cyrilzakka/clinical-trials huggingface dataset:
Dixon MRI Imaging Histology for Predicting Postoperative Infection in Posterior Lumbar Fusion for Myasthenia Gravis

Sarcopenia is an age-related condition that manifests itself as a persistent decrease in muscle mass and function, which may lead to decreased physical function, increased risk of disease, and reduced quality of life. In surgical patients, sarcopenia has been shown to be associated with increased postoperative complications, prolonged hospitalization, and decreased survival. In patients undergoing lumbar fusion, the presence of sarcopenia may increase the risk of postoperative infection.Lumbar fusion is a common procedure to treat lumbar spine disorders such as lumbar disc herniation, lumbar spondylolisthesis, or lumbar spinal stenosis. However, this procedure is associated with a high rate of complications, especially postoperative infections, which can lead to reoperation, prolonged hospitalization, and even affect patient survival. In recent years, more and more studies have found a significant association between sarcopenia and postoperative infections after lumbar fusion surgery.Imagingomics belongs to a branch of machine learning, which is the process of acquiring images from various imaging devices such as CT, MRI and ultrasound, outlining the region of interest through image segmentation, extracting the features of the image within the region of interest, downscaling the features, and finally building an imagingomics model. MRI Imagingomics, utilizing its rich data information, has shown great potential for application in several medical fields. Among them, the accuracy of Dixon MRI imaging histology in muscle mass and texture assessment makes it particularly important in predicting postoperative infections.Based on this, it is reasonable to believe that Dixon MRI imaging histology can be a powerful tool to help us predict a patient's risk of postoperative infection.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over 18 years of age.
* Inclusion of patients with sarcopenia is subject to the definition and diagnostic criteria of the European Consensus on Definition and Diagnosis of Sarcopenia.
* The patient underwent posterior lumbar fusion and had a Dixon MRI scan within 2 weeks prior to surgery.
* Patients were able to understand the purpose and procedures of the study and were willing to sign an informed consent form.
* The patient's clinical consultation and follow-up information was complete.

Exclusion Criteria:

* The patient has contraindications to MRI, such as implanted metal devices (e.g., pacemakers) or severe claustrophobia.
* Patients with serious other medical conditions, such as heart disease, kidney disease or liver disease, which may affect their post-operative recovery.
* Patients have known immune system disorders or are on immunosuppressive therapy, which may affect their risk of infection.
* The patient has had other spinal surgery within the last 6 months.
Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock
* Mechanically ventilated
* Expected length of stay in ICU ≥ 4 days
* Written informed consent obtained from authorized surrogates

Exclusion Criteria:

* Pregnancy
* Requirement for inspired oxygen content (FIO2) \> 0.60
* High output bronchopleural fistula
Remote Breast Cancer Screening Study

A multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on Automated Breast Ultrasound (AB US) with remote reading mode.

The burden of breast cancer incidence and mortality is rapidly growing during the past two decades in China. Screening has been proven to be effective in detecting early-stage disease and reducing mortality of 10% to 39% due to breast cancer. US is used as a primary screening method among Chinese women because Asian women characteristically have higher-density breasts than other ethnic groups. However, US is dependent on operator experience, lack of standardized scanning protocols, limited ultrasound physician and heavy workloads. In order to improve the efficiency and quality of breast cancer screening among Chinese women, a new remote screening pattern based on AB US was proposed and studied for breast cancer in China. This multi-center, prospective, cohort study aims to evaluate the efficiency of breast cancer screening based on AB US with remote reading mode. In addition, we will also explore the practice value of AI on AB US screening and efficient image acquiring and reading modes of AB US.

Eligibility Criteria:
Inclusion Criteria:

1. Any age at 35 and over
2. Screening breast cancer with AB US
3. Obtaining written informed consent

Exclusion Criteria:

1. symptoms of breast cancer
2. surgical of breast within 12 months prior to the study
3. known diagnosis breast cancer
4. poor image quality
5. follow-up was less than 12 months
Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs

The aim of the study is to determine the effectiveness of breathing exercises combined with core stabilization exercises in mothers with chronic non-specific low back pain of children with special health care needs.

A total of 46 mothers having children with special health care needs participate in the study.

