cyrilzakka/clinical-trials huggingface dataset:
Plasma Free Amino Acids in Patients With Hepatic Encephalopathy

This is study to investigate the plasma free amino acids profile in patients with decompensated liver cirrhosis and hepatic encephalopathy and its relation to the nutritional state of these patients.

* To investigate the plasma free amino acids relation to the nutritional state of patients with liver cirrhosis and hepatic encephalopathy.
* To determine the effectiveness, cost, cost-benefit and in-hospital prognosis of branched chain amino acid (BCAA) infusion as an adjuvant to conventional mainstay therapy in the treatment of hepatic encephalopathy due to liver cirrhosis.
* To determine the effectiveness of branched chain amino acid (BCAA) infusion on improving amino acid imbalance and Fischer ratio (Branched chain amino acids/Aromatic amino acids ratio).

Alterations in amino acid profiles observed in patients with liver cirrhosis are very specific and markedly differ from those observed in other disorders..

Until present time the treatment of hepatic encephalopathy is mainly aimed at reducing the production and intestinal absorption of ammonia by antibiotics and non-absorbable disaccharides, although the available data indicate a low success rate of these strategies.

Beneficial effects of branched chain amino acids supplementation (BCAA) may be more pronounced in patients with marked depression of BCAA and/or low Branched chain amino acids/Aromatic amino acids (BCAA/AAA) ratio in extracellular fluid.

It also may be suggested that the beneficial effect of long term intake of BCAA on hepatic encephalopathy demonstrated in clinical studies is related to improved muscle mass and nutritional status.

The current recommendation only includes oral BCAA to patients with liver disease who are intolerant to standard protein intake.

The rationale for this limitation is based on the fact that in the mentioned randomized trials, hepatic encephalopathy was not part of the inclusion criteria. Additionally, the positive effect was difficult to interpret as it was observed on compound end points, which combine survival, hospitalization, and cirrhosis complications. From these results, it is not possible to ascertain the role of BCAA in hepatic encephalopathy, which patients benefit and to what extent .

For this reason, the investigators designed this study to assess effectiveness of BCAA in improving clinical, nutritional and laboratory status of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient has decompensated liver cirrhosis
* Patient has overt hepatic encephalopathy

Exclusion Criteria:

1. Protein losing enteropathy.
2. Neurological conditions that make the assessment of hepatic encephalopathy difficult

   1. Parkinson's disease
   2. Alzheimer's disease
   3. Concomitant stroke
3. Gastrointestinal Bleeding requiring blood transfusion

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Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis

The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce anti-inflammatory type II monocyte development during treatment of MS, and if these antigen presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting (RR) MS patients (McDonald criteria)
* Ages 18-55
* Males and females
* EDSS score ≤5
* No prior treatment with Copaxone
* Prior treatment with corticosteroids or interferon-beta (-1a or -1b) is acceptable, provided there is a washout period of at least one month

Exclusion Criteria:

* Treatment with Tysabri, Novantrone or cyclophosphamide
* Treatment with other immunomodulatory therapies (e.g. imuran, mycophenolate or methotrexate)
* Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis
* Pregnancy
The Effects of Warm Application in Birth on Birth Pain, Birth Satisfaction and Birth Results

The use of non-pharmacological methods in labor pain is very important in order to improve the birth process, increase comfort and provide relaxation. The role of midwives, acting as patient advocate is to maintain comfort throughout the birth process. In order to do this, she should know very well the non-pharmacological methods to be applied to the pregnant woman and choose the most appropriate one. Applying a warm shower, which is one of the non-pharmacological methods; the uterus Increases perfusion, makes labor painless felt, increases the release of oxytocin, and decreases the release of stress hormones.

