cyrilzakka/clinical-trials huggingface dataset:
The Impact of Maternal Obesity on Pregnancy Outcomes in El-Minia Locality

A study will carried out over a period of one year , all obese pregnant women as diagnosed with BMI at the time of 1st ANC visit and before labor ,observation of events during both intra-partum \&postpartum periods it will be recorded.outcome will compared with normal other pregnant women

It is known that obesity during pregnancy has drawbacks for both maternal and foetal outcome The aim of this study is to evaluate and measure the proportion of the adverse pregnancy outcomes attributable to maternal obesity and so reaching to recommendations in order to improve the outcomes and wellbeing of these women and their children.patient will be divided into two groups control group with normal BMI and study group and both compared as regard foetal and maternal outcome The assessed fetal variables will be: fetal birthweight \& incubators admission. Data will be retrieved from patients before labor and from investigator observation both intrapartum and postpartum.

Eligibility Criteria:
Inclusion Criteria:

* obese
* pregnant
* age 18 -40
* single viable cephalic foetus

Exclusion Criteria:

less than 18 years more than 40 years associated medical disorders patient refusal non cephalic presentation

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Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)

This is a prospective, single-center, single-arm study to evaluate the feasibility and safety of the combination of Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the treatment of diffuse, small vessel coronary artery disease. The objective of the study is to demonstrate the feasibility and safety of the combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patientsaged≥18years.
2. Presence of epicardial coronary artery disease with lesion length ≥ 20 mm and vessel diameter less than 2.75 mm and more than 1.5 mm with diameter stenosis \>50% by visual evaluation.

Exclusion Criteria:

1. Life expectancy \< 2 years
2. Left ventricular EF ≤40%
3. Pregnantorlactatingfemales.
4. Moderate and moderate-to-severe valvular heart disease.
5. Hemodynamic instability.
6. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
7. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, bivalirudin, prasugrel, ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil, PVP or any contrast media.
8. Patients in whom anti-platelet and/or anti-coagulant therapy are contraindicated.
9. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
10. Transplant patients.
11. Patients with calcified lesion requiring other type of treatment such as Rotational Atherectomy.
12. Unprotected left main coronary artery lesions
13. Coronary artery spasm in the absence of a significant stenosis.
14. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
Cenobamate in Adults With Focal-Onset Seizures

The BLESS Study contributes to filling this information gap by collecting data from the Italian clinical practice and the Compassionate Use Program, to better characterize the clinical profile of cenobamate describing its effectiveness, safety and tolerability in adult patients diagnosed with uncontrolled focal epilepsy despite the use of at least two antiepileptic medicinal products.

The main objective of the study is to describe the effectiveness of adjunctive cenobamate treatment in adult patients with uncontrolled focal epilepsy in Italy, overall and according to age class, setting of cenobamate treatment, cenobamate final target daily dose prescribed, and number of concomitant Anti Seizure Medications (ASMs). This will be assessed by intra-patient percent change and achievement of a ≥50% reduction in the seizure frequency from the pre-treatment baseline over a period of 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at the time of cenobamate treatment initiation
* Male or female patients
* Patients diagnosed with focal epilepsy uncontrolled despite a history of treatment with at least two antiepileptic medicinal products at the time of cenobamate treatment initiation in agreement with the Summary of Product Characteristics (SmPC)
* Patients who at enrolment had received at least 12 weeks (titration period up to the initial recommended target dose of 200 mg daily completed) but no more than 52 weeks of cenobamate as adjunctive treatment of focal-onset seizures with or without secondary generalization
* Patients with available retrospective data in medical charts and seizure diaries, including information about baseline seizure frequency prior to cenobamate treatment initiation
* Patients who gave written informed consent to take part into the study and personal data processing consent following local regulation.
* Patients who received adjunctive cenobamate for at least 12 weeks and discontinued permanently treatment before enrolment will also be included in the study-

Exclusion Criteria:

