cyrilzakka/clinical-trials huggingface dataset:
Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study

We seek to investigate whether hospitals in England and Wales vary in their rate of mortality following admission for heart attack or unstable angina, the extent of such variation, whether discharge diagnosis affects the extent of variation, and whether such variation has changed over time. Furthermore, we will investigate what individual- or hospital-level factors explain variation in mortality between hospitals.

Several studies have looked at between-hospital variation in mortality following myocardial infarction but have lacked patient-level data. Those with individual-level data have been limited by:

* use of in-hospital mortality as an outcome measure, which can be affected by length of stay,
* restriction to patients aged 65 and over, or otherwise selected patients, and
* patient-level explanatory factors lacking clinical detail, particularly medications given in hospital.

MINAP patient-level data allow the investigation of hospital variation in mortality (in-hospital and 30-day) in a group of unselected patients, taking into account clinical details such as medication use in hospital, as well as features of the hospitals providing care. The proposed study will establish the extent of variation between hospitals in England and Wales, whether this varies by ACS diagnosis, whether the variation has reduced over time and finally which patient-level or hospital-level factors explain any variation found.

A statistical analytic protocol for this study, dated 15.4.2010, is available on request.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* admitted between January 2003 to June 2009 (or latest date data available)

Exclusion Criteria:

* admitted to hospital with fewer than 25 admissions in given year
Alternative of Treatment in Obesity Hypoventilation Syndrome

Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables. As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, echocardiography and the incidence and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, \>=30 and \< 30, using conventional polysomnography. The AHI \>=30 group will be randomized to CPAP, NIV or life style modification treatments. The AHI \<=30 groups will be randomized to NIV or life style modification treatments. Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI.

The AHI \>=30 group will be analyzed to CPAP, NIV or life style modification treatments for two mouths.Once an evaluation is done during this period, the life style modification treatment will be randomized with the NIV/CPAP treatment for a continuation of three years.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 80 years old.
* Absence of moderate or severe chronic obstructive pulmonary disease (COPD).
* Absence of neuromuscular, chest wall or metabolic disease which cause daytime hypercapnia.
* Absence of narcolepsy or restless legs syndrome
* Exceed correctly treatment of at least 30 minutes with CPAP/NIV at wakefulness.

Exclusion Criteria:

* Psychophysical incapacity to answer questionnaires.
* Patients who are not able to be evaluated by means of quality of life questionnaires for suffering restrictive chronic disease previously diagnosed (neoplasy, chronic pain of any origin, renal failure, severe chronic obstructive pulmonary disease and any other restrictive chronic disease).
* Subjects with important chronic nasal obstruction that prevents from using CPAP/NIV.
* Informed consent not obtained.
Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients

The adoption of total mesorectal excision (TME) has standardized rectal cancer surgery and improved oncological outcomes. In locally advanced rectal cancer, neoadjuvant radio chemotherapy (NACRT) has further improved oncological benefit. Although these strategies result in good 5-year disease-free survival rates, they are associated with significant morbidity, in particular permanent long-term bowel, urinary and sexual dysfunction. In rectal cancer management, the main objective of organ preservation is to avoid or reduce morbidity and impact on quality of life after rectal resection, without compromising oncological outcomes.

The aim of this project is to evaluate the efficacy of a defined response monitoring program, including a shared decision process, as a strategy for assessing tumor response in locally advanced rectal cancer after neoadjuvant therapy.

This is a national, phase III, randomized, open-label, multicenter clinical trial comparing the tumor response monitoring program with shared decision-making, versus standard tumor response assessment in organ preservation strategies in rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 80
* Histologically proven lieberkuhnian adenocarcinoma with MSS status ;
* Patient who has or is due to receive neoadjuvant treatment (4 to 6 courses of (m)FOLFIRINOX or FOLFOX chemotherapy + CAP 50 radiochemotherapy or CAP 50 radiochemotherapy alone);
* BEFORE any neoadjuvant treatment:

  * Tumor classified T2T3 (on MRI)
  * N0-N1 (≤ 3 positive lymph nodes \* or size ≤ 8 mm) (on MRI)
  * \* positive node = node size \> 5 mm minor axis and/or morphologically suspicious appearance Tumor size ≤4 cm (ON MRI)
  * No distant metastasis (M0)_ TAP scan or PET scan
  * ≤ 8 cm from anal margin (On MRI) (Clinical examination\*)

    \*if the clinical examination is not possible, then the source data is that of the MRI.
  * No invasion of the anal canal and/or sphincters (internal and external) (On MRI)
* Operable patient
* Ability to comply with the protocol and follow-up appointments (repeated assessment consultations and close follow-up if randomized to the Experimental Group);
* Person affiliated with or benefiting from a social security scheme;
* Free and informed consent signed by the patient.

