cyrilzakka/clinical-trials huggingface dataset:
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure.

Heart failure patients will be enrolled and randomized to cervical VNS implantation on either the left side or right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 6 months, with data collection at 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability

The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability.

The primary objectives are:

* To assess the level of cooperation during regular dental care using different procedural sedation protocols
* To assess patient safety during regular dental care using different sedation protocols
* To assess patient comfort and possible side-effects after regular dental care using different sedation protocols


Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18yrs
* Patient resides at least 6 months in nursing home "het Gielsbos".
* Patient always gets a sedative protocol to make dental care delivery possible.
* Informed consent was obtained from parent/guardian
* No medical contra-indication for any of tested sedative protocols

Exclusion Criteria:

* Age under 18yrs
* The patient is no resident of the nursing home "het Gielsbos" or lives there for less than 6 months.
* No need for medicinal support during dental treatment
* No informed consent was obtained by parents or the guardian of the patient.
* Medical contra-indication for 1 of the sedative protocols
The Role of Intravitreal Glucose in Macular Thinning Following Surgery for Retinal Detachment or Epimacular Membrane

Comparison between intravitreous glucose rate and macular thinning measured by Ocular Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular membrane. Hypothesis : Association between post-operative macular thickness and intravitreous glucose rate

Comparison between intravitreous glucose rate and macular thinning measured by OCT at 3 months post vitrectomy for retinal detachment or epimacular membrane. The cohort is divided in 2 groups, one with the thinnest macular measurement under 190µm, and the others above 190µm. We are looking for a correlation between increasing glucose rates and decreased macular thickness.

Eligibility Criteria:
Inclusion Criteria:

* patient who underwent vitrectomy for retinal detachment or epimacular membrane

Exclusion Criteria:

* patient suffering of diabetes,
* recurrence of retinal detachment,
* age-related macular degeneration,
* post surgical macular oedema
Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery

Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.

The study is aimed to compare clinical superiority of ultra fast-track versus conventional early postoperative extubation in patients undergoing cardiac surgery in our center. The estimated sample size is 612 patients. They will be randomized 1:1 to any of the two arms of the study (ultra fast-track vs. fast-track). The randomization will be stratified according the type of surgery performed. The period of recruitment will start in January 2023 and is supposed to finish by September 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery.
* The patient's desire to participate in the clinical trial verified by signing the informed consent.

Exclusion Criteria:

1. Pregnancy.
2. Emergent surgery or cardiorespiratory arrest.
3. Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.
4. Aortic arch procedures.
5. Procedures in which hypothermia \< 28ºC of temperature is expected during the intervention.
6. Minor cardiac surgery procedures.
7. Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting).
8. Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).
9. Active endocarditis.
Atomoxetine and Oxybutynin in Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of atomoxetine (a norepinephrine reuptake inhibitor) and oxybutynin (an antimuscarinic drug) administered together on OSA phenotype traits and OSA severity during sleep.


Eligibility Criteria:
Inclusion Criterion:

- AHI \> 20

Exclusion Criteria:

* Any medical condition other than well controlled hypertension.
* Any medication known to influence breathing, sleep/arousal or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to lidocaine, Oxymetazoline HCl, atomoxetine/oxybutynin.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, such as atomoxetine, or any of the studied medications for medical care.
* History of seizures
* For women: Pregnancy.
* History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

The purpose of this study is

* To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
* To evaluate the tolerance of this treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years with RA, RARS, RAEB (blasts \<10%)
* Hb\< 10g/dl \> of 2 months or transfused since less 2 months
* Hb\<12g/dl \> of 2 months and thrombocytopenia defined by platelets \< 50 000/mm3, or neutropenia\<10 000mm3
* For women of child bearing age, necessity of contraception during all the duration of the study

Exclusion Criteria:

* Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia
* Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol
* RAEBt
* RAEB \>10% blasts
* Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion
* Patient presenting an iron , B12 vitamin or folic acid uncorrected deficit
* CMML
* Uncontrolled systemic hypertension
* creatinine clearance \< 300 µM/L
* Pregnant patient or in period of lactation
* Life expectancy \< 6 months
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.


