cyrilzakka/clinical-trials huggingface dataset:
PharmacoKINEtics of TAMoxifen and Its Metabolites in Breast Cancer Patients: the Influence of a Dose Increase in Phenotypic Poor Metabolizers of CYP2D6 (KINETAM)

All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of tamoxifen treatment.However CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as co-medication may influence the treatment outcome of tamoxifen.

The investigators propose a prospective study in women taking tamoxifen at a dose of 20mg QD. In each woman, information will be collected on endoxifen levels, CYP2D6 status, adherence and use of co-medication. In women who are phenotypically poor metabolizers of tamoxifen, a dose increase to 40mg QD will be applied and the effect of this intervention on tamoxifen pharmacokinetics will be evaluated after 4 weeks.

Although already some information is available on the importance of CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as co-medication that may influence the treatment outcome of tamoxifen, this information does currently not lead to a change in the management of this patient population. All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of tamoxifen treatment.

In an attempt to at least resolve some of these issues we propose a prospective study in women taking tamoxifen at a dose of 20mg QD who are being followed at several large oncology clinics in the south-eastern part of the Netherlands (Nijmegen (CWZ \& Radboud), Den Bosch, Harderwijk and Arnhem). In each woman, information will be collected on endoxifen levels, CYP2D6 status, adherence and use of co-medication. In women who are phenotypically poor metabolizers of tamoxifen, a dose increase to 40mg QD will be applied and the effect of this intervention on tamoxifen pharmacokinetics will be evaluated after 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years at screening.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject is a female patient with (a history of) breast cancer and has been treated with tamoxifen 20mg QD for at least 4 weeks and is expected to be treated for at least another 4 weeks

Exclusion Criteria:

* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to the first dose.
PSC Clinical Epidemiology in China

Primary sclerosing cholangitis (PSC) is a rare disease but is increasingly reported in China (mainly in the Chinese language). However, most of the PSC literatures reported from China are case reports, small case series, and review articles. Up to now, there is no information on the epidemiology and disease burden of PSC in China. This study would use EMR/HIS and research databases to investigate the epidemiology, cascade, and treatment pattern of PSC in China.

Identify the PSC cases diagnosed from the earliest date available to the present in the SuValue Research Database and the HIS/EMR from clinical sites through diagnostic ICD codes, laboratory, pathology, imaging, endoscopy, surgery, medication, hospitalization, and health outcomes.

Collect information on PSC cases' key demographic, the time of PSC diagnosis, hematological/biochemical variables (ALT, AST, ALP, GGT, ALP TBil, ALB), MRCP or ERCP or pathological report, IBD (UC or CD) symptoms, or colon, medication information, clinical outcomes (including cirrhosis, decompensated cirrhosis, death or liver transplantation) as well as current or past treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Retrospectively review PSC cases before April 1, 2002 will be identified by diagnostic codes from the International Classification of Diseases (ICD)-9, and for those after April 1, 2002, we used ICD-10.
2. We identified patients using an electronic search of SuValue Research Database and HIS of BFH-CMU and BYH-CMU using PSC related ICD codes (ICD-9: 576.1; ICD-10: K83.016/K83.016(China version)). To supplement the ICD search, an electronic keyword search for "primary sclerosing cholangitis" or "seclerosing cholangitis" was conducted on all radiology, endoscopy, pathology reports beginning on earliest date available in the database of SuValue Research Database and HIS of BFH-CMU and BYH-CMU. We reviewed the medical charts of identified patients and diagnostic criteria including cholestatic biochemistry (ALP, GGT elevations), and typical imaging (MRCP or ERCP) or pathological features, excluding other known etiology. For patients with multiple visits for PSC, we reviewed only the index visit. To ensure consistency, chart review was independently assessed by two hepatologists. Discrepancies in compliance were resolved by discussion between the two main reviewers. Any unresolved discrepancies were decided by a third expert hepatologist.

Exclusion Criteria:

1. The cases with secondary sclerosing cholangitis caused by cholelithiasis, IgG4 related disease, malignancy or other known etiologies.
2. The cases with missing key results on clinical, biochemical (ALP, GGT, bilirubin), radiological (MRCP or ERCP) or histological investigations.
Communication Regarding Organ and Tissue Donation in Intensive Care

The overarching aim of this study is to examine the process of organ donation decision-making and to determine whether changes in requesting practices change rates of consent for donation, and other family-based outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Donation events identified by a patient who is a potential organ and tissue donor in a participating ICU or under the care of ICU health professionals.
* For the primary endpoint only, patients must not have registered their donation wishes.