In addition, while reducing the intervention rates, it improves birth and newborn outcomes and affects positively. Purpose of the research; labor pain of warm shower application, labor to evaluate the effect on satisfaction and birth outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 35,
* Between 37 and 42 weeks of pregnancy,
* Planning a normal birth,
* Does not have a chronic health problem,
* At least 20 minutes of non-stress test (NST) tracing is reactive,
* Those without premature rupture of membranes (EMR) or those with PROM Not exceeding 6 hours from the opening time of the membranes,
* Speaking Turkish and not having any communication barriers,
* Including pregnant women who voluntarily accepted to participate in the study will be.

Exclusion Criteria:

* The mother's refusal to be involved in the study
* The use of analgesic methods during the birth process,
* Abnormal changes in fetal heartbeats,
* Unexpected complications (Dizziness, fatigue)
* Pregnant women who decided to have an emergency cesarean section
UNMET CARE PERCEPTIONS OF INTENSIVE CARE NURSES

This study was conducted to determine the perceptions of intensive care nurses regarding unmet care. A qualitative descriptive approach. The study was completed between April and September 2023 by conducting semi-structured individual interviews with 20 intensive care nurses in a Training and Research Hospital in Turkey and analyzed using the inductive content analysis method.

Unmet nursing care may occur due to systemic, institutional or nursing-related reasons. Reasons such as insufficient staff and equipment, excessive workload (Pereira et al., 2020), confusion between disciplines, and failure to prioritize care play an important role in missed care (Chaboyer et al., 2021; Dutra \& Guirardello, 2021; Kılıç et al., 2023). In summary, while improvements should be made in nursing care practices to ensure patient safety and quality of care, systemic improvements should also be made. In order to make these improvements, it should be determined what the missed nursing care experienced and perceived in the clinical field is and what causes them. This research was conducted to determine the perceptions of intensive care nurses about unmet nursing care. This study is a qualitative design research conducted with intensive care nurses. In the study, a purposeful sample selection was made in accordance with the qualitative research approach. The number of participants was determined according to data saturation and is based on the volunteering of a total of 20 intensive care nurses. During the interview, the participants were asked a personal information form and expert opinion on the subject, as well as in-depth interview questions in a semi-structured information form consisting of eight questions.

Eligibility Criteria:
Inclusion Criteria:

* working in intensive care
* volunteering to participate in the study

Exclusion Criteria:

* not volunteering to participate in the study
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.

OBJECTIVES:

* Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy.
* Determine the safety and feasibility of GM-CSF and thalidomide.

OUTLINE: This is an open-label study.

Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity.

Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease:

  * Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen \[PSA\])
  * Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)
  * Serum PSA ≥ 10 ng/dL (any grade or stage)
  * Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram
* No clinical evidence of CNS metastases
* No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry
* Appropriate medical candidate for radical prostatectomy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Creatinine ≤ 2.0 mg/dL
* Granulocyte count ≥ 1,800/mm³
* Platelet count ≥ 100,000/mm³
* AST \< 3 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL
* Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
* No active unresolved infection
* No pre-existing peripheral neuropathy \> grade 1
* No known HIV positivity
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of the bladder
* No known contraindication to sargramostim (GM-CSF) or thalidomide

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the prostate or pelvis
* No prior chemotherapy or hormonal therapy for prostate cancer
* No parenteral antibiotics within the past 7 days
Targeted Next Generation Sequencing and Intellectual Disability

The purpose is to determine the benefit of next generation sequencing (NGS) targeted on genes involved in intellectual disability for etiologic diagnosis of intellectual disabilities. In other words, it concerns the number of patients whose etiologic diagnosis will be established with NGS and could not with common techniques. Actually, the molecular etiology of intellectual disability is crucial to calculate the risk of recurrence and allows the perinatal diagnosis to these families.

