cyrilzakka/clinical-trials huggingface dataset:
Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol

This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral roflumilast and inhaled formoterol. Healthy male subjects were assigned to treatment A or treatment B. Subjects in treatment A received 500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18. Subjects in treatment B received 48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. Impedance cardiography, ECG, serum potassium and glucose concentrations and effects on blood eosinophils assessed potential pharmacodynamic interactions. In addition, the safety and tolerability were evaluated. Pharmacokinetic parameters were assessed for roflumilast, roflumilast N-oxide, and formoterol.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years
* Normal body weight as indicated by a Body Mass Index (BMI) between 18 and 30 kg/m2 and a body weight \> 50 kg
* Assessed as healthy, based on a screening examination including medical history, physical examination, BP, PuR, ECG, and clinical laboratory results
* Caucasian

Exclusion Criteria:

* Suspected lack of compliance
* Participant in any other study or donation of blood during the last 30 d before start of this study (last day of intake of medication - first day of medication in the following study)
* Any active disease, acute or chronic (also psychiatric diseases)
* Any signs or present history of cardiac diseases (e.g. QTc interval acc. to Bazett ≥ 430 ms, PQ ≥ 220 ms), in particular tachycardiac arrhythmia, third-degree AV-block, idiopathic-subvalvular aortic stenosis or hypertrophic-obstructive cardiomyopathia
* Proneness to symptomatic orthostatic dysregulation, fainting or "blackouts" (medical history), or to orthostatic hypotension defined by SBP \< 90 mm Hg (standing blood pressure, 30 s after raising up from a supine position)
* Gastrointestinal surgery except from appendectomy and herniotomy
* HIV or hepatitis screening positive or not performed (in case of a positive HIV test, the subject had to be informed by a physician in personal communication
* Drug screening positive or not performed
* Excessive xanthine consumption (more than 5 cups of coffee or equivalent per day)
* Non-compliance for measurements of impedance cardiography (feasibility was proven and documented at the screening visit by one test procedure)
The Use of a Quality of Life Questionnaire in Patients With Lung Cancer

This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. The study will assess whether using the questionnaire will result in an improvement in QoL.

Patients with lung cancer who have completed a course of treatment (or who are in-between treatment) at the Royal Marsden Hospital would be eligible for inclusion in the study. Participants will be randomised into 3 groups. Group 1 - this group will complete the QoL questionnaire and will receive targeted therapies by a doctor (and other members of the oncology team) during a clinic consultation. Group 2 - will complete the QoL questionnaire however the questionnaire will not be seen by the doctor during a clinic consultation. Group 3 - the control group will not complete the QoL questionnaire before a clinic consultation. All patients will complete a diary of all contact they have with health care professionals during the study. The study will last for 6 weeks and at the end of the study all patients will complete the QoL questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* male or female age \> 18 years
* patients who are able to adequately understand written and spoken english
* diagnosis of lung cancer (non small cell, small cell, mesothelioma)
* no plan to commence treatment (chemotheraphy, targeted therapies, radioterhapy, surgery) with 6 weeks
* both radically or palliatively treated patients remain eligible
* patients whose toxicities from their primary treatment has resolved or have stabilised for a period of 7 days

Exclusion Criteria:

* patients are taking part on any other QoL studies
* taking part in any other studies that requires QoL questionnaires, extra visits or investigations
* currently on treatment (chemotherapy, radiotherapy, surgery or targeted therapies)
* they have on going toxicities from their treatment which have not been stablised (required intervention within last 7 days)
Significance of Disseminated Intravascular Coagulation Score in Mortality for Children With Shock

Evaluates whether the DIC score, as defined according to the International Society of Thrombosis and Hemostasis guidelines is associated with mortality in Children with shock and DIC

Disseminated intravascular coagulation (DIC) is an acquired syndrome characterized by excessive systemic activation of coagulation, resulting in both hemorrhage and thrombosis. DIC can progress rapidly into lifethreatening multiorgan failure. Under normal hemostatic conditions, clot formation and resolution are tightly regulated. In DIC, dysregulated activation of the coagulation system results in a consumptive coagulopathy and microvascular thrombosis. DIC is always a secondary process caused by a variety of underlying disorders (eg, sepsis, trauma, or malignancy), which can cause endothelial tissue damage and procoagulant exposure .