Exclusion Criteria:

* A patient who is not medically suitable for organ or tissue donation.
* A patient who does not have next of kin available to participate in donation conversations.
* A patient in the ICU who is able to provide first person consent for deceased donation, for example a patient with spinal injuries.
* A patient who is suitable to donate only tissue after death.
HCV Seek, Test and Rapid Treatment for Young PWID

The purpose of this randomized study is to determine whether a community-based test and treat model of hepatitis C (HCV) care delivery will be superior to the usual care practice of referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between ages 18 and 29 who are naïve to HCV treatment

ST\&RT is a randomized open-label clinical trial in which 54 HCV infected PWID between ages 18 and 29 will be randomized to either receive the same-day treatment initiation of the FDA-approved fixed dose combination of sofosbuvir 400mg and velpatasvir 100mg (SOF/VEL) with follow up and medical monitoring at a community site (Intervention arm) or to receive referral to an HCV treatment provider's office (Usual Care Arm).

Eligibility Criteria:
Inclusion Criteria:

* Persons are eligible for study inclusion if they: (a) are HCV antibody positive, (b) are 18 to 29 years of age, (c) have injected drugs in the past 30 days, (d) are HCV treatment naïve, (e) are English speaking

Exclusion Criteria:

* Persons excluded from the study will be (a) HIV coinfected persons (b) pregnant women, or women planning on becoming pregnant (c) participants with end-stage renal disease (d) participants with decompensated cirrhosis (c) participants on medications with treatment limiting interactions with sofosbuvir/velpatasvir
Protopic Ointment in Adult Atopic Eczema of the Face

Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment.

Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe AD (Rajka \& Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD
* At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated
* Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
* Informed consent
* Therapeutic washout for atopic dermatitis treatments

Exclusion Criteria:

* Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
* Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin
* Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
* Superinfected eczema
* Known hypersensitivity to macrolides or to any other excipient in tacrolimus 0.1% ointment
* Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
* Ulcerated lesions, of whatever type
* Moderate to severe acne or rosacea
* Patients who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study
* Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
* Serologically-proven HIV positivity
Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)

This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(35mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.


Eligibility Criteria:
Inclusion Criteria:

* age≥18 years
* Typical angina symptoms
* Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (\<20%)
* Never used trimetazidine
* The CFR measured by the pressure guide wire is less than 2.0
* agree to participant the study and sign informed written consent
* available for six months follow up

Exclusion Criteria:

* Severe liver and kidney disease
* Contraindications of Trimetazidine
* Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements
* QT interval extension
* Atrial fibrillation or left bundle branch block
* Left ventricular systolic dysfunction (EF \<55%)
* Coronary artery fistula
* Myocardial bridge
* Non-cardiogenic chest pain and other heart diseases
* Severe heart valve disease
* Diabetes
* Recent ACS( Acute coronary syndrome)
* Pregnancy
* Failed to complete inspection
Myeloid-Related Protein in Evaluation of Acute Chest Pain in the Emergency Departement

The purpose of the study is the evaluation of multiple biomarkers related to acute coronary syndromes, including myeloid-related protein 8/14 (MRP 8/14), along with established clinical markers, for early diagnosis and risk stratification in patients presenting with acute chest pain at the emergency department.

Study hypothesis: MRP 8/14, alone or together with other established or new biomarkers, increases the earliness, sensitivity, and specificity of diagnosing acute coronary syndromes.


Eligibility Criteria:
Inclusion Criteria:

* All patients in the emergency department of the University Hospital Zurich with measurement of troponin during the routine diagnostic evaluation.

Exclusion Criteria:

* Refusal or inability to give informed consent.
An Observational Study of Hepatitis C Virus in Pregnancy

This multi-center observational study examines risk factors for HCV transmission from mother to baby.

This multi-center observational study examines risk factors for HCV transmission from mother to baby. The study will also assess risk factors associated with Hepatitis C Virus (HCV) infection in pregnant women. Also, the study will describe the outcomes of pregnant women with HCV as well as the outcomes of their infants to 18 months of age.

Approximately 750 HCV antibody positive pregnant women and their infants will be followed from baseline until the infant is 18 months. A randomly selected control cohort of 500 pregnant women who are HCV antibody negative will be followed until delivery.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy
2. An HCV antibody positive screen (case) measured using two FDA-approved ELISA tests, the Abbott Architect version 3.0 system and the Ortho HCV 3.0.
3. Gestational age at screening no later than 23 weeks and 6 days, and gestational age at enrollment no later than 27 weeks and 6 days, based on clinical information and evaluation of the earliest ultrasound as described below.

