cyrilzakka/clinical-trials huggingface dataset:
Estimation of the Placental Volume by 3D Ultrasound at 12, 16 and 22 Weeks : Relation With Growth Factors and D-Dimers

Pregnancy complications called PVP are mainly responsible for perinatal mortality. In these cases, the placenta is smaller and often the centre of thrombotic lesions. The estimation of the placenta volume by 3D ultrasound coupled with growth factors and D-Dimers measures could improve the understanding of these pathologies to optimize their detection.

Pregnancy complications called Placental Vascular Pathologies (PVP) are mainly responsible for perinatal mortality. In these cases, the placenta is smaller and often the centre of thrombotic lesions. The estimation of the placenta volume by 3D ultrasound coupled with growth factors and D-Dimers measures could improve the understanding of these pathologies to optimize their detection. Thus, the identification of predictive factors of the risk of occurrence or recurrence of PVP could allow us to propose a monitoring of patients at risk, to anticipate corticoids administration for the foetuses pulmonary maturation and perhaps later to adapt anti hypertensive and antithrombotic therapeutics.

Eligibility Criteria:
Inclusion Criteria:

* previous history of one or more PVC episodes : preeclampsia, HELLPs, retroplacental hematoma, vascular IUGR\<10th percentile, recurrence miscarriage \>2, unexplained IUFD or IUFD after abruption placentae, eclampsia.
* coming for a 12 weeks ultrasound

Exclusion Criteria:

* Multiple pregnancy
* past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection
* previous history of IUGR which etiology was a chromosomal, genic or infectious anomaly
Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers

This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure \[pharmacokinetics (PK)\] to budesonide following administration of Symbicort MDI.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed written informed consent form
* 18 and 45 years (inclusive)
* Healthy subject confirmed by a thorough medical history and physical examination, ECG, vital signs and clinical laboratory tests
* Females of childbearing potential and males with female partners of childbearing potential must agree to use medically acceptable contraception
* Body mass index (BMI) between 18.5 and 32 kg/m2 (inclusive) and a minimum weight of 50 kg at the screening visit
* Results of complete laboratory analyses should be within the normal range or determined to be not clinically significant by the Investigator

Exclusion Criteria:

* Pregnancy, nursing female subjects, or subjects trying to conceive
* Clinically significant medical conditions
* History of ECG abnormalities
* Symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
* Known diagnosis of glaucoma
* Known or suspected history of substance-related disorders within 1 year of screening
* Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) prior to screening period
* Hypersensitivity to lactose or any drug or component of the formulation(s) used in this study
* Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at screening.
* Major surgery within four weeks or minor surgery within 2 weeks of drug administration
* Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for study participation
Enhancing Palliative Care in ICU

The aim of this study is to reduce the suffering in intensive care through palliative care consultations.

This project investigates the effectiveness and cost-effectiveness of palliative care consultations in the Intensive care unit. Charité will implement the Working Package 2 "Europe-wide harmonized and recommended palliative care practice for ICU" of the approved HORIZON funding application EPIC, to which this ethics application refers.

An accompanying anonymous employee survey (doctors/nurses) is conducted once in the intervention phase and once in the control phase in all study centers (see secondary endpoints 57-68 and 71).

Eligibility Criteria:
Patients:

Inclusion Criteria:

* Patients in ICU who can give consent and those who can not (via their authorized representative or legal guardian, also possible with delayed consent)
* From 18 years
* The leading cause of critical illness is not cancer
* New admission on the participating ICU \> 72h
* Assessment of the need for palliative care by the in-charge physi-cian of the ICU, because (1) there is a significant disagreement about ICU treatment or (2) because the physician considers ther-apy limitations for the patient or (3) the physician considers a benefit from specialized PC consultation for ICU physician, nurse, or patient or family.

Exclusion Criteria:

- Patient is moribund and is expected to die within the next 24h

Study cohort relatives:

Inclusion criteria:

- At least one relative(s) of a patient. This may or may not be the legal representative, depending on national legislation.

Exclusion criteria:

* Refusal by the relative
* Refusal of the patient to participate in the intervention study
* \<18 years of age

Cohort of employees:

Inclusion criteria

* Employed on the ITS as a doctor/nurse
* Employed in the clinical center as a member of the palliative care consultation service

Exclusion criterion Refusal to participate
Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation

Ursodeoxycholic acid is a clinically approved drug which widely used in patients with chronic liver diseases, especially liver transplantation. In China, the COVID-19 infection is in an epidemic state, and the population is generally susceptible to COVID-19. More attention needs to be paid to the prevalence and severity of people taking immunosuppressants after organ transplantation. Recent cohort studies and experiments based on tissue cells, animals and human beings suggest that ursodeoxycholic acid has the potential ability to prevent the entry of COVID-19 into cells, revealing that Ursodeoxycholic acid may be used to prevent the COVID-19 infection. Based on the medical records of patients( already registered on the management website http://www.cltr.org or www.csrkt.org.cn) who received organ transplantation in the First Affiliated Hospital of Xi'an Jiaotong University and the First Affiliated Hospital of Zhengzhou University, this project intends to collect information and data from patients received organ transplantation, aim to understand the COVID-19 infection and severe condition of organ transplantation patients, also explore whether ursodeoxycholic acid has preventive and therapeutic effects on COVID-19 infection and severity rate in patients. This research provides a theoretical basis for further standardizing the prevention and treatment of COVID-19 in patients received organ transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years; 2. Patients received liver or renal transplantation from 2015 to 2022

Exclusion Criteria:

1.Age \< 18 years; 2. Multi-organ transplantation; 3. Patients with incomplete information or loss of follow-up; 4.COVID-19 infection before organ transplantation; 5. Patients hospitalized with rejection or other infection within two weeks before COVID-19 diagnosis.
Study of Speech Disorders , Voice and Swallowing in Primary Dystonia Oromandibular

To better define the clinical characteristics of oromandibular dystonia, we aimed to study voice, speech and swallowing disorders in idiopathic oromandibular We planned to include consecutive patients followed in Lille Movement disorders department for idiopathic oromandibular dystonia and matched, healthy control subjects. Voice and speech disorders had to be assessed with the phonetic analysis, perceptive analysis and motor examination modules of the "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria), the Grade, Rough, Breathy, Asthenic, Strained scale, and a computer recording. Activities of daily living had to be assessed with the Oromandibular Dystonia Questionnaire, the Voice Handicap Index and the Deglutition Handicap Index.


Eligibility Criteria:
Inclusion Criteria:

* Both groups: Man or woman Age \> 18 years French social security French speaking: fluent
* Oromandibular dystonia group: Idiopathic oromandibular dystonia (focal or associated to other dystonic symptoms)
* Healthy controls group: Same age +/- 2 years than a patient from the oromandibular dystonia group Normal clinical examination

Exclusion Criteria:

* Both groups: Any pathology making the orthophonic evaluation difficult Property protection regime Deprivation of liberty -Oromandibular dystonia group: Abnormal neurological examination, except dystonic features
* Healthy controls group: History of brain lesion Abnormal neurological examination Swallowing difficulties
A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer

This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.

This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy.

The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* The subject will participate voluntarily and sign the informed consent form.
* Female, aged ≥18 years when signing the informed consent form.
* Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
* At least one measurable lesion is needed.
* The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
* Adequate reserves of organ function is needed.

Exclusion Criteria:

* Active autoimmune disease.
* Central nervous system (CNS) metastasis.
* Concomitant diseases such as cardiovascular and cerebrovascular diseases.
* Fistula of female genital tract.
* Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
* Previous recipients of immune checkpoint inhibitors.
* Received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; Received proprietary Chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug.
* Received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; Received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug.
* History of immunodeficiency.
* History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Ectopic Adipose Tissue, Exercise Training and IL-6

Aim: Exercise training improves the risk of cardiometabolic diseases; yet the underlying mechanisms are unclear. Exercise induces release of IL-6 from skeletal muscle. Acute elevations in IL-6 improve lipid and glucose metabolism, the latter partly through a delayed gastric emptying. Physical inactivity causes accumulation of visceral fat (VAT). Visceral and epicardial adipose tissue (EAT) is more inflamed than subcutaneous adipose tissue. Thus, the investigators hypothesize that exercise-induced IL-6 mediates the exercise-induced reduction in EAT and VAT. Secondly, the investigators hypothesize that exercise-induced adaptations in glucose metabolism and gastric motility are dependent on IL-6. Finally the investigators hypothesise that both endurance and resistance exercise training reduce VAT and EAT.

Primary aim: To investigate the effects of exercise training on VAT and to determine to what extend IL-6 mediates this effect.

Secondary aims: 1) To determine whether 12 weeks of endurance and strength training can reduce the amount of EAT. 2) To study whether the effects of exercise on glucose metabolism and gastric emptying are dependent on IL-6.

Methods: Inclusion: 70 inactive men and women, \>18 years, waist to height ratio \> 0.5 and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) Design: A 12-week, double-blinded randomised, placebo-controlled exercise intervention study.

Intervention: Subjects will be randomised to one of five groups: i) Tocilizumab (IL-6 receptor antibody) and endurance training, ii) Placebo to Tocilizumab and endurance training, iii) Tocilizumab, no exercise iv) Placebo to Tocilizumab and no training, and v) Placebo to Tocilizumab, and resistance training. Tocilizumab/placebo dose will be administered (according to standard recommendations) before the first training session, and maintained during the 12-week training program. Training will be supervised to ensure intensity and compliance. Subjects will be instructed not to change eating habits and informed that this study does not aim for a weight loss.

