cyrilzakka/clinical-trials huggingface dataset:
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

HYPOTHESIS An advanced practice nursing intervention in the area of pharmacovigilance performed on patients and professionals improves the identification and reporting of suspected adverse drug reactions (ADR) and improves the overall experience of hospitalized patients.

PRIMARY OBJETIVES

1. To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR.

SECONDARY OBJECTIVES

1. To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire.
2. Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients.
3. Know the incidence and describe ADRs: severity, preventability, and causality using validated scales.
4. Describe the degree of nursing intervention according to the North American Nursing Diagnosis Association (NANDA) Taxonomy, and the classification of nursing interventions (NIC) Related to drug use.
5. Quantify the number of interconsultation generated by patients and professionals related to the use of drugs.
6. Determine the degree of adherence and compliance with the regimens prescribed to the patients.

STUDY DESIGN Prospective, randomized and controlled study of an intervention that compares a group of patients according to the usual practice of the nursing care process, against another on which a more intensive nursing intervention is carried out for the identification and notification of ADRs. It is carried out on a representative sample of patients admitted to a tertiary level hospital with 860 beds of the Madrid Health Service during the year 2022.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pharmacological treatment.
2. Patients of both sexes aged between 0 and 100 years.
3. Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours.
4. Patients who have received the information and agreed to participate in the study.

Exclusion Criteria:

1. Patients included in other clinical trials or drug studies at the time of selection.
2. Patients with significant cognitive impairment, without adequate family support or primary caregiver.
3. Patients and/or caregivers who, once offered to participate in the study, do not give their consent
4. Impossibility of communication due to language barriers or other biopsychosocial problems.
Evaluation of Web-based Transition Education to Enhance Transition Readiness

The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital heart disease
* Ages 13-25
* Routine outpatient cardiology follow-up visit

Exclusion Criteria:

* New patients to cardiology clinic
* Patients being evaluated for an acute medical problem
* Patients who do not speak English
* Severe neurocognitive impairment that precludes ability to complete the questionnaire
A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema

Objectives and perspective:

1. To estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . To investigate the knowledge of skin protection among health care workers.
2. To classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema
3. To evaluate the effect of a combination of classification of hand eczema and individual work-related counseling in skin protective behavior.

The overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers.

Hypotheses:

* Irritant contact dermatitis is more common than allergic contact dermatitis.
* The combination of precise classification (subtyping of HE) and individual counseling will have a positive impact on the prognosis of hand eczema.
* The positive impact on the prognosis of hand eczema will have a positive impact on quality of life (QoL).
* The knowledge of protective behavior will increase.
* Education in a skin care program will have a positive impact on skin protective behavior.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
* Informed written consent must be present in order to participate.

Exclusion Criteria:

* Pregnancy
* Systemic use of immunosuppressive drugs
* Systemic use of retinoids
* Active psoriatic lesions on the hands
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
* Lack of informed written consent
Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock

This registry will provide information about the efficacy and safety of cangrelor in a very high-risk group of patients with acute myocardial infarction undergoing PCI. It will not only include patients with cardiogenic shock, but a variety of patients not able to swallow tablets, such as those after CPR and/or with invasive or non-invasive ventilation. Therefore it will provide information about the use of cangrelor beyond the current knowledge.

This registry is a non-interventional, multicentre, retrospective cohort study in patients with acute myocardial infarction undergoing PCI after CRP, ventilated and/or with cardiogenic shock.

The study is purely observational; data will be documented retrospectively based on available medical records. No additional data will be collected, no study-related treatment will be initiated.

About 10 - 20 high-volume PCI clinics in Germany treating patients with myocardial infarction are eligible for participation. Participating sites will be given a maximum of 6 months for retrospectively documenting eligible patients.

