cyrilzakka/clinical-trials huggingface dataset:
Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.


Eligibility Criteria:
Inclusion Criteria:

1. Elder than 60 years old
2. Speak Chinese Mandarin
3. Scheduled to undergo hip or knee replacement surgery and lumbar spine surgery
4. The operation time is more than 2 hours.
5. Signed the informed consent
6. American Society of Anesthesiologists (ASA) classification I-II

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis
2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
3. Several audition or vision disorder
4. Patients with tumors or infections
5. Unwillingness to comply with the protocol or procedures
6. Can not communicate normally in Mandarin Chinese
7. Existing bradycardiac arrhythmia (Heart rate \<60 bpm for any reasons)
8. Existing gastrointestinal ulcer
9. Existing urinary incontinence
10. Existing asthma or chronic obstructive pulmonary disease
11. Postoperative admission to ICU
12. Allergic to donepezil
Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis

This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.

This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients were randomized in a 1:1 ratio to Pegmolesatide optimize medication regimen group and Pegmolesatide standard medication regimen group. Patients in the investigational group received 2.0 mg (in patients weighing ≤60 kg) or 3.2 mg (in patients weighing \>60 kg) as the initial dose, the initial dose of the control group was 0.04mg/kg, then were adjusted for every 4 weeks based on Hb levels and its changes. The primary endpoint was the change in Hb levels from baseline in week 24.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 80 years old, gender not limited;
2. Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg/m\^2;
3. Diagnosed with CKD ≥ 6 months and estimated glomerular filtration rate (eGFR) ≥ 15mL/min/1.73m\^2 before enrollment, and\<60 mL/min/1.73m\^2 (estimated GFR using CKD-EPI formula), with no expected renal replacement therapy plan during the study period;
4. rHuEPO or HIF-PHI should be used for ≥ 4 weeks and ≤ 12 weeks;
5. During the 28days and 3days before randomization, with Hb ≥ 70g/L and \< 110g/L;
6. Understand the research procedure and voluntarily sign an informed consent form (ICF) in writing.

Exclusion Criteria:

1. Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia/Cooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors;
2. Known to be allergic to iron agents or polyethylene glycol;
3. Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
4. Have received oral or intravenous immunosuppressive or glucocorticoid therapy within the 12 weeks prior to randomization;
5. Individuals with poor blood pressure control;
6. C-reactive protein ≥ 30mg/L within the first 3 days of randomization;
7. Pregnant and lactating women, women of childbearing age who have a positive urine β - HCG test result before the trial, or those who have a pregnancy plan during the study period;
8. Assessment of cardiac function level III or IV within the first 3 days of randomization;
9. Within the first 3 days of randomization, the liver function was assessed as Grade C;
10. Researchers believe that subjects with any other factors that are not suitable for participating in this trial.
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)

The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.

Eligibility Criteria:
Inclusion Criteria:

* Aged: 35-43 years old
* Vaginal pH \> 4,5 and low Lactobacillus count or Nugent score of 4-6
* With interest in getting pregnant and ideally in IVF waiting list
* History of recurrent genitourinary infections

Exclusion Criteria:

* Any pathology that interferes with the study
* Current intake of food supplements or probiotics
* Current intake of contraceptives
* Use of oral or vaginal probiotics in the last 6 months
* Hypersensitivity to any of the components of the studied product
* Current vaginal infection
* Pregnant women
* Breastfeeding
* Use of intrauterine device
* Use of spermicide
* Use of cervical caps as hormonal therapy
Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation

Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.

• Twenty patients with generalized vitiligo will be included in this study.

All patients will be subjected to:

* Clinical evaluation:
* An informed written consent.
* History taking include age, previous treatment, disease activity
* Clinical examination including Vitiligo Area Scoring Index (VASI) and Vitiligo Disease Activity Score (VIDA)
* Photography (before starting the treatment and every 2 weeks till the end of the study)

Laboratory evaluation:

* 2 mm punch skin biopsies will be taken from vitiligo patients, 1 from lesional and the other from perilesional skin before treatment.
* The patients will be randomly assigned to two groups:

Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.