* Patients diagnosed with familial short-QT syndrome
* Patients affected by hypersensitivity to the active substance cenobamate or to any of the excipients (e.g., lactose monohydrate)
* Patients with history of severe drug-induced hypersensitivity reaction, including (but not limited to) drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens Johnson syndrome
* Patients enrolled in a clinical trial in which treatments for epilepsy are managed through a study protocol
* Patient unable to read and write in Italian language and to autonomously fill in questionnaires and scales
* Patients with a known pregnancy or who are breast-feeding from cenobamate treatment initiation till enrolment visit.
Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis

Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in Japanese adult patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Eligibility Criteria:
Inclusion Criteria:

* Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
* Patients who had given written informed consent to participation in this study

Exclusion Criteria:

* Patients who failed in treatment compliance in the core study
* Patients who had a major violation of the protocol in the core study
Testicular Torsion

Background:

Testicular torsion is a scrotal emergency that results in impaired blood supply to the testis and ischemia of the testis as a result of the rotation of the spermatic cord around itself. The etiology of testicular torsion is not clear, but various predisposing factors are responsible for the occurrence of testicular torsion.

Recently, with the discovery of "Toll-Like Receptors" (TLRs), new horizons have been opened in the field of innate immune system-related diseases.

Objective: To mediate the relationship between testicular torsion and TLR4 receptors.

Material-Method: Testicular specimens of patients who developed testicular ischemia after testicular torsion and underwent orchiectomy between 2012-2022 were reached. A study of TLR 4 receptors was performed in these testicular specimens. The patients were divided into two groups according to their ages newborns and adolescents.

Analysis of 32 newborns and 32 adolescents between the ages of 14 and 16 (mean age was 15.17 ± 0.98) testicular tissue lysate using Toll-Like Receptor antibody 4 (TLR4) ELISA (Enzyme-Linked ImmunoSorbent Assay).

Toll-like receptor 4 is a transmembrane protein that in humans is encoded by the TLR4 gene. Its activation leads to the production of inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

testicular torsion

* newborn, adolescent,

Exclusion Criteria:

* orchitis, urinary infection, trauma,
Hyperglycemia in Neurosurgery

Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Neurosurgical patients often receive high doses of medications that increase blood glucose levels such as steroids, placing them at a potentially higher risk for postoperative infection. The purpose of this multisite observational study is to assess the impact of severe intraoperative hyperglycemia as a risk factor for postoperative infection in the neurosurgical patient.

This is a multisite \[3 locations\] prospective observational study of adult patients (18-89 years old) scheduled for elective intracranial (open or endoscopic) procedures that require general anesthesia and a hospital stay of at least 1 day after the surgery. All sites will follow the standard of care clinical protocol for glycemic management that was developed at Boston Medical Center (BMC). Laboratory tests will be collected at the discretion of the primary clinician. This observational study does not require any change to routine clinical practice.

The following perioperative data (timeframe between Pre-Procedure Clinic visit through Post-Anesthesia Care Unit discharge): blood glucose measurements, total insulin dose, total dexamethasone dose, estimated intraoperative blood loss, antibiotic prophylaxis regimen.

The patient's electronic medical records data will be reviewed 7 days after the neurosurgical procedure to abstract all available culture data (blood, urine, sputum, CSF), available treatment regimen data prescribed for infection (antibiotics), complications from hyperglycemia (diabetic ketoacidosis, hyperglycemic nonketotic coma) or insulin therapy (hypoglycemia episodes). Intensive care unit (ICU) and hospital length of stay will also be obtained form the medical records.

The investigators anticipate finding four groups of patients with regards to intraoperative blood glucose levels and management: 1) patients with no episodes of severe intraoperative hyperglycemia, 2) patients with intraoperative hyperglycemia who received insulin treatment, 3) patients with intraoperative hyperglycemia who did not receive insulin treatment and 4) patients with no available laboratory data.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective intracranial (open surgical or endoscopic) intervention
* General anesthesia
* Hospital stay of at least 1 day post-procedure

Exclusion Criteria:

* Diagnosis of infection (local or systemic) in preoperative period
* Emergency procedures
Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty

The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.