Twenty-three mothers in the experimental group receive stabilization exercises with breathing exercises 3 times a week for 8 weeks while 23 mothers in the control group receive only stabilization exercises during the same period of time. Each exercise session lasts about 60 minutes and was performed 3 days per week, for 8 weeks. All mothers in both groups perform 15 minutes warm-up stretching exercises prior to the core exercises and 10 minutes cool-down exercises at the end of each session.

Breathing with the stabilization exercise group receives breathing exercises before the stabilization exercise program. A one-hour theoretical training is given to the mothers about the techniques of diaphragmatic and pursed-lip breathing at the beginning of the study. The pursed-lip breathing is one step further to the diaphragmatic breathing. Patients are instructed to do breathing exercises during the stabilization exercises, in which patients focus on their breathing circle, time, and movement while doing the stabilization exercises.

All 46 mothers in both groups are given a one-hour training about the stabilization exercises before starting the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface. Closed-chain segmental control exercises, a series of weight-bearing exercises, and open kinetic chain exercises to promote distal stability are performed.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of the child
* Suffering from LBP for at least three months
* Lumbar instability
* Absence of radiculopathy or other damages to the spine
* Not receiving any types of physical therapy during the trial or at least six months prior to the study
* Enough physical autonomy to participate in the physical activities
* Be volunteer
* Be compliant for the study

Exclusion Criteria:

* Taking any anti-depressant medications and/or having psychotherapy
* Any surgery within the last 3 months
* Be pregnant
* Presence of dysfunction of the musculoskeletal system during the study
* Participation rate lower than 80% of the program schedule
Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1

This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1.

Out of every three participants, two will receive terlipressin and one will receive placebo.

Assignments will be made randomly.

The primary objective of this trial is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent by participant or legally authorized representative
* Cirrhosis and ascites
* Rapidly progressive worsening in renal function to a serum creatinine (SCr) at least 2.25 mg/dL and meeting a trajectory for SCr to double over 2 weeks
* No sustained improvement in renal function (less than 20% decrease in SCr and SCr at least 2.25 mg/dL) at least 48 hours after diuretic withdrawal and the beginning of plasma volume expansion with albumin
* Discontinues midodrine and octreotide before randomization if applicable

Exclusion Criteria:

* Serum creatinine level greater than 7.0 mg/dL
* At least 1 event of large volume paracentesis (LVP) at least 4 L within 2 days of randomization
* Sepsis and/or uncontrolled bacterial infection
* Less than 2 days anti-infective therapy for documented or suspected infection
* Shock
* Being treatment with or exposure to nephrotoxic agents, nonsteroidal anti-inflammatory drugs, or significant radiographic contrast agents (within the last 4 weeks)
* Estimated life expectancy of less than 3 days
* Superimposed acute liver injury due to drugs, dietary supplements, herbal preparations, viral hepatitis, or toxins, with the exception of acute alcoholic hepatitis
* Proteinuria greater than 500 mg/day
* Evidence of obstructive uropathy or parenchymal renal disease on ultrasound or other imaging
* Tubular epithelial casts, heme granular casts, hematuria or microhematuria (greater than 50 red blood cells per high power field in the absence of recent catheterization) on urinalysis
* Pregnancy; all women of child-bearing age and potential must have a negative pregnancy test
* Cardiovascular disease judged by the investigator to be severe
* Current or recent renal replacement therapy (RRT) within the past 4 weeks
* Participation in other clinical research involving investigational medicinal products within 30 days of randomization
* Transjugular intrahepatic portosystemic shunt (TIPS) within 30 days of randomization
* Use of vasopressors for at least 3 consecutive days within the 14-day screening period - patients receiving any vasopressor other than midodrine and octreotide within 24 hours of qualifying SCr are also excluded, ie, a 24-hour washout is required prior to enrollment
* Known allergy or sensitivity to terlipressin or another component of the study treatment
Individualized Exercise Prescription with a Data-driven Approach in Individuals with Stroke

The goal of this clinical trial is to evaluate if the exercised via data-driven approach is effective in enhance the gait pattern in people with stroke. It will reduce burdun of patient consultations for clinicians in reality.The main questions it aims to answer are:

Does individualized exercise training programmes via data-driven approach could improve gait patterns in individuals with chronic stroke? Does individualized exercise training programmes via data-driven approach could improve improve motor recovery, motor functions (including gait speed and balance performance), and community integration in individuals with chronic stroke?

Participants will:

Undergo 12 supervised-exercise (training sessions (60 minutes, two times a week, for six weeks), Participants will receive a data-driven exercise prescription or conventional exercise prescription which consists of 5 different exercises.