* Controls: 20 individuals age and sex matched will be biopsied from the skin of their abdominoplasty surgery.
* Another two 2 mm punch skin biopsies will be taken from lesional and perilesional skin at the onset of repigmentation if repigmentation starts before completion of the 48 treatment session or after completion of the treatment period if repigmentation does not occur.
* .All biopsies from patients and controls will be stained Immunohistochemically by anti-E cadherin antibody.

Eligibility Criteria:
Inclusion Criteria:

* Patients with generalized non-segmental vitiligo (25%-75%)
* Males, postmenopausal females and premenopausal females not planning to get pregnant during the period of treatment and after 2 years from the end of treatment.
* Age more than 18 years.

Exclusion Criteria:

* Children ˂ 18 years old
* Pregnant females
* Premenopausal females planning to get pregnant within the period of treatment or within 2 years after.
* Patients receiving treatment for vitiligo within the past 2 months.
* Patients with abnormal liver profile
* Patients with abnormal lipid profile
* Patients with associated photosensitive disorders
* Patients having associated skin diseases other than vitiligo
* Cataract and aphakia
* High cumulative dose from previous sessions of narrowband ˃ 200-300 session
Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)

Study Objective:

1. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progression, as evaluated by quantitative B-mode carotid ultrasound (US).

The HART study is designed as a substudy of the Heart Outcomes Prevention Evaluation-2 (HOPE-2)trial which evaluates the effect of combined therapy ? folic acid and vitamin B6 and B12 on clinical events. The study is designed to enrol 900 study participants randomized to homocysteine lowering therapies or placebo. Follow-up will estimate over 5 years. Study participants will undergo yearly carotid B-Mode ultrasound examinations.

Eligibility Criteria:
Inclusion Criteria:Women and Men aged ≥ 55 years at high risk for CV events with: (a) Documented (CAD): i) History of prior MI; ii) stable or unstable angina with documented multivessel CAD or strongly positive stress test; iii) Multivessel CAD and PTCA ≥ 6 months prior to randomization; iv) multivessel CABG ≥ 4 years prior to randomization; v) Multivessel CAD on angiography; (b) Documented peripheral vascular disease (PVD): i) Previous limp bypass surgery and/or previous peripheral percutaneous transluminal angioplasty and/or previous limp or foot amputation due to PVD.ii) History of intermittent claudication with ankle/arm blood pressure ratio of ≤ 0.80 or with significant arterial stenosis on angiography; (c) Documented cerebrovascular disease: i) History of previous ischemic stroke; and (d) Diabetes mellitus with ≥ 1 additional major CV risk factor(s). (2) Provision of informed consent.(3) Adequate baseline carotid US examination.

Exclusion Criteria:1. Current use of folic acid supplements \> 200 mg/day. 2. Known previous adverse reactions to folic acid, Vitamin B6 or B12. 3. Planned cardiac, peripheral or cerebrovascular.

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Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis: Reliability and Validity Study

The main objective of this study will be to translate and culturally adapt Questionnaire for Female Urinary Incontinence Diagnosis into the Urdu language and to evaluate its reliability and validity in the Pakistani urinary incontinence population. Also assess its correlation with Pelvic Floor Impact Questionnaire, Pelvic Floor Distress Inventory, International Consultation on Incontinence Questionnaire-short form for severity and also check the quality of life.

According to the previous recommendation, Questionnaire for Female Urinary Incontinence Diagnosis will be translated into the Urdu language from its original English version and adapted culturally in Pakistan. Amongst the urinary incontinence population, Questionnaire for Female Urinary Incontinence Diagnosis will be distributed in 200 patients who would be recruited by a convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing the informed consent forms. To test the inter-observer reliability and intra-observer reliability of the Pelvic Floor Impact Questionnaire, Pelvic Floor Distress Inventory, International Consultation on Incontinence Questionnaire-short form questionnaires will be completed by two observers, on the same day, with a time interval of 2 hours between first and second distribution. For the 3rd assessment, questionnaires will be completed after 7 days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be analyzed by Cronbach alpha value. Test-retest reliability will be assessed by using an intra-class correlation coefficient. The Questionnaire for Female Urinary Incontinence Diagnosis will be evaluated for content validity, construct validity, criterion validity, and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 years or above.
* Women who answered 'yes' to one or both of the following questions: "In the last month have your urine leaked involuntarily when you lifted weights, exercised, sneezed or coughed?" and "In the last month, have you sensed very strong urge to urinate, leaking urine before getting into the bathroom?"

