cyrilzakka/clinical-trials huggingface dataset:
Osteoporosis Screening Tools' Re-validation in Egypt Guide for the Management of the Condition in Males

To demonstrate the predictive ability of the different screening scores (i.e. OST, ORAI, ABONE, body weight criterion, age alone or others) and their potential use in the primary care setting.

* A primary care sample of records at a local radiology center will be retrospectively reviewed and those of Egyptian adults who underwent DXA scanning will be included.
* Those with prior diagnoses that can affect bone mineral density (BMD) (i.e. prior osteoporosis, Paget's disease, osteomalacia, hyperparathyroidism, or hypogonadism) or history of using certain medications (i.e. bone-protective or anticonvulsant drugs) prior to undergoing the DXA scan will be excluded.
* Scores will be calculated as indicated in their respective studies after collecting the data pertaining to them (Crandall, 2015); (Cass \& Shepherd, 2013); (Reginster, et al., 2004); (Adler, et al., 2003); (Cadarette, et al., 2000); (Weinstein \& Ulery, 2000); (Black, et al., 1998); (Lydick, et al., 1998).
* Data will be treated as dichotomous for both DXA T-scores and screening scores (i.e. Osteoporosis (Yes or NO) versus positive/negative score). A 2 x 2 contingency table will be constructed and the different diagnostic test statistics (i.e. Sensitivities, specificities, Receiver operating characteristic curve) will be calculated using different Cut-off points to carry out sensitivity analyses (Moreover, different DXA sites and cut-offs will be included in the analyses). SPSS version 25 software (IBM Corp., USA) will be used for the statistical operations.
* Using an expected proportion of false negatives of 10% for sensitivity (i.e. based on the previous reported sensitivities for most tools being \>90% (Crandall, 2015) and the performance of OST in Egypt of 83% (El-Masry, et al., 2015)) and a 95% confidence interval's width of 10% the needed sample size was estimated to be 138 (Browner, et al., 2013, p. 81 Table 6E). Power analysis will be calculated for any deviation from this estimation. Failure to meet sample size at the outset will be dealt with by prospectively screening new records for a period of 3 months.

Depending on the result, further recommendations and plans will be provided for possible applications and future research. All Deviations from the protocol will be justified.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing dexa scan testing.

Exclusion Criteria:

* people with prior diagnoses that can affect bone mineral density (BMD) (i.e. prior osteoporosis, Paget's disease, osteomalacia, hyperparathyroidism, or hypogonadism) or history of using certain medications (i.e. bone-protective or anticonvulsant drugs) prior to undergoing the DXA scan.
SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

The treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. This complex and aggressive surgery is associated with high postoperative complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. Multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. It has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.

Main objective: To determine the efficacy of multimodal prehabilitation in decreasing postoperative complications in patients undergoing gynecological cancer surgery of high complexity by laparotomy (primary cytoreductive surgery, interval surgery and secondary cytoreductive surgery in advanced ovarian cancer).

Design: Multicenter randomized controlled clinical trial. Subjects: 146 patients: 73 in the intervention group and 73 in the control group.

Intervention group: PreHAB intervention consists on:

1. High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies).
2. Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements.
3. Psychological coping. Control group will receive standard preoperative care. Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines.

Measures: Aerobic capacity (incremental stress test), physical activity, operative complications and hospital length and associated costs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced ovarian cancer subject to primary debulking surgery or interval surgery after 3-4 cycles of chemotherapy or secondary and / or tertiary debulking surgery .
2. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 2-0.
3. Adherence of at least 75 % of the program or minimum of 6 sessions.

Exclusion Criteria:

1. Surgery without a minimum of 3 weeks of prehabilitation time.
2. Unstable respiratory or heart disease.
3. Locomotor or cognitive limitations that makes not feasible the adherence to the program.
4. Refusal of the patient.
Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC

The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.

High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.

This study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis.

This prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.

Eligibility Criteria:
Inclusion Criteria:

1. Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;
2. Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;
3. Tumors located either in the left or right hemiliver;
4. Resection extent was a hemi-hepatectomy or less;
5. Informed consent.

