cyrilzakka/clinical-trials huggingface dataset:
The Use of HE4 With Simple Ultrasound Rules to Predict Malignancy in a Pelvic Mass

Our objective is to determine if the combination of simple ultrasound features (IOTA simple rules) and a new biomarker (HE4) together with a common tumour marker (CA 125) can accurately predict ovarian cancer in women found to have a pelvic mass on ultrasound. The investigators hypothesize that the use of two biomarkers (HE4 and CA 125) in a mathematical algorithm (Risk of Malignancy Algorithm, ROMA) can be used to predict malignancy in a pelvic mass which has indeterminate ultrasound features. This is a prospective cohort study involving women undergoing operation for a pelvic mass. 720 women scheduled to have an operation to remove a pelvic mass would be recruited from 3 hospitals (QMH, UCH and PYNEH). Pre-operatively, each woman will have an ultrasound assessment using the IOTA simple rules criteria and have blood taken for tumour markers HE4 and CA 125. In women where IOTA ultrasound rules are inconclusive, 2 strategies for prediction will be compared - calculation of risk by ROMA (Strategy A) vs referral for an expert ultrasound (Strategy B). These pre-operative risk predictions will be correlated with the final pathology found at the operations.

Main outcome measures include the sensitivity, specificity, positive and negative predictive powers for Strategy A compared to Strategy B. Sensitivity and specificity will be compared using the McNemar test. Area Under the ROC Curve (AUC) will be calculated and compared using the Delong method for the 2 strategies.

The investigators expect AUC of both strategies will be similar. This would suggest that ROMA can replace expert ultrasound in the pre-operative prediction of ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18
* Found to have a pelvic mass on ultrasound, MRI, CT or PET scan
* Scheduled for operation (laparoscopic or open) for a pelvic mass (including ovarian cystectomy and oophorectomy)
* Women who would understand the informed consent

Exclusion Criteria:

* Women who refused a transvaginal scan
* Pregnant women
* Surgical removal is delayed for more than 120 days from the date of the ultrasound examination
* Previous history of ovarian, peritoneal or fallopian tube cancer or unknown malignancy
* History of bilateral oophorectomy
Appendectomy in Children Performed by Residents in the Era of Laparoscopic Surgery

Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic appendectomy (LA). The investigators wanted to elucidate the outcome of childhood appendicitis treated primarily by residents in a university hospital.

Material and methods: All children (age\<16 years) treated surgically with appendectomy in our department between January 2006 and January 2011 were retrospectively identified. Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were considered as non-satisfactory outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age below 16 years. operated on suspicion of appendicitis

Exclusion Criteria:

* appendectomy for causes other than suspicion of appendicitis
CXCR4-targeted PET/CT Imaging in Hematological Malignancies

The incidence and mortality of hematological malignancies remain high. Although 18F-FDG PET/CT imaging is the most common molecular imaging technique used in clinic, the non-specific uptake of 18F-FDG leads to the problems of false negative or positive in hematological malignancies, which makes it difficult to diagnose and evaluate the efficacy. CXCR4 (C-X-C Chemokine Receptor Type 4) is overexpressed in various hematological malignancies, and is associated with poor prognosis. CXCR4-targeted molecular imaging, such as 68Ga-pentixafor PET/CT imaging, has an important potential in hematological malignancies. Therefore, this study will evaluate the efficacy of CXCR4-targeted PET/CT imaging for diagnosis and staging of hematological malignancies, compared with 18F-FDG PET/CT imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate and sign an informed consent form;
2. 18 ≤ Age ≤ 90 years;
3. Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;
4. Willing and able to follow schedule visits, treatment plans and laboratory tests.

Exclusion Criteria:

1. pregnancy or breastfeeding;
2. Allergic to CXCR4-targeted tracers or excipients;
3. Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG;
4. Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;
5. Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.
Metabolic Viral Host Properties

Patients' metabolic properties may affect their immune response. This study aims to assess the effect of hosts' metabolic properties to viral infection.

Blood samples were drawn from patients with Gaucher disease and healthy individuals, with and without HCV. Blood samples were tested for protein specific T cell proliferation, IFNg and IL-10 using ELISPOT assays, serum IFNg, IL-2, IL-6, IL-10 and IL-4 levels. FACS analysis was used for evaluation of lymphocytes subsets.

Eligibility Criteria:
Inclusion Criteria:

* inform consent

Exclusion Criteria:

* at patients request
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.

The study will enrol adult participants with refractory Systemic Lupus Erythematosus (SLE) The study will be run in 2 parts;

First part is Phase 1b during which the study aims to assess safety and tolerability of AZD0120 in patients in refractory SLE cohorts

Second part is Phase 2, during which the study aims to assess safety, tolerability and efficacy of the selected dose, following Phase 1b completion, in patients with refractory SLE

Eligibility Criteria:
INCLUSION:

1. Males or females aged 18 through 70 years inclusive at the time of consent.
2. Written informed consent in accordance with federal, local, and institutional guidelines.
3. Must be able and willing to adhere to the study visit schedule and other protocol requirements
4. Adequate hepatic, renal, pulmonary, and cardiac function
5. Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.
6. Have used at least two standard immunosuppressants (including one biological agent).
7. SLEDAI-2K score ≥6 at screening.
8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
9. For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification.