Eligibility Criteria:
Inclusion Criteria:

Patients with alcoholic hepatitis based on the following criteria

* Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier.
* Serum bilirubin level above 80 mmol/l
* exclusion of other types of liver disease.
* Liver biopsy when diagnosis is unclear.

Exclusion Criteria:

* Heart failure
* Pregnancy
* non fluent danish speakers
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial

This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.

OUTLINE: Patients are randomized to the interventional groups or control group.

INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms.

ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and resistance exercise (RE) sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.

ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.

CONTROL GROUP: After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 75 years, inclusive
2. Female gender
3. Prior diagnosis of invasive breast cancer
4. Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)
5. Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls

Exclusion Criteria:

1. Actively receiving radiation treatment
2. Medical history of heart failure, coronary artery disease or arrhythmia
3. Contraindications to cardiopulmonary exercise testing (CPET)
4. Contraindications to magnetic resonance imaging (MRI) (e.g ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices), weight over 550 lbs, or symptomatic claustrophobia
5. Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
6. Unwilling to complete intervention procedures or outcome measures
First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors

The purpose of this study will be to determine the Maximum Tolerated Dose (MTD) and describe dose-limiting toxicities (DLTs) of W0180 given as monotherapy and in combination with pembrolizumab (anti-PD-1).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors, whose disease has progressed or for whom no further standard therapy is available or appropriate
* Evidence of measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (or modified RECIST 1.1 for mesothelioma)
* Adequate blood counts at baseline
* Adequate liver function at screening and baseline
* Sexually active participants must use medically acceptable methods of contraception during the course of this study

Exclusion Criteria:

* Participants previously treated with an anti-V-domain Ig suppressor of T cell activation (VISTA) (small molecule or antibody) agent
* Participants with known central nervous system (CNS) metastases and/or carcinomatous meningitis
* History of severe hypersensitivity reactions to other monoclonal antibodies
* Positive for hepatitis B virus(HBV), hepatitis C virus (HCV) or HIV infection
* History of anti-cancer therapies within the last 4 weeks (or \<=5 half-lives for targeted agents) prior to initiating study treatment.
USZ BioResource COVID-19

Mono-centric. Blood sampling for biobank development, including linkage to patient data (resource for research on COVID19).


Eligibility Criteria:
Inclusion Criteria:

* m/f age \> 18 years
* SARS-CoV-2 infektion (according to WHO guideline)
* hospitalisation, general ward
* acceptable language knowledge
* voluntary IFC and biobank appendix

Exclusion Criteria:

* contra indication for blood sampling
CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia

This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL

This study will use droplet digital PCR (ddPCR) method to quantify peripheral blood plasma mutant allele frequency (MAF) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of CtDNA .

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male
* not pregnant female
* patients \>=60 years old
* Diagnosis of acute leukemia

Exclusion Criteria:

* Pregnancy
* HIV positive
* patients \>=100 years old
Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age

The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once daily.

The perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.


Eligibility Criteria:
Inclusion Criteria for antiretroviral treatment initiation:

* infant follow-up in one of the trial site
* HIV-1 infection diagnose by RT PCR after 6 weeks of life
* age between 3 and 12 month at the antiretroviral treatment initiation
* naive of antiretrovirals except if received for the prevention of mother to child HIV transmission
* HB\>=7 g/dl, neutrophiles\>750/mm3, creatinin\<3xULN, TGO and TGP\<3xULN
* signed informed consent

Exclusion Criteria for antiretroviral treatment initiation:

* HIV-2 infection or HIV-1/HIV-2 co-infection
* Known intolerance to one of the trial treatment
* HB\<7 g/dl, neutrophiles\<750/mm3, creatinin\>3xULN, TGO or TGP\>3xULN

Inclusion Criteria for randomisation at 12 months in the simplification phase:

* age 24 months at most
* virological success define as 2 consecutive indetectable HIV RNA measured by RT PCR at least 3 months apart.