This activates the coagulation cascade, which promotes fibrin production and deposition and consumption of clotting factors. The subsequent consumption of coagulation factors and platelets, inhibition of natural anticoagulants and fibrinolysis, and fibrin deposition result in the clinical picture of DIC: a bleeding diathesis accompanied by microvascular thrombosis that often leads to end-organ damage . The International Society of Thrombosis and Hemostasis and the Japanese Association for Acute Medicine scoring systems are useful for detection of the DIC in critically ill pediatric patients . The overall incidence of DIC to be 1.2%, using a scoring system comprised of etiologic factors, clinical features, platelet count, prothrombin time, fibrinogen, and fibrin degradation products (FDPs) . The DIC score, easily computed in real-time at the bedside with routine laboratory values, is associated with mortality for children with sepsis andshock.

Diagnosis of DIC through test of the D-dimer. Accordingly, testing for Ddimer or FDPs may be helpful for evulating relationship between DIC score and mortality rate among children with shock .

Eligibility Criteria:
Inclusion Criteria:

* All Children with shock and DIC will developed during the period from 1-1-2025 to 31-12-2025

Exclusion Criteria:

* Any shock not complicated with DIC
The STOP-HPV Trial 6: Single Arm Evaluation of the Maintenance of the STOP-HPV Bundle

Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This single arm evaluation (embedded within arm 1 of a 2-arm cluster randomized clinical trial (RCT)) will test the sustainability of improvement made in response to a bundled intervention including HPV vaccine communication, performance feedback and provider prompts to reduce MOs and increase HPV vaccination rates.

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This single arm evaluation (embedded within arm 1 of a 2-arm cluster RCT) will test the sustainability of improvement made in repose to a bundled intervention including HPV vaccine communication (done through online educational modules and live office practice sessions), performance feedback reports (that pull from electronic health record (EHR) data, and compare participants performance to their own previous performance and those of others) and provider prompts (via EHR and also office staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and increase HPV vaccination rates.

Eligibility Criteria:
Practice Inclusion Criteria:

* The practice provides HPV vaccination services to adolescents.
* The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
* The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
* The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

Practice Exclusion Criteria:

* The practice plans to change EHR systems in the next three years.
* The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
* Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).

Patient inclusion criteria:

-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.

Patient exclusion criteria:

-None apart from age of patients (above).
Aortic Dimensions in Turner Syndrome

An observational study of 102 women with Turner syndrome followed for 6 years with a two-yearly examination including ECHO, MRI of the heart and 24 ambulatory blood pressure. It has been found that besides an significantly increased risk of congenital cardiac malformations, TS have an increased risk of developing cardiac disease including the life threatening condition of aortic dilatation and rupture. The aim of the study is to describe the cardiac conditions of TS, evaluate different methods of examination and identify possible risc factors.


Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome
* Age 18-70 years

Exclusion Criteria:

* Extreme adipositas
* Contraindications to a MRI scan
* Malignant disease
Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device with a Follow-up of 3 Years.

Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement. ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.

This multicentre, open-label study will take place at the Women's Clinic of Ghent University Hospital in Belgium (International Coordinating Centre) and at the University Hospital AOU Federico II of Naples in Italy.

Primary aim:

To evaluate the safety of the ReLARC® inserter during the insertion procedure of GyneFix® intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations.