Secondary purposes are:

1. To determine the place of NGS in the strategy of etiologic diagnosis of intellectual disability, to determine the order of analyses performed for a patient with intellectual disability without clinical signs.
2. To evaluate the number of variants with unknown significance and thus non-usable for genetic counselling without supplementary analysis.
3. To determine the number of samples that can be at most pooled keeping a good efficacy of capture and results with suitable read depth
4. To determine the possibility of detecting copy number variations (CNVs) in genes of interest with NGS
5. To establish genotype/phenotype correlations for each gene for which a mutation has been identified
6. To optimize the software pipelining for a rapid analysis for diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe intellectual disability
* Availability of patient and parent DNA
* No etiologic diagnosis with standard approaches: negative fragile X, normal pangenomic 180K and 1M array-CGH
* Informed consent of person having parental authority

Exclusion Criteria:

* Non availability of parent DNA
* Patient lost to follow-up
Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia

The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).

This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The intervention program includes not only the knowledge of dementia and how to manage behavioral problems of patients with dementia but also individual psychological counselling about caregiver's distress. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS). Secondary outcomes are changes in scores of neuropsychiatric inventory and Korean -instrumental Activities of Daily Living of patients as well as depression scores of caregivers.

Eligibility Criteria:
Inclusion Criteria:

* 30-80years old
* Caregivers who spend their own time with dementia patients over 4 hours a day
* caregiver distress scores \>= 2
* caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10\~26)

Exclusion Criteria:

* illiterate
* severe hearing/visual acuity difficulty
* cognitive impairment
Comparative Study Between Rezum Therapy in Small and Large Prostates

The investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) in small and large prostates.

For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size \<80 gm and for those wishing to maintain antegrade ejaculation. While investigators still offer no clear recommendation to Rezūm use for those with large prostates.

Eligibility Criteria:
Inclusion Criteria:

1. prostate size 45-75 gm
2. sexually active
3. mod - sever LUTS
4. Q max \< 15
5. IPSS \> 15
6. failed medical treatment with alpha blockers

Exclusion Criteria:

1. neurogenic bladder
2. urethral stricture
3. UB stones
4. cancer prostate
Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial

BioBOOST is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury.

This study is a prospective observational, multi-center study of subjects enrolled in the Brain Oxygen Optimization in Severe Traumatic Brain Injury-Phase 3 (BOOST-3) trial. BOOST-3 is a multicenter, randomized, blinded-endpoint, comparative effectiveness study of goal-directed critical care based upon monitoring of brain tissue oxygen and intracranial pressure versus monitoring of intracranial pressure alone in patients with severe traumatic brain injury.

The investigators will obtain an initial set of biospecimens (serum, plasma, cerebrospinal fluid (CSF), DNA and RNA) shortly after randomization into BOOST-3 and within 24 hours of injury. Subsequent biospecimens will be obtained every 8 hours for the first 24 hours post-enrollment. This will allow the characterization of acute changes in biomarker levels. On study days 2 through 5, biospecimens will be obtained twice a day to allow characterization of sub-acute changes in biomarker levels, without overburdening study teams or taking too much blood from individual subjects. On study days 7 and 14 and at 6-months post-enrollment, one set of biospecimen will be obtained, preferably in the morning. Biospecimens collected at each time point will consist of 6 ml of whole blood for serum extraction, 6 ml of whole blood for plasma extraction, 2.5 ml of whole blood for RNA extraction (a total of 14.5 ml \[one tablespoon\] of blood) and 5 ml of cerebrospinal fluid (CSF).

BioBOOST will utilize data collected in the BOOST-3 trial. This data includes: demographic data and clinical data such as injury characteristics, vital signs, head CT findings, laboratory data and data on physiologic parameters such as intracranial pressure (ICP), partial pressure of brain tissue oxygen (PbtO2), mean arterial pressure (MAP), and cerebral perfusion pressure (CPP), among others.