They will be assessed on Baseline assessment before training (A0); after six sessions (A1); after 12 sessions (A2); and three months after training (A3).

Based on the results of the gait patterns and Electromyography (EMG) analysis, the principal investigator (PI) will design appropriate exercises that target the specific gait impairment at a specific time period during the gait cycle. Exercises will utilize various modalities that are commonly used in clinical practice, including TheraBand, gym equipment, free weight. The training may target single-joint movement or targeting a movement pattern that involves multiple joint holistically. A body harness system will be used to protect the participant during the exercise training. The participant will be supervised by a research assistant who has rich experience in conducting exercise training on people with disability. Below are potential exercises that will be prescribed to the participant based on their impairment revealed by the analyses. eg. Lack of hip flexion during swing phase: Open kinetic chain strengthing exercise for hip flexor in a concentric manner...

Eligibility Criteria:
Inclusion Criteria:

* between 45 and 75 years old;
* have received a diagnosis of stroke more than six months earlier;
* able to walk 10 m independently;
* able to score at least 6 of 10 on the Abbreviated Mental Test;
* able to follow instructions and give informed consent.

Exclusion Criteria:

* any existing medical condition such as uncontrolled hypertension that hindered training or assessment;
* unable to offer consent due to impaired cognitive function.
STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

The investigators propose to conduct a cross-sectional study of 60 participants who are 18-30 years of age to undergo research PET/CT. The purpose of this study is to investigate the relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and components of the metabolic syndrome in young adults.

We propose to conduct a cross-sectional study of 60 participants who are 18-30 years of age to undergo research PET/CT. The purpose of this study is to investigate the relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and components of the metabolic syndrome in young adults. This study is part of a larger study aimed at understanding the mechanism of brown adipose tissue as a potential protective factor against metabolic dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-30 years of age at enrollment, who are obese (BMI greater or equal to 30 kg/m2, weight less than 159 kg) and healthy
* Without medications and endocrine/genetic disorders known to affect weight.
* Participants may have insulin resistance, impaired glucose tolerance, dyslipidemia, or hypertension.

Exclusion Criteria:

* Anyone who refuses participation.
* A genetic syndrome or other endocrine disorder known to cause obesity (Prader-Willi, Cushing Syndrome, Leptin deficiency, etc.).
* Use of the following medications: psychotropics, sulphonylurea, thiazolidinediones, insulin, glucocorticoids, anti-neoplastic agents, angiotensin receptor blocker, angiotensin-converting enzyme inhibitors.
* Pregnancy or history of pregnancy.
* Active infectious disease
* History of CVD or stroke during the previous 36 months
* Total cholesterol 300 mg/dl, triglycerides 400 mg/dl
* Blood pressure 140/90 mmHg
* Fasting plasma glucose 126 mg/dl.
* Diabetes mellitus, type 1 or 2.
Effects of Nicotine Salt Aerosol on Cigarette Smokers

This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.

The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine "salt" (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.

Eligibility Criteria:
Inclusion Criteria:

Participants must be:

* healthy (determined by self-report)
* between 21-55 years old
* wiling to provide informed consent
* able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol
* cigarette smokers

Exclusion Criteria:

• Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening

Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
High-Intensity, Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-intensity, brief-duration chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia.

OBJECTIVES: I. Determine the complete response rate to high-intensity, brief-duration chemotherapy with cyclophosphamide, methotrexate, vincristine, doxorubicin, and dexamethasone followed by ifosfamide, methotrexate, vincristine, cytarabine, etoposide, and dexamethasone in patients with relapsed or refractory acute lymphocytic leukemia (ALL). II. Determine the toxic effects of these regimens in these patients.

OUTLINE: All patients receive up to six alternating courses (every 3-4 weeks) of two chemotherapy regimens: cyclophosphamide, oral dexamethasone, methotrexate with leucovorin rescue, vincristine, and doxorubicin over 5 days; and ifosfamide/mesna, oral dexamethasone, methotrexate with leucovorin rescue, vincristine, cytarabine, and etoposide over 5 days. G-CSF is given following each course until recovery of the neutrophil count. All patients receive triple intrathecal chemotherapy on day 1. Patients with CNS disease receive intrathecal therapy twice weekly until the CSF is clear, then weekly for 4 weeks, and monthly for 1 year; those who have not received prior CNS irradiation also receive whole-brain radiotherapy. Patients are followed monthly for 6 months, every 3 months for 18 months, every 6 months for 2 years, then annually.