Exclusion Criteria:

* Patients with a history of chemotherapy or pelvic irradiation (excluding neoadjuvant treatment)
* Contraindication to pelvic MRI
* Patients with MSI status undergoing immunotherapy
* Other concomitant cancer or history of cancer within 5 years, with the exception of carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured
* Women who are pregnant, likely to become pregnant, or who are breast-feeding;
* Person under guardianship, curatorship or safeguard of justice, or person deprived of liberty.
* Unable to undergo medical follow-up for geographical, social or psychological reasons.
Association Between Prolactin Levels in Pregnant Women in COVID-19. Gether With Rates of Breastfeeding and the Covid-19 Virus

Background: Currently in the world, 41% of children under 6 months are exclusively breastfed. The Covid-19 pandemic has had a major impact on breastfeeding.; Methods: A statistical analysis of linear regression, prolactin analysis in the 3rd trimester of pregnancy and 15 days 15 after delivery was performed in women with Covid- 19 infection and healthy, finally the rates of 16 breastfeeding were evaluated. The sample was made up of 680 pregnant women from the Valladolid 17 Health Area, central region of Spain.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women under the coding of the clinical process of normal pregnancy or diagnosis of Covid-19 infection

Exclusion Criteria:

* No informed consent.
* No pregnant women.
* Older than 50 years old.
* Younger than 16 years old.
Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis

The purpose of this clinical trial is to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild osteoarthritis (OA).

This is a 12-week, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild OA. One hundred subjects with mild OA will be recruited and randomly divided into 2 groups, each group will receive Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) or placebo and will take CE or placebo for 12 weeks. Outcomes will be evaluated by self-administered questionnaires and lab test results. The hypothesis is that Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) which as a dietary supplementation may slow down or reverse OA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 40 \~ 75 years of age
* VAS (Visual Analogue Scale) over 30mm
* Kellgren \& Lawrence Grade I\~II by X-ray
* Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)

Exclusion Criteria:

* Joint space under 2mm by X-ray
* Kellgren \& Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray
* Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthtritis, gout), or articulation fracture with abnormal values at ESR and CRP
* Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases
* Subjects having gastrointestinal diseases
* Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
* Uncontrolled diabetes melitusl patients (fasting glucose level ≥ 180mg/dl)
* Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values)
* Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values)
* Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
* Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening
* History of osteoarthritis treatment therapy within 2 weeks prior to screening
* Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
* Have participated in another clinical trial within the 3 months prior to screening
* Subjects who have hypersensitivity history about investigational product
* Have difficulty to be participated in this clinical trial by investigator's decision
12-Week Study Assessing Change in Psoriasis Severity and Level of Stress Using TEN

This is a 12-Week, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate to severe psoriasis treated with TEN. Psoriasis severity and stress levels will be measured at Weeks 0, 4, 8 and 12.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient, male or female of any race, 18 years of age or older.
* Moderate (\>3 to \<10% BSA) with a PASI of at least 6 and less than 12 or severe (≥10% BSA) plaque psoriasis with a minimal PASI score of 12.
* Subject diagnosed with psoriasis at least 6 months prior to entering the study.
* Subjects who have received treatment in the past for psoriasis and are currently untreated or subjects who are on stable treatment for psoriasis that is expected to remain unchanged throughout the entire duration.
* Subjects who have not received psoriasis treatments in the past should be stable in their disease for the last 4 weeks.

Exclusion Criteria:

* Guttate, erythrodermic, or pustular psoriasis subtypes.
* Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
* Unstable psoriasis or unstable treatment of psoriasis over the entire duration of the study.
* Subjects with moderate psoriasis are not allowed to use concurrent systemic therapies for psoriasis (i.e., phototherapy, orals, biologics, etc.). Topical medications are allowed;
* Subjects with severe psoriasis are allowed to use any concurrent therapy for psoriasis, provided that disease state is stable for ≥2 months and they meet minimum PASI requirements.
* Cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.
Pattern of Non Valvular Atrial Fibrillation in Acute Ischemic Stroke Patients at Assiut University Hospitals

Pattern of non valvular Atrial fibrillation in acute ischemic stroke patients at Assiut University Hospitals.

Percentage of patients with AF admitted with acute cerebrovascular stroke at Assuit University and correlation between AF and severity of stroke at admission and discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with acute cerebrovascular stroke aged more than 18 years old.

Exclusion Criteria:

1. Patients below 18 years old.
2. Patient admitted with cerebral hemohrrage.
3. Patients with significant valvular heart disease.
Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)

This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.

The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a \< 24 hour post-operative hospital stay in \> 50% of patients undergoing this procedure.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic benign prostatic hyperplasia including patients with acute urinary retention;
* Peak urinary flow rate \< 12 ml/sec;
* American Urological Association (AUA) symptom score \> 12.