Exclusion Criteria:

* Current pregnancy or 3 months postpartum
* Any neurological disease
* Urinary tract infection, urogenital cancer, interstitial cystitis
* Taking treatment for PFD in the last 3 months
A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome

The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS. Participants will be randomly assigned to one of four treatment groups;

1. MMF07 Foot Massager device
2. Heat therapy
3. Heat therapy and the MMF07 Foot Massage device
4. Neither heat nor MMF07 Foot Massager device (no treatment group)

Few clinical trials have looked into non-pharmacological, non-invasive treatments for restless legs syndrome, despite reports that massage, baths and vibrations can alleviate RLS symptoms. We would like to assess whether the MMF007 Foot Massager device and/or heat therapy is associated with improved severity of RLS symptoms.

For this study the investigator will enroll 40 participants who have been diagnosed with restless legs syndrome, who will be followed over the course of four weeks and asked to complete two in person study visits. In the study the investigator is comparing the use of the MMF007 Foot Massager device and/ or heat therapy to a non treatment group to assess if the symptoms of RLS improve.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between 18-75 years old diagnosed with RLS according to the diagnostic criteria of the International Restless Legs Syndrome Study Group (11)
2. Subjects should have bothersome RLS symptoms, despite best medical therapy
3. Subjects should be stable on all RLS medication for at least 4 weeks prior to enrollment
4. All subjects must have vision and be proficient in English for compliance with testing and surveys
5. All women of childbearing age must be using an acceptable form of birth control, including abstinence, intrauterine device (IUD) or intrauterine system in place for at least 3 months prior to screening, subject or partner using barrier method (e.g., condom, diaphragm, or cervical cap) with spermicide from screening through study completion; partner has a documented vasectomy \> 6 months prior to Baseline, Stable hormonal contraception (with approved oral, transdermal, or depot regimen) for at least 3 months prior to screening

Exclusion Criteria:

1. RLS secondary associated with end stage renal disease, iron deficiency or pregnancy
2. Concomitant sleep disorders
3. Any other condition (other than the primary indications), which in the opinion of the investigators might contribute to difficulty complying with the protocol
Assessment of Maternal and Fetal Serum Biomarkers in Women With Pre-eclampsia

The findings of markers of placental dysfunction in women with preeclampsia may suggest that these biomarkers may be useful tools for early detection of preeclampsia

Preeclampsia is a pregnancy-specific hypertension illness that is characterized by widespread maternal endothelial dysfunction and appears to be a systemic syndrome that originates in the placenta. Through binding to and blocking the interaction of placental growth factor (PlGF) and vascular endothelial growth factor (VEGF) with their receptors Flt1, soluble fms-like tyrosine kinase (sFlt1) functions as an antagonist of these growth factors. Most seromucoid and protein-bound hexose are released during an acute phase and are inflammatory glycoproteins. Hepatocytes in the liver, which are highly sensitive to stress, increase and leak into the bloodstream during any disease state. It is a time when the placenta demands more vascular development. In order to identify and explain the differences in sFLT-1, VEGF, PlGF levels, and inflammatory biomarker responses. Current study will investigate the differences in blood level of sFLT-1, VEGF, PLGF, Seromucoid and protein-bound hexose inflammatory biomarkers between those with PE (cases) and healthy pregnant women (controls).

