cyrilzakka/clinical-trials huggingface dataset:
A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting

The study is descriptive and aims to characterize the treatment patterns of advanced breast cancer in Poland in the real-world data setting. The main goals are to assess the current treatment patterns of hormone receptor-positive (HR+) Human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer and their changes in clinical practice and relate them to patients' demographics, disease characteristics, type of other therapies used in patients as well as disease progression and visceral crisis occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with histologically diagnosed advanced breast cancer (with locoregional recurrence not eligible for radical local treatment or with distant metastases)
* Patient has a documented hormone (estrogen and/or progesterone) receptor expression and lack of HER2 receptor overexpression or lack of HER2 gene amplification (HR+/HER2- breast cancer subtype)
* Patient had no prior treatment for advanced breast cancer
* Patient has no symptomatic metastases to the central nervous system
* There is no other malignancies in patient requiring active treatment
* Patient is without co-occurring other malignancies treated with palliative assumption

Exclusion Criteria:

* Parallel patient's participation in any other clinical trial at the time when the decision over the advanced breast cancer treatment was made or up to 30 days before it.
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy

The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.

Primary closed angle glaucoma is responsible to almost half glaucoma related blindness around the world. Laser peripheral iridotomy (LPI) is a common and simple treatment used for both treatment and prevention of acute angle closure event.

Anti-inflammatory drops are commonly prescribed to patients undergoing LPI in order to prevent or reduce post-treatment discomfort. However, to date, there are no specific guidelines for post LPI anti-inflammatory treatment, nor sufficient clinical evidence regarding the efficacy of such treatment.

In the current study, the investigators aim to evaluate the effect of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) on post LPI symptoms and inflammation markers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary narrow/closed angle by gonioscopy
* Able to give consent
* Ability to attend follow-up visits

Exclusion Criteria:

* Corneal disease preventing sufficient evaluation of the angle
* Secondary closed angle (e.g. uveitis related)
* Pregnant women
* Previous eye surgery other than laser refractive correction
Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study

The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.

Many experts advocate the use of Photobiomodulation (PBM) therapy in patients with cancer and demand studies of higher methodological quality such as randomized controlled clinical trials. However, there is no consensus on the most effective dosimetry that allows us to establish an effective and safe approach to treat radiotherapy-induced xerostomia in head and neck cancer survivors. Finally, recent reviews highlight the importance of determining whether or not the effects of Photobiomodulation therapy are maintained after a follow-up period.

Eligibility Criteria:
Patients will be included in the study if they meet the following inclusion criteria:

* men or women aged 18 years or older and were diagnosed with HNC.
* chronic xerostomia.
* received RT in the parotid, submandibular and/or sublingual salivary glands.
* grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).
* medical treatment completed and in complete remission.
* received medical clearance for participation in this study.
* at least one month passed since the end of RT to avoid the possible presence of oral mucositis and/or radiodermatitis, which limits adherence to treatment and maximum 36 months.
* no history of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion.
* and able to access mobile applications or living with someone who has this ability.

The exclusion criteria will be as follows:

* patients with metastases.
* a score \<60 on the Karnofsky Performance Status Scale.
* contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy).
* other comorbidities such as diabetes and polypharmacy.
* and retraction of the declaration of consent.
This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood

The primary objective of this trial is to investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the 4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral administration in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (BP (Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* BMI of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP (Blood Pressure), PR (Pulse Rate) or ECG (Electrocardiogram)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm (beats per minute)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders, including but not limited to mood disorders and any history of suicidality.
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients or other Azoles )
* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
* Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
* Further exclusion criteria apply
Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases

Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid

Fluorescence with 5-aminolevulinic acid, fluorescein and intraoperative magnetic resonance imaging (MRI) are the most common modalities used to intraoperatively rate extent of brain tumor resection. Intraoperative sonography is another promising method of intraoperative visualization. It's advantages include possibility of real-time estimation of tumor remnants without disturbing of surgical workflow, opportunity to discover residual tumor under normal brain tissue and chipper cost. At this time there are no published results of randomized control trials comparing ultrasound and fluorescence-guided brain tumor resection.

Objective of this study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as 5-aminolevulinic acid fluorescence-guided surgery.

Participants of the study will be randomly operated using intraoperative ultrasound or fluorescence with 5-aminolevulinic acid. Extent of resection will be assessed in postoperative MRI by blinded radiologists

Eligibility Criteria:
Inclusion Criteria:

* single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
* one or several brain metastases
* newly diagnosed
* Karnofsky Performance Status 60-100%
* age 18-79 years
* performed magnetic resonance imaging with contrast enhancement

Exclusion Criteria:

* tumor spreading to corpus callosum or brainstem
* previously performed brain radiotherapy
* planned supratotal tumor resection until neurophysiologically revealed eloquent areas
* known hypersensibility to 5-aminolevulinic or to porphyrin
* hepatic or renal insufficiency
* porphyria
* pregnancy
* breast feeding
Impact of Smoking on Ultrasound-Guided Infraclavicular Brachial Plexus Block Onset and Duration

The present study will be conducted involving 40 patients aged 18-65 years with ASA physical status I and II, scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block. Patients will be divided into two groups based on smoking status: Group I (non-smokers) and Group II (smokers who smoke ≥20 cigarettes/day for over 1 year).