Eligibility Criteria:
Inclusion Criteria:

* agreed to participate the study
* American Society of Anesthesiologist s physical status classification 1-3
* elective hip arthroplasty planned
* no contraindications to the study drugs
* no contraindication to lumbar puncture

Exclusion Criteria:

* refused to participate the study
* age less than 40 or over 75 years
* Planned anesthesia method other than spinal anesthesia
* contraindications to the study drugs
* Contraindications to lumbar puncture
SNIFF Multi-Device Study 2

The SNIFF Device study will involve using one of three devices to administer insulin through each participant's nose or intra-nasally, accompanied by a lumbar puncture. This goal of this study is to measure how much insulin the device delivers to the cerebrospinal fluid (CSF). In addition, this study will look at the effects of insulin administered intra-nasally on memory, and on blood levels of insulin.

The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF).

A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels.

The study will consist of a single site, randomized, double-blind trial comparing the acute effects of INI 20 International Units or 40 International Units delivered with one of three nebulizer-like devices on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either 20 or 40 IU insulin first, and the opposite dose on a second visit. Participants who are cognitively normal or who have aMCI (n=30) will be enrolled. The primary outcome measure will be to establish which device and which dose provides the greatest increase in CSF insulin which will provide important evidence to be used in the design of future trials.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Cognitively normal or diagnosis of aMCI
* Stable medical condition for 3 months prior to screening visit
* Stable medications for 4 weeks prior to the screening and study visits
* Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

Exclusion Criteria:

* A diagnosis of dementia
* History of a clinically significant stroke
* Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
* Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
* Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit.
* History of seizure within past five years
* Pregnancy or possible pregnancy.
* Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa)
* Residence in a skilled nursing facility at screening
* Use of an investigational agent within two months of screening visit
* Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications
Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment

Perioperative neurocognitive disorder (PND) is one of the most common postoperative complications among elderly patients. However, the mechanism and targeted intervention of PND remains unclear. Our previous clinical studies demonstrated the association between olfactory impairment and PND. Moreover, our translational studies showed that anesthesia/surgery induced olfactory impairment and caused cognitive impairment in mice and olfactory enrichment could prevent the anesthesia/surgery-induced cognitive impairment. However, there was no clinical investigation to determine whether olfactory enrichment can mitigate PND in elderly patients. Therefore, we propose determining whether olfactory enrichment can prevent and/or treat PND in elderly patients.

The study will be a double-blinded, randomized controlled trial. Participants (65 years old or older) undergoing scheduled orthopaedic surgery (≥2 hours, under general anesthesia) will be randomized to either olfactory enrichment group or sham group. Participants in olfactory enrichment group will receive olfactory enrichment with a dispenser twice sessions per day on preoperative day 1-3 and postoperative day 1-3 (30 min per session, 4 odors for each session) while participants in sham group will be equipped with the same pattern except that water will be used in the dispenser. Participants will be assessed twice daily by a research assistant blinded to allocation. The primary outcome will be the incidence of postoperative delirium measured by the Confusion Assessment Method on postoperative days 1, 2 and 3. The secondary outcomes will be the severity of postoperative delirium, cognitive function, plasma Tau-PT217 level, and olfactory function.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥65 years old.
2. Having a scheduled surgery (≥2 hours, general anesthesia) (e.g., total hip replacement, toal knee replacement, open reduction and internal fixation of hip and lumbar spine).
3. Being able to complete neuropsychological tests, 3D-CAM and CAM-S.
4. Chinese Mandarin as their native language.
5. Edmonton frailty scale (EFS) score ≥ 6.

Exclusion Criteria:

1. Having delirium, assessed by 3D-CAM, before surgery.
2. Having a brain tumour, stroke or mental disorders (eg, major depressive disorder or dementia).
3. Participating in other clinical studies at the time of screening.
4. Unwillingness to comply with the protocol or procedures.
The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia

This is a multisite, double-blind, randomized, placebo-controlled, and parallel study designed to evaluate the clinical efficacy and safety of Huaiqihuang granule for treatment to children with chronic primary immune thrombocytopenia (Qi Yin deficiency).

