past 4 weeks;
  * Patients who have experienced one or more acute exacerbation of COPD in the past 4 weeks.
Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease

Prematurely born infants with ductal-dependent congenital heart disease (CHD) are at increased risk to develop necrotizing enterocolitis (NEC). Abnormal left to right blood flow through a patent ductus arteriosus can cause intestinal ischemia and compromise the gastrointestinal tract as a barrier to infection. In some infants, bacterial translocation leads to NEC which may result in death, intestinal perforation, cholestasis and, at the very least, feeding problems. Predicting which infants with CHD will develop NEC will potentially decrease the severity of disease if interventions were started earlier.

Near-infrared spectroscopy (NIRS) allows determination of regional oxygen saturation levels in tissues such as brain, kidney, and as recently reported, intestine. This study will test whether or not decreasing intestinal oxygen saturations can predict the development of NEC in this at risk population before the symptoms become severe. NIRS probes will be placed on the forehead, flank and abdomen of eligible infants and regional oxygen saturations will be recorded prospectively and continuously with the clinical care team blinded to the data. The development of NEC and significant feeding problems will then be correlated with the regional oxygen saturations to determine whether decreased intestinal oxygen saturations predicted early signs and symptoms of NEC.

We anticipate generating pilot data in 30 infants who meet inclusion criteria. Support of this research will be provided partially by Somanetics, the manufacturer of the INVOS regional oxygen saturation monitors. They will, however, have no control over the data generated by this study.


Eligibility Criteria:
Inclusion Criteria:

* \>/+ 30 and 0/7 weeks gestation age at birth
* Anticipated time to surgical repair is \> 7 days
* Meets criteria for management via the PCMC CHD feeding protocol

Exclusion Criteria:

* Any extracardiac major congenital anomalies
Thromboelastogram During Total Knee Replacement

Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.

The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthrosis
* TKR operation elective
* ASA I-III

Exclusion Criteria:

* TKR due to any reason but osteoarthrosis
* known coagulation problems
* platelets \< 100,000/DcL
* Hb \< 12 g%
* past thrombo-embolic event
* treatment with aspiring during last week
* treatment with NSAID's during last 48 hours
* malignancy
* known allergy to tranexamic acid
* general anesthesia