Exclusion Criteria:

1. Planned termination of pregnancy
2. Known major fetal anomalies or demise
3. Intention of the patient or the managing obstetricians for the delivery to be outside a MFMU Network center, unless special provisions are made to insure infant follow-up at two and 18 months of age.
4. Participation in this study in a previous pregnancy.
5. Unwilling or unable to commit to 18 months of follow-up for HCV positive infants
Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer

One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. The possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2 overexpression (+ or 2+) will be included in the study. Patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of metastatic breast cancer
* presence of at least 1 measurable lesion according to modified RECIST criteria
* Evidence (fluorescence in situ hybridization FISH) of
* Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++
* EGFR-expressing disease as assessed by immunohistochemistry
* Recovered from relevant toxicities from other treatment prior to study entry

Exclusion Criteria:

* Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed)
* Prior treatment with cetuximab
* Concomitant cytotoxic chemotherapy
* Treatment with any investigational agent(s) within 4 weeks prior to study entry
* Known allergic/hypersensitivity reaction to any of the components of study treatments
* severe dyspnea
* Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment
* History of significant neurologic or psychiatric disorders
Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection.

The study will consist of a treatment phase and follow-up phase. The treatment period is 12 months. Discontinuation of study treatment may occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. Patients will be followed for disease recurrence every 6 months and up to 24 months after the end of treatment (EOT)

Eligibility Criteria:
Inclusion Criteria:

Patient(s) must meet all of the following criteria to be eligible for inclusion:

1. ≥18 years old of age at the time of informed consent and of Chinese descent
2. Signed written informed consent
3. Going to receive commercial dabrafenib and trametinib according to approved label
4. Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems:

   * for stage III cutaneous melanoma: as per American Joint Committee on Cancer (AJCC) 8th edition for melanoma
   * for stage III mucosal melanoma of the head and neck origin: as per AJCC 8th edition for mucosal melanoma of the head and neck
   * for stage III mucosal melanoma of anal canal, rectum and genital track origin: as per Chinese guidelines on the diagnosis and treatment of melanoma 2019 edition
5. Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
6. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Exclusion Criteria:

Patient will be excluded from this study if he/she meets any of the following criteria:

1. Known ocular melanoma
2. Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
3. Patient is not able to comply with the planned study procedures
4. Taken an investigational drug within 28 days prior to enrolment
5. History of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.
Impact of Chloroprocaine (CLOROTEKAL®) on Eligibility for Discharge From Hospital After Outpatient Surgery

The purpose of this study is to assess, in real life, the efficacy and the eligibility for discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short outpatient surgery.

This is a longitudinal, observational, prospective, multicentre, national study, conducted in France, from a representative sample of physician anesthetists.

The efficacy and safety in real life of CLOROTEKAL® will be assessed in patients undergoing a short outpatient surgery under spinal anesthesia. Data will be collected by the physician during two visits (pre-anesthesia and per-postoperative consultation). Additional data regarding the patient's perception (safety, pain and satisfaction) will be collected using a self-questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients seen in pre-anesthesia consultation for ambulatory surgery
* Patients for whom a spinal anesthesia using CLOROTEKAL® is planned
* Patients accepting and able to complete a satisfaction self-administered questionnaire
* Informed patients who accept the computer processing of their medical data and their right of access and correction

Exclusion Criteria:

* Patients with contra-indications to spinal anesthesia (eg decompensated cardiac insufficiency, hypovolemic shock....)
* Patients with contra-indications to chloroprocaine (hypersensitivity to the active substance, medicinal products of the para-aminobenzoic acid ester group, other ester-type local anaesthetics or to any of the excipients ; Intravenous regional anaesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area), serious problems with cardiac conduction, severe anemia)
* Patients participating or having participated in the previous month in a clinical trial in anesthesiology
Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy

The purpose of this study is to determine the acceptance and efficacy of the online self-help program deprexis® for depressed patients in reducing the clinical symptoms of their depression. The patients of the experimental group use deprexis® for 90 days, the patients of the placebo group receive weekly online information about depression for 90 days as well. Both groups receive their treatment in addition to their regular inpatient psychosomatic treatment and as an aftercare intervention.The investigators hypothesize that the online self-help group achieves a greater reduction of depression compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient treatment
* Private internet access
* Informed consent
* Age between 18 and 65 years
* Knowledge of the German language
* Score in the BDI-II \> 13 and clinical diagnosis of a depression (ICD-10: F32.x, F33.x, F34.1, F43.2) verified by the inpatient therapist

Exclusion Criteria:

* Psychosis
* Current alcohol or drug dependency
* Borderline, antisocial, schizoid or schizotypal personality disorder
* Anorexia nervosa
* Life time diagnosis of a schizophrenia, schizoaffective , bipolar oder organic psychic disorder
Prevalence of Diabetes Mellitus Among Patients Treated With Atypical and Conventional Antipsychotics

This pilot study hypothesizes that diagnosed and undiagnosed prevalence of diabetes mellitus may differ across antipsychotioc medications in a community mental health center. The study further hypothesizes that control of diabetes among diagnosed cases may be suboptimal.

Study of longitudinal incidence proved impractical within the limitations of the project.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with antipsychotic medication at a community mental health center

Exclusion Criteria:

* None