The randomized clinical trial included subjects (n =216) will be randomly divided into experimental (n = 162) and control groups (n =54) according to a random number table. Patients in the experimental group will receive Huaiqihuang Granule . Patients in the control group will receive placebo a placebo-controlled designed is used for this study. To minimize the risks, treatment stopping rules and subsequent measures are established for subjects whose disease under study become worsening during the study. Subjects receiving placebo treatment will switch to investigational drug after Week 24 to reduce the risk of lack of efficacy by placebo.

The primary outcome measures is proportion of patients whose hemorrhage has improved (clinical effective rate).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged between 1 and 14 years (inclusive) ;
2. Is diagnosed as immune thrombocytopenia according to the criteria of ICD-10, i.e., platelet \< 100×109/L for at least two hematology tests with normal blood cell morphology; skin petechia, ecchymosis and (or) the clinical manifestations of mucosa and visceral hemorrhage; no splenomegaly; exclusion of other secondary thrombocytopenia, such as aplastic leukemia, aplastic anemia characterized by thrombocytopenia as the first hematologic abnormality, hereditary thrombocytopenia, thrombocytopenia secondary to other autoimmune diseases, infections or drugs etc...
3. Meet the diagnosis criteria for Qi Yin deficiency in traditional Chinese medicine;
4. Time since initial diagnosis of ITP until randomization is at least 12 month, i.e., course of disease ≥1 year;
5. Values of prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) are within 1.2 times of normal reference range;
6. Values of biochemistry parameters including creatinine, ALT, AST, glucose, total bilirubin are less than 1.2 time of the corresponding upper limit of normal range;
7. Has signed and dated the informed consent in volunteer by the subject and the subject's legal guardian(s) (for subject who is less than 8 years old, the informed consent will be signed and dated by the subject's legal guardian(s) in volunteer).

Exclusion Criteria:

1. Is diagnosed as congenital thrombocytopenia;
2. Is diagnosed as secondary thrombocytopenia;
3. Is diagnosed as non-immune thrombocytopenia;
4. Has medical history of diabetes;
5. In the judgement of Investigator, the subject is not appropriate to participate in this study.
Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use

This is a study to develop and evaluate a peer mentoring intervention for Black and Latinx adolescents with type 1 diabetes to increase the initiation and maintenance of a continuous glucose monitoring (CGM) device. This device is a standard of care to improve diabetes management related to diet, exercise, and insulin. Use of CGM has been shown to improve health outcomes, but is not used by adolescents of color. Peer mentors may help improve usage.

In Phase 1, investigators developed the intervention with a stakeholder advisory group. In Phase 2, investigators will conduct a small clinical trial to evaluate the intervention. Phase 1 is complete with the focus of this registration being Phase 2, the clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes, as determined clinically by the presence of ketosis or ketoacidosis at presentation and/or the presence of at least one diabetes-related auto-antibody
* Self-identification as Black and/or Latinx.
* Ability of participant to comprehend and communicate in written and spoken English, in order to complete surveys and participate in mentioning sessions and other interview (parents/caregivers do not need to have English fluency)
* Access to personal cellphone or tablet to participate in remote video sessions with the peer mentor
* Naïve to or not currently using CGM. "Current" use is defined as any CGM used for clinical management of T1D for \> 1 week within the last three months.

Exclusion Criteria:

* Participants with a prior severe skin reaction to CGM sensor or adhesive.
* Current use of CGM
* Current or planned pregnancy
* Inability to comprehend or communicate in spoken/written English
* Subjects with other medical or mental health conditions that would, in the opinion of the investigators, interfere with the conduct of the study or present additional risk to the individual.
Evaluate the Predictive Impact of the EHMRG

External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

It is a prospective cohort study carried out in the ED of Monastir which included patients admitted to the ED with a discharge diagnosis of AHF.

Eligibility Criteria:
Inclusion Criteria:

* Patients consulted for acute dyspnea and were diagnosed with acute heart failure.
* Major patient.
* Subject who accept to participate in the research.

Exclusion Criteria:

* Patient who refuse to participate in the study.
* Impossibility of giving the patient informed information