BioBOOST will also utilize outcome assessment data collected from BOOST-3 participants at 6 months after injury (180 Days ± 30 days). Trained study personnel who are blinded to the treatment arm will administer the outcome assessments, which will include the measures listed below. The battery includes measures of functional status (GOSE), cognition, and emotional health. The 6-month follow-up interview will be done in person whenever possible. It may be done by telephone or video conference with participants where an in-person interview is not possible.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in BOOST-3 (this is an ancillary study to the BOOST-3 trial)
* BOOST-3 participant is enrolled at a BioBOOST site
* Able to maintain initial blood sample within 24 hours of injury
* Provide proxy informed consent

Exclusion Criteria:

* Profoundly anemic (subjects who are profoundly anemic require blood transfusion)
* Age less than 18 years
Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF

As part of the proposed work, the investigators would like to examine whether there is a need to use a training video to train IDF combat soldiers to improve the use of ear plugs and to prevent hearing loss from exposure to noise, and to characterize the hearing impaired epidemiology of recruits and the basic rate of hearing loss During basic training.

1. Auditory screening examination using an OAE (Oto Acoustic Emission) device during the first week of training in the unit and before starting to be exposed to noise .
2. If the indication obtained by the OAE device is negative, the soldier will be transferred to perform an audiometer test by a medic.
3. If the audiometer is subjected to a significant drop (over 25 decibels), the soldier will be referred to an audiologic examination that includes a comprehensive hearing test and an examination by the ENT (Ear, Nose and Throat).
4. All participants will be randomly assigned to two groups after signing an agreement form:

   A - The video group - will be guided by a screening of a 7 minute video that explains the importance of using ear plugs and correct installation.

   B- The control group, will be instructed to use earplugs properly, including practical exercises by a medic.
5. After two months of training, all participants will undergo further instruction in the use of earplugs, the video clip group and the control group trained by a medic only,
6. Towards the end of the training After six months of the recruitment, the investigators will perform an additional hearing test for all the participants in order to compare the results to the examination performed near their recruitment. Similar to the first stage, the test will be performed using an OAE device.
7. A comparison shall be made in the auditory results data between the group that underwent training via video and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Soldiers who joined the IDF from August 2018

Exclusion Criteria:

* Lack of informed consent.
* recruits who have auditory impairment that is disqualified from fighting
The Value of CEUS in Assessing the Response of Cervical Lymph Nodes After NACI for HNSCC

The head and neck squamous cell carcinoma is the sixth most common malignant tumor worldwide. For patients with locally advanced head and neck cancer, neoadjuvant therapy is recommended before surgery, including neoadjuvant chemotherapy and immunotherapy. There is a significant variation in patients' responses to neoadjuvant therapy, with approximately 37%-52% of patients achieving a complete pathological response after neoadjuvant therapy. Current research mainly focuses on the efficacy evaluation of the primary tumor, while there is less research on the treatment efficacy evaluation of cervical lymph nodes. In clinical practice, accurate assessment of the status of cervical lymph nodes after neoadjuvant chemoimmunotherapy in patients with squamous cell carcinoma of the head and neck can directly affect the choice of treatment plan by clinicians, reducing unnecessary neck dissection. In recent years, contrast-enhanced ultrasound has been widely used in the diagnosis of thyroid cancer and other head and neck tumors, as well as in the assessment of the benign and malignant nature of cervical lymph nodes. This study aims to explore the value of contrast-enhanced ultrasound in the assessment of cervical lymph nodes after neoadjuvant chemoimmunotherapy in squamous cell carcinoma of the head and neck, in order to guide clinicians in formulating personalized treatment plans.


Eligibility Criteria:
Inclusion Criteria:

* (1) Histopathologically confirmed head and neck squamous cell carcinoma; (2) Received neoadjuvant chemoimmunotherapy; (3) Diagnosed with cN+ by CT/MRI before treatment; (4) Underwent radical surgical treatment plus cervical lymph node dissection at this center.

Exclusion Criteria:

* (1) Did not receive a full course of neoadjuvant therapy; (2) History of treatment for head and neck; (3) Clinical evidence of distant metastasis found during preoperative examination.