Statistical considerations: Study investigators are blinded to treatment allocation. Dropouts will be replaced. A sample size of 70 subjects is needed to detect a 10% change in visceral adipose, with a power of 80% and a significance level of 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Sedentary
* Waist to height ratio ≥ ½ and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men)
* Age ≥ 18 y

Exclusion Criteria:

* Pregnancy
* Diagnosed with diabetes (HbA1c ≥ 48 mmol/mol or fasting glucose ≥ 7.0 mmol/l)
* Diagnosed with ischemic heart disease
* Atrial fibrillation
* Treatment with biologic rheumatic drugs, systemic prednisolone or other immunosuppressive treatments
* Health conditions that prevents individuals from participating in the exercise training intervention e.g. severe obesity
* Patients who cannot undergo MRI scans (e.g. kidney disease, metallic implants or claustrophobia)
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage

Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)


Eligibility Criteria:
Inclusion Criteria:

* 23-34w
* IVH grade 3-4, confirmed with brain ultrasonogram
* within 7 days after IVH diagnosis

Exclusion Criteria:

* severe congenital anomaly
* intrauterine intracranial bleeding
* intracranial infection
* severe congenital infection
* active and uncontrolled infection, CRP\>10mg/dl
* Platelet count \<50,000/ml
* severe metabolic acidosis (PH\<7.1, BE\<-20)
Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples

Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.


Eligibility Criteria:
Inclusion Criteria:

- hematological patients with lung infiltrates at high risk for invasive aspergillosis

Exclusion Criteria:

- patients without informed consent
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.

The expected benefits will be a result of the reduction of the percentage of ventricular pacing.

It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.

The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)


Eligibility Criteria:
Inclusion Criteria:

* Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
* Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
* Patient implanted with a bipolar right atrial lead and a right ventricular lead
* Patient has signed a consent form after having received the appropriate information

Exclusion Criteria:

* Patient with permanent AF
* Patient suffering from sustained ventricular arrhythmias
* Patient with congenital complete heart block
* Patient with vasovagal syncope, carotid sinus syndrome
* Patient with AV node ablation
* Patient having suffered from a myocardial infarction within the last month
* Patient suffering from severe aortic stenosis
* Patient suffering from unstable angina pectoris
* Patient is not able to understand the study objectives and protocol or refuses to co-operate
* Patient is not available for scheduled follow-up
* Patient has a life expectancy less than one year
* Patient is included into another clinical study
* Patient is minor, this is \< 18 years
* Patient is a pregnant woman
* Any patient with a contra-indication for the device labeling
Novel Medication as a Potential Smoking Cessation Aid

The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.


Eligibility Criteria:
Inclusion Criteria:

* Be between 25 years old and 55 years old
* Smoke a minimum number of cigarettes per day
* Indicate motivation to quit smoking

Exclusion Criteria:

* Current or history of medical or psychiatric conditions that could interfere with measures being studied or that could be affected by the study medication
* Use of medication that could interfere with measures to be studied or that could be expected to interact with levomilnacipran
* Are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not be eligible to participate
Intestinal Microbiota and Thyroid Cancer

Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. Much progress has been made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. Besides the improvement of diagnosis, TC increasing incidence emphasize that other important factors such as the environment play an important role in disease pathogenesis. While microbiota as an environment factor to some cancers accept widespread attention, if microbiota also as a risk factor for TC, it is worthy to be considered.

Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. According to the China National Cancer Registry data in 2015 (3), there were estimated 90,000 new TC cases in China, and its incidence has risen sharply. Much progress has been made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. Besides the improvement of diagnosis, TC increasing incidence emphasize that other important factors such as the environment play an important role in disease pathogenesis. While microbiota as an environment factor to some cancers accept widespread attention, if microbiota also as a risk factor for TC, it is worthy to be considered.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* Patients of thyroid cancer

Exclusion Criteria:

* Pregnancy
* Lactation
* Cigarette smoking
* Alcohol addiction
* Hypertension
* Diabetes mellitus
* Lipid dysregulation
* BMI \> 27
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
* History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
* History of malignancy or any gastrointestinal tract surgery
Multimodal Imaging Evaluation and Prognostic Analysis of Cardiac Allograft Vasculopathy in Heart Transplantation

The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.

This study will enrolled 1000 HT patients, and the cardiac allograft vasculopathy will be evaluated by multimodal imaging technology. The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.

Eligibility Criteria:
Inclusion Criteria:

• Heart transplantation after January 1st, 2015.

Exclusion Criteria:

•Age \< 18 years at the time of transplantation; Died within 48 h; Heart-lung transplantation; Heart/kidney transplantation; Re-transplanted within 7 days after transplantation.