cyrilzakka/clinical-trials huggingface dataset:
Effect Of Clustered Nursing Interventions On Physiological Response In Critically Ill Patients

To determine physiological responses related to clustered nursing interventions among critically ill patients.

Clustered nursing interventions are defined as group of interventions more than six for each patient in one nursing interaction.The study was conducted on 80 mechanically ventilated adult patients admitted to intensive care units of Alexandria Main University Hospital and Damanhour Medical National Institute. The most common procedures provided by nurses in direct care for those patients were vital signs measurements, central venous pressure measurement, suctioning, feeding, laboratory sampling, general care, repositioning, and administration of medications. Physiological parameters measured were end-tidal carbon dioxide using capnography, vital signs using bed side monitor, and oxygen saturation using pulse oximeter.

Eligibility Criteria:
Inclusion Criteria:

* adult patients of both sex, aged 18 years and over
* mechanically ventilated for ≥ 48 hours.

Exclusion Criteria:

* lung disorder (eg, COPD, asthma, lung cancer, pneumonia, ARDS)
* pregnancy.
A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT)
* Decision made to prescribe ADT prior to enrolment
* Willing and able to provide written informed consent

Exclusion Criteria:

* Participation in an interventional clinical study in which any treatment or follow-up is mandated
* Treatment with a GnRH receptor antagonist other than FIRMAGON
* Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence

Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life.

The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 to 60 years
* Had ≥ 1 deliveries
* Suffering from genuine stress urinary incontinence confirmed by urodynamic testing (Urodynamic stress urinary incontinence) and normal voiding without abnormal residual urine
* Baseline PWG (no usage of TIPI device) ≥ 6gr/8hrs
* Average reduction of urinary incontinence of at least 70% following 3 days usage of the cleared TIPI G3 device
* The patient has the ability to understand the nature of the study and give her consent by signing a written informed consent form.
* Successful experience with the use of vaginal tampons
* Willing to undergo urodynamic investigation
* Normal pap smear within past 24 months
* Patient is able and agrees to arrive to the study site area for a period of about 4-6 hours during 6-12 non consequent study days.

Exclusion Criteria:

* Patient is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
* Patients with present or suspected urinary infection
* Patients with present or suspected vaginal infection
* Severely atrophic vagina
* Women who did not manage to insert a vaginal tampon, for any reason, in the past
* Abnormal vaginal bleeding
* Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study
* Was/is being treated for urinary incontinence by other means such as medications, surgical intervention etc. that might influence study results
* Vaginal wall prolapse of any type reaching the level of the introitus (grade 2)
* Co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study
A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.

1. To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
2. To explore domains relevant to participants experiencing rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, and attitudes to domains identified from the literature

Eligibility Criteria:
Inclusion Criteria

The criteria are:

* Patients aged 18 years and above
* English (conversational level) speaking, with the ability to give informed consent
* Patients with a rheumatologist clinician diagnosis of inflammatory arthritis irAE or PMR irAE following ICI therapy

Exclusion Criteria

* Acutely life-threatening or worsening cancer
* Hearing impairment functionally limiting participation in verbal interview
Modified Intrapartum Sims Position-related Efficiency in Correction of Persistent Foetal OP Positions

Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.

Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.

The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.

Aim: To evaluate the efficiency of the modified Sims position versus maternal free positions in the rotation of persistent foetal occipito-posterior position intrapartum in pregnant women with epidural anaesthesia.

Background: There is a theoretical basis for the possible effects of maternal positions on foetal positions. Despite all the studies published in recent years, conclusive trials providing significant scientific evidence are lacking.

Design: An open, randomised, controlled and parallel clinical trial will be conducted at the Delivery Room of the Area Materno-Infantil, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

Method: Fifty-six pregnant women with persistent foetal occipito-posterior position will be selected. Each woman will be assigned to a control or experimental group via an opaque envelope at a 1:1 ratio.

The control group will deliver in free intrapartum positions, and the experimental group in a modified Sims position. Correction of foetal position is the key study variable, and delivery type the secondary variable. Statistical analyses will be made with the SPSS v.20 program.

Discussion: If the modified maternal Sims position proved to correct persistent foetal occipito-posterior positions and being a non-invasive, low-cost, non-prejudicial method for both mother and foetus, maternal and foetal morbidity problem would be reduced

Eligibility Criteria:
Inclusion Criteria:

* adult pregnant women (\>18 years of age)
* persistent posterior foetal position diagnosed during labour through two vaginal examinations two hours apart.
* at-term gestations (37 to 42 weeks)
* women in labour with epidural anaesthesia

Exclusion Criteria:

* multiple gestations
* previous severe foetal malformation diagnosed
* macrosomic foetus diagnosed by ultrasound in the 3rd trimester (\> percentile 95), or IUGR (\< percentile 10)
* women with contraindicated vaginal delivery owing to previous vaginal surgeries
* women with severe heart diseases
* diabetic pregnant women (types I, II and gestational)
* hypertension problems during labour
* myopathies
The Effect of the Number of Central Lymph Nodes on Changes in Parathyroid Function

This study collected data from patients who underwent thyroidectomy in the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. The main calculation indicator was the changes in PTH before and after surgery. This study grouped patients based on the number of central lymph nodes under postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function, and to provide reference for surgical selection in thyroid cancer patients with multiple cervical lymph node metastases.