Eligible are all patients with acute myocardial infarction (STEMI, NSTEMI) who underwent PCI after CRP, ventilated and/or with cardiogenic shock and were treated with cangrelor during index procedure. It is planned to enrol about 400 patients in total. Patient characteristics, procedural details and clinical events occurring during the period between index MI and discharge or death (whichever came first) will be documented based on the relevant existing medical charts of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Acute Myocardial infarction (NSTEMI or STEMI)
* PCI with stent implantation
* Treatment with cangrelor during index procedure
* At least one of the following criteria:
* CPR prior to PCI
* Cardiogenic shock
* Heart failure with the need for mechanical or non-invasive ventila-tion

Exclusion Criteria:

No explicit medical exclusion criteria are stated to avoid selection bias.
A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy

The purpose of this study is to evaluate the efficacy and safety of HSK39297 tablets compared to eculizumab in Patients with PNH who Are Naive to Complement Inhibitor Therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years, Male and female patients;
2. Diagnosis of PNH based on flow cytometry with clone size \> 10% by granulocytes;
3. Have not received complement inhibitor treatment;
4. Blood LDH values \> 1.5 ×upper limit of the normal range (ULN) ;
5. Hemoglobin level \< 10 g/dL at screening.

Exclusion Criteria:

1. Hereditary or acquired complement deficiency;
2. Active primary or secondary immunodeficiency;
3. History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
4. History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
5. Patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x10\^9/L, or platelets \< 30x10\^9/L or neutrophils \< 0.5x10\^9/L) ;
6. Active systemic infection within 2 weeks prior to study drug administration;
7. History of serious comorbidities that have been determined to be unsuitable for participation in the study.
8. Pregnant or Lactating women.
Rate of Microbial Colonization Over Native Calcified Cardiac Valves

The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed
* Male or Female subject, 50 years or older
* Subjects are scheduled to go through any cardiac valve replacement or repair due to degenerative calcified process. For control, subjects with no evidence of valve disease

Exclusion Criteria:

* Subjects have an established or indicated history of IE.
* Subjects have complaint that might indicate IE- intermittent fever and physical finding according to IE diagnosis criteria (not including a heart murmur)
* Subjects are current users or have a close history of drug abuse
Study of Genotype and Phenotype in Patients With Alpha 1-Antitrypsin Deficiency

OBJECTIVES:

I. Establish cell lines from patients with alpha 1-antitrypsin deficiency in order to examine genetic traits that predispose to liver injury.

PROTOCOL OUTLINE:

Patients undergo blood draw and skin biopsy. Cells are isolated from patients' blood and skin, cell lines are established, and genetic traits are examined.

Eligibility Criteria:
* Alpha 1-antitrypsin deficiency
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
* Completed the required wait/washout period
* Qualifying Day 1 IOP measurement at 3 time-points in both eyes

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy
* Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
* History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
* Presence of advanced glaucoma in either eye
A Study of Evacetrapib in Healthy Japanese Participants

The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy Japanese, as determined by medical history and physical examination
* Have a body mass index (BMI) of 18.0 to 29.9 kg/m\^2
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal supine blood pressure as determined by the investigator
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Are women who are pregnant or lactating
* Have used or intend to use over-the-counter, prescription medications, or herbal medicine 14 days prior to enrollment and during the study
* Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
* Are participants who currently smoke more than 10 cigarettes per day or are unwilling to abide by smoking restrictions
MammaPrint Value for Pre-menopausal Breast Cancer Patients

Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC\*4, TC\*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.


Eligibility Criteria:
Inclusion Criteria:

1. pre-menopausal breast cancer patients aged less than 50 years old.
2. Pathology confirmed invasive dutal carcinoma or invasive lobular carcinoma.
3. receiving breast conserving surgery or mastectomy with/without reconstruction; sentinel lymph node biopsy or axillary lymph node dissection.
4. TNM staging: T1b-T2N0-1M0.
5. molecular subtype: ER positive/HER2 negative.
6. MammaPrint testing before initiation of adjuvant therapy.