Providing no complications develop, participants will remain in the study for 3 years. 120 women will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopy
* Be willing to come back for the follow-ups
* Be willing to refrain from having intercourse the first two weeks and using tampons and menstrual cups in the first 2 months, following insertion
* Sign a written informed consent
* Fundus thickness should be 11mm or more

Exclusion Criteria:

* T and Y shaped uterus
* U1, dysmorphic uterus (abnormal myometrium may result in bad device fixation)
* Complete septate U2b uterus
* Bicorporal U3-U6 uterus
* Injectables contraceptive use in the last 6 months
* The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out)
* Intrauterine fibroids (intra-mural, intracavitary or submucosal)
* Cancer or other disease of the uterus
* Malignancy, or treatment for malignancy. Melanoma or any gynaecological cancer at any time excludes the subject
* Blood clotting disorders
* Intrauterine polyps
* Subjects receiving corticosteroid therapy or immunosuppressive drugs
* Morbus Wilson
* AIDS
* Pregnancy
Surgical Trial in Lobar Intracerebral Haemorrhage

To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment. The trial will also help to better define the indications for early surgery.

This will overcome two of the criticisms of STICH (timing was too late and sometimes location was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis identified for STICH II is in line with current neurosurgical opinion.

STICH II is an international multicentre randomised parallel group trial comparing early craniotomy to evacuate the haematoma with initial conservative treatment, following spontaneous superficial intracerebral haemorrhage affecting the lobar region only. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible for the trial. Outcome is measured at six months via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, EuroQol and Barthel. Six hundred patients will be recruited to the trial over thirty months. Follow-up will take six months with analysis and reporting taking one year.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from the cortex surface of the brain)
* Patient within 48 hours of ictus
* Best MOTOR score on the GCS of 5 or 6 and best EYE score on the GCS of 2 or more.
* Volume of haematoma between 10 and 100ml \[Calculated using (a x b x c)/2 method\]

Exclusion Criteria:

* Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
* Intraventricular haemorrhage of any sort
* ICH secondary to tumour or trauma.
* Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions.
* Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome.
* If surgery cannot be performed within 12 hours.
* If the haematological effects of any previous anticoagulants are not completely reversed.
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.


Eligibility Criteria:
Inclusion Criteria:

* First-ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on CT/MRI is not counted as previous stroke)
* CT/MRI scan required to classify ischaemic / haemorrhagic stroke
* Patient recruited 2-12 weeks after stroke
* Modified Ashworth Spasticity Score 1+ or above in either elbow or wrist joint

Exclusion Criteria:

* The patient has bleeding disturbances or having used coumarin derivatives
* The patient is currently receiving drugs affecting neuromuscular transmission
* Co-existing severe systemic illness which may adversely affect the functional outcome
* Pre-existing neuromuscular junction disease or any neurogenic disorders which can interfere with spasticity
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
* At least one other MDE before the current one
* Moderate to severe depression

Exclusion Criteria:

* Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR
* Any substance disorder within the previous 6 months
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study

Randomisation Criteria: Patients in remission (MADRS total score \<=10) at both Week 10 and Week 12

Other protocol-defined inclusion and exclusion criteria may apply.
Non-Invasive Diagnosis of Endometrial Cancer

The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.

Definitive diagnosis of endometrial cancer relies on endometrial biopsy, in addition to imaging. Biopsy is however invasive and often painful, and its sensitivity in only moderate. Cervical cytology could be an alternative. This is a proof-of-concept study. The investigators will carry out next generation sequencing of cervical cytology in patients with confirmed endometrial carcinoma, in order to determine whether activating variants are identified. About 15% of endometrial carcinomas are microsatellite instable (MSI). The investigators will therefore also carry out MSI analysis using MSICare in the subset of cases with MMR-deficient cancer.

Eligibility Criteria:
Inclusion Criteria:

* Endometrial cancer requiring hysterectomy
* Patient covered by French social Security
* Patient capable of giving written informed consent

Exclusion Criteria:

- Chemotherapy
Effects of Platelet-rich Plasma in the Surgery of Carpal Tunnel Syndrome: A Randomized Controlled Trial

The Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of carpal tunnel syndrome (CTS). Here we propose to assess the effectiveness of PRP as co-adjuvant in surgical treatment of CTS by open carpal tunnel release.

Design: Randomized Controlled Trial. Setting: Local Hospital.

Carpal tunnel syndrome (CTS) is a common disorder with an estimated annual incidence of 125-542 in adults, and an estimated prevalence of 1 to 5 percent in the general population. CTS is the most frequent compressive focal mononeuropathy and causes pain, paresthesia and weakness of the median nerve distribution in patients.