EXCLUSION:

1. Have received prior treatment with CAR T therapy directed at any target.
2. Have received any therapy that is targeted to CD19 and/or BCMA
3. Received allogenic stem cell transplant or autologous stem cell transplant.
4. An active malignancy that is progressing or requires active treatment.
5. Primary immunodeficiency
6. Active viral or bacterial infection
Randomized Comparison of Morning Versus Bedtime Administration of Statins: a Cardiovascular Circadian Chronotherapy (C3) Trial

Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among individuals both with and without a history of atherosclerotic cardiovascular Several pilot studies have suggested potential benefits of taking statin in the evening rather than in the morning.

The primary objective of this study is to examine whether statin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking statin.

The study is a pragmatic, registry-based, open-label, randomized controlled trial combining the utilization of the Danish nationwide health registries and the official Danish electronic letter system (Digital Post/eBoks) into an innovative, decentralized trial requiring no study visits from participants. The nationwide health registries will be used for identification of potential participants and data collection, including baseline information and follow-up data, while the electronic letter system will be used for sending recruitment letters and communicating with participants. Study participants will provide electronic informed consent from home before inclusion and randomization.

The trial will include patients currently in statin treatment regardless of the presence or absence of established cardiovascular disease. Participants will be randomized 1:1 to either statin administration at bedtime or in the morning. The trial is event-driven.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* Current treatment with atorvastatin 10-80 mg, rosuvastatin 5-40 mg, simvastatin 10-80 mg or pravastatin 20-40 mg (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
* Signed informed consent

Exclusion Criteria:

* none
Exploring Radiotherapy of Temporomandibular Joint Arthritis

With this pilot study, the acute side effects and potential pain relieve after radiotherapy (RT) of the temporomandibular joint (TMJ) are prospectively recorded.

For this purpose, the symptoms of the jaw joint arthrosis/arthritis are recorded using a symptom-oriented questionnaire and the numeric rating scale for pain assessment.

Furthermore, it is examined whether the irradiation is feasible.


Eligibility Criteria:
Inclusion Criteria:

* TMJ arthritis
* diagnosed by a surgeon for oral and maxillofacial surgery or a dentist

Exclusion Criteria:

* Previous irradiation in the TMJ area
* Age below 50 years
COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"

The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay.

The study will be carried out in Surgical Unit-III, Lahore General Hospital. It will be a randomized control trial. Patients undergoing surgery for Ileostomy were randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow-up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay. The data will be statistically analyzed by using SPSS v23.0.t test (independent sample) used for the comparison of hospital stay mean. Chi-square will also used for the comparison of the frequencies of SSI. Data were stratified for gender and age. A p-value ≤0.05 will be considered as significant.

Eligibility Criteria:
Inclusion Criteria:

* included in the study 1. Patients of both gender 2. Patients ages between 25-70 3. Patients undergoing surgery for having ileostomy for benign disease of intestine (as per operational definitions).

Exclusion Criteria:

* Following patients were excluded 1. Patients with pre-existing stomal site wound infection 2. Reversal of stoma through laparatomy 3. Post-operative anastomotic leak 4. Ureamic patients 5. Patients on chemotherapy and radiations
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting

The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.


Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory female ≥18 years of age.
2. Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
3. Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren).
4. Participant has no history of sleep apnea or any clinically significant respiratory conditions.
5. Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.
6. Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator.
7. Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria:

   * safe environment for the home infusion provider staff.
   * access to a working telephone.
   * electricity and grounded electrical outlets.
   * running water.
   * access to back-up emergency services (911 service or ambulance availability).
   * sanitary environment.
8. Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency.
9. Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion.

Exclusion Criteria:

1. Participant has end stage renal failure.
2. Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection.
3. Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.
Energy Expenditure and Gastric Bypass Surgery

The aim of this study is to assess whether activity thermogenesis increases in patients undergoing bariatric surgery post-operatively compared to pre-operatively. The investigators will assess non-exercise activity thermogenesis using a validated Physical Activity Monitoring System and doubly labeled water, immediately pre-operatively and again at 6 and 18 months post-operatively. PAMS has been validated in lean and obese individuals. This is to assess energy expenditure, activity thermogenesis and NEAT during the phase of greatest weight loss and once weight loss has plateaued. This will permit us to address our primary hypothesis that activity thermogenesis as a fraction of total daily energy expenditure increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared to pre-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing gastric bypass surgery, 18-60 years

Exclusion Criteria:

* Eligible subjects will be excluded who cannot walk at 2.4 mph for 15 minutes, or weigh greater than 227 kg at the screening visit.
Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries

Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.

Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV).

Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists.

There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax.

Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.

Eligibility Criteria:
Inclusion Criteria:

* Parturient of American Society of Anaesthesiologists (ASA) class I or II physical status.
* Age: 20-40 years.
* At term gestation (≥ 37 weeks) with a singleton uncomplicated pregnancy.
* Elective cesarean delivery under intrathecal anaesthesia

Exclusion Criteria:

* Parturient refusal.

  * Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
  * Morbid obesity (BMI \>35).
  * Parturient with known hypersensitivity to propofol, morphine or amide local anaesthetics.
  * Parturient with pruritogenic systemic disease.
  * A coexisting skin disorder or preexisting pregnancy induced pruritus.
  * Parturient with any contraindication for intrathecal anaesthesia, e.g. coagulopathy.
  * Emergency cesarean section.
  * Failed or unsatisfactory intrathecal block.
Community-Based Conscious Discipline Program in Grenada

To improve neurocognitive outcomes in 2-year-old children by implementing a community-based intervention program that follows the principles of Conscious Discipline.

We aimed to introduce Conscious Discipline (CD) in Grenada as a means of improving neurodevelopment in 2-year-old children. The CD intervention promotes improved social-emotional connections between parents/guardians and children that reduces harsh discipline and corporal punishment and provides an ideal environment for the development of higher cognitive functioning (e.g. working memory, inhibition, emotional regulation).

The intervention is implemented by using a distributed local, train-the-trainer model in partnership with the Grenada Roving Caregiver Program, managed by GRENCASE. CD training was provided to 85 existing Roving Caregivers, 70 of whom were certified as Conscious Discipline Paraprofessionals (CDPPs). Certified CDPPs traveled out to communities and villages throughout Grenada, to impart knowledge and skills to new and expecting parents.

Following the intervention, parents who received CD training were assessed in their ability to implement CD skills with their child(ren). Neurocognition was assessed in children post-intervention using the INTERGROWTH 21st Neurodevelopmental Assessment (INTERNDA). Neurocognitive outcomes were compared between the intervention arm and the waitlist control arm of the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants actively enrolled in the Roving Caregiver Program (0-2-year-olds living with parents in at-risk communities served by the RCP)

Exclusion Criteria:

* Not enrolled in the Roving Caregiver Program
SIRT1(rs7069102 ) Gene Polymorphism in Chronic Obstructive Pulmonary Disease at Egyptian Patients

Chronic obstructive pulmonary disease (COPD) prevalence, morbidity, and mortality vary across countries and across different groups within countries with a direct relation to the prevalence of tobacco smoking. Other risk factors for COPD include genetic factors, longstanding asthma, outdoor air pollution, second-hand smoke exposure, biomass smoke, indoor air pollution, occupational exposures, and tuberculosis . The prevalence and burden of COPD are projected to increase in the coming decades because of continued exposure to COPD risk factors and the changing age structure of the world's population. As these factors are rapidly increasing in developing countries, COPD will become a major health problem, exerting a huge demand on economic and healthcare resources in developing countries \[2\]. In Egypt, although COPD is a rising significant health problem, data on its prevalence, morbidity, and mortality are still lacking and have to be estimated .

Sirtuin 1 (SIRT1) is a protein/histone deacetylase dependent NAD. It plays a crucial role in various human diseases such as cardiovascular diseases, cancer, inflammation, aging, neurodegenerative disease, obesity and type 2 diabetes. Seven isoforms of the SIRT1 gene (SIRT1- SIRT7) have been determined in mammals. Expression of the SIRT1 gene is regulated by transcription factors such as CREB, FOXO3, HIC1, NF-KB, p53, PARP-2 and PPAR. SIRT1


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Sohag University Hospital, chest department.

Exclusion Criteria:

* Patients with malignancies, any other chronic disease, Individuals with a history of known chronic cardiorespiratory diseases and those with collagen vascular diseases were excluded.
Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes

Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS. Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural progression of AS, some data even suggesting that it may accelerate the formation of syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit ossification phenomena independently of their anti-inflammatory properties, owing to a specific action on bone formation via prostaglandin inhibition.

Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF treatment, to prevent syndesmophyte formation in AS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old
* Patients who fulfil 1984 modified New York criteria for ankylosing spondylitis:
* SA patients with indications for anti-TNF treatment initiation according to the French society of Rheumatology guidelines.
* Being affiliated to a health insurance system
* Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)

Exclusion Criteria:

* Patients who present another chronic systemic inflammatory disorder, different from ankylosing spondylitis.
* Patients who present contraindications to treatment with NSAIDs.
* Patient with daily corticosteroid treatment at a dosage ≥ 10 mg/day
* Pregnant or breastfeeding women
* Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing to undergo MRI
* Women that refuse to an effective contraception method for all the study duration