Exclusion Criteria:

1. Incomplete medical history.
2. Pregnancy or lactation.
3. Contradiction of chemotherapy or ovarian function suppression.
A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose

The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.


Eligibility Criteria:
Inclusion Criteria:

* Female healthy volunteers must be post-menopausal (cessation of menses \>1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination
* Have normal physical exam, vital signs ECG findings, and laboratory values

Exclusion Criteria:

* Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
* History or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the Investigator
* Previous participation in an AstraZeneca (AZ) or Bristol-Myers Squibb (BMS) dapagliflozin study
Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair

The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.


Eligibility Criteria:
Inclusion Criteria:

* The subject is 18 years old or older
* An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
* The subject is able to return for all follow-up evaluations of the study.

Exclusion Criteria:

* The subject or subject's legal representative is unwilling to sign the informed consent.
* The subject is or will be participating in another medical device or drug clinical trial.
* The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
* The subject has a life expectance of less than 1 year.
Radial Nerve Block for Treatment of Tennis Elbow

Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.

Objectives: The primary objective of this study is to assess the effectiveness of nerve stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.

Methods: This is a prospective randomized, double blind clinical trial. Patients will be randomly allocated into two groups. Group I will receive radial nerve block guided by a nerve stimulator. Group II patients will receive placebo through radial nerve block. Patients will be followed up for 2 weeks.

Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. It is a major arm disorder which occurs commonly in adults between 30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. Lateral epicondylitis results from the overuse of the extensor muscles, causing inflammation or irritation of the tendon insertion. It is common in workers whose job requires manual and repetitive work .

Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.

To our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block for the treatment of lateral epicondylitis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* presenting with refractory elbow pain

Exclusion Criteria:

patients with:

* osteoarthritis,
* rheumatoid arthritis,
* olecranon bursitis,
* radial nerve entrapment
Sitagliptin Added-on to Insulin Study (0431-051)

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Patient is poorly controlled while on insulin or insulin and metformin

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient is taking oral antidiabetic agents other than metformin during the past 3 months
* Patient is currently on treatment with daily use of pre-prandial short-acting or rapid-acting insulin
Molecular Analysis of IgE Antibodies in Walnut Allergic Patients

Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.

Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). Thus, full characterization of the major allergens of walnut and their clinical importance is an important undertaking.

The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.

With a view towards improved in vitro diagnostic methods, we intend to evaluate the diagnostic potential of recombinant walnut allergens in patients with walnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to walnut in the past, patients with pollinosis but no symptoms of walnut allergy and non-atopic control subjects.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Group A: positive case history of allergic reaction(s) to walnut
* Group B: positive case history of allergy to birch, grass or olive pollen and no case history of allergic reaction(s) to walnut
* Group C: no case history of atopic disease

Exclusion Criteria:

* Known pregnancy
* Breast-feeding of infant
* Treatment with the following drugs (or shortest interval between last treatment and food challenge or SPT):
* corticosteroids (2 weeks): applied systemically, to the nose or locally on the skin test area.
* antihistamines (3 days) except hydroxyzine (10 days)
* betablocker agents (1 day)
* angiotensin converting enzyme inhibitors (2 days)
* Any major organic or infectious disease
A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy

The purpose of this observational registry is to evaluate the safety and the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical). The goal of the study will be achieved by reporting peri- and postoperative complications and the clinical outcome after surgery in a prospectively maintained database.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age at registry entry
* Patient and investigator signed and dated the informed consent form prior to the index-procedure.
* Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.
* Patient has a BMI ≥ 40 kg/m2.
* Patient is eligible for laparoscopic bariatric surgery.

Exclusion Criteria:

* Patient is unable/unwilling to provide informed consent.
* Patient has a history of bariatric surgery.
* Patient is unable to comply with the registry protocol or the proposed follow-up visits.
* Patient has a contra-indication for laparoscopic bariatric surgery.