The treatment of the CTS includes both, conservative and surgical treatment depending on the severity of the symptoms.

Platelet-rich plasma (PRP) has been proved to be efficient in the non-surgical treatment of CTS, however its potential used as co-adjuvant in surgical treatment has not been assessed.

We propose a randomized clinical trial in patients in which the surgical treatment is indicated. Participants in the intervention group receive a PRP injection, and in the control group a platelet-poor plasma injection after open carpal tunnel release. The evaluation is performed pretreatment as well as on the 6st week after treatment. Outcome measures include: hand grip strength (primary outcome), pain, sympton severity and functional status.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Carpal Tunnel Syndrome (CTS)
* Conservative treatment failure

Exclusion Criteria:

* Previous CTS surgery on the same side
* Wrist fracture/trauma in history
* Polyneuropathy
* Diabetes mellitus
* Cervical neuropathy
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age more than or equal to 8 years
* Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux
* Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar
* Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast

Includes healthy volunteers

Exclusion Criteria:

* Age less than 8years
* Allergy to contrast or related products
* Cardiac shunt/ congenital heart anomalies
* Abnormal baseline ECG
* Open heart surgery
* Evidence of retinopathy
* Patient in intensive care
* Unable to comply with study requirement
* History of emphysema
* Unable to maintain oxygen saturation of 92% on at room air
* Pregnancy and lactation
Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients

The purpose of this study is to explore the efficacy, safety and cost-effectiveness of Xueshuantong (lyophilized) for the prevention of venous thromboembolism (VTE) in patients at risk of bleeding.

This is a non-randomized, observational study.

This study primarily aims to investigate the efficacy, safety, and cost-effectiveness of using Xueshuantong injection (lyophilized) for preventing venous thromboembolism (VTE) in patients susceptible to bleeding. The subjects of the study comprise patients during the perioperative period (undergoing procedures lasting 45 minutes or longer), patients with a confirmed spontaneous cerebral hemorrhage (ICH), and patients with a confirmed acute ischemic stroke (AIS).

Additional objectives of this study including:

1. to evaluate the possible dose-dependency of Xueshuantong injection (lyophilized);
2. to evaluate the impact in coagulation function after administration of Xueshuantong injection (lyophilized)

Eligibility Criteria:
Inclusion Criteria:

* Men or women of ≥18 year old;
* Hospitalized between Jan 1, 2016 and Aug. 1, 2023;
* Received intravenous (IV) Xueshuantong (lyophilized) for ≥3 days;
* Who also meet one of the following criteria:

  1. Perioperative patients:

     Performed any of the following surgical procedures (≥ 45 minutes in duration) during hospitalization- general surgery, orthopedic surgery, obstetrics and gynecology surgery, neurosurgery, urology surgery, cardiothoracic surgery, obesity surgery or cancer surgery;
  2. Hospitalization due to acute spontaneous cerebral hemorrhage:

     Diagnosed as cerebral hemorrhage (acute/subacute), or subarachnoid hemorrhage, with clinical manifestations such as conscious disturbance, dyskinesia, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging;
  3. Hospitalization due to acute ischemic stroke:

Diagnosed as ischemic stroke, ischemic stroke (acute/subacute), cerebral infarction, or cerebral infarction (acute/subacute), acute stage or subacute stage of ischemic stroke, with clinical manifestations such as disturbance of consciousness, motor dysfunction, or sensory dysfunction. Presence of cerebral hemorrhage was confirmed by imaging.

Exclusion Criteria:

* Received any traditional Chinese medicine (TCM) that contains total saponins of panax notoginseseng (PNS) other than Xueshuantong (lyophilized);
* Females who are pregnant or breast-feeding;
* Diagnosed venous thromboembolism occurred before enrollment;
* Received intravenous thrombolytic therapy for other reasons during hospitalization;
* Received prophylactic or therapeutic doses of anticoagulants after major surgery;
* Placed vena cava filters for VTE prophylaxis before surgery;
* Received therapeutic dose of anticoagulants during the patient's hospital stay (AIS patients);