Eligibility Criteria:
Inclusion Criteria:

* Age group 18-45 years
* Gestational age of 26-41 weeks at the time of diagnosis for preeclampsia
* Delivered vaginally or abdominally
* Being of any parity (para 1 and more)
* Pregnancy being singleton or multiple pregnancies
* Willingness to provide informed consent

Exclusion Criteria:

* Pregnant woman having chronic hypertension
* Having Diabetes mellitus
* The lady on medications that can affect inflammatory markers or blood pressure
* Pregnant with fetal anomalies
* Refused to involve in the research
In-hospital Healthcare Professionals' Attitudes and Their Experience in Performing Cardiopulmonary Resuscitation.

Attitudes among healthcare professionals can possibly affect the treatment given in cardiac arrest situations. The attitudes of healthcare professionals towards cardiopulmonary resuscitation (CPR) has been poorly studied. The few existing previous international results shows attitudes reported by nurses as hesitation, fear of defibrillation, anxiety and fear of harming the patient.

The aim of this study was to describe the attitudes towards performing cardiopulmonary resuscitation among in-hospital healthcare professionals, furthermore to assess if experience in performing CPR has an effect on attitudes.

Data will be collected using questionnaires containing attitude questions. The questionnaires contains questions regarding attitudes towards being required to perform CPR (6 questions), previous experience in performing CPR (time since last performance and number of performances) and attitudes during the latest CPR performance (8 questions). All attitude questions are constructed as multiple choice questions.

Results regarding attitudes towards being required to perform CPR and attitudes during the latest CPR performance will be presented descriptively. To analyse a possible effect of time since CPR performance and number of CPR performances on attitudes during the latest CPR performance logistic regression will be used. Response variables will be "yes" or "no" on 8 specific attitude questions with predictors consisting of time since CPR performance (0-3 months ago, 4-23 months ago and \>24 months) and number of CPR performances (1-3 times, 4-10 times and \>10 times).

Eligibility Criteria:
Inclusion Criteria:

* In-hospital healthcare professionals.
* Patient contact

Exclusion Criteria:

* Absent during the survey
* Parental leave
* Leave of absence
* Sick leave.
Colonic Polypectomy in Cirrhotic Patients With Portal Hypertension

The goal of this retrospective cohort study is to evaluate the risk of post-polypectomy bleeding following the colonoscopy resection of lower gastrointestinal polyps in patients with liver cirrhosis with portal hypertension. The main question it aims to answer is:

Does the risk of bleeding increase after colonoscopy polypectomy in patients with liver cirrhosis with portal hypertension?

Participants will be subjected to polypectomy of any colonic polyps.


Eligibility Criteria:
Inclusion Criteria:

* All liver cirrhosis patients with portal hypertension and colonic polyps

Exclusion Criteria:

* Patients with platelet count less than 50,000/µL.
* Patients with hemoglobin levels less than 8 g/dL.
* Prothrombin Time more than 20 seconds.
Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial

The DETECT AS Trial is a randomized clinical trial and quality improvement initiative that seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization of aortic valve replacement (AVR), and on ethnic and racial disparities in AVR utilization.

After the investigators identify patients in whom echocardiography shows severe aortic stenosis, defined by an aortic valve area (AVA) \<1.0cm2, the ordering provider of the echocardiogram will then be randomly assigned to either the intervention group or to the control group. Providers randomly assigned to the intervention group will be sent an electronic (email or message via the electronic health record) physician notification for every one of their patients with severe aortic stenosis on TTE. Electronic notification will also highlight relevant ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS. No intervention will be performed for patients belonging to physicians assigned to the control group.

The primary endpoint will be AVR utilization, defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. Clinical indications will be based upon the 2020 AHA/ACC Clinical Practice Guidelines for Valvular Heart Disease.

Secondary end-points will be mortality, heart failure hospitalization, TTE utilization/surveillance, AS billing code diagnosis, and cardiology/Heart Valve Team referral. Pre-defined subgroup analyses will be performed to assess AVR utilization among women, racial/ethnic minority groups, low-gradient AS, cardiologist and non-cardiologist ordering provider, and inpatient and outpatient practice settings.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with severe aortic stenosis having an aortic valve area of less than or equal to 1.0cm2.

Exclusion Criteria:

* Subjects with bioprosthetic or mechanical valves in the aortic position