The central lymph nodes of the thyroid gland refer to the lymph nodes located around the thyroid and trachea. The central lymph nodes are the primary site of thyroid cancer metastasis, and therefore play an important role in thyroid surgery. In thyroid surgery, preventive central lymph node dissection is a routine procedure, but during this process, the parathyroid gland may be impaired due to surgical injury or insufficient blood supply.

Hypothyroidism, also known as parathyroidism, is a common complication of thyroid surgery. When the parathyroid gland is accidentally injured or its blood supply is disrupted, it can lead to insufficient production of parathyroid hormone. Parathyroid hormone is a key hormone that regulates blood calcium levels. Insufficient levels can lead to hypocalcemia, manifested as hand and foot spasms, muscle spasms, and even arrhythmia.

From a surgical perspective, the number of lymph nodes in the central region of the thyroid gland may affect the preservation and functional protection of the parathyroid gland. A large number of lymph nodes indicates that they may have a wider range of disease invasion, requiring more thorough lymph node dissection, thereby increasing the risk of damaging the parathyroid gland or its blood supply.

Eligibility Criteria:
Inclusion Criteria:

* All cases were the first to undergo thyroidectomy surgery.
* All clinical data and research materials of the cases are complete.
* All cases underwent thyroid function examination before and after surgery.
* All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital.

Exclusion Criteria:

* Except for cases of recurrence.
* Cases with incomplete clinical data and research materials are excluded.
* Cases that have not undergone thyroid function tests before and after surgery are excluded.
* Excluding cases of secondary surgery.
* Cases that have not undergone thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital before surgery are excluded.
Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels

The objective of the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (\> 70 years age) and another age group (30 to 50 years). In addition, impact of MSPrebiotic on short chain fatty acids, glucose and insulin levels as well as metabolomic changes will also be studied. A randomized, double-blinded study will be conducted to assess the health benefits of MSPrebiotic and compared with a placebo. This study will provide substantiation for a beneficial effect of MSPrebiotic resistant starch on gut microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent (or by the authorized 3rd party).
* Willing to provide stool (2 times) and blood (6 times) samples over the 14 week study period
* Subjects between 30-50 and above 70 years of age
* Subjects willing to provide fasting blood during Screening and weeks 0, 2, 6, 10 and 14 visits
* Female subjects not pregnant or breast feeding
* Female subjects not planning for pregnancy during the study period

Exclusion Criteria:

* Crohn's disease or any other inflammatory bowel disease
* Individuals with Lupus, or on cancer chemotherapy
* Pre-diabetes or Diabetes
* Thyroid disease
* Renal disease
* Hepatic disease
* Previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery)
* Subjects on probiotic (e.g. yoghurt),
* Subjects on antibiotics at time of recruitment or on antibiotics within the previous five weeks
* Individuals experiencing dysphagia
* Subjects using additional fiber supplements
* Subjects on digestants, emetics and antiemetics, medications for acid peptic disease and antacids.
* Subjects allergic to potato or corn
* Have conditions, factors, medication (other than those listed above) that the Investigator believes may affect the response of the gut or the interpretation of the test results
Guided Tissue Regeneration With a Periodontal Dressing

This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years.

  * A minimum of 18 teeth, wisdom teeth excluded.
  * Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss \>30%.
  * Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP.
  * Presence of at least three teeth per quadrant.

Exclusion Criteria:

* Periodontal treatment in the last 3 years.

  * Antibiotic intake 6 months before • the screening visit.
  * Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Dia- betes).
Biomarkers in Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in patients with acute myeloid leukemia.

OBJECTIVES:

* To determine whether clonally expanded somatic mitochondrial DNA mutations are associated with acute myeloid leukemia.

OUTLINE: Genomic DNA from blood samples obtained at diagnosis, remission, and relapse are analyzed for mitochondrial DNA mutations via PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Available blood samples from diagnosis, remission, and relapse

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Game to Improve Hearing Health Care Outcomes

The investigators are studying the educational potential of games, with the goal of developing a game to improve learning and promote healthy hearing behaviors.

The project is looking for adolescents and young adults that play games to share their experience and learning from playing games.

The investigators ask participants to fill out an enrollment form/informed consent, complete surveys on healthy hearing habits, and play a game provided by the project.

This projects aims the development and evaluation of a game to educate teenagers and young adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy hearing behaviors with the potential to improve hearing health care.


Eligibility Criteria:
Inclusion Criteria:

* Participants have to be between the ages of 13 and 20 years of age (either gender).
* Participants who are between the ages of 13 and 17 years of age must have a willing and able parent or legal guardian who permits them to participate.
* Participants must have Internet access, an email address (or be able to use parent's/legal guardian's email address), and agree to play a game (random assignment to a group with a different game).