Exclusion Criteria for randomisation at 12 months in the simplification phase:

* virological failure after the first 12 months of antiretroviral treatment
Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
* Age 18 years or older
* Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
* Karnofsky performance status (KPS) of at least 70%
* Adequate renal function, adequate hepatic function, adequate bone marrow function

Exclusion Criteria:

* The presence of any severe concomitant disease that could interrupt the planned treatment
* Intractable pain
* Hypersensitivity to study drugs
* Serious cardiovascular disease
* If female, pregnancy or breastfeeding
China Post-marketing Surveillance (PMS) Study of Fabrazyme®

This is a 54-week Phase 4, open label, single arm study to evaluate the safety and the efficacy of Fabrazyme (agalsidase beta) as enzyme replacement therapy (ERT) in Chinese participants with Fabry Disease.

Study participation for each patient will be total of 54 weeks which will include 4 weeks of screening, 48 weeks of treatment period and 2 weeks of post study treatment observation

Eligibility Criteria:
Inclusion Criteria:

* Participant must be 8 years of age or older, at the time of signing the informed consent
* Participants naive to agalsidase beta and agalsidase alpha
* Chinese participants diagnosed with Fabry disease and with documented plasma or leukocyte αGAL activity deficient below laboratory's reference range, and/or documented diagnosis by genotyping
* Participants must have one or more symptoms and signs consistent with manifestations of Fabry disease (not limited to neuropathic pain, chronic kidney disease, hypertrophic cardiomyopathy, cardiac rhythm disturbances, cerebrovascular involvement, cornea verticillata, angiokeratoma, gastrointestinal symptoms, hypo- or anhydrosis)
* A female participant is eligible to participate if she is not pregnant or breastfeeding and use an acceptable contraceptive method
* Participants and/or participant's legal representative capable of giving signed informed consent.

Exclusion Criteria:

* The participant has undergone kidney transplantation.
* The participant has a clinically significant organic disease (with the exception of symptoms relating to Fabry disease) in the opinion of the Investigator, would preclude participation in the trial.
* Received an investigational drug, or device, other than Fabrazyme, within 30 days of anticipated IMPs administration or 5 half-lives of the previous investigational drug, whichever is longer.
* The patient has current evidence of kidney failure or renal insufficiency, as defined by eGFR \<30 mL/min/1.73 m2.
* Individuals who have life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients

To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.


Eligibility Criteria:
Chronic DME patients considered insufficiently responsive to available therapies (laser, anti-VEGF) with or without intravitreal corticosteroid therapy.

Inclusion Criteria:

* Adults (≥18 years) with chronic DME;
* Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following:

  1. Mean central foveal thickness (central subfield thickness) ≥ 290 um in women and ≥ 305 um in men in Zeiss Cirrus OR ≥ 305 um in women and ≥ 320 um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT;
  2. Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME;
  3. If in the Investigator's opinion a further improvement is possible.

Exclusion Criteria:

* IOP \> 21 mmHg at screening (day -14) in the study eye.
* Historical rise in IOP \> 25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
* Use of ≥ 2 active agents as IOP-lowering medications to control IOP at screening in the study eye.
* Vitreomacular traction in DME and opaque media in the study eye.
* Severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
* Pregnant or breastfeeding women.
* Active angiographic central macular ischaemia before baseline in the study eye.
* Pan retinal photocoagulation or cataract surgery 3 months before baseline in the study eye.
* Presence of pre-existing glaucoma, active or suspected ocular or periocular infection and/or hypersensitive to the active agent or to one of the excipients.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: using a highly effective method of birth control.
Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response

The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy.

Furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with chemotherapy naive metastatic castration resistant prostate cancer\*
* Age at least 18 years
* Patients from who it is possible to collect blood samples
* Patient who are able and willing to give written informed consent prior to screening and enrollment
* Life expectancy of \> 6 months
* Measurable disease \*definition of CRPC according to EAU guidelines 2014

Exclusion Criteria:

* None The study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. Therefore no strict exclusion criteria will be used in this study
Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects

To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. 18-45 years old;
2. BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
3. Normal liver function indexes;
4. Willing to complete study-related questionnaires and diaries and complete all clinical visits.

Exclusion Criteria:

1. Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test;
2. Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies;
3. Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.;
4. Recently treated with antibiotics (i.e., \< 3 months prior to the start of the study);
5. Participants who smoked more than 10 cigarettes per day were excluded;
6. It is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products;
7. Pregnant and lactating women are not suitable for experiments.