PROJECTED ACCRUAL: A total of 37 evaluable patients will be accrued if at least 4 of the first 17 patients respond.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia that is relapsed after or refractory to induction therapy 1 or 2 prior inductions allowed, but refractory to only 1 regimen CNS involvement allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-3 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times normal (unless directly attributable to leukemia) Renal: Creatinine no greater than 1.5 times normal (unless directly attributable to leukemia) Cardiovascular: No uncontrolled or severe cardiovascular disease including: Myocardial infarction within 6 months Congestive heart failure Other: No uncontrolled duodenal ulcer No uncontrolled infection No second malignancy within 5 years except curatively treated: In situ cervical cancer Basal cell skin cancer No other serious medical illness that would limit survival to under 2 years No psychiatric illness that would prevent informed consent or compliance No pregnant or nursing women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: See Disease Characteristics
A Single-patient Study of Repeat-dose Administration of Prometic Plasminogen (Human) Intravenous

These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV infusion in one adult and one child with hypoplasminogenemia. These patients are under treatment to address wound healing and obstructions.


Eligibility Criteria:
Inclusion Criteria:

* Patient has provided informed consent.
* Patient has a diagnosis of compound homozygous Type 1 plasminogen deficiency as evidence by ligneous conjunctivitis since birth as well as involvement of the conjunctiva, nasopharynx, gingiva, tracheobronchial tree, gastrointestinal tract, and urinary tract.

Exclusion Criteria:

* Not applicable
Adherence to Activity Limitations in Diabetes

This study aims to develop and test a theory-based motivation communication training programme for healthcare professionals working with diabetic foot ulcer patients. The investigators will explore the acceptability of the training programme and examine whether the training leads to changes in healthcare professionals' communication style, and results in greater adherence to treatment recommendations (i.e., reduced weight-bearing) in patients.

This is a proof of concept, two-arm non-randomised, controlled before-and-after study. Patient outcomes (perceptions of healthcare professional communication style, treatment self-regulation and adherence to activity reduction) will be collected first during a control/usual care period. Healthcare professionals will then receive the theory-based motivation communication training programme. Subsequently a new group of patients will be recruited as the intervention group and the same outcome measures collected. Control group outcomes will be compared to intervention group outcomes. Interviews will be conducted with healthcare professionals and patients to assess acceptability of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Be aged 18 years and over
* Have diabetes according to WHO criteria
* Have a diabetic foot ulcer being treated at the foot clinic at Royal Derby Hospital
* Be able to communicate and complete questionnaire measures in English
* Have capacity to consent and agree to participate.

Exclusion Criteria:

- Patients who are not currently engaging in walking behaviour (e.g., wheelchair-bound patients) or have other physical limitations that restrict ability to use an accelerometer will be excluded.
Gemzar (Gemcitabine) and Alimta (Pemetrexed) in the Treatment of Patients With Recurrent Platinum-Sensitive and Platinum-Resistant Ovarian or Peritoneal Cancer

This study hopes to evaluate whether the combination of Gemzar plus Alimta will have any beneficial effects for patients with recurrent platinum-sensitive or platinum-resistant ovarian or peritoneal cancer. Treatments are weekly for two weeks, with the 3rd week off and will be repeated every 21 days. Side effects and the overall safety of the treatment will also be monitored and evaluated. In addition, a Quality of Life questionnaire is part of this study to help measure patient perceived benefits or drawbacks to this treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have disease that can be measured.
* Patients must meet criteria for either platinum-resistant or platinum-sensitive ovarian or peritoneal cancer.
* Patients may only have had one prior platinum-based chemotherapy regimen.
* Patients must be willing and able to stop all aspirin and NSAID medications immediately before and for a time after each treatment cycle (approx. 5-8 days)
* Patients must have normal kidney function.

Exclusion Criteria:

* Patients may not have a Low Malignant Potential or Borderline Ovarian Tumor.
* Patients may not have received pelvic or abdominal radiotherapy.
* Patients must not have evidence of or received treatment for another cancer within the last 5 years.
* Patients must not have been diagnosed with a heart attack in the last 6 months.
* Patients who are unwilling or unable to take folic acid tablets, vitamin B12 injections or dexamethasone tablets.