Using a high-frequency linear ultrasound transducer, the axillary artery, vein, and the three nerve cords will be identified in the lateral infraclavicular region. After disinfection with ethanol-chlorhexidine, a sterile drape will be placed, and the attending anesthesiologist will perform the ultrasound-guided infraclavicular brachial plexus block with a triple injection technique. A total of 10 mL of bupivacaine 0.25% and prilocaine 0.05% will be injected at all three nerve cords.

The primary outcome will be the sensory blockade onset time, while secondary outcomes will include the duration of sensory and motor blockade, motor blockade onset time, time to first postoperative rescue analgesia, and total consumption of rescue analgesia. Postoperative pain will be assessed using the Visual Analogue Scale (VAS) within the first 24 hours at intervals of 2, 4, 8, 12, 16, and 24 hours. If VAS exceeds 30 cm, rescue analgesia with 0.05 mg/kg intravenous morphine sulfate will be administered.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II
* Scheduled for acute or elective hand or forearm surgery under the lateral infraclavicular block

Exclusion Criteria:

* morbid obesity (body mass index \> 40)
* bleeding disorder
* coagulopathy
* medication with vitamin K antagonists
* high-dose or fractionated heparin treatment
* allergy to local anaesthetics
* infection at the site of needle insertion
* peripheral neurological disease
* pregnancy
Clinical Prediction Model for In-Hospital Rebleeding in Acute Non-Variceal Upper Gastrointestinal Bleeding

ANVUGIB is a serious condition that can cause symptoms like vomiting blood or passing black stools. Although treatments have improved, about 10% to 30% of patients experience rebleeding shortly after their initial treatment, which increases the risk of death.

Currently, doctors use tools like the Glasgow-Blatchford Score, Rockall Score, and AIM65 Score to predict how patients with ANVUGIB might recover. However, these tools are not very effective at identifying patients who are at risk for rebleeding. This study aims to create a new, more accurate prediction model to help doctors identify high-risk patients earlier. The investigators believe that a new predictive model, which combines patient symptoms, lab test results, and imaging findings, will improve the ability to identify patients at high risk of rebleeding compared to existing tools.The goal is to provide doctors with a more reliable tool to guide their decisions, such as when to give preventive treatments or increase monitoring. This could lead to better outcomes and reduce the risk of complications or death.

This study uses patient data collected during routine care to develop and test the new model, ensuring the findings are directly applicable to real-world clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* age exceeding 18 years,
* Clinical diagnosis of Acute Non-Variceal Upper Gastrointestinal Bleeding ,
* patients who underwent endoscopy within 24 hours of admission with confirmation of non-variceal bleeding

Exclusion Criteria:

* Upper Gastrointestinal Bleeding during hospitalization;
* transfer from other hospitals;
* variceal bleeding;
* lower gastrointestinal bleeding.;
* bleeding attributed to systemic diseases like disseminated intravascular coagulation (DIC) and hematological disorders;
* patients with incomplete clinical data or laboratory test results;
* patients who either requested early discharge or declined gastroscopy.
Prospective Validation Study of an E-health Tool for Patient Selection for SCS

The goal of this observational study is to learn more about the selection of patients with chronic pain for spinal cord stimulation. The main question it aims to answer is to assess the predictive value of an e-health tool for patient outcomes.

Participants will be treated as normal and will be asked to complete patient questionnaires to evaluate their pain relief after receiving spinal cord stimulation. The e-health tool will not be used during the conduct of the study, as patient outcomes will only at the end of the study be compared with the recommendations made by the e-health tool.

This is a multicentre study within Europe, prospectively collecting data from patients with a positive decision on SCS, receiving either a direct implant or an SCS screening trial. Data will be collected by implant centres who have not previously used the e-health tool for SCS patient selection (i.e. tool-naïve). Furthermore, participating centres should declare neither to use the tool during the conduct of study nor on patients included in the study population. In addition, participating implant centres should have previous experience in conducting prospective clinical trials.

Baseline data should be collected at the moment of the final decision on SCS (i.e., after multidisciplinary team consultation if applicable) using an online data capture program:

* General baseline data
* e-Health tool variables
* Centre decision on SCS (direct implant or trial)

Only for patients receiving SCS (direct implant or positive trial), follow-up data at 6 and 12 months will be collected.

Afterwards, the prospectively collected data will be applied to the e-health tool and its recommendations compared with the centre decisions, trial results and patient outcomes.