Exclusion Criteria:

1. Having comorbidity that contraindicates surgery;
2. Participation in concurrent interventional trials with interference to this study;
3. Eligible for laparoscopic hepatectomy;
4. Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;
5. Lack of compliance for treatment or future follow-up.
Furosemide Pharmacodynamics and Pharmacokinetics After Subcutaneous or Oral Administration

The purpose of this pilot study is to investigate the pharmacodynamic and pharmacokinetic parameters of a novel furosemide formulation administered subcutaneously as compared to oral furosemide.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before any assessment is performed
* Male and female subjects ≥18 years of age, with body weight \<120 kg and body mass index (BMI) \<30 kg/m2
* Female subjects must be at least 2 years post-menopausal
* Participant must have been on oral furosemide (40 mg oid or bid) or therapeutic equivalent (bumetanide 1 mg oid or bid) for a period 90 days before the first dose of study medication
* History of chronic heart failure according to 2012 ESC guidelines with presence of moderate symptoms of chronic fluid overload. Chronic fluid overload is defined as presence of stable signs and symptoms of heart failure and congestion, like dyspnea at mild exertion or minimal exertion, pulmonary congestion and/or peripheral edema at the time of presentation in combination with elevated levels on natriuretic peptides (NT-proBNP \> 300 ng/L)
* In the opinion of the investigator, able to participate in the study

Exclusion Criteria:

* Acute Decompensated Heart Failure (ADHF) or recent history of ADHF or significant worsening in their HF symptoms (within prior 2 weeks)
* Contraindication to furosemide
* Systolic BP (SBP) \< 90 mm Hg
* Temperature \> 38°C (oral or equivalent) or sepsis or active infection requiring i.v. anti-microbial treatment
* Serum sodium \< 130 mmol/L and Serum potassium \< 3.0 mmol/L
* Current or planned (throughout the completion of study drug infusion) treatment with any i.v. therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues; or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
* History of gastric or intestinal surgery that may affect absorption of oral medication
* Presence or need for urinary catheterization
* Current or planned ultrafiltration, hemofiltration, or dialysis
* Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on admission \< 30 mL/min/1.73 m2 will be calculated as per standard at local laboratory
* Administration of intravenous radiographic contrast agent within 72 hours prior to screening or acute contrast-induced nephropathy at the time of screening
* Major surgery within 30 days prior to screening
* Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening
* Inability to follow instructions or comply with procedures
* Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study
Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

This is an observational study to assess the change in several psychological screening tools before and after a series of six ketamine infusions in paramedics who suffer from post traumatic stress disorder as a result of working in emergency medical services.

Working as a paramedic in a prehospital emergency medical services system (EMS) has been shown to lead to increased incidence of post traumatic stress disorder (PTSD) and increased risk of suicide in prehospital personnel. In recent years a growing body of literature has shown that ketamine hydrochloride can be an effective treatment for PTSD. This study seeks to look specifically at paramedic level emergency medical technicians ("paramedics") with PTSD related to their prehospital work and assess whether ketamine infusion therapy can be an effective treatment for them. This is an observational study where the results of psychological screening tools that are administered before and after a six-infusion series are reported. Additionally the same assessment tools will be administered again 30 days after the final treatment to measure the durability of any changes. The participants will receive the Periodic Health Questionnaire-9 (PHQ-9), the PTSD Checklist for Diagnostic and Statistical Manual, DSM-5 (PCL-5), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck Anxiety Inventory (BAI) before the infusions, after the series of six, and thirty days later. Additionally, after the series of six infusions, participants will receive the Revised Mystical Experience Questionnaire-30 (RMEQ-30) and a one question survey to assess the impact of the experiential aspect of ketamine.

Eligibility Criteria:
Inclusion Criteria:

* Must have worked as a paramedic (EMT-P) on a 911 prehospital service for at least five years.
* Must be diagnosed with post traumatic stress disorder that happened as a result of working as a paramedic
* Diagnosis must have been made by a mental health professional
* The symptoms of PTSD must be having a significant adverse effect on the subject's life
* Subjects must be able to speak and read English

Exclusion Criteria:

* Currently participating in another PTSD treatment program and/or research study
* Diagnosis of psychosis
* Uncontrolled hypertension or a history of heart failure
Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®)

The goal of this clinical trial is to compare the effectiveness of AR-based training with traditional guideline-based self-learning in practical nurses without prior Level-1® experience. The main questions it aims to answer are:

Does AR-based training using Microsoft HoloLens 2® improve clinical performance compared to traditional guideline-based self-learning? Does AR-based training affect self-efficacy and educational satisfaction compared to traditional methods?