Exclusion Criteria:

* Participants will be excluded if they are cognitively impaired, have any serious medical problem that may interfere with their ability to engage with the online game.
* Those who are not able to read/follow written instructions and individuals with an excessive addiction to games will be excluded.
Study of Opioid Immunosuppressive Effects

This trial aims to investigate the effects of opioid-inducing immune suppression on opioid drug abused patients. The methods of the investigators research mainly includes the expression of morphine-related miRNAs in peripheral blood mononuclear cells and cytokine in plasma.


Eligibility Criteria:
Inclusion Criteria:

* subjects were excluded if they had a chronic systemic illness (cardiac, renal, pulmonary, hepatic, endocrine, metabolic, or autoimmune disorders) or
* a major psychiatric disorder or
* if they were abusing substances other than heroin (as determined by urine drug test result). For women, pregnancy was also a reason for exclusion.

Exclusion Criteria:

* Control subjects with no history of drug or alcohol abuse were also excluded if they had
* major medical or psychiatric disorders
Effectiveness of Midwife Phone Support With the to Reduce the Early Abandonment of Breastfeeding

Objective: To evaluate the effectiveness of telephone support of the reference midwife, in relation to the abandonment of breastfeeding of primiparous mothers and to identify, both the risk factors and the protective factors for the early abandonment of breastfeeding.

Material and Method Randomized parallel controlled clinical trial.

Sample: 220 primiparous mothers with access, during the 8 weeks postpartum, to a mobile phone to contact the midwife randomization of 110 mothers to the experimental group and 110 to the control group. The mothers of the experimental group will be offered the mobile phone number to contact their midwife after delivery. The mothers of the control group will receive the usual attention of the portfolio of services that includes the spontaneous visit in the center, the telephone call in the center, the home visit and the health education groups.

Eligibility Criteria:
Inclusion Criteria:

* Primiparians who carry out the follow-up of pregnancy for the midwife
* The pregnant woman is of low risk
* Possibility of the mother to make calls to the mobile phone.
* The pregnant woman wishes to participate in the study.

Exclusion Criteria

* Maternal or fetal pathology that can condition maternal breastfeeding.
* idiomatic barrier.
* Prematurity.
* Baby with weight \<2,500 gr. at birth
* Home delivery during the puerperium
MEditation for Post Stroke Depression

The purpose of this study is to establish the feasibility and acceptability of a breath-based meditation in stroke survivors with post-stroke depression (PSD) and their informal caregivers, as well as to examine the effects of the breath-based meditation. The hypothesis is that the breath-based meditation will lead to decreases in the severity of symptoms of PSD, post-stroke anxiety (PSA), and post-traumatic stress disorder (PTSD), and decreases in plasma IL-1 pro-inflammatory cytokines post-intervention in stroke survivors with PSD and their informal caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Stroke survivors will be included if they speak English, can provide written informed consent, have a history of ischemic stroke, hemorrhagic, or transient ischemic attack within the past 8 weeks, have a Center for Epidemiologic Studies-Depression (CES-D) total score of 16 or greater suggestive of clinically significant depressive symptoms, and currently live at home.
* Informal caregivers will be included if they are speak English, can provide written informed consent, and self-identify as a first-time informal caregiver of a stroke survivor. -
* To reflect standard practice, stroke survivors and their informal caregivers will be eligible to participate in the study regardless of whether they are currently receiving anti-depressant medications; however, the dose must have been stable for at least one month prior to recruitment into the study.

Exclusion Criteria:

* Stroke survivors will be excluded if they currently reside outside of the home (e.g., rehabilitation center).
* Stroke survivors and their informal caregivers will be excluded if they have severe cognitive impairment (Montreal Cognitive Assessment (MoCA) cutoff score of 20), active psychosis, or bipolar disorder; if they currently abuse substances; or if they are acutely suicidal. Those currently receiving formal psychotherapy or currently engaging in self-identified meditation practices will also be excluded.
Transoral Gastric Volume Reduction as an Intervention for Weight Management

The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System


Eligibility Criteria:
Inclusion Criteria:

* Male, Female; ages \>18yrs - £ 60 yrs
* BMI 30-45 kg/m2
* History of obesity for 5 yrs; attempts at weight control ineffective
* Weight stable
* Willing to comply with study requirements
* Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure
* Sign informed consent form

Exclusion Criteria:

* Women of childbearing age not practicing effective birth control method or pregnant or lactating
* Mallampati score = 4
* Uncontrolled hypothyroidism
* Previous interventional/surgical treatment of obesity; any prior gastric surgery
* History of diabetes for \> 10 yrs or difficult to control diabetes
* Presence of hiatal hernia
* Congenital or acquired anomalies of the GI tract
* Severe cardiovascular, cerebrovascular, or cardiopulmonary disease
* Chronic or acute upper gastrointestinal bleeding conditions
* Helicobacter pylori positive
* Immunocompromised
* Subjects with eating disorders
* Acute or chronic infection
* Significant movement limitations
* Not a candidate for conscious or general anesthesia
* Active substance abuse
* Life expectancy \< 2 years
* Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study