Eligibility Criteria:
Inclusion criteria

* Age ≥18 years
* Chronic pain with a duration of least 6 months
* One of the following primary indications: Persistent Spinal Pain Syndrome (PSPS) (type 1 and type 2), Complex Regional Pain Syndrome, Neuropathic Pain Syndrome, Ischaemic Pain Syndrome
* Pain severity at least moderate (VAS ≥ 5, on average over the last month) having a substantial impact on daily functioning and quality of life at the discretion of the attending physician
* Insufficiently responding to appropriate trials of medication, conservative management (e.g. physiotherapy) and/or minimally invasive treatments (such as local anaesthetic nerve blocks), and/or experiencing intolerable side effects of these treatments
* No clear benefits of surgery expected

Exclusion criteria

* Unwilling to have an implant
* Unable to manage the device
* Absolute contra-indications for active treatment (e.g. unfit for undergoing SCS, pregnancy, spine- or skin-related infections, coagulation disorder)
* Uncontrolled disruptive psychological or psychiatric disorder at the discretion of the attending physician
* Ongoing alcohol and drug misuse
* Widespread pain
* Lack of reimbursement of SCS
Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM

In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).

The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 40 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group. Duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 and ≤75 years with type 1 diabetes;
* Diagnosed as T1DM ≥ 12 months before enrollment in the study;
* HbA1c ≥ 7.0 to ≤10.0%;
* Receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study;
* BMI ≤ 35kg / m2.

Exclusion Criteria:

* Patients with any of the following conditions will be excluded:
* Pregnant or lactating women
* Severe hypoglycemia within one month;
* Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
* Receipt of Sulfonylureas, Meglitinides derivatives, Thiazolidinediones, Dpp-4 inhibitors or GLP-1 agonists within 3 months prior to informed consent;
* Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent
* Severe mental instability, or alcohol abuse, or drug abuse
* Cancer within 5 years prior to informed consent
* Pancreatitis of severe infectious diseases within 1 months prior to informed consent
* Known hypersensitivity or allergy to the insulin
* Renal impairment (CKD-EPI eGFR\<60ml/min)
* Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined
* Participation in another trial within 2 months prior to informed consent
* Patients that investigators believe may fail to complete the study
Fetal Scalp pH During Labour: is it Worth Repeating

In order to reduce the cesarean sections rate, an adjunctive test is recommended in case of non-reassuring fetal heart rate tracing. In France, the reference adjunctive test is fetal scalp blood sampling. However, there is no study about the repetition of fetal blood sampling. Our hypothesis is that the repetition of fetal blood sampling is useful when fetal heart rate stays non-reassuring and may lead to vaginal delivery without impair neonatal prognostic. Therefore, our objective was to compare the patients with three or more fetal blood sampling with the patients with one or two.


Eligibility Criteria:
Inclusion Criteria:

* One fetal blood sampling during labour or more
* Singleton pregnancy
* Gestational age equal or above 37 weeks
* No contra-indication of fetal blood sampling
* No pregnancy complication

Exclusion Criteria:

* Sampling failure
* Incomplete file
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods

The objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not.

The endometrium goes through huge gene expression changes during a cycle, the cells are transformed, the mucous membrane thickens, then loosens, and finally sheds. In this process, the expression of the genes also goes through significant changes, which can be determined from a small tissue sample.

Endometrium biopsy samples can be used for endometrium phasing. A question of the study is the feasibility of using for endometrium phasing beside endometrium tissue biopsy also samples generated by endometrium lavage. The advantage of this latter method is that it is minimally invasive, it does not cause haemorrhage and has minimal side effects. In some selected cases endometrial lavage will be performed on the same day with endometrial tissue sampling together with the drawing of a peripheral blood sample.

A list of potential biomarkers was proposed from the meta-analysis of published gene expression datasets. From the endometrium derived samples, RNA will be isolated and gene expression biomarkers will be measured. Expression profiles will be compared to published reference samples.

Eligibility Criteria:
Inclusion Criteria:

* infertile women participating in the diagnostic evaluation of infertility.

Exclusion Criteria:

* patients who are legally incapable or partially capable
* pregnancy should be excluded before sampling
* bleeding problems
* the active phase of severe psychiatric disorders
Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Intraoperative hypotension occurs often and is associated with adverse patient outcomes such as stroke, myocardial infarction and renal injury.

The aim of this study was to test the accuracy of a physiology-based machine-learning algorithm using continuous non-invasive measurement of the blood pressure waveform with the Nexfin® finger cuff during surgery.


Eligibility Criteria:
Inclusion Criteria:

* all adult patients undergoing surgery

Exclusion Criteria:

* none
The Gut Immune System During Immune Checkpoint Inhibitor Therapy

This exploratory study aims to gain insight in gut immune system phenotypes before and after immunotherapy. After informed consent is obtained, sigmoidoscopies at baseline and during treatment with immunotherapy will be performed, During the endoscopies, biopsies from the sigmoid and rectum will be obtained. Subsequent immune cell analyses in these biopsies will be performed. Parallel to the sigmoidoscopies, venous blood samples will be obtained to monitor inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* Indication for treatment with anti PD1/PDL1 based immunotherapy
* Written informed consent
* Evaluable according to iRECIST v1.1

Exclusion Criteria:

* Concomitant, chronic or infectious illness in the past 6 months causing moderate to severe colitis
* Use of a medication in the past 6 months with an elevated risk of moderate to severe colitis
* Gastrointestinal resection or enterostomy
* Abdominal radiotherapy in the past 6 months