Participants will:

Receive AR-based training using Microsoft HoloLens 2® (experimental group) Follow traditional guideline-based self-learning (control group) Researchers will compare the AR-based training group to the traditional self-learning group to see if AR-based training leads to better clinical performance, higher self-efficacy, and greater educational satisfaction.

In critical situations like hypovolemic shock, nurses must master skills for using devices like the Level-1® rapid infusion system. However, limited exposure poses challenges. Augmented reality (AR) offers a solution by providing realistic practice scenarios. While AR has shown effectiveness in cardiopulmonary resuscitation and intubation education, its application in Level-1® training remains underexplored.

This study was conducted at the Samsung Medical Center in Seoul, Korea, and involved 42 practical nurses without prior Level-1® experience. Participants were randomly assigned to one of two groups: the experimental group, which received AR-based training using Microsoft HoloLens 2®, and the control group, which followed traditional guideline-based self-learning.

The study aimed to investigate the impact of AR-based Level-1® education on nurses' clinical performance, self-efficacy, and educational satisfaction. Clinical performance, self-efficacy, and educational satisfaction were assessed through structured measurements.

Results data and conclusions drawn from the data are excluded from this section and will be reported separately in the Results Section of the record.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate voluntarily and understanding of the study's purpose.
* No prior experience with the Level-1® rapid infusion system.

Exclusion Criteria:

* Failure to meet the inclusion criteria.
* Prior experience with the Level-1® rapid infusion system.
* Inability to comprehend the study's purpose or express voluntary participation.
* Inability to attend required training and evaluations.
A Study of LY3537031 in Overweight, Obese, and Healthy Participants

This is a 3-part study that includes a Part A, Part B, and Part C. Part A will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants.

Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 20 weeks excluding a screening period.


Eligibility Criteria:
Inclusion Criteria:

* Have a BMI within the range of:

  * Part A: 27.0 to 45.0 kilogram per square meter (kg/m²)
  * Part B: 22.0 to 26.9 kg/m²
* Parts B and C: Weigh 60 kg (80 lbs) or more at screening
* Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
* Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.

Exclusion Criteria:

* Have undergone any form of bariatric surgery
* Participants who are lactating
* Have taken medications that promote weight loss within 90 days before screening
* Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL))
Early Intervention in Very Preterm Children

* The aim of the present study is to examine the effectiveness of a short, highly structured parent based speech intervention program on speech development in very preterm children with a Speech Sound Disorder (SSD) at 2 years of age.
* The hypothesis of this study is that early intervention on speech development is effective in improving the speech development in preterm children with SSD at 2 years of age compared to a no treatment group (usual care at this age).


Eligibility Criteria:
Inclusion Criteria:

* birth weight \< 1500 grams or gestational age \< 32 weeks
* singleton birth
* no major neurodevelopmental disabilities, and
* Dutch speaking family background
Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 21 years with a diagnosis of acute AH. The diagnosis of acute alcoholic hepatitis will be based on clinical features and testing including hepatomegaly, jaundice, fever, leukocytosis, compatible liver biochemistries in the context of heavy alcohol consumption. A liver biopsy is not mandatory, but will be required to confirm the diagnosis if a firm diagnosis of AH cannot be made on clinical and laboratory criteria
* Moderate severity defined as MELD score \> 11 and \< 20
* Heavy alcohol consumption (defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment)
* Written informed consent
* Negative urine pregnancy test where appropriate
* Women of child bearing potential should be willing to practice contraception throughout the treatment period

Exclusion Criteria:

* Significant active infection (e.g., sepsis, or spontaneous bacterial peritonitis; SBP). Subjects can be reconsidered after the infection is under control.
* Serum creatinine \> 2.5 mg/dL
* Must not be receiving systemic steroids \> 1 week at the time of Screening or any experimental medicines for AH
* Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
* Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium

Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .

Compare the effects of

0.5 mg/kg oral midazolam,

watching film "Suko is being operated 'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and

playing a game named "fishing games" on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Investigators also evaluated "Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores"

Pain evaluated by FLACC (behoviaral pain assesment scale),at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Blood pressure(mmHg), heart rate(beat/min) and SpO2(%) measured and recorded at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Pediatric patients
* Elective surgery
* Adenotonsillectomi

Exclusion Criteria:

* Cronicdesease
* Mental retarde
* Hearing and visual impaired
* Prematurite