Exclusion Criteria:

* Previous open or transurethral prostatic surgery;
* History of urethral stricture;
* Failure to discontinue alpha-adrenergic blocking agents for at least 14 days prior to surgery;
* Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior to surgery;
* Patient interested in future fertility;
* Patient with known neurogenic bladder dysfunction;
* Untreated urinary tract infection;
* American Society of Anesthesiologist (ASA) Class \>III;
* Patients requiring anticoagulation with Coumadin or Heparin;
* Patient unable or unwilling to comply with follow-up schedule.
Comprehensive Review of Retinal Pseudo-Holes: Clinical Presentation, Diagnosis, Pathophysiology, and Management

Retinal pseudo-holes (RPH) are macular abnormalities that mimic macular holes (MH) but lack full-thickness retinal disruption. This systematic review, based on 35 studies, explores their clinical presentation, diagnosis, pathophysiology, and management.

Diagnosis: Differentiating RPH from MH is challenging due to overlapping symptoms such as central scotomas and visual distortion. Optical coherence tomography (OCT) has become the gold standard for diagnosis, surpassing older imaging techniques like fundus photography and fluorescein angiography. OCT provides detailed, non-invasive imaging that helps identify RPH's hallmark feature: a foveal depression without retinal break.

Pathophysiology: RPH is primarily caused by mechanical forces exerted on the macula by epiretinal membranes (ERM) and vitreomacular traction (VMT). These forces distort the retina, creating a pseudo-hole. Risk factors include aging, high myopia, trauma, and diabetes.

Management: Many RPH cases are managed conservatively with regular monitoring, as the condition often remains stable. Surgical intervention, such as pars plana vitrectomy (PPV) with membrane peeling, is reserved for symptomatic cases with significant visual impairment. Surgery has shown promising outcomes, with most patients experiencing improved visual acuity.

Research Needs: Further studies are needed to explore the long-term outcomes of RPH, identify factors predicting progression to MH, and assess the utility of advanced imaging techniques like OCT angiography in improving diagnosis and monitoring.

This review underscores the importance of accurate differentiation between RPH and MH to ensure appropriate management and avoid unnecessary treatments.

This is a REVIEW study on Retinal pseudo-holes.

Eligibility Criteria:
Inclusion Criteria:

* Studies that directly addressed retinal pseudo-holes, their clinical presentation, diagnostic modalities, pathophysiology, or treatment.
* Peer-reviewed clinical trials, case reports, observational studies, and reviews.
* Studies that utilized OCT or other imaging techniques (such as fluorescein angiography or fundus photography) to diagnose retinal pseudo-holes.
* Studies that were published in English and provided full-text access.

Exclusion Criteria:

* Studies that did not specifically focus on retinal pseudo-holes but instead dealt with other retinal conditions (e.g., full-thickness macular holes, retinal detachment).
* Studies that were not peer-reviewed (e.g., conference abstracts, opinion pieces).
* Non-English language studies or those without available full texts.
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes

This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age diagnosed with IBD.
* Confirmed pregnancy.
* - Treatment with non-anti-TNF biologics or other advanced therapies (i.e JAK inhibitors, S1P receptor modulators and molecules approved in the forthcoming years).

Exclusion Criteria:

* Patients who do not accept to participate in the study
Zirconia Bars for Mandibular Implant Overdentures

Purpose: To assess the clinical and radiographic outcomes of computer-aided designed and manufactured (CAD-CAM) zirconia bars supporting mandibular implant-retained overdentures (IODs) after a 3-year follow-up.

Methods: A prospective observational single-center study involving 30 edentulous patients rehabilitated with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design - computer-assisted manufacturing zirconia bar with distal extensions was performed assessing clinical and radiographic parameters.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous individuals for more than one year.
* Individuals with sufficient anatomical bone conditions in the interforaminal area to place implants of 4.3mm in diameter and at least 10.0mm in length without bone augmentation needs.
* Written consent to participate and to attend the study and the yearly follow-ups.

Exclusion Criteria:

* Individuals suffered from psychiatric problems.
* History of cerebrovascular or cardiovascular accident within the last six months.
* Uncontrolled or insulin-dependent diabetes, immuno-compromised status, current chemotherapy, and leukocyte system diseases.
* Severe systemic health conditions do not allow surgical intervention with local anesthesia.
* Irradiated bone.
* Severe parafunctional habits
* Drugs or alcohol abuse.
* Insufficient oral hygiene.
* Unrealistic treatment demands.
* Smokers were not excluded, but a cessation protocol was suggested before the implant treatment.
* Unwillingness to participate in the study.
Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial

The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening and labor induction in term parous women with unfavorable cervix.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* parous women
* gestational age \>=37.0 weeks
* Bishop score \<=5
* intact amniotic membrane
* absence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria:

* major congenital anomaly