cyrilzakka/clinical-trials huggingface dataset:
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury

The goal of this clinical trial is to evaluate the effect of probiotic and prebiotic supplementation in individuals with chronic spinal cord injury experiencing gastrointestinal complaints.

The main questions this trail aims to answer are:

* what are the effects of the supplementation on gastrointestinal symptoms?
* what are the effects of the supplementation on gut microbiome composition?
* what are the effects of the supplementation on inflammatory serum markers?
* what are the effects of the supplementation on gastrointestinal transit time?

Participants will:

* take either the probiotic or prebiotic supplement daily for eight weeks, followed by a four-week "wash-out period" (= no intake of either supplement) and a subsequent eight-week intake of the other supplement.
* visit the study center for four appointments, during which various measurements will be performed.


Eligibility Criteria:
Inclusion Criteria (at screening):

* Age: ≥ 18 years
* Sex: male and female.
* Chronic SCI (\>1 year post-injury)
* Individuals with para- and tetraplegia (American Spinal Cord Injury (ASIA) Impairment Scale (AIS) score A-D)
* Having significant gastrointestinal complaints, indicated with "yes" at screening and by a GIQLI questionnaire score below 110 at baseline
* Signed written informed consent

Exclusion Criteria (at screening):

* Antibiotic use within the last four weeks before starting the study
* Major dietary changes within the last four weeks before starting the study, such as initiating a vegan or ketogenic diet
* Presence of clinically relevant medical conditions, including Crohn's disease, diagnosed eating or gastrointestinal disorders, assessed on an individual basis
* Intake of significant concomitant medication, including immunomodulating therapy, mesalazines, or steroids, assessed on an individual basis
* Concurrent participation in other clinical trials investigating or potentially affecting GI health
* Insufficient German language skills to follow the study procedures
* Pregnancy (anamnestic)
Teach-Back Educational Method On Diabetes Knowledge Level

It was aimed to research the effect of teach-back educational method on diabetes knowledge level and clinical parameters in type 2 diabetes patients undergoing insulin therapy. This is a randomized-controlled trial. Teach-back method will used for intervention group, routin diabetes education will used for control group. The primary outcome is diabetes knowledge levels (DKL), and secondary outcome is clinical patameters (fasting blood glucose, HbA1c, blood pressure). DKL and clinical parameters will measured and compared between two groups before and three months after the interventions.


Eligibility Criteria:
Inclusion Criteria:

* To have Type 2 Diabetes
* To be over 18 years old
* Not have any barriers in understanding and speaking Turkish
* Who started insulin treatment for the first time

Exclusion Criteria:

* Patients with a diagnosis of dementia
* To have vision or hearing loss
Biomarkers in Patients at Risk of Developing Myelodysplastic Syndrome or Other Disorders and in Healthy Participants

RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk of developing myelodysplastic syndrome may help doctors learn more about changes that occur in DNA and identify biomarkers related to disorders of the blood and bone marrow.

PURPOSE: This research study is looking at biomarkers in patients at risk of developing myelodysplastic syndrome or other disorders and in healthy participants.

OBJECTIVES:

Primary

* To identify novel biomarkers of disease that would help in the initial diagnosis of myelodysplastic syndromes (MDS).

Secondary

* To understand the genesis of anemia in cancers.
* To identify novel biomarkers of disease that predict progression of MDS to acute myeloid leukemia.

OUTLINE: Blood and bone marrow samples are collected. Hemopoietic stem cells (HSC) and progenitor cells are isolated from samples for analysis. Some of these HSC and progenitor cells are used for functional assays. From the rest of the cells, DNA, RNA, and protein is extracted for molecular analyses, including gene mutation analysis, gene methylation assays, chromatin immunoprecipitation, microarray, and real-time polymerase chain reaction.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Must meet 1 of the following criteria:

  * Being investigated for a potential blood disorder due to abnormal blood count
  * Patients with a known blood disorder who are having a bone marrow sample taken as part of the assessment of that disorder
  * Patients undergoing hip replacement surgery at Nuffield Orthopaedic Centre, Oxford meeting the following criteria:

    * Not on treatment likely to impair bone marrow function
    * No history of having had treatment likely to have impaired bone marrow function
    * Normal blood count
  * Archived samples from patients with known blood disorder

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
High Protein Diet in Patients With Long-chain Fatty Acid Oxidation Disorders

The study also determines if eating a diet higher in protein alters body composition, energy balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.

At baseline, the amount of muscle and fat in the whole body and inside the liver and muscle will be measured. All subjects will complete a moderate treadmill exercise test and a test to determine how they use sugar (oral glucose tolerance test). The amount and type of energy burned by each subject will be measured. Subjects will be randomly assigned to follow either a high carbohydrate diet or a reduced carbohydrate, high protein diet for 4 months. At the end of 4 months, the tests will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of a long-chain fatty acid oxidation disorder including VLCAD, CPT2, LCHAD or TFP deficiency
* 7 years old or greater
* able to comply with diet guidelines

Exclusion Criteria:

* pregnant
* enrolled in another study that alters diet composition
* cannot complete treadmill exercise study
Comparative Study of Learning Curve for First Trimester Fetal Anomaly Scan

Ultrasound scans during first trimester are more difficult than routine mid-trimester ultrasound scans. Practice guidelines for first trimester fetal ultrasound scans have been provided by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) since 2013. Using this guidelines, different levels of proficiency operators might have equal ability to complete first trimester ultrasound scans.

Nowadays, high-resolution transabdominal ultrasounds are widely used, and ultrasound scans for fetal structural abnormalities at the first trimester are indeed possible. First trimester ultrasound scans are important and essential for detecting fetal structural anomalies, and they help provide optimized early antenatal management. However, ultrasound scans, during this period, are more difficult than routine mid-trimester ultrasound scans, as fetal organs are small and experienced operators are needed to use the transducer to obtain informative pictures. Practice guidelines for first trimester fetal ultrasound scans have been provided by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) since 2013. Since then, the percentage of complete scans and the high detection rate of fetal structural abnormalities during first trimester ultrasound scans have been reported. From our perspective, ultrasound operators who have different experiences in mid-trimester ultrasound scanning might have equal ability to complete first trimester ultrasound scans using the ISUOG guidelines. The objective of this study is to compare the rate of completed scans regarding fetal structures at the first trimester ultrasound scan between two different levels of proficiency operators.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Maternal age ≥ 18 years
* Gestational age between 11-13 + 6 weeks by last menstrual date or ultrasound report if uncertain date

Exclusion Criteria:

* Multifetal gestation
* Miscarriage before first trimester ultrasound
* Loss to follow up at mid-trimester ultrasound scan
* Loss to follow up after birth
The Glycaemic Effects of Glucerna® in Critically Ill Patients.

To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Patients with an anticipated stay of at least 48 hours of admission to the intensive care
* Expected to receive enteral feeding for at least 48 hrs
* Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
* Patient or surrogate understands and signs informed consent document.

Exclusion Criteria:

* Patients with pre-existing contraindications to enteral feeding or to placement of a continuous glucose monitoring system
* Patients previously randomised into the GluCip trial
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.
A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia

RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients who are hospitalized due to an acutely agitated psychotic episode. The patients should be managed according to normal clinical practice until discharge time. Data will be collected by review of medical records of the hospitalisation prior the study visit. During the study the patients will conduct one visit on the day of their discharge after hospitalisation due to an acutely agitated psychotic episode. On the study visit data on demographics, diagnosis and medical history will be recorded. Data on antipsychotic and concomitant medication will be collected by review of medical records.

RECONNECT-S ALPHA: A non-interventional study to observe real-life allocation of antipsychotics in the acute inpatient management of schizophrenia

Eligibility Criteria:
Inclusion Criteria:

* male or female patients,
* 18 years or older,
* meeting the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders,
* meeting 4th edition (DSM-IV) criteria hospitalization due to an acutely agitated psychotic episode.

Exclusion Criteria:

* patient in acutely agitated state upon discharge from the hospital,
* current participation in any clinical trial,
* previous enrolment in the present NIS.
Improving Safety in Pediatric Thyroidectomy by PTH Measurements

We implemented a previously reported algorithm based on intra-postoperative PTH measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. The objective of the study was to assess if this strategy was useful to reduce hypocalcemia, post-surgery calcium sampling and hospitalization length.

Sixty-six patients were included in the analysis. Based on their intra-operatory PTH determinations, patients were classified according to their post-surgical hypoparathyroidism risk and were either immediately treated with calcium and vitamin D1-25 supplementation (high-risk) or assigned to clinical control and routine calcium sampling (low-risk). The outcomes and overall results of these therapeutical approaches were compared with those of a control group, started on treatment when TCa levels dropped below normal.

In the high-risk subgroup (n=30) five patients showed hypocalcemia within the first 24 hours. Compared with the high-risk control subgroup, the incidence of hypocalcemia fell from 100% to 17% (p\<0.001), and the median hospitalization length from 6 to 3 days (p\<0.001).

In the low-risk subgroup (n=36) 28 patients remained normocalcemic with significantly less calcium sampling (p\<0.001). Eight patients had hypocalcemia; 7 of them required neck dissection, which was the only risk factor related to post-surgical hypoparathyroidism (RR: 2.1 \[CI 95% 1.4-3.1\], P\<0.001).

Compared to the control group, overall incidence of hypocalcemia was reduced by 58 %.

This approach improved patient's safety by reducing the occurrence of hypocalcemia and the length of hospitalization after thyroidectomy in pediatric patients. Preventive calcium supplementation seems to be more beneficial in patients undergoing neck dissection.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent total thyroidectomy between January 2014 and April 2020

Exclusion Criteria:

* Patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism
Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy

Patients with primary head and neck squamous cell carcinoma (HNSCC) planned for treatment with radiotherapy with or without chemotherapy in curative setting will be treated with an adaptive radiotherapy scheme. An FDG-PET/CT scan for re-delineation and re-planning will be made at the end of the second and fourth of week of radiotherapy. The non-responding part of the tumor on FDG-PET will receive a mild dose-escalation. Depending on the metabolic response, the entire tumor will receive 70 Gy or the residual FDG-avid area will receive 74 or 78 Gy.

If there is a complete metabolic response on the FDG-PET after 2 weeks, the entire tumor will receive 70 Gy. If there is a complete metabolic response after 4 weeks of treatment, the residual FDG-avid area will receive 74 Gy. If there also is no complete metabolic response after 4 weeks of treatment, the residual FDG-avid area will receive 78 Gy.

Eligibility Criteria:
Inclusion Criteria:

* Histologic biopsy confirmed squamous cell carcinoma of the oral cavity, HPV-negative oropharynx, HPV-positive oropharynx with a minimum of 10 pack-years, hypopharynx or larynx
* T2-T4
* Scheduled for radiotherapy or radiotherapy with cisplatin or cetuximab

Exclusion Criteria:

* GFR\<30
* Other neoplasms with metastases in the previous 3 years
Effects of Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain

The study will be Randomized controlled trail, Subject diagnosed with low back pain meeting predetermined inclusion and exclusion criteria will be divided into two groups.

Pre assessment will be done using pain and disability as subjective measurement through Numeric pain rating scale (NPRS) \& modified Oswestry disability index and the lumber range by goniometer as objective measurement. One group is subject will be treated with therapeutic neuroscience education and core stability exercise and second group is core stability exercise. Each subject received 18 sessions with 3 treatments per week. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore

Chronic low back pain (LBP) is very common musculoskeletal disorders and leading causes of disability worldwide. Numerous epidemiological data show that 11%-84% of people experience, have experienced,or will experience pain in the lower spine at least once in their lives . With a global prevalence of 9.4%, LBP was ranked highest in the number of years lived with a disability and sixth in overall burden of disease Pakistan can suffer 56% from the LBP Nociplastic pain can be mechanistically defined as pain arising from the altered function of pain-related sensory pathways in the periphery and CNS, causing increased sensitivity Nociplastic pain should be viewed as an overarching terminology that can be applied to a diverse range of clinical conditions that share common neurophysiological mechanisms.

The main concern of TNE concept is that increasing the patient feeling of biology and physiology underpinning their pain condition instead of focus on anatomy and structure issues of tissue.In order to improve health of patient with CLBP healthcare provider proper educate their patient about experiencing pain and it may not result of tissue damage Several non surgical treatments have been offered to help and decrease LBP, such as joint manipulation, traditional therapeutic exercises , and medication

core stability training (CST) program this type of exercise focuses on the ability of the spine to stabilize in different positions and emphasize smaller, deeper, and posterior muscles. By increasing the endurance of these muscles, they retrain and maintain the correct physical condition to stabilize the spine to improve pain, performance, and ROM

There are few studies in literature which compare the TNE effect with core stability exercisein CLBP however there have been no studies which can compare TNE with nociplastic pain which effects on CLBP

Eligibility Criteria:
Inclusion Criteria:

* Diffused chronic low back pain
* Stop movement due to fear of increasing pain
* Anxiety and sleep problem with CLBP
* Symptoms duration most of days in 6 months
* No treatment other than analgesics

Exclusion Criteria:

* Diabetes mellites
* Radiating pain
* Spine surgery, fracture, arthritis
Swiss Trauma Registry

The Swiss Conference of Cantonal Health Directors has transferred the planning of highly specialized medicine to a specialized body under the direction of the Swiss Academy of Sciences. This specialist body has defined the treatment of critically ill as part of highly specialized medicine and founded the Swiss Trauma Registry at 12 hospitals in Switzerland. The registry is designed to provide a consistent and standardized approach and treatment outcomes in the short and long term quality control and as a basis for planning highly specialized medicine.


Eligibility Criteria:
Inclusion Criteria:

* injury severity code \> 16 and 7 or abbreviated injury scale \>3 for region of skull and brain

Exclusion Criteria:

* patients who will transferred in a burn unit
* drowned patients
Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)

This overall goal of this trial will be to demonstrate that DYV700 is safe and effective as a treatment for acute gout flares.

Gout presents as intermittent acute painful and debilitating gout flares. High serum uric acid levels lead to the deposition of urate crystals in and around the joints, most commonly the big toe (also called podagra) and other peripheral joints. An acute gout flare causes extreme pain and inflammation of the afflicted joints. It initially presents as a monoarticular condition but can affect several joints as the disease progresses. Gout flares typically take 7-10 days to resolve.

Currently, the inflammation and pain associated with acute gout flares are treated anti-inflammatories, including non steroidal anti-inflammatory drugs (NSAIDs), colchicine, corticosteroids, and adrenocorticotropic hormone. However these drugs are limited in efficacy, contraindicated for some patients and may take more than 24 hours to relieve gout symptoms (e.g. colchicine).

DYV700 will be developed to reduce the pain associated with acute gout flares. DYV700 is applied topically and utilizes a proprietary drug delivery system to deliver it's active ingredients.

Eligibility Criteria:
Key Inclusion Criteria:

1. Females and males, age 18 to 75 years of age.
2. Diagnosis of gout using ACR/EULAR criteria (must have a score of equal to or greater than 8)
3. Subjects must have experienced ≥2 gout flares in the 12 months prior to screening;
4. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial.
5. If taking NSAID, oral steroids, opioids, or other pain medications at standard doses (as stated on drug label) for pain unrelated to their gout flare, must be taking the same drug for at least 7 days prior to the gout flare and throughout the length of the trial.
6. Women of childbearing potential are excluded. Women not considered of childbearing potential must have one of the following documented in their study medical history:

   1. Postmenopausal for at least 12 months prior to study;
   2. Without a uterus and/or both ovaries; or
   3. Bilateral tubal ligation at least six months prior to study enrollment.

Key Exclusion Criteria:

1. BMI of \>40kg/m2 at the time of screening
2. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial.
3. Subjects who are contraindicated for the use of colchicine or whom are unable to take the SOC dose of 1.2mg followed by 0.6mg an hour later.
4. Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of infectious/septic arthritis, acute polyarticular gout (4 or more joints), with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion.
5. Subjects who have experienced \>2 gout flares per month, or \>12 attacks overall in the months prior to randomization.

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Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia

Molecular testing is a largely validated approach allowing rapid identification of positive blood cultures. However, due to its high cost and its limited information on susceptibility, it is considered as an add-on technique reserved for specific patient populations. In our study, we specifically evaluated molecular testing in a critical care setting and measured its impact on the therapeutic management of critically ill with positive blood cultures. Through the analysis of 110 positive blood culture episodes included in both pre- and post intervention period, we measured a drastic 14h-reduction of the time to administration of the optimal antimicrobial treatment with the use of the molecular approach.


Eligibility Criteria:
Inclusion Criteria:

* adult intensive care unit patients with positive blood cultures

Exclusion